Cures 2.0 Act
This bill addresses pandemic preparedness and public health issues, caregiver and patient engagement, drug development, insurance coverage, and biomedical research.
The Department of Health and Human Services (HHS) must undertake research and other activities concerning COVID-19 and develop a strategy for future pandemics and declared emergencies. Additionally, the bill specifies actions to combat antimicrobial resistance.
HHS may award grants for caregiver training. The bill also addresses diversity in clinical trials, collecting patient experience data during clinical trials, and coverage for care related to participation in specified clinical trials.
The bill modifies the timeframe and requires additional guidance relating to expedited approval of certain breakthrough drugs, devices, or products. It also establishes two intercenter institutes within the Food and Drug Administration (FDA) focused on particular diseases that meet specified criteria.
The bill also addresses (1) coverage in Medicare, Medicaid, and the Children's Health Insurance Program for telehealth, genetic and genomic testing, and other services; (2) electronic prescribing standards for Medicare drug benefits; and (3) access to Medicare and Medicaid claims data by certain registries. Furthermore, the bill prohibits the use of geographic tracking or biometrics in Medicaid electronic visit verification systems.
The bill establishes the Advanced Research Projects Agency for Health (ARPA-H) within the National Institutes of Health to accelerate biomedical research and innovation through grants, contracts, cash prizes, and other means. The FDA may work with ARPA-H to expedite the development of medical products through specified activities.
[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).''.
<all>
Introduced in House
Introduced in House
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.
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.
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.
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.
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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.
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.
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.
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.
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.
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.
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.
Referred to the Subcommittee on Health.
Referred to the Subcommittee on Health.
Referred to the Subcommittee on Oversight, Management, and Accountability.
Referred to the Subcommittee for Indigenous Peoples of the United States.
Referred to the Subcommittee on Health.
Referred to the Subcommittee on Biotechnology, Horticulture, and Research.