§ 1397n–1. Social impact partnership application

• (a) Not later than 1 year after February 9, 2018 , the Secretary of the Treasury, in consultation with the Federal Interagency Council on Social Impact Partnerships, shall publish in the Federal Register a request for proposals from States or local governments for social impact partnership projects in accordance with this section.
• (b) To qualify as a social impact partnership project under this division, a project must produce one or more measurable, clearly defined outcomes that result in social benefit and Federal, State, or local savings through any of the following:
  • (1) Increasing work and earnings by individuals in the United States who are unemployed for more than 6 consecutive months.
  • (2) Increasing employment and earnings of individuals who have attained 16 years of age but not 25 years of age.
  • (3) Increasing employment among individuals receiving Federal disability benefits.
  • (4) Reducing the dependence of low-income families on Federal means-tested benefits.
  • (5) Improving rates of high school graduation.
  • (6) Reducing teen and unplanned pregnancies.
  • (7) Improving birth outcomes and early childhood health and development among low-income families and individuals.
  • (8) Reducing rates of asthma, diabetes, or other preventable diseases among low-income families and individuals to reduce the utilization of emergency and other high-cost care.
  • (9) Increasing the proportion of children living in two-parent families.
  • (10) Reducing incidences and adverse consequences of child abuse and neglect.
  • (11) Reducing the number of youth in foster care by increasing adoptions, permanent guardianship arrangements, reunifications, or placements with a fit and willing relative, or by avoiding placing children in foster care by ensuring they can be cared for safely in their own homes.
  • (12) Reducing the number of children and youth in foster care residing in group homes, child care institutions, agency-operated foster homes, or other non-family foster homes, unless it is determined that it is in the interest of the child’s long-term health, safety, or psychological well-being to not be placed in a family foster home.
  • (13) Reducing the number of children returning to foster care.
  • (14) Reducing recidivism among juvenile offenders, individuals released from prison, or other high-risk populations.
  • (15) Reducing the rate of homelessness among our most vulnerable populations.
  • (16) Improving the health and well-being of those with mental, emotional, and behavioral health needs.
  • (17) Improving the educational outcomes of special-needs or low-income children.
  • (18) Improving the employment and well-being of returning United States military members.
  • (19) Increasing the financial stability of low-income families.
  • (20) Increasing the independence and employability of individuals who are physically or mentally disabled.
  • (21) Other measurable outcomes defined by the State or local government that result in positive social outcomes and Federal savings.
• (c) The notice described in subsection (a) shall require a State or local government to submit an application for the social impact partnership project that addresses the following:
  • (1) The outcome goals of the project.
  • (2) A description of each intervention in the project and anticipated outcomes of the intervention.
  • (3) Rigorous evidence demonstrating that the intervention can be expected to produce the desired outcomes.
  • (4) The target population that will be served by the project.
  • (5) The expected social benefits to participants who receive the intervention and others who may be impacted.
  • (6) Projected Federal, State, and local government costs and other costs to conduct the project.
  • (7) Projected Federal, State, and local government savings and other savings, including an estimate of the savings to the Federal Government, on a program-by-program basis and in the aggregate, if the project is implemented and the outcomes are achieved as a result of the intervention.
  • (8) If savings resulting from the successful completion of the project are estimated to accrue to the State or local government, the likelihood of the State or local government to realize those savings.
  • (9) A plan for delivering the intervention through a social impact partnership model.
  • (10) A description of the expertise of each service provider that will administer the intervention, including a summary of the experience of the service provider in delivering the proposed intervention or a similar intervention, or demonstrating that the service provider has the expertise necessary to deliver the proposed intervention.
  • (11) An explanation of the experience of the State or local government, the intermediary, or the service provider in raising private and philanthropic capital to fund social service investments.
  • (12) The detailed roles and responsibilities of each entity involved in the project, including any State or local government entity, intermediary, service provider, independent evaluator, investor, or other stakeholder.
  • (13) A summary of the experience of the service provider in delivering the proposed intervention or a similar intervention, or a summary demonstrating the service provider has the expertise necessary to deliver the proposed intervention.
  • (14) A summary of the unmet need in the area where the intervention will be delivered or among the target population who will receive the intervention.
  • (15) The proposed payment terms, the methodology used to calculate outcome payments, the payment schedule, and performance thresholds.
  • (16) The project budget.
  • (17) The project timeline.
  • (18) The criteria used to determine the eligibility of an individual for the project, including how selected populations will be identified, how they will be referred to the project, and how they will be enrolled in the project.
  • (19) The evaluation design.
  • (20) The metrics that will be used in the evaluation to determine whether the outcomes have been achieved as a result of the intervention and how the metrics will be measured.
  • (21) An explanation of how the metrics used in the evaluation to determine whether the outcomes achieved as a result of the intervention are independent, objective indicators of impact and are not subject to manipulation by the service provider, intermediary, or investor.
  • (22) A summary explaining the independence of the evaluator from the other entities involved in the project and the evaluator’s experience in conducting rigorous evaluations of program effectiveness including, where available, well-implemented randomized controlled trials on the intervention or similar interventions.
  • (23) The capacity of the service provider to deliver the intervention to the number of participants the State or local government proposes to serve in the project.
  • (24) A description of whether and how the State or local government and service providers plan to sustain the intervention, if it is timely and appropriate to do so, to ensure that successful interventions continue to operate after the period of the social impact partnership.
• (d) The application described in subsection (c) shall also contain the following information about any intermediary for the social impact partnership project (whether an intermediary is a service provider or other entity):
  • (1) Experience and capacity for providing or facilitating the provision of the type of intervention proposed.
  • (2) The mission and goals.
  • (3) Information on whether the intermediary is already working with service providers that provide this intervention or an explanation of the capacity of the intermediary to begin working with service providers to provide the intervention.
  • (4) Experience working in a collaborative environment across government and nongovernmental entities.
  • (5) Previous experience collaborating with public or private entities to implement evidence-based programs.
  • (6) Ability to raise or provide funding to cover operating costs (if applicable to the project).
  • (7) Capacity and infrastructure to track outcomes and measure results, including—
    • (A) capacity to track and analyze program performance and assess program impact; and
    • (B) experience with performance-based awards or performance-based contracting and achieving project milestones and targets.
  • (8) Role in delivering the intervention.
  • (9) How the intermediary would monitor program success, including a description of the interim benchmarks and outcome measures.
• (e) The notice described in subsection (a) shall permit a State or local government to submit an application for social impact partnership funding that contains information from a feasibility study developed for purposes other than applying for funding under this division.

§ 1396r–1a. Presumptive eligibility for children

• (a) A State plan approved under section 1396a of this title may provide for making medical assistance with respect to health care items and services covered under the State plan available to a child during a presumptive eligibility period.
• (b) For purposes of this section:
  • (1) The term “child” means an individual under 19 years of age.
  • (2) The term “presumptive eligibility period” means, with respect to a child, the period that—
    • (A) begins with the date on which a qualified entity determines, on the basis of preliminary information, that the family income of the child does not exceed the applicable income level of eligibility under the State plan, and
    • (B) ends with (and includes) the earlier of—
      • (i) the day on which a determination is made with respect to the eligibility of the child for medical assistance under the State plan, or
      • (ii) in the case of a child on whose behalf an application is not filed by the last day of the month following the month during which the entity makes the determination referred to in subparagraph (A), such last day.
  • (3)
    • (A) Subject to subparagraph (B), the term “qualified entity” means any entity that—
      • (i)
        • (I) is eligible for payments under a State plan approved under this subchapter and provides items and services described in subsection (a), (II) is authorized to determine eligibility of a child to participate in a Head Start program under the Head Start Act ( 42 U.S.C. 9831 et seq.), eligibility of a child to receive child care services for which financial assistance is provided under the Child Care and Development Block Grant Act of 1990 [ 42 U.S.C. 9857 et seq.], eligibility of an infant or child to receive assistance under the special supplemental nutrition program for women, infants, and children (WIC) under section 1786 of this title 1 1 So in original. A comma probably should appear after “title”. eligibility of a child for medical assistance under the State plan under this subchapter, or eligibility of a child for child health assistance under the program funded under subchapter XXI, (III) is an elementary school or secondary school, as such terms are defined in section 8801 of title 20 , 2 2 See References in Text note below. an elementary or secondary school operated or supported by the Bureau of Indian Affairs, a State or tribal child support enforcement agency, an organization that is providing emergency food and shelter under a grant under the Stewart B. McKinney Homeless Assistance Act 2 [ 42 U.S.C. 11301 et seq.], or a State or tribal office or entity involved in enrollment in the program under this subchapter, under part A of subchapter IV, under subchapter XXI, or that determines eligibility for any assistance or benefits provided under any program of public or assisted housing that receives Federal funds, including the program under section 8 [ 42 U.S.C. 1437f ] or any other section of the United States Housing Act of 1937 ( 42 U.S.C. 1437 et seq.) or under the Native American Housing Assistance and Self-Determination Act of 1996 ( 25 U.S.C. 4101 et seq.), or (IV) any other entity the State so deems, as approved by the Secretary; and
      • (ii) is determined by the State agency to be capable of making determinations of the type described in paragraph (2).
    • (B) The Secretary may issue regulations further limiting those entities that may become qualified entities in order to prevent fraud and abuse and for other reasons.
    • (C) Nothing in this section shall be construed as preventing a State from limiting the classes of entities that may become qualified entities, consistent with any limitations imposed under subparagraph (B).
• (c)
  • (1) The State agency shall provide qualified entities with—
    • (A) such forms as are necessary for an application to be made on behalf of a child for medical assistance under the State plan, and
    • (B) information on how to assist parents, guardians, and other persons in completing and filing such forms.
  • (2) A qualified entity that determines under subsection (b)(2) that a child is presumptively eligible for medical assistance under a State plan shall—
    • (A) notify the State agency of the determination within 5 working days after the date on which determination is made, and
    • (B) inform the parent or custodian of the child at the time the determination is made that an application for medical assistance under the State plan is required to be made by not later than the last day of the month following the month during which the determination is made.
  • (3) In the case of a child who is determined by a qualified entity to be presumptively eligible for medical assistance under a State plan, the parent, guardian, or other person shall make application on behalf of the child for medical assistance under such plan by not later than the last day of the month following the month during which the determination is made, which application may be the application used for the receipt of medical assistance by individuals described in section 1396a( l )(1) of this title.
• (d) Notwithstanding any other provision of this subchapter, medical assistance for items and services described in subsection (a) that—
  • (1) are furnished to a child—
    • (A) during a presumptive eligibility period,
    • (B) by an entity that is eligible for payments under the State plan; and
  • (2) are included in the care and services covered by a State plan;

§ 1396r–1b. Presumptive eligibility for certain breast or cervical cancer patients

• (a) A State plan approved under section 1396a of this title may provide for making medical assistance available to an individual described in section 1396a(aa) of this title (relating to certain breast or cervical cancer patients) during a presumptive eligibility period.
• (b) For purposes of this section:
  • (1) The term “presumptive eligibility period” means, with respect to an individual described in subsection (a), the period that—
    • (A) begins with the date on which a qualified entity determines, on the basis of preliminary information, that the individual is described in section 1396a(aa) of this title ; and
    • (B) ends with (and includes) the earlier of—
      • (i) the day on which a determination is made with respect to the eligibility of such individual for services under the State plan; or
      • (ii) in the case of such an individual who does not file an application by the last day of the month following the month during which the entity makes the determination referred to in subparagraph (A), such last day.
  • (2)
    • (A) Subject to subparagraph (B), the term “qualified entity” means any entity that—
      • (i) is eligible for payments under a State plan approved under this subchapter; and
      • (ii) is determined by the State agency to be capable of making determinations of the type described in paragraph (1)(A).
    • (B) The Secretary may issue regulations further limiting those entities that may become qualified entities in order to prevent fraud and abuse and for other reasons.
    • (C) Nothing in this paragraph shall be construed as preventing a State from limiting the classes of entities that may become qualified entities, consistent with any limitations imposed under subparagraph (B).
• (c)
  • (1) The State agency shall provide qualified entities with—
    • (A) such forms as are necessary for an application to be made by an individual described in subsection (a) for medical assistance under the State plan; and
    • (B) information on how to assist such individuals in completing and filing such forms.
  • (2) A qualified entity that determines under subsection (b)(1)(A) that an individual described in subsection (a) is presumptively eligible for medical assistance under a State plan shall—
    • (A) notify the State agency of the determination within 5 working days after the date on which determination is made; and
    • (B) inform such individual at the time the determination is made that an application for medical assistance under the State plan is required to be made by not later than the last day of the month following the month during which the determination is made.
  • (3) In the case of an individual described in subsection (a) who is determined by a qualified entity to be presumptively eligible for medical assistance under a State plan, the individual shall apply for medical assistance under such plan by not later than the last day of the month following the month during which the determination is made.
• (d) Notwithstanding any other provision of this subchapter, medical assistance that—
  • (1) is furnished to an individual described in subsection (a)—
    • (A) during a presumptive eligibility period;
    • (B) by a 1 1 So in original. Probably should be “an”. entity that is eligible for payments under the State plan; and
  • (2) is included in the care and services covered by the State plan,

§ 1396r–1c. Presumptive eligibility for family planning services

• (a) State 1 1 So in original. Probably should be preceded by “A”. plan approved under section 1396a of this title may provide for making medical assistance available to an individual described in section 1396a(ii) of this title (relating to individuals who meet certain income eligibility standard) during a presumptive eligibility period. In the case of an individual described in section 1396a(ii) of this title , such medical assistance shall be limited to family planning services and supplies described in 1396d(a)(4)(C) 2 2 So in original. Probably should be preceded by “section”. of this title and, at the State’s option, medical diagnosis and treatment services that are provided in conjunction with a family planning service in a family planning setting.
• (b) For purposes of this section:
  • (1) The term “presumptive eligibility period” means, with respect to an individual described in subsection (a), the period that—
    • (A) begins with the date on which a qualified entity determines, on the basis of preliminary information, that the individual is described in section 1396a(ii) of this title ; and
    • (B) ends with (and includes) the earlier of—
      • (i) the day on which a determination is made with respect to the eligibility of such individual for services under the State plan; or
      • (ii) in the case of such an individual who does not file an application by the last day of the month following the month during which the entity makes the determination referred to in subparagraph (A), such last day.
  • (2)
    • (A) Subject to subparagraph (B), the term “qualified entity” means any entity that—
      • (i) is eligible for payments under a State plan approved under this subchapter; and
      • (ii) is determined by the State agency to be capable of making determinations of the type described in paragraph (1)(A).
    • (B) Nothing in this paragraph shall be construed as preventing a State from limiting the classes of entities that may become qualified entities in order to prevent fraud and abuse.
• (c)
  • (1) The State agency shall provide qualified entities with—
    • (A) such forms as are necessary for an application to be made by an individual described in subsection (a) for medical assistance under the State plan; and
    • (B) information on how to assist such individuals in completing and filing such forms.
  • (2) A qualified entity that determines under subsection (b)(1)(A) that an individual described in subsection (a) is presumptively eligible for medical assistance under a State plan shall—
    • (A) notify the State agency of the determination within 5 working days after the date on which determination is made; and
    • (B) inform such individual at the time the determination is made that an application for medical assistance is required to be made by not later than the last day of the month following the month during which the determination is made.
  • (3) In the case of an individual described in subsection (a) who is determined by a qualified entity to be presumptively eligible for medical assistance under a State plan, the individual shall apply for medical assistance by not later than the last day of the month following the month during which the determination is made.
• (d) Notwithstanding any other provision of law, medical assistance that—
  • (1) is furnished to an individual described in subsection (a)—
    • (A) during a presumptive eligibility period; and
    • (B) by a 3 3 So in original. Probably should be “an”. entity that is eligible for payments under the State plan; and
  • (2) is included in the care and services covered by the State plan,

§ 1397n–2. Awarding social impact partnership agreements

• (a) Not later than 6 months after receiving an application in accordance with section 1397n–1 of this title , the Secretary, in consultation with the Federal Interagency Council on Social Impact Partnerships, shall determine whether to enter into an agreement for a social impact partnership project with a State or local government.
• (b) In determining whether to enter into an agreement for a social impact partnership project (the application for which was submitted under section 1397n–1 of this title ) the Secretary, in consultation with the Federal Interagency Council on Social Impact Partnerships and the head of any Federal agency administering a similar intervention or serving a population similar to that served by the project, shall consider each of the following:
  • (1) The recommendations made by the Commission on Social Impact Partnerships.
  • (2) The value to the Federal Government of the outcomes expected to be achieved if the outcomes specified in the agreement are achieved as a result of the intervention.
  • (3) The likelihood, based on evidence provided in the application and other evidence, that the State or local government in collaboration with the intermediary and the service providers will achieve the outcomes.
  • (4) The savings to the Federal Government if the outcomes specified in the agreement are achieved as a result of the intervention.
  • (5) The savings to the State and local governments if the outcomes specified in the agreement are achieved as a result of the intervention.
  • (6) The expected quality of the evaluation that would be conducted with respect to the agreement.
  • (7) The capacity and commitment of the State or local government to sustain the intervention, if appropriate and timely and if the intervention is successful, beyond the period of the social impact partnership.
• (c)
  • (1) In accordance with this section, the Secretary, in consultation with the Federal Interagency Council on Social Impact Partnerships and the head of any Federal agency administering a similar intervention or serving a population similar to that served by the project, may enter into an agreement for a social impact partnership project with a State or local government if the Secretary, in consultation with the Federal Interagency Council on Social Impact Partnerships, determines that each of the following requirements are met:
    • (A) The State or local government agrees to achieve one or more outcomes as a result of the intervention, as specified in the agreement and validated by independent evaluation, in order to receive payment.
    • (B) The Federal payment to the State or local government for each specified outcome achieved as a result of the intervention is less than or equal to the value of the outcome to the Federal Government over a period not to exceed 10 years, as determined by the Secretary, in consultation with the State or local government.
    • (C) The duration of the project does not exceed 10 years.
    • (D) The State or local government has demonstrated, through the application submitted under section 1397n–1 of this title , that, based on prior rigorous experimental evaluations or rigorous quasi-experimental studies, the intervention can be expected to achieve each outcome specified in the agreement.
    • (E) The State, local government, intermediary, or service provider has experience raising private or philanthropic capital to fund social service investments (if applicable to the project).
    • (F) The State or local government has shown that each service provider has experience delivering the intervention, a similar intervention, or has otherwise demonstrated the expertise necessary to deliver the intervention.
  • (2) The Secretary shall pay the State or local government only if the independent evaluator described in section 1397n–4 of this title determines that the social impact partnership project has met the requirements specified in the agreement and achieved an outcome as a result of the intervention, as specified in the agreement and validated by independent evaluation.
• (d) Not later than 30 days after entering into an agreement under this section the Secretary shall publish a notice in the Federal Register that includes, with regard to the agreement, the following:
  • (1) The outcome goals of the social impact partnership project.
  • (2) A description of each intervention in the project.
  • (3) The target population that will be served by the project.
  • (4) The expected social benefits to participants who receive the intervention and others who may be impacted.
  • (5) The detailed roles, responsibilities, and purposes of each Federal, State, or local government entity, intermediary, service provider, independent evaluator, investor, or other stakeholder.
  • (6) The payment terms, the methodology used to calculate outcome payments, the payment schedule, and performance thresholds.
  • (7) The project budget.
  • (8) The project timeline.
  • (9) The project eligibility criteria.
  • (10) The evaluation design.
  • (11) The metrics that will be used in the evaluation to determine whether the outcomes have been achieved as a result of each intervention and how these metrics will be measured.
  • (12) The estimate of the savings to the Federal, State, and local government, on a program-by-program basis and in the aggregate, if the agreement is entered into and implemented and the outcomes are achieved as a result of each intervention.
• (e) The Secretary may transfer to the head of another Federal agency the authority to administer (including making payments under) an agreement entered into under subsection (c), and any funds necessary to do so.
• (f) Not less than 50 percent of all Federal payments made to carry out agreements under this section shall be used for initiatives that directly benefit children.

§ 1395i–2a. Hospital insurance benefits for disabled individuals who have exhausted other entitlement

• (a) Every individual who—
  • (1) has not attained the age of 65;
  • (2)
    • (A) has been entitled to benefits under this part under section 426(b) of this title , and
    • (B)
      • (i) continues to have the disabling physical or mental impairment on the basis of which the individual was found to be under a disability or to be a disabled qualified railroad retirement beneficiary, or (ii) is blind (within the meaning of section 416(i)(1) of this title ), but
    • (C) whose entitlement under section 426(b) of this title ends due solely to the individual having earnings that exceed the substantial gainful activity amount (as defined in section 423(d)(4) of this title ); and
  • (3) is not otherwise entitled to benefits under this part,
• (b)
  • (1) An individual may enroll under this section only in such manner and form as may be prescribed in regulations, and only during an enrollment period prescribed in or under this section.
  • (2) The individual’s initial enrollment period shall begin with the month in which the individual receives notice that the individual’s entitlement to benefits under section 426(b) of this title will end due solely to the individual having earnings that exceed the substantial gainful activity amount (as defined in section 423(d)(4) of this title and shall end 7 months later.
  • (3) There shall be a general enrollment period during the period beginning on January 1 and ending on March 31 of each year (beginning with 1990).
• (c)
  • (1) The period (in this subsection referred to as a “coverage period”) during which an individual is entitled to benefits under the insurance program under this part shall begin on whichever of the following is the latest:
    • (A) In the case of an individual who enrolls under subsection (b)(2) before the month in which the individual first satisfies subsection (a), the first day of such month.
    • (B) In the case of an individual who enrolls under subsection (b)(2) in the month in which the individual first satisfies subsection (a), the first day of the month following the month in which the individual so enrolls.
    • (C) In the case of an individual who enrolls under subsection (b)(2) in the month following the month in which the individual first satisfies subsection (a), the first day of the second month following the month in which the individual so enrolls.
    • (D) In the case of an individual who enrolls under subsection (b)(2) more than one month following the month in which the individual first satisfies subsection (a), the first day of the third month following the month in which the individual so enrolls.
    • (E) In the case of an individual who enrolls under subsection (b)(3), the July 1 following the month in which the individual so enrolls.
  • (2) An individual’s coverage period under this section shall continue until the individual’s enrollment is terminated as follows:
    • (A) As of the month following the month in which the Secretary provides notice to the individual that the individual no longer meets the condition described in subsection (a)(2)(B).
    • (B) As of the month following the month in which the individual files notice that the individual no longer wishes to participate in the insurance program established by this part.
    • (C) As of the month before the first month in which the individual becomes eligible for hospital insurance benefits under section 426(a) or 426–1 of this title.
    • (D) As of a date, determined under regulations of the Secretary, for nonpayment of premiums.
  • (3) The provisions of subsections (h) and (i) of section 1395p of this title apply to enrollment and nonenrollment under this section in the same manner as they apply to enrollment and nonenrollment and special enrollment periods under section 1395i–2 of this title .
• (d)
  • (1)
    • (A) Premiums for enrollment under this section shall be paid to the Secretary at such times, and in such manner, as the Secretary shall by regulations prescribe, and shall be deposited in the Treasury to the credit of the Federal Hospital Insurance Trust Fund.
    • (B)
      • (i) Subject to clause (ii), such premiums shall be payable for the period commencing with the first month of an individual’s coverage period and ending with the month in which the individual dies or, if earlier, in which the individual’s coverage period terminates.
      • (ii) Such premiums shall not be payable for any month in which the individual is eligible for benefits under this part pursuant to section 426(b) of this title .
  • (2) The provisions of subsections (d) through (f) of section 1395i–2 of this title (relating to premiums) shall apply to individuals enrolled under this section in the same manner as they apply to individuals enrolled under that section.

§ 1397n–3. Feasibility study funding

• (a) The Secretary shall reserve a portion of the amount made available to carry out this division to assist States or local governments in developing feasibility studies to apply for social impact partnership funding under section 1397n–1 of this title . To be eligible to receive funding to assist with completing a feasibility study, a State or local government shall submit an application for feasibility study funding addressing the following:
  • (1) A description of the outcome goals of the social impact partnership project.
  • (2) A description of the intervention, including anticipated program design, target population, an estimate regarding the number of individuals to be served, and setting for the intervention.
  • (3) Evidence to support the likelihood that the intervention will produce the desired outcomes.
  • (4) A description of the potential metrics to be used.
  • (5) The expected social benefits to participants who receive the intervention and others who may be impacted.
  • (6) Estimated costs to conduct the project.
  • (7) Estimates of Federal, State, and local government savings and other savings if the project is implemented and the outcomes are achieved as a result of each intervention.
  • (8) An estimated timeline for implementation and completion of the project, which shall not exceed 10 years.
  • (9) With respect to a project for which the State or local government selects an intermediary to operate the project, any partnerships needed to successfully execute the project and the ability of the intermediary to foster the partnerships.
  • (10) The expected resources needed to complete the feasibility study for the State or local government to apply for social impact partnership funding under section 1397n–1 of this title .
• (b) Not later than 6 months after receiving an application for feasibility study funding under subsection (a), the Secretary, in consultation with the Federal Interagency Council on Social Impact Partnerships and the head of any Federal agency administering a similar intervention or serving a population similar to that served by the project, shall select State or local government feasibility study proposals for funding based on the following:
  • (1) The recommendations made by the Commission on Social Impact Partnerships.
  • (2) The likelihood that the proposal will achieve the desired outcomes.
  • (3) The value of the outcomes expected to be achieved as a result of each intervention.
  • (4) The potential savings to the Federal Government if the social impact partnership project is successful.
  • (5) The potential savings to the State and local governments if the project is successful.
• (c) Not later than 30 days after selecting a State or local government for feasibility study funding under this section, the Secretary shall cause to be published on the website of the Federal Interagency Council on Social Impact Partnerships information explaining why a State or local government was granted feasibility study funding.
• (d)
  • (1) The Secretary may not provide feasibility study funding under this section for more than 50 percent of the estimated total cost of the feasibility study reported in the State or local government application submitted under subsection (a).
  • (2) Of the total amount made available to carry out this division, the Secretary may not use more than $10,000,000 to provide feasibility study funding to States or local governments under this section.
  • (3) The Secretary shall have the option to award no funding under this section.
• (e) Not later than 9 months after the receipt of feasibility study funding under this section, a State or local government receiving the funding shall complete the feasibility study and submit the study to the Federal Interagency Council on Social Impact Partnerships.
• (f) The Secretary may transfer to the head of another Federal agency the authorities provided in this section and any funds necessary to exercise the authorities.

§ 1396w–3a. Requirements relating to qualified prescription drug monitoring programs and prescribing certain controlled substances

• (a) Subject to subsection (d), beginning October 1, 2021 , a State—
  • (1) shall require each covered provider to check, in accordance with such timing, manner, and form as specified by the State, the prescription drug history of a covered individual being treated by the covered provider through a qualified prescription drug monitoring program described in subsection (b) before prescribing to such individual a controlled substance; and
  • (2) in the case that such a provider is not able to conduct such a check despite a good faith effort by such provider—
    • (A) shall require the provider to document such good faith effort, including the reasons why the provider was not able to conduct the check; and
    • (B) may require the provider to submit, upon request, such documentation to the State.
• (b) A qualified prescription drug monitoring program described in this subsection is, with respect to a State, a prescription drug monitoring program administered by the State that, at a minimum, satisfies each of the following criteria:
  • (1) The program facilitates access by a covered provider to, at a minimum, the following information with respect to a covered individual, in as close to real-time as possible:
    • (A) Information regarding the prescription drug history of a covered individual with respect to controlled substances.
    • (B) The number and type of controlled substances prescribed to and filled for the covered individual during at least the most recent 12-month period.
    • (C) The name, location, and contact information (or other identifying number selected by the State, such as a national provider identifier issued by the National Plan and Provider Enumeration System of the Centers for Medicare & Medicaid Services) of each covered provider who prescribed a controlled substance to the covered individual during at least the most recent 12-month period.
  • (2) The program facilitates the integration of information described in paragraph (1) into the workflow of a covered provider, which may include the electronic system the covered provider uses to prescribe controlled substances.
• (c) The Secretary shall clarify privacy requirements, including requirements under the regulations promulgated pursuant to section 264(c) of the Health Insurance Portability and Accountability Act of 1996 ( 42 U.S.C. 1320d–2 note), related to the sharing of data under subsection (b) in the same manner as the Secretary is required under subparagraph (J) of section 1395w–104(c)(5) of this title to clarify privacy requirements related to the sharing of data described in such subparagraph.
• (d) In order to ensure reasonable access to health care, the Secretary shall waive the application of the requirement under subsection (a), with respect to a State, in the case of natural disasters and similar situations, and in the case of the provision of emergency services (as defined for purposes of section 1395w–104(c)(5)(D)(ii)(II) of this title ).
• (e)
  • (1) Each State shall include in the annual report submitted to the Secretary under section 1396r–8(g)(3)(D) of this title , beginning with such reports submitted for 2023, information including, at a minimum, the following information for the most recent 12-month period:
    • (A) The percentage of covered providers (as determined pursuant to a process established by the State) who checked the prescription drug history of a covered individual through a qualified prescription drug monitoring program described in subsection (b) before prescribing to such individual a controlled substance.
    • (B) Aggregate trends with respect to prescribing controlled substances such as—
      • (i) the quantity of daily morphine milligram equivalents prescribed for controlled substances;
      • (ii) the number and quantity of daily morphine milligram equivalents prescribed for controlled substances per covered individual; and
      • (iii) the types of controlled substances prescribed, including the dates of such prescriptions, the supplies authorized (including the duration of such supplies), and the period of validity of such prescriptions, in different populations (such as individuals who are elderly, individuals with disabilities, and individuals who are enrolled under both this subchapter and subchapter XVIII).
    • (C) Whether or not the State requires (and a detailed explanation as to why the State does or does not require) pharmacists to check the prescription drug history of a covered individual through a qualified prescription drug monitoring program described in subsection (b) before dispensing a controlled substance to such individual.
    • (D) An accounting of any data or privacy breach of a qualified prescription drug monitoring program described in subsection (b), the number of covered individuals impacted by each such breach, and a description of the steps the State has taken to address each such breach, including, to the extent required by State or Federal law or otherwise determined appropriate by the State, alerting any such impacted individual and law enforcement of the breach.
  • (2) Not later than October 1, 2023 , the Administrator of the Centers for Medicare & Medicaid Services shall publish on the publicly available website of the Centers for Medicare & Medicaid Services a report including the following information:
    • (A) Guidance for States on how States can increase the percentage of covered providers who use qualified prescription drug monitoring programs described in subsection (b).
    • (B) Best practices for how States and covered providers should use such qualified prescription drug monitoring programs to reduce the occurrence of abuse of controlled substances.
• (f)
  • (1) With respect to a State that meets the condition described in paragraph (2) and any quarter occurring during fiscal year 2019 or fiscal year 2020, the Federal medical assistance percentage or Federal matching rate that would otherwise apply to such State under section 1396b(a) of this title for such quarter, with respect to expenditures by the State for activities under the State plan (or a waiver of such plan) to design, develop, or implement a prescription drug monitoring program (and to make connections to such program) that satisfies the criteria described in paragraphs (1) and (2) of subsection (b), shall be equal to 100 percent.
  • (2) The condition described in this paragraph, with respect to a State, is that the State (in this paragraph referred to as the “administering State”) has in place agreements with all States that are contiguous to such administering State that, when combined, enable covered providers in all such contiguous States to access, through the prescription drug monitoring program, the information that is described in subsection (b)(1) of covered individuals of such administering State and that covered providers in such administering State are able to access through such program.
• (g) Nothing in this section prevents a State from requiring pharmacists to check the prescription drug history of covered individuals through a qualified prescription drug monitoring program before dispensing controlled substances to such individuals.
• (h) In this section:
  • (1) The term “controlled substance” means a drug that is included in schedule II of section 812(c) of title 21 and, at the option of the State involved, a drug included in schedule III or IV of such section.
  • (2) The term “covered individual” means, with respect to a State, an individual who is enrolled in the State plan (or under a waiver of such plan). Such term does not include an individual who—
    • (A) is receiving—
      • (i) hospice or palliative care; or
      • (ii) treatment for cancer;
    • (B) is a resident of a long-term care facility, of a facility described in section 1396d(d) of this title , or of another facility for which frequently abused drugs are dispensed for residents through a contract with a single pharmacy; or
    • (C) the State elects to treat as exempted from such term.
  • (3)
    • (A) The term “covered provider” means, subject to subparagraph (B), with respect to a State, a health care provider who is participating under the State plan (or waiver of the State plan) and licensed, registered, or otherwise permitted by the State to prescribe a controlled substance (or the designee of such provider).
    • (B)
      • (i) Beginning October 1, 2021 , for purposes of this section, such term does not include a health care provider included in any type of health care provider determined by the Secretary to be exempt from application of this section under clause (ii).
      • (ii) Not later than October 1, 2020 , the Secretary, after consultation with the National Association of Medicaid Directors, national health care provider associations, Medicaid beneficiary advocates, and advocates for individuals with rare diseases, shall determine, based on such consultations, the types of health care providers (if any) that should be exempted from the definition of the term “covered provider” for purposes of this section.

§ 1395w–3b. Competitive acquisition of outpatient drugs and biologicals

• (a)
  • (1)
    • (A) The Secretary shall establish and implement a competitive acquisition program under which—
      • (i) competitive acquisition areas are established for contract award purposes for acquisition of and payment for categories of competitively biddable drugs and biologicals (as defined in paragraph (2)) under this part;
      • (ii) each physician is given the opportunity annually to elect to obtain drugs and biologicals under the program, rather than under section 1395w–3a of this title ; and
      • (iii) each physician who elects to obtain drugs and biologicals under the program makes an annual selection under paragraph (5) of the contractor through which drugs and biologicals within a category of drugs and biologicals will be acquired and delivered to the physician under this part.
    • (B) For purposes of implementing the program, the Secretary shall establish categories of competitively biddable drugs and biologicals. The Secretary shall phase in the program with respect to those categories beginning in 2006 in such manner as the Secretary determines to be appropriate.
    • (C) In order to promote competition, in carrying out the program the Secretary may waive such provisions of the Federal Acquisition Regulation as are necessary for the efficient implementation of this section, other than provisions relating to confidentiality of information and such other provisions as the Secretary determines appropriate.
    • (D) The Secretary may exclude competitively biddable drugs and biologicals (including a class of such drugs and biologicals) from the competitive bidding system under this section if the application of competitive bidding to such drugs or biologicals—
      • (i) is not likely to result in significant savings; or
      • (ii) is likely to have an adverse impact on access to such drugs or biologicals.
  • (2) For purposes of this section—
    • (A) The term “competitively biddable drugs and biologicals” means a drug or biological described in section 1395u( o )(1)(C) of this title and furnished on or after January 1, 2006 .
    • (B) The term “program” means the competitive acquisition program under this section.
    • (C) The terms “competitive acquisition area” and “area” mean an appropriate geographic region established by the Secretary under the program.
    • (D) The term “contractor” means an entity that has entered into a contract with the Secretary under this section.
  • (3)
    • (A) With respect to competitively biddable drugs and biologicals which are supplied under the program in an area and which are prescribed by a physician who has elected this section to apply—
      • (i) the claim for such drugs and biologicals shall be submitted by the contractor that supplied the drugs and biologicals;
      • (ii) collection of amounts of any deductible and coinsurance applicable with respect to such drugs and biologicals shall be the responsibility of such contractor and shall not be collected unless the drug or biological is administered to the individual involved; and
      • (iii) the payment under this section (and related amounts of any applicable deductible and coinsurance) for such drugs and biologicals shall be made only to such contractor upon receipt of a claim for a drug or biological supplied by the contractor for administration to a beneficiary.
    • (B) The Secretary shall provide a process for adjustments to payments in the case in which payment is made for drugs and biologicals which were billed at the time of dispensing but which were not actually administered.
    • (C) The Secretary shall provide a process by which physicians submit information to contractors for purposes of the collection of any applicable deductible or coinsurance amounts under subparagraph (A)(ii).
    • (D) The Secretary shall establish (by program instruction or otherwise) a post-payment review process (which may include the use of statistical sampling) to assure that payment is made for a drug or biological under this section only if the drug or biological has been administered to a beneficiary. The Secretary shall recoup, offset, or collect any overpayments determined by the Secretary under such process.
  • (4) Payment may not be made under this part for competitively biddable drugs and biologicals prescribed by a physician who has elected this section to apply within a category and a competitive acquisition area with respect to which the program applies unless—
    • (A) the drugs or biologicals are supplied by a contractor with a contract under this section for such category of drugs and biologicals and area; and
    • (B) the physician has elected such contractor under paragraph (5) for such category and area.
  • (5)
    • (A)
      • (i) The Secretary shall provide a process for the selection of a contractor, on an annual basis and in such exigent circumstances as the Secretary may provide and with respect to each category of competitively biddable drugs and biologicals for an area by selecting physicians.
      • (ii) The selection of a contractor under clause (i) shall be made at the time of the election described in section 1395w–3a(a) of this title for this section to apply and shall be coordinated with agreements entered into under section 1395u(h) of this title .
    • (B) The Secretary shall make available to physicians on an ongoing basis, through a directory posted on the Internet website of the Centers for Medicare & Medicaid Services or otherwise and upon request, a list of the contractors under this section in the different competitive acquisition areas.
    • (C) For purposes of this section, the term “selecting physician” means, with respect to a contractor and category and competitive acquisition area, a physician who has elected this section to apply and has selected to apply under this section such contractor for such category and area.
• (b)
  • (1) The Secretary shall conduct a competition among entities for the acquisition of competitively biddable drugs and biologicals. Notwithstanding any other provision of this subchapter, in the case of a multiple source drug, the Secretary shall conduct such competition among entities for the acquisition of at least one competitively biddable drug and biological within each billing and payment code within each category for each competitive acquisition area.
  • (2)
    • (A) The Secretary may not award a contract to any entity under the competition conducted in a competitive acquisition area pursuant to paragraph (1) with respect to the acquisition of competitively biddable drugs and biologicals within a category unless the Secretary finds that the entity meets all of the following with respect to the contract period involved:
      • (i)
        • (I) The entity has sufficient arrangements to acquire and to deliver competitively biddable drugs and biologicals within such category in the area specified in the contract.
        • (II) The entity has arrangements in effect for the shipment at least 5 days each week of competitively biddable drugs and biologicals under the contract and for the timely delivery (including for emergency situations) of such drugs and biologicals in the area under the contract.
      • (ii) The entity meets quality, service, financial performance, and solvency standards specified by the Secretary, including—
        • (I) the establishment of procedures for the prompt response and resolution of complaints of physicians and individuals and of inquiries regarding the shipment of competitively biddable drugs and biologicals; and
        • (II) a grievance and appeals process for the resolution of disputes.
    • (B) The Secretary may refuse to award a contract under this section, and may terminate such a contract, with an entity based upon—
      • (i) the suspension or revocation, by the Federal Government or a State government, of the entity’s license for the distribution of drugs or biologicals (including controlled substances); or
      • (ii) the exclusion of the entity under section 1320a–7 of this title from participation under this subchapter.
    • (C) For provision providing for a program-wide Medicare Provider Ombudsman to review complaints, see section 1395ee(b) of this title , as added by section 923 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003. 1 1 See References in Text note below.
  • (3) The Secretary may limit (but not below 2) the number of qualified entities that are awarded such contracts for any category and area. The Secretary shall select among qualified entities based on the following:
    • (A) The bid prices for competitively biddable drugs and biologicals within the category and area.
    • (B) Bid price for distribution of such drugs and biologicals.
    • (C) Ability to ensure product integrity.
    • (D) Customer service.
    • (E) Past experience in the distribution of drugs and biologicals, including controlled substances.
    • (F) Such other factors as the Secretary may specify.
  • (4)
    • (A) A contract entered into with an entity under the competition conducted pursuant to paragraph (1) is subject to terms and conditions that the Secretary may specify consistent with this section.
    • (B) A contract under this section shall be for a term of 3 years, but may be terminated by the Secretary or the entity with appropriate, advance notice.
    • (C) A contractor (as defined in subsection (a)(2)(D)) shall—
      • (i) acquire all drug and biological products it distributes directly from the manufacturer or from a distributor that has acquired the products directly from the manufacturer; and
      • (ii) comply with any product integrity safeguards as may be determined to be appropriate by the Secretary.
    • (D) Under the contract—
      • (i) the contractor shall comply with a code of conduct, specified or recognized by the Secretary, that includes standards relating to conflicts of interest; and
      • (ii) the contractor shall comply with all applicable provisions relating to prevention of fraud and abuse, including compliance with applicable guidelines of the Department of Justice and the Inspector General of the Department of Health and Human Services.
    • (E) Under the contract the contractor shall only supply competitively biddable drugs and biologicals directly to the selecting physicians and not directly to individuals, except under circumstances and settings where an individual currently receives a drug or biological in the individual’s home or other non-physician office setting as the Secretary may provide. The contractor shall not deliver drugs and biologicals to a selecting physician except upon receipt of a prescription for such drugs and biologicals, and such necessary data as may be required by the Secretary to carry out this section. This section does not—
      • (i) require a physician to submit a prescription for each individual treatment; or
      • (ii) change a physician’s flexibility in terms of writing a prescription for drugs or biologicals for a single treatment or a course of treatment.
  • (5) The Secretary shall establish rules under this section under which drugs and biologicals which are acquired through a contractor under this section may be used to resupply inventories of such drugs and biologicals which are administered consistent with safe drug practices and with adequate safeguards against fraud and abuse. The previous sentence shall apply if the physicians can demonstrate to the Secretary all of the following:
    • (A) The drugs or biologicals are required immediately.
    • (B) The physician could not have reasonably anticipated the immediate requirement for the drugs or biologicals.
    • (C) The contractor could not deliver to the physician the drugs or biologicals in a timely manner.
    • (D) The drugs or biologicals were administered in an emergency situation.
  • (6) Nothing in this section shall be construed as waiving applicable State requirements relating to licensing of pharmacies.
• (c)
  • (1) In awarding a contract for a category of drugs and biologicals in an area under the program, the Secretary shall consider with respect to each entity seeking to be awarded a contract the bid price and the other factors referred to in subsection (b)(3).
  • (2) In this section, the term “bid” means an offer to furnish a competitively biddable drug or biological for a particular price and time period.
  • (3) Nothing in this section shall be construed as precluding a bidder from bidding for contracts in all areas of the United States or as requiring a bidder to submit a bid for all areas of the United States.
  • (4) The amount of the bid submitted under a contract offer for any competitively biddable drug or biological for an area shall be the same for that drug or biological for all portions of that area.
  • (5) The provisions of subparagraph (D) of section 1396r–8(b)(3) of this title shall apply to periods during which a bid is submitted with respect to a competitively biddable drug or biological under this section in the same manner as it applies to information disclosed under such section, except that any reference—
    • (A) in that subparagraph to a “manufacturer or wholesaler” is deemed a reference to a “bidder” under this section;
    • (B) in that section to “prices charged for drugs” is deemed a reference to a “bid” submitted under this section; and
    • (C) in clause (i) of that section to “this section”, is deemed a reference to “part B of subchapter XVIII”.
  • (6) The bid price submitted in a contract offer for a competitively biddable drug or biological shall—
    • (A) include all costs related to the delivery of the drug or biological to the selecting physician (or other point of delivery); and
    • (B) include the costs of dispensing (including shipping) of such drug or biological and management fees, but shall not include any costs related to the administration of the drug or biological, or wastage, spillage, or spoilage.
  • (7) Each contract awarded shall provide for—
    • (A) disclosure to the Secretary the contractor’s reasonable, net acquisition costs for periods specified by the Secretary, not more often than quarterly, of the contract; and
    • (B) appropriate price adjustments over the period of the contract to reflect significant increases or decreases in a contractor’s reasonable, net acquisition costs, as so disclosed.
• (d)
  • (1) Payment under this section for competitively biddable drugs or biologicals shall be based on bids submitted and accepted under this section for such drugs or biologicals in an area. Based on such bids the Secretary shall determine a single payment amount for each competitively biddable drug or biological in the area.
  • (2) The Secretary shall establish rules regarding the use under this section of the alternative payment amount provided under section 1395w–3a of this title to the use of a price for specific competitively biddable drugs and biologicals in the following cases:
    • (A) A competitively biddable drug or biological for which a payment and billing code has not been established.
    • (B) Such other exceptional cases as the Secretary may specify in regulations.
• (e)
  • (1) Payment under this section for competitively biddable drugs and biologicals shall be in an amount equal to 80 percent of the payment basis described in subsection (d)(1).
  • (2) Before applying paragraph (1), the individual shall be required to meet the deductible described in section 1395 l (b) of this title.
  • (3) Such coinsurance and deductible shall be collected by the contractor that supplies the drug or biological involved. Subject to subsection (a)(3)(B), such coinsurance and deductible may be collected in a manner similar to the manner in which the coinsurance and deductible are collected for durable medical equipment under this part.
• (f)
  • (1) If the Secretary excludes a drug or biological (or class of drugs or biologicals) under subsection (a)(1)(D), the Secretary may provide for payment to be made under this part for such drugs and biologicals (or class) using the payment methodology under section 1395w–3a of this title .
  • (2) For provision requiring assignment of claims for competitively biddable drugs and biologicals, see section 1395u( o )(3) of this title.
  • (3) For protection of individuals against liability in the case of medical necessity determinations, see section 1395u(b)(3)(B)(ii)(III) of this title .
• (g) There shall be no administrative or judicial review under section 1395ff of this title , section 1395 oo of this title, or otherwise, of—
  • (1) the establishment of payment amounts under subsection (d)(1);
  • (2) the awarding of contracts under this section;
  • (3) the establishment of competitive acquisition areas under subsection (a)(2)(C);
  • (4) the phased-in implementation under subsection (a)(1)(B);
  • (5) the selection of categories of competitively biddable drugs and biologicals for competitive acquisition under such subsection or the selection of a drug in the case of multiple source drugs; or
  • (6) the bidding structure and number of contractors selected under this section.

§ 1397n–4. Evaluations

• (a) For each State or local government awarded a social impact partnership project approved by the Secretary under this division, the head of the relevant agency, as recommended by the Federal Interagency Council on Social Impact Partnerships and determined by the Secretary, shall enter into an agreement with the State or local government to pay for all or part of the independent evaluation to determine whether the State or local government project has achieved a specific outcome as a result of the intervention in order for the State or local government to receive outcome payments under this division.
• (b) The head of the relevant agency may not enter into an agreement with a State or local government unless the head determines that the evaluator is independent of the other parties to the agreement and has demonstrated substantial experience in conducting rigorous evaluations of program effectiveness including, where available and appropriate, well-implemented randomized controlled trials on the intervention or similar interventions.
• (c) The evaluation used to determine whether a State or local government will receive outcome payments under this division shall use experimental designs using random assignment or other reliable, evidence-based research methodologies, as certified by the Federal Interagency Council on Social Impact Partnerships, that allow for the strongest possible causal inferences when random assignment is not feasible.
• (d)
  • (1) The independent evaluator shall—
    • (A) not later than 2 years after a project has been approved by the Secretary and biannually thereafter until the project is concluded, submit to the head of the relevant agency and the Federal Interagency Council on Social Impact Partnerships a written report summarizing the progress that has been made in achieving each outcome specified in the agreement; and
    • (B) before the scheduled time of the first outcome payment and before the scheduled time of each subsequent payment, submit to the head of the relevant agency and the Federal Interagency Council on Social Impact Partnerships a written report that includes the results of the evaluation conducted to determine whether an outcome payment should be made along with information on the unique factors that contributed to achieving or failing to achieve the outcome, the challenges faced in attempting to achieve the outcome, and information on the improved future delivery of this or similar interventions.
  • (2) Not later than 30 days after receipt of the written report pursuant to paragraph (1)(B), the Federal Interagency Council on Social Impact Partnerships shall submit the report to the Secretary and each committee of jurisdiction in the House of Representatives and the Senate.
• (e)
  • (1) Within 6 months after the social impact partnership project is completed, the independent evaluator shall—
    • (A) evaluate the effects of the activities undertaken pursuant to the agreement with regard to each outcome specified in the agreement; and
    • (B) submit to the head of the relevant agency and the Federal Interagency Council on Social Impact Partnerships a written report that includes the results of the evaluation and the conclusion of the evaluator as to whether the State or local government has fulfilled each obligation of the agreement, along with information on the unique factors that contributed to the success or failure of the project, the challenges faced in attempting to achieve the outcome, and information on the improved future delivery of this or similar interventions.
  • (2) Not later than 30 days after receipt of the written report pursuant to paragraph (1)(B), the Federal Interagency Council on Social Impact Partnerships shall submit the report to the Secretary and each committee of jurisdiction in the House of Representatives and the Senate.
• (f) Of the amount made available under this division for social impact partnership projects, the Secretary may not obligate more than 15 percent to evaluate the implementation and outcomes of the projects.
• (g) The Secretary may transfer to the head of another Federal agency the authorities provided in this section and any funds necessary to exercise the authorities.

§ 1396w–4a. State option to provide coordinated care through a health home for children with medically complex conditions

• (a) Notwithstanding section 1396a(a)(1) of this title (relating to statewideness) and section 1396a(a)(10)(B) of this title (relating to comparability), beginning October 1, 2022 , a State, at its option as a State plan amendment, may provide for medical assistance under this subchapter to children with medically complex conditions who choose to enroll in a health home under this section by selecting a designated provider, a team of health care professionals operating with such a provider, or a health team as the child’s health home for purposes of providing the child with health home services.
• (b) The Secretary shall establish standards for qualification as a health home for purposes of this section. Such standards shall include requiring designated providers, teams of health care professionals operating with such providers, and health teams to demonstrate to the State the ability to do the following:
  • (1) Coordinate prompt care for children with medically complex conditions, including access to pediatric emergency services at all times.
  • (2) Develop an individualized comprehensive pediatric family-centered care plan for children with medically complex conditions that accommodates patient preferences.
  • (3) Work in a culturally and linguistically appropriate manner with the family of a child with medically complex conditions to develop and incorporate into such child’s care plan, in a manner consistent with the needs of the child and the choices of the child’s family, ongoing home care, community-based pediatric primary care, pediatric inpatient care, social support services, and local hospital pediatric emergency care.
  • (4) Coordinate access to—
    • (A) subspecialized pediatric services and programs for children with medically complex conditions, including the most intensive diagnostic, treatment, and critical care levels as medically necessary; and
    • (B) palliative services if the State provides such services under the State plan (or a waiver of such plan).
  • (5) Coordinate care for children with medically complex conditions with out-of-State providers furnishing care to such children to the maximum extent practicable for the families of such children and where medically necessary, in accordance with guidance issued under subsection (e)(1) and section 431.52 of title 42, Code of Federal Regulations.
  • (6) Collect and report information under subsection (g)(1).
• (c)
  • (1) A State shall provide a designated provider, a team of health care professionals operating with such a provider, or a health team with payments for the provision of health home services to each child with medically complex conditions that selects such provider, team of health care professionals, or health team as the child’s health home. Payments made to a designated provider, a team of health care professionals operating with such a provider, or a health team for such services shall be treated as medical assistance for purposes of section 1396b(a) of this title , except that, during the first 2 fiscal year quarters that the State plan amendment is in effect, the Federal medical assistance percentage applicable to such payments shall be increased by 15 percentage points, but in no case may exceed 90 percent.
  • (2)
    • (A) The State shall specify in the State plan amendment the methodology the State will use for determining payment for the provision of health home services. Such methodology for determining payment—
      • (i) may be tiered to reflect, with respect to each child with medically complex conditions provided such services by a designated provider, a team of health care professionals operating with such a provider, or a health team, the severity or number of each such child’s chronic conditions, life-threatening illnesses, disabilities, or rare diseases, or the specific capabilities of the provider, team of health care professionals, or health team; and
      • (ii) shall be established consistent with section 1396a(a)(30)(A) of this title .
    • (B) The methodology for determining payment for provision of health home services under this section shall not be limited to a per-member per-month basis and may provide (as proposed by the State and subject to approval by the Secretary) for alternate models of payment.
  • (3)
    • (A) Beginning October 1, 2022 , the Secretary may award planning grants to States for purposes of developing a State plan amendment under this section. A planning grant awarded to a State under this paragraph shall remain available until expended.
    • (B) A State awarded a planning grant shall contribute an amount equal to the State percentage determined under section 1396d(b) of this title (without regard to section 5001 of Public Law 111–5 ) for each fiscal year for which the grant is awarded.
    • (C) The total amount of payments made to States under this paragraph shall not exceed $5,000,000.
• (d)
  • (1) A State with a State plan amendment approved under this section shall require each hospital that is a participating provider under the State plan (or a waiver of such plan) to establish procedures for, in the case of a child with medically complex conditions who is enrolled in a health home pursuant to this section and seeks treatment in the emergency department of such hospital, notifying the health home of such child of such treatment.
  • (2) In order for a State plan amendment to be approved under this section, a State shall include in the State plan amendment a description of the State’s process for educating providers participating in the State plan (or a waiver of such plan) on the availability of health home services for children with medically complex conditions, including the process by which such providers can refer such children to a designated provider, team of health care professionals operating such 1 1 So in original. Probably should be preceded by “with”. a provider, or health team for the purpose of establishing a health home through which such children may receive such services.
  • (3) In order for a State plan amendment to be approved under this section, a State shall include in the State plan amendment a description of the State’s process for educating families with children eligible to receive health home services pursuant to this section of the availability of such services. Such process shall include the participation of family-to-family entities or other public or private organizations or entities who provide outreach and information on the availability of health care items and services to families of individuals eligible to receive medical assistance under the State plan (or a waiver of such plan).
  • (4) A State with a State plan amendment approved under this section shall consult and coordinate, as appropriate, with the Secretary in addressing issues regarding the prevention and treatment of mental illness and substance use among children with medically complex conditions receiving health home services under this section.
• (e)
  • (1) Not later than October 1, 2020 , the Secretary shall issue (and update as the Secretary determines necessary) guidance to State Medicaid directors on—
    • (A) best practices for using out-of-State providers to provide care to children with medically complex conditions;
    • (B) coordinating care for such children provided by such out-of-State providers (including when provided in emergency and non-emergency situations);
    • (C) reducing barriers for such children receiving care from such providers in a timely fashion; and
    • (D) processes for screening and enrolling such providers in the respective State plan (or a waiver of such plan), including efforts to streamline such processes or reduce the burden of such processes on such providers.
  • (2) In carrying out paragraph (1), the Secretary shall issue a request for information to seek input from children with medically complex conditions and their families, States, providers (including children’s hospitals, hospitals, pediatricians, and other providers), managed care plans, children’s health groups, family and beneficiary advocates, and other stakeholders with respect to coordinating the care for such children provided by out-of-State providers.
• (f) A State shall include in the State plan amendment—
  • (1) a methodology for tracking reductions in inpatient days and reductions in the total cost of care resulting from improved care coordination and management under this section;
  • (2) a proposal for use of health information technology in providing health home services under this section and improving service delivery and coordination across the care continuum (including the use of wireless patient technology to improve coordination and management of care and patient adherence to recommendations made by their provider); and
  • (3) a methodology for tracking prompt and timely access to medically necessary care for children with medically complex conditions from out-of-State providers.
• (g)
  • (1) In order to receive payments from a State under subsection (c), a designated provider, a team of health care professionals operating with such a provider, or a health team shall report to the State, at such time and in such form and manner as may be required by the State, the following information:
    • (A) With respect to each such provider, team of health care professionals, or health team, the name, National Provider Identification number, address, and specific health care services offered to be provided to children with medically complex conditions who have selected such provider, team of health care professionals, or health team as the health home of such children.
    • (B) Information on all applicable measures for determining the quality of health home services provided by such provider, team of health care professionals, or health team, including, to the extent applicable, child health quality measures and measures for centers of excellence for children with complex needs developed under this subchapter, subchapter XXI, and section 1320b–9a of this title .
    • (C) Such other information as the Secretary shall specify in guidance.
  • (2)
    • (A) A State with a State plan amendment approved under this section shall report to the Secretary (and, upon request, to the Medicaid and CHIP Payment and Access Commission), at such time and in such form and manner determined by the Secretary to be reasonable and minimally burdensome, the following information:
      • (i) Information reported under paragraph (1).
      • (ii) The number of children with medically complex conditions who have selected a health home pursuant to this section.
      • (iii) The nature, number, and prevalence of chronic conditions, life-threatening illnesses, disabilities, or rare diseases that such children have.
      • (iv) The type of delivery systems and payment models used to provide services to such children under this section.
      • (v) The number and characteristics of designated providers, teams of health care professionals operating with such providers, and health teams selected as health homes pursuant to this section, including the number and characteristics of out-of-State providers, teams of health care professionals operating with such providers, and health teams who have provided health care items and services to such children.
      • (vi) The extent to which such children receive health care items and services under the State plan.
      • (vii) Quality measures developed specifically with respect to health care items and services provided to children with medically complex conditions.
    • (B) Not later than 90 days after a State has a State plan amendment approved under this section, such State shall submit to the Secretary, and make publicly available on the appropriate State website, a report on how the State is implementing guidance issued under subsection (e)(1), including through any best practices adopted by the State.
• (h) Nothing in this section may be construed—
  • (1) to require a child with medically complex conditions to enroll in a health home under this section;
  • (2) to limit the choice of a child with medically complex conditions in selecting a designated provider, team of health care professionals operating with such a provider, or health team that meets the health home qualification standards established under subsection (b) as the child’s health home; or
  • (3) to reduce or otherwise modify—
    • (A) the entitlement of children with medically complex conditions to early and periodic screening, diagnostic, and treatment services (as defined in section 1396d(r) of this title ); or
    • (B) the informing, providing, arranging, and reporting requirements of a State under section 1396a(a)(43) of this title .
• (i) In this section:
  • (1)
    • (A) Subject to subparagraph (B), the term “child with medically complex conditions” means an individual under 21 years of age who—
      • (i) is eligible for medical assistance under the State plan (or under a waiver of such plan); and
      • (ii) has at least—
        • (I) one or more chronic conditions that cumulatively affect three or more organ systems and severely reduces cognitive or physical functioning (such as the ability to eat, drink, or breathe independently) and that also requires the use of medication, durable medical equipment, therapy, surgery, or other treatments; or
        • (II) one life-limiting illness or rare pediatric disease (as defined in section 360ff(a)(3) of title 21 ).
    • (B) Nothing in this paragraph shall prevent the Secretary from establishing higher levels as to the number or severity of chronic, life threatening illnesses, disabilities, rare diseases or mental health conditions for purposes of determining eligibility for receipt of health home services under this section.
  • (2) The term “chronic condition” means a serious, long-term physical, mental, or developmental disability or disease, including the following:
    • (A) Cerebral palsy.
    • (B) Cystic fibrosis.
    • (C) HIV/AIDS.
    • (D) Blood diseases, such as anemia or sickle cell disease.
    • (E) Muscular dystrophy.
    • (F) Spina bifida.
    • (G) Epilepsy.
    • (H) Severe autism spectrum disorder.
    • (I) Serious emotional disturbance or serious mental health illness.
  • (3) The term “health home” means a designated provider (including a provider that operates in coordination with a team of health care professionals) or a health team selected by a child with medically complex conditions (or the family of such child) to provide health home services.
  • (4)
    • (A) The term “health home services” means comprehensive and timely high-quality services described in subparagraph (B) that are provided by a designated provider, a team of health care professionals operating with such a provider, or a health team.
    • (B) The services described in this subparagraph shall include—
      • (i) comprehensive care management;
      • (ii) care coordination, health promotion, and providing access to the full range of pediatric specialty and subspecialty medical services, including services from out-of-State providers, as medically necessary;
      • (iii) comprehensive transitional care, including appropriate follow-up, from inpatient to other settings;
      • (iv) patient and family support (including authorized representatives);
      • (v) referrals to community and social support services, if relevant; and
      • (vi) use of health information technology to link services, as feasible and appropriate.
  • (5) The term “designated provider” means a physician (including a pediatrician or a pediatric specialty or subspecialty provider), children’s hospital, clinical practice or clinical group practice, prepaid inpatient health plan or prepaid ambulatory health plan (as defined by the Secretary), rural clinic, community health center, community mental health center, home health agency, or any other entity or provider that is determined by the State and approved by the Secretary to be qualified to be a health home for children with medically complex conditions on the basis of documentation evidencing that the entity has the systems, expertise, and infrastructure in place to provide health home services. Such term may include providers who are employed by, or affiliated with, a children’s hospital.
  • (6) The term “team of health care professionals” means a team of health care professionals (as described in the State plan amendment under this section) that may—
    • (A) include—
      • (i) physicians and other professionals, such as pediatricians or pediatric specialty or subspecialty providers, nurse care coordinators, dietitians, nutritionists, social workers, behavioral health professionals, physical therapists, occupational therapists, speech pathologists, nurses, individuals with experience in medical supportive technologies, or any professionals determined to be appropriate by the State and approved by the Secretary;
      • (ii) an entity or individual who is designated to coordinate such a team; and
      • (iii) community health workers, translators, and other individuals with culturally-appropriate expertise; and
    • (B) be freestanding, virtual, or based at a children’s hospital, hospital, community health center, community mental health center, rural clinic, clinical practice or clinical group practice, academic health center, or any entity determined to be appropriate by the State and approved by the Secretary.
  • (7) The term “health team” has the meaning given such term for purposes of section 256a–1 of this title .

§ 1397n–5. Federal Interagency Council on Social Impact Partnerships

• (a) There is established the Federal Interagency Council on Social Impact Partnerships (in this section referred to as the “Council”) to—
  • (1) coordinate with the Secretary on the efforts of social impact partnership projects funded under this division;
  • (2) advise and assist the Secretary in the development and implementation of the projects;
  • (3) advise the Secretary on specific programmatic and policy matter related to the projects;
  • (4) provide subject-matter expertise to the Secretary with regard to the projects;
  • (5) certify to the Secretary that each State or local government that has entered into an agreement with the Secretary for a social impact partnership project under this division and each evaluator selected by the head of the relevant agency under section 1397n–4 of this title has access to Federal administrative data to assist the State or local government and the evaluator in evaluating the performance and outcomes of the project;
  • (6) address issues that will influence the future of social impact partnership projects in the United States;
  • (7) provide guidance to the executive branch on the future of social impact partnership projects in the United States;
  • (8) prior to approval by the Secretary, certify that each State and local government application for a social impact partnership contains rigorous, independent data and reliable, evidence-based research methodologies to support the conclusion that the project will yield savings to the State or local government or the Federal Government if the project outcomes are achieved;
  • (9) certify to the Secretary, in the case of each approved social impact partnership that is expected to yield savings to the Federal Government, that the project will yield a projected savings to the Federal Government if the project outcomes are achieved, and coordinate with the relevant Federal agency to produce an after-action accounting once the project is complete to determine the actual Federal savings realized, and the extent to which actual savings aligned with projected savings; and
  • (10) provide periodic reports to the Secretary and make available reports periodically to Congress and the public on the implementation of this division.
• (b) The Council shall have 11 members, as follows:
  • (1) The Chair of the Council shall be the Director of the Office of Management and Budget.
  • (2) The head of each of the following entities shall designate one officer or employee of the entity to be a Council member:
    • (A) The Department of Labor.
    • (B) The Department of Health and Human Services.
    • (C) The Social Security Administration.
    • (D) The Department of Agriculture.
    • (E) The Department of Justice.
    • (F) The Department of Housing and Urban Development.
    • (G) The Department of Education.
    • (H) The Department of Veterans Affairs.
    • (I) The Department of the Treasury.
    • (J) The Corporation for National and Community Service.

§ 1397n–6. Commission on Social Impact Partnerships

• (a) There is established the Commission on Social Impact Partnerships (in this section referred to as the “Commission”).
• (b) The duties of the Commission shall be to—
  • (1) assist the Secretary and the Federal Interagency Council on Social Impact Partnerships in reviewing applications for funding under this division;
  • (2) make recommendations to the Secretary and the Federal Interagency Council on Social Impact Partnerships regarding the funding of social impact partnership agreements and feasibility studies; and
  • (3) provide other assistance and information as requested by the Secretary or the Federal Interagency Council on Social Impact Partnerships.
• (c) The Commission shall be composed of nine members, of whom—
  • (1) one shall be appointed by the President, who will serve as the Chair of the Commission;
  • (2) one shall be appointed by the Majority Leader of the Senate;
  • (3) one shall be appointed by the Minority Leader of the Senate;
  • (4) one shall be appointed by the Speaker of the House of Representatives;
  • (5) one shall be appointed by the Minority Leader of the House of Representatives;
  • (6) one shall be appointed by the Chairman of the Committee on Finance of the Senate;
  • (7) one shall be appointed by the ranking member of the Committee on Finance of the Senate;
  • (8) one member shall be appointed by the Chairman of the Committee on Ways and Means of the House of Representatives; and
  • (9) one shall be appointed by the ranking member of the Committee on Ways and Means of the House of Representatives.
• (d) The members of the Commission shall—
  • (1) be experienced in finance, economics, pay for performance, or program evaluation;
  • (2) have relevant professional or personal experience in a field related to one or more of the outcomes listed in this division; or
  • (3) be qualified to review applications for social impact partnership projects to determine whether the proposed metrics and evaluation methodologies are appropriately rigorous and reliant upon independent data and evidence-based research.
• (e) The appointments of the members of the Commission shall be made not later than 120 days after February 9, 2018 , or, in the event of a vacancy, not later than 90 days after the date the vacancy arises. If a member of Congress fails to appoint a member by that date, the President may select a member of the President’s choice on behalf of the member of Congress. Notwithstanding the preceding sentence, if not all appointments have been made to the Commission as of that date, the Commission may operate with no fewer than five members until all appointments have been made.
• (f)
  • (1) The members appointed under subsection (c) shall serve as follows:
    • (A) Three members shall serve for 2 years.
    • (B) Three members shall serve for 3 years.
    • (C) Three members (one of which shall be Chair of the Commission appointed by the President) shall serve for 4 years.
  • (2) The Commission shall designate the term length that each member appointed under subsection (c) shall serve by unanimous agreement. In the event that unanimous agreement cannot be reached, term lengths shall be assigned to the members by a random process.
• (g) Subject to subsection (e), in the event of a vacancy in the Commission, whether due to the resignation of a member, the expiration of a member’s term, or any other reason, the vacancy shall be filled in the manner in which the original appointment was made and shall not affect the powers of the Commission.
• (h) Members of the Commission appointed under subsection (c) shall not be subject to confirmation by the Senate.

§ 1320a–6a. Interagency coordination to improve program administration

• (a) Notwithstanding any other provision of law, including section 407 of this title , the Commissioner of Social Security (referred to in this section as “the Commissioner”) and the Director of the Office of Personnel Management (referred to in this section as “the Director”) shall enter into an agreement under which a system is established to carry out the following procedure:
  • (1) The Director shall notify the Commissioner when any individual is determined to be entitled to a monthly disability annuity payment pursuant to subchapter V of chapter 84 of subpart G of part III of title 5 and shall certify that such individual has provided the authorization described in subsection (f).
  • (2) If the Commissioner determines that an individual described in paragraph (1) is also entitled to past-due benefits under section 423 of this title , the Commissioner shall notify the Director of such fact.
  • (3) Not later than 30 days after receiving a notification described in paragraph (2) with respect to an individual, the Director shall provide the Commissioner with the total amount of any disability annuity overpayments made to such individual, as well as any other information (in such form and manner as the Commissioner shall require) that the Commissioner determines is necessary to carry out this section.
  • (4) If the Director provides the Commissioner with the information described in paragraph (3) in a timely manner, the Commissioner may withhold past-due benefits under section 423 of this title to which such individual is entitled and may pay the amount described in paragraph (3) to the Office of Personnel Management for any disability annuity overpayments made to such individual.
  • (5) The Director shall credit any amount received under paragraph (4) with respect to an individual toward any disability annuity overpayment owed by such individual.
• (b)
  • (1) Benefits shall only be withheld under this section after any other reduction applicable under this chapter, including sections 406(a)(4), 424a, and 1320a–6(a) of this title.
  • (2) The Commissioner may not withhold benefits under this section if the Director does not provide the notice described in subsection (a)(3) within the time period described in such subsection.
• (c) If the Commissioner is required to make a notification described in subsection (a)(2) with respect to an individual, the Commissioner shall not make any payment of past-due benefits under section 423 of this title to such individual until after the period described in subsection (a)(3).
• (d) Notwithstanding section 405 of this title or any other provision of law, any determination regarding the withholding of past-due benefits under this section shall only be subject to adjudication and review by the Director under section 8461 of title 5 .
• (e) For purposes of this section, the term “disability annuity overpayment” means the amount of the reduction under section 8452(a)(2) of title 5 applicable to a monthly annuity payment made to an individual pursuant to subchapter V of chapter 84 of subpart G of part III of such title due to the individual’s concurrent entitlement to a disability insurance benefit under section 423 of this title during such month.
• (f) The authorization described in this subsection, with respect to an individual, is written authorization provided by the individual to the Director which authorizes the Commissioner to withhold past-due benefits under section 423 of this title to which such individual is entitled in order to pay the amount withheld to the Office of Personnel Management for any disability overpayments made to such individual.
• (g) The Director shall pay to the Social Security Administration an amount equal to the amount estimated by the Commissioner as the total cost incurred by the Social Security Administration in carrying out this section for each calendar quarter.

§ 1397n–7. Limitation on use of funds

Of the amounts made available to carry out this division, the Secretary may not use more than $2,000,000 in any fiscal year to support the review, approval, and oversight of social impact partnership projects, including activities conducted by—

• (1) the Federal Interagency Council on Social Impact Partnerships; and
• (2) any other agency consulted by the Secretary before approving a social impact partnership project or a feasibility study under section 1397n–3 of this title .

§ 1320a–7a. Civil monetary penalties

• (a) Any person (including an organization, agency, or other entity, but excluding a beneficiary, as defined in subsection (i)(5)) that—
  • (1) knowingly presents or causes to be presented to an officer, employee, or agent of the United States, or of any department or agency thereof, or of any State agency (as defined in subsection (i)(1)), a claim (as defined in subsection (i)(2)) that the Secretary determines—
    • (A) is for a medical or other item or service that the person knows or should know was not provided as claimed, including any person who engages in a pattern or practice of presenting or causing to be presented a claim for an item or service that is based on a code that the person knows or should know will result in a greater payment to the person than the code the person knows or should know is applicable to the item or service actually provided,
    • (B) is for a medical or other item or service and the person knows or should know the claim is false or fraudulent,
    • (C) is presented for a physician’s service (or an item or service incident to a physician’s service) by a person who knows or should know that the individual who furnished (or supervised the furnishing of) the service—
      • (i) was not licensed as a physician,
      • (ii) was licensed as a physician, but such license had been obtained through a misrepresentation of material fact (including cheating on an examination required for licensing), or
      • (iii) represented to the patient at the time the service was furnished that the physician was certified in a medical specialty by a medical specialty board when the individual was not so certified,
    • (D) is for a medical or other item or service furnished during a period in which the person was excluded from the Federal health care program (as defined in section 1320a–7b(f) of this title ) under which the claim was made pursuant to Federal law. 1 1 So in original. Probably should be “law, or”.
    • (E) is for a pattern of medical or other items or services that a person knows or should know are not medically necessary;
  • (2) knowingly presents or causes to be presented to any person a request for payment which is in violation of the terms of (A) an assignment under section 1395u(b)(3)(B)(ii) of this title , or (B) an agreement with a State agency (or other requirement of a State plan under subchapter XIX) not to charge a person for an item or service in excess of the amount permitted to be charged, or (C) an agreement to be a participating physician or supplier under section 1395u(h)(1) of this title , or (D) an agreement pursuant to section 1395cc(a)(1)(G) of this title ;
  • (3) knowingly gives or causes to be given to any person, with respect to coverage under subchapter XVIII of inpatient hospital services subject to the provisions of section 1395ww of this title , information that he knows or should know is false or misleading, and that could reasonably be expected to influence the decision when to discharge such person or another individual from the hospital;
  • (4) in the case of a person who is not an organization, agency, or other entity, is excluded from participating in a program under subchapter XVIII or a State health care program in accordance with this subsection or under section 1320a–7 of this title and who, at the time of a violation of this subsection—
    • (A) retains a direct or indirect ownership or control interest in an entity that is participating in a program under subchapter XVIII or a State health care program, and who knows or should know of the action constituting the basis for the exclusion; or
    • (B) is an officer or managing employee (as defined in section 1320a–5(b) of this title ) of such an entity;
  • (5) offers to or transfers remuneration to any individual eligible for benefits under subchapter XVIII of this chapter, or under a State health care program (as defined in section 1320a–7(h) of this title ) that such person knows or should know is likely to influence such individual to order or receive from a particular provider, practitioner, or supplier any item or service for which payment may be made, in whole or in part, under subchapter XVIII, or a State health care program (as so defined);
  • (6) arranges or contracts (by employment or otherwise) with an individual or entity that the person knows or should know is excluded from participation in a Federal health care program (as defined in section 1320a–7b(f) of this title ), for the provision of items or services for which payment may be made under such a program;
  • (7) commits an act described in paragraph (1) or (2) of section 1320a–7b(b) of this title ;
  • (8) 2 2 So in original. Two pars. (8) have been enacted. knowingly makes, uses, or causes to be made or used, a false record or statement material to a false or fraudulent claim for payment for items and services furnished under a Federal health care program; or 3 3 So in original. The word “or” probably should not appear.
  • (9) 4 4 So in original. Two pars. (9) have been enacted. fails to grant timely access, upon reasonable request (as defined by the Secretary in regulations), to the Inspector General of the Department of Health and Human Services, for the purpose of audits, investigations, evaluations, or other statutory functions of the Inspector General of the Department of Health and Human Services;
  • (8) 2 orders or prescribes a medical or other item or service during a period in which the person was excluded from a Federal health care program (as so defined), in the case where the person knows or should know that a claim for such medical or other item or service will be made under such a program;
  • (9) 4 knowingly makes or causes to be made any false statement, omission, or misrepresentation of a material fact in any application, bid, or contract to participate or enroll as a provider of services or a supplier under a Federal health care program (as so defined), including Medicare Advantage organizations under part C of subchapter XVIII, prescription drug plan sponsors under part D of subchapter XVIII, medicaid managed care organizations under subchapter XIX, and entities that apply to participate as providers of services or suppliers in such managed care organizations and such plans; 5 5 So in original. Probably should be followed by “or”.
  • (10) knows of an overpayment (as defined in paragraph (4) of section 1320a–7k(d) of this title ) and does not report and return the overpayment in accordance with such section;
• (b)
  • (1) If a hospital or a critical access hospital knowingly makes a payment, directly or indirectly, to a physician as an inducement to reduce or limit medically necessary services provided with respect to individuals who—
    • (A) are entitled to benefits under part A or part B of subchapter XVIII or to medical assistance under a State plan approved under subchapter XIX, and
    • (B) are under the direct care of the physician,
  • (2) Any physician who knowingly accepts receipt of a payment described in paragraph (1) shall be subject, in addition to any other penalties that may be prescribed by law, to a civil money penalty of not more than $5,000 for each individual described in such paragraph with respect to whom the payment is made.
  • (3)
    • (A) Any physician who executes a document described in subparagraph (B) with respect to an individual knowing that all of the requirements referred to in such subparagraph are not met with respect to the individual shall be subject to a civil monetary penalty of not more than the greater of—
      • (i) $10,000, or
      • (ii) three times the amount of the payments under subchapter XVIII for home health services which are made pursuant to such certification.
    • (B) A document described in this subparagraph is any document that certifies, for purposes of subchapter XVIII, that an individual meets the requirements of section 1395f(a)(2)(C) or 1395n(a)(2)(A) of this title in the case of home health services furnished to the individual.
• (c)
  • (1) The Secretary may initiate a proceeding to determine whether to impose a civil money penalty, assessment, or exclusion under subsection (a) or (b) only as authorized by the Attorney General pursuant to procedures agreed upon by them. The Secretary may not initiate an action under this section with respect to any claim, request for payment, or other occurrence described in this section later than six years after the date the claim was presented, the request for payment was made, or the occurrence took place. The Secretary may initiate an action under this section by serving notice of the action in any manner authorized by Rule 4 of the Federal Rules of Civil Procedure.
  • (2) The Secretary shall not make a determination adverse to any person under subsection (a) or (b) until the person has been given written notice and an opportunity for the determination to be made on the record after a hearing at which the person is entitled to be represented by counsel, to present witnesses, and to cross-examine witnesses against the person.
  • (3) In a proceeding under subsection (a) or (b) which—
    • (A) is against a person who has been convicted (whether upon a verdict after trial or upon a plea of guilty or nolo contendere) of a Federal crime charging fraud or false statements, and
    • (B) involves the same transaction as in the criminal action,
  • (4) The official conducting a hearing under this section may sanction a person, including any party or attorney, for failing to comply with an order or procedure, failing to defend an action, or other misconduct as would interfere with the speedy, orderly, or fair conduct of the hearing. Such sanction shall reasonably relate to the severity and nature of the failure or misconduct. Such sanction may include—
    • (A) in the case of refusal to provide or permit discovery, drawing negative factual inferences or treating such refusal as an admission by deeming the matter, or certain facts, to be established,
    • (B) prohibiting a party from introducing certain evidence or otherwise supporting a particular claim or defense,
    • (C) striking pleadings, in whole or in part,
    • (D) staying the proceedings,
    • (E) dismissal of the action,
    • (F) entering a default judgment,
    • (G) ordering the party or attorney to pay attorneys’ fees and other costs caused by the failure or misconduct, and
    • (H) refusing to consider any motion or other action which is not filed in a timely manner.
• (d) In determining the amount or scope of any penalty, assessment, or exclusion imposed pursuant to subsection (a) or (b), the Secretary shall take into account—
  • (1) the nature of claims and the circumstances under which they were presented,
  • (2) the degree of culpability, history of prior offenses, and financial condition of the person presenting the claims, and
  • (3) such other matters as justice may require.
• (e) Any person adversely affected by a determination of the Secretary under this section may obtain a review of such determination in the United States Court of Appeals for the circuit in which the person resides, or in which the claim or specified claim was presented, by filing in such court (within sixty days following the date the person is notified of the Secretary’s determination) a written petition requesting that the determination be modified or set aside. A copy of the petition shall be forthwith transmitted by the clerk of the court to the Secretary, and thereupon the Secretary shall file in the Court 12 12 So in original. Probably should not be capitalized. the record in the proceeding as provided in section 2112 of title 28 . Upon such filing, the court shall have jurisdiction of the proceeding and of the question determined therein, and shall have the power to make and enter upon the pleadings, testimony, and proceedings set forth in such record a decree affirming, modifying, remanding for further consideration, or setting aside, in whole or in part, the determination of the Secretary and enforcing the same to the extent that such order is affirmed or modified. No objection that has not been urged before the Secretary shall be considered by the court, unless the failure or neglect to urge such objection shall be excused because of extraordinary circumstances. The findings of the Secretary with respect to questions of fact, if supported by substantial evidence on the record considered as a whole, shall be conclusive. If any party shall apply to the court for leave to adduce additional evidence and shall show to the satisfaction of the court that such additional evidence is material and that there were reasonable grounds for the failure to adduce such evidence in the hearing before the Secretary, the court may order such additional evidence to be taken before the Secretary and to be made a part of the record. The Secretary may modify his findings as to the facts, or make new findings, by reason of additional evidence so taken and filed, and he shall file with the court such modified or new findings, which findings with respect to questions of fact, if supported by substantial evidence on the record considered as a whole, shall be conclusive, and his recommendations, if any, for the modification or setting aside of his original order. Upon the filing of the record with it, the jurisdiction of the court shall be exclusive and its judgment and decree shall be final, except that the same shall be subject to review by the Supreme Court of the United States, as provided in section 1254 of title 28 .
• (f) Civil money penalties and assessments imposed under this section may be compromised by the Secretary and may be recovered in a civil action in the name of the United States brought in United States district court for the district where the claim or specified claim (as defined in subsection (r)) was presented, or where the claimant (or, with respect to a person described in subsection ( o ), the person) resides, as determined by the Secretary. Amounts recovered under this section shall be paid to the Secretary and disposed of as follows:
  • (1)
    • (A) In the case of amounts recovered arising out of a claim under subchapter XIX, there shall be paid to the State agency an amount bearing the same proportion to the total amount recovered as the State’s share of the amount paid by the State agency for such claim bears to the total amount paid for such claim.
    • (B) In the case of amounts recovered arising out of a claim under an allotment to a State under subchapter V, there shall be paid to the State agency an amount equal to three-sevenths of the amount recovered.
  • (2) Such portion of the amounts recovered as is determined to have been paid out of the trust funds under sections 1395i and 1395t of this title shall be repaid to such trust funds.
  • (3) With respect to amounts recovered arising out of a claim under a Federal health care program (as defined in section 1320a–7b(f) of this title ), the portion of such amounts as is determined to have been paid by the program shall be repaid to the program, and the portion of such amounts attributable to the amounts recovered under this section by reason of the amendments made by the Health Insurance Portability and Accountability Act of 1996 (as estimated by the Secretary) shall be deposited into the Federal Hospital Insurance Trust Fund pursuant to section 1395i(k)(2)(C) of this title .
  • (4) The remainder of the amounts recovered shall be deposited as miscellaneous receipts of the Treasury of the United States.
• (g) A determination by the Secretary to impose a penalty, assessment, or exclusion under subsection (a) or (b) shall be final upon the expiration of the sixty-day period referred to in subsection (e). Matters that were raised or that could have been raised in a hearing before the Secretary or in an appeal pursuant to subsection (e) may not be raised as a defense to a civil action by the United States to collect a penalty, assessment, or exclusion assessed under this section.
• (h) Whenever the Secretary’s determination to impose a penalty, assessment, or exclusion under subsection (a) or (b) becomes final, he shall notify the appropriate State or local medical or professional organization, the appropriate State agency or agencies administering or supervising the administration of State health care programs (as defined in section 1320a–7(h) of this title ), and the appropriate utilization and quality control peer review organization, and the appropriate State or local licensing agency or organization (including the agency specified in section 1395aa(a) and 1396a(a)(33) of this title) that such a penalty, assessment, or exclusion has become final and the reasons therefor.
• (i) For the purposes of this section:
  • (1) The term “State agency” means the agency established or designated to administer or supervise the administration of the State plan under subchapter XIX of this chapter or designated to administer the State’s program under subchapter V or division A 13 13 See References in Text note below. of subchapter XX of this chapter.
  • (2) The term “claim” means an application for payments for items and services under a Federal health care program (as defined in section 1320a–7b(f) of this title ).
  • (3) The term “item or service” includes (A) any particular item, device, medical supply, or service claimed to have been provided to a patient and listed in an itemized claim for payment, and (B) in the case of a claim based on costs, any entry in the cost report, books of account or other documents supporting such claim.
  • (4) The term “agency of the United States” includes any contractor acting as a fiscal intermediary, carrier, or fiscal agent or any other claims processing agent for a Federal health care program (as so defined).
  • (5) The term “beneficiary” means an individual who is eligible to receive items or services for which payment may be made under a Federal health care program (as so defined) but does not include a provider, supplier, or practitioner.
  • (6) The term “remuneration” includes the waiver of coinsurance and deductible amounts (or any part thereof), and transfers of items or services for free or for other than fair market value. The term “remuneration” does not include—
    • (A) the waiver of coinsurance and deductible amounts by a person, if—
      • (i) the waiver is not offered as part of any advertisement or solicitation;
      • (ii) the person does not routinely waive coinsurance or deductible amounts; and
      • (iii) the person—
        • (I) waives the coinsurance and deductible amounts after determining in good faith that the individual is in financial need; or
        • (II) fails to collect coinsurance or deductible amounts after making reasonable collection efforts;
    • (B) subject to subsection (n), any permissible practice described in any subparagraph of section 1320a–7b(b)(3) of this title or in regulations issued by the Secretary;
    • (C) differentials in coinsurance and deductible amounts as part of a benefit plan design as long as the differentials have been disclosed in writing to all beneficiaries, third party payers, and providers, to whom claims are presented and as long as the differentials meet the standards as defined in regulations promulgated by the Secretary not later than 180 days after August 21, 1996 ;
    • (D) incentives given to individuals to promote the delivery of preventive care as determined by the Secretary in regulations so promulgated;
    • (E) a reduction in the copayment amount for covered OPD services under section 1395 l (t)(5)(B) 13 of this title; or 8
    • (F) any other remuneration which promotes access to care and poses a low risk of harm to patients and Federal health care programs (as defined in section 1320a–7b(f) of this title and designated by the Secretary under regulations);
    • (G) the offer or transfer of items or services for free or less than fair market value by a person, if—
      • (i) the items or services consist of coupons, rebates, or other rewards from a retailer;
      • (ii) the items or services are offered or transferred on equal terms available to the general public, regardless of health insurance status; and
      • (iii) the offer or transfer of the items or services is not tied to the provision of other items or services reimbursed in whole or in part by the program under subchapter XVIII or a State health care program (as defined in section 1320a–7(h) of this title );
    • (H) the offer or transfer of items or services for free or less than fair market value by a person, if—
      • (i) the items or services are not offered as part of any advertisement or solicitation;
      • (ii) the items or services are not tied to the provision of other services reimbursed in whole or in part by the program under subchapter XVIII or a State health care program (as so defined);
      • (iii) there is a reasonable connection between the items or services and the medical care of the individual; and
      • (iv) the person provides the items or services after determining in good faith that the individual is in financial need;
    • (I) effective on a date specified by the Secretary (but not earlier than January 1, 2011 ), the waiver by a PDP sponsor of a prescription drug plan under part D of subchapter XVIII or an MA organization offering an MA–PD plan under part C of such subchapter of any copayment for the first fill of a covered part D drug (as defined in section 1395w–102(e) of this title ) that is a generic drug for individuals enrolled in the prescription drug plan or MA–PD plan, respectively; or
    • (J) the provision of telehealth technologies (as defined by the Secretary) on or after January 1, 2019 , by a provider of services or a renal dialysis facility (as such terms are defined for purposes of subchapter XVIII) to an individual with end stage renal disease who is receiving home dialysis for which payment is being made under part B of such subchapter, if—
      • (i) the telehealth technologies are not offered as part of any advertisement or solicitation;
      • (ii) the telehealth technologies are provided for the purpose of furnishing telehealth services related to the individual’s end stage renal disease; and
      • (iii) the provision of the telehealth technologies meets any other requirements set forth in regulations promulgated by the Secretary.
  • (7) The term “should know” means that a person, with respect to information—
    • (A) acts in deliberate ignorance of the truth or falsity of the information; or
    • (B) acts in reckless disregard of the truth or falsity of the information,
• (j)
  • (1) The provisions of subsections (d) and (e) of section 405 of this title shall apply with respect to this section to the same extent as they are applicable with respect to subchapter II. The Secretary may delegate the authority granted by section 405(d) of this title (as made applicable to this section) to the Inspector General of the Department of Health and Human Services for purposes of any investigation under this section.
  • (2) The Secretary may delegate authority granted under this section and under section 1320a–7 of this title to the Inspector General of the Department of Health and Human Services.
• (k) Whenever the Secretary has reason to believe that any person has engaged, is engaging, or is about to engage in any activity which makes the person subject to a civil monetary penalty under this section, the Secretary may bring an action in an appropriate district court of the United States (or, if applicable, a United States court of any territory) to enjoin such activity, or to enjoin the person from concealing, removing, encumbering, or disposing of assets which may be required in order to pay a civil monetary penalty if any such penalty were to be imposed or to seek other appropriate relief.
• (l) A principal is liable for penalties, assessments, and an exclusion under this section for the actions of the principal’s agent acting within the scope of the agency.
• (m)
  • (1) For purposes of this section, with respect to a Federal health care program not contained in this chapter, references to the Secretary in this section shall be deemed to be references to the Secretary or Administrator of the department or agency with jurisdiction over such program and references to the Inspector General of the Department of Health and Human Services in this section shall be deemed to be references to the Inspector General of the applicable department or agency.
  • (2)
    • (A) The Secretary and Administrator of the departments and agencies referred to in paragraph (1) may include in any action pursuant to this section, claims within the jurisdiction of other Federal departments or agencies as long as the following conditions are satisfied:
      • (i) The case involves primarily claims submitted to the Federal health care programs of the department or agency initiating the action.
      • (ii) The Secretary or Administrator of the department or agency initiating the action gives notice and an opportunity to participate in the investigation to the Inspector General of the department or agency with primary jurisdiction over the Federal health care programs to which the claims were submitted.
    • (B) If the conditions specified in subparagraph (A) are fulfilled, the Inspector General of the department or agency initiating the action is authorized to exercise all powers granted under the Inspector General Act of 1978 (5 U.S.C. App.) with respect to the claims submitted to the other departments or agencies to the same manner and extent as provided in that Act with respect to claims submitted to such departments or agencies.
• (n)
  • (1) Subparagraph (B) of subsection (i)(6) shall not apply to a practice described in paragraph (2) unless—
    • (A) the Secretary, through the Inspector General of the Department of Health and Human Services, promulgates a rule authorizing such a practice as an exception to remuneration; and
    • (B) the remuneration is offered or transferred by a person under such rule during the 2-year period beginning on the date the rule is first promulgated.
  • (2) A practice described in this paragraph is a practice under which a health care provider or facility pays, in whole or in part, premiums for medicare supplemental policies for individuals entitled to benefits under part A of subchapter XVIII pursuant to section 426–1 of this title .
• (o) Any person (including an organization, agency, or other entity, but excluding a program beneficiary, as defined in subsection (q)(4)) that, with respect to a grant, contract, or other agreement for which the Secretary provides funding—
  • (1) knowingly presents or causes to be presented a specified claim (as defined in subsection (r)) under such grant, contract, or other agreement that the person knows or should know is false or fraudulent;
  • (2) knowingly makes, uses, or causes to be made or used any false statement, omission, or misrepresentation of a material fact in any application, proposal, bid, progress report, or other document that is required to be submitted in order to directly or indirectly receive or retain funds provided in whole or in part by such Secretary pursuant to such grant, contract, or other agreement;
  • (3) knowingly makes, uses, or causes to be made or used, a false record or statement material to a false or fraudulent specified claim under such grant, contract, or other agreement;
  • (4) knowingly makes, uses, or causes to be made or used, a false record or statement material to an obligation (as defined in subsection (s)) to pay or transmit funds or property to such Secretary with respect to such grant, contract, or other agreement, or knowingly conceals or knowingly and improperly avoids or decreases an obligation to pay or transmit funds or property to such Secretary with respect to such grant, contract, or other agreement; or
  • (5) fails to grant timely access, upon reasonable request (as defined by such Secretary in regulations), to the Inspector General of the Department, for the purpose of audits, investigations, evaluations, or other statutory functions of such Inspector General in matters involving such grants, contracts, or other agreements;
• (p) The provisions of subsections (c), (d), (g), and (h) shall apply to a civil money penalty or assessment under subsection ( o ) in the same manner as such provisions apply to a penalty, assessment, or proceeding under subsection (a). In applying subsection (d), each reference to a claim under such subsection shall be treated as including a reference to a specified claim (as defined in subsection (r)).
• (q) For purposes of this subsection and subsections ( o ) and (p):
  • (1) The term “Department” means the Department of Health and Human Services.
  • (2) The term “material” means having a natural tendency to influence, or be capable of influencing, the payment or receipt of money or property.
  • (3) The term “other agreement” includes a cooperative agreement, scholarship, fellowship, loan, subsidy, payment for a specified use, donation agreement, award, or subaward (regardless of whether one or more of the persons entering into the agreement is a contractor or subcontractor).
  • (4) The term “program beneficiary” means, in the case of a grant, contract, or other agreement designed to accomplish the objective of awarding or otherwise furnishing benefits or assistance to individuals and for which the Secretary provides funding, an individual who applies for, or who receives, such benefits or assistance from such grant, contract, or other agreement. Such term does not include, with respect to such grant, contract, or other agreement, an officer, employee, or agent of a person or entity that receives such grant or that enters into such contract or other agreement.
  • (5) The term “recipient” includes a subrecipient or subcontractor.
  • (6) The term “specified State agency” means an agency of a State government established or designated to administer or supervise the administration of a grant, contract, or other agreement funded in whole or in part by the Secretary.
• (r) For purposes of this section, the term “specified claim” means any application, request, or demand under a grant, contract, or other agreement for money or property, whether or not the United States or a specified State agency has title to the money or property, that is not a claim (as defined in subsection (i)(2)) and that—
  • (1) is presented or caused to be presented to an officer, employee, or agent of the Department or agency thereof, or of any specified State agency; or
  • (2) is made to a contractor, grantee, or any other recipient if the money or property is to be spent or used on the Department’s behalf or to advance a Department program or interest, and if the Department—
    • (A) provides or has provided any portion of the money or property requested or demanded; or
    • (B) will reimburse such contractor, grantee, or other recipient for any portion of the money or property which is requested or demanded.
• (s) For purposes of subsection ( o ), the term “obligation” means an established duty, whether or not fixed, arising from an express or implied contractual, grantor-grantee, or licensor-licensee relationship, for a fee-based or similar relationship, from statute or regulation, or from the retention of any overpayment.

§ 1320a–7b. Criminal penalties for acts involving Federal health care programs

• (a) Whoever—
  • (1) knowingly and willfully makes or causes to be made any false statement or representation of a material fact in any application for any benefit or payment under a Federal health care program (as defined in subsection (f)),
  • (2) at any time knowingly and willfully makes or causes to be made any false statement or representation of a material fact for use in determining rights to such benefit or payment,
  • (3) having knowledge of the occurrence of any event affecting (A) his initial or continued right to any such benefit or payment, or (B) the initial or continued right to any such benefit or payment of any other individual in whose behalf he has applied for or is receiving such benefit or payment, conceals or fails to disclose such event with an intent fraudulently to secure such benefit or payment either in a greater amount or quantity than is due or when no such benefit or payment is authorized,
  • (4) having made application to receive any such benefit or payment for the use and benefit of another and having received it, knowingly and willfully converts such benefit or payment or any part thereof to a use other than for the use and benefit of such other person,
  • (5) presents or causes to be presented a claim for a physician’s service for which payment may be made under a Federal health care program and knows that the individual who furnished the service was not licensed as a physician, or
  • (6) for a fee knowingly and willfully counsels or assists an individual to dispose of assets (including by any transfer in trust) in order for the individual to become eligible for medical assistance under a State plan under subchapter XIX, if disposing of the assets results in the imposition of a period of ineligibility for such assistance under section 1396p(c) of this title ,
• (b)
  • (1) Whoever knowingly and willfully solicits or receives any remuneration (including any kickback, bribe, or rebate) directly or indirectly, overtly or covertly, in cash or in kind—
    • (A) in return for referring an individual to a person for the furnishing or arranging for the furnishing of any item or service for which payment may be made in whole or in part under a Federal health care program, or
    • (B) in return for purchasing, leasing, ordering, or arranging for or recommending purchasing, leasing, or ordering any good, facility, service, or item for which payment may be made in whole or in part under a Federal health care program,
  • (2) Whoever knowingly and willfully offers or pays any remuneration (including any kickback, bribe, or rebate) directly or indirectly, overtly or covertly, in cash or in kind to any person to induce such person—
    • (A) to refer an individual to a person for the furnishing or arranging for the furnishing of any item or service for which payment may be made in whole or in part under a Federal health care program, or
    • (B) to purchase, lease, order, or arrange for or recommend purchasing, leasing, or ordering any good, facility, service, or item for which payment may be made in whole or in part under a Federal health care program,
  • (3) Paragraphs (1) and (2) shall not apply to—
    • (A) a discount or other reduction in price obtained by a provider of services or other entity under a Federal health care program if the reduction in price is properly disclosed and appropriately reflected in the costs claimed or charges made by the provider or entity under a Federal health care program;
    • (B) any amount paid by an employer to an employee (who has a bona fide employment relationship with such employer) for employment in the provision of covered items or services;
    • (C) any amount paid by a vendor of goods or services to a person authorized to act as a purchasing agent for a group of individuals or entities who are furnishing services reimbursed under a Federal health care program if—
      • (i) the person has a written contract, with each such individual or entity, which specifies the amount to be paid the person, which amount may be a fixed amount or a fixed percentage of the value of the purchases made by each such individual or entity under the contract, and
      • (ii) in the case of an entity that is a provider of services (as defined in section 1395x(u) of this title ), the person discloses (in such form and manner as the Secretary requires) to the entity and, upon request, to the Secretary the amount received from each such vendor with respect to purchases made by or on behalf of the entity;
    • (D) a waiver of any coinsurance under part B of subchapter XVIII by a Federally qualified health care center with respect to an individual who qualifies for subsidized services under a provision of the Public Health Service Act [ 42 U.S.C. 201 et seq.];
    • (E) any payment practice specified by the Secretary in regulations promulgated pursuant to section 14(a) of the Medicare and Medicaid Patient and Program Protection Act of 1987 or in regulations under section 1395w–104(e)(6) 1 1 See References in Text note below. of this title;
    • (F) any remuneration between an organization and an individual or entity providing items or services, or a combination thereof, pursuant to a written agreement between the organization and the individual or entity if the organization is an eligible organization under section 1395mm of this title or if the written agreement, through a risk-sharing arrangement, places the individual or entity at substantial financial risk for the cost or utilization of the items or services, or a combination thereof, which the individual or entity is obligated to provide;
    • (G) the waiver or reduction by pharmacies (including pharmacies of the Indian Health Service, Indian tribes, tribal organizations, and urban Indian organizations) of any cost-sharing imposed under part D of subchapter XVIII, if the conditions described in clauses (i) through (iii) of section 1320a–7a(i)(6)(A) of this title are met with respect to the waiver or reduction (except that, in the case of such a waiver or reduction on behalf of a subsidy eligible individual (as defined in section 1395w–114(a)(3) of this title ), section 1320a–7a(i)(6)(A) of this title shall be applied without regard to clauses (ii) and (iii) of that section);
    • (H) any remuneration between a federally qualified health center (or an entity controlled by such a health center) and an MA organization pursuant to a written agreement described in section 1395w–23(a)(4) of this title ;
    • (I) any remuneration between a health center entity described under clause (i) or (ii) of section 1396d( l )(2)(B) of this title and any individual or entity providing goods, items, services, donations, loans, or a combination thereof, to such health center entity pursuant to a contract, lease, grant, loan, or other agreement, if such agreement contributes to the ability of the health center entity to maintain or increase the availability, or enhance the quality, of services provided to a medically underserved population served by the health center entity;
    • (J) a discount in the price of an applicable drug (as defined in paragraph (2) of section 1395w–114a(g) of this title ) of a manufacturer that is furnished to an applicable beneficiary (as defined in paragraph (1) of such section) under the Medicare coverage gap discount program under section 1395w–114a of this title ; and
    • (K) an incentive payment made to a Medicare fee-for-service beneficiary by an ACO under an ACO Beneficiary Incentive Program established under subsection (m) of section 1395jjj of this title , if the payment is made in accordance with the requirements of such subsection and meets such other conditions as the Secretary may establish.
  • (4) Whoever without lawful authority knowingly and willfully purchases, sells or distributes, or arranges for the purchase, sale, or distribution of a beneficiary identification number or unique health identifier for a health care provider under subchapter XVIII, subchapter XIX, or subchapter XXI shall be imprisoned for not more than 10 years or fined not more than $500,000 ($1,000,000 in the case of a corporation), or both.
• (c) Whoever knowingly and willfully makes or causes to be made, or induces or seeks to induce the making of, any false statement or representation of a material fact with respect to the conditions or operation of any institution, facility, or entity in order that such institution, facility, or entity may qualify (either upon initial certification or upon recertification) as a hospital, critical access hospital, skilled nursing facility, nursing facility, intermediate care facility for the mentally retarded, home health agency, or other entity (including an eligible organization under section 1395mm(b) of this title ) for which certification is required under subchapter XVIII or a State health care program (as defined in section 1320a–7(h) of this title ), or with respect to information required to be provided under section 1320a–3a of this title , shall be guilty of a felony and upon conviction thereof shall be fined not more than $100,000 or imprisoned for not more than 10 years, or both.
• (d) Whoever knowingly and willfully—
  • (1) charges, for any service provided to a patient under a State plan approved under subchapter XIX, money or other consideration at a rate in excess of the rates established by the State (or, in the case of services provided to an individual enrolled with a medicaid managed care organization under subchapter XIX under a contract under section 1396b(m) of this title or under a contractual, referral, or other arrangement under such contract, at a rate in excess of the rate permitted under such contract), or
  • (2) charges, solicits, accepts, or receives, in addition to any amount otherwise required to be paid under a State plan approved under subchapter XIX, any gift, money, donation, or other consideration (other than a charitable, religious, or philanthropic contribution from an organization or from a person unrelated to the patient)—
    • (A) as a precondition of admitting a patient to a hospital, nursing facility, or intermediate care facility for the mentally retarded, or
    • (B) as a requirement for the patient’s continued stay in such a facility,
• (e) Whoever accepts assignments described in section 1395u(b)(3)(B)(ii) of this title or agrees to be a participating physician or supplier under section 1395u(h)(1) of this title and knowingly, willfully, and repeatedly violates the term of such assignments or agreement, shall be guilty of a misdemeanor and upon conviction thereof shall be fined not more than $4,000 or imprisoned for not more than six months, or both.
• (f) For purposes of this section, the term “Federal health care program” means—
  • (1) any plan or program that provides health benefits, whether directly, through insurance, or otherwise, which is funded directly, in whole or in part, by the United States Government (other than the health insurance program under chapter 89 of title 5); or
  • (2) any State health care program, as defined in section 1320a–7(h) of this title .
• (g) In addition to the penalties provided for in this section or section 1320a–7a of this title , a claim that includes items or services resulting from a violation of this section constitutes a false or fraudulent claim for purposes of subchapter III of chapter 37 of title 31.
• (h) With respect to violations of this section, a person need not have actual knowledge of this section or specific intent to commit a violation of this section.

§ 1320a–7c. Fraud and abuse control program

• (a)
  • (1) Not later than January 1, 1997 , the Secretary, acting through the Office of the Inspector General of the Department of Health and Human Services, and the Attorney General shall establish a program—
    • (A) to coordinate Federal, State, and local law enforcement programs to control fraud and abuse with respect to health plans,
    • (B) to conduct investigations, audits, evaluations, and inspections relating to the delivery of and payment for health care in the United States,
    • (C) to facilitate the enforcement of the provisions of sections 1320a–7, 1320a–7a, and 1320a–7b of this title and other statutes applicable to health care fraud and abuse, and
    • (D) to provide for the modification and establishment of safe harbors and to issue advisory opinions and special fraud alerts pursuant to section 1320a–7d of this title .
  • (2) In carrying out the program established under paragraph (1), the Secretary and the Attorney General shall consult with, and arrange for the sharing of data with representatives of health plans.
  • (3)
    • (A) The Secretary and the Attorney General shall issue guidelines to carry out the program under paragraph (1). The provisions of sections 553, 556, and 557 of title 5 shall not apply in the issuance of such guidelines.
    • (B)
      • (i) Such guidelines shall include guidelines relating to the furnishing of information by health plans, providers, and others to enable the Secretary and the Attorney General to carry out the program (including coordination with health plans under paragraph (2)).
      • (ii) Such guidelines shall include procedures to assure that such information is provided and utilized in a manner that appropriately protects the confidentiality of the information and the privacy of individuals receiving health care services and items.
      • (iii) The provisions of section 1320c–6(a) of this title (relating to limitation on liability) shall apply to a person providing information to the Secretary or the Attorney General in conjunction with their performance of duties under this section.
  • (4) The Inspector General of the Department of Health and Human Services is authorized to exercise such authority described in paragraphs (3) through (9) of section 6 1 1 See References in Text note below. of the Inspector General Act of 1978 (5 U.S.C. App.) as necessary with respect to the activities under the fraud and abuse control program established under this subsection.
  • (5) Nothing in this chapter shall be construed to diminish the authority of any Inspector General, including such authority as provided in the Inspector General Act of 1978 (5 U.S.C. App.).
• (b)
  • (1) The Inspector General of the Department of Health and Human Services is authorized to receive and retain for current use reimbursement for the costs of conducting investigations and audits and for monitoring compliance plans when such costs are ordered by a court, voluntarily agreed to by the payor, or otherwise.
  • (2) Funds received by the Inspector General under paragraph (1) as reimbursement for costs of conducting investigations shall be deposited to the credit of the appropriation from which initially paid, or to appropriations for similar purposes currently available at the time of deposit, and shall remain available for obligation for 1 year from the date of the deposit of such funds.
• (c) For purposes of this section, the term “health plan” means a plan or program that provides health benefits, whether directly, through insurance, or otherwise, and includes—
  • (1) a policy of health insurance;
  • (2) a contract of a service benefit organization; and
  • (3) a membership agreement with a health maintenance organization or other prepaid health plan.

§ 1320a–7d. Guidance regarding application of health care fraud and abuse sanctions

• (a)
  • (1)
    • (A) Not later than January 1, 1997 , and not less than annually thereafter, the Secretary shall publish a notice in the Federal Register soliciting proposals, which will be accepted during a 60-day period, for—
      • (i) modifications to existing safe harbors issued pursuant to section 14(a) of the Medicare and Medicaid Patient and Program Protection Act of 1987 ( 42 U.S.C. 1320a–7b note);
      • (ii) additional safe harbors specifying payment practices that shall not be treated as a criminal offense under section 1320a–7b(b) of this title and shall not serve as the basis for an exclusion under section 1320a–7(b)(7) of this title ;
      • (iii) advisory opinions to be issued pursuant to subsection (b); and
      • (iv) special fraud alerts to be issued pursuant to subsection (c).
    • (B) After considering the proposals described in clauses (i) and (ii) of subparagraph (A), the Secretary, in consultation with the Attorney General, shall publish in the Federal Register proposed modifications to existing safe harbors and proposed additional safe harbors, if appropriate, with a 60-day comment period. After considering any public comments received during this period, the Secretary shall issue final rules modifying the existing safe harbors and establishing new safe harbors, as appropriate.
    • (C) The Inspector General of the Department of Health and Human Services (in this section referred to as the “Inspector General”) shall, in an annual report to Congress or as part of the year-end semiannual report required by section 5 of the Inspector General Act of 1978 (5 U.S.C. App.), describe the proposals received under clauses (i) and (ii) of subparagraph (A) and explain which proposals were included in the publication described in subparagraph (B), which proposals were not included in that publication, and the reasons for the rejection of the proposals that were not included.
  • (2) In modifying and establishing safe harbors under paragraph (1)(B), the Secretary may consider the extent to which providing a safe harbor for the specified payment practice may result in any of the following:
    • (A) An increase or decrease in access to health care services.
    • (B) An increase or decrease in the quality of health care services.
    • (C) An increase or decrease in patient freedom of choice among health care providers.
    • (D) An increase or decrease in competition among health care providers.
    • (E) An increase or decrease in the ability of health care facilities to provide services in medically underserved areas or to medically underserved populations.
    • (F) An increase or decrease in the cost to Federal health care programs (as defined in section 1320a–7b(f) of this title ).
    • (G) An increase or decrease in the potential overutilization of health care services.
    • (H) The existence or nonexistence of any potential financial benefit to a health care professional or provider which may vary based on their decisions of—
      • (i) whether to order a health care item or service; or
      • (ii) whether to arrange for a referral of health care items or services to a particular practitioner or provider.
    • (I) Any other factors the Secretary deems appropriate in the interest of preventing fraud and abuse in Federal health care programs (as so defined).
• (b)
  • (1) The Secretary, in consultation with the Attorney General, shall issue written advisory opinions as provided in this subsection.
  • (2) The Secretary shall issue advisory opinions as to the following matters:
    • (A) What constitutes prohibited remuneration within the meaning of section 1320a–7b(b) of this title or section 1320a–7a(i)(6) of this title .
    • (B) Whether an arrangement or proposed arrangement satisfies the criteria set forth in section 1320a–7b(b)(3) of this title for activities which do not result in prohibited remuneration.
    • (C) Whether an arrangement or proposed arrangement satisfies the criteria which the Secretary has established, or shall establish by regulation for activities which do not result in prohibited remuneration.
    • (D) What constitutes an inducement to reduce or limit services to individuals entitled to benefits under subchapter XVIII or subchapter XIX within the meaning of section 1320a–7a(b) of this title .
    • (E) Whether any activity or proposed activity constitutes grounds for the imposition of a sanction under section 1320a–7, 1320a–7a, or 1320a–7b of this title.
  • (3) Such advisory opinions shall not address the following matters:
    • (A) Whether the fair market value shall be, or was paid or received for any goods, services or property.
    • (B) Whether an individual is a bona fide employee within the requirements of section 3121(d)(2) of the Internal Revenue Code of 1986.
  • (4)
    • (A) Each advisory opinion issued by the Secretary shall be binding as to the Secretary and the party or parties requesting the opinion.
    • (B) The failure of a party to seek an advisory opinion may not be introduced into evidence to prove that the party intended to violate the provisions of sections 1 1 So in original. Probably should be “section”. 1320a–7, 1320a–7a, or 1320a–7b of this title.
  • (5)
    • (A) Not later than 180 days after August 21, 1996 , the Secretary shall issue regulations to carry out this section. Such regulations shall provide for—
      • (i) the procedure to be followed by a party applying for an advisory opinion;
      • (ii) the procedure to be followed by the Secretary in responding to a request for an advisory opinion;
      • (iii) the interval in which the Secretary shall respond;
      • (iv) the reasonable fee to be charged to the party requesting an advisory opinion; and
      • (v) the manner in which advisory opinions will be made available to the public.
    • (B) Under the regulations promulgated pursuant to subparagraph (A)—
      • (i) the Secretary shall be required to issue to a party requesting an advisory opinion by not later than 60 days after the request is received; and
      • (ii) the fee charged to the party requesting an advisory opinion shall be equal to the costs incurred by the Secretary in responding to the request.
  • (6) This subsection shall apply to requests for advisory opinions made on or after the date which is 6 months after August 21, 1996 .
• (c)
  • (1)
    • (A) Any person may present, at any time, a request to the Inspector General for a notice which informs the public of practices which the Inspector General considers to be suspect or of particular concern under the Medicare program under subchapter XVIII or a State health care program, as defined in section 1320a–7(h) of this title (in this subsection referred to as a “special fraud alert”).
    • (B) Upon receipt of a request described in subparagraph (A), the Inspector General shall investigate the subject matter of the request to determine whether a special fraud alert should be issued. If appropriate, the Inspector General shall issue a special fraud alert in response to the request. All special fraud alerts issued pursuant to this subparagraph shall be published in the Federal Register.
  • (2) In determining whether to issue a special fraud alert upon a request described in paragraph (1), the Inspector General may consider—
    • (A) whether and to what extent the practices that would be identified in the special fraud alert may result in any of the consequences described in subsection (a)(2); and
    • (B) the volume and frequency of the conduct that would be identified in the special fraud alert.

§ 1320a–7e. Health care fraud and abuse data collection program

• (a) The Secretary shall maintain a national health care fraud and abuse data collection program under this section for the reporting of certain final adverse actions (not including settlements in which no findings of liability have been made) against health care providers, suppliers, or practitioners as required by subsection (b), with access as set forth in subsection (d), and shall furnish the information collected under this section to the National Practitioner Data Bank established pursuant to the Health Care Quality Improvement Act of 1986 ( 42 U.S.C. 11101 et seq.).
• (b)
  • (1) Each Government agency and health plan shall report any final adverse action (not including settlements in which no findings of liability have been made) taken against a health care provider, supplier, or practitioner.
  • (2) The information to be reported under paragraph (1) includes:
    • (A) The name and TIN (as defined in section 7701(a)(41) of the Internal Revenue Code of 1986) of any health care provider, supplier, or practitioner who is the subject of a final adverse action.
    • (B) The name (if known) of any health care entity with which a health care provider, supplier, or practitioner, who is the subject of a final adverse action, is affiliated or associated.
    • (C) The nature of the final adverse action and whether such action is on appeal.
    • (D) A description of the acts or omissions and injuries upon which the final adverse action was based, and such other information as the Secretary determines by regulation is required for appropriate interpretation of information reported under this section.
  • (3) In determining what information is required, the Secretary shall include procedures to assure that the privacy of individuals receiving health care services is appropriately protected.
  • (4) The information required to be reported under this subsection shall be reported regularly (but not less often than monthly) and in such form and manner as the Secretary prescribes. Such information shall first be required to be reported on a date specified by the Secretary.
  • (5) The information required to be reported under this subsection shall be reported to the Secretary.
  • (6)
    • (A) Any health plan that fails to report information on an adverse action required to be reported under this subsection shall be subject to a civil money penalty of not more than $25,000 for each such adverse action not reported. Such penalty shall be imposed and collected in the same manner as civil money penalties under subsection (a) of section 1320a–7a of this title are imposed and collected under that section.
    • (B) The Secretary shall provide for a publication of a public report that identifies those Government agencies that have failed to report information on adverse actions as required to be reported under this subsection.
• (c)
  • (1) With respect to the information about final adverse actions (not including settlements in which no findings of liability have been made) reported to the Secretary under this section with respect to a health care provider, supplier, or practitioner, the Secretary shall, by regulation, provide for—
    • (A) disclosure of the information, upon request, to the health care provider, supplier, or licensed practitioner, and
    • (B) procedures in the case of disputed accuracy of the information.
  • (2) Each Government agency and health plan shall report corrections of information already reported about any final adverse action taken against a health care provider, supplier, or practitioner, in such form and manner that the Secretary prescribes by regulation.
• (d)
  • (1) The information collected under this section shall be available from the National Practitioner Data Bank to the agencies, authorities, and officials which are provided under section 1396r–2(b) of this title information reported under section 1396r–2(a) of this title .
  • (2) The Secretary may establish or approve reasonable fees for the disclosure of information under this section. The amount of such a fee may not exceed the costs of processing the requests for disclosure and of providing such information. Such fees shall be available to the Secretary to cover such costs.
• (e) No person or entity, including the agency designated by the Secretary in subsection (b)(5) shall be held liable in any civil action with respect to any report made as required by this section, without knowledge of the falsity of the information contained in the report.
• (f) In implementing this section, the Secretary shall provide for the maximum appropriate coordination with part B of the Health Care Quality Improvement Act of 1986 ( 42 U.S.C. 11131 et seq.) and section 1396r–2 of this title .
• (g) For purposes of this section:
  • (1)
    • (A) The term “final adverse action” includes:
      • (i) Civil judgments against a health care provider, supplier, or practitioner in Federal or State court related to the delivery of a health care item or service.
      • (ii) Federal or State criminal convictions related to the delivery of a health care item or service.
      • (iii) Actions by Federal agencies responsible for the licensing and certification of health care providers, suppliers, and licensed health care practitioners, including—
        • (I) formal or official actions, such as revocation or suspension of a license (and the length of any such suspension), reprimand, censure or probation,
        • (II) any dismissal or closure of the proceedings by reason of the provider, supplier, or practitioner surrendering their license or leaving the State or jurisdiction 1 1 So in original. Probably should be followed by a comma.
        • (III) any other loss of license or the right to apply for, or renew, a license of the provider, supplier, or practitioner, whether by operation of law, voluntary surrender, non-renewability, or otherwise, or
        • (IV) any other negative action or finding by such Federal agency that is publicly available information.
      • (iv) Exclusion from participation in a Federal health care program (as defined in section 1320a–7b(f) of this title ).
      • (v) Any other adjudicated actions or decisions that the Secretary shall establish by regulation.
    • (B) The term does not include any action with respect to a malpractice claim.
  • (2) The terms “licensed health care practitioner”, “licensed practitioner”, and “practitioner” mean, with respect to a State, an individual who is licensed or otherwise authorized by the State to provide health care services (or any individual who, without authority holds himself or herself out to be so licensed or authorized).
  • (3) The term “Government agency” shall include:
    • (A) The Department of Justice.
    • (B) The Department of Health and Human Services.
    • (C) Any other Federal agency that either administers or provides payment for the delivery of health care services, including, but not limited to the Department of Defense and the Department of Veterans Affairs.
    • (D) Federal agencies responsible for the licensing and certification of health care providers and licensed health care practitioners.
  • (4) The term “health plan” has the meaning given such term by section 1320a–7c(c) of this title .
  • (5) For purposes of paragraph (1), the existence of a conviction shall be determined under paragraphs (1) through (4) of section 1320a–7(i) of this title .

§ 1320a–7f. Coordination of medicare and medicaid surety bond provisions

In the case of a home health agency that is subject to a surety bond requirement under subchapter XVIII and subchapter XIX, the surety bond provided to satisfy the requirement under one such subchapter shall satisfy the requirement under the other such subchapter so long as the bond applies to guarantee return of overpayments under both such subchapters.

§ 1320a–7g. Funds to reduce medicaid fraud and abuse

• (1) For purposes of reducing fraud and abuse in the Medicaid program under title XIX of the Social Security Act [ 42 U.S.C. 1396 et seq.]—
  • (A) there is appropriated to the Office of the Inspector General of the Department of Health and Human Services, out of any money in the Treasury not otherwise appropriated, $25,000,000, for fiscal year 2009; and
  • (B) there is authorized to be appropriated to such Office $25,000,000 for fiscal year 2010 and each subsequent fiscal year.
• (2) Not later than September 30 of 2009 and of each subsequent year, the Inspector General of the Department of Health and Human Services shall submit to the Committees on Energy and Commerce and Appropriations of the House of Representatives and the Committees on Finance and Appropriations of the Senate a report on the activities (and the results of such activities) funded under paragraph (1) to reduce waste, fraud, and abuse in the Medicaid program under title XIX of the Social Security Act [ 42 U.S.C. 1396 et seq.] during the previous 12 month period, including the amount of funds appropriated under such paragraph for each such activity and an estimate of the savings to the Medicaid program resulting from each such activity.

§ 1320a–7h. Transparency reports and reporting of physician ownership or investment interests

• (a)
  • (1)
    • (A) On March 31, 2013 , and on the 90th day of each calendar year beginning thereafter, any applicable manufacturer that provides a payment or other transfer of value to a covered recipient (or to an entity or individual at the request of or designated on behalf of a covered recipient), shall submit to the Secretary, in such electronic form as the Secretary shall require, the following information with respect to the preceding calendar year:
      • (i) The name of the covered recipient.
      • (ii) The business address of the covered recipient and, in the case of a covered recipient who is a physician, the specialty and National Provider Identifier of the covered recipient.
      • (iii) The amount of the payment or other transfer of value.
      • (iv) The dates on which the payment or other transfer of value was provided to the covered recipient.
      • (v) A description of the form of the payment or other transfer of value, indicated (as appropriate for all that apply) as—
        • (I) cash or a cash equivalent;
        • (II) in-kind items or services;
        • (III) stock, a stock option, or any other ownership interest, dividend, profit, or other return on investment; or
        • (IV) any other form of payment or other transfer of value (as defined by the Secretary).
      • (vi) A description of the nature of the payment or other transfer of value, indicated (as appropriate for all that apply) as—
        • (I) consulting fees;
        • (II) compensation for services other than consulting;
        • (III) honoraria;
        • (IV) gift;
        • (V) entertainment;
        • (VI) food;
        • (VII) travel (including the specified destinations);
        • (VIII) education;
        • (IX) research;
        • (X) charitable contribution;
        • (XI) royalty or license;
        • (XII) current or prospective ownership or investment interest;
        • (XIII) direct compensation for serving as faculty or as a speaker for a medical education program;
        • (XIV) grant; or
        • (XV) any other nature of the payment or other transfer of value (as defined by the Secretary).
      • (vii) If the payment or other transfer of value is related to marketing, education, or research specific to a covered drug, device, biological, or medical supply, the name of that covered drug, device, biological, or medical supply.
      • (viii) Any other categories of information regarding the payment or other transfer of value the Secretary determines appropriate.
    • (B) In the case where an applicable manufacturer provides a payment or other transfer of value to an entity or individual at the request of or designated on behalf of a covered recipient, the applicable manufacturer shall disclose that payment or other transfer of value under the name of the covered recipient.
  • (2) In addition to the requirement under paragraph (1)(A), on March 31, 2013 , and on the 90th day of each calendar year beginning thereafter, any applicable manufacturer or applicable group purchasing organization shall submit to the Secretary, in such electronic form as the Secretary shall require, the following information regarding any ownership or investment interest (other than an ownership or investment interest in a publicly traded security and mutual fund, as described in section 1395nn(c) of this title ) held by a physician (or an immediate family member of such physician (as defined for purposes of section 1395nn(a) of this title )) in the applicable manufacturer or applicable group purchasing organization during the preceding year:
    • (A) The dollar amount invested by each physician holding such an ownership or investment interest.
    • (B) The value and terms of each such ownership or investment interest.
    • (C) Any payment or other transfer of value provided to a physician holding such an ownership or investment interest (or to an entity or individual at the request of or designated on behalf of a physician holding such an ownership or investment interest), including the information described in clauses (i) through (viii) of paragraph (1)(A), except that in applying such clauses, “physician” shall be substituted for “covered recipient” each place it appears.
    • (D) Any other information regarding the ownership or investment interest the Secretary determines appropriate.
• (b)
  • (1)
    • (A) Subject to subparagraph (B) except as provided in paragraph (2), any applicable manufacturer or applicable group purchasing organization that fails to submit information required under subsection (a) in a timely manner in accordance with rules or regulations promulgated to carry out such subsection, shall be subject to a civil money penalty of not less than $1,000, but not more than $10,000, for each payment or other transfer of value or ownership or investment interest not reported as required under such subsection. Such penalty shall be imposed and collected in the same manner as civil money penalties under subsection (a) of section 1320a–7a of this title are imposed and collected under that section.
    • (B) The total amount of civil money penalties imposed under subparagraph (A) with respect to each annual submission of information under subsection (a) by an applicable manufacturer or applicable group purchasing organization shall not exceed $150,000.
  • (2)
    • (A) Subject to subparagraph (B), any applicable manufacturer or applicable group purchasing organization that knowingly fails to submit information required under subsection (a) in a timely manner in accordance with rules or regulations promulgated to carry out such subsection, shall be subject to a civil money penalty of not less than $10,000, but not more than $100,000, for each payment or other transfer of value or ownership or investment interest not reported as required under such subsection. Such penalty shall be imposed and collected in the same manner as civil money penalties under subsection (a) of section 1320a–7a of this title are imposed and collected under that section.
    • (B) The total amount of civil money penalties imposed under subparagraph (A) with respect to each annual submission of information under subsection (a) by an applicable manufacturer or applicable group purchasing organization shall not exceed $1,000,000.
  • (3) Funds collected by the Secretary as a result of the imposition of a civil money penalty under this subsection shall be used to carry out this section.
• (c)
  • (1)
    • (A) Not later than October 1, 2011 , the Secretary shall establish procedures—
      • (i) for applicable manufacturers and applicable group purchasing organizations to submit information to the Secretary under subsection (a); and
      • (ii) for the Secretary to make such information submitted available to the public.
    • (B) The procedures established under subparagraph (A) shall provide for the definition of terms (other than those terms defined in subsection (e)), as appropriate, for purposes of this section.
    • (C) Except as provided in subparagraph (E), the procedures established under subparagraph (A)(ii) shall ensure that, not later than September 30, 2013 , and on June 30 of each calendar year beginning thereafter, the information submitted under subsection (a) with respect to the preceding calendar year is made available through an Internet website that—
      • (i) is searchable and is in a format that is clear and understandable;
      • (ii) contains information that is presented by the name of the applicable manufacturer or applicable group purchasing organization, the name of the covered recipient, the business address of the covered recipient, the specialty of the covered recipient, the value of the payment or other transfer of value, the date on which the payment or other transfer of value was provided to the covered recipient, the form of the payment or other transfer of value, indicated (as appropriate) under subsection (a)(1)(A)(v), the nature of the payment or other transfer of value, indicated (as appropriate) under subsection (a)(1)(A)(vi), and the name of the covered drug, device, biological, or medical supply, as applicable;
      • (iii) contains information that is able to be easily aggregated and downloaded;
      • (iv) contains a description of any enforcement actions taken to carry out this section, including any penalties imposed under subsection (b), during the preceding year;
      • (v) contains background information on industry-physician relationships;
      • (vi) in the case of information submitted with respect to a payment or other transfer of value described in subparagraph (E)(i), lists such information separately from the other information submitted under subsection (a) and designates such separately listed information as funding for clinical research;
      • (vii) contains any other information the Secretary determines would be helpful to the average consumer;
      • (viii) in the case of information made available under this subparagraph prior to January 1, 2022 , does not contain the National Provider Identifier of the covered recipient, and
      • (ix) subject to subparagraph (D), provides the applicable manufacturer, applicable group purchasing organization, or covered recipient an opportunity to review and submit corrections to the information submitted with respect to the applicable manufacturer, applicable group purchasing organization, or covered recipient, respectively, for a period of not less than 45 days prior to such information being made available to the public.
    • (D) In no case may the 45-day period for review and submission of corrections to information under subparagraph (C)(ix) prevent such information from being made available to the public in accordance with the dates described in the matter preceding clause (i) in subparagraph (C).
    • (E)
      • (i) In the case of information submitted under subsection (a) with respect to a payment or other transfer of value made to a covered recipient by an applicable manufacturer pursuant to a product research or development agreement for services furnished in connection with research on a potential new medical technology or a new application of an existing medical technology or the development of a new drug, device, biological, or medical supply, or by an applicable manufacturer in connection with a clinical investigation regarding a new drug, device, biological, or medical supply, the procedures established under subparagraph (A)(ii) shall provide that such information is made available to the public on the first date described in the matter preceding clause (i) in subparagraph (C) after the earlier of the following:
        • (I) The date of the approval or clearance of the covered drug, device, biological, or medical supply by the Food and Drug Administration.
        • (II) Four calendar years after the date such payment or other transfer of value was made.
      • (ii) Information described in clause (i) shall be considered confidential and shall not be subject to disclosure under section 552 of title 5 or any other similar Federal, State, or local law, until on or after the date on which the information is made available to the public under such clause.
  • (2) In establishing the procedures under paragraph (1), the Secretary shall consult with the Inspector General of the Department of Health and Human Services, affected industry, consumers, consumer advocates, and other interested parties in order to ensure that the information made available to the public under such paragraph is presented in the appropriate overall context.
• (d)
  • (1) Not later than April 1 of each year beginning with 2013, the Secretary shall submit to Congress a report that includes the following:
    • (A) The information submitted under subsection (a) during the preceding year, aggregated for each applicable manufacturer and applicable group purchasing organization that submitted such information during such year (except, in the case of information submitted with respect to a payment or other transfer of value described in subsection (c)(1)(E)(i), such information shall be included in the first report submitted to Congress after the date on which such information is made available to the public under such subsection).
    • (B) A description of any enforcement actions taken to carry out this section, including any penalties imposed under subsection (b), during the preceding year.
  • (2) Not later than September 30, 2013 and on June 30 of each calendar year thereafter, the Secretary shall submit to States a report that includes a summary of the information submitted under subsection (a) during the preceding year with respect to covered recipients in the State (except, in the case of information submitted with respect to a payment or other transfer of value described in subsection (c)(1)(E)(i), such information shall be included in the first report submitted to States after the date on which such information is made available to the public under such subsection).
  • (3)
    • (A) In the case of a payment or other transfer of value provided by an applicable manufacturer that is received by a covered recipient (as defined in subsection (e)) on or after January 1, 2012 , subject to subparagraph (B), the provisions of this section shall preempt any statute or regulation of a State or of a political subdivision of a State that requires an applicable manufacturer (as so defined) to disclose or report, in any format, the type of information (as described in subsection (a)) regarding such payment or other transfer of value.
    • (B) Subparagraph (A) shall not preempt any statute or regulation of a State or of a political subdivision of a State that requires the disclosure or reporting of information—
      • (i) not of the type required to be disclosed or reported under this section;
      • (ii) described in subsection (e)(10)(B), except in the case of information described in clause (i) of such subsection;
      • (iii) by any person or entity other than an applicable manufacturer (as so defined) or a covered recipient (as defined in subsection (e)); or
      • (iv) to a Federal, State, or local governmental agency for public health surveillance, investigation, or other public health purposes or health oversight purposes.
    • (C) Nothing in subparagraph (A) shall be construed to limit the discovery or admissibility of information described in such subparagraph in a criminal, civil, or administrative proceeding.
  • (4) The Secretary shall consult with the Inspector General of the Department of Health and Human Services on the implementation of this section.
• (e) In this section:
  • (1) The term “applicable group purchasing organization” means a group purchasing organization (as defined by the Secretary) that purchases, arranges for, or negotiates the purchase of a covered drug, device, biological, or medical supply which is operating in the United States, or in a territory, possession, or commonwealth of the United States.
  • (2) The term “applicable manufacturer” means a manufacturer of a covered drug, device, biological, or medical supply which is operating in the United States, or in a territory, possession, or commonwealth of the United States.
  • (3) The term “clinical investigation” means any experiment involving 1 or more human subjects, or materials derived from human subjects, in which a drug or device is administered, dispensed, or used.
  • (4) The term “covered device” means any device for which payment is available under subchapter XVIII or a State plan under subchapter XIX or XXI (or a waiver of such a plan).
  • (5) The term “covered drug, device, biological, or medical supply” means any drug, biological product, device, or medical supply for which payment is available under subchapter XVIII or a State plan under subchapter XIX or XXI (or a waiver of such a plan).
  • (6)
    • (A) Except as provided in subparagraph (B), the term “covered recipient” means the following:
      • (i) A physician.
      • (ii) A teaching hospital.
      • (iii) A physician assistant, nurse practitioner, or clinical nurse specialist (as such terms are defined in section 1395x(aa)(5) of this title ).
      • (iv) A certified registered nurse anesthetist (as defined in section 1395x(bb)(2) of this title ).
      • (v) A certified nurse-midwife (as defined in section 1395x(gg)(2) of this title ).
    • (B) Such term does not include a physician, physician assistant, nurse practitioner, clinical nurse specialist, certified nurse anesthetist, or certified nurse-midwife who is an employee of the applicable manufacturer that is required to submit information under subsection (a).
  • (7) The term “employee” has the meaning given such term in section 1395nn(h)(2) of this title .
  • (8) The term “knowingly” has the meaning given such term in section 3729(b) of title 31 .
  • (9) The term “manufacturer of a covered drug, device, biological, or medical supply” means any entity which is engaged in the production, preparation, propagation, compounding, or conversion of a covered drug, device, biological, or medical supply (or any entity under common ownership with such entity which provides assistance or support to such entity with respect to the production, preparation, propagation, compounding, conversion, marketing, promotion, sale, or distribution of a covered drug, device, biological, or medical supply).
  • (10)
    • (A) The term “payment or other transfer of value” means a transfer of anything of value. Such term does not include a transfer of anything of value that is made indirectly to a covered recipient through a third party in connection with an activity or service in the case where the applicable manufacturer is unaware of the identity of the covered recipient.
    • (B) An applicable manufacturer shall not be required to submit information under subsection (a) with respect to the following:
      • (i) A transfer of anything the value of which is less than $10, unless the aggregate amount transferred to, requested by, or designated on behalf of the covered recipient by the applicable manufacturer during the calendar year exceeds $100. For calendar years after 2012, the dollar amounts specified in the preceding sentence shall be increased by the same percentage as the percentage increase in the consumer price index for all urban consumers (all items; U.S. city average) for the 12-month period ending with June of the previous year.
      • (ii) Product samples that are not intended to be sold and are intended for patient use.
      • (iii) Educational materials that directly benefit patients or are intended for patient use.
      • (iv) The loan of a covered device for a short-term trial period, not to exceed 90 days, to permit evaluation of the covered device by the covered recipient.
      • (v) Items or services provided under a contractual warranty, including the replacement of a covered device, where the terms of the warranty are set forth in the purchase or lease agreement for the covered device.
      • (vi) A transfer of anything of value to a covered recipient when the covered recipient is a patient and not acting in the professional capacity of a covered recipient.
      • (vii) Discounts (including rebates).
      • (viii) In-kind items used for the provision of charity care.
      • (ix) A dividend or other profit distribution from, or ownership or investment interest in, a publicly traded security and mutual fund (as described in section 1395nn(c) of this title ).
      • (x) In the case of an applicable manufacturer who offers a self-insured plan, payments for the provision of health care to employees under the plan.
      • (xi) In the case of a covered recipient who is a licensed non-medical professional, a transfer of anything of value to the covered recipient if the transfer is payment solely for the non-medical professional services of such licensed non-medical professional.
      • (xii) In the case of a covered recipient who is a physician, a transfer of anything of value to the covered recipient if the transfer is payment solely for the services of the covered recipient with respect to a civil or criminal action or an administrative proceeding.
  • (11) The term “physician” has the meaning given that term in section 1395x(r) of this title .

§ 1320a–7i. Reporting of information relating to drug samples

• (a) Not later than April 1 of each year (beginning with 2012), each manufacturer and authorized distributor of record of an applicable drug shall submit to the Secretary (in a form and manner specified by the Secretary) the following information with respect to the preceding year:
  • (1) In the case of a manufacturer or authorized distributor of record which makes distributions by mail or common carrier under subsection (d)(2) of section 353 of title 21 , the identity and quantity of drug samples requested and the identity and quantity of drug samples distributed under such subsection during that year, aggregated by—
    • (A) the name, address, professional designation, and signature of the practitioner making the request under subparagraph (A)(i) of such subsection, or of any individual who makes or signs for the request on behalf of the practitioner; and
    • (B) any other category of information determined appropriate by the Secretary.
  • (2) In the case of a manufacturer or authorized distributor of record which makes distributions by means other than mail or common carrier under subsection (d)(3) of such section 353 of title 21 , the identity and quantity of drug samples requested and the identity and quantity of drug samples distributed under such subsection during that year, aggregated by—
    • (A) the name, address, professional designation, and signature of the practitioner making the request under subparagraph (A)(i) of such subsection, or of any individual who makes or signs for the request on behalf of the practitioner; and
    • (B) any other category of information determined appropriate by the Secretary.
• (b) In this section:
  • (1) The term “applicable drug” means a drug—
    • (A) which is subject to subsection (b) of such section 353 of title 21 ; and
    • (B) for which payment is available under subchapter XVIII or a State plan under subchapter XIX or XXI (or a waiver of such a plan).
  • (2) The term “authorized distributor of record” has the meaning given that term in subsection (e)(3)(A) of such section.
  • (3) The term “manufacturer” has the meaning given that term for purposes of subsection (d) of such section.

§ 1320a–7j. Accountability requirements for facilities

• (a) In this section, the term “facility” means—
  • (1) a skilled nursing facility (as defined in section 1395i–3(a) of this title ); or
  • (2) a nursing facility (as defined in section 1396r(a) of this title ).
• (b)
  • (1) On or after the date that is 36 months after March 23, 2010 , a facility shall, with respect to the entity that operates the facility (in this subparagraph 1 1 So in original. Probably should be “subsection”. referred to as the “operating organization” or “organization”), have in operation a compliance and ethics program that is effective in preventing and detecting criminal, civil, and administrative violations under this chapter and in promoting quality of care consistent with regulations developed under paragraph (2).
  • (2)
    • (A) Not later than the date that is 2 years after March 23, 2010 , the Secretary, working jointly with the Inspector General of the Department of Health and Human Services, shall promulgate regulations for an effective compliance and ethics program for operating organizations, which may include a model compliance program.
    • (B) Such regulations with respect to specific elements or formality of a program shall, in the case of an organization that operates 5 or more facilities, vary with the size of the organization, such that larger organizations should have a more formal program and include established written policies defining the standards and procedures to be followed by its employees. Such requirements may specifically apply to the corporate level management of multi unit nursing home chains.
    • (C) Not later than 3 years after the date of the promulgation of regulations under this paragraph, the Secretary shall complete an evaluation of the compliance and ethics programs required to be established under this subsection. Such evaluation shall determine if such programs led to changes in deficiency citations, changes in quality performance, or changes in other metrics of patient quality of care. The Secretary shall submit to Congress a report on such evaluation and shall include in such report such recommendations regarding changes in the requirements for such programs as the Secretary determines appropriate.
  • (3) In this subsection, the term “compliance and ethics program” means, with respect to a facility, a program of the operating organization that—
    • (A) has been reasonably designed, implemented, and enforced so that it generally will be effective in preventing and detecting criminal, civil, and administrative violations under this chapter and in promoting quality of care; and
    • (B) includes at least the required components specified in paragraph (4).
  • (4) The required components of a compliance and ethics program of an operating organization are the following:
    • (A) The organization must have established compliance standards and procedures to be followed by its employees and other agents that are reasonably capable of reducing the prospect of criminal, civil, and administrative violations under this chapter.
    • (B) Specific individuals within high-level personnel of the organization must have been assigned overall responsibility to oversee compliance with such standards and procedures and have sufficient resources and authority to assure such compliance.
    • (C) The organization must have used due care not to delegate substantial discretionary authority to individuals whom the organization knew, or should have known through the exercise of due diligence, had a propensity to engage in criminal, civil, and administrative violations under this chapter.
    • (D) The organization must have taken steps to communicate effectively its standards and procedures to all employees and other agents, such as by requiring participation in training programs or by disseminating publications that explain in a practical manner what is required.
    • (E) The organization must have taken reasonable steps to achieve compliance with its standards, such as by utilizing monitoring and auditing systems reasonably designed to detect criminal, civil, and administrative violations under this chapter by its employees and other agents and by having in place and publicizing a reporting system whereby employees and other agents could report violations by others within the organization without fear of retribution.
    • (F) The standards must have been consistently enforced through appropriate disciplinary mechanisms, including, as appropriate, discipline of individuals responsible for the failure to detect an offense.
    • (G) After an offense has been detected, the organization must have taken all reasonable steps to respond appropriately to the offense and to prevent further similar offenses, including any necessary modification to its program to prevent and detect criminal, civil, and administrative violations under this chapter.
    • (H) The organization must periodically undertake reassessment of its compliance program to identify changes necessary to reflect changes within the organization and its facilities.
• (c)
  • (1) Not later than December 31, 2011 , the Secretary shall establish and implement a quality assurance and performance improvement program (in this subparagraph referred to as the “QAPI program”) for facilities, including multi unit chains of facilities. Under the QAPI program, the Secretary shall establish standards relating to quality assurance and performance improvement with respect to facilities and provide technical assistance to facilities on the development of best practices in order to meet such standards. Not later than 1 year after the date on which the regulations are promulgated under paragraph (2), a facility must submit to the Secretary a plan for the facility to meet such standards and implement such best practices, including how to coordinate the implementation of such plan with quality assessment and assurance activities conducted under sections 1395i–3(b)(1)(B) and 1396r(b)(1)(B) of this title, as applicable.
  • (2) The Secretary shall promulgate regulations to carry out this subsection.
• (f)
  • (1) The Secretary shall develop a standardized complaint form for use by a resident (or a person acting on the resident’s behalf) in filing a complaint with a State survey and certification agency and a State long-term care ombudsman program with respect to a facility.
  • (2)
    • (A) The State must make the standardized complaint form developed under paragraph (1) available upon request to—
      • (i) a resident of a facility; and
      • (ii) any person acting on the resident’s behalf.
    • (B) The State must establish a complaint resolution process in order to ensure that the legal representative of a resident of a facility or other responsible party is not denied access to such resident or otherwise retaliated against if they have complained about the quality of care provided by the facility or other issues relating to the facility. Such complaint resolution process shall include—
      • (i) procedures to assure accurate tracking of complaints received, including notification to the complainant that a complaint has been received;
      • (ii) procedures to determine the likely severity of a complaint and for the investigation of the complaint; and
      • (iii) deadlines for responding to a complaint and for notifying the complainant of the outcome of the investigation.
  • (3) Nothing in this subsection shall be construed as preventing a resident of a facility (or a person acting on the resident’s behalf) from submitting a complaint in a manner or format other than by using the standardized complaint form developed under paragraph (1) (including submitting a complaint orally).
• (g) Beginning not later than 2 years after March 23, 2010 , and after consulting with State long-term care ombudsman programs, consumer advocacy groups, provider stakeholder groups, employees and their representatives, and other parties the Secretary deems appropriate, the Secretary shall require a facility to electronically submit to the Secretary direct care staffing information (including information with respect to agency and contract staff) based on payroll and other verifiable and auditable data in a uniform format (according to specifications established by the Secretary in consultation with such programs, groups, and parties). Such specifications shall require that the information submitted under the preceding sentence—
  • (1) specify the category of work a certified employee performs (such as whether the employee is a registered nurse, licensed practical nurse, licensed vocational nurse, certified nursing assistant, therapist, or other medical personnel);
  • (2) include resident census data and information on resident case mix;
  • (3) include a regular reporting schedule; and
  • (4) include information on employee turnover and tenure and on the hours of care provided by each category of certified employees referenced in paragraph (1) per resident per day.
• (h)
  • (1) Any individual who is the administrator of a facility must—
    • (A) submit to the Secretary, the State long-term care ombudsman, residents of the facility, and the legal representatives of such residents or other responsible parties, written notification of an impending closure—
      • (i) subject to clause (ii), not later than the date that is 60 days prior to the date of such closure; and
      • (ii) in the case of a facility where the Secretary terminates the facility’s participation under this subchapter, not later than the date that the Secretary determines appropriate;
    • (B) ensure that the facility does not admit any new residents on or after the date on which such written notification is submitted; and
    • (C) include in the notice a plan for the transfer and adequate relocation of the residents of the facility by a specified date prior to closure that has been approved by the State, including assurances that the residents will be transferred to the most appropriate facility or other setting in terms of quality, services, and location, taking into consideration the needs, choice, and best interests of each resident.
  • (2)
    • (A) The State shall ensure that, before a facility closes, all residents of the facility have been successfully relocated to another facility or an alternative home and community-based setting.
    • (B) The Secretary may, as the Secretary determines appropriate, continue to make payments under this subchapter with respect to residents of a facility that has submitted a notification under paragraph (1) during the period beginning on the date such notification is submitted and ending on the date on which the resident is successfully relocated.
  • (3) Any individual who is the administrator of a facility that fails to comply with the requirements of paragraph (1)—
    • (A) shall be subject to a civil monetary penalty of up to $100,000;
    • (B) may be subject to exclusion from participation in any Federal health care program (as defined in section 1320a–7b(f) of this title ); and
    • (C) shall be subject to any other penalties that may be prescribed by law.
  • (4) The provisions of section 1320a–7a of this title (other than subsections (a) and (b) and the second sentence of subsection (f)) shall apply to a civil money penalty or exclusion under paragraph (3) in the same manner as such provisions apply to a penalty or proceeding under section 1320a–7a(a) of this title .

§ 1320a–7k. Medicare and Medicaid program integrity provisions

• (a)
  • (1)
    • (A)
      • (i) The Integrated Data Repository of the Centers for Medicare & Medicaid Services shall include, at a minimum, claims and payment data from the following:
        • (I) The programs under subchapters XVIII and XIX (including parts A, B, C, and D of subchapter XVIII).
        • (II) The program under subchapter XXI.
        • (III) Health-related programs administered by the Secretary of Veterans Affairs.
        • (IV) Health-related programs administered by the Secretary of Defense.
        • (V) The program of old-age, survivors, and disability insurance benefits established under subchapter II.
        • (VI) The Indian Health Service and the Contract Health Service program.
      • (ii) Inclusion of the data described in subclause (I) of such clause 1 1 So in original. Probably should be “clause (i)”. in the Integrated Data Repository shall be a priority. Data described in subclauses (II) through (VI) of such clause 1 shall be included in the Integrated Data Repository as appropriate.
    • (B)
      • (i) The Secretary shall enter into agreements with the individuals described in clause (ii) under which such individuals share and match data in the system of records of the respective agencies of such individuals with data in the system of records of the Department of Health and Human Services for the purpose of identifying potential fraud, waste, and abuse under the programs under subchapters XVIII and XIX.
      • (ii) The following individuals are described in this clause:
        • (I) The Commissioner of Social Security.
        • (II) The Secretary of Veterans Affairs.
        • (III) The Secretary of Defense.
        • (IV) The Director of the Indian Health Service.
      • (iii) For purposes of this paragraph, the term “system of records” has the meaning given such term in section 552a(a)(5) of title 5 .
  • (2) For purposes of conducting law enforcement and oversight activities and to the extent consistent with applicable information, privacy, security, and disclosure laws, including the regulations promulgated under the Health Insurance Portability and Accountability Act of 1996 and section 552a of title 5 , and subject to any information systems security requirements under such laws or otherwise required by the Secretary, the Inspector General of the Department of Health and Human Services and the Attorney General shall have access to claims and payment data of the Department of Health and Human Services and its contractors related to subchapters XVIII, XIX, and XXI.
• (b)
  • (1) Notwithstanding and in addition to any other provision of law, the Inspector General of the Department of Health and Human Services may, for purposes of protecting the integrity of the programs under subchapters XVIII and XIX, obtain information from any individual (including a beneficiary provided all applicable privacy protections are followed) or entity that—
    • (A) is a provider of medical or other items or services, supplier, grant recipient, contractor, or subcontractor; or
    • (B) directly or indirectly provides, orders, manufactures, distributes, arranges for, prescribes, supplies, or receives medical or other items or services payable by any Federal health care program (as defined in section 1320a–7b(f) of this title ) regardless of how the item or service is paid for, or to whom such payment is made.
  • (2) Information which the Inspector General may obtain under paragraph (1) includes any supporting documentation necessary to validate claims for payment or payments under subchapter XVIII or XIX, including a prescribing physician’s medical records for an individual who is prescribed an item or service which is covered under part B of subchapter XVIII, a covered part D drug (as defined in section 1395w–102(e) of this title ) for which payment is made under an MA–PD plan under part C of such subchapter, or a prescription drug plan under part D of such subchapter, and any records necessary for evaluation of the economy, efficiency, and effectiveness of the programs under subchapters XVIII and XIX.
• (c)
  • (1) In addition to any other applicable remedies, if an applicable individual has knowingly participated in a Federal health care fraud offense or a conspiracy to commit a Federal health care fraud offense, the Secretary shall impose an appropriate administrative penalty commensurate with the offense or conspiracy.
  • (2) For purposes of paragraph (1), the term “applicable individual” means an individual—
    • (A) entitled to, or enrolled for, benefits under part A of subchapter XVIII or enrolled under part B of such subchapter;
    • (B) eligible for medical assistance under a State plan under subchapter XIX or under a waiver of such plan; or
    • (C) eligible for child health assistance under a child health plan under subchapter XXI.
• (d)
  • (1) If a person has received an overpayment, the person shall—
    • (A) report and return the overpayment to the Secretary, the State, an intermediary, a carrier, or a contractor, as appropriate, at the correct address; and
    • (B) notify the Secretary, State, intermediary, carrier, or contractor to whom the overpayment was returned in writing of the reason for the overpayment.
  • (2) An overpayment must be reported and returned under paragraph (1) by the later of—
    • (A) the date which is 60 days after the date on which the overpayment was identified; or
    • (B) the date any corresponding cost report is due, if applicable.
  • (3) Any overpayment retained by a person after the deadline for reporting and returning the overpayment under paragraph (2) is an obligation (as defined in section 3729(b)(3) of title 31 ) for purposes of section 3729 of such title.
  • (4) In this subsection:
    • (A) The terms “knowing” and “knowingly” have the meaning given those terms in section 3729(b) of title 31 .
    • (B) The term “overpayment” means any funds that a person receives or retains under subchapter XVIII or XIX to which the person, after applicable reconciliation, is not entitled under such subchapter.
    • (C)
      • (i) The term “person” means a provider of services, supplier, medicaid managed care organization (as defined in section 1396b(m)(1)(A) of this title ), Medicare Advantage organization (as defined in section 1395w–28(a)(1) of this title ), or PDP sponsor (as defined in section 1395w–151(a)(13) of this title ).
      • (ii) Such term does not include a beneficiary.
• (e) The Secretary shall promulgate a regulation that requires, not later than January 1, 2011 , all providers of medical or other items or services and suppliers under the programs under subchapters XVIII and XIX that qualify for a national provider identifier to include their national provider identifier on all applications to enroll in such programs and on all claims for payment submitted under such programs.

§ 1320a–7l. Nationwide program for national and State background checks on direct patient access employees of long-term care facilities and providers

• (a) The Secretary of Health and Human Services (in this section referred to as the “Secretary”), shall establish a program to identify efficient, effective, and economical procedures for long term care facilities or providers to conduct background checks on prospective direct patient access employees on a nationwide basis (in this subsection, such program shall be referred to as the “nationwide program”). Except for the following modifications, the Secretary shall carry out the nationwide program under similar terms and conditions as the pilot program under section 307 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 ( Public Law 108–173 ; 117 Stat. 2257 ), including the prohibition on hiring abusive workers and the authorization of the imposition of penalties by a participating State under subsection (b)(3)(A) and (b)(6), respectively, of such section 307:
  • (1)
    • (A) The Secretary shall enter into agreements with each State—
      • (i) that the Secretary has not entered into an agreement with under subsection (c)(1) of such section 307;
      • (ii) that agrees to conduct background checks under the nationwide program on a Statewide basis; and
      • (iii) that submits an application to the Secretary containing such information and at such time as the Secretary may specify.
    • (B) The Secretary shall enter into agreements with each State—
      • (i) that the Secretary has entered into an agreement with under such subsection (c)(1), but only in the case where such agreement did not require the State to conduct background checks under the program established under subsection (a) of such section 307 on a Statewide basis;
      • (ii) that agrees to conduct background checks under the nationwide program on a Statewide basis; and
      • (iii) that submits an application to the Secretary containing such information and at such time as the Secretary may specify.
  • (2) The selection criteria required under subsection (c)(3)(B) of such section 307 shall not apply.
  • (3) The procedures established under subsection (b)(1) of such section 307 shall—
    • (A) require that the long-term care facility or provider (or the designated agent of the long-term care facility or provider) obtain State and national criminal history background checks on the prospective employee through such means as the Secretary determines appropriate, efficient, and effective that utilize a search of State-based abuse and neglect registries and databases, including the abuse and neglect registries of another State in the case where a prospective employee previously resided in that State, State criminal history records, the records of any proceedings in the State that may contain disqualifying information about prospective employees (such as proceedings conducted by State professional licensing and disciplinary boards and State Medicaid Fraud Control Units), and Federal criminal history records, including a fingerprint check using the Integrated Automated Fingerprint Identification System of the Federal Bureau of Investigation;
    • (B) require States to describe and test methods that reduce duplicative fingerprinting, including providing for the development of “rap back” capability by the State such that, if a direct patient access employee of a long-term care facility or provider is convicted of a crime following the initial criminal history background check conducted with respect to such employee, and the employee’s fingerprints match the prints on file with the State law enforcement department, the department will immediately inform the State and the State will immediately inform the long-term care facility or provider which employs the direct patient access employee of such conviction; and
    • (C) require that criminal history background checks conducted under the nationwide program remain valid for a period of time specified by the Secretary.
  • (4) An agreement entered into under paragraph (1) shall require that a participating State—
    • (A) be responsible for monitoring compliance with the requirements of the nationwide program;
    • (B) have procedures in place to—
      • (i) conduct screening and criminal history background checks under the nationwide program in accordance with the requirements of this section;
      • (ii) monitor compliance by long-term care facilities and providers with the procedures and requirements of the nationwide program;
      • (iii) as appropriate, provide for a provisional period of employment by a long-term care facility or provider of a direct patient access employee, not to exceed 60 days, pending completion of the required criminal history background check and, in the case where the employee has appealed the results of such background check, pending completion of the appeals process, during which the employee shall be subject to direct on-site supervision (in accordance with procedures established by the State to ensure that a long-term care facility or provider furnishes such direct on-site supervision);
      • (iv) provide an independent process by which a provisional employee or an employee may appeal or dispute the accuracy of the information obtained in a background check performed under the nationwide program, including the specification of criteria for appeals for direct patient access employees found to have disqualifying information which shall include consideration of the passage of time, extenuating circumstances, demonstration of rehabilitation, and relevancy of the particular disqualifying information with respect to the current employment of the individual;
      • (v) provide for the designation of a single State agency as responsible for—
        • (I) overseeing the coordination of any State and national criminal history background checks requested by a long-term care facility or provider (or the designated agent of the long-term care facility or provider) utilizing a search of State and Federal criminal history records, including a fingerprint check of such records;
        • (II) overseeing the design of appropriate privacy and security safeguards for use in the review of the results of any State or national criminal history background checks conducted regarding a prospective direct patient access employee to determine whether the employee has any conviction for a relevant crime;
        • (III) immediately reporting to the long-term care facility or provider that requested the criminal history background check the results of such review; and
        • (IV) in the case of an employee with a conviction for a relevant crime that is subject to reporting under section 1128E of the Social Security Act ( 42 U.S.C. 1320a–7e ), reporting the existence of such conviction to the database established under that section;
      • (vi) determine which individuals are direct patient access employees (as defined in paragraph (6)(B)) for purposes of the nationwide program;
      • (vii) as appropriate, specify offenses, including convictions for violent crimes, for purposes of the nationwide program; and
      • (viii) describe and test methods that reduce duplicative fingerprinting, including providing for the development of “rap back” capability such that, if a direct patient access employee of a long-term care facility or provider is convicted of a crime following the initial criminal history background check conducted with respect to such employee, and the employee’s fingerprints match the prints on file with the State law enforcement department—
        • (I) the department will immediately inform the State agency designated under clause (v) and such agency will immediately inform the facility or provider which employs the direct patient access employee of such conviction; and
        • (II) the State will provide, or will require the facility to provide, to the employee a copy of the results of the criminal history background check conducted with respect to the employee at no charge in the case where the individual requests such a copy.
  • (5)
    • (A)
      • (i) As part of the application submitted by a State under paragraph (1)(A)(iii), the State shall guarantee, with respect to the costs to be incurred by the State in carrying out the nationwide program, that the State will make available (directly or through donations from public or private entities) a particular amount of non-Federal contributions, as a condition of receiving the Federal match under clause (ii).
      • (ii) The payment amount to each State that the Secretary enters into an agreement with under paragraph (1)(A) shall be 3 times the amount that the State guarantees to make available under clause (i), except that in no case may the payment amount exceed $3,000,000.
    • (B)
      • (i) As part of the application submitted by a State under paragraph (1)(B)(iii), the State shall guarantee, with respect to the costs to be incurred by the State in carrying out the nationwide program, that the State will make available (directly or through donations from public or private entities) a particular amount of non-Federal contributions, as a condition of receiving the Federal match under clause (ii).
      • (ii) The payment amount to each State that the Secretary enters into an agreement with under paragraph (1)(B) shall be 3 times the amount that the State guarantees to make available under clause (i), except that in no case may the payment amount exceed $1,500,000.
  • (6) Under the nationwide program:
    • (A) The term “conviction for a relevant crime” means any Federal or State criminal conviction for—
      • (i) any offense described in section 1128(a) of the Social Security Act ( 42 U.S.C. 1320a–7 [(a)]); or
      • (ii) such other types of offenses as a participating State may specify for purposes of conducting the program in such State.
    • (B) The term “disqualifying information” means a conviction for a relevant crime or a finding of patient or resident abuse.
    • (C) The term “finding of patient or resident abuse” means any substantiated finding by a State agency under section 1819(g)(1)(C) or 1919(g)(1)(C) of the Social Security Act ( 42 U.S.C. 1395i–3(g)(1)(C) , 1396r(g)(1)(C)) or a Federal agency that a direct patient access employee has committed—
      • (i) an act of patient or resident abuse or neglect or a misappropriation of patient or resident property; or
      • (ii) such other types of acts as a participating State may specify for purposes of conducting the program in such State.
    • (D) The term “direct patient access employee” means any individual who has access to a patient or resident of a long-term care facility or provider through employment or through a contract with such facility or provider and has duties that involve (or may involve) one-on-one contact with a patient or resident of the facility or provider, as determined by the State for purposes of the nationwide program. Such term does not include a volunteer unless the volunteer has duties that are equivalent to the duties of a direct patient access employee and those duties involve (or may involve) one-on-one contact with a patient or resident of the long-term care facility or provider.
    • (E) The term “long-term care facility or provider” means the following facilities or providers which receive payment for services under title XVIII or XIX of the Social Security Act [ 42 U.S.C. 1395 et seq., 1396 et seq.]:
      • (i) A skilled nursing facility (as defined in section 1819(a) of the Social Security Act ( 42 U.S.C. 1395i–3(a) )).
      • (ii) A nursing facility (as defined in section 1919(a) of such Act ( 42 U.S.C. 1396r(a) )).
      • (iii) A home health agency.
      • (iv) A provider of hospice care (as defined in section 1861(dd)(1) of such Act ( 42 U.S.C. 1395x(dd)(1) )).
      • (v) A long-term care hospital (as described in section 1886(d)(1)(B)(iv) of such Act ( 42 U.S.C. 1395ww(d)(1)(B)(iv) )).
      • (vi) A provider of personal care services.
      • (vii) A provider of adult day care.
      • (viii) A residential care provider that arranges for, or directly provides, long-term care services, including an assisted living facility that provides a level of care established by the Secretary.
      • (ix) An intermediate care facility for the mentally retarded (as defined in section 1905(d) of such Act ( 42 U.S.C. 1396d(d) )).
      • (x) Any other facility or provider of long-term care services under such titles as the participating State determines appropriate.
  • (7)
    • (A)
      • (i) The Inspector General of the Department of Health and Human Services shall conduct an evaluation of the nationwide program.
      • (ii) The evaluation conducted under clause (i) shall include the following:
        • (I) A review of the various procedures implemented by participating States for long-term care facilities or providers, including staffing agencies, to conduct background checks of direct patient access employees under the nationwide program and identification of the most appropriate, efficient, and effective procedures for conducting such background checks.
        • (II) An assessment of the costs of conducting such background checks (including start up and administrative costs).
        • (III) A determination of the extent to which conducting such background checks leads to any unintended consequences, including a reduction in the available workforce for long-term care facilities or providers.
        • (IV) An assessment of the impact of the nationwide program on reducing the number of incidents of neglect, abuse, and misappropriation of resident property to the extent practicable.
        • (V) An evaluation of other aspects of the nationwide program, as determined appropriate by the Secretary.
    • (B) Not later than 180 days after the completion of the nationwide program, the Inspector General of the Department of Health and Human Services shall submit a report to Congress containing the results of the evaluation conducted under subparagraph (A).
• (b)
  • (1) The Secretary of Health and Human Services shall notify the Secretary of the Treasury of the amount necessary to carry out the nationwide program under this section for the period of fiscal years 2010 through 2012, except that in no case shall such amount exceed $160,000,000.
  • (2)
    • (A) Out of any funds in the Treasury not otherwise appropriated, the Secretary of the Treasury shall provide for the transfer to the Secretary of Health and Human Services of the amount specified as necessary to carry out the nationwide program under paragraph (1). Such amount shall remain available until expended.
    • (B) The Secretary may reserve not more than $3,000,000 of the amount transferred under subparagraph (A) to provide for the conduct of the evaluation under subsection (a)(7)(A).

§ 1320a–7m. Use of predictive modeling and other analytics technologies to identify and prevent waste, fraud, and abuse in the Medicare fee-for-service program

• (a) The Secretary shall use predictive modeling and other analytics technologies (in this section referred to as “predictive analytics technologies”) to identify improper claims for reimbursement and to prevent the payment of such claims under the Medicare fee-for-service program.
• (b) The predictive analytics technologies used by the Secretary shall—
  • (1) capture Medicare provider and Medicare beneficiary activities across the Medicare fee-for-service program to provide a comprehensive view across all providers, beneficiaries, and geographies within such program in order to—
    • (A) identify and analyze Medicare provider networks, provider billing patterns, and beneficiary utilization patterns; and
    • (B) identify and detect any such patterns and networks that represent a high risk of fraudulent activity;
  • (2) be integrated into the existing Medicare fee-for-service program claims flow with minimal effort and maximum efficiency;
  • (3) be able to—
    • (A) analyze large data sets for unusual or suspicious patterns or anomalies or contain other factors that are linked to the occurrence of waste, fraud, or abuse;
    • (B) undertake such analysis before payment is made; and
    • (C) prioritize such identified transactions for additional review before payment is made in terms of the likelihood of potential waste, fraud, and abuse to more efficiently utilize investigative resources;
  • (4) capture outcome information on adjudicated claims for reimbursement to allow for refinement and enhancement of the predictive analytics technologies on the basis of such outcome information, including post-payment information about the eventual status of a claim; and
  • (5) prevent the payment of claims for reimbursement that have been identified as potentially wasteful, fraudulent, or abusive until such time as the claims have been verified as valid.
• (c)
  • (1) Not later than January 1, 2011 , the Secretary shall issue a request for proposals to carry out this section during the first year of implementation. To the extent the Secretary determines appropriate—
    • (A) the initial request for proposals may include subsequent implementation years; and
    • (B) the Secretary may issue additional requests for proposals with respect to subsequent implementation years.
  • (2) The initial request for proposals issued under paragraph (1) shall require the contractors selected to commence using predictive analytics technologies on July 1, 2011 , in the 10 States identified by the Secretary as having the highest risk of waste, fraud, or abuse in the Medicare fee-for-service program.
  • (3) Based on the results of the report and recommendation required under subsection (e)(1)(B), the Secretary shall expand the use of predictive analytics technologies on October 1, 2012 , to apply to an additional 10 States identified by the Secretary as having the highest risk of waste, fraud, or abuse in the Medicare fee-for-service program, after the States identified under paragraph (2).
  • (4) Based on the results of the report and recommendation required under subsection (e)(2), the Secretary shall expand the use of predictive analytics technologies on January 1, 2014 , to apply to the Medicare fee-for-service program in any State not identified under paragraph (2) or (3) and the commonwealths and territories.
  • (5) Based on the results of the report and recommendation required under subsection (e)(3), the Secretary shall expand the use of predictive analytics technologies, beginning April 1, 2015 , to apply to Medicaid and CHIP. To the extent the Secretary determines appropriate, such expansion may be made on a phased-in basis.
  • (6) If, with respect to the first, second, or third implementation year, the Inspector General of the Department of Health and Human Services certifies as part of the report required under subsection (e) for that year no or only nominal actual savings to the Medicare fee-for-service program, the Secretary may impose a moratorium, not to exceed 12 months, on the expansion of the use of predictive analytics technologies under this section for the succeeding year in order to refine the use of predictive analytics technologies to achieve more than nominal savings before further expansion. If a moratorium is imposed in accordance with this paragraph, the implementation dates applicable for the succeeding year or years shall be adjusted to reflect the length of the moratorium period.
• (d)
  • (1)
    • (A) The Secretary shall select contractors to carry out this section using competitive procedures as provided for in the Federal Acquisition Regulation.
    • (B) The Secretary shall select at least 2 contractors to carry out this section with respect to any year.
  • (2)
    • (A) The Secretary shall enter into a contract under this section with an entity only if the entity—
      • (i) has leadership and staff who—
        • (I) have the appropriate clinical knowledge of, and experience with, the payment rules and regulations under the Medicare fee-for-service program; and
        • (II) have direct management experience and proficiency utilizing predictive analytics technologies necessary to carry out the requirements under subsection (b); or
      • (ii) has a contract, or will enter into a contract, with another entity that has leadership and staff meeting the criteria described in clause (i).
    • (B) The Secretary may only enter into a contract under this section with an entity to the extent that the entity complies with such conflict of interest standards as are generally applicable to Federal acquisition and procurement.
  • (3) The Secretary shall provide entities with a contract under this section with appropriate access to data necessary for the entity to use predictive analytics technologies in accordance with the contract.
• (e)
  • (1) Not later than 3 months after the completion of the first implementation year under this section, the Secretary shall submit to the appropriate committees of Congress and make available to the public a report that includes the following:
    • (A) A description of the implementation of the use of predictive analytics technologies during the year.
    • (B) A certification of the Inspector General of the Department of Health and Human Services that—
      • (i) specifies the actual and projected savings to the Medicare fee-for-service program as a result of the use of predictive analytics technologies, including estimates of the amounts of such savings with respect to both improper payments recovered and improper payments avoided;
      • (ii) the actual and projected savings to the Medicare fee-for-service program as a result of such use of predictive analytics technologies relative to the return on investment for the use of such technologies and in comparison to other strategies or technologies used to prevent and detect fraud, waste, and abuse in the Medicare fee-for-service program; and
      • (iii) includes recommendations regarding—
        • (I) whether the Secretary should continue to use predictive analytics technologies;
        • (II) whether the use of such technologies should be expanded in accordance with the requirements of subsection (c); and
        • (III) any modifications or refinements that should be made to increase the amount of actual or projected savings or mitigate any adverse impact on Medicare beneficiaries or providers.
    • (C) An analysis of the extent to which the use of predictive analytics technologies successfully prevented and detected waste, fraud, or abuse in the Medicare fee-for-service program.
    • (D) A review of whether the predictive analytics technologies affected access to, or the quality of, items and services furnished to Medicare beneficiaries.
    • (E) A review of what effect, if any, the use of predictive analytics technologies had on Medicare providers.
    • (F) Any other items determined appropriate by the Secretary.
  • (2) Not later than 3 months after the completion of the second implementation year under this section, the Secretary shall submit to the appropriate committees of Congress and make available to the public a report that includes, with respect to such year, the items required under paragraph (1) as well as any other additional items determined appropriate by the Secretary with respect to the report for such year.
  • (3) Not later than 3 months after the completion of the third implementation year under this section, the Secretary shall submit to the appropriate committees of Congress, and make available to the public, a report that includes 1 1 So in original. Probably should be followed by a comma. with respect to such year, the items required under paragraph (1), 2 2 So in original. The comma probably should not appear. as well as any other additional items determined appropriate by the Secretary with respect to the report for such year, and the following:
    • (A) An analysis of the cost-effectiveness and feasibility of expanding the use of predictive analytics technologies to Medicaid and CHIP.
    • (B) An analysis of the effect, if any, the application of predictive analytics technologies to claims under Medicaid and CHIP would have on States and the commonwealths and territories.
    • (C) Recommendations regarding the extent to which technical assistance may be necessary to expand the application of predictive analytics technologies to claims under Medicaid and CHIP, and the type of any such assistance.
• (f)
  • (1) Upon completion of the first year in which predictive analytics technologies are used with respect to claims under Medicaid and CHIP, the Secretary shall, by grant, contract, or interagency agreement, conduct an independent evaluation of the use of predictive analytics technologies under the Medicare fee-for-service program and Medicaid and CHIP. The evaluation shall include an analysis with respect to each such program of the items required for the third year implementation report under subsection (e)(3).
  • (2) Not later than 18 months after the evaluation required under paragraph (1) is initiated, the Secretary shall submit a report to Congress on the evaluation that shall include the results of the evaluation, the Secretary’s response to such results and, to the extent the Secretary determines appropriate, recommendations for legislation or administrative actions.
• (g) The Secretary may waive such provisions of titles XI, XVIII, XIX, and XXI of the Social Security Act [ 42 U.S.C. 1301 et seq., 1395 et seq., 1396 et seq., 1397aa et seq.], including applicable prompt payment requirements under titles XVIII and XIX of such Act, as the Secretary determines to be appropriate to carry out this section.
• (h)
  • (1) Out of any funds in the Treasury not otherwise appropriated, there is appropriated to the Secretary to carry out this section, $100,000,000 for the period beginning January 1, 2011 , to remain available until expended.
  • (2)
    • (A) The Secretary shall reserve not more than 5 percent of the funds appropriated under paragraph (1) for purposes of conducting the independent evaluation required under subsection (f).
    • (B) The Secretary shall reserve such portion of the funds appropriated under paragraph (1) as the Secretary determines appropriate for purposes of providing assistance to States for administrative expenses in the event of the expansion of predictive analytics technologies to claims under Medicaid and CHIP.
• (i) In this section:
  • (1) The term “commonwealth and territories” includes the Commonwealth of Puerto Rico, the Virgin Islands, Guam, American Samoa, the Commonwealth of the Northern Mariana Islands, and any other territory or possession of the United States in which the Medicare fee-for-service program, Medicaid, or CHIP operates.
  • (2) The term “CHIP” means the Children’s Health Insurance Program established under title XXI of the Social Security Act ( 42 U.S.C. 1397aa et seq.).
  • (3) The term “Medicaid” means the program to provide grants to States for medical assistance programs established under title XIX of the Social Security Act ( 42 U.S.C. 1396 et seq.).
  • (4) The term “Medicare beneficiary” means an individual enrolled in the Medicare fee-for-service program.
  • (5) The term “Medicare fee-for-service program” means the original medicare fee-for-service program under parts A and B of title XVIII of the Social Security Act ( 42 U.S.C. 1395 [c] et seq.[; 1395j et seq.]).
  • (6) The term “Medicare provider” means a provider of services (as defined in subsection (u) of section 1861 of the Social Security Act ( 42 U.S.C. 1395x )) and a supplier (as defined in subsection (d) of such section).
  • (7) The term “Secretary” means the Secretary of Health and Human Services, acting through the Administrator of the Centers for Medicare & Medicaid Services.
  • (8) The term “State” means each of the 50 States and the District of Columbia.

§ 1320a–7n. Disclosure of predictive modeling and other analytics technologies to identify and prevent waste, fraud, and abuse

• (a) For provisions relating to the use of predictive modeling and other analytics technologies to identify and prevent waste, fraud, and abuse with respect to the Medicare program under subchapter XVIII, the Medicaid program under subchapter XIX, and the Children’s Health Insurance Program under subchapter XXI, see section 1320a–7m of this title .
• (b) In implementing such provisions under such section 1320a–7m with respect to covered algorithms (as defined in subsection (c)), the following shall apply:
  • (1) The covered algorithms used or developed for purposes of such section 1320a–7m (including by the Secretary or a State (or an entity operating under a contract with a State)) shall be exempt from disclosure under section 552(b)(3) of title 5 .
  • (2)
    • (A) A State agency may not use or disclose covered algorithms used or developed for purposes of such section 1320a–7m except for purposes of administering the State plan (or a waiver of the plan) under the Medicaid program under subchapter XIX or the State child health plan (or a waiver of the plan) under the Children’s Health Insurance Program under subchapter XXI, including by enabling an entity operating under a contract with a State to assist the State to identify or prevent waste, fraud, and abuse with respect to such programs.
    • (B) A State agency shall have in effect data security and control policies that the Secretary finds adequate to ensure the security of covered algorithms used or developed for purposes of such section 1320a–7m and to ensure that access to such information is restricted to authorized persons for purposes of authorized uses and disclosures described in subparagraph (A).
    • (C) State agencies to which information is disclosed pursuant to such section 1320a–7m shall adhere to uniform procedures established by the Secretary.
• (c) In this section, the term “covered algorithm”—
  • (1) means a predictive modeling or other analytics technology, as used for purposes of section 1320a–7m(a) of this title to identify and prevent waste, fraud, and abuse with respect to the Medicare program under subchapter XVIII, the Medicaid program under subchapter XIX, and the Children’s Health Insurance Program under subchapter XXI; and
  • (2) includes the mathematical expressions utilized in the application of such technology and the means by which such technology is developed.

§ 1397n–8. No Federal funding for credit enhancements

No amount made available to carry out this division may be used to provide any insurance, guarantee, or other credit enhancement to a State or local government under which a Federal payment would be made to a State or local government as the result of a State or local government failing to achieve an outcome specified in an agreement.

§ 1320a–8a. Administrative procedure for imposing penalties for false or misleading statements

• (a) Any person who—
  • (1) makes, or causes to be made, a statement or representation of a material fact, for use in determining any initial or continuing right to or the amount of monthly insurance benefits under subchapter II or benefits or payments under subchapter XVI that the person knows or should know is false or misleading,
  • (2) makes such a statement or representation for such use with knowing disregard for the truth, or
  • (3) omits from a statement or representation for such use, or otherwise withholds disclosure of, a fact which the person knows or should know is material to the determination of any initial or continuing right to or the amount of monthly insurance benefits under subchapter II or benefits or payments under subchapter XVI, if the person knows, or should know, that the statement or representation with such omission is false or misleading or that the withholding of such disclosure is misleading,
• (b) The penalty described in this subsection is—
  • (1) nonpayment of benefits under subchapter II that would otherwise be payable to the person; and
  • (2) ineligibility for cash benefits under subchapter XVI,
• (c) The duration of the applicable period, with respect to a determination by the Commissioner under subsection (a) that a person has engaged in conduct described in subsection (a), shall be—
  • (1) six consecutive months, in the case of the first such determination with respect to the person;
  • (2) twelve consecutive months, in the case of the second such determination with respect to the person; and
  • (3) twenty-four consecutive months, in the case of the third or subsequent such determination with respect to the person.
• (d) A person subject to a period of nonpayment of benefits under subchapter II or ineligibility for subchapter XVI benefits by reason of this section nevertheless shall be considered to be eligible for and receiving such benefits, to the extent that the person would be receiving or eligible for such benefits but for the imposition of the penalty, for purposes of—
  • (1) determination of the eligibility of the person for benefits under subchapters XVIII and XIX; and
  • (2) determination of the eligibility or amount of benefits payable under subchapter II or XVI to another person.
• (e) In this section, the term “benefits under subchapter VIII or XVI” includes State supplementary payments made by the Commissioner pursuant to an agreement under section 1010a or 1382e(a) of this title or section 212(b) of Public Law 93–66 , as the case may be.
• (f) The Commissioner of Social Security shall consult with the Inspector General of the Social Security Administration regarding initiating actions under this section.

§ 1320a–8b. Attempts to interfere with administration of this chapter

Whoever corruptly or by force or threats of force (including any threatening letter or communication) attempts to intimidate or impede any officer, employee, or contractor of the Social Security Administration (including any State employee of a disability determination service or any other individual designated by the Commissioner of Social Security) acting in an official capacity to carry out a duty under this chapter, or in any other way corruptly or by force or threats of force (including any threatening letter or communication) obstructs or impedes, or attempts to obstruct or impede, the due administration of this chapter, shall be fined not more than $5,000, imprisoned not more than 3 years, or both, except that if the offense is committed only by threats of force, the person shall be fined not more than $3,000, imprisoned not more than 1 year, or both. In this subsection, the term “threats of force” means threats of harm to the officer or employee of the United States or to a contractor of the Social Security Administration, or to a member of the family of such an officer or employee or contractor.

§ 1397n–9. Availability of funds

Amounts made available to carry out this division shall remain available until 10 years after February 9, 2018 .

§ 1320b–9a. Child health quality measures

• (a)
  • (1) Not later than January 1, 2010 , the Secretary shall identify and publish for general comment an initial, recommended core set of child health quality measures for use by State programs administered under subchapters XIX and XXI, health insurance issuers and managed care entities that enter into contracts with such programs, and providers of items and services under such programs.
  • (2) In consultation with the individuals and entities described in subsection (b)(3), the Secretary shall identify existing quality of care measures for children that are in use under public and privately sponsored health care coverage arrangements, or that are part of reporting systems that measure both the presence and duration of health insurance coverage over time.
  • (3) Based on such existing and identified measures, the Secretary shall publish an initial core set of child health quality measures that includes (but is not limited to) the following:
    • (A) The duration of children’s health insurance coverage over a 12-month time period.
    • (B) The availability and effectiveness of a full range of—
      • (i) preventive services, treatments, and services for acute conditions, including services to promote healthy birth, prevent and treat premature birth, and detect the presence or risk of physical or mental conditions that could adversely affect growth and development; and
      • (ii) treatments to correct or ameliorate the effects of physical and mental conditions, including chronic conditions and, with respect to dental care, conditions requiring the restoration of teeth, relief of pain and infection, and maintenance of dental health, in infants, young children, school-age children, and adolescents.
    • (C) The availability of care in a range of ambulatory and inpatient health care settings in which such care is furnished.
    • (D) The types of measures that, taken together, can be used to estimate the overall national quality of health care for children, including children with special needs, and to perform comparative analyses of pediatric health care quality and racial, ethnic, and socioeconomic disparities in child health and health care for children.
  • (4)
    • (A) Not later than 2 years after February 4, 2009 , the Secretary, in consultation with States, shall develop a standardized format for reporting information and procedures and approaches that encourage States to use the initial core measurement set to voluntarily report information regarding the quality of pediatric health care under subchapters XIX and XXI.
    • (B) Beginning with the annual State report on fiscal year 2024 required under subsection (c)(1), the Secretary shall require States to use the initial core measurement set and any updates or changes to that set to report information regarding the quality of pediatric health care under subchapters XIX and XXI using the standardized format for reporting information and procedures developed under subparagraph (A).
  • (5) The Secretary shall disseminate information to States regarding best practices among States with respect to measuring and reporting on the quality of health care for children, and shall facilitate the adoption of such best practices. In developing best practices approaches, the Secretary shall give particular attention to State measurement techniques that ensure the timeliness and accuracy of provider reporting, encourage provider reporting compliance, encourage successful quality improvement strategies, and improve efficiency in data collection using health information technology.
  • (6) Not later than January 1, 2011 , and every 3 years thereafter, the Secretary shall report to Congress on—
    • (A) the status of the Secretary’s efforts to improve—
      • (i) quality related to the duration and stability of health insurance coverage for children under subchapters XIX and XXI;
      • (ii) the quality of children’s health care under such subchapters, including preventive health services, dental care, health care for acute conditions, chronic health care, and health services to ameliorate the effects of physical and mental conditions and to aid in growth and development of infants, young children, school-age children, and adolescents with special health care needs; and
      • (iii) the quality of children’s health care under such subchapters across the domains of quality, including clinical quality, health care safety, family experience with health care, health care in the most integrated setting, and elimination of racial, ethnic, and socioeconomic disparities in health and health care;
    • (B) the status of voluntary reporting by States under subchapters XIX and XXI, utilizing the initial core quality measurement set and, beginning with the report required on January 1, 2025 , and for each annual report thereafter, the status of mandatory reporting by States under subchapters XIX and XXI, utilizing the initial core quality measurement set and any updates or changes to that set; and
    • (C) any recommendations for legislative changes needed to improve the quality of care provided to children under subchapters XIX and XXI, including recommendations for quality reporting by States.
  • (7) The Secretary shall provide technical assistance to States to assist them in adopting and utilizing core child health quality measures in administering the State plans under subchapters XIX and XXI.
  • (8) In this section, the term “core set” means a group of valid, reliable, and evidence-based quality measures that, taken together—
    • (A) provide information regarding the quality of health coverage and health care for children;
    • (B) address the needs of children throughout the developmental age span; and
    • (C) allow purchasers, families, and health care providers to understand the quality of care in relation to the preventive needs of children, treatments aimed at managing and resolving acute conditions, and diagnostic and treatment services whose purpose is to correct or ameliorate physical, mental, or developmental conditions that could, if untreated or poorly treated, become chronic.
• (b)
  • (1) Not later than January 1, 2011 , the Secretary shall establish a pediatric quality measures program to—
    • (A) improve and strengthen the initial core child health care quality measures established by the Secretary under subsection (a);
    • (B) expand on existing pediatric quality measures used by public and private health care purchasers and advance the development of such new and emerging quality measures; and
    • (C) increase the portfolio of evidence-based, consensus pediatric quality measures available to public and private purchasers of children’s health care services, providers, and consumers.
  • (2) The measures developed under the pediatric quality measures program shall, at a minimum, be—
    • (A) evidence-based and, where appropriate, risk adjusted;
    • (B) designed to identify and eliminate racial and ethnic disparities in child health and the provision of health care;
    • (C) designed to ensure that the data required for such measures is collected and reported in a standard format that permits comparison of quality and data at a State, plan, and provider level;
    • (D) periodically updated; and
    • (E) responsive to the child health needs, services, and domains of health care quality described in clauses (i), (ii), and (iii) of subsection (a)(6)(A).
  • (3) In identifying gaps in existing pediatric quality measures and establishing priorities for development and advancement of such measures, the Secretary shall consult with—
    • (A) States;
    • (B) pediatricians, children’s hospitals, and other primary and specialized pediatric health care professionals (including members of the allied health professions) who specialize in the care and treatment of children, particularly children with special physical, mental, and developmental health care needs;
    • (C) dental professionals, including pediatric dental professionals;
    • (D) health care providers that furnish primary health care to children and families who live in urban and rural medically underserved communities or who are members of distinct population sub-groups at heightened risk for poor health outcomes;
    • (E) national organizations representing children, including children with disabilities and children with chronic conditions;
    • (F) national organizations representing consumers and purchasers of children’s health care;
    • (G) national organizations and individuals with expertise in pediatric health quality measurement; and
    • (H) voluntary consensus standards setting organizations and other organizations involved in the advancement of evidence-based measures of health care.
  • (4) As part of the program to advance pediatric quality measures, the Secretary shall—
    • (A) award grants and contracts for the development, testing, and validation of new, emerging, and innovative evidence-based measures for children’s health care services across the domains of quality described in clauses (i), (ii), and (iii) of subsection (a)(6)(A); and
    • (B) award grants and contracts for—
      • (i) the development of consensus on evidence-based measures for children’s health care services;
      • (ii) the dissemination of such measures to public and private purchasers of health care for children; and
      • (iii) the updating of such measures as necessary.
  • (5) Beginning no later than January 1, 2013 , and annually thereafter, the Secretary shall publish recommended changes to the core measures described in subsection (a) that shall reflect the testing, validation, and consensus process for the development of pediatric quality measures described in subsection 1 1 So in original. paragraphs (1) through (4).
  • (6) In this subsection, the term “pediatric quality measure” means a measurement of clinical care that is capable of being examined through the collection and analysis of relevant information, that is developed in order to assess 1 or more aspects of pediatric health care quality in various institutional and ambulatory health care settings, including the structure of the clinical care system, the process of care, the outcome of care, or patient experiences in care.
  • (7) Nothing in this section shall be construed as supporting the restriction of coverage, under subchapter XIX or XXI or otherwise, to only those services that are evidence-based.
• (c)
  • (1) Each State with a State plan approved under subchapter XIX or a State child health plan approved under subchapter XXI shall annually report to the Secretary on the—
    • (A) State-specific child health quality measures applied by the States under such plans, including measures described in subparagraphs (A) and (B) of subsection (a)(6) and, beginning with the annual report on fiscal year 2024, all of the core measures described in subsection (a) and any updates or changes to those measures; and
    • (B) State-specific information on the quality of health care furnished to children under such plans, including information collected through external quality reviews of managed care organizations under section 1396u–2 of this title and benchmark plans under sections 1396u–7 and 1397cc of this title.
  • (2) Not later than September 30, 2010 , and annually thereafter, the Secretary shall collect, analyze, and make publicly available the information reported by States under paragraph (1).
• (d)
  • (1) During the period of fiscal years 2009 through 2013, the Secretary shall award not more than 10 grants to States and child health providers to conduct demonstration projects to evaluate promising ideas for improving the quality of children’s health care provided under subchapter XIX or XXI, including projects to—
    • (A) experiment with, and evaluate the use of, new measures of the quality of children’s health care under such subchapters (including testing the validity and suitability for reporting of such measures);
    • (B) promote the use of health information technology in care delivery for children under such subchapters;
    • (C) evaluate provider-based models which improve the delivery of children’s health care services under such subchapters, including care management for children with chronic conditions and the use of evidence-based approaches to improve the effectiveness, safety, and efficiency of health care services for children; or
    • (D) demonstrate the impact of the model electronic health record format for children developed and disseminated under subsection (f) on improving pediatric health, including the effects of chronic childhood health conditions, and pediatric health care quality as well as reducing health care costs.
  • (2) In awarding grants under this subsection, the Secretary shall ensure that—
    • (A) only 1 demonstration project funded under a grant awarded under this subsection shall be conducted in a State; and
    • (B) demonstration projects funded under grants awarded under this subsection shall be conducted evenly between States with large urban areas and States with large rural areas.
  • (3) A demonstration project conducted with a grant awarded under this subsection may be conducted on a multistate basis, as needed.
  • (4) $20,000,000 of the amount appropriated under subsection (i) for a fiscal year shall be used to carry out this subsection.
• (e)
  • (1) The Secretary, in consultation with the Administrator of the Centers for Medicare & Medicaid Services, shall conduct a demonstration project to develop a comprehensive and systematic model for reducing childhood obesity by awarding grants to eligible entities to carry out such project. Such model shall—
    • (A) identify, through self-assessment, behavioral risk factors for obesity among children;
    • (B) identify, through self-assessment, needed clinical preventive and screening benefits among those children identified as target individuals on the basis of such risk factors;
    • (C) provide ongoing support to such target individuals and their families to reduce risk factors and promote the appropriate use of preventive and screening benefits; and
    • (D) be designed to improve health outcomes, satisfaction, quality of life, and appropriate use of items and services for which medical assistance is available under subchapter XIX or child health assistance is available under subchapter XXI among such target individuals.
  • (2) For purposes of this subsection, an eligible entity is any of the following:
    • (A) A city, county, or Indian tribe.
    • (B) A local or tribal educational agency.
    • (C) An accredited university, college, or community college.
    • (D) A Federally-qualified health center.
    • (E) A local health department.
    • (F) A health care provider.
    • (G) A community-based organization.
    • (H) Any other entity determined appropriate by the Secretary, including a consortia 3 3 So in original. Probably should be “consortium”. or partnership of entities described in any of subparagraphs (A) through (G).
  • (3) An eligible entity awarded a grant under this subsection shall use the funds made available under the grant to—
    • (A) carry out community-based activities related to reducing childhood obesity, including by—
      • (i) forming partnerships with entities, including schools and other facilities providing recreational services, to establish programs for after school and weekend community activities that are designed to reduce childhood obesity;
      • (ii) forming partnerships with daycare facilities to establish programs that promote healthy eating behaviors and physical activity; and
      • (iii) developing and evaluating community educational activities targeting good nutrition and promoting healthy eating behaviors;
    • (B) carry out age-appropriate school-based activities that are designed to reduce childhood obesity, including by—
      • (i) developing and testing educational curricula and intervention programs designed to promote healthy eating behaviors and habits in youth, which may include—
        • (I) after hours physical activity programs; and
        • (II) science-based interventions with multiple components to prevent eating disorders including nutritional content, understanding and responding to hunger and satiety, positive body image development, positive self-esteem development, and learning life skills (such as stress management, communication skills, problemsolving and decisionmaking skills), as well as consideration of cultural and developmental issues, and the role of family, school, and community;
      • (ii) providing education and training to educational professionals regarding how to promote a healthy lifestyle and a healthy school environment for children;
      • (iii) planning and implementing a healthy lifestyle curriculum or program with an emphasis on healthy eating behaviors and physical activity; and
      • (iv) planning and implementing healthy lifestyle classes or programs for parents or guardians, with an emphasis on healthy eating behaviors and physical activity for children;
    • (C) carry out educational, counseling, promotional, and training activities through the local health care delivery systems including by—
      • (i) promoting healthy eating behaviors and physical activity services to treat or prevent eating disorders, being overweight, and obesity;
      • (ii) providing patient education and counseling to increase physical activity and promote healthy eating behaviors;
      • (iii) training health professionals on how to identify and treat obese and overweight individuals which may include nutrition and physical activity counseling; and
      • (iv) providing community education by a health professional on good nutrition and physical activity to develop a better understanding of the relationship between diet, physical activity, and eating disorders, obesity, or being overweight; and
    • (D) provide, through qualified health professionals, training and supervision for community health workers to—
      • (i) educate families regarding the relationship between nutrition, eating habits, physical activity, and obesity;
      • (ii) educate families about effective strategies to improve nutrition, establish healthy eating patterns, and establish appropriate levels of physical activity; and
      • (iii) educate and guide parents regarding the ability to model and communicate positive health behaviors.
  • (4) In awarding grants under paragraph (1), the Secretary shall give priority to awarding grants to eligible entities—
    • (A) that demonstrate that they have previously applied successfully for funds to carry out activities that seek to promote individual and community health and to prevent the incidence of chronic disease and that can cite published and peer-reviewed research demonstrating that the activities that the entities propose to carry out with funds made available under the grant are effective;
    • (B) that will carry out programs or activities that seek to accomplish a goal or goals set by the State in the Healthy People 2010 plan of the State;
    • (C) that provide non-Federal contributions, either in cash or in-kind, to the costs of funding activities under the grants;
    • (D) that develop comprehensive plans that include a strategy for extending program activities developed under grants in the years following the fiscal years for which they receive grants under this subsection;
    • (E) located in communities that are medically underserved, as determined by the Secretary;
    • (F) located in areas in which the average poverty rate is at least 150 percent or higher of the average poverty rate in the State involved, as determined by the Secretary; and
    • (G) that submit plans that exhibit multisectoral, cooperative conduct that includes the involvement of a broad range of stakeholders, including—
      • (i) community-based organizations;
      • (ii) local governments;
      • (iii) local educational agencies;
      • (iv) the private sector;
      • (v) State or local departments of health;
      • (vi) accredited colleges, universities, and community colleges;
      • (vii) health care providers;
      • (viii) State and local departments of transportation and city planning; and
      • (ix) other entities determined appropriate by the Secretary.
  • (5)
    • (A) Not later than 1 year after February 4, 2009 , the Secretary shall design the demonstration project. The demonstration should draw upon promising, innovative models and incentives to reduce behavioral risk factors. The Administrator of the Centers for Medicare & Medicaid Services shall consult with the Director of the Centers for Disease Control and Prevention, the Director of the Office of Minority Health, the heads of other agencies in the Department of Health and Human Services, and such professional organizations, as the Secretary determines to be appropriate, on the design, conduct, and evaluation of the demonstration.
    • (B) Not later than 2 years after February 4, 2009 , the Secretary shall award 1 grant that is specifically designed to determine whether programs similar to programs to be conducted by other grantees under this subsection should be implemented with respect to the general population of children who are eligible for child health assistance under State child health plans under subchapter XXI in order to reduce the incidence of childhood obesity among such population.
  • (6) Not later than 3 years after the date the Secretary implements the demonstration project under this subsection, the Secretary shall submit to Congress a report that describes the project, evaluates the effectiveness and cost effectiveness of the project, evaluates the beneficiary satisfaction under the project, and includes any such other information as the Secretary determines to be appropriate.
  • (7) In this subsection:
    • (A) The term “Federally-qualified health center” has the meaning given that term in section 1396d( l )(2)(B) of this title.
    • (B) The term “Indian tribe” has the meaning given that term in section 1603 of title 25 .
    • (C) The term “self-assessment” means a form that—
      • (i) includes questions regarding—
        • (I) behavioral risk factors;
        • (II) needed preventive and screening services; and
        • (III) target individuals’ preferences for receiving follow-up information;
      • (ii) is assessed using such computer generated assessment programs; and
      • (iii) allows for the provision of such ongoing support to the individual as the Secretary determines appropriate.
    • (D) The term “ongoing support” means—
      • (i) to provide any target individual with information, feedback, health coaching, and recommendations regarding—
        • (I) the results of a self-assessment given to the individual;
        • (II) behavior modification based on the self-assessment; and
        • (III) any need for clinical preventive and screening services or treatment including medical nutrition therapy;
      • (ii) to provide any target individual with referrals to community resources and programs available to assist the target individual in reducing health risks; and
      • (iii) to provide the information described in clause (i) to a health care provider, if designated by the target individual to receive such information.
  • (8) Out of any funds in the Treasury not otherwise appropriated, there is appropriated to carry out this subsection, $25,000,000 for the period of fiscal years 2010 through 2014,, 1 $10,000,000 for the period of fiscal years 2016 and 2017, and $30,000,000 for the period of fiscal years 2018 through 2023.
• (f)
  • (1) Not later than January 1, 2010 , the Secretary shall establish a program to encourage the development and dissemination of a model electronic health record format for children enrolled in the State plan under subchapter XIX or the State child health plan under subchapter XXI that is—
    • (A) subject to State laws, accessible to parents, caregivers, and other consumers for the sole purpose of demonstrating compliance with school or leisure activity requirements, such as appropriate immunizations or physicals;
    • (B) designed to allow interoperable exchanges that conform with Federal and State privacy and security requirements;
    • (C) structured in a manner that permits parents and caregivers to view and understand the extent to which the care their children receive is clinically appropriate and of high quality; and
    • (D) capable of being incorporated into, and otherwise compatible with, other standards developed for electronic health records.
  • (2) $5,000,000 of the amount appropriated under subsection (i) for a fiscal year shall be used to carry out this subsection.
• (g)
  • (1) Not later than July 1, 2010 , the Institute of Medicine shall study and report to Congress on the extent and quality of efforts to measure child health status and the quality of health care for children across the age span and in relation to preventive care, treatments for acute conditions, and treatments aimed at ameliorating or correcting physical, mental, and developmental conditions in children. In conducting such study and preparing such report, the Institute of Medicine shall—
    • (A) consider all of the major national population-based reporting systems sponsored by the Federal Government that are currently in place, including reporting requirements under Federal grant programs and national population surveys and estimates conducted directly by the Federal Government;
    • (B) identify the information regarding child health and health care quality that each system is designed to capture and generate, the study and reporting periods covered by each system, and the extent to which the information so generated is made widely available through publication;
    • (C) identify gaps in knowledge related to children’s health status, health disparities among subgroups of children, the effects of social conditions on children’s health status and use and effectiveness of health care, and the relationship between child health status and family income, family stability and preservation, and children’s school readiness and educational achievement and attainment; and
    • (D) make recommendations regarding improving and strengthening the timeliness, quality, and public transparency and accessibility of information about child health and health care quality.
  • (2) Up to $1,000,000 of the amount appropriated under subsection (i) for a fiscal year shall be used to carry out this subsection.
• (h) Notwithstanding any other provision in this section, no evidence based quality measure developed, published, or used as a basis of measurement or reporting under this section may be used to establish an irrebuttable presumption regarding either the medical necessity of care or the maximum permissible coverage for any individual child who is eligible for and receiving medical assistance under subchapter XIX or child health assistance under subchapter XXI.
• (i)
  • (1) Out of any funds in the Treasury not otherwise appropriated, there is appropriated—
    • (A) for each of fiscal years 2009 through 2013, $45,000,000 for the purpose of carrying out this section (other than subsection (e));
    • (B) for the period of fiscal years 2016 and 2017, $20,000,000 for the purpose of carrying out this section (other than subsections (e), (f), and (g));
    • (C) for the period of fiscal years 2018 through 2023, $90,000,000 for the purpose of carrying out this section (other than subsections (e), (f), and (g)); and
    • (D) for the period of fiscal years 2024 through 2027, $60,000,000 for the purpose of carrying out this section (other than subsections (e), (f), and (g)).
  • (2) Funds appropriated under this subsection shall remain available until expended.

§ 1320b–9b. Adult health quality measures

• (a) The Secretary shall identify and publish a recommended core set of adult health quality measures for Medicaid eligible adults in the same manner as the Secretary identifies and publishes a core set of child health quality measures under section 1320b–9a of this title , including with respect to identifying and publishing existing adult health quality measures that are in use under public and privately sponsored health care coverage arrangements, or that are part of reporting systems that measure both the presence and duration of health insurance coverage over time, that may be applicable to Medicaid eligible adults.
• (b)
  • (1) Not later than January 1, 2011 , the Secretary shall identify and publish for comment a recommended core set of adult health quality measures for Medicaid eligible adults.
  • (2) Not later than January 1, 2012 , the Secretary shall publish an initial core set of adult health quality measures that are applicable to Medicaid eligible adults.
  • (3)
    • (A) Not later than January 1, 2013 , the Secretary, in consultation with States, shall develop a standardized format for reporting information based on the initial core set of adult health quality measures and create procedures to encourage States to use such measures to voluntarily report information regarding the quality of health care for Medicaid eligible adults.
    • (B) Beginning with the State report required under subsection (d)(1) for 2024, the Secretary shall require States to use all behavioral health measures included in the core set of adult health quality measures and any updates or changes to such measures to report information, using the standardized format for reporting information and procedures developed under subparagraph (A), regarding the quality of behavioral health care for Medicaid eligible adults.
  • (4) Not later than January 1, 2014 , and every 3 years thereafter, the Secretary shall include in the report to Congress required under section 1320b–9a(a)(6) of this title information similar to the information required under that section with respect to the measures established under this section.
  • (5)
    • (A) Not later than 12 months after the release of the recommended core set of adult health quality measures under paragraph (1)) 1 1 So in original. The second closing parenthesis probably should not appear. , the Secretary shall establish a Medicaid Quality Measurement Program in the same manner as the Secretary establishes the pediatric quality measures program under section 1320b–9a(b) of this title .
    • (B) Beginning not later than 24 months after the establishment of the Medicaid Quality Measurement Program, and annually thereafter, the Secretary shall publish recommended changes to the initial core set of adult health quality measures that shall reflect the results of the testing, validation, and consensus process for the development of adult health quality measures.
    • (C) Beginning with respect to State reports required under subsection (d)(1) for 2024, the core set of adult health quality measures maintained under this paragraph (and any updates or changes to such measures) shall include behavioral health measures.
• (c) Nothing in this section shall be construed as supporting the restriction of coverage, under subchapter XIX or XXI or otherwise, to only those services that are evidence-based, or in anyway limiting available services.
• (d)
  • (1) Each State with a State plan or waiver approved under subchapter XIX shall annually report (separately or as part of the annual report required under section 1320b–9a(c) of this title ), to the Secretary on the—
    • (A) State-specific adult health quality measures applied by the State under such plan, including measures described in subsection (b)(5) and, beginning with the report for 2024, all behavioral health measures included in the core set of adult health quality measures maintained under such subsection (b)(5) and any updates or changes to such measures (as required under subsection (b)(3)); and
    • (B) State-specific information on the quality of health care furnished to Medicaid eligible adults under such plan, including information collected through external quality reviews of managed care organizations under section 1396u–2 of this title and benchmark plans under section 1396u–7 of this title .
  • (2) Not later than September 30, 2014 , and annually thereafter, the Secretary shall collect, analyze, and make publicly available the information reported by States under paragraph (1).
• (e) Out of any funds in the Treasury not otherwise appropriated, there is appropriated for each of fiscal years 2010 through 2014, $60,000,000 for the purpose of carrying out this section. Funds appropriated under this subsection shall remain available until expended. Of the funds appropriated under this subsection, not less than $15,000,000 shall be used to carry out section 1320b–9a(b) of this title .

§ 1397n–10. Website

The Federal Interagency Council on Social Impact Partnerships shall establish and maintain a public website that shall display the following:

• (1) A copy of, or method of accessing, each notice published regarding a social impact partnership project pursuant to this division.
• (2) A copy of each feasibility study funded under this division.
• (3) For each State or local government that has entered into an agreement with the Secretary for a social impact partnership project, the website shall contain the following information:
  • (A) The outcome goals of the project.
  • (B) A description of each intervention in the project.
  • (C) The target population that will be served by the project.
  • (D) The expected social benefits to participants who receive the intervention and others who may be impacted.
  • (E) The detailed roles, responsibilities, and purposes of each Federal, State, or local government entity, intermediary, service provider, independent evaluator, investor, or other stakeholder.
  • (F) The payment terms, methodology used to calculate outcome payments, the payment schedule, and performance thresholds.
  • (G) The project budget.
  • (H) The project timeline.
  • (I) The project eligibility criteria.
  • (J) The evaluation design.
  • (K) The metrics used to determine whether the proposed outcomes have been achieved and how these metrics are measured.
• (4) A copy of the progress reports and the final reports relating to each social impact partnership project.
• (5) An estimate of the savings to the Federal, State, and local government, on a program-by-program basis and in the aggregate, resulting from the successful completion of the social impact partnership project.

§ 1397n–11. Regulations

The Secretary, in consultation with the Federal Interagency Council on Social Impact Partnerships, may issue regulations as necessary to carry out this division.

§ 1397n–12. Definitions

In this division:

• (1) The term “agency” has the meaning given that term in section 551 of title 5 .
• (2) The term “intervention” means a specific service delivered to achieve an impact through a social impact partnership project.
• (3) The term “Secretary” means the Secretary of the Treasury.
• (4) The term “social impact partnership project” means a project that finances social services using a social impact partnership model.
• (5) The term “social impact partnership model” means a method of financing social services in which—
  • (A) Federal funds are awarded to a State or local government only if a State or local government achieves certain outcomes agreed on by the State or local government and the Secretary; and
  • (B) the State or local government coordinates with service providers, investors (if applicable to the project), and (if necessary) an intermediary to identify—
    • (i) an intervention expected to produce the outcome;
    • (ii) a service provider to deliver the intervention to the target population; and
    • (iii) investors to fund the delivery of the intervention.
• (6) The term “State” means each State of the United States, the District of Columbia, each commonwealth, territory or possession of the United States, and each federally recognized Indian tribe.

§ 1397n–13. Funding

Out of any money in the Treasury of the United States not otherwise appropriated, there is hereby appropriated $100,000,000 for fiscal year 2018 to carry out this division.

§ 1320b–14. Outreach efforts to increase awareness of the availability of medicare cost-sharing and subsidies for low-income individuals under subchapter XVIII

• (a)
  • (1) The Commissioner of Social Security (in this section referred to as the “Commissioner”) shall conduct outreach efforts to—
    • (A) identify individuals entitled to benefits under the medicare program under subchapter XVIII who may be eligible for medical assistance for payment of the cost of medicare cost-sharing under the medicaid program pursuant to sections 1396a(a)(10)(E) and 1396u–3 of this title 1 1 So in original. Probably should be followed by a comma. for the transitional assistance under section 1395w–141(f) of this title , or for premium and cost-sharing subsidies under section 1395w–114 of this title ; and
    • (B) notify such individuals of the availability of such medical assistance, program, and subsidies under such sections.
  • (2) Any notice furnished under paragraph (1) shall state that eligibility for medicare cost-sharing assistance, the transitional assistance under section 1395w–141(f) of this title , or premium and cost-sharing subsidies under section 1395w–114 of this title under such sections is conditioned upon—
    • (A) the individual providing to the State information about income and resources (in the case of an individual residing in a State that imposes an assets test for eligibility for medicare cost-sharing under the medicaid program); and
    • (B) meeting the applicable eligibility criteria.
• (b)
  • (1) In conducting the outreach efforts under this section, the Commissioner shall—
    • (A) furnish the agency of each State responsible for the administration of the medicaid program and any other appropriate State agency with information consisting of the name and address of individuals residing in the State that the Commissioner determines may be eligible for medical assistance for payment of the cost of medicare cost-sharing under the medicaid program pursuant to sections 1396a(a)(10)(E) and 1396u–3 of this title, for transitional assistance under section 1395w–141(f) of this title , or for premium and cost-sharing subsidies for low-income individuals under section 1395w–114 of this title ; and
    • (B) update any such information not less frequently than once per year.
  • (2) The periodic updates described in paragraph (1)(B) shall include information on individuals who are or may be eligible for the medical assistance, program, and subsidies described in paragraph (1)(A) because such individuals have experienced reductions in benefits under subchapter II.
• (c)
  • (1) For each individual who submits an application for low-income subsidies under section 1395w–114 of this title , requests an application for such subsidies, or is otherwise identified as an individual who is potentially eligible for such subsidies, the Commissioner shall do the following:
    • (A) Provide information describing the low-income subsidy program under section 1395w–114 of this title and the Medicare Savings Program (as defined in paragraph (7)).
    • (B) Provide an application for enrollment under such low-income subsidy program (if not already received by the Commissioner).
    • (C) In accordance with paragraph (3), transmit data from such an application for purposes of initiating an application for benefits under the Medicare Savings Program.
    • (D) Provide information on how the individual may obtain assistance in completing such application and an application under the Medicare Savings Program, including information on how the individual may contact the State health insurance assistance program (SHIP).
    • (E) Make the application described in subparagraph (B) and the information described in subparagraphs (A) and (D) available at local offices of the Social Security Administration.
  • (2) The Commissioner shall provide training to those employees of the Social Security Administration who are involved in receiving applications for benefits described in paragraph (1)(B) in order that they may promote beneficiary understanding of the low-income subsidy program and the Medicare Savings Program in order to increase participation in these programs. Such employees shall provide assistance in completing an application described in paragraph (1)(B) upon request.
  • (3) Beginning on January 1, 2010 , with the consent of an individual completing an application for benefits described in paragraph (1)(B), the Commissioner shall electronically transmit to the appropriate State Medicaid agency data from such application, as determined by the Commissioner, which transmittal shall initiate an application of the individual for benefits under the Medicare Savings Program with the State Medicaid agency. In order to ensure that such data transmittal provides effective assistance for purposes of State adjudication of applications for benefits under the Medicare Savings Program, the Commissioner shall consult with the Secretary, after the Secretary has consulted with the States, regarding the content, form, frequency, and manner in which data (on a uniform basis for all States) shall be transmitted under this subparagraph.
  • (4) The Commissioner shall coordinate outreach activities under this subsection in connection with the low-income subsidy program and the Medicare Savings Program.
  • (5)
    • (A)
      • (i) There are hereby appropriated to the Commissioner to carry out this subsection, out of any funds in the Treasury not otherwise appropriated, $24,100,000. The amount appropriated under ths 2 2 So in original. Probably should be “this”. clause shall be available on October 1, 2008 , and shall remain available until expended.
      • (ii) There are hereby appropriated to the Commissioner, out of any funds in the Treasury not otherwise appropriated, $24,800,000 for fiscal year 2009 to carry out low-income subsidy activities under section 1395w–114 of this title and the Medicare Savings Program (in accordance with this subsection), to remain available until expended. Such funds shall be in addition to the Social Security Administration’s Limitation on Administrative Expenditure appropriations for such fiscal year.
    • (B)
      • (i) Effective for fiscal years beginning on or after October 1, 2010 , the Commissioner and the Secretary shall enter into an agreement which shall provide funding (subject to the amount appropriated under clause (ii)) to cover the administrative costs of the Commissioner’s activities under this subsection. Such agreement shall—
        • (I) provide funds to the Commissioner for the full cost of the Social Security Administration’s work related to the Medicare Savings Program required under this section;
        • (II) provide such funding quarterly in advance of the applicable quarter based on estimating methodology agreed to by the Commissioner and the Secretary; and
        • (III) require an annual accounting and reconciliation of the actual costs incurred and funds provided under this subsection.
      • (ii) There are hereby appropriated to the Secretary solely for the purpose of providing payments to the Commissioner pursuant to an agreement specified in clause (i) that is in effect, out of any funds in the Treasury not otherwise appropriated, not more than $3,000,000 for fiscal year 2011 and each fiscal year thereafter.
    • (C) In no case shall funds from the Social Security Administration’s Limitation on Administrative Expenses be used to carry out activities related to the Medicare Savings Program. For fiscal years beginning on or after October 1, 2010 , no such activities shall be undertaken by the Social Security Administration unless the agreement specified in subparagraph (B) is in effect and full funding has been provided to the Commissioner as specified in such subparagraph.
  • (6)
    • (A) The Comptroller General of the United States shall prepare an analysis of the impact of this subsection—
      • (i) in increasing participation in the Medicare Savings Program, and
      • (ii) on States and the Social Security Administration.
    • (B) Not later than January 1, 2012 , the Comptroller General shall submit to Congress, the Commissioner, and the Secretary a report on the analysis conducted under subparagraph (A).
  • (7) For purposes of this subsection, the term “Medicare Savings Program” means the program of medical assistance for payment of the cost of medicare cost-sharing under the Medicaid program pursuant to sections 1396a(a)(10)(E) and 1396u–3 of this title.

§ 1320b–15. Protection of social security and medicare trust funds

• (a) No officer or employee of the United States shall—
  • (1) delay the deposit of any amount into (or delay the credit of any amount to) any Federal fund or otherwise vary from the normal terms, procedures, or timing for making such deposits or credits,
  • (2) refrain from the investment in public debt obligations of amounts in any Federal fund, or
  • (3) redeem prior to maturity amounts in any Federal fund which are invested in public debt obligations for any purpose other than the payment of benefits or administrative expenses from such Federal fund.
• (b) For purposes of this section, the term “public debt obligation” means any obligation subject to the public debt limit established under section 3101 of title 31 .
• (c) For purposes of this section, the term “Federal fund” means—
  • (1) the Federal Old-Age and Survivors Insurance Trust Fund;
  • (2) the Federal Disability Insurance Trust Fund;
  • (3) the Federal Hospital Insurance Trust Fund; and
  • (4) the Federal Supplementary Medical Insurance Trust Fund.

§ 1320b–16. Public disclosure of certain information on hospital financial interest and referral patterns

The Secretary shall make available to the public, in a form and manner specified by the Secretary, information disclosed to the Secretary pursuant to section 1395cc(a)(1)(S) of this title .

§ 1320b–17. Cross-program recovery of overpayments from benefits

• (a) Subject to subsection (b), whenever the Commissioner of Social Security determines that more than the correct amount of any payment has been made to a person under a program described in subsection (e), the Commissioner of Social Security may recover the amount incorrectly paid by decreasing any amount which is payable to such person under any other program specified in that subsection.
• (b)
  • (1) In carrying out subsection (a), the Commissioner of Social Security may not decrease the monthly amount payable to an individual under a program described in subsection (e) that is paid when regularly due—
    • (A) in the case of benefits under subchapter II or VIII, by more than 10 percent of the amount of the benefit payable to the person for that month under such subchapter; and
    • (B) in the case of benefits under subchapter XVI, by an amount greater than the lesser of—
      • (i) the amount of the benefit payable to the person for that month; or
      • (ii) an amount equal to 10 percent of the person’s income for that month (including such monthly benefit but excluding payments under subchapter II when recovery is also made from subchapter II payments and excluding income excluded pursuant to section 1382a(b) of this title ).
  • (2) Paragraph (1) shall not apply if—
    • (A) the person or the spouse of the person was involved in willful misrepresentation or concealment of material information in connection with the amount incorrectly paid; or
    • (B) the person so requests.
• (c) In any case in which the Commissioner of Social Security takes action in accordance with subsection (a) to recover an amount incorrectly paid to any person, neither that person, nor (with respect to the program described in subsection (e)(3)) any individual whose eligibility for benefits under such program or whose amount of such benefits, is determined by considering any part of that person’s income, shall, as a result of such action—
  • (1) become eligible for benefits under the program described in paragraph (2) or (3) of subsection (e); or
  • (2) if such person or individual is otherwise so eligible, become eligible for increased benefits under such program.
• (d) Section 407 of this title shall not apply to actions taken under the provisions of this section to decrease amounts payable under subchapters II and XVI.
• (e) The programs described in this subsection are the following:
  • (1) The old-age, survivors, and disability insurance benefits program under subchapter II.
  • (2) The special benefits for certain World War II veterans program under subchapter VIII.
  • (3) The supplemental security income benefits program under subchapter XVI (including, for purposes of this section, State supplementary payments paid by the Commissioner pursuant to an agreement under section 1382e(a) of this title or section 212(b) of Public Law 93–66 ).

§ 1395w–21. Eligibility, election, and enrollment

• (a)
  • (1) Subject to the provisions of this section, each Medicare+Choice eligible individual (as defined in paragraph (3)) is entitled to elect to receive benefits (other than qualified prescription drug benefits) under this subchapter—
    • (A) through the original medicare fee-for-service program under parts A and B, or
    • (B) through enrollment in a Medicare+Choice plan under this part,
  • (2) A Medicare+Choice plan may be any of the following types of plans of health insurance:
    • (A)
      • (i) Coordinated care plans which provide health care services, including but not limited to health maintenance organization plans (with or without point of service options), plans offered by provider-sponsored organizations (as defined in section 1395w–25(d) of this title ), and regional or local preferred provider organization plans (including MA regional plans).
      • (ii) Specialized MA plans for special needs individuals (as defined in section 1395w–28(b)(6) of this title ) may be any type of coordinated care plan.
    • (B) An MSA plan, as defined in section 1395w–28(b)(3) of this title , and a contribution into a Medicare+Choice medical savings account (MSA).
    • (C) A Medicare+Choice private fee-for-service plan, as defined in section 1395w–28(b)(2) of this title .
  • (3) In this subchapter, the term “Medicare+Choice eligible individual” means an individual who is entitled to benefits under part A and enrolled under part B.
• (b)
  • (1)
    • (A) Except as the Secretary may otherwise provide and except as provided in subparagraph (C), an individual is eligible to elect a Medicare+Choice plan offered by a Medicare+Choice organization only if the plan serves the geographic area in which the individual resides.
    • (B) Pursuant to rules specified by the Secretary, the Secretary shall provide that an MA local plan may offer to all individuals residing in a geographic area the option to continue enrollment in the plan, notwithstanding that the individual no longer resides in the service area of the plan, so long as the plan provides that individuals exercising this option have, as part of the benefits under the original medicare fee-for-service program option, reasonable access within that geographic area to the full range of basic benefits, subject to reasonable cost sharing liability in obtaining such benefits.
    • (C) Notwithstanding subparagraph (A) and in addition to subparagraph (B), if a Medicare+Choice organization eliminates from its service area a Medicare+Choice payment area that was previously within its service area, the organization may elect to offer individuals residing in all or portions of the affected area who would otherwise be ineligible to continue enrollment the option to continue enrollment in an MA local plan it offers so long as—
      • (i) the enrollee agrees to receive the full range of basic benefits (excluding emergency and urgently needed care) exclusively at facilities designated by the organization within the plan service area; and
      • (ii) there is no other Medicare+Choice plan offered in the area in which the enrollee resides at the time of the organization’s election.
  • (2)
    • (A) An individual who is enrolled in a health benefit plan under chapter 89 of title 5 is not eligible to enroll in an MSA plan until such time as the Director of the Office of Management and Budget certifies to the Secretary that the Office of Personnel Management has adopted policies which will ensure that the enrollment of such individuals in such plans will not result in increased expenditures for the Federal Government for health benefit plans under such chapter.
    • (B) The Secretary may apply rules similar to the rules described in subparagraph (A) in the case of individuals who are eligible for health care benefits under chapter 55 of title 10 or under chapter 17 of title 38.
  • (3) An individual who is a qualified medicare beneficiary (as defined in section 1396d(p)(1) of this title ), a qualified disabled and working individual (described in section 1396d(s) of this title ), an individual described in section 1396a(a)(10)(E)(iii) of this title , or otherwise entitled to medicare cost-sharing under a State plan under subchapter XIX is not eligible to enroll in an MSA plan.
  • (4)
    • (A) Under rules established by the Secretary, an individual is not eligible to enroll (or continue enrollment) in an MSA plan for a year unless the individual provides assurances satisfactory to the Secretary that the individual will reside in the United States for at least 183 days during the year.
    • (B) The Secretary shall regularly evaluate the impact of permitting enrollment in MSA plans under this part on selection (including adverse selection), use of preventive care, access to care, and the financial status of the Trust Funds under this subchapter.
    • (C) The Secretary shall submit to Congress periodic reports on the numbers of individuals enrolled in such plans and on the evaluation being conducted under subparagraph (B).
• (c)
  • (1) The Secretary shall establish a process through which elections described in subsection (a) are made and changed, including the form and manner in which such elections are made and changed. Subject to paragraph (4), such elections shall be made or changed only during coverage election periods specified under subsection (e) and shall become effective as provided in subsection (f).
  • (2)
    • (A) Such process shall permit an individual who wishes to elect a Medicare+Choice plan offered by a Medicare+Choice organization to make such election through the filing of an appropriate election form with the organization.
    • (B) Such process shall permit an individual, who has elected a Medicare+Choice plan offered by a Medicare+Choice organization and who wishes to terminate such election, to terminate such election through the filing of an appropriate election form with the organization.
  • (3)
    • (A)
      • (i) Subject to clause (ii), an individual who fails to make an election during an initial election period under subsection (e)(1) is deemed to have chosen the original medicare fee-for-service program option.
      • (ii) The Secretary may establish procedures under which an individual who is enrolled in a health plan (other than Medicare+Choice plan) offered by a Medicare+Choice organization at the time of the initial election period and who fails to elect to receive coverage other than through the organization is deemed to have elected the Medicare+Choice plan offered by the organization (or, if the organization offers more than one such plan, such plan or plans as the Secretary identifies under such procedures).
    • (B) An individual who has made (or is deemed to have made) an election under this section is considered to have continued to make such election until such time as—
      • (i) the individual changes the election under this section, or
      • (ii) the Medicare+Choice plan with respect to which such election is in effect is discontinued or, subject to subsection (b)(1)(B), no longer serves the area in which the individual resides.
  • (4)
    • (A) On the first day of the annual, coordinated election period under subsection (e)(3) for plan years beginning on or after January 1, 2017 , an MA eligible individual described in clause (i) or (ii) of subparagraph (B) is deemed, unless the individual elects otherwise, to have elected to receive benefits under this subchapter through an applicable MA plan (and shall be enrolled in such plan) beginning with such plan year, if—
      • (i) the individual is enrolled in a reasonable cost reimbursement contract under section 1395mm(h) of this title in the previous plan year;
      • (ii) such reasonable cost reimbursement contract was extended or renewed for the last reasonable cost reimbursement contract year of the contract (as described in subclause (I) of section 1395mm(h)(5)(C)(iv) of this title ) pursuant to such section;
      • (iii) the eligible organization that is offering such reasonable cost reimbursement contract provided the notice described in subclause (III) of such section that the contract was to be converted;
      • (iv) the applicable MA plan—
        • (I) is the plan that was converted from the reasonable cost reimbursement contract described in clause (iii);
        • (II) is offered by the same entity (or an organization affiliated with such entity that has a common ownership interest of control) that entered into such contract; and
        • (III) is offered in the service area where the individual resides;
      • (v) in the case of reasonable cost reimbursement contracts that provide coverage under parts A and B (and, to the extent the Secretary determines it to be feasible, contracts that provide only part B coverage), the difference between the estimated individual costs (as determined applicable by the Secretary) for the applicable MA plan and such costs for the predecessor cost plan does not exceed a threshold established by the Secretary; and
      • (vi) the applicable MA plan—
        • (I) provides coverage for enrollees transitioning from the converted reasonable cost reimbursement contract to such plan to maintain current providers of services and suppliers and course of treatment at the time of enrollment for a period of at least 90 days after enrollment; and
        • (II) during such period, pays such providers of services and suppliers for items and services furnished to the enrollee an amount that is not less than the amount of payment applicable for such items and services under the original Medicare fee-for-service program under parts A and B.
    • (B)
      • (i) An MA eligible individual described in this clause, with respect to a plan year, is an MA eligible individual who is enrolled in a reasonable cost reimbursement contract under section 1395mm(h) of this title in the previous plan year and who is not, for such previous plan year, enrolled in a prescription drug plan under part D, including coverage under section 1395w–132 of this title .
      • (ii) An MA eligible individual described in this clause, with respect to a plan year, is an MA eligible individual who is enrolled in a reasonable cost reimbursement contract under section 1395mm(h) of this title in the previous plan year and who, for such previous plan year, is enrolled in a prescription drug plan under part D—
        • (I) through such contract; or
        • (II) through a prescription drug plan, if the sponsor of such plan is the same entity (or an organization affiliated with such entity) that entered into such contract.
    • (C) In this paragraph, the term “applicable MA plan” means, in the case of an individual described in—
      • (i) subparagraph (B)(i), an MA plan that is not an MA–PD plan; and
      • (ii) subparagraph (B)(ii), an MA–PD plan.
    • (D) Not later than 45 days before the first day of the annual, coordinated election period under subsection (e)(3) for plan years beginning on or after January 1, 2017 , the Secretary shall identify and notify the individuals who will be subject to deemed elections under subparagraph (A) on the first day of such period.
• (d)
  • (1) The Secretary shall provide for activities under this subsection to broadly disseminate information to medicare beneficiaries (and prospective medicare beneficiaries) on the coverage options provided under this section in order to promote an active, informed selection among such options.
  • (2)
    • (A) At least 15 days before the beginning of each annual, coordinated election period (as defined in subsection (e)(3)(B)), the Secretary shall mail to each Medicare+Choice eligible individual residing in an area the following:
      • (i) The general information described in paragraph (3).
      • (ii) A list identifying the Medicare+Choice plans that are (or will be) available to residents of the area and information described in paragraph (4) concerning such plans. Such information shall be presented in a comparative form.
      • (iii) Any other information that the Secretary determines will assist the individual in making the election under this section.
    • (B)
      • (i) To the extent practicable, the Secretary shall, not later than 30 days before the beginning of the initial Medicare+Choice enrollment period for an individual described in subsection (e)(1), mail to the individual the information described in subparagraph (A).
      • (ii) The Secretary shall require a Medicare Advantage organization that is offering a Medicare Advantage plan that has been converted from a reasonable cost reimbursement contract pursuant to section 1395mm(h)(5)(C)(iv) of this title to mail, not later than 30 days prior to the first day of the annual, coordinated election period under subsection (e)(3) of a year, to any individual enrolled under such contract and identified by the Secretary under subsection (c)(4)(D) for such year—
        • (I) a notification that such individual will, on such day, be deemed to have made an election with respect to such plan to receive benefits under this subchapter through an MA plan or MA–PD plan (and shall be enrolled in such plan) for the next plan year under subsection (c)(4)(A), but that the individual may make a different election during the annual, coordinated election period for such year;
        • (II) the information described in subparagraph (A);
        • (III) a description of the differences between such MA plan or MA–PD plan and the reasonable cost reimbursement contract in which the individual was most recently enrolled with respect to benefits covered under such plans, including cost-sharing, premiums, drug coverage, and provider networks;
        • (IV) information about the special period for elections under subsection (e)(2)(F); and
        • (V) other information the Secretary may specify.
    • (C) The information disseminated under this paragraph shall be written and formatted using language that is easily understandable by medicare beneficiaries.
    • (D) The information described in subparagraph (A) shall be updated on at least an annual basis to reflect changes in the availability of Medicare+Choice plans and the benefits and Medicare+Choice monthly basic and supplemental beneficiary premiums for such plans.
  • (3) General information under this paragraph, with respect to coverage under this part during a year, shall include the following:
    • (A) A general description of the benefits covered under the original medicare fee-for-service program under parts A and B, including—
      • (i) covered items and services,
      • (ii) beneficiary cost sharing, such as deductibles, coinsurance, and copayment amounts, and
      • (iii) any beneficiary liability for balance billing.
    • (B) Information and instructions on how to exercise election options under this section.
    • (C) A general description of procedural rights (including grievance and appeals procedures) of beneficiaries under the original medicare fee-for-service program and the Medicare+Choice program and the right to be protected against discrimination based on health status-related factors under section 1395w–22(b) of this title .
    • (D) A general description of the benefits, enrollment rights, and other requirements applicable to medicare supplemental policies under section 1395ss of this title and provisions relating to medicare select policies described in section 1395ss(t) of this title .
    • (E) The fact that a Medicare+Choice organization may terminate its contract, refuse to renew its contract, or reduce the service area included in its contract, under this part, and the effect of such a termination, nonrenewal, or service area reduction may have on individuals enrolled with the Medicare+Choice plan under this part.
    • (F) In the case of an MA regional plan, a description of the catastrophic coverage and single deductible applicable under the plan.
  • (4) Information under this paragraph, with respect to a Medicare+Choice plan for a year, shall include the following:
    • (A) The benefits covered under the plan, including the following:
      • (i) Covered items and services beyond those provided under the original medicare fee-for-service program.
      • (ii) Any beneficiary cost sharing, including information on the single deductible (if applicable) under section 1395w–27a(b)(1) of this title .
      • (iii) Any maximum limitations on out-of-pocket expenses.
      • (iv) In the case of an MSA plan, differences in cost sharing, premiums, and balance billing under such a plan compared to under other Medicare+Choice plans.
      • (v) In the case of a Medicare+Choice private fee-for-service plan, differences in cost sharing, premiums, and balance billing under such a plan compared to under other Medicare+Choice plans.
      • (vi) The extent to which an enrollee may obtain benefits through out-of-network health care providers.
      • (vii) The extent to which an enrollee may select among in-network providers and the types of providers participating in the plan’s network.
      • (viii) The organization’s coverage of emergency and urgently needed care.
    • (B)
      • (i) The monthly amount of the premium charged to an individual.
      • (ii) The reduction in part B premiums, if any.
    • (C) The service area of the plan.
    • (D) To the extent available, plan quality and performance indicators for the benefits under the plan (and how they compare to such indicators under the original medicare fee-for-service program under parts A and B in the area involved), including—
      • (i) disenrollment rates for medicare enrollees electing to receive benefits through the plan for the previous 2 years (excluding disenrollment due to death or moving outside the plan’s service area),
      • (ii) information on medicare enrollee satisfaction,
      • (iii) information on health outcomes, and
      • (iv) the recent record regarding compliance of the plan with requirements of this part (as determined by the Secretary).
    • (E) Supplemental health care benefits, including any reductions in cost-sharing under section 1395w–22(a)(3) of this title and the terms and conditions (including premiums) for such benefits.
  • (5) The Secretary shall maintain a toll-free number for inquiries regarding Medicare+Choice options and the operation of this part in all areas in which Medicare+Choice plans are offered and an Internet site through which individuals may electronically obtain information on such options and Medicare+Choice plans.
  • (6) The Secretary may enter into contracts with non-Federal entities to carry out activities under this subsection.
  • (7) A Medicare+Choice organization shall provide the Secretary with such information on the organization and each Medicare+Choice plan it offers as may be required for the preparation of the information referred to in paragraph (2)(A).
• (e)
  • (1) If, at the time an individual first becomes entitled to benefits under part A and enrolled under part B, there is one or more Medicare+Choice plans offered in the area in which the individual resides, the individual shall make the election under this section during a period specified by the Secretary such that if the individual elects a Medicare+Choice plan during the period, coverage under the plan becomes effective as of the first date on which the individual may receive such coverage. If any portion of an individual’s initial enrollment period under part B occurs after the end of the annual, coordinated election period described in paragraph (3)(B)(iii), the initial enrollment period under this part shall further extend through the end of the individual’s initial enrollment period under part B.
  • (2) Subject to paragraph (5)—
    • (A) At any time during the period beginning January 1, 1998 , and ending on December 31, 2005 , a Medicare+Choice eligible individual may change the election under subsection (a)(1).
    • (B)
      • (i) Subject to clause (ii), subparagraph (C)(iii), 1 1 See References in Text note below. and subparagraph (D), at any time during the first 6 months of 2006, or, if the individual first becomes a Medicare+Choice eligible individual during 2006, during the first 6 months during 2006 in which the individual is a Medicare+Choice eligible individual, a Medicare+Choice eligible individual may change the election under subsection (a)(1).
      • (ii) An individual may exercise the right under clause (i) only once. The limitation under this clause shall not apply to changes in elections effected during an annual, coordinated election period under paragraph (3) or during a special enrollment period under the first sentence of paragraph (4).
    • (C) Subject to subparagraph (D), at any time during the first 45 days of a year (beginning with 2011 and ending with 2018), an individual who is enrolled in a Medicare Advantage plan may change the election under subsection (a)(1), but only with respect to coverage under the original medicare fee-for-service program under parts A and B, and may elect qualified prescription drug coverage in accordance with section 1395w–101 of this title .
    • (D) At any time after 2005 in the case of a Medicare+Choice eligible individual who is institutionalized (as defined by the Secretary), the individual may elect under subsection (a)(1)—
      • (i) to enroll in a Medicare+Choice plan; or
      • (ii) to change the Medicare+Choice plan in which the individual is enrolled.
    • (E)
      • (i) On any date during the period beginning on January 1, 2007 , and ending on July 31, 2007 , on which a Medicare Advantage eligible individual is an unenrolled fee-for-service individual (as defined in clause (ii)), the individual may elect under subsection (a)(1) to enroll in a Medicare Advantage plan that is not an MA–PD plan.
      • (ii) In this subparagraph, the term “unenrolled fee-for-service individual” means, with respect to a date, a Medicare Advantage eligible individual who—
        • (I) is receiving benefits under this subchapter through enrollment in the original medicare fee-for-service program under parts A and B;
        • (II) is not enrolled in an MA plan on such date; and
        • (III) as of such date is not otherwise eligible to elect to enroll in an MA plan.
      • (iii) An individual may exercise the right under clause (i) only once during the period described in such clause.
      • (iv) Nothing in this subparagraph shall be construed as permitting an individual exercising the right under clause (i)—
        • (I) who is enrolled in a prescription drug plan under part D, to disenroll from such plan or to enroll in a different prescription drug plan; or
        • (II) who is not enrolled in a prescription drug plan, to enroll in such a plan.
    • (F)
      • (i) At any time during the period beginning after the last day of the annual, coordinated election period under paragraph (3) in which an individual is deemed to have elected to enroll in an MA plan or MA–PD plan under subsection (c)(4) and ending on the last day of February of the first plan year for which the individual is enrolled in such plan, such individual may change the election under subsection (a)(1) (including changing the MA plan or MA–PD plan in which the individual is enrolled).
      • (ii) An individual may exercise the right under clause (i) only once during the applicable period described in such clause. The limitation under this clause shall not apply to changes in elections effected during an annual, coordinated election period under paragraph (3) or during a special enrollment period under paragraph (4).
    • (G)
      • (i) Subject to clause (ii) and subparagraph (D)—
        • (I) in the case of an MA eligible individual who is enrolled in an MA plan, at any time during the first 3 months of a year (beginning with 2019); or
        • (II) in the case of an individual who first becomes an MA eligible individual during a year (beginning with 2019) and enrolls in an MA plan, during the first 3 months during such year in which the individual is an MA eligible individual;
      • (ii) An individual may change the election pursuant to clause (i) only once during the applicable 3-month period described in such clause in each year. The limitation under this clause shall not apply to changes in elections effected during an annual, coordinated election period under paragraph (3) or during a special enrollment period under paragraph (4).
      • (iii) Clauses (i) and (ii) of this subparagraph shall only apply with respect to changes in enrollment in a prescription drug plan under part D in the case of an individual who, previous to such change in enrollment, is enrolled in a Medicare Advantage plan.
      • (iv) Pursuant to subsection (j), no unsolicited marketing or marketing materials may be sent to an individual described in clause (i) during the continuous open enrollment and disenrollment period established for the individual under such clause, notwithstanding marketing guidelines established by the Centers for Medicare & Medicaid Services.
  • (3)
    • (A) Subject to paragraph (5), each individual who is eligible to make an election under this section may change such election during an annual, coordinated election period.
    • (B) For purposes of this section, the term “annual, coordinated election period” means—
      • (i) with respect to a year before 2002, the month of November before such year;
      • (ii) with respect to 2002, 2003, 2004, and 2005, the period beginning on November 15 and ending on December 31 of the year before such year;
      • (iii) with respect to 2006, the period beginning on November 15, 2005 , and ending on May 15, 2006 ;
      • (iv) with respect to 2007, 2008, 2009, and 2010, the period beginning on November 15 and ending on December 31 of the year before such year; and
      • (v) with respect to 2012 and succeeding years, the period beginning on October 15 and ending on December 7 of the year before such year.
    • (C) During the fall season of each year (beginning with 1999) and during the period described in subparagraph (B)(iii), in conjunction with the annual coordinated election period defined in subparagraph (B), the Secretary shall provide for a nationally coordinated educational and publicity campaign to inform Medicare+Choice eligible individuals about Medicare+Choice plans and the election process provided under this section.
    • (D) During November 1998 the Secretary shall provide for an educational and publicity campaign to inform Medicare+Choice eligible individuals about the availability of Medicare+Choice plans, and eligible organizations with risk-sharing contracts under section 1395mm of this title , offered in different areas and the election process provided under this section. During the period described in subparagraph (B)(iii), the Secretary shall provide for an educational and publicity campaign to inform MA eligible individuals about the availability of MA plans (including MA–PD plans) offered in different areas and the election process provided under this section.
  • (4) Effective as of January 1, 2006 , an individual may discontinue an election of a Medicare+ÐChoice plan offered by a Medicare+Choice organization other than during an annual, coordinated election period and make a new election under this section if—
    • (A)
      • (i) the certification of the organization or plan under this part has been terminated, or the organization or plan has notified the individual of an impending termination of such certification; or
      • (ii) the organization has terminated or otherwise discontinued providing the plan in the area in which the individual resides, or has notified the individual of an impending termination or discontinuation of such plan;
    • (B) the individual is no longer eligible to elect the plan because of a change in the individual’s place of residence or other change in circumstances (specified by the Secretary, but not including termination of the individual’s enrollment on the basis described in clause (i) or (ii) of subsection (g)(3)(B));
    • (C) the individual demonstrates (in accordance with guidelines established by the Secretary) that—
      • (i) the organization offering the plan substantially violated a material provision of the organization’s contract under this part in relation to the individual (including the failure to provide an enrollee on a timely basis medically necessary care for which benefits are available under the plan or the failure to provide such covered care in accordance with applicable quality standards); or
      • (ii) the organization (or an agent or other entity acting on the organization’s behalf) materially misrepresented the plan’s provisions in marketing the plan to the individual; or
    • (D) the individual meets such other exceptional conditions as the Secretary may provide.
  • (5) Notwithstanding the preceding provisions of this subsection, an individual—
    • (A) may elect an MSA plan only during—
      • (i) an initial open enrollment period described in paragraph (1), or
      • (ii) an annual, coordinated election period described in paragraph (3)(B);
    • (B) subject to subparagraph (C), may not discontinue an election of an MSA plan except during the periods described in clause (ii) or (iii) of subparagraph (A) and under the first sentence of paragraph (4); and
    • (C) who elects an MSA plan during an annual, coordinated election period, and who never previously had elected such a plan, may revoke such election, in a manner determined by the Secretary, by not later than December 15 following the date of the election.
  • (6) Subject to paragraph (5), a Medicare+Choice organization—
    • (A) shall accept elections or changes to elections during the initial enrollment periods described in paragraph (1), during the period described in paragraph (2)(F), during the month of November 1998 and during the annual, coordinated election period under paragraph (3) for each subsequent year, and during special election periods described in the first sentence of paragraph (4); and
    • (B) may accept other changes to elections at such other times as the organization provides.
• (f)
  • (1) An election of coverage made during the initial coverage election period under subsection (e)(1) shall take effect upon the date the individual becomes entitled to benefits under part A and enrolled under part B, except as the Secretary may provide (consistent with section 1395q of this title ) in order to prevent retroactive coverage.
  • (2) An election or change of coverage made under subsection (e)(2) shall take effect with the first day of the first calendar month following the date on which the election or change is made.
  • (3) An election or change of coverage made during an annual, coordinated election period (as defined in subsection (e)(3)(B), other than the period described in clause (iii) of such subsection) in a year shall take effect as of the first day of the following year.
  • (4) An election or change of coverage made during any other period under subsection (e)(4) shall take effect in such manner as the Secretary provides in a manner consistent (to the extent practicable) with protecting continuity of health benefit coverage.
• (g)
  • (1) Except as provided in this subsection, a Medicare+Choice organization shall provide that at any time during which elections are accepted under this section with respect to a Medicare+Choice plan offered by the organization, the organization will accept without restrictions individuals who are eligible to make such election.
  • (2) If the Secretary determines that a Medicare+Choice organization, in relation to a Medicare+Choice plan it offers, has a capacity limit and the number of Medicare+Choice eligible individuals who elect the plan under this section exceeds the capacity limit, the organization may limit the election of individuals of the plan under this section but only if priority in election is provided—
    • (A) first to such individuals as have elected the plan at the time of the determination, and
    • (B) then to other such individuals in such a manner that does not discriminate, on a basis described in section 1395w–22(b) of this title , among the individuals (who seek to elect the plan).
  • (3)
    • (A) Subject to subparagraph (B), a Medicare+ÐChoice organization may not for any reason terminate the election of any individual under this section for a Medicare+Choice plan it offers.
    • (B) A Medicare+Choice organization may terminate an individual’s election under this section with respect to a Medicare+Choice plan it offers if—
      • (i) any Medicare+Choice monthly basic and supplemental beneficiary premiums required with respect to such plan are not paid on a timely basis (consistent with standards under section 1395w–26 of this title that provide for a grace period for late payment of such premiums),
      • (ii) the individual has engaged in disruptive behavior (as specified in such standards), or
      • (iii) the plan is terminated with respect to all individuals under this part in the area in which the individual resides.
    • (C)
      • (i) Any individual whose election is terminated under clause (i) or (ii) of subparagraph (B) is deemed to have elected the original medicare fee-for-service program option described in subsection (a)(1)(A).
      • (ii) Any individual whose election is terminated under subparagraph (B)(iii) shall have a special election period under subsection (e)(4)(A) in which to change coverage to coverage under another Medicare+Choice plan. Such an individual who fails to make an election during such period is deemed to have chosen to change coverage to the original medicare fee-for-service program option described in subsection (a)(1)(A).
    • (D) Pursuant to a contract under section 1395w–27 of this title , each Medicare+Choice organization receiving an election form under subsection (c)(2) shall transmit to the Secretary (at such time and in such manner as the Secretary may specify) a copy of such form or such other information respecting the election as the Secretary may specify.
• (h)
  • (1) No marketing material or application form may be distributed by a Medicare+Choice organization to (or for the use of) Medicare+ÐChoice eligible individuals unless—
    • (A) at least 45 days (or 10 days in the case described in paragraph (5)) before the date of distribution the organization has submitted the material or form to the Secretary for review, and
    • (B) the Secretary has not disapproved the distribution of such material or form.
  • (2) The standards established under section 1395w–26 of this title shall include guidelines for the review of any material or form submitted and under such guidelines the Secretary shall disapprove (or later require the correction of) such material or form if the material or form is materially inaccurate or misleading or otherwise makes a material misrepresentation.
  • (3) In the case of material or form that is submitted under paragraph (1)(A) to the Secretary or a regional office of the Department of Health and Human Services and the Secretary or the office has not disapproved the distribution of marketing material or form under paragraph (1)(B) with respect to a Medicare+Choice plan in an area, the Secretary is deemed not to have disapproved such distribution in all other areas covered by the plan and organization except with regard to that portion of such material or form that is specific only to an area involved.
  • (4) Each Medicare+Choice organization shall conform to fair marketing standards, in relation to Medicare+Choice plans offered under this part, included in the standards established under section 1395w–26 of this title . Such standards—
    • (A) shall not permit a Medicare+Choice organization to provide for, subject to subsection (j)(2)(C), cash, gifts, prizes, or other monetary rebates as an inducement for enrollment or otherwise;
    • (B) may include a prohibition against a Medicare+Choice organization (or agent of such an organization) completing any portion of any election form used to carry out elections under this section on behalf of any individual;
    • (C) shall not permit a Medicare Advantage organization (or the agents, brokers, and other third parties representing such organization) to conduct the prohibited activities described in subsection (j)(1); and
    • (D) shall only permit a Medicare Advantage organization (and the agents, brokers, and other third parties representing such organization) to conduct the activities described in subsection (j)(2) in accordance with the limitations established under such subsection.
  • (5) In the case of marketing material of an organization that uses, without modification, proposed model language specified by the Secretary, the period specified in paragraph (1)(A) shall be reduced from 45 days to 10 days.
  • (6) For plan years beginning on or after January 1, 2010 , a Medicare Advantage organization must ensure that the name of each Medicare Advantage plan offered by the Medicare Advantage organization includes the plan type of the plan (using standard terminology developed by the Secretary).
  • (7)
    • (A) Each Medicare Advantage organization shall—
      • (i) only use agents and brokers who have been licensed under State law to sell Medicare Advantage plans offered by the Medicare Advantage organization;
      • (ii) in the case where a State has a State appointment law, abide by such law; and
      • (iii) report to the applicable State the termination of any such agent or broker, including the reasons for such termination (as required under applicable State law).
    • (B) Each Medicare Advantage organization shall comply in a timely manner with any request by a State for information regarding the performance of a licensed agent, broker, or other third party representing the Medicare Advantage organization as part of an investigation by the State into the conduct of the agent, broker, or other third party.
• (i)
  • (1) Subject to sections 1395w–22(a)(5), 1395w–23(a)(4), 1395w–23(g), 1395w–23(h), 1395ww(d)(11), 1395ww(h)(3)(D), and 1395w–23(m) of this title, payments under a contract with a Medicare+Choice organization under section 1395w–23(a) of this title with respect to an individual electing a Medicare+Choice plan offered by the organization shall be instead of the amounts which (in the absence of the contract) would otherwise be payable under parts A and B for items and services furnished to the individual.
  • (2) Subject to sections 1395w–23(a)(4), 1395w–23(e), 1395w–23(g), 1395w–23(h), 1395w–27(f)(2), 1395w–27a(h), 1395ww(d)(11), and 1395ww(h)(3)(D) of this title, only the Medicare+Choice organization shall be entitled to receive payments from the Secretary under this subchapter for services furnished to the individual.
  • (3) Paragraphs (1) and (2) shall not apply with respect to expenses for organ acquisitions for kidney transplants described in section 1395w–22(a)(1)(B)(i) of this title .
• (j)
  • (1) The following prohibited activities are described in this paragraph:
    • (A) Any unsolicited means of direct contact of prospective enrollees, including soliciting door-to-door or any outbound telemarketing without the prospective enrollee initiating contact.
    • (B) The sale of other non-health related products (such as annuities and life insurance) during any sales or marketing activity or presentation conducted with respect to a Medicare Advantage plan.
    • (C) The provision of meals of any sort, regardless of value, to prospective enrollees at promotional and sales activities.
    • (D) Sales and marketing activities for the enrollment of individuals in Medicare Advantage plans that are conducted—
      • (i) in health care settings in areas where health care is delivered to individuals (such as physician offices and pharmacies), except in the case where such activities are conducted in common areas in health care settings; and
      • (ii) at educational events.
  • (2) The Secretary shall establish limitations with respect to at least the following:
    • (A) The scope of any appointment with respect to the marketing of a Medicare Advantage plan. Such limitation shall require advance agreement with a prospective enrollee on the scope of the marketing appointment and documentation of such agreement by the Medicare Advantage organization. In the case where the marketing appointment is in person, such documentation shall be in writing.
    • (B) The use of the name or logo of a co-branded network provider on Medicare Advantage plan membership and marketing materials.
    • (C) The offering of gifts and other promotional items other than those that are of nominal value (as determined by the Secretary) to prospective enrollees at promotional activities.
    • (D) The use of compensation other than as provided under guidelines established by the Secretary. Such guidelines shall ensure that the use of compensation creates incentives for agents and brokers to enroll individuals in the Medicare Advantage plan that is intended to best meet their health care needs.
    • (E) The use by a Medicare Advantage organization of any individual as an agent, broker, or other third party representing the organization that has not completed an initial training and testing program and does not complete an annual retraining and testing program.

§ 1395w–22. Benefits and beneficiary protections

• (a)
  • (1)
    • (A) Except as provided in section 1395w–28(b)(3) of this title for MSA plans and except as provided in paragraph (6) for MA regional plans, each Medicare+Choice plan shall provide to members enrolled under this part, through providers and other persons that meet the applicable requirements of this subchapter and part A of subchapter XI, benefits under the original medicare fee-for-service program option (and, for plan years before 2006, additional benefits required under section 1395w–24(f)(1)(A) of this title ).
    • (B)
      • (i) For purposes of this part, the term “benefits under the original medicare fee-for-service program option” means, subject to subsection (m), those items and services (other than hospice care or coverage for organ acquisitions for kidney transplants, including as covered under section 1395rr(d) of this title ) for which benefits are available under parts A and B to individuals entitled to benefits under part A and enrolled under part B, with cost-sharing for those services as required under parts A and B or, subject to clause (iii), an actuarially equivalent level of cost-sharing as determined in this part.
      • (ii) In the case of an MA regional plan in determining an actuarially equivalent level of cost-sharing with respect to benefits under the original medicare fee-for-service program option, there shall only be taken into account, with respect to the application of section 1395w–27a(b)(2) of this title , such expenses only with respect to subparagraph (A) of such section.
      • (iii) Subject to clause (v), cost-sharing for services described in clause (iv) shall not exceed the cost-sharing required for those services under parts A and B.
      • (iv) The following services are described in this clause:
        • (I) Chemotherapy administration services.
        • (II) Renal dialysis services (as defined in section 1395rr(b)(14)(B) of this title ).
        • (III) Skilled nursing care.
        • (IV) Clinical diagnostic laboratory test administered during any portion of the emergency period defined in paragraph (1)(B) of section 1320b–5(g) of this title beginning on or after March 18, 2020 , for the detection of SARS–CoV–2 or the diagnosis of the virus that causes COVID–19 and the administration of such test.
        • (V) Specified COVID–19 testing-related services (as described in section 1395 l (cc)(1) of this title) for which payment would be payable under a specified outpatient payment provision described in section 1395 l (cc)(2) of this title.
        • (VI) A COVID–19 vaccine and its administration described in section 1395x(s)(10)(A) of this title .
        • (VII) Such other services that the Secretary determines appropriate (including services that the Secretary determines require a high level of predictability and transparency for beneficiaries).
      • (v) In the case of services described in clause (iv), other than subclauses (IV), (V), and (VI) of such clause, for which there is no cost-sharing required under parts A and B, cost-sharing may be required for those services in accordance with clause (i).
      • (vi) In the case of a product or service described in subclause (IV) or (V), respectively, of clause (iv) that is administered or furnished during any portion of the emergency period described in such subclause beginning on or after March 18, 2020 , an MA plan may not impose any prior authorization or other utilization management requirements with respect to the coverage of such a product or service under such plan.
  • (2)
    • (A) A Medicare+Choice plan (other than an MSA plan) offered by a Medicare+Choice organization satisfies paragraph (1)(A), with respect to benefits for items and services furnished other than through a provider or other person that has a contract with the organization offering the plan, if the plan provides payment in an amount so that—
      • (i) the sum of such payment amount and any cost sharing provided for under the plan, is equal to at least
      • (ii) the total dollar amount of payment for such items and services as would otherwise be authorized under parts A and B (including any balance billing permitted under such parts).
    • (B) For provision relating to—
      • (i) limitations on balance billing against Medicare+Choice organizations for non-contract providers, see subsection (k) and section 1395cc(a)(1)(O) of this title , and
      • (ii) limiting actuarial value of enrollee liability for covered benefits, see section 1395w–24(e) of this title .
    • (C) In the case of a Medicare+Choice organization that offers a Medicare+Choice plan in an area in which more than one local coverage determination is applied with respect to different parts of the area, the organization may elect to have the local coverage determination for the part of the area that is most beneficial to Medicare+Choice enrollees (as identified by the Secretary) apply with respect to all Medicare+Choice enrollees enrolled in the plan.
  • (3)
    • (A) Subject to subparagraph (D), each Medicare+Choice organization may provide to individuals enrolled under this part, other than under an MSA plan (without affording those individuals an option to decline the coverage), supplemental health care benefits that the Secretary may approve. The Secretary shall approve any such supplemental benefits unless the Secretary determines that including such supplemental benefits would substantially discourage enrollment by Medicare+Choice eligible individuals with the organization.
    • (B)
      • (i) Subject to clause (ii), a Medicare+Choice organization may provide to individuals enrolled under this part supplemental health care benefits that the individuals may elect, at their option, to have covered.
      • (ii) A Medicare+Choice organization may not provide, under an MSA plan, supplemental health care benefits that cover the deductible described in section 1395w–28(b)(2)(B) of this title . In applying the previous sentence, health benefits described in section 1395ss(u)(2)(B) of this title shall not be treated as covering such deductible.
    • (C) Nothing in this paragraph shall be construed as preventing a Medicare+Choice private fee-for-service plan from offering supplemental benefits that include payment for some or all of the balance billing amounts permitted consistent with subsection (k) and coverage of additional services that the plan finds to be medically necessary. Such benefits may include reductions in cost-sharing below the actuarial value specified in section 1395w–24(e)(4)(B) of this title .
    • (D)
      • (i) For plan year 2020 and subsequent plan years, in addition to any supplemental health care benefits otherwise provided under this paragraph, an MA plan, including a specialized MA plan for special needs individuals (as defined in section 1395w–28(b)(6) of this title ), may provide supplemental benefits described in clause (ii) to a chronically ill enrollee (as defined in clause (iii)).
      • (ii)
        • (I) Supplemental benefits described in this clause are supplemental benefits that, with respect to a chronically ill enrollee, have a reasonable expectation of improving or maintaining the health or overall function of the chronically ill enrollee and may not be limited to being primarily health related benefits.
        • (II) The Secretary may, only with respect to supplemental benefits provided to a chronically ill enrollee under this subparagraph, waive the uniformity requirements under this part, as determined appropriate by the Secretary.
      • (iii) In this subparagraph, the term “chronically ill enrollee” means an enrollee in an MA plan that the Secretary determines—
        • (I) has one or more comorbid and medically complex chronic conditions that is life threatening or significantly limits the overall health or function of the enrollee;
        • (II) has a high risk of hospitalization or other adverse health outcomes; and
        • (III) requires intensive care coordination.
  • (4) Notwithstanding any other provision of law, a Medicare+Choice organization may (in the case of the provision of items and services to an individual under a Medicare+Choice plan under circumstances in which payment under this subchapter is made secondary pursuant to section 1395y(b)(2) of this title ) charge or authorize the provider of such services to charge, in accordance with the charges allowed under a law, plan, or policy described in such section—
    • (A) the insurance carrier, employer, or other entity which under such law, plan, or policy is to pay for the provision of such services, or
    • (B) such individual to the extent that the individual has been paid under such law, plan, or policy for such services.
  • (5) If there is a national coverage determination or legislative change in benefits required to be provided under this part made in the period beginning on the date of an announcement under section 1395w–23(b) of this title and ending on the date of the next announcement under such section and the Secretary projects that the determination will result in a significant change in the costs to a Medicare+Choice organization of providing the benefits that are the subject of such national coverage determination and that such change in costs was not incorporated in the determination of the annual Medicare+Choice capitation rate under section 1395w–23 of this title included in the announcement made at the beginning of such period, then, unless otherwise required by law—
    • (A) such determination or legislative change in benefits shall not apply to contracts under this part until the first contract year that begins after the end of such period, and
    • (B) if such coverage determination or legislative change provides for coverage of additional benefits or coverage under additional circumstances, section 1395w–21(i)(1) of this title shall not apply to payment for such additional benefits or benefits provided under such additional circumstances until the first contract year that begins after the end of such period.
  • (6) In the case of an MA plan that is an MA regional plan, benefits under the plan shall include the benefits described in paragraphs (1) and (2) of section 1395w–27a(b) of this title .
  • (7) In the case of an individual who is a full-benefit dual eligible individual (as defined in section 1396u–5(c)(6) of this title ) or a qualified medicare beneficiary (as defined in section 1396d(p)(1) of this title ) and who is enrolled in a specialized Medicare Advantage plan for special needs individuals described in section 1395w–28(b)(6)(B)(ii) of this title , the plan may not impose cost-sharing that exceeds the amount of cost-sharing that would be permitted with respect to the individual under subchapter XIX if the individual were not enrolled in such plan.
• (b)
  • (1) A Medicare Advantage organization may not deny, limit, or condition the coverage or provision of benefits under this part, for individuals permitted to be enrolled with the organization under this part, based on any health status-related factor described in section 2702(a)(1) of the Public Health Service Act. 1 1 See References in Text note below. The Secretary shall not approve a plan of an organization if the Secretary determines that the design of the plan and its benefits are likely to substantially discourage enrollment by certain MA eligible individuals with the organization.
  • (2) A Medicare+Choice organization shall not discriminate with respect to participation, reimbursement, or indemnification as to any provider who is acting within the scope of the provider’s license or certification under applicable State law, solely on the basis of such license or certification. This paragraph shall not be construed to prohibit a plan from including providers only to the extent necessary to meet the needs of the plan’s enrollees or from establishing any measure designed to maintain quality and control costs consistent with the responsibilities of the plan.
• (c)
  • (1) A Medicare+Choice organization shall disclose, in clear, accurate, and standardized form to each enrollee with a Medicare+Choice plan offered by the organization under this part at the time of enrollment and at least annually thereafter, the following information regarding such plan:
    • (A) The plan’s service area.
    • (B) Benefits offered under the plan, including information described in section 1395w–21(d)(3)(A) of this title and exclusions from coverage and, if it is an MSA plan, a comparison of benefits under such a plan with benefits under other Medicare+Choice plans.
    • (C) The number, mix, and distribution of plan providers, out-of-network coverage (if any) provided by the plan, and any point-of-service option (including the supplemental premium for such option).
    • (D) Out-of-area coverage provided by the plan.
    • (E) Coverage of emergency services, including—
      • (i) the appropriate use of emergency services, including use of the 911 telephone system or its local equivalent in emergency situations and an explanation of what constitutes an emergency situation;
      • (ii) the process and procedures of the plan for obtaining emergency services; and
      • (iii) the locations of (I) emergency departments, and (II) other settings, in which plan physicians and hospitals provide emergency services and post-stabilization care.
    • (F) Supplemental benefits available from the organization offering the plan, including—
      • (i) whether the supplemental benefits are optional,
      • (ii) the supplemental benefits covered, and
      • (iii) the Medicare+Choice monthly supplemental beneficiary premium for the supplemental benefits.
    • (G) Rules regarding prior authorization or other review requirements that could result in nonpayment.
    • (H) All plan appeal or grievance rights and procedures.
    • (I) A description of the organization’s quality improvement program under subsection (e).
  • (2) Upon request of a Medicare+Choice eligible individual, a Medicare+Choice organization must provide the following information to such individual:
    • (A) The general coverage information and general comparative plan information made available under clauses (i) and (ii) of section 1395w–21(d)(2)(A) of this title .
    • (B) Information on procedures used by the organization to control utilization of services and expenditures.
    • (C) Information on the number of grievances, redeterminations, and appeals and on the disposition in the aggregate of such matters.
    • (D) An overall summary description as to the method of compensation of participating physicians.
• (d)
  • (1) A Medicare+Choice organization offering a Medicare+Choice plan may select the providers from whom the benefits under the plan are provided so long as—
    • (A) the organization makes such benefits available and accessible to each individual electing the plan within the plan service area with reasonable promptness and in a manner which assures continuity in the provision of benefits;
    • (B) when medically necessary the organization makes such benefits available and accessible 24 hours a day and 7 days a week;
    • (C) the plan provides for reimbursement with respect to services which are covered under subparagraphs (A) and (B) and which are provided to such an individual other than through the organization, if—
      • (i) the services were not emergency services (as defined in paragraph (3)), but (I) the services were medically necessary and immediately required because of an unforeseen illness, injury, or condition, and (II) it was not reasonable given the circumstances to obtain the services through the organization,
      • (ii) the services were renal dialysis services and were provided other than through the organization because the individual was temporarily out of the plan’s service area, or
      • (iii) the services are maintenance care or post-stabilization care covered under the guidelines established under paragraph (2);
    • (D) the organization provides access to appropriate providers, including credentialed specialists, for medically necessary treatment and services; and
    • (E) coverage is provided for emergency services (as defined in paragraph (3)) without regard to prior authorization or the emergency care provider’s contractual relationship with the organization.
  • (2) A Medicare+Choice plan shall comply with such guidelines as the Secretary may prescribe relating to promoting efficient and timely coordination of appropriate maintenance and post-stabilization care of an enrollee after the enrollee has been determined to be stable under section 1395dd of this title .
  • (3) In this subsection—
    • (A) The term “emergency services” means, with respect to an individual enrolled with an organization, covered inpatient and outpatient services that—
      • (i) are furnished by a provider that is qualified to furnish such services under this subchapter, and
      • (ii) are needed to evaluate or stabilize an emergency medical condition (as defined in subparagraph (B)).
    • (B) The term “emergency medical condition” means a medical condition manifesting itself by acute symptoms of sufficient severity (including severe pain) such that a prudent layperson, who possesses an average knowledge of health and medicine, could reasonably expect the absence of immediate medical attention to result in—
      • (i) placing the health of the individual (or, with respect to a pregnant woman, the health of the woman or her unborn child) in serious jeopardy,
      • (ii) serious impairment to bodily functions, or
      • (iii) serious dysfunction of any bodily organ or part.
  • (4) In addition to any other requirements under this part, in the case of a Medicare+Choice private fee-for-service plan, the organization offering the plan must demonstrate to the Secretary that the organization has sufficient number and range of health care professionals and providers willing to provide services under the terms of the plan. Subject to paragraphs (5) and (6), the Secretary shall find that an organization has met such requirement with respect to any category of health care professional or provider if, with respect to that category of provider—
    • (A) the plan has established payment rates for covered services furnished by that category of provider that are not less than the payment rates provided for under part A, part B, or both, for such services, or
    • (B) the plan has contracts or agreements (other than deemed contracts or agreements under subsection (j)(6)) with a sufficient number and range of providers within such category to meet the access standards in subparagraphs (A) through (E) of paragraph (1),
  • (5)
    • (A) For plan year 2011 and subsequent plan years, in the case of a Medicare Advantage private fee-for-service plan not described in paragraph (1) or (2) of section 1395w–27(i) of this title operating in a network area (as defined in subparagraph (B)), the plan shall meet the access standards under paragraph (4) in that area only through entering into written contracts as provided for under subparagraph (B) of such paragraph and not, in whole or in part, through the establishment of payment rates meeting the requirements under subparagraph (A) of such paragraph.
    • (B) For purposes of subparagraph (A), the term “network area” means, for a plan year, an area which the Secretary identifies (in the Secretary’s announcement of the proposed payment rates for the previous plan year under section 1395w–23(b)(1)(B) of this title ) as having at least 2 network-based plans (as defined in subparagraph (C)) with enrollment under this part as of the first day of the year in which such announcement is made.
    • (C)
      • (i) For purposes of subparagraph (B), the term “network-based plan” means—
        • (I) except as provided in clause (ii), a Medicare Advantage plan that is a coordinated care plan described in section 1395w–21(a)(2)(A)(i) of this title ;
        • (II) a network-based MSA plan; and
        • (III) a reasonable cost reimbursement plan under section 1395mm of this title .
      • (ii) The term “network-based plan” shall not include an MA regional plan that, with respect to the area, meets access adequacy standards under this part substantially through the authority of section 422.112(a)(1)(ii) of title 42, Code of Federal Regulations, rather than through written contracts.
  • (6) For plan year 2011 and subsequent plan years, in the case of a Medicare Advantage private fee-for-service plan that is described in paragraph (1) or (2) of section 1395w–27(i) of this title , the plan shall meet the access standards under paragraph (4) only through entering into written contracts as provided for under subparagraph (B) of such paragraph and not, in whole or in part, through the establishment of payment rates meeting the requirements under subparagraph (A) of such paragraph.
• (e)
  • (1) Each MA organization shall have an ongoing quality improvement program for the purpose of improving the quality of care provided to enrollees in each MA plan offered by such organization.
  • (2) As part of the quality improvement program under paragraph (1), each MA organization shall have a chronic care improvement program. Each chronic care improvement program shall have a method for monitoring and identifying enrollees with multiple or sufficiently severe chronic conditions that meet criteria established by the organization for participation under the program.
  • (3)
    • (A)
      • (i) Except as provided in clauses (ii) and (iii) with respect to plans described in such clauses and subject to subparagraph (B), as part of the quality improvement program under paragraph (1), each MA organization shall provide for the collection, analysis, and reporting of data that permits the measurement of health outcomes and other indices of quality. With respect to MA private fee-for-service plans and MSA plans, the requirements under the preceding sentence may not exceed the requirements under this subparagraph with respect to MA local plans that are preferred provider organization plans, except that, for plan year 2010, the limitation under clause (iii) shall not apply and such requirements shall apply only with respect to administrative claims data.
      • (ii) In addition to the data required to be collected, analyzed, and reported under clause (i) and notwithstanding the limitations under subparagraph (B), as part of the quality improvement program under paragraph (1), each MA organization offering a specialized Medicare Advantage plan for special needs individuals shall provide for the collection, analysis, and reporting of data that permits the measurement of health outcomes and other indices of quality with respect to the requirements described in paragraphs (2) through (5) of subsection (f). Such data may be based on claims data and shall be at the plan level.
      • (iii) Clause (i) shall apply to MA organizations with respect to MA local plans that are preferred provider organization plans and to MA regional plans only insofar as services are furnished by providers or services, physicians, and other health care practitioners and suppliers that have contracts with such organization to furnish services under such plans.
      • (iv) In this subparagraph, the term “preferred provider organization plan” means an MA plan that—
        • (I) has a network of providers that have agreed to a contractually specified reimbursement for covered benefits with the organization offering the plan;
        • (II) provides for reimbursement for all covered benefits regardless of whether such benefits are provided within such network of providers; and
        • (III) is offered by an organization that is not licensed or organized under State law as a health maintenance organization.
    • (B)
      • (i) The Secretary shall not collect under subparagraph (A) data on quality, outcomes, and beneficiary satisfaction to facilitate consumer choice and program administration other than the types of data that were collected by the Secretary as of November 1, 2003 .
      • (ii) Subject to subclause (iii), the Secretary may only change the types of data that are required to be submitted under subparagraph (A) after submitting to Congress a report on the reasons for such changes that was prepared in consultation with MA organizations and private accrediting bodies.
      • (iii) Nothing in the 2 2 So in original. Probably should be “this”. subsection shall be construed as restricting the ability of the Secretary to carry out the duties under section 1395w–21(d)(4)(D) of this title .
  • (4)
    • (A) The Secretary shall provide that a Medicare+Choice organization is deemed to meet all the requirements described in any specific clause of subparagraph (B) if the organization is accredited (and periodically reaccredited) by a private accrediting organization under a process that the Secretary has determined assures that the accrediting organization applies and enforces standards that meet or exceed the standards established under section 1395w–26 of this title to carry out the requirements in such clause.
    • (B) The provisions described in this subparagraph are the following:
      • (i) Paragraphs (1) through (3) of this subsection (relating to quality improvement programs).
      • (ii) Subsection (b) (relating to antidiscrimination).
      • (iii) Subsection (d) (relating to access to services).
      • (iv) Subsection (h) (relating to confidentiality and accuracy of enrollee records).
      • (v) Subsection (i) (relating to information on advance directives).
      • (vi) Subsection (j) (relating to provider participation rules).
      • (vii) The requirements described in section 1395w–104(j) of this title , to the extent such requirements apply under section 1395w–131(c) of this title .
    • (C) The Secretary shall determine, within 210 days after the date the Secretary receives an application by a private accrediting organization and using the criteria specified in section 1395bb(a)(2) of this title , whether the process of the private accrediting organization meets the requirements with respect to any specific clause in subparagraph (B) with respect to which the application is made. The Secretary may not deny such an application on the basis that it seeks to meet the requirements with respect to only one, or more than one, such specific clause.
    • (D) Nothing in this paragraph shall be construed as limiting the authority of the Secretary under section 1395w–27 of this title , including the authority to terminate contracts with Medicare+Choice organizations under subsection (c)(2) of such section.
• (f) Each Medicare+Choice organization must provide meaningful procedures for hearing and resolving grievances between the organization (including any entity or individual through which the organization provides health care services) and enrollees with Medicare+Choice plans of the organization under this part.
• (g)
  • (1)
    • (A) A Medicare+Choice organization shall have a procedure for making determinations regarding whether an individual enrolled with the plan of the organization under this part is entitled to receive a health service under this section and the amount (if any) that the individual is required to pay with respect to such service. Subject to paragraph (3), such procedures shall provide for such determination to be made on a timely basis.
    • (B) Such a determination that denies coverage, in whole or in part, shall be in writing and shall include a statement in understandable language of the reasons for the denial and a description of the reconsideration and appeals processes.
  • (2)
    • (A) The organization shall provide for reconsideration of a determination described in paragraph (1)(B) upon request by the enrollee involved. The reconsideration shall be within a time period specified by the Secretary, but shall be made, subject to paragraph (3), not later than 60 days after the date of the receipt of the request for reconsideration.
    • (B) A reconsideration relating to a determination to deny coverage based on a lack of medical necessity shall be made only by a physician with appropriate expertise in the field of medicine which necessitates treatment who is other than a physician involved in the initial determination.
  • (3)
    • (A)
      • (i) An enrollee in a Medicare+Choice plan may request, either in writing or orally, an expedited determination under paragraph (1) or an expedited reconsideration under paragraph (2) by the Medicare+ÐChoice organization.
      • (ii) A physician, regardless whether the physician is affiliated with the organization or not, may request, either in writing or orally, such an expedited determination or reconsideration.
    • (B)
      • (i) The Medicare+Choice organization shall maintain procedures for expediting organization determinations and reconsiderations when, upon request of an enrollee, the organization determines that the application of the normal time frame for making a determination (or a reconsideration involving a determination) could seriously jeopardize the life or health of the enrollee or the enrollee’s ability to regain maximum function.
      • (ii) In the case of a request for an expedited determination or reconsideration made under subparagraph (A)(ii), the organization shall expedite the determination or reconsideration if the request indicates that the application of the normal time frame for making a determination (or a reconsideration involving a determination) could seriously jeopardize the life or health of the enrollee or the enrollee’s ability to regain maximum function.
      • (iii) In cases described in clauses (i) and (ii), the organization shall notify the enrollee (and the physician involved, as appropriate) of the determination or reconsideration under time limitations established by the Secretary, but not later than 72 hours of the time of receipt of the request for the determination or reconsideration (or receipt of the information necessary to make the determination or reconsideration), or such longer period as the Secretary may permit in specified cases.
  • (4) The Secretary shall contract with an independent, outside entity to review and resolve in a timely manner reconsiderations that affirm denial of coverage, in whole or in part. The provisions of section 1395ff(c)(5) of this title shall apply to independent outside entities under contract with the Secretary under this paragraph.
  • (5) An enrollee with a Medicare+Choice plan of a Medicare+Choice organization under this part who is dissatisfied by reason of the enrollee’s failure to receive any health service to which the enrollee believes the enrollee is entitled and at no greater charge than the enrollee believes the enrollee is required to pay is entitled, if the amount in controversy is $100 or more, to a hearing before the Secretary to the same extent as is provided in section 405(b) of this title , and in any such hearing the Secretary shall make the organization a party. If the amount in controversy is $1,000 or more, the individual or organization shall, upon notifying the other party, be entitled to judicial review of the Secretary’s final decision as provided in section 405(g) of this title , and both the individual and the organization shall be entitled to be parties to that judicial review. In applying subsections (b) and (g) of section 405 of this title as provided in this paragraph, and in applying section 405( l ) of this title thereto, any reference therein to the Commissioner of Social Security or the Social Security Administration shall be considered a reference to the Secretary or the Department of Health and Human Services, respectively. The provisions of section 1395ff(b)(1)(E)(iii) of this title shall apply with respect to dollar amounts specified in the first 2 sentences of this paragraph in the same manner as they apply to the dollar amounts specified in section 1395ff(b)(1)(E)(i) of this title .
• (h) Insofar as a Medicare+Choice organization maintains medical records or other health information regarding enrollees under this part, the Medicare+Choice organization shall establish procedures—
  • (1) to safeguard the privacy of any individually identifiable enrollee information;
  • (2) to maintain such records and information in a manner that is accurate and timely; and
  • (3) to assure timely access of enrollees to such records and information.
• (i) Each Medicare+Choice organization shall meet the requirement of section 1395cc(f) of this title (relating to maintaining written policies and procedures respecting advance directives).
• (j)
  • (1) Insofar as a Medicare+Choice organization offers benefits under a Medicare+Choice plan through agreements with physicians, the organization shall establish reasonable procedures relating to the participation (under an agreement between a physician and the organization) of physicians under such a plan. Such procedures shall include—
    • (A) providing notice of the rules regarding participation,
    • (B) providing written notice of participation decisions that are adverse to physicians, and
    • (C) providing a process within the organization for appealing such adverse decisions, including the presentation of information and views of the physician regarding such decision.
  • (2) A Medicare+Choice organization shall consult with physicians who have entered into participation agreements with the organization regarding the organization’s medical policy, quality, and medical management procedures.
  • (3)
    • (A) Subject to subparagraphs (B) and (C), a Medicare+Choice organization (in relation to an individual enrolled under a Medicare+ÐChoice plan offered by the organization under this part) shall not prohibit or otherwise restrict a covered health care professional (as defined in subparagraph (D)) from advising such an individual who is a patient of the professional about the health status of the individual or medical care or treatment for the individual’s condition or disease, regardless of whether benefits for such care or treatment are provided under the plan, if the professional is acting within the lawful scope of practice.
    • (B) Subparagraph (A) shall not be construed as requiring a Medicare+Choice plan to provide, reimburse for, or provide coverage of a counseling or referral service if the Medicare+ÐChoice organization offering the plan—
      • (i) objects to the provision of such service on moral or religious grounds; and
      • (ii) in the manner and through the written instrumentalities such Medicare+ÐChoice organization deems appropriate, makes available information on its policies regarding such service to prospective enrollees before or during enrollment and to enrollees within 90 days after the date that the organization or plan adopts a change in policy regarding such a counseling or referral service.
    • (C) Nothing in subparagraph (B) shall be construed to affect disclosure requirements under State law or under the Employee Retirement Income Security Act of 1974 [ 29 U.S.C. 1001 et seq.].
    • (D) For purposes of this paragraph, the term “health care professional” means a physician (as defined in section 1395x(r) of this title ) or other health care professional if coverage for the professional’s services is provided under the Medicare+Choice plan for the services of the professional. Such term includes a podiatrist, optometrist, chiropractor, psychologist, dentist, physician assistant, physical or occupational therapist and therapy assistant, speech-language pathologist, audiologist, registered or licensed practical nurse (including nurse practitioner, clinical nurse specialist, certified registered nurse anesthetist, and certified nurse-midwife), licensed certified social worker, registered respiratory therapist, and certified respiratory therapy technician.
  • (4)
    • (A) No Medicare+Choice organization may operate any physician incentive plan (as defined in subparagraph (B)) unless the organization provides assurances satisfactory to the Secretary that the following requirements are met:
      • (i) No specific payment is made directly or indirectly under the plan to a physician or physician group as an inducement to reduce or limit medically necessary services provided with respect to a specific individual enrolled with the organization.
      • (ii) If the plan places a physician or physician group at substantial financial risk (as determined by the Secretary) for services not provided by the physician or physician group, the organization provides stop-loss protection for the physician or group that is adequate and appropriate, based on standards developed by the Secretary that take into account the number of physicians placed at such substantial financial risk in the group or under the plan and the number of individuals enrolled with the organization who receive services from the physician or group.
    • (B) In this paragraph, the term “physician incentive plan” means any compensation arrangement between a Medicare+Choice organization and a physician or physician group that may directly or indirectly have the effect of reducing or limiting services provided with respect to individuals enrolled with the organization under this part.
  • (5) A Medicare+Choice organization may not provide (directly or indirectly) for a health care professional, provider of services, or other entity providing health care services (or group of such professionals, providers, or entities) to indemnify the organization against any liability resulting from a civil action brought for any damage caused to an enrollee with a Medicare+Choice plan of the organization under this part by the organization’s denial of medically necessary care.
  • (6) For purposes of applying this part (including subsection (k)(1)) and section 1395cc(a)(1)(O) of this title , a hospital (or other provider of services), a physician or other health care professional, or other entity furnishing health care services is treated as having an agreement or contract in effect with a Medicare+Choice organization (with respect to an individual enrolled in a Medicare+Choice private fee-for-service plan it offers), if—
    • (A) the provider, professional, or other entity furnishes services that are covered under the plan to such an enrollee; and
    • (B) before providing such services, the provider, professional, or other entity—
      • (i) has been informed of the individual’s enrollment under the plan, and
      • (ii) either—
        • (I) has been informed of the terms and conditions of payment for such services under the plan, or
        • (II) is given a reasonable opportunity to obtain information concerning such terms and conditions,
  • (7)
    • (A) An MA–PD plan may provide for a separate payment or otherwise provide for a differential payment for a participating physician that prescribes covered part D drugs in accordance with an electronic prescription drug program that meets standards established under section 1395w–104(e) of this title .
    • (B) Such payment may take into consideration the costs of the physician in implementing such a program and may also be increased for those participating physicians who significantly increase—
      • (i) formulary compliance;
      • (ii) lower cost, therapeutically equivalent alternatives;
      • (iii) reductions in adverse drug interactions; and
      • (iv) efficiencies in filing prescriptions through reduced administrative costs.
    • (C) Additional or increased payments under this subsection may be structured in the same manner as medication therapy management fees are structured under section 1395w–104(c)(2)(E) 1 of this title.
• (k)
  • (1) Except as provided in paragraph (2), a physician or other entity (other than a provider of services) that does not have a contract establishing payment amounts for services furnished to an individual enrolled under this part with a Medicare+Choice organization described in section 1395w–21(a)(2)(A) of this title or with an organization offering an MSA plan shall accept as payment in full for covered services under this subchapter that are furnished to such an individual the amounts that the physician or other entity could collect if the individual were not so enrolled. Any penalty or other provision of law that applies to such a payment with respect to an individual entitled to benefits under this subchapter (but not enrolled with a Medicare+Choice organization under this part) also applies with respect to an individual so enrolled.
  • (2)
    • (A)
      • (i) In the case of an individual enrolled in a Medicare+Choice private fee-for-service plan under this part, a physician, provider of services, or other entity that has a contract (including through the operation of subsection (j)(6)) establishing a payment rate for services furnished to the enrollee shall accept as payment in full for covered services under this subchapter that are furnished to such an individual an amount not to exceed (including any deductibles, coinsurance, copayments, or balance billing otherwise permitted under the plan) an amount equal to 115 percent of such payment rate.
      • (ii) The Medicare+Choice organization that offers such a plan shall establish procedures, similar to the procedures described in section 1395w–4(g)(1)(A) of this title , in order to carry out the previous sentence.
      • (iii) If the Medicare+Choice organization fails to establish and enforce procedures required under clause (ii), the organization is subject to intermediate sanctions under section 1395w–27(g) of this title .
    • (B) For provision—
      • (i) establishing minimum payment rate in the case of noncontract providers under a Medicare+Choice private fee-for-service plan, see subsection (a)(2); or
      • (ii) limiting enrollee liability in the case of covered services furnished by such providers, see paragraph (1) and section 1395cc(a)(1)(O) of this title .
    • (C)
      • (i) Each Medicare+Choice organization that offers a Medicare+Choice private fee-for-service plan shall provide that enrollees under the plan who are furnished services for which payment is sought under the plan are provided an appropriate explanation of benefits (consistent with that provided under parts A and B and, if applicable, under medicare supplemental policies) that includes a clear statement of the amount of the enrollee’s liability (including any liability for balance billing consistent with this subsection) with respect to payments for such services.
      • (ii) In addition, such organization shall, in its terms and conditions of payments to hospitals for inpatient hospital services and for other services identified by the Secretary for which the amount of the balance billing under subparagraph (A) could be substantial, require the hospital to provide to the enrollee, before furnishing such services and if the hospital imposes balance billing under subparagraph (A)—
        • (I) notice of the fact that balance billing is permitted under such subparagraph for such services, and
        • (II) a good faith estimate of the likely amount of such balance billing (if any), with respect to such services, based upon the presenting condition of the enrollee.
• (l)
  • (1)
    • (A) In providing coverage of post-hospital extended care services, a Medicare+Choice plan shall provide for such coverage through a home skilled nursing facility if the following conditions are met:
      • (i) The enrollee elects to receive such coverage through such facility.
      • (ii) The facility has a contract with the Medicare+Choice organization for the provision of such services, or the facility agrees to accept substantially similar payment under the same terms and conditions that apply to similarly situated skilled nursing facilities that are under contract with the Medicare+Choice organization for the provision of such services and through which the enrollee would otherwise receive such services.
    • (B) The organization shall provide payment to the home skilled nursing facility consistent with the contract or the agreement described in subparagraph (A)(ii), as the case may be.
  • (2) The coverage provided under paragraph (1) (including scope of services, cost-sharing, and other criteria of coverage) shall be no less favorable to the enrollee than the coverage that would be provided to the enrollee with respect to a skilled nursing facility the post-hospital extended care services of which are otherwise covered under the Medicare+Choice plan.
  • (3) Nothing in this subsection shall be construed to do the following:
    • (A) To require coverage through a skilled nursing facility that is not otherwise qualified to provide benefits under part A for medicare beneficiaries not enrolled in a Medicare+Choice plan.
    • (B) To prevent a skilled nursing facility from refusing to accept, or imposing conditions upon the acceptance of, an enrollee for the receipt of post-hospital extended care services.
  • (4) In this subsection:
    • (A) The term “home skilled nursing facility” means, with respect to an enrollee who is entitled to receive post-hospital extended care services under a Medicare+Choice plan, any of the following skilled nursing facilities:
      • (i) The skilled nursing facility in which the enrollee resided at the time of admission to the hospital preceding the receipt of such post-hospital extended care services.
      • (ii) A skilled nursing facility that is providing such services through a continuing care retirement community (as defined in subparagraph (B)) which provided residence to the enrollee at the time of such admission.
      • (iii) The skilled nursing facility in which the spouse of the enrollee is residing at the time of discharge from such hospital.
    • (B) The term “continuing care retirement community” means, with respect to an enrollee in a Medicare+Choice plan, an arrangement under which housing and health-related services are provided (or arranged) through an organization for the enrollee under an agreement that is effective for the life of the enrollee or for a specified period.
• (m)
  • (1) For plan year 2020 and subsequent plan years, subject to the requirements of paragraph (3), an MA plan may provide additional telehealth benefits (as defined in paragraph (2)) to individuals enrolled under this part.
  • (2)
    • (A) For purposes of this subsection and section 1395w–24 of this title :
      • (i) The term “additional telehealth benefits” means services—
        • (I) for which benefits are available under part B, including services for which payment is not made under section 1395m(m) of this title due to the conditions for payment under such section; and
        • (II) that are identified for such year as clinically appropriate to furnish using electronic information and telecommunications technology when a physician (as defined in section 1395x(r) of this title ) or practitioner (described in section 1395u(b)(18)(C) of this title ) providing the service is not at the same location as the plan enrollee.
      • (ii) The term “additional telehealth benefits” does not include capital and infrastructure costs and investments relating to such benefits.
    • (B) Not later than November 30, 2018 , the Secretary shall solicit comments on—
      • (i) what types of items and services (including those provided through supplemental health care benefits, such as remote patient monitoring, secure messaging, store and forward technologies, and other non-face-to-face communication) should be considered to be additional telehealth benefits; and
      • (ii) the requirements for the provision or furnishing of such benefits (such as training and coordination requirements).
  • (3) The Secretary shall specify requirements for the provision or furnishing of additional telehealth benefits, including with respect to the following:
    • (A) Physician or practitioner qualifications (other than licensure) and other requirements such as specific training.
    • (B) Factors necessary for the coordination of such benefits with other items and services including those furnished in-person.
    • (C) Such other areas as determined by the Secretary.
  • (4) If an MA plan provides a service as an additional telehealth benefit (as defined in paragraph (2))—
    • (A) the MA plan shall also provide access to such benefit through an in-person visit (and not only as an additional telehealth benefit); and
    • (B) an individual enrollee shall have discretion as to whether to receive such service through the in-person visit or as an additional telehealth benefit.
  • (5) For purposes of this subsection and section 1395w–24 of this title , if a plan provides additional telehealth benefits, such additional telehealth benefits shall be treated as if they were benefits under the original Medicare fee-for-service program option.
  • (6) Nothing in this subsection shall be construed as affecting the requirement under subsection (a)(1) that MA plans provide enrollees with items and services (other than hospice care) for which benefits are available under parts A and B, including benefits available under section 1395m(m) of this title .
• (n)
  • (1) In the case of an individual enrolled under an MA or MA–PD plan who is furnished an in-home health risk assessment on or after January 1, 2021 , such plan shall ensure that such assessment includes information on the safe disposal of prescription drugs that are controlled substances that meets the criteria established under paragraph (2). Such information shall include information on drug takeback programs that meet such requirements determined appropriate by the Secretary and information on in-home disposal.
  • (2) The Secretary shall, through rulemaking, establish criteria the Secretary determines appropriate with respect to information provided to an individual to ensure that such information sufficiently educates such individual on the safe disposal of prescription drugs that are controlled substances.

§ 1395w–23. Payments to Medicare+Choice organizations

• (a)
  • (1)
    • (A) Under a contract under section 1395w–27 of this title and subject to subsections (e), (g), (i), and ( l ) and section 1395w–28(e)(4) of this title , the Secretary shall make monthly payments under this section in advance to each Medicare+Choice organization, with respect to coverage of an individual under this part in a Medicare+Choice payment area for a month, in an amount determined as follows:
      • (i) For years before 2006, the payment amount shall be equal to 1 ⁄ 12 of the annual MA capitation rate (as calculated under subsection (c)(1)) with respect to that individual for that area, adjusted under subparagraph (C) and reduced by the amount of any reduction elected under section 1395w–24(f)(1)(E) of this title .
      • (ii) For years beginning with 2006, the amount specified in subparagraph (B).
    • (B)
      • (i) In the case of a plan for which there are average per capita monthly savings described in section 1395w–24(b)(3)(C) or 1395w–24(b)(4)(C) of this title, as the case may be, the amount specified in this subparagraph is equal to the unadjusted MA statutory non-drug monthly bid amount, adjusted under subparagraph (C) and (if applicable) under subparagraphs (F) and (G), plus the amount (if any) of any rebate under subparagraph (E).
      • (ii) In the case of a plan for which there are no average per capita monthly savings described in section 1395w–24(b)(3)(C) or 1395w–24(b)(4)(C) of this title, as the case may be, the amount specified in this subparagraph is equal to the MA area-specific non-drug monthly benchmark amount, adjusted under subparagraph (C) and (if applicable) under subparagraphs (F) and (G).
      • (iii) Notwithstanding clauses (i) and (ii), in the case of an MSA plan, the amount specified in this subparagraph is equal to the MA area-specific non-drug monthly benchmark amount, adjusted under subparagraph (C).
      • (iv)
        • (I) Notwithstanding the preceding provisions of this paragraph, for plan year 2011 and subsequent plan years, in the case of a plan described in subclause (II), the Secretary may apply the payment rules under section 1395eee(d) of this title (other than paragraph (3) of such section) rather than the payment rules that would otherwise apply under this part, but only to the extent necessary to reflect the costs of treating high concentrations of frail individuals.
        • (II) A plan described in this subclause is a specialized MA plan for special needs individuals described in section 1395w–28(b)(6)(B)(ii) of this title that is fully integrated with capitated contracts with States for Medicaid benefits, including long-term care, and that have similar average levels of frailty (as determined by the Secretary) as the PACE program.
    • (C)
      • (i) Subject to subparagraph (I), the Secretary shall adjust the payment amount under subparagraph (A)(i) and the amount specified under subparagraph (B)(i), (B)(ii), and (B)(iii) for such risk factors as age, disability status, gender, institutional status, and such other factors as the Secretary determines to be appropriate, including adjustment for health status under paragraph (3), so as to ensure actuarial equivalence. The Secretary may add to, modify, or substitute for such adjustment factors if such changes will improve the determination of actuarial equivalence.
      • (ii) For 2006 and each subsequent year:
        • (I) In applying the adjustment under clause (i) for health status to payment amounts, the Secretary shall ensure that such adjustment reflects changes in treatment and coding practices in the fee-for-service sector and reflects differences in coding patterns between Medicare Advantage plans and providers under part 1 1 So in original. Probably should be “parts”. A and B to the extent that the Secretary has identified such differences.
        • (II) In order to ensure payment accuracy, the Secretary shall annually conduct an analysis of the differences described in subclause (I). The Secretary shall complete such analysis by a date necessary to ensure that the results of such analysis are incorporated on a timely basis into the risk scores for 2008 and subsequent years. In conducting such analysis, the Secretary shall use data submitted with respect to 2004 and subsequent years, as available and updated as appropriate.
        • (III) In calculating each year’s adjustment, the adjustment factor shall be for 2014, not less than the adjustment factor applied for 2010, plus 1.5 percentage points; for each of years 2015 through 2018, not less than the adjustment factor applied for the previous year, plus 0.25 percentage point; and for 2019 and each subsequent year, not less than 5.9 percent.
        • (IV) Such adjustment shall be applied to risk scores until the Secretary implements risk adjustment using Medicare Advantage diagnostic, cost, and use data.
      • (iii)
        • (I) For 2011 and subsequent years, for purposes of the adjustment under clause (i) with respect to individuals described in subclause (II), the Secretary shall use a risk score that reflects the known underlying risk profile and chronic health status of similar individuals. Such risk score shall be used instead of the default risk score for new enrollees in Medicare Advantage plans that are not specialized MA plans for special needs individuals (as defined in section 1395w–28(b)(6) of this title ).
        • (II) An individual described in this subclause is a special needs individual described in subsection (b)(6)(B)(iii) 2 2 See References in Text note below. who enrolls in a specialized MA plan for special needs individuals on or after January 1, 2011 .
        • (III) For 2011 and periodically thereafter, the Secretary shall evaluate and revise the risk adjustment system under this subparagraph in order to, as accurately as possible, account for higher medical and care coordination costs associated with frailty, individuals with multiple, comorbid chronic conditions, and individuals with a diagnosis of mental illness, and also to account for costs that may be associated with higher concentrations of beneficiaries with those conditions.
        • (IV) The Secretary shall publish, as part of an announcement under subsection (b), a description of any evaluation conducted under subclause (III) during the preceding year and any revisions made under such subclause as a result of such evaluation.
    • (D) In the case of an enrollee in an MA–PD plan, the MA organization offering such plan also receives—
      • (i) subsidies under section 1395w–115 of this title (other than under subsection (g)); and
      • (ii) reimbursement for premium and cost-sharing reductions for low-income individuals under section 1395w–114(c)(1)(C) of this title .
    • (E) In the case of a plan for which there are average per capita monthly savings described in section 1395w–24(b)(3)(C) or 1395w–24(b)(4)(C) of this title, as the case may be, the amount specified in this subparagraph is the amount of the monthly rebate computed under section 1395w–24(b)(1)(C)(i) of this title for that plan and year (as reduced by the amount of any credit provided under section 1395w–24(b)(1)(C)(iv) 2 of this title).
    • (F)
      • (i) In the case of payment with respect to an MA regional plan for an MA region, the Secretary shall also adjust the amounts specified under subparagraphs (B)(i) and (B)(ii) in a manner to take into account variations in MA local payment rates under this part among the different MA local areas included in such region.
      • (ii) In the case of payment with respect to an MA local plan for a service area that covers more than one MA local area, the Secretary shall also adjust the amounts specified under subparagraphs (B)(i) and (B)(ii) in a manner to take into account variations in MA local payment rates under this part among the different MA local areas included in such service area.
    • (G) The Secretary shall adjust payments with respect to MA plans as necessary to ensure that—
      • (i) the sum of—
        • (I) the monthly payment made under subparagraph (A)(ii); and
        • (II) the MA monthly basic beneficiary premium under section 1395w–24(b)(2)(A) of this title ; equals
      • (ii) the unadjusted MA statutory non-drug monthly bid amount, adjusted in the manner described in subparagraph (C) and, for an MA regional plan, subparagraph (F).
    • (H) The Secretary shall establish separate rates of payment to a Medicare+Choice organization with respect to classes of individuals determined to have end-stage renal disease and enrolled in a Medicare+Choice plan of the organization. Such rates of payment shall be actuarially equivalent to rates that would have been paid with respect to other enrollees in the MA payment area (or such other area as specified by the Secretary) under the provisions of this section as in effect before December 8, 2003 . In accordance with regulations, the Secretary shall provide for the application of the seventh sentence of section 1395rr(b)(7) of this title to payments under this section covering the provision of renal dialysis treatment in the same manner as such sentence applies to composite rate payments described in such sentence. In establishing such rates, the Secretary shall provide for appropriate adjustments to increase each rate to reflect the demonstration rate (including the risk adjustment methodology associated with such rate) of the social health maintenance organization end-stage renal disease capitation demonstrations (established by section 2355 of the Deficit Reduction Act of 1984, as amended by section 13567(b) of the Omnibus Budget Reconciliation Act of 1993), and shall compute such rates by taking into account such factors as renal treatment modality, age, and the underlying cause of the end-stage renal disease. The Secretary may apply the competitive bidding methodology provided for in this section, with appropriate adjustments to account for the risk adjustment methodology applied to end stage renal disease payments.
    • (I)
      • (i) In order to determine the appropriate adjustment for health status under subparagraph (C)(i), the following shall apply:
        • (I) The Secretary shall take into account the total number of diseases or conditions of an individual enrolled in an MA plan. The Secretary shall make an additional adjustment under such subparagraph as the number of diseases or conditions of an individual increases.
        • (II) The Secretary may use at least 2 years of diagnosis data.
        • (III) With respect to individuals who are dually eligible for benefits under this subchapter and subchapter XIX, the Secretary shall make separate adjustments for each of the following:
        • (IV) The Secretary shall evaluate the impact of including additional diagnosis codes related to mental health and substance use disorders in the risk adjustment model.
        • (V) The Secretary shall evaluate the impact of including the severity of chronic kidney disease in the risk adjustment model.
        • (VI) The Secretary shall evaluate whether other factors (in addition to those described in subparagraph (H)) should be taken into consideration when computing payment rates under such subparagraph.
      • (ii) The Secretary shall phase-in any changes to risk adjustment payment amounts under subparagraph (C)(i) under this subparagraph over a 3-year period, beginning with 2019, with such changes being fully implemented for 2022 and subsequent years.
      • (iii) The Secretary shall provide an opportunity for review of the proposed changes to such risk adjustment payment amounts under this subparagraph and a public comment period of not less than 60 days before implementing such changes.
  • (2)
    • (A) The amount of payment under this subsection may be retroactively adjusted to take into account any difference between the actual number of individuals enrolled with an organization under this part and the number of such individuals estimated to be so enrolled in determining the amount of the advance payment.
    • (B)
      • (i) Subject to clause (ii), the Secretary may make retroactive adjustments under subparagraph (A) to take into account individuals enrolled during the period beginning on the date on which the individual enrolls with a Medicare+Choice organization under a plan operated, sponsored, or contributed to by the individual’s employer or former employer (or the employer or former employer of the individual’s spouse) and ending on the date on which the individual is enrolled in the organization under this part, except that for purposes of making such retroactive adjustments under this subparagraph, such period may not exceed 90 days.
      • (ii) No adjustment may be made under clause (i) with respect to any individual who does not certify that the organization provided the individual with the disclosure statement described in section 1395w–22(c) of this title at the time the individual enrolled with the organization.
  • (3)
    • (A) The Secretary shall develop, and submit to Congress by not later than March 1, 1999 , a report on the method of risk adjustment of payment rates under this section, to be implemented under subparagraph (C), that accounts for variations in per capita costs based on health status. Such report shall include an evaluation of such method by an outside, independent actuary of the actuarial soundness of the proposal.
    • (B) In order to carry out this paragraph, the Secretary shall require Medicare+Choice organizations (and eligible organizations with risk-sharing contracts under section 1395mm of this title ) to submit data regarding inpatient hospital services for periods beginning on or after July 1, 1997 , and data regarding other services and other information as the Secretary deems necessary for periods beginning on or after July 1, 1998 . The Secretary may not require an organization to submit such data before January 1, 1998 .
    • (C)
      • (i) The Secretary shall first provide for implementation of a risk adjustment methodology that accounts for variations in per capita costs based on health status and other demographic factors for payments by no later than January 1, 2000 .
      • (ii) Except as provided in clause (iv), such risk adjustment methodology shall be implemented in a phased-in manner so that the methodology insofar as it makes adjustments to capitation rates for health status applies to—
        • (I) 10 percent of 1 ⁄ 12 of the annual Medicare+Choice capitation rate in 2000 and each succeeding year through 2003;
        • (II) 30 percent of such capitation rate in 2004;
        • (III) 50 percent of such capitation rate in 2005;
        • (IV) 75 percent of such capitation rate in 2006; and
        • (V) 100 percent of such capitation rate in 2007 and succeeding years.
      • (iii) Such risk adjustment methodology for 2004 and each succeeding year, shall be based on data from inpatient hospital and ambulatory settings.
      • (iv)
        • (I) Subject to subclause (II), the Secretary shall fully implement the risk adjustment methodology described in clause (i) with respect to each individual who has had a qualifying congestive heart failure inpatient diagnosis (as determined by the Secretary under such risk adjustment methodology) during the period beginning on July 1, 1999 , and ending on June 30, 2000 , and who is enrolled in a coordinated care plan that is the only coordinated care plan offered on January 1, 2001 , in the service area of the individual.
        • (II) Subclause (I) shall only apply during the 1-year period beginning on January 1, 2001 .
    • (D) Subject to section 1395w–28(e)(4) of this title , the methodology shall be applied uniformly without regard to the type of plan.
  • (4) If an individual who is enrolled with an MA plan under this part receives a service from a federally qualified health center that has a written agreement with the MA organization that offers such plan for providing such a service (including any agreement required under section 1395w–27(e)(3) of this title )—
    • (A) the Secretary shall pay the amount determined under section 1395 l (a)(3)(B) of this title directly to the federally qualified health center not less frequently than quarterly; and
    • (B) the Secretary shall not reduce the amount of the monthly payments under this subsection as a result of the application of subparagraph (A).
• (b)
  • (1)
    • (A) The Secretary shall determine, and shall announce (in a manner intended to provide notice to interested parties), not later than the second Monday in May of 2004, with respect to each MA payment area, the following:
      • (i) The annual MA capitation rate for each MA payment area for 2005.
      • (ii) The risk and other factors to be used in adjusting such rates under subsection (a)(1)(C) for payments for months in 2005.
    • (B) For a year after 2005—
      • (i) The Secretary shall determine, and shall announce (in a manner intended to provide notice to interested parties), not later than the first Monday in April before the calendar year concerned, with respect to each MA payment area, the following:
        • (I) The annual MA capitation rate for each MA payment area for the year.
        • (II) The risk and other factors to be used in adjusting such rates under subsection (a)(1)(C) for payments for months in such year.
      • (ii) The Secretary shall determine, and shall announce (in a manner intended to provide notice to interested parties), on a timely basis before the calendar year concerned, with respect to each MA region and each MA regional plan for which a bid was submitted under section 1395w–24 of this title , the MA region-specific non-drug monthly benchmark amount for that region for the year involved.
      • (iii) The Secretary shall determine, and shall announce (in a manner intended to provide notice to interested parties), on a timely basis before the calendar year concerned, with respect to each CCA area (as defined in section 1395w–29(b)(1)(A) 2 of this title), the CCA non-drug monthly benchmark amount under section 1395w–29(e)(1) 2 of this title for that area for the year involved.
  • (2) At least 45 days (or, in 2017 and each subsequent year, at least 60 days) before making the announcement under paragraph (1) for a year, the Secretary shall provide for notice to Medicare+Choice organizations of proposed changes to be made in the methodology from the methodology and assumptions used in the previous announcement and shall provide such organizations an opportunity (in 2017 and each subsequent year, of no less than 30 days) to comment on such proposed changes.
  • (3) In each announcement made under paragraph (1), the Secretary shall include an explanation of the assumptions and changes in methodology used in such announcement.
  • (4) The Secretary, through the Chief Actuary of the Centers for Medicare & Medicaid Services, shall provide for the computation and publication, on an annual basis beginning with 2001 at the time of publication of the annual Medicare+Choice capitation rates under paragraph (1), of the following information for the original medicare fee-for-service program under parts A and B (exclusive of individuals eligible for coverage under section 426–1 of this title ) for each Medicare+Choice payment area for the second calendar year ending before the date of publication:
    • (A) Total expenditures per capita per month, computed separately for part A and for part B.
    • (B) The expenditures described in subparagraph (A) reduced by the best estimate of the expenditures (such as graduate medical education and disproportionate share hospital payments) not related to the payment of claims.
    • (C) The average risk factor for the covered population based on diagnoses reported for medicare inpatient services, using the same methodology as is expected to be applied in making payments under subsection (a).
    • (D) Such average risk factor based on diagnoses for inpatient and other sites of service, using the same methodology as is expected to be applied in making payments under subsection (a).
• (c)
  • (1) For purposes of this part, subject to paragraphs (6)(C) and (7), each annual Medicare+Choice capitation rate, for a Medicare+Choice payment area that is an MA local area for a contract year consisting of a calendar year, is equal to the largest of the amounts specified in the following subparagraph (A), (B), (C), or (D):
    • (A) For a year before 2005, the sum of—
      • (i) the area-specific percentage (as specified under paragraph (2) for the year) of the annual area-specific Medicare+Choice capitation rate for the Medicare+Choice payment area, as determined under paragraph (3) for the year, and
      • (ii) the national percentage (as specified under paragraph (2) for the year) of the input-price-adjusted annual national Medicare+Choice capitation rate, as determined under paragraph (4) for the year,
    • (B) 12 multiplied by the following amount:
      • (i) For 1998, $367 (but not to exceed, in the case of an area outside the 50 States and the District of Columbia, 150 percent of the annual per capita rate of payment for 1997 determined under section 1395mm(a)(1)(C) of this title for the area).
      • (ii) For 1999 and 2000, the minimum amount determined under clause (i) or this clause, respectively, for the preceding year, increased by the national per capita Medicare+Choice growth percentage described in paragraph (6)(A) applicable to 1999 or 2000, respectively.
      • (iii)
        • (I) Subject to subclause (II), for 2001, for any area in a Metropolitan Statistical Area with a population of more than 250,000, $525, and for any other area $475.
        • (II) In the case of an area outside the 50 States and the District of Columbia, the amount specified in this clause shall not exceed 120 percent of the amount determined under clause (ii) for such area for 2000.
      • (iv) For 2002, 2003, and 2004, the minimum amount specified in this clause (or clause (iii)) for the preceding year increased by the national per capita Medicare+Choice growth percentage, described in paragraph (6)(A) for that succeeding year.
    • (C)
      • (i) For 1998, 102 percent of the annual per capita rate of payment for 1997 determined under section 1395mm(a)(1)(C) of this title for the Medicare+Choice payment area.
      • (ii) For 1999 and 2000, 102 percent of the annual Medicare+Choice capitation rate under this paragraph for the area for the previous year.
      • (iii) For 2001, 103 percent of the annual Medicare+Choice capitation rate under this paragraph for the area for 2000.
      • (iv) For 2002 and 2003, 102 percent of the annual Medicare+Choice capitation rate under this paragraph for the area for the previous year.
      • (v) For 2004 and each succeeding year, the greater of—
        • (I) 102 percent of the annual MA capitation rate under this paragraph for the area for the previous year; or
        • (II) the annual MA capitation rate under this paragraph for the area for the previous year increased by the national per capita MA growth percentage, described in paragraph (6) for that succeeding year, but not taking into account any adjustment under paragraph (6)(C) for a year before 2004.
    • (D)
      • (i) For each year specified in clause (ii), the adjusted average per capita cost for the year involved, determined under section 1395mm(a)(4) of this title and adjusted as appropriate for the purpose of risk adjustment, for the MA payment area for individuals who are not enrolled in an MA plan under this part for the year, but adjusted to exclude costs attributable to payments under sections, 3 3 So in original. 1395w–4( o ), and 3 1395ww(n) and 1395ww(h) of this title.
      • (ii) The provisions of clause (i) shall apply for 2004 and for subsequent years as the Secretary shall specify (but not less than once every 3 years).
      • (iii) In determining the adjusted average per capita cost under clause (i) for a year, such cost shall be adjusted to include the Secretary’s estimate, on a per capita basis, of the amount of additional payments that would have been made in the area involved under this subchapter if individuals entitled to benefits under this subchapter had not received services from facilities of the Department of Defense or the Department of Veterans Affairs.
  • (2) For purposes of paragraph (1)(A)—
    • (A) for 1998, the “area-specific percentage” is 90 percent and the “national percentage” is 10 percent,
    • (B) for 1999, the “area-specific percentage” is 82 percent and the “national percentage” is 18 percent,
    • (C) for 2000, the “area-specific percentage” is 74 percent and the “national percentage” is 26 percent,
    • (D) for 2001, the “area-specific percentage” is 66 percent and the “national percentage” is 34 percent,
    • (E) for 2002, the “area-specific percentage” is 58 percent and the “national percentage” is 42 percent, and
    • (F) for a year after 2002, the “area-specific percentage” is 50 percent and the “national percentage” is 50 percent.
  • (3)
    • (A) For purposes of paragraph (1)(A), subject to subparagraphs (B) and (E), the annual area-specific Medicare+Choice capitation rate for a Medicare+Choice payment area—
      • (i) for 1998 is, subject to subparagraph (D), the annual per capita rate of payment for 1997 determined under section 1395mm(a)(1)(C) of this title for the area, increased by the national per capita Medicare+Choice growth percentage for 1998 (described in paragraph (6)(A)); or
      • (ii) for a subsequent year is the annual area-specific Medicare+Choice capitation rate for the previous year determined under this paragraph for the area, increased by the national per capita Medicare+Choice growth percentage for such subsequent year.
    • (B)
      • (i) In determining the area-specific Medicare+Choice capitation rate under subparagraph (A) for a year (beginning with 1998), the annual per capita rate of payment for 1997 determined under section 1395mm(a)(1)(C) of this title shall be adjusted to exclude from the rate the applicable percent (specified in clause (ii)) of the payment adjustments described in subparagraph (C).
      • (ii) For purposes of clause (i), the applicable percent for—
        • (I) 1998 is 20 percent,
        • (II) 1999 is 40 percent,
        • (III) 2000 is 60 percent,
        • (IV) 2001 is 80 percent, and
        • (V) a succeeding year is 100 percent.
    • (C)
      • (i) Subject to clause (ii), the payment adjustments described in this subparagraph are payment adjustments which the Secretary estimates were payable during 1997—
        • (I) for the indirect costs of medical education under section 1395ww(d)(5)(B) of this title , and
        • (II) for direct graduate medical education costs under section 1395ww(h) of this title .
      • (ii) To the extent that the Secretary estimates that an annual per capita rate of payment for 1997 described in clause (i) reflects payments to hospitals reimbursed under section 1395f(b)(3) of this title , the Secretary shall estimate a payment adjustment that is comparable to the payment adjustment that would have been made under clause (i) if the hospitals had not been reimbursed under such section.
    • (D) In the case of a Medicare+Choice payment area for which the annual per capita rate of payment determined under section 1395mm(a)(1)(C) of this title for 1997 varies by more than 20 percent from such rate for 1996, for purposes of this subsection the Secretary may substitute for such rate for 1997 a rate that is more representative of the costs of the enrollees in the area.
    • (E) In determining the area-specific MA capitation rate under subparagraph (A) for a year (beginning with 2004), the annual per capita rate of payment for 1997 determined under section 1395mm(a)(1)(C) of this title shall be adjusted to include in the rate the Secretary’s estimate, on a per capita basis, of the amount of additional payments that would have been made in the area involved under this subchapter if individuals entitled to benefits under this subchapter had not received services from facilities of the Department of Defense or the Department of Veterans Affairs.
  • (4)
    • (A) For purposes of paragraph (1)(A), the input-price-adjusted annual national Medicare+Choice capitation rate for a Medicare+Choice payment area for a year is equal to the sum, for all the types of medicare services (as classified by the Secretary), of the product (for each such type of service) of—
      • (i) the national standardized annual Medicare+Choice capitation rate (determined under subparagraph (B)) for the year,
      • (ii) the proportion of such rate for the year which is attributable to such type of services, and
      • (iii) an index that reflects (for that year and that type of services) the relative input price of such services in the area compared to the national average input price of such services.
    • (B) In subparagraph (A)(i), the “national standardized annual Medicare+Choice capitation rate” for a year is equal to—
      • (i) the sum (for all Medicare+Choice payment areas) of the product of—
        • (I) the annual area-specific Medicare+ÐChoice capitation rate for that year for the area under paragraph (3), and
        • (II) the average number of medicare beneficiaries residing in that area in the year, multiplied by the average of the risk factor weights used to adjust payments under subsection (a)(1)(A) for such beneficiaries in such area; divided by
      • (ii) the sum of the products described in clause (i)(II) for all areas for that year.
    • (C) In applying this paragraph for 1998—
      • (i) medicare services shall be divided into 2 types of services: part A services and part B services;
      • (ii) the proportions described in subparagraph (A)(ii)—
        • (I) for part A services shall be the ratio (expressed as a percentage) of the national average annual per capita rate of payment for part A for 1997 to the total national average annual per capita rate of payment for parts A and B for 1997, and
        • (II) for part B services shall be 100 percent minus the ratio described in subclause (I);
      • (iii) for part A services, 70 percent of payments attributable to such services shall be adjusted by the index used under section 1395ww(d)(3)(E) of this title to adjust payment rates for relative hospital wage levels for hospitals located in the payment area involved;
      • (iv) for part B services—
        • (I) 66 percent of payments attributable to such services shall be adjusted by the index of the geographic area factors under section 1395w–4(e) of this title used to adjust payment rates for physicians’ services furnished in the payment area, and
        • (II) of the remaining 34 percent of the amount of such payments, 40 percent shall be adjusted by the index described in clause (iii); and
      • (v) the index values shall be computed based only on the beneficiary population who are 65 years of age or older and who are not determined to have end stage renal disease.
  • (5) For purposes of paragraph (1)(A), for each year (other than 2004), the Secretary shall determine a budget neutrality adjustment factor so that the aggregate of the payments under this part (other than those attributable to subsections (a)(3)(C)(iv), (a)(4), and (i)) shall equal the aggregate payments that would have been made under this part if payment were based entirely on area-specific capitation rates.
  • (6)
    • (A) In this part, the “national per capita Medicare+Choice growth percentage” for a year is the percentage determined by the Secretary, by March 1st before the beginning of the year involved, to reflect the Secretary’s estimate of the projected per capita rate of growth in expenditures under this subchapter for an individual entitled to benefits under part A and enrolled under part B, excluding expenditures attributable to subsections (a)(7) and ( o ) of section 1395w–4 of this title and subsections (b)(3)(B)(ix) and (n) of section 1395ww of this title , reduced by the number of percentage points specified in subparagraph (B) for the year. Separate determinations may be made for aged enrollees, disabled enrollees, and enrollees with end-stage renal disease.
    • (B) The number of percentage points specified in this subparagraph is—
      • (i) for 1998, 0.8 percentage points,
      • (ii) for 1999, 0.5 percentage points,
      • (iii) for 2000, 0.5 percentage points,
      • (iv) for 2001, 0.5 percentage points,
      • (v) for 2002, 0.3 percentage points, and
      • (vi) for a year after 2002, 0 percentage points.
    • (C) Beginning with rates calculated for 1999, before computing rates for a year as described in paragraph (1), the Secretary shall adjust all area-specific and national Medicare+Choice capitation rates (and beginning in 2000, the minimum amount) for the previous year for the differences between the projections of the national per capita Medicare+Choice growth percentage for that year and previous years and the current estimate of such percentage for such years, except that for purposes of paragraph (1)(C)(v)(II), no such adjustment shall be made for a year before 2004.
  • (7) If the Secretary makes a determination with respect to coverage under this subchapter or there is a change in benefits required to be provided under this part that the Secretary projects will result in a significant increase in the costs to Medicare+Choice of providing benefits under contracts under this part (for periods after any period described in section 1395w–22(a)(5) of this title ), the Secretary shall adjust appropriately the payments to such organizations under this part. Such projection and adjustment shall be based on an analysis by the Chief Actuary of the Centers for Medicare & Medicaid Services of the actuarial costs associated with the new benefits.
• (d)
  • (1) In this part, except as provided in this subsection, the term “MA payment area” means—
    • (A) with respect to an MA local plan, an MA local area (as defined in paragraph (2)); and
    • (B) with respect to an MA regional plan, an MA region (as established under section 1395w–27a(a)(2) of this title ).
  • (2) The term “MA local area” means a county or equivalent area specified by the Secretary.
  • (3) In the case of individuals who are determined to have end stage renal disease, the Medicare+Choice payment area shall be a State or such other payment area as the Secretary specifies.
  • (4)
    • (A) Upon written request of the chief executive officer of a State for a contract year (beginning after 1998) made by not later than February 1 of the previous year, the Secretary shall make a geographic adjustment to a Medicare+Choice payment area in the State otherwise determined under paragraph (1) for MA local plans—
      • (i) to a single statewide Medicare+Choice payment area,
      • (ii) to the metropolitan based system described in subparagraph (C), or
      • (iii) to consolidating into a single Medicare+Choice payment area noncontiguous counties (or equivalent areas described in paragraph (1)(A)) within a State.
    • (B) In the case of a State requesting an adjustment under this paragraph, the Secretary shall initially (and annually thereafter) adjust the payment rates otherwise established under this section with respect to MA local plans for Medicare+Choice payment areas in the State in a manner so that the aggregate of the payments under this section for such plans in the State shall not exceed the aggregate payments that would have been made under this section for such plans for Medicare+Choice payment areas in the State in the absence of the adjustment under this paragraph.
    • (C) The metropolitan based system described in this subparagraph is one in which—
      • (i) all the portions of each metropolitan statistical area in the State or in the case of a consolidated metropolitan statistical area, all of the portions of each primary metropolitan statistical area within the consolidated area within the State, are treated as a single Medicare+Choice payment area, and
      • (ii) all areas in the State that do not fall within a metropolitan statistical area are treated as a single Medicare+Choice payment area.
    • (D) In subparagraph (C), the terms “metropolitan statistical area”, “consolidated metropolitan statistical area”, and “primary metropolitan statistical area” mean any area designated as such by the Secretary of Commerce.
• (e)
  • (1) If the amount of the Medicare+Choice monthly MSA premium (as defined in section 1395w–24(b)(2)(C) of this title ) for an MSA plan for a year is less than 1 ⁄ 12 of the annual Medicare+Choice capitation rate applied under this section for the area and year involved, the Secretary shall deposit an amount equal to 100 percent of such difference in a Medicare+Choice MSA established (and, if applicable, designated) by the individual under paragraph (2).
  • (2) In the case of an individual who has elected coverage under an MSA plan, no payment shall be made under paragraph (1) on behalf of an individual for a month unless the individual—
    • (A) has established before the beginning of the month (or by such other deadline as the Secretary may specify) a Medicare+Choice MSA (as defined in section 138(b)(2) of the Internal Revenue Code of 1986), and
    • (B) if the individual has established more than one such Medicare+Choice MSA, has designated one of such accounts as the individual’s Medicare+Choice MSA for purposes of this part.
  • (3) In the case of an individual electing an MSA plan effective beginning with a month in a year, the amount of the contribution to the Medicare+Choice MSA on behalf of the individual for that month and all successive months in the year shall be deposited during that first month. In the case of a termination of such an election as of a month before the end of a year, the Secretary shall provide for a procedure for the recovery of deposits attributable to the remaining months in the year.
• (f) The payment to a Medicare+Choice organization under this section for individuals enrolled under this part with the organization and for payments under subsection ( l ) and subsection (m) and payments to a Medicare+Choice MSA under subsection (e)(1) shall be made from the Federal Hospital Insurance Trust Fund and the Federal Supplementary Medical Insurance Trust Fund in such proportion as the Secretary determines reflects the relative weight that benefits under part A and under part B represents of the actuarial value of the total benefits under this subchapter. Payments to MA organizations for statutory drug benefits provided under this subchapter are made from the Medicare Prescription Drug Account in the Federal Supplementary Medical Insurance Trust Fund. Monthly payments otherwise payable under this section for October 2000 shall be paid on the first business day of such month. Monthly payments otherwise payable under this section for October 2001 shall be paid on the last business day of September 2001. Monthly payments otherwise payable under this section for October 2006 shall be paid on the first business day of October 2006.
• (g) In the case of an individual who is receiving inpatient hospital services from a subsection (d) hospital (as defined in section 1395ww(d)(1)(B) of this title ), a rehabilitation hospital described in section 1395ww(d)(1)(B)(ii) of this title or a distinct part rehabilitation unit described in the matter following clause (v) 2 of section 1395ww(d)(1)(B) of this title , or a long-term care hospital (described in section 1395ww(d)(1)(B)(iv) of this title ) as of the effective date of the individual’s—
  • (1) election under this part of a Medicare+ÐChoice plan offered by a Medicare+Choice organization—
    • (A) payment for such services until the date of the individual’s discharge shall be made under this subchapter through the Medicare+Choice plan or the original medicare fee-for-service program option described in section 1395w–21(a)(1)(A) of this title (as the case may be) elected before the election with such organization,
    • (B) the elected organization shall not be financially responsible for payment for such services until the date after the date of the individual’s discharge, and
    • (C) the organization shall nonetheless be paid the full amount otherwise payable to the organization under this part; or
  • (2) termination of election with respect to a Medicare+Choice organization under this part—
    • (A) the organization shall be financially responsible for payment for such services after such date and until the date of the individual’s discharge,
    • (B) payment for such services during the stay shall not be made under section 1395ww(d) of this title or other payment provision under this subchapter for inpatient services for the type of facility, hospital, or unit involved, described in the matter preceding paragraph (1), as the case may be, or by any succeeding Medicare+Choice organization, and
    • (C) the terminated organization shall not receive any payment with respect to the individual under this part during the period the individual is not enrolled.
• (h)
  • (1) A contract under this part shall require the Medicare+Choice organization to inform each individual enrolled under this part with a Medicare+Choice plan offered by the organization about the availability of hospice care if—
    • (A) a hospice program participating under this subchapter is located within the organization’s service area; or
    • (B) it is common practice to refer patients to hospice programs outside such service area.
  • (2) If an individual who is enrolled with a Medicare+Choice organization under this part makes an election under section 1395d(d)(1) of this title to receive hospice care from a particular hospice program—
    • (A) payment for the hospice care furnished to the individual shall be made to the hospice program elected by the individual by the Secretary;
    • (B) payment for other services for which the individual is eligible notwithstanding the individual’s election of hospice care under section 1395d(d)(1) of this title , including services not related to the individual’s terminal illness, shall be made by the Secretary to the Medicare+Choice organization or the provider or supplier of the service instead of payments calculated under subsection (a); and
    • (C) the Secretary shall continue to make monthly payments to the Medicare+Choice organization in an amount equal to the value of the additional benefits required under section 1395w–24(f)(1)(A) of this title .
• (i)
  • (1) Subject to paragraphs (2) and (3), in the case of Medicare+Choice payment area in which a Medicare+Choice plan has not been offered since 1997 (or in which all organizations that offered a plan since such date have filed notice with the Secretary, as of October 13, 1999 , that they will not be offering such a plan as of January 1, 2000 , or filed notice with the Secretary as of October 3, 2000 , that they will not be offering such a plan as of January 1, 2001 ), the amount of the monthly payment otherwise made under this section shall be increased—
    • (A) only for the first 12 months in which any Medicare+Choice plan is offered in the area, by 5 percent of the total monthly payment otherwise computed for such payment area; and
    • (B) only for the subsequent 12 months, by 3 percent of the total monthly payment otherwise computed for such payment area.
  • (2) Paragraph (1) shall only apply to payment for Medicare+Choice plans which are first offered in a Medicare+Choice payment area during the 2-year period beginning on January 1, 2000 .
  • (3) Paragraph (1) shall only apply to payment to the first Medicare+Choice organization that offers a Medicare+Choice plan in each Medicare+Choice payment area, except that if more than one such organization first offers such a plan in an area on the same date, paragraph (1) shall apply to payment for such organizations.
  • (4) Nothing in paragraph (1) shall be construed as affecting the calculation of the annual Medicare+Choice capitation rate under subsection (c) for any payment area or as applying to payment for any period not described in such paragraph and paragraph (2).
  • (5) In this subsection, the term “offered” means, with respect to a Medicare+Choice plan as of a date, that a Medicare+Choice eligible individual may enroll with the plan on that date, regardless of when the enrollment takes effect or when the individual obtains benefits under the plan.
• (j) For purposes of this part, subject to subsection ( o ), the term “MA area-specific non-drug monthly benchmark amount” means for a month in a year—
  • (1) with respect to—
    • (A) a service area that is entirely within an MA local area, subject to section 1395w–29(d)(2)(A) 2 of this title, an amount equal to 1 ⁄ 12 of the annual MA capitation rate under subsection (c)(1) for the area for the year (or, for 2007, 2008, 2009, and 2010, 1 ⁄ 12 of the applicable amount determined under subsection (k)(1) for the area for the year; for 2011, 1 ⁄ 12 of the applicable amount determined under subsection (k)(1) for the area for 2010; and, beginning with 2012, 1 ⁄ 12 of the blended benchmark amount determined under subsection (n)(1) for the area for the year), adjusted as appropriate (for years before 2007) for the purpose of risk adjustment; or
    • (B) a service area that includes more than one MA local area, an amount equal to the average of the amounts described in subparagraph (A) for each such local MA area, weighted by the projected number of enrollees in the plan residing in the respective local MA areas (as used by the plan for purposes of the bid and disclosed to the Secretary under section 1395w–24(a)(6)(A)(iii) of this title ), adjusted as appropriate (for years before 2007) for the purpose of risk adjustment; or
  • (2) with respect to an MA region for a month in a year, the MA region-specific non-drug monthly benchmark amount, as defined in section 1395w–27a(f) of this title for the region for the year.
• (k)
  • (1) For purposes of subsection (j), subject to paragraphs (2), (4), and (5), the term “applicable amount” means for an area—
    • (A) for 2007—
      • (i) if such year is not specified under subsection (c)(1)(D)(ii), an amount equal to the amount specified in subsection (c)(1)(C) for the area for 2006—
        • (I) first adjusted by the rescaling factor for 2006 for the area (as made available by the Secretary in the announcement of the rates on April 4, 2005 , under subsection (b)(1), but excluding any national adjustment factors for coding intensity and risk adjustment budget neutrality that were included in such factor); and
        • (II) then increased by the national per capita MA growth percentage, described in subsection (c)(6) for 2007, but not taking into account any adjustment under subparagraph (C) of such subsection for a year before 2004;
      • (ii) if such year is specified under subsection (c)(1)(D)(ii), an amount equal to the greater of—
        • (I) the amount determined under clause (i) for the area for the year; or
        • (II) the amount specified in subsection (c)(1)(D) for the area for the year; and
    • (B) for a subsequent year—
      • (i) if such year is not specified under subsection (c)(1)(D)(ii), an amount equal to the amount determined under this paragraph for the area for the previous year (determined without regard to paragraphs (2), (4), and (5)), increased by the national per capita MA growth percentage, described in subsection (c)(6) for that succeeding year, but not taking into account any adjustment under subparagraph (C) of such subsection for a year before 2004; and
      • (ii) if such year is specified under subsection (c)(1)(D)(ii), an amount equal to the greater of—
        • (I) the amount determined under clause (i) for the area for the year; or
        • (II) the amount specified in subsection (c)(1)(D) for the area for the year.
  • (2)
    • (A) Except as provided in subparagraph (D), in the case of 2007 through 2010, the applicable amount determined under paragraph (1) shall be multiplied by a factor equal to 1 plus the product of—
      • (i) the percent determined under subparagraph (B) for the year; and
      • (ii) the applicable phase-out factor for the year under subparagraph (C).
    • (B)
      • (i) For purposes of subparagraph (A)(i), subject to clause (iv), the percent determined under this subparagraph for a year is a percent equal to a fraction the numerator of which is described in clause (ii) and the denominator of which is described in clause (iii).
      • (ii)
        • (I) The numerator described in this clause is an amount equal to the amount by which the demographic rate described in subclause (II) exceeds the risk rate described in subclause (III).
        • (II) The demographic rate described in this subclause is the Secretary’s estimate of the total payments that would have been made under this part in the year if all the monthly payment amounts for all MA plans were equal to 1 ⁄ 12 of the annual MA capitation rate under subsection (c)(1) for the area and year, adjusted pursuant to subsection (a)(1)(C).
        • (III) The risk rate described in this subclause is the Secretary’s estimate of the total payments that would have been made under this part in the year if all the monthly payment amounts for all MA plans were equal to the amount described in subsection (j)(1)(A) (determined as if this paragraph had not applied) under subsection (j) for the area and year, adjusted pursuant to subsection (a)(1)(C).
      • (iii) The denominator described in this clause is equal to the total amount estimated for the year under clause (ii)(III).
      • (iv) In estimating the amounts under the previous clauses, the Secretary shall—
        • (I) use a complete set of the most recent and representative Medicare Advantage risk scores under subsection (a)(3) that are available from the risk adjustment model announced for the year;
        • (II) adjust the risk scores to reflect changes in treatment and coding practices in the fee-for-service sector;
        • (III) adjust the risk scores for differences in coding patterns between Medicare Advantage plans and providers under the original Medicare fee-for-service program under parts A and B to the extent that the Secretary has identified such differences, as required in subsection (a)(1)(C);
        • (IV) as necessary, adjust the risk scores for late data submitted by Medicare Advantage organizations;
        • (V) as necessary, adjust the risk scores for lagged cohorts; and
        • (VI) as necessary, adjust the risk scores for changes in enrollment in Medicare Advantage plans during the year.
      • (v) In computing such amounts the Secretary may take into account the estimated health risk of enrollees in preferred provider organization plans (including MA regional plans) for the year.
    • (C) For purposes of subparagraph (A)(ii), the term “applicable phase-out factor” means—
      • (i) for 2007, 0.55;
      • (ii) for 2008, 0.40;
      • (iii) for 2009, 0.25; and
      • (iv) for 2010, 0.05.
    • (D) Subparagraph (A) shall not apply in a year if the amount estimated under subparagraph (B)(ii)(III) for the year is equal to or greater than the amount estimated under subparagraph (B)(ii)(II) for the year.
  • (3)
    • (A) The Secretary may not make any adjustment to the percent determined under paragraph (2)(B) for any year.
    • (B) Nothing in this subsection shall be construed to limit the authority of the Secretary to make adjustments to the applicable amounts determined under paragraph (1) as appropriate for purposes of updating data or for purposes of adopting an improved risk adjustment methodology.
  • (4)
    • (A) After determining the applicable amount for an area for a year under paragraph (1) (beginning with 2010), the Secretary shall adjust such applicable amount to exclude from such applicable amount the phase-in percentage (as defined in subparagraph (B)(i)) for the year of the Secretary’s estimate of the standardized costs for payments under section 1395ww(d)(5)(B) of this title in the area for the year. Any adjustment under the preceding sentence shall be made prior to the application of paragraph (2).
    • (B) For purposes of this paragraph:
      • (i) The term “phase-in percentage” means, for an area for a year, the ratio (expressed as a percentage, but in no case greater than 100 percent) of—
        • (I) the maximum cumulative adjustment percentage for the year (as defined in clause (ii)); to
        • (II) the standardized IME cost percentage (as defined in clause (iii)) for the area and year.
      • (ii) The term “maximum cumulative adjustment percentage” means, for—
        • (I) 2010, 0.60 percent; and
        • (II) a subsequent year, the maximum cumulative adjustment percentage for the previous year increased by 0.60 percentage points.
      • (iii) The term “standardized IME cost percentage” means, for an area for a year, the per capita costs for payments under section 1395ww(d)(5)(B) of this title (expressed as a percentage of the fee-for-service amount specified in subparagraph (C)) for the area and the year.
    • (C) The fee-for-service amount specified in this subparagraph for an area for a year is the amount specified under subsection (c)(1)(D) for the area and the year.
  • (5) After determining the applicable amount for an area for a year under paragraph (1) (beginning with 2021), the Secretary shall adjust such applicable amount to exclude from such applicable amount the Secretary’s estimate of the standardized costs for payments for organ acquisitions for kidney transplants covered under this subchapter (including expenses covered under section 1395rr(d) of this title ) in the area for the year.
• (l)
  • (1) Subject to paragraphs (3) and (4), in the case of a qualifying MA organization, the provisions of sections 1395w–4( o ) and 1395w–4(a)(7) of this title shall apply with respect to eligible professionals described in paragraph (2) of the organization who the organization attests under paragraph (6) to be meaningful EHR users in a similar manner as they apply to eligible professionals under such sections. Incentive payments under paragraph (3) shall be made to and payment adjustments under paragraph (4) shall apply to such qualifying organizations.
  • (2) With respect to a qualifying MA organization, an eligible professional described in this paragraph is an eligible professional (as defined for purposes of section 1395w–4( o ) of this title) who—
    • (A)
      • (i) is employed by the organization; or
      • (ii)
        • (I) is employed by, or is a partner of, an entity that through contract with the organization furnishes at least 80 percent of the entity’s Medicare patient care services to enrollees of such organization; and
        • (II) furnishes at least 80 percent of the professional services of the eligible professional covered under this subchapter to enrollees of the organization; and
    • (B) furnishes, on average, at least 20 hours per week of patient care services.
  • (3)
    • (A) In applying section 1395w–4( o ) of this title under paragraph (1), instead of the additional payment amount under section 1395w–4( o )(1)(A) of this title and subject to subparagraph (B), the Secretary may substitute an amount determined by the Secretary to the extent feasible and practical to be similar to the estimated amount in the aggregate that would be payable if payment for services furnished by such professionals was payable under part B instead of this part.
    • (B)
      • (i) In the case of an eligible professional described in paragraph (2)—
        • (I) that is eligible for the maximum incentive payment under section 1395w–4( o )(1)(A) of this title for the same payment period, the payment incentive shall be made only under such section and not under this subsection; and
        • (II) that is eligible for less than such maximum incentive payment for the same payment period, the payment incentive shall be made only under this subsection and not under section 1395w–4( o )(1)(A) of this title.
      • (ii) In the case of an eligible professional described in paragraph (2) who is eligible for an incentive payment under section 1395w–4( o )(1)(A) of this title but is not described in clause (i) for the same payment period, the Secretary shall develop a process—
        • (I) to ensure that duplicate payments are not made with respect to an eligible professional both under this subsection and under section 1395w–4( o )(1)(A) of this title; and
        • (II) to collect data from Medicare Advantage organizations to ensure against such duplicate payments.
    • (C) In applying section 1395w–4( o )(1)(B)(ii) of this title under subparagraph (A), in accordance with rules specified by the Secretary, a qualifying MA organization shall specify a year (not earlier than 2011) that shall be treated as the first payment year for all eligible professionals with respect to such organization.
  • (4)
    • (A) In applying section 1395w–4(a)(7) of this title under paragraph (1), instead of the payment adjustment being an applicable percent of the fee schedule amount for a year under such section, subject to subparagraph (D), the payment adjustment under paragraph (1) shall be equal to the percent specified in subparagraph (B) for such year of the payment amount otherwise provided under this section for such year.
    • (B) The percent specified under this subparagraph for a year is 100 percent minus a number of percentage points equal to the product of—
      • (i) the number of percentage points by which the applicable percent (under section 1395w–4(a)(7)(A)(ii) of this title ) for the year is less than 100 percent; and
      • (ii) the Medicare physician expenditure proportion specified in subparagraph (C) for the year.
    • (C) The Medicare physician expenditure proportion under this subparagraph for a year is the Secretary’s estimate of the proportion, of the expenditures under parts A and B that are not attributable to this part, that are attributable to expenditures for physicians’ services.
    • (D) In the case that a qualifying MA organization attests that not all eligible professionals of the organization are meaningful EHR users with respect to a year, the Secretary shall apply the payment adjustment under this paragraph based on the proportion of all such eligible professionals of the organization that are not meaningful EHR users for such year.
  • (5) In this subsection and subsection (m), the term “qualifying MA organization” means a Medicare Advantage organization that is organized as a health maintenance organization (as defined in section 300gg–91(b)(3) of this title ).
  • (6) For purposes of this subsection and subsection (m), a qualifying MA organization shall submit an attestation, in a form and manner specified by the Secretary which may include the submission of such attestation as part of submission of the initial bid under section 1395w–24(a)(1)(A)(iv) 4 4 So in original. Section 1395w–24(a)(1)(A) of this title does not contain a cl. (iv). of this title, identifying—
    • (A) whether each eligible professional described in paragraph (2), with respect to such organization is a meaningful EHR user (as defined in section 1395w–4( o )(2) of this title) for a year specified by the Secretary; and
    • (B) whether each eligible hospital described in subsection (m)(1), 5 5 So in original. Probably should be “(m)(2),”. with respect to such organization, is a meaningful EHR user (as defined in section 1395ww(n)(3) of this title ) for an applicable period specified by the Secretary.
  • (7) The Secretary shall post on the Internet website of the Centers for Medicare & Medicaid Services, in an easily understandable format, a list of the names, business addresses, and business phone numbers of—
    • (A) each qualifying MA organization receiving an incentive payment under this subsection for eligible professionals of the organization; and
    • (B) the eligible professionals of such organization for which such incentive payment is based.
  • (8) There shall be no administrative or judicial review under section 1395ff of this title , section 1395 oo of this title, or otherwise, of—
    • (A) the methodology and standards for determining payment amounts and payment adjustments under this subsection, including avoiding duplication of payments under paragraph (3)(B) and the specification of rules for the fixed schedule for application of limitation on incentive payments for all eligible professionals under paragraph (3)(C);
    • (B) the methodology and standards for determining eligible professionals under paragraph (2); and
    • (C) the methodology and standards for determining a meaningful EHR user under section 1395w–4( o )(2) of this title, including specification of the means of demonstrating meaningful EHR use under section 1395w–4( o )(3)(C) 6 6 So in original. Probably should be “1395w–4( o )(2)(C)”. of this title and selection of measures under section 1395w–4( o )(3)(B) 7 7 So in original. Probably should be “1395w–4( o )(2)(B)”. of this title.
• (m)
  • (1) Subject to paragraphs (3) and (4), in the case of a qualifying MA organization, the provisions of sections 1395ww(n) and 1395ww(b)(3)(B)(ix) of this title shall apply with respect to eligible hospitals described in paragraph (2) of the organization which the organization attests under subsection ( l )(6) to be meaningful EHR users in a similar manner as they apply to eligible hospitals under such sections. Incentive payments under paragraph (3) shall be made to and payment adjustments under paragraph (4) shall apply to such qualifying organizations.
  • (2) With respect to a qualifying MA organization, an eligible hospital described in this paragraph is an eligible hospital (as defined in section 1395ww(n)(6)(B) of this title ) that is under common corporate governance with such organization and serves individuals enrolled under an MA plan offered by such organization.
  • (3)
    • (A) In applying section 1395ww(n)(2) of this title under paragraph (1), instead of the additional payment amount under section 1395ww(n)(2) of this title , there shall be substituted an amount determined by the Secretary to be similar to the estimated amount in the aggregate that would be payable if payment for services furnished by such hospitals was payable under part A instead of this part. In implementing the previous sentence, the Secretary—
      • (i) shall, insofar as data to determine the discharge related amount under section 1395ww(n)(2)(C) of this title for an eligible hospital are not available to the Secretary, use such alternative data and methodology to estimate such discharge related amount as the Secretary determines appropriate; and
      • (ii) shall, insofar as data to determine the medicare share described in section 1395ww(n)(2)(D) of this title for an eligible hospital are not available to the Secretary, use such alternative data and methodology to estimate such share, which data and methodology may include use of the inpatient-bed-days (or discharges) with respect to an eligible hospital during the appropriate period which are attributable to both individuals for whom payment may be made under part A or individuals enrolled in an MA plan under a Medicare Advantage organization under this part as a proportion of the estimated total number of patient-bed-days (or discharges) with respect to such hospital during such period.
    • (B)
      • (i) In the case of a hospital that for a payment year is an eligible hospital described in paragraph (2) and for which at least one-third of their discharges (or bed-days) of Medicare patients for the year are covered under part A, payment for the payment year shall be made only under section 1395ww(n) of this title and not under this subsection.
      • (ii) In the case of a hospital that is an eligible hospital described in paragraph (2) and also is eligible for an incentive payment under section 1395ww(n) of this title but is not described in clause (i) for the same payment period, the Secretary shall develop a process—
        • (I) to ensure that duplicate payments are not made with respect to an eligible hospital both under this subsection and under section 1395ww(n) of this title ; and
        • (II) to collect data from Medicare Advantage organizations to ensure against such duplicate payments.
  • (4)
    • (A) Subject to paragraph (3), in the case of a qualifying MA organization (as defined in subsection ( l )(5)), if, according to the attestation of the organization submitted under subsection ( l )(6) for an applicable period, one or more eligible hospitals (as defined in section 1395ww(n)(6)(B) of this title ) that are under common corporate governance with such organization and that serve individuals enrolled under a plan offered by such organization are not meaningful EHR users (as defined in section 1395ww(n)(3) of this title ) with respect to a period, the payment amount payable under this section for such organization for such period shall be the percent specified in subparagraph (B) for such period of the payment amount otherwise provided under this section for such period.
    • (B) The percent specified under this subparagraph for a year is 100 percent minus a number of percentage points equal to the product of—
      • (i) the number of the percentage point reduction effected under section 1395ww(b)(3)(B)(ix)(I) of this title for the period; and
      • (ii) the Medicare hospital expenditure proportion specified in subparagraph (C) for the year.
    • (C) The Medicare hospital expenditure proportion under this subparagraph for a year is the Secretary’s estimate of the proportion, of the expenditures under parts A and B that are not attributable to this part, that are attributable to expenditures for inpatient hospital services.
    • (D) In the case that a qualifying MA organization attests that not all eligible hospitals are meaningful EHR users with respect to an applicable period, the Secretary shall apply the payment adjustment under this paragraph based on a methodology specified by the Secretary, taking into account the proportion of such eligible hospitals, or discharges from such hospitals, that are not meaningful EHR users for such period.
  • (5) The Secretary shall post on the Internet website of the Centers for Medicare & Medicaid Services, in an easily understandable format—
    • (A) a list of the names, business addresses, and business phone numbers of each qualifying MA organization receiving an incentive payment under this subsection for eligible hospitals described in paragraph (2); and
    • (B) a list of the names of the eligible hospitals for which such incentive payment is based.
  • (6) There shall be no administrative or judicial review under section 1395ff of this title , section 1395 oo of this title, or otherwise, of—
    • (A) the methodology and standards for determining payment amounts and payment adjustments under this subsection, including avoiding duplication of payments under paragraph (3)(B);
    • (B) the methodology and standards for determining eligible hospitals under paragraph (2); and
    • (C) the methodology and standards for determining a meaningful EHR user under section 1395ww(n)(3) of this title , including specification of the means of demonstrating meaningful EHR use under subparagraph (C) of such section and selection of measures under subparagraph (B) of such section.
• (n)
  • (1) For purposes of subsection (j), subject to paragraphs (3), (4), and (5), the term “blended benchmark amount” means for an area—
    • (A) for 2012 the sum of—
      • (i) ½ of the applicable amount for the area and year; and
      • (ii) ½ of the amount specified in paragraph (2)(A) for the area and year; and
    • (B) for a subsequent year the amount specified in paragraph (2)(A) for the area and year.
  • (2)
    • (A) The amount specified in this subparagraph for an area and year is the product of—
      • (i) the base payment amount specified in subparagraph (E) for the area and year adjusted to take into account the phase-out in the indirect costs of medical education from capitation rates described in subsection (k)(4) and, for 2021 and subsequent years, the exclusion of payments for organ acquisitions for kidney transplants from the capitation rate as described in subsection (k)(5); and
      • (ii) the applicable percentage for the area for the year specified under subparagraph (B).
    • (B) Subject to subparagraph (D), the applicable percentage specified in this subparagraph for an area for a year in the case of an area that is ranked—
      • (i) in the highest quartile under subparagraph (C) for the previous year is 95 percent;
      • (ii) in the second highest quartile under such subparagraph for the previous year is 100 percent;
      • (iii) in the third highest quartile under such subparagraph for the previous year is 107.5 percent; or
      • (iv) in the lowest quartile under such subparagraph for the previous year is 115 percent.
    • (C) For purposes of this paragraph in the case of an area located—
      • (i) in 1 of the 50 States or the District of Columbia, the Secretary shall rank such area in each year specified under subsection (c)(1)(D)(ii) based upon the level of the amount specified in subparagraph (A)(i) for such areas; or
      • (ii) in a territory, the Secretary shall rank such areas in each such year based upon the level of the amount specified in subparagraph (A)(i) for such area relative to quartile rankings computed under clause (i).
    • (D) If, for a year after 2012, there is a change in the quartile in which an area is ranked compared to the previous year, the applicable percentage for the area in the year shall be the average of—
      • (i) the applicable percentage for the area for the previous year; and
      • (ii) the applicable percentage that would otherwise apply for the area for the year.
    • (E) Subject to subparagraphs (F) and (G), the base payment amount specified in this subparagraph—
      • (i) for 2012 is the amount specified in subsection (c)(1)(D) for the area for the year; or
      • (ii) for a subsequent year that—
        • (I) is not specified under subsection (c)(1)(D)(ii), is the base amount specified in this subparagraph for the area for the previous year, increased by the national per capita MA growth percentage, described in subsection (c)(6) for that succeeding year, but not taking into account any adjustment under subparagraph (C) of such subsection for a year before 2004; and
        • (II) is specified under subsection (c)(1)(D)(ii), is the amount specified in subsection (c)(1)(D) for the area for the year.
    • (F) The base payment amount specified in subparagraph (E) for a year shall be adjusted in the same manner under paragraph (4) of subsection (k) as the applicable amount is adjusted under such subsection.
    • (G) The base payment amount specified in subparagraph (E) for a year (beginning with 2021) shall be adjusted in the same manner under paragraph (5) of subsection (k) as the applicable amount is adjusted under such subsection.
  • (3)
    • (A) If the difference between the applicable amount (as defined in subsection (k)) for an area for 2010 and the projected 2010 benchmark amount (as defined in subparagraph (C)) for the area is at least $30 but less than $50, the blended benchmark amount for the area is—
      • (i) for 2012 the sum of—
        • (I) ¾ of the applicable amount for the area and year; and
        • (II) ¼ of the amount specified in paragraph (2)(A) for the area and year;
      • (ii) for 2013 the sum of—
        • (I) ½ of the applicable amount for the area and year; and
        • (II) ½ of the amount specified in paragraph (2)(A) for the area and year;
      • (iii) for 2014 the sum of—
        • (I) ¼ of the applicable amount for the area and year; and
        • (II) ¾ of the amount specified in paragraph (2)(A) for the area and year; and
      • (iv) for a subsequent year the amount specified in paragraph (2)(A) for the area and year.
    • (B) If the difference between the applicable amount (as defined in subsection (k)) for an area for 2010 and the projected 2010 benchmark amount (as defined in subparagraph (C)) for the area is at least $50, the blended benchmark amount for the area is—
      • (i) for 2012 the sum of—
        • (I) ⅚ of the applicable amount for the area and year; and
        • (II) ⅙ of the amount specified in paragraph (2)(A) for the area and year;
      • (ii) for 2013 the sum of—
        • (I) ⅔ of the applicable amount for the area and year; and
        • (II) ⅓ of the amount specified in paragraph (2)(A) for the area and year;
      • (iii) for 2014 the sum of—
        • (I) ½ of the applicable amount for the area and year; and
        • (II) ½ of the amount specified in paragraph (2)(A) for the area and year;
      • (iv) for 2015 the sum of—
        • (I) ⅓ of the applicable amount for the area and year; and
        • (II) ⅔ of the amount specified in paragraph (2)(A) for the area and year; and
      • (v) for 2016 the sum of—
        • (I) ⅙ of the applicable amount for the area and year; and
        • (II) ⅚ of the amount specified in paragraph (2)(A) for the area and year; and
      • (vi) for a subsequent year the amount specified in paragraph (2)(A) for the area and year.
    • (C) The projected 2010 benchmark amount described in this subparagraph for an area is equal to the sum of—
      • (i) ½ of the applicable amount (as defined in subsection (k)) for the area for 2010; and
      • (ii) ½ of the amount specified in paragraph (2)(A) for the area for 2010 but determined as if there were substituted for the applicable percentage specified in clause (ii) of such paragraph the sum of—
        • (I) the applicable percent that would be specified under subparagraph (B) of paragraph (2) (determined without regard to subparagraph (D) of such paragraph) for the area for 2010 if any reference in such paragraph to “the previous year” were deemed a reference to 2010; and
        • (II) the applicable percentage increase that would apply to a qualifying plan in the area under subsection ( o ) as if any reference in such subsection to 2012 were deemed a reference to 2010 and as if the determination of a qualifying county under paragraph (3)(B) of such subsection were made for 2010.
  • (4) In no case shall the blended benchmark amount for an area for a year (determined taking into account subsection ( o )) be greater than the applicable amount that would (but for the application of this subsection) be determined under subsection (k)(1) for the area for the year.
  • (5) This subsection shall not apply to payments to a PACE program under section 1395eee of this title .
• (o)
  • (1) Subject to the succeeding paragraphs, in the case of a qualifying plan with respect to a year beginning with 2012, the applicable percentage under subsection (n)(2)(B) shall be increased on a plan or contract level, as determined by the Secretary—
    • (A) for 2012, by 1.5 percentage points;
    • (B) for 2013, by 3.0 percentage points; and
    • (C) for 2014 or a subsequent year, by 5.0 percentage points.
  • (2) The increase applied under paragraph (1) for a qualifying plan located in a qualifying county for a year shall be doubled.
  • (3) For purposes of this subsection:
    • (A)
      • (i) The term “qualifying plan” means, for a year and subject to paragraph (4), a plan that had a quality rating under paragraph (4) of 4 stars or higher based on the most recent data available for such year.
      • (ii)
        • (I) For 2012, the term “qualifying plan” includes an MA plan that the Secretary determines is not able to have a quality rating under paragraph (4) because of low enrollment.
        • (II) For 2013 and subsequent years, for purposes of determining whether an MA plan with low enrollment (as defined by the Secretary) is included as a qualifying plan, the Secretary shall establish a method to apply to MA plans with low enrollment (as defined by the Secretary) the computation of quality rating and the rating system under paragraph (4).
      • (iii)
        • (I) A new MA plan that meets criteria specified by the Secretary shall be treated as a qualifying plan, except that in applying paragraph (1), the applicable percentage under subsection (n)(2)(B) shall be increased—
        • (II) The term “new MA plan” means, with respect to a year, a plan offered by an organization or sponsor that has not had a contract as a Medicare Advantage organization in the preceding 3-year period.
    • (B) The term “qualifying county” means, for a year, a county—
      • (i) that has an MA capitation rate that, in 2004, was based on the amount specified in subsection (c)(1)(B) for a Metropolitan Statistical Area with a population of more than 250,000;
      • (ii) for which, as of December 2009, of the Medicare Advantage eligible individuals residing in the county at least 25 percent of such individuals were enrolled in Medicare Advantage plans; and
      • (iii) that has per capita fee-for-service spending that is lower than the national monthly per capita cost for expenditures for individuals enrolled under the original medicare fee-for-service program for the year.
  • (4)
    • (A) The quality rating for a plan shall be determined according to a 5-star rating system (based on the data collected under section 1395w–22(e) of this title ).
    • (B) An MA plan which does not report data that enables the Secretary to rate the plan for purposes of this paragraph shall be counted as having a rating of fewer than 3.5 stars.
    • (C) For purposes of applying paragraph (1) and section 1395w–24(b)(1)(C) of this title for the first 3 plan years under this part in the case of an MA plan to which deemed enrollment applies under section 1395w–21(c)(4) of this title —
      • (i) such plan shall not be treated as a new MA plan (as defined in paragraph (3)(A)(iii)(II)); and
      • (ii) in determining the star rating of the plan under subparagraph (A), to the extent that Medicare Advantage data for such plan is not available for a measure used to determine such star rating, the Secretary shall use data from the period in which such plan was a reasonable cost reimbursement contract.
    • (D)
      • (i) If—
        • (I) a Medicare Advantage organization has entered into more than one contract with the Secretary with respect to the offering of Medicare Advantage plans; and
        • (II) on or after January 1, 2019 , the Secretary approves a request from the organization to consolidate the plans under one or more contract 8 8 So in original. Probably should be “contracts”. (in this subparagraph referred to as a “closed contract”) with the plans offered under a separate contract (in this subparagraph referred to as the “continuing contract”);
      • (ii) An adjustment under clause (i) shall apply for any year for which the quality rating of the continuing contract is based primarily on a measurement period that is prior to the first year in which a closed contract is no longer offered.
  • (5) This subsection shall not apply to payments to a PACE program under section 1395eee of this title .
  • (6)
    • (A) Subject to subparagraph (B), the Secretary may require reporting of data under section 1395w–22(e) of this title for, and apply under this subsection, quality measures at the plan level for specialized MA plans for special needs individuals instead of at the contract level.
    • (B) Prior to applying quality measurement at the plan level under this paragraph, the Secretary shall—
      • (i) take into consideration the minimum number of enrollees in a specialized MA plan for special needs individuals in order to determine if a statistically significant or valid measurement of quality at the plan level is possible under this paragraph;
      • (ii) take into consideration the impact of such application on plans that serve a disproportionate number of individuals dually eligible for benefits under this subchapter and under subchapter XIX;
      • (iii) if quality measures are reported at the plan level, ensure that MA plans are not required to provide duplicative information; and
      • (iv) ensure that such reporting does not interfere with the collection of encounter data submitted by MA organizations or the administration of any changes to the program under this part as a result of the collection of such data.
    • (C) If the Secretary applies quality measurement at the plan level under this paragraph—
      • (i) such quality measurement may include Medicare Health Outcomes Survey (HOS), Healthcare Effectiveness Data and Information Set (HEDIS), Consumer Assessment of Healthcare Providers and Systems (CAHPS) measures and quality measures under part D; and
      • (ii) the Secretary shall consider applying administrative actions, such as remedies described in section 1395w–27(g)(2) of this title , at the plan level.
  • (7)
    • (A) The Secretary shall determine the feasibility of requiring reporting of data under section 1395w–22(e) of this title for, and applying under this subsection, quality measures at the plan level for all MA plans under this part.
    • (B) After making a determination under subparagraph (A), the Secretary shall consider requiring such reporting and applying such quality measures at the plan level as described in such subparagraph 3

§ 1395w–24. Premiums and bid amounts

• (a)
  • (1)
    • (A) Not later than the second Monday in September of 2002, 2003, and 2004 (or the first Monday in June of each subsequent year), each MA organization shall submit to the Secretary, in a form and manner specified by the Secretary and for each MA plan for the service area (or segment of such an area if permitted under subsection (h)) in which it intends to be offered in the following year the following:
      • (i) The information described in paragraph (2), (3), (4), or (6)(A) for the type of plan and year involved.
      • (ii) The plan type for each plan.
      • (iii) The enrollment capacity (if any) in relation to the plan and area.
    • (B) In the case of a plan required to provide a monthly rebate under subsection (b)(1)(C) for a year, the MA organization offering the plan shall submit to the Secretary, in such form and manner and at such time as the Secretary specifies, information on—
      • (i) the manner in which such rebate will be provided under clause (ii) of such subsection; and
      • (ii) the MA monthly prescription drug beneficiary premium (if any) and the MA monthly supplemental beneficiary premium (if any).
    • (C) The Secretary shall establish requirements for information submission under this subsection in a manner that promotes the offering of MA regional plans in more than one region (including all regions) through the filing of consolidated information.
  • (2) For a Medicare+Choice plan described in section 1395w–21(a)(2)(A) of this title for a year before 2006, the information described in this paragraph is as follows:
    • (A) For benefits described in section 1395w–22(a)(1)(A) of this title —
      • (i) the adjusted community rate (as defined in subsection (f)(3));
      • (ii) the Medicare+Choice monthly basic beneficiary premium (as defined in subsection (b)(2)(A));
      • (iii) a description of deductibles, coinsurance, and copayments applicable under the plan and the actuarial value of such deductibles, coinsurance, and copayments, described in subsection (e)(1)(A); and
      • (iv) if required under subsection (f)(1), a description of the additional benefits to be provided pursuant to such subsection and the value determined for such proposed benefits under such subsection.
    • (B) For benefits described in section 1395w–22(a)(3) of this title —
      • (i) the adjusted community rate (as defined in subsection (f)(3));
      • (ii) the Medicare+Choice monthly supplemental beneficiary premium (as defined in subsection (b)(2)(B)); and
      • (iii) a description of deductibles, coinsurance, and copayments applicable under the plan and the actuarial value of such deductibles, coinsurance, and copayments, described in subsection (e)(2).
  • (3) For an MSA plan for any year, the information described in this paragraph is as follows:
    • (A) For benefits described in section 1395w–22(a)(1)(A) of this title , the amount of the Medicare+Choice monthly MSA premium.
    • (B) For benefits described in section 1395w–22(a)(3) of this title , the amount of the Medicare+Choice monthly supplementary beneficiary premium.
  • (4) For a Medicare+Choice plan described in section 1395w–21(a)(2)(C) of this title for benefits described in section 1395w–22(a)(1)(A) of this title for a year before 2006, the information described in this paragraph is as follows:
    • (A) For benefits described in section 1395w–22(a)(1)(A) of this title —
      • (i) the adjusted community rate (as defined in subsection (f)(3));
      • (ii) the amount of the Medicare+Choice monthly basic beneficiary premium;
      • (iii) a description of the deductibles, coinsurance, and copayments applicable under the plan, and the actuarial value of such deductibles, coinsurance, and copayments, as described in subsection (e)(4)(A); and
      • (iv) if required under subsection (f)(1), a description of the additional benefits to be provided pursuant to such subsection and the value determined for such proposed benefits under such subsection.
    • (B) For benefits described in section 1395w–22(a)(3) of this title , the amount of the Medicare+Choice monthly supplemental beneficiary premium (as defined in subsection (b)(2)(B)).
  • (5)
    • (A) Subject to subparagraph (B), the Secretary shall review the adjusted community rates, the amounts of the basic and supplemental premiums, and values filed under paragraphs (2) and (4) of this subsection and shall approve or disapprove such rates, amounts, and values so submitted. The Chief Actuary of the Centers for Medicare & Medicaid Services shall review the actuarial assumptions and data used by the Medicare+Choice organization with respect to such rates, amounts, and values so submitted to determine the appropriateness of such assumptions and data.
    • (B) The Secretary shall not review, approve, or disapprove the amounts submitted under paragraph (3) or, in the case of an MA private fee-for-service plan, subparagraphs (A)(ii) and (B) of paragraph (4).
    • (C)
      • (i) Nothing in this section shall be construed as requiring the Secretary to accept any or every bid submitted by an MA organization under this subsection.
      • (ii) The Secretary may deny a bid submitted by an MA organization for an MA plan if it proposes significant increases in cost sharing or decreases in benefits offered under the plan.
  • (6)
    • (A) For an MA plan (other than an MSA plan) for a plan year beginning on or after January 1, 2006 , the information described in this subparagraph is as follows:
      • (i) The monthly aggregate bid amount for the provision of all items and services under the plan, which amount shall be based on average revenue requirements (as used for purposes of section 300e–1(8) of this title ) in the payment area for an enrollee with a national average risk profile for the factors described in section 1395w–23(a)(1)(C) of this title (as specified by the Secretary).
      • (ii) The proportions of such bid amount that are attributable to—
        • (I) the provision of benefits under the original medicare fee-for-service program option (as defined in section 1395w–22(a)(1)(B) of this title ), including, for plan year 2020 and subsequent plan years, the provision of additional telehealth benefits as described in section 1395w–22(m) of this title ;
        • (II) the provision of basic prescription drug coverage; and
        • (III) the provision of supplemental health care benefits.
      • (iii) The actuarial basis for determining the amount under clause (i) and the proportions described in clause (ii) and such additional information as the Secretary may require to verify such actuarial bases and the projected number of enrollees in each MA local area.
      • (iv) A description of deductibles, coinsurance, and copayments applicable under the plan and the actuarial value of such deductibles, coinsurance, and copayments, described in subsection (e)(4)(A).
      • (v) With respect to qualified prescription drug coverage, the information required under section 1395w–104 of this title , as incorporated under section 1395w–111(b)(2) of this title , with respect to such coverage.
    • (B)
      • (i) Subject to clauses (iii) and (iv), the Secretary has the authority to negotiate regarding monthly bid amounts submitted under subparagraph (A) (and the proportions described in subparagraph (A)(ii)), including supplemental benefits provided under subsection (b)(1)(C)(ii)(I) and in exercising such authority the Secretary shall have authority similar to the authority of the Director of the Office of Personnel Management with respect to health benefits plans under chapter 89 of title 5.
      • (ii) Subject to clause (iv), the Secretary may only accept such a bid amount or proportion if the Secretary determines that such amount and proportions are supported by the actuarial bases provided under subparagraph (A) and reasonably and equitably reflects the revenue requirements (as used for purposes of section 300e–1(8) of this title ) of benefits provided under that plan.
      • (iii) In order to promote competition under this part and part D and in carrying out such parts, the Secretary may not require any MA organization to contract with a particular hospital, physician, or other entity or individual to furnish items and services under this subchapter or require a particular price structure for payment under such a contract to the extent consistent with the Secretary’s authority under this part.
      • (iv) In the case of a plan described in section 1395w–21(a)(2)(C) of this title , the provisions of clauses (i) and (ii) shall not apply and the provisions of paragraph (5)(B), prohibiting the review, approval, or disapproval of amounts described in such paragraph, shall apply to the negotiation and rejection of the monthly bid amounts and the proportions referred to in subparagraph (A).
• (b)
  • (1)
    • (A) Subject to the rebate under subparagraph (C), the monthly amount (if any) of the premium charged to an individual enrolled in a Medicare+Choice plan (other than an MSA plan) offered by a Medicare+Choice organization shall be equal to the sum of the Medicare+Choice monthly basic beneficiary premium, the Medicare+Choice monthly supplementary beneficiary premium (if any), and, if the plan provides qualified prescription drug coverage, the MA monthly prescription drug beneficiary premium.
    • (B) The monthly amount of the premium charged to an individual enrolled in an MSA plan offered by a Medicare+Choice organization shall be equal to the Medicare+Choice monthly supplemental beneficiary premium (if any).
    • (C)
      • (i) The MA plan shall provide to the enrollee a monthly rebate equal to 75 percent (or the applicable rebate percentage specified in clause (iii) in the case of plan years beginning on or after January 1, 2012 ) of the average per capita savings (if any) described in paragraph (3)(C) or (4)(C), as applicable to the plan and year involved.
      • (ii) For plan years before 2012, a rebate required under this subparagraph shall be provided through the application of the amount of the rebate toward one or more of the following:
        • (I) The provision of supplemental health care benefits described in section 1395w–22(a)(3) of this title in a manner specified under the plan, which may include the reduction of cost-sharing otherwise applicable as well as additional health care benefits which are not benefits under the original medicare fee-for-service program option, or crediting toward an MA monthly supplemental beneficiary premium (if any).
        • (II) Crediting toward the MA monthly prescription drug beneficiary premium.
        • (III) Crediting toward the premium imposed under part B (determined without regard to the application of subsections (b), (h), and (i) of section 1395r of this title ).
      • (iii) The applicable rebate percentage specified in this clause for a plan for a year, based on the system under section 1395w–23( o )(4)(A), is the sum of—
        • (I) the product of the old phase-in proportion for the year under clause (iv) and 75 percent; and
        • (II) the product of the new phase-in proportion for the year under clause (iv) and the final applicable rebate percentage under clause (v).
      • (iv) For purposes of clause (iv)—
        • (I) for 2012, the old phase-in proportion is ⅔ and the new phase-in proportion is ⅓;
        • (II) for 2013, the old phase-in proportion is ⅓ and the new phase-in proportion is ⅔; and
        • (III) for 2014 and any subsequent year, the old phase-in proportion is 0 and the new phase-in proportion is 1.
      • (v) Subject to clause (vi), the final applicable rebate percentage under this clause is—
        • (I) in the case of a plan with a quality rating under such system of at least 4.5 stars, 70 percent;
        • (II) in the case of a plan with a quality rating under such system of at least 3.5 stars and less than 4.5 stars, 65 percent; and
        • (III) in the case of a plan with a quality rating under such system of less than 3.5 stars, 50 percent.
      • (vi) For purposes of clause (v)—
        • (I) for 2012, in the case of a plan described in subclause (I) of subsection ( o )(3)(A)(ii), 1 1 So in original. Probably means subclause (I) of section 1395w–23( o )(3)(A)(ii) of this title. the plan shall be treated as having a rating of 4.5 stars; and
        • (II) for 2012 or a subsequent year, in the case of a new MA plan (as defined under subclause (III) of subsection ( o )(3)(A)(iii) 2 2 So in original. Probably means subclause (II) of section 1395w–23( o )(3)(A)(iii) of this title. ) that is treated as a qualifying plan pursuant to subclause (I) of such subsection, the plan shall be treated as having a rating of 3.5 stars.
      • (vii) The plan shall disclose to the Secretary information on the form and amount of the rebate provided under this subparagraph or the actuarial value in the case of supplemental health care benefits.
      • (viii) Insofar as an MA organization elects to provide a rebate under this subparagraph under a plan as a credit toward the part B premium under clause (ii)(III), the Secretary shall apply such credit to reduce the premium under section 1395r of this title of each enrollee in such plan as provided in section 1395s(i) of this title .
  • (2) For purposes of this part:
    • (A) The term “MA monthly basic beneficiary premium” means, with respect to an MA plan—
      • (i) described in section 1395w–23(a)(1)(B)(i) of this title (relating to plans providing rebates), zero; or
      • (ii) described in section 1395w–23(a)(1)(B)(ii) of this title , the amount (if any) by which the unadjusted MA statutory non-drug monthly bid amount (as defined in subparagraph (E)) exceeds the applicable unadjusted MA area-specific non-drug monthly benchmark amount (as defined in section 1395w–23(j) of this title ).
    • (B) The term “MA monthly prescription drug beneficiary premium” means, with respect to an MA plan, the base beneficiary premium (as determined under section 1395w–113(a)(2) of this title and as adjusted under section 1395w–113(a)(1)(B) of this title ), less the amount of rebate credited toward such amount under subsection (b)(1)(C)(ii)(II).
    • (C)
      • (i) The term “MA monthly supplemental beneficiary premium” means, with respect to an MA plan, the portion of the aggregate monthly bid amount submitted under clause (i) of subsection (a)(6)(A) for the year that is attributable under clause (ii)(III) of such subsection to the provision of supplemental health care benefits, less the amount of rebate credited toward such portion under subsection (b)(1)(C)(ii)(I).
      • (ii) For plan years beginning on or after January 1, 2012 , any MA monthly supplementary beneficiary premium charged to an individual enrolled in an MA plan shall be used for the purposes, and in the priority order, described in subclauses (I) through (III) of paragraph (1)(C)(iii). 3 3 See References in Text note below.
    • (D) The term “Medicare+Choice monthly MSA premium” means, with respect to a Medicare+Choice plan, the amount of such premium filed under subsection (a)(3)(A) for the plan.
    • (E) The term “unadjusted MA statutory non-drug monthly bid amount” means the portion of the bid amount submitted under clause (i) of subsection (a)(6)(A) for the year that is attributable under clause (ii)(I) of such subsection to the provision of benefits under the original medicare fee-for-service program option (as defined in section 1395w–22(a)(1)(B) of this title ).
  • (3) For purposes of paragraph (1)(C)(i), the average per capita monthly savings referred to in such paragraph for an MA local plan and year is computed as follows:
    • (A)
      • (i) Subject to clause (iii), the Secretary shall determine, at the same time rates are promulgated under section 1395w–23(b)(1) of this title (beginning with 2006) for each State, the average of the risk adjustment factors to be applied under section 1395w–23(a)(1)(C) of this title to payment for enrollees in that State for MA local plans.
      • (ii) In the case of a State in which no MA local plan was offered in the previous year, the Secretary shall estimate such average. In making such estimate, the Secretary may use average risk adjustment factors applied to comparable States or applied on a national basis.
      • (iii) The Secretary may provide for the determination and application of risk adjustment factors under this subparagraph on the basis of areas other than States or on a plan-specific basis.
    • (B) For each MA plan offered in a local area in a State, the Secretary shall—
      • (i) adjust the applicable MA area-specific non-drug monthly benchmark amount (as defined in section 1395w–23(j)(1) of this title ) for the area by the average risk adjustment factor computed under subparagraph (A); and
      • (ii) adjust the unadjusted MA statutory non-drug monthly bid amount by such applicable average risk adjustment factor.
    • (C) The average per capita monthly savings described in this subparagraph for an MA local plan is equal to the amount (if any) by which—
      • (i) the risk-adjusted benchmark amount computed under subparagraph (B)(i); exceeds
      • (ii) the risk-adjusted bid computed under subparagraph (B)(ii).
  • (4) For purposes of paragraph (1)(C)(i), the average per capita monthly savings referred to in such paragraph for an MA regional plan and year is computed as follows:
    • (A)
      • (i) The Secretary shall determine, at the same time rates are promulgated under section 1395w–23(b)(1) of this title (beginning with 2006) for each MA region the average of the risk adjustment factors to be applied under section 1395w–23(a)(1)(C) of this title to payment for enrollees in that region for MA regional plans.
      • (ii) In the case of an MA region in which no MA regional plan was offered in the previous year, the Secretary shall estimate such average. In making such estimate, the Secretary may use average risk adjustment factors applied to comparable regions or applied on a national basis.
      • (iii) The Secretary may provide for the determination and application of risk adjustment factors under this subparagraph on the basis of areas other than MA regions or on a plan-specific basis.
    • (B) For each MA regional plan offered in a region, the Secretary shall—
      • (i) adjust the applicable MA area-specific non-drug monthly benchmark amount (as defined in section 1395w–23(j)(2) of this title ) for the region by the average risk adjustment factor computed under subparagraph (A); and
      • (ii) adjust the unadjusted MA statutory non-drug monthly bid amount by such applicable average risk adjustment factor.
    • (C) The average per capita monthly savings described in this subparagraph for an MA regional plan is equal to the amount (if any) by which—
      • (i) the risk-adjusted benchmark amount computed under subparagraph (B)(i); exceeds
      • (ii) the risk-adjusted bid computed under subparagraph (B)(ii).
• (c) Except as permitted under section 1395w–27(i) of this title , the MA monthly bid amount submitted under subsection (a)(6), the amounts of the MA monthly basic, prescription drug, and supplemental beneficiary premiums, and the MA monthly MSA premium charged under subsection (b) of an MA organization under this part may not vary among individuals enrolled in the plan.
• (d)
  • (1) Each Medicare+Choice organization shall permit the payment of Medicare+Choice monthly basic, prescription drug, and supplemental beneficiary premiums on a monthly basis, may terminate election of individuals for a Medicare+Choice plan for failure to make premium payments only in accordance with section 1395w–21(g)(3)(B)(i) of this title , and may not provide for cash or other monetary rebates as an inducement for enrollment or otherwise.
  • (2) In accordance with regulations, an MA organization shall permit each enrollee, at the enrollee’s option, to make payment of premiums (if any) under this part to the organization through—
    • (A) withholding from benefit payments in the manner provided under section 1395s of this title with respect to monthly premiums under section 1395r of this title ;
    • (B) an electronic funds transfer mechanism (such as automatic charges of an account at a financial institution or a credit or debit card account); or
    • (C) such other means as the Secretary may specify, including payment by an employer or under employment-based retiree health coverage (as defined in section 1395w–132(c)(1) of this title ) on behalf of an employee or former employee (or dependent).
  • (3) In order to carry out paragraph (2)(A) with respect to an enrollee who has elected such paragraph to apply, the Secretary shall transmit to the Commissioner of Social Security—
    • (A) by the beginning of each year, the name, social security account number, consolidated monthly beneficiary premium described in paragraph (4) owed by such enrollee for each month during the year, and other information determined appropriate by the Secretary, in consultation with the Commissioner of Social Security; and
    • (B) periodically throughout the year, information to update the information previously transmitted under this paragraph for the year.
  • (4) In the case of an enrollee in an MA plan, the Secretary shall provide a mechanism for the consolidation of—
    • (A) the MA monthly basic beneficiary premium (if any);
    • (B) the MA monthly supplemental beneficiary premium (if any); and
    • (C) the MA monthly prescription drug beneficiary premium (if any).
• (e)
  • (1) For periods before 2006, in no event may—
    • (A) the Medicare+Choice monthly basic beneficiary premium (multiplied by 12) and the actuarial value of the deductibles, coinsurance, and copayments applicable on average to individuals enrolled under this part with a Medicare+Choice plan described in section 1395w–21(a)(2)(A) of this title of an organization with respect to required benefits described in section 1395w–22(a)(1)(A) of this title and additional benefits (if any) required under subsection (f)(1)(A) for a year, exceed
    • (B) the actuarial value of the deductibles, coinsurance, and copayments that would be applicable on average to individuals entitled to benefits under part A and enrolled under part B if they were not members of a Medicare+Choice organization for the year.
  • (2) For periods before 2006, if the Medicare+Choice organization provides to its members enrolled under this part in a Medicare+Choice plan described in section 1395w–21(a)(2)(A) of this title with respect to supplemental benefits described in section 1395w–22(a)(3) of this title , the sum of the Medicare+Choice monthly supplemental beneficiary premium (multiplied by 12) charged and the actuarial value of its deductibles, coinsurance, and copayments charged with respect to such benefits may not exceed the adjusted community rate for such benefits (as defined in subsection (f)(3)).
  • (3) If the Secretary determines that adequate data are not available to determine the actuarial value under paragraph (1)(A), (2), or (4), the Secretary may determine such amount with respect to all individuals in same geographic area, the State, or in the United States, eligible to enroll in the Medicare+Choice plan involved under this part or on the basis of other appropriate data.
  • (4) With respect to a Medicare+Choice private fee-for-service plan (other than a plan that is an MSA plan) and for periods beginning with 2006, with respect to an MA plan described in section 1395w–21(a)(2)(A) of this title , in no event may—
    • (A) the actuarial value of the deductibles, coinsurance, and copayments applicable on average to individuals enrolled under this part with such a plan of an organization with respect to benefits under the original medicare fee-for-service program option, exceed
    • (B) the actuarial value of the deductibles, coinsurance, and copayments that would be applicable with respect to such benefits on average to individuals entitled to benefits under part A and enrolled under part B if they were not members of a Medicare+Choice organization for the year.
• (f)
  • (1)
    • (A) For years before 2006, each Medicare+Choice organization (in relation to a Medicare+Choice plan, other than an MSA plan, it offers) shall provide that if there is an excess amount (as defined in subparagraph (B)) for the plan for a contract year, subject to the succeeding provisions of this subsection, the organization shall provide to individuals such additional benefits (as the organization may specify) in a value which the Secretary determines is at least equal to the adjusted excess amount (as defined in subparagraph (C)).
    • (B) For purposes of this paragraph, the “excess amount”, for an organization for a plan, is the amount (if any) by which—
      • (i) the average of the capitation payments made to the organization under section 1395w–23 of this title for the plan at the beginning of contract year, exceeds
      • (ii) the actuarial value of the required benefits described in section 1395w–22(a)(1)(A) of this title under the plan for individuals under this part, as determined based upon an adjusted community rate described in paragraph (3) (as reduced for the actuarial value of the coinsurance, copayments, and deductibles under parts A and B).
    • (C) For purposes of this paragraph, the “adjusted excess amount”, for an organization for a plan, is the excess amount reduced to reflect any amount withheld and reserved for the organization for the year under paragraph (2).
    • (D) This paragraph shall be applied uniformly for all enrollees for a plan.
    • (E)
      • (i) Subject to clause (ii), as part of providing any additional benefits required under subparagraph (A), a Medicare+Choice organization may elect a reduction in its payments under section 1395w–23(a)(1)(A) of this title with respect to a Medicare+Choice plan and the Secretary shall apply such reduction to reduce the premium under section 1395r of this title of each enrollee in such plan as provided in section 1395s(i) of this title .
      • (ii) The amount of the reduction under clause (i) with respect to any enrollee in a Medicare+Choice plan—
        • (I) may not exceed 125 percent of the premium described under section 1395r(a)(3) of this title ; and
        • (II) shall apply uniformly to each enrollee of the Medicare+Choice plan to which such reduction applies.
    • (F) Nothing in this subsection shall be construed as preventing a Medicare+Choice organization from providing supplemental benefits (described in section 1395w–22(a)(3) of this title ) that are in addition to the health care benefits otherwise required to be provided under this paragraph and from imposing a premium for such supplemental benefits.
  • (2) A Medicare+Choice organization may provide that a part of the value of an excess amount described in paragraph (1) be withheld and reserved in the Federal Hospital Insurance Trust Fund and in the Federal Supplementary Medical Insurance Trust Fund (in such proportions as the Secretary determines to be appropriate) by the Secretary for subsequent annual contract periods, to the extent required to stabilize and prevent undue fluctuations in the additional benefits offered in those subsequent periods by the organization in accordance with such paragraph. Any of such value of the amount reserved which is not provided as additional benefits described in paragraph (1)(A) to individuals electing the Medicare+Choice plan of the organization in accordance with such paragraph prior to the end of such periods, shall revert for the use of such trust funds.
  • (3) For purposes of this subsection, subject to paragraph (4), the term “adjusted community rate” for a service or services means, at the election of a Medicare+Choice organization, either—
    • (A) the rate of payment for that service or services which the Secretary annually determines would apply to an individual electing a Medicare+Choice plan under this part if the rate of payment were determined under a “community rating system” (as defined in section 300e–1(8) of this title , other than subparagraph (C)), or
    • (B) such portion of the weighted aggregate premium, which the Secretary annually estimates would apply to such an individual, as the Secretary annually estimates is attributable to that service or services,
  • (4) For purposes of this subsection, if the Secretary finds that there is insufficient enrollment experience to determine an average of the capitation payments to be made under this part at the beginning of a contract period or to determine (in the case of a newly operated provider-sponsored organization or other new organization) the adjusted community rate for the organization, the Secretary may determine such an average based on the enrollment experience of other contracts entered into under this part and may determine such a rate using data in the general commercial marketplace.
• (g) No State may impose a premium tax or similar tax with respect to payments to Medicare+Choice organizations under section 1395w–23 of this title or premiums paid to such organizations under this part.
• (h) The Secretary shall permit a Medicare+Choice organization to elect to apply the provisions of this section uniformly to separate segments of a service area (rather than uniformly to an entire service area) as long as such segments are composed of one or more Medicare+Choice payment areas.