[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6000 Introduced in House (IH)]

<DOC>






117th CONGRESS
  1st Session
                                H. R. 6000

    To continue the acceleration of the discovery, development, and 
        delivery of 21st century cures, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           November 17, 2021

Ms. DeGette (for herself and Mr. Upton) introduced the following bill; 
  which was referred to the Committee on Energy and Commerce, and in 
  addition to the Committees on Ways and Means, the Budget, Science, 
    Space, and Technology, Agriculture, Education and Labor, Armed 
Services, Natural Resources, Veterans' Affairs, Homeland Security, and 
   the Judiciary, for a period to be subsequently determined by the 
  Speaker, in each case for consideration of such provisions as fall 
           within the jurisdiction of the committee concerned

_______________________________________________________________________

                                 A BILL


 
    To continue the acceleration of the discovery, development, and 
        delivery of 21st century cures, and for other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Cures 2.0 Act''.

SEC. 2. TABLE OF CONTENTS.

    The table of contents of this Act is as follows:

Sec. 1. Short title.
Sec. 2. Table of contents.
                         TITLE I--PUBLIC HEALTH

Sec. 101. Further understanding the implications of long COVID.
Sec. 102. National strategy to prevent and respond to pandemics.
Sec. 103. Pandemic preparedness rare disease support program.
Sec. 104. Vaccine and immunization programs.
Sec. 105. Developing antimicrobial innovations.
                   TITLE II--PATIENTS AND CAREGIVERS

Sec. 201. Educational programs and training for caregivers.
Sec. 202. Increasing health literacy to promote better outcomes for 
                            patients.
Sec. 203. Increasing diversity in clinical trials.
Sec. 204. Patient experience data.
Sec. 205. Ensuring coverage for clinical trials under existing standard 
                            of care.
                TITLE III--FOOD AND DRUG ADMINISTRATION

Sec. 301. Report on collaboration and alignment in regulating digital 
                            health technologies.
Sec. 302. Grants for novel trial designs and other innovations in drug 
                            development.
Sec. 303. FDA cell and gene therapy.
Sec. 304. Increasing use of real world evidence.
Sec. 305. Improving FDA-CMS communication regarding transformative new 
                            therapies.
Sec. 306. Establishment of additional Intercenter Institutes at the 
                            Food and Drug Administration.
Sec. 307. Accelerating timeline for breakthrough and RMAT designations.
Sec. 308. Guidance regarding development and submission of chemistry, 
                            manufacturing, and controls information for 
                            expedited approval.
Sec. 309. Post-approval study requirements for accelerated approval.
Sec. 310. Recommendations to decentralize clinical trials.
           TITLE IV--CENTERS FOR MEDICARE & MEDICAID SERVICES

Sec. 401. GAO study and report.
Sec. 402. Strategies to increase access to telehealth under Medicaid 
                            and Children's Health Insurance Program.
Sec. 403. Extending Medicare telehealth flexibilities.
Sec. 404. Coverage and payment for breakthrough devices under the 
                            Medicare program.
Sec. 405. Secretary of Health and Human Services report on coverage for 
                            innovative technologies.
Sec. 406. Secretary of Health and Human Services report on CMS computer 
                            systems.
Sec. 407. Precision Medicine Answers for Kids Today.
Sec. 408. Medicare coverage for consultations.
Sec. 409. Prohibiting the use of geographic tracking features and 
                            biometrics within Medicaid electronic visit 
                            verification systems.
Sec. 410. Generally accepted standard for electronic prescribing.
Sec. 411. Meaningful access to Federal health plan claims data.
                           TITLE V--RESEARCH

Sec. 501. Advanced Research Projects Agency for Health.
Sec. 502. Research investment to spark the economy.
Sec. 503. Research Policy Board reauthorization.

                         TITLE I--PUBLIC HEALTH

SEC. 101. FURTHER UNDERSTANDING THE IMPLICATIONS OF LONG COVID.

    (a) Sources of Coverage Survey.--The Secretary of Health and Human 
Services shall--
            (1) conduct a large national survey of patients who self-
        identify as having long COVID to assess sources of health 
        coverage, long-term care coverage, and disability coverage for 
        long COVID and related symptoms; and
            (2) not later than 6 months after the date of the enactment 
        of this Act, complete such survey and submit a report on the 
        results of such survey to the Committees on Energy and 
        Commerce, Ways and Means, and Education and Labor of the House 
        of Representatives and the Committees on Health, Education, 
        Labor, and Pensions and Finance of the Senate.
    (b) Learning Collaborative.--
            (1) National meetings.--The Secretary of Health and Human 
        Services shall--
                    (A) convene a series of not less than four national 
                meetings, that may be virtual, to serve as the basis of 
                an ongoing long COVID learning collaborative with 
                individuals and organizations representing key sectors 
                of the health care community; and
                    (B) invite to participate in such meetings 
                individuals who represent the views of health plan 
                representatives, health care providers (including 
                hospitals, physicians, and nurses), medical and 
                scientific researchers, patient and consumer advocates, 
                data scientists, health care service providers, 
                providers of workers compensation, employers, and 
                developers of diagnostic and therapeutic products, 
                including clinical laboratories.
            (2) Termination of meetings.--The Secretary shall continue 
        to convene national meetings under paragraph (1) for--
                    (A) not less than 2 years after the date of the 
                enactment of this Act; and
                    (B) each fiscal year thereafter, unless the 
                Secretary determines that the public health and medical 
                knowledge with respect to long COVID has sufficiently 
                advanced to ensure widespread understanding of the 
                characteristics of long COVID, including--
                            (i) the etiology, progression, similarity 
                        to other conditions, and duration of long 
                        COVID; and
                            (ii) conditions that interact with long 
                        COVID.
    (c) Long COVID Scientific Research for Children.--
            (1) In general.--Beginning not later than 180 days after 
        the date of the enactment of this Act, the Director of the 
        National Institutes of Health shall award grants to hospitals 
        for children, pediatric researchers, academic medical centers, 
        and other appropriate organizations to research the long-term 
        effects and treatment of COVID-19 in children, including long 
        COVID.
            (2) Authorization of appropriations.--Of the amounts made 
        available for research and clinical trials related to long-term 
        studies of COVID-19 under the heading ``National Institutes of 
        Health--Office of the Director'' of title III of the 
        Consolidated Appropriations Act, 2021 (Public Law 116-260), 
        there are authorized to be appropriated such sums as may be 
        necessary to carry out this subsection.
    (d) Study on Disparities in Long COVID.--
            (1) In general.--Not later than 90 days after the date of 
        the enactment of this Act, the Secretary of Health and Human 
        Services shall seek to enter into an arrangement with the 
        National Academy of Medicine under which the Academy conducts a 
        study to evaluate disparities in racial and ethnic minority 
        groups with respect to diagnosis of, severity of symptoms, 
        access to care, and treatment for long COVID.
            (2) Content.--The study under paragraph (1) shall--
                    (A) with respect to individuals who are Black, 
                Hispanic, American Indian, Alaska Native, or who belong 
                to other racial and ethnic populations--
                            (i) evaluate the prevalence of long COVID;
                            (ii) evaluate the rates of hospitalization 
                        and death from COVID-19; and
                            (iii) evaluate and identify factors that 
                        increase the risk of severity of long COVID; 
                        and
                    (B) include recommendations to identify and address 
                the disparities described in paragraph (1), including 
                the causes of such disparities.
            (3) Authorization of appropriations.--There is authorized 
        to be appropriated to carry out this subsection $5,000,000 for 
        fiscal year 2022, to remain available until expended.
    (e) Education and Dissemination of Information With Respect to 
Long-Term Symptoms of COVID-19.--
            (1) Long covid public education program.--The Secretary of 
        Health and Human Services, acting through the Director of the 
        Centers for Disease Control and Prevention, shall develop and 
        disseminate to the public information regarding long COVID, 
        including information on--
                    (A) the awareness, incidence, and common symptoms 
                of long COVID; and
                    (B) the availability, as medically appropriate, of 
                treatment options for long COVID.
            (2) Long covid provider education program.--The Secretary 
        of Health and Human Services, acting through the Director of 
        the Centers for Disease Control and Prevention, shall in 
        consultation with communities of individuals diagnosed with 
        long COVID, develop and disseminate to health care providers 
        information on long COVID for the purpose of ensuring that such 
        providers remain informed about current information on long 
        COVID.
            (3) Arrangement authority.--The Secretary of Health and 
        Human Services may disseminate information under paragraphs (1) 
        and (2) directly or through arrangements with intra-agency 
        initiatives, nonprofit organizations, consumer groups, 
        institutions of higher learning (as defined in section 101 of 
        the Higher Education Act of 1965 (20 U.S.C. 1001)), or Federal, 
        State, or local public private partnerships.
            (4) Authorization of appropriations.--There is authorized 
        to be appropriated to carry out this section $30,000,000 for 
        fiscal year 2022, which shall remain available until expended.

SEC. 102. NATIONAL STRATEGY TO PREVENT AND RESPOND TO PANDEMICS.

    (a) In General.--Not later than 90 days after the date of the 
enactment of this Act, the President, acting through the Secretary of 
Health and Human Services, shall--
            (1) develop and implement a national strategy to prevent 
        and respond to pandemics and other public health emergencies 
        for which a declaration is made under section 319 of the Public 
        Health Service Act (42 U.S.C. 247d); and
            (2) base such strategy on lessons learned, and best 
        practices developed, as a result of the COVID-19 pandemic.
    (b) Contents.--The national strategy under subsection (a) shall at 
a minimum address each of the following:
            (1) Strategies for testing (including point-of-care testing 
        and testing at nonmedical sites) to foster expedient results 
        and personalized medical responses for patients and 
        communities, including for medically underserved populations.
            (2) Methods of data sharing to use testing to inform 
        surveillance and other pandemic monitoring and response 
        efforts.
            (3) Strategies to enable Americans to continue to work, or 
        return to work, or continue to remain in, or return to, in-
        person school and childcare settings safely.
            (4) Modernizing and expanding domestic drug manufacturing, 
        including through the use of continuous manufacturing.
            (5) Developing and administering vaccines, therapeutics, 
        and other medical supplies, including for children, racial and 
        ethnic minorities, and people with disabilities.

SEC. 103. PANDEMIC PREPAREDNESS RARE DISEASE SUPPORT PROGRAM.

    Subtitle B of title XXVIII of the Public Health Service Act (42 
U.S.C. 300hh-10 et seq.) is amended by inserting after section 2815 of 
such Act the following:

``SEC. 2816. PANDEMIC PREPAREDNESS PLAN.

    ``(a) In General.--The Secretary, acting through the Administrator 
of the Health Resources and Services Administration and in 
collaboration with the Director of the Centers for Disease Control and 
Prevention, shall award grants to eligible organizations to develop a 
pandemic preparedness plan regarding--
            ``(1) the challenges faced by patients and the family 
        caregivers of such patients served by the respective eligible 
        organizations during the COVID-19 pandemic;
            ``(2) potential challenges for the respective eligible 
        organizations during future pandemics and other public health 
        emergencies;
            ``(3) how the respective eligible organizations plan to 
        overcome the challenges described in paragraphs (1) and (2), 
        including how the respective organizations plan to support 
        patients, their families, and health care providers to overcome 
        such challenges; and
            ``(4) efforts to partner with local, State, and Federal 
        governments to promote a coordinated response to future 
        pandemics and other public health emergencies.
    ``(b) Priority.--In awarding grants under this section, the 
Secretary shall give priority to eligible organizations that are rare 
disease or condition organizations.
    ``(c) Definitions.--In this section:
            ``(1) The term `eligible organization' means an 
        organization that--
                    ``(A) is described in section 501(c) of the 
                Internal Revenue Code of 1986 and exempt from tax under 
                section 501(a) of such Code; and
                    ``(B) provides support and other resources to 
                patients and their families for accessing and paying 
                for medical care.
            ``(2) The term `public health emergency' means a public 
        health emergency declared under section 319.
            ``(3) The term `rare disease or condition' has the meaning 
        given to such term in section 526(a) of the Federal Food, Drug, 
        and Cosmetic Act.
    ``(d) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section $25,000,000 for each of fiscal 
years 2022 through 2024.''.

SEC. 104. VACCINE AND IMMUNIZATION PROGRAMS.

    (a) Additional Funding for Vaccine Awareness.--There are authorized 
to be appropriated to the Centers for Disease Control and Prevention 
$25,000,000 for each of fiscal years 2022 through 2024 for the purpose 
of carrying out an awareness campaign to educate the public with 
respect to the safety and importance of vaccines. The amounts 
authorized by the preceding sentence are in addition to amounts 
otherwise available for such purpose.
    (b) Strengthening the Immunization Information System.--There are 
authorized to be appropriated to the Centers for Disease Control and 
Prevention $25,000,000 for each of fiscal years 2022 through 2024 for 
the purpose of strengthening immunization information systems. The 
amounts authorized by the preceding sentence are in addition to amounts 
otherwise available for such purpose.

SEC. 105. DEVELOPING ANTIMICROBIAL INNOVATIONS.

    Title III of the Public Health Service Act (42 U.S.C. 241 et seq.) 
is amended by adding at the end the following:

             ``PART W--DEVELOPING ANTIMICROBIAL INNOVATIONS

``SEC. 399OO. ESTABLISHMENT OF COMMITTEE; SUBSCRIPTION MODEL; ADVISORY 
              GROUP.

    ``(a) In General.--Not later than 60 days after the date of the 
enactment of this part, the Secretary shall establish a Committee on 
Critical Need Antimicrobials and appoint members to the Committee.
    ``(b) Members.--
            ``(1) In general.--The Committee shall consist of at least 
        one representative from each of the National Institute of 
        Allergy and Infectious Diseases, the Centers for Disease 
        Control and Prevention, the Biomedical Advanced Research and 
        Development Authority, the Food and Drug Administration, the 
        Centers for Medicare & Medicaid Services, the Veterans Health 
        Administration, and the Department of Defense.
            ``(2) Chair.--The Secretary shall appoint one of the 
        members of the Committee to serve as the Chair of the 
        Committee.
    ``(c) Duties.--Not later than 1 year after the appointment of all 
initial members of the Committee, the Secretary, in collaboration with 
the Committee, and in consultation with the Critical Need 
Antimicrobials Advisory Group established under subsection (g), shall 
do the following:
            ``(1) Develop a list of infections for which new 
        antimicrobial drug development is needed, taking into account 
        organisms, sites of infection, and type of infections for which 
        there is an unmet medical need, findings from the most recent 
        report entitled `Antibiotic Resistance Threats in the United 
        States' issued by the Centers for Disease Control and 
        Prevention, or an anticipated unmet medical need, including a 
        potential global health security threat. For the list developed 
        under this paragraph, the Secretary, in collaboration with the 
        Committee, may use the infection list in such most recent 
        report for up to 3 years following the date of the enactment of 
        this part and subsequently update the list under this paragraph 
        in accordance with subsection (e).
            ``(2) Develop regulations, in accordance with subsection 
        (d), outlining favored characteristics of critical need 
        antimicrobial drugs, that are evidence based, clinically 
        focused, and designed to treat the infections described in 
        paragraph (1), and establishing criteria for how each such 
        characteristic will adjust the monetary value of a subscription 
        contract awarded under subsection (f) or section 399QQ. The 
        favored characteristics shall be weighed for purposes of such 
        monetary value such that meeting certain characteristics, or 
        meeting more than one such characteristic, increases the 
        monetary value. Such favored characteristics of an 
        antimicrobial drug shall include--
                    ``(A) treating infections on the list under 
                paragraph (1);
                    ``(B) improving clinical outcomes for patients with 
                multi-drug-resistant infections;
                    ``(C) being a first-approved antimicrobial drug 
                that has the potential to address unmet medical needs 
                for the treatment of a serious or life-threatening 
                infection, and, to a lesser extent, second and third 
                drugs that treat such infections;
                    ``(D) route of administration, especially through 
                oral administration;
                    ``(E)(i) containing no active moiety (as defined by 
                the Secretary in section 314.3 of title 21, Code of 
                Federal Regulations (or any successor regulations)) 
                that has been approved in any other application under 
                section 505(b) of the Federal Food, Drug, and Cosmetic 
                Act or intending to be the subject of a new original 
                biologics license application under section 351(a);
                    ``(ii) being a member of a new class of drugs with 
                a novel target and novel mode of action that are 
                distinctly different from the target or mode of any 
                antimicrobial drug approved under section 505 of such 
                Act or licensed under section 351, including reduced 
                toxicity;
                    ``(iii) not being affected by cross-resistance to 
                any antimicrobial drug approved under such section 505 
                or licensed under such section 351;
                    ``(F) addressing a multi-drug-resistant infection 
                through a novel chemical scaffold or mechanism of 
                action;
                    ``(G) having received a transitional subscription 
                contract under subsection (f); and
                    ``(H) any other characteristic the Secretary, in 
                collaboration with the Committee, determines necessary.
    ``(d) Regulations.--
            ``(1) In general.--Not later than 1 year after the 
        appointment of the initial members of the Committee, the 
        Secretary shall issue proposed regulations which shall 
        include--
                    ``(A) a process by which the sponsors can apply for 
                an antimicrobial drug to become a critical need 
                antimicrobial drug under section 399PP;
                    ``(B) how subscription contracts under such section 
                shall be established and paid;
                    ``(C) the favored characteristics under subsection 
                (c)(2), how such characteristics will be weighed, and 
                the minimum number and kind of favored characteristics 
                needed for an antimicrobial drug to be designated a 
                critical need antimicrobial drug; and
                    ``(D) other elements of the subscription contract 
                process, in accordance with this part.
            ``(2) Development of final regulations.--Before finalizing 
        the regulations under paragraph (1), the Secretary shall 
        solicit public comment and hold public meetings for the period 
        beginning on the date on which the proposed regulations are 
        issued and ending on the date that is 120 days after such date 
        of issuance. The Secretary shall finalize and publish such 
        regulations not later than 120 days after the close of such 
        period of public comment and meetings.
            ``(3) Subscription contract office.--Not later than 6 
        months after the date of the enactment of this part, the 
        Secretary shall propose an agency or office in the Department 
        of Health and Human Services to manage the establishment and 
        payment of subscription contracts awarded under section 399QQ, 
        including eligibility, requirements, and contract amounts. The 
        Secretary shall solicit public comment and finalize the agency 
        or office no later than 45 days following the proposed agency 
        or office. Such agency or office shall be referred to as the 
        `Subscription Contract Office'.
    ``(e) List of Infections.--The Secretary, in collaboration with the 
Committee, shall update the list of infections under subsection (c)(1) 
at least every 2 years.
    ``(f) Transitional Subscription Contracts.--
            ``(1) In general.--Not earlier than 30 days after the date 
        of the enactment of this part and ending on the date that the 
        Secretary finalizes the subscription contract regulations under 
        subsection (d), the Secretary may use up to $1,000,000,000 of 
        the amount appropriated under section 399SS(a) to engage in 
        transitional subscription contracts of up to 3 years in length 
        with antimicrobial developers, as determined by the Secretary, 
        that have developed antimicrobial drugs treating infections 
        listed in the most recent report entitled `Antibiotic 
        Resistance Threats in the United States' issued by the Centers 
        for Disease Control and Prevention, and may include 
        antimicrobial drugs that are qualified infectious disease 
        products (as defined in section 505E(g) of the Federal Food, 
        Drug, and Cosmetic Act), innovative biological products, or 
        innovative drugs that achieve a clinical outcome through 
        immunomodulation. Such a contract may authorize the contractor 
        to use funds made available under the contract for completion 
        of postmarketing clinical studies, manufacturing, and other 
        preclinical and clinical efforts.
            ``(2) Requirements.--
                    ``(A) In general.--The Secretary, through the 
                office described in paragraph (4), may enter into a 
                contract under paragraph (1)--
                            ``(i) if the Secretary determines that the 
                        antimicrobial drug is intended to treat an 
                        infection for which there is an unmet clinical 
                        need, an anticipated clinical need, or drug 
                        resistance;
                            ``(ii) subject to terms including--
                                    ``(I) that the Secretary shall 
                                cease any payment installments under a 
                                transitional subscription contract if 
                                the sponsor does not--
                                            ``(aa) ensure commercial 
                                        and Federal availability of the 
                                        antimicrobial drug within 30 
                                        days of receiving first payment 
                                        under the contract;
                                            ``(bb) identify, track, and 
                                        publicly report drug resistance 
                                        data and trends using available 
                                        data related to the 
                                        antimicrobial drug;
                                            ``(cc) develop and 
                                        implement education and 
                                        communications strategies, 
                                        including communications for 
                                        individuals with limited 
                                        English proficiency and 
                                        individuals with disabilities, 
                                        for health care professionals 
                                        and patients about appropriate 
                                        use of the antimicrobial drug;
                                            ``(dd) submit a plan for 
                                        registering the antimicrobial 
                                        drug in additional countries 
                                        where an unmet medical need 
                                        exists, which such plan may be 
                                        consistent with the Stewardship 
                                        and Access Plan (SAP) 
                                        Development Guide (2021);
                                            ``(ee) subject to 
                                        subparagraph (B), ensure a 
                                        reliable drug supply chain, 
                                        thus leading to an interruption 
                                        of the supply of the 
                                        antimicrobial drug in the 
                                        United States for more than 60 
                                        days; or
                                            ``(ff) make meaningful 
                                        progress toward completion of 
                                        Food and Drug Administration-
                                        required postmarketing studies, 
                                        including such studies that are 
                                        evidence based; and
                                    ``(II) other terms as determined by 
                                the Secretary; and
                            ``(iii) if--
                                    ``(I) a phase 3 clinical study has 
                                been initiated for the antimicrobial 
                                drug; or
                                    ``(II) the antimicrobial drug has 
                                been approved under section 505(c) of 
                                the Federal Food, Drug, and Cosmetic 
                                Act or licensed under section 351(a).
                    ``(B) Waiver.--The requirement under subparagraph 
                (A)(ii)(I)(ee) may be waived in the case that an 
                emergency prohibits access to a reliable drug supply 
                chain.
            ``(3) Transitional guidance.--Not later than 120 days after 
        the appointment of the initial members of the Committee, the 
        Secretary shall issue, in consultation with the Committee, 
        transitional guidance outlining the antimicrobial drugs that 
        are eligible for transitional subscription contracts under 
        paragraph (1), the requirements to enter into a transitional 
        subscription contract under paragraph (2), and the process by 
        which drug developers can enter into transitional subscription 
        contracts with the Secretary under this subsection.
            ``(4) Payment office and mechanism.--Not later than 30 days 
        after the date of the enactment of this part, the Secretary 
        shall determine the agency or office in the Department of 
        Health and Human Services that will manage the transitional 
        subscription contracts, including eligibility, requirements, 
        and contract amounts, during the period described in paragraph 
        (1).
    ``(g) Critical Need Antimicrobial Advisory Group.--
            ``(1) In general.--Not later than 30 days after the 
        appointment of all initial members of the Committee, the 
        Secretary, in collaboration with the Committee, shall establish 
        a Critical Need Antimicrobial Advisory Group (referred to in 
        this subsection as the `Advisory Group') and appoint members to 
        the Advisory Group.
            ``(2) Members.--The members of the Advisory Group shall 
        include--
                    ``(A) not fewer than 6 individuals who are--
                            ``(i) infectious disease specialists; or
                            ``(ii) other health experts with expertise 
                        in researching antimicrobial resistance, health 
                        economics, or commercializing antimicrobial 
                        drugs; and
                    ``(B) not fewer than 5 patient advocates.
            ``(3) Chair.--The Secretary shall appoint one of the 
        members of the Advisory Group to serve as the Chair.
            ``(4) Conflicts of interest.--In appointing members under 
        paragraph (2), the Secretary shall ensure that no member 
        receives compensation in any manner from a commercial or for-
        profit entity that develops antimicrobials or that might 
        benefit from antimicrobial development.
            ``(5) Applicability of faca.--Except as otherwise provided 
        in this subsection, the Federal Advisory Committee Act shall 
        apply to the Advisory Group.

``SEC. 399PP. CRITICAL NEED ANTIMICROBIAL DRUG APPLICATION AND PAYMENT 
              THROUGH SUBSCRIPTION CONTRACTS.

    ``(a) In General.--
            ``(1) Submission of request.--The sponsor of an application 
        under section 505(b) of the Federal Food, Drug, and Cosmetic 
        Act or section 351(a) for an antimicrobial drug may request 
        that the Secretary designate the drug as a critical need 
        antimicrobial. A request for such designation may be submitted 
        after the Secretary grants for such drug an investigational new 
        drug exemption under section 505(i) of the Federal Food, Drug, 
        and Cosmetic Act or section 351(a)(3), and shall be submitted 
        not later than 5 years after the date of approval under section 
        505(c) of the Federal Food, Drug, and Cosmetic Act or licensure 
        under section 351(a).
            ``(2) Content of request.--A request under paragraph (1) 
        shall include information, such as clinical, preclinical and 
        postmarketing data, a list of the favorable characteristics 
        described in section 399OO(c)(2), and any other material that 
        the Secretary in consultation with the Committee requires.
            ``(3) Review by secretary.--The Secretary shall promptly 
        review all requests for designation submitted under this 
        subsection, assess all required application components, and 
        determine if the antimicrobial drug is likely to meet the 
        favorable characteristics identified in the application upon 
        the completion of clinical development. After review, the 
        Secretary shall approve or deny each request for designation 
        not later than 90 days after receiving a request. If the 
        Secretary approves a request, it shall publish the value of the 
        contract that the critical need antimicrobial developer would 
        be eligible to receive if such developer successfully 
        demonstrates that the drug meets the maximum value of the 
        favored characteristics listed in the application.
            ``(4) Length of designation period.--A designation granted 
        under this section shall be in effect for a period of 10 years 
        after the date that the designation is approved, and shall 
        remain in effect for such period even if the infection treated 
        by such drug is later removed from the list of infections under 
        section 399OO(c)(1).
            ``(5) Subsequent reviews.--No sooner than 2 years after a 
        designation approval or denial under subsection (3), the 
        sponsor may request a subsequent review to reevaluate the value 
        of a contract to include any new information.
    ``(b) Development of Designated Drugs.--If a critical need 
antimicrobial designation is granted during clinical development of an 
antimicrobial drug, the Secretary may work with the sponsor to maximize 
the opportunity for the sponsor to successfully demonstrate that the 
antimicrobial drug possesses the favored characteristics of high-
monetary valued products identified under section 399OO(c)(2).
    ``(c) Appropriate Use of Critical Need Antimicrobial.--
            ``(1) In general.--The sponsor of an antimicrobial drug 
        that receives designation under subsection (a) shall within 90 
        days of such designation, submit to the Secretary a plan for 
        appropriate use of diagnostics, in order for the Secretary and 
        Committee to consider such plan in developing clinical 
        guidelines. An appropriate use plan--
                    ``(A) shall include--
                            ``(i) the appropriate use of the drug; and
                            ``(ii) the appropriate use of diagnostic 
                        tools, where available, such as diagnostic 
                        testing for biomarkers related to 
                        antimicrobial-resistant pathogens, or other 
                        targeted diagnostic approaches, to inform use 
                        of the drug; and
                    ``(B) may be developed in partnership with the 
                Secretary, infectious disease experts, diagnostic 
                experts or developers, laboratory experts, or another 
                entity.
            ``(2) Consultation.--The Secretary shall consult with 
        relevant professional societies and the Critical Need 
        Antimicrobial Advisory Group established under section 399OO(g) 
        to ensure that clinical guidelines issued by the Secretary 
        under paragraph (3), with respect to an antimicrobial drug 
        designated under subsection (a), includes the use of 
        appropriate diagnostic approaches, taking into consideration 
        the diagnostic plan submitted by a sponsor under paragraph (1).
            ``(3) Publication of clinical guidelines.--Not later than 1 
        year after the Secretary makes the first designation under 
        subsection (a), and not less than every 3 years thereafter, the 
        Secretary shall publish clinical guidelines in consultation 
        with relevant professional societies with respect to each 
        antimicrobial drug that has been approved or licensed as 
        described in subsection (a)(1) and that has been designated 
        under subsection (a), which guidelines shall set forth the 
        evidence-based recommendations for prescribing the drug, in 
        accordance with the submissions of the sponsor under paragraph 
        (1) and after consultation under paragraph (2), as appropriate.

``SEC. 399QQ. SUBSCRIPTION CONTRACTS.

    ``(a) Application for a Subscription Contract.--
            ``(1) Submission of applications.--After approval under 
        section 505(c) of the Federal Food, Drug, and Cosmetic Act or 
        licensure under section 351(a), the sponsor of an antimicrobial 
        drug designated as a critical need antimicrobial under section 
        399PP may submit an application for a subscription contract 
        with the Secretary, under a procedure established by the 
        Secretary.
            ``(2) Review of applications.--The Secretary shall, in 
        consultation with the Committee--
                    ``(A) review all applications for subscription 
                contracts under paragraph (1) and assess all required 
                application components;
                    ``(B) determine the extent to which the critical 
                need antimicrobial meets the favored characteristics 
                identified under section 399OO(c)(2), and deny any 
                application for a drug that meets none of such 
                characteristics; and
                    ``(C) assign a monetary value to the contract based 
                on the regulations developed under section 399OO(d).
    ``(b) Criteria.--To qualify for a subscription contract under this 
section, the sponsor of an antimicrobial drug designated as a critical 
need antimicrobial shall agree to--
            ``(1) ensure commercial and Federal availability of the 
        antimicrobial drug within 30 days of receiving first payment 
        under the contract, and sufficient supply for susceptibility 
        device manufacturers;
            ``(2) identify, track, and publicly report drug resistance 
        data and trends using available data related to the 
        antimicrobial drug;
            ``(3) develop and implement education and communications 
        strategies, including communications for individuals with 
        limited English proficiency and individuals with disabilities, 
        for health care professionals and patients about appropriate 
        use of the antimicrobial drug;
            ``(4) submit an appropriate use assessment to the 
        Secretary, Committee, Food and Drug Administration, and Centers 
        for Disease Control and Prevention every 2 years regarding use 
        of the antimicrobial drug, including how the drug is being 
        marketed;
            ``(5) submit a plan for registering the drug in additional 
        countries where an unmet medical need exists;
            ``(6) ensure a reliable drug supply chain, where any 
        interruption to the supply chain will not last for more than 60 
        days in the United States;
            ``(7) complete any postmarketing studies required by the 
        Food and Drug Administration in a timely manner;
            ``(8) produce the drug at a reasonable volume determined 
        with the Secretary to ensure patient access to the drug;
            ``(9) price the drug at a price that is not lower than a 
        comparable generic drug;
            ``(10) abide by the manufacturing and environmental best 
        practices in the supply chain to ensure that there is no 
        discharge into, or contamination of, the environment by 
        antimicrobial agents or products as a result of the 
        manufacturing process; and
            ``(11) abide by other terms as the Secretary may require.
    ``(c) Amount and Terms of Contracts.--
            ``(1) Amounts.--A subscription contract under this section 
        shall be for the sale to the Secretary of any quantity of the 
        antimicrobial drug needed over the term of the contract under 
        paragraph (2), at an agreed upon price, for a total projected 
        amount determined by the Secretary that is not less than 
        $750,000,000 and not more than $3,000,000,000, adjusted for 
        inflation, accounting for the favored characteristics of the 
        drug, as determined by the Secretary, in consultation with the 
        Committee, under subsection (a)(2), and shall be allocated from 
        the amount made available under section 399SS(a). Not later 
        than 6 months after the subscription contract is granted under 
        subsection (a), the Secretary shall provide payments for 
        purchased drugs in installments established by the Secretary in 
        consultation with the sponsor of the antimicrobial drug and in 
        accordance with subsection (d)(3). Funds received by the 
        sponsor shall be used to support criteria qualification under 
        subsection (b), the completion of postmarketing clinical 
        studies, manufacturing, other preclinical and clinical 
        activities, or other activities agreed to by the Secretary and 
        sponsor in the contract.
            ``(2) Terms.--
                    ``(A) Initial term.--The initial term of a contract 
                under this subsection shall be no less than 5 years or 
                greater than the greater of 10 years or the remaining 
                period of time during which the sponsor has patent 
                protections or a remaining exclusivity period with 
                respect to the antimicrobial drug in the United States, 
                as listed in the publication of the Food and Drug 
                Administration entitled `Approved Drug Products with 
                Therapeutic Equivalence Evaluations'. Payments may be 
                in equal annual installments with the option to redeem 
                50 percent of the last year's reimbursement in year 1 
                of the contract in order to offset costs of 
                establishing manufacturing capacity, or another 
                subscription arrangement to which the Secretary and 
                sponsor agree. Subscription contracts shall remain in 
                effect for such period even if the infection treated by 
                such antimicrobial drug is later removed from the list 
                of infections under section 399OO(c)(1).
                    ``(B) Extension of contracts.--The Secretary may 
                extend a subscription contract with a sponsor under 
                this subsection beyond the initial contract period. A 
                single contract extension may be in effect not later 
                than the date on which all periods of exclusivity 
                granted by the Food and Drug Administration expire and 
                shall be in an amount not to exceed $25,000,000 per 
                year. All other terms of an extended contract shall be 
                the same as the terms of the initial contract. The 
                total amount of funding used on such contract 
                extensions shall be no more than $1,000,000,000, and 
                shall be allocated from the amount made available under 
                section 399SS.
                    ``(C) Modification of contracts.--The Secretary or 
                sponsor, 1 year after the start of the contract period 
                under this subsection and every 2 years thereafter, may 
                request a modification of the amount of the contract 
                based on information that adjusts favored 
                characteristics in section 399OO(c)(2).
            ``(3) Adjustment.--In the case of an antimicrobial drug 
        that received a transitional subscription contract under 
        section 399OO(f), the amount of a subscription contract for 
        such drug under this section shall be reduced by the amount of 
        the transitional subscription contract under such section 
        399OO(f) for such drug.
            ``(4) Contracts for generic and biosimilar versions.--
        Notwithstanding any other provision in this part, the Secretary 
        may award a subscription contract under this section to a 
        manufacturer of a generic or biosimilar version of an 
        antimicrobial drug for which a subscription contract has been 
        awarded under this section. Such contracts shall be awarded in 
        accordance with a procedure, including for determining the 
        terms and amounts of such contracts, established by the 
        Secretary.
    ``(d) Annual Antimicrobial Drug Sponsor Revenue Limitations.--
            ``(1) Reporting requirement.--
                    ``(A) In general.--Not later than a date determined 
                appropriate by the Secretary following the end of each 
                calendar year, and not earlier than 6 months after the 
                end of each calendar year, the head (or a designee of 
                such head) of each Federal agency carrying out a 
                specified government program shall, in accordance with 
                this paragraph, report to the Subscription Contract 
                Office established under section 399OO(d)(3) the total 
                prescription drug sales for each applicable 
                antimicrobial drug under contract with respect to such 
                program for such calendar year.
                    ``(B) Medicare part d program.--For purposes of 
                subparagraph (A), the Secretary shall report, for each 
                applicable antimicrobial drug covered under part D of 
                title XVIII of the Social Security Act, the product 
                of--
                            ``(i) the per-unit ingredient cost, as 
                        reported to the Secretary by prescription drug 
                        plans and Medicare Advantage prescription drug 
                        plans, minus any per-unit rebate, discount, or 
                        other price concession provided by the sponsor 
                        of such applicable antimicrobial drug, as 
                        reported to the Secretary by the prescription 
                        drug plans and the Medicare Advantage 
                        prescription drug plans; and
                            ``(ii) the number of units of such 
                        applicable antimicrobial drug paid for under 
                        such part D.
                    ``(C) Medicare part b program.--
                            ``(i) In general.--For purposes of 
                        subparagraph (A), the Secretary shall report, 
                        for each applicable antimicrobial drug covered 
                        under part B of title XVIII of the Social 
                        Security Act, the product of--
                                    ``(I) the per-unit average sales 
                                price (as defined in section 1847A(c) 
                                of such Act) or the per-unit payment 
                                rate under such part B for a separately 
                                paid prescription drug without a 
                                reported average sales price; and
                                    ``(II) the number of units of such 
                                applicable antimicrobial drug paid for 
                                under such part B.
                            ``(ii) Units and allocated prices.--The 
                        Secretary shall establish a process for 
                        determining the units and the allocated price 
                        for purposes of this subparagraph for those 
                        applicable antimicrobial drugs that are not 
                        separately payable or for which National Drug 
                        Codes are not reported.
                    ``(D) Medicare part a program.--
                            ``(i) In general.--For purposes of 
                        subparagraph (A), the Secretary shall report, 
                        for each applicable antimicrobial drug covered 
                        under part A of title XVIII of the Social 
                        Security Act, the product of--
                                    ``(I) the per-unit price under such 
                                part A for the antimicrobial drug; and
                                    ``(II) the number of units of such 
                                antimicrobial drug paid for under such 
                                part A.
                            ``(ii) Special rule.--For purposes of 
                        clause (i), the Secretary shall establish a 
                        process for determining the units and the 
                        allocated price for those prescription drugs 
                        that are not separately payable or for which 
                        National Drug Codes are not reported in the 
                        diagnosis-related groups.
                    ``(E) Medicaid program.--Under the authority of 
                section 1902(a)(6) of the Social Security Act, the 
                Secretary shall require each State that makes medical 
                assistance available under the State plan under title 
                XIX of such Act (or any waiver of such plan) for an 
                applicable antimicrobial drug (including, if 
                applicable, any such drug which is a covered outpatient 
                drug under a rebate agreement entered into under 
                section 1927 of such Act) to report, in a form 
                consistent with a standard reporting format established 
                by the Secretary, not later than the date determined 
                under subparagraph (A)--
                            ``(i) information on the total number of 
                        units of each dosage form and strength and 
                        package size of each applicable antimicrobial 
                        drug dispensed during the preceding calendar 
                        year under such State plan or waiver (including 
                        any such drugs dispensed to an individual 
                        enrolled with a medicaid managed care 
                        organization or other specified entity (as such 
                        terms are defined in section 1903(m) of such 
                        Act)); and
                            ``(ii) with respect to each dosage form and 
                        strength and package size of each such drug, 
                        the amount equal to--
                                    ``(I) the product of--
                                            ``(aa) the total number of 
                                        units dispensed under the State 
                                        plan or waiver during the 
                                        preceding calendar year (as 
                                        determined under clause (i)); 
                                        and
                                            ``(bb) the per-unit 
                                        ingredient cost paid by the 
                                        State for each such unit; minus
                                    ``(II) any discounts or other price 
                                concessions provided and rebates paid 
                                to the State with respect to the dosage 
                                form and strength and package size of 
                                such drug and such calendar year 
                                (including rebates paid under a rebate 
                                agreement under section 1927 of such 
                                Act and any State supplemental rebates 
                                paid under a supplemental rebate 
                                agreement).
                    ``(F) Department of veterans affairs.--For purposes 
                of subparagraph (A), the Secretary of Veterans Affairs 
                shall report the total amount paid for each applicable 
                antimicrobial drug procured by the Veterans Health 
                Administration for individuals who receive health care 
                from the Administration.
                    ``(G) Department of defense and tricare program.--
                For purposes of subparagraph (A), the Secretary of 
                Defense shall report the sum of--
                            ``(i) the total amount paid for each 
                        applicable antimicrobial drug procured by the 
                        Department of Defense for individuals who 
                        receive health care from the Department; and
                            ``(ii) for each applicable antimicrobial 
                        drug dispensed under the TRICARE retail 
                        pharmacy program under section 
                        1074g(a)(2)(E)(ii) of title 10, United States 
                        Code, the product of--
                                    ``(I) the per-unit ingredient cost, 
                                minus any per-unit rebate paid by the 
                                sponsor of the applicable antimicrobial 
                                drug; and
                                    ``(II) the number of units of such 
                                applicable antimicrobial drug dispensed 
                                under such program.
                    ``(H) Department of homeland security.--For 
                purposes of subparagraph (A), the Secretary of Homeland 
                Security shall report the total amount paid for each 
                applicable antimicrobial drug procured by the 
                Department of Homeland Security for individuals who 
                receive health care through a program carried out by 
                the Department.
                    ``(I) Bureau of prisons.--For purposes of 
                subparagraph (A), the Director of the Bureau of Prisons 
                shall report the total amount paid for each applicable 
                antimicrobial drug procured by the Bureau of Prisons 
                for individuals who receive health care through the 
                Bureau.
                    ``(J) Indian health service.--For purposes of 
                subparagraph (A), the Secretary, acting through the 
                Indian Health Service, shall report the total amount 
                paid for each applicable antimicrobial drug procured by 
                the Service for individuals who receive health care 
                through the Service.
            ``(2) Regulations.--Not later than 1 year after the date of 
        the enactment of this part, the Secretary, in consultation with 
        the heads of Federal agencies carrying out specified government 
        programs, shall issue regulations to assist such heads (or 
        their designees) in carrying out the requirements under this 
        section.
            ``(3) Subscription contract adjustment.--Pursuant to the 
        contract entered into under this section with respect to an 
        applicable antimicrobial drug, for each year of the term of 
        such contract, the Secretary shall, not earlier than 6 months 
        after the end of each calendar year, subtract from the payment 
        installments determined for such contract under subsection 
        (c)(1) for such year the revenue of the sponsor of such drug 
        from the previous year from sales of the applicable 
        antimicrobial drug reported under paragraph (1) for specified 
        government programs.
            ``(4) Definitions.--In this subsection:
                    ``(A) Applicable antimicrobial drug.--The term 
                `applicable antimicrobial drug' means an antimicrobial 
                drug for which the sponsor of such drug receives a 
                subscription contract under subsection (a).
                    ``(B) Specified government program.--The term 
                `specified government program' means--
                            ``(i) the Medicare part D program under 
                        part D of title XVIII of the Social Security 
                        Act;
                            ``(ii) the Medicare Part B program under 
                        part B of such title XVIII;
                            ``(iii) the Medicare Part A program under 
                        part A of such title XVIII;
                            ``(iv) the Medicaid program established 
                        under title XIX of the Social Security Act and 
                        includes, with respect to a State, any waiver 
                        in effect with respect to such program;
                            ``(v) any program under which prescription 
                        drugs are procured by the Department of 
                        Veterans Affairs;
                            ``(vi) any program under which prescription 
                        drugs are procured by the Department of 
                        Defense;
                            ``(vii) the TRICARE retail pharmacy program 
                        under section 1074g(a)(2)(E)(ii) of title 10, 
                        United States Code;
                            ``(viii) any program under which 
                        prescription drugs are procured by the 
                        Department of Homeland Security;
                            ``(ix) any program under which prescription 
                        drugs are procured by the Bureau of Prisons; or
                            ``(x) any program under which prescription 
                        drugs are procured by the Indian Health 
                        Service.
    ``(e) Failure To Adhere to Terms.--The Secretary shall cease any 
payment installments under a contract under this section if--
            ``(1) the sponsor--
                    ``(A) permanently withdraws the antimicrobial drug 
                from the market in the United States;
                    ``(B) fails to meet criteria under subsection (b); 
                or
                    ``(C) does not complete a postmarket study required 
                by the Food and Drug Administration during the length 
                of the term of the contract;
            ``(2) the annual international and private insurance market 
        revenues with respect to an antimicrobial drug (not counting 
        any subscription revenues from any source pursuant to a 
        contract under this section or other international or private 
        entities) exceed 5 times the average annual amount of the 
        subscription contract paid by the Secretary as certified by the 
        sponsor annually; or
            ``(3) if the total revenue of the sponsor from specified 
        government programs, as defined in subsection (d)(4), for a 
        year exceeds the amount of the subscription contract paid by 
        the Secretary for that year.
    ``(f) Private Payer and International Payer Participation.--The 
Secretary shall make efforts to increase the participation of domestic 
private payors and international payors in subscription contracts or 
other types of value-based arrangements that are similar to the 
subscription contracts authorized under this section.

``SEC. 399RR. ENCOURAGING APPROPRIATE USE OF ANTIBIOTICS AND COMBATING 
              RESISTANCE.

    ``(a) Establishment of Hospital Grant Program.--
            ``(1) In general.--Not later than 1 year after the date of 
        the enactment of this part, the Secretary and the Director of 
        the Centers for Disease Control and Prevention shall coordinate 
        with the Administrator of the Health Resources and Services 
        Administration, the Administrator of the Centers for Medicare & 
        Medicaid Services, the National Coordinator for Health 
        Information Technology, and other relevant agencies, to 
        establish a grant program under the Centers for Disease Control 
        and Prevention to support hospital and other inpatient facility 
        efforts--
                    ``(A) to judiciously use antimicrobial drugs, such 
                as by establishing or implementing appropriate use 
                programs, including infectious disease telehealth 
                programs, using appropriate diagnostic tools, 
                partnering with academic hospitals, increasing health 
                care-associated infection reporting, and monitoring 
                antimicrobial resistance; and
                    ``(B) to participate in the National Healthcare 
                Safety Network Antimicrobial Use and Resistance Module 
                or the Emerging Infections Program Healthcare-
                Associated Infections Community Interface activity of 
                the Centers for Disease Control and Prevention or a 
                similar reporting program, as specified by the 
                Secretary, relating to antimicrobial drugs.
            ``(2) Prioritization.--In awarding grants under paragraph 
        (1), the Secretary shall prioritize hospitals without an 
        existing program to judiciously use antimicrobial drugs, 
        subsection (d) hospitals (as defined in subparagraph (B) of 
        section 1886(d)(2) of the Social Security Act that are located 
        in rural areas (as defined in subparagraph (D) of such 
        section), critical access hospitals (as defined in section 
        1861(mm)(1) of such Act), hospitals serving Tribal-populations, 
        and safety-net hospitals.
            ``(3) Funding.--Of the amounts appropriated under section 
        399SS, the Secretary shall reserve $500,000,000 to carry out 
        this subsection.
    ``(b) Surveillance and Reporting of Antibiotic Use and 
Resistance.--
            ``(1) In general.--The Secretary, acting through the 
        Director of the Centers for Disease Control and Prevention, 
        shall use the National Healthcare Safety Network and other 
        appropriate surveillance systems to assess--
                    ``(A) appropriate conditions, outcomes, and 
                measures causally related to antibacterial resistance, 
                including types of infections, the causes for 
                infections, and whether infections are acquired in a 
                community or hospital setting, increased lengths of 
                hospital stay, increased costs, and rates of mortality; 
                and
                    ``(B) changes in bacterial resistance to 
                antimicrobial drugs in relation to patient outcomes, 
                including changes in percent resistance, prevalence of 
                antibiotic-resistant infections, and other such 
                changes.
            ``(2) Antibiotic use data.--The Secretary, acting through 
        the Director of the Centers for Disease Control and Prevention, 
        shall work with Federal agencies (including the Department of 
        Veterans Affairs, the Department of Defense, the Department of 
        Homeland Security, the Bureau of Prisons, the Indian Health 
        Service, and the Centers for Medicare & Medicaid Services), 
        private vendors, health care organizations, pharmacy benefit 
        managers, and other entities as appropriate to obtain reliable 
        and comparable human antibiotic drug consumption data 
        (including, as available and appropriate, volume antibiotic 
        distribution data and antibiotic use data, including 
        prescription data) by State or metropolitan areas.
            ``(3) Antibiotic resistance trend data.--The Secretary, 
        acting through the Director of the Centers for Disease Control 
        and Prevention, shall intensify and expand efforts to collect 
        antibiotic resistance data and encourage adoption of the 
        Antibiotic Use and Resistance Module within the National 
        Healthcare Safety Network among all health care facilities 
        across the continuum of care, including, as appropriate, acute 
        care hospitals, dialysis facilities, nursing homes, ambulatory 
        surgical centers, and other ambulatory health care settings in 
        which antimicrobial drugs are routinely prescribed. The 
        Secretary shall seek to collect such data from electronic 
        medication administration reports and laboratory systems to 
        produce the reports described in paragraph (4).
            ``(4) Public availability of data.--The Secretary, acting 
        through the Director of the Centers for Disease Control and 
        Prevention, shall, for the purposes of improving the monitoring 
        of important trends in patient outcomes in relation to 
        antibacterial resistance--
                    ``(A) make the data derived from surveillance under 
                this subsection publicly available through reports 
                issued on a regular basis that is not less than 
                annually; and
                    ``(B) examine opportunities to make such data 
                available in near real time.

``SEC. 399SS. APPROPRIATIONS.

    ``(a) In General.--To carry out this part, there are hereby 
appropriated to the Secretary, out of amounts in the Treasury not 
otherwise appropriated, $11,000,000,000, for fiscal year 2022, to 
remain available until expended.
    ``(b) Emergency Designation.--
            ``(1) In general.--The amounts provided by this section are 
        designated as an emergency requirement pursuant to section 4(g) 
        of the Statutory Pay-As-You-Go Act of 2010.
            ``(2) Designation in senate.--In the Senate, this section 
        is designated as an emergency requirement pursuant to section 
        4112(a) of H. Con. Res. 71 (115th Congress), the concurrent 
        resolution on the budget for fiscal year 2018.

``SEC. 399TT. STUDIES AND REPORTS.

    ``(a) In General.--Not later than 6 years after the date of the 
enactment of this part, the Comptroller General of the United States 
shall complete a study on the effectiveness of this part in developing 
priority antimicrobial drugs. Such study shall examine the indications 
for, usage of, development of resistance with respect to, and private 
and societal value of critical need antimicrobial drugs, and the impact 
of the programs under this part on patients and markets of critical 
need antimicrobial drugs. The Comptroller General 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 findings of such study.
    ``(b) Antibiotic Use in the United States; Annual Reports.--The 
Director of the Centers for Disease Control and Prevention shall, each 
year, update the report entitled `Antibiotic Use in the United States' 
to include updated information on progress and opportunities with 
respect to data, programs, and resources for prescribers to promote 
appropriate use of antimicrobial drugs.
    ``(c) Report on Antimicrobial Prophylactics.--Not later than 3 
years after the date of the enactment of this part, the Director of the 
Centers for Disease Control and Prevention shall publish a report on 
antimicrobial prophylactics.

``SEC. 399UU. DEFINITIONS.

    ``In this part--
            ``(1) the term `antimicrobial drug'--
                    ``(A) means, subject to subparagraph (B), a product 
                that is--
                            ``(i) a drug that directly inhibits 
                        replication of or kills bacteria or fungi 
                        relevant to the proposed indication at 
                        concentrations likely to be attainable in 
                        humans to achieve the intended therapeutic 
                        effect; or
                            ``(ii) a biological product that acts 
                        directly on bacteria or fungi or on the 
                        substances produced by such bacteria or fungi; 
                        and
                    ``(B) does not include--
                            ``(i) a drug that achieves the effect 
                        described by subparagraph (A)(i) only at a 
                        concentration that cannot reasonably be studied 
                        in humans because of its anticipated toxicity; 
                        or
                            ``(ii) a vaccine; and
            ``(2) the term `Committee' means the Committee on Critical 
        Need Antimicrobials established under section 399OO.''.

                   TITLE II--PATIENTS AND CAREGIVERS

SEC. 201. EDUCATIONAL PROGRAMS AND TRAINING FOR CAREGIVERS.

    Part D of title VII of the Public Health Service Act (42 U.S.C. 294 
et seq.) is amended by adding at the end the following:

``SEC. 760A. EDUCATIONAL PROGRAMS AND TRAINING FOR CAREGIVERS.

    ``(a) In General.--The Secretary may award grants for educational 
programs and training for caregivers to learn skills to empower them--
            ``(1) to be a member of a care team; and
            ``(2) to complement a clinical visit.
    ``(b) Types of Programs and Training.--Educational programs and 
training funded under subsection (a) may include--
            ``(1) specialized training in medication adherence and 
        injections;
            ``(2) complementary strategies to ensure adherence to 
        physical, occupational, speech, and habilitative therapy 
        regimens;
            ``(3) nutritional compliance;
            ``(4) caregiver psychosocial support (including cognitive-
        behavioral, supportive, and bereavement counseling);
            ``(5) caregiver health self-management; and
            ``(6) other services provided in the home.
    ``(c) Non-Duplication.--The Secretary may not use the same 
requirements under this section for a grant, contract, or cooperative 
agreement under the Geriatric Workforce Enhancement Program under 
section 753 of the Public Health Service Act (42 U.S.C. 294c).
    ``(d) Caregiver Defined.--In this section, the term `caregiver' 
means an adult family member or other individual who has a significant 
relationship with, and who provides a broad range of assistance to, an 
individual with a chronic or other health condition, disability, or 
functional limitation.
    ``(e) Authorization of Appropriations.--To carry out this section, 
there is authorized to be appropriated $25,000,000 for each of fiscal 
years 2022 through 2024.''.

SEC. 202. INCREASING HEALTH LITERACY TO PROMOTE BETTER OUTCOMES FOR 
              PATIENTS.

    (a) In General.--Not later than one year after the date of the 
enactment of this Act, the Secretary of Health and Human Services, 
acting through the Administrator of the Centers for Medicare & Medicaid 
Services, shall issue a request for information to solicit 
recommendations on ways the Centers for Medicare & Medicaid Services 
can work with stakeholders of the Federal health care programs (as 
defined in section 1128B(f) of the Social Security Act (42 U.S.C. 
1320a-7b(f))) to promote increased patient and family caregiver health 
literacy, including recommendations for--
            (1) identifying culturally competent, evidence-based 
        interventions that have been proven to improve health literacy 
        in populations served by such programs;
            (2) identifying evidence-based health literacy approaches 
        that can be used by the Medicare program under title XVIII of 
        the Social Security Act (42 U.S.C. 1395 et seq.), a State plan 
        (or waiver of such plan) under title XIX of such Act (42 U.S.C. 
        1396 et seq.), a State child health plan (or waiver of such 
        plan) under title XXI of such Act (42 U.S.C. 1397aa et seq.), 
        or health care providers participating in such program under 
        such title XVIII, under a State plan (or waiver of such plan) 
        under such title XIX, or under a State child health plan (or 
        waiver of such plan) under such title XXI, and that--
                    (A) have been proven to, or show promise to, reduce 
                costs to individuals enrolled under a State plan (or 
                waiver of such plan) under such title XIX, or under a 
                State child health plan (or waiver of such plan) under 
                such title XXI, respectively, and reduce expenditures 
                under such respective titles; or
                    (B) have been proven to increase patient and family 
                caregiver satisfaction or improve the quality of care 
                for at-risk populations, including holistic and non-
                medication-based forms of care;
            (3) how the Centers for Medicare & Medicaid Services can 
        encourage the use of evidence-based health literacy 
        interventions through payment policies under the Medicare 
        program under title XVIII of the Social Security Act (42 U.S.C. 
        1395 et seq.), a State plan under title XIX of such Act (42 
        U.S.C. 1396 et seq.), a State child health plan under title XXI 
        of such Act (42 U.S.C. 1397 et seq.); and
            (4) improving patient and family caregiver health literacy 
        with respect to health insurance, including an understanding of 
        in-network providers, deductibles, co-insurance, co-payments, 
        and differences between payors.

SEC. 203. INCREASING DIVERSITY IN CLINICAL TRIALS.

    (a) Updated Reporting on Inclusion of Demographic Subgroups.--The 
Secretary of Health and Human Services, acting through the Commissioner 
of Food and Drugs, shall--
            (1) not later than 90 days after the date of the enactment 
        of this Act, submit to the Food and Drug Administration, and 
        provide to the Congress, an updated version of the report under 
        section 907(a) of the Food and Drug Administration Safety and 
        Innovation Act (Public Law 115-52); and
            (2) not later than 1 year after the publication of the 
        updated report pursuant to paragraph (1), publish on the 
        website of the Food and Drug Administration, and provide to the 
        Congress, an updated version of the action plan under section 
        907(b) of such Act.
    (b) GAO Study on Barriers to Participation.--Not later than 1 year 
after the date of the enactment of this Act, the Comptroller General of 
the United States shall--
            (1) complete a study--
                    (A) to review how the Department of Health and 
                Human Services addresses barriers to participation by 
                individuals from underrepresented populations in 
                conducting or supporting clinical trials; and
                    (B) to formulate recommendations for addressing 
                such barriers; and
            (2) submit a report to the Congress on the results of such 
        study.
    (c) Public Awareness Campaign.--The Secretary of Health and Human 
Services shall--
            (1) carry out a public awareness campaign to increase 
        awareness and understanding, particularly in minority 
        communities, of--
                    (A) upcoming and ongoing clinical trials;
                    (B) how to enroll as subjects in such clinical 
                trials; and
                    (C) the availability of databases and other 
                resources relevant to clinical trial enrollment, such 
                as ClinicalTrials.gov; and
            (2) in carrying out such campaign, utilize a variety of 
        communication channels, including through use of the 
        explanation of Medicare benefits under section 1806 of the 
        Social Security Act (42 U.S.C. 1395b-7).
    (d) Task Force for Making ClinicalTrials.gov More User-Friendly.--
            (1) In general.--The Secretary of Health and Human Services 
        shall convene a permanent task force to propose, on a biennial 
        basis, recommendations for improving ClinicalTrials.gov by 
        making it more user-friendly, including for patients.
            (2) Membership.--The membership of the task force shall 
        include representatives of--
                    (A) the National Institutes of Health;
                    (B) the Food and Drug Administration;
                    (C) academic researchers; and
                    (D) patient organizations.
    (e) Definition.--In this section, the term ``ClinicalTrials.gov'' 
refers to the data bank described in section 402(i) of the Public 
Health Service Act (42 U.S.C. 282(i)).

SEC. 204. PATIENT EXPERIENCE DATA.

    (a) Policy.--Section 569C of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360bbb-8c) is amended--
            (1) by redesignating subsections (b) and (c) as subsections 
        (c) and (d), respectively; and
            (2) by inserting after subsection (a) the following new 
        subsection:
    ``(b) Collection, Submission, and Use of Data.--
            ``(1) In general.--The Secretary shall--
                    ``(A) for any drug for which an exemption is 
                granted for investigational use under section 505(i) of 
                this Act or section 351(a) of the Public Health Service 
                Act, require the sponsor of the drug to collect 
                standardized patient experience data as part of the 
                clinical trials conducted pursuant to such exemption;
                    ``(B) require any application for the approval or 
                licensing of such drug under section 505(b) of this Act 
                or section 351(a) of the Public Health Service Act to 
                include--
                            ``(i) the standardized patient experience 
                        data so collected; and
                            ``(ii) such related information as the 
                        Secretary may require; and
                    ``(C) consider patient experience data and related 
                information that is submitted pursuant to subparagraph 
                (B) in deciding whether to approve or license, as 
                applicable, the drug involved.
            ``(2) Applicability.--Paragraph (1) applies only with 
        respect to drugs for which a request for an exemption described 
        in paragraph (1)(A) is submitted on or after the date of the 
        enactment of the Cures 2.0 Act, or an application under section 
        505(b) of this Act or section 351(a) of the Public Health 
        Service Act is filed, as applicable, on or after the day that 
        is 2 years after the date of the enactment of the Cures 2.0 
        Act.''.
    (b) Regulations.--Not later than 1 year after the date of the 
enactment of this Act, the Secretary of Health and Human Services, 
acting through the Commissioner of Food and Drugs, shall promulgate 
final regulations to implement section 569C(b) of the Federal Food, 
Drug, and Cosmetic Act, as added by this section.

SEC. 205. ENSURING COVERAGE FOR CLINICAL TRIALS UNDER EXISTING STANDARD 
              OF CARE.

    (a) Revision to Definition of Approved Clinical Trial in Individual 
and Group Market.--
            (1) In general.--Subsection (d)(1) of the first section 
        2709 of the Public Health Service Act (42 U.S.C. 300gg-8) 
        (relating to coverage for individuals participating in approved 
        clinical trials) is amended by adding at the end the following 
        new subparagraph:
                    ``(D) The study or investigation is approved or 
                funded (which may include funding through in-kind 
                contributions) by the Patient Centered Outcomes 
                Research Institute established under section 1181 of 
                the Social Security Act.''.
            (2) Effective date.--The amendment made by this paragraph 
        shall apply with respect to plan years beginning on or after 
        January 1, 2022.
    (b) Medicare Coverage of Routine Costs Associated With Certain 
Clinical Trials.--
            (1) In general.--Section 1862(m)(2) of the Social Security 
        Act (42 U.S.C.1395y(m)(2)) is amended, in the matter preceding 
        subparagraph (A), by inserting ``(including a trial funded by 
        the Patient Centered Outcomes Research Institute established 
        under section 1181)'' after ``means a trial''.
            (2) Effective date.--The amendment made by this paragraph 
        shall apply with respect to items and services furnished on or 
        after the date of the enactment of this Act.

                TITLE III--FOOD AND DRUG ADMINISTRATION

SEC. 301. REPORT ON COLLABORATION AND ALIGNMENT IN REGULATING DIGITAL 
              HEALTH TECHNOLOGIES.

    (a) In General.--Not later than 1 year after the date of the 
enactment of this Act, the Secretary of Health and Human Services, 
acting through the Commissioner of Food and Drugs, shall submit a 
report to the Congress on the efforts to ensure collaboration and 
alignment across the centers and offices of the Food and Drug 
Administration with respect to the regulation of digital health 
technologies.
    (b) Contents.-- The report under subsection (a) shall include a 
description of the following:
            (1) How the Commissioner of Food and Drugs and the heads of 
        the centers and offices of the Food and Drug Administration 
        collaborate in regulating digital health technologies, 
        including recommendations with respect to--
                    (A) the use of digital endpoints for regulatory 
                review, including the validation and qualification of 
                digital endpoints and digital biomarkers;
                    (B) the acceptance of decentralized trials;
                    (C) the use of digital health technologies in 
                patient-focused development of products; and
                    (D) the use and validation of digital health 
                technology tools;
            (2) How the Food and Drug Administration coordinates with 
        foreign regulators to ensure harmonization on the regulation 
        and use of digital health technologies.
    (c) Definition.--In this section, the term ``digital health 
technologies'' includes those technologies in health care or society 
that help deliver or provide access to health care products and 
services such as hardware (for example, wearable sensors, virtual 
reality headsets, and digitally-enabled drug delivery devices), 
advanced analytics (for example, artificial intelligence, machine 
learning, and sophisticated computation), cloud services (for example, 
storage, computing, and data processing), and software (for example, 
mobile medical applications, and software as a medical device).

SEC. 302. GRANTS FOR NOVEL TRIAL DESIGNS AND OTHER INNOVATIONS IN DRUG 
              DEVELOPMENT.

    (a) In General.--The Secretary of Health and Human Services, acting 
through the Commissioner of Food and Drugs, shall award grants for--
            (1) incorporating complex adaptive and other novel trial 
        designs into clinical protocols and applications for drugs 
        pursuant to an exemption for investigational use under section 
        505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
        355(i)) or section 351(a) of the Public Health Service Act (42 
        U.S.C. 262(a)); and
            (2) the collection of patient experience data with respect 
        to drugs and the use of such data and related information in 
        drug development.
    (b) Prioritization.--In awarding grants under this section, the 
Secretary shall prioritize the incorporation of digital health 
technologies and real world evidence in drug development.
    (c) Definitions.--In this section:
            (1) The term ``digital health technologies'' has the 
        meaning given to such term in section 301.
            (2) The term ``patient experience data'' has the meaning 
        given to such term by section 569C(d) of the Federal Food, 
        Drug, and Cosmetic Act, as redesignated by section 204 of this 
        Act.
            (3) The term ``real world evidence'' has the meaning given 
        to that term in section 505F of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 355g).
    (d) Authorization of Appropriations.--To carry out this section, 
there is authorized to be appropriated $25,000,000 for each of fiscal 
years 2022 through 2024.

SEC. 303. FDA CELL AND GENE THERAPY.

    Not later than 1 year after the date of the enactment of this Act, 
the Secretary of Health and Human Services, acting through the 
Commissioner of Food and Drugs, shall submit a report to the Congress 
on the following:
            (1) The foreseeable challenges to the Food and Drug 
        Administration with respect to cell and gene therapies during 
        the next ten years.
            (2) How the Food and Drug Administration will address these 
        challenges.
            (3) The additional resources and authorities the Food and 
        Drug Administration needs to address these challenges.
            (4) The current state of cell and gene therapies regulation 
        by the Food and Drug Administration, including--
                    (A) the amount and nature of the submissions filed 
                with the Food and Drug Administration;
                    (B) the status of such applications in the review 
                process; and
                    (C) the therapeutic areas intended to be addressed 
                by the products that are subject to such applications.

SEC. 304. INCREASING USE OF REAL WORLD EVIDENCE.

    (a) Guidance.--
            (1) Issuance.--Not later than 6 months after the date of 
        the enactment of this Act, the Secretary of Health and Human 
        Services (in this section referred to as the ``Secretary'') 
        shall issue guidance on the use of real world evidence in 
        evaluating the safety and effectiveness of breakthrough devices 
        (developed pursuant to section 515B of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 360e-3)) and breakthrough drugs 
        subsequent to the approval or licensing of such drugs pursuant 
        to subsection (a), (b), or (c) of section 506 of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 356) as a breakthrough 
        therapy, a fast track product, or a product considered for 
        accelerated approval.
            (2) Considerations.--The guidance under paragraph (1) shall 
        take into consideration each of the following:
                    (A) Special and underrepresented populations.
                    (B) Acceptable endpoints and outcomes measures.
                    (C) Data quality standards.
                    (D) Data transparency requirements.
                    (E) Study design considerations.
    (b) Identification and Implementation of Approaches.--
            (1) Identification.--Consistent with the framework 
        established under 505F of the Federal Food, Drug, and Cosmetic 
        Act (21 U.S.C. 355g), the Secretary of Health and Human 
        Services shall, by not later than 1 year after the date of the 
        enactment of this Act--
                    (A) identify consistent, clear approaches for the 
                Department of Health and Human Services to use real 
                world evidence (as defined in such section 505F)--
                            (i) in conducting and supporting research; 
                        and
                            (ii) in regulating, purchasing, and 
                        supporting the purchase of health care products 
                        and services;
                    (B) include in such approaches recommendations for 
                any additional statutory authorities needed;
                    (C) publish such approaches in the Federal 
                Register; and
                    (D) submit a report to the Congress on such 
                approaches.
            (2) Implementation.--Upon publication under paragraph (1) 
        of the approaches identified pursuant to such paragraph, 
        consistent with the authorities vested in the Department of 
        Health and Human Services by other provisions of law, the 
        Secretary take such actions as may be appropriate to implement 
        the approaches identified pursuant to paragraph (1).
    (c) Real World Evidence Task Force.--
            (1) Establishment.--The Secretary shall establish a 
        permanent task force, to be known as the Real World Evidence 
        Task Force (in this subsection referred to as the ``Task 
        Force'') to coordinate the programs and activities of the 
        Department of Health and Human Services with regard to the 
        collection and use of real world evidence.
            (2) Membership.--The members of the Task Force shall 
        include the following:
                    (A) The Secretary (or the Secretary's designee), 
                who shall serve as the Chair of the Task Force.
                    (B) The Administrator of the Centers for Medicare & 
                Medicaid Services (or the Administrator's designee).
                    (C) The Commissioner of Food and Drugs (or the 
                Commissioner's designee).
                    (D) The Director of the National Institutes of 
                Health (or the Director's designee).
                    (E) Such additional Federal officials (or their 
                designees) as the Secretary determines appropriate.
                    (F) Private sector representatives, including 
                patient group representatives, to be appointed by the 
                Secretary.
            (3) Recommendations.--In carrying paragraph (1), the Task 
        Force shall--
                    (A) develop and periodically update recommendations 
                on ways to encourage patients to--
                            (i) engage in the generation of real world 
                        evidence; and
                            (ii) participate in postapproval clinical 
                        trials for the collection of real world 
                        evidence; and
                    (B) not later than 2 years after the date of the 
                enactment of this Act, and every 2 years thereafter, 
                submit a report to the Congress on such 
                recommendations.

SEC. 305. IMPROVING FDA-CMS COMMUNICATION REGARDING TRANSFORMATIVE NEW 
              THERAPIES.

    (a) In General.--Upon the designation of a product as a 
breakthrough therapy, a fast track product, or a product eligible for 
accelerated approval under subsection (a), (b), or (c), respectively, 
of section 506 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
356), the Commissioner of Food and Drugs and the Administrator of the 
Centers for Medicare & Medicaid Services shall--
            (1) maintain communication with each other regarding 
        approval and coverage decisions with respect to such product; 
        and
            (2) share such information with each other as may be 
        appropriate to inform and coordinate such decisions.
    (b) Separate and Distinct.--In approving or designating a product 
described in subsection (a), the Commissioner of Food and Drugs and the 
Administrator of the Centers for Medicare & Medicaid Services shall 
ensure that the process for approval or designation remains separate 
and distinct.

SEC. 306. ESTABLISHMENT OF ADDITIONAL INTERCENTER INSTITUTES AT THE 
              FOOD AND DRUG ADMINISTRATION.

    (a) Establishment.--Subsection (c) of section 1014 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 399g(c)) is amended to read as 
follows:
    ``(c) Timing.--Not later than the date that is one year after the 
date of the enactment of the Cures 2.0 Act or the end of the 
coronavirus disease 2019 (COVID-19) pandemic public health emergency 
under section 319 of the Public Health Service Act, whichever is later, 
the Secretary shall establish, in accordance with this section, at 
least two additional Institutes under subsection (a).''.
    (b) Criteria.--In establishing the focus of the two Institutes 
referenced in the amendment made by subsection (a), the Secretary of 
Health and Human Services shall ensure the following:
            (1) One of the Institutes focuses on a group of diseases 
        meeting the following criteria:
                    (A) Negatively affects at least one major body 
                system.
                    (B) Represents a major disease burden in the United 
                States.
                    (C) Represents a leading cause of mortality or 
                disability in the United States.
                    (D) According to the National Institutes of Health, 
                affects at least an estimated 50,000,000 Americans each 
                year.
                    (E) Contributes to increasing health care 
                (personal, familial, private sector, and governmental) 
                expenditures and impacts the United States economy as a 
                whole.
                    (F) For which the SARS-CoV-2 virus exacerbates 
                symptoms or causes serious complications.
                    (G) For which medical products are approved by the 
                Food and Drug Administration at a much lower rate than 
                products for other disease areas, including in 
                abbreviated pathways.
            (2) One of the Institutes focuses on a group of diseases 
        meeting the following criteria:
                    (A) Affects, individually, fewer than 200,000 
                people in the United States.
                    (B) Over 90 percent of such diseases have no 
                therapy approved by the Food and Drug Administration.
                    (C) Affects, in total, over 30,000,000 Americans.
                    (D) Over 50 percent of patients are children.
    (c) Report on Intercenter Institutes.--Not later than 2 years after 
the date of the enactment of this Act, and annually thereafter, the 
Secretary of Health and Human Services, acting through the Commissioner 
of Food and Drugs, shall submit a report to the Committee on Energy and 
Commerce of the House of Representatives and the Committee on Health, 
Education, Labor, and Pensions of the Senate on the activities of the 
Institutes established pursuant to this section.

SEC. 307. ACCELERATING TIMELINE FOR BREAKTHROUGH AND RMAT DESIGNATIONS.

    (a) Breakthrough Therapies.--Section 506(a)(2) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 356(a)(2)) is amended by striking ``A 
request for the designation may be made concurrently with, or at any 
time after, the submission of an application for the investigation of 
the drug under section 505(i) or section 351(a)(3) of the Public Health 
Service Act'' and inserting ``A request for the designation may be made 
at any point before or after submission of an application for approval 
of the drug under section 505(b) of this Act or licensure of the drug 
under section 351(a)(2) of the Public Health Service Act and shall 
include clinical evidence, including preliminary clinical evidence from 
clinical trials conducted outside of the United States''.
    (b) Regenerative Advanced Therapies.--Section 506(g)(3) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356(g)(3)) is amended 
by striking ``concurrently with, or at any time after, submission of an 
application for the investigation of the drug under section 505(i) of 
this Act or section 351(a)(3) of the Public Health Service Act'' and 
inserting ``at any point before or after submission of an application 
for approval of the drug under section 505(b) of this Act or licensure 
of the drug under section 351(a)(2) of the Public Health Service Act 
and shall include clinical evidence, including preliminary clinical 
evidence from clinical trials conducted outside of the United States''.

SEC. 308. GUIDANCE REGARDING DEVELOPMENT AND SUBMISSION OF CHEMISTRY, 
              MANUFACTURING, AND CONTROLS INFORMATION FOR EXPEDITED 
              APPROVAL.

    (a) In General.--The Secretary of Health and Human Services shall--
            (1) not later than 6 months after the date of the enactment 
        of this Act, issue draft revised guidance to provide clarity 
        regarding the development and submission of chemistry, 
        manufacturing, and controls information for purposes of 
        subsections (a), (b), (c), and (g) of section 506 of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356; relating 
        to breakthrough therapies, fast track products, accelerated 
        approval, and regenerative advanced therapies); and
            (2) not later than 90 days after the close of a period of 
        public comment on such draft guidance, finalize the guidance.
    (b) Contents.--The guidance under subsection (a) shall address--
            (1) how the Food and Drug Administration will determine 
        how, and by when, chemistry, manufacturing, and controls 
        information is required to be submitted throughout development 
        and during the pre- and post-approval phases, taking into 
        consideration--
                    (A) how such determinations will reflect the risks 
                and benefits of such information given the seriousness 
                or life-threatening nature of the disease the product 
                is intended to diagnose, cure, mitigate, treat, or 
                prevent;
                    (B) the phase and expedited nature of development; 
                and
                    (C) the availability of relevant data and 
                information from nonclinical and clinical studies, 
                product applications, and post-approval oversight; and
            (2) how the Food and Drug Administration will provide 
        ongoing advice and opportunities for sponsors to interact with 
        the Food and Drug Administration on, and how the Food and Drug 
        Administration will facilitate, the submission of chemistry, 
        manufacturing, and controls information throughout the life 
        cycle of the product.

SEC. 309. POST-APPROVAL STUDY REQUIREMENTS FOR ACCELERATED APPROVAL.

    Section 506(c)(2)(A) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 356(c)(2)(A)) is amended after ``studies'' by inserting ``, 
or otherwise submit evidence based on analyses of data in clinical care 
data repositories, patient registries, or other sources of real world 
evidence,''.

SEC. 310. RECOMMENDATIONS TO DECENTRALIZE CLINICAL TRIALS.

    (a) In General.--Not later than the end of fiscal year 2022, the 
Secretary of Health and Human Services, acting through the Commissioner 
of Food and Drugs, shall convene a meeting of covered representatives 
to recommend to the Secretary innovative approaches and incentives to 
adopt decentralized clinical trials.
    (b) Definitions.--In this section:
            (1) Covered representative.--The term ``covered 
        representative'' means a representative of the following:
                    (A) Sponsors of an application for approval of a 
                drug under section 505 of the Federal Food, Drug, and 
                Cosmetic Act (21 U.S.C. 355).
                    (B) A manufacturer of a device (as defined in 
                section 201 of the Federal Food, Drug, and Cosmetic Act 
                (21 U.S.C. 321)).
                    (C) Clinical research organizations.
                    (D) The technology community.
                    (E) The patient community.
            (2) Decentralized clinical trial.--The term ``decentralized 
        clinical trial'' means a clinical trial method that includes 
        the use of telemedicine or digital technologies to allow for 
        the remote collection of clinical trial data from subjects, 
        including in the home or office setting.

           TITLE IV--CENTERS FOR MEDICARE & MEDICAID SERVICES

SEC. 401. GAO STUDY AND REPORT.

    Not later than one year after the date of the enactment of this 
Act, the Comptroller General of the United States shall submit to 
Congress a report on recommendations for administrative actions that 
may be taken by the Secretary of Health and Human Services (as well as 
recommendations for legislative changes needed) to--
            (1) enhance coverage and reimbursement approaches under the 
        Medicare program under title XVIII of the Social Security Act 
        for innovative technologies that increase access to health 
        care, improve health care quality, decrease expenditures under 
        such program, or otherwise improve the Medicare program or 
        health care for beneficiaries under such program; and
            (2) better harmonize and integrate the operating structure 
        of the Medicare program (and the Centers for Medicare & 
        Medicaid Services) to improve interagency collaboration and 
        communication.

SEC. 402. STRATEGIES TO INCREASE ACCESS TO TELEHEALTH UNDER MEDICAID 
              AND CHILDREN'S HEALTH INSURANCE PROGRAM.

    (a) Guidance.--Not later than one year after the date of the 
enactment of this Act, the Secretary of Health and Human Services shall 
issue and disseminate guidance to States to clarify strategies to 
overcome existing barriers and increase access to telehealth under the 
Medicaid program under title XIX of the Social Security Act (42 U.S.C. 
1396 et seq.) and the Children's Health Insurance Program under title 
XXI of such Act (42 U.S.C. 1397aa et seq.). Such guidance shall include 
technical assistance and best practices regarding--
            (1) existing strategies States can use to integrate 
        telehealth and other virtual health care services into value-
        based health care models; and
            (2) examples of States that have used waivers under the 
        Medicaid program to test expanded access to telehealth, 
        including during the emergency period described in section 
        1135(g)(1)(B) of the Social Security Act (42 U.S.C. 1320b-
        5(g)(1)(B)).
    (b) Studies.--
            (1) Telehealth impact on health care access.--Not later 
        than one year after the date of the enactment of this Act, the 
        Medicaid and CHIP Payment and Access Commission shall conduct a 
        study, with respect to a minimum of 10 States across geographic 
        regions of the United States, and submit to Congress a report, 
        on the impact of telehealth on health care access, utilization, 
        cost, and outcomes, broken down by race, ethnicity, sex, age, 
        disability status, and zip code. Such report shall--
                    (A) evaluate cost, access, utilization, outcomes, 
                and patient experience data from across the health care 
                field, including States, Medicaid managed care 
                organizations, provider organizations, and other 
                organizations that provide or pay for telehealth under 
                the Medicaid program and Children's Health Insurance 
                Program;
                    (B) identify barriers and potential solutions to 
                provider entry and participation in telehealth that 
                States are experiencing, as well as barriers to 
                providing telehealth across State lines, including 
                during times of public health crisis or public health 
                emergency;
                    (C) determine the frequency at which out-of-State 
                telehealth is provided to patients enrolled in the 
                Medicaid program and the potential impact on access to 
                telehealth if State Medicaid policies were more 
                aligned; and
                    (D) identify and evaluate opportunities for more 
                alignment among such policies to promote access to 
                telehealth across all States, State Medicaid plans 
                under title XIX of the Social Security Act (42 U.S.C. 
                1396 et seq.), State child health plans under title XXI 
                of such Act (42 U.S.C. 1397aa et seq.), and Medicaid 
                managed care organizations, including the potential for 
                regional compacts or reciprocity agreements.
            (2) Federal agency telehealth collaboration.--Not later 
        than 1 year after the date of the enactment of this Act, the 
        Comptroller General of the United States shall conduct a study 
        and submit to Congress a report evaluating collaboration 
        between Federal agencies with respect to telehealth services 
        furnished under the Medicaid or CHIP program to individuals 
        under the age of 18, including such services furnished to such 
        individuals in early care and education settings. Such report 
        shall include recommendations on--
                    (A) opportunities for Federal agencies to improve 
                collaboration with respect to such telehealth services; 
                and
                    (B) opportunities for collaboration between Federal 
                agencies to expand telehealth access to such 
                individuals enrolled under the Medicaid or CHIP 
                program, including in early care and education 
                settings.

SEC. 403. EXTENDING MEDICARE TELEHEALTH FLEXIBILITIES.

    (a) Expanding Access to Telehealth Services.--
            (1) In general.--Section 1834(m)(4)(C) of the Social 
        Security Act (42 U.S.C. 1395m(m)(4)(C)) is amended by adding at 
        the end the following new clause:
                            ``(iii) Expanding access to telehealth 
                        services.--With respect to telehealth services 
                        furnished beginning on the first day after the 
                        end of the emergency period described in 
                        section 1135(g)(1)(B) of this clause, the term 
                        `originating site' means any site at which the 
                        eligible telehealth individual is located at 
                        the time the service is furnished via a 
                        telecommunications system, including the home 
                        of an individual.''.
            (2) Conforming amendments.--Such section is amended--
                    (A) in paragraph (2)(B)--
                            (i) in clause (i), in the matter preceding 
                        subclause (I), by striking ``clause (ii)'' and 
                        inserting ``clauses (ii) and (iii)''; and
                            (ii) by adding at the end the following new 
                        clause:
                            ``(iii) No facility fee for new sites.--
                        With respect to telehealth services furnished 
                        on or after the date of the enactment of this 
                        clause, a facility fee shall only be paid under 
                        this subparagraph to an originating site that 
                        is described in paragraph (4)(C)(ii) (other 
                        than subclause (X) of such paragraph).'';
                    (B) in paragraph (4)(C)--
                            (i) in clause (i), in the matter preceding 
                        subclause (I), by inserting ``and clause 
                        (iii)'' after ``and (7)''; and
                            (ii) in clause (ii)(X), by inserting 
                        ``prior to the first day after the end of the 
                        emergency period described in section 
                        1135(g)(1)(B)'' before the period;
                    (C) in paragraph (5), by inserting ``and prior to 
                the first day after the end of the emergency period 
                described in section 1135(g)(1)(B)'' after ``January 1, 
                2019,'';
                    (D) in paragraph (6)(A), by inserting ``and prior 
                to the first day after the end of the emergency period 
                described in section 1135(g)(1)(B),'' after ``January 
                1, 2019,''; and
                    (E) in paragraph (7), by adding at the end the 
                following new subparagraph:
                    ``(C) Sunset.--The provisions of this paragraph 
                shall not apply with respect to services furnished on 
                or after the first day after the end of the emergency 
                period described in section 1135(g)(1)(B).''.
    (b) Expanding Practitioners Eligible To Furnish Telehealth 
Services.--Section 1834(m) of the Social Security Act (42 U.S.C. 
1395m(m)) is amended--
            (1) in paragraph (1), by striking ``(described in section 
        1842(b)(18)(C))'' and inserting ``(defined in paragraph 
        (4)(E))''; and
            (2) in paragraph (4)(E)--
                    (A) by striking ``Practitioner.--The term'' and 
                inserting ``Practitioner.--
                    ``(A) In general.--Subject to subparagraph (B), the 
                term''; and
                    (B) by adding at the end the following new 
                subparagraph:
                    ``(B) Expansion.--The Secretary, after consulting 
                with stakeholders regarding services that are 
                clinically appropriate, may expand the types of 
                practitioners who may furnish telehealth services to 
                include any health care professional that is eligible 
                to bill the program under this title for their 
                professional services.''.
    (c) Retention of Additional Services and Subregulatory Process for 
Modifications Following Emergency Period.--Section 1834(m)(4)(F) of the 
Social Security Act (42 U.S.C. 1395m(m)(4)(F)) is amended--
            (1) in clause (i), by inserting ``and clause (iii)'' after 
        ``paragraph (8)'';
            (2) in clause (ii), by striking ``The Secretary'' and 
        inserting ``Subject to clause (iii), the Secretary''; and
            (3) by adding at the end the following new clause:
                            ``(iii) Retention of additional services 
                        and subregulatory process for modifications 
                        following emergency period.--With respect to 
                        telehealth services furnished after the last 
                        day of the emergency period described in 
                        section 1135(g)(1)(B), the Secretary may--
                                    ``(I) retain as appropriate the 
                                expanded list of telehealth services 
                                specified in clause (i) pursuant to the 
                                waiver authority under section 
                                1135(b)(8) during such emergency 
                                period; and
                                    ``(II) retain the subregulatory 
                                process used to modify the services 
                                included on the list of such telehealth 
                                services pursuant to clause (ii) during 
                                such emergency period.''.
    (d) Enhancing Telehealth Services for Federally Qualified Health 
Centers and Rural Health Clinics.--Section 1834(m)(8) of the Social 
Security Act (42 U.S.C. 1395m(m)(8)) is amended--
            (1) in the paragraph heading by inserting ``and after'' 
        after ``during'';
            (2) in subparagraph (A), in the matter preceding clause 
        (i), by inserting ``and after'' after ``During''; and
            (3) in the first sentence of subparagraph (B)(i), by 
        inserting ``and after'' after ``during''.
    (e) Use of Telehealth, as Clinically Appropriate, To Conduct Face-
to-Face Encounter for Hospice Care.--Section 1814(a)(7)(D)(i)(II) of 
the Social Security Act (42 U.S.C. 1395f(a)(7)(D)(i)(II)) is amended by 
inserting ``and after such emergency period as clinically appropriate'' 
after ``1135(g)(1)(B)''.
    (f) Use of Telehealth, as Clinically Appropriate, To Conduct Face-
to-Face Clinical Assessments for Home Dialysis.--Clause (iii) of 
section 1881(b)(3)(B) of the Social Security Act (42 U.S.C. 
1395rr(b)(3)(B)) is amended--
            (1) by moving such clause 4 ems to the left; and
            (2) by inserting ``and after such emergency period as 
        clinically appropriate'' before the period.
    (g) Implementation.--Notwithstanding any provision of law, the 
Secretary may implement the provisions of, and amendments made by, this 
section by interim final rule, program instruction, or otherwise.

SEC. 404. COVERAGE AND PAYMENT FOR BREAKTHROUGH DEVICES UNDER THE 
              MEDICARE PROGRAM.

    (a) In General.--Part E of title XVIII of the Social Security Act 
(42 U.S.C. 1395x et seq.) is amended by adding at the end the following 
new section:

``SEC. 1899C. COVERAGE OF BREAKTHROUGH DEVICES.

    ``(a) Breakthrough Devices.--For purposes of this section, the term 
`breakthrough device' means a medical device that is a device (as 
defined in section 201 of the Federal Food, Drug, and Cosmetic Act) and 
that is--
            ``(1) provided with review priority by the Secretary under 
        subsection (d)(5) of section 515 of such Act; and
            ``(2) approved or cleared pursuant to section 510(k), 
        513(f), or 515 of such Act for use in treating an indication on 
        or after March 15, 2021.
Such term also includes a breakthrough device that is a specified 
breakthrough device (as defined in subsection (e)(1)(B)) approved or 
cleared pursuant to section 510(k), 513(f), or 515 of such Act for use 
in treating an indication on or after March 15, 2021.
    ``(b) Coverage.--
            ``(1) Transitional coverage.--
                    ``(A) In general.--During the transitional coverage 
                period (as defined in subparagraph (B)) a breakthrough 
                device shall be--
                            ``(i) deemed to be reasonable and necessary 
                        for purposes of section 1862(a)(1)(A);
                            ``(ii) deemed to be approved for an 
                        additional payment under section 1886(d)(5)(K) 
                        (other than with respect to the cost criterion 
                        under clause (ii)(I) of such section);
                            ``(iii) deemed to be approved for pass-
                        through payment under section 1833(t)(6) and 
                        section 1833(i) (other than with respect to the 
                        cost criterion under section 
                        1833(t)(6)(A)(iv)); and
                            ``(iv) insofar as such breakthrough device 
                        may be furnished in a setting for which payment 
                        is made under an applicable payment system 
                        described in subparagraphs (D) through (I) of 
                        subsection (c)(4), deemed eligible for an 
                        additional payment or payment adjustment, as 
                        the case may be, pursuant to subsection (d)(3) 
                        when furnished in a setting for which payment 
                        is made under such an applicable payment system 
                        during such transitional coverage period.
                    ``(B) Transitional coverage period defined.--As 
                used in this section, the term `transitional coverage 
                period' means, with respect to a breakthrough device, 
                the period that--
                            ``(i) begins on the date of the approval 
                        under section 515 of the Federal Food, Drug, 
                        and Cosmetic Act or of the clearance under 
                        section 510(k) of such Act, as applicable, of 
                        such device by the Secretary for the indication 
                        described in subsection (a)(1); and
                            ``(ii) ends on the last day of the 4-year 
                        period that begins on the date that the 
                        Secretary, pursuant to subsection (c)(2), 
                        updates the relevant applicable payment system 
                        (as defined in subsection (c)(4)) to recognize 
                        the unique temporary or permanent code or codes 
                        assigned under subsection (c)(1) to such 
                        breakthrough device, except as provided in 
                        subsections (d)(1)(B) and (d)(2)(B).
                    ``(C) Data used to meet the ntap and pass-through 
                cost criteria.--In determining whether a breakthrough 
                device qualifies for an additional payment under 
                section 1886(d)(5)(K) or for pass-through payment under 
                section 1833(t)(6) or section 1833(i), the Secretary 
                shall use the most recently available data and 
                information on the costs of such breakthrough device, 
                which may include list prices and invoice prices 
                charged for such breakthrough device.
            ``(2) Process for regular coverage.--For purposes of the 
        application of section 1862(a)(1)(A) to a breakthrough device 
        furnished after the transitional coverage period (as defined in 
        paragraph (1)(B)) for such device, the Secretary shall 
        establish a process for the coverage of such breakthrough 
        devices under this title after such period as follows:
                    ``(A) Identification of additional evidence.--
                            ``(i) In general.--With respect to a 
                        breakthrough device, not later than 1 year 
                        after the date of the approval of such device 
                        under section 515 of the Federal Food, Drug, 
                        and Cosmetic Act or of the clearance of such 
                        device under section 510(k) of such Act, as 
                        applicable, the Secretary shall identify 
                        whether any additional data or evidence is 
                        required with respect to any indications for 
                        such device for purposes of the application of 
                        such section 1862(a)(1)(A) to such device for 
                        such indications.
                            ``(ii) Non-duplication of data requests.--
                        In carrying out clause (i) with respect to a 
                        breakthrough device, the Secretary shall ensure 
                        that data or evidence identified--
                                    ``(I) does not duplicate data 
                                required to be collected by the Food 
                                and Drug Administration with respect to 
                                such breakthrough device;
                                    ``(II) minimizes the administrative 
                                burdens of data collection and 
                                reporting on providers of services, 
                                suppliers, and manufacturers of 
                                breakthrough devices; and
                                    ``(III) is not otherwise 
                                unnecessary or redundant.
                    ``(B) Proposal for coverage after the transitional 
                coverage period.--Not later than 2 years after the date 
                of the approval or clearance of a breakthrough device 
                by the Food and Drug Administration, the Secretary 
                shall develop a proposal for coverage under this title 
                of such breakthrough device for such indications as the 
                Secretary determines to be appropriate, based on the 
                data and evidence collected under subparagraph (A), for 
                such devices furnished after the transitional coverage 
                period under paragraph (1) for such device. If the 
                Secretary does not, on a date that is before the end of 
                such two-year period, take action to modify the 
                indications for which coverage of a breakthrough device 
                may be provided under this title after such period, for 
                purposes of section 1862(a)(1)(A) coverage under this 
                title of such breakthrough device shall be made for all 
                indications for which such device is approved under 
                section 515 of the Federal Food, Drug, and Cosmetic Act 
                or cleared under section 510(k) of such Act.
            ``(3) Rules of construction.--Nothing in this section shall 
        be construed to--
                    ``(A) affect the ability of the manufacturer of a 
                breakthrough device to seek approval for pass-through 
                payment status under section 1833(t)(6) or to seek 
                approval for an additional payment under section 
                1886(d)(5)(K) insofar as such breakthrough device does 
                not qualify for transitional coverage under paragraph 
                (1);
                    ``(B) affect the application and approval process 
                for pass-through payment status under section 
                1833(t)(6) or for an additional payment under section 
                1886(d)(5)(K) in the case of a medical device that is 
                not approved by the Food and Drug Administration as a 
                breakthrough device; or
                    ``(C) prohibit the Secretary from using existing 
                authority under this title to suspend or terminate 
                coverage of a breakthrough device if the Secretary, 
                based on clinical evidence, determines that--
                            ``(i) such breakthrough device offers no 
                        clinical benefit to Medicare beneficiaries; or
                            ``(ii) furnishing such breakthrough device 
                        to Medicare beneficiaries causes, or may cause, 
                        serious harm to Medicare beneficiaries.
    ``(c) Coding.--
            ``(1) Prompt assignment.--Not later than three months after 
        the date of approval or clearance of a breakthrough device by 
        the Food and Drug Administration, the Secretary shall assign a 
        unique temporary or permanent code or codes for purposes of 
        coverage and payment for such breakthrough device under the 
        applicable payment systems (described in paragraph (4)).
            ``(2) Updates.--
                    ``(A) IPPS.--The Secretary shall provide for 
                semiannual updates under the applicable payment system 
                described in paragraph (4)(A) (relating to the 
                inpatient hospital prospective payment system) to 
                recognize the code or codes assigned under paragraph 
                (1).
                    ``(B) OPPS.--The Secretary shall provide for 
                quarterly updates under the applicable payment system 
                described in paragraph (4)(B) (relating to the 
                outpatient hospital prospective payment system) to 
                recognize the code or codes assigned under paragraph 
                (1).
                    ``(C) Other payment systems.--The Secretary shall 
                provide for semiannual or quarterly updates, as the 
                case may be, under the applicable payment systems 
                described in subparagraphs (C) through (L) of paragraph 
                (4) to recognize the code or codes assigned under 
                paragraph (1).
            ``(3) Transparency.--The process for the assignment of a 
        code or codes under this subsection shall provide for public 
        notice and a meaningful opportunity for public comment from 
        affected parties.
            ``(4) Applicable payment systems described.--For purposes 
        of this subsection, the term `applicable payment systems' 
        means--
                    ``(A) with respect to inpatient hospital services, 
                the prospective payment system for inpatient hospital 
                services established under section 1886(d);
                    ``(B) with respect to outpatient hospital services, 
                the prospective payment system for covered OPD services 
                established under section 1833(t);
                    ``(C) with respect to ambulatory surgical center 
                services, the fee schedule for such services 
                established under 1833(i);
                    ``(D) with respect to physicians' services, the 
                physician fee schedules established under section 1848;
                    ``(E) with respect to covered items of durable 
                medical equipment, the applicable fee schedules 
                established under section 1834;
                    ``(F) with respect to diagnostic laboratory tests, 
                the payment amounts under section 1834A and the fee 
                schedules establish under section 1848, as the case may 
                be;
                    ``(G) with respect to inpatient hospital services 
                furnished by rehabilitation facilities, the prospective 
                payment system established under section 1886(j);
                    ``(H) with respect to inpatient hospital services 
                furnished by long-term care hospitals, the prospective 
                payment system under section 1886(m);
                    ``(I) with respect to inpatient hospital services 
                furnished by psychiatric hospitals and psychiatric 
                units, the prospective payment system under section 
                1886(s);
                    ``(J) with respect to home health services, the 
                prospective payment system under section 1895; and
                    ``(K) with respect to items and services, or a 
                provider of services or supplier, not described in 
                subparagraphs (A) through (I), the payment system 
                established under this title for such items and 
                services when furnished by such provider of services or 
                supplier.
    ``(d) Payment.--
            ``(1) Inpatient hospital prospective payment system: deemed 
        eligibility for breakthrough payment.--The Secretary shall deem 
        each breakthrough device as approved for an additional payment 
        under section 1886(d)(5)(K) for the 4-year period that begins--
                    ``(A) except as provided in subparagraph (B), on 
                the date that the Secretary, pursuant to subsection 
                (c)(2)(A), updates the payment system under section 
                1886(d) to recognize the unique temporary or permanent 
                code or codes assigned under subsection (c)(1) to such 
                breakthrough device; or
                    ``(B) in the case of a device that has not received 
                approval or clearance as a breakthrough device by the 
                Food and Drug Administration before such payment system 
                is updated under subsection (c)(2)(A) to recognize the 
                unique temporary or permanent code or codes assigned 
                under subsection (c)(1) to such device, on the date of 
                such approval or clearance.
        Nothing in this paragraph shall be construed to affect the 
        authority of the Secretary to use claims data to establish new 
        diagnosis or procedure codes for breakthrough devices or to 
        identify appropriate diagnosis-related groups for the 
        assignment of breakthrough devices under annual rulemaking to 
        carry out section 1886(d)(5)(K).
            ``(2) Outpatient prospective payment system: deemed 
        eligibility for pass-through payment.--The Secretary shall deem 
        each breakthrough device as approved for pass-through payment 
        under section 1833(t)(6) (including for purposes of section 
        1833(i)(2)(D)) during the 4-year period that begins--
                    ``(A) except as provided in subparagraph (B), on 
                the date that the Secretary, pursuant to subsection 
                (c)(2)(B), updates the payment system under section 
                1833(t) to recognize the unique temporary or permanent 
                code or codes assigned under subsection (c)(1) to such 
                breakthrough device; or
                    ``(B) in the case of a device that has not received 
                approval or clearance as a breakthrough device by the 
                Food and Drug Administration before such payment system 
                is updated under subsection (c)(2)(B) to recognize the 
                unique temporary or permanent code or codes assigned 
                under subsection (c)(1) to such device, on the date of 
                such approval or clearance.
        Nothing in this paragraph shall be construed to affect the 
        authority of the Secretary to use claims data to establish new 
        ambulatory payment classification groups for breakthrough 
        devices or to revise such groups to take into account 
        breakthrough devices under annual rulemaking to carry out 
        section 1833(t).
            ``(3) Other payment systems.--
                    ``(A) In general.--In the case of a breakthrough 
                device that is furnished and for which payment may be 
                made under the payment system established under section 
                1834, 1834A, 1848, 1886(j), 1886(m), 1886(s), or 1895 
                or any other provision of this title (other than 
                sections 1833(i), 1833(t), and 1886(d)), the Secretary 
                shall provide for an additional payment for such 
                breakthrough device under such applicable payment 
                system or an adjustment to such applicable payment 
                system, as the case may be. The payment basis for such 
                additional payment or adjustment, as the case may be, 
                shall equal an amount that the Secretary determines 
                covers the costs of such breakthrough device.
                    ``(B) Cost information.--In determining the costs 
                of a breakthrough device for purposes of determining an 
                additional payment or payment adjustment under 
                subparagraph (A), the Secretary shall use the most 
                recently available data and information on the costs of 
                such breakthrough device, which may include list prices 
                and invoice prices charged for such breakthrough 
                device.
                    ``(C) Rule of construction.--Nothing in this 
                paragraph shall be construed to affect the authority of 
                the Secretary to use claims data to establish new or 
                modify existing ambulatory payment classification 
                groups, diagnosis-related groups, level II HCPCS codes 
                or such other groups or codes as the Secretary may 
                establish under the annual rulemaking authority under 
                the provisions referred to in subparagraph (A).
                    ``(D) Clinical diagnostic laboratory tests.--An 
                additional payment or payment adjustment under 
                subparagraph (A) for a breakthrough device under the 
                applicable payment system established in section 1834A 
                may be in the form of an increase to the amount 
                determined for the breakthrough device using cross-
                walking under section 1834A(c)(1)(A), an extension of 
                the initial period of payment applicable to advance 
                diagnostic laboratory tests under section 
                1834A(d)(1)(A), and in such other form or manner as the 
                Secretary determines reflects the costs for such 
                breakthrough device under the relevant provisions of 
                section 1834A.
            ``(4) Payment for breakthrough devices after the 
        transitional coverage period.--Payment for a breakthrough 
        device that is furnished after the conclusion of the 
        transitional coverage period under subsection (b)(1) for such 
        device shall be made pursuant to the applicable payment system 
        involved, taking into account the additional evidence and data 
        collected under subsection (b)(2).
    ``(e) Special Rules for Certain Breakthrough Devices.--
            ``(1) Coverage of specified breakthrough devices.--
                    ``(A) In general.--Subject to the succeeding 
                provisions of this subsection and notwithstanding any 
                other provision of law, the Secretary shall provide for 
                coverage and payment pursuant to this section of a 
                specified breakthrough device (as defined in 
                subparagraph (B)).
                    ``(B) Specified breakthrough device defined.--In 
                this section, the term `specified breakthrough device' 
                means a breakthrough device with respect to which no 
                Medicare benefit category exists.
            ``(2) Period of transitional coverage.--
                    ``(A) In general.--Subject to subparagraph (C), the 
                provisions of subsection (b)(1) (relating to the 
                transitional coverage period and payment for 
                breakthrough devices, including the use of the most 
                recently available data and information on costs) shall 
                apply to a specified breakthrough device in the same 
                manner as such provisions apply to a breakthrough 
                device. The Secretary may use methodologies under 
                existing payment systems established under this title, 
                may provide for appropriate adjustments to such 
                methodologies, or may establish a new payment 
                methodology under this title, to provide for payment 
                for a specified breakthrough device to ensure the 
                payment basis for such payment covers costs of the 
                specified breakthrough device are covered by such 
                payment.
                    ``(B) Report.--
                            ``(i) In general.--With respect to each 
                        specified breakthrough device, the Secretary 
                        shall submit to Congress a report on the 
                        coverage of and payment for such specified 
                        breakthrough device under this section that 
                        includes the following information:
                                    ``(I) The manner in which coverage 
                                is provided and payment is made for the 
                                specified breakthrough device, 
                                including how such device was 
                                classified (such as an item of durable 
                                medical equipment or otherwise) and the 
                                payment methodology the Secretary 
                                applied with respect to such device.
                                    ``(II) The impact of the 
                                availability of the specified 
                                breakthrough device to Medicare 
                                beneficiaries, including impacts on the 
                                quality of patient care, patient 
                                outcomes, and patient experience.
                                    ``(III) The impact of the 
                                availability of the specified 
                                breakthrough device to Medicare 
                                beneficiaries on program expenditures 
                                under this title.
                                    ``(IV) Such other information as 
                                the Secretary determines to be 
                                appropriate.
                            ``(ii) Deadline.--
                                    ``(I) In general.--Except as 
                                provided in subclause (II), the 
                                Secretary shall submit a report 
                                required under this subparagraph no 
                                later than the end of the transitional 
                                period of coverage and payment 
                                applicable to such specified 
                                breakthrough device.
                                    ``(II) Extension to generate 
                                additional data.--If the Secretary 
                                determines that additional data or 
                                evidence is required to complete a 
                                report required under this subparagraph 
                                with respect to a specified 
                                breakthrough device, the deadline under 
                                this clause may be extended for an 
                                additional two years.
                    ``(C) Additional period of transitional coverage to 
                develop additional data.--Insofar as the Secretary 
                determines that additional data or evidence is required 
                to complete a report required under subparagraph (B) 
                with respect to a specified breakthrough device, the 
                transitional coverage period of coverage and payment 
                for such device shall be extended by the lesser of--
                            ``(i) two years; or
                            ``(ii) the amount of additional time 
                        required for the submission of the report with 
                        respect to such device.
            ``(3) Coverage and payment after the transitional period.--
        The Secretary may continue to provide for coverage of and 
        payment for a specified breakthrough device after the end of 
        the transitional period of coverage and payment for 
        breakthrough devices through the national coverage 
        determination process if the Secretary determines that the 
        specified breakthrough device--
                    ``(A) improves the quality of care and patient 
                outcomes;
                    ``(B) improves the delivery of care; or
                    ``(C) reduces spending under this title without 
                reducing the quality of care.''.
    (b) Conforming Amendments.--
            (1) Inpatient prospective payment system.--Section 
        1886(d)(5)(K) of the Social Security Act (42 U.S.C. 
        1395ww(d)(5)(K)) is amended by adding at the end the following 
        new clause:
                    ``(x) Effective for discharges occurring on or 
                after October 1, 2019, in the case of a new medical 
                service or technology that is a breakthrough device (as 
                defined in section 1899C(a)), the additional payment 
                established for such breakthrough device under this 
                subparagraph shall be made for the 4-year period 
                applicable to such breakthrough device under section 
                1899C(d)(1). In determining the amount of the 
                additional payment for a breakthrough device under this 
                subparagraph during such 4-year period, the Secretary 
                shall apply section 412.88(b) of title 42, Code of 
                Federal Regulations, as in effect on the date of the 
                enactment of this clause, except as if the reference in 
                such section to `65 percent' were a reference to `65 
                percent (or such greater percent specified by the 
                Secretary)'.''.
            (2) Outpatient prospective payment system.--Section 
        1833(t)(6)(C) of such Act (42 U.S.C. 1395l(t)(6)(C)) is amended 
        by adding at the end the following new clause:
                            ``(iii) Special rule for breakthrough 
                        devices.--Notwithstanding clause (i) or (ii), 
                        or any other provision of this paragraph to the 
                        contrary, in the case of a breakthrough device 
                        (as defined in section 1899C(a)) that is 
                        furnished on or after January 1, 2020, payment 
                        under this paragraph for such breakthrough 
                        device shall be made for the 4-year period 
                        applicable to such breakthrough device under 
                        section 1899C(d)(2). The provisions of this 
                        clause shall also apply for purposes of 
                        transitional pass-through payment under section 
                        1833(i)(2)(D).''.
    (c) Effective Date.--This section, and the amendments made by this 
section, shall take effect on the date of the enactment of this Act 
and, unless otherwise specified in this section (or in an amendment 
made by this section), shall apply to breakthrough devices (as defined 
in section 1899C(a) of the Social Security Act, as added by subsection 
(a)), approved or cleared on or after July 1, 2019, or, in the case of 
a specified breakthrough device (as defined in such section as so 
added), approved or cleared on or after December 1, 2018.

SEC. 405. SECRETARY OF HEALTH AND HUMAN SERVICES REPORT ON COVERAGE FOR 
              INNOVATIVE TECHNOLOGIES.

    Not later than 1 year after the date of the enactment of this Act, 
the Secretary of Health and Human Services, in collaboration with the 
Administrator of the Centers for Medicare & Medicaid Services, and 
following a request for information, shall submit to Congress a report 
containing a proposal that--
            (1) specifies, for purposes of payment and coverage under 
        title XVIII of the Social Security Act, a definition for 
        digital alternatives to treatment and therapies, including 
        wearables and digital applications and platforms;
            (2) establishes a standardized process for determining 
        which technologies satisfy the definition pursuant to paragraph 
        (1);
            (3) establishes a standardized process for determining 
        coverage under such title of digital alternatives as defined 
        pursuant to paragraph (1) that are prescribed by a physician; 
        and
            (4) identifies an innovative system for payment under such 
        title for such alternatives.

SEC. 406. SECRETARY OF HEALTH AND HUMAN SERVICES REPORT ON CMS COMPUTER 
              SYSTEMS.

    Not later than one year after the date of the enactment of this 
Act, the Secretary of Health and Human Services shall submit to 
Congress a report on the following:
            (1) The current state of computer systems of the Centers 
        for Medicare & Medicaid Services, including an analysis of the 
        capabilities and deficiencies of such systems in helping to 
        managing the operations of the programs administered by the 
        Centers for Medicare & Medicaid Services.
            (2) The cost, taking into account ways to lower or defray 
        costs to the Federal Government, of each of the following:
                    (A) Replacing or updating such systems identified 
                under paragraph (1).
                    (B) Contractors and other third parties to solve 
                for deficiencies in such system identified under 
                paragraph (1).

SEC. 407. PRECISION MEDICINE ANSWERS FOR KIDS TODAY.

    (a) Centers for Medicare & Medicaid Services Guidance on the Early 
and Periodic Screening, Diagnostic, and Treatment Benefit.--Not later 
than 6 months after the date of the enactment of this Act, the Centers 
for Medicare & Medicaid Services shall issue guidance to States on 
authority and requirements under the Medicaid program under title XIX 
of the Social Security Act to provide medically necessary health care 
that falls within the scope of services specified under section 1905(r) 
of the Social Security Act (42 U.S.C. 1396d(r)) to a child, regardless 
of whether the service is available for adults under the State plan (or 
waiver of such plan) under such title. The guidance shall--
            (1) include technical and educational assistance on how to 
        increase the frequency of coverage under the State plan (or 
        waiver) pursuant to paragraphs (4) and (16) of section 1905(a) 
        of such Act (42 U.S.C. 1396d(a)) for genetic and genomic 
        testing diagnostic services, including whole exome sequencing, 
        whole genome sequencing, and gene panels when recommended by a 
        qualified treating provider as a first- or second-tier test for 
        pediatric patients, including those who--
                    (A) have a positive result from a newborn screening 
                program;
                    (B) have one or more neurodevelopmental or 
                congenital anomalies;
                    (C) are experiencing developmental delay or 
                intellectual disability;
                    (D) are having seizures;
                    (E) have been referred or admitted to a pediatric 
                or neonatal intensive care unit for a chronic or 
                undiagnosed disease;
                    (F) have been seen by at least one medical 
                specialist for such chronic or undiagnosed disease; or
                    (G) are suspected by at least one healthcare 
                provider to have a neonatal- or pediatric-onset genetic 
                disease;
            (2) provide education and support to providers to minimize 
        denials of claims for medical assistance under the State plan 
        under title XIX of the Social Security Act resulting from 
        deficient or inadequate paperwork; and
            (3) ensure that providers and Medicaid-eligible children 
        and the families are aware of the Early and Periodic Screening, 
        Diagnostic and Treatment Benefit under title XIX of the Social 
        Security Act and have access to required screenings and 
        necessary treatment services.
    (b) Demonstration Program To Provide Genetic and Genomic Testing 
for Certain Children.--
            (1) In general.--The Secretary of Health and Human Services 
        shall enter into agreements with up to 15 States submitting 
        applications under paragraph (3) for the purpose of conducting, 
        in accordance with this subsection, demonstration projects 
        under section 1115 of the Social Security Act (42 U.S.C. 1315) 
        in such States during the 3-year period beginning on the first 
        date of the first fiscal quarter than begins on or after the 
        date of the enactment of this subsection to test and evaluate 
        the provision of medical assistance under the State plans under 
        title XIX of such Act (or waivers of such plans) to eligible 
        individuals for purposes of providing such individuals with 
        genetic and genomic testing.
            (2) Demonstration project payment requirements.--Under each 
        demonstration project under this section conducted by a State, 
        the following shall apply:
                    (A) The State shall provide a health care provider 
                (as defined by the State) with payments for the 
                provision of genetic and genomic testing to any 
                eligible individual. Payments made to a health care 
                provider for such services shall be treated as medical 
                assistance for purposes of section 1903(a) of the 
                Social Security Act (42 U.S.C. 1396b(a)), except that 
                the Federal medical assistance percentage applicable to 
                such payments shall be equal to 100 percent.
                    (B) The State shall specify the methodology the 
                State will use for determining payment for the 
                provision of genetic and genomic testing. Such 
                methodology for determining payment shall be 
                established consistent with section 1902(a)(30)(A) of 
                such Act (42 U.S.C. 1396a(a)(30)(A)).
            (3) Applications.--
                    (A) In general.--A State desiring to enter into an 
                agreement under paragraph (1) with the Secretary for 
                conducting a demonstration project shall submit to the 
                Secretary an application, in accordance with such form 
                and manner, and application priorities, as specified by 
                the Secretary and that at a minimum includes the 
                following:
                            (i) An explanation of how and the extent to 
                        which genetic and genomic testing under the 
                        demonstration project of the State will provide 
                        information and data on how such services 
                        improve the diagnosis of eligible individuals.
                            (ii) An explanation of how and the extent 
                        to which coverage under the State plan (or 
                        waiver) pursuant to the demonstration project 
                        will increase the use of genetic and genomic 
                        testing that may increase the use of genetic 
                        and genomic testing that may improve clinical 
                        outcomes for eligible individuals.
                            (iii) Procedures for referring any eligible 
                        individual who seeks or needs treatment in a 
                        hospital emergency department to a health care 
                        provider who is qualified (as determined by the 
                        State) to provide genetic and genomic testing.
                            (iv) An explanation of how genetic and 
                        genomic testing may improve health outcomes for 
                        all populations in the State, including--
                                    (I) individuals with a rare genetic 
                                disease, including a metabolic disease, 
                                neurologic disorders, or hereditary 
                                cancer testing in the presence of a 
                                suspected or confirmed cancer 
                                diagnosis; and
                                    (II) special populations, including 
                                infants and children who are critically 
                                ill (non-infectious and non-trauma) 
                                patients, transplant patients, 
                                individuals with cardiac disease, and 
                                individuals with, or who have a family 
                                history of, a birth defect or 
                                developmental disability.
                    (B) Preferences in considering applications.--In 
                considering applications submitted under subparagraph 
                (A), the Secretary of Health and Human Services shall 
                give preference to States that can demonstrate 
                underutilization of genetic and genomic sequencing 
                clinical services (with priority given to States that 
                do not cover whole-genome sequencing or do not cover 
                the majority of genetic and genomic clinical services) 
                in pediatric populations under the State plan under 
                title XIX of the Social Security Act (or waiver of such 
                plan).
            (4) Technical assistance.--The Secretary of Health and 
        Human Services shall provide technical assistance to assist 
        States in planning and designing the demonstration project for 
        purposes of applying for conducting such project under this 
        section.
            (5) Reports by states.--Not later than one year after the 
        date on which a State enters into an agreement under paragraph 
        (1) with the Secretary for conducting a demonstration project, 
        the State shall submit a report to the Administrator of the 
        Centers for Medicare & Medicaid Services and the Administrator 
        of the Health Resources and Services Administration on the 
        extent to which genetic and genomic testing improved outcomes 
        and reduced health disparities. Such report shall include 
        information on the number of patients receiving genetic and 
        genomic testing, the types of services provided, and such other 
        information as the Secretary shall prescribe.
            (6) Reports by health care providers.--As a condition for 
        receiving payment for genetic and genomic testing provided to 
        an eligible individual under a demonstration project conducted 
        by a State under this subsection, a health care provider shall 
        report to the State, in accordance with such requirements as 
        the Secretary shall specify, on all applicable measures for 
        determining the quality and efficacy of such services.
            (7) Definitions.--In this subsection:
                    (A) Eligible individual.--The term ``eligible 
                individual'' means, with respect to a State, an 
                individual who--
                            (i) is eligible for medical assistance 
                        under the State plan under title XIX of the 
                        Social Security Act (or a waiver of such plan);
                            (ii) is under the age of 21 (or, at the 
                        option of the State, under the age of 20, 19, 
                        or 18 as the State may choose), or in the case 
                        of an individual described in section 
                        1902(a)(10)(A)(i)(IX) of such Act (42 U.S.C. 
                        1396a(a)(10)(A)(i)(IX)), under the age of 26;
                            (iii) has been referred or admitted to an 
                        intensive care unit, or has been seen by at 
                        least one medical specialist, for a suspected 
                        genetic or undiagnosed disease; or
                            (iv) is suspected by at least one medical 
                        specialist to have a neonatal-onset or 
                        pediatric-onset genetic disease.
                    (B) Genetic and genomic testing.--The term 
                ``genetic and genomic testing'', with respect to an 
                eligible individual--
                            (i) means the determination of a sequence 
                        of deoxyribonucleic acid bases in the genome of 
                        such individual, and, if for the sole benefit 
                        of the individual, a biological parent of such 
                        individual for the purpose of determining 
                        whether one or more potentially disease-causing 
                        genetic variants are present in the genome of 
                        such individual or such biological parent; and
                            (ii) includes--
                                    (I) the sequencing of the whole 
                                genome, the whole exome, or a panel of 
                                genes; and
                                    (II) any analysis, interpretation, 
                                and data report derived from such 
                                sequencing.
    (c) National Academy of Medicine Study.--
            (1) In general.--Not later than one year after the date of 
        the enactment of this Act, the Secretary of Health and Human 
        Services shall enter into an arrangement with the National 
        Academy of Medicine under which the Academy agrees to study--
                    (A) how genetic and genomic testing may improve 
                preventative care and precision medicine;
                    (B) disparities in access to precision diagnostics 
                and associated therapeutics;
                    (C) how genetic and genomic testing may be used to 
                reduce health disparities in marginalized communities;
                    (D) how the Federal Government may help to reduce 
                barriers to genetic and genomic testing, including--
                            (i) encouraging the expansion of health 
                        insurance coverage of genetic and genomic 
                        testing, including diagnostic, predictive, and 
                        presymptomatic testing, and genetic and genomic 
                        testing (as defined in subsection (b)(7)(B));
                            (ii) supporting the collection of evidence 
                        for the clinical utility and appropriate use of 
                        genetic and genomic tests; and
                            (iii) improving access to genetic 
                        counselors, pathologists, and other relevant 
                        professions, including strengthening related 
                        workforce education and training efforts;
                    (E)(i) the extent to which coverage provisions in 
                the Medicare and Medicaid programs under titles XVIII 
                and XIX of the Social Security Act (42 U.S.C. 1395 et 
                seq., 1396 et seq.) may restrain the use of genetic and 
                genomic testing that may improve clinical outcomes for 
                beneficiaries;
                    (ii) the extent to which coverage provided pursuant 
                to subsection (a) increased the use of genetic and 
                genomic testing and improved clinical outcomes for 
                beneficiaries; and
                    (iii) how the Centers for Medicare & Medicaid 
                Services may make coverage determinations that better 
                suit a precision medicine approach to treatment; and
                    (F) how genetic and genomic testing may improve 
                health outcomes for all pediatric populations in the 
                United States, including--
                            (i) children with a rare disease, including 
                        a metabolic disease, neurologic disorder, or 
                        hereditary cancer testing in the presence of a 
                        suspected or confirmed cancer diagnosis; and
                            (ii) special populations, including--
                                    (I) critically ill (non-infectious 
                                and non-trauma) patients;
                                    (II) transplant patients;
                                    (III) individuals with cardiac 
                                disease; and
                                    (IV) individuals with, or who have 
                                a family history of, a birth defect or 
                                developmental disability.
            (2) Report.--
                    (A) In general.--The arrangement under paragraph 
                (1) shall provide for the National Academy of Medicine 
                to submit, not later than 2 years after the date of the 
                enactment of this Act, a report on the results of the 
                study under paragraph (1) to--
                            (i) the Secretary of Health and Human 
                        Services;
                            (ii) the Committee on Ways and Means and 
                        the Committee on Energy and Commerce of the 
                        House of Representatives; and
                            (iii) the Committee on Finance and the 
                        Committee on Health, Education, Labor, and 
                        Pensions of the Senate.
                    (B) Consultation.--The arrangement under paragraph 
                (1) shall provide for the National Academy of Medicine, 
                in developing the report required by subparagraph (A), 
                to consult with physicians, other health professionals, 
                health educators, health professional organizations, 
                relevant companies, patients, patient organizations, 
                the Health Resources and Services Administration, the 
                National Cancer Institute, the National Institutes of 
                Health, the Agency for Healthcare Research and Quality, 
                and the Centers for Medicare & Medicaid Services.
                    (C) Use of information.--The National Academy of 
                Medicine shall, to the extent possible, in conducting 
                the study under paragraph (1), utilize information 
                included in the reports submitted pursuant to 
                subsections (f) and (g) of section 2.
    (d) Centers for Medicare & Medicaid Services Report on Medicaid 
Coverage for Genetic and Genomic Testing.--Not later than one year 
after the date of the enactment of this Act, and annually thereafter 
for the subsequent 3 years, the Centers for Medicare & Medicaid 
Services shall submit to the Secretary of Health and Human Services, 
the Committees on Ways and Means and on Energy and Commerce of the 
House of Representatives, and the Committees on Finance and Health, 
Education, Labor, and Pensions of the Senate a report on the extent to 
which each of the 50 States provide coverage under the State plan under 
title XIX of the Social Security Act (or waiver of such plan) of 
genetic and genomic testing (as defined in subsection (b)(7)(B)) 
(including whole exome, whole genome, gene panels, single gene tests, 
Chromosomal microarray analysis, Fluorescence in situ hybridization, 
and other genetic and genomic tests), including information on--
            (1) how often genetic and genomic diagnostic testing 
        services are covered and reimbursed;
            (2) the frequency of denials for coverage and the rationale 
        for denying coverage;
            (3) an analysis of which genetic and genomic diagnostic 
        tests are being approved or denied;
            (4) how often test genetic counseling is covered pre- and 
        post-genetic and genomic diagnostic testing;
            (5) the turn-around time for prior authorization requests; 
        and
            (6) any barriers to coverage of genetic and genomic testing 
        services identified.

SEC. 408. MEDICARE COVERAGE FOR CONSULTATIONS.

    (a) Inclusion of Consultations as a Medicare Benefit.--Section 1861 
of the Social Security Act (42 U.S.C. 1395x) is amended--
            (1) in subsection (s)(2)--
                    (A) by striking ``and'' at the end of subparagraph 
                (GG);
                    (B) by striking the period at the end of 
                subparagraph (HH) and inserting ``; and''; and
                    (C) by adding at the end the following new 
                subparagraph:
                    ``(II) pharmacogenetic consultations provided by a 
                qualified clinical pharmacist, genetic counselor, or 
                pathologist (as such terms are defined in subsection 
                (lll)).''; and
            (2) by adding at the end the following new subsection:
    ``(lll) Definitions.--In this section:
            ``(1) Pharmacogenetic consultation.--The term 
        `pharmacogenetic consultation' means, with respect to a genetic 
        or genomic test furnished to an individual, a consultation with 
        respect to such test requested by the physician treating such 
        individual to provide such physician with advice and 
        recommendations regarding the dosage, safety, and efficacy of 
        particular drugs, biologicals, and other treatments based on 
        the individual's pharmacogenetic result.
            ``(2) Genetic counselor.--The term `genetic counselor' 
        means an individual who--
                    ``(A) is licensed as a genetic counselor by the 
                State in which the individual furnishes genetic 
                counseling services; or
                    ``(B) in the case of an individual practicing in a 
                State that does not license genetic counselors, meets 
                such other criteria as the Secretary establishes.
            ``(3) Qualified clinical pharmacist.--The term `qualified 
        clinical pharmacist' means an individual--
                    ``(A) with a doctoral degree in pharmacy;
                    ``(B) who is licensed as a pharmacist in the State 
                in which such individual furnishes consultations;
                    ``(C) has appropriate pharmacy specialty 
                certifications or appropriate training, as determined 
                by the Secretary; and
                    ``(D) meets other qualifications as specified by 
                the Secretary.''.
    (b) Payment for Pharmacogenetic Consultation.--Section 1832(a)(2) 
of the Social Security Act (42 U.S.C. 1395k(a)(2)) is amended--
            (1) by striking ``and'' at the end of subparagraph (I);
            (2) by striking the period at the end of subparagraph (J) 
        and inserting ``; and''; and
            (3) by adding at the end the following new subparagraph:
                    ``(K) pharmacogenetic consultations (as defined in 
                subsection (lll)).''.
    (c) Effective Date.--The amendments made by subsections (a) and (b) 
shall apply to consultations furnished during a cost reporting period 
beginning on or after the date of the enactment of such subsections.

SEC. 409. PROHIBITING THE USE OF GEOGRAPHIC TRACKING FEATURES AND 
              BIOMETRICS WITHIN MEDICAID ELECTRONIC VISIT VERIFICATION 
              SYSTEMS.

    (a) In General.--Section 1903(l)(5)(A) of the Social Security Act 
(42 U.S.C. 1396b(l)(5)(A)) is amended by inserting ``(without the use 
of geographic tracking or biometrics)'' after ``electronically 
verified''.
    (b) Effective Date.--The amendment made by subsection (a) shall 
apply with respect to calendar quarters beginning on or after June 1, 
2022.

SEC. 410. GENERALLY ACCEPTED STANDARD FOR ELECTRONIC PRESCRIBING.

    Section 1860D-4(e) of the Social Security Act (42 U.S.C. 1395w-
104(e)) is amended by adding at the end the following new paragraph:
            ``(8) Generally accepted standards.--
                    ``(A) Designation of standards maintenance 
                organization to recognize generally accepted 
                standards.--Not later than 6 months after the date of 
                the enactment of this paragraph, the Secretary shall 
                designate through rulemaking a standards maintenance 
                organization with the authority to establish, maintain, 
                and modify generally accepted standards for electronic 
                prescribing and electronic prior authorization. The 
                standards maintenance organization named by the 
                Secretary shall be a standard setting body that--
                            ``(i) is a not-for-profit;
                            ``(ii) has established a multi-stakeholder 
                        forum for development and approval of 
                        electronic prescribing and electronic prior 
                        authorization standards;
                            ``(iii) is a standards development 
                        organization accredited by the American 
                        National Standards Institute; and
                            ``(iv) includes in its membership 
                        pharmacies, prescribers, prescription drug 
                        plans, health information technology 
                        developers, and representatives from the 
                        Centers for Medicare & Medicaid Services and 
                        the Food and Drug Administration.
                In providing the standards maintenance organization 
                with the authority to establish, maintain, and modify 
                generally accepted standards, the Secretary shall 
                permit the standards maintenance organization to 
                recognize up to two versions of a standard as being 
                generally accepted to facilitate the testing of newer 
                standards and to allow a smooth transition from one 
                standard to another.
                    ``(B) Adoption of generally accepted standards.--
                Not later than six months after making the designation 
                under paragraph (8), the Secretary shall require 
                prescriptions and other information described in 
                paragraph (2)(A) for covered Part D drugs prescribed 
                for Part D eligible individuals that are transmitted 
                electronically to be transmitted only in accordance 
                with generally accepted standards, as designated by the 
                standards maintenance organization named by the 
                Secretary under subparagraph (A), under an electronic 
                prescription drug program that meets the requirements 
                of paragraph (2).''.

SEC. 411. MEANINGFUL ACCESS TO FEDERAL HEALTH PLAN CLAIMS DATA.

    (a) Findings.--Congress finds as follows:
            (1) Clinician-led clinical data registries serve an 
        important role in promoting, facilitating, and conducting 
        medical research and improving quality of healthcare by 
        providing timely and actionable feedback to practitioners on 
        their performance in relation to other practitioners and best 
        clinical practices.
            (2) Clinician-led clinical data registries are hindered in 
        their ability to promote medical research and quality 
        improvement by their lack of meaningful access to claims data.
            (3) While the Centers for Medicare & Medicaid Services has 
        established programs for providing access to claims data, those 
        programs fail to provide clinician-led clinical data registries 
        with meaningful access to such data.
            (4) Ensuring clinician-led clinical data registries 
        meaningful access to claims data will enable such entities to 
        better track patient outcomes over time, expand their ability 
        to assess the safety and effectiveness of medical treatments, 
        and provide them with the information necessary to assess the 
        cost-effectiveness of therapies.
    (b) Ensuring Meaningful Access to Claims Data.--
            (1) Establishment of a new program.--The Secretary shall 
        establish a new program (separate from any existing data access 
        programs, including, without limitation, the Centers for 
        Medicare & Medicaid Services Qualified Entity (in this section, 
        referred to as ``QE'') Program (42 U.S.C. 1395kk(e), 1395kk-2) 
        (in this section, referred to as the ``Medicare Data Sharing 
        for Performance Measurement Program'') and the Research Data 
        Assistance Center (in this section, referred to as the 
        ``ResDAC'') process) under which the Secretary shall, at the 
        request of a clinician-led clinical data registry, provide 
        timely, broad, and continuous access to a database of claims 
        data to such clinician-led clinical data registry for purposes 
        of research, quality of care measurement and reporting to 
        health care providers, linking such data with clinical data and 
        performing risk-adjusted, scientifically valid analyses and 
        research to support quality improvement or patient safety, and 
        other purposes and uses described herein or approved by the 
        Secretary. Access to a database of claims data pursuant to this 
        subsection shall not be more restrictive than access to data 
        provided under the QE Program or the ResDAC process.
            (2) Streamlined application process.--
                    (A) Initial and recertification application.--Prior 
                to gaining access to a database of claims data under 
                the program established in subsection (a), a clinician-
                led clinical data registry shall submit to the 
                Secretary an application demonstrating that it is 
                qualified (as determined by the Secretary) to use 
                claims data. Upon the Secretary's approval of a 
                clinician-led clinical data registry's application 
                described in this subparagraph, the Secretary shall 
                provide access to a database of claims data to such 
                clinician-led clinical data registry for a period of at 
                least 5 years. After the expiration of the time period 
                described in this subparagraph, the clinician-led 
                clinical data registry shall reapply to access the 
                database of claims data under the program established 
                in subsection (a).
                    (B) Process.--The Secretary shall establish a 
                streamlined initial application and recertification 
                application process under which the Secretary shall 
                approve or deny the clinician-led clinical data 
                registry's application described in subparagraph (2)(A) 
                within 60 calendar days after receiving the application 
                unless the Secretary demonstrates a compelling reason 
                for needing additional time to complete the process. If 
                the clinician-led clinical data registry's application 
                described in subparagraph (2)(A) is denied, the 
                Secretary shall provide the reason(s) for denial.
            (3) Appeal rights.--
                    (A) Opportunity to appeal.--The Secretary shall 
                develop and maintain a process by which a clinician-led 
                clinical data registry may appeal--
                            (i) the Secretary's decision to deny an 
                        application described in paragraph (2); and
                            (ii) the Secretary's failure to approve or 
                        deny the clinician-led clinical data registry's 
                        application described in paragraph (2) within a 
                        reasonable time frame established by the 
                        Secretary.
                    (B) Deadline for decision.--The Secretary shall 
                render a decision with respect to an appeal filed by a 
                clinician-led clinical data registry pursuant to 
                subparagraph (A) in a timely manner, not to exceed 60 
                calendar days after the Secretary receives the 
                clinician-led clinical data registry's request for an 
                appeal. Notice of such decision shall be provided to 
                the clinician-led clinical data registry filing the 
                appeal before the conclusion of such 60-day period.
            (4) Broad and timely access to data.--The Secretary shall 
        structure its database of claims data to allow for various data 
        set queries, including, but not limited to, provider-specific 
        claims data, clinical specialty-specific claims data, state-
        specific claims data, and nationwide claims data. The Secretary 
        shall promptly make available to a clinician-led clinical data 
        registry access to claims data requested by such clinician-led 
        clinical data registry within a reasonable timeframe, not to 
        exceed 30 calendar days, after the Secretary approves the 
        request from the clinician-led clinical data registry.
    (c) Permissible Uses of Claims Data.--Clinician-led clinical data 
registries may--
            (1) make available to the public reports evaluating the 
        performance of providers of services and suppliers using the 
        claims data provided to such clinician-led clinical data 
        registry under subsection (a) in combination with registry 
        data;
            (2) use claims data received under subsection (a) combined 
        with registry data to conduct additional nonpublic analyses and 
        provide or charge an access fee for such analyses to authorized 
        users for nonpublic use;
            (3) provide or charge an access fee for data sets that link 
        claims data received under subsection (a) with registry data to 
        authorized users for nonpublic use; and
            (4) provide or charge an access fee for claims data 
        received under subsection (a) to authorized users for nonpublic 
        use.
    (d) Fees.--
            (1) Claims data provided to clinician-led clinical data 
        registries.--Claims data shall be provided to a clinician-led 
        clinical data registry under subsection (a) at a reasonable fee 
        based on the cost of providing such data to the clinician-led 
        clinical data registry. Such fee shall be based at least in 
        part on the number of patients included in the claims data 
        provided to such clinician-led clinical data registry. Any fee 
        collected pursuant to the preceding sentences shall be 
        deposited in the Centers for Medicare & Medicaid Services 
        Program Management Account.
            (2) Analyses and data provided to authorized users.--A 
        clinician-led clinical data registry may charge a reasonable, 
        cost-based fee for providing to authorized users claims data, 
        data sets linking claims data with registry data, or analyses 
        described in subsection (b).
    (e) Protection of Information.--
            (1) Privacy, security, and disclosure laws.--The Secretary 
        shall provide access to a database of claims data pursuant to 
        subsection (a) in accordance with applicable information, 
        privacy, security, and disclosure laws, including, without 
        limitation, the Health Insurance Portability and Accountability 
        Act of 1996 (Public Law 104-191) as amended by the privacy and 
        security provisions set forth in section 13400 of the Health 
        Information Technology for Economic and Clinical Health Act 
        (Public Law 111-5), the regulations promulgated thereunder 
        codified at parts 160 and 164 of title 45, Code of Federal 
        Regulations, and subparagraphs (A) through (B) of section 
        105(a)(3) of the Medicare Access and CHIP Reauthorization Act 
        of 2015 (42 U.S.C. 1395kk-2(a)(3)).
            (2) Prohibition on using analyses or data for marketing 
        purposes.--An authorized user shall not use analyses or data 
        provided or sold under paragraphs (2) through (4) of subsection 
        (b) for marketing purposes.
            (3) No redisclosure of analyses or data.--An authorized 
        user in receipt of an analysis or datum provided or sold under 
        paragraphs (2) through (4) of subsection (b) shall comply with 
        section 105(a)(5) of Medicare Access and CHIP Reauthorization 
        Act of 2015 (42 U.S.C. 1395kk-2(a)(5)).
            (4) Opportunity for providers of services and suppliers to 
        review.--Prior to a clinician-led clinical data registry using, 
        providing, or charging an access fee for claims data, data sets 
        linking claims data with registry data, or analyses described 
        in subsection (b), to the extent that such data, data sets, or 
        analyses would individually identify a provider of services or 
        supplier who is not being provided or sold such data, data 
        sets, or analyses, such clinician-led clinical data registry 
        shall confidentially make available such data, data sets, or 
        analyses to such provider of services or supplier and provide 
        such provider of services or supplier with the opportunity to 
        appeal and correct errors.
    (f) Data Use Agreement.--A clinician-led clinical data registry and 
an authorized user shall enter into a data use agreement regarding the 
use or disclosure of any claims data or data sets that link claims data 
with registry data that the clinician-led clinical data registry is 
providing or charging an access fee to the authorized user under 
paragraphs (3) through (4) of subsection (b). Such agreement shall 
include the requirements and prohibitions described in section 
105(a)(4) of the Medicare Access and CHIP Reauthorization Act of 2015 
(42 U.S.C. 1395kk-2(a)(4)).
    (g) Assessment for a Breach.--
            (1) In general.--In the case of a breach of a data use 
        agreement described in subsection (e), the Secretary shall 
        impose an assessment on the clinician-led clinical data 
        registry and the authorized user.
            (2) Assessment.--The assessment under paragraph (1) shall 
        be in an amount up to $100 for each individual entitled to, or 
        enrolled for, benefits under part A of title XVIII of the 
        Social Security Act or enrolled for benefits under part B of 
        such title for whom the clinician-led clinical data registry 
        provided data on to the authorized user.
            (3) Deposit of amounts collected.--Any amounts collected 
        pursuant to this subsection shall be deposited in the Federal 
        Supplementary Medical Insurance Trust Fund under section 1841 
        of the Social Security Act (42 U.S.C. 1395t).
    (h) Discovery or Admission as Evidence.--Claims data released to a 
clinician-led clinical data registry under subsection (a) shall not be 
subject to discovery or admission as evidence in judicial or 
administrative proceedings without consent of the applicable provider 
of services or supplier.
    (i) Report to Congress.--Not later than 2 years after the date of 
the enactment of this Act, and annually thereafter, the Secretary shall 
submit to Congress a report on the extent to which clinician-led 
clinical data registries are afforded meaningful access to claims data.
    (j) Definitions.--In this subtitle:
            (1) Authorized user.--The term ``authorized user'' has the 
        meaning given such term in section 105(a)(9)(A) of the Medicare 
        Access and CHIP Reauthorization Act of 2015 (42 U.S.C. 1395kk-
        2(a)(9)(A)), as well as a government agency or other 
        governmental entity, researchers, entities that seek data for 
        purposes of complying with regulations or other requirements of 
        the Federal Food and Drug Administration, and other entities 
        approved by the Secretary.
            (2) Claims data.--The term ``claims data'' has the meaning 
        given to the term ``data'' in section 105(b)(1)(B) of the 
        Medicare Access and CHIP Reauthorization Act of 2015 (42 U.S.C. 
        1395kk-2(b)(1)(B)).
            (3) Clinician-led clinical data registry.--The term 
        ``clinician-led clinical data registry'' has the meaning given 
        such term in section 4005(b) of the 21st Century Cures Act.
            (4) Nonpublic use.--The term ``nonpublic use'' means a use 
        for the purpose of--
                    (A) promoting, facilitating, and conducting medical 
                research, assisting providers of services and suppliers 
                to improve patient safety, and to develop and 
                participate in quality and patient care improvement 
                activities, including developing new models of care;
                    (B) assisting clinician-led clinical data 
                registries in developing and reporting quality measures 
                to health care providers quality measures;
                    (C) educating a government agency or other 
                governmental entity; and
                    (D) supporting clinical trials and other activities 
                necessary to comply with pre- or post-market approval 
                or adverse event reporting requirements or conditions 
                imposed by the Food and Drug Administration, and other 
                purpose approved by the Secretary.
            (5) Provider of services.--The term ``provider of 
        services'' has the meaning given such term in section 1861(u) 
        of the Social Security Act (42 U.S.C. 1395x(u)).
            (6) Supplier.--The term ``supplier'' has the meaning given 
        such term in section 1861(d) of the Social Security Act (42 
        U.S.C. 1395x(d)).
    (k) Regulations.--Not later than 1 year after the date of the 
enactment of this Act, the Secretary of Health and Human Services shall 
promulgate final regulations to implement the provisions of the 
preceding sections of this subtitle.

                           TITLE V--RESEARCH

SEC. 501. ADVANCED RESEARCH PROJECTS AGENCY FOR HEALTH.

    (a) Establishment.--The Secretary of Health and Human Services, 
acting through the Director of the National Institutes of Health, shall 
establish the Advanced Research Projects Agency for Health (to be 
referred to in this Act as ``ARPA-H'') to transform and improve 
important areas of medicine and health for the well-being of all 
individuals in the United States.
    (b) Goals.--
            (1) In general.--The goals of ARPA-H shall be to deliver 
        breakthrough capabilities through technologies, systems, and 
        platforms that--
                    (A) accelerate the discovery and application of 
                transformational innovations in health and medical 
                product development; and
                    (B) reduce the human and economic cost of disease.
            (2) Means.--ARPA-H may achieve the established goals under 
        paragraph (1), including by any of the following means:
                    (A) Promoting high-risk, high-reward innovation.
                    (B) Identifying and promoting revolutionary 
                advances in biomedical and health research that enable 
                new paradigms in health.
                    (C) Accelerating transformational health advances 
                in areas that the relevant industries by themselves are 
                not likely to undertake because of technical, 
                financial, or other uncertainty.
                    (D) Prioritizing project investments based on 
                scientific opportunity and uniqueness of fit to ARPA-H 
                strategies and operating practice, together with the 
                prospective impact on disease burden (regardless of 
                disease prevalence), both human and fiscal, including 
                the health care fiscal liability of the Federal 
                government.
                    (E) Partnering with, and providing funding to, a 
                broad range of institutions, including universities, 
                national laboratories, public sector organizations, 
                private companies, nonprofit organizations, and foreign 
                institutions.
    (c) Director.--
            (1) In general.-- ARPA-H shall be headed by a Director, who 
        shall be appointed by and serve at the pleasure of the 
        President (referred to in this section as the ``Director of 
        ARPA-H'').
            (2) Selection.--The Director of ARPA-H shall--
                    (A) be an individual who, by reason of professional 
                background and experience, is qualified to advise the 
                Secretary on, and manage research programs addressing, 
                matters pertaining to long-term and high-risk barriers 
                to the development of health innovation;
                    (B) have authority to execute contracts developed 
                by in-house program managers who select external 
                performers, and maintain, enhance or terminate projects 
                based on performance against explicit milestones; and
                    (C) have a time-limited appointment of 5 years with 
                the opportunity, at the discretion of the President, of 
                one extension.
            (3) Duties.--The duties of the Director of ARPA-H shall be 
        to--
                    (A) set national research priorities to advance the 
                mission of the agency as informed by a multi-sectoral 
                board of advisors;
                    (B) approve all new programs within ARPA-H;
                    (C) have final funding authority to initiate and 
                terminate program funding;
                    (D) establish criteria for funding and assessing 
                the success of programs through the establishment of 
                technical milestones;
                    (E) appoint the personnel necessary, consistent 
                with subsection (d), to successfully execute the goals 
                of ARPA-H; and
                    (F) designate employees to serve as program 
                managers to carry out the duties described in 
                subsection (e) for each of the programs established 
                pursuant to the responsibilities established for ARPA-
                H.
            (4) Authority.--The Director of ARPA-H is authorized to--
                    (A) acquire (by purchase, lease, condemnation, or 
                otherwise), construct, improve, repair, operate, and 
                maintain such real and personal property as are 
                necessary to carry out this section; and
                    (B) lease an interest in property for not more than 
                20 years, notwithstanding section 1341(a)(1) of title 
                31, United States Code.
    (d) Personnel Management Authority.--
            (1) Special personnel management authority.--The Director 
        of ARPA-H may--
                    (A) make appointments to positions of 
                administration or management of ARPA-H without regard 
                to any provision in title 5, United States Code, 
                governing appointments under the civil service laws and 
                fix the compensation of such positions at a rate not to 
                exceed the amount of annual compensation (excluding 
                expenses) specified in section 102 of title 3, United 
                States Code, notwithstanding section 202 of Department 
                of Health and Human Services Appropriations Act, 1993 
                (Public Law 102-394);
                    (B) hire personnel under section 207(f) of the 
                Public Health Service Act (42 U.S.C. 209(f)) and 
                establish governing criteria to recruit, appoint, and 
                compensate personnel under this section notwithstanding 
                section 202 of Department of Health and Human Services 
                Appropriations Act, 1993 (Public Law 102-394) or any 
                provision of title 5, United States Code, governing the 
                rates of pay or classification of employees in the 
                Executive branch;
                    (C) make additional appointments of scientific, 
                medical, and professional personnel under this section 
                without regard to any provision in title 5, United 
                States Code, governing appointments under the civil 
                service laws and fix the compensation of such personnel 
                at a rate to be determined by the Director, up to the 
                amount of annual compensation (excluding expenses) 
                specified in section 102 of title 3, United States 
                Code, notwithstanding section 202 of Department of 
                Health and Human Services Appropriations Act, 1993 
                (Public Law 102-394) or any provision of title 5, 
                United States Code, governing the rates of pay or 
                classification of employees in the Executive branch; 
                and
                    (D) recruit and retain a diverse workforce, 
                including individuals underrepresented in science and 
                medicine and racial and ethnic minorities.
            (2) Additional staff.--The Director of ARPA-H may use all 
        authorities in existence on the date of enactment of this Act 
        that are provided to the Secretary to hire administrative, 
        financial, information technology staff, and any other staff 
        the Director of ARPA-H determines are necessary to carry out 
        this section.
            (3) Limitation on term.--
                    (A) In general.--Except as provided in subparagraph 
                (B), the service of an employee under an appointment 
                under paragraph (1)(A) in the position of a program 
                manager may not exceed 3 years.
                    (B) Extension.--The Director of ARPA-H may, in the 
                case of a particular employee, extend the period to 
                which service is limited under subparagraph (A) by up 
                to 3 years if the Director determines that such action 
                is necessary to promote the efficiency of ARPA-H.
            (4) Limitation on additional payments.--The total amount of 
        the additional payments paid to an employee under paragraph 
        (1)(C) for any 12-month period may not exceed the least of the 
        following amounts:
                    (A) $25,000.
                    (B) The amount equal to 25 percent of the 
                employee's annual rate of basic pay.
                    (C) The amount of the limitation that is applicable 
                for a calendar year under section 5307(a)(1) of title 
                5, United States Code.
    (e) Program Managers.--An employee designated as a program manager 
pursuant to subsection (c)(3)(F) shall--
            (1) define the research and development goals and 
        milestones of the program involved, in line with guidance from 
        the Director;
            (2) track progress and course-correct projects when needed;
            (3) recommend, as necessary, the restructuring or 
        termination of projects supported by ARPA-H; and
            (4) select, on the basis of merit and need, each of the 
        projects to be supported under the program involved after 
        considering--
                    (A) the novelty and scientific and technical merit 
                of the proposed projects;
                    (B) the demonstrated capabilities of the applicants 
                to successfully carry out the proposed project;
                    (C) the consideration by the applicant of future 
                commercial applications of the project; or
                    (D) the unmet need within patient populations.
    (f) Reports.--
            (1) Strategic vision.--Not later than 180 days after the 
        date of the enactment of this Act, the Director of ARPA-H shall 
        provide to the Committee on Energy and Commerce and the 
        Committee on Appropriations of the House of Representatives and 
        the Committee on Health, Education, Labor, and Pensions and the 
        Committee on Appropriations of the Senate a report describing 
        the strategic vision that ARPA-H will use to guide the choices 
        of ARPA-H for future health investments over the following 3 
        fiscal years beginning on or after the date of the enactment of 
        this Act.
            (2) Annual budget request.--As part of the annual budget 
        request submitted for each fiscal year, the Director of ARPA-H 
        shall provide to the congressional committees specified in 
        paragraph (1) a report describing--
                    (A) projects supported by ARPA-H during the 
                previous fiscal year, including--
                            (i) the transition of projects' outcomes to 
                        clinical practice;
                            (ii) the impact on clinical outcome; and
                            (iii) the creation of biomedical 
                        capabilities; and
                    (B) successes and barriers to scientific 
                interchanges;
                    (C) rapid knowledge transfer;
                    (D) resource optimization; and
                    (E) heightened investment impact among 
                collaborators.
            (3) Report on cooperative agreements and other 
        transaction.--Not later than 90 days after the end of each 
        fiscal year, the Director of ARPA-H shall submit to the 
        congressional committees specified in paragraph (1) a report on 
        all cooperative agreements and other transactions (other than 
        contracts and grants) entered into under this subsection during 
        such fiscal year. The report shall contain, with respect to 
        such cooperative agreement and transaction, the following:
                    (A) A general description of the cooperative 
                agreement or other transaction (as the case may be), 
                including the innovations for which advanced research 
                is provided for under such agreement or transaction.
                    (B) The potential clinical and, if any, commercial 
                utility of such innovations.
                    (C) The reasons for not using a contract or grant 
                to provide support for such advanced research.
                    (D) The amount of the payments, if any, referred to 
                in subsection (i)(2) that were received by the Federal 
                Government in connection with such cooperative 
                agreement or other transaction during the fiscal year 
                covered by the report.
                    (E) The amount of the payments reported under 
                subparagraph (D), if any, that were credited to the 
                account established under subsection (i)(7).
    (g) Coordination and Nonduplication.--
            (1) In general.--The Director of ARPA-H shall ensure 
        effective, early, and frequent coordination between ARPA-H and 
        the heads of the research, public health, and regulatory 
        agencies of the Department of Health and Human Services, 
        including--
                    (A) the Director of the National Institutes of 
                Health;
                    (B) the Commissioner of Food and Drugs;
                    (C) the Administrator of the Centers for Medicare & 
                Medicaid Services;
                    (D) the Director of the Centers for Disease Control 
                and Prevention; and
                    (E) the Assistant Secretary for Preparedness and 
                Response.
                    (F) The Director of the National Science 
                Foundation.
                    (G) The Director of the Office of Science of the 
                Department of Energy.
            (2) Coordination.--The Director shall also coordinate among 
        the full set of advanced research project agencies including--
                    (A) the Defense Advanced Research Project Agency;
                    (B) the Advanced Research Project Agency-Energy; 
                and
                    (C) others as they may be established.
    (h) Advice.--
            (1) In general.--The Director of ARPA-H may seek advice on 
        any aspect of ARPA-H from--
                    (A) any advisory committee that, as of the date of 
                the enactment of this Act, is providing advice to the 
                Secretary of Health and Human Services (or any head of 
                a research, public health, or regulatory agency of the 
                Department of Health and Human Services); and
                    (B) an advisory committee established on or after 
                such date of the enactment to support the programs of 
                ARPA-H and to provide advice and assistance on--
                            (i) specific program tasks; or
                            (ii) overall direction of ARPA-H.
            (2) Additional sources.--In addition to the advisory 
        committees specified in paragraph (1), the Director of ARPA-H 
        may seek advice and review from--
                    (A) the President's Committee of Advisors on 
                Science and Technology;
                    (B) any professional or scientific organization 
                with expertise in specific processes or technologies 
                under development by ARPA-H; and
                    (C) representatives of patient communities.
    (i) Cooperative Agreements and Other Transactions.--
            (1) In general.--The Director of ARPA-H, in carrying out 
        advanced research projects through ARPA-H, may enter into 
        grants, contracts, cooperative agreements, cash prizes, and 
        other transactions (as defined in section 319L(a) of the Public 
        Health Service Act (42 U.S.C. 247d-7e(a))) with any person, any 
        agency or instrumentality of the United States, any unit of 
        State or local government, and any other entity institutions, 
        including universities, national laboratories, public sector 
        organizations, private companies, nonprofit organizations, and 
        foreign institutions.
            (2) Terms.--
                    (A) Required provisions.--The Director of ARPA-H 
                shall ensure that, in entering into cooperative 
                agreements and other transactions under paragraph (1)--
                            (i) to the extent the Director of ARPA-H 
                        determines practicable, the Federal funds 
                        provided under the cooperative agreement or 
                        other transaction do not exceed the total 
                        amount provided by other parties to the 
                        cooperative agreement or other transaction; and
                            (ii) the authority under paragraph (1) is 
                        used only when the use of standard contracts or 
                        grants is not feasible or appropriate.
                    (B) Optional provision.--Cooperative agreements and 
                other transactions entered into by the Director of 
                ARPA-H under paragraph (1) may include a clause that 
                requires a person or other entity to make payments to 
                ARPA-H (or any other department or agency of the 
                Federal Government) as a condition for receiving 
                support under the agreement or other transaction.
            (3) Duplicative research.--The Director of ARPA-H shall 
        ensure that to the maximum extent practicable, a cooperative 
        agreement or other transaction under this section does not 
        provide for research that duplicates research being conducted 
        under existing programs carried out by the Department of Health 
        and Human Services, the Department of Defense, or other Federal 
        Government entities.
            (4) Amount of payments.--The amount of any payment received 
        by the Federal Government pursuant to a requirement imposed 
        under paragraph (1) may be credited, to the extent authorized 
        by the Director of ARPA-H, to the account established under 
        paragraph (7). Amounts so credited shall be merged with other 
        funds in the account and shall be available for the same 
        purposes and the same period for which other funds in such 
        account are available.
            (5) Multi-year contracts.--
                    (A) In general.--The Director of ARPA-H may enter 
                into a multi-year contract if--
                            (i) funds are available and obligated for 
                        the contract for the full period of the 
                        contract, or for the first fiscal year in which 
                        the contract is in effect, and for the 
                        estimated costs associated with a necessary 
                        termination of the contract;
                            (ii) the Director determines that a 
                        multiyear contract will serve the best 
                        interests of the Federal Government in carrying 
                        out this section; and
                            (iii) the contract includes a provision 
                        that the contract shall be terminated if funds 
                        are not made available for the continuation of 
                        the contract in a fiscal year covered by the 
                        contract.
                    (B) Termination costs.--A provision referred to in 
                subparagraph (A)(iii) shall provide that funds 
                available for paying termination costs shall remain 
                available for that purpose until the costs associated 
                with termination of the contract are paid.
            (6) Application of other provisions.--The authority 
        provided under paragraph (1) may be exercised without regard to 
        section 3324 of title 31, United States Code.
            (7) Account.--There is hereby established on the books of 
        the Treasury an account for support of advanced research 
        projects provided for in cooperative agreements and other 
        transactions entered into under paragraph (1). Funds in such 
        account shall be available for the payment of such support.
            (8) Prize competitions.--The Director of ARPA-H may carry 
        out prize competitions in accordance with section 24 of the 
        Stevenson-Wydler Technology Innovation Act of 1980 (15 U.S.C. 
        3719)) in support of the goals specified in subsection (b).
            (9) Nonapplicability of certain provisions.--Research 
        funded pursuant to this section shall not be subject to--
                    (A) advisory council approval under section 
                405(b)(2) of the Public Health Service Act (42 U.S.C. 
                284(b)(2));
                    (B) advisory council review under section 
                406(a)(3)(A)(ii) of such Act (42 U.S.C. 
                284a(a)(3)(A)(ii)); or
                    (C) the peer review requirements under section 492 
                of such Act (42 U.S.C. 284(b)(2), 289a).
    (j) Confidentiality.--
            (1) In general.--The information specified in paragraph (2) 
        shall be exempt from disclosure under section 552 of title 5, 
        United States Code (commonly referred to as the Freedom of 
        Information Act). 
            (2) Information.--The information specified in this 
        paragraph is information collected by ARPA-H from recipients of 
        financial assistance awards, including the following:
                    (A) Plans for commercialization of technologies 
                developed under the award, including business plans, 
                technology-to-market plans, market studies, and cost 
                and performance models.
                    (B) Investments provided to an awardee from third 
                parties (such as venture capital firms, hedge funds, 
                and private equity firms), including the amounts and 
                the percentage of ownership of the awardee provided in 
                return for the investments.
    (k) Expediting Breakthroughs Through Cooperation With Food and Drug 
Administration.--
            (1) In general.--The Secretary of Health and Human 
        Services, acting through the Commissioner of Food and Drugs and 
        in consultation with the Director of ARPA-H, may take actions 
        to facilitate transformation of biomedical breakthroughs into 
        tangible solutions for patients and to expedite development of 
        medical products, including through any of the following means:
                    (A) Helping to ensure that medical product 
                development programs, in as efficient a manner as 
                possible, gather the nonclinical and clinical data 
                necessary to advancing the development of such products 
                and to obtaining their approval, licensure, or 
                clearance, as applicable, by the Food and Drug 
                Administration under sections 505, 510(k), and 515 of 
                such Act (21 U.S.C. 355, 360(k), 360) and section 351 
                of the Public Health Service Act (42 U.S.C. 262).
                    (B) Expediting review of investigational new drug 
                applications under section 505(i) of the Federal Food, 
                Drug, and Cosmetic Act (21 U.S.C. 355(i)), review of 
                investigational device exemptions under section 520(g) 
                of such Act (21 U.S.C. 360j(g)), and review of 
                applications for approval, licensure, and clearance of 
                medical products under sections 505, 510(k), and 515 of 
                such Act (21 U.S.C. 355, 360(k), 360) and section 351 
                of the Public Health Service Act (42 U.S.C. 262).
                    (C) Meeting at appropriate intervals with the 
                Director of ARPA-H and any other appropriate medical 
                product development partners, such as the Director of 
                the Biomedical Advanced Research and Development 
                Authority to discuss the development status of medical 
                products and projects that are the highest priorities 
                to ARPA-H, unless the Director of ARPA-H and the 
                Commissioner of Food and Drugs determine that any such 
                meetings are not necessary.
            (2) Relation to otherwise authorized activities of the 
        fda.--The authority specified in paragraph (1) shall not be 
        construed as limiting the authority of the Secretary of Health 
        and Human Services, acting through the Commissioner of Food and 
        Drugs with respect to the review and approval, clearance, 
        authorization for emergency use, or licensure of a medical 
        product under the Federal Food, Drug and Cosmetic Act (21 
        U.S.C. 321 et seq.) or section 351 of the Public Health Service 
        Act (42 U.S.C. 262).
            (3) Reimbursement.--Utilizing interagency agreements or 
        other appropriate resource allocation mechanisms available, the 
        Director of ARPA-H, using funds made available to ARPA-H, shall 
        reimburse the Food and Drug Administration for expenditures 
        made by the Food and Drug Administration for activities carried 
        out under this section that have been identified by the 
        Commissioner of Food and Drugs and the Director of ARPA-H as 
        being carried out by the Food and Drug Administration.
            (4) Medical product defined.--In this section, the term 
        ``medical product'' means a drug (as defined in section 201 of 
        the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321)), a 
        device (as defined in such section 201), or a biological 
        product (as defined in section 351 of the Public Health Service 
        Act (42 U.S.C. 262)).
    (l) Authorization of Appropriations and Bypass Budget Authority.--
            (1) Authorization of appropriations.--There is authorized 
        to be appropriated to carry out this section $6,500,000,000 for 
        fiscal year 2022, to remain available until expended.
            (2) Bypass budget authority.--The budget of ARPA-H shall be 
        a separate line item in the annual budget request submitted by 
        the President to the Congress. ARPA-H shall have the authority 
        to submit its annual budget request directly to Congress 
        concurrently with its submission to the Office of Management 
        and Budget.

SEC. 502. RESEARCH INVESTMENT TO SPARK THE ECONOMY.

    (a) Authority.--
            (1) In general.--Each officer specified in paragraph (2) 
        may exercise the authorities described in paragraph (3).
            (2) Officers.--The officers specified in this paragraph are 
        as follows:
                    (A) The Secretary of Commerce, acting through the 
                Administrator of the National Oceanic and Atmospheric 
                Administration and the Director of the National 
                Institute of Standards and Technology.
                    (B) The Secretary of Agriculture.
                    (C) The Secretary of Defense.
                    (D) The Secretary of Education.
                    (E) The Secretary of Energy, acting for the 
                Department of Energy (with respect to Energy Efficiency 
                and Renewable Energy, Nuclear Energy, and Fossil 
                Research and Development) and through the Office of 
                Science, the Advanced Research Projects Agency-Energy 
                (ARPA-E), and the Office of Electricity.
                    (F) The Secretary of the Interior, acting through 
                the Director of the United States Geological Survey.
                    (G) The Secretary of Health and Human Services, 
                acting through the Director of the National Institutes 
                of Health.
                    (H) The Secretary of Transportation.
                    (I) The Administrator of the National Aeronautics 
                and Space Administration.
                    (J) The Administrator of the Environmental 
                Protection Agency.
                    (K) The Director of the National Science 
                Foundation.
            (3) Authorities.--The officers specified in paragraph (2) 
        may--
                    (A) provide supplemental funding to extend the 
                duration of an award disrupted because of the COVID-19 
                public health emergency to a research institution, 
                Research Laboratory, or individual that was awarded 
                before the date of the enactment of this Act, or to 
                expand the purposes of such an award, in order to--
                            (i) enable a postsecondary student or post-
                        doctoral researcher to complete work;
                            (ii) enable research scientists, technical 
                        staff, research associates, and principal 
                        investigators to complete work;
                            (iii) extend the training of a 
                        postsecondary student, or the employment of a 
                        post-doctoral researcher, on an ongoing 
                        research project for up to 2 years because of 
                        the disruption of the job market;
                            (iv) create research opportunities for up 
                        to 2 years for graduate students and post-
                        doctoral researchers;
                            (v) replace, refurbish, or otherwise make 
                        usable laboratory animals, reagents, equipment, 
                        or other items required for research;
                            (vi) facilitate other research (including 
                        field work), training, and ongoing construction 
                        activities, including at institutions that are 
                        disproportionately affected by the COVID-19 
                        public health emergency (such as minority-
                        serving institutions and 2-year institutions of 
                        higher education);
                            (vii) enable experimental field campaigns 
                        and maintenance of field infrastructure, 
                        including through replacement of disrupted 
                        experimental data to enable completion of 
                        impacted research; and
                            (viii) support training in online course 
                        delivery and virtual research experiences that 
                        will improve quality and access needed to 
                        continue undergraduate, graduate, and post-
                        doctoral training;
                    (B) issue awards to research institutions, Research 
                Laboratories, or other individuals to conduct research 
                on the effects of the COVID-19 and future potential 
                pandemics, on the effects and effectiveness of 
                responses to such diseases, and on improving the 
                prediction of the possible courses of such pandemics; 
                and
                    (C) provide flexibility on an award for funds made 
                available to an agency, by any prior or subsequent Act, 
                by modifying the terms and conditions of the award with 
                a research institution, Research Laboratory, or 
                individual due to facility closures or other 
                limitations during the COVID-19 public health 
                emergency.
            (4) Modifications.--The modifications authorized by 
        paragraph (3)(C) include--
                    (A) the provision of supplemental funding to extend 
                the duration of the award concerned; or
                    (B) flexibility on the allowable expenses under 
                such award.
    (b) Procedures.--The officers specified in subsection (a)(2) shall 
each establish procedures to carry out subsection (a).
    (c) Expedited Awards.--Awards under subsection (a) shall be issued 
as expeditiously as possible.
    (d) Authorizations of Appropriations.--
            (1) Department of commerce.--There is authorized to be 
        appropriated for fiscal year 2021 for the Department of 
        Commerce, $450,000,000 to carry out subsection (a), of which--
                    (A) $300,000,000 shall be for use by the National 
                Oceanic and Atmospheric Administration; and
                    (B) $150,000,000 shall be for use by the National 
                Institute of Standards and Technology.
            (2) Department of agriculture.--There is authorized to be 
        appropriated for fiscal year 2021 for the Department of 
        Agriculture, $380,000,000 to carry out subsection (a).
            (3) Department of defense.--There is authorized to be 
        appropriated for fiscal year 2021 for the Department of 
        Defense, $3,000,000,000 to carry out subsection (a).
            (4) Department of education.--There is authorized to be 
        appropriated for fiscal year 2021 for the Department of 
        Education, $200,000,000 to carry out subsection (a), which 
        shall be for use by the Institute for Education Sciences.
            (5) Department of energy.--There is authorized to be 
        appropriated for fiscal year 2021 for the Department of Energy, 
        $5,000,000,000 to carry out subsection (a), of which--
                    (A) not less than $3,000,000,000 shall be for use 
                by the Office of Science;
                    (B) not less than $900,000,000 shall be for Energy 
                Efficiency and Renewable Energy;
                    (C) not less than $450,000,000 shall be for Nuclear 
                Energy;
                    (D) not less than $300,000,000 shall be for Fossil 
                Research and Development;
                    (E) not less than $150,000,000 shall be for use by 
                the Advanced Research Projects Agency-Energy; and
                    (F) not less than $100,000,000 shall be for use by 
                the Office of Electricity.
            (6) Department of the interior.--There is authorized to be 
        appropriated for fiscal year 2021 for the Department of the 
        Interior, $300,000,000 to carry out subsection (a), which shall 
        be for use by the United States Geological Survey.
            (7) Department of health and human services.--There is 
        authorized to be appropriated for fiscal year 2021 for the 
        Department of Health and Human Services, $10,000,000,000 to 
        carry out subsection (a), which shall be for use by the 
        National Institutes of Health.
            (8) Department of transportation.--There is authorized to 
        be appropriated for fiscal year 2021 for the Department of 
        Transportation, $300,000,000 to carry out subsection (a), of 
        which not less than $130,000,000 shall be for use by the 
        Federal Aviation Administration.
            (9) National aeronautics and space administration.--There 
        is authorized to be appropriated for fiscal year 2021 for the 
        National Aeronautics and Space Administration, $2,000,000,000 
        to carry out subsection (a).
            (10) Environmental protection agency.--There is authorized 
        to be appropriated for fiscal year 2021 for the Environmental 
        Protection Agency, $200,000,000 to carry out subsection (a).
            (11) National science foundation.--There is authorized to 
        be appropriated for fiscal year 2021 for the National Science 
        Foundation, $3,000,000,000 to carry out subsection (a).
            (12) Availability of funds for administration.--
                    (A) In general.--Amounts authorized to be 
                appropriated by this subsection may be used for the 
                payment of indirect costs of Federal awards under 
                subsection (a), up to the limit otherwise allowable by 
                law and subject to the requirements of part 200 of 
                title 2, Code of Federal Regulations.
                    (B) Limitation.--Not more than 5 percent of each of 
                the amounts appropriated pursuant to this subsection 
                may be used for administration of awards under 
                subsection (a).
            (13) Duration of availability.--Amounts authorized to be 
        appropriated by this subsection shall be available for the 
        purposes described in this subsection through fiscal year 2021.
    (e) Definitions.--In this section:
            (1) Award.--The term ``award'' includes a grant, 
        cooperative agreement, or other financial assistance.
            (2) COVID-19 public health emergency.--The term ``COVID-19 
        public health emergency'' means the public health emergency 
        declared by the Secretary of Health and Human Services under 
        section 319 of the Public Health Service Act (42 U.S.C. 247d) 
        on January 31, 2020, with respect to coronavirus disease 2019 
        (COVID-19).
            (3) Research institution.--The term ``research 
        institution'' means the following:
                    (A) An institution of higher education (as defined 
                in section 101(a) of the Higher Education Act of 1965 
                (20 U.S.C. 1001(a))).
                    (B) A Tribal College or University (as defined in 
                section 316 of the Higher Education Act of 1965 (20 
                U.S.C. 1059c)).
                    (C) A nonprofit entity that conducts federally 
                funded research.
            (4) Research laboratory.--The term ``Research Laboratory'' 
        means the following:
                    (A) A National Laboratory (as defined in section 2 
                of the Energy Policy Act of 2005 (42 U.S.C. 15801)).
                    (B) A Federally Funded Research and Development 
                Center for purposes of section 3.5.017 of title 48, 
                Code of Federal Regulations.

SEC. 503. RESEARCH POLICY BOARD REAUTHORIZATION.

    (a) Extension of Sunset.--Section 2034(f)(6) of the 21st Century 
Cures Act (42 U.S.C. 3501 note) is amended by striking ``September 30, 
2021'' and inserting ``September 30, 2026''.
    (b) Participation by Director of NIH.--
            (1) Inclusion as member.--Section 2034(f)(2)(A) of the 21st 
        Century Cures Act (42 U.S.C. 3501 note) is amended--
                    (A) by redesignating clause (v) as clause (vi);
                    (B) by inserting after clause (iv) the following:
                            ``(iv) The Director of the National 
                        Institutes of Health.''.
            (2) Limitations relating to indirect costs.--Section 
        2034(f)(2) of the 21st Century Cures Act (42 U.S.C. 3501 note) 
        is amended by adding at the end the following:
                    ``(C) Limitations relating to indirect costs.--
                Notwithstanding any other provision of law, the 
                Director of the National Institutes of Health may 
                participate in the activities of the Board, including 
                the formulation of recommendations, without regard to 
                limitations relating to indirect costs in part 75 of 
                title 45, Code of Federal Regulations (or any successor 
                regulations).''.
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