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 REPRESENTATIVESNOVEMBER 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, ineach 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.
1

Be it enacted by the Senate and House of Representa-

2 tives of the United States of America in Congress assembled,
3

SECTION 1. SHORT TITLE.

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5This Act may be cited as the ‘‘Cures 2.0 Act’’.
SEC. 2. TABLE OF CONTENTS.

6

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 healthtechnologies.
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 newtherapies.
Sec. 306. Establishment of additional Intercenter Institutes at the Food andDrug 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

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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.

•HR 6000 IH
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Sec. 502. Research investment to spark the economy.
Sec. 503. Research Policy Board reauthorization.

1

TITLE I—PUBLIC HEALTH

2

SEC. 101. FURTHER UNDERSTANDING THE IMPLICATIONS

3
4OF LONG COVID.

(a) SOURCES

OF

COVERAGE SURVEY.—The Sec-

5 retary of Health and Human Services shall—
6(1) conduct a large national survey of patients7

who self-identify as having long COVID to assess8sources of health coverage, long-term care coverage,9and disability coverage for long COVID and related

10

symptoms; and11(2) not later than 6 months after the date of12

the enactment of this Act, complete such survey and13

submit a report on the results of such survey to the14

Committees on Energy and Commerce, Ways and15

Means, and Education and Labor of the House of16

Representatives and the Committees on Health,17

Education, Labor, and Pensions and Finance of the18

Senate.

19(b) LEARNING COLLABORATIVE.—

20

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21(1) NATIONAL MEETINGS.—The Secretary of
Health and Human Services shall—

22(A) convene a series of not less than four23

national meetings, that may be virtual, to serve24

as the basis of an ongoing long COVID learning•HR 6000 IH

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1

collaborative with individuals and organizations2

representing key sectors of the health care com-3

munity; and4(B) invite to participate in such meetings

5

individuals who represent the views of health6plan representatives, health care providers (in-7cluding hospitals, physicians, and nurses), med-8

ical and scientific researchers, patient and con-9

sumer advocates, data scientists, health care

10service providers, providers of workers com-11

pensation, employers, and developers of diag-12

nostic and therapeutic products, including clin-

13

ical laboratories.

14(2) TERMINATION

retary shall continue to convene national meetings

16

under paragraph (1) for—(A) not less than 2 years after the date of18

the enactment of this Act; and19(B) each fiscal year thereafter, unless the20

Secretary determines that the public health and21

medical knowledge with respect to long COVID

22

has sufficiently advanced to ensure widespread

23

understanding of the characteristics of long

24

COVID, including—•HR 6000 IH
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17

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(i) the etiology, progression, similarity

2

to other conditions, and duration of long

3

COVID; and4(ii) conditions that interact with long

5

COVID.

6

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7(c) LONG COVID SCIENTIFIC RESEARCH FOR CHILDREN.—

8(1) IN GENERAL.—Beginning not later than9

180 days after the date of the enactment of this Act,10

the Director of the National Institutes of Health11

shall award grants to hospitals for children, pedi-

12

atric researchers, academic medical centers, and13other appropriate organizations to research the long-14

term effects and treatment of COVID–19 in chil-15

dren, including long COVID.

16(2) AUTHORIZATION OF APPROPRIATIONS.—Of17

the amounts made available for research and clinical

18

trials related to long-term studies of COVID–19

19

under the heading ‘‘National Institutes of Health—20

Office of the Director’’ of title III of the Consoli-

21

dated Appropriations Act, 2021 (Public Law 116–22260), there are authorized to be appropriated such

23

sums as may be necessary to carry out this sub-24

section.

25(d) STUDY ON DISPARITIES IN LONG COVID.—•HR 6000 IH
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(1) IN GENERAL.—Not later than 90 days after2

the date of the enactment of this Act, the Secretary

3of Health and Human Services shall seek to enter4

into an arrangement with the National Academy of5

Medicine under which the Academy conducts a study

6

to evaluate disparities in racial and ethnic minority

7groups with respect to diagnosis of, severity of

8

symptoms, access to care, and treatment for long

9

COVID.

1011(2) CONTENT.—The study under paragraph (1)shall—

12(A) with respect to individuals who are

13

Black, Hispanic, American Indian, Alaska Na-

14

tive, or who belong to other racial and ethnic

15

populations—

16(i) evaluate the prevalence of long

17

COVID;

18(ii) evaluate the rates of hospitaliza-

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19tion and death from COVID–19; and20(iii) evaluate and identify factors that21

increase the risk of severity of long

22

COVID; and23(B) include recommendations to identify

24

and address the disparities described in para-•HR 6000 IH
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graph (1), including the causes of such dispari-

2

ties.

3

(3) AUTHORIZATIONOFAPPROPRIATIONS.—

4

There is authorized to be appropriated to carry out

5this subsection $5,000,000 for fiscal year 2022, to6remain available until expended.

7(e) EDUCATION AND DISSEMINATION OF INFORMA-

8

TION

WITH RESPECT TO LONG-TERM SYMPTOMS OF

9 COVID–19.—
10(1) LONG

PUBLICEDUCATION

GRAM.—The Secretary of Health and Human Serv-

12

ices, acting through the Director of the Centers for

13

Disease Control and Prevention, shall develop and

14

disseminate to the public information regarding long

15

COVID, including information on—(A) the awareness, incidence, and common

17

symptoms of long COVID; and18(B) the availability, as medically appro-

19

priate, of treatment options for long COVID.

20(2) LONG COVID PROVIDER EDUCATION PRO-

21

GRAM.—The Secretary of Health and Human Serv-

22

ices, acting through the Director of the Centers for

23

Disease Control and Prevention, shall in consulta-

24

tion with communities of individuals diagnosed with25

long COVID, develop and disseminate to health care

•HR 6000 IH
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16

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providers information on long COVID for the pur-2

pose of ensuring that such providers remain in-

3

formed about current information on long COVID.

4(3)

ARRANGEMENTAUTHORITY.—The

Sec-

5

retary of Health and Human Services may dissemi-

6nate information under paragraphs (1) and (2) di-7

rectly or through arrangements with intra-agency

8

initiatives,

9groups, institutions of higher learning (as defined in

10

section 101 of the Higher Education Act of 1965

11

(20 U.S.C. 1001)), or Federal, State, or local public

12

private partnerships.

13

nonprofit

organizations,(4) AUTHORIZATION

OF

consumer

APPROPRIATIONS.—

14

There is authorized to be appropriated to carry out

15this section $30,000,000 for fiscal year 2022, which

16

shall remain available until expended.

17

SEC. 102. NATIONAL STRATEGY TO PREVENT AND RESPOND

18
19

TO PANDEMICS.

(a) IN GENERAL.—Not later than 90 days after the

20 date of the enactment of this Act, the President, acting
21 through the Secretary of Health and Human Services,pbinns on DSKJLVW7X2PROD with BILLS

22 shall—23(1) develop and implement a national strategy

24

to prevent and respond to pandemics and other pub-25

lic health emergencies for which a declaration is•HR 6000 IH
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made under section 319 of the Public Health Service2

Act (42 U.S.C. 247d); and3(2) base such strategy on lessons learned, and4best practices developed, as a result of the COVID–

5

19 pandemic.

6(b) CONTENTS.—The national strategy under sub-7 section (a) shall at a minimum address each of the fol-pbinns on DSKJLVW7X2PROD with BILLS

8 lowing:
9(1) Strategies for testing (including point-of-

10care testing and testing at nonmedical sites) to fos-11

ter expedient results and personalized medical re-12

sponses for patients and communities, including for13

medically underserved populations.

14(2) Methods of data sharing to use testing to

15

inform surveillance and other pandemic monitoring

16

and response efforts.

17(3) Strategies to enable Americans to continue

18

to work, or return to work, or continue to remain in,

19

or return to, in-person school and childcare settings

20

safely.

21(4) Modernizing and expanding domestic drug

22

manufacturing, including through the use of contin-

23

uous manufacturing.

24(5) Developing and administering vaccines,

25

therapeutics, and other medical supplies, including•HR 6000 IH
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for children, racial and ethnic minorities, and people2

with disabilities.

3

SEC. 103. PANDEMIC PREPAREDNESS RARE DISEASE SUP-

4

PORT PROGRAM.

5

Subtitle B of title XXVIII of the Public Health Serv-

6 ice Act (42 U.S.C. 300hh–10 et seq.) is amended by in7 serting after section 2815 of such Act the following:
8‘‘SEC. 2816. PANDEMIC PREPAREDNESS PLAN.

9‘‘(a) IN GENERAL.—The Secretary, acting through10 the Administrator of the Health Resources and Services
11 Administration and in collaboration with the Director of
12 the Centers for Disease Control and Prevention, shall
13 award grants to eligible organizations to develop a pan-pbinns on DSKJLVW7X2PROD with BILLS

14 demic preparedness plan regarding—15‘‘(1) the challenges faced by patients and the16family caregivers of such patients served by the re-17

spective eligible organizations during the COVID–19

18

pandemic;

19‘‘(2) potential challenges for the respective eligi-

20

ble organizations during future pandemics and other21

public health emergencies;22‘‘(3) how the respective eligible organizations

23

plan to overcome the challenges described in para-

24

graphs (1) and (2), including how the respective or-25

ganizations plan to support patients, their families,•HR 6000 IH
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and health care providers to overcome such chal-

2

lenges; and3‘‘(4) efforts to partner with local, State, and4Federal governments to promote a coordinated re-5sponse to future pandemics and other public health6

emergencies.

7‘‘(b) PRIORITY.—In awarding grants under this sec-

8 tion, the Secretary shall give priority to eligible organiza9 tions that are rare disease or condition organizations.
10‘‘(c) DEFINITIONS.—In this section:

11

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12‘‘(1) The term ‘eligible organization’ means anorganization that—

13‘‘(A) is described in section 501(c) of the

14

Internal Revenue Code of 1986 and exempt

15

from tax under section 501(a) of such Code;

16

and

17

‘‘(B) provides support and other resources18

to patients and their families for accessing and19

paying for medical care.

20‘‘(2) The term ‘public health emergency’ means

21

a public health emergency declared under section

22

319.

23

‘‘(3) The term ‘rare disease or condition’ has24

the meaning given to such term in section 526(a) of

25

the Federal Food, Drug, and Cosmetic Act.

•HR 6000 IH
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‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—There

2 is authorized to be appropriated to carry out this section
3 $25,000,000 for each of fiscal years 2022 through 2024.’’.
4SEC. 104. VACCINE AND IMMUNIZATION PROGRAMS.

5(a) ADDITIONAL FUNDING FOR VACCINE AWARE-

6

NESS.—There are authorized to be appropriated to the

7 Centers for Disease Control and Prevention $25,000,000
8 for each of fiscal years 2022 through 2024 for the purpose
9 of carrying out an awareness campaign to educate the
10 public with respect to the safety and importance of vac11 cines. The amounts authorized by the preceding sentence
12 are in addition to amounts otherwise available for such
13 purpose.
14(b) STRENGTHENING THE IMMUNIZATION INFORMA-

15

TION SYSTEM.—There are authorized to be appropriated

16 to the Centers for Disease Control and Prevention
17 $25,000,000 for each of fiscal years 2022 through 2024
18 for the purpose of strengthening immunization informa19 tion systems. The amounts authorized by the preceding
20 sentence are in addition to amounts otherwise available
21 for such purpose.
22

SEC. 105. DEVELOPING ANTIMICROBIAL INNOVATIONS.

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23

Title III of the Public Health Service Act (42 U.S.C.

24 241 et seq.) is amended by adding at the end the fol25 lowing:•HR 6000 IH
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‘‘PART W—DEVELOPING ANTIMICROBIAL

2INNOVATIONS

3‘‘SEC. 399OO. ESTABLISHMENT OF COMMITTEE; SUBSCRIP-

4

TION MODEL; ADVISORY GROUP.

5‘‘(a) IN GENERAL.—Not later than 60 days after the

6 date of the enactment of this part, the Secretary shall es7 tablish a Committee on Critical Need Antimicrobials and8 appoint members to the Committee.
9‘‘(b) MEMBERS.—

10‘‘(1) IN GENERAL.—The Committee shall con-11

sist of at least one representative from each of the

12

National Institute of Allergy and Infectious Dis-13

eases, the Centers for Disease Control and Preven-

14

tion, the Biomedical Advanced Research and Devel-

15

opment Authority, the Food and Drug Administra-

16tion, the Centers for Medicare & Medicaid Services,17

the Veterans Health Administration, and the De-

18partment of Defense.

19‘‘(2) CHAIR.—The Secretary shall appoint one

20of the members of the Committee to serve as the21

Chair of the Committee.

22‘‘(c) DUTIES.—Not later than 1 year after the ap-

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23 pointment of all initial members of the Committee, the24 Secretary, in collaboration with the Committee, and in
25 consultation with the Critical Need Antimicrobials Advi-•HR 6000 IH
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1 sory Group established under subsection (g), shall do thepbinns on DSKJLVW7X2PROD with BILLS

2 following:
3‘‘(1) Develop a list of infections for which new

4antimicrobial drug development is needed, taking

5

into account organisms, sites of infection, and type6

of infections for which there is an unmet medical

7

need, findings from the most recent report entitled

8‘Antibiotic Resistance Threats in the United States’

9

issued by the Centers for Disease Control and Pre-10vention, or an anticipated unmet medical need, in-11

cluding a potential global health security threat. For

12

the list developed under this paragraph, the Sec-13

retary, in collaboration with the Committee, may use

14

the infection list in such most recent report for up

15

to 3 years following the date of the enactment of

16

this part and subsequently update the list under this17

paragraph in accordance with subsection (e).

18‘‘(2) Develop regulations, in accordance with

19

subsection (d), outlining favored characteristics of20

critical need antimicrobial drugs, that are evidence

21

based, clinically focused, and designed to treat the22

infections described in paragraph (1), and estab-

23

lishing criteria for how each such characteristic will24

adjust the monetary value of a subscription contract

25

awarded under subsection (f) or section 399QQ. The•HR 6000 IH
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favored characteristics shall be weighed for purposes2

of such monetary value such that meeting certain

3

characteristics, or meeting more than one such char-4

acteristic, increases the monetary value. Such fa-

5vored characteristics of an antimicrobial drug shall6

include—7‘‘(A) treating infections on the list under8

paragraph (1);9‘‘(B) improving clinical outcomes for pa-

10tients with multi-drug-resistant infections;

11‘‘(C) being a first-approved antimicrobial

12

drug that has the potential to address unmet

13

medical needs for the treatment of a serious or

14

life-threatening infection, and, to a lesser ex-

15tent, second and third drugs that treat such in-

16

fections;

17‘‘(D) route of administration, especiallypbinns on DSKJLVW7X2PROD with BILLS

18

through oral administration;

19‘‘(E)(i) containing no active moiety (as de-20

fined by the Secretary in section 314.3 of title

21

21, Code of Federal Regulations (or any suc-22

cessor regulations)) that has been approved in23

any other application under section 505(b) of

24

the Federal Food, Drug, and Cosmetic Act or25

intending to be the subject of a new original•HR 6000 IH
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biologics

2351(a);

application

under‘‘(ii) being a member of a new class of4

drugs with a novel target and novel mode of ac-

5tion that are distinctly different from the target

6

or mode of any antimicrobial drug approved

7

under section 505 of such Act or licensed under8

section 351, including reduced toxicity;

9‘‘(iii) not being affected by cross-resistance10

to any antimicrobial drug approved under such

11

section 505 or licensed under such section 351;

12‘‘(F) addressing a multi-drug-resistant in-

13

fection through a novel chemical scaffold or

14

mechanism of action;‘‘(G) having received a transitional sub-16

scription contract under subsection (f); and17‘‘(H) any other characteristic the Sec-18

retary, in collaboration with the Committee, de-19

termines necessary.

20‘‘(d) REGULATIONS.—

21‘‘(1) IN GENERAL.—Not later than 1 year after

22

the appointment of the initial members of the Com-23

mittee, the Secretary shall issue proposed regula-

24

tions which shall include—•HR 6000 IH
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15

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‘‘(A) a process by which the sponsors can2apply for an antimicrobial drug to become a3

critical need antimicrobial drug under section

4399PP;

5‘‘(B) how subscription contracts underpbinns on DSKJLVW7X2PROD with BILLS

6such section shall be established and paid;

7‘‘(C) the favored characteristics under sub-8

section (c)(2), how such characteristics will be

9weighed, and the minimum number and kind of

10

favored characteristics needed for an anti-

11

microbial drug to be designated a critical need

12

antimicrobial drug; and13‘‘(D) other elements of the subscription

14

contract process, in accordance with this part.

15

‘‘(2)

16

TIONS.—Before

17

paragraph (1), the Secretary shall solicit public com-18

ment and hold public meetings for the period begin-

19

ning on the date on which the proposed regulations

20

are issued and ending on the date that is 120 days

21

after such date of issuance. The Secretary shall fi-

22

nalize and publish such regulations not later than23

120 days after the close of such period of public

24

comment and meetings.

DEVELOPMENT

OF

FINAL

finalizing the regulations under•HR 6000 IH
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‘‘(3) SUBSCRIPTION CONTRACT OFFICE.—Not

2

later than 6 months after the date of the enactment

3of this part, the Secretary shall propose an agency

4or office in the Department of Health and Human

5

Services to manage the establishment and payment

6of subscription contracts awarded under section

7

399QQ, including eligibility, requirements, and con-8

tract amounts. The Secretary shall solicit public

9comment and finalize the agency or office no later10

than 45 days following the proposed agency or of-

11

fice. Such agency or office shall be referred to as the12‘Subscription Contract Office’.

13‘‘(e) LIST OF INFECTIONS.—The Secretary, in col-14 laboration with the Committee, shall update the list of in15 fections under subsection (c)(1) at least every 2 years.

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16‘‘(f) TRANSITIONAL SUBSCRIPTION CONTRACTS.—

17‘‘(1) IN GENERAL.—Not earlier than 30 days

18

after the date of the enactment of this part and end-19

ing on the date that the Secretary finalizes the sub-20

scription contract regulations under subsection (d),21the Secretary may use up to $1,000,000,000 of the22amount appropriated under section 399SS(a) to en-

23

gage in transitional subscription contracts of up to24

3 years in length with antimicrobial developers, as

25

determined by the Secretary, that have developed•HR 6000 IH
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antimicrobial drugs treating infections listed in the2most recent report entitled ‘Antibiotic Resistance3

Threats in the United States’ issued by the Centers

4for Disease Control and Prevention, and may include

5

antimicrobial drugs that are qualified infectious dis-6

ease products (as defined in section 505E(g) of the7

Federal Food, Drug, and Cosmetic Act), innovative8

biological products, or innovative drugs that achieve

9

a clinical outcome through immunomodulation. Such10a contract may authorize the contractor to use funds

11

made available under the contract for completion of

12

postmarketing clinical studies, manufacturing, and13other preclinical and clinical efforts.

14‘‘(2) REQUIREMENTS.—

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15

‘‘(A)

IN

GENERAL.—The

16

through the office described in paragraph (4),17

may enter into a contract under paragraph

18

(1)—

19

‘‘(i) if the Secretary determines that20

the antimicrobial drug is intended to treat21

an infection for which there is an unmet

22

clinical need, an anticipated clinical need,23

or drug resistance;

24‘‘(ii) subject to terms including—•HR 6000 IH
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201‘‘(I) that the Secretary shall2

cease any payment installments under3

a transitional subscription contract if

4

the sponsor does not—5‘‘(aa) ensure commercial and6

Federal availability of the anti-

7

microbial drug within 30 days of

8receiving first payment under the9contract;

10‘‘(bb) identify, track, and11

publicly report drug resistance12

data and trends using available

13

data related to the antimicrobial

14

drug;

15

‘‘(cc) develop and implement

16

education and communications

17

strategies, including communica-

18

tions for individuals with limited

19

English proficiency and individ-20

uals with disabilities, for health21

care professionals and patients

22

about appropriate use of the23

antimicrobial drug;

24‘‘(dd) submit a plan for reg-25

istering the antimicrobial drug in•HR 6000 IH
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21
1

additional countries where an2unmet medical need exists, which

3

such plan may be consistent with4

the Stewardship and Access Plan

5

(SAP)

6

(2021);‘‘(ee) subject to subpara-

8graph (B), ensure a reliable drug

9

supply chain, thus leading to an

10interruption of the supply of the11

antimicrobial drug in the United

12

States for more than 60 days; or‘‘(ff)

makemeaningful

14

progress toward completion of

15

Food and Drug Administration-

16

required postmarketing studies,17

including such studies that are18

evidence based; and19‘‘(II) other terms as determined

20

by the Secretary; and21‘‘(iii) if—

22‘‘(I) a phase 3 clinical study has

23

been initiated for the antimicrobial

24

drug; or•HR 6000 IH
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7

13

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Development

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22
1‘‘(II) the antimicrobial drug has

2

been approved under section 505(c) of

3

the Federal Food, Drug, and Cos-

4

metic Act or licensed under section

5351(a).

6‘‘(B) WAIVER.—The requirement under7

subparagraph (A)(ii)(I)(ee) may be waived in8

the case that an emergency prohibits access to9a reliable drug supply chain.

10

‘‘(3)

TRANSITIONALGUIDANCE.—Not

11than 120 days after the appointment of the initial

12

members of the Committee, the Secretary shall13

issue, in consultation with the Committee, transi-

14

tional guidance outlining the antimicrobial drugs

15that are eligible for transitional subscription con-16

tracts under paragraph (1), the requirements to17

enter into a transitional subscription contract under18

paragraph (2), and the process by which drug devel-

19

opers can enter into transitional subscription con-20

tracts with the Secretary under this subsection.

21‘‘(4) PAYMENT OFFICE AND MECHANISM.—Not

22

later than 30 days after the date of the enactment

23of this part, the Secretary shall determine the agen-24

cy or office in the Department of Health and25

Human Services that will manage the transitional•HR 6000 IH
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1

subscription contracts, including eligibility, require-2

ments, and contract amounts, during the period de-3

scribed in paragraph (1).

4‘‘(g) CRITICAL NEED ANTIMICROBIAL ADVISORY

5 GROUP.—
6‘‘(1) IN GENERAL.—Not later than 30 days

7

after the appointment of all initial members of the8

Committee, the Secretary, in collaboration with the9Committee, shall establish a Critical Need Anti-

10

microbial Advisory Group (referred to in this sub-11

section as the ‘Advisory Group’) and appoint mem-12

bers to the Advisory Group.

1314‘‘(2) MEMBERS.—The members of the Advisory
Group shall include—

15‘‘(A) not fewer than 6 individuals who

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16

are—

17

‘‘(i) infectious disease specialists; or18‘‘(ii) other health experts with exper-

19

tise in researching antimicrobial resistance,

20

health economics, or commercializing anti-

21

microbial drugs; and22‘‘(B) not fewer than 5 patient advocates.

23‘‘(3) CHAIR.—The Secretary shall appoint one

24of the members of the Advisory Group to serve as

25

the Chair.

•HR 6000 IH
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1

‘‘(4) CONFLICTS OF INTEREST.—In appointing

2

members under paragraph (2), the Secretary shall3

ensure that no member receives compensation in any

4manner from a commercial or for-profit entity that5

develops antimicrobials or that might benefit from6

antimicrobial development.

7‘‘(5) APPLICABILITY OF FACA.—Except as oth-8

erwise provided in this subsection, the Federal Advi-

9sory Committee Act shall apply to the Advisory

10

Group.

11‘‘SEC. 399PP. CRITICAL NEED ANTIMICROBIAL DRUG APPLI-12CATION AND PAYMENT THROUGH SUBSCRIP-

13

TION CONTRACTS.

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14‘‘(a) IN GENERAL.—

15‘‘(1) SUBMISSION OF REQUEST.—The sponsor

16of an application under section 505(b) of the Fed-17

eral Food, Drug, and Cosmetic Act or section 351(a)18

for an antimicrobial drug may request that the Sec-19

retary designate the drug as a critical need anti-

20

microbial. A request for such designation may be

21submitted after the Secretary grants for such drug

22

an investigational new drug exemption under section

23

505(i) of the Federal Food, Drug, and Cosmetic Act

24

or section 351(a)(3), and shall be submitted not25

later than 5 years after the date of approval under•HR 6000 IH
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25
1

section 505(c) of the Federal Food, Drug, and Cos-2

metic Act or licensure under section 351(a).

3‘‘(2) CONTENT OF REQUEST.—A request under4

paragraph (1) shall include information, such as

5clinical, preclinical and postmarketing data, a list of6

the favorable characteristics described in section

7

399OO(c)(2), and any other material that the Sec-8

retary in consultation with the Committee requires.

9‘‘(3) REVIEW BY SECRETARY.—The Secretary

10

shall promptly review all requests for designation

11

submitted under this subsection, assess all required

12

application components, and determine if the anti-

13

microbial drug is likely to meet the favorable charac-

14

teristics identified in the application upon the com-15

pletion of clinical development. After review, the Sec-16

retary shall approve or deny each request for des-17

ignation not later than 90 days after receiving a re-18

quest. If the Secretary approves a request, it shall19

publish the value of the contract that the critical20

need antimicrobial developer would be eligible to re-21

ceive if such developer successfully demonstrates

22

that the drug meets the maximum value of the fa-

23

vored characteristics listed in the application.

2425‘‘(4) LENGTH

OF DESIGNATION PERIOD.—A

designation granted under this section shall be in ef-•HR 6000 IH
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1

fect for a period of 10 years after the date that the2designation is approved, and shall remain in effect3

for such period even if the infection treated by such4

drug is later removed from the list of infections

5

under section 399OO(c)(1).

6‘‘(5) SUBSEQUENT REVIEWS.—No sooner than

7

2 years after a designation approval or denial under8

subsection (3), the sponsor may request a subse-

9quent review to reevaluate the value of a contract to10

include any new information.

11‘‘(b) DEVELOPMENT OF DESIGNATED DRUGS.—If a

12 critical need antimicrobial designation is granted during
13 clinical development of an antimicrobial drug, the Sec14 retary may work with the sponsor to maximize the oppor15 tunity for the sponsor to successfully demonstrate that the
16 antimicrobial drug possesses the favored characteristics of
17 high-monetary valued products identified under section
18 399OO(c)(2).
19

pbinns on DSKJLVW7X2PROD with BILLS20‘‘(c) APPROPRIATE USE OF CRITICAL NEED ANTIMICROBIAL.—

21‘‘(1) IN GENERAL.—The sponsor of an anti-

22

microbial drug that receives designation under sub-23

section (a) shall within 90 days of such designation,

24

submit to the Secretary a plan for appropriate use

25

of diagnostics, in order for the Secretary and Com-

•HR 6000 IH
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1

mittee to consider such plan in developing clinical2

guidelines. An appropriate use plan—

3‘‘(A) shall include—

4‘‘(i) the appropriate use of the drug;

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5

and

6

‘‘(ii) the appropriate use of diagnostic

7

tools, where available, such as diagnostic

8

testing for biomarkers related to anti-

9

microbial-resistant pathogens, or other tar-10

geted diagnostic approaches, to inform use

11of the drug; and12‘‘(B) may be developed in partnership with13

the Secretary, infectious disease experts, diag-14

nostic experts or developers, laboratory experts,

15

or another entity.

16‘‘(2) CONSULTATION.—The Secretary shall con-17

sult with relevant professional societies and the Crit-18

ical Need Antimicrobial Advisory Group established19

under section 399OO(g) to ensure that clinical20

guidelines issued by the Secretary under paragraph21(3), with respect to an antimicrobial drug designated22

under subsection (a), includes the use of appropriate

23

diagnostic approaches, taking into consideration the24diagnostic plan submitted by a sponsor under para-

25

graph (1).

•HR 6000 IH
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‘‘(3) PUBLICATION OF CLINICAL GUIDELINES.—2

Not later than 1 year after the Secretary makes the3

first designation under subsection (a), and not less4

than every 3 years thereafter, the Secretary shall5

publish clinical guidelines in consultation with rel-

6

evant professional societies with respect to each anti-

7

microbial drug that has been approved or licensed as

8

described in subsection (a)(1) and that has been des-9

ignated under subsection (a), which guidelines shall10

set forth the evidence-based recommendations for

11

prescribing the drug, in accordance with the submis-

12

sions of the sponsor under paragraph (1) and after

13

consultation under paragraph (2), as appropriate.

14‘‘SEC. 399QQ. SUBSCRIPTION CONTRACTS.

15

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16‘‘(a) APPLICATIONFORA

SUBSCRIPTION CON-

TRACT.—

17‘‘(1) SUBMISSION OF APPLICATIONS.—After ap-

18

proval under section 505(c) of the Federal Food,

19

Drug, and Cosmetic Act or licensure under section

20

351(a), the sponsor of an antimicrobial drug des-21

ignated as a critical need antimicrobial under section

22399PP may submit an application for a subscription

23

contract with the Secretary, under a procedure es-

24tablished by the Secretary.

•HR 6000 IH
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‘‘(2) REVIEW2OFAPPLICATIONS.—TheSec-

retary shall, in consultation with the Committee—

3‘‘(A) review all applications for subscrip-

4tion contracts under paragraph (1) and assess5

all required application components;

6‘‘(B) determine the extent to which the7

critical need antimicrobial meets the favored8

characteristics

9

399OO(c)(2), and deny any application for a10

drug that meets none of such characteristics;

11

and

identified

under

section12‘‘(C) assign a monetary value to the con-13

tract based on the regulations developed under14

section 399OO(d).

15‘‘(b) CRITERIA.—To qualify for a subscription con-

16 tract under this section, the sponsor of an antimicrobial
17 drug designated as a critical need antimicrobial shall agree

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18 to—
19‘‘(1) ensure commercial and Federal availability

20of the antimicrobial drug within 30 days of receiving

21

first payment under the contract, and sufficient sup-22

ply for susceptibility device manufacturers;

23‘‘(2) identify, track, and publicly report drug

24

resistance data and trends using available data re-25

lated to the antimicrobial drug;•HR 6000 IH
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pbinns on DSKJLVW7X2PROD with BILLS301‘‘(3) develop and implement education and com-2

munications strategies, including communications

3

for individuals with limited English proficiency and4individuals with disabilities, for health care profes-

5

sionals and patients about appropriate use of the6

antimicrobial drug;

7‘‘(4) submit an appropriate use assessment to8

the Secretary, Committee, Food and Drug Adminis-

9

tration, and Centers for Disease Control and Pre-10vention every 2 years regarding use of the anti-

11

microbial drug, including how the drug is being mar-12

keted;

13‘‘(5) submit a plan for registering the drug in

14

additional countries where an unmet medical need15

exists;16‘‘(6) ensure a reliable drug supply chain, where17

any interruption to the supply chain will not last for

18

more than 60 days in the United States;

19‘‘(7) complete any postmarketing studies re-20

quired by the Food and Drug Administration in a

21

timely manner;

22‘‘(8) produce the drug at a reasonable volume23

determined with the Secretary to ensure patient ac-

24

cess to the drug;•HR 6000 IH
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1
2

‘‘(9) price the drug at a price that is not lower
than a comparable generic drug;

3‘‘(10) abide by the manufacturing and environ-4

mental best practices in the supply chain to ensure

5

that there is no discharge into, or contamination of,6

the environment by antimicrobial agents or products

7

as a result of the manufacturing process; andpbinns on DSKJLVW7X2PROD with BILLS

8‘‘(11) abide by other terms as the Secretary

9

may require.

10‘‘(c) AMOUNT AND TERMS OF CONTRACTS.—

11‘‘(1) AMOUNTS.—A subscription contract under

12

this section shall be for the sale to the Secretary of13

any quantity of the antimicrobial drug needed over14

the term of the contract under paragraph (2), at an

15

agreed upon price, for a total projected amount de-16

termined by the Secretary that is not less than

17

$750,000,000 and not more than $3,000,000,000,

18

adjusted for inflation, accounting for the favored19

characteristics of the drug, as determined by the20

Secretary, in consultation with the Committee, under21

subsection (a)(2), and shall be allocated from the22amount made available under section 399SS(a). Not

23

later than 6 months after the subscription contract

24

is granted under subsection (a), the Secretary shall25

provide payments for purchased drugs in install-•HR 6000 IH
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1

ments established by the Secretary in consultation

2

with the sponsor of the antimicrobial drug and in ac-

3

cordance with subsection (d)(3). Funds received by

4

the sponsor shall be used to support criteria quali-

5

fication under subsection (b), the completion of post-

6

marketing clinical studies, manufacturing, other pre-7

clinical and clinical activities, or other activities

8

agreed to by the Secretary and sponsor in the con-9

tract.

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10‘‘(2) TERMS.—

11‘‘(A) INITIAL TERM.—The initial term of a12

contract under this subsection shall be no less13

than 5 years or greater than the greater of 10

14years or the remaining period of time during

15

which the sponsor has patent protections or a16

remaining exclusivity period with respect to the17

antimicrobial drug in the United States, as list-18

ed in the publication of the Food and Drug Ad-

19ministration entitled ‘Approved Drug Products

20

with

21

Payments may be in equal annual installments

22with the option to redeem 50 percent of the last

23

year’s reimbursement in year 1 of the contract24

in order to offset costs of establishing manufac-

25

turing capacity, or another subscription ar-

Therapeutic

Equivalence

Evaluations’.

•HR 6000 IH
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1

rangement to which the Secretary and sponsor

2

agree. Subscription contracts shall remain in ef-

3fect for such period even if the infection treated4

by such antimicrobial drug is later removed

5

from the list of infections under section

6

399OO(c)(1).

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7‘‘(B) EXTENSIONOFCONTRACTS.—The

8

Secretary may extend a subscription contract

9

with a sponsor under this subsection beyond the10

initial contract period. A single contract exten-

11sion may be in effect not later than the date on

12which all periods of exclusivity granted by the13

Food and Drug Administration expire and shall14

be in an amount not to exceed $25,000,000 per

15

year. All other terms of an extended contract

16

shall be the same as the terms of the initial

17

contract. The total amount of funding used on

18such contract extensions shall be no more than19

$1,000,000,000, and shall be allocated from the20

amount made available under section 399SS.

21‘‘(C) MODIFICATION OF CONTRACTS.—The

22

Secretary or sponsor, 1 year after the start of23

the contract period under this subsection and24

every 2 years thereafter, may request a modi-

25

fication of the amount of the contract based on•HR 6000 IH
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1

information that adjusts favored characteristics

2in section 399OO(c)(2).

3‘‘(3) ADJUSTMENT.—In the case of an anti-

4

microbial drug that received a transitional subscrip-

5tion contract under section 399OO(f), the amount of

6

a subscription contract for such drug under this sec-

7

tion shall be reduced by the amount of the transi-

8tional subscription contract under such section

9

399OO(f) for such drug.

10‘‘(4) CONTRACTS

GENERICANDSIMILAR12

provision in this part, the Secretary may award a

13

subscription contract under this section to a manu-

14

facturer of a generic or biosimilar version of an anti-

15

microbial drug for which a subscription contract has

16

been awarded under this section. Such contracts

17

shall be awarded in accordance with a procedure, in-18

cluding for determining the terms and amounts of

19such contracts, established by the Secretary.

20‘‘(d) ANNUAL ANTIMICROBIAL DRUG SPONSOR REV-VERSIONS.—Notwithstanding

any other

ENUE LIMITATIONS.—

22‘‘(1) REPORTING REQUIREMENT.—

23‘‘(A) IN GENERAL.—Not later than a date24

determined appropriate by the Secretary fol-25

lowing the end of each calendar year, and not•HR 6000 IH
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11

21

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35
1earlier than 6 months after the end of each cal-2

endar year, the head (or a designee of such3head) of each Federal agency carrying out a4

specified government program shall, in accord-

5

ance with this paragraph, report to the Sub-6

scription Contract Office established under sec-

7

tion 399OO(d)(3) the total prescription drug

8

sales for each applicable antimicrobial drug

9

under contract with respect to such program for

10such calendar year.

11‘‘(B) MEDICARE PART D PROGRAM.—For12

purposes of subparagraph (A), the Secretary

13

shall report, for each applicable antimicrobial

14

drug covered under part D of title XVIII of the15

Social Security Act, the product of—

16‘‘(i) the per-unit ingredient cost, as

17reported to the Secretary by prescription

18

drug plans and Medicare Advantage pre-19

scription drug plans, minus any per-unit

20

rebate, discount, or other price concession

21

provided by the sponsor of such applicable22

antimicrobial drug, as reported to the Sec-23

retary by the prescription drug plans and24

the Medicare Advantage prescription drug

25plans; and•HR 6000 IH
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36
1‘‘(ii) the number of units of such ap-

2

plicable antimicrobial drug paid for under3

such part D.

4‘‘(C) MEDICARE PART B PROGRAM.—5‘‘(i) IN GENERAL.—For purposes of

6

subparagraph (A), the Secretary shall re-7

port, for each applicable antimicrobial drug

8

covered under part B of title XVIII of the9Social Security Act, the product of—10‘‘(I) the per-unit average sales

11

price (as defined in section 1847A(c)12of such Act) or the per-unit payment

13

rate under such part B for a sepa-

14

rately paid prescription drug without

15

a reported average sales price; and16‘‘(II) the number of units of such

17

applicable antimicrobial drug paid for18

under such part B.

19‘‘(ii)

20

PRICES.—The21

process for determining the units and the22

allocated price for purposes of this sub-23

paragraph24

microbial drugs that are not separately

UNITS

AND

ALLOCATED

Secretary shall establish a

for

those

applicable•HR 6000 IH
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37
1

payable or for which National Drug Codes2

are not reported.

3‘‘(D) MEDICARE PART A PROGRAM.—4‘‘(i) IN GENERAL.—For purposes of5

subparagraph (A), the Secretary shall re-6

port, for each applicable antimicrobial drug

7

covered under part A of title XVIII of the8

Social Security Act, the product of—9‘‘(I) the per-unit price under

10

such part A for the antimicrobial

11drug; and

12‘‘(II) the number of units of such

13

antimicrobial drug paid for under

14

such part A.

15‘‘(ii) SPECIAL RULE.—For purposes of

16

clause (i), the Secretary shall establish a

17

process for determining the units and the18

allocated price for those prescription drugs

19that are not separately payable or for20

which National Drug Codes are not re-21

ported in the diagnosis-related groups.

22‘‘(E) MEDICAID PROGRAM.—Under the au-

23

thority of section 1902(a)(6) of the Social Secu-

24

rity Act, the Secretary shall require each State

25

that makes medical assistance available under•HR 6000 IH
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38
1

the State plan under title XIX of such Act (or2any waiver of such plan) for an applicable anti-

3

microbial drug (including, if applicable, any

4such drug which is a covered outpatient drug

5

under a rebate agreement entered into under6

section 1927 of such Act) to report, in a form

7

consistent with a standard reporting format es-

8tablished by the Secretary, not later than the9date determined under subparagraph (A)—10‘‘(i) information on the total number

11of units of each dosage form and strength12and package size of each applicable anti-

13

microbial drug dispensed during the pre-14

ceding calendar year under such State plan15

or waiver (including any such drugs dis-16

pensed to an individual enrolled with a17

medicaid managed care organization or18

other specified entity (as such terms are19

defined in section 1903(m) of such Act));

20

and

21

‘‘(ii) with respect to each dosage form

22

and strength and package size of each such

23

drug, the amount equal to—24‘‘(I) the product of—•HR 6000 IH
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1

‘‘(aa) the total number of2units dispensed under the State3

plan or waiver during the pre-4

ceding calendar year (as deter-5mined under clause (i)); and6‘‘(bb) the per-unit ingredient7

cost paid by the State for each8such unit; minus

9‘‘(II) any discounts or other price10

concessions provided and rebates paid

11

to the State with respect to the dos-

12

age form and strength and package

13

size of such drug and such calendar

14

year (including rebates paid under a15rebate agreement under section 1927

16

of such Act and any State supple-

17

mental rebates paid under a supple-

18

mental rebate agreement).

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19‘‘(F) DEPARTMENTOF

VETERANS20FAIRS.—For purposes of subparagraph (A), the21

Secretary of Veterans Affairs shall report the22

total amount paid for each applicable anti-

23

microbial drug procured by the Veterans Health24

Administration for individuals who receive

25

health care from the Administration.

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1

‘‘(G) DEPARTMENT

DEFENSE

TRICARE PROGRAM.—For purposes of subpara-

3graph (A), the Secretary of Defense shall report4

the sum of—5‘‘(i) the total amount paid for each6

applicable antimicrobial drug procured by

7

the Department of Defense for individuals

8

who receive health care from the Depart-

9

ment; and10‘‘(ii) for each applicable antimicrobial

11

drug dispensed under the TRICARE retail12

pharmacy13

1074g(a)(2)(E)(ii) of title 10, United

14

States Code, the product of—programunder

section15‘‘(I) the per-unit ingredient cost,

16

minus any per-unit rebate paid by the17

sponsor of the applicable antimicrobial

18

drug; and‘‘(II) the number of units of such

20

applicable21

pensed under such program.

antimicrobial

drug

dis-

22

‘‘(H) DEPARTMENT OF HOMELAND SECU-

23

RITY.—For purposes of subparagraph (A), the24Secretary of Homeland Security shall report the25

total amount paid for each applicable anti-•HR 6000 IH
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AND

2

19

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41
1

microbial drug procured by the Department of2

Homeland Security for individuals who receive

3

health care through a program carried out by

4

the Department.

5‘‘(I) BUREAU OF PRISONS.—For purposes

6

of subparagraph (A), the Director of the Bu-

7reau of Prisons shall report the total amount8

paid for each applicable antimicrobial drug pro-9

cured by the Bureau of Prisons for individuals

10

who receive health care through the Bureau.

11‘‘(J) INDIAN HEALTH SERVICE.—For pur-12

poses of subparagraph (A), the Secretary, act-

13

ing through the Indian Health Service, shall re-

14

port the total amount paid for each applicable15

antimicrobial drug procured by the Service for16

individuals who receive health care through the17Service.

18‘‘(2) REGULATIONS.—Not later than 1 year

19

after the date of the enactment of this part, the Sec-20

retary, in consultation with the heads of Federal

21

agencies carrying out specified government pro-

22

grams, shall issue regulations to assist such heads

23(or their designees) in carrying out the requirements

24

under this section.

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421‘‘(3) SUBSCRIPTION CONTRACT ADJUSTMENT.—

2

Pursuant to the contract entered into under this sec-

3

tion with respect to an applicable antimicrobial drug,

4for each year of the term of such contract, the Sec-5

retary shall, not earlier than 6 months after the end

6of each calendar year, subtract from the payment in-7stallments determined for such contract under sub-8

section (c)(1) for such year the revenue of the spon-9

sor of such drug from the previous year from sales

10of the applicable antimicrobial drug reported under11

paragraph (1) for specified government programs.

12‘‘(4) DEFINITIONS.—In this subsection:

13

‘‘(A)

14

DRUG.—The

15

drug’ means an antimicrobial drug for which16

the sponsor of such drug receives a subscription

17

contract under subsection (a).

APPLICABLE
term

18

‘‘(B)

19

GRAM.—The

20

gram’ means—

ANTIMICROBIAL‘applicable

SPECIFIED

antimicrobial

GOVERNMENT

term ‘specified government pro-21‘‘(i) the Medicare part D program

22

under part D of title XVIII of the Social

23

Security Act;

24‘‘(ii) the Medicare Part B program

25

under part B of such title XVIII;•HR 6000 IH
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1

‘‘(iii) the Medicare Part A program

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2

under part A of such title XVIII;

3‘‘(iv) the Medicaid program estab-4lished under title XIX of the Social Secu-

5

rity Act and includes, with respect to a6

State, any waiver in effect with respect to

7such program;

8‘‘(v) any program under which pre-9

scription drugs are procured by the De-

10partment of Veterans Affairs;

11‘‘(vi) any program under which pre-12

scription drugs are procured by the De-

13partment of Defense;

14‘‘(vii) the TRICARE retail pharmacy

15

program under section 1074g(a)(2)(E)(ii)

16

of title 10, United States Code;17‘‘(viii) any program under which pre-18

scription drugs are procured by the De-

19partment of Homeland Security;

20‘‘(ix) any program under which pre-21

scription drugs are procured by the Bu-

22reau of Prisons; or23‘‘(x) any program under which pre-24

scription drugs are procured by the Indian25

Health Service.

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1

‘‘(e) FAILURE TO ADHERE TO TERMS.—The Sec-

2 retary shall cease any payment installments under a con3 tract under this section if—
4‘‘(1) the sponsor—

5‘‘(A) permanently withdraws the anti-

6

microbial drug from the market in the United

7

States;8‘‘(B) fails to meet criteria under subsection

pbinns on DSKJLVW7X2PROD with BILLS9(b); or

10‘‘(C) does not complete a postmarket study

11

required by the Food and Drug Administration

12

during the length of the term of the contract;13‘‘(2) the annual international and private insur-

14

ance market revenues with respect to an anti-

15

microbial drug (not counting any subscription reve-

16

nues from any source pursuant to a contract under17

this section or other international or private entities)

18

exceed 5 times the average annual amount of the

19

subscription contract paid by the Secretary as cer-20

tified by the sponsor annually; or21‘‘(3) if the total revenue of the sponsor from22

specified government programs, as defined in sub-23

section (d)(4), for a year exceeds the amount of the24

subscription contract paid by the Secretary for that

25

year.

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1

‘‘(f) PRIVATE PAYER AND INTERNATIONAL PAYER

2 PARTICIPATION.—The Secretary shall make efforts to in3 crease the participation of domestic private payors and4 international payors in subscription contracts or other5 types of value-based arrangements that are similar to the
6 subscription contracts authorized under this section.
7
8

BIOTICS AND COMBATING RESISTANCE.

9‘‘(a) ESTABLISHMENT OF HOSPITAL GRANT PRO-10pbinns on DSKJLVW7X2PROD with BILLS‘‘SEC. 399RR. ENCOURAGING APPROPRIATE USE OF ANTI-

GRAM.—

11‘‘(1) IN GENERAL.—Not later than 1 year after

12

the date of the enactment of this part, the Secretary

13

and the Director of the Centers for Disease Control

14

and Prevention shall coordinate with the Adminis-

15

trator of the Health Resources and Services Admin-

16

istration, the Administrator of the Centers for Medi-17

care & Medicaid Services, the National Coordinator

18

for Health Information Technology, and other rel-19

evant agencies, to establish a grant program under20

the Centers for Disease Control and Prevention to

21

support hospital and other inpatient facility ef-

22forts—

23‘‘(A) to judiciously use antimicrobial drugs,

24such as by establishing or implementing appro-

25

priate use programs, including infectious dis-

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46
1ease telehealth programs, using appropriate di-2

agnostic tools, partnering with academic hos-3

pitals, increasing health care-associated infec-

4

tion reporting, and monitoring antimicrobial re-5

sistance; and

6

‘‘(B)

to

participate

in

the

7

Healthcare Safety Network Antimicrobial Use

8

and Resistance Module or the Emerging Infec-

9

tions Program Healthcare-Associated Infections

10

Community Interface activity of the Centers for

11

Disease Control and Prevention or a similar re-12

porting program, as specified by the Secretary,13

relating to antimicrobial drugs.

14‘‘(2) PRIORITIZATION.—In awarding grants

15

under paragraph (1), the Secretary shall prioritize

16

hospitals without an existing program to judiciously

17

use antimicrobial drugs, subsection (d) hospitals (as18

defined in subparagraph (B) of section 1886(d)(2)19of the Social Security Act that are located in rural

20

areas (as defined in subparagraph (D) of such sec-

21tion), critical access hospitals (as defined in section22

1861(mm)(1) of such Act), hospitals serving Tribal-

23

populations, and safety-net hospitals.

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1

‘‘(3) FUNDING.—Of the amounts appropriated2

under section 399SS, the Secretary shall reserve

3$500,000,000 to carry out this subsection.

4‘‘(b) SURVEILLANCE AND REPORTING OF ANTIBIOTIC

5 USE AND RESISTANCE.—

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6‘‘(1) IN

GENERAL.—The

Secretary, acting

7

through the Director of the Centers for Disease8

Control and Prevention, shall use the National

9

Healthcare Safety Network and other appropriate

10

surveillance systems to assess—

11‘‘(A) appropriate conditions, outcomes, and12

measures causally related to antibacterial resist-

13

ance, including types of infections, the causes

14

for infections, and whether infections are ac-

15

quired in a community or hospital setting, in-16

creased lengths of hospital stay, increased costs,

17

and rates of mortality; and18‘‘(B) changes in bacterial resistance to19

antimicrobial drugs in relation to patient out-

20

comes, including changes in percent resistance,

21

prevalence of antibiotic-resistant infections, and22

other such changes.

23‘‘(2) ANTIBIOTIC USE DATA.—The Secretary,24

acting through the Director of the Centers for Dis-25

ease Control and Prevention, shall work with Fed-•HR 6000 IH
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48
1eral agencies (including the Department of Veterans2

Affairs, the Department of Defense, the Department

3of Homeland Security, the Bureau of Prisons, the4Indian Health Service, and the Centers for Medicare

5& Medicaid Services), private vendors, health care

6organizations, pharmacy benefit managers, and7other entities as appropriate to obtain reliable and8comparable human antibiotic drug consumption data9

(including, as available and appropriate, volume an-

10tibiotic distribution data and antibiotic use data, in-11

cluding prescription data) by State or metropolitan

12

areas.

13‘‘(3) ANTIBIOTIC RESISTANCE TREND DATA.—

14The Secretary, acting through the Director of the

15

Centers for Disease Control and Prevention, shall in-

16

tensify and expand efforts to collect antibiotic resist-17

ance data and encourage adoption of the Antibiotic

18

Use and Resistance Module within the National

19

Healthcare Safety Network among all health care fa-

20

cilities across the continuum of care, including, as

21

appropriate, acute care hospitals, dialysis facilities,

22

nursing homes, ambulatory surgical centers, and23other ambulatory health care settings in which anti-

24

microbial drugs are routinely prescribed. The Sec-25

retary shall seek to collect such data from electronic•HR 6000 IH
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1

medication administration reports and laboratory2

systems to produce the reports described in para-

3graph (4).

4‘‘(4) PUBLICAVAILABILITYOF

DATA.—The

5

Secretary, acting through the Director of the Cen-

6

ters for Disease Control and Prevention, shall, for7

the purposes of improving the monitoring of impor-8tant trends in patient outcomes in relation to anti-

9bacterial resistance—

10‘‘(A) make the data derived from surveil-

11

lance under this subsection publicly available

12

through reports issued on a regular basis that13

is not less than annually; and

14‘‘(B) examine opportunities to make such

15
16

data available in near real time.
‘‘SEC. 399SS. APPROPRIATIONS.

17‘‘(a) IN GENERAL.—To carry out this part, there are

18 hereby appropriated to the Secretary, out of amounts in
19 theTreasurynototherwise

appropriated,

20 $11,000,000,000, for fiscal year 2022, to remain available
21 until expended.

pbinns on DSKJLVW7X2PROD with BILLS22‘‘(b) EMERGENCY DESIGNATION.—

23‘‘(1) IN GENERAL.—The amounts provided by24

this section are designated as an emergency require-•HR 6000 IH
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1

ment pursuant to section 4(g) of the Statutory Pay-

2

As-You-Go Act of 2010.

3‘‘(2) DESIGNATION IN SENATE.—In the Senate,4

this section is designated as an emergency require-5

ment pursuant to section 4112(a) of H. Con. Res.

6

71 (115th Congress), the concurrent resolution on

7

the budget for fiscal year 2018.

8‘‘SEC. 399TT. STUDIES AND REPORTS.

9‘‘(a) IN GENERAL.—Not later than 6 years after the

10 date of the enactment of this part, the Comptroller Gen11 eral of the United States shall complete a study on the
12 effectiveness of this part in developing priority anti13 microbial drugs. Such study shall examine the indications
14 for, usage of, development of resistance with respect to,
15 and private and societal value of critical need anti16 microbial drugs, and the impact of the programs under
17 this part on patients and markets of critical need anti18 microbial drugs. The Comptroller General shall report to
19 the Committee on Health, Education, Labor, and Pen20 sions of the Senate and the Committee on Energy and
21 Commerce of the House of Representatives on the findings

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22 of such study.
23‘‘(b) ANTIBIOTIC USE IN THE UNITED STATES; AN-

24

NUAL REPORTS.—The Director of the Centers for Disease

25 Control and Prevention shall, each year, update the report•HR 6000 IH
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51
1 entitled ‘Antibiotic Use in the United States’ to include
2 updated information on progress and opportunities with
3 respect to data, programs, and resources for prescribers
4 to promote appropriate use of antimicrobial drugs.
5‘‘(c) REPORT ON ANTIMICROBIAL PROPHYLACTICS.—

6 Not later than 3 years after the date of the enactment
7 of this part, the Director of the Centers for Disease Con8 trol and Prevention shall publish a report on antimicrobial
9 prophylactics.
10‘‘SEC. 399UU. DEFINITIONS.

11‘‘In this part—

12‘‘(1) the term ‘antimicrobial drug’—

13‘‘(A) means, subject to subparagraph (B),pbinns on DSKJLVW7X2PROD with BILLS

14

a product that is—15‘‘(i) a drug that directly inhibits rep-

16

lication of or kills bacteria or fungi rel-17

evant to the proposed indication at con-18

centrations likely to be attainable in hu-

19mans to achieve the intended therapeutic20

effect; or21‘‘(ii) a biological product that acts di-22

rectly on bacteria or fungi or on the sub-23

stances produced by such bacteria or fungi;

24

and

25

‘‘(B) does not include—•HR 6000 IH
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1

‘‘(i) a drug that achieves the effect de-2

scribed by subparagraph (A)(i) only at a3

concentration that cannot reasonably be

4

studied in humans because of its antici-

5

pated toxicity; or6‘‘(ii) a vaccine; and7‘‘(2) the term ‘Committee’ means the Com-8

mittee on Critical Need Antimicrobials established9

under section 399OO.’’.

11

TITLE II—PATIENTS AND
CAREGIVERS

12

SEC. 201. EDUCATIONAL PROGRAMS AND TRAINING FOR

10

13

CAREGIVERS.

14

Part D of title VII of the Public Health Service Act

15 (42 U.S.C. 294 et seq.) is amended by adding at the end
16 the following:
17‘‘SEC. 760A. EDUCATIONAL PROGRAMS AND TRAINING FOR

18
19

CAREGIVERS.

‘‘(a) IN GENERAL.—The Secretary may award grants

20 for educational programs and training for caregivers topbinns on DSKJLVW7X2PROD with BILLS

21 learn skills to empower them—
22‘‘(1) to be a member of a care team; and23‘‘(2) to complement a clinical visit.

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‘‘(b) TYPES OF PROGRAMS AND TRAINING.—Edu-

2 cational programs and training funded under subsection
3 (a) may include—45‘‘(1) specialized training in medication adherence and injections;

6‘‘(2) complementary strategies to ensure adher-

7

ence

8

habilitative therapy regimens;tophysical,occupational,

speech,and9‘‘(3) nutritional compliance;

10‘‘(4) caregiver psychosocial support (including

11

cognitive-behavioral, supportive, and bereavement

12

counseling);

13‘‘(5) caregiver health self-management; and14‘‘(6) other services provided in the home.

15‘‘(c) NON-DUPLICATION.—The Secretary may not

16 use the same requirements under this section for a grant,
17 contract, or cooperative agreement under the Geriatric
18 Workforce Enhancement Program under section 753 of
19 the Public Health Service Act (42 U.S.C. 294c).
20‘‘(d) CAREGIVER DEFINED.—In this section, the21 term ‘caregiver’ means an adult family member or other
22 individual who has a significant relationship with, and who

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23 provides a broad range of assistance to, an individual with
24 a chronic or other health condition, disability, or func25 tional limitation.
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1

‘‘(e) AUTHORIZATIONOFAPPROPRIATIONS.—To

2 carry out this section, there is authorized to be appro3 priated $25,000,000 for each of fiscal years 2022 through4 2024.’’.
5SEC. 202. INCREASING HEALTH LITERACY TO PROMOTE

6

BETTER OUTCOMES FOR PATIENTS.

7(a) IN GENERAL.—Not later than one year after the

8 date of the enactment of this Act, the Secretary of Health
9 and Human Services, acting through the Administrator of
10 the Centers for Medicare & Medicaid Services, shall issue
11 a request for information to solicit recommendations on
12 ways the Centers for Medicare & Medicaid Services can
13 work with stakeholders of the Federal health care pro14 grams (as defined in section 1128B(f) of the Social Secu15 rity Act (42 U.S.C. 1320a–7b(f))) to promote increased
16 patient and family caregiver health literacy, including rec-pbinns on DSKJLVW7X2PROD with BILLS

17 ommendations for—18(1) identifying culturally competent, evidence-

19

based interventions that have been proven to im-

20

prove health literacy in populations served by such21

programs;

22(2) identifying evidence-based health literacy

23

approaches that can be used by the Medicare pro-

24

gram under title XVIII of the Social Security Act

25(42 U.S.C. 1395 et seq.), a State plan (or waiver of•HR 6000 IH
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55
1such plan) under title XIX of such Act (42 U.S.C.

21396 et seq.), a State child health plan (or waiver3of such plan) under title XXI of such Act (424

U.S.C. 1397aa et seq.), or health care providers par-5

ticipating in such program under such title XVIII,

6

under a State plan (or waiver of such plan) under

7

such title XIX, or under a State child health plan8

(or waiver of such plan) under such title XXI, and

9

that—

10

(A) have been proven to, or show promise

11

to, reduce costs to individuals enrolled under a12State plan (or waiver of such plan) under such

13

title XIX, or under a State child health plan (or14waiver of such plan) under such title XXI, re-15spectively, and reduce expenditures under such16

respective titles; or

17(B) have been proven to increase patient18

and family caregiver satisfaction or improve the19quality of care for at-risk populations, including

20

holistic and non-medication-based forms of care;21(3) how the Centers for Medicare & Medicaid

22

Services can encourage the use of evidence-based

23

health literacy interventions through payment poli-

24

cies under the Medicare program under title XVIII

25of the Social Security Act (42 U.S.C. 1395 et seq.),•HR 6000 IH
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1

a State plan under title XIX of such Act (42 U.S.C.

21396 et seq.), a State child health plan under title

3

XXI of such Act (42 U.S.C. 1397 et seq.); and4(4) improving patient and family caregiver5

health literacy with respect to health insurance, in-6

cluding an understanding of in-network providers,7

deductibles, co-insurance, co-payments, and dif-8

ferences between payors.

9SEC. 203. INCREASING DIVERSITY IN CLINICAL TRIALS.

1011(a) UPDATED REPORTING ON INCLUSION OF DEMOGRAPHICSUBGROUPS.—The Secretary of Health and

12 Human Services, acting through the Commissioner ofpbinns on DSKJLVW7X2PROD with BILLS

13 Food and Drugs, shall—
14(1) not later than 90 days after the date of the15

enactment of this Act, submit to the Food and Drug

16

Administration, and provide to the Congress, an up-

17

dated version of the report under section 907(a) of18

the Food and Drug Administration Safety and Inno-

19

vation Act (Public Law 115–52); and20(2) not later than 1 year after the publication

21of the updated report pursuant to paragraph (1),22

publish on the website of the Food and Drug Ad-

23

ministration, and provide to the Congress, an up-

24

dated version of the action plan under section

25

907(b) of such Act.

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1

(b) GAO STUDY ON BARRIERS TO PARTICIPATION.—

2 Not later than 1 year after the date of the enactment of
3 this Act, the Comptroller General of the United States
4 shall—5(1) complete a study—

6(A) to review how the Department of

7

Health and Human Services addresses barriers

8

to participation by individuals from underrep-

9

resented populations in conducting or sup-10

porting clinical trials; and11(B) to formulate recommendations for ad-

12

dressing such barriers; and13(2) submit a report to the Congress on the re-14

sults of such study.

15(c) PUBLIC AWARENESS CAMPAIGN.—The Secretary

16 of Health and Human Services shall—
17(1) carry out a public awareness campaign to18

increase awareness and understanding, particularly

19

in minority communities, of—

20(A) upcoming and ongoing clinical trials;

21(B) how to enroll as subjects in such clin-

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22

ical trials; and23(C) the availability of databases and other24

resources relevant to clinical trial enrollment,

25

such as ClinicalTrials.gov; and•HR 6000 IH
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1

(2) in carrying out such campaign, utilize a va-

2

riety of communication channels, including through3

use of the explanation of Medicare benefits under4

section 1806 of the Social Security Act (42 U.S.C.

51395b–7).

6(d) TASK FORCE FOR MAKING CLINICALTRIALS.GOV

7 MORE USER-FRIENDLY.—
8(1) IN GENERAL.—The Secretary of Health and9Human Services shall convene a permanent task

10force to propose, on a biennial basis, recommenda-

11

tions for improving ClinicalTrials.gov by making it

12more user-friendly, including for patients.

1314(2) MEMBERSHIP.—The membership of thetask force shall include representatives of—15(A) the National Institutes of Health;16(B) the Food and Drug Administration;

17(C) academic researchers; and18(D) patient organizations.

19

(e)

DEFINITION.—In

thissection,

the

term

20 ‘‘ClinicalTrials.gov’’ refers to the data bank described in
21 section 402(i) of the Public Health Service Act (42 U.S.C.

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22 282(i)).

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SEC. 204. PATIENT EXPERIENCE DATA.

2(a) POLICY.—Section 569C of the Federal Food,

3 Drug, and Cosmetic Act (21 U.S.C. 360bbb–8c) is amend4 ed—
56(1) by redesignating subsections (b) and (c) as
subsections (c) and (d), respectively; and7(2) by inserting after subsection (a) the fol-8

lowing new subsection:

9‘‘(b) COLLECTION, SUBMISSION,

AND

USE

OF

10 DATA.—
11‘‘(1) IN GENERAL.—The Secretary shall—

12‘‘(A) for any drug for which an exemption

13

is granted for investigational use under section

14505(i) of this Act or section 351(a) of the Pub-15

lic Health Service Act, require the sponsor of16

the drug to collect standardized patient experi-

17

ence data as part of the clinical trials conducted18

pursuant to such exemption;

19‘‘(B) require any application for the ap-

20

proval or licensing of such drug under section

21505(b) of this Act or section 351(a) of the Pub-22

lic Health Service Act to include—pbinns on DSKJLVW7X2PROD with BILLS

23‘‘(i) the standardized patient experi-

24

ence data so collected; and25‘‘(ii) such related information as the26

Secretary may require; and•HR 6000 IH

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‘‘(C) consider patient experience data and2

related information that is submitted pursuant

3

to subparagraph (B) in deciding whether to ap-

4

prove or license, as applicable, the drug in-

5

volved.

6‘‘(2) APPLICABILITY.—Paragraph (1) applies

7

only with respect to drugs for which a request for8

an exemption described in paragraph (1)(A) is sub-9

mitted on or after the date of the enactment of the10

Cures 2.0 Act, or an application under section

11505(b) of this Act or section 351(a) of the Public

12

Health Service Act is filed, as applicable, on or after13

the day that is 2 years after the date of the enact-

14

ment of the Cures 2.0 Act.’’.

15(b) REGULATIONS.—Not later than 1 year after the

16 date of the enactment of this Act, the Secretary of Health
17 and Human Services, acting through the Commissioner of
18 Food and Drugs, shall promulgate final regulations to im19 plement section 569C(b) of the Federal Food, Drug, and20 Cosmetic Act, as added by this section.

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21

SEC. 205. ENSURING COVERAGE FOR CLINICAL TRIALS

22

UNDER EXISTING STANDARD OF CARE.

23(a) REVISION TO DEFINITION OF APPROVED CLIN-

24

ICAL TRIAL IN INDIVIDUAL AND GROUP MARKET.—•HR 6000 IH
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(1) IN GENERAL.—Subsection (d)(1) of the first2

section 2709 of the Public Health Service Act (423

U.S.C. 300gg–8) (relating to coverage for individ-

4

uals participating in approved clinical trials) is

5amended by adding at the end the following new

6

subparagraph:7‘‘(D) The study or investigation is ap-

8

proved or funded (which may include funding

9

through in-kind contributions) by the Patient

10

Centered Outcomes Research Institute estab-

11

lished under section 1181 of the Social Security

12Act.’’.

13(2) EFFECTIVE DATE.—The amendment made14

by this paragraph shall apply with respect to plan15

years beginning on or after January 1, 2022.

16(b) MEDICARE COVERAGE OF ROUTINE COSTS ASSO-

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17

CIATED WITH CERTAIN CLINICAL TRIALS.—

18(1) IN GENERAL.—Section 1862(m)(2) of the19

Social Security Act (42 U.S.C.1395y(m)(2)) is20

amended, in the matter preceding subparagraph (A),21

by inserting ‘‘(including a trial funded by the Pa-

22

tient Centered Outcomes Research Institute estab-

23

lished under section 1181)’’ after ‘‘means a trial’’.

24(2) EFFECTIVE DATE.—The amendment made25

by this paragraph shall apply with respect to items•HR 6000 IH
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and services furnished on or after the date of the en-2

actment of this Act.

3
4

TITLE III—FOOD AND DRUG
ADMINISTRATION

5SEC. 301. REPORT ON COLLABORATION AND ALIGNMENT IN

6

REGULATING

7NOLOGIES.

8DIGITALHEALTHTECH-(a) IN GENERAL.—Not later than 1 year after the

9 date of the enactment of this Act, the Secretary of Health
10 and Human Services, acting through the Commissioner of
11 Food and Drugs, shall submit a report to the Congress
12 on the efforts to ensure collaboration and alignment across13 the centers and offices of the Food and Drug Administra14 tion with respect to the regulation of digital health tech15 nologies.
16(b) CONTENTS.— The report under subsection (a)pbinns on DSKJLVW7X2PROD with BILLS

17 shall include a description of the following:18(1) How the Commissioner of Food and Drugs

19

and the heads of the centers and offices of the Food

20

and Drug Administration collaborate in regulating

21

digital health technologies, including recommenda-

22

tions with respect to—23(A) the use of digital endpoints for regu-

24

latory review, including the validation and qual-•HR 6000 IH
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ification of digital endpoints and digital bio-2

markers;

3(B) the acceptance of decentralized trials;

4(C) the use of digital health technologies in5patient-focused development of products; and6(D) the use and validation of digital health7

technology tools;

8(2) How the Food and Drug Administration co-

9ordinates with foreign regulators to ensure harmoni-10

zation on the regulation and use of digital health11

technologies.

12(c) DEFINITION.—In this section, the term ‘‘digital

13 health technologies’’ includes those technologies in health
14 care or society that help deliver or provide access to health
15 care products and services such as hardware (for example,
16 wearable sensors, virtual reality headsets, and digitally-en17 abled drug delivery devices), advanced analytics (for exam18 ple, artificial intelligence, machine learning, and sophisti19 cated computation), cloud services (for example, storage,
20 computing, and data processing), and software (for exam21 ple, mobile medical applications, and software as a medical

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22 device).

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SEC. 302. GRANTS FOR NOVEL TRIAL DESIGNS AND OTHER2INNOVATIONS IN DRUG DEVELOPMENT.

3(a) IN GENERAL.—The Secretary of Health and4 Human Services, acting through the Commissioner of
5 Food and Drugs, shall award grants for—6(1) incorporating complex adaptive and other7

novel trial designs into clinical protocols and applica-

8

tions for drugs pursuant to an exemption for inves-

9

tigational use under section 505(i) of the Federal

10

Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) or

11

section 351(a) of the Public Health Service Act (4212

U.S.C. 262(a)); and13(2) the collection of patient experience data

14

with respect to drugs and the use of such data and15

related information in drug development.

16(b) PRIORITIZATION.—In awarding grants under this17 section, the Secretary shall prioritize the incorporation of
18 digital health technologies and real world evidence in drug
19 development.
20(c) DEFINITIONS.—In this section:

21

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22(1) The term ‘‘digital health technologies’’ has
the meaning given to such term in section 301.

23(2) The term ‘‘patient experience data’’ has the24meaning given to such term by section 569C(d) of25

the Federal Food, Drug, and Cosmetic Act, as re-26

designated by section 204 of this Act.
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(3) The term ‘‘real world evidence’’ has the2meaning given to that term in section 505F of the3

Federal Food, Drug, and Cosmetic Act (21 U.S.C.

4355g).

5(d) AUTHORIZATION OF APPROPRIATIONS.—To carry

6 out this section, there is authorized to be appropriated
7 $25,000,000 for each of fiscal years 2022 through 2024.
8

SEC. 303. FDA CELL AND GENE THERAPY.

9

Not later than 1 year after the date of the enactment

10 of this Act, the Secretary of Health and Human Services,
11 acting through the Commissioner of Food and Drugs,
12 shall submit a report to the Congress on the following:
13(1) The foreseeable challenges to the Food and14

Drug Administration with respect to cell and gene

15

therapies during the next ten years.

16

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17(2) How the Food and Drug Administration
will address these challenges.

18(3) The additional resources and authorities the19

Food and Drug Administration needs to address

20

these challenges.

21(4) The current state of cell and gene therapies

22

regulation by the Food and Drug Administration, in-23

cluding—•HR 6000 IH
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(A) the amount and nature of the submis-

2

sions filed with the Food and Drug Administra-

3

tion;

4

(B) the status of such applications in the5review process; and6(C) the therapeutic areas intended to be7

addressed by the products that are subject to

8such applications.

9SEC. 304. INCREASING USE OF REAL WORLD EVIDENCE.

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10(a) GUIDANCE.—

11(1) ISSUANCE.—Not later than 6 months after

12

the date of the enactment of this Act, the Secretary

13of Health and Human Services (in this section re-

14

ferred to as the ‘‘Secretary’’) shall issue guidance on

15

the use of real world evidence in evaluating the safe-

16

ty and effectiveness of breakthrough devices (devel-

17

oped pursuant to section 515B of the Federal Food,

18

Drug, and Cosmetic Act (21 U.S.C. 360e–3)) and19

breakthrough drugs subsequent to the approval or li-

20

censing of such drugs pursuant to subsection (a),21(b), or (c) of section 506 of the Federal Food, Drug,

22

and Cosmetic Act (21 U.S.C. 356) as a break-23

through therapy, a fast track product, or a product24

considered for accelerated approval.

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(2) CONSIDERATIONS.—The guidance under2

paragraph (1) shall take into consideration each of3

the following:

4(A) Special and underrepresented popu-

5

lations.

6(B) Acceptable endpoints and outcomes7

measures.

8(C) Data quality standards.

9(D) Data transparency requirements.

10(E) Study design considerations.

11(b) IDENTIFICATION AND IMPLEMENTATION OF AP-

12PROACHES.—

13

(1)

the

framework established under 505F of the Federal

15

Food, Drug, and Cosmetic Act (21 U.S.C. 355g),

16

the Secretary of Health and Human Services shall,17

by not later than 1 year after the date of the enact-

18

ment of this Act—

19(A) identify consistent, clear approaches

20

for the Department of Health and Human

21

Services to use real world evidence (as defined22

in such section 505F)—(i) in conducting and supporting re-24

search; and•HR 6000 IH
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14

23
pbinns on DSKJLVW7X2PROD with BILLSIDENTIFICATION.—Consistent

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1

(ii) in regulating, purchasing, and2

supporting the purchase of health care3

products and services;

4(B) include in such approaches rec-5

ommendations for any additional statutory au-

6thorities needed;

7(C) publish such approaches in the Federal

8

Register; andpbinns on DSKJLVW7X2PROD with BILLS

9(D) submit a report to the Congress on

10such approaches.

11

(2)

IMPLEMENTATION.—Upon

publication

12

under paragraph (1) of the approaches identified

13

pursuant to such paragraph, consistent with the au-

14

thorities vested in the Department of Health and15

Human Services by other provisions of law, the Sec-16

retary take such actions as may be appropriate to17

implement the approaches identified pursuant to18

paragraph (1).

19(c) REAL WORLD EVIDENCE TASK FORCE.—

20(1) ESTABLISHMENT.—The Secretary shall es-

21

tablish a permanent task force, to be known as the

22

Real World Evidence Task Force (in this subsection

23

referred to as the ‘‘Task Force’’) to coordinate the24

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1

and Human Services with regard to the collection

2and use of real world evidence.

34(2) MEMBERSHIP.—The members of the Task
Force shall include the following:

5(A) The Secretary (or the Secretary’s des-6

ignee), who shall serve as the Chair of the Task

7

Force.

8(B) The Administrator of the Centers for9

Medicare & Medicaid Services (or the Adminis-

10

trator’s designee).

11(C) The Commissioner of Food and Drugs

12(or the Commissioner’s designee).

13(D) The Director of the National Insti-

1415(E) Such additional Federal officials (or16their designees) as the Secretary determines ap-

17

propriate.

18(F) Private sector representatives, includ-19

ing patient group representatives, to be ap-

20

pointed by the Secretary.

21(3) RECOMMENDATIONS.—In carrying para-

22

pbinns on DSKJLVW7X2PROD with BILLS

tutes of Health (or the Director’s designee).

graph (1), the Task Force shall—

23(A) develop and periodically update rec-24

ommendations on ways to encourage patients

25

to—

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(i) engage in the generation of real

2

world evidence; and3(ii) participate in postapproval clinical4

trials for the collection of real world evi-

5

dence; and6(B) not later than 2 years after the date7of the enactment of this Act, and every 2 years

8

thereafter, submit a report to the Congress on

9such recommendations.

10

SEC. 305. IMPROVING FDA–CMS COMMUNICATION REGARD-

11
12

ING TRANSFORMATIVE NEW THERAPIES.

(a) IN GENERAL.—Upon the designation of a product13 as a breakthrough therapy, a fast track product, or a
14 product eligible for accelerated approval under subsection
15 (a), (b), or (c), respectively, of section 506 of the Federal
16 Food, Drug, and Cosmetic Act (21 U.S.C. 356), the Com17 missioner of Food and Drugs and the Administrator of

pbinns on DSKJLVW7X2PROD with BILLS

18 the Centers for Medicare & Medicaid Services shall—
19(1) maintain communication with each other re-20

garding approval and coverage decisions with respect

21

to such product; and22(2) share such information with each other as

23

may be appropriate to inform and coordinate such

24

decisions.

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(b) SEPARATE AND DISTINCT.—In approving or des-2 ignating a product described in subsection (a), the Com3 missioner of Food and Drugs and the Administrator of
4 the Centers for Medicare & Medicaid Services shall ensure
5 that the process for approval or designation remains sepa6 rate and distinct.
7

SEC. 306. ESTABLISHMENT OF ADDITIONAL INTERCENTER

8

INSTITUTES AT THE FOOD AND DRUG ADMIN-

9ISTRATION.

10(a) ESTABLISHMENT.—Subsection (c) of section

11 1014 of the Federal Food, Drug, and Cosmetic Act (2112 U.S.C. 399g(c)) is amended to read as follows:13‘‘(c) TIMING.—Not later than the date that is one

14 year after the date of the enactment of the Cures 2.0 Act
15 or the end of the coronavirus disease 2019 (COVID–19)
16 pandemic public health emergency under section 319 of
17 the Public Health Service Act, whichever is later, the Sec18 retary shall establish, in accordance with this section, at
19 least two additional Institutes under subsection (a).’’.
20(b) CRITERIA.—In establishing the focus of the two

21 Institutes referenced in the amendment made by sub22 section (a), the Secretary of Health and Human Services

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23 shall ensure the following:
24
25(1) One of the Institutes focuses on a group of
diseases meeting the following criteria:•HR 6000 IH
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(A) Negatively affects at least one major

2

body system.

3(B) Represents a major disease burden in

4

the United States.

5(C) Represents a leading cause of mor-

6

tality or disability in the United States.

7
8

Health,950,000,000 Americans each year.

affects

at

least

an

estimated

10(E) Contributes to increasing health care11(personal, familial, private sector, and govern-

12

mental) expenditures and impacts the United

13

States economy as a whole.

14(F) For which the SARS–CoV–2 virus ex-

15

acerbates symptoms or causes serious complica-

16

tions.

17(G) For which medical products are ap-

18

proved by the Food and Drug Administration

19

at a much lower rate than products for other20

disease areas, including in abbreviated path-

21

ways.

22

(2) One of the Institutes focuses on a group of23
pbinns on DSKJLVW7X2PROD with BILLS(D) According to the National Institutes of

diseases meeting the following criteria:

24

(A)

25

Affects,

individually,

fewer

200,000 people in the United States.

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than

73
1

(B) Over 90 percent of such diseases have2

no therapy approved by the Food and Drug Ad-

3ministration.

4(C) Affects, in total, over 30,000,000

5Americans.

6(D) Over 50 percent of patients are chil-

7

dren.

8

(c) REPORT ON INTERCENTER INSTITUTES.—Not

9 later than 2 years after the date of the enactment of this10 Act, and annually thereafter, the Secretary of Health and
11 Human Services, acting through the Commissioner of
12 Food and Drugs, shall submit a report to the Committee
13 on Energy and Commerce of the House of Representatives
14 and the Committee on Health, Education, Labor, and
15 Pensions of the Senate on the activities of the Institutes
16 established pursuant to this section.
17

SEC. 307. ACCELERATING TIMELINE FOR BREAKTHROUGH

18
19

AND RMAT DESIGNATIONS.

(a)

BREAKTHROUGH

THERAPIES.—Section

20 506(a)(2) of the Federal Food, Drug, and Cosmetic Act
21 (21 U.S.C. 356(a)(2)) is amended by striking ‘‘A request
22 for the designation may be made concurrently with, or at

pbinns on DSKJLVW7X2PROD with BILLS

23 any time after, the submission of an application for the
24 investigation of the drug under section 505(i) or section
25 351(a)(3) of the Public Health Service Act’’ and inserting•HR 6000 IH
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1 ‘‘A request for the designation may be made at any point
2 before or after submission of an application for approval
3 of the drug under section 505(b) of this Act or licensure
4 of the drug under section 351(a)(2) of the Public Health
5 Service Act and shall include clinical evidence, including
6 preliminary clinical evidence from clinical trials conducted
7 outside of the United States’’.
8(b) REGENERATIVE ADVANCED THERAPIES.—Sec-

9 tion 506(g)(3) of the Federal Food, Drug, and Cosmetic
10 Act (21 U.S.C. 356(g)(3)) is amended by striking ‘‘con11 currently with, or at any time after, submission of an ap12 plication for the investigation of the drug under section
13 505(i) of this Act or section 351(a)(3) of the Public
14 Health Service Act’’ and inserting ‘‘at any point before
15 or after submission of an application for approval of the
16 drug under section 505(b) of this Act or licensure of the
17 drug under section 351(a)(2) of the Public Health Service
18 Act and shall include clinical evidence, including prelimi19 nary clinical evidence from clinical trials conducted outside

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20 of the United States’’.

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SEC. 308. GUIDANCE REGARDING DEVELOPMENT AND SUB-2MISSION OF CHEMISTRY, MANUFACTURING,

3

AND CONTROLS INFORMATION FOR EXPE-

4

DITED APPROVAL.

5(a) IN GENERAL.—The Secretary of Health and6 Human Services shall—
7(1) not later than 6 months after the date of8

the enactment of this Act, issue draft revised guid-9

ance to provide clarity regarding the development

10

and submission of chemistry, manufacturing, and11

controls information for purposes of subsections (a),12(b), (c), and (g) of section 506 of the Federal Food,

13

Drug, and Cosmetic Act (21 U.S.C. 356; relating to14

breakthrough therapies, fast track products, acceler-

15

ated approval, and regenerative advanced therapies);

16

and

17

(2) not later than 90 days after the close of a18

period of public comment on such draft guidance, fi-

19

nalize the guidance.

20(b) CONTENTS.—The guidance under subsection (a)pbinns on DSKJLVW7X2PROD with BILLS

21 shall address—
22(1) how the Food and Drug Administration will23

determine how, and by when, chemistry, manufac-

24

turing, and controls information is required to be25

submitted throughout development and during the•HR 6000 IH
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pre- and post-approval phases, taking into consider-2

ation—

3(A) how such determinations will reflect

4

the risks and benefits of such information given5

the seriousness or life-threatening nature of the6disease the product is intended to diagnose,

7

cure, mitigate, treat, or prevent;8(B) the phase and expedited nature of de-

9velopment; and10(C) the availability of relevant data and in-11

formation from nonclinical and clinical studies,12

product applications, and post-approval over-13

sight; and

14(2) how the Food and Drug Administration will

15

provide ongoing advice and opportunities for spon-

16

sors to interact with the Food and Drug Administra-

17

tion on, and how the Food and Drug Administration

18

will facilitate, the submission of chemistry, manufac-

19

turing, and controls information throughout the life

20

cycle of the product.

21

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

22

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CELERATED APPROVAL.

Section 506(c)(2)(A) of the Federal Food, Drug, and24 Cosmetic Act (21 U.S.C. 356(c)(2)(A)) is amended after
25 ‘‘studies’’ by inserting ‘‘, or otherwise submit evidence•HR 6000 IH
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77
1 based on analyses of data in clinical care data repositories,
2 patient registries, or other sources of real world evi3 dence,’’.
4

SEC. 310. RECOMMENDATIONS TO DECENTRALIZE CLIN-

56

ICAL TRIALS.

(a) IN GENERAL.—Not later than the end of fiscal

7 year 2022, the Secretary of Health and Human Services,
8 acting through the Commissioner of Food and Drugs,
9 shall convene a meeting of covered representatives to rec10 ommend to the Secretary innovative approaches and in11 centives to adopt decentralized clinical trials.
12(b) DEFINITIONS.—In this section:pbinns on DSKJLVW7X2PROD with BILLS

13(1) COVEREDREPRESENTATIVE.—The

14‘‘covered representative’’ means a representative of15

the following:

16(A) Sponsors of an application for approval

17of a drug under section 505 of the Federal

18

Food, Drug, and Cosmetic Act (21 U.S.C.

19

355).

20

(B) A manufacturer of a device (as defined21

in section 201 of the Federal Food, Drug, and22

Cosmetic Act (21 U.S.C. 321)).

23(C) Clinical research organizations.

24(D) The technology community.

25(E) The patient community.

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(2) DECENTRALIZED

CLINICAL

TRIAL.—The2

term ‘‘decentralized clinical trial’’ means a clinical

3

trial method that includes the use of telemedicine or4

digital technologies to allow for the remote collection

5of clinical trial data from subjects, including in the6home or office setting.

TITLE IV—CENTERS FOR MEDI8
CARE & MEDICAID SERVICES
7

9SEC. 401. GAO STUDY AND REPORT.

10

Not later than one year after the date of the enact-

11 ment of this Act, the Comptroller General of the United
12 States shall submit to Congress a report on recommenda13 tions for administrative actions that may be taken by the
14 Secretary of Health and Human Services (as well as rec-pbinns on DSKJLVW7X2PROD with BILLS

15 ommendations for legislative changes needed) to—16(1) enhance coverage and reimbursement ap-

17

proaches under the Medicare program under title

18

XVIII of the Social Security Act for innovative tech-

19

nologies that increase access to health care, improve20

health care quality, decrease expenditures under

21

such program, or otherwise improve the Medicare

22

program or health care for beneficiaries under such23

program; and24(2) better harmonize and integrate the oper-

25

ating structure of the Medicare program (and the•HR 6000 IH
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1

Centers for Medicare & Medicaid Services) to im-2

prove interagency collaboration and communication.

3

SEC. 402. STRATEGIES TO INCREASE ACCESS TO TELE-

4HEALTH UNDER MEDICAID AND CHILDREN’S

5

HEALTH INSURANCE PROGRAM.

6(a) GUIDANCE.—Not later than one year after the

7 date of the enactment of this Act, the Secretary of Health
8 and Human Services shall issue and disseminate guidance
9 to States to clarify strategies to overcome existing barriers
10 and increase access to telehealth under the Medicaid pro11 gram under title XIX of the Social Security Act (4212 U.S.C. 1396 et seq.) and the Children’s Health Insurance
13 Program under title XXI of such Act (42 U.S.C. 1397aa
14 et seq.). Such guidance shall include technical assistancepbinns on DSKJLVW7X2PROD with BILLS

15 and best practices regarding—16(1) existing strategies States can use to inte-

17

grate telehealth and other virtual health care serv-

18

ices into value-based health care models; and19(2) examples of States that have used waivers

20

under the Medicaid program to test expanded access21

to telehealth, including during the emergency period

22

described in section 1135(g)(1)(B) of the Social Se-

23

curity Act (42 U.S.C. 1320b–5(g)(1)(B)).

24(b) STUDIES.—•HR 6000 IH
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pbinns on DSKJLVW7X2PROD with BILLS801(1) TELEHEALTH IMPACT ON HEALTH CARE

2

ACCESS.—Not later than one year after the date of3

the enactment of this Act, the Medicaid and CHIP

4

Payment and Access Commission shall conduct a

5

study, with respect to a minimum of 10 States6

across geographic regions of the United States, and7

submit to Congress a report, on the impact of tele-8

health on health care access, utilization, cost, and9outcomes, broken down by race, ethnicity, sex, age,10

disability status, and zip code. Such report shall—

11(A) evaluate cost, access, utilization, out-

12

comes, and patient experience data from across13

the health care field, including States, Medicaid

14

managed care organizations, provider organiza-

15

tions, and other organizations that provide or16

pay for telehealth under the Medicaid program

17

and Children’s Health Insurance Program;

18(B) identify barriers and potential solu-

19

tions to provider entry and participation in tele-20

health that States are experiencing, as well as

21

barriers to providing telehealth across State

22

lines, including during times of public health23

crisis or public health emergency;

24(C) determine the frequency at which out-

25

of-State telehealth is provided to patients en-•HR 6000 IH
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pbinns on DSKJLVW7X2PROD with BILLS

81
1rolled in the Medicaid program and the poten-

2tial impact on access to telehealth if State Med-3

icaid policies were more aligned; and4(D) identify and evaluate opportunities for5

more alignment among such policies to promote

6

access to telehealth across all States, State

7

Medicaid plans under title XIX of the Social

8

Security Act (42 U.S.C. 1396 et seq.), State

9child health plans under title XXI of such Act

10(42 U.S.C. 1397aa et seq.), and Medicaid man-11

aged care organizations, including the potential

12

for regional compacts or reciprocity agreements.

13(2) FEDERAL AGENCY TELEHEALTH COLLABO-

14RATION.—Not later than 1 year after the date of the15

enactment of this Act, the Comptroller General of

16

the United States shall conduct a study and submit

17

to Congress a report evaluating collaboration be-

18

tween Federal agencies with respect to telehealth19

services furnished under the Medicaid or CHIP pro-

20

gram to individuals under the age of 18, including

21

such services furnished to such individuals in early22

care and education settings. Such report shall in-23

clude recommendations on—•HR 6000 IH
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(A) opportunities for Federal agencies to2

improve collaboration with respect to such tele-3

health services; and4(B) opportunities for collaboration between

5

Federal agencies to expand telehealth access to

6such individuals enrolled under the Medicaid or

7

CHIP program, including in early care and8

education settings.

9SEC. 403. EXTENDING MEDICARE TELEHEALTH FLEXIBILI-

10

TIES.

11

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12(a) EXPANDING ACCESS TO TELEHEALTH SERVICES.—

13(1) IN GENERAL.—Section 1834(m)(4)(C) of

14

the Social Security Act (42 U.S.C. 1395m(m)(4)(C))

15

is amended by adding at the end the following new16clause:17‘‘(iii) EXPANDING ACCESS TO TELE-

18HEALTH SERVICES.—With respect to tele-19

health services furnished beginning on the20

first day after the end of the emergency

21

period described in section 1135(g)(1)(B)22of this clause, the term ‘originating site’23

means any site at which the eligible tele-24

health individual is located at the time the25

service is furnished via a telecommuni-•HR 6000 IH
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cations system, including the home of an2

individual.’’.

34(2) CONFORMING AMENDMENTS.—Such sectionis amended—

5(A) in paragraph (2)(B)—6(i) in clause (i), in the matter pre-7

ceding subclause (I), by striking ‘‘clause

8(ii)’’ and inserting ‘‘clauses (ii) and (iii)’’;

9

and

10

(ii) by adding at the end the following

11

new clause:

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12‘‘(iii) NO

FACILITY FEE FOR NEW

13

SITES.—With respect to telehealth services

14

furnished on or after the date of the enact-

15

ment of this clause, a facility fee shall only

16

be paid under this subparagraph to an

17

originating site that is described in para-

18

graph (4)(C)(ii) (other than subclause (X)19

of such paragraph).’’;

20(B) in paragraph (4)(C)—21(i) in clause (i), in the matter pre-22

ceding subclause (I), by inserting ‘‘and23

clause (iii)’’ after ‘‘and (7)’’; and24(ii) in clause (ii)(X), by inserting25‘‘prior to the first day after the end of the•HR 6000 IH
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emergency period described in section

21135(g)(1)(B)’’ before the period;

3(C) in paragraph (5), by inserting ‘‘and

4prior to the first day after the end of the emer-

5

gency

6

1135(g)(1)(B)’’ after ‘‘January 1, 2019,’’;perioddescribed

insection7(D) in paragraph (6)(A), by inserting ‘‘and

8prior to the first day after the end of the emer-

9

gency

10

1135(g)(1)(B),’’ after ‘‘January 1, 2019,’’; and11(E) in paragraph (7), by adding at the end

12perioddescribed

insectionthe following new subparagraph:13‘‘(C) SUNSET.—The provisions of this14

paragraph shall not apply with respect to serv-

15

ices furnished on or after the first day after the16

end of the emergency period described in sec-

17

tion 1135(g)(1)(B).’’.

18(b) EXPANDING PRACTITIONERS ELIGIBLE TO FUR-

19

NISH TELEHEALTH SERVICES.—Section 1834(m) of thepbinns on DSKJLVW7X2PROD with BILLS

20 Social Security Act (42 U.S.C. 1395m(m)) is amended—21(1) in paragraph (1), by striking ‘‘(described in

22

section 1842(b)(18)(C))’’ and inserting ‘‘(defined in

23

paragraph (4)(E))’’; and24(2) in paragraph (4)(E)—•HR 6000 IH
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(A) by striking ‘‘PRACTITIONER.—The2

term’’ and inserting ‘‘PRACTITIONER.—

3‘‘(A) IN GENERAL.—Subject to subpara-

4graph (B), the term’’; and5(B) by adding at the end the following new

6

subparagraph:7‘‘(B) EXPANSION.—The Secretary, after

8

consulting with stakeholders regarding services

9

that are clinically appropriate, may expand the10types of practitioners who may furnish tele-11

health services to include any health care pro-12

fessional that is eligible to bill the program

13

under this title for their professional services.’’.

14(c) RETENTION OF ADDITIONAL SERVICES AND SUB-

15

REGULATORY PROCESS FOR MODIFICATIONS FOLLOWING

16 EMERGENCY PERIOD.—Section 1834(m)(4)(F) of the So17 cial Security Act (42 U.S.C. 1395m(m)(4)(F)) is amend18 ed—
19

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20(1) in clause (i), by inserting ‘‘and clause (iii)’’
after ‘‘paragraph (8)’’;21(2) in clause (ii), by striking ‘‘The Secretary’’22

and inserting ‘‘Subject to clause (iii), the Sec-23

retary’’; and2425(3) by adding at the end the following newclause:•HR 6000 IH
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‘‘(iii) RETENTIONOFADDITIONAL

2

SERVICES AND SUBREGULATORY PROCESS

3

FOR

4

GENCY

5

health services furnished after the last day

6of the emergency period described in sec-

7

tion 1135(g)(1)(B), the Secretary may—

MODIFICATIONSFOLLOWINGPERIOD.—With

EMER-

respect to tele-8‘‘(I) retain as appropriate the ex-

9panded list of telehealth services spec-

10

ified in clause (i) pursuant to the11

waiver121135(b)(8) during such emergency pe-

13riod; andauthority

under

section14‘‘(II) retain the subregulatory

15

process used to modify the services in-16

cluded on the list of such telehealth17

services pursuant to clause (ii) during

18

such emergency period.’’.

19(d) ENHANCING TELEHEALTH SERVICES FOR FED-

20

ERALLYQUALIFIED HEALTH CENTERS

AND

RURAL

21 HEALTH CLINICS.—Section 1834(m)(8) of the Social Se22 curity Act (42 U.S.C. 1395m(m)(8)) is amended—pbinns on DSKJLVW7X2PROD with BILLS2324(1) in the paragraph heading by inserting ‘‘AND
AFTER’’ after ‘‘DURING’’;•HR 6000 IH
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(2) in subparagraph (A), in the matter pre-2

ceding clause (i), by inserting ‘‘and after’’ after3‘‘During’’; and4(3) in the first sentence of subparagraph (B)(i),5by inserting ‘‘and after’’ after ‘‘during’’.

6(e) USE OF TELEHEALTH, AS CLINICALLY APPRO-7PRIATE, TO CONDUCT FACE-TO-FACE ENCOUNTER FOR

8 HOSPICE CARE.—Section 1814(a)(7)(D)(i)(II) of the So9 cial Security Act (42 U.S.C. 1395f(a)(7)(D)(i)(II)) is
10 amended by inserting ‘‘and after such emergency period
11 as clinically appropriate’’ after ‘‘1135(g)(1)(B)’’.
12(f) USE OF TELEHEALTH, AS CLINICALLY APPRO-13

PRIATE, TO CONDUCT FACE-TO-FACE CLINICAL ASSESS-

14

MENTS FORHOME DIALYSIS.—Clause (iii) of section

15 1881(b)(3)(B) of the Social Security Act (42 U.S.C.
16 1395rr(b)(3)(B)) is amended—1718(1) by moving such clause 4 ems to the left;and19(2) by inserting ‘‘and after such emergency pe-

20

riod as clinically appropriate’’ before the period.

21(g) IMPLEMENTATION.—Notwithstanding any provi-

22 sion of law, the Secretary may implement the provisions

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23 of, and amendments made by, this section by interim final
24 rule, program instruction, or otherwise.

•HR 6000 IH
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SEC. 404. COVERAGE AND PAYMENT FOR BREAKTHROUGH

2

DEVICES UNDER THE MEDICARE PROGRAM.

3(a) IN GENERAL.—Part E of title XVIII of the Social

4 Security Act (42 U.S.C. 1395x et seq.) is amended by add5 ing at the end the following new section:
6‘‘SEC. 1899C. COVERAGE OF BREAKTHROUGH DEVICES.

7‘‘(a) BREAKTHROUGH DEVICES.—For purposes of

8 this section, the term ‘breakthrough device’ means a med9 ical device that is a device (as defined in section 201 of
10 the Federal Food, Drug, and Cosmetic Act) and that is—11‘‘(1) provided with review priority by the Sec-12

retary under subsection (d)(5) of section 515 of such

13

Act; and14‘‘(2) approved or cleared pursuant to section

15

510(k), 513(f), or 515 of such Act for use in treat-16

ing an indication on or after March 15, 2021.

17 Such term also includes a breakthrough device that is a
18 specified breakthrough device (as defined in subsection
19 (e)(1)(B)) approved or cleared pursuant to section 510(k),20 513(f), or 515 of such Act for use in treating an indication
21 on or after March 15, 2021.
22‘‘(b) COVERAGE.—

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23‘‘(1) TRANSITIONAL COVERAGE.—

24‘‘(A) IN

GENERAL.—During

the transi-

25

tional coverage period (as defined in subpara-

26

graph (B)) a breakthrough device shall be—•HR 6000 IH

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‘‘(i) deemed to be reasonable and nec-

2

essary3

1862(a)(1)(A);pbinns on DSKJLVW7X2PROD with BILLS

4

forpurposesof‘‘(ii) deemed to be approved for an ad-

5ditional6

1886(d)(5)(K) (other than with respect to7

the cost criterion under clause (ii)(I) of

8such section);

payment

under

section9‘‘(iii) deemed to be approved for pass-

10

through payment under section 1833(t)(6)11

and section 1833(i) (other than with re-

12spect to the cost criterion under section

13

1833(t)(6)(A)(iv)); and14‘‘(iv) insofar as such breakthrough de-15

vice may be furnished in a setting for

16

which payment is made under an applica-17

ble payment system described in subpara-

18

graphs (D) through (I) of subsection

19(c)(4), deemed eligible for an additional

20

payment or payment adjustment, as the21case may be, pursuant to subsection (d)(3)22

when furnished in a setting for which pay-23

ment is made under such an applicable24

payment system during such transitional25

coverage period.

•HR 6000 IH
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1‘‘(B) TRANSITIONAL

COVERAGE

2

DEFINED.—As

3‘transitional coverage period’ means, with re-4spect to a breakthrough device, the period

5

that—

used in this section, the term

6‘‘(i) begins on the date of the approval

7

under section 515 of the Federal Food,

8

Drug, and Cosmetic Act or of the clear-9ance under section 510(k) of such Act, as

10

applicable, of such device by the Secretary

11for the indication described in subsection

12(a)(1); and13‘‘(ii) ends on the last day of the 4-

14

year period that begins on the date that15

the Secretary, pursuant to subsection

16(c)(2), updates the relevant applicable pay-17

ment system (as defined in subsection

18(c)(4)) to recognize the unique temporary

19

or permanent code or codes assigned under20

subsection (c)(1) to such breakthrough de-21vice, except as provided in subsections

22(d)(1)(B) and (d)(2)(B).

23‘‘(C) DATA USED TO MEET THE NTAP AND

24

PASS-THROUGH

25

mining whether a breakthrough device qualifies

COST

CRITERIA.—In•HR 6000 IH
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deter-

91
1

for

2

1886(d)(5)(K) or for pass-through payment

3

under section 1833(t)(6) or section 1833(i), the4Secretary shall use the most recently available

5

data and information on the costs of such6

breakthrough device, which may include list

7

prices and invoice prices charged for such8

breakthrough device.

9‘‘(2) PROCESS FOR REGULAR COVERAGE.—For10

purposes of the application of section 1862(a)(1)(A)11

to a breakthrough device furnished after the transi-

12tional coverage period (as defined in paragraph

13(1)(B)) for such device, the Secretary shall establish

14

a process for the coverage of such breakthrough de-15

vices under this title after such period as follows:

16

additional

payment

under

DENCE.—

18‘‘(i) IN GENERAL.—With respect to a19

breakthrough device, not later than 1 year

20

after the date of the approval of such de-21

vice under section 515 of the Federal

22

Food, Drug, and Cosmetic Act or of the

23

clearance of such device under section

24

510(k) of such Act, as applicable, the Sec-25

retary shall identify whether any additional•HR 6000 IH
VerDate Sep 11 2014section‘‘(A) IDENTIFICATION OF ADDITIONAL EVI-

17

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data or evidence is required with respect to2

any indications for such device for pur-3

poses of the application of such section

4

1862(a)(1)(A) to such device for such indi-5

cations.

6‘‘(ii) NON-DUPLICATION OF DATA RE-

7

QUESTS.—In

8respect to a breakthrough device, the Sec-9

retary shall ensure that data or evidence

10

identified—

11‘‘(I) does not duplicate data re-12

quired to be collected by the Food and13

Drug Administration with respect to

14such breakthrough device;

15‘‘(II) minimizes the administra-

16

tive burdens of data collection and re-17

porting on providers of services, sup-18

pliers, and manufacturers of break-19

through devices; and20‘‘(III) is not otherwise unneces-

21sary or redundant.

22

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carrying out clause (i) with‘‘(B) PROPOSALFOR

COVERAGE

23

THE TRANSITIONAL COVERAGE PERIOD.—Not

24

later than 2 years after the date of the approval

25

or clearance of a breakthrough device by the•HR 6000 IH
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Food and Drug Administration, the Secretary2

shall develop a proposal for coverage under this3

title of such breakthrough device for such indi-4

cations as the Secretary determines to be ap-

5

propriate, based on the data and evidence col-6

lected under subparagraph (A), for such devices

7

furnished after the transitional coverage period8

under paragraph (1) for such device. If the Sec-9

retary does not, on a date that is before the end

10of such two-year period, take action to modify

11

the indications for which coverage of a break-12

through device may be provided under this title

13

after such period, for purposes of section14

1862(a)(1)(A) coverage under this title of such15

breakthrough device shall be made for all indi-

16

cations for which such device is approved under17

section 515 of the Federal Food, Drug, and18

Cosmetic Act or cleared under section 510(k) of

19such Act.

20‘‘(3) RULES OF CONSTRUCTION.—Nothing inpbinns on DSKJLVW7X2PROD with BILLS

21

this section shall be construed to—22‘‘(A) affect the ability of the manufacturer

23of a breakthrough device to seek approval for24

pass-through payment status under section25

1833(t)(6) or to seek approval for an additional•HR 6000 IH
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payment under section 1886(d)(5)(K) insofar

2

as such breakthrough device does not qualify

3

for transitional coverage under paragraph (1);4‘‘(B) affect the application and approval

5

process for pass-through payment status under6

section 1833(t)(6) or for an additional payment

7

under section 1886(d)(5)(K) in the case of a8

medical device that is not approved by the Food

9and Drug Administration as a breakthrough de-

10vice; or

11‘‘(C) prohibit the Secretary from using ex-

12

isting authority under this title to suspend or

13

terminate coverage of a breakthrough device if

14

the Secretary, based on clinical evidence, deter-

15

mines that—

16‘‘(i) such breakthrough device offers

17

no clinical benefit to Medicare bene-

18

ficiaries; or19‘‘(ii) furnishing such breakthrough de-20

vice to Medicare beneficiaries causes, or21

may cause, serious harm to Medicare bene-

22

ficiaries.

pbinns on DSKJLVW7X2PROD with BILLS23‘‘(c) CODING.—

2425‘‘(1) PROMPTASSIGNMENT.—Notlater than

three months after the date of approval or clearance•HR 6000 IH
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of a breakthrough device by the Food and Drug Ad-

2ministration, the Secretary shall assign a unique3

temporary or permanent code or codes for purposes4

of coverage and payment for such breakthrough de-5vice under the applicable payment systems (de-6scribed in paragraph (4)).

7‘‘(2) UPDATES.—

8‘‘(A) IPPS.—The Secretary shall provide

9for semiannual updates under the applicable

10

payment system described in paragraph (4)(A)11(relating to the inpatient hospital prospective

12

payment system) to recognize the code or codes13

assigned under paragraph (1).

14‘‘(B) OPPS.—The Secretary shall provide

15

for quarterly updates under the applicable pay-

16

ment system described in paragraph (4)(B) (re-17lating to the outpatient hospital prospective

18

payment system) to recognize the code or codes19

assigned under paragraph (1).

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20‘‘(C) OTHERPAYMENTSYSTEMS.—The

21

Secretary shall provide for semiannual or quar-

22

terly updates, as the case may be, under the ap-

23

plicable payment systems described in subpara-

24

graphs (C) through (L) of paragraph (4) to rec-•HR 6000 IH
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ognize the code or codes assigned under para-

2graph (1).

3‘‘(3) TRANSPARENCY.—The process for the as-4signment of a code or codes under this subsection

5

shall provide for public notice and a meaningful op-

6

portunity for public comment from affected parties.

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7

‘‘(4)

APPLICABLEPAYMENTSYSTEMS8SCRIBED.—For purposes of this subsection, the term

9‘applicable payment systems’ means—

10‘‘(A) with respect to inpatient hospital

11

services, the prospective payment system for in-

12

patient hospital services established under sec-

13

tion 1886(d);14‘‘(B) with respect to outpatient hospital

15

services, the prospective payment system for16

covered OPD services established under section

17

1833(t);18‘‘(C) with respect to ambulatory surgical19

center services, the fee schedule for such serv-

20

ices established under 1833(i);21‘‘(D) with respect to physicians’ services,22

the physician fee schedules established under23

section 1848;•HR 6000 IH
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pbinns on DSKJLVW7X2PROD with BILLS

971‘‘(E) with respect to covered items of dura-

2

ble medical equipment, the applicable fee sched-3

ules established under section 1834;

4‘‘(F) with respect to diagnostic laboratory5

tests, the payment amounts under section

6

1834A and the fee schedules establish under7

section 1848, as the case may be;8‘‘(G) with respect to inpatient hospital

9

services furnished by rehabilitation facilities,

10

the prospective payment system established11

under section 1886(j);12‘‘(H) with respect to inpatient hospital

13

services furnished by long-term care hospitals,

14

the prospective payment system under section15

1886(m);16‘‘(I) with respect to inpatient hospital serv-

17

ices furnished by psychiatric hospitals and psy-18

chiatric units, the prospective payment system

19

under section 1886(s);20‘‘(J) with respect to home health services,21

the prospective payment system under section

22

1895; and

23‘‘(K) with respect to items and services, or

24

a provider of services or supplier, not described25

in subparagraphs (A) through (I), the payment•HR 6000 IH
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1

system established under this title for such2

items and services when furnished by such pro-3

vider of services or supplier.

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4‘‘(d) PAYMENT.—

5‘‘(1) INPATIENT HOSPITAL PROSPECTIVE PAY-

6

MENT SYSTEM: DEEMED ELIGIBILITY FOR BREAK-

7

THROUGH8each breakthrough device as approved for an addi-

9tional payment under section 1886(d)(5)(K) for the10

4-year period that begins—

PAYMENT.—The

Secretary shall deem

11‘‘(A) except as provided in subparagraph

12(B), on the date that the Secretary, pursuant to

13

subsection (c)(2)(A), updates the payment sys-

14

tem under section 1886(d) to recognize the15

unique temporary or permanent code or codes16

assigned under subsection (c)(1) to such break-17

through device; or

18‘‘(B) in the case of a device that has not

19

received approval or clearance as a break-20

through device by the Food and Drug Adminis-

21

tration before such payment system is updated

22

under subsection (c)(2)(A) to recognize the23

unique temporary or permanent code or codes24

assigned under subsection (c)(1) to such device,25

on the date of such approval or clearance.

•HR 6000 IH
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Nothing in this paragraph shall be construed to af-

2fect the authority of the Secretary to use claims

3data to establish new diagnosis or procedure codes4

for breakthrough devices or to identify appropriate

5

diagnosis-related groups for the assignment of

6

breakthrough devices under annual rulemaking to7carry out section 1886(d)(5)(K).

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8‘‘(2) OUTPATIENT PROSPECTIVE PAYMENT SYS-

9

TEM:

10

PAYMENT.—The

11

through device as approved for pass-through pay-

12

ment under section 1833(t)(6) (including for pur-13

poses of section 1833(i)(2)(D)) during the 4-year pe-

14

riod that begins—

DEEMEDELIGIBILITYFOR

PASS-THROUGH

Secretary shall deem each break-

15‘‘(A) except as provided in subparagraph

16(B), on the date that the Secretary, pursuant to

17subsection (c)(2)(B), updates the payment sys-18

tem under section 1833(t) to recognize the19unique temporary or permanent code or codes20

assigned under subsection (c)(1) to such break-21

through device; or

22‘‘(B) in the case of a device that has not

23

received approval or clearance as a break-24

through device by the Food and Drug Adminis-

25

tration before such payment system is updated•HR 6000 IH
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100
1

under subsection (c)(2)(B) to recognize the2unique temporary or permanent code or codes3

assigned under subsection (c)(1) to such device,4on the date of such approval or clearance.

5

Nothing in this paragraph shall be construed to af-

6fect the authority of the Secretary to use claims

7

data to establish new ambulatory payment classifica-

8

tion groups for breakthrough devices or to revise

9such groups to take into account breakthrough de-10vices under annual rulemaking to carry out section11

1833(t).

12‘‘(3) OTHER PAYMENT SYSTEMS.—

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13‘‘(A) IN

GENERAL.—In

the case of a14

breakthrough device that is furnished and for

15

which payment may be made under the pay-

16

ment system established under section 1834,

17

1834A, 1848, 1886(j), 1886(m), 1886(s), or

18

1895 or any other provision of this title (other19

than sections 1833(i), 1833(t), and 1886(d)),

20

the Secretary shall provide for an additional

21

payment for such breakthrough device under

22

such applicable payment system or an adjust-23

ment to such applicable payment system, as the24case may be. The payment basis for such addi-

25

tional payment or adjustment, as the case may•HR 6000 IH
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101
1

be, shall equal an amount that the Secretary2

determines covers the costs of such break-3

through device.

4‘‘(B) COST INFORMATION.—In determining

5

the costs of a breakthrough device for purposes6

of determining an additional payment or pay-7

ment adjustment under subparagraph (A), the8Secretary shall use the most recently available

9

data and information on the costs of such10

breakthrough device, which may include list

11

prices and invoice prices charged for such12

breakthrough device.

13‘‘(C) RULE OF CONSTRUCTION.—Nothing

14

in this paragraph shall be construed to affect15

the authority of the Secretary to use claims

16

data to establish new or modify existing ambu-

17

latory payment classification groups, diagnosis-

18

related groups, level II HCPCS codes or such19

other groups or codes as the Secretary may es-

20tablish under the annual rulemaking authority

21

under the provisions referred to in subpara-

22

graph (A).

23‘‘(D) CLINICAL DIAGNOSTIC LABORATORY24

TESTS.—An additional payment or payment ad-

25

justment under subparagraph (A) for a break-•HR 6000 IH
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102
1

through device under the applicable payment2system established in section 1834A may be in3

the form of an increase to the amount deter-

4mined for the breakthrough device using cross-5

walking under section 1834A(c)(1)(A), an ex-

6tension of the initial period of payment applica-

7

ble to advance diagnostic laboratory tests under8

section 1834A(d)(1)(A), and in such other form

9or manner as the Secretary determines reflects10

the costs for such breakthrough device under11

the relevant provisions of section 1834A.

12‘‘(4) PAYMENT FOR BREAKTHROUGH DEVICES

13

AFTER THE TRANSITIONAL COVERAGE PERIOD.—

14

Payment for a breakthrough device that is furnished

15

after the conclusion of the transitional coverage pe-

16

riod under subsection (b)(1) for such device shall be

17

made pursuant to the applicable payment system in-18

volved, taking into account the additional evidence

19

and data collected under subsection (b)(2).

20‘‘(e) SPECIAL RULES FOR CERTAIN BREAKTHROUGH

21 DEVICES.—
22

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23‘‘(1) COVERAGE OF SPECIFIED BREAKTHROUGH
DEVICES.—

24‘‘(A) IN GENERAL.—Subject to the suc-25

ceeding provisions of this subsection and not-•HR 6000 IH
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103
1

withstanding any other provision of law, the2Secretary shall provide for coverage and pay-3

ment pursuant to this section of a specified

4

breakthrough device (as defined in subpara-

5graph (B)).

6‘‘(B) SPECIFIED BREAKTHROUGH DEVICE

7

DEFINED.—In this section, the term ‘specified

8

breakthrough device’ means a breakthrough de-9vice with respect to which no Medicare benefit

10

category exists.

11‘‘(2) PERIOD OF TRANSITIONAL COVERAGE.—

12‘‘(A) IN GENERAL.—Subject to subpara-

13

graph (C), the provisions of subsection (b)(1)14(relating to the transitional coverage period and15

payment for breakthrough devices, including the16

use of the most recently available data and in-17

formation on costs) shall apply to a specified

18

breakthrough device in the same manner as

19such provisions apply to a breakthrough device.

20

The Secretary may use methodologies under ex-

21

isting payment systems established under this22

title, may provide for appropriate adjustments

23

to such methodologies, or may establish a new24

payment methodology under this title, to pro-25

vide for payment for a specified breakthrough•HR 6000 IH
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104
1

device to ensure the payment basis for such2

payment covers costs of the specified break-3

through device are covered by such payment.

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4‘‘(B) REPORT.—

5‘‘(i) IN GENERAL.—With respect to6each specified breakthrough device, the7Secretary shall submit to Congress a re-8

port on the coverage of and payment for

9such specified breakthrough device under

10

this section that includes the following in-

11

formation:

12‘‘(I) The manner in which cov-

13

erage is provided and payment is

14

made for the specified breakthrough15

device, including how such device was

16classified (such as an item of durable

17

medical equipment or otherwise) and18

the payment methodology the Sec-19

retary applied with respect to such de-

20

vice.

21

‘‘(II) The impact of the avail-22

ability of the specified breakthrough23

device to Medicare beneficiaries, in-24

cluding impacts on the quality of pa-•HR 6000 IH
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105
1

tient care, patient outcomes, and pa-

2tient experience.

3‘‘(III) The impact of the avail-4

ability of the specified breakthrough5

device to Medicare beneficiaries on

6

program expenditures under this title.

7‘‘(IV) Such other information as

8

the Secretary determines to be appro-

9

priate.

10‘‘(ii) DEADLINE.—

11‘‘(I) IN

provided in subclause (II), the Sec-13

retary shall submit a report required

14

under this subparagraph no later than15

the end of the transitional period of

16

coverage and payment applicable to17

such specified breakthrough device.
‘‘(II) EXTENSION TO GENERATE19

ADDITIONAL DATA.—If

20

determines that additional data or evi-

21

dence is required to complete a report22

required23

with respect to a specified break-24

through device, the deadline under

under

this

the Secretarysubparagraph•HR 6000 IH
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as

12

18

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106
1

this clause may be extended for an

2

additional two years.

3‘‘(C) ADDITIONALOFTIONAL COVERAGE TO DEVELOP ADDITIONAL

5

DATA.—Insofar

6

that additional data or evidence is required to7complete a report required under subparagraph

8(B) with respect to a specified breakthrough de-9vice, the transitional coverage period of cov-

10

erage and payment for such device shall be ex-

11tended by the lesser of—as the Secretary determines

12‘‘(i) two years; or13‘‘(ii) the amount of additional time re-14

quired for the submission of the report15

with respect to such device.
‘‘(3) COVERAGE

AND PAYMENT AFTER THE

17

TRANSITIONAL PERIOD.—The

18

tinue to provide for coverage of and payment for a

19

specified breakthrough device after the end of the20

transitional period of coverage and payment for21

breakthrough devices through the national coverage

22determination process if the Secretary determines

23

that the specified breakthrough device—24

Secretary may con-‘‘(A) improves the quality of care and pa-

25tient outcomes;•HR 6000 IH
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16

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1

‘‘(B) improves the delivery of care; or2‘‘(C) reduces spending under this title

34

without reducing the quality of care.’’.
(b) CONFORMING AMENDMENTS.—

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5(1) INPATIENTPROSPECTIVE PAYMENT SYS-

6

TEM.—Section 1886(d)(5)(K) of the Social Security

7

Act (42 U.S.C. 1395ww(d)(5)(K)) is amended by

8

adding at the end the following new clause:

9‘‘(x) Effective for discharges occurring on

10

or after October 1, 2019, in the case of a new

11

medical service or technology that is a break-12

through

13

1899C(a)), the additional payment established

14

for such breakthrough device under this sub-15

paragraph shall be made for the 4-year period

16

applicable to such breakthrough device under17

section18

amount of the additional payment for a break-19

through device under this subparagraph during

20

such 4-year period, the Secretary shall apply

21

section 412.88(b) of title 42, Code of Federal

22

Regulations, as in effect on the date of the en-23

actment of this clause, except as if the ref-24

erence in such section to ‘65 percent’ were adevice(as

1899C(d)(1).

definedInindetermining•HR 6000 IH
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the

108
1

reference to ‘65 percent (or such greater per-2cent specified by the Secretary)’.’’.

3(2) OUTPATIENT PROSPECTIVE PAYMENT SYS-

4

TEM.—Section 1833(t)(6)(C) of such Act (42 U.S.C.

51395l(t)(6)(C)) is amended by adding at the end the6following new clause:

7‘‘(iii) SPECIAL

RULE

FOR

BREAK-

8

THROUGH9clause (i) or (ii), or any other provision of

10

this paragraph to the contrary, in the case11of a breakthrough device (as defined in

12section 1899C(a)) that is furnished on or

13

after January 1, 2020, payment under this14

paragraph for such breakthrough device

15

shall be made for the 4-year period appli-

16

cable to such breakthrough device under17

section 1899C(d)(2). The provisions of this18

clause shall also apply for purposes of19transitional pass-through payment under20

section 1833(i)(2)(D).’’.

21

DEVICES.—Notwithstanding(c) EFFECTIVE DATE.—This section, and the amend-

22 ments made by this section, shall take effect on the datepbinns on DSKJLVW7X2PROD with BILLS

23 of the enactment of this Act and, unless otherwise speci24 fied in this section (or in an amendment made by this sec25 tion), shall apply to breakthrough devices (as defined in•HR 6000 IH
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109
1 section 1899C(a) of the Social Security Act, as added by
2 subsection (a)), approved or cleared on or after July 1,
3 2019, or, in the case of a specified breakthrough device
4 (as defined in such section as so added), approved or
5 cleared on or after December 1, 2018.
6

SEC. 405. SECRETARY OF HEALTH AND HUMAN SERVICES

7REPORT ON COVERAGE FOR INNOVATIVE8TECHNOLOGIES.

9

Not later than 1 year after the date of the enactment

10 of this Act, the Secretary of Health and Human Services,
11 in collaboration with the Administrator of the Centers for
12 Medicare & Medicaid Services, and following a request for
13 information, shall submit to Congress a report containing

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14 a proposal that—15(1) specifies, for purposes of payment and cov-

16

erage under title XVIII of the Social Security Act,17

a definition for digital alternatives to treatment and18

therapies, including wearables and digital applica-

19

tions and platforms;

20(2) establishes a standardized process for deter-21

mining which technologies satisfy the definition pur-22

suant to paragraph (1);23

(3) establishes a standardized process for deter-24

mining coverage under such title of digital alter-•HR 6000 IH
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110
1

natives as defined pursuant to paragraph (1) that2

are prescribed by a physician; and3(4) identifies an innovative system for payment

4
5

under such title for such alternatives.
SEC. 406. SECRETARY OF HEALTH AND HUMAN SERVICES

6REPORT ON CMS COMPUTER SYSTEMS.

7

Not later than one year after the date of the enact-

8 ment of this Act, the Secretary of Health and Human
9 Services shall submit to Congress a report on the fol10 lowing:
11(1) The current state of computer systems of

12

the Centers for Medicare & Medicaid Services, in-13

cluding an analysis of the capabilities and defi-

14

ciencies of such systems in helping to managing the15

operations of the programs administered by the Cen-

16

ters for Medicare & Medicaid Services.

17(2) The cost, taking into account ways to lower

18

or defray costs to the Federal Government, of each

19of the following:

20(A) Replacing or updating such systems

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21

identified under paragraph (1).

22(B) Contractors and other third parties to23

solve for deficiencies in such system identified

24

under paragraph (1).

•HR 6000 IH
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111
1

SEC.

407.

PRECISION

23

MEDICINEANSWERSFORKIDSTODAY.

(a) CENTERS FOR MEDICARE & MEDICAID SERVICES

4 GUIDANCE ON THE EARLY AND PERIODIC SCREENING,
5 DIAGNOSTIC, AND TREATMENT BENEFIT.—Not later than
6 6 months after the date of the enactment of this Act, the
7 Centers for Medicare & Medicaid Services shall issue guid8 ance to States on authority and requirements under the
9 Medicaid program under title XIX of the Social Security
10 Act to provide medically necessary health care that falls
11 within the scope of services specified under section
12 1905(r) of the Social Security Act (42 U.S.C. 1396d(r))
13 to a child, regardless of whether the service is available
14 for adults under the State plan (or waiver of such plan)

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15 under such title. The guidance shall—
16(1) include technical and educational assistance17

on how to increase the frequency of coverage under18

the State plan (or waiver) pursuant to paragraphs

19(4) and (16) of section 1905(a) of such Act (4220

U.S.C. 1396d(a)) for genetic and genomic testing di-21

agnostic services, including whole exome sequencing,22

whole genome sequencing, and gene panels when rec-23

ommended by a qualified treating provider as a first-

24

or second-tier test for pediatric patients, including

25

those who—

•HR 6000 IH
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112
1

(A) have a positive result from a newborn

2

screening program;

3(B) have one or more neurodevelopmental

4

or congenital anomalies;

5(C) are experiencing developmental delay

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6

or intellectual disability;

7(D) are having seizures;

8(E) have been referred or admitted to a9

pediatric or neonatal intensive care unit for a10

chronic or undiagnosed disease;11(F) have been seen by at least one medical

12

specialist for such chronic or undiagnosed dis-13ease; or

14

(G)

are

suspected

by

at

least

15

healthcare provider to have a neonatal- or pedi-

16

atric-onset genetic disease;17(2) provide education and support to providers

18

to minimize denials of claims for medical assistance19

under the State plan under title XIX of the Social

20

Security Act resulting from deficient or inadequate

21

paperwork; and22(3) ensure that providers and Medicaid-eligible

23

children and the families are aware of the Early and24

Periodic Screening, Diagnostic and Treatment Ben-25

efit under title XIX of the Social Security Act and•HR 6000 IH
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113
1

have access to required screenings and necessary

2treatment services.

3(b) DEMONSTRATION PROGRAM TO PROVIDE GE-

4NETIC AND

5

DREN.—FOR

CERTAIN CHIL-

6(1) IN GENERAL.—The Secretary of Health and7

Human Services shall enter into agreements with up8

to 15 States submitting applications under para-

9graph (3) for the purpose of conducting, in accord-

10

ance with this subsection, demonstration projects

11

under section 1115 of the Social Security Act (4212

U.S.C. 1315) in such States during the 3-year pe-

13

riod beginning on the first date of the first fiscal

14

quarter than begins on or after the date of the en-15

actment of this subsection to test and evaluate the16

provision of medical assistance under the State plans

17

under title XIX of such Act (or waivers of such

18

plans) to eligible individuals for purposes of pro-19

viding such individuals with genetic and genomic

20

testing.

21

pbinns on DSKJLVW7X2PROD with BILLSGENOMIC TESTING(2) DEMONSTRATION PROJECT PAYMENT RE-

22

QUIREMENTS.—Under

23

under this section conducted by a State, the fol-24

lowing shall apply:

each demonstration project•HR 6000 IH
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114
1

(A) The State shall provide a health care2

provider (as defined by the State) with pay-3

ments for the provision of genetic and genomic

4

testing to any eligible individual. Payments

5

made to a health care provider for such services

6

shall be treated as medical assistance for pur-7

poses of section 1903(a) of the Social Security

8

Act (42 U.S.C. 1396b(a)), except that the Fed-9eral medical assistance percentage applicable to

10such payments shall be equal to 100 percent.

11(B) The State shall specify the method-

12

ology the State will use for determining pay-

13

ment for the provision of genetic and genomic

14

testing. Such methodology for determining pay-

15

ment shall be established consistent with section16

1902(a)(30)(A)17

1396a(a)(30)(A)).

18(3) APPLICATIONS.—

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19(A) IN

ofsuch

GENERAL.—A

Act

(42

State desiring to20

enter into an agreement under paragraph (1)21with the Secretary for conducting a demonstra-

22tion project shall submit to the Secretary an

23application, in accordance with such form and24manner, and application priorities, as specified•HR 6000 IH
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U.S.C.

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pbinns on DSKJLVW7X2PROD with BILLS

115
1

by the Secretary and that at a minimum in-2

cludes the following:

3(i) An explanation of how and the ex-

4tent to which genetic and genomic testing5

under the demonstration project of the

6State will provide information and data on

7

how such services improve the diagnosis of8

eligible individuals.

9(ii) An explanation of how and the ex-

10tent to which coverage under the State

11

plan (or waiver) pursuant to the dem-

12

onstration project will increase the use of13

genetic and genomic testing that may in-14

crease the use of genetic and genomic test-

15

ing that may improve clinical outcomes for

16

eligible individuals.

17(iii) Procedures for referring any eligi-

18

ble individual who seeks or needs treat-19

ment in a hospital emergency department20

to a health care provider who is qualified

21(as determined by the State) to provide ge-

22

netic and genomic testing.

23(iv) An explanation of how genetic24

and genomic testing may improve health•HR 6000 IH
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116
1

outcomes for all populations in the State,2

including—3(I) individuals with a rare genetic4

disease, including a metabolic disease,5

neurologic disorders, or hereditary

6cancer testing in the presence of a7

suspected or confirmed cancer diag-8

nosis; and9(II) special populations, including

10

infants and children who are critically11ill (non-infectious and non-trauma)

12

patients, transplant patients, individ-

13

uals with cardiac disease, and individ-

14

uals with, or who have a family his-15

tory of, a birth defect or develop-

16

mental disability.

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17(B) PREFERENCES IN CONSIDERING AP-

18

PLICATIONS.—In

19

mitted under subparagraph (A), the Secretary

20of Health and Human Services shall give pref-21

erence to States that can demonstrate under-

22

utilization of genetic and genomic sequencing

23

clinical services (with priority given to States

24

that do not cover whole-genome sequencing or

25

do not cover the majority of genetic andconsidering applications sub-•HR 6000 IH
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117
1

genomic clinical services) in pediatric popu-

2

lations under the State plan under title XIX of

3

the Social Security Act (or waiver of such4plan).

5(4) TECHNICAL ASSISTANCE.—The Secretary of

6

Health and Human Services shall provide technical7

assistance to assist States in planning and designing

8

the demonstration project for purposes of applying

9

for conducting such project under this section.

10(5) REPORTS BY STATES.—Not later than one

11

year after the date on which a State enters into an

12agreement under paragraph (1) with the Secretary

13

for conducting a demonstration project, the State

14

shall submit a report to the Administrator of the

15

Centers for Medicare & Medicaid Services and the16

Administrator of the Health Resources and Services

17

Administration on the extent to which genetic and18

genomic testing improved outcomes and reduced

19

health disparities. Such report shall include informa-

20tion on the number of patients receiving genetic and21

genomic testing, the types of services provided, and22such other information as the Secretary shall pre-23

scribe.

24(6) REPORTS BY HEALTH CARE PROVIDERS.—

25

As a condition for receiving payment for genetic and•HR 6000 IH
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1

genomic testing provided to an eligible individual

2

under a demonstration project conducted by a State

3

under this subsection, a health care provider shall4

report to the State, in accordance with such require-

5

ments as the Secretary shall specify, on all applica-

6

ble measures for determining the quality and effi-

7cacy of such services.

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8(7) DEFINITIONS.—In this subsection:

9(A) ELIGIBLE INDIVIDUAL.—The term ‘‘el-

10igible individual’’ means, with respect to a

11

State, an individual who—

12(i) is eligible for medical assistance13

under the State plan under title XIX of

14

the Social Security Act (or a waiver of15such plan);

16(ii) is under the age of 21 (or, at the17

option of the State, under the age of 20,

18

19, or 18 as the State may choose), or in19

the case of an individual described in sec-

20

tion 1902(a)(10)(A)(i)(IX) of such Act (4221

U.S.C. 1396a(a)(10)(A)(i)(IX)), under the22

age of 26;

23(iii) has been referred or admitted to24

an intensive care unit, or has been seen by•HR 6000 IH
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1

at least one medical specialist, for a sus-2pected genetic or undiagnosed disease; or3(iv) is suspected by at least one med-4

ical specialist to have a neonatal-onset or5pediatric-onset genetic disease.

6(B) GENETIC AND GENOMIC TESTING.—

7

The term ‘‘genetic and genomic testing’’, with8

respect to an eligible individual—

9(i) means the determination of a se-

10

quence of deoxyribonucleic acid bases in

11

the genome of such individual, and, if for12

the sole benefit of the individual, a biologi-

13

cal parent of such individual for the pur-14

pose of determining whether one or more

15

potentially disease-causing genetic variants

16

are present in the genome of such indi-

17

vidual or such biological parent; andpbinns on DSKJLVW7X2PROD with BILLS

18(ii) includes—

19(I) the sequencing of the whole20

genome, the whole exome, or a panel

21

of genes; and22(II) any analysis, interpretation,23

and data report derived from such se-

24

quencing.

25(c) NATIONAL ACADEMY OF MEDICINE STUDY.—•HR 6000 IH
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1

(1) IN GENERAL.—Not later than one year2

after the date of the enactment of this Act, the Sec-3

retary of Health and Human Services shall enter4

into an arrangement with the National Academy of5

Medicine under which the Academy agrees to6

study—

7(A) how genetic and genomic testing may

8

improve preventative care and precision medi-

9

cine;

10

(B) disparities in access to precision

11

diagnostics and associated therapeutics;

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12(C) how genetic and genomic testing may

13

be

14

marginalized communities;

used

to

reducehealthdisparities

15(D) how the Federal Government may help

16

to reduce barriers to genetic and genomic test-

17

ing, including—18(i) encouraging the expansion of19

health insurance coverage of genetic and20

genomic testing, including diagnostic, pre-21

dictive, and presymptomatic testing, and22

genetic and genomic testing (as defined in23

subsection (b)(7)(B));24(ii) supporting the collection of evi-

25

dence for the clinical utility and appro-•HR 6000 IH
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pbinns on DSKJLVW7X2PROD with BILLS

121
1

priate use of genetic and genomic tests;

2

and

3

(iii) improving access to genetic coun-

4

selors, pathologists, and other relevant pro-5

fessions, including strengthening related

6

workforce education and training efforts;

7(E)(i) the extent to which coverage provi-8

sions in the Medicare and Medicaid programs

9

under titles XVIII and XIX of the Social Secu-

10

rity Act (42 U.S.C. 1395 et seq., 1396 et seq.)11

may restrain the use of genetic and genomic

12

testing that may improve clinical outcomes for13

beneficiaries;

14(ii) the extent to which coverage provided

15

pursuant to subsection (a) increased the use of16

genetic and genomic testing and improved clin-

17

ical outcomes for beneficiaries; and18(iii) how the Centers for Medicare & Med-

19

icaid Services may make coverage determina-

20

tions that better suit a precision medicine ap-

21

proach to treatment; and22(F) how genetic and genomic testing may

23

improve health outcomes for all pediatric popu-

24

lations in the United States, including—•HR 6000 IH
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1

(i) children with a rare disease, in-2

cluding a metabolic disease, neurologic dis-

3

order, or hereditary cancer testing in the4presence of a suspected or confirmed can-5

cer diagnosis; and6(ii) special populations, including—

7(I) critically ill (non-infectious

8and non-trauma) patients;

9(II) transplant patients;

10(III) individuals with cardiac dis-11

ease; and

12(IV) individuals with, or who

13

have a family history of, a birth defect14

or developmental disability.

15(2) REPORT.—

16

(A)

GENERAL.—Thearrangement

17

under paragraph (1) shall provide for the Na-18tional Academy of Medicine to submit, not later19

than 2 years after the date of the enactment of

20

this Act, a report on the results of the study

21

under paragraph (1) to—22(i) the Secretary of Health and23
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IN

Human Services;

24(ii) the Committee on Ways and25

Means and the Committee on Energy and•HR 6000 IH
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pbinns on DSKJLVW7X2PROD with BILLS

123
1Commerce of the House of Representa-

2

tives; and3(iii) the Committee on Finance and4

the Committee on Health, Education,

5

Labor, and Pensions of the Senate.

6(B)

CONSULTATION.—Thearrangement

7

under paragraph (1) shall provide for the Na-

8tional Academy of Medicine, in developing the9report required by subparagraph (A), to consult

10with physicians, other health professionals,

11

health educators, health professional organiza-

12

tions, relevant companies, patients, patient or-

13

ganizations, the Health Resources and Services

14

Administration, the National Cancer Institute,15

the National Institutes of Health, the Agency

16

for Healthcare Research and Quality, and the17

Centers for Medicare & Medicaid Services.

18(C) USE OF INFORMATION.—The National

19

Academy of Medicine shall, to the extent pos-20

sible, in conducting the study under paragraph21(1), utilize information included in the reports

22submitted pursuant to subsections (f) and (g)23of section 2.

24(d) CENTERS FOR MEDICARE & MEDICAID SERVICES

25 REPORT ON MEDICAID COVERAGE FOR GENETIC AND•HR 6000 IH
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124
1 GENOMIC TESTING.—Not later than one year after the
2 date of the enactment of this Act, and annually thereafter
3 for the subsequent 3 years, the Centers for Medicare &4 Medicaid Services shall submit to the Secretary of Health
5 and Human Services, the Committees on Ways and Means
6 and on Energy and Commerce of the House of Represent7 atives, and the Committees on Finance and Health, Edu8 cation, Labor, and Pensions of the Senate a report on the
9 extent to which each of the 50 States provide coverage
10 under the State plan under title XIX of the Social Secu11 rity Act (or waiver of such plan) of genetic and genomic
12 testing (as defined in subsection (b)(7)(B)) (including
13 whole exome, whole genome, gene panels, single gene tests,
14 Chromosomal microarray analysis, Fluorescence in situ
15 hybridization, and other genetic and genomic tests), in16 cluding information on—
1718(1) how often genetic and genomic diagnostic
testing services are covered and reimbursed;

1920(2) the frequency of denials for coverage andthe rationale for denying coverage;

21

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22(3) an analysis of which genetic and genomic
diagnostic tests are being approved or denied;23(4) how often test genetic counseling is covered

24

pre- and post-genetic and genomic diagnostic test-

25

ing;

•HR 6000 IH
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1

(5) the turn-around time for prior authorization

2

requests; and3(6) any barriers to coverage of genetic and4
5genomic testing services identified.
SEC. 408. MEDICARE COVERAGE FOR CONSULTATIONS.

6(a) INCLUSION OF CONSULTATIONS AS A MEDICARE

7 BENEFIT.—Section 1861 of the Social Security Act (428 U.S.C. 1395x) is amended—
9(1) in subsection (s)(2)—10(A) by striking ‘‘and’’ at the end of sub-11

paragraph (GG);

12(B) by striking the period at the end of

13

subparagraph (HH) and inserting ‘‘; and’’; and14(C) by adding at the end the following new

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15subparagraph:

16‘‘(II) pharmacogenetic consultations pro-17

vided by a qualified clinical pharmacist, genetic

18

counselor, or pathologist (as such terms are de-19

fined in subsection (lll)).’’; and20(2) by adding at the end the following new sub-21

section:22‘‘(lll) DEFINITIONS.—In this section:

23‘‘(1) PHARMACOGENETIC CONSULTATION.—The24

term ‘pharmacogenetic consultation’ means, with re-25

spect to a genetic or genomic test furnished to an•HR 6000 IH
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1

individual, a consultation with respect to such test2

requested by the physician treating such individual3

to provide such physician with advice and rec-4

ommendations regarding the dosage, safety, and effi-

5cacy of particular drugs, biologicals, and other treat-

6

ments based on the individual’s pharmacogenetic re-

7

sult.

8

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9‘‘(2) GENETIC COUNSELOR.—The term ‘genetic
counselor’ means an individual who—

10‘‘(A) is licensed as a genetic counselor by

11

the State in which the individual furnishes ge-

12

netic counseling services; or13‘‘(B) in the case of an individual practicing

14

in a State that does not license genetic coun-

15

selors, meets such other criteria as the Sec-16

retary establishes.

17‘‘(3) QUALIFIED CLINICAL PHARMACIST.—The

18

term ‘qualified clinical pharmacist’ means an indi-

19

vidual—20‘‘(A) with a doctoral degree in pharmacy;

21‘‘(B) who is licensed as a pharmacist in

22

the State in which such individual furnishes

23

consultations;•HR 6000 IH
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1

‘‘(C) has appropriate pharmacy specialty

2certifications or appropriate training, as deter-3

mined by the Secretary; and4‘‘(D) meets other qualifications as specified

5by the Secretary.’’.

6(b) PAYMENT FOR PHARMACOGENETIC CONSULTA-

7

TION.—Section 1832(a)(2) of the Social Security Act (428 U.S.C. 1395k(a)(2)) is amended—
910(1) by striking ‘‘and’’ at the end of subparagraph (I);1112(2) by striking the period at the end of subparagraph (J) and inserting ‘‘; and’’; and1314(3) by adding at the end the following new subparagraph:

15‘‘(K) pharmacogenetic consultations (as1617defined in subsection (lll)).’’.
(c) EFFECTIVE DATE.—The amendments made by

18 subsections (a) and (b) shall apply to consultations fur19 nished during a cost reporting period beginning on or afterpbinns on DSKJLVW7X2PROD with BILLS

20 the date of the enactment of such subsections.

•HR 6000 IH
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1

SEC. 409. PROHIBITING THE USE OF GEOGRAPHIC TRACK-2

ING FEATURES AND BIOMETRICS WITHIN

3

MEDICAID ELECTRONIC VISIT VERIFICATION

4SYSTEMS.

5(a) IN GENERAL.—Section 1903(l)(5)(A) of the So-

6 cial Security Act (42 U.S.C. 1396b(l)(5)(A)) is amended
7 by inserting ‘‘(without the use of geographic tracking or
8 biometrics)’’ after ‘‘electronically verified’’.
9(b) EFFECTIVE DATE.—The amendment made by

10 subsection (a) shall apply with respect to calendar quar11 ters beginning on or after June 1, 2022.
12

SEC. 410. GENERALLY ACCEPTED STANDARD FOR ELEC-

13
14

TRONIC PRESCRIBING.

Section 1860D–4(e) of the Social Security Act (4215 U.S.C. 1395w–104(e)) is amended by adding at the end
16 the following new paragraph:pbinns on DSKJLVW7X2PROD with BILLS

17‘‘(8) GENERALLY ACCEPTED STANDARDS.—

18‘‘(A) DESIGNATION OF STANDARDS MAIN-

19

TENANCE ORGANIZATION TO RECOGNIZE GEN-

20

ERALLY21

than 6 months after the date of the enactment

22of this paragraph, the Secretary shall designate

23

through rulemaking a standards maintenance24

organization with the authority to establish,

25

maintain, and modify generally accepted stand-26

ards for electronic prescribing and electronic

ACCEPTEDSTANDARDS.—Not•HR 6000 IH
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129
1

prior authorization. The standards maintenance2organization named by the Secretary shall be a

3standard setting body that—4‘‘(i) is a not-for-profit;

5‘‘(ii) has established a multi-stake-6

holder forum for development and approval

7of electronic prescribing and electronic8

prior authorization standards;

9‘‘(iii) is a standards development or-

10

ganization accredited by the American Na-

11tional Standards Institute; andpbinns on DSKJLVW7X2PROD with BILLS

12‘‘(iv) includes in its membership phar-13

macies,14plans, health information technology devel-

15

opers, and representatives from the Cen-

16

ters for Medicare & Medicaid Services and17

the Food and Drug Administration.

18

In providing the standards maintenance organi-19

zation with the authority to establish, maintain,

20

and modify generally accepted standards, the21

Secretary shall permit the standards mainte-

22

nance organization to recognize up to two

23

versions of a standard as being generally ac-

24

cepted to facilitate the testing of newer stand-prescribers,prescription•HR 6000 IH
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drug

130
1

ards and to allow a smooth transition from one

2standard to another.

3‘‘(B) ADOPTION OF GENERALLY ACCEPTED

4

STANDARDS.—Not later than six months after5

making the designation under paragraph (8),6the Secretary shall require prescriptions and

7

other

8

(2)(A) for covered Part D drugs prescribed for

9Part D eligible individuals that are transmitted

10electronically to be transmitted only in accord-

11

ance with generally accepted standards, as des-12

ignated by the standards maintenance organiza-

13

tion named by the Secretary under subpara-

14

graph (A), under an electronic prescription

15

drug program that meets the requirements of

16

paragraph (2).’’.

17

described

in

19

PLAN CLAIMS DATA.

(a) FINDINGS.—Congress finds as follows:20(1) Clinician-led clinical data registries serve an

21

important role in promoting, facilitating, and con-22

ducting medical research and improving quality of23

healthcare by providing timely and actionable feed-

24back to practitioners on their performance in rela-

25

tion to other practitioners and best clinical practices.

•HR 6000 IH
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paragraph

SEC. 411. MEANINGFUL ACCESS TO FEDERAL HEALTH

18

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1

(2) Clinician-led clinical data registries are hin-2dered in their ability to promote medical research3and quality improvement by their lack of meaningful

4access to claims data.

5(3) While the Centers for Medicare & Medicaid

6Services has established programs for providing ac-

7

cess to claims data, those programs fail to provide

8

clinician-led clinical data registries with meaningful

9access to such data.

10(4) Ensuring clinician-led clinical data reg-11

istries meaningful access to claims data will enable

12

such entities to better track patient outcomes over13

time, expand their ability to assess the safety and ef-

14fectiveness of medical treatments, and provide them15

with the information necessary to assess the cost-ef-

16fectiveness of therapies.

17(b) ENSURING MEANINGFUL ACCESS TO CLAIMS

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18 DATA.—19(1) ESTABLISHMENT OF A NEW PROGRAM.—20

The Secretary shall establish a new program (sepa-

21

rate from any existing data access programs, includ-22

ing, without limitation, the Centers for Medicare &23

Medicaid Services Qualified Entity (in this section,

24

referred

251395kk(e), 1395kk–2) (in this section, referred to as

toas‘‘QE’’)

Program(42•HR 6000 IH
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U.S.C.

132
1

the ‘‘Medicare Data Sharing for Performance Meas-

2

urement Program’’) and the Research Data Assist-3

ance Center (in this section, referred to as the

4‘‘ResDAC’’) process) under which the Secretary

5

shall, at the request of a clinician-led clinical data

6

registry, provide timely, broad, and continuous ac-

7

cess to a database of claims data to such clinician-8

led clinical data registry for purposes of research,

9

quality of care measurement and reporting to health10

care providers, linking such data with clinical data

11

and performing risk-adjusted, scientifically valid

12

analyses and research to support quality improve-13

ment or patient safety, and other purposes and uses

14

described herein or approved by the Secretary. Ac-

15cess to a database of claims data pursuant to this16

subsection shall not be more restrictive than access17

to data provided under the QE Program or the18

ResDAC process.

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19(2) STREAMLINED APPLICATION PROCESS.—

20(A) INITIAL AND RECERTIFICATION APPLI-21

CATION.—Prior to gaining access to a database22of claims data under the program established in23

subsection (a), a clinician-led clinical data reg-24

istry shall submit to the Secretary an applica-

25

tion demonstrating that it is qualified (as deter-•HR 6000 IH
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pbinns on DSKJLVW7X2PROD with BILLS

133
1mined by the Secretary) to use claims data.

2

Upon the Secretary’s approval of a clinician-led

3clinical data registry’s application described in4

this subparagraph, the Secretary shall provide

5

access to a database of claims data to such cli-

6

nician-led clinical data registry for a period of

7

at least 5 years. After the expiration of the time8

period described in this subparagraph, the clini-9

cian-led clinical data registry shall reapply to10

access the database of claims data under the11

program established in subsection (a).

12

(B) PROCESS.—The Secretary shall estab-

13

lish a streamlined initial application and recer-

14tification application process under which the15

Secretary shall approve or deny the clinician-led

16

clinical data registry’s application described in

17

subparagraph (2)(A) within 60 calendar days

18

after receiving the application unless the Sec-19

retary demonstrates a compelling reason for

20

needing additional time to complete the process.

21

If the clinician-led clinical data registry’s appli-

22

cation described in subparagraph (2)(A) is de-

23

nied, the Secretary shall provide the reason(s)24

for denial.

25(3) APPEAL RIGHTS.—•HR 6000 IH
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pbinns on DSKJLVW7X2PROD with BILLS

134
1(A) OPPORTUNITY TO APPEAL.—The Sec-2

retary shall develop and maintain a process by3

which a clinician-led clinical data registry may

4appeal—5(i) the Secretary’s decision to deny an

6application described in paragraph (2); and7(ii) the Secretary’s failure to approve8

or deny the clinician-led clinical data reg-9

istry’s application described in paragraph

10(2) within a reasonable time frame estab-

11

lished by the Secretary.

12(B) DEADLINE FOR DECISION.—The Sec-13

retary shall render a decision with respect to an

14

appeal filed by a clinician-led clinical data reg-15

istry pursuant to subparagraph (A) in a timely

16

manner, not to exceed 60 calendar days after17

the Secretary receives the clinician-led clinical18

data registry’s request for an appeal. Notice of

19such decision shall be provided to the clinician-20

led clinical data registry filing the appeal before

21

the conclusion of such 60-day period.

22(4) BROAD AND TIMELY ACCESS TO DATA.—

23

The Secretary shall structure its database of claims

24

data to allow for various data set queries, including,25

but not limited to, provider-specific claims data, clin-•HR 6000 IH
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135
1

ical specialty-specific claims data, state-specific2claims data, and nationwide claims data. The Sec-3

retary shall promptly make available to a clinician-4

led clinical data registry access to claims data re-5quested by such clinician-led clinical data registry6

within a reasonable timeframe, not to exceed 30 cal-

7

endar days, after the Secretary approves the request

8from the clinician-led clinical data registry.

9(c) PERMISSIBLE USES OF CLAIMS DATA.—Clini-

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10 cian-led clinical data registries may—
11(1) make available to the public reports evalu-

12

ating the performance of providers of services and13

suppliers using the claims data provided to such cli-

14

nician-led clinical data registry under subsection (a)15in combination with registry data;

16(2) use claims data received under subsection

17(a) combined with registry data to conduct addi-

18

tional nonpublic analyses and provide or charge an

19access fee for such analyses to authorized users for20

nonpublic use;

21(3) provide or charge an access fee for data sets

22

that link claims data received under subsection (a)23with registry data to authorized users for nonpublic

24

use; and•HR 6000 IH
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1361(4) provide or charge an access fee for claims

2data received under subsection (a) to authorized3

users for nonpublic use.

4(d) FEES.—

5(1) CLAIMS DATA PROVIDED TO CLINICIAN-LED

6

CLINICAL DATA REGISTRIES.—Claims data shall be

7

provided to a clinician-led clinical data registry8

under subsection (a) at a reasonable fee based on9

the cost of providing such data to the clinician-led

10clinical data registry. Such fee shall be based at

11

least in part on the number of patients included in12

the claims data provided to such clinician-led clinical13

data registry. Any fee collected pursuant to the pre-14

ceding sentences shall be deposited in the Centers

15for Medicare & Medicaid Services Program Manage-

16

ment Account.

17(2) ANALYSES AND DATA PROVIDED TO AU-

18

THORIZED USERS.—A clinician-led clinical data reg-

19

istry may charge a reasonable, cost-based fee for20

providing to authorized users claims data, data sets

21

linking claims data with registry data, or analyses

22

described in subsection (b).

23(e) PROTECTION OF INFORMATION.—

24
25(1) PRIVACY,
LAWS.—The

SECURITY,ANDDISCLOSURE

Secretary shall provide access to a

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database of claims data pursuant to subsection (a)2in accordance with applicable information, privacy,

3

security, and disclosure laws, including, without limi-

4

tation, the Health Insurance Portability and Ac-

5countability Act of 1996 (Public Law 104–191) as

6amended by the privacy and security provisions set

7

forth in section 13400 of the Health Information

8

Technology for Economic and Clinical Health Act

9(Public Law 111–5), the regulations promulgated10

thereunder codified at parts 160 and 164 of title 45,

11

Code of Federal Regulations, and subparagraphs (A)12through (B) of section 105(a)(3) of the Medicare

13

Access and CHIP Reauthorization Act of 2015 (4214

U.S.C. 1395kk–2(a)(3)).

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15(2) PROHIBITION ON USING ANALYSES OR DATA

16

FOR MARKETING PURPOSES.—An

17

shall not use analyses or data provided or sold under18

paragraphs (2) through (4) of subsection (b) for

19

marketing purposes.

20(3) NOREDISCLOSURE

OF

authorized user

ANALYSES

21

DATA.—An authorized user in receipt of an analysis

22

or datum provided or sold under paragraphs (2)23through (4) of subsection (b) shall comply with sec-

24

tion 105(a)(5) of Medicare Access and CHIP Reau-

25

thorization Act of 2015 (42 U.S.C. 1395kk–2(a)(5)).

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(4) OPPORTUNITY FOR PROVIDERS OF SERV-2ICES AND SUPPLIERS TO REVIEW.—Prior to a clini-3

cian-led clinical data registry using, providing, or4charging an access fee for claims data, data sets

5

linking claims data with registry data, or analyses

6

described in subsection (b), to the extent that such

7

data, data sets, or analyses would individually iden-

8

tify a provider of services or supplier who is not

9being provided or sold such data, data sets, or anal-

10yses, such clinician-led clinical data registry shall11

confidentially make available such data, data sets, or

12

analyses to such provider of services or supplier and13

provide such provider of services or supplier with the14

opportunity to appeal and correct errors.

15(f) DATA USE AGREEMENT.—A clinician-led clinical

16 data registry and an authorized user shall enter into a
17 data use agreement regarding the use or disclosure of any
18 claims data or data sets that link claims data with registry
19 data that the clinician-led clinical data registry is pro20 viding or charging an access fee to the authorized user
21 under paragraphs (3) through (4) of subsection (b). Such
22 agreement shall include the requirements and prohibitions

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23 described in section 105(a)(4) of the Medicare Access and
24 CHIP Reauthorization Act of 2015 (42 U.S.C. 1395kk–
25 2(a)(4)).
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(g) ASSESSMENT FOR A BREACH.—

2(1) IN GENERAL.—In the case of a breach of a3data use agreement described in subsection (e), the4Secretary shall impose an assessment on the clini-5

cian-led clinical data registry and the authorized

6

user.

7

(2) ASSESSMENT.—The assessment under para-

8graph (1) shall be in an amount up to $100 for each9

individual entitled to, or enrolled for, benefits under10

part A of title XVIII of the Social Security Act or

11

enrolled for benefits under part B of such title for12

whom the clinician-led clinical data registry provided

13

data on to the authorized user.

14(3) DEPOSIT OF AMOUNTS COLLECTED.—Any

15

amounts collected pursuant to this subsection shall16

be deposited in the Federal Supplementary Medical

17

Insurance Trust Fund under section 1841 of the So-

18

cial Security Act (42 U.S.C. 1395t).

19(h) DISCOVERYOR

ADMISSIONASEVIDENCE.—

20 Claims data released to a clinician-led clinical data reg21 istry under subsection (a) shall not be subject to discovery
22 or admission as evidence in judicial or administrative pro-pbinns on DSKJLVW7X2PROD with BILLS

23 ceedings without consent of the applicable provider of
24 services or supplier.

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(i) REPORT TO CONGRESS.—Not later than 2 years

2 after the date of the enactment of this Act, and annually
3 thereafter, the Secretary shall submit to Congress a report
4 on the extent to which clinician-led clinical data registries
5 are afforded meaningful access to claims data.

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6(j) DEFINITIONS.—In this subtitle:

7(1) AUTHORIZED USER.—The term ‘‘authorized

8

user’’ has the meaning given such term in section

9

105(a)(9)(A) of the Medicare Access and CHIP Re-

10authorization Act of 2015 (42 U.S.C. 1395kk–

11

2(a)(9)(A)), as well as a government agency or other12

governmental entity, researchers, entities that seek

13

data for purposes of complying with regulations or

14

other requirements of the Federal Food and Drug

15

Administration, and other entities approved by the16

Secretary.

17(2) CLAIMS DATA.—The term ‘‘claims data’’18

has the meaning given to the term ‘‘data’’ in section

19

105(b)(1)(B) of the Medicare Access and CHIP Re-

20

authorization Act of 2015 (42 U.S.C. 1395kk–

21

2(b)(1)(B)).

22

(3)

23

ISTRY.—The24

istry’’ has the meaning given such term in section

254005(b) of the 21st Century Cures Act.

CLINICIAN-LED

CLINICAL

DATA

term ‘‘clinician-led clinical data reg-

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1
2

(4) NONPUBLIC

term ‘‘nonpublicuse’’ means a use for the purpose of—3(A) promoting, facilitating, and conducting

4

medical research, assisting providers of services

5and suppliers to improve patient safety, and to6

develop and participate in quality and patient

7

care improvement activities, including devel-

8

oping new models of care;

9(B) assisting clinician-led clinical data reg-10

istries in developing and reporting quality meas-

11

ures to health care providers quality measures;

12(C) educating a government agency or

13pbinns on DSKJLVW7X2PROD with BILLS

USE.—The

other governmental entity; and14(D) supporting clinical trials and other ac-

15

tivities necessary to comply with pre- or post-

16

market approval or adverse event reporting re-17

quirements or conditions imposed by the Food18

and Drug Administration, and other purpose

19

approved by the Secretary.

20(5) PROVIDER OF SERVICES.—The term ‘‘pro-21

vider of services’’ has the meaning given such term

22

in section 1861(u) of the Social Security Act (4223

U.S.C. 1395x(u)).

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(6) SUPPLIER.—The term ‘‘supplier’’ has the2meaning given such term in section 1861(d) of the3

Social Security Act (42 U.S.C. 1395x(d)).

4(k) REGULATIONS.—Not later than 1 year after the

5 date of the enactment of this Act, the Secretary of Health
6 and Human Services shall promulgate final regulations to
7 implement the provisions of the preceding sections of this
8 subtitle.
9

TITLE V—RESEARCH

10SEC. 501. ADVANCED RESEARCH PROJECTS AGENCY FOR

11
12

HEALTH.

(a) ESTABLISHMENT.—The Secretary of Health and

13 Human Services, acting through the Director of the Na14 tional Institutes of Health, shall establish the Advanced
15 Research Projects Agency for Health (to be referred to
16 in this Act as ‘‘ARPA–H’’) to transform and improve im17 portant areas of medicine and health for the well-being
18 of all individuals in the United States.

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19(b) GOALS.—

20(1) IN GENERAL.—The goals of ARPA–H shall21

be to deliver breakthrough capabilities through tech-22

nologies, systems, and platforms that—

23(A) accelerate the discovery and applica-

24tion of transformational innovations in health25

and medical product development; and•HR 6000 IH
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(B) reduce the human and economic cost2of disease.

3(2) MEANS.—ARPA–H may achieve the estab-4lished goals under paragraph (1), including by any

5of the following means:

6(A) Promoting high-risk, high-reward inno-

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7

vation.

8(B) Identifying and promoting revolu-

9

tionary advances in biomedical and health re-10

search that enable new paradigms in health.

11(C) Accelerating transformational health12

advances in areas that the relevant industries

13

by themselves are not likely to undertake be-14cause of technical, financial, or other uncer-

15

tainty.

16(D) Prioritizing project investments based17

on scientific opportunity and uniqueness of fit

18

to ARPA–H strategies and operating practice,

19

together with the prospective impact on disease20

burden (regardless of disease prevalence), both21

human and fiscal, including the health care fis-22

cal liability of the Federal government.

23(E) Partnering with, and providing fund-24

ing to, a broad range of institutions, including

25

universities, national laboratories, public sector•HR 6000 IH
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1

organizations, private companies, nonprofit or-2

ganizations, and foreign institutions.

3(c) DIRECTOR.—

4(1) IN GENERAL.— ARPA–H shall be headed5

by a Director, who shall be appointed by and serve6

at the pleasure of the President (referred to in this7

section as the ‘‘Director of ARPA–H’’).

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9(2) SELECTION.—The Director of ARPA–H
shall—

10(A) be an individual who, by reason of pro-11

fessional background and experience, is quali-

12

fied to advise the Secretary on, and manage re-13

search programs addressing, matters pertaining

14

to long-term and high-risk barriers to the devel-

15

opment of health innovation;

16(B) have authority to execute contracts de-17veloped by in-house program managers who se-

18lect external performers, and maintain, enhance19

or terminate projects based on performance

20

against explicit milestones; and21(C) have a time-limited appointment of 5

22years with the opportunity, at the discretion of

23

the President, of one extension.

24(3) DUTIES.—The duties of the Director of

25

ARPA–H shall be to—•HR 6000 IH
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(A) set national research priorities to ad-

2vance the mission of the agency as informed by3

a multi-sectoral board of advisors;

4(B) approve all new programs within

5

ARPA–H;6(C) have final funding authority to initiate

78(D) establish criteria for funding and as-

9sessing the success of programs through the es-

10tablishment of technical milestones;

11(E) appoint the personnel necessary, con-12

sistent with subsection (d), to successfully exe-

13

cute the goals of ARPA–H; and

14(F) designate employees to serve as pro-

15

gram managers to carry out the duties de-16

scribed in subsection (e) for each of the pro-17

grams established pursuant to the responsibil-

18

ities established for ARPA–H.

19(4) AUTHORITY.—The Director of ARPA–H is20pbinns on DSKJLVW7X2PROD with BILLS

and terminate program funding;authorized to—21(A) acquire (by purchase, lease, condemna-

22tion, or otherwise), construct, improve, repair,23

operate, and maintain such real and personal

24

property as are necessary to carry out this sec-

25tion; and•HR 6000 IH
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(B) lease an interest in property for not2

more than 20 years, notwithstanding section

3

1341(a)(1) of title 31, United States Code.

4(d) PERSONNEL MANAGEMENT AUTHORITY.—

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6(1) SPECIALPERSONNEL

MANAGEMENTTHORITY.—The Director of ARPA–H may—

7(A) make appointments to positions of ad-

8

ministration or management of ARPA–H with-9

out regard to any provision in title 5, United

10

States Code, governing appointments under the11

civil service laws and fix the compensation of

12such positions at a rate not to exceed the13amount of annual compensation (excluding ex-

14penses) specified in section 102 of title 3,

15

United States Code, notwithstanding section

16

202 of Department of Health and Human Serv-

17

ices Appropriations Act, 1993 (Public Law

18

102–394);19(B) hire personnel under section 207(f) of20

the Public Health Service Act (42 U.S.C.

21

209(f)) and establish governing criteria to re-22

cruit, appoint, and compensate personnel under

23

this section notwithstanding section 202 of De-

24partment of Health and Human Services Ap-

25

propriations Act, 1993 (Public Law 102–394)•HR 6000 IH
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1

or any provision of title 5, United States Code,2

governing the rates of pay or classification of3

employees in the Executive branch;

4(C) make additional appointments of sci-

5

entific, medical, and professional personnel

6

under this section without regard to any provi-

7

sion in title 5, United States Code, governing

8

appointments under the civil service laws and9

fix the compensation of such personnel at a rate10

to be determined by the Director, up to the11amount of annual compensation (excluding ex-

12penses) specified in section 102 of title 3,

13

United States Code, notwithstanding section

14

202 of Department of Health and Human Serv-

15

ices Appropriations Act, 1993 (Public Law

16

102–394) or any provision of title 5, United

17

States Code, governing the rates of pay or clas-

18sification of employees in the Executive branch;

19

and

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20(D) recruit and retain a diverse workforce,

21

including22

science and medicine and racial and ethnic mi-

23

norities.

24(2) ADDITIONAL

25

individuals

underrepresented

STAFF.—The

Director of

ARPA–H may use all authorities in existence on the•HR 6000 IH
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date of enactment of this Act that are provided to2

the Secretary to hire administrative, financial, infor-

3

mation technology staff, and any other staff the Di-

4

rector of ARPA–H determines are necessary to5carry out this section.

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6(3) LIMITATION ON TERM.—

7(A) IN GENERAL.—Except as provided in

8

subparagraph (B), the service of an employee

9

under an appointment under paragraph (1)(A)10

in the position of a program manager may not

11

exceed 3 years.

12(B) EXTENSION.—The Director of ARPA–13

H may, in the case of a particular employee, ex-

14

tend the period to which service is limited under15

subparagraph (A) by up to 3 years if the Direc-

16

tor determines that such action is necessary to

17

promote the efficiency of ARPA–H.

18(4) LIMITATION ON ADDITIONAL PAYMENTS.—

19

The total amount of the additional payments paid to20

an employee under paragraph (1)(C) for any 12-

21month period may not exceed the least of the fol-22

lowing amounts:

23(A) $25,000.

24(B) The amount equal to 25 percent of the25

employee’s annual rate of basic pay.

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(C) The amount of the limitation that is2

applicable for a calendar year under section

35307(a)(1) of title 5, United States Code.

4(e) PROGRAM MANAGERS.—An employee designated

5 as a program manager pursuant to subsection (c)(3)(F)
6 shall—7(1) define the research and development goals

8

and milestones of the program involved, in line with

9

guidance from the Director;

1011(2) track progress and course-correct projects
when needed;

12(3) recommend, as necessary, the restructuring

13

or termination of projects supported by ARPA–H;

14

and

15

(4) select, on the basis of merit and need, each

16of the projects to be supported under the program

17

involved after considering—

18(A) the novelty and scientific and technicalpbinns on DSKJLVW7X2PROD with BILLS

19

merit of the proposed projects;

20(B) the demonstrated capabilities of the21

applicants to successfully carry out the pro-22

posed project;

23(C) the consideration by the applicant of

24

future commercial applications of the project;

25

or•HR 6000 IH
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(D) the unmet need within patient popu-

2

lations.

3(f) REPORTS.—

4(1) STRATEGIC VISION.—Not later than 180

5days after the date of the enactment of this Act, the6

Director of ARPA–H shall provide to the Committee

7

on Energy and Commerce and the Committee on

8

Appropriations of the House of Representatives and9

the Committee on Health, Education, Labor, and10

Pensions and the Committee on Appropriations of

11

the Senate a report describing the strategic vision

12

that ARPA–H will use to guide the choices of

13

ARPA–H for future health investments over the fol-14

lowing 3 fiscal years beginning on or after the date15of the enactment of this Act.

16(2) ANNUAL BUDGET REQUEST.—As part of17

the annual budget request submitted for each fiscal

18

year, the Director of ARPA–H shall provide to the19congressional committees specified in paragraph (1)20a report describing—

21(A) projects supported by ARPA–H during

22

the previous fiscal year, including—pbinns on DSKJLVW7X2PROD with BILLS

23(i) the transition of projects’ outcomes24

to clinical practice;•HR 6000 IH
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(ii) the impact on clinical outcome;

2

and

3

(iii) the creation of biomedical capa-

4bilities; and5(B) successes and barriers to scientificpbinns on DSKJLVW7X2PROD with BILLS

6interchanges;

7(C) rapid knowledge transfer;

8(D) resource optimization; and9(E) heightened investment impact among

10

collaborators.

11(3) REPORTON COOPERATIVE AGREEMENTS

12

AND OTHER TRANSACTION.—Not later than 90 days

13

after the end of each fiscal year, the Director of

14

ARPA–H shall submit to the congressional commit-

15

tees specified in paragraph (1) a report on all coop-

16

erative agreements and other transactions (other17

than contracts and grants) entered into under this18

subsection during such fiscal year. The report shall19

contain, with respect to such cooperative agreement

20

and transaction, the following:

21(A) A general description of the coopera-

22

tive agreement or other transaction (as the case23

may be), including the innovations for which

24

advanced research is provided for under such

25

agreement or transaction.

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(B) The potential clinical and, if any, com-2

mercial utility of such innovations.

3(C) The reasons for not using a contract

4

or grant to provide support for such advanced

5

research.

6(D) The amount of the payments, if any,7

referred to in subsection (i)(2) that were re-8

ceived by the Federal Government in connection

9with such cooperative agreement or other trans-

10

action during the fiscal year covered by the re-

11

port.

12

(E) The amount of the payments reported

13

under subparagraph (D), if any, that were cred-

14

ited to the account established under subsection

15(i)(7).

16(g) COORDINATION AND NONDUPLICATION.—

17(1) IN GENERAL.—The Director of ARPA–H

18

shall ensure effective, early, and frequent coordina-

19tion between ARPA–H and the heads of the re-20

search, public health, and regulatory agencies of the21

Department of Health and Human Services, includ-

22

ing—

pbinns on DSKJLVW7X2PROD with BILLS23(A) the Director of the National Institutes

24of Health;25(B) the Commissioner of Food and Drugs;•HR 6000 IH
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(C) the Administrator of the Centers for2

Medicare & Medicaid Services;

3(D) the Director of the Centers for Disease4

Control and Prevention; and5(E) the Assistant Secretary for Prepared-

6

ness and Response.

7(F) The Director of the National Science

8Foundation.

9(G) The Director of the Office of Science

10of the Department of Energy.

11(2) COORDINATION.—The Director shall also

12

coordinate among the full set of advanced research

13

project agencies including—

14

(A)

15

Project Agency;

16

Advanced(C) others as they may be established.
(h) ADVICE.—

20(1) IN GENERAL.—The Director of ARPA–H

21

may seek advice on any aspect of ARPA–H from—

22(A) any advisory committee that, as of the23

date of the enactment of this Act, is providing

24

advice to the Secretary of Health and Human

25

Services (or any head of a research, public•HR 6000 IH
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Defense(B) the Advanced Research Project Agen-

17

19

the

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health, or regulatory agency of the Department

2of Health and Human Services); and3(B) an advisory committee established on

4

or after such date of the enactment to support

5

the programs of ARPA–H and to provide advice

6

and assistance on—7(i) specific program tasks; or8(ii) overall direction of ARPA–H.

9(2) ADDITIONAL SOURCES.—In addition to the10advisory committees specified in paragraph (1), the11

Director of ARPA–H may seek advice and review

12

from—

13

(A) the President’s Committee of Advisors

1415(B) any professional or scientific organiza-

16

tion with expertise in specific processes or tech-17

nologies under development by ARPA–H; and18(C) representatives of patient communities.

19(i) COOPERATIVE AGREEMENTS AND OTHER TRANS-

20

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on Science and Technology;

ACTIONS.—

21(1) IN GENERAL.—The Director of ARPA–H,

22

in carrying out advanced research projects through

23

ARPA–H, may enter into grants, contracts, coopera-

24

tive agreements, cash prizes, and other transactions

25(as defined in section 319L(a) of the Public Health•HR 6000 IH
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Service Act (42 U.S.C. 247d–7e(a))) with any per-2son, any agency or instrumentality of the United

3

States, any unit of State or local government, and4any other entity institutions, including universities,

5

national laboratories, public sector organizations,6

private companies, nonprofit organizations, and for-7

eign institutions.

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8(2) TERMS.—

9(A) REQUIRED PROVISIONS.—The Director

10of ARPA–H shall ensure that, in entering into

11

cooperative agreements and other transactions

12

under paragraph (1)—13(i) to the extent the Director of

14

ARPA–H determines practicable, the Fed-15

eral funds provided under the cooperative

16

agreement or other transaction do not ex-17

ceed the total amount provided by other18

parties to the cooperative agreement or

19other transaction; and20(ii) the authority under paragraph (1)21

is used only when the use of standard con-22

tracts or grants is not feasible or appro-

23

priate.

24(B) OPTIONAL

25

PROVISION.—Cooperative

agreements and other transactions entered into

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156
1

by the Director of ARPA–H under paragraph2(1) may include a clause that requires a person

3or other entity to make payments to ARPA–H

4(or any other department or agency of the Fed-5eral Government) as a condition for receiving

6

support under the agreement or other trans-

7

action.

8(3) DUPLICATIVE RESEARCH.—The Director of

9

ARPA–H shall ensure that to the maximum extent

10practicable, a cooperative agreement or other trans-

11

action under this section does not provide for re-12

search that duplicates research being conducted13

under existing programs carried out by the Depart-

14

ment of Health and Human Services, the Depart-

15

ment of Defense, or other Federal Government enti-

16

ties.

17

(4) AMOUNT OF PAYMENTS.—The amount of18

any payment received by the Federal Government

19

pursuant to a requirement imposed under paragraph20(1) may be credited, to the extent authorized by the21

Director of ARPA–H, to the account established22

under paragraph (7). Amounts so credited shall be

23merged with other funds in the account and shall be

24

available for the same purposes and the same period25

for which other funds in such account are available.

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1

(5) MULTI-YEAR CONTRACTS.—

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2

(A)

IN

GENERAL.—The

Director

3

ARPA–H may enter into a multi-year contract

4

if—

5

(i) funds are available and obligated6

for the contract for the full period of the7contract, or for the first fiscal year in8

which the contract is in effect, and for the9estimated costs associated with a necessary

10

termination of the contract;11(ii) the Director determines that a

12

multiyear contract will serve the best inter-13

ests of the Federal Government in carrying

14

out this section; and15(iii) the contract includes a provision

16

that the contract shall be terminated if

17funds are not made available for the con-18

tinuation of the contract in a fiscal year

19

covered by the contract.

20(B) TERMINATION COSTS.—A provision re-21

ferred to in subparagraph (A)(iii) shall provide

22that funds available for paying termination

23

costs shall remain available for that purpose

24

until the costs associated with termination of25

the contract are paid.

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(6) APPLICATION OF OTHER PROVISIONS.—The2

authority provided under paragraph (1) may be ex-

3

ercised without regard to section 3324 of title 31,

4

United States Code.

5(7) ACCOUNT.—There is hereby established on

6

the books of the Treasury an account for support of7

advanced research projects provided for in coopera-

8

tive agreements and other transactions entered into

9

under paragraph (1). Funds in such account shall be

10available for the payment of such support.

11(8) PRIZE

Director of

12

ARPA–H may carry out prize competitions in ac-

13

cordance with section 24 of the Stevenson-Wydler

14Technology Innovation Act of 1980 (15 U.S.C.

153719)) in support of the goals specified in sub-16

section (b).

17(9) NONAPPLICABILITY

18

SIONS.—Research

19

shall not be subject to—OF

CERTAIN

funded pursuant to this section(A) advisory council approval under section

21405(b)(2) of the Public Health Service Act (4222

U.S.C. 284(b)(2));(B) advisory council review under section

24

406(a)(3)(A)(ii)25

284a(a)(3)(A)(ii)); or

of

such

Act

(42

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20

23
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U.S.C.

159
1(C) the peer review requirements under2

section 492 of such Act (42 U.S.C. 284(b)(2),

3289a).

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4(j) CONFIDENTIALITY.—

5(1) IN GENERAL.—The information specified in

6paragraph (2) shall be exempt from disclosure under7

section 552 of title 5, United States Code (com-8

monly referred to as the Freedom of Information

9

Act).

10

(2) INFORMATION.—The information specified

11

in this paragraph is information collected by ARPA–12

H from recipients of financial assistance awards, in-13

cluding the following:

14(A) Plans for commercialization of tech-15

nologies developed under the award, including

16

business

17

market studies, and cost and performance mod-

18

els.

plans,

technology-to-market

19(B) Investments provided to an awardee

20

from third parties (such as venture capital

21

firms, hedge funds, and private equity firms),

22

including the amounts and the percentage of23

ownership of the awardee provided in return for24

the investments.

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2

OPERATION WITH FOOD AND DRUG ADMINISTRATION.—

3(1) IN GENERAL.—The Secretary of Health and4

Human Services, acting through the Commissioner

5of Food and Drugs and in consultation with the Di-

6

rector of ARPA–H, may take actions to facilitate

7

transformation of biomedical breakthroughs into

8

tangible solutions for patients and to expedite devel-

9opment of medical products, including through any

10of the following means:

11(A) Helping to ensure that medical prod-12

uct development programs, in as efficient a13manner as possible, gather the nonclinical and14

clinical data necessary to advancing the devel-

15

opment of such products and to obtaining their

16

approval, licensure, or clearance, as applicable,

17by the Food and Drug Administration under18

sections 505, 510(k), and 515 of such Act (2119

U.S.C. 355, 360(k), 360) and section 351 of

20

the Public Health Service Act (42 U.S.C. 262).

21(B) Expediting review of investigational22

new drug applications under section 505(i) of

23

the Federal Food, Drug, and Cosmetic Act (2124

U.S.C. 355(i)), review of investigational device

25

exemptions under section 520(g) of such Act•HR 6000 IH
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161
1(21 U.S.C. 360j(g)), and review of applications

2

for approval, licensure, and clearance of medical

3

products under sections 505, 510(k), and 515

4

of such Act (21 U.S.C. 355, 360(k), 360) and5

section 351 of the Public Health Service Act

6(42 U.S.C. 262).

7(C) Meeting at appropriate intervals with8

the Director of ARPA–H and any other appro-

9

priate medical product development partners,

10such as the Director of the Biomedical Ad-

11vanced Research and Development Authority to

12discuss the development status of medical prod-13

ucts and projects that are the highest priorities

14

to ARPA–H, unless the Director of ARPA–H

15

and the Commissioner of Food and Drugs de-16

termine that any such meetings are not nec-

17

essary.

18(2) RELATION TO OTHERWISE AUTHORIZED AC-

19

TIVITIES OF THE FDA.—The authority specified in20paragraph (1) shall not be construed as limiting the21

authority of the Secretary of Health and Human

22

Services, acting through the Commissioner of Food

23

and Drugs with respect to the review and approval,

24clearance, authorization for emergency use, or licen-25

sure of a medical product under the Federal Food,•HR 6000 IH
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162
1

Drug and Cosmetic Act (21 U.S.C. 321 et seq.) or

2

section 351 of the Public Health Service Act (423

U.S.C. 262).

4(3) REIMBURSEMENT.—Utilizing interagency

5agreements or other appropriate resource allocation

6

mechanisms available, the Director of ARPA–H,

7

using funds made available to ARPA–H, shall reim-

8burse the Food and Drug Administration for ex-

9penditures made by the Food and Drug Administra-

10tion for activities carried out under this section that

11

have been identified by the Commissioner of Food

12and Drugs and the Director of ARPA–H as being

13

carried out by the Food and Drug Administration.

14(4) MEDICAL PRODUCT DEFINED.—In this sec-

15

tion, the term ‘‘medical product’’ means a drug (as16

defined in section 201 of the Federal Food, Drug,

17

and Cosmetic Act (21 U.S.C. 321)), a device (as de-18

fined in such section 201), or a biological product19(as defined in section 351 of the Public Health Serv-20

ice Act (42 U.S.C. 262)).

21(l) AUTHORIZATION OF APPROPRIATIONS AND BY-

22PASS BUDGET AUTHORITY.—

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1

this section $6,500,000,000 for fiscal year 2022, to2remain available until expended.

3(2) BYPASS BUDGET AUTHORITY.—The budget

4of ARPA–H shall be a separate line item in the an-5nual budget request submitted by the President to

6

the Congress. ARPA–H shall have the authority to

7submit its annual budget request directly to Con-8

gress concurrently with its submission to the Office9of Management and Budget.

10

SEC. 502. RESEARCH INVESTMENT TO SPARK THE ECON-

11

OMY.

12

(a) AUTHORITY.—

13(1) IN

officer specified in

14paragraph (2) may exercise the authorities described15

in paragraph (3).

16
17pbinns on DSKJLVW7X2PROD with BILLSGENERAL.—Each(2) OFFICERS.—The officers specified in thisparagraph are as follows:

18(A) The Secretary of Commerce, acting

19

through the Administrator of the National Oce-20

anic and Atmospheric Administration and the21

Director of the National Institute of Standards

22

and Technology.

23(B) The Secretary of Agriculture.

24(C) The Secretary of Defense.

25(D) The Secretary of Education.

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(E) The Secretary of Energy, acting for2

the Department of Energy (with respect to En-

3ergy Efficiency and Renewable Energy, Nuclear

4

Energy, and Fossil Research and Development)

5

and through the Office of Science, the Ad-

6vanced7(ARPA–E), and the Office of Electricity.

Projects

Agency–Energy

8(F) The Secretary of the Interior, acting

9

through the Director of the United States Geo-

10

logical Survey.

11(G) The Secretary of Health and Human

12

Services, acting through the Director of the Na-

13tional Institutes of Health.

14(H) The Secretary of Transportation.

15(I) The Administrator of the National Aer-

16

onautics and Space Administration.

17(J) The Administrator of the Environ-18

mental Protection Agency.

19(K) The Director of the National Science

20

Foundation.

21(3) AUTHORITIES.—The officers specified in

22

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Research

paragraph (2) may—

23(A) provide supplemental funding to ex-

24

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165
1gency to a research institution, Research Lab-

2

oratory, or individual that was awarded before3

the date of the enactment of this Act, or to ex-

4pand the purposes of such an award, in order

5

to—

6

(i) enable a postsecondary student or7

post-doctoral researcher to complete work;

8(ii) enable research scientists, tech-

9

nical staff, research associates, and prin-10

cipal investigators to complete work;

11(iii) extend the training of a postsec-

12

ondary student, or the employment of a13

post-doctoral researcher, on an ongoing re-14

search project for up to 2 years because of15

the disruption of the job market;

16(iv) create research opportunities for17

up to 2 years for graduate students and18

post-doctoral researchers;

19(v) replace, refurbish, or otherwise

20

make usable laboratory animals, reagents,

21

equipment, or other items required for re-22

search;23(vi) facilitate other research (including

24

field work), training, and ongoing con-25

struction activities, including at institu-•HR 6000 IH
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1

tions that are disproportionately affected2

by the COVID–19 public health emergency

3(such as minority-serving institutions and42-year institutions of higher education);

5(vii) enable experimental field cam-

6

paigns and maintenance of field infrastruc-7ture, including through replacement of dis-8

rupted experimental data to enable comple-

9tion of impacted research; and10(viii) support training in online course

11

delivery and virtual research experiences

12

that will improve quality and access needed13

to continue undergraduate, graduate, and14

post-doctoral training;

15(B) issue awards to research institutions,16

Research Laboratories, or other individuals to

17

conduct research on the effects of the COVID–

18

19 and future potential pandemics, on the ef-

19fects and effectiveness of responses to such dis-20

eases, and on improving the prediction of the21

possible courses of such pandemics; and22(C) provide flexibility on an award for23

funds made available to an agency, by any prior24

or subsequent Act, by modifying the terms and25

conditions of the award with a research institu-•HR 6000 IH
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tion, Research Laboratory, or individual due to2

facility closures or other limitations during the3

COVID–19 public health emergency.

4(4) MODIFICATIONS.—The modifications au-

5thorized by paragraph (3)(C) include—

6(A) the provision of supplemental funding7

to extend the duration of the award concerned;

8

or

9

(B) flexibility on the allowable expenses

10
11

under such award.
(b) PROCEDURES.—The officers specified in sub-

12 section (a)(2) shall each establish procedures to carry out
13 subsection (a).
14(c) EXPEDITED AWARDS.—Awards under subsection

15 (a) shall be issued as expeditiously as possible.

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16(d) AUTHORIZATIONS OF APPROPRIATIONS.—

17(1) DEPARTMENT OF COMMERCE.—There is au-

18

thorized to be appropriated for fiscal year 2021 for19

the Department of Commerce, $450,000,000 to20

carry out subsection (a), of which—

21(A) $300,000,000 shall be for use by the22

National Oceanic and Atmospheric Administra-

23tion; and•HR 6000 IH
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(B) $150,000,000 shall be for use by the2

National Institute of Standards and Tech-

3

nology.

4(2) DEPARTMENT OF AGRICULTURE.—There is

5

authorized to be appropriated for fiscal year 2021

6

for the Department of Agriculture, $380,000,000 to

7

carry out subsection (a).

8(3) DEPARTMENT OF DEFENSE.—There is au-

9thorized to be appropriated for fiscal year 2021 for10

the Department of Defense, $3,000,000,000 to carry11

out subsection (a).

12(4) DEPARTMENT OF EDUCATION.—There is

13

authorized to be appropriated for fiscal year 2021

14

for the Department of Education, $200,000,000 to

15

carry out subsection (a), which shall be for use by

16

the Institute for Education Sciences.

17(5) DEPARTMENT OF ENERGY.—There is au-

18

thorized to be appropriated for fiscal year 2021 for19

the Department of Energy, $5,000,000,000 to carry20

out subsection (a), of which—

21(A) not less than $3,000,000,000 shall be

22

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24

for Energy Efficiency and Renewable Energy;•HR 6000 IH
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(C) not less than $450,000,000 shall be

2

for Nuclear Energy;

3(D) not less than $300,000,000 shall be

4

for Fossil Research and Development;

5(E) not less than $150,000,000 shall be

6

for use by the Advanced Research Projects

7

Agency–Energy; and8(F) not less than $100,000,000 shall be

9for use by the Office of Electricity.

10(6) DEPARTMENT OF THE INTERIOR.—There is

11

authorized to be appropriated for fiscal year 2021

12

for the Department of the Interior, $300,000,000 to

13

carry out subsection (a), which shall be for use by

14

the United States Geological Survey.

15(7) DEPARTMENT16

SERVICES.—There is authorized to be appropriated17

for fiscal year 2021 for the Department of Health18

and Human Services, $10,000,000,000 to carry out

19subsection (a), which shall be for use by the Na-

20tional Institutes of Health.

21

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DEPARTMENTOF

TRANSPORTATION.—

22

There is authorized to be appropriated for fiscal

23

year 2021 for the Department of Transportation,

24$300,000,000 to carry out subsection (a), of which•HR 6000 IH
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not less than $130,000,000 shall be for use by the2Federal Aviation Administration.

3(9) NATIONAL AERONAUTICS AND SPACE AD-

4MINISTRATION.—There5

priated for fiscal year 2021 for the National Aero-

6

nautics and Space Administration, $2,000,000,000

7

to carry out subsection (a).

8(10) ENVIRONMENTAL PROTECTION AGENCY.—

9

There is authorized to be appropriated for fiscal

10year 2021 for the Environmental Protection Agency,

11$200,000,000 to carry out subsection (a).

12(11) NATIONAL SCIENCE FOUNDATION.—There13

is authorized to be appropriated for fiscal year 2021

14

for

15

$3,000,000,000 to carry out subsection (a).

1617pbinns on DSKJLVW7X2PROD with BILLS

is authorized to be appro-the

National

ScienceFoundation,(12) AVAILABILITY OF FUNDS FOR ADMINISTRATION.—

18(A) IN GENERAL.—Amounts authorized to19

be appropriated by this subsection may be used

20

for the payment of indirect costs of Federal

21

awards under subsection (a), up to the limit

22

otherwise allowable by law and subject to the23

requirements of part 200 of title 2, Code of24

Federal Regulations.

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(B) LIMITATION.—Not more than 5 per-2cent of each of the amounts appropriated pur-3

suant to this subsection may be used for admin-

4

istration of awards under subsection (a).

5(13) DURATION

6authorized to be appropriated by this subsection

7

shall be available for the purposes described in this8

subsection through fiscal year 2021.

9(e) DEFINITIONS.—In this section:

10(1) AWARD.—The term ‘‘award’’ includes a11

grant, cooperative agreement, or other financial as-

12

sistance.

13(2) COVID–19 PUBLIC HEALTH EMERGENCY.—

14

The term ‘‘COVID–19 public health emergency’’

15

means the public health emergency declared by the16

Secretary of Health and Human Services under sec-

17

tion 319 of the Public Health Service Act (4218

U.S.C. 247d) on January 31, 2020, with respect to19coronavirus disease 2019 (COVID–19).

20
21

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OF AVAILABILITY.—Amounts(3) RESEARCH INSTITUTION.—The term ‘‘research institution’’ means the following:

22(A) An institution of higher education (as23defined in section 101(a) of the Higher Edu-

24

cation Act of 1965 (20 U.S.C. 1001(a))).

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(B) A Tribal College or University (as de-2

fined in section 316 of the Higher Education

3

Act of 1965 (20 U.S.C. 1059c)).

4(C) A nonprofit entity that conducts feder-

5

ally funded research.

6(4) RESEARCH LABORATORY.—The term ‘‘Re-

7

search Laboratory’’ means the following:

8(A) A National Laboratory (as defined in

9section 2 of the Energy Policy Act of 2005 (4210U.S.C. 15801)).

11(B) A Federally Funded Research and De-

12velopment Center for purposes of section

13

3.5.017 of title 48, Code of Federal Regula-

14

tions.

15

SEC. 503. RESEARCH POLICY BOARD REAUTHORIZATION.

16(a) EXTENSION OF SUNSET.—Section 2034(f)(6) of

17 the 21st Century Cures Act (42 U.S.C. 3501 note) is
18 amended by striking ‘‘September 30, 2021’’ and inserting
19 ‘‘September 30, 2026’’.
20(b) PARTICIPATION BY DIRECTOR OF NIH.—

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21

(1)

INCLUSIONASMEMBER.—Section

222034(f)(2)(A) of the 21st Century Cures Act (4223

U.S.C. 3501 note) is amended—

24(A) by redesignating clause (v) as clause

25

(vi);

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(B) by inserting after clause (iv) the fol-2

lowing:3‘‘(iv) The Director of the National In-

4stitutes of Health.’’.

5(2)

LIMITATIONSRELATINGTO6

COSTS.—Section

7

Cures Act (42 U.S.C. 3501 note) is amended by

8

adding at the end the following:

92034(f)(2) of the 21st Century‘‘(C) LIMITATIONS RELATING TO INDIRECT

10

COSTS.—Notwithstanding

11of law, the Director of the National Institutes

12of Health may participate in the activities of13

the Board, including the formulation of rec-14

ommendations, without regard to limitations re-15

lating to indirect costs in part 75 of title 45,

16

Code of Federal Regulations (or any successor

17

regulations).’’.

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