I 
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 Serv-
ices, 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 jurisdic-
tion 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 Representa-
tives 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. 
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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 develop-
ment. 
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, manu-
facturing, 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 Chil-
dren’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 inno-
vative 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. 
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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 Sec-
retary 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 
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collaborative with individuals and organizations 
representing key sectors of the health care com-
munity; and 
(B) invite to participate in such meetings 
individuals who represent the views of health 
plan representatives, health care providers (in-
cluding hospitals, physicians, and nurses), med-
ical and scientific researchers, patient and con-
sumer advocates, data scientists, health care 
service providers, providers of workers com-
pensation, employers, and developers of diag-
nostic and therapeutic products, including clin-
ical laboratories. 
(2) TERMINATION
OF
MEETINGS.—The Sec-
retary 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— 
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(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 CHIL-
DREN.— 
(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, pedi-
atric researchers, academic medical centers, and 
other appropriate organizations to research the long- 
term effects and treatment of COVID–19 in chil-
dren, 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 Consoli-
dated Appropriations Act, 2021 (Public Law 116– 
260), there are authorized to be appropriated such 
sums as may be necessary to carry out this sub-
section. 
(d) STUDY ON DISPARITIES IN LONG COVID.— 
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(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 Na-
tive, or who belong to other racial and ethnic 
populations— 
(i) evaluate the prevalence of long 
COVID; 
(ii) evaluate the rates of hospitaliza-
tion 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 para-
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graph (1), including the causes of such dispari-
ties. 
(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 INFORMA-
TION WITH RESPECT
TO LONG-TERM SYMPTOMS
OF 
COVID–19.— 
(1) LONG
COVID
PUBLIC
EDUCATION
PRO-
GRAM.—The Secretary of Health and Human Serv-
ices, 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 appro-
priate, of treatment options for long COVID. 
(2) LONG COVID PROVIDER EDUCATION PRO-
GRAM.—The Secretary of Health and Human Serv-
ices, acting through the Director of the Centers for 
Disease Control and Prevention, shall in consulta-
tion with communities of individuals diagnosed with 
long COVID, develop and disseminate to health care 
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providers information on long COVID for the pur-
pose of ensuring that such providers remain in-
formed about current information on long COVID. 
(3) ARRANGEMENT
AUTHORITY.—The Sec-
retary of Health and Human Services may dissemi-
nate information under paragraphs (1) and (2) di-
rectly 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 pub-
lic health emergencies for which a declaration is 
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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 sub-
section (a) shall at a minimum address each of the fol-
lowing: 
(1) Strategies for testing (including point-of- 
care testing and testing at nonmedical sites) to fos-
ter expedient results and personalized medical re-
sponses 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 contin-
uous manufacturing. 
(5) Developing and administering vaccines, 
therapeutics, and other medical supplies, including 
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for children, racial and ethnic minorities, and people 
with disabilities. 
SEC. 103. PANDEMIC PREPAREDNESS RARE DISEASE SUP-
PORT PROGRAM. 
Subtitle B of title XXVIII of the Public Health Serv-
ice Act (42 U.S.C. 300hh–10 et seq.) is amended by in-
serting 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 pan-
demic preparedness plan regarding— 
‘‘(1) the challenges faced by patients and the 
family caregivers of such patients served by the re-
spective eligible organizations during the COVID–19 
pandemic; 
‘‘(2) potential challenges for the respective eligi-
ble organizations during future pandemics and other 
public health emergencies; 
‘‘(3) how the respective eligible organizations 
plan to overcome the challenges described in para-
graphs (1) and (2), including how the respective or-
ganizations plan to support patients, their families, 
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and health care providers to overcome such chal-
lenges; and 
‘‘(4) efforts to partner with local, State, and 
Federal governments to promote a coordinated re-
sponse to future pandemics and other public health 
emergencies. 
‘‘(b) PRIORITY.—In awarding grants under this sec-
tion, the Secretary shall give priority to eligible organiza-
tions 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. 
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‘‘(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 AWARE-
NESS.—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 vac-
cines. The amounts authorized by the preceding sentence 
are in addition to amounts otherwise available for such 
purpose. 
(b) STRENGTHENING THE IMMUNIZATION INFORMA-
TION 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 informa-
tion 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 fol-
lowing: 
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‘‘PART W—DEVELOPING ANTIMICROBIAL 
INNOVATIONS 
‘‘SEC. 399OO. ESTABLISHMENT OF COMMITTEE; SUBSCRIP-
TION MODEL; ADVISORY GROUP. 
‘‘(a) IN GENERAL.—Not later than 60 days after the 
date of the enactment of this part, the Secretary shall es-
tablish a Committee on Critical Need Antimicrobials and 
appoint members to the Committee. 
‘‘(b) MEMBERS.— 
‘‘(1) IN GENERAL.—The Committee shall con-
sist of at least one representative from each of the 
National Institute of Allergy and Infectious Dis-
eases, the Centers for Disease Control and Preven-
tion, the Biomedical Advanced Research and Devel-
opment Authority, the Food and Drug Administra-
tion, the Centers for Medicare & Medicaid Services, 
the Veterans Health Administration, and the De-
partment 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 ap-
pointment of all initial members of the Committee, the 
Secretary, in collaboration with the Committee, and in 
consultation with the Critical Need Antimicrobials Advi-
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sory 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 Pre-
vention, or an anticipated unmet medical need, in-
cluding a potential global health security threat. For 
the list developed under this paragraph, the Sec-
retary, 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 estab-
lishing criteria for how each such characteristic will 
adjust the monetary value of a subscription contract 
awarded under subsection (f) or section 399QQ. The 
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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 subpara-
graph (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 
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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 par-
ticipating 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, re-
spectively, 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 poli-
cies under the Medicare program under title XVIII 
of the Social Security Act (42 U.S.C. 1395 et seq.), 
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