§ 290aa–0. National Mental Health and Substance Use Policy Laboratory

• (a) There shall be established within the Administration a National Mental Health and Substance Use Policy Laboratory (referred to in this section as the “Laboratory”).
• (b) The Laboratory shall—
  • (1) continue to carry out the authorities and activities that were in effect for the Office of Policy, Planning, and Innovation as such Office existed prior to December 13, 2016 ;
  • (2) identify, coordinate, and facilitate the implementation of policy changes likely to have a significant effect on mental health, mental illness, recovery supports, and the prevention and treatment of substance use disorder services;
  • (3) work with the Center for Behavioral Health Statistics and Quality to collect, as appropriate, information from grantees under programs operated by the Administration in order to evaluate and disseminate information on evidence-based practices, including culturally and linguistically appropriate services, as appropriate, and service delivery models;
  • (4) provide leadership in identifying and coordinating policies and programs, including evidence-based programs, related to mental and substance use disorders;
  • (5) periodically review programs and activities operated by the Administration relating to the diagnosis or prevention of, treatment for, and recovery from, mental and substance use disorders to—
    • (A) identify any such programs or activities that are duplicative;
    • (B) identify any such programs or activities that are not evidence-based, effective, or efficient; and
    • (C) formulate recommendations for coordinating, eliminating, or improving programs or activities identified under subparagraph (A) or (B) and merging such programs or activities into other successful programs or activities;
  • (6) issue and periodically update information for entities applying for grants or cooperative agreements from the Substance Abuse and Mental Health Services Administration in order to—
    • (A) encourage the implementation and replication of evidence-based practices; and
    • (B) provide technical assistance to applicants for funding, including with respect to justifications for such programs and activities; and
  • (7) carry out other activities as deemed necessary to continue to encourage innovation and disseminate evidence-based programs and practices.
• (c)
  • (1) In carrying out subsection (b)(3), the Laboratory—
    • (A) may give preference to models that improve—
      • (i) the coordination between mental health and physical health providers;
      • (ii) the coordination among such providers and the justice and corrections system; and
      • (iii) the cost effectiveness, quality, effectiveness, and efficiency of health care services furnished to adults with a serious mental illness, children with a serious emotional disturbance, or individuals in a mental health crisis; and
    • (B) may include clinical protocols and practices that address the needs of individuals with early serious mental illness.
  • (2) In carrying out this section, the Laboratory shall consult with—
    • (A) the Chief Medical Officer appointed under section 290aa(g) of this title ;
    • (B) representatives of the National Institute of Mental Health, the National Institute on Drug Abuse, and the National Institute on Alcohol Abuse and Alcoholism, on an ongoing basis;
    • (C) other appropriate Federal agencies;
    • (D) clinical and analytical experts with expertise in psychiatric medical care and clinical psychological care, health care management, education, corrections health care, and mental health court systems, as appropriate; and
    • (E) other individuals and agencies as determined appropriate by the Assistant Secretary.
• (d) The Laboratory shall begin implementation of this section not later than January 1, 2018 .
• (e)
  • (1) The Assistant Secretary, in coordination with the Laboratory, may award grants to States, local governments, Indian tribes or tribal organizations (as such terms are defined in section 5304 of title 25 ), educational institutions, and nonprofit organizations to develop evidence-based interventions, including culturally and linguistically appropriate services, as appropriate, for—
    • (A) evaluating a model that has been scientifically demonstrated to show promise, but would benefit from further applied development, for—
      • (i) enhancing the prevention, diagnosis, intervention, and treatment of, and recovery from, mental illness, serious emotional disturbances, substance use disorders, and co-occurring illness or disorders; or
      • (ii) integrating or coordinating physical health services and mental and substance use disorders services; and
    • (B) expanding, replicating, or scaling evidence-based programs across a wider area to enhance effective screening, early diagnosis, intervention, and treatment with respect to mental illness, serious mental illness, serious emotional disturbances, and substance use disorders, primarily by—
      • (i) applying such evidence-based programs to the delivery of care, including by training staff in effective evidence-based treatments; or
      • (ii) integrating such evidence-based programs into models of care across specialties and jurisdictions.
  • (2) In awarding grants under this subsection, the Assistant Secretary shall, as appropriate, consult with the Chief Medical Officer, appointed under section 290aa(g) of this title , the advisory councils described in section 290aa–1 of this title , the National Institute of Mental Health, the National Institute on Drug Abuse, and the National Institute on Alcohol Abuse and Alcoholism, as appropriate.
  • (3) There are authorized to be appropriated—
    • (A) to carry out paragraph (1)(A), $7,000,000 for the period of fiscal years 2018 through 2020; and
    • (B) to carry out paragraph (1)(B), $7,000,000 for the period of fiscal years 2018 through 2020.

§ 300mm–1. WTC Health Program Scientific/Technical Advisory Committee; WTC Health Program Steering Committees

• (a)
  • (1) The WTC Program Administrator shall establish an advisory committee to be known as the WTC Health Program Scientific/Technical Advisory Committee (in this subsection referred to as the “Advisory Committee”) to review scientific and medical evidence and to make recommendations to the Administrator on additional WTC Program eligibility criteria and on additional WTC-related health conditions.
  • (2) The WTC Program Administrator shall appoint the members of the Advisory Committee and shall include at least—
    • (A) 4 occupational physicians, at least 2 of whom have experience treating WTC rescue and recovery workers;
    • (B) 1 physician with expertise in pulmonary medicine;
    • (C) 2 environmental medicine or environmental health specialists;
    • (D) 2 representatives of WTC responders;
    • (E) 2 representatives of certified-eligible WTC survivors;
    • (F) an industrial hygienist;
    • (G) a toxicologist;
    • (H) an epidemiologist; and
    • (I) a mental health professional.
  • (3) The Advisory Committee shall meet at such frequency as may be required to carry out its duties.
  • (4) The WTC Program Administrator shall provide for publication of recommendations of the Advisory Committee on the public Web site established for the WTC Program.
  • (5) Notwithstanding any other provision of law, the Advisory Committee shall continue in operation during the period in which the WTC Program is in operation.
  • (6) Except as otherwise specifically provided, the Advisory Committee shall be subject to the Federal Advisory Committee Act.
• (b)
  • (1) The WTC Program Administrator shall consult with 2 steering committees (each in this section referred to as a “Steering Committee”) that are established as follows:
    • (A) One Steering Committee, to be known as the WTC Responders Steering Committee, for the purpose of receiving input from affected stakeholders and facilitating the coordination of monitoring and treatment programs for the enrolled WTC responders under subpart 1 of part B.
    • (B) One Steering Committee, to be known as the WTC Survivors Steering Committee, for the purpose of receiving input from affected stakeholders and facilitating the coordination of initial health evaluations, monitoring, and treatment programs for screening-eligible and certified-eligible WTC survivors under subpart 2 of part B.
  • (2)
    • (A)
      • (i) The WTC Responders Steering Committee shall include—
        • (I) representatives of the Centers of Excellence providing services to WTC responders;
        • (II) representatives of labor organizations representing firefighters, police, other New York City employees, and recovery and cleanup workers who responded to the September 11, 2001 , terrorist attacks; and
        • (III) 3 representatives of New York City, 1 of whom will be selected by the police commissioner of New York City, 1 by the health commissioner of New York City, and 1 by the mayor of New York City.
      • (ii) The WTC Responders Steering Committee shall initially be composed of members of the WTC Monitoring and Treatment Program Steering Committee (as in existence on the day before January 2, 2011 ).
    • (B)
      • (i) The WTC Survivors Steering Committee shall include representatives of—
        • (I) the Centers of Excellence providing services to screening-eligible and certified-eligible WTC survivors;
        • (II) the population of residents, students, and area and other workers affected by the September 11, 2001 , terrorist attacks;
        • (III) screening-eligible and certified-eligible survivors receiving initial health evaluations, monitoring, or treatment under subpart 2 of part B and organizations advocating on their behalf; and
        • (IV) New York City.
      • (ii) The WTC Survivors Steering Committee shall initially be composed of members of the WTC Environmental Health Center Survivor Advisory Committee (as in existence on the day before January 2, 2011 ).
    • (C) Each Steering Committee may recommend, if approved by a majority of voting members of the Committee, additional members to the Committee.
    • (D) A vacancy in a Steering Committee shall be filled by an individual recommended by the Steering Committee.

§ 300s–1a. Recovery of expenditures under certain conditions

• (a) If any facility with respect to which funds have been paid under this subchapter shall, at any time within 20 years after the completion of construction or modernization—
  • (1) be sold or transferred to any entity (A) which is not qualified to file an application under section 300s–1 or 300t–12 of this title or (B) which is not approved as a transferee by the State Agency of the State in which such facility is located, or its successor, or
  • (2) cease to be a public health center or a public or other nonprofit hospital, outpatient facility, facility for long-term care, or rehabilitation facility,
• (b) The transferor of a facility which is sold or transferred as described in subsection (a)(1), or the owner of a facility the use of which is changed as described in subsection (a)(2), shall provide the Secretary written notice of such sale, transfer, or change not later than the expiration of 10 days from the date on which such sale, transfer, or change occurs.
• (c)
  • (1) Except as provided in paragraph (2), the amount the United States shall be entitled to recover under subsection (a) is an amount bearing the same ratio to the then value (as determined by the agreement of the parties or in an action brought in the district court of the United States for the district for which the facility involved is situated) of so much of the facility as constituted an approved project or projects as the amount of the Federal participation bore to the cost of the construction or modernization of such project or projects.
  • (2)
    • (A) After the expiration of—
      • (i) 180 days after the date of the sale, transfer, or change of use for which a notice is required by subsection (b) in the case of a facility which is sold or transferred or the use of which changes after July 18, 1984 , or
      • (ii) thirty days after July 18, 1984 , or if later 180 days after the date of the sale, transfer, or change of use for which a notice is required by subsection (b), in the case of a facility which was sold or transferred or the use of which changed before July 18, 1984 ,
    • (B) The period referred to in subparagraph (A) is the period beginning—
      • (i) in the case of a facility which was sold or transferred or the use of which changed before July 18, 1984 , thirty days after such date or if later 180 days after the date of the sale, transfer, or change of use for which a notice is required by subsection (b). 1 1 So in original. The period probably should be a comma.
      • (ii) in the case of a facility with respect to which notice is provided in accordance with subsection (b), upon the expiration of 180 days after the receipt of such notice, or
      • (iii) in the case of a facility with respect to which such notice is not provided as prescribed by subsection (b), on the date of the sale, transfer, or changes of use for which such notice was to be provided,
• (d)
  • (1) The Secretary may waive the recovery rights of the United States under subsection (a)(1) with respect to a facility in any State if the Secretary determines, in accordance with regulations, that the entity to which the facility was sold or transferred—
    • (A) has established an irrevocable trust—
      • (i) in an amount equal to the greater of twice the cost of the remaining obligation of the facility under clause (ii) of section 300s–1(b)(1)(K) of this title or the amount, determined under subsection (c), that the United States is entitled to recover, and
      • (ii) which will only be used by the entity to provide the care required by clause (ii) of section 300s–1(b)(1)(K) of this title ; and
    • (B) will meet the obligation of the facility under clause (i) of section 300s–1(b)(1)(K) of this title .
  • (2) The Secretary may waive the recovery rights of the United States under subsection (a)(2) with respect to a facility in any State if the Secretary determines, in accordance with regulations, that there is good cause for waiving such rights with respect to such facility.
• (e) The right of recovery of the United States under subsection (a) shall not constitute a lien on any facility with respect to which funds have been paid under this subchapter.

§ 280b–1b. Use of allotments for rape prevention education

• (a) The Secretary, acting through the National Center for Injury Prevention and Control at the Centers for Disease Control and Prevention, shall award targeted grants to States to be used for rape prevention and education programs conducted by rape crisis centers, State, territorial or tribal sexual assault coalitions, and other public and private nonprofit entities for—
  • (1) educational seminars;
  • (2) the operation of hotlines;
  • (3) training programs for professionals;
  • (4) the preparation of informational material;
  • (5) education and training programs for students and campus personnel designed to reduce the incidence of sexual assault at colleges and universities;
  • (6) education to increase awareness about drugs and alcohol used to facilitate rapes or sexual assaults; and
  • (7) other efforts to increase awareness of the facts about, or to help prevent, sexual assault, including efforts to increase awareness in underserved communities and awareness among individuals with disabilities (as defined in section 12102 of this title ).
• (b) The Secretary shall, through the National Resource Center on Sexual Assault established under the National Center for Injury Prevention and Control at the Centers for Disease Control and Prevention, provide resource information, policy, training, and technical assistance to Federal, State, local, and Indian tribal agencies, as well as to State sexual assault coalitions and local sexual assault programs and to other professionals and interested parties on issues relating to sexual assault, including maintenance of a central resource library in order to collect, prepare, analyze, and disseminate information and statistics and analyses thereof relating to the incidence and prevention of sexual assault.
• (c)
  • (1) There is authorized to be appropriated to carry out this section $50,000,000 for each of fiscal years 2014 through 2018.
  • (2) Of the total amount made available under this subsection in each fiscal year, not less than $1,500,000 shall be available for allotment under subsection (b).
  • (3) A minimum allocation of $150,000 shall be awarded in each fiscal year for each of the States, the District of Columbia, and Puerto Rico. A minimum allocation of $35,000 shall be awarded in each fiscal year for each Territory. Any unused or remaining funds shall be allotted to each State, the District of Columbia, and Puerto Rico on the basis of population.
• (d)
  • (1) Amounts provided to States under this section shall be used to supplement and not supplant other Federal, State, and local public funds expended to provide services of the type described in subsection (a).
  • (2) A State may not use more than 2 percent of the amount received by the State under this section for each fiscal year for surveillance studies or prevalence studies.
  • (3) A State may not use more than 5 percent of the amount received by the State under this section for each fiscal year for administrative expenses.

§ 280b–1c. Prevention of traumatic brain injury

• (a) The Secretary, acting through the Director of the Centers for Disease Control and Prevention, may carry out projects to reduce the incidence of traumatic brain injury. Such projects may be carried out by the Secretary directly or through awards of grants or contracts to public or nonprofit private entities. The Secretary may directly or through such awards provide technical assistance with respect to the planning, development, and operation of such projects.
• (b) Activities under subsection (a) may include—
  • (1) the conduct of research into identifying effective strategies for the prevention of traumatic brain injury;
  • (2) the implementation of public information and education programs for the prevention of such injury and for broadening the awareness of the public concerning the public health consequences of such injury; and
  • (3) the implementation of a national education and awareness campaign regarding such injury (in conjunction with the program of the Secretary regarding health-status goals for 2020, commonly referred to as Healthy People 2020), including—
    • (A) the national dissemination of information on—
      • (i) incidence and prevalence; and
      • (ii) information relating to traumatic brain injury and the sequelae of secondary conditions arising from traumatic brain injury upon discharge from hospitals and emergency departments; and
    • (B) the provision of information in primary care settings, including emergency rooms and trauma centers, concerning the availability of State level services and resources.
• (c) The Secretary shall ensure that activities under this section are coordinated as appropriate with other agencies of the Public Health Service that carry out activities regarding traumatic brain injury.
• (d) For purposes of this section, the term “traumatic brain injury” means an acquired injury to the brain. Such term does not include brain dysfunction caused by congenital or degenerative disorders, nor birth trauma, but may include brain injuries caused by anoxia due to trauma. The Secretary may revise the definition of such term as the Secretary determines necessary, after consultation with States and other appropriate public or nonprofit private entities.

§ 280b–1d. National program for traumatic brain injury surveillance and registries

• (a) The Secretary, acting through the Director of the Centers for Disease Control and Prevention, may make grants to States or their designees to develop or operate the State’s traumatic brain injury surveillance system or registry to determine the incidence and prevalence of traumatic brain injury and related disability, to ensure the uniformity of reporting under such system or registry, to link individuals with traumatic brain injury to services and supports, and to link such individuals with academic institutions to conduct applied research that will support the development of such surveillance systems and registries as may be necessary. A surveillance system or registry under this section shall provide for the collection of data concerning—
  • (1) demographic information about each traumatic brain injury;
  • (2) information about the circumstances surrounding the injury event associated with each traumatic brain injury;
  • (3) administrative information about the source of the collected information, dates of hospitalization and treatment, and the date of injury; and
  • (4) information characterizing the clinical aspects of the traumatic brain injury, including the severity of the injury, outcomes of the injury, the types of treatments received, and the types of services utilized.
• (b) Not later than 18 months after April 28, 2008 , the Secretary, acting through the Director of the Centers for Disease Control and Prevention and the Director of the National Institutes of Health and in consultation with the Secretary of Defense and the Secretary of Veterans Affairs, shall submit to the relevant committees of Congress a report that contains the findings derived from an evaluation concerning activities and procedures that can be implemented by the Centers for Disease Control and Prevention to improve the collection and dissemination of compatible epidemiological studies on the incidence and prevalence of traumatic brain injury in individuals who were formerly in the military. The report shall include recommendations on the manner in which such agencies can further collaborate on the development and improvement of traumatic brain injury diagnostic tools and treatments.
• (c) The Secretary, acting through the Director of the Centers for Disease Control and Prevention, may implement concussion data collection and analysis to determine the prevalence and incidence of concussion.

§ 280b–1f. Prevention of falls among older adults

• (a) The Secretary may—
  • (1) oversee and support a national education campaign to be carried out by a nonprofit organization with experience in designing and implementing national injury prevention programs, that is directed principally to older adults, their families, and health care providers, and that focuses on reducing falls among older adults and preventing repeat falls; and
  • (2) award grants, contracts, or cooperative agreements to qualified organizations, institutions, or consortia of qualified organizations and institutions, specializing, or demonstrating expertise, in falls or fall prevention, for the purpose of organizing State-level coalitions of appropriate State and local agencies, safety, health, senior citizen, and other organizations to design and carry out local education campaigns, focusing on reducing falls among older adults and preventing repeat falls.
• (b)
  • (1) The Secretary may—
    • (A) conduct and support research to—
      • (i) improve the identification of older adults who have a high risk of falling;
      • (ii) improve data collection and analysis to identify fall risk and protective factors;
      • (iii) design, implement, and evaluate the most effective fall prevention interventions;
      • (iv) improve strategies that are proven to be effective in reducing falls by tailoring these strategies to specific populations of older adults;
      • (v) conduct research in order to maximize the dissemination of proven, effective fall prevention interventions;
      • (vi) intensify proven interventions to prevent falls among older adults;
      • (vii) improve the diagnosis, treatment, and rehabilitation of elderly fall victims and older adults at high risk for falls; and
      • (viii) assess the risk of falls occurring in various settings;
    • (B) conduct research concerning barriers to the adoption of proven interventions with respect to the prevention of falls among older adults;
    • (C) conduct research to develop, implement, and evaluate the most effective approaches to reducing falls among high-risk older adults living in communities and long-term care and assisted living facilities; and
    • (D) evaluate the effectiveness of community programs designed to prevent falls among older adults.
  • (2) The Secretary, either directly or through awarding grants, contracts, or cooperative agreements to qualified organizations, institutions, or consortia of qualified organizations and institutions, specializing, or demonstrating expertise, in falls or fall prevention, may provide professional education for physicians and allied health professionals, and aging service providers in fall prevention, evaluation, and management.
• (c) The Secretary may carry out the following:
  • (1) Oversee and support demonstration and research projects to be carried out by qualified organizations, institutions, or consortia of qualified organizations and institutions, specializing, or demonstrating expertise, in falls or fall prevention, in the following areas:
    • (A) A multistate demonstration project assessing the utility of targeted fall risk screening and referral programs.
    • (B) Programs designed for community-dwelling older adults that utilize multicomponent fall intervention approaches, including physical activity, medication assessment and reduction when possible, vision enhancement, and home modification strategies.
    • (C) Programs that are targeted to new fall victims who are at a high risk for second falls and which are designed to maximize independence and quality of life for older adults, particularly those older adults with functional limitations.
    • (D) Private sector and public-private partnerships to develop technologies to prevent falls among older adults and prevent or reduce injuries if falls occur.
  • (2)
    • (A) Award grants, contracts, or cooperative agreements to qualified organizations, institutions, or consortia of qualified organizations and institutions, specializing, or demonstrating expertise, in falls or fall prevention, to design, implement, and evaluate fall prevention programs using proven intervention strategies in residential and institutional settings.
    • (B) Award 1 or more grants, contracts, or cooperative agreements to 1 or more qualified organizations, institutions, or consortia of qualified organizations and institutions, specializing, or demonstrating expertise, in falls or fall prevention, in order to carry out a multistate demonstration project to implement and evaluate fall prevention programs using proven intervention strategies designed for single and multifamily residential settings with high concentrations of older adults, including—
      • (i) identifying high-risk populations;
      • (ii) evaluating residential facilities;
      • (iii) conducting screening to identify high-risk individuals;
      • (iv) providing fall assessment and risk reduction interventions and counseling;
      • (v) coordinating services with health care and social service providers; and
      • (vi) coordinating post-fall treatment and rehabilitation.
  • (3) Award 1 or more grants, contracts, or cooperative agreements to qualified organizations, institutions, or consortia of qualified organizations and institutions, specializing, or demonstrating expertise, in falls or fall prevention, to conduct evaluations of the effectiveness of the demonstration projects described in this subsection.
• (d) In awarding grants, contracts, or cooperative agreements under this section, the Secretary may give priority to entities that explore the use of cost-sharing with respect to activities funded under the grant, contract, or agreement to ensure the institutional commitment of the recipients of such assistance to the projects funded under the grant, contract, or agreement. Such non-Federal cost sharing contributions may be provided directly or through donations from public or private entities and may be in cash or in-kind, fairly evaluated, including plant, equipment, or services.
• (e)
  • (1) The Secretary may conduct a review of the effects of falls on health care costs, the potential for reducing falls, and the most effective strategies for reducing health care costs associated with falls.
  • (2) If the Secretary conducts the review under paragraph (1), the Secretary shall, not later than 36 months after April 23, 2008 , submit to Congress a report describing the findings of the Secretary in conducting such review.

§ 300mm–2. Education and outreach

The WTC Program Administrator shall institute a program that provides education and outreach on the existence and availability of services under the WTC Program. The outreach and education program—

• (1) shall include—
  • (A) the establishment of a public Web site with information about the WTC Program;
  • (B) meetings with potentially eligible populations;
  • (C) development and dissemination of outreach materials informing people about the program; and
  • (D) the establishment of phone information services; and
• (2) shall be conducted in a manner intended—
  • (A) to reach all affected populations; and
  • (B) to include materials for culturally and linguistically diverse populations.

§ 290ee–2a. Peer support technical assistance center

• (a) The Secretary, acting through the Assistant Secretary, shall establish or operate a National Peer-Run Training and Technical Assistance Center for Addiction Recovery Support (referred to in this section as the “Center”).
• (b) The Center established under subsection (a) shall provide technical assistance and support to recovery community organizations and peer support networks, including such assistance and support related to—
  • (1) training on identifying—
    • (A) signs of substance use disorder;
    • (B) resources to assist individuals with a substance use disorder, or resources for families of an individual with a substance use disorder; and
    • (C) best practices for the delivery of recovery support services;
  • (2) the provision of translation services, interpretation, or other such services for clients with limited English speaking proficiency;
  • (3) data collection to support research, including for translational research;
  • (4) capacity building; and
  • (5) evaluation and improvement, as necessary, of the effectiveness of such services provided by recovery community organizations.
• (c) The Center established under subsection (a) shall periodically issue best practices for use by recovery community organizations and peer support networks.
• (d) In this section, the term “recovery community organization” has the meaning given such term in section 290ee–2 of this title .
• (e) There is authorized to be appropriated to carry out this section $1,000,000 for each of fiscal years 2019 through 2023.

§ 300mm–3. Uniform data collection and analysis

• (a) The WTC Program Administrator shall provide for the uniform collection of data, including claims data (and analysis of data and regular reports to the Administrator) on the prevalence of WTC-related health conditions and the identification of new WTC-related health conditions. Such data shall be collected for all individuals provided monitoring or treatment benefits under part B and regardless of their place of residence or Clinical Center of Excellence through which the benefits are provided. The WTC Program Administrator shall provide, through the Data Centers or otherwise, for the integration of such data into the monitoring and treatment program activities under this subchapter.
• (b) Each Clinical Center of Excellence shall collect data described in subsection (a) and report such data to the corresponding Data Center for analysis by such Data Center.
• (c) The WTC Program Administrator shall provide for collaboration between the Data Centers and the World Trade Center Health Registry described in section 300mm–52 of this title .
• (d) The data collection and analysis under this section shall be conducted and maintained in a manner that protects the confidentiality of individually identifiable health information consistent with applicable statutes and regulations, including, as applicable, HIPAA privacy and security law (as defined in section 300jj–19(a)(2) of this title ) and section 552a of title 5 .

§ 300j–3a. Grants to public sector agencies

• (a) The Administrator of the Environmental Protection Agency shall offer grants to public sector agencies for the purposes of—
  • (1) assisting in the development and demonstration (including construction) of any proj­ect which will demonstrate a new or improved method, approach, or technology for providing a dependably safe supply of drinking water to the public; and
  • (2) assisting in the development and demonstration (including construction) of any proj­ect which will investigate and demonstrate health and conservation implications involved in the reclamation, recycling, and reuse of wastewaters for drinking and agricultural use or the processes and methods for the preparation of safe and acceptable drinking water.
• (b) Grants made by the Administrator under this section shall be subject to the following limitations:
  • (1) Grants under this section shall not exceed 66⅔ per centum of the total cost of construction of any facility and 75 per centum of any other costs, as determined by the Administrator.
  • (2) Grants under this section shall not be made for any project involving the construction or modification of any facilities for any public water system in a State unless such project has been approved by the State agency charged with the responsibility for safety of drinking water (or if there is no such agency in a State, by the State health authority).
  • (3) Grants under this section shall not be made for any project unless the Administrator determines, after consultation, that such project will serve a useful purpose relating to the development and demonstration of new or improved techniques, methods, or technologies for the provision of safe water to the public for drinking.
• (c) There are authorized to be appropriated for the purposes of this section $25,000,000 for fiscal year 1978.

§ 300j–3b. Contaminant standards or treatment technique guidelines

• (1) Not later than nine months after October 18, 1978 , the Administrator shall promulgate guidelines establishing supplemental standards or treatment technique requirements for microbiological, viral, radiological, organic, and inorganic contaminants, which guidelines shall be conditions, as provided in paragraph (2), of any grant for a demonstration project for water reclamation, recycling, and reuse funded under section 300j–3a of this title or under section 300j–3(a)(2) of this title , where such project involves direct human consumption of treated wastewater. Such guidelines shall provide for sufficient control of each such contaminant, such that in the Administrator’s judgement, no adverse effects on the health of persons may reasonably be anticipated to occur, allowing an adequate margin of safety.
• (2) A grant referred to in paragraph (1) for a project which involves direct human consumption of treated wastewater may be awarded on or after the date of promulgation of guidelines under this section only if the applicant demonstrates to the satisfaction of the Administrator that the project—
  • (A) will comply with all national primary drinking water regulations under section 300g–1 of this title ;
  • (B) will comply with all guidelines under this section; and
  • (C) will in other respects provide safe drinking water.
• (3) Guidelines under this section may, in the discretion of the Administrator—
  • (A) be nationally and uniformly applicable to all projects funded under section 300j–3a of this title or section 300j–1(a)(2) 1 1 See References in Text note below. of this title;
  • (B) vary for different classes or categories of such projects (as determined by the Administrator);
  • (C) be established and applicable on a proj­ect-by-project basis; or
  • (D) any combination of the above.
• (4) Nothing in this section shall be construed to prohibit or delay the award of any grant referred to in paragraph (1) prior to the date of promulgation of such guidelines.

§ 300j–3c. National assistance program for water infrastructure and watersheds

• (a) The Administrator of the Environmental Protection Agency may provide technical and financial assistance in the form of grants to States (1) for the construction, rehabilitation, and improvement of water supply systems, and (2) consistent with nonpoint source management programs established under section 1329 of title 33 , for source water quality protection programs to address pollutants in navigable waters for the purpose of making such waters usable by water supply systems.
• (b) Not more than 30 percent of the amounts appropriated to carry out this section in a fiscal year may be used for source water quality protection programs described in subsection (a)(2).
• (c) As a condition to receiving assistance under this section, a State shall ensure that such assistance is carried out in the most cost-effective manner, as determined by the State.
• (d)
  • (1) There are authorized to be appropriated to carry out this section $25,000,000 for each of fiscal years 1997 through 2003. Such sums shall remain available until expended.
  • (2) In addition to amounts authorized under paragraph (1), there are authorized to be appropriated to carry out this section $25,000,000 for each of fiscal years 1997 through 2003, provided that such authorization shall be in effect for a fiscal year only if at least 75 percent of the total amount of funds authorized to be appropriated for such fiscal year by section 300j–12(m) of this title are appropriated.
• (e) Assistance provided with funds made available under this section may be used for the acquisition of lands and other interests in lands; however, nothing in this section authorizes the acquisition of lands or other interests in lands from other than willing sellers.
• (f) The Federal share of the cost of activities for which grants are made under this section shall be 50 percent.
• (g) In this section, the following definitions apply:
  • (1) The term “State” means a State, the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Commonwealth of the Northern Mariana Islands.
  • (2) The term “water supply system” means a system for the provision to the public of piped water for human consumption if such system has at least 15 service connections or regularly serves at least 25 individuals and a draw and fill system for the provision to the public of water for human consumption. Such term does not include a system owned by a Federal agency. Such term includes (A) any collection, treatment, storage, and distribution facilities under control of the operator of such system and used primarily in connection with such system, and (B) any collection or pretreatment facilities not under such control that are used primarily in connection with such system.

§ 300j–3d. Water supply cost savings

• (a) The Administrator, in consultation with the Secretary of Agriculture, shall—
  • (1) develop a technology clearinghouse for information on the cost-effectiveness of innovative and alternative drinking water delivery systems, including wells and well systems; and
  • (2) disseminate such information to the public and to communities and not-for-profit organizations seeking Federal funding for drinking water delivery systems serving 500 or fewer persons.
• (b) In any application for a grant or loan for the purpose of construction, replacement, or rehabilitation of a drinking water delivery system serving 500 or fewer persons, the funding for which would come from the Federal Government (either directly or through a State), a unit of local government or not-for-profit organization shall self-certify that the unit of local government or organization has considered, as an alternative drinking water supply, drinking water delivery systems sourced by publicly owned—
  • (1) individual wells;
  • (2) shared wells; and
  • (3) community wells.
• (c) Not later than 3 years after December 16, 2016 , the Comptroller General of the United States shall submit to Congress a report that describes—
  • (1) the use of innovative and alternative drinking water delivery systems described in this section;
  • (2) the range of cost savings for communities using innovative and alternative drinking water delivery systems described in this section; and
  • (3) the use of drinking water technical assistance programs operated by the Administrator and the Secretary of Agriculture.

§ 300mm–4. Clinical Centers of Excellence and Data Centers

• (a)
  • (1) The WTC Program Administrator shall, subject to subsection (b)(1)(B), enter into contracts with Clinical Centers of Excellence (as defined in subsection (b)(1)(A))—
    • (A) for the provision of monitoring and treatment benefits and initial health evaluation benefits under part B;
    • (B) for the provision of outreach and retention activities to individuals eligible for such monitoring and treatment benefits, for initial health evaluation benefits, and for followup to individuals who are enrolled in the monitoring program;
    • (C) for the provision of counseling for benefits under part B, with respect to WTC-related health conditions, for individuals eligible for such benefits;
    • (D) for the provision of counseling for benefits for WTC-related health conditions that may be available under workers’ compensation or other benefit programs for work-related injuries or illnesses, health insurance, disability insurance, or other insurance plans or through public or private social service agencies and assisting eligible individuals in applying for such benefits;
    • (E) for the provision of translational and interpretive services for program participants who are not English language proficient; and
    • (F) for the collection and reporting of data, including claims data, in accordance with section 300mm–3 of this title .
  • (2)
    • (A) The WTC Program Administrator shall enter into contracts with one or more Data Centers (as defined in subsection (b)(2))—
      • (i) for receiving, analyzing, and reporting to the WTC Program Administrator on data, in accordance with section 300mm–3 of this title , that have been collected and reported to such Data Centers by the corresponding Clinical Centers of Excellence under subsection (b)(1)(B)(iii);
      • (ii) for the development of monitoring, initial health evaluation, and treatment protocols, with respect to WTC-related health conditions;
      • (iii) for coordinating the outreach and retention activities conducted under paragraph (1)(B) by each corresponding Clinical Center of Excellence;
      • (iv) for establishing criteria for the credentialing of medical providers participating in the nationwide network under section 300mm–23 of this title ;
      • (v) for coordinating and administering the activities of the WTC Health Program Steering Committees established under section 300mm–1(b) 1 1 See References in Text note below. of this title; and
      • (vi) for meeting periodically with the corresponding Clinical Centers of Excellence to obtain input on the analysis and reporting of data collected under clause (i) and on the development of monitoring, initial health evaluation, and treatment protocols under clause (ii).
    • (B) The medical providers under subparagraph (A)(iv) shall be selected by the WTC Program Administrator on the basis of their experience treating or diagnosing the health conditions included in the list of WTC-related health conditions.
    • (C) In carrying out subparagraph (A)(ii), a Data Center shall engage in clinical discussions across the WTC Program to guide treatment approaches for individuals with a WTC-related health condition.
    • (D) A contract entered into under this subsection with a Data Center shall require the Data Center to make any data collected and reported to such Center under subsection (b)(1)(B)(iii) available to health researchers and others as provided in the CDC/ATSDR Policy on Releasing and Sharing Data.
  • (3) A contract entered into under this subsection with a Clinical Center of Excellence or a Data Center may be with respect to one or more class of enrolled WTC responders, screening-eligible WTC survivors, or certified-eligible WTC survivors.
  • (4) Any contract under this subchapter between the WTC Program Administrator and a Data Center or a Clinical Center of Excellence may be in the form of a cooperative agreement.
  • (5) Not later than July 1, 2011 , the Comptroller General of the United States shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report on the feasibility of consolidating Data Centers into a single Data Center.
• (b)
  • (1)
    • (A) For purposes of this subchapter, the term “Clinical Center of Excellence” means a Center that demonstrates to the satisfaction of the Administrator that the Center—
      • (i) uses an integrated, centralized health care provider approach to create a comprehensive suite of health services under this subchapter that are accessible to enrolled WTC responders, screening-eligible WTC survivors, or certified-eligible WTC survivors;
      • (ii) has experience in caring for WTC responders and screening-eligible WTC survivors or includes health care providers who have been trained pursuant to section 300mm–23(c) of this title ;
      • (iii) employs health care provider staff with expertise that includes, at a minimum, occupational medicine, environmental medicine, trauma-related psychiatry and psychology, and social services counseling; and
      • (iv) meets such other requirements as specified by the Administrator.
    • (B) The WTC Program Administrator shall not enter into a contract with a Clinical Center of Excellence under subsection (a)(1) unless the Center agrees to do each of the following:
      • (i) Establish a formal mechanism for consulting with and receiving input from representatives of eligible populations receiving monitoring and treatment benefits under part B from such Center.
      • (ii) Coordinate monitoring and treatment benefits under part B with routine medical care provided for the treatment of conditions other than WTC-related health conditions.
      • (iii) Collect and report to the corresponding Data Center data, including claims data, in accordance with section 300mm–3(b) of this title .
      • (iv) Have in place safeguards against fraud that are satisfactory to the Administrator, in consultation with the Inspector General of the Department of Health and Human Services.
      • (v) Treat or refer for treatment all individuals who are enrolled WTC responders or certified-eligible WTC survivors with respect to such Center who present themselves for treatment of a WTC-related health condition.
      • (vi) Have in place safeguards, consistent with section 300mm–3(d) of this title , to ensure the confidentiality of an individual’s individually identifiable health information, including requiring that such information not be disclosed to the individual’s employer without the authorization of the individual.
      • (vii) Use amounts paid under subsection (c)(1) only for costs incurred in carrying out the activities described in subsection (a), other than those described in subsection (a)(1)(A).
      • (viii) Utilize health care providers with occupational and environmental medicine expertise to conduct physical and mental health assessments, in accordance with protocols developed under subsection (a)(2)(A)(ii).
      • (ix) Communicate with WTC responders and screening-eligible and certified-eligible WTC survivors in appropriate languages and conduct outreach activities with relevant stakeholder worker or community associations.
      • (x) Meet all the other applicable requirements of this subchapter, including regulations implementing such requirements.
    • (C) The WTC Program Administrator shall to the maximum extent feasible ensure continuity of care in any period of transition from monitoring and treatment of an enrolled WTC responder or certified-eligible WTC survivor by a provider to a Clinical Center of Excellence or a health care provider participating in the nationwide network under section 300mm–23 of this title .
  • (2) For purposes of this subchapter, the term “Data Center” means a Center that the WTC Program Administrator determines has the capacity to carry out the responsibilities for a Data Center under subsection (a)(2).
  • (3) For purposes of this subchapter, a Clinical Center of Excellence and a Data Center shall be treated as “corresponding” to the extent that such Clinical Center and Data Center serve the same population group.
• (c)
  • (1) The WTC Program Administrator shall reimburse a Clinical Center of Excellence for the fixed infrastructure costs of such Center in carrying out the activities described in part B at a rate negotiated by the Administrator and such Centers. Such negotiated rate shall be fair and appropriate and take into account the number of enrolled WTC responders receiving services from such Center under this subchapter.
  • (2) For purposes of paragraph (1), the term “fixed infrastructure costs” means, with respect to a Clinical Center of Excellence, the costs incurred by such Center that are not otherwise reimbursable by the WTC Program Administrator under section 300mm–22(c) of this title for patient evaluation, monitoring, or treatment but which are needed to operate the WTC program such as the costs involved in outreach to participants or recruiting participants, data collection and analysis, social services for counseling patients on other available assistance outside the WTC program, and the development of treatment protocols. Such term does not include costs for new construction or other capital costs.
• (d) Not later than July 1, 2011 , the Comptroller General shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate an analysis on whether Clinical Centers of Excellence with which the WTC Program Administrator enters into a contract under this section have financial systems that will allow for the timely submission of claims data for purposes of section 300mm–3 of this title and subsections (a)(1)(F) and (b)(1)(B)(iii).

§ 300n–4a. Supplemental grants for additional preventive health services

• (a) In the case of States receiving grants under section 300k of this title , the Secretary, acting through the Director of the Centers for Disease Control and Prevention, may make grants to not more than 3 such States to carry out demonstration projects for the purpose of—
  • (1) providing preventive health services in addition to the services authorized in such section, including screenings regarding blood pressure and cholesterol, and including health education;
  • (2) providing appropriate referrals for medical treatment of women receiving services pursuant to paragraph (1) and ensuring, to the extent practicable, the provision of appropriate follow-up services; and
  • (3) evaluating activities conducted under paragraphs (1) and (2) through appropriate surveillance or program-monitoring activities.
• (b) The Secretary may not make a grant under subsection (a) unless the State involved agrees that services under the grant will be provided only through entities that are screening women for breast or cervical cancer pursuant to a grant under section 300k of this title .
• (c) This subchapter applies to a grant under subsection (a) to the same extent and in the same manner as such subchapter applies to a grant under section 300k of this title .
• (d)
  • (1) Subject to paragraph (2), for the purpose of carrying out this section, there are authorized to be appropriated $3,000,000 for fiscal year 1994, and such sums as may be necessary for each of the fiscal years 1995 through 2003.
  • (2) The authorization of appropriations established in paragraph (1) is not effective for a fiscal year unless the amount appropriated under section 300n–5(a) of this title for the fiscal year is equal to or greater than $100,000,000.

§ 247d–4b. Children’s Preparedness Unit

• (a) The Secretary, acting through the Director of the Centers for Disease Control and Prevention (referred to in this subsection as the “Director”), shall maintain an internal team of experts, to be known as the Children’s Preparedness Unit (referred to in this subsection as the “Unit”), to work collaboratively to provide guidance on the considerations for, and the specific needs of, children before, during, and after public health emergencies. The Unit shall inform the Director regarding emergency preparedness and response efforts pertaining to children at the Centers for Disease Control and Prevention.
• (b) The team described in subsection (a) shall include one or more pediatricians, which may be a developmental-behavioral pediatrician, and may also include behavioral scientists, child psychologists, epidemiologists, biostatisticians, health communications staff, and individuals with other areas of expertise, as the Secretary determines appropriate.
• (c) The team described in subsection (a) may—
  • (1) assist State, local, Tribal, and territorial emergency planning and response activities related to children, which may include developing, identifying, and sharing best practices;
  • (2) provide technical assistance, training, and consultation to Federal, State, local, Tribal, and territorial public health officials to improve preparedness and response capabilities with respect to the needs of children, including providing such technical assistance, training, and consultation to eligible entities in order to support the achievement of measurable evidence-based benchmarks and objective standards applicable to sections 247d–3a and 247d–3b of this title;
  • (3) improve the utilization of methods to incorporate the needs of children in planning for and responding to a public health emergency, including public awareness of such methods;
  • (4) coordinate with, and improve, public-private partnerships, such as health care coalitions pursuant to sections 247d–3b and 247d–3c of this title, to address gaps and inefficiencies in emergency preparedness and response efforts for children;
  • (5) provide expertise and input during the development of guidance and clinical recommendations to address the needs of children when preparing for, and responding to, public health emergencies, including pursuant to section 247d–3c of this title ; and
  • (6) carry out other duties related to preparedness and response activities for children, as the Secretary determines appropriate.

§ 247b–4f. Research relating to preterm labor and delivery and the care, treatment, and outcomes of preterm and low birthweight infants

• (a)
• (b)
  • (1) The Secretary of Health and Human Services, acting through the Director of the Centers for Disease Control and Prevention, may, subject to the availability of appropriations—
    • (A) conduct epidemiological studies on the factors relating to prematurity, such as clinical, biological, social, environmental, genetic, and behavioral factors, and other determinants that contribute to health disparities and are related to prematurity, as appropriate;
    • (B) conduct activities to improve national data to facilitate tracking the burden of preterm birth; and
    • (C) continue efforts to prevent preterm birth, including late preterm birth, through the identification of opportunities for prevention and the assessment of the impact of such efforts.
  • (2) Not later than 2 years after November 27, 2013 , and every 2 years thereafter, the Secretary of Health and Human Services, acting through the Director of the Centers for Disease Control and Prevention, shall submit to the appropriate committees of Congress reports regarding activities and studies conducted under paragraph (1), including any applicable analyses of preterm birth. Such report shall be posted on the Internet website of the Department of Health and Human Services.. 1 1 So in original.
• (c) The Secretary of Health and Human Services, acting through the Director of the Centers for Disease Control and Prevention, shall—
  • (1) continue systems for the collection of maternal-infant clinical and biomedical information, including electronic health records, electronic databases, and biobanks, to link with the Pregnancy Risk Assessment Monitoring System (PRAMS) and other epidemiological studies of prematurity in order to track, to the extent practicable, all pregnancy outcomes and prevent preterm birth; and
  • (2) provide technical assistance, as appropriate, to support States in improving the collection of information pursuant to this subsection.
• (d) The Secretary of Health and Human Services shall review existing tools and measures to ensure that such tools and measures include information related to the known risk factors of low birth weight and preterm birth.
• (e) There is authorized to be appropriated to carry out this section, $2,000,000 for each of fiscal years 2019 through 2023.

§ 300mm–5. Definitions

In this subchapter:

• (1) The term “aggravating” means, with respect to a health condition, a health condition that existed on September 11, 2001 , and that, as a result of exposure to airborne toxins, any other hazard, or any other adverse condition resulting from the September 11, 2001 , terrorist attacks, requires medical treatment that is (or will be) in addition to, more frequent than, or of longer duration than the medical treatment that would have been required for such condition in the absence of such exposure.
• (2) The term “certified-eligible WTC survivor” has the meaning given such term in section 300mm–31(a)(2) of this title .
• (3) The terms “Clinical Center of Excellence” and “Data Center” have the meanings given such terms in section 300mm–4 of this title .
• (4) The term “enrolled WTC responder” means a WTC responder enrolled under section 300mm–21(a)(3) of this title .
• (5) The term “initial health evaluation” includes, with respect to an individual, a medical and exposure history, a physical examination, and additional medical testing as needed to evaluate whether the individual has a WTC-related health condition and is eligible for treatment under the WTC Program.
• (6) The term “list of WTC-related health conditions” means—
  • (A) for WTC responders, the health conditions listed in section 300mm–22(a)(3) of this title ; and
  • (B) for screening-eligible and certified-eligible WTC survivors, the health conditions listed in section 300mm–32(b) of this title .
• (7) The term “New York City disaster area” means the area within New York City that is—
  • (A) the area of Manhattan that is south of Houston Street; and
  • (B) any block in Brooklyn that is wholly or partially contained within a 1.5-mile radius of the former World Trade Center site.
• (8) The term “New York metropolitan area” means an area, specified by the WTC Program Administrator, within which WTC responders and eligible WTC screening-eligible survivors who reside in such area are reasonably able to access monitoring and treatment benefits and initial health evaluation benefits under this subchapter through a Clinical Center of Excellence described in subparagraphs (A), (B), or (C) of section 300mm–4(b)(1) of this title .
• (9) The term “screening-eligible WTC survivor” has the meaning given such term in section 300mm–31(a)(1) of this title .
• (10) Any reference to “ September 11, 2001 ” shall be deemed a reference to the period on such date subsequent to the terrorist attacks at the World Trade Center, Shanksville, Pennsylvania, or the Pentagon, as applicable, on such date.
• (11) The term “ September 11, 2001 , terrorist attacks” means the terrorist attacks that occurred on September 11, 2001 , in New York City, in Shanksville, Pennsylvania, and at the Pentagon, and includes the aftermath of such attacks.
• (12) The term “WTC Health Program Steering Committee” means such a Steering Committee established under section 300mm–1(b) of this title .
• (13) The term “WTC Program” means the Word Trade Center Health Program established under section 300mm(a) of this title .
• (14)
  • (A) The term “WTC Program Administrator” means—
    • (i) subject to subparagraph (B), with respect to paragraphs (3) and (4) of section 300mm–21(a) of this title (relating to enrollment of WTC responders), section 300mm–22(c) of this title and the corresponding provisions of section 300mm–32 of this title (relating to payment for initial health evaluation, monitoring, and treatment, 1 1 So in original. A closing parenthesis probably should precede the comma. paragraphs (1)(C), (2)(B), and (3) of section 300mm–31(a) of this title (relating to determination or certification of screening-eligible or certified-eligible WTC responders), and subpart 3 of part B (relating to payor provisions), an official in the Department of Health and Human Services, to be designated by the Secretary; and
    • (ii) with respect to any other provision of this subchapter, the Director of the National Institute for Occupational Safety and Health, or a designee of such Director.
  • (B) In no case may the Secretary designate under subparagraph (A)(i) the Director of the National Institute for Occupational Safety and Health or a designee of such Director with respect to section 300mm–32 of this title (relating to payment for initial health evaluation, monitoring, and treatment).
• (15) The term “WTC-related health condition” is defined in section 300mm–22(a) of this title .
• (16) The term “WTC responder” is defined in section 300mm–21(a) of this title .
• (17) The term “WTC Scientific/Technical Advisory Committee” means such Committee established under section 300mm–1(a) of this title .

§ 290aa–5a. Alcohol and drug prevention or treatment services for Indians and Native Alaskans

• (a) The Secretary shall award grants, contracts, or cooperative agreements to public and private nonprofit entities, including Native Alaskan entities and Indian tribes and tribal organizations, for the purpose of providing alcohol and drug prevention or treatment services for Indians and Native Alaskans.
• (b) In awarding grants, contracts, or cooperative agreements under subsection (a), the Secretary shall give priority to applicants that—
  • (1) propose to provide alcohol and drug prevention or treatment services on reservations;
  • (2) propose to employ culturally-appropriate approaches, as determined by the Secretary, in providing such services; and
  • (3) have provided prevention or treatment services to Native Alaskan entities and Indian tribes and tribal organizations for at least 1 year prior to applying for a grant under this section.
• (c) The Secretary shall award grants, contracts, or cooperative agreements under subsection (a) for a period not to exceed 5 years.
• (d) An entity desiring a grant, contract, or cooperative agreement under subsection (a) shall submit an application to the Secretary at such time, in such manner, and accompanied by such information as the Secretary may reasonably require.
• (e) An entity that receives a grant, contract, or cooperative agreement under subsection (a) shall submit, in the application for such grant, a plan for the evaluation of any project undertaken with funds provided under this section. Such entity shall provide the Secretary with periodic evaluations of the progress of such project and such evaluation at the completion of such project as the Secretary determines to be appropriate. The final evaluation submitted by such entity shall include a recommendation as to whether such project shall continue.
• (f) Not later than 3 years after October 17, 2000 , and annually thereafter, the Secretary shall prepare and submit, to the Committee on Health, Education, Labor, and Pensions of the Senate, a report describing the services provided pursuant to this section.
• (g) There are authorized to be appropriated to carry out this section, $15,000,000 for fiscal year 2001, and such sums as may be necessary for fiscal years 2002 and 2003.

§ 300gg–6. Comprehensive health insurance coverage

• (a) A health insurance issuer that offers health insurance coverage in the individual or small group market shall ensure that such coverage includes the essential health benefits package required under section 18022(a) of this title .
• (b) A group health plan shall ensure that any annual cost-sharing imposed under the plan does not exceed the limitations provided for under paragraph (1) of section 18022(c) 1 1 See References in Text note below. of this title.
• (c) If a health insurance issuer offers health insurance coverage in any level of coverage specified under section 18022(d) of this title , the issuer shall also offer such coverage in that level as a plan in which the only enrollees are individuals who, as of the beginning of a plan year, have not attained the age of 21.
• (d) This section shall not apply to a plan described in section 18031(d)(2)(B)(ii) 1 of this title.

§ 300u–6a. Individual offices of minority health within the Department

• (a) The head of each agency specified in subsection (b)(1) 1 1 So in original. Subsec. (b) does not contain a par. (1). shall establish within the agency an office to be known as the Office of Minority Health. The head of each such Office shall be appointed by the head of the agency within which the Office is established, and shall report directly to the head of the agency. The head of such agency shall carry out this section (as this section relates to the agency) acting through such Director.
• (b) The agencies referred to in subsection (a) are the Centers for Disease Control and Prevention, the Health Resources and Services Administration, the Substance Abuse and Mental Health Services Administration, the Agency for Healthcare Research and Quality, the Food and Drug Administration, and the Centers for Medicare & Medicaid Services.
• (c) Each Office of Minority Health established in an agency listed in subsection (a) 2 2 So in original. Probably should be “subsection (b)”. shall be headed by a director, with documented experience and expertise in minority health services research and health disparities elimination.
• (d) Except as otherwise specified, any reference in Federal law to an Office of Minority Health (in the Department of Health and Human Services) is deemed to be a reference to the Office of Minority Health in the Office of the Secretary.
• (e)
  • (1) Of the amounts appropriated for a specified agency for a fiscal year, the Secretary must designate an appropriate amount of funds for the purpose of carrying out activities under this section through the minority health office of the agency. In reserving an amount under the preceding sentence for a minority health office for a fiscal year, the Secretary shall reduce, by substantially the same percentage, the amount that otherwise would be available for each of the programs of the designated agency involved.
  • (2) The purposes for which amounts made available under paragraph 3 3 So in original. Probably should be “paragraph (1)”. may be expended by a minority health office include the costs of employing staff for such office.

§ 247d–6b. Strategic National Stockpile and security countermeasure procurements

• (a)
  • (1) The Secretary, in collaboration with the Assistant Secretary for Preparedness and Response and the Director of the Centers for Disease Control and Prevention, and in coordination with the Secretary of Homeland Security (referred to in this section as the “Homeland Security Secretary”), shall maintain a stockpile or stockpiles of drugs, vaccines and other biological products, medical devices, and other supplies (including personal protective equipment, ancillary medical supplies, and other applicable supplies required for the administration of drugs, vaccines and other biological products, medical devices, and diagnostic tests in the stockpile) in such numbers, types, and amounts as are determined consistent with section 300hh–10 of this title by the Secretary to be appropriate and practicable, taking into account other available sources, to provide for and optimize the emergency health security of the United States, including the emergency health security of children and other vulnerable populations, in the event of a bioterrorist attack or other public health emergency and, as informed by existing recommendations of, or consultations with, the Public Health Emergency Medical Countermeasure Enterprise established under section 300hh–10a of this title , make necessary additions or modifications to the contents of such stockpile or stockpiles based on the review conducted under paragraph (2).
  • (2)
    • (A) The Secretary shall conduct an annual threat-based review (taking into account at-risk individuals) of the contents of the stockpile under paragraph (1), including non-pharmaceutical supplies, and, in consultation with the Public Health Emergency Medical Countermeasures Enterprise established under section 300hh–10a of this title , review contents within the stockpile and assess whether such contents are consistent with the recommendations made pursuant to section 300hh–10a(c)(1)(A) of this title . Such review shall be submitted on June 15, 2019 , and on March 15 of each year thereafter, to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives, in a manner that does not compromise national security.
    • (B) Each annual threat-based review under subparagraph (A) shall, for each new or modified countermeasure procurement or replenishment, provide—
      • (i) information regarding—
        • (I) the quantities of the additional or modified countermeasure procured for, or contracted to be procured for, the stockpile;
        • (II) planning considerations for appropriate manufacturing capacity and capability to meet the goals of such additions or modifications (without disclosing proprietary information), including consideration of the effect such additions or modifications may have on the availability of such products and ancillary medical supplies in the health care system;
        • (III) the presence or lack of a commercial market for the countermeasure at the time of procurement;
        • (IV) the emergency health security threat or threats such countermeasure procurement is intended to address, including whether such procurement is consistent with meeting emergency health security needs associated with such threat or threats;
        • (V) an assessment of whether the emergency health security threat or threats described in subclause (IV) could be addressed in a manner that better utilizes the resources of the stockpile and permits the greatest possible increase in the level of emergency preparedness to address such threats;
        • (VI) whether such countermeasure is replenishing an expiring or expired countermeasure, is a different countermeasure with the same indication that is replacing an expiring or expired countermeasure, or is a new addition to the stockpile;
        • (VII) a description of how such additions or modifications align with projected investments under previous countermeasures budget plans under section 300hh–10(b)(7) of this title , including expected life-cycle costs, expenditures related to countermeasure procurement to address the threat or threats described in subclause (IV), replenishment dates (including the ability to extend the maximum shelf life of a countermeasure), and the manufacturing capacity required to replenish such countermeasure; and
        • (VIII) appropriate protocols and processes for the deployment, distribution, or dispensing of the countermeasure at the State and local level, including plans for relevant capabilities of State and local entities to dispense, distribute, and administer the countermeasure; and
      • (ii) an assurance, which need not be provided in advance of procurement, that for each countermeasure procured or replenished under this subsection, the Secretary completed a review addressing each item listed under this subsection in advance of such procurement or replenishment.
  • (3) The Secretary, in managing the stockpile under paragraph (1), shall—
    • (A) consult with the working group under section 247d–6(a) of this title and the Public Health Emergency Medical Countermeasures Enterprise established under section 300hh–10a of this title ;
    • (B) ensure that adequate procedures are followed with respect to such stockpile for inventory management and accounting, and for the physical security of the stockpile;
    • (C) in consultation with Federal, State, and local officials, take into consideration the timing and location of special events, and the availability, deployment, dispensing, and administration of countermeasures;
    • (D) review and revise, as appropriate, the contents of the stockpile on a regular basis to ensure that emerging threats, advanced technologies, and new countermeasures are adequately considered and that the potential depletion of countermeasures currently in the stockpile is identified and appropriately addressed, including through necessary replenishment;
    • (E) devise plans for effective and timely supply-chain management of the stockpile, in consultation with the Director of the Centers for Disease Control and Prevention, the Assistant Secretary for Preparedness and Response, the Secretary of Transportation, the Secretary of Homeland Security, the Secretary of Veterans Affairs, and the heads of other appropriate Federal agencies; State, local, Tribal, and territorial agencies; and the public and private health care infrastructure, as applicable, taking into account the manufacturing capacity and other available sources of products and appropriate alternatives to supplies in the stockpile;
    • (F) deploy the stockpile as required by the Secretary of Homeland Security to respond to an actual or potential emergency;
    • (G) deploy the stockpile at the discretion of the Secretary to respond to an actual or potential public health emergency or other situation in which deployment is necessary to protect the public health or safety;
    • (H) ensure the adequate physical security of the stockpile;
    • (I) ensure that each countermeasure or product under consideration for procurement pursuant to this subsection receives the same consideration regardless of whether such countermeasure or product receives or had received funding under section 247d–7e of this title , including with respect to whether the countermeasure or product is most appropriate to meet the emergency health security needs of the United States; and
    • (J) provide assistance, including technical assistance, to maintain and improve State and local public health preparedness capabilities to distribute and dispense medical countermeasures and products from the stockpile, as appropriate.
  • (4) The Secretary shall ensure timely and accurate recommended utilization guidelines for qualified countermeasures (as defined in section 247d–6a of this title ), qualified pandemic and epidemic products (as defined in section 247d–6d of this title ), and security countermeasures (as defined in subsection (c)), including for such products in the stockpile.
  • (5)
    • (A) Not later than 3 years after June 24, 2019 , and every 5 years thereafter, the Comptroller General of the United States shall conduct a review of any changes to the contents or management of the stockpile since January 1, 2015 . Such review shall include—
      • (i) an assessment of the comprehensiveness and completeness of each annual threat-based review under paragraph (2), including whether all newly procured or replenished countermeasures within the stockpile were described in each annual review, and whether, consistent with paragraph (2)(B), the Secretary conducted the necessary internal review in advance of such procurement or replenishment;
      • (ii) an assessment of whether the Secretary established health security and science-based justifications, and a description of such justifications for procurement decisions related to health security needs with respect to the identified threat, for additions or modifications to the stockpile based on the information provided in such reviews under paragraph (2)(B), including whether such review was conducted prior to procurement, modification, or replenishment;
      • (iii) an assessment of the plans developed by the Secretary for the deployment, distribution, and dispensing of countermeasures procured, modified, or replenished under paragraph (1), including whether such plans were developed prior to procurement, modification, or replenishment;
      • (iv) an accounting of countermeasures procured, modified, or replenished under paragraph (1) that received advanced research and development funding from the Biomedical Advanced Research and Development Authority;
      • (v) an analysis of how such procurement decisions made progress toward meeting emergency health security needs related to the identified threats for countermeasures added, modified, or replenished under paragraph (1);
      • (vi) a description of the resources expended related to the procurement of countermeasures (including additions, modifications, and replenishments) in the stockpile, and how such expenditures relate to the ability of the stockpile to meet emergency health security needs;
      • (vii) an assessment of the extent to which additions, modifications, and replenishments reviewed under paragraph (2) align with previous relevant reports or reviews by the Secretary or the Comptroller General;
      • (viii) with respect to any change in the Federal organizational management of the stockpile, an assessment and comparison of the processes affected by such change, including planning for potential countermeasure deployment, distribution, or dispensing capabilities and processes related to procurement decisions, use of stockpiled countermeasures, and use of resources for such activities; and
      • (ix) an assessment of whether the processes and procedures described by the Secretary pursuant to section 403(b) of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 are sufficient to ensure countermeasures and products under consideration for procurement pursuant to subsection (a) receive the same consideration regardless of whether such countermeasures and products receive or had received funding under section 247d–7e of this title , including with respect to whether such countermeasures and products are most appropriate to meet the emergency health security needs of the United States.
    • (B) Not later than 6 months after completing a classified version of the review under subparagraph (A), the Comptroller General shall submit an unclassified version of the review to the congressional committees of jurisdiction.
• (b)
  • (1) The Secretary shall award contracts, enter into cooperative agreements, or carry out such other activities as may reasonably be required in order to ensure that the stockpile under subsection (a) includes an amount of vaccine against smallpox as determined by such Secretary to be sufficient to meet the health security needs of the United States.
  • (2) Nothing in this section shall be construed to limit the private distribution, purchase, or sale of vaccines from sources other than the stockpile described in subsection (a).
• (c)
  • (1)
    • (A) A security countermeasure may, in accordance with this subsection, be procured with amounts in the special reserve fund as defined in subsection (h).
    • (B) For purposes of this subsection, the term “security countermeasure” means a drug (as that term is defined by section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321(g)(1) )), biological product (as that term is defined by section 262(i) of this title ), or device (as that term is defined by section 201(h) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321(h) )) that—
      • (i)
        • (I) the Secretary determines to be a priority (consistent with sections 182(2) and 184(a) of title 6) to diagnose, mitigate, prevent, or treat harm from any biological, chemical, radiological, or nuclear agent identified as a material threat under paragraph (2)(A)(ii), or to diagnose, mitigate, prevent, or treat harm from a condition that may result in adverse health consequences or death and may be caused by administering a drug, biological product, or device against such an agent;
        • (II) the Secretary determines under paragraph (2)(B)(ii) to be a necessary countermeasure; and
        • (III)
      • (ii) is authorized for emergency use under section 564 of the Federal Food, Drug, and Cosmetic Act [ 21 U.S.C. 360bbb–3 ].
  • (2)
    • (A) The Homeland Security Secretary, in consultation with the Secretary and the heads of other agencies as appropriate, shall on an ongoing basis—
      • (i) assess current and emerging threats of chemical, biological, radiological, and nuclear agents; and
      • (ii) determine which of such agents present a material threat against the United States population sufficient to affect national security.
    • (B) The Secretary shall on an ongoing basis—
      • (i) assess the potential public health consequences for the United States population of exposure to agents identified under subparagraph (A)(ii); and
      • (ii) determine, on the basis of such assessment, the agents identified under subparagraph (A)(ii) for which countermeasures are necessary to protect the public health.
    • (C) The Secretary and the Secretary of Homeland Security shall send to Congress, on an annual basis, all current material threat determinations and shall promptly notify the Committee on Health, Education, Labor, and Pensions and the Committee on Homeland Security and Governmental Affairs of the Senate and the Committee on Energy and Commerce and the Committee on Homeland Security of the House of Representatives that a determination has been made pursuant to subparagraph (A) or (B).
    • (D) In making the assessment and determination required under subparagraph (A), the Homeland Security Secretary shall use all relevant information to which such Secretary is entitled under section 122 of title 6 , including but not limited to information, regardless of its level of classification, relating to current and emerging threats of chemical, biological, radiological, and nuclear agents.
  • (3)
    • (A) The Secretary, in consultation with the Homeland Security Secretary, shall assess on an ongoing basis the availability and appropriateness of specific countermeasures to address specific threats identified under paragraph (2).
    • (B) The Secretary shall institute a process for making publicly available the results of assessments under subparagraph (A) while withholding such information as—
      • (i) would, in the judgment of the Secretary, tend to reveal public health vulnerabilities; or
      • (ii) would otherwise be exempt from disclosure under section 552 of title 5 .
  • (4)
    • (A) If, pursuant to an assessment under paragraph (3), the Homeland Security Secretary and the Secretary make a determination that a countermeasure would be appropriate but is either currently not developed or unavailable for procurement as a security countermeasure or is approved, licensed, or cleared only for alternative uses, such Secretaries may jointly submit to the President a proposal to—
      • (i) issue a call for the development of such countermeasure; and
      • (ii) make a commitment that, upon the first development of such countermeasure that meets the conditions for procurement under paragraph (5), the Secretaries will, based in part on information obtained pursuant to such call, and subject to the availability of appropriations, make available the special reserve fund as defined in subsection (h) for procurement of such countermeasure, as applicable.
    • (B) The Homeland Security Secretary and the Secretary shall, to the extent practicable, include in the proposal under subparagraph (A)—
      • (i) estimated quantity of purchase (in the form of number of doses or number of effective courses of treatments regardless of dosage form);
      • (ii) necessary measures of minimum safety and effectiveness;
      • (iii) estimated price for each dose or effective course of treatment regardless of dosage form; and
      • (iv) other information that may be necessary to encourage and facilitate research, development, and manufacture of the countermeasure or to provide specifications for the countermeasure.
    • (C) If the President approves a proposal under subparagraph (A), the Homeland Security Secretary and the Secretary shall make known to persons who may respond to a call for the countermeasure involved—
      • (i) the call for the countermeasure;
      • (ii) specifications for the countermeasure under subparagraph (B); and
      • (iii) the commitment described in subparagraph (A)(ii).
  • (5)
    • (A) The Secretary, in accordance with the provisions of this paragraph, shall identify specific security countermeasures that the Secretary determines, in consultation with the Homeland Security Secretary, to be appropriate for inclusion in the stockpile under subsection (a) pursuant to procurements made with amounts in the special reserve fund as defined in subsection (h) (referred to in this subsection individually as a “procurement under this subsection”).
    • (B) In making a determination under subparagraph (A) with respect to a security countermeasure, the Secretary shall determine and consider the following:
      • (i) The quantities of the product that will be needed to meet the stockpile needs.
      • (ii) The feasibility of production and delivery within 10 years of sufficient quantities of the product.
      • (iii) Whether there is a lack of a significant commercial market for the product at the time of procurement, other than as a security countermeasure.
  • (6)
    • (A) The Secretary shall notify the Committee on Appropriations and the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Appropriations and the Committee on Energy and Commerce of the House of Representatives of each decision to make available the special reserve fund as defined in subsection (h) for procurement of a security countermeasure, including, where available, the number of, the nature of, and other information concerning potential suppliers of such countermeasure, and whether other potential suppliers of the same or similar countermeasures were considered and rejected for procurement under this section and the reasons for each such rejection.
    • (B) Procurement under this subsection of a security countermeasure for a particular purpose does not preclude the subsequent procurement under this subsection of any other security countermeasure for such purpose if the Secretary has determined under paragraph (5)(A) that such countermeasure is appropriate for inclusion in the stockpile and if, as determined by the Secretary, such countermeasure provides improved safety or effectiveness, or for other reasons enhances preparedness to respond to threats of use of a biological, chemical, radiological, or nuclear agent. Such a determination by the Secretary is committed to agency discretion.
  • (7)
    • (A) The special reserve fund as defined in subsection (h) shall be available for payments made by the Secretary to a vendor for procurement of a security countermeasure in accordance with the provisions of this paragraph.
    • (B)
      • (i) The Secretary shall be responsible for—
        • (I) arranging for procurement of a security countermeasure, including negotiating terms (including quantity, production schedule, and price) of, and entering into, contracts and cooperative agreements, and for carrying out such other activities as may reasonably be required, including advanced research and development, in accordance with the provisions of this subparagraph; and
        • (II) promulgating such regulations as the Secretary determines necessary to implement the provisions of this subsection.
      • (ii) A contract for procurements under this subsection shall (or, as specified below, may) include the following terms:
        • (I) The contract shall provide that no payment may be made until delivery of a portion, acceptable to the Secretary, of the total number of units contracted for, except that, notwithstanding any other provision of law, the contract may provide that, if the Secretary determines (in the Secretary’s discretion) that an advance payment, partial payment for significant milestones, or payment to increase manufacturing capacity is necessary to ensure success of a project, the Secretary shall pay an amount, not to exceed 10 percent of the contract amount, in advance of delivery. The Secretary shall, to the extent practicable, make the determination of advance payment at the same time as the issuance of a solicitation. The contract shall provide that such advance payment is required to be repaid if there is a failure to perform by the vendor under the contract. The contract may also provide for additional advance payments of 5 percent each for meeting the milestones specified in such contract, except that such payments shall not exceed 50 percent of the total contract amount. If the specified milestones are reached, the advanced payments of 5 percent shall not be required to be repaid. Nothing in this subclause shall be construed as affecting the rights of vendors under provisions of law or regulation (including the Federal Acquisition Regulation) relating to the termination of contracts for the convenience of the Government.
        • (II) The contract may provide for a discounted price per unit of a product that is not licensed, cleared, or approved as described in paragraph (1)(B)(i)(III)(aa) at the time of delivery, and may provide for payment of an additional amount per unit if the product becomes so licensed, cleared, or approved before the expiration date of the contract (including an additional amount per unit of product delivered before the effective date of such licensing, clearance, or approval).
        • (III) The contract shall be for a period not to exceed five years, except that, in first awarding the contract, the Secretary may provide for a longer duration, not exceeding 10 years, if the Secretary determines that complexities or other difficulties in performance under the contract justify such a period. The contract shall be renewable for additional periods, none of which shall exceed five years. The Secretary shall notify the vendor within 90 days of a determination by the Secretary to renew, extend, or terminate such contract.
        • (IV) The contract may provide that the vendor will provide storage for stocks of a product delivered to the ownership of the Federal Government under the contract, for such period and under such terms and conditions as the Secretary may specify, and in such case amounts from the special reserve fund as defined in subsection (h) shall be available for costs of shipping, handling, storage, and related costs for such product.
        • (V) The contract shall provide that the vendor seek approval, clearance, or licensing of the product from the Secretary; for a timetable for the development of data and other information to support such approval, clearance, or licensing; and that the Secretary may waive part or all of this contract term on request of the vendor or on the initiative of the Secretary.
        • (VI) The contract shall provide that the vendor will comply with all applicable export-related controls with respect to such countermeasure.
        • (VII) The contract may provide that the vendor is the exclusive supplier of the product to the Federal Government for a specified period of time, not to exceed the term of the contract, on the condition that the vendor is able to satisfy the needs of the Government. During the agreed period of sales exclusivity, the vendor shall not assign its rights of sales exclusivity to another entity or entities without approval by the Secretary. Such a sales exclusivity provision in such a contract shall constitute a valid basis for a sole source procurement under section 3304(a)(1) of title 41 .
        • (VIII) The contract may provide that the vendor establish domestic manufacturing capacity of the product to ensure that additional production of the product is available in the event that the Secretary determines that there is a need to quickly purchase additional quantities of the product. Such contract may provide a fee to the vendor for establishing and maintaining such capacity in excess of the initial requirement for the purchase of the product. Additionally, the cost of maintaining the domestic manufacturing capacity shall be an allowable and allocable direct cost of the contract.
        • (IX) The Secretary, in any contract for procurement under this section—
      • (iii)
        • (I) If the Secretary determines that there is a pressing need for a procurement of a specific countermeasure, the amount of the procurement under this subsection shall be deemed to be below the threshold amount specified in section 134 of title 41 , for purposes of application to such procurement, pursuant to section 3101(b)(1)(A) of title 41 , of—
        • (II) Notwithstanding subclause (I) and the provision of law and regulations referred to in such clause, each of the following provisions shall apply to procurements described in this clause to the same extent that such provisions would apply to such procurements in the absence of subclause (I):
        • (III) The Secretary shall establish appropriate internal controls for procurements made under this clause, including requirements with respect to documentation of the justification for the use of the authority provided under this paragraph with respect to the procurement involved.
        • (IV) In conducting a procurement under this subparagraph, the Secretary may not use the authority provided for under subclause (I) to conduct a procurement on a basis other than full and open competition unless the Secretary determines that the mission of the BioShield Program under the Project BioShield Act of 2004 would be seriously impaired without such a limitation.
      • (iv)
        • (I) In using the authority provided in section 3304(a)(1) of title 41 to use procedures other than competitive procedures in the case of a procurement under this subsection, the phrase “available from only one responsible source” in such section 3304(a)(1) shall be deemed to mean “available from only one responsible source or only from a limited number of responsible sources”.
        • (II) The authority under subclause (I) is in addition to any other authority to use procedures other than competitive procedures.
        • (III) The Secretary shall implement this clause in accordance with government-wide regulations implementing such section 3304(a)(1) (including requirements that offers be solicited from as many potential sources as is practicable under the circumstances, that required notices be published, and that submitted offers be considered), as such regulations apply to procurements for which an agency has authority to use procedures other than competitive procedures when the property or services needed by the agency are available from only one responsible source or only from a limited number of responsible sources and no other type of property or services will satisfy the needs of the agency.
      • (v)
        • (I) If, under this subsection, the Secretary enters into contracts with more than one vendor to procure a security countermeasure, such Secretary may, notwithstanding any other provision of law, include in each of such contracts a provision that—
        • (II) If the Secretary includes in each of a set of contracts a provision as described in subclause (I), such Secretary’s determination of the total quantity of security countermeasure required, and any amendment of such determination, is committed to agency discretion.
      • (vi) A decision by the Secretary to extend the closing date for receipt of proposals for a procurement under this subsection is committed to agency discretion.
      • (vii) In conducting a procurement under this subsection, the Secretary may exclude a source that has not responded to a request for information under section 3306(a)(1)(B) of title 41 if such request has given notice that the Secretary may so exclude such a source.
      • (viii) In carrying out this section, the Secretary may, consistent with the applicable provisions of this section, enter into contracts and other agreements that are in the best interest of the Government in meeting identified security countermeasure needs, including with respect to reimbursement of the cost of advanced research and development as a reasonable, allowable, and allocable direct cost of the contract involved.
  • (8)
    • (A) In carrying out activities under this section, the Homeland Security Secretary and the Secretary are authorized, subject to subparagraph (B), to enter into interagency agreements and other collaborative undertakings with other agencies of the United States Government. Such agreements may allow other executive agencies to order qualified and security countermeasures under procurement contracts or other agreements established by the Secretary. Such ordering process (including transfers of appropriated funds between an agency and the Department of Health and Human Services as reimbursements for such orders for countermeasures) may be conducted under the authority of section 1535 of title 31 , except that all such orders shall be processed under the terms established under this subsection for the procurement of countermeasures.
    • (B) An agreement or undertaking under this paragraph shall not authorize another agency to exercise the authorities provided by this section to the Homeland Security Secretary or to the Secretary.
• (d) No Federal agency may disclose under section 552 of title 5 any information identifying the location at which materials in the stockpile described in subsection (a) are stored, or other information regarding the contents or deployment capability of the stockpile that could compromise national security.
• (e) For purposes of subsection (a), the term “stockpile” includes—
  • (1) a physical accumulation (at one or more locations) of the supplies described in subsection (a); or
  • (2) a contractual agreement between the Secretary and a vendor or vendors under which such vendor or vendors agree to provide to such Secretary supplies described in subsection (a).
• (f)
  • (1) For the purpose of carrying out subsection (a), there are authorized to be appropriated $610,000,000 for each of fiscal years 2019 through 2023, to remain available until expended. Such authorization is in addition to amounts in the special reserve fund referred to in subsection (h).
  • (2) For the purpose of carrying out subsection (b), there are authorized to be appropriated $509,000,000 for fiscal year 2002, and such sums as may be necessary for each of fiscal years 2003 through 2006.
• (g)
  • (1) In addition to amounts appropriated to the special reserve fund prior to March 13, 2013 , there is authorized to be appropriated, for the procurement of security countermeasures under subsection (c) and for carrying out section 247d–7e of this title (relating to the Biomedical Advanced Research and Development Authority), $7,100,000,000 for the period of fiscal years 2019 through 2028, to remain available until expended.
  • (2) The Secretary may utilize not more than 50 percent of the amounts authorized to be appropriated under paragraph (1) to carry out section 247d–7e of this title (related to the Biomedical Advanced Research and Development Authority). Amounts authorized to be appropriated under this subsection to carry out section 247d–7e of this title are in addition to amounts otherwise authorized to be appropriated to carry out such section.
  • (3) Amounts in the special reserve fund shall not be used to pay costs other than payments made by the Secretary to a vendor for advanced development (under section 247d–7e of this title ) or for procurement of a security countermeasure under subsection (c)(7).
  • (4) Not later than March 1 of each year in which the Secretary determines that the amount of funds available for procurement of security countermeasures is less than $1,500,000,000, the Secretary shall submit to the Committee on Appropriations and the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Appropriations and the Committee on Energy and Commerce of the House of Representatives a report detailing the amount of such funds available for procurement and the impact such amount of funding will have—
    • (A) in meeting the security countermeasure needs identified under this section; and
    • (B) on the annual Public Health Emergency Medical Countermeasures Enterprise and Strategy Implementation Plan (pursuant to section 300hh–10(d) of this title ).
  • (5) The Secretary, acting through the Director of the Biomedical Advanced Research and Development Authority, shall carry out the programs funded by the special reserve fund (for the procurement of security countermeasures under subsection (c) and for carrying out section 247d–7e of this title ), including the execution of procurement contracts, grants, and cooperative agreements pursuant to this section and section 247d–7e of this title .
• (h) In this section:
  • (1) The term “advanced research and development” has the meaning given such term in section 247d–7e(a) of this title .
  • (2) The term “special reserve fund” means the “Biodefense Countermeasures” appropriations account, any appropriation made available pursuant to section 321j(a) of title 6 , and any appropriation made available pursuant to subsection (g)(1).

§ 247d–6d. Targeted liability protections for pandemic and epidemic products and security countermeasures

• (a)
  • (1) Subject to the other provisions of this section, a covered person shall be immune from suit and liability under Federal and State law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration to or the use by an individual of a covered countermeasure if a declaration under subsection (b) has been issued with respect to such countermeasure.
  • (2)
    • (A) For purposes of this section, the term “loss” means any type of loss, including—
      • (i) death;
      • (ii) physical, mental, or emotional injury, illness, disability, or condition;
      • (iii) fear of physical, mental, or emotional injury, illness, disability, or condition, including any need for medical monitoring; and
      • (iv) loss of or damage to property, including business interruption loss.
    • (B) The immunity under paragraph (1) applies to any claim for loss that has a causal relationship with the administration to or use by an individual of a covered countermeasure, including a causal relationship with the design, development, clinical testing or investigation, manufacture, labeling, distribution, formulation, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administration, licensing, or use of such countermeasure.
  • (3) Subject to the other provisions of this section, immunity under paragraph (1) with respect to a covered countermeasure applies only if—
    • (A) the countermeasure was administered or used during the effective period of the declaration that was issued under subsection (b) with respect to the countermeasure;
    • (B) the countermeasure was administered or used for the category or categories of diseases, health conditions, or threats to health specified in the declaration; and
    • (C) in addition, in the case of a covered person who is a program planner or qualified person with respect to the administration or use of the countermeasure, the countermeasure was administered to or used by an individual who—
      • (i) was in a population specified by the declaration; and
      • (ii) was at the time of administration physically present in a geographic area specified by the declaration or had a connection to such area specified in the declaration.
  • (4) With respect to immunity under paragraph (1) and subject to the other provisions of this section:
    • (A) In the case of a covered person who is a manufacturer or distributor of the covered countermeasure involved, the immunity applies without regard to whether such countermeasure was administered to or used by an individual in accordance with the conditions described in paragraph (3)(C).
    • (B) In the case of a covered person who is a program planner or qualified person with respect to the administration or use of the covered countermeasure, the scope of immunity includes circumstances in which the countermeasure was administered to or used by an individual in circumstances in which the covered person reasonably could have believed that the countermeasure was administered or used in accordance with the conditions described in paragraph (3)(C).
  • (5) The provisions of this section apply to a covered countermeasure regardless of whether such countermeasure is obtained by donation, commercial sale, or any other means of distribution, except to the extent that, under paragraph (2)(E) of subsection (b), the declaration under such subsection provides that subsection (a) applies only to covered countermeasures obtained through a particular means of distribution.
  • (6) For purposes of paragraph (1), there shall be a rebuttable presumption that any administration or use, during the effective period of the emergency declaration by the Secretary under subsection (b), of a covered countermeasure shall have been for the category or categories of diseases, health conditions, or threats to health with respect to which such declaration was issued.
• (b)
  • (1) Subject to paragraph (2), if the Secretary makes a determination that a disease or other health condition or other threat to health constitutes a public health emergency, or that there is a credible risk that the disease, condition, or threat may in the future constitute such an emergency, the Secretary may make a declaration, through publication in the Federal Register, recommending, under conditions as the Secretary may specify, the manufacture, testing, development, distribution, administration, or use of one or more covered countermeasures, and stating that subsection (a) is in effect with respect to the activities so recommended.
  • (2) In issuing a declaration under paragraph (1), the Secretary shall identify, for each covered countermeasure specified in the declaration—
    • (A) the category or categories of diseases, health conditions, or threats to health for which the Secretary recommends the administration or use of the countermeasure;
    • (B) the period or periods during which, including as modified by paragraph (3), subsection (a) is in effect, which period or periods may be designated by dates, or by milestones or other description of events, including factors specified in paragraph (6);
    • (C) the population or populations of individuals for which subsection (a) is in effect with respect to the administration or use of the countermeasure (which may be a specification that such subsection applies without geographic limitation to all individuals);
    • (D) the geographic area or areas for which subsection (a) is in effect with respect to the administration or use of the countermeasure (which may be a specification that such subsection applies without geographic limitation), including, with respect to individuals in the populations identified under subparagraph (C), a specification, as determined appropriate by the Secretary, of whether the declaration applies only to individuals physically present in such areas or whether in addition the declaration applies to individuals who have a connection to such areas, which connection is described in the declaration; and
    • (E) whether subsection (a) is effective only to a particular means of distribution as provided in subsection (a)(5) for obtaining the countermeasure, and if so, the particular means to which such subsection is effective.
  • (3)
    • (A) The Secretary may, in describing periods under paragraph (2)(B), have different periods for different covered persons to address different logistical, practical or other differences in responsibilities.
    • (B) In each declaration under paragraph (1), the Secretary, after consulting, to the extent the Secretary deems appropriate, with the manufacturer of the covered countermeasure, shall also specify a date that is after the ending date specified under paragraph (2)(B) and that allows what the Secretary determines is—
      • (i) a reasonable period for the manufacturer to arrange for disposition of the covered countermeasure, including the return of such product to the manufacturer; and
      • (ii) a reasonable period for covered persons to take such other actions as may be appropriate to limit administration or use of the covered countermeasure.
    • (C) With respect to a covered countermeasure that is in the stockpile under section 247d–6b of this title , if such countermeasure was the subject of a declaration under paragraph (1) at the time that it was obtained for the stockpile, the effective period of such declaration shall include a period when the countermeasure is administered or used pursuant to a distribution or release from the stockpile.
  • (4) The Secretary may through publication in the Federal Register amend any portion of a declaration under paragraph (1). Such an amendment shall not retroactively limit the applicability of subsection (a) with respect to the administration or use of the covered countermeasure involved.
  • (5) In publishing a declaration under paragraph (1) in the Federal Register, the Secretary is not required to disclose any matter described in section 552(b) of title 5 .
  • (6) In deciding whether and under what circumstances or conditions to issue a declaration under paragraph (1) with respect to a covered countermeasure, the Secretary shall consider the desirability of encouraging the design, development, clinical testing or investigation, manufacture, labeling, distribution, formulation, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administration, licensing, and use of such countermeasure.
  • (7) No court of the United States, or of any State, shall have subject matter jurisdiction to review, whether by mandamus or otherwise, any action by the Secretary under this subsection.
  • (8) During the effective period of a declaration under subsection (b), or at any time with respect to conduct undertaken in accordance with such declaration, no State or political subdivision of a State may establish, enforce, or continue in effect with respect to a covered countermeasure any provision of law or legal requirement that—
    • (A) is different from, or is in conflict with, any requirement applicable under this section; and
    • (B) relates to the design, development, clinical testing or investigation, formulation, manufacture, distribution, sale, donation, purchase, marketing, promotion, packaging, labeling, licensing, use, any other aspect of safety or efficacy, or the prescribing, dispensing, or administration by qualified persons of the covered countermeasure, or to any matter included in a requirement applicable to the covered countermeasure under this section or any other provision of this chapter, or under the Federal Food, Drug, and Cosmetic Act [ 21 U.S.C. 301 et seq.].
  • (9) Within 30 days after making a declaration under paragraph (1), the Secretary shall submit to the appropriate committees of the Congress a report that provides an explanation of the reasons for issuing the declaration and the reasons underlying the determinations of the Secretary with respect to paragraph (2). Within 30 days after making an amendment under paragraph (4), the Secretary shall submit to such committees a report that provides the reasons underlying the determination of the Secretary to make the amendment.
• (c)
  • (1)
    • (A) Except as the meaning of such term is further restricted pursuant to paragraph (2), the term “willful misconduct” shall, for purposes of subsection (d), denote an act or omission that is taken—
      • (i) intentionally to achieve a wrongful purpose;
      • (ii) knowingly without legal or factual justification; and
      • (iii) in disregard of a known or obvious risk that is so great as to make it highly probable that the harm will outweigh the benefit.
    • (B) The criterion stated in subparagraph (A) shall be construed as establishing a standard for liability that is more stringent than a standard of negligence in any form or recklessness.
  • (2)
    • (A) The Secretary, in consultation with the Attorney General, shall promulgate regulations, which may be promulgated through interim final rules, that further restrict the scope of actions or omissions by a covered person that may qualify as “willful misconduct” for purposes of subsection (d).
    • (B) In promulgating the regulations under this paragraph, the Secretary, in consultation with the Attorney General, shall consider the need to define the scope of permissible civil actions under subsection (d) in a way that will not adversely affect the public health.
    • (C) The regulations under this paragraph may specify the temporal effect that they shall be given for purposes of subsection (d).
    • (D) Within 180 days after December 30, 2005 , the Secretary, in consultation with the Attorney General, shall commence and complete an initial rulemaking process under this paragraph.
  • (3) In an action under subsection (d), the plaintiff shall have the burden of proving by clear and convincing evidence willful misconduct by each covered person sued and that such willful misconduct caused death or serious physical injury.
  • (4) Notwithstanding any other provision of law, a program planner or qualified person shall not have engaged in “willful misconduct” as a matter of law where such program planner or qualified person acted consistent with applicable directions, guidelines, or recommendations by the Secretary regarding the administration or use of a covered countermeasure that is specified in the declaration under subsection (b), provided either the Secretary, or a State or local health authority, was provided with notice of information regarding serious physical injury or death from the administration or use of a covered countermeasure that is material to the plaintiff’s alleged loss within 7 days of the actual discovery of such information by such program planner or qualified person.
  • (5)
    • (A) If an act or omission by a manufacturer or distributor with respect to a covered countermeasure, which act or omission is alleged under subsection (e)(3)(A) to constitute willful misconduct, is subject to regulation by this chapter or by the Federal Food, Drug, and Cosmetic Act [ 21 U.S.C. 301 et seq.], such act or omission shall not constitute “willful misconduct” for purposes of subsection (d) if—
      • (i) neither the Secretary nor the Attorney General has initiated an enforcement action with respect to such act or omission; or
      • (ii) such an enforcement action has been initiated and the action has been terminated or finally resolved without a covered remedy.
    • (B) For purposes of this paragraph, the following terms have the following meanings:
      • (i) The term “enforcement action” means a criminal prosecution, an action seeking an injunction, a seizure action, a civil monetary proceeding based on willful misconduct, a mandatory recall of a product because voluntary recall was refused, a proceeding to compel repair or replacement of a product, a termination of an exemption under section 505(i) or 520(g) of the Federal Food, Drug, and Cosmetic Act [ 21 U.S.C. 355(i) , 360j(g)], a debarment proceeding, an investigator disqualification proceeding where an investigator is an employee or agent of the manufacturer, a revocation, based on willful misconduct, of an authorization under section 564 of such Act [ 21 U.S.C. 360bbb–3 ], or a suspension or withdrawal, based on willful misconduct, of an approval or clearance under chapter V of such Act [ 21 U.S.C. 351 et seq.] or of a licensure under section 262 of this title .
      • (ii) The term “covered remedy” means an outcome—
        • (I) that is a criminal conviction, an injunction, or a condemnation, a civil monetary payment, a product recall, a repair or replacement of a product, a termination of an exemption under section 505(i) or 520(g) of the Federal Food, Drug, and Cosmetic Act [ 21 U.S.C. 355(i) , 360j(g)], a debarment, an investigator disqualification, a revocation of an authorization under section 564 of such Act [ 21 U.S.C. 360bbb–3 ], or a suspension or withdrawal of an approval or clearance under chapter 5 1 1 So in original. Probably should be chapter “V”. of such Act or of a licensure under section 262 of this title ; and
        • (II) that results from a final determination by a court or from a final agency action.
      • (iii) The terms “final” and “finally”—
        • (I) with respect to a court determination, or to a final resolution of an enforcement action that is a court determination, mean a judgment from which an appeal of right cannot be taken or a voluntary or stipulated dismissal; and
        • (II) with respect to an agency action, or to a final resolution of an enforcement action that is an agency action, mean an order that is not subject to further review within the agency and that has not been reversed, vacated, enjoined, or otherwise nullified by a final court determination or a voluntary or stipulated dismissal.
    • (C)
      • (i) Nothing in this paragraph shall be construed—
        • (I) to affect the interpretation of any provision of the Federal Food, Drug, and Cosmetic Act [ 21 U.S.C. 301 et seq.], of this chapter, or of any other applicable statute or regulation; or
        • (II) to impair, delay, alter, or affect the authority, including the enforcement discretion, of the United States, of the Secretary, of the Attorney General, or of any other official with respect to any administrative or court proceeding under this chapter, under the Federal Food, Drug, and Cosmetic Act [ 21 U.S.C. 301 et seq.], under title 18, or under any other applicable statute or regulation.
      • (ii) A mandatory recall called for in the declaration is not a Food and Drug Administration enforcement action.
• (d)
  • (1) Subject to subsection (f), the sole exception to the immunity from suit and liability of covered persons set forth in subsection (a) shall be for an exclusive Federal cause of action against a covered person for death or serious physical injury proximately caused by willful misconduct, as defined pursuant to subsection (c), by such covered person. For purposes of section 2679(b)(2)(B) of title 28 , such a cause of action is not an action brought for violation of a statute of the United States under which an action against an individual is otherwise authorized.
  • (2) An action under this subsection may be brought for wrongful death or serious physical injury by any person who suffers such injury or by any representative of such a person.
• (e)
  • (1) Any action under subsection (d) shall be filed and maintained only in the United States District Court for the District of Columbia.
  • (2) The substantive law for decision in an action under subsection (d) shall be derived from the law, including choice of law principles, of the State in which the alleged willful misconduct occurred, unless such law is inconsistent with or preempted by Federal law, including provisions of this section.
  • (3) In an action under subsection (d), the complaint shall plead with particularity each element of the plaintiff’s claim, including—
    • (A) each act or omission, by each covered person sued, that is alleged to constitute willful misconduct relating to the covered countermeasure administered to or used by the person on whose behalf the complaint was filed;
    • (B) facts supporting the allegation that such alleged willful misconduct proximately caused the injury claimed; and
    • (C) facts supporting the allegation that the person on whose behalf the complaint was filed suffered death or serious physical injury.
  • (4)
    • (A) In an action under subsection (d), the plaintiff shall verify the complaint in the manner stated in subparagraph (B) and shall file with the complaint the materials described in subparagraph (C). A complaint that does not substantially comply with subparagraphs (B) and (C) shall not be accepted for filing and shall not stop the running of the statute of limitations.
    • (B)
      • (i) The complaint shall include a verification, made by affidavit of the plaintiff under oath, stating that the pleading is true to the knowledge of the deponent, except as to matters specifically identified as being alleged on information and belief, and that as to those matters the plaintiff believes it to be true.
      • (ii) Any matter that is not specifically identified as being alleged upon the information and belief of the plaintiff, shall be regarded for all purposes, including a criminal prosecution, as having been made upon the knowledge of the plaintiff.
    • (C) In an action under subsection (d), the plaintiff shall file with the complaint—
      • (i) an affidavit, by a physician who did not treat the person on whose behalf the complaint was filed, certifying, and explaining the basis for such physician’s belief, that such person suffered the serious physical injury or death alleged in the complaint and that such injury or death was proximately caused by the administration or use of a covered countermeasure; and
      • (ii) certified medical records documenting such injury or death and such proximate causal connection.
  • (5) Any action under subsection (d) shall be assigned initially to a panel of three judges. Such panel shall have jurisdiction over such action for purposes of considering motions to dismiss, motions for summary judgment, and matters related thereto. If such panel has denied such motions, or if the time for filing such motions has expired, such panel shall refer the action to the chief judge for assignment for further proceedings, including any trial. Section 1253 of title 28 and paragraph (3) of subsection (b) of section 2284 of title 28 shall not apply to actions under subsection (d).
  • (6)
    • (A) In an action under subsection (d), no discovery shall be allowed—
      • (i) before each covered person sued has had a reasonable opportunity to file a motion to dismiss;
      • (ii) in the event such a motion is filed, before the court has ruled on such motion; and
      • (iii) in the event a covered person files an interlocutory appeal from the denial of such a motion, before the court of appeals has ruled on such appeal.
    • (B) Notwithstanding any other provision of law, the court in an action under subsection (d) shall permit discovery only with respect to matters directly related to material issues contested in such action, and the court shall compel a response to a discovery request (including a request for admission, an interrogatory, a request for production of documents, or any other form of discovery request) under Rule 37, Federal Rules of Civil Procedure, only if the court finds that the requesting party needs the information sought to prove or defend as to a material issue contested in such action and that the likely benefits of a response to such request equal or exceed the burden or cost for the responding party of providing such response.
  • (7)
    • (A) In an action under subsection (d), the amount of an award of damages that would otherwise be made to a plaintiff shall be reduced by the amount of collateral source benefits to such plaintiff.
    • (B) No provider of collateral source benefits shall recover any amount against the plaintiff or receive any lien or credit against the plaintiff’s recovery or be equitably or legally subrogated to the right of the plaintiff in an action under subsection (d).
    • (C) For purposes of this paragraph, the term “collateral source benefit” means any amount paid or to be paid in the future to or on behalf of the plaintiff, or any service, product, or other benefit provided or to be provided in the future to or on behalf of the plaintiff, as a result of the injury or wrongful death, pursuant to—
      • (i) any State or Federal health, sickness, income-disability, accident, or workers’ compensation law;
      • (ii) any health, sickness, income-disability, or accident insurance that provides health benefits or income-disability coverage;
      • (iii) any contract or agreement of any group, organization, partnership, or corporation to provide, pay for, or reimburse the cost of medical, hospital, dental, or income disability benefits; or
      • (iv) any other publicly or privately funded program.
  • (8) In an action under subsection (d), any noneconomic damages may be awarded only in an amount directly proportional to the percentage of responsibility of a defendant for the harm to the plaintiff. For purposes of this paragraph, the term “noneconomic damages” means damages for losses for physical and emotional pain, suffering, inconvenience, physical impairment, mental anguish, disfigurement, loss of enjoyment of life, loss of society and companionship, loss of consortium, hedonic damages, injury to reputation, and any other nonpecuniary losses.
  • (9) Whenever a district court of the United States determines that there has been a violation of Rule 11 of the Federal Rules of Civil Procedure in an action under subsection (d), the court shall impose upon the attorney, law firm, or parties that have violated Rule 11 or are responsible for the violation, an appropriate sanction, which may include an order to pay the other party or parties for the reasonable expenses incurred as a direct result of the filing of the pleading, motion, or other paper that is the subject of the violation, including a reasonable attorney’s fee. Such sanction shall be sufficient to deter repetition of such conduct or comparable conduct by others similarly situated, and to compensate the party or parties injured by such conduct.
  • (10) The United States Court of Appeals for the District of Columbia Circuit shall have jurisdiction of an interlocutory appeal by a covered person taken within 30 days of an order denying a motion to dismiss or a motion for summary judgment based on an assertion of the immunity from suit conferred by subsection (a) or based on an assertion of the exclusion under subsection (c)(5).
• (f) Nothing in this section shall be construed to abrogate or limit any right, remedy, or authority that the United States or any agency thereof may possess under any other provision of law or to waive sovereign immunity or to abrogate or limit any defense or protection available to the United States or its agencies, instrumentalities, officers, or employees under any other law, including any provision of chapter 171 of title 28 (relating to tort claims procedure).
• (g) If any provision of this section, or the application of such provision to any person or circumstance, is held to be unconstitutional, the remainder of this section and the application of such remainder to any person or circumstance shall not be affected thereby.
• (h) Nothing in this section, or any amendment made by the Public Readiness and Emergency Preparedness Act, shall be construed to affect the National Vaccine Injury Compensation Program under subchapter XIX of this chapter.
• (i) In this section:
  • (1) The term “covered countermeasure” means—
    • (A) a qualified pandemic or epidemic product (as defined in paragraph (7));
    • (B) a security countermeasure (as defined in section 247d–6b(c)(1)(B) of this title );
    • (C) a drug (as such term is defined in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321(g)(1) ), biological product (as such term is defined by section 262(i) of this title ), or device (as such term is defined by section 201(h) of the Federal Food, Drug and Cosmetic Act ( 21 U.S.C. 321(h) ) that is authorized for emergency use in accordance with section 564, 564A, or 564B of the Federal Food, Drug, and Cosmetic Act [ 21 U.S.C. 360bbb–3 , 360bbb–3a, 360bbb–3b]; or
    • (D) a respiratory protective device that is approved by the National Institute for Occupational Safety and Health under part 84 of title 42, Code of Federal Regulations (or any successor regulations), and that the Secretary determines to be a priority for use during a public health emergency declared under section 247d of this title .
  • (2) The term “covered person”, when used with respect to the administration or use of a covered countermeasure, means—
    • (A) the United States; or
    • (B) a person or entity that is—
      • (i) a manufacturer of such countermeasure;
      • (ii) a distributor of such countermeasure;
      • (iii) a program planner of such countermeasure;
      • (iv) a qualified person who prescribed, administered, or dispensed such countermeasure; or
      • (v) an official, agent, or employee of a person or entity described in clause (i), (ii), (iii), or (iv).
  • (3) The term “distributor” means a person or entity engaged in the distribution of drugs, biologics, or devices, including but not limited to manufacturers; repackers; common carriers; contract carriers; air carriers; own-label distributors; private-label distributors; jobbers; brokers; warehouses, and wholesale drug warehouses; independent wholesale drug traders; and retail pharmacies.
  • (4) The term “manufacturer” includes—
    • (A) a contractor or subcontractor of a manufacturer;
    • (B) a supplier or licenser of any product, intellectual property, service, research tool, or component or other article used in the design, development, clinical testing, investigation, or manufacturing of a covered countermeasure; and
    • (C) any or all of the parents, subsidiaries, affiliates, successors, and assigns of a manufacturer.
  • (5) The term “person” includes an individual, partnership, corporation, association, entity, or public or private corporation, including a Federal, State, or local government agency or department.
  • (6) The term “program planner” means a State or local government, including an Indian tribe, a person employed by the State or local government, or other person who supervised or administered a program with respect to the administration, dispensing, distribution, provision, or use of a security countermeasure or a qualified pandemic or epidemic product, including a person who has established requirements, provided policy guidance, or supplied technical or scientific advice or assistance or provides a facility to administer or use a covered countermeasure in accordance with a declaration under subsection (b).
  • (7) The term “qualified pandemic or epidemic product” means a drug (as such term is defined in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321(g)(1) ), 2 2 So in original. A third closing parenthesis probably should appear. biological product (as such term is defined by section 262(i) of this title ), or device (as such term is defined by section 201(h) of the Federal Food, Drug and Cosmetic Act ( 21 U.S.C. 321(h) ) 2 that is—
    • (A)
      • (i) a product manufactured, used, designed, developed, modified, licensed, or procured—
        • (I) to diagnose, mitigate, prevent, treat, or cure a pandemic or epidemic; or
        • (II) to limit the harm such pandemic or epidemic might otherwise cause;
      • (ii) a product manufactured, used, designed, developed, modified, licensed, or procured to diagnose, mitigate, prevent, treat, or cure a serious or life-threatening disease or condition caused by a product described in clause (i); or
      • (iii) a product or technology intended to enhance the use or effect of a drug, biological product, or device described in clause (i) or (ii); and
    • (B)
      • (i) approved or cleared under chapter V of the Federal Food, Drug, and Cosmetic Act [ 21 U.S.C. 351 et seq.] or licensed under section 262 of this title ;
      • (ii) the object of research for possible use as described by subparagraph (A) and is the subject of an exemption under section 505(i) or 520(g) of the Federal Food, Drug, and Cosmetic Act [ 21 U.S.C. 355(i) , 360j(g)]; or
      • (iii) authorized for emergency use in accordance with section 564, 564A, or 564B of the Federal Food, Drug, and Cosmetic Act [ 21 U.S.C. 360bbb–3 , 360bbb–3a, 360bbb–3b].
  • (8) The term “qualified person”, when used with respect to the administration or use of a covered countermeasure, means—
    • (A) a licensed health professional or other individual who is authorized to prescribe, administer, or dispense such countermeasures under the law of the State in which the countermeasure was prescribed, administered, or dispensed; or
    • (B) a person within a category of persons so identified in a declaration by the Secretary under subsection (b).
  • (9) The term “security countermeasure” has the meaning given such term in section 247d–6b(c)(1)(B) of this title .
  • (10) The term “serious physical injury” means an injury that—
    • (A) is life threatening;
    • (B) results in permanent impairment of a body function or permanent damage to a body structure; or
    • (C) necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.

§ 247d–6e. Covered countermeasure process

• (a) Upon the issuance by the Secretary of a declaration under section 247d–6d(b) of this title , there is hereby established in the Treasury an emergency fund designated as the “Covered Countermeasure Process Fund” for purposes of providing timely, uniform, and adequate compensation to eligible individuals for covered injuries directly caused by the administration or use of a covered countermeasure pursuant to such declaration, which Fund shall consist of such amounts designated as emergency appropriations under section 402 of H. Con. Res. 95 of the 109th Congress, this emergency designation shall remain in effect through October 1, 2006 .
• (b)
  • (1) If the Secretary issues a declaration under 247d–6d(b) of this title, the Secretary shall, after amounts have by law been provided for the Fund under subsection (a), provide compensation to an eligible individual for a covered injury directly caused by the administration or use of a covered countermeasure pursuant to such declaration.
  • (2) The compensation that shall be provided pursuant to paragraph (1) shall have the same elements, and be in the same amount, as is prescribed by sections 239c, 239d, and 239e of this title in the case of certain individuals injured as a result of administration of certain countermeasures against smallpox, except that section 239e(a)(2)(B) of this title shall not apply.
  • (3) Neither reasonable and necessary medical benefits nor lifetime total benefits for lost employment income due to permanent and total disability shall be limited by section 239e of this title .
  • (4) Except as provided in this section, the procedures for determining, and for reviewing a determination of, whether an individual is an eligible individual, whether such individual has sustained a covered injury, whether compensation may be available under this section, and the amount of such compensation shall be those stated in section 239a of this title (other than in subsection (d)(2) of such section), in regulations issued pursuant to that section, and in such additional or alternate regulations as the Secretary may promulgate for purposes of this section. In making determinations under this section, other than those described in paragraph (5)(A) as to the direct causation of a covered injury, the Secretary may only make such determination based on compelling, reliable, valid, medical and scientific evidence.
  • (5)
    • (A) The Secretary shall by regulation establish a table identifying covered injuries that shall be presumed to be directly caused by the administration or use of a covered countermeasure and the time period in which the first symptom or manifestation of onset of each such adverse effect must manifest in order for such presumption to apply. The Secretary may only identify such covered injuries, for purpose of inclusion on the table, where the Secretary determines, based on compelling, reliable, valid, medical and scientific evidence that administration or use of the covered countermeasure directly caused such covered injury.
    • (B) The provisions of section 239b of this title (other than a provision of subsection (a)(2) of such section that relates to accidental vaccinia inoculation) shall apply to the table established under this section.
    • (C) No court of the United States, or of any State, shall have subject matter jurisdiction to review, whether by mandamus or otherwise, any action by the Secretary under this paragraph.
  • (6) In applying sections 239a, 239b, 239c, 239d, and 239e of this title for purposes of this section—
    • (A) the terms “vaccine” and “smallpox vaccine” shall be deemed to mean a covered countermeasure;
    • (B) the terms “smallpox vaccine injury table” and “table established under section 239b of this title ” shall be deemed to refer to the table established under paragraph (4); and
    • (C) other terms used in those sections shall have the meanings given to such terms by this section.
• (c) The Secretary shall ensure that a State, local, or Department of Health and Human Services plan to administer or use a covered countermeasure is consistent with any declaration under 247d–6d of this title and any applicable guidelines of the Centers for Disease Control and Prevention and that potential participants are educated with respect to contraindications, the voluntary nature of the program, and the availability of potential benefits and compensation under this part.
• (d)
  • (1) Subject to paragraph (5), a covered individual may not bring a civil action under section 247d–6d(d) of this title against a covered person (as such term is defined in section 247d–6d(i)(2) of this title ) unless such individual has exhausted such remedies as are available under subsection (a), except that if amounts have not by law been provided for the Fund under subsection (a), or if the Secretary fails to make a final determination on a request for benefits or compensation filed in accordance with the requirements of this section within 240 days after such request was filed, the individual may seek any remedy that may be available under section 247d–6d(d) of this title .
  • (2) The time limit for filing a civil action under section 247d–6d(d) of this title for an injury or death shall be tolled during the pendency of a claim for compensation under subsection (a).
  • (3) This section shall not be construed as superseding or otherwise affecting the application of a requirement, under chapter 171 of title 28, to exhaust administrative remedies.
  • (4) The remedy provided by subsection (a) shall be exclusive of any other civil action or proceeding for any claim or suit this section encompasses, except for a proceeding under section 247d–6d of this title .
  • (5) If under subsection (a) the Secretary determines that a covered individual qualifies for compensation, the individual has an election to accept the compensation or to bring an action under section 247d–6d(d) of this title . If such individual elects to accept the compensation, the individual may not bring such an action.
• (e) For purposes of this section, the following terms shall have the following meanings:
  • (1) The term “covered countermeasure” has the meaning given such term in section 247d–6d of this title .
  • (2) The term “covered individual”, with respect to administration or use of a covered countermeasure pursuant to a declaration, means an individual—
    • (A) who is in a population specified in such declaration, and with respect to whom the administration or use of the covered countermeasure satisfies the other specifications of such declaration; or
    • (B) who uses the covered countermeasure, or to whom the covered countermeasure is administered, in a good faith belief that the individual is in the category described by subparagraph (A).
  • (3) The term “covered injury” means serious physical injury or death.
  • (4) The term “declaration” means a declaration under section 247d–6d(b) of this title .
  • (5) The term “eligible individual” means an individual who is determined, in accordance with subsection (b), to be a covered individual who sustains a covered injury.

§ 300gg–7. Prohibition on excessive waiting periods

A group health plan and a health insurance issuer offering group health insurance coverage shall not apply any waiting period (as defined in section 300gg–3(b)(4) of this title ) that exceeds 90 days.

§ 290bb–7a. Youth prevention and recovery

• (a)
• (b) The Secretary of Health and Human Services (referred to in this section as the “Secretary”, except as otherwise provided), in consultation with the Secretary of Education and other heads of agencies, including the Assistant Secretary for Mental Health and Substance Use and the Administrator of the Health Resources and Services Administration, as appropriate, shall establish a resource center to provide technical support to recipients of grants under subsection (c).
• (c)
  • (1) The Secretary, in consultation with the Secretary of Education, shall administer a program to provide support for communities to support the prevention of, treatment of, and recovery from, substance use disorders for children, adolescents, and young adults.
  • (2) In this subsection:
    • (A) The term “eligible entity” means—
      • (i) a local educational agency that is seeking to establish or expand substance use prevention or recovery support services at one or more high schools;
      • (ii) a State educational agency;
      • (iii) an institution of higher education (or consortia of such institutions), which may include a recovery program at an institution of higher education;
      • (iv) a local board or one-stop operator;
      • (v) a nonprofit organization with appropriate expertise in providing services or programs for children, adolescents, or young adults, excluding a school;
      • (vi) a State, political subdivision of a State, Indian tribe, or tribal organization; or
      • (vii) a high school or dormitory serving high school students that receives funding from the Bureau of Indian Education.
    • (B) The term “foster care” has the meaning given such term in section 1355.20(a) of title 45, Code of Federal Regulations (or any successor regulations).
    • (C) The term “high school” has the meaning given such term in section 7801 of title 20 .
    • (D) The term “homeless youth” has the meaning given the term “homeless children or youths” in section 11434a of this title .
    • (E) The terms “Indian tribe” and “tribal organization” have the meanings given such terms in section 5304 of title 25 .
    • (F) The term “institution of higher education” has the meaning given such term in section 1001 of title 20 and includes a “postsecondary vocational institution” as defined in section 1002(c) of such title.
    • (G) The term “local educational agency” has the meaning given such term in section 7801 of title 20 .
    • (H) The terms “local board” and “one-stop operator” have the meanings given such terms in section 3102 of title 29 .
    • (I) The term “out-of-school youth” has the meaning given such term in section 3164(a)(1)(B) of title 29 .
    • (J) The term “recovery program” means a program—
      • (i) to help children, adolescents, or young adults who are recovering from substance use disorders to initiate, stabilize, and maintain healthy and productive lives in the community; and
      • (ii) that includes peer-to-peer support delivered by individuals with lived experience in recovery, and communal activities to build recovery skills and supportive social networks.
    • (K) The term “State educational agency” has the meaning given such term in section 7801 of title 20 .
  • (3) The Secretary, in consultation with the Secretary of Education, shall—
    • (A) identify or facilitate the development of evidence-based best practices for prevention of substance misuse and abuse by children, adolescents, and young adults, including for specific populations such as youth in foster care, homeless youth, out-of-school youth, and youth who are at risk of or have experienced trafficking that address—
      • (i) primary prevention;
      • (ii) appropriate recovery support services;
      • (iii) appropriate use of medication-assisted treatment for such individuals, if applicable, and ways of overcoming barriers to the use of medication-assisted treatment in such population; and
      • (iv) efficient and effective communication, which may include the use of social media, to maximize outreach efforts;
    • (B) disseminate such best practices to State educational agencies, local educational agencies, schools and dormitories funded by the Bureau of Indian Education, institutions of higher education, recovery programs at institutions of higher education, local boards, one-stop operators, family and youth homeless providers, and nonprofit organizations, as appropriate;
    • (C) conduct a rigorous evaluation of each grant funded under this subsection, particularly its impact on the indicators described in paragraph (7)(B); and
    • (D) provide technical assistance for grantees under this subsection.
  • (4) The Secretary, in consultation with the Secretary of Education, shall award 3-year grants, on a competitive basis, to eligible entities to enable such entities, in coordination with Indian tribes, if applicable, and State agencies responsible for carrying out substance use disorder prevention and treatment programs, to carry out evidence-based programs for—
    • (A) prevention of substance misuse and abuse by children, adolescents, and young adults, which may include primary prevention;
    • (B) recovery support services for children, adolescents, and young adults, which may include counseling, job training, linkages to community-based services, family support groups, peer mentoring, and recovery coaching; or
    • (C) treatment or referrals for treatment of substance use disorders, which may include the use of medication-assisted treatment, as appropriate.
  • (5) In awarding grants under this subsection, the Secretary shall give special consideration to the unique needs of tribal, urban, suburban, and rural populations.
  • (6) To be eligible for a grant under this subsection, an entity shall submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may require. Such application shall include—
    • (A) a description of—
      • (i) the impact of substance use disorders in the population that will be served by the grant program;
      • (ii) how the eligible entity has solicited input from relevant stakeholders, which may include faculty, teachers, staff, families, students, and experts in substance use disorder prevention, treatment, and recovery in developing such application;
      • (iii) the goals of the proposed project, including the intended outcomes;
      • (iv) how the eligible entity plans to use grant funds for evidence-based activities, in accordance with this subsection to prevent, provide recovery support for, or treat substance use disorders amongst such individuals, or a combination of such activities; and
      • (v) how the eligible entity will collaborate with relevant partners, which may include State educational agencies, local educational agencies, institutions of higher education, juvenile justice agencies, prevention and recovery support providers, local service providers, including substance use disorder treatment programs, providers of mental health services, youth serving organizations, family and youth homeless providers, child welfare agencies, and primary care providers, in carrying out the grant program; and
    • (B) an assurance that the eligible entity will participate in the evaluation described in paragraph (3)(C).
  • (7) Each eligible entity awarded a grant under this subsection shall submit to the Secretary a report at such time and in such manner as the Secretary may require. Such report shall include—
    • (A) a description of how the eligible entity used grant funds, in accordance with this subsection, including the number of children, adolescents, and young adults reached through programming; and
    • (B) a description, including relevant data, of how the grant program has made an impact on the intended outcomes described in paragraph (6)(A)(iii), including—
      • (i) indicators of student success, which, if the eligible entity is an educational institution, shall include student well-being and academic achievement;
      • (ii) substance use disorders amongst children, adolescents, and young adults, including the number of overdoses and deaths amongst children, adolescents, and young adults served by the grant during the grant period; and
      • (iii) other indicators, as the Secretary determines appropriate.
  • (8) The Secretary shall, not later than October 1, 2022 , submit a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce and the Committee on Education and the Workforce of the House of Representatives a report summarizing the effectiveness of the grant program under this subsection, based on the information submitted in reports required under paragraph (7).
  • (9) There is authorized to be appropriated $10,000,000 to carry out this subsection for each of fiscal years 2019 through 2023.

§ 285b–7b. Coordination of Federal asthma activities

• (a) The Director of 1 1 So in original. Probably should be followed by “the”. Institute shall, through the National Asthma Education Prevention Program Coordinating Committee—
  • (1) identify all Federal programs that carry out asthma-related activities; and
  • (2) develop, in consultation with appropriate Federal agencies and professional and voluntary health organizations, a Federal plan for responding to asthma.
• (b) A representative of the Department of Housing and Urban Development shall be included on the National Asthma Education Prevention Program Coordinating Committee for the purpose of performing the tasks described in subsection (a).

§ 285b–7c. Tuberculosis

• (a) The Director of the National Institutes of Health may expand, intensify, and coordinate research and development and related activities of the Institutes with respect to tuberculosis including activities toward the goal of eliminating such disease.
• (b) Activities under subsection (a) may include—
  • (1) enhancing basic and clinical research on tuberculosis, including drug resistant tuberculosis;
  • (2) expanding research on the relationship between such disease and the human immunodeficiency virus; and
  • (3) developing new tools for the elimination of tuberculosis, including public health interventions and methods to enhance detection and response to outbreaks of tuberculosis, including multidrug resistant tuberculosis.

§ 247d–7d. Security for countermeasure development and production

• (a) The Secretary, in consultation with the Attorney General and the Secretary of Defense, may provide technical or other assistance to provide security to persons or facilities that conduct development, production, distribution, or storage of priority countermeasures (as defined in section 247d–6(e)(4) of this title ).
• (b) The Secretary may develop guidelines to enable entities eligible to receive assistance under subsection (a) to secure their facilities against potential terrorist attack.

§ 247d–7e. Biomedical Advanced Research and Development Authority

• (a) In this section:
  • (1) The term “BARDA” means the Biomedical Advanced Research and Development Authority.
  • (2) The term “Fund” means the Biodefense Medical Countermeasure Development Fund established under subsection (d).
  • (3) The term “other transactions” means transactions, other than procurement contracts, grants, and cooperative agreements.
  • (4) The term “qualified countermeasure” has the meaning given such term in section 247d–6a of this title .
  • (5) The term “qualified pandemic or epidemic product” has the meaning given the term in section 247d–6d of this title .
  • (6)
    • (A) The term “advanced research and development” means, with respect to a product that is or may become a qualified countermeasure or a qualified pandemic or epidemic product, activities that predominantly—
      • (i) are conducted after basic research and preclinical development of the product; and
      • (ii) are related to manufacturing the product on a commercial scale and in a form that satisfies the regulatory requirements under the Federal Food, Drug, and Cosmetic Act [ 21 U.S.C. 301 et seq.] or under section 262 of this title .
    • (B) The term under subparagraph (A) includes—
      • (i) testing of the product to determine whether the product may be approved, cleared, or licensed under the Federal Food, Drug, and Cosmetic Act [ 21 U.S.C. 301 et seq.] or under section 262 of this title for a use that is or may be the basis for such product becoming a qualified countermeasure or qualified pandemic or epidemic product, or to help obtain such approval, clearance, or license;
      • (ii) design and development of tests or models, including animal models, for such testing;
      • (iii) activities to facilitate manufacture of the product on a commercial scale with consistently high quality, as well as to improve and make available new technologies to increase manufacturing surge capacity;
      • (iv) activities to improve the shelf-life of the product or technologies for administering the product; and
      • (v) such other activities as are part of the advanced stages of testing, refinement, improvement, or preparation of the product for such use and as are specified by the Secretary.
  • (7) The term “security countermeasure” has the meaning given such term in section 247d–6b of this title .
  • (8) The term “research tool” means a device, technology, biological material (including a cell line or an antibody), reagent, animal model, computer system, computer software, or analytical technique that is developed to assist in the discovery, development, or manufacture of qualified countermeasures or qualified pandemic or epidemic products.
  • (9) The term “program manager” means an individual appointed to carry out functions under this section and authorized to provide project oversight and management of strategic initiatives.
  • (10) The term “person” includes an individual, partnership, corporation, association, entity, or public or private corporation, and a Federal, State, or local government agency or department.
• (b)
  • (1) Not later than 6 months after December 19, 2006 , the Secretary shall develop and make public a strategic plan to integrate biodefense and emerging infectious disease requirements with the advanced research and development, strategic initiatives for innovation, and the procurement of qualified countermeasures and qualified pandemic or epidemic products. The Secretary shall carry out such activities as may be practicable to disseminate the information contained in such plan to persons who may have the capacity to substantially contribute to the activities described in such strategic plan. The Secretary shall update and incorporate such plan as part of the National Health Security Strategy described in section 300hh–1 of this title .
  • (2) The strategic plan under paragraph (1) shall guide—
    • (A) research and development, conducted or supported by the Department of Health and Human Services, of qualified countermeasures and qualified pandemic or epidemic products against possible biological, chemical, radiological, and nuclear agents and to emerging infectious diseases;
    • (B) innovation in technologies that may assist advanced research and development of qualified countermeasures and qualified pandemic or epidemic products (such research and development referred to in this section as “countermeasure and product advanced research and development”); and
    • (C) procurement of such qualified countermeasures and qualified pandemic or epidemic products by such Department.
• (c)
  • (1) There is established within the Department of Health and Human Services the Biomedical Advanced Research and Development Authority.
  • (2) Based upon the strategic plan described in subsection (b), the Secretary shall coordinate the acceleration of countermeasure and product advanced research and development by—
    • (A) facilitating collaboration between the Department of Health and Human Services and other Federal agencies, relevant industries, academia, and other persons, with respect to such advanced research and development;
    • (B) promoting countermeasure and product advanced research and development;
    • (C) facilitating contacts between interested persons and the offices or employees authorized by the Secretary to advise such persons regarding requirements under the Federal Food, Drug, and Cosmetic Act [ 21 U.S.C. 301 et seq.] and under section 262 of this title ; and
    • (D) promoting innovation to reduce the time and cost of countermeasure and product advanced research and development.
  • (3) The BARDA shall be headed by a Director (referred to in this section as the “Director”) who shall be appointed by the Secretary and to whom the Secretary shall delegate such functions and authorities as necessary to implement this section, including the execution of procurement contracts, grants, and cooperative agreements pursuant to this section.
  • (4)
    • (A) To carry out the purpose described in paragraph (2)(A), the Secretary shall—
      • (i) facilitate and increase the expeditious and direct communication between the Department of Health and Human Services and relevant persons with respect to countermeasure and product advanced research and development, including by—
        • (I) facilitating such communication regarding the processes for procuring such advanced research and development with respect to qualified countermeasures and qualified pandemic or epidemic products of interest; and
        • (II) soliciting information about and data from research on potential qualified countermeasures and qualified pandemic or epidemic products and related technologies;
      • (ii) at least annually—
        • (I) convene meetings with representatives from relevant industries, academia, other Federal agencies, international agencies as appropriate, and other interested persons;
        • (II) sponsor opportunities to demonstrate the operation and effectiveness of relevant biodefense countermeasure technologies; and
        • (III) convene such working groups on countermeasure and product advanced research and development as the Secretary may determine are necessary to carry out this section; and
      • (iii) carry out the activities described in section 247d–7f of this title .
    • (B) To carry out the purpose described in paragraph (2)(B), the Secretary shall—
      • (i) conduct ongoing searches for, and support calls for, potential qualified countermeasures and qualified pandemic or epidemic products;
      • (ii) direct and coordinate the countermeasure and product advanced research and development activities of the Department of Health and Human Services;
      • (iii) establish strategic initiatives to accelerate countermeasure and product advanced research and development (which may include advanced research and development for purposes of fulfilling requirements under the Federal Food, Drug, and Cosmetic Act [ 21 U.S.C. 301 et seq.] or section 262 of this title ) and innovation in such areas as the Secretary may identify as priority unmet need areas; and
      • (iv) award contracts, grants, cooperative agreements, and enter into other transactions, for countermeasure and product advanced research and development.
    • (C) To carry out the purpose described in paragraph (2)(C) the Secretary shall—
      • (i) connect interested persons with the offices or employees authorized by the Secretary to advise such persons regarding the regulatory requirements under the Federal Food, Drug, and Cosmetic Act [ 21 U.S.C. 301 et seq.] and under section 262 of this title related to the approval, clearance, or licensure of qualified countermeasures or qualified pandemic or epidemic products; and
      • (ii) with respect to persons performing countermeasure and product advanced research and development funded under this section, enable such offices or employees to provide to the extent practicable such advice in a manner that is ongoing and that is otherwise designed to facilitate expeditious development of qualified countermeasures and qualified pandemic or epidemic products that may achieve such approval, clearance, or licensure.
    • (D) To carry out the purpose described in paragraph (2)(D), the Secretary may award contracts, grants, and cooperative agreements, or enter into other transactions, such as prize payments, to promote—
      • (i) innovation in technologies that may assist countermeasure and product advanced research and development;
      • (ii) research on and development of research tools and other devices and technologies; and
      • (iii) research to promote strategic initiatives, such as rapid diagnostics, broad spectrum antimicrobials, vaccine-manufacturing technologies, dose-sparing technologies, efficacy-increasing technologies, platform technologies, technologies to administer countermeasures, and technologies to improve storage and transportation of countermeasures.
    • (E)
      • (i) To support the purposes described in paragraph (2), the Secretary, acting through the Director of BARDA, may enter into an agreement (including through the use of grants, contracts, cooperative agreements, or other transactions as described in paragraph (5)) with an independent, nonprofit entity to—
        • (I) foster and accelerate the development and innovation of medical countermeasures and technologies that may assist advanced research and the development of qualified countermeasures and qualified pandemic or epidemic products, including through the use of strategic venture capital practices and methods;
        • (II) promote the development of new and promising technologies that address urgent medical countermeasure needs, as identified by the Secretary;
        • (III) address unmet public health needs that are directly related to medical countermeasure requirements, such as novel antimicrobials for multidrug resistant organisms and multiuse platform technologies for diagnostics, prophylaxis, vaccines, and therapeutics; and
        • (IV) provide expert consultation and advice to foster viable medical countermeasure innovators, including helping qualified countermeasure innovators navigate unique industry challenges with respect to developing chemical, biological, radiological, and nuclear countermeasure products.
      • (ii)
        • (I) To be eligible to enter into an agreement under clause (i) an entity shall—
        • (II) In selecting an entity with which to enter into an agreement under clause (i), the Secretary shall place a high value on the demonstrated experience of the entity in partnering with the Federal Government to meet identified strategic needs.
      • (iii) An entity that enters into an agreement under clause (i) shall not be deemed to be a Federal agency for any purpose, including for any purpose under title 5.
      • (iv) Pursuant to an agreement entered into under this subparagraph, the Secretary, acting through the Director of BARDA, shall provide direction to the entity that enters into an agreement under clause (i). As part of this agreement the Director of BARDA shall—
        • (I) communicate the medical countermeasure needs, requirements, and problems to be addressed by the entity under the agreement;
        • (II) develop a description of work to be performed by the entity under the agreement;
        • (III) provide technical feedback and appropriate oversight over work carried out by the entity under the agreement, including subsequent development and partnerships consistent with the needs and requirements set forth in this subparagraph;
        • (IV) ensure fair consideration of products developed under the agreement in order to maintain competition to the maximum practical extent, as applicable and appropriate under applicable provisions of this section; and
        • (V) ensure, as a condition of the agreement that the entity—
      • (v) Activities carried out under this subparagraph shall supplement, and not supplant, other activities carried out under this section.
      • (vi) To prevent unnecessary duplication and target resources effectively, nothing in this subparagraph shall be construed to authorize the Secretary to establish within the Department of Health and Human Services an entity for the purposes of carrying out this subparagraph.
      • (vii) Upon request, the Secretary shall provide to Congress the information provided to the Secretary under clause (iv)(V)(dd).
      • (viii) Not later than 4 years after December 13, 2016 , the Comptroller General of the United States shall conduct an independent evaluation, and submit to the Secretary and the appropriate committees of Congress a report, concerning the activities conducted under this subparagraph. Such report shall include recommendations with respect to any agreement or activities carried out pursuant to this subparagraph.
      • (ix) This subparagraph shall have no force or effect after September 30, 2023 .
    • (F) The Secretary, acting through the Director of BARDA, may implement strategic initiatives, including by building on existing programs and by awarding contracts, grants, and cooperative agreements, or entering into other transactions, to support innovative candidate products in preclinical and clinical development that address priority, naturally occurring and man-made threats that, as determined by the Secretary, pose a significant level of risk to national security based on the characteristics of a chemical, biological, radiological or nuclear threat, or existing capabilities to respond to such a threat (including medical response and treatment capabilities and manufacturing infrastructure). Such initiatives shall accelerate and support the advanced research, development, and procurement of countermeasures and products, as applicable, to address areas including—
      • (i) chemical, biological, radiological, or nuclear threats, including emerging infectious diseases, for which insufficient approved, licensed, or authorized countermeasures exist, or for which such threat, or the result of an exposure to such threat, may become resistant to countermeasures or existing countermeasures may be rendered ineffective;
      • (ii) threats that consistently exist or continually circulate and have a significant potential to become a pandemic, such as pandemic influenza, which may include the advanced research and development, manufacturing, and appropriate stockpiling of qualified pandemic or epidemic products, and products, technologies, or processes to support the advanced research and development of such countermeasures (including multiuse platform technologies for diagnostics, vaccines, and therapeutics; virus seeds; clinical trial lots; novel virus strains; and antigen and adjuvant material); and
      • (iii) threats that may result primarily or secondarily from a chemical, biological, radiological, or nuclear agent, or emerging infectious diseases, and which may present increased treatment complications such as the occurrence of resistance to available countermeasures or potential countermeasures, including antimicrobial resistant pathogens.
  • (5)
    • (A)
      • (i) The Secretary shall have the authority to enter into other transactions (as defined in subsection (a)(3)) under this subsection.
      • (ii)
        • (I) To the maximum extent practicable, competitive procedures shall be used when entering into transactions to carry out projects under this subsection.
        • (II) The authority of this subparagraph may be exercised for a project that is expected to cost the Department of Health and Human Services in excess of $100,000,000 only upon a written determination by the Assistant Secretary for Financial Resources, that the use of such authority is essential to promoting the success of the project. The authority of the Assistant Secretary for Financial Resources under this subclause may not be delegated.
      • (iii)
        • (I) Notwithstanding clause (ii), the Secretary, shall, to the maximum extent practicable, use competitive procedures when entering into transactions to carry out projects under this subsection for purposes of a public health emergency declared by the Secretary under section 247d of this title . Any such transactions entered into during such public health emergency shall not be terminated solely due to the expiration of such public health emergency, if such public health emergency ends before the completion of the terms of such agreement.
        • (II) After the expiration of the public health emergency declared by the Secretary under section 247d of this title , the Secretary shall provide a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives regarding the use of any funds pursuant to the authority under subclause (I), including any outcomes, benefits, and risks associated with the use of such funds, and a description of the reasons for the use of such authority for the project or projects.
      • (iv) The Secretary shall establish guidelines regarding the use of the authority under clause (i). Such guidelines shall include auditing requirements.
    • (B)
      • (i) In awarding contracts, grants, and cooperative agreements, and in entering into other transactions under subparagraph (B) or (D) of paragraph (4), the Secretary shall have the expedited procurement authorities, the authority to expedite peer review, and the authority for personal services contracts, supplied by subsections (b), (c), and (d) of section 247d–6a of this title .
      • (ii) Provisions in such section 247d–6a of this title that apply to such authorities and that require institution of internal controls, limit review, provide for Federal Tort Claims Act coverage of personal services contractors, and commit decisions to the discretion of the Secretary shall apply to the authorities as exercised pursuant to this paragraph.
      • (iii) For purposes of applying section 247d–6a(b)(1)(D) of this title to this paragraph, the phrase “BioShield Program under the Project BioShield Act of 2004” shall be deemed to mean the countermeasure and product advanced research and development program under this section.
      • (iv) The Secretary shall require that, as a condition of being awarded a contract, grant, cooperative agreement, or other transaction under subparagraph (B) or (D) of paragraph (4), a person make available to the Secretary on an ongoing basis, and submit upon request to the Secretary, all data related to or resulting from countermeasure and product advanced research and development carried out pursuant to this section.
    • (C) The Secretary may waive the requirements of section 3324(a) of title 31 or section 6101 of title 41 upon the determination by the Secretary that such waiver is necessary to obtain countermeasures or products under this section.
    • (D) In awarding contracts, grants, and cooperative agreements, and in entering into other transactions, under this section, the Secretary may use milestone-based awards and payments.
    • (E) The Secretary may under this section award contracts, grants, and cooperative agreements to, and may enter into other transactions with, highly qualified foreign national persons outside the United States, alone or in collaboration with American participants, when such transactions may inure to the benefit of the American people.
    • (F) The Secretary may assess the feasibility and appropriateness of establishing, through contract, grant, cooperative agreement, or other transaction, an arrangement with an existing research center in order to achieve the goals of this section. If such an agreement is not feasible and appropriate, the Secretary may establish one or more federally-funded research and development centers, or university-affiliated research centers, in accordance with section 3304(a)(3) of title 41 .
    • (G) In awarding contracts, grants, and cooperative agreements under this section, the Secretary shall provide a clear statement of defined Government purpose related to activities included in subsection (a)(6)(B) for a qualified countermeasure or qualified pandemic or epidemic product.
  • (6) In carrying out the functions under this section, the Secretary may give priority to the advanced research and development of qualified countermeasures and qualified pandemic or epidemic products that are likely to be safe and effective with respect to children, pregnant women, older adults, and other at-risk individuals with relevant characteristics that warrant consideration during the process of researching and developing such countermeasures and products.
  • (7)
    • (A)
      • (i) In addition to any other personnel authorities, the Secretary may—
        • (I) without regard to those provisions of title 5 governing appointments in the competitive service, appoint highly qualified individuals to scientific or professional positions in BARDA, such as program managers, to carry out this section; and
        • (II) compensate them in the same manner and subject to the same terms and conditions in which individuals appointed under section 9903 of such title are compensated, without regard to the provisions of chapter 51 and subchapter III of chapter 53 of such title relating to classification and General Schedule pay rates.
      • (ii) The authority provided for in this subparagraph shall be exercised subject to the same limitations described in section 247d–6a(e)(2) of this title .
      • (iii) The term limitations described in section 9903(c) of title 5 shall apply to appointments under this subparagraph, except that the references to the “Secretary” and to the “Department of Defense’s national security missions” shall be deemed to be to the Secretary of Health and Human Services and to the mission of the Department of Health and Human Services under this section.
    • (B) In carrying out this section, the Secretary may appoint special consultants pursuant to section 209(f) of this title .
    • (C)
      • (i) The Secretary may hire up to 100 highly qualified individuals, or up to 50 percent of the total number of employees, whichever is less, under the authorities provided for in subparagraphs (A) and (B).
      • (ii) The Secretary shall report to Congress on a biennial basis on the implementation of this subparagraph.
• (d)
  • (1) There is established the Biodefense Medical Countermeasure Development Fund, which shall be available to carry out this section in addition to such amounts as are otherwise available for this purpose.
  • (2) To carry out the purposes of this section, there is authorized to be appropriated to the Fund $611,700,000 for each of fiscal years 2019 through 2023, such amounts to remain available until expended.
• (e)
  • (1)
    • (A)
      • (i) Information described in clause (ii) shall be deemed to be information described in section 552(b)(3) of title 5 .
      • (ii) The information described in this clause is information relevant to programs of the Department of Health and Human Services that could compromise national security and reveal significant and not otherwise publicly known vulnerabilities of existing medical or public health defenses against chemical, biological, radiological, or nuclear threats, and is comprised of—
        • (I) specific technical data or scientific information that is created or obtained during the countermeasure and product advanced research and development carried out under subsection (c);
        • (II) information pertaining to the location security, personnel, and research materials and methods of high-containment laboratories conducting research with select agents, toxins, or other agents with a material threat determination under section 247d–6b(c)(2) of this title ; or
        • (III) security and vulnerability assessments.
    • (B) Information subject to nondisclosure under subparagraph (A) shall be reviewed by the Secretary every 5 years, or more frequently as determined necessary by the Secretary, to determine the relevance or necessity of continued nondisclosure.
    • (C) One year after June 24, 2019 , and annually thereafter, the Secretary shall report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives on the number of instances in which the Secretary has used the authority under this subsection to withhold information from disclosure, as well as the nature of any request under section 552 of title 5 that was denied using such authority.
    • (D) This paragraph shall cease to have force or effect on the date that is 17 years after December 19, 2006 .
  • (2) Notwithstanding section 14 of the Federal Advisory Committee Act, a working group of BARDA under this section and the National Biodefense Science Board under section 247d–7g of this title shall each terminate on the date that is 5 years after the date on which each such group or Board, as applicable, was established. Such 5-year period may be extended by the Secretary for one or more additional 5-year periods if the Secretary determines that any such extension is appropriate.
• (f)
  • (1) Not later than 180 days after March 13, 2013 , the Comptroller General of the United States shall conduct an independent evaluation of the activities carried out to facilitate flexible manufacturing capacity pursuant to this section.
  • (2) Not later than 1 year after March 13, 2013 , the Comptroller General of the United States shall submit to the appropriate committees of Congress a report concerning the results of the evaluation conducted under paragraph (1). Such report shall review and assess—
    • (A) the extent to which flexible manufacturing capacity under this section is dedicated to chemical, biological, radiological, and nuclear threats;
    • (B) the activities supported by flexible manufacturing initiatives; and
    • (C) the ability of flexible manufacturing activities carried out under this section to—
      • (i) secure and leverage leading technical expertise with respect to countermeasure advanced research, development, and manufacturing processes; and
      • (ii) meet the surge manufacturing capacity needs presented by novel and emerging threats, including chemical, biological, radiological, and nuclear agents.

§ 247d–7f. Collaboration and coordination

• (a)
  • (1)
    • (A) The Secretary, in coordination with the Attorney General and the Secretary of Homeland Security, may conduct meetings and consultations with persons engaged in the development of a security countermeasure (as defined in section 247d–6b of this title ), a qualified countermeasure (as defined in section 247d–6a of this title ), or a qualified pandemic or epidemic product (as defined in section 247d–6d of this title ) for the purpose of the development, manufacture, distribution, purchase, or storage of a countermeasure or product. The Secretary may convene such meeting or consultation at the request of the Secretary of Homeland Security, the Attorney General, the Chairman of the Federal Trade Commission (referred to in this section as the “Chairman”), or any interested person, or upon initiation by the Secretary. The Secretary shall give prior notice of any such meeting or consultation, and the topics to be discussed, to the Attorney General, the Chairman, and the Secretary of Homeland Security.
    • (B) A meeting or consultation conducted under subparagraph (A) shall—
      • (i) be chaired or, in the case of a consultation, facilitated by the Secretary;
      • (ii) be open to persons involved in the development, manufacture, distribution, purchase, or storage of a countermeasure or product, as determined by the Secretary;
      • (iii) be open to the Attorney General, the Secretary of Homeland Security, and the Chairman;
      • (iv) be limited to discussions involving covered activities; and
      • (v) be conducted in such manner as to ensure that no national security, confidential commercial, or proprietary information is disclosed outside the meeting or consultation.
    • (C) The Secretary may not require participants to disclose confidential commercial or proprietary information.
    • (D) The Secretary shall maintain a complete verbatim transcript of each meeting or consultation conducted under this subsection. Such transcript (or a portion thereof) shall not be disclosed under section 552 of title 5 to the extent that the Secretary, in consultation with the Attorney General and the Secretary of Homeland Security, determines that disclosure of such transcript (or portion thereof) would pose a threat to national security. The transcript (or portion thereof) with respect to which the Secretary has made such a determination shall be deemed to be information described in subsection (b)(3) of such section 552.
    • (E)
      • (i) Subject to clause (ii), it shall not be a violation of the antitrust laws for any person to participate in a meeting or consultation conducted in accordance with this paragraph.
      • (ii) Clause (i) shall not apply to any agreement or conduct that results from a meeting or consultation and that is not covered by an exemption granted under paragraph (4).
  • (2) The Secretary shall submit each written agreement regarding covered activities that is made pursuant to meetings or consultations conducted under paragraph (1) to the Attorney General and the Chairman for consideration. In addition to the proposed agreement itself, any submission shall include—
    • (A) an explanation of the intended purpose of the agreement;
    • (B) a specific statement of the substance of the agreement;
    • (C) a description of the methods that will be utilized to achieve the objectives of the agreement;
    • (D) an explanation of the necessity for a cooperative effort among the particular participating persons to achieve the objectives of the agreement; and
    • (E) any other relevant information determined necessary by the Attorney General, in consultation with the Chairman and the Secretary.
  • (3) It shall not be a violation of the antitrust laws for a person to engage in conduct in accordance with a written agreement to the extent that such agreement has been granted an exemption under paragraph (4), during the period for which the exemption is in effect.
  • (4)
    • (A) The Attorney General, in consultation with the Chairman, shall grant, deny, grant in part and deny in part, or propose modifications to an exemption request regarding a written agreement submitted under paragraph (2), in a written statement to the Secretary, within 15 business days of the receipt of such request. An exemption granted under this paragraph shall take effect immediately.
    • (B) The Attorney General may extend the 15-day period referred to in subparagraph (A) for an additional period of not to exceed 10 business days.
    • (C) An exemption shall be granted regarding a written agreement submitted in accordance with paragraph (2) only to the extent that the Attorney General, in consultation with the Chairman and the Secretary, finds that the conduct that will be exempted will not have any substantial anticompetitive effect that is not reasonably necessary for ensuring the availability of the countermeasure or product involved.
  • (5) An exemption granted under paragraph (4) shall be limited to covered activities, and such exemption shall be renewed (with modifications, as appropriate, consistent with the finding described in paragraph (4)(C)), on the date that is 3 years after the date on which the exemption is granted unless the Attorney General in consultation with the Chairman determines that the exemption should not be renewed (with modifications, as appropriate) considering the factors described in paragraph (4).
  • (6) Consideration by the Attorney General for granting or renewing an exemption submitted under this section shall be considered an antitrust investigation for purposes of the Antitrust Civil Process Act ( 15 U.S.C. 1311 et seq.).
  • (7) The use of any information acquired under an agreement for which an exemption has been granted under paragraph (4), for any purpose other than specified in the exemption, shall be subject to the antitrust laws and any other applicable laws.
  • (8) Not later than one year after the date of enactment of this Act 1 1 See References in Text note below. and biannually thereafter, the Attorney General and the Chairman shall report to Congress on the use of the exemption from the antitrust laws provided by this subsection.
• (b) The applicability of this section shall expire at the end of the 17-year period that begins on the date of enactment of this Act. 1
• (c) In this section:
  • (1) The term “antitrust laws”—
    • (A) has the meaning given such term in subsection (a) of section 12 of title 15 , except that such term includes section 45 of title 15 to the extent such section 45 of title 15 applies to unfair methods of competition; and
    • (B) includes any State law similar to the laws referred to in subparagraph (A).
  • (2) The term “countermeasure or product” refers to a security countermeasure, qualified countermeasure, or qualified pandemic or epidemic product (as those terms are defined in subsection (a)(1)).
  • (3)
    • (A) Except as provided in subparagraph (B), the term “covered activities” includes any activity relating to the development, manufacture, distribution, purchase, or storage of a countermeasure or product.
    • (B) The term “covered activities” shall not include, with respect to a meeting or consultation conducted under subsection (a)(1) or an agreement for which an exemption has been granted under subsection (a)(4), the following activities involving 2 or more persons:
      • (i) Exchanging information among competitors relating to costs, profitability, or distribution of any product, process, or service if such information is not reasonably necessary to carry out covered activities—
        • (I) with respect to a countermeasure or product regarding which such meeting or consultation is being conducted; or
        • (II) that are described in the agreement as exempted.
      • (ii) Entering into any agreement or engaging in any other conduct—
        • (I) to restrict or require the sale, licensing, or sharing of inventions, developments, products, processes, or services not developed through, produced by, or distributed or sold through such covered activities; or
        • (II) to restrict or require participation, by any person participating in such covered activities, in other research and development activities, except as reasonably necessary to prevent the misappropriation of proprietary information contributed by any person participating in such covered activities or of the results of such covered activities.
      • (iii) Entering into any agreement or engaging in any other conduct allocating a market with a competitor that is not expressly exempted from the antitrust laws under subsection (a)(4).
      • (iv) Exchanging information among competitors relating to production (other than production by such covered activities) of a product, process, or service if such information is not reasonably necessary to carry out such covered activities.
      • (v) Entering into any agreement or engaging in any other conduct restricting, requiring, or otherwise involving the production of a product, process, or service that is not expressly exempted from the antitrust laws under subsection (a)(4).
      • (vi) Except as otherwise provided in this subsection, entering into any agreement or engaging in any other conduct to restrict or require participation by any person participating in such covered activities, in any unilateral or joint activity that is not reasonably necessary to carry out such covered activities.
      • (vii) Entering into any agreement or engaging in any other conduct restricting or setting the price at which a countermeasure or product is offered for sale, whether by bid or otherwise.

§ 247d–7g. National Biodefense Science Board and working groups

• (a)
  • (1) The Secretary shall establish the National Biodefense Science Board (referred to in this section as the “Board”) to provide expert advice and guidance to the Secretary on scientific, technical and other matters of special interest to the Department of Health and Human Services regarding current and future chemical, biological, nuclear, and radiological agents, whether naturally occurring, accidental, or deliberate.
  • (2) The membership of the Board shall be comprised of individuals who represent the Nation’s preeminent scientific, public health, and medical experts, as follows—
    • (A) such Federal officials as the Secretary may determine are necessary to support the functions of the Board;
    • (B) four individuals representing the pharmaceutical, biotechnology, and device industries;
    • (C) four individuals representing academia; and
    • (D) five other members as determined appropriate by the Secretary, of whom—
      • (i) one such member shall be a practicing healthcare professional;
      • (ii) one such member shall be an individual from an organization representing healthcare consumers;
      • (iii) one such member shall be an individual with pediatric subject matter expertise; and
      • (iv) one such member shall be a State, tribal, territorial, or local public health official.
  • (3) A member of the Board described in subparagraph (B), (C), or (D) of paragraph (2) shall serve for a term of 3 years, except that the Secretary may adjust the terms of the initial Board appointees in order to provide for a staggered term of appointment for all members.
  • (4) A member may be appointed to serve not more than 3 terms on the Board and may serve not more than 2 consecutive terms.
  • (5) The Board shall—
    • (A) advise the Secretary on current and future trends, challenges, and opportunities presented by advances in biological and life sciences, biotechnology, and genetic engineering with respect to threats posed by naturally occurring infectious diseases and chemical, biological, radiological, and nuclear agents;
    • (B) at the request of the Secretary, review and consider any information and findings received from the working groups established under subsection (b);
    • (C) at the request of the Secretary, provide recommendations and findings for expanded, intensified, and coordinated biodefense research and development activities; and
    • (D) provide any recommendation, finding, or report provided to the Secretary under this paragraph to the appropriate committees of Congress.
  • (6)
    • (A) Not later than one year after December 19, 2006 , the Secretary shall hold the first meeting of the Board.
    • (B) The Board shall meet at the call of the Secretary, but in no case less than twice annually.
  • (7) Any vacancy in the Board shall not affect its powers, but shall be filled in the same manner as the original appointment.
  • (8) The Secretary shall appoint a chairperson from among the members of the Board.
  • (9)
    • (A) The Board may hold such hearings, sit and act at such times and places, take such testimony, and receive such evidence as the Board considers advisable to carry out this subsection.
    • (B) The Board may use the United States mails in the same manner and under the same conditions as other departments and agencies of the Federal Government.
  • (10)
    • (A) A member of the Board that is an employee of the Federal Government may not receive additional pay, allowances, or benefits by reason of the member’s service on the Board.
    • (B) A member of the Board that is not an employee of the Federal Government may be compensated at a rate not to exceed the daily equivalent of the annual rate of basic pay prescribed for level IV of the Executive Schedule under section 5315 of title 5 for each day (including travel time) during which the member is engaged in the actual performance of duties as a member of the Board.
    • (C) Each member of the Board shall receive travel expenses, including per diem in lieu of subsistence, in accordance with applicable provisions under subchapter I of chapter 57 of title 5.
    • (D) Any Federal Government employee may be detailed to the Board with the approval for the contributing agency without reimbursement, and such detail shall be without interruption or loss of civil service status or privilege.
• (b) The Secretary may establish a working group of experts, or may use an existing working group or advisory committee, to—
  • (1) identify innovative research with the potential to be developed as a qualified countermeasure or a qualified pandemic or epidemic product;
  • (2) identify accepted animal models for particular diseases and conditions associated with any biological, chemical, radiological, or nuclear agent, any toxin, or any potential pandemic infectious disease, and identify strategies to accelerate animal model and research tool development and validation; and
  • (3) obtain advice regarding supporting and facilitating advanced research and development related to qualified countermeasures and qualified pandemic or epidemic products that are likely to be safe and effective with respect to children, pregnant women, and other vulnerable populations, and other issues regarding activities under this section that affect such populations.
• (c) Any term that is defined in section 247d–7e of this title and that is used in this section shall have the same meaning in this section as such term is given in section 247d–7e of this title .
• (d) There are authorized to be appropriated $1,000,000 to carry out this section for fiscal year 2007 and each fiscal year thereafter.

§ 300gg–8. Coverage for individuals participating in approved clinical trials

• (a)
  • (1) If a group health plan or a health insurance issuer offering group or individual health insurance coverage provides coverage to a qualified individual, then such plan or issuer—
    • (A) may not deny the individual participation in the clinical trial referred to in subsection (b)(2);
    • (B) subject to subsection (c), may not deny (or limit or impose additional conditions on) the coverage of routine patient costs for items and services furnished in connection with participation in the trial; and
    • (C) may not discriminate against the individual on the basis of the individual’s participation in such trial.
  • (2)
    • (A) For purposes of paragraph (1)(B), subject to subparagraph (B), routine patient costs include all items and services consistent with the coverage provided in the plan (or coverage) that is typically covered for a qualified individual who is not enrolled in a clinical trial.
    • (B) For purposes of paragraph (1)(B), routine patient costs does not include—
      • (i) the investigational item, device, or service, itself;
      • (ii) items and services that are provided solely to satisfy data collection and analysis needs and that are not used in the direct clinical management of the patient; or
      • (iii) a service that is clearly inconsistent with widely accepted and established standards of care for a particular diagnosis.
  • (3) If one or more participating providers is participating in a clinical trial, nothing in paragraph (1) shall be construed as preventing a plan or issuer from requiring that a qualified individual participate in the trial through such a participating provider if the provider will accept the individual as a participant in the trial.
  • (4) Notwithstanding paragraph (3), paragraph (1) shall apply to a qualified individual participating in an approved clinical trial that is conducted outside the State in which the qualified individual resides.
• (b) For purposes of subsection (a), the term “qualified individual” means an individual who is a participant or beneficiary in a health plan or with coverage described in subsection (a)(1) and who meets the following conditions:
  • (1) The individual is eligible to participate in an approved clinical trial according to the trial protocol with respect to treatment of cancer or other life-threatening disease or condition.
  • (2) Either—
    • (A) the referring health care professional is a participating health care provider and has concluded that the individual’s participation in such trial would be appropriate based upon the individual meeting the conditions described in paragraph (1); or
    • (B) the participant or beneficiary provides medical and scientific information establishing that the individual’s participation in such trial would be appropriate based upon the individual meeting the conditions described in paragraph (1).
• (c) This section shall not be construed to require a group health plan, or a health insurance issuer offering group or individual health insurance coverage, to provide benefits for routine patient care services provided outside of the plan’s (or coverage’s) health care provider network unless out-of-network benefits are otherwise provided under the plan (or coverage).
• (d)
  • (1) In this section, the term “approved clinical trial” means a phase I, phase II, phase III, or phase IV clinical trial that is conducted in relation to the prevention, detection, or treatment of cancer or other life-threatening disease or condition and is described in any of the following subparagraphs:
    • (A) The study or investigation is approved or funded (which may include funding through in-kind contributions) by one or more of the following:
      • (i) The National Institutes of Health.
      • (ii) The Centers for Disease Control and Prevention.
      • (iii) The Agency for Health Care Research and Quality.
      • (iv) The Centers for Medicare & Medicaid Services.
      • (v) cooperative 1 1 So in original. Probably should be preceded by “A”. group or center of any of the entities described in clauses (i) through (iv) or the Department of Defense or the Department of Veterans Affairs.
      • (vi) A qualified non-governmental research entity identified in the guidelines issued by the National Institutes of Health for center support grants.
      • (vii) Any of the following if the conditions described in paragraph (2) are met:
        • (I) The Department of Veterans Affairs.
        • (II) The Department of Defense.
        • (III) The Department of Energy.
    • (B) The study or investigation is conducted under an investigational new drug application reviewed by the Food and Drug Administration.
    • (C) The study or investigation is a drug trial that is exempt from having such an investigational new drug application.
  • (2) The conditions described in this paragraph, for a study or investigation conducted by a Department, are that the study or investigation has been reviewed and approved through a system of peer review that the Secretary determines—
    • (A) to be comparable to the system of peer review of studies and investigations used by the National Institutes of Health, and
    • (B) assures unbiased review of the highest scientific standards by qualified individuals who have no interest in the outcome of the review.
• (e) In this section, the term “life-threatening condition” means any disease or condition from which the likelihood of death is probable unless the course of the disease or condition is interrupted.
• (f) Nothing in this section shall be construed to limit a plan’s or issuer’s coverage with respect to clinical trials.
• (g) Notwithstanding any provision of chapter 89 of title 5, this section shall apply to health plans offered under the program under such chapter.
• (h) Notwithstanding any other provision of this chapter, nothing in this section shall preempt State laws that require a clinical trials policy for State regulated health insurance plans that is in addition to the policy required under this section..

§ 247b–9a. Better diabetes care

• (a) This section may be cited as the “Catalyst to Better Diabetes Care Act of 2009”.
• (b)
  • (1) The Secretary, in collaboration with the Director of the Centers for Disease Control and Prevention (referred to in this section as the “Director”), shall prepare on a biennial basis a national diabetes report card (referred to in this section as a “Report Card”) and, to the extent possible, for each State. 1 1 So in original.
  • (2)
    • (A) Each Report Card shall include aggregate health outcomes related to individuals diagnosed with diabetes and prediabetes including—
      • (i) preventative care practices and quality of care;
      • (ii) risk factors; and
      • (iii) outcomes.
    • (B) Each Report Card that is prepared after the initial Report Card shall include trend analysis for the Nation and, to the extent possible, for each State, for the purpose of—
      • (i) tracking progress in meeting established national goals and objectives for improving diabetes care, costs, and prevalence (including Healthy People 2010); and
      • (ii) informing policy and program development.
  • (3) The Secretary, in collaboration with the Director, shall make each Report Card publicly available, including by posting the Report Card on the Internet.
• (c)
  • (1) The Secretary, acting through the Director of the Centers for Disease Control and Prevention and in collaboration with appropriate agencies and States, shall—
    • (A) promote the education and training of physicians on the importance of birth and death certificate data and how to properly complete these documents, including the collection of such data for diabetes and other chronic diseases;
    • (B) encourage State adoption of the latest standard revisions of birth and death certificates; and
    • (C) work with States to re-engineer their vital statistics systems in order to provide cost-effective, timely, and accurate vital systems data.
  • (2) In carrying out this subsection, the Secretary may promote improvements to the collection of diabetes mortality data, including the addition of a question for the individual certifying the cause of death regarding whether the deceased had diabetes.
• (d)
  • (1) The Secretary shall, in collaboration with the Institute of Medicine and appropriate associations and councils, conduct a study of the impact of diabetes on the practice of medicine in the United States and the appropriateness of the level of diabetes medical education that should be required prior to licensure, board certification, and board recertification.
  • (2) Not later than 2 years after March 23, 2010 , the Secretary shall submit a report on the study under paragraph (1) to the Committees on Ways and Means and Energy and Commerce of the House of Representatives and the Committees on Finance and Health, Education, Labor, and Pensions of the Senate.
• (e) There are authorized to be appropriated to carry out this section such sums as may be necessary.

§ 300hh–10. Coordination of preparedness for and response to all-hazards public health emergencies

• (a) There is established within the Department of Health and Human Services the position of the Assistant Secretary for Preparedness and Response. The President, with the advice and consent of the Senate, shall appoint an individual to serve in such position. Such Assistant Secretary shall report to the Secretary.
• (b) Subject to the authority of the Secretary, the Assistant Secretary for Preparedness and Response shall utilize experience related to public health emergency preparedness and response, biodefense, medical countermeasures, and other relevant topics to carry out the following functions:
  • (1) Serve as the principal advisor to the Secretary on all matters related to Federal public health and medical preparedness and response for public health emergencies.
  • (2) Register, credential, organize, train, equip, and have the authority to deploy Federal public health and medical personnel under the authority of the Secretary, including the National Disaster Medical System, and coordinate such personnel with the Medical Reserve Corps and the Emergency System for Advance Registration of Volunteer Health Professionals.
  • (3) Oversee advanced research, development, and procurement of qualified countermeasures (as defined in section 247d–6a of this title ), security countermeasures (as defined in section 247d–6b of this title ), and qualified pandemic or epidemic products (as defined in section 247d–6d of this title ).
  • (4)
    • (A) Coordinate with relevant Federal officials to ensure integration of Federal preparedness and response activities for public health emergencies.
    • (B) Coordinate with State, local, and tribal public health officials, the Emergency Management Assistance Compact, health care systems, and emergency medical service systems to ensure effective integration of Federal public health and medical assets during a public health emergency.
    • (C) Promote improved emergency medical services medical direction, system integration, research, and uniformity of data collection, treatment protocols, and policies with regard to public health emergencies.
    • (D) Provide integrated policy coordination and strategic direction, before, during, and following public health emergencies, with respect to all matters related to Federal public health and medical preparedness and execution and deployment of the Federal response for public health emergencies and incidents covered by the National Response Plan described in section 314(a)(6) of title 6 , or any successor plan; and such Federal responses covered by the National Cybersecurity Incident Response Plan developed under section 660(c) 1 1 See References in Text note below. of title 6, including public health emergencies or incidents related to cybersecurity threats that present a threat to national health security.
    • (E) Identify and minimize gaps, duplication, and other inefficiencies in medical and public health preparedness and response activities and the actions necessary to overcome these obstacles.
    • (F) Align and coordinate medical and public health grants and cooperative agreements as applicable to preparedness and response activities authorized under this chapter, to the extent possible, including program requirements, timelines, and measurable goals, and in consultation with the Secretary of Homeland Security, to—
      • (i) optimize and streamline medical and public health preparedness and response capabilities and the ability of local communities to respond to public health emergencies; and
      • (ii) gather and disseminate best practices among grant and cooperative agreement recipients, as appropriate.
    • (G) Carry out drills and operational exercises, in consultation with the Department of Homeland Security, the Department of Defense, the Department of Veterans Affairs, and other applicable Federal departments and agencies, as necessary and appropriate, to identify, inform, and address gaps in and policies related to all-hazards medical and public health preparedness and response, including exercises based on—
      • (i) identified threats for which countermeasures are available and for which no countermeasures are available; and
      • (ii) unknown threats for which no countermeasures are available.
    • (H) On a periodic basis consult with, as applicable and appropriate, the Assistant to the President for National Security Affairs, to provide an update on, and discuss, medical and public health preparedness and response activities pursuant to this chapter and the Federal Food, Drug, and Cosmetic Act [ 21 U.S.C. 301 et seq.], including progress on the development, approval, clearance, and licensure of medical countermeasures.
    • (I) Coordinate with the Director of the Centers for Disease Control and Prevention, the Director of National Intelligence, the Secretary of Homeland Security, the Assistant to the President for National Security Affairs, the Secretary of Defense, and other relevant Federal officials, such as the Secretary of Agriculture, to maintain a current assessment of national security threats and inform preparedness and response capabilities based on the range of the threats that have the potential to result in a public health emergency.
  • (5) In coordination with the Secretary of Veterans Affairs, the Secretary of Homeland Security, the General Services Administration, and other public and private entities, provide logistical support for medical and public health aspects of Federal responses to public health emergencies. Such logistical support shall include working with other relevant Federal, State, local, Tribal, and territorial public health officials and private sector entities to identify the critical infrastructure assets, systems, and networks needed for the proper functioning of the health care and public health sectors that need to be maintained through any emergency or disaster, including entities capable of assisting with, responding to, and mitigating the effect of a public health emergency, including a public health emergency determined by the Secretary pursuant to section 247d(a) of this title or an emergency or major disaster declared by the President under the Robert T. Stafford Disaster Relief and Emergency Assistance Act or the National Emergencies Act, including by establishing methods to exchange critical information and deliver products consumed or used to preserve, protect, or sustain life, health, or safety, and sharing of specialized expertise.
  • (6) Provide leadership in international programs, initiatives, and policies that deal with public health and medical emergency preparedness and response.
  • (7) Develop, and update not later than March 15 of each year, a coordinated 5-year budget plan based on the medical countermeasure priorities described in subsection (d), including with respect to chemical, biological, radiological, and nuclear agent or agents that may present a threat to the Nation, including such agents that are novel or emerging infectious diseases, and the corresponding efforts to develop qualified countermeasures (as defined in section 247d–6a of this title ), security countermeasures (as defined in section 247d–6b of this title ), and qualified pandemic or epidemic products (as defined in section 247d–6d of this title ) for each such threat. Each such plan shall—
    • (A) include consideration of the entire medical countermeasures enterprise, including—
      • (i) basic research and advanced research and development;
      • (ii) approval, clearance, licensure, and authorized uses of products;
      • (iii) procurement, stockpiling, maintenance, and potential replenishment (including manufacturing capabilities) of all products in the Strategic National Stockpile;
      • (iv) the availability of technologies that may assist in the advanced research and development of countermeasures and opportunities to use such technologies to accelerate and navigate challenges unique to countermeasure research and development; and
      • (v) potential deployment, distribution, and utilization of medical countermeasures; development of clinical guidance and emergency use instructions for the use of medical countermeasures; and, as applicable, potential postdeployment activities related to medical countermeasures;
    • (B) inform prioritization of resources and include measurable outputs and outcomes to allow for the tracking of the progress made toward identified priorities;
    • (C) identify medical countermeasure life-cycle costs to inform planning, budgeting, and anticipated needs within the continuum of the medical countermeasure enterprise consistent with section 247d–6b of this title ;
    • (D) identify the full range of anticipated medical countermeasure needs related to research and development, procurement, and stockpiling, including the potential need for indications, dosing, and administration technologies, and other countermeasure needs as applicable and appropriate;
    • (E) be made available, not later than March 15 of each year, to the Committee on Appropriations and the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Appropriations and the Committee on Energy and Commerce of the House of Representatives; and
    • (F) not later than March 15 of each year, be made publicly available in a manner that does not compromise national security.
• (c) The Assistant Secretary for Preparedness and Response shall—
  • (1) have lead responsibility within the Department of Health and Human Services for emergency preparedness and response policy coordination and strategic direction;
  • (2) have authority over and responsibility for—
    • (A) the National Disaster Medical System pursuant to section 300hh–11 of this title ;
    • (B) the Hospital Preparedness Cooperative Agreement Program pursuant to section 247d–3b of this title ;
    • (C) the Biomedical Advanced Research and Development Authority pursuant to section 247d–7e of this title ;
    • (D) the Medical Reserve Corps pursuant to section 300hh–15 of this title ;
    • (E) the Emergency System for Advance Registration of Volunteer Health Professionals pursuant to section 247d–7b of this title ; and
    • (F) administering grants and related authorities related to trauma care under parts A through C of subchapter X, such authority to be transferred by the Secretary from the Administrator of the Health Resources and Services Administration to such Assistant Secretary;
  • (3) exercise the responsibilities and authorities of the Secretary with respect to the coordination of—
    • (A) the Public Health Emergency Preparedness Cooperative Agreement Program pursuant to section 247d–3a of this title ;
    • (B) the Strategic National Stockpile pursuant to section 247d–6b of this title ; and
    • (C) the Cities Readiness Initiative; and
  • (4) assume other duties as determined appropriate by the Secretary.
• (d)
  • (1) Not later than March 15, 2020 , and biennially thereafter, the Assistant Secretary for Preparedness and Response shall develop and submit to the appropriate committees of Congress a coordinated strategy and accompanying implementation plan for medical countermeasures to address chemical, biological, radiological, and nuclear threats. In developing such a plan, the Assistant Secretary for Preparedness and Response shall consult with the Public Health Emergency Medical Countermeasures Enterprise established under section 300hh–10a of this title . Such strategy and plan shall be known as the “Public Health Emergency Medical Countermeasures Enterprise Strategy and Implementation Plan”.
  • (2) The plan under paragraph (1) shall—
    • (A) describe the chemical, biological, radiological, and nuclear agent or agents that may present a threat to the Nation and the corresponding efforts to develop qualified countermeasures (as defined in section 247d–6a of this title ), security countermeasures (as defined in section 247d–6b of this title ), or qualified pandemic or epidemic products (as defined in section 247d–6d of this title ) for each threat;
    • (B) evaluate the progress of all activities with respect to such countermeasures or products, including research, advanced research, development, procurement, stockpiling, deployment, distribution, and utilization;
    • (C) identify and prioritize near-, mid-, and long-term needs with respect to such countermeasures or products, and ancillary medical supplies to assist with the utilization of such countermeasures or products, to address a chemical, biological, radiological, and nuclear threat or threats;
    • (D) identify, with respect to each category of threat, a summary of all awards and contracts, including advanced research and development and procurement, that includes—
      • (i) the time elapsed from the issuance of the initial solicitation or request for a proposal to the adjudication (such as the award, denial of award, or solicitation termination); and
      • (ii) an identification of projected timelines, anticipated funding allocations, benchmarks, and milestones for each medical countermeasure priority under subparagraph (C), including projected needs with regard to replenishment of the Strategic National Stockpile;
    • (E) be informed by the recommendations of the National Biodefense Science Board pursuant to section 247d–7g of this title ;
    • (F) evaluate progress made in meeting timelines, allocations, benchmarks, and milestones identified under subparagraph (D)(ii);
    • (G) report on the amount of funds available for procurement in the special reserve fund as defined in section 247d–6b(h) of this title and the impact this funding will have on meeting the requirements under section 247d–6b of this title ;
    • (H) incorporate input from Federal, State, local, and tribal stakeholders;
    • (I) identify the progress made in meeting the medical countermeasure priorities for at-risk individuals (as defined in 2 2 So in original. The word “section” probably should appear. 300hh–1(b)(4)(B) of this title), as applicable under subparagraph (C), including with regard to the projected needs for related stockpiling and replenishment of the Strategic National Stockpile, including by addressing the needs of pediatric populations with respect to such countermeasures and products in the Strategic National Stockpile, including—
      • (i) a list of such countermeasures and products necessary to address the needs of pediatric populations;
      • (ii) a description of measures taken to coordinate with the Office of Pediatric Therapeutics of the Food and Drug Administration to maximize the labeling, dosages, and formulations of such countermeasures and products for pediatric populations;
      • (iii) a description of existing gaps in the Strategic National Stockpile and the development of such countermeasures and products to address the needs of pediatric populations; and
      • (iv) an evaluation of the progress made in addressing priorities identified pursuant to subparagraph (C);
    • (J) identify the use of authority and activities undertaken pursuant to sections 247d–6a(b)(1), 247d–6a(b)(2), 247d–6a(b)(3), 247d–6a(c), 247d–6a(d), 247d–6a(e), 247d–6b(c)(7)(C)(iii), 247d–6b(c)(7)(C)(iv), and 247d–6b(c)(7)(C)(v) of this title, and subsections (a)(1), (b)(1), and (e) of section 564 of the Federal Food, Drug, and Cosmetic Act [ 21 U.S.C. 360bbb–3 ], by summarizing—
      • (i) the particular actions that were taken under the authorities specified, including, as applicable, the identification of the threat agent, emergency, or the biomedical countermeasure with respect to which the authority was used;
      • (ii) the reasons underlying the decision to use such authorities, including, as applicable, the options that were considered and rejected with respect to the use of such authorities;
      • (iii) the number of, nature of, and other information concerning the persons and entities that received a grant, cooperative agreement, or contract pursuant to the use of such authorities, and the persons and entities that were considered and rejected for such a grant, cooperative agreement, or contract, except that the report need not disclose the identity of any such person or entity;
      • (iv) whether, with respect to each procurement that is approved by the President under section 247d–6b(c)(6) of this title , a contract was entered into within one year after such approval by the President; and
      • (v) with respect to section 247d–6a(d) of this title , for the 2-year period for which the report is submitted, the number of persons who were paid amounts totaling $100,000 or greater and the number of persons who were paid amounts totaling at least $50,000 but less than $100,000; and
    • (K) be made publicly available.
  • (3)
    • (A) Not later than 1 year after the date of the submission to the Congress of the first Public Health Emergency Medical Countermeasures Enterprise Strategy and Implementation Plan, the Comptroller General of the United States shall conduct an independent evaluation, and submit to the appropriate committees of Congress a report, concerning such Strategy and Implementation Plan.
    • (B) The report described in subparagraph (A) shall review and assess—
      • (i) the near-term, mid-term, and long-term medical countermeasure needs and identified priorities of the Federal Government pursuant to paragraph (2)(C);
      • (ii) the activities of the Department of Health and Human Services with respect to advanced research and development pursuant to section 247d–7e of this title ; and
      • (iii) the progress made toward meeting the timelines, allocations, benchmarks, and milestones identified in the Public Health Emergency Medical Countermeasures Enterprise Strategy and Implementation Plan under this subsection.
• (e) In carrying out subsections (b)(7) and (d), the Secretary shall ensure that information and items that could compromise national security, contain confidential commercial information, or contain proprietary information are not disclosed.
• (f)
  • (1) In carrying out subsection (b)(3), the Assistant Secretary for Preparedness and Response shall implement strategic initiatives or activities to address threats, including pandemic influenza and which may include a chemical, biological, radiological, or nuclear agent (including any such agent with a significant potential to become a pandemic), that pose a significant level of risk to public health and national security based on the characteristics of such threat. Such initiatives shall include activities to—
    • (A) accelerate and support the advanced research, development, manufacturing capacity, procurement, and stockpiling of countermeasures, including initiatives under section 247d–7e(c)(4)(F) of this title ;
    • (B) support the development and manufacturing of virus seeds, clinical trial lots, and stockpiles of novel virus strains; and
    • (C) maintain or improve preparedness activities, including for pandemic influenza.
  • (2)
    • (A) To carry out this subsection, there is authorized to be appropriated $250,000,000 for each of fiscal years 2019 through 2023.
    • (B) Amounts appropriated under this paragraph shall be used to supplement and not supplant funds provided under sections 247d–7e(d) and 247d–6b(g) of this title.
    • (C) The Assistant Secretary for Preparedness and Response, in accordance with subsection (b)(7), shall document amounts expended for purposes of carrying out this subsection, including amounts appropriated under the heading “Public Health and Social Services Emergency Fund” under the heading “Office of the Secretary” under title II of division H of the Consolidated Appropriations Act, 2018 ( Public Law 115–141 ) and allocated to carrying out section 247d–7e(c)(4)(F) of this title .

§ 300hh–10a. Public Health Emergency Medical Countermeasures Enterprise

• (a) The Secretary shall establish the Public Health Emergency Medical Countermeasures Enterprise (referred to in this section as the “PHEMCE”). The Assistant Secretary for Preparedness and Response shall serve as chair of the PHEMCE.
• (b) The PHEMCE shall include each of the following members, or the designee of such members:
  • (1) The Assistant Secretary for Preparedness and Response.
  • (2) The Director of the Centers for Disease Control and Prevention.
  • (3) The Director of the National Institutes of Health.
  • (4) The Commissioner of Food and Drugs.
  • (5) The Secretary of Defense.
  • (6) The Secretary of Homeland Security.
  • (7) The Secretary of Agriculture.
  • (8) The Secretary of Veterans Affairs.
  • (9) The Director of National Intelligence.
  • (10) Representatives of any other Federal agency, which may include the Director of the Biomedical Advanced Research and Development Authority, the Director of the Strategic National Stockpile, the Director of the National Institute of Allergy and Infectious Diseases, and the Director of the Office of Public Health Preparedness and Response, as the Secretary determines appropriate.
• (c)
  • (1) The functions of the PHEMCE shall include the following:
    • (A) Utilize a process to make recommendations to the Secretary regarding research, advanced research, development, procurement, stockpiling, deployment, distribution, and utilization with respect to countermeasures, as defined in section 247d–6b(c) of this title , including prioritization based on the health security needs of the United States. Such recommendations shall be informed by, when available and practicable, the National Health Security Strategy pursuant to section 300hh–1 of this title , the Strategic National Stockpile needs pursuant to section 247d–6b of this title , and assessments of current national security threats, including chemical, biological, radiological, and nuclear threats, including emerging infectious diseases. In the event that members of the PHEMCE do not agree upon a recommendation, the Secretary shall provide a determination regarding such recommendation.
    • (B) Identify national health security needs, including gaps in public health preparedness and response related to countermeasures and challenges to addressing such needs (including any regulatory challenges), and support alignment of countermeasure procurement with recommendations to address such needs under subparagraph (A).
    • (C) Assist the Secretary in developing strategies related to logistics, deployment, distribution, dispensing, and use of countermeasures that may be applicable to the activities of the strategic national stockpile under section 247d–6b(a) of this title .
    • (D) Provide consultation for the development of the strategy and implementation plan under section 300hh–10(d) of this title .
  • (2) In carrying out subparagraphs (B) and (C) of paragraph (1), the PHEMCE shall solicit and consider input from State, local, Tribal, and territorial public health departments or officials, as appropriate.

§ 300hh–10b. National Advisory Committee on Children and Disasters

• (a) The Secretary, in consultation with the Secretary of Homeland Security, shall establish an advisory committee to be known as the “National Advisory Committee on Children and Disasters” (referred to in this section as the “Advisory Committee”).
• (b) The Advisory Committee shall—
  • (1) provide advice and consultation with respect to the activities carried out pursuant to section 300hh–16 of this title , as applicable and appropriate;
  • (2) evaluate and provide input with respect to the medical, mental and behavioral, and public health needs of children as they relate to preparation for, response to, and recovery from all-hazards emergencies; and
  • (3) provide advice and consultation with respect to State emergency preparedness and response activities and children, including related drills and exercises pursuant to the preparedness goals under section 300hh–1(b) of this title .
• (c) The Advisory Committee may provide advice and recommendations to the Secretary with respect to children and the medical and public health grants and cooperative agreements as applicable to preparedness and response activities authorized under this subchapter and subchapter II.
• (d)
  • (1) The Secretary, in consultation with such other Secretaries as may be appropriate, shall appoint not to exceed 25 members to the Advisory Committee. In appointing such members, the Secretary shall ensure that the total membership of the Advisory Committee is an odd number.
  • (2) The Secretary, in consultation with such other heads of Federal agencies as may be appropriate, shall appoint to the Advisory Committee under paragraph (1) at least 13 individuals, including—
    • (A) at least 2 non-Federal professionals with expertise in pediatric medical disaster planning, preparedness, response, or recovery;
    • (B) at least 2 representatives from State, local, Tribal, or territorial agencies with expertise in pediatric disaster planning, preparedness, response, or recovery;
    • (C) at least 4 members representing health care professionals, which may include members with expertise in pediatric emergency medicine; pediatric trauma, critical care, or surgery; the treatment of pediatric patients affected by chemical, biological, radiological, or nuclear agents, including emerging infectious diseases; pediatric mental or behavioral health related to children affected by a public health emergency; or pediatric primary care; and
    • (D) other members as the Secretary determines appropriate, of whom—
      • (i) at least one such member shall represent a children’s hospital;
      • (ii) at least one such member shall be an individual with expertise in schools or child care settings;
      • (iii) at least one such member shall be an individual with expertise in children and youth with special health care needs; and
      • (iv) at least one such member shall be an individual with expertise in the needs of parents or family caregivers, including the parents or caregivers of children with disabilities.
  • (3) The Advisory Committee under paragraph (1) shall include the following Federal members or their designees (who may be nonvoting members, as determined by the Secretary):
    • (A) The Assistant Secretary for Preparedness and Response.
    • (B) The Director of the Biomedical Advanced Research and Development Authority.
    • (C) The Director of the Centers for Disease Control and Prevention.
    • (D) The Commissioner of Food and Drugs.
    • (E) The Director of the National Institutes of Health.
    • (F) The Assistant Secretary of the Administration for Children and Families.
    • (G) The Administrator of the Health Resources and Services Administration.
    • (H) The Administrator of the Federal Emergency Management Agency.
    • (I) The Administrator of the Administration for Community Living.
    • (J) The Secretary of Education.
    • (K) Representatives from such Federal agencies (such as the Substance Abuse and Mental Health Services Administration and the Department of Homeland Security) as the Secretary determines appropriate to fulfill the duties of the Advisory Committee under subsections (b) and (c).
  • (4) Each member of the Advisory Committee appointed under paragraph (2) shall serve for a term of 3 years, except that the Secretary may adjust the terms of the Advisory Committee appointees serving on June 24, 2019 , or appointees who are initially appointed after such date, in order to provide for a staggered term of appointment for all members.
  • (5) A member appointed under paragraph (2) may serve not more than 3 terms on the Advisory Committee, and not more than two of such terms may be served consecutively.
• (e) The Advisory Committee shall meet not less than biannually. At least one meeting per year shall be an in-person meeting.
• (f) The Secretary shall coordinate duties and activities authorized under this section in accordance with section 300hh–10e of this title .
• (g) The Advisory Committee shall terminate on September 30, 2023 .

§ 300hh–10c. National Advisory Committee on Seniors and Disasters

• (a) The Secretary, in consultation with the Secretary of Homeland Security and the Secretary of Veterans Affairs, shall establish an advisory committee to be known as the National Advisory Committee on Seniors and Disasters (referred to in this section as the “Advisory Committee”).
• (b) The Advisory Committee shall—
  • (1) provide advice and consultation with respect to the activities carried out pursuant to section 300hh–16 of this title , as applicable and appropriate;
  • (2) evaluate and provide input with respect to the medical and public health needs of seniors related to preparation for, response to, and recovery from all-hazards emergencies; and
  • (3) provide advice and consultation with respect to State emergency preparedness and response activities relating to seniors, including related drills and exercises pursuant to the preparedness goals under section 300hh–1(b) of this title .
• (c) The Advisory Committee may provide advice and recommendations to the Secretary with respect to seniors and the medical and public health grants and cooperative agreements as applicable to preparedness and response activities under this subchapter and subchapter III.
• (d)
  • (1) The Secretary, in consultation with such other heads of agencies as appropriate, shall appoint not more than 17 members to the Advisory Committee. In appointing such members, the Secretary shall ensure that the total membership of the Advisory Committee is an odd number.
  • (2) The Advisory Committee shall include Federal members or their designees (who may be nonvoting members, as determined by the Secretary) and non-Federal members, as follows:
    • (A) The Assistant Secretary for Preparedness and Response.
    • (B) The Director of the Biomedical Advanced Research and Development Authority.
    • (C) The Director of the Centers for Disease Control and Prevention.
    • (D) The Commissioner of Food and Drugs.
    • (E) The Director of the National Institutes of Health.
    • (F) The Administrator of the Centers for Medicare & Medicaid Services.
    • (G) The Administrator of the Administration for Community Living.
    • (H) The Administrator of the Federal Emergency Management Agency.
    • (I) The Under Secretary for Health of the Department of Veterans Affairs.
    • (J) At least 2 non-Federal health care professionals with expertise in geriatric medical disaster planning, preparedness, response, or recovery.
    • (K) At least 2 representatives of State, local, Tribal, or territorial agencies with expertise in geriatric disaster planning, preparedness, response, or recovery.
    • (L) Representatives of such other Federal agencies (such as the Department of Energy and the Department of Homeland Security) as the Secretary determines necessary to fulfill the duties of the Advisory Committee.
• (e) The Advisory Committee shall meet not less frequently than biannually. At least one meeting per year shall be an in-person meeting.
• (f) The Secretary shall coordinate duties and activities authorized under this section in accordance with section 300hh–10e of this title .
• (g)
  • (1) The Advisory Committee shall terminate on September 30, 2023 .
  • (2) Not later than October 1, 2022 , the Secretary shall submit to Congress a recommendation on whether the Advisory Committee should be extended.

§ 300hh–10d. National Advisory Committee on Individuals With Disabilities and Disasters

• (a) The Secretary, in consultation with the Secretary of Homeland Security, shall establish a national advisory committee to be known as the National Advisory Committee on Individuals with Disabilities and Disasters (referred to in this section as the “Advisory Committee”).
• (b) The Advisory Committee shall—
  • (1) provide advice and consultation with respect to activities carried out pursuant to section 300hh–16 of this title , as applicable and appropriate;
  • (2) evaluate and provide input with respect to the medical, public health, and accessibility needs of individuals with disabilities related to preparation for, response to, and recovery from all-hazards emergencies; and
  • (3) provide advice and consultation with respect to State emergency preparedness and response activities, including related drills and exercises pursuant to the preparedness goals under section 300hh–1(b) of this title .
• (c)
  • (1) The Secretary, in consultation with such other heads of agencies and departments as appropriate, shall appoint not more than 17 members to the Advisory Committee. In appointing such members, the Secretary shall ensure that the total membership of the Advisory Committee is an odd number.
  • (2) The Advisory Committee shall include Federal members or their designees (who may be nonvoting members, as determined by the Secretary) and non-Federal members, as follows:
    • (A) The Assistant Secretary for Preparedness and Response.
    • (B) The Administrator of the Administration for Community Living.
    • (C) The Director of the Biomedical Advanced Research and Development Authority.
    • (D) The Director of the Centers for Disease Control and Prevention.
    • (E) The Commissioner of Food and Drugs.
    • (F) The Director of the National Institutes of Health.
    • (G) The Administrator of the Federal Emergency Management Agency.
    • (H) The Chair of the National Council on Disability.
    • (I) The Chair of the United States Access Board.
    • (J) The Under Secretary for Health of the Department of Veterans Affairs.
    • (K) At least 2 non-Federal health care professionals with expertise in disability accessibility before, during, and after disasters, medical and mass care disaster planning, preparedness, response, or recovery.
    • (L) At least 2 representatives from State, local, Tribal, or territorial agencies with expertise in disaster planning, preparedness, response, or recovery for individuals with disabilities.
    • (M) At least 2 individuals with a disability with expertise in disaster planning, preparedness, response, or recovery for individuals with disabilities.
• (d) The Advisory Committee shall meet not less frequently than biannually. At least one meeting per year shall be an in-person meeting.
• (e) For purposes of this section, the term “disability” has the meaning given such term in section 12102 of this title .
• (f) The Secretary shall coordinate duties and activities authorized under this section in accordance with section 300hh–10e of this title .
• (g)
  • (1) The Advisory Committee shall terminate on September 30, 2023 .
  • (2) Not later than October 1, 2022 , the Secretary shall submit to Congress a recommendation on whether the Advisory Committee should be extended.

§ 300hh–10e. Advisory Committee Coordination

• (a) The Secretary shall coordinate duties and activities authorized under sections 300hh–10b, 300hh–10c, and 300hh–10d of this title, and make efforts to reduce unnecessary or duplicative reporting, or unnecessary duplicative meetings and recommendations under such sections, as practicable. Members of the advisory committees authorized under such sections, or their designees, shall annually meet to coordinate any recommendations, as appropriate, that may be similar, duplicative, or overlapping with respect to addressing the needs of children, seniors, and individuals with disabilities during public health emergencies. If such coordination occurs through an in-person meeting, it shall not be considered the required in-person meetings under any of sections 300hh–10b(e), 300hh–10c(e), or 300hh–10d(d) of this title.
• (b) The Secretary, acting through the employee designated pursuant to section 300hh–16 of this title , shall align preparedness and response programs or activities to address similar, dual, or overlapping needs of children, seniors, and individuals with disabilities, and any challenges in preparing for and responding to such needs.
• (c) The Secretary shall annually notify the congressional committees of jurisdiction regarding the steps taken to coordinate, as appropriate, the recommendations under this section, and provide a summary description of such coordination.

§ 300jj–11. Office of the National Coordinator for Health Information Technology

• (a) There is established within the Department of Health and Human Services an Office of the National Coordinator for Health Information Technology (referred to in this section as the “Office”). The Office shall be headed by a National Coordinator who shall be appointed by the Secretary and shall report directly to the Secretary.
• (b) The National Coordinator shall perform the duties under subsection (c) in a manner consistent with the development of a nationwide health information technology infrastructure that allows for the electronic use and exchange of information and that—
  • (1) ensures that each patient’s health information is secure and protected, in accordance with applicable law;
  • (2) improves health care quality, reduces medical errors, reduces health disparities, and advances the delivery of patient-centered medical care;
  • (3) reduces health care costs resulting from inefficiency, medical errors, inappropriate care, duplicative care, and incomplete information;
  • (4) provides appropriate information to help guide medical decisions at the time and place of care;
  • (5) ensures the inclusion of meaningful public input in such development of such infrastructure;
  • (6) improves the coordination of care and information among hospitals, laboratories, physician offices, and other entities through an effective infrastructure for the secure and authorized exchange of health care information;
  • (7) improves public health activities and facilitates the early identification and rapid response to public health threats and emergencies, including bioterror events and infectious disease outbreaks;
  • (8) facilitates health and clinical research and health care quality;
  • (9) promotes early detection, prevention, and management of chronic diseases;
  • (10) promotes a more effective marketplace, greater competition, greater systems analysis, increased consumer choice, and improved outcomes in health care services; and
  • (11) improves efforts to reduce health disparities.
• (c)
  • (1) The National Coordinator shall—
    • (A) review and determine whether to endorse each standard, implementation specification, and certification criterion for the electronic exchange and use of health information that is recommended by the HIT Advisory Committee under section 300jj–12 of this title for purposes of adoption under section 300jj–14 of this title ;
    • (B) make such determinations under subparagraph (A), and report to the Secretary such determinations, not later than 45 days after the date the recommendation is received by the Coordinator; and
    • (C) review Federal health information technology investments to ensure that Federal health information technology programs are meeting the objectives of the strategic plan published under paragraph (3).
  • (2)
    • (A) The National Coordinator shall coordinate health information technology policy and programs of the Department with those of other relevant executive branch agencies with a goal of avoiding duplication of efforts and of helping to ensure that each agency undertakes health information technology activities primarily within the areas of its greatest expertise and technical capability and in a manner towards a coordinated national goal.
    • (B) The National Coordinator shall be a leading member in the establishment and operations of the HIT Advisory Committee and shall serve as a liaison between that Committee and the Federal Government.
  • (3)
    • (A) The National Coordinator shall, in consultation with other appropriate Federal agencies (including the National Institute of Standards and Technology), update the Federal Health IT Strategic Plan (developed as of June 3, 2008 ) to include specific objectives, milestones, and metrics with respect to the following:
      • (i) The electronic exchange and use of health information and the enterprise integration of such information.
      • (ii) The utilization of an electronic health record for each person in the United States by 2014.
      • (iii) The incorporation of privacy and security protections for the electronic exchange of an individual’s individually identifiable health information.
      • (iv) Ensuring security methods to ensure appropriate authorization and electronic authentication of health information and specifying technologies or methodologies for rendering health information unusable, unreadable, or indecipherable.
      • (v) Specifying a framework for coordination and flow of recommendations and policies under this part among the Secretary, the National Coordinator, the HIT Advisory Committee, and other health information exchanges and other relevant entities.
      • (vi) Methods to foster the public understanding of health information technology.
      • (vii) Strategies to enhance the use of health information technology in improving the quality of health care, reducing medical errors, reducing health disparities, improving public health, increasing prevention and coordination with community resources, and improving the continuity of care among health care settings.
      • (viii) Specific plans for ensuring that populations with unique needs, such as children, are appropriately addressed in the technology design, as appropriate, which may include technology that automates enrollment and retention for eligible individuals.
    • (B) The strategic plan shall be updated through collaboration of public and private entities.
    • (C) The strategic plan update shall include measurable outcome goals.
    • (D) The National Coordinator shall republish the strategic plan, including all updates.
  • (4) The National Coordinator shall maintain and frequently update an Internet website on which there is posted information on the work, schedules, reports, recommendations, and other information to ensure transparency in promotion of a nationwide health information technology infrastructure.
  • (5)
    • (A) The National Coordinator, in consultation with the Director of the National Institute of Standards and Technology, shall keep or recognize a program or programs for the voluntary certification of health information technology as being in compliance with applicable certification criteria adopted under this part. Such program shall include, as appropriate, testing of the technology in accordance with section 17911(b) of this title .
    • (B) In this subchapter, the term “certification criteria” means, with respect to standards and implementation specifications for health information technology, criteria to establish that the technology meets such standards and implementation specifications.
    • (C)
      • (i) The National Coordinator shall encourage, keep, or recognize, through existing authorities, the voluntary certification of health information technology under the program developed under subparagraph (A) for use in medical specialties and sites of service for which no such technology is available or where more technological advancement or integration is needed.
      • (ii) The Secretary shall accept public comment on specific medical specialties and sites of service, in addition to those described in clause (i), for the purpose of selecting additional specialties and sites of service as necessary.
      • (iii) Not later than 18 months after December 13, 2016 , the Secretary, in consultation with relevant stakeholders, shall make recommendations for the voluntary certification of health information technology for use by pediatric health providers to support the health care of children. Not later than 2 years after December 13, 2016 , the Secretary shall adopt certification criteria under section 300jj–14 of this title to support the voluntary certification of health information technology for use by pediatric health providers to support the health care of children.
    • (D) Not later than 1 year after December 13, 2016 , the Secretary, through notice and comment rulemaking, shall require, as a condition of certification and maintenance of certification for programs maintained or recognized under this paragraph, consistent with other conditions and requirements under this subchapter, that the health information technology developer or entity—
      • (i) does not take any action that constitutes information blocking as defined in section 300jj–52(a) of this title ;
      • (ii) provides assurances satisfactory to the Secretary that such developer or entity, unless for legitimate purposes specified by the Secretary, will not take any action described in clause (i) or any other action that may inhibit the appropriate exchange, access, and use of electronic health information;
      • (iii) does not prohibit or restrict communication regarding—
        • (I) the usability of the health information technology;
        • (II) the interoperability of the health information technology;
        • (III) the security of the health information technology;
        • (IV) relevant information regarding users’ experiences when using the health information technology;
        • (V) the business practices of developers of health information technology related to exchanging electronic health information; and
        • (VI) the manner in which a user of the health information technology has used such technology;
      • (iv) has published application programming interfaces and allows health information from such technology to be accessed, exchanged, and used without special effort through the use of application programming interfaces or successor technology or standards, as provided for under applicable law, including providing access to all data elements of a patient’s electronic health record to the extent permissible under applicable privacy laws;
      • (v) has successfully tested the real world use of the technology for interoperability (as defined in section 300jj of this title ) in the type of setting in which such technology would be marketed;
      • (vi) provides to the Secretary an attestation that the developer or entity—
        • (I) has not engaged in any of the conduct described in clause (i);
        • (II) has provided assurances satisfactory to the Secretary in accordance with clause (ii);
        • (III) does not prohibit or restrict communication as described in clause (iii);
        • (IV) has published information in accordance with clause (iv);
        • (V) ensures that its technology allows for health information to be exchanged, accessed, and used, in the manner described in clause (iv); and
        • (VI) has undertaken real world testing as described in clause (v); and
      • (vii) submits reporting criteria in accordance with section 300jj–19a(b) of this title .
    • (E) The Secretary may encourage compliance with the conditions of certification described in subparagraph (D) and take action to discourage noncompliance, as appropriate.
  • (6)
    • (A) Not later than 12 months after February 17, 2009 , the National Coordinator shall submit to the appropriate committees of jurisdiction of the House of Representatives and the Senate a report on any additional funding or authority the Coordinator or the HIT Policy Committee or HIT Standards Committee requires to evaluate and develop standards, implementation specifications, and certification criteria, or to achieve full participation of stakeholders in the adoption of a nationwide health information technology infrastructure that allows for the electronic use and exchange of health information.
    • (B) The National Coordinator shall prepare a report that identifies lessons learned from major public and private health care systems in their implementation of health information technology, including information on whether the technologies and practices developed by such systems may be applicable to and usable in whole or in part by other health care providers.
    • (C) The National Coordinator shall assess and publish the impact of health information technology in communities with health disparities and in areas with a high proportion of individuals who are uninsured, underinsured, and medically underserved individuals (including urban and rural areas) and identify practices to increase the adoption of such technology by health care providers in such communities, and the use of health information technology to reduce and better manage chronic diseases.
    • (D) The National Coordinator shall evaluate and publish evidence on the benefits and costs of the electronic use and exchange of health information and assess to whom these benefits and costs accrue.
    • (E) The National Coordinator shall estimate and publish resources required annually to reach the goal of utilization of an electronic health record for each person in the United States by 2014, including—
      • (i) the required level of Federal funding;
      • (ii) expectations for regional, State, and private investment;
      • (iii) the expected contributions by volunteers to activities for the utilization of such records; and
      • (iv) the resources needed to establish a health information technology workforce sufficient to support this effort (including education programs in medical informatics and health information management).
  • (7) The National Coordinator may provide financial assistance to consumer advocacy groups and not-for-profit entities that work in the public interest for purposes of defraying the cost to such groups and entities to participate under, whether in whole or in part, the National Technology Transfer Act of 1995 ( 15 U.S.C. 272 note). 1 1 See References in Text note below.
  • (8) The National Coordinator shall establish a governance mechanism for the nationwide health information network.
  • (9)
    • (A) The National Coordinator shall, in collaboration with the National Institute of Standards and Technology and other relevant agencies within the Department of Health and Human Services, for the purpose of ensuring full network-to-network exchange of health information, convene public-private and public-public partnerships to build consensus and develop or support a trusted exchange framework, including a common agreement among health information networks nationally. Such convention may occur at a frequency determined appropriate by the Secretary.
    • (B)
      • (i) Not later than 6 months after December 13, 2016 , the National Coordinator shall convene appropriate public and private stakeholders to develop or support a trusted exchange framework for trust policies and practices and for a common agreement for exchange between health information networks. The common agreement may include—
        • (I) a common method for authenticating trusted health information network participants;
        • (II) a common set of rules for trusted exchange;
        • (III) organizational and operational policies to enable the exchange of health information among networks, including minimum conditions for such exchange to occur; and
        • (IV) a process for filing and adjudicating noncompliance with the terms of the common agreement.
      • (ii) The National Coordinator, in collaboration with the National Institute of Standards and Technology, shall provide technical assistance on how to implement the trusted exchange framework and common agreement under this paragraph.
      • (iii) The National Coordinator, in consultation with the National Institute of Standards and Technology, shall provide for the pilot testing of the trusted exchange framework and common agreement established or supported under this subsection (as authorized under section 17911 of this title ). The National Coordinator, in consultation with the National Institute of Standards and Technology, may delegate pilot testing activities under this clause to independent entities with appropriate expertise.
    • (C) Not later than 1 year after convening stakeholders under subparagraph (A), the National Coordinator shall publish on its public Internet website, and in the Federal register, 2 2 So in original. Probably should be “Register,”. the trusted exchange framework and common agreement developed or supported under subparagraph (B). Such trusted exchange framework and common agreement shall be published in a manner that protects proprietary and security information, including trade secrets and any other protected intellectual property.
    • (D)
      • (i) Not later than 2 years after convening stakeholders under subparagraph (A), and annually thereafter, the National Coordinator shall publish on its public Internet website a list of the health information networks that have adopted the common agreement and are capable of trusted exchange pursuant to the common agreement developed or supported under paragraph 3 3 So in original. Probably should be “subparagraph”. (B).
      • (ii) The Secretary shall, through notice and comment rulemaking, establish a process for health information networks that voluntarily elect to adopt the trusted exchange framework and common agreement to attest to such adoption of the framework and agreement.
    • (E) As appropriate, Federal agencies contracting or entering into agreements with health information exchange networks may require that as each such network upgrades health information technology or trust and operational practices, such network may adopt, where available, the trusted exchange framework and common agreement published under subparagraph (C).
    • (F)
      • (i) Nothing in this paragraph shall be construed to require a health information network to adopt the trusted exchange framework or common agreement.
      • (ii) Nothing in this paragraph shall be construed to require a health information network to adopt the trusted exchange framework or common agreement for the exchange of electronic health information between participants of the same network.
      • (iii) The trusted exchange framework and common agreement published under subparagraph (C) shall take into account existing trusted exchange frameworks and agreements used by health information networks to avoid the disruption of existing exchanges between participants of health information networks.
      • (iv) Notwithstanding clauses (i), (ii), and (iii), Federal agencies may require the adoption of the trusted exchange framework and common agreement published under subparagraph (C) for health information exchanges contracting with or entering into agreements pursuant to subparagraph (E).
      • (v) In carrying out this paragraph, the Secretary shall ensure the consideration of activities carried out by public and private organizations related to exchange between health information exchanges to avoid duplication of efforts.
• (d)
  • (1) Upon the request of the National Coordinator, the head of any Federal agency is authorized to detail, with or without reimbursement from the Office, any of the personnel of such agency to the Office to assist it in carrying out its duties under this section.
  • (2) Any detail of personnel under paragraph (1) shall—
    • (A) not interrupt or otherwise affect the civil service status or privileges of the Federal employee; and
    • (B) be in addition to any other staff of the Department employed by the National Coordinator.
  • (3) Notwithstanding any other provision of law, the Office may accept detailed personnel from other Federal agencies without regard to whether the agency described under paragraph (1) is reimbursed.
• (e) Not later than 12 months after February 17, 2009 , the Secretary shall appoint a Chief Privacy Officer of the Office of the National Coordinator, whose duty it shall be to advise the National Coordinator on privacy, security, and data stewardship of electronic health information and to coordinate with other Federal agencies (and similar privacy officers in such agencies), with State and regional efforts, and with foreign countries with regard to the privacy, security, and data stewardship of electronic individually identifiable health information.

§ 285a–11a. Cancer survivorship programs

• (a)
  • (1) The Secretary of Health and Human Services (referred to in this section as the “Secretary”) may make awards to eligible entities to establish pilot programs to develop, study, or evaluate model systems for monitoring and caring for childhood cancer survivors throughout their lifespan, including evaluation of models for transition to adult care and care coordination.
  • (2)
    • (A) In making awards under this subsection, the Secretary shall, to the extent practicable, include—
      • (i) small, medium, and large-sized eligible entities; and
      • (ii) sites located in different geographic areas, including rural and urban areas.
    • (B) In this subsection, the term “eligible entity” means—
      • (i) a medical school;
      • (ii) a children’s hospital;
      • (iii) a cancer center;
      • (iv) a community-based medical facility; or
      • (v) any other entity with significant experience and expertise in treating survivors of childhood cancers.
  • (3) Funds awarded under this subsection may be used—
    • (A) to develop, study, or evaluate one or more models for monitoring and caring for cancer survivors; and
    • (B) in developing, studying, and evaluating such models, to give special emphasis to—
      • (i) design of models of follow-up care, monitoring, and other survivorship programs (including peer support and mentoring programs);
      • (ii) development of models for providing multidisciplinary care;
      • (iii) dissemination of information to health care providers about culturally and linguistically appropriate follow-up care for cancer survivors and their families, as appropriate and practicable;
      • (iv) development of psychosocial and support programs to improve the quality of life of cancer survivors and their families, which may include peer support and mentoring programs;
      • (v) design of systems for the effective transfer of treatment information and care summaries from cancer care providers to other health care providers (including risk factors and a plan for recommended follow-up care);
      • (vi) dissemination of the information and programs described in clauses (i) through (v) to other health care providers (including primary care physicians and internists) and to cancer survivors and their families, where appropriate and in accordance with Federal and State law; and
      • (vii) development of initiatives that promote the coordination and effective transition of care between cancer care providers, primary care physicians, mental health professionals, and other health care professionals, as appropriate, including models that use a team-based or multi-disciplinary approach to care.
• (b)
  • (1) The Secretary shall, not later than 1 year after June 5, 2018 , conduct a review of the activities of the Department of Health and Human Services related to workforce development for health care providers who treat pediatric cancer patients and survivors. Such review shall include—
    • (A) an assessment of the effectiveness of supportive psychosocial care services for pediatric cancer patients and survivors, including pediatric cancer survivorship care patient navigators and peer support programs;
    • (B) identification of existing models relevant to providing medical and psychosocial services to individuals surviving pediatric cancers, and programs related to training for health professionals who provide such services to individuals surviving pediatric cancers; and
    • (C) recommendations for improving the provision of psychosocial care for pediatric cancer survivors and patients.
  • (2) Not later than 2 years after June 5, 2018 , the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and Committee on Energy and Commerce of the House of Representatives, a report concerning the findings and recommendations from the review conducted under paragraph (1).

§ 285a–11b. Best practices for long-term follow-up services for pediatric cancer survivors

The Secretary of Health and Human Services may facilitate the identification of best practices for childhood and adolescent cancer survivorship care, and, as appropriate, may consult with individuals who have expertise in late effects of disease and treatment of childhood and adolescent cancers, which may include—

• (1) oncologists, which may include pediatric oncologists;
• (2) primary care providers engaged in survivorship care;
• (3) survivors of childhood and adolescent cancer;
• (4) parents of children and adolescents who have been diagnosed with and treated for cancer and parents of long-term survivors;
• (5) nurses and social workers;
• (6) mental health professionals;
• (7) allied health professionals, including physical therapists and occupational therapists; and
• (8) others, as the Secretary determines appropriate.

§ 300jj–12. Health Information Technology Advisory Committee

• (a) There is established a Health Information Technology Advisory Committee (referred to in this section as the “HIT Advisory Committee”) to recommend to the National Coordinator, consistent with the implementation of the strategic plan described in section 300jj–11(c)(3) of this title , policies, and, for purposes of adoption under section 300jj–14 of this title , standards, implementation specifications, and certification criteria, relating to the implementation of a health information technology infrastructure, nationally and locally, that advances the electronic access, exchange, and use of health information. Such Committee shall serve to unify the roles of, and replace, the HIT Policy Committee and the HIT Standards Committee, as in existence before December 13, 2016 .
• (b)
  • (1)
    • (A) The HIT Advisory Committee shall recommend to the National Coordinator a policy framework for adoption by the Secretary consistent with the strategic plan under section 300jj–11(c)(3) of this title for advancing the target areas described in this subsection. Such policy framework shall seek to prioritize achieving advancements in the target areas specified in subparagraph (B) of paragraph (2) and may, to the extent consistent with this section, incorporate policy recommendations made by the HIT Policy Committee, as in existence before December 13, 2016 .
    • (B) The HIT Advisory Committee shall propose updates to such recommendations to the policy framework and make new recommendations, as appropriate.
  • (2)
    • (A) The HIT Advisory Committee shall recommend to the National Coordinator for purposes of adoption under section 300jj–14 of this title , standards, implementation specifications, and certification criteria and an order of priority for the development, harmonization, and recognition of such standards, specifications, and certification criteria. Such recommendations shall include recommended standards, architectures, and software schemes for access to electronic individually identifiable health information across disparate systems including user vetting, authentication, privilege management, and access control.
    • (B) For purposes of this section, the HIT Advisory Committee shall make recommendations under subparagraph (A) with respect to at least each of the following target areas:
      • (i) Achieving a health information technology infrastructure, nationally and locally, that allows for the electronic access, exchange, and use of health information, including through technology that provides accurate patient information for the correct patient, including exchanging such information, and avoids the duplication of patient records.
      • (ii) The promotion and protection of privacy and security of health information in health information technology, including technologies that allow for an accounting of disclosures and protections against disclosures of individually identifiable health information made by a covered entity for purposes of treatment, payment, and health care operations (as such terms are defined for purposes of the regulation promulgated under section 264(c) of the Health Insurance Portability and Accountability Act of 1996), including for the segmentation and protection from disclosure of specific and sensitive individually identifiable health information with the goal of minimizing the reluctance of patients to seek care.
      • (iii) The facilitation of secure access by an individual to such individual’s protected health information and access to such information by a family member, caregiver, or guardian acting on behalf of a patient, including due to age-related and other disability, cognitive impairment, or dementia.
      • (iv) Subject to subparagraph (D), any other target area that the HIT Advisory Committee identifies as an appropriate target area to be considered under this subparagraph.
    • (C) For purposes of this section, the HIT Advisory Committee may make recommendations under subparagraph (A), in addition to areas described in subparagraph (B), with respect to any of the following areas:
      • (i) The use of health information technology to improve the quality of health care, such as by promoting the coordination of health care and improving continuity of health care among health care providers, reducing medical errors, improving population health, reducing chronic disease, and advancing research and education.
      • (ii) The use of technologies that address the needs of children and other vulnerable populations.
      • (iii) The use of electronic systems to ensure the comprehensive collection of patient demographic data, including at a minimum, race, ethnicity, primary language, and gender information.
      • (iv) The use of self-service, telemedicine, home health care, and remote monitoring technologies.
      • (v) The use of technologies that meet the needs of diverse populations.
      • (vi) The use of technologies that support—
        • (I) data for use in quality and public reporting programs;
        • (II) public health; or
        • (III) drug safety.
      • (vii) The use of technologies that allow individually identifiable health information to be rendered unusable, unreadable, or indecipherable to unauthorized individuals when such information is transmitted in a health information network or transported outside of the secure facilities or systems where the disclosing covered entity is responsible for security conditions.
      • (viii) The use of a certified health information technology for each individual in the United States.
    • (D) For purposes of subparagraph (B)(iv), the HIT Advisory Committee may identify an area to be considered for purposes of recommendations under this subsection as a target area described in subparagraph (B) if—
      • (i) the area is so identified for purposes of responding to new circumstances that have arisen in the health information technology community that affect the interoperability, privacy, or security of health information, or affect patient safety; and
      • (ii) at least 30 days prior to treating such area as if it were a target area described in subparagraph (B), the National Coordinator provides adequate notice to Congress of the intent to treat such area as so described.
    • (E) It is the sense of Congress that the HIT Advisory Committee shall focus its work on the priority areas described in subparagraph (B) before proceeding to other work under subparagraph (C).
  • (3)
    • (A) The HIT Advisory Committee shall recommend to the National Coordinator standards, implementation specifications, and certification criteria described in subsection (a), which may include standards, implementation specifications, and certification criteria that have been developed, harmonized, or recognized by the HIT Advisory Committee or predecessor committee. The HIT Advisory Committee shall update such recommendations and make new recommendations as appropriate, including in response to a notification sent under section 300jj–14(a)(2)(B) of this title . Such recommendations shall be consistent with the latest recommendations made by the Committee.
    • (B) The HIT Advisory Committee may recognize harmonized or updated standards from an entity or entities for the purpose of harmonizing or updating standards and implementation specifications in order to achieve uniform and consistent implementation of the standards and implementation specification.
    • (C) In the development, harmonization, or recognition of standards and implementation specifications, the HIT Advisory Committee for purposes of recommendations under paragraph (2)(B), shall, as appropriate, provide for the testing of such standards and specifications by the National Institute for Standards and Technology under section 17911(a) of this title .
    • (D) The standards, implementation specifications, and certification criteria recommended under paragraph (2)(B) shall be consistent with the standards for information transactions and data elements adopted pursuant to section 1320d–2 of this title .
    • (E) Any recommendation made by the HIT Advisory Committee after December 13, 2016 , with respect to interoperability of health information technology shall be consistent with interoperability as described in section 300jj of this title .
  • (4) The HIT Advisory Committee shall serve as a forum for the participation of a broad range of stakeholders with specific expertise in policies, including technical expertise, relating to the matters described in paragraphs (1), (2), and (3) to provide input on the development, harmonization, and recognition of standards, implementation specifications, and certification criteria necessary for the development and adoption of health information technology infrastructure nationally and locally that allows for the electronic access, exchange, and use of health information.
  • (5) Not later than 30 days after the date on which the HIT Advisory Committee first meets, such HIT Advisory Committee shall develop a schedule for the assessment of policy recommendations developed under paragraph (1). The HIT Advisory Committee shall update such schedule annually. The Secretary shall publish such schedule in the Federal Register.
  • (6) The HIT Advisory Committee shall conduct open public meetings and develop a process to allow for public comment on the schedule described in paragraph (5) and recommendations described in this subsection. Under such process comments shall be submitted in a timely manner after the date of publication of a recommendation under this subsection.
• (c)
  • (1) For purposes of this section, the National Coordinator, in collaboration with the Secretary, shall establish, and update as appropriate, objectives and benchmarks for advancing and measuring the advancement of the priority target areas described in subsection (b)(2)(B).
  • (2)
    • (A) The HIT Advisory Committee, in consultation with the National Coordinator, shall annually submit to the Secretary and Congress a report on the progress made during the preceding fiscal year in—
      • (i) achieving a health information technology infrastructure, nationally and locally, that allows for the electronic access, exchange, and use of health information; and
      • (ii) meeting the objectives and benchmarks described in paragraph (1).
    • (B) Each such report shall include, for a fiscal year—
      • (i) a description of the work conducted by the HIT Advisory Committee during the preceding fiscal year with respect to the areas described in subsection (b)(2)(B);
      • (ii) an assessment of the status of the infrastructure described in subparagraph (A), including the extent to which electronic health information is appropriately and readily available to enhance the access, exchange, and the use of electronic health information between users and across technology offered by different developers;
      • (iii) the extent to which advancements have been achieved with respect to areas described in subsection (b)(2)(B);
      • (iv) an analysis identifying existing gaps in policies and resources for—
        • (I) achieving the objectives and benchmarks established under paragraph (1); and
        • (II) furthering interoperability throughout the health information technology infrastructure;
      • (v) recommendations for addressing the gaps identified in clause (iii); and
      • (vi) a description of additional initiatives as the HIT Advisory Committee and National Coordinator determine appropriate.
  • (3) The Secretary shall periodically, based on the reports submitted under this subsection, review the target areas described in subsection (b)(2)(B), and, based on the objectives and benchmarks established under paragraph (1), the Secretary shall determine if significant advancement has been achieved with respect to such an area. Such determination shall be taken into consideration by the HIT Advisory Committee when determining to what extent the Committee makes recommendations for an area other than an area described in subsection (b)(2)(B).
• (d)
  • (1) The National Coordinator shall take a leading position in the establishment and operations of the HIT Advisory Committee.
  • (2) The membership of the HIT Advisory Committee shall—
    • (A) include at least 25 members, of which—
      • (i) no fewer than 2 members are advocates for patients or consumers of health information technology;
      • (ii) 3 members are appointed by the Secretary, 1 of whom shall be appointed to represent the Department of Health and Human Services and 1 of whom shall be a public health official;
      • (iii) 2 members are appointed by the majority leader of the Senate;
      • (iv) 2 members are appointed by the minority leader of the Senate;
      • (v) 2 members are appointed by the Speaker of the House of Representatives;
      • (vi) 2 members are appointed by the minority leader of the House of Representatives; and
      • (vii) such other members are appointed by the Comptroller General of the United States; and
    • (B) at least reflect providers, ancillary health care workers, consumers, purchasers, health plans, health information technology developers, researchers, patients, relevant Federal agencies, and individuals with technical expertise on health care quality, system functions, privacy, security, and on the electronic exchange and use of health information, including the use standards for such activity.
  • (3) The members of the HIT Advisory Committee shall represent a balance among various sectors of the health care system so that no single sector unduly influences the recommendations of the Committee.
  • (4)
    • (A) The terms of the members of the HIT Advisory Committee shall be for 3 years, except that the Secretary shall designate staggered terms of the members first appointed.
    • (B) Any member appointed to fill a vacancy in the membership of the HIT Advisory Committee that occurs prior to the expiration of the term for which the member’s predecessor was appointed shall be appointed only for the remainder of that term. A member may serve after the expiration of that member’s term until a successor has been appointed. A vacancy in the HIT Advisory Committee shall be filled in the manner in which the original appointment was made.
    • (C) Members of the HIT Advisory Committee shall be limited to two 3-year terms, for a total of not to exceed 6 years of service on the Committee.
  • (5) The HIT Advisory Committee shall ensure an opportunity for the participation in activities of the Committee of outside advisors, including individuals with expertise in the development of policies and standards for the electronic exchange and use of health information, including in the areas of health information privacy and security.
  • (6) A majority of the members of the HIT Advisory Committee shall constitute a quorum for purposes of voting, but a lesser number of members may meet and hold hearings.
  • (7) The National Coordinator shall ensure that the relevant and available recommendations and comments from the National Committee on Vital and Health Statistics are considered in the development of policies.
  • (8) For the purposes of carrying out this section, the Secretary may provide or ensure that financial assistance is provided by the HIT Advisory Committee to defray in whole or in part any membership fees or dues charged by such Committee to those consumer advocacy groups and not-for-profit entities that work in the public interest as a party of their mission.
• (e) The Federal Advisory Committee Act (5 U.S.C. App.), other than section 14 of such Act, shall apply to the HIT Advisory Committee.
• (f) The Secretary shall provide for publication in the Federal Register and the posting on the Internet website of the Office of the National Coordinator for Health Information Technology of all policy recommendations made by the HIT Advisory Committee under this section.

§ 300jj–13. Setting priorities for standards adoption

• (a)
  • (1) Not later than 6 months after the date on which the HIT Advisory Committee first meets, the National Coordinator shall periodically convene the HIT Advisory Committee to—
    • (A) identify priority uses of health information technology, focusing on priorities—
      • (i) arising from the implementation of the incentive programs for the meaningful use of certified EHR technology, the Merit-based Incentive Payment System, Alternative Payment Models, the Hospital Value-Based Purchasing Program, and any other value-based payment program determined appropriate by the Secretary;
      • (ii) related to the quality of patient care;
      • (iii) related to public health;
      • (iv) related to clinical research;
      • (v) related to the privacy and security of electronic health information;
      • (vi) related to innovation in the field of health information technology;
      • (vii) related to patient safety;
      • (viii) related to the usability of health information technology;
      • (ix) related to individuals’ access to electronic health information; and
      • (x) other priorities determined appropriate by the Secretary;
    • (B) identify existing standards and implementation specifications that support the use and exchange of electronic health information needed to meet the priorities identified in subparagraph (A); and
    • (C) publish a report summarizing the findings of the analysis conducted under subparagraphs (A) and (B) and make appropriate recommendations.
  • (2) In identifying such standards and implementation specifications under paragraph (1)(B), the HIT Advisory Committee shall prioritize standards and implementation specifications developed by consensus-based standards development organizations.
  • (3) In consultation with the consensus-based entity described in section 1395aaa of this title and other appropriate Federal agencies, the analysis of existing standards under paragraph (1)(B) shall include an evaluation of the need for a core set of common data elements and associated value sets to enhance the ability of certified health information technology to capture, use, and exchange structured electronic health information.
• (b)
  • (1) Beginning 5 years after December 13, 2016 , and every 3 years thereafter, the National Coordinator shall convene stakeholders to review the existing set of adopted standards and implementation specifications and make recommendations with respect to whether to—
    • (A) maintain the use of such standards and implementation specifications; or
    • (B) phase out such standards and implementation specifications.
  • (2) The HIT Advisory Committee, in collaboration with the National Institute for Standards and Technology, shall annually and through the use of public input, review and publish priorities for the use of health information technology, standards, and implementation specifications to support those priorities.
• (c) Nothing in this section shall be construed to prevent the use or adoption of novel standards that improve upon the existing health information technology infrastructure and facilitate the secure exchange of health information.

§ 247b–13a. Screening and treatment for maternal depression

• (a) The Secretary shall make grants to States to establish, improve, or maintain programs for screening, assessment, and treatment services, including culturally and linguistically appropriate services, as appropriate, for women who are pregnant, or who have given birth within the preceding 12 months, for maternal depression.
• (b) To seek a grant under this section, a State shall submit an application to the Secretary at such time, in such manner, and containing such information as the Secretary may require. At a minimum, any such application shall include explanations of—
  • (1) how a program, or programs, will increase the percentage of women screened and treated, as appropriate, for maternal depression in 1 or more communities; and
  • (2) how a program, or programs, if expanded, would increase access to screening and treatment services for maternal depression.
• (c) In awarding grants under this section, the Secretary may give priority to States proposing to improve or enhance access to screening services for maternal depression in primary care settings.
• (d) The activities eligible for funding through a grant under subsection (a)—
  • (1) shall include—
    • (A) providing appropriate training to health care providers; and
    • (B) providing information to health care providers, including information on maternal depression screening, treatment, and followup support services, and linkages to community-based resources; and
  • (2) may include—
    • (A) enabling health care providers (including obstetrician-gynecologists, pediatricians, psychiatrists, mental health care providers, and adult primary care clinicians) to provide or receive real-time psychiatric consultation (in-person or remotely) to aid in the treatment of pregnant and parenting women;
    • (B) establishing linkages with and among community-based resources, including mental health resources, primary care resources, and support groups; and
    • (C) utilizing telehealth services for rural areas and medically underserved areas (as defined in section 254c–14(a) of this title ).
• (e) To carry out this section, there are authorized to be appropriated $5,000,000 for each of fiscal years 2018 through 2022.

§ 300jj–14. Process for adoption of endorsed recommendations; adoption of initial set of standards, implementation specifications, and certification criteria

• (a)
  • (1) Not later than 90 days after the date of receipt of standards, implementation specifications, or certification criteria endorsed under section 300jj–11(c) of this title , the Secretary, in consultation with representatives of other relevant Federal agencies, shall jointly review such standards, implementation specifications, or certification criteria and shall determine whether or not to propose adoption of such standards, implementation specifications, or certification criteria.
  • (2) If the Secretary determines—
    • (A) to propose adoption of any grouping of such standards, implementation specifications, or certification criteria, the Secretary shall, by regulation under section 553 of title 5 , determine whether or not to adopt such grouping of standards, implementation specifications, or certification criteria; or
    • (B) not to propose adoption of any grouping of standards, implementation specifications, or certification criteria, the Secretary shall notify the National Coordinator and the HIT Advisory Committee in writing of such determination and the reasons for not proposing the adoption of such recommendation.
  • (3) The Secretary shall provide for publication in the Federal Register of all determinations made by the Secretary under paragraph (1).
• (b)
  • (1) Not later than December 31, 2009 , the Secretary shall, through the rulemaking process consistent with subsection (a)(2)(A), adopt an initial set of standards, implementation specifications, and certification criteria for the areas required for consideration under section 300jj–12(b)(2)(B) 1 1 See References in Text note below. of this title. The rulemaking for the initial set of standards, implementation specifications, and certification criteria may be issued on an interim, final basis.
  • (2) The standards, implementation specifications, and certification criteria adopted before February 17, 2009 , through the process existing through the Office of the National Coordinator for Health Information Technology may be applied towards meeting the requirement of paragraph (1).
  • (3) The Secretary shall adopt additional standards, implementation specifications, and certification criteria as necessary and consistent with the schedule published under section 300jj–12(b)(4) of this title .
• (c) In adopting and implementing standards under this section, the Secretary shall give deference to standards published by standards development organizations and voluntary consensus-based standards bodies.

§ 300e–14a. Health services for Indians and domestic agricultural migratory and seasonal workers

The Secretary of Health and Human Services, in connection with existing authority (except section 254b 1 1 See References in Text note below. of this title) for the provisions of health services to domestic agricultural migratory workers, to persons who perform seasonal agricultural services similar to the services performed by such workers, and to the families of such workers and persons, is authorized to arrange for the provision of health services to such workers and persons and their families through health maintenance organizations. In carrying out this section the Secretary may only use sums appropriated after December 29, 1973 .

§ 300jj–15. Application and use of adopted standards and implementation specifications by Federal agencies

For requirements relating to the application and use by Federal agencies of the standards and implementation specifications adopted under section 300jj–14 of this title , see section 17901 of this title .

§ 300gg–15a. Provision of additional information

A group health plan and a health insurance issuer offering group or individual health insurance coverage shall comply with the provisions of section 18031(e)(3) of this title , except that a plan or coverage that is not offered through an Exchange shall only be required to submit the information required to the Secretary and the State insurance commissioner, and make such information available to the public.

§ 300jj–16. Voluntary application and use of adopted standards and implementation specifications by private entities

• (a) Except as provided under section 13112 of the HITECH Act [ 42 U.S.C. 17902 ], nothing in such Act or in the amendments made by such Act shall be construed—
  • (1) to require a private entity to adopt or comply with a standard or implementation specification adopted under section 300jj–14 of this title ; or
  • (2) to provide a Federal agency authority, other than the authority such agency may have under other provisions of law, to require a private entity to comply with such a standard or implementation specification.
• (b) Nothing in this part shall be construed to require that a private entity that enters into a contract with the Federal Government apply or use the standards and implementation specifications adopted under section 300jj–14 of this title with respect to activities not related to the contract.

§ 300jj–17. Federal health information technology

• (a) The National Coordinator shall support the development and routine updating of qualified electronic health record technology (as defined in section 300jj of this title ) consistent with subsections (b) and (c) and make available such qualified electronic health record technology unless the Secretary determines through an assessment that the needs and demands of providers are being substantially and adequately met through the marketplace.
• (b) In making such electronic health record technology publicly available, the National Coordinator shall ensure that the qualified electronic health record technology described in subsection (a) is certified under the program developed under section 300jj–11(c)(3) of this title to be in compliance with applicable standards adopted under section 300jj–12(a)(2) 1 1 So in original. No par. (2) of section 300jj–12(a) has been enacted. of this title.
• (c) The National Coordinator may impose a nominal fee for the adoption by a health care provider of the health information technology system developed or approved under subsection 2 2 So in original. Probably should be “subsections”. (a) and (b). Such fee shall take into account the financial circumstances of smaller providers, low income providers, and providers located in rural or other medically underserved areas.
• (d) Nothing in this section shall be construed to require that a private or government entity adopt or use the technology provided under this section.

§ 300jj–18. Transitions

• (a) To the extent consistent with section 300jj–11 of this title , all functions, personnel, assets, liabilities, and administrative actions applicable to the National Coordinator for Health Information Technology appointed under Executive Order No. 13335 or the Office of such National Coordinator on the date before February 17, 2009 , shall be transferred to the National Coordinator appointed under section 300jj–11(a) of this title and the Office of such National Coordinator as of February 17, 2009 .
• (b) Nothing in sections 1 1 So in original. Probably should be “section”. 300jj–12 of this title or this subsection shall be construed as prohibiting the AHIC Successor, Inc. doing business as the National eHealth Collaborative from modifying its charter, duties, membership, and any other structure or function required to be consistent with section 2 2 So in original. Probably should be “sections”. 300jj–12 and 300jj–13 3 3 See References in Text note below. of this title so as to allow the Secretary to recognize such AHIC Successor, Inc. as the HIT Advisory Committee.
• (c) In carrying out section 300jj–12(b)(2) of this title , until recommendations are made by the HIT Advisory Committee, 4 4 So in original. See 2016 Amendment note below. recommendations of the HIT Advisory Committee 4 shall be consistent with the most recent recommendations made by such AHIC Successor, Inc.

§ 300jj–19. Miscellaneous provisions

• (a)
  • (1) With respect to the relation of this subchapter to HIPAA privacy and security law:
    • (A) This subchapter may not be construed as having any effect on the authorities of the Secretary under HIPAA privacy and security law.
    • (B) The purposes of this subchapter include ensuring that the health information technology standards and implementation specifications adopted under section 300jj–14 of this title take into account the requirements of HIPAA privacy and security law.
  • (2) For purposes of this section, the term “HIPAA privacy and security law” means—
    • (A) the provisions of part C of title XI of the Social Security Act [ 42 U.S.C. 1320d et seq.], section 264 of the Health Insurance Portability and Accountability Act of 1996, and subtitle D of title IV 1 1 See References in Text note below. of the Health Information Technology for Economic and Clinical Health Act; and
    • (B) regulations under such provisions.
• (b) In administering the provisions of this subchapter, the Secretary shall have flexibility in applying the definition of health care provider under section 300jj(3) of this title , including the authority to omit certain entities listed in such definition when applying such definition under this subchapter, where appropriate.
• (c)
  • (1) The Secretary shall use existing authorities to encourage partnerships between health information exchange organizations and networks and health care providers, health plans, and other appropriate entities with the goal of offering patients access to their electronic health information in a single, longitudinal format that is easy to understand, secure, and may be updated automatically.
  • (2) The Secretary, in coordination with the Office for Civil Rights of the Department of Health and Human Services, shall—
    • (A) educate health care providers on ways of leveraging the capabilities of health information exchanges (or other relevant platforms) to provide patients with access to their electronic health information;
    • (B) clarify misunderstandings by health care providers about using health information exchanges (or other relevant platforms) for patient access to electronic health information; and
    • (C) to the extent practicable, educate providers about health information exchanges (or other relevant platforms) that employ some or all of the capabilities described in paragraph (1).
  • (3) In carrying out paragraph (1), the Secretary, in coordination with the Office for Civil Rights, shall issue guidance to health information exchanges related to best practices to ensure that the electronic health information provided to patients is—
    • (A) private and secure;
    • (B) accurate;
    • (C) verifiable; and
    • (D) where a patient’s authorization to exchange information is required by law, easily exchanged pursuant to such authorization.
  • (4) Nothing in this subsection shall be construed to preempt State laws applicable to patient consent for the access of information through a health information exchange (or other relevant platform) that provide protections to patients that are greater than the protections otherwise provided for under applicable Federal law.
• (d) The National Coordinator and the Office for Civil Rights of the Department of Health and Human Services shall jointly promote patient access to health information in a manner that would ensure that such information is available in a form convenient for the patient, in a reasonable manner, without burdening the health care provider involved.
• (e)
  • (1)
    • (A) The Secretary, in consultation with the National Coordinator, shall promote policies that ensure that a patient’s electronic health information is accessible to that patient and the patient’s designees, in a manner that facilitates communication with the patient’s health care providers and other individuals, including researchers, consistent with such patient’s consent.
    • (B) To promote awareness that an individual has a right of access to inspect, obtain a copy of, and transmit to a third party a copy of such individual’s protected health information pursuant to the Health Information Portability and Accountability Act, Privacy Rule (subpart E of part 164 of title 45, Code of Federal Regulations), the Director of the Office for Civil Rights, in consultation with the National Coordinator, shall assist individuals and health care providers in understanding a patient’s rights to access and protect personal health information under the Health Insurance Portability and Accountability Act of 1996 ( Public Law 104–191 ), including providing best practices for requesting personal health information in a computable format, including using patient portals or third-party applications and common cases when a provider is permitted to exchange and provide access to health information.”. 2 2 So in original.
  • (2) In carrying out certification programs under section 300jj–11(c)(5) of this title , the National Coordinator may require that—
    • (A) the certification criteria support—
      • (i) patient access to their electronic health information, including in a single longitudinal format that is easy to understand, secure, and may be updated automatically;
      • (ii) the patient’s ability to electronically communicate patient-reported information (such as family history and medical history); and
      • (iii) patient access to their personal electronic health information for research at the option of the patient; and
    • (B) the HIT Advisory Committee develop and prioritize standards, implementation specifications, and certification criteria required to help support patient access to electronic health information, patient usability, and support for technologies that offer patients access to their electronic health information in a single, longitudinal format that is easy to understand, secure, and may be updated automatically.

§ 300jj–19a. Electronic health record reporting program

• (a)
  • (1) Not later than 1 year after December 13, 2016 , the Secretary shall convene stakeholders, as described in paragraph (2), for the purpose of developing the reporting criteria in accordance with paragraph (3).
  • (2) The reporting criteria under this subsection shall be developed through a public, transparent process that reflects input from relevant stakeholders, including—
    • (A) health care providers, including primary care and specialty care health care professionals;
    • (B) hospitals and hospital systems;
    • (C) health information technology developers;
    • (D) patients, consumers, and their advocates;
    • (E) data sharing networks, such as health information exchanges;
    • (F) authorized certification bodies and testing laboratories;
    • (G) security experts;
    • (H) relevant manufacturers of medical devices;
    • (I) experts in health information technology market economics;
    • (J) public and private entities engaged in the evaluation of health information technology performance;
    • (K) quality organizations, including the consensus based entity described in section 1395aaa of this title ;
    • (L) experts in human factors engineering and the measurement of user-centered design; and
    • (M) other entities or individuals, as the Secretary determines appropriate.
  • (3) The reporting criteria developed under this subsection—
    • (A) shall include measures that reflect categories including—
      • (i) security;
      • (ii) usability and user-centered design;
      • (iii) interoperability;
      • (iv) conformance to certification testing; and
      • (v) other categories, as appropriate to measure the performance of electronic health record technology;
    • (B) may include categories such as—
      • (i) enabling the user to order and view the results of laboratory tests, imaging tests, and other diagnostic tests;
      • (ii) submitting, editing, and retrieving data from registries such as clinician-led clinical data registries;
      • (iii) accessing and exchanging information and data from and through health information exchanges;
      • (iv) accessing and exchanging information and data from medical devices;
      • (v) accessing and exchanging information and data held by Federal, State, and local agencies and other applicable entities useful to a health care provider or other applicable user in the furtherance of patient care;
      • (vi) accessing and exchanging information from other health care providers or applicable users;
      • (vii) accessing and exchanging patient generated information;
      • (viii) providing the patient or an authorized designee with a complete copy of their health information from an electronic record in a computable format;
      • (ix) providing accurate patient information for the correct patient, including exchanging such information, and avoiding the duplication of patients records; and
      • (x) other categories regarding performance, accessibility, 1 1 So in original. Probably should be “performance or accessibility,”. as the Secretary determines appropriate; and
    • (C) shall be designed to ensure that small and startup health information technology developers are not unduly disadvantaged by the reporting criteria.
  • (4) After the reporting criteria have been developed under paragraph (3), the Secretary may convene stakeholders and conduct a public comment period for the purpose of modifying the reporting criteria developed under such paragraph.
• (b) As a condition of maintaining certification under section 300jj–11(c)(5)(D) of this title , a developer of certified electronic health records shall submit to an appropriate recipient of a grant, contract, or agreement under subsection (c)(1) responses to the criteria developed under subsection (a), with respect to all certified technology offered by such developer.
• (c)
  • (1) Not later than 1 year after December 13, 2016 , the Secretary shall award grants, contracts, or agreements to independent entities on a competitive basis to support the convening of stakeholders as described in subsection (a)(2), collect the information required to be reported in accordance with the criteria established as described subsection (a)(3), and develop and implement a process in accordance with paragraph (5) and report such information to the Secretary.
  • (2) An independent entity that seeks a grant, contract, or agreement under this subsection shall submit an application to the Secretary at such time, in such manner, and containing such information as the Secretary may reasonably require, including a description of—
    • (A) the proposed method for reviewing and summarizing information gathered based on reporting criteria established under subsection (a);
    • (B) if applicable, the intended focus on a specific subset of certified electronic health record technology users, such as health care providers, including primary care, specialty care, and care provided in rural settings; hospitals and hospital systems; and patients, consumers, and patients and consumer advocates;
    • (C) the plan for widely distributing reports described in paragraph (6);
    • (D) the period for which the grant, contract, or agreement is requested, which may be up to 2 years; and
    • (E) the budget for reporting program participation, and whether the eligible independent entity intends to continue participation after the period of the grant, contract, or agreement.
  • (3) In awarding grants, contracts, and agreements under paragraph (1), the Secretary shall give priority to independent entities with appropriate expertise in health information technology usability, interoperability, and security (especially entities with such expertise in electronic health records) with respect to—
    • (A) health care providers, including primary care, specialty care, and care provided in rural settings;
    • (B) hospitals and hospital systems; and
    • (C) patients, consumers, and patient and consumer advocates.
  • (4)
    • (A) Not later than 4 years after December 13, 2016 , and every 2 years thereafter, the Secretary, in consultation with stakeholders, shall—
      • (i) assess performance of the recipients of the grants, contracts, and agreements under paragraph (1) based on quality and usability of reports described in paragraph (6); and
      • (ii) re-determine grants, contracts, and agreements as necessary.
    • (B) The Secretary may not award a grant, contract, or cooperative agreement under paragraph (1) to—
      • (i) a proprietor of certified health information technology or a business affiliate of such a proprietor;
      • (ii) a developer of certified health information technology; or
      • (iii) a State or local government agency.
  • (5) Based on reporting criteria established under subsection (a), the recipients of grants, contracts, and agreements under paragraph (1) shall develop and implement a process to collect and verify confidential feedback on such criteria from—
    • (A) health care providers, patients, and other users of certified electronic health record technology; and
    • (B) developers of certified electronic health record technology.
  • (6)
    • (A) Each recipient of a grant, contract, or agreement under paragraph (1) shall report on the information reported to such recipient pursuant to subsection (a) and the user feedback collected under paragraph (5) by preparing summary reports and detailed reports of such information.
    • (B) Each recipient of a grant, contract, or agreement under paragraph (1) shall submit the reports prepared under subparagraph (A) to the Secretary for public distribution in accordance with subsection (d).
• (d) The Secretary shall distribute widely, as appropriate, and publish, on the Internet website of the Office of the National Coordinator—
  • (1) the reporting criteria developed under subsection (a); and
  • (2) the summary and detailed reports under subsection (c)(6).
• (e) Each recipient of a grant, contract, or agreement under paragraph (1) shall develop and implement a process through which participating electronic health record technology developers may review and recommend changes to the reports created under subsection (c)(6) for products developed by such developer prior to the publication of such report under subsection (d).
• (f) The Secretary may provide additional resources on the Internet website of the Office of the National Coordinator to better inform consumers of health information technology. Such reports may be carried out through partnerships with private organizations with appropriate expertise.

§ 300gg–19b. Information on prescription drugs

• (a) A group health plan or a health insurance issuer offering group or individual health insurance coverage shall—
  • (1) not restrict, directly or indirectly, any pharmacy that dispenses a prescription drug to an enrollee in the plan or coverage from informing (or penalize such pharmacy for informing) an enrollee of any differential between the enrollee’s out-of-pocket cost under the plan or coverage with respect to acquisition of the drug and the amount an individual would pay for acquisition of the drug without using any health plan or health insurance coverage; and
  • (2) ensure that any entity that provides pharmacy benefits management services under a contract with any such health plan or health insurance coverage does not, with respect to such plan or coverage, restrict, directly or indirectly, a pharmacy that dispenses a prescription drug from informing (or penalize such pharmacy for informing) an enrollee of any differential between the enrollee’s out-of-pocket cost under the plan or coverage with respect to acquisition of the drug and the amount an individual would pay for acquisition of the drug without using any health plan or health insurance coverage.
• (b) For purposes of this section, the term “out-of-pocket cost”, with respect to acquisition of a drug, means the amount to be paid by the enrollee under the plan or coverage, including any cost-sharing (including any deductible, copayment, or coinsurance) and, as determined by the Secretary, any other expenditure.

§ 300j–19c. Study on intractable water systems

• (a) In this section, the term “intractable water system” means a community water system or a noncommunity water system—
  • (1) that serves fewer than 1,000 individuals;
  • (2) the owner or operator of which—
    • (A) is unable or unwilling to provide safe and adequate service to those individuals;
    • (B) has abandoned or effectively abandoned the community water system or noncommunity water system, as applicable;
    • (C) has defaulted on a financial obligation relating to the community water system or noncommunity water system, as applicable; or
    • (D) fails to maintain the facilities of the community water system or noncommunity water system, as applicable, in a manner so as to prevent a potential public health hazard; and
  • (3) that is, as of October 23, 2018 —
    • (A) in significant noncompliance with this chapter or any regulation promulgated pursuant to this chapter; or
    • (B) listed as having a history of significant noncompliance with this subchapter pursuant to section 300g–9(b)(1) of this title .
• (b)
  • (1) Not later than 2 years after October 23, 2018 , the Administrator, in consultation with the Secretary of Agriculture and the Secretary of Health and Human Services, shall complete a study that—
    • (A) identifies intractable water systems; and
    • (B) describes barriers to delivery of potable water to individuals served by an intractable water system.
  • (2) Not later than 2 years after October 23, 2018 , the Administrator shall submit to Congress a report describing findings and recommendations based on the study under this subsection.

§ 300j–19d. Review of technologies

• (a) The Administrator, after consultation with appropriate departments and agencies of the Federal Government and with State and local governments, shall review (or enter into contracts or cooperative agreements to provide for a review of) existing and potential methods, means, equipment, and technologies (including review of cost, availability, and efficacy of such methods, means, equipment, and technologies) that—
  • (1) ensure the physical integrity of community water systems;
  • (2) prevent, detect, and respond to any contaminant for which a national primary drinking water regulation has been promulgated in community water systems and source water for community water systems;
  • (3) allow for use of alternate drinking water supplies from nontraditional sources; and
  • (4) facilitate source water assessment and protection.
• (b) The review under subsection (a) shall include review of methods, means, equipment, and technologies—
  • (1) that are used for corrosion protection, metering, leak detection, or protection against water loss;
  • (2) that are intelligent systems, including hardware, software, or other technology, used to assist in protection and detection described in paragraph (1);
  • (3) that are point-of-use devices or point-of-entry devices;
  • (4) that are physical or electronic systems that monitor, or assist in monitoring, contaminants in drinking water in real-time; and
  • (5) that allow for the use of nontraditional sources for drinking water, including physical separation and chemical and biological transformation technologies.
• (c) The Administrator shall make the results of the review under subsection (a) available to the public.
• (d) There is authorized to be appropriated to the Administrator to carry out this section $10,000,000 for fiscal year 2019, which shall remain available until expended.

§ 300j–19e. Water infrastructure and workforce investment

• (a) It is the sense of Congress that—
  • (1) water and wastewater utilities provide a unique opportunity for access to stable, high-quality careers;
  • (2) as water and wastewater utilities make critical investments in infrastructure, water and wastewater utilities can invest in the development of local workers and local small businesses to strengthen communities and ensure a strong pipeline of skilled and diverse workers for today and tomorrow; and
  • (3) to further the goal of ensuring a strong pipeline of skilled and diverse workers in the water and wastewater utilities sector, Congress urges—
    • (A) increased collaboration among Federal, State, and local governments; and
    • (B) institutions of higher education, apprentice programs, high schools, and other community-based organizations to align workforce training programs and community resources with water and wastewater utilities to accelerate career pipelines and provide access to workforce opportunities.
• (b)
  • (1) The Administrator of the Environmental Protection Agency (referred to in this section as the “Administrator”), in consultation with the Secretary of Agriculture, shall establish a competitive grant program—
    • (A) to assist the development and utilization of innovative activities relating to workforce development and career opportunities in the water utility sector; and
    • (B) to expand public awareness about water utilities and connect individuals to careers in the water utility sector.
  • (2) In awarding grants under paragraph (1), the Administrator shall, to the extent practicable, select nonprofit professional or service organizations, labor organizations, community colleges, institutions of higher education, or other training and educational institutions—
    • (A) that have qualifications and experience—
      • (i) in the development of training programs and curricula relevant to workforce needs of water utilities;
      • (ii) working in cooperation with water utilities; or
      • (iii) developing public education materials appropriate for communicating with groups of different ages and educational backgrounds; and
    • (B) that will address the human resources and workforce needs of water utilities that—
      • (i) are geographically diverse;
      • (ii) are of varying sizes; and
      • (iii) serve urban, suburban, and rural populations.
  • (3) Grants awarded under paragraph (1) may be used for activities such as—
    • (A) targeted internship, apprenticeship, pre-apprenticeship, and post-secondary bridge programs for skilled water utility trades that provide—
      • (i) on-the-job training;
      • (ii) skills development;
      • (iii) test preparation for skilled trade apprenticeships;
      • (iv) advance training in the water utility sector relating to construction, utility operations, treatment and distribution, green infrastructure, customer service, maintenance, and engineering; or
      • (v) other support services to facilitate post-secondary success;
    • (B) education programs designed for elementary, secondary, and higher education students that—
      • (i) inform people about the role of water and wastewater utilities in their communities;
      • (ii) increase the awareness of career opportunities and exposure of students to water utility careers through various work-based learning opportunities inside and outside the classroom; and
      • (iii) connect students to career pathways related to water utilities;
    • (C) regional industry and workforce development collaborations to address water utility employment needs and coordinate candidate development, particularly in areas of high unemployment or for water utilities with a high proportion of retirement eligible employees;
    • (D) integrated learning laboratories in secondary educational institutions that provide students with—
      • (i) hands-on, contextualized learning opportunities;
      • (ii) dual enrollment credit for post-secondary education and training programs; and
      • (iii) direct connection to industry employers; and
    • (E) leadership development, occupational training, mentoring, or cross-training programs that ensure that incumbent water and waste water utilities workers are prepared for higher level supervisory or management-level positions.
  • (4) There is authorized to be appropriated to carry out this subsection $1,000,000 for each of fiscal years 2019 and 2020.

§ 300ff–20. Authorization of appropriations

• (a) For the purpose of carrying out this part, there are authorized to be appropriated $604,000,000 for fiscal year 2007, $626,300,000 for fiscal year 2008, $649,500,000 for fiscal year 2009, $681,975,000 for fiscal year 2010, $716,074,000 for fiscal year 2011, $751,877,000 for fiscal year 2012, and $789,471,000 for fiscal year 2013. Amounts appropriated under the preceding sentence for a fiscal year are available for obligation by the Secretary until the end of the second succeeding fiscal year.
• (b)
  • (1) Of the amount appropriated under subsection (a) for fiscal year 2007, the Secretary shall reserve—
    • (A) $458,310,000 for grants under subpart I; and
    • (B) $145,690,000 for grants under section 300ff–19 of this title .
  • (2) Of the amount appropriated under subsection (a) for fiscal year 2008 and each subsequent fiscal year—
    • (A) the Secretary shall reserve an amount for grants under subpart I; and
    • (B) the Secretary shall reserve an amount for grants under section 300ff–19 of this title .
• (c) Notwithstanding subsection (b):
  • (1) If a metropolitan area is an eligible area under subpart I for a fiscal year, but for a subsequent fiscal year ceases to be an eligible area by reason of section 300ff–11(b) of this title —
    • (A)
      • (i) the amount reserved under paragraph (1)(A) or (2)(A) of subsection (b) of this section for the first such subsequent year of not being an eligible area is deemed to be reduced by an amount equal to the amount of the grant made pursuant to section 300ff–13(a) of this title for the metropolitan area for the preceding fiscal year; and
      • (ii)
        • (I) if the metropolitan area qualifies for such first subsequent fiscal year as a transitional area under 300ff–19 1 1 So in original. Probably should be preceded by “section”. of this title, the amount reserved under paragraph (1)(B) or (2)(B) of subsection (b) for such fiscal year is deemed to be increased by an amount equal to the amount of the reduction under subparagraph (A) for such year; or
        • (II) if the metropolitan area does not qualify for such first subsequent fiscal year as a transitional area under 300ff–19 1 of this title, an amount equal to the amount of such reduction is, notwithstanding subsection (a), transferred and made available for grants pursuant to section 300ff–28(a)(1) of this title , in addition to amounts available for such grants under section 300ff–31b of this title ; and
    • (B) if a transfer under subparagraph (A)(ii)(II) is made with respect to the metropolitan area for such first subsequent fiscal year, then—
      • (i) the amount reserved under paragraph (1)(A) or (2)(A) of subsection (b) of this section for such year is deemed to be reduced by an additional $500,000; and
      • (ii) an amount equal to the amount of such additional reduction is, notwithstanding subsection (a), transferred and made available for grants pursuant to section 300ff–28(a)(1) of this title , in addition to amounts available for such grants under section 300ff–31b of this title .
  • (2) If a metropolitan area is a transitional area under section 300ff–19 of this title for a fiscal year, but for a subsequent fiscal year ceases to be a transitional area by reason of section 300ff–19(c)(2) of this title (and does not qualify for such subsequent fiscal year as an eligible area under subpart I)—
    • (A) the amount reserved under subsection (b)(2)(B) of this section for the first such subsequent fiscal year of not being a transitional area is deemed to be reduced by an amount equal to the total of—
      • (i) the amount of the grant that, pursuant to section 300ff–13(a) of this title , was made under section 300ff–19(d)(2)(A) of this title for the metropolitan area for the preceding fiscal year; and
      • (ii) $500,000; and
    • (B)
      • (i) subject to clause (ii), an amount equal to the amount of the reduction under subparagraph (A) for such year is, notwithstanding subsection (a), transferred and made available for grants pursuant to section 300ff–28(a)(1) of this title , in addition to amounts available for such grants under section 300ff–31b of this title ; and
      • (ii) for each of fiscal years 2010 through 2013, notwithstanding subsection (a)—
        • (I) there shall be transferred to the State containing the metropolitan area, for purposes described in section 300ff–22(a) of this title , an amount (which shall not be taken into account in applying section 300ff–28(a)(2)(H) of this title ) equal to—
        • (II) there shall be transferred and made available for grants pursuant to section 300ff–28(a)(1) of this title for the fiscal year, in addition to amounts available for such grants under section 300ff–31b of this title , an amount equal to the total amount of the reduction for such fiscal year under subparagraph (A), less the amount transferred for such fiscal year under subclause (I).
  • (3) If a metropolitan area is a transitional area under section 300ff–19 of this title for a fiscal year, but for a subsequent fiscal year qualifies as an eligible area under subpart I—
    • (A) the amount reserved under subsection (b)(2)(B) of this section for the first such subsequent fiscal year of becoming an eligible area is deemed to be reduced by an amount equal to the amount of the grant that, pursuant to section 300ff–13(a) of this title , was made under section 300ff–19(d)(2)(A) of this title for the metropolitan area for the preceding fiscal year; and
    • (B) the amount reserved under subsection (b)(2)(A) for such fiscal year is deemed to be increased by an amount equal to the amount of the reduction under subparagraph (A) for such year.
• (d) With respect to paragraphs (1)(B)(i) and (2)(A)(ii) of subsection (c), the Secretary shall administer any reductions under such paragraphs for a fiscal year in accordance with the following:
  • (1) The reductions shall be made from amounts available for the single program referred to in section 300ff–19(d)(2)(C) of this title (relating to supplemental grants).
  • (2) The reductions shall be made before the amounts referred to in paragraph (1) are used for purposes of section 300ff–13(a)(4) of this title .
  • (3) If the amounts referred to in paragraph (1) are not sufficient for making all the reductions, the reductions shall be reduced until the total amount of the reductions equals the total of the amounts referred to in such paragraph.
• (e) Paragraphs (1) and (2) of subsection (c) apply with respect to each series of fiscal years during which a metropolitan area is an eligible area under subpart I or a transitional area under section 300ff–19 of this title for a fiscal year and then for a subsequent fiscal year ceases to be such an area by reason of section 300ff–11(b) or 300ff–19(c)(2) of this title, respectively, rather than applying to a single such series. Paragraph (3) of subsection (c) applies with respect to each series of fiscal years during which a metropolitan area is a transitional area under section 300ff–19 of this title for a fiscal year and then for a subsequent fiscal year becomes an eligible area under subpart I, rather than applying to a single such series.

§ 300mm–21. Identification of WTC responders and provision of WTC-related monitoring services

• (a)
  • (1) For purposes of this subchapter, the term “WTC responder” means any of the following individuals, subject to paragraph (4):
    • (A) An individual who has been identified as eligible for monitoring under the arrangements as in effect on January 2, 2011 , between the National Institute for Occupational Safety and Health and—
      • (i) the consortium coordinated by Mt. Sinai Hospital in New York City that coordinates the monitoring and treatment for enrolled WTC responders other than with respect to those covered under the arrangement with the Fire Department of New York City; or
      • (ii) the Fire Department of New York City.
    • (B) An individual who meets the current eligibility criteria described in paragraph (2).
    • (C) An individual who—
      • (i) performed rescue, recovery, demolition, debris cleanup, or other related services in the New York City disaster area in response to the September 11, 2001 , terrorist attacks, regardless of whether such services were performed by a State or Federal employee or member of the National Guard or otherwise; and
      • (ii) meets such eligibility criteria relating to exposure to airborne toxins, other hazards, or adverse conditions resulting from the September 11, 2001 , terrorist attacks as the WTC Program Administrator, after consultation with the WTC Scientific/Technical Advisory Committee, determines appropriate.
  • (2) The eligibility criteria described in this paragraph for an individual is that the individual is described in any of the following categories:
    • (A) The individual—
      • (i) was a member of the Fire Department of New York City (whether fire or emergency personnel, active or retired) who participated at least one day in the rescue and recovery effort at any of the former World Trade Center sites (including Ground Zero, Staten Island Landfill, and the New York City Chief Medical Examiner’s Office) for any time during the period beginning on September 11, 2001 , and ending on July 31, 2002 ; or
      • (ii)
        • (I) is a surviving immediate family member of an individual who was a member of the Fire Department of New York City (whether fire or emergency personnel, active or retired) and was killed at the World Trade site on September 11, 2001 ; and
        • (II) received any treatment for a WTC-related health condition described in section 300mm–22(a)(1)(A)(ii) of this title (relating to mental health conditions) on or before September 1, 2008 .
    • (B) The individual—
      • (i) worked or volunteered onsite in rescue, recovery, debris cleanup, or related support services in lower Manhattan (south of Canal St.), the Staten Island Landfill, or the barge loading piers, for at least 4 hours during the period beginning on September 11, 2001 , and ending on September 14, 2001 , for at least 24 hours during the period beginning on September 11, 2001 , and ending on September 30, 2001 , or for at least 80 hours during the period beginning on September 11, 2001 , and ending on July 31, 2002 ;
      • (ii)
        • (I) was a member of the Police Department of New York City (whether active or retired) or a member of the Port Authority Police of the Port Authority of New York and New Jersey (whether active or retired) who participated onsite in rescue, recovery, debris cleanup, or related services in lower Manhattan (south of Canal St.), including Ground Zero, the Staten Island Landfill, or the barge loading piers, for at least 4 hours during the period beginning September 11, 2001 , and ending on September 14, 2001 ;
        • (II) participated onsite in rescue, recovery, debris cleanup, or related services at Ground Zero, the Staten Island Landfill, or the barge loading piers, for at least one day during the period beginning on September 11, 2001 , and ending on July 31, 2002 ;
        • (III) participated onsite in rescue, recovery, debris cleanup, or related services in lower Manhattan (south of Canal St.) for at least 24 hours during the period beginning on September 11, 2001 , and ending on September 30, 2001 ; or
        • (IV) participated onsite in rescue, recovery, debris cleanup, or related services in lower Manhattan (south of Canal St.) for at least 80 hours during the period beginning on September 11, 2001 , and ending on July 31, 2002 ;
      • (iii) was an employee of the Office of the Chief Medical Examiner of New York City involved in the examination and handling of human remains from the World Trade Center attacks, or other morgue worker who performed similar post-September 11 functions for such Office staff, during the period beginning on September 11, 2001 , and ending on July 31, 2002 ;
      • (iv) was a worker in the Port Authority Trans-Hudson Corporation Tunnel for at least 24 hours during the period beginning on February 1, 2002 , and ending on July 1, 2002 ; or
      • (v) was a vehicle-maintenance worker who was exposed to debris from the former World Trade Center while retrieving, driving, cleaning, repairing, and maintaining vehicles contaminated by airborne toxins from the September 11, 2001 , terrorist attacks during a duration and period described in subparagraph (A).
    • (C) The individual—
      • (i)
        • (I) was a member of a fire or police department (whether fire or emergency personnel, active or retired), worked for a recovery or cleanup contractor, or was a volunteer; and performed rescue, recovery, demolition, debris cleanup, or other related services at the Pentagon site of the terrorist-related aircraft crash of September 11, 2001 , during the period beginning on September 11, 2001 , and ending on the date on which the cleanup of the site was concluded, as determined by the WTC Program Administrator; or
        • (II) was a member of a fire or police department (whether fire or emergency personnel, active or retired), worked for a recovery or cleanup contractor, or was a volunteer; and performed rescue, recovery, demolition, debris cleanup, or other related services at the Shanksville, Pennsylvania, site of the terrorist-related aircraft crash of September 11, 2001 , during the period beginning on September 11, 2001 , and ending on the date on which the cleanup of the site was concluded, as determined by the WTC Program Administrator; and
      • (ii) is determined by the WTC Program Administrator to be at an increased risk of developing a WTC-related health condition as a result of exposure to airborne toxins, other hazards, or adverse conditions resulting from the September 11, 2001 , terrorist attacks, and meets such eligibility criteria related to such exposures, as the WTC Program Administrator determines are appropriate, after consultation with the WTC Scientific/Technical Advisory Committee.
  • (3)
    • (A) The WTC Program Administrator shall establish a process for enrolling WTC responders in the WTC Program. Under such process—
      • (i) WTC responders described in paragraph (1)(A) shall be deemed to be enrolled in such Program;
      • (ii) subject to clause (iii), the Administrator shall enroll in such program individuals who are determined to be WTC responders;
      • (iii) the Administrator shall deny such enrollment to an individual if the Administrator determines that the numerical limitation in paragraph (4) on enrollment of WTC responders has been met;
      • (iv) there shall be no fee charged to the applicant for making an application for such enrollment;
      • (v) the Administrator shall make a determination on such an application not later than 60 days after the date of filing the application; and
      • (vi) an individual who is denied enrollment in such Program shall have an opportunity to appeal such determination in a manner established under such process.
    • (B)
      • (i) In accordance with subparagraph (A)(i), the WTC Program Administrator shall enroll an individual described in paragraph (1)(A) in the WTC Program not later than July 1, 2011 .
      • (ii) In accordance with subparagraph (A)(ii) and consistent with paragraph (4), the WTC Program Administrator shall enroll any other individual who is determined to be a WTC responder in the WTC Program at the time of such determination.
  • (4)
    • (A) The total number of individuals not described in paragraph (1)(A) or (2)(A)(ii) who may be enrolled under paragraph (3)(A)(ii) shall not exceed 75,000 at any time, of which no more than 2,500 may be individuals enrolled based on modified eligibility criteria established under paragraph (1)(C).
    • (B) In implementing subparagraph (A), the WTC Program Administrator shall—
      • (i) limit the number of enrollments made under paragraph (3)—
        • (I) in accordance with such subparagraph; and
        • (II) to such number, as determined by the Administrator based on the best available information and subject to amounts available under section 300mm–61 of this title , that will ensure sufficient funds will be available to provide treatment and monitoring benefits under this subchapter, with respect to all individuals who are enrolled; and
      • (ii) provide priority (subject to paragraph (3)(A)(i)) in such enrollments in the order in which individuals apply for enrollment under paragraph (3).
  • (5) No individual who is on the terrorist watch list maintained by the Department of Homeland Security shall qualify as an eligible WTC responder. Before enrolling any individual as a WTC responder in the WTC Program under paragraph (3), the Administrator, in consultation with the Secretary of Homeland Security, shall determine whether the individual is on such list.
• (b)
  • (1) In the case of an enrolled WTC responder (other than one described in subsection (a)(2)(A)(ii)), the WTC Program shall provide for monitoring benefits that include monitoring consistent with protocols approved by the WTC Program Administrator and including clinical examinations and long-term health monitoring and analysis. In the case of an enrolled WTC responder who is an active member of the Fire Department of New York City, the responder shall receive such benefits as part of the individual’s periodic company medical exams.
  • (2) The monitoring benefits under paragraph (1) shall be provided through the Clinical Center of Excellence for the type of individual involved or, in the case of an individual residing outside the New York metropolitan area, under an arrangement under section 300mm–23 of this title .

§ 300mm–22. Treatment of enrolled WTC responders for WTC-related health conditions

• (a)
  • (1) For purposes of this subchapter, the term “WTC-related health condition” means a condition that—
    • (A)
      • (i) is an illness or health condition for which exposure to airborne toxins, any other hazard, or any other adverse condition resulting from the September 11, 2001 , terrorist attacks, based on an examination by a medical professional with experience in treating or diagnosing the health conditions included in the applicable list of WTC-related health conditions, is substantially likely to be a significant factor in aggravating, contributing to, or causing the illness or health condition, as determined under paragraph (2); or
      • (ii) is a mental health condition for which such attacks, based on an examination by a medical professional with experience in treating or diagnosing the health conditions included in the applicable list of WTC-related health conditions, is substantially likely to be a significant factor in aggravating, contributing to, or causing the condition, as determined under paragraph (2); and
    • (B) is included in the applicable list of WTC-related health conditions or—
      • (i) with respect to a WTC responder, is provided certification of coverage under subsection (b)(2)(B)(iii); or
      • (ii) with respect to a screening-eligible WTC survivor or certified-eligible WTC survivor, is provided certification of coverage under subsection (b)(2)(B)(iii), as applied under section 300mm–32(a) of this title .
  • (2) The determination under paragraph (1) or subsection (b) of whether the September 11, 2001 , terrorist attacks were substantially likely to be a significant factor in aggravating, contributing to, or causing an individual’s illness or health condition shall be made based on an assessment of the following:
    • (A) The individual’s exposure to airborne toxins, any other hazard, or any other adverse condition resulting from the terrorist attacks. Such exposure shall be—
      • (i) evaluated and characterized through the use of a standardized, population-appropriate questionnaire approved by the Director of the National Institute for Occupational Safety and Health; and
      • (ii) assessed and documented by a medical professional with experience in treating or diagnosing health conditions included on the list of WTC-related health conditions.
    • (B) The type of symptoms and temporal sequence of symptoms. Such symptoms shall be—
      • (i) assessed through the use of a standardized, population-appropriate medical questionnaire approved by the Director of the National Institute for Occupational Safety and Health and a medical examination; and
      • (ii) diagnosed and documented by a medical professional described in subparagraph (A)(ii).
  • (3) The list of health conditions for WTC responders consists of the following:
    • (A)
      • (i) Interstitial lung diseases.
      • (ii) Chronic respiratory disorder—fumes/vapors.
      • (iii) Asthma.
      • (iv) Reactive airways dysfunction syndrome (RADS).
      • (v) WTC-exacerbated chronic obstructive pulmonary disease (COPD).
      • (vi) Chronic cough syndrome.
      • (vii) Upper airway hyperreactivity.
      • (viii) Chronic rhinosinusitis.
      • (ix) Chronic nasopharyngitis.
      • (x) Chronic laryngitis.
      • (xi) Gastroesophageal reflux disorder (GERD).
      • (xii) Sleep apnea exacerbated by or related to a condition described in a previous clause.
    • (B)
      • (i) Posttraumatic stress disorder (PTSD).
      • (ii) Major depressive disorder.
      • (iii) Panic disorder.
      • (iv) Generalized anxiety disorder.
      • (v) Anxiety disorder (not otherwise specified).
      • (vi) Depression (not otherwise specified).
      • (vii) Acute stress disorder.
      • (viii) Dysthymic disorder.
      • (ix) Adjustment disorder.
      • (x) Substance abuse.
    • (C) In the case of a WTC responder described in paragraph (4), a condition described in such paragraph.
    • (D) Any cancer (or type of cancer) or other condition added, pursuant to paragraph (5) or (6), to the list under this paragraph.
  • (4)
    • (A) For purposes of this subchapter, in the case of a WTC responder who received any treatment for a WTC-related musculoskeletal disorder on or before September 11, 2003 , the list of health conditions in paragraph (3) shall include:
      • (i) Low back pain.
      • (ii) Carpal tunnel syndrome (CTS).
      • (iii) Other musculoskeletal disorders.
    • (B) The term “WTC-related musculoskeletal disorder” means a chronic or recurrent disorder of the musculoskeletal system caused by heavy lifting or repetitive strain on the joints or musculoskeletal system occurring during rescue or recovery efforts in the New York City disaster area in the aftermath of the September 11, 2001 , terrorist attacks.
  • (5)
    • (A) The WTC Program Administrator shall periodically conduct a review of all available scientific and medical evidence, including findings and recommendations of Clinical Centers of Excellence, published in peer-reviewed journals to determine if, based on such evidence, cancer or a certain type of cancer should be added to the applicable list of WTC-related health conditions. The WTC Program Administrator shall conduct the first review under this subparagraph not later than 180 days after January 2, 2011 .
    • (B) Based on the periodic reviews under subparagraph (A), if the WTC Program Administrator determines that cancer or a certain type of cancer should be added to such list of WTC-related health conditions, the WTC Program Administrator shall propose regulations, through rulemaking, to add cancer or the certain type of cancer to such list.
    • (C) Based on all the available evidence in the rulemaking record, the WTC Program Administrator shall make a final determination of whether cancer or a certain type of cancer should be added to such list of WTC-related health conditions. If such a determination is made to make such an addition, the WTC Program Administrator shall by regulation add cancer or the certain type of cancer to such list.
    • (D) In the case that the WTC Program Administrator determines under subparagraph (B) or (C) that cancer or a certain type of cancer should not be added to such list of WTC-related health conditions, the WTC Program Administrator shall publish an explanation for such determination in the Federal Register. Any such determination to not make such an addition shall not preclude the addition of cancer or the certain type of cancer to such list at a later date.
  • (6)
    • (A) Whenever the WTC Program Administrator determines that a proposed rule should be promulgated to add a health condition to the list of health conditions in paragraph (3), the Administrator may request a recommendation of the Advisory Committee or may publish such a proposed rule in the Federal Register in accordance with subparagraph (D).
    • (B) In the case that the WTC Program Administrator receives a written petition by an interested party to add a health condition to the list of health conditions in paragraph (3), not later than 90 days after the date of receipt of such petition the Administrator shall—
      • (i) request a recommendation of the Advisory Committee;
      • (ii) publish a proposed rule in the Federal Register to add such health condition, in accordance with subparagraph (D);
      • (iii) publish in the Federal Register the Administrator’s determination not to publish such a proposed rule and the basis for such determination; or
      • (iv) publish in the Federal Register a determination that insufficient evidence exists to take action under clauses (i) through (iii).
    • (C) In the case that the Administrator requests a recommendation of the Advisory Committee under this paragraph, with respect to adding a health condition to the list in paragraph (3), the Advisory Committee shall submit to the Administrator such recommendation not later than 90 days after the date of such request or by such date (not to exceed 180 days after such date of request) as specified by the Administrator. Not later than 90 days after the date of receipt of such recommendation, the Administrator shall, in accordance with subparagraph (D), publish in the Federal Register a proposed rule with respect to such recommendation or a determination not to propose such a proposed rule and the basis for such determination.
    • (D) The WTC Program Administrator shall, with respect to any proposed rule under this paragraph—
      • (i) publish such proposed rule in accordance with section 553 of title 5 ; and
      • (ii) provide interested parties a period of 30 days after such publication to submit written comments on the proposed rule.
    • (E) For purposes of this paragraph, the term “interested party” includes a representative of any organization representing WTC responders, a nationally recognized medical association, a Clinical or Data Center, a State or political subdivision, or any other interested person.
    • (F) Prior to issuing a final rule to add a health condition to the list in paragraph (3), the WTC Program Administrator shall provide for an independent peer review of the scientific and technical evidence that would be the basis for issuing such final rule.
    • (G)
      • (i)
        • (I) Not later than 1 year after December 18, 2015 , the WTC Program Administrator shall request the Advisory Committee to review and evaluate the policies and procedures, in effect at the time of the review and evaluation, that are used to determine whether sufficient evidence exists to support adding a health condition to the list in paragraph (3).
        • (II) Prior to establishing any substantive new policy or procedure used to make the determination described in subclause (I) or prior to making any substantive amendment to any policy or procedure described in such subclause, the WTC Program Administrator shall request the Advisory Committee to review and evaluate such substantive policy, procedure, or amendment.
      • (ii) Not later than 1 year after December 18, 2015 , and not less than every 2 years thereafter, the WTC Program Administrator shall seek recommendations from the Advisory Committee regarding the identification of individuals to conduct the independent peer reviews under subparagraph (F).
• (b)
  • (1)
    • (A) If a physician at a Clinical Center of Excellence that is providing monitoring benefits under section 300mm–21 of this title for an enrolled WTC responder makes a determination that the responder has a WTC-related health condition that is in the list in subsection (a)(3) and that exposure to airborne toxins, other hazards, or adverse conditions resulting from the September 1, 2001 , terrorist attacks is substantially likely to be a significant factor in aggravating, contributing to, or causing the condition—
      • (i) the physician shall promptly transmit such determination to the WTC Program Administrator and provide the Administrator with the medical facts supporting such determination; and
      • (ii) on and after the date of such transmittal and subject to subparagraph (B), the WTC Program shall provide for payment under subsection (c) for medically necessary treatment for such condition.
    • (B)
      • (i) A Federal employee designated by the WTC Program Administrator shall review determinations made under subparagraph (A).
      • (ii) The Administrator shall provide a certification of such condition based upon reviews conducted under clause (i). Such a certification shall be provided unless the Administrator determines that the responder’s condition is not a WTC-related health condition in the list in subsection (a)(3) or that exposure to airborne toxins, other hazards, or adverse conditions resulting from the September 1, 2001 , terrorist attacks is not substantially likely to be a significant factor in aggravating, contributing to, or causing the condition.
      • (iii) The Administrator shall establish, by rule, a process for the appeal of determinations under clause (ii).
  • (2)
    • (A) If a physician at a Clinical Center of Excellence determines pursuant to subsection (a) that the enrolled WTC responder has a health condition described in subsection (a)(1)(A) that is not in the list in subsection (a)(3) but which is medically associated with a WTC-related health condition—
      • (i) the physician shall promptly transmit such determination to the WTC Program Administrator and provide the Administrator with the facts supporting such determination; and
      • (ii) the Administrator shall make a determination under subparagraph (B) with respect to such physician’s determination.
    • (B) The WTC Program Administrator shall, by rule, establish procedures for the review and certification of physician determinations under subparagraph (A). Such rule shall provide for—
      • (i) the timely review of such a determination by a physician panel with appropriate expertise for the condition and recommendations to the WTC Program Administrator;
      • (ii) not later than 60 days after the date of the transmittal under subparagraph (A)(i), a determination by the WTC Program Administrator on whether or not the condition involved is described in subsection (a)(1)(A) and is medically associated with a WTC-related health condition;
      • (iii) certification in accordance with paragraph (1)(B)(ii) of coverage of such condition if determined to be described in subsection (a)(1)(A) and medically associated with a WTC-related health condition; and
      • (iv) a process for appeals of determinations relating to such conditions.
    • (C) If the WTC Program Administrator provides certification under subparagraph (B)(iii) for coverage of a condition, the Administrator may, pursuant to subsection (a)(6), add the condition to the list in subsection (a)(3).
    • (D) If the WTC Program Administrator publishes a determination under subsection (a)(6)(B) not to include a condition in the list in subsection (a)(3), the WTC Program Administrator shall not provide certification under subparagraph (B)(iii) for coverage of the condition. In the case of an individual who is certified under subparagraph (B)(iii) with respect to such condition before the date of the publication of such determination the previous sentence shall not apply.
  • (3)
    • (A) In providing treatment for a WTC-related health condition, a physician or other provider shall provide treatment that is medically necessary and in accordance with medical treatment protocols established under subsection (d).
    • (B) For the purpose of this subchapter, the WTC Program Administrator shall issue regulations specifying a standard for determining medical necessity with respect to health care services and prescription pharmaceuticals, a process for determining whether treatment furnished and pharmaceuticals prescribed under this subchapter meet such standard (including any prior authorization requirement), and a process for appeal of a determination under subsection (c)(3).
  • (4)
    • (A) The scope of treatment covered under this subsection includes services of physicians and other health care providers, diagnostic and laboratory tests, prescription drugs, inpatient and outpatient hospital services, and other medically necessary treatment.
    • (B) With respect to ensuring coverage of medically necessary outpatient prescription drugs, such drugs shall be provided, under arrangements made by the WTC Program Administrator, directly through participating Clinical Centers of Excellence or through one or more outside vendors.
    • (C) The WTC Program Administrator may provide for necessary and reasonable transportation and expenses incident to the securing of medically necessary treatment through the nationwide network under section 300mm–23 of this title involving travel of more than 250 miles and for which payment is made under this section in the same manner in which individuals may be furnished necessary and reasonable transportation and expenses incident to services involving travel of more than 250 miles under regulations implementing section 7384t(c) of this title .
  • (5) With respect to an enrolled WTC responder for whom a determination is made by an examining physician under paragraph (1) or (2), but for whom the WTC Program Administrator has not yet determined whether to certify the determination, the WTC Program Administrator may establish by rule a process through which the Administrator may approve the provision of medical treatment under this subsection (and payment under subsection (c)) with respect to such responder and such responder’s WTC-related health condition (under such terms and conditions as the Administrator may provide) until the Administrator makes a decision on whether to certify the determination.
• (c)
  • (1)
    • (A)
      • (i) Subject to clause (ii):
        • (I) Subject to subparagraphs (B) and (C), the WTC Program Administrator shall reimburse costs for medically necessary treatment under this subchapter for WTC-related health conditions according to the payment rates that would apply to the provision of such treatment and services by the facility under the Federal Employees Compensation Act.
        • (II) For treatment not covered under subclause (i) or subparagraph (B), the WTC Program Administrator shall establish by regulation a reimbursement rate for such treatment.
      • (ii) In no case shall payments for products or services under clause (i) be made at a rate higher than the Office of Worker’s Compensation Programs in the Department 1 1 So in original. The word “of” probably should appear. Labor would pay for such products or services rendered at the time such products or services were provided.
    • (B)
      • (i) The WTC Program Administrator shall establish a program for paying for the medically necessary outpatient prescription pharmaceuticals prescribed under this subchapter for WTC-related health conditions through one or more contracts with outside vendors.
      • (ii) Under such program the Administrator shall—
        • (I) select one or more appropriate vendors through a Federal competitive bid process; and
        • (II) select the lowest bidder (or bidders) meeting the requirements for providing pharmaceutical benefits for participants in the WTC Program.
      • (iii) Under such program the Administrator may enter into an agreement with a separate vendor to provide pharmaceutical benefits to enrolled WTC responders for whom the Clinical Center of Excellence is described in section 300mm—4 of this title if such an arrangement is deemed necessary and beneficial to the program by the WTC Program Administrator.
      • (iv) Not later than July 1, 2011 , the Comptroller General of the United States shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report on whether existing Federal pharmaceutical purchasing programs can provide pharmaceutical benefits more efficiently and effectively than through the WTC program.
    • (C) The WTC Program Administrator may modify the amounts and methodologies for making payments for initial health evaluations, monitoring, or treatment, if, taking into account utilization and quality data furnished by the Clinical Centers of Excellence under section 300mm–4(b)(1)(B)(iii) of this title , the Administrator determines that a bundling, capitation, pay for performance, or other payment methodology would better ensure high quality and efficient delivery of initial health evaluations, monitoring, or treatment to an enrolled WTC responder, screening-eligible WTC survivor, or certified-eligible WTC survivor.
  • (2) The WTC Program Administrator shall reimburse the costs of monitoring and the costs of an initial health evaluation provided under this subchapter at a rate set by the Administrator by regulation.
  • (3)
    • (A) As part of the process for reimbursement or payment under this subsection, the WTC Program Administrator shall provide for the review of claims for reimbursement or payment for the provision of medical treatment to determine if such treatment is medically necessary and in accordance with medical treatment protocols established under subsection (d).
    • (B) The Administrator shall withhold such reimbursement or payment for treatment that the Administrator determines is not medically necessary or is not in accordance with such medical treatment protocols.
• (d)
  • (1) The Data Centers shall develop medical treatment protocols for the treatment of enrolled WTC responders and certified-eligible WTC survivors for health conditions included in the applicable list of WTC-related health conditions.
  • (2) The medical treatment protocols developed under paragraph (1) shall be subject to approval by the WTC Program Administrator.

§ 300mm–23. National arrangement for benefits for eligible individuals outside New York

• (a) In order to ensure reasonable access to benefits under this part for individuals who are enrolled WTC responders, screening-eligible WTC survivors, or certified-eligible WTC survivors and who reside in any State, as defined in section 201(f) of this title , outside the New York metropolitan area, the WTC Program Administrator shall establish a nationwide network of health care providers to provide monitoring and treatment benefits and initial health evaluations near such individuals’ areas of residence in such States. Nothing in this subsection shall be construed as preventing such individuals from being provided such monitoring and treatment benefits or initial health evaluation through any Clinical Center of Excellence.
• (b) Any health care provider participating in the network under subsection (a) shall—
  • (1) meet criteria for credentialing established by the Data Centers;
  • (2) follow the monitoring, initial health evaluation, and treatment protocols developed under section 300mm–4(a)(2)(A)(ii) of this title ;
  • (3) collect and report data in accordance with section 300mm–3 of this title ; and
  • (4) meet such fraud, quality assurance, and other requirements as the WTC Program Administrator establishes, including sections 1320a–7 through 1320a–7e of this title, as applied by section 300mm(d) of this title .
• (c) The WTC Program Administer 1 1 So in original. Probably should be “Administrator”. may provide, including through contract, for the provision of training and technical assistance to health care providers participating in the network under subsection (a).
• (d)
  • (1) The WTC Program Administrator may enter into an agreement with the Secretary of Veterans Affairs for the Secretary to provide services under this section through facilities of the Department of Veterans Affairs.
  • (2) Not later than July 1, 2011 , the Comptroller General of the United States shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report on whether the Department of Veterans Affairs can provide monitoring and treatment services to individuals under this section more efficiently and effectively than through the nationwide network to be established under subsection (a).

§ 300ff–24. Grants for home- and community-based care

• (a) A State may use amounts provided under a grant awarded under section 300ff–21 of this title to make grants under section 300ff–22(b)(3)(J) of this title to entities to—
  • (1) provide home- and community-based health services for individuals with HIV/AIDS pursuant to written plans of care prepared by a case management team, that shall include appropriate health care professionals, in such State for providing such services to such individuals;
  • (2) provide outreach services to individuals with HIV/AIDS, including those individuals in rural areas; and
  • (3) provide for the coordination of the provision of services under this section with the provision of HIV-related health services, including specialty care and vaccinations for hepatitis co-infection, provided by public and private entities.
• (b) In awarding grants under subsection (a), a State shall give priority to entities that provide assurances to the State that—
  • (1) such entities will participate in HIV care consortia if such consortia exist within the State; and
  • (2) such entities will utilize amounts provided under such grants for the provision of home- and community-based services to low-income individuals with HIV/AIDS.
• (c) As used in section 300ff–21 of this title , the term “home- and community-based health services”—
  • (1) means, with respect to an individual with HIV/AIDS, skilled health services furnished to the individual in the individual’s home pursuant to a written plan of care established by a case management team, that shall include appropriate health care professionals, for the provision of such services and items described in paragraph (2);
  • (2) includes—
    • (A) durable medical equipment;
    • (B) home health aide services and personal care services furnished in the home of the individual;
    • (C) day treatment or other partial hospitalization services;
    • (D) home intravenous and aerosolized drug therapy (including prescription drugs administered as part of such therapy);
    • (E) routine diagnostic testing administered in the home of the individual; and
    • (F) appropriate mental health, developmental, and rehabilitation services; and
  • (3) does not include—
    • (A) inpatient hospital services; and
    • (B) nursing home and other long term care facilities.

§ 299b–24a. Activities regarding women’s health

• (a) There is established within the Office of the Director, an Office of Women’s Health and Gender-Based Research (referred to in this section as the “Office”). The Office shall be headed by a director who shall be appointed by the Director of Healthcare and Research Quality.
• (b) The official designated under subsection (a) shall—
  • (1) report to the Director on the current Agency level of activity regarding women’s health, across, where appropriate, age, biological, and sociocultural contexts, in all aspects of Agency work, including the development of evidence reports and clinical practice protocols and the conduct of research into patient outcomes, delivery of health care services, quality of care, and access to health care;
  • (2) establish short-range and long-range goals and objectives within the Agency for research important to women’s health and, as relevant and appropriate, coordinate with other appropriate offices on activities within the Agency that relate to health services and medical effectiveness research, for issues of particular concern to women;
  • (3) identify projects in women’s health that should be conducted or supported by the Agency;
  • (4) consult with health professionals, nongovernmental organizations, consumer organizations, women’s health professionals, and other individuals and groups, as appropriate, on Agency policy with regard to women; and
  • (5) serve as a member of the Department of Health and Human Services Coordinating Committee on Women’s Health (established under section 237a(b)(4) of this title ).
• (c) For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2010 through 2014.

§ 300gg–25. Standards relating to benefits for mothers and newborns

• (a)
  • (1) A group health plan, and a health insurance issuer offering group or individual health insurance coverage, may not—
    • (A) except as provided in paragraph (2)—
      • (i) restrict benefits for any hospital length of stay in connection with childbirth for the mother or newborn child, following a normal vaginal delivery, to less than 48 hours, or
      • (ii) restrict benefits for any hospital length of stay in connection with childbirth for the mother or newborn child, following a cesarean section, to less than 96 hours, or
    • (B) require that a provider obtain authorization from the plan or the issuer for prescribing any length of stay required under subparagraph (A) (without regard to paragraph (2)).
  • (2) Paragraph (1)(A) shall not apply in connection with any group health plan or health insurance issuer in any case in which the decision to discharge the mother or her newborn child prior to the expiration of the minimum length of stay otherwise required under paragraph (1)(A) is made by an attending provider in consultation with the mother.
• (b) A group health plan, and a health insurance issuer offering group or individual health insurance coverage, may not—
  • (1) deny to the mother or her newborn child eligibility, or continued eligibility, to enroll or to renew coverage under the terms of the plan or coverage, solely for the purpose of avoiding the requirements of this section;
  • (2) provide monetary payments or rebates to mothers to encourage such mothers to accept less than the minimum protections available under this section;
  • (3) penalize or otherwise reduce or limit the reimbursement of an attending provider because such provider provided care to an individual participant or beneficiary in accordance with this section;
  • (4) provide incentives (monetary or otherwise) to an attending provider to induce such provider to provide care to an individual participant or beneficiary in a manner inconsistent with this section; or
  • (5) subject to subsection (c)(3), restrict benefits for any portion of a period within a hospital length of stay required under subsection (a) in a manner which is less favorable than the benefits provided for any preceding portion of such stay.
• (c)
  • (1) Nothing in this section shall be construed to require a mother who is a participant or beneficiary—
    • (A) to give birth in a hospital; or
    • (B) to stay in the hospital for a fixed period of time following the birth of her child.
  • (2) This section shall not apply with respect to any group health plan, or any health insurance issuer offering group or individual health insurance coverage, which does not provide benefits for hospital lengths of stay in connection with childbirth for a mother or her newborn child.
  • (3) Nothing in this section shall be construed as preventing a group health plan or health insurance issuer from imposing deductibles, coinsurance, or other cost-sharing in relation to benefits for hospital lengths of stay in connection with childbirth for a mother or newborn child under the plan (or under health insurance coverage offered in connection with a group health plan), except that such coinsurance or other cost-sharing for any portion of a period within a hospital length of stay required under subsection (a) may not be greater than such coinsurance or cost-sharing for any preceding portion of such stay.
• (d) A group health plan under this part shall comply with the notice requirement under section 1185(d) of title 29 with respect to the requirements of this section as if such section applied to such plan.
• (e) Nothing in this section shall be construed to prevent a group health plan or a health insurance issuer offering group or individual health insurance coverage from negotiating the level and type of reimbursement with a provider for care provided in accordance with this section.
• (f)
  • (1) The requirements of this section shall not apply with respect to health insurance coverage if there is a State law (as defined in section 300gg–23(d)(1) 1 1 See References in Text note below. of this title) for a State that regulates such coverage that is described in any of the following subparagraphs:
    • (A) Such State law requires such coverage to provide for at least a 48-hour hospital length of stay following a normal vaginal delivery and at least a 96-hour hospital length of stay following a cesarean section.
    • (B) Such State law requires such coverage to provide for maternity and pediatric care in accordance with guidelines established by the American College of Obstetricians and Gynecologists, the American Academy of Pediatrics, or other established professional medical associations.
    • (C) Such State law requires, in connection with such coverage for maternity care, that the hospital length of stay for such care is left to the decision of (or required to be made by) the attending provider in consultation with the mother.
  • (2) Section 300gg–23(a)(1) 1 of this title shall not be construed as superseding a State law described in paragraph (1).

§ 290bb–25b. Programs to reduce underage drinking

• (a) For purposes of this section:
  • (1) The term “alcohol beverage industry” means the brewers, vintners, distillers, importers, distributors, and retail or online outlets that sell or serve beer, wine, and distilled spirits.
  • (2) The term “school-based prevention” means programs, which are institutionalized, and run by staff members or school-designated persons or organizations in any grade of school, kindergarten through 12th grade.
  • (3) The term “youth” means persons under the age of 21.
  • (4) The term “IOM report” means the report released in September 2003 by the National Research Council, Institute of Medicine, and entitled “Reducing Underage Drinking: A Collective Responsibility”.
• (b) It is the sense of the Congress that:
  • (1) A multi-faceted effort is needed to more successfully address the problem of underage drinking in the United States. A coordinated approach to prevention, intervention, treatment, enforcement, and research is key to making progress. This chapter recognizes the need for a focused national effort, and addresses particulars of the Federal portion of that effort, as well as Federal support for State activities.
  • (2) The Secretary of Health and Human Services shall continue to conduct research and collect data on the short and long-range impact of alcohol use and abuse upon adolescent brain development and other organ systems.
  • (3) States and communities, including colleges and universities, are encouraged to adopt comprehensive prevention approaches, including—
    • (A) evidence-based screening, programs and curricula;
    • (B) brief intervention strategies;
    • (C) consistent policy enforcement; and
    • (D) environmental changes that limit underage access to alcohol.
  • (4) Public health groups, consumer groups, and the alcohol beverage industry should continue and expand evidence-based efforts to prevent and reduce underage drinking.
  • (5) The entertainment industries have a powerful impact on youth, and they should use rating systems and marketing codes to reduce the likelihood that underage audiences will be exposed to movies, recordings, or television programs with unsuitable alcohol content.
  • (6) The National Collegiate Athletic Association, its member colleges and universities, and athletic conferences should affirm a commitment to a policy of discouraging alcohol use among underage students and other young fans.
  • (7) Alcohol is a unique product and should be regulated differently than other products by the States and Federal Government. States have primary authority to regulate alcohol distribution and sale, and the Federal Government should support and supplement these State efforts. States also have a responsibility to fight youth access to alcohol and reduce underage drinking. Continued State regulation and licensing of the manufacture, importation, sale, distribution, transportation and storage of alcoholic beverages are clearly in the public interest and are critical to promoting responsible consumption, preventing illegal access to alcohol by persons under 21 years of age from commercial and non-commercial sources, maintaining industry integrity and an orderly marketplace, and furthering effective State tax collection.
• (c)
  • (1)
    • (A) The Secretary, in collaboration with the Federal officials specified in subparagraph (B), shall formally establish and enhance the efforts of the interagency coordinating committee, that began operating in 2004, focusing on underage drinking (referred to in this subsection as the “Committee”).
    • (B) The officials referred to in paragraph (1) are the Secretary of Education, the Attorney General, the Secretary of Transportation, the Secretary of the Treasury, the Secretary of Defense, the Surgeon General, the Director of the Centers for Disease Control and Prevention, the Director of the National Institute on Alcohol Abuse and Alcoholism, the Assistant Secretary for Mental Health and Substance Use, the Director of the National Institute on Drug Abuse, the Assistant Secretary for Children and Families, the Director of the Office of National Drug Control Policy, the Administrator of the National Highway Traffic Safety Administration, the Administrator of the Office of Juvenile Justice and Delinquency Prevention, the Chairman of the Federal Trade Commission, and such other Federal officials as the Secretary of Health and Human Services determines to be appropriate.
    • (C) The Secretary of Health and Human Services shall serve as the chair of the Committee.
    • (D) The Committee shall guide policy and program development across the Federal Government with respect to underage drinking, provided, however, that nothing in this section shall be construed as transferring regulatory or program authority from an Agency to the Coordinating Committee.
    • (E) The Committee shall actively seek the input of and shall consult with all appropriate and interested parties, including States, public health research and interest groups, foundations, and alcohol beverage industry trade associations and companies.
    • (F)
      • (i) The Secretary, on behalf of the Committee, shall annually submit to the Congress a report that summarizes—
        • (I) all programs and policies of Federal agencies designed to prevent and reduce underage drinking;
        • (II) the extent of progress in preventing and reducing underage drinking nationally;
        • (III) data that the Secretary shall collect with respect to the information specified in clause (ii); and
        • (IV) such other information regarding underage drinking as the Secretary determines to be appropriate.
      • (ii) The report under clause (i) shall include information on the following:
        • (I) Patterns and consequences of underage drinking as reported in research and surveys such as, but not limited to Monitoring the Future, Youth Risk Behavior Surveillance System, the National Survey on Drug Use and Health, and the Fatality Analysis Reporting System.
        • (II) Measures of the availability of alcohol from commercial and non-commercial sources to underage populations.
        • (III) Measures of the exposure of underage populations to messages regarding alcohol in advertising and the entertainment media as reported by the Federal Trade Commission.
        • (IV) Surveillance data, including information on the onset and prevalence of underage drinking, consumption patterns and the means of underage access. The Secretary shall develop a plan to improve the collection, measurement and consistency of reporting Federal underage alcohol data.
        • (V) Any additional findings resulting from research conducted or supported under subsection (f).
        • (VI) Evidence-based best practices to prevent and reduce underage drinking and provide treatment services to those youth who need them.
  • (2)
    • (A) The Secretary shall, with input and collaboration from other appropriate Federal agencies, States, Indian tribes, territories, and public health, consumer, and alcohol beverage industry groups, annually issue a report on each State’s performance in enacting, enforcing, and creating laws, regulations, and programs to prevent or reduce underage drinking.
    • (B)
      • (i) The Secretary shall develop, in consultation with the Committee, a set of measures to be used in preparing the report on best practices.
      • (ii) In developing these measures, the Secretary shall consider categories including, but not limited to:
        • (I) Whether or not the State has comprehensive anti-underage drinking laws such as for the illegal sale, purchase, attempt to purchase, consumption, or possession of alcohol; illegal use of fraudulent ID; illegal furnishing or obtaining of alcohol for an individual under 21 years; the degree of strictness of the penalties for such offenses; and the prevalence of the enforcement of each of these infractions.
        • (II) Whether or not the State has comprehensive liability statutes pertaining to underage access to alcohol such as dram shop, social host, and house party laws, and the prevalence of enforcement of each of these laws.
        • (III) Whether or not the State encourages and conducts comprehensive enforcement efforts to prevent underage access to alcohol at retail outlets, such as random compliance checks and shoulder tap programs, and the number of compliance checks within alcohol retail outlets measured against the number of total alcohol retail outlets in each State, and the result of such checks.
        • (IV) Whether or not the State encourages training on the proper selling and serving of alcohol for all sellers and servers of alcohol as a condition of employment.
        • (V) Whether or not the State has policies and regulations with regard to direct sales to consumers and home delivery of alcoholic beverages.
        • (VI) Whether or not the State has programs or laws to deter adults from purchasing alcohol for minors; and the number of adults targeted by these programs.
        • (VII) Whether or not the State has programs targeted to youths, parents, and caregivers to deter underage drinking; and the number of individuals served by these programs.
        • (VIII) Whether or not the State has enacted graduated drivers licenses and the extent of those provisions.
        • (IX) The amount that the State invests, per youth capita, on the prevention of underage drinking, further broken down by the amount spent on—
  • (3) There are authorized to be appropriated to carry out this subsection $1,000,000 for each of the fiscal years 2018 through 2022.
• (d)
  • (1) The Secretary shall continue to fund and oversee the production, broadcasting, and evaluation of the national adult-oriented media public service campaign if the Secretary determines that such campaign is effective in achieving the media campaign’s measurable objectives.
  • (2) The Secretary shall provide a report to the Congress annually detailing the production, broadcasting, and evaluation of the campaign referred to in paragraph (1), and to detail in the report the effectiveness of the campaign in reducing underage drinking, the need for and likely effectiveness of an expanded adult-oriented media campaign, and the feasibility and the likely effectiveness of a national youth-focused media campaign to combat underage drinking.
  • (3) In carrying out the media campaign, the Secretary shall direct the entity carrying out the national adult-oriented media public service campaign to consult with interested parties including both the alcohol beverage industry and public health and consumer groups. The progress of this consultative process is to be covered in the report under paragraph (2).
  • (4) There are authorized to be appropriated to carry out this subsection, $1,000,000 for each of the fiscal years 2018 through 2022.
• (e)
  • (1)
    • (A) The Assistant Secretary for Mental Health and Substance Use, in consultation with the Director of the Office of National Drug Control Policy, shall award, if the Assistant Secretary determines that the Department of Health and Human Services is not currently conducting activities that duplicate activities of the type described in this subsection, “enhancement grants” to eligible entities to design, test, evaluate and disseminate effective strategies to maximize the effectiveness of community-wide approaches to preventing and reducing underage drinking. This subsection is subject to the availability of appropriations.
    • (B) The purposes of this paragraph are to—
      • (i) prevent and reduce alcohol use among youth in communities throughout the United States;
      • (ii) strengthen collaboration among communities, the Federal Government, and State, local, and tribal governments;
      • (iii) enhance intergovernmental cooperation and coordination on the issue of alcohol use among youth;
      • (iv) serve as a catalyst for increased citizen participation and greater collaboration among all sectors and organizations of a community that first demonstrates a long-term commitment to reducing alcohol use among youth;
      • (v) disseminate to communities timely information regarding state-of-the-art practices and initiatives that have proven to be effective in preventing and reducing alcohol use among youth; and
      • (vi) enhance, not supplant, effective local community initiatives for preventing and reducing alcohol use among youth.
    • (C) An eligible entity desiring an enhancement grant under this paragraph shall submit an application to the Assistant Secretary at such time, and in such manner, and accompanied by such information as the Assistant Secretary may require. Each application shall include—
      • (i) a complete description of the entity’s current underage alcohol use prevention initiatives and how the grant will appropriately enhance the focus on underage drinking issues; or
      • (ii) a complete description of the entity’s current initiatives, and how it will use this grant to enhance those initiatives by adding a focus on underage drinking prevention.
    • (D) Each eligible entity that receives a grant under this paragraph shall use the grant funds to carry out the activities described in such entity’s application submitted pursuant to subparagraph (C). Grants under this paragraph shall not exceed $50,000 per year and may not exceed four years.
    • (E) Grant funds provided under this paragraph shall be used to supplement, not supplant, Federal and non-Federal funds available for carrying out the activities described in this paragraph.
    • (F) Grants under this paragraph shall be subject to the same evaluation requirements and procedures as the evaluation requirements and procedures imposed on recipients of drug free community grants.
    • (G) For purposes of this paragraph, the term “eligible entity” means an organization that is currently receiving or has received grant funds under the Drug-Free Communities Act of 1997 ( 21 U.S.C. 1521 et seq.).
    • (H) Not more than 6 percent of a grant under this paragraph may be expended for administrative expenses.
    • (I) There are authorized to be appropriated to carry out this paragraph $5,000,000 for each of the fiscal years 2018 through 2022.
  • (2)
    • (A) The Secretary shall award grants to eligible entities to enable the entities to prevent and reduce the rate of underage alcohol consumption including binge drinking among students at institutions of higher education.
    • (B) An eligible entity that desires to receive a grant under this paragraph shall submit an application to the Secretary at such time, in such manner, and accompanied by such information as the Secretary may require. Each application shall include—
      • (i) a description of how the eligible entity will work to enhance an existing, or where none exists to build a, statewide coalition;
      • (ii) a description of how the eligible entity will target underage students in the State;
      • (iii) a description of how the eligible entity intends to ensure that the statewide coalition is actually implementing the purpose of this section and moving toward indicators described in subparagraph (D);
      • (iv) a list of the members of the statewide coalition or interested parties involved in the work of the eligible entity;
      • (v) a description of how the eligible entity intends to work with State agencies on substance abuse prevention and education;
      • (vi) the anticipated impact of funds provided under this paragraph in preventing and reducing the rates of underage alcohol use;
      • (vii) outreach strategies, including ways in which the eligible entity proposes to—
        • (I) reach out to students and community stakeholders;
        • (II) promote the purpose of this paragraph;
        • (III) address the range of needs of the students and the surrounding communities; and
        • (IV) address community norms for underage students regarding alcohol use; and
      • (viii) such additional information as required by the Secretary.
    • (C) Each eligible entity that receives a grant under this paragraph shall use the grant funds to carry out the activities described in such entity’s application submitted pursuant to subparagraph (B).
    • (D) On the date on which the Secretary first publishes a notice in the Federal Register soliciting applications for grants under this paragraph, the Secretary shall include in the notice achievement indicators for the program authorized under this paragraph. The achievement indicators shall be designed—
      • (i) to measure the impact that the statewide coalitions assisted under this paragraph are having on the institutions of higher education and the surrounding communities, including changes in the number of incidents of any kind in which students have abused alcohol or consumed alcohol while under the age of 21 (including violations, physical assaults, sexual assaults, reports of intimidation, disruptions of school functions, disruptions of student studies, mental health referrals, illnesses, or deaths);
      • (ii) to measure the quality and accessibility of the programs or information offered by the eligible entity; and
      • (iii) to provide such other measures of program impact as the Secretary determines appropriate.
    • (E) Grant funds provided under this paragraph shall be used to supplement, and not supplant, Federal and non-Federal funds available for carrying out the activities described in this paragraph.
    • (F) For purposes of this paragraph:
      • (i) The term “eligible entity” means a State, institution of higher education, or nonprofit entity.
      • (ii) The term “institution of higher education” has the meaning given the term in section 1001(a) of title 20 .
      • (iii) The term “Secretary” means the Secretary of Education.
      • (iv) The term “State” means each of the 50 States, the District of Columbia, and the Commonwealth of Puerto Rico.
      • (v) The term “statewide coalition” means a coalition that—
        • (I) includes, but is not limited to—
        • (II) works toward lowering the alcohol abuse rate by targeting underage students at institutions of higher education throughout the State and in the surrounding communities.
      • (vi) The term “surrounding community” means the community—
        • (I) that surrounds an institution of higher education participating in a statewide coalition;
        • (II) where the students from the institution of higher education take part in the community; and
        • (III) where students from the institution of higher education live in off-campus housing.
    • (G) Not more than 5 percent of a grant under this paragraph may be expended for administrative expenses.
    • (H) There are authorized to be appropriated to carry out this paragraph $5,000,000 for fiscal year 2007, and $5,000,000 for each of the fiscal years 2008 through 2010.
• (f)
  • (1)
    • (A) The Secretary shall, subject to the availability of appropriations, collect data, and conduct or support research that is not duplicative of research currently being conducted or supported by the Department of Health and Human Services, on underage drinking, with respect to the following:
      • (i) Comprehensive community-based programs or strategies and statewide systems to prevent and reduce underage drinking, across the underage years from early childhood to age 21, including programs funded and implemented by government entities, public health interest groups and foundations, and alcohol beverage companies and trade associations.
      • (ii) Annually obtain and report more precise information than is currently collected on the scope of the underage drinking problem and patterns of underage alcohol consumption, including improved knowledge about the problem and progress in preventing, reducing and treating underage drinking; as well as information on the rate of exposure of youth to advertising and other media messages encouraging and discouraging alcohol consumption.
      • (iii) Compiling information on the involvement of alcohol in unnatural deaths of persons ages 12 to 20 in the United States, including suicides, homicides, and unintentional injuries such as falls, drownings, burns, poisonings, and motor vehicle crash deaths.
    • (B) The Secretary shall carry out activities toward the following objectives with respect to underage drinking:
      • (i) Obtaining new epidemiological data within the national or targeted surveys that identify alcohol use and attitudes about alcohol use during pre- and early adolescence, including harm caused to self or others as a result of adolescent alcohol use such as violence, date rape, risky sexual behavior, and prenatal alcohol exposure.
      • (ii) Developing or identifying successful clinical treatments for youth with alcohol problems.
    • (C) Research under subparagraph (A) shall meet current Federal standards for scientific peer review.
  • (2) There are authorized to be appropriated to carry out this subsection $3,000,000 for each of the fiscal years 2018 through 2022 1 1 So in original. A period probably should appear.
• (g)
  • (1) The Assistant Secretary may make grants to eligible entities to increase implementation of practices for reducing the prevalence of alcohol use among individuals under the age of 21, including college students.
  • (2) Grants under this subsection shall be made to improve—
    • (A) screening children and adolescents for alcohol use;
    • (B) offering brief interventions to children and adolescents to discourage such use;
    • (C) educating parents about the dangers of, and methods of discouraging, such use;
    • (D) diagnosing and treating alcohol use disorders; and
    • (E) referring patients, when necessary, to other appropriate care.
  • (3) An entity receiving a grant under this subsection may use such funding for the purposes identified in paragraph (2) by—
    • (A) providing training to health care providers;
    • (B) disseminating best practices, including culturally and linguistically appropriate best practices, as appropriate, and developing and distributing materials; and
    • (C) supporting other activities, as determined appropriate by the Assistant Secretary.
  • (4) To be eligible to receive a grant under this subsection, an entity shall submit an application to the Assistant Secretary at such time, and in such manner, and accompanied by such information as the Assistant Secretary may require. Each application shall include—
    • (A) a description of the entity;
    • (B) a description of activities to be completed;
    • (C) a description of how the services specified in paragraphs (2) and (3) will be carried out and the qualifications for providing such services; and
    • (D) a timeline for the completion of such activities.
  • (5) For the purpose of this subsection:
    • (A) The term “brief intervention” means, after screening a patient, providing the patient with brief advice and other brief motivational enhancement techniques designed to increase the insight of the patient regarding the patient’s alcohol use, and any realized or potential consequences of such use, to effect the desired related behavioral change.
    • (B) The term “children and adolescents” means any person under 21 years of age.
    • (C) The term “eligible entity” means an entity consisting of pediatric health care providers and that is qualified to support or provide the activities identified in paragraph (2).
    • (D) The term “pediatric health care provider” means a provider of primary health care to individuals under the age of 21 years.
    • (E) The term “screening” means using validated patient interview techniques to identify and assess the existence and extent of alcohol use in a patient.

§ 290bb–25d. Centers of excellence on services for individuals with fetal alcohol syndrome and alcohol-related birth defects and treatment for individuals with such conditions and their families

• (a) The Secretary shall make awards of grants, cooperative agreements, or contracts to public or nonprofit private entities for the purposes of establishing not more than four centers of excellence to study techniques for the prevention of fetal alcohol syndrome and alcohol-related birth defects and adaptations of innovative clinical interventions and service delivery improvements for the provision of comprehensive services to individuals with fetal alcohol syndrome or alcohol-related birth defects and their families and for providing training on such conditions.
• (b) An award under subsection (a) may be used to—
  • (1) study adaptations of innovative clinical interventions and service delivery improvements strategies for children and adults with fetal alcohol syndrome or alcohol-related birth defects and their families;
  • (2) identify communities which have an exemplary comprehensive system of care for such individuals so that they can provide technical assistance to other communities attempting to set up such a system of care;
  • (3) provide technical assistance to communities who do not have a comprehensive system of care for such individuals and their families;
  • (4) train community leaders, mental health and substance abuse professionals, families, law enforcement personnel, judges, health professionals, persons working in financial assistance programs, social service personnel, child welfare professionals, and other service providers on the implications of fetal alcohol syndrome and alcohol-related birth defects, the early identification of and referral for such conditions;
  • (5) develop innovative techniques for preventing alcohol use by women in child bearing years;
  • (6) perform other functions, to the extent authorized by the Secretary after consideration of recommendations made by the National Task Force on Fetal Alcohol Syndrome.
• (c)
  • (1) A recipient of an award under subsection (a) shall at the end of the period of funding report to the Secretary on any innovative techniques that have been discovered for preventing alcohol use among women of child bearing years.
  • (2) The Secretary shall upon receiving a report under paragraph (1) disseminate the findings to appropriate public and private entities.
• (d) With respect to an award under subsection (a), the period during which payments under such award are made to the recipient may not exceed 5 years.
• (e) The Secretary shall evaluate each project carried out under subsection (a) and shall disseminate the findings with respect to each such evaluation to appropriate public and private entities.
• (f) For the purpose of carrying out this section, there are authorized to be appropriated $5,000,000 for fiscal year 2001, and such sums as may be necessary for each of the fiscal years 2002 and 2003.

§ 290bb–25f. Prevention and education programs

• (a) The Secretary of Health and Human Services (referred to in this Act as the “Secretary”) shall award grants to public and nonprofit private entities to enable such entities to carry out science-based education programs in elementary and secondary schools to highlight the harmful effects of anabolic steroids.
• (b)
  • (1) To be eligible for grants under subsection (a), an entity shall prepare and submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may require.
  • (2) In awarding grants under subsection (a), the Secretary shall give preference to applicants that intend to use grant funds to carry out programs based on—
    • (A) the Athletes Training and Learning to Avoid Steroids program;
    • (B) The Athletes Targeting Healthy Exercise and Nutrition Alternatives program; and
    • (C) other programs determined to be effective by the National Institute on Drug Abuse.
• (c) Amounts received under a grant under subsection (a) shall be used for education programs that will directly communicate with teachers, principals, coaches, as well as elementary and secondary school children concerning the harmful effects of anabolic steroids.
• (d) There is authorized to be appropriated to carry out this section, $15,000,000 for each of fiscal years 2005 through 2010.

§ 290bb–25g. Awareness campaigns

• (a) The Secretary of Health and Human Services, acting through the Director of the Centers for Disease Control and Prevention and in coordination with the heads of other departments and agencies, shall advance education and awareness regarding the risks related to misuse and abuse of opioids, as appropriate, which may include developing or improving existing programs, conducting activities, and awarding grants that advance the education and awareness of—
  • (1) the public, including patients and consumers—
    • (A) generally; and
    • (B) regarding such risks related to unused opioids and the dispensing options under section 829(f) of title 21 , as applicable; and
  • (2) providers, which may include—
    • (A) providing for continuing education on appropriate prescribing practices;
    • (B) education related to applicable State or local prescriber limit laws, information on the use of non-addictive alternatives for pain management, and the use of overdose reversal drugs, as appropriate;
    • (C) disseminating and improving the use of evidence-based opioid prescribing guidelines across relevant health care settings, as appropriate, and updating guidelines as necessary;
    • (D) implementing strategies, such as best practices, to encourage and facilitate the use of prescriber guidelines, in accordance with State and local law;
    • (E) disseminating information to providers about prescribing options for controlled substances, including such options under section 829(f) of title 21 , as applicable; and
    • (F) disseminating information, as appropriate, on the National Pain Strategy developed by or in consultation with the Assistant Secretary for Health; and
  • (3) other appropriate entities.
• (b) The education and awareness campaigns under subsection (a) shall address—
  • (1) the dangers of opioid misuse and abuse;
  • (2) the prevention of opioid misuse and abuse, including through non-addictive treatment options, safe disposal options for prescription medications, and other applicable safety precautions; and
  • (3) the detection of early warning signs of addiction.
• (c) The education and awareness campaigns under subsection (a) shall, as appropriate—
  • (1) take into account any association between prescription opioid abuse and heroin use;
  • (2) emphasize—
    • (A) the similarities between heroin and prescription opioids; and
    • (B) the effects of heroin and prescription opioids on the human body; and
  • (3) bring greater public awareness to the dangerous effects of fentanyl when mixed with heroin or abused in a similar manner.

§ 300gg–26. Parity in mental health and substance use disorder benefits

• (a)
  • (1) In the case of a group health plan or a health insurance issuer offering group or individual health insurance coverage that provides both medical and surgical benefits and mental health or substance use disorder benefits—
    • (A) If the plan or coverage does not include an aggregate lifetime limit on substantially all medical and surgical benefits, the plan or coverage may not impose any aggregate lifetime limit on mental health or substance use disorder benefits.
    • (B) If the plan or coverage includes an aggregate lifetime limit on substantially all medical and surgical benefits (in this paragraph referred to as the “applicable lifetime limit”), the plan or coverage shall either—
      • (i) apply the applicable lifetime limit both to the medical and surgical benefits to which it otherwise would apply and to mental health and substance use disorder benefits and not distinguish in the application of such limit between such medical and surgical benefits and mental health and substance use disorder benefits; or
      • (ii) not include any aggregate lifetime limit on mental health or substance use disorder benefits that is less than the applicable lifetime limit.
    • (C) In the case of a plan or coverage that is not described in subparagraph (A) or (B) and that includes no or different aggregate lifetime limits on different categories of medical and surgical benefits, the Secretary shall establish rules under which subparagraph (B) is applied to such plan or coverage with respect to mental health and substance use disorder benefits by substituting for the applicable lifetime limit an average aggregate lifetime limit that is computed taking into account the weighted average of the aggregate lifetime limits applicable to such categories.
  • (2) In the case of a group health plan or a health insurance issuer offering group or individual health insurance coverage that provides both medical and surgical benefits and mental health or substance use disorder benefits—
    • (A) If the plan or coverage does not include an annual limit on substantially all medical and surgical benefits, the plan or coverage may not impose any annual limit on mental health or substance use disorder benefits.
    • (B) If the plan or coverage includes an annual limit on substantially all medical and surgical benefits (in this paragraph referred to as the “applicable annual limit”), the plan or coverage shall either—
      • (i) apply the applicable annual limit both to medical and surgical benefits to which it otherwise would apply and to mental health and substance use disorder benefits and not distinguish in the application of such limit between such medical and surgical benefits and mental health and substance use disorder benefits; or
      • (ii) not include any annual limit on mental health or substance use disorder benefits that is less than the applicable annual limit.
    • (C) In the case of a plan or coverage that is not described in subparagraph (A) or (B) and that includes no or different annual limits on different categories of medical and surgical benefits, the Secretary shall establish rules under which subparagraph (B) is applied to such plan or coverage with respect to mental health and substance use disorder benefits by substituting for the applicable annual limit an average annual limit that is computed taking into account the weighted average of the annual limits applicable to such categories.
  • (3)
    • (A) In the case of a group health plan or a health insurance issuer offering group or individual health insurance coverage that provides both medical and surgical benefits and mental health or substance use disorder benefits, such plan or coverage shall ensure that—
      • (i) the financial requirements applicable to such mental health or substance use disorder benefits are no more restrictive than the predominant financial requirements applied to substantially all medical and surgical benefits covered by the plan (or coverage), and there are no separate cost sharing requirements that are applicable only with respect to mental health or substance use disorder benefits; and
      • (ii) the treatment limitations applicable to such mental health or substance use disorder benefits are no more restrictive than the predominant treatment limitations applied to substantially all medical and surgical benefits covered by the plan (or coverage) and there are no separate treatment limitations that are applicable only with respect to mental health or substance use disorder benefits.
    • (B) In this paragraph:
      • (i) The term “financial requirement” includes deductibles, copayments, coinsurance, and out-of-pocket expenses, but excludes an aggregate lifetime limit and an annual limit subject to paragraphs (1) and (2).
      • (ii) A financial requirement or treatment limit is considered to be predominant if it is the most common or frequent of such type of limit or requirement.
      • (iii) The term “treatment limitation” includes limits on the frequency of treatment, number of visits, days of coverage, or other similar limits on the scope or duration of treatment.
  • (4) The criteria for medical necessity determinations made under the plan with respect to mental health or substance use disorder benefits (or the health insurance coverage offered in connection with the plan with respect to such benefits) shall be made available by the plan administrator (or the health insurance issuer offering such coverage) in accordance with regulations to any current or potential participant, beneficiary, or contracting provider upon request. The reason for any denial under the plan (or coverage) of reimbursement or payment for services with respect to mental health or substance use disorder benefits in the case of any participant or beneficiary shall, on request or as otherwise required, be made available by the plan administrator (or the health insurance issuer offering such coverage) to the participant or beneficiary in accordance with regulations.
  • (5) In the case of a plan or coverage that provides both medical and surgical benefits and mental health or substance use disorder benefits, if the plan or coverage provides coverage for medical or surgical benefits provided by out-of-network providers, the plan or coverage shall provide coverage for mental health or substance use disorder benefits provided by out-of-network providers in a manner that is consistent with the requirements of this section.
  • (6)
    • (A) Not later than 12 months after December 13, 2016 , the Secretary, the Secretary of Labor, and the Secretary of the Treasury, in consultation with the Inspector General of the Department of Health and Human Services, the Inspector General of the Department of Labor, and the Inspector General of the Department of the Treasury, shall issue a compliance program guidance document to help improve compliance with this section, section 1185a of title 29 , and section 9812 of title 26 , as applicable. In carrying out this paragraph, the Secretaries may take into consideration the 2016 publication of the Department of Health and Human Services and the Department of Labor, entitled “Warning Signs - Plan or Policy Non-Quantitative Treatment Limitations (NQTLs) that Require Additional Analysis to Determine Mental Health Parity Compliance”.
    • (B)
      • (i) The compliance program guidance document required under this paragraph shall provide illustrative, de-identified examples (that do not disclose any protected health information or individually identifiable information) of previous findings of compliance and noncompliance with this section, section 1185a of title 29 , or section 9812 of title 26 , as applicable, based on investigations of violations of such sections, including—
        • (I) examples illustrating requirements for information disclosures and nonquantitative treatment limitations; and
        • (II) descriptions of the violations uncovered during the course of such investigations.
      • (ii) To the extent that any example described in clause (i) involves a finding of compliance or noncompliance with regard to any requirement for nonquantitative treatment limitations, the example shall provide sufficient detail to fully explain such finding, including a full description of the criteria involved for approving medical and surgical benefits and the criteria involved for approving mental health and substance use disorder benefits.
      • (iii) In developing and issuing the compliance program guidance document required under this paragraph, the Secretaries specified in subparagraph (A)—
        • (I) shall enter into interagency agreements with the Inspector General of the Department of Health and Human Services, the Inspector General of the Department of Labor, and the Inspector General of the Department of the Treasury to share findings of compliance and noncompliance with this section, section 1185a of title 29 , or section 9812 of title 26 , as applicable; and
        • (II) shall seek to enter into an agreement with a State to share information on findings of compliance and noncompliance with this section, section 1185a of title 29 , or section 9812 of title 26 , as applicable.
    • (C) The compliance program guidance document shall include recommendations to advance compliance with this section, section 1185a of title 29 , or section 9812 of title 26 , as applicable, and encourage the development and use of internal controls to monitor adherence to applicable statutes, regulations, and program requirements. Such internal controls may include illustrative examples of nonquantitative treatment limitations on mental health and substance use disorder benefits, which may fail to comply with this section, section 1185a of title 29 , or section 9812 of title 26 , as applicable, in relation to nonquantitative treatment limitations on medical and surgical benefits.
    • (D) The Secretary, the Secretary of Labor, and the Secretary of the Treasury, in consultation with the Inspector General of the Department of Health and Human Services, the Inspector General of the Department of Labor, and the Inspector General of the Department of the Treasury, shall update the compliance program guidance document every 2 years to include illustrative, de-identified examples (that do not disclose any protected health information or individually identifiable information) of previous findings of compliance and noncompliance with this section, section 1185a of title 29 , or section 9812 of title 26 , as applicable.
  • (7)
    • (A) Not later than 12 months after December 13, 2016 , the Secretary, the Secretary of Labor, and the Secretary of the Treasury shall issue guidance to group health plans and health insurance issuers offering group or individual health insurance coverage to assist such plans and issuers in satisfying the requirements of this section, section 1185a of title 29 , or section 9812 of title 26 , as applicable.
    • (B)
      • (i) The guidance issued under this paragraph shall include clarifying information and illustrative examples of methods that group health plans and health insurance issuers offering group or individual health insurance coverage may use for disclosing information to ensure compliance with the requirements under this section, section 1185a of title 29 , or section 9812 of title 26 , as applicable, (and any regulations promulgated pursuant to such sections, as applicable).
      • (ii) The guidance issued under this paragraph shall include clarifying information and illustrative examples of methods that group health plans and health insurance issuers offering group or individual health insurance coverage may use to provide any participant, beneficiary, contracting provider, or authorized representative, as applicable, with documents containing information that the health plans or issuers are required to disclose to participants, beneficiaries, contracting providers, or authorized representatives to ensure compliance with this section, section 1185a of title 29 , or section 9812 of title 26 , as applicable, compliance with any regulation issued pursuant to such respective section, or compliance with any other applicable law or regulation. Such guidance shall include information that is comparative in nature with respect to—
        • (I) nonquantitative treatment limitations for both medical and surgical benefits and mental health and substance use disorder benefits;
        • (II) the processes, strategies, evidentiary standards, and other factors used to apply the limitations described in subclause (I); and
        • (III) the application of the limitations described in subclause (I) to ensure that such limitations are applied in parity with respect to both medical and surgical benefits and mental health and substance use disorder benefits.
    • (C) The guidance issued under this paragraph shall include clarifying information and illustrative examples of methods, processes, strategies, evidentiary standards, and other factors that group health plans and health insurance issuers offering group or individual health insurance coverage may use regarding the development and application of nonquantitative treatment limitations to ensure compliance with this section, section 1185a of title 29 , or section 9812 of title 26 , as applicable, (and any regulations promulgated pursuant to such respective section), including—
      • (i) examples of methods of determining appropriate types of nonquantitative treatment limitations with respect to both medical and surgical benefits and mental health and substance use disorder benefits, including nonquantitative treatment limitations pertaining to—
        • (I) medical management standards based on medical necessity or appropriateness, or whether a treatment is experimental or investigative;
        • (II) limitations with respect to prescription drug formulary design; and
        • (III) use of fail-first or step therapy protocols;
      • (ii) examples of methods of determining—
        • (I) network admission standards (such as credentialing); and
        • (II) factors used in provider reimbursement methodologies (such as service type, geographic market, demand for services, and provider supply, practice size, training, experience, and licensure) as such factors apply to network adequacy;
      • (iii) examples of sources of information that may serve as evidentiary standards for the purposes of making determinations regarding the development and application of nonquantitative treatment limitations;
      • (iv) examples of specific factors, and the evidentiary standards used to evaluate such factors, used by such plans or issuers in performing a nonquantitative treatment limitation analysis;
      • (v) examples of how specific evidentiary standards may be used to determine whether treatments are considered experimental or investigative;
      • (vi) examples of how specific evidentiary standards may be applied to each service category or classification of benefits;
      • (vii) examples of methods of reaching appropriate coverage determinations for new mental health or substance use disorder treatments, such as evidence-based early intervention programs for individuals with a serious mental illness and types of medical management techniques;
      • (viii) examples of methods of reaching appropriate coverage determinations for which there is an indirect relationship between the covered mental health or substance use disorder benefit and a traditional covered medical and surgical benefit, such as residential treatment or hospitalizations involving voluntary or involuntary commitment; and
      • (ix) additional illustrative examples of methods, processes, strategies, evidentiary standards, and other factors for which the Secretary determines that additional guidance is necessary to improve compliance with this section, section 1185a of title 29 , or section 9812 of title 26 , as applicable.
    • (D) Prior to issuing any final guidance under this paragraph, the Secretary shall provide a public comment period of not less than 60 days during which any member of the public may provide comments on a draft of the guidance.
• (b) Nothing in this section shall be construed—
  • (1) as requiring a group health plan or a health insurance issuer offering group or individual health insurance coverage to provide any mental health or substance use disorder benefits; or
  • (2) in the case of a group health plan or a health insurance issuer offering group or individual health insurance coverage that provides mental health or substance use disorder benefits, as affecting the terms and conditions of the plan or coverage relating to such benefits under the plan or coverage, except as provided in subsection (a).
• (c)
  • (1) This section shall not apply to any group health plan and a health insurance issuer offering group or individual health insurance coverage for any plan year of a small employer (as defined in section 300gg–91(e)(4) of this title , except that for purposes of this paragraph such term shall include employers with 1 employee in the case of an employer residing in a State that permits small groups to include a single individual).
  • (2)
    • (A) With respect to a group health plan or a health insurance issuer offering group or individual health insurance coverage, if the application of this section to such plan (or coverage) results in an increase for the plan year involved of the actual total costs of coverage with respect to medical and surgical benefits and mental health and substance use disorder benefits under the plan (as determined and certified under subparagraph (C)) by an amount that exceeds the applicable percentage described in subparagraph (B) of the actual total plan costs, the provisions of this section shall not apply to such plan (or coverage) during the following plan year, and such exemption shall apply to the plan (or coverage) for 1 plan year. An employer may elect to continue to apply mental health and substance use disorder parity pursuant to this section with respect to the group health plan (or coverage) involved regardless of any increase in total costs.
    • (B) With respect to a plan (or coverage), the applicable percentage described in this subparagraph shall be—
      • (i) 2 percent in the case of the first plan year in which this section is applied; and
      • (ii) 1 percent in the case of each subsequent plan year.
    • (C) Determinations as to increases in actual costs under a plan (or coverage) for purposes of this section shall be made and certified by a qualified and licensed actuary who is a member in good standing of the American Academy of Actuaries. All such determinations shall be in a written report prepared by the actuary. The report, and all underlying documentation relied upon by the actuary, shall be maintained by the group health plan or health insurance issuer for a period of 6 years following the notification made under subparagraph (E).
    • (D) If a group health plan (or a health insurance issuer offering coverage in connection with a group health plan) seeks an exemption under this paragraph, determinations under subparagraph (A) shall be made after such plan (or coverage) has complied with this section for the first 6 months of the plan year involved.
    • (E)
      • (i) A group health plan (or a health insurance issuer offering coverage in connection with a group health plan) that, based upon a certification described under subparagraph (C), qualifies for an exemption under this paragraph, and elects to implement the exemption, shall promptly notify the Secretary, the appropriate State agencies, and participants and beneficiaries in the plan of such election.
      • (ii) A notification to the Secretary under clause (i) shall include—
        • (I) a description of the number of covered lives under the plan (or coverage) involved at the time of the notification, and as applicable, at the time of any prior election of the cost-exemption under this paragraph by such plan (or coverage);
        • (II) for both the plan year upon which a cost exemption is sought and the year prior, a description of the actual total costs of coverage with respect to medical and surgical benefits and mental health and substance use disorder benefits under the plan; and
        • (III) for both the plan year upon which a cost exemption is sought and the year prior, the actual total costs of coverage with respect to mental health and substance use disorder benefits under the plan.
      • (iii) A notification to the Secretary under clause (i) shall be confidential. The Secretary shall make available, upon request and on not more than an annual basis, an anonymous itemization of such notifications, that includes—
        • (I) a breakdown of States by the size and type of employers submitting such notification; and
        • (II) a summary of the data received under clause (ii).
    • (F) To determine compliance with this paragraph, the Secretary may audit the books and records of a group health plan or health insurance issuer relating to an exemption, including any actuarial reports prepared pursuant to subparagraph (C), during the 6 year period following the notification of such exemption under subparagraph (E). A State agency receiving a notification under subparagraph (E) may also conduct such an audit with respect to an exemption covered by such notification.
• (d) In the case of a group health plan that offers a participant or beneficiary two or more benefit package options under the plan, the requirements of this section shall be applied separately with respect to each such option.
• (e) For purposes of this section—
  • (1) The term “aggregate lifetime limit” means, with respect to benefits under a group health plan or health insurance coverage, a dollar limitation on the total amount that may be paid with respect to such benefits under the plan or health insurance coverage with respect to an individual or other coverage unit.
  • (2) The term “annual limit” means, with respect to benefits under a group health plan or health insurance coverage, a dollar limitation on the total amount of benefits that may be paid with respect to such benefits in a 12-month period under the plan or health insurance coverage with respect to an individual or other coverage unit.
  • (3) The term “medical or surgical benefits” means benefits with respect to medical or surgical services, as defined under the terms of the plan or coverage (as the case may be), but does not include mental health or substance use disorder benefits.
  • (4) The term “mental health benefits” means benefits with respect to services for mental health conditions, as defined under the terms of the plan and in accordance with applicable Federal and State law.
  • (5) The term “substance use disorder benefits” means benefits with respect to services for substance use disorders, as defined under the terms of the plan and in accordance with applicable Federal and State law.