a State plan under title XIX of such Act (42 U.S.C. 
1396 et seq.), a State child health plan under title 
XXI of such Act (42 U.S.C. 1397 et seq.); and 
(4) improving patient and family caregiver 
health literacy with respect to health insurance, in-
cluding an understanding of in-network providers, 
deductibles, co-insurance, co-payments, and dif-
ferences between payors. 
SEC. 203. INCREASING DIVERSITY IN CLINICAL TRIALS. 
(a) UPDATED REPORTING ON INCLUSION OF DEMO-
GRAPHIC SUBGROUPS.—The Secretary of Health and 
Human Services, acting through the Commissioner of 
Food and Drugs, shall— 
(1) not later than 90 days after the date of the 
enactment of this Act, submit to the Food and Drug 
Administration, and provide to the Congress, an up-
dated version of the report under section 907(a) of 
the Food and Drug Administration Safety and Inno-
vation Act (Public Law 115–52); and 
(2) not later than 1 year after the publication 
of the updated report pursuant to paragraph (1), 
publish on the website of the Food and Drug Ad-
ministration, and provide to the Congress, an up-
dated version of the action plan under section 
907(b) of such Act. 
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(b) GAO STUDY ON BARRIERS TO PARTICIPATION.— 
Not later than 1 year after the date of the enactment of 
this Act, the Comptroller General of the United States 
shall— 
(1) complete a study— 
(A) to review how the Department of 
Health and Human Services addresses barriers 
to participation by individuals from underrep-
resented populations in conducting or sup-
porting clinical trials; and 
(B) to formulate recommendations for ad-
dressing such barriers; and 
(2) submit a report to the Congress on the re-
sults of such study. 
(c) PUBLIC AWARENESS CAMPAIGN.—The Secretary 
of Health and Human Services shall— 
(1) carry out a public awareness campaign to 
increase awareness and understanding, particularly 
in minority communities, of— 
(A) upcoming and ongoing clinical trials; 
(B) how to enroll as subjects in such clin-
ical trials; and 
(C) the availability of databases and other 
resources relevant to clinical trial enrollment, 
such as ClinicalTrials.gov; and 
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(2) in carrying out such campaign, utilize a va-
riety of communication channels, including through 
use of the explanation of Medicare benefits under 
section 1806 of the Social Security Act (42 U.S.C. 
1395b–7). 
(d) TASK FORCE FOR MAKING CLINICALTRIALS.GOV 
MORE USER-FRIENDLY.— 
(1) IN GENERAL.—The Secretary of Health and 
Human Services shall convene a permanent task 
force to propose, on a biennial basis, recommenda-
tions for improving ClinicalTrials.gov by making it 
more user-friendly, including for patients. 
(2) MEMBERSHIP.—The membership of the 
task force shall include representatives of— 
(A) the National Institutes of Health; 
(B) the Food and Drug Administration; 
(C) academic researchers; and 
(D) patient organizations. 
(e) 
DEFINITION.—In 
this 
section, 
the 
term 
‘‘ClinicalTrials.gov’’ refers to the data bank described in 
section 402(i) of the Public Health Service Act (42 U.S.C. 
282(i)). 
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SEC. 204. PATIENT EXPERIENCE DATA. 
(a) POLICY.—Section 569C of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360bbb–8c) is amend-
ed— 
(1) by redesignating subsections (b) and (c) as 
subsections (c) and (d), respectively; and 
(2) by inserting after subsection (a) the fol-
lowing new subsection: 
‘‘(b) COLLECTION, SUBMISSION, 
AND
USE
OF 
DATA.— 
‘‘(1) IN GENERAL.—The Secretary shall— 
‘‘(A) for any drug for which an exemption 
is granted for investigational use under section 
505(i) of this Act or section 351(a) of the Pub-
lic Health Service Act, require the sponsor of 
the drug to collect standardized patient experi-
ence data as part of the clinical trials conducted 
pursuant to such exemption; 
‘‘(B) require any application for the ap-
proval or licensing of such drug under section 
505(b) of this Act or section 351(a) of the Pub-
lic Health Service Act to include— 
‘‘(i) the standardized patient experi-
ence data so collected; and 
‘‘(ii) such related information as the 
Secretary may require; and 
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‘‘(C) consider patient experience data and 
related information that is submitted pursuant 
to subparagraph (B) in deciding whether to ap-
prove or license, as applicable, the drug in-
volved. 
‘‘(2) APPLICABILITY.—Paragraph (1) applies 
only with respect to drugs for which a request for 
an exemption described in paragraph (1)(A) is sub-
mitted on or after the date of the enactment of the 
Cures 2.0 Act, or an application under section 
505(b) of this Act or section 351(a) of the Public 
Health Service Act is filed, as applicable, on or after 
the day that is 2 years after the date of the enact-
ment of the Cures 2.0 Act.’’. 
(b) REGULATIONS.—Not later than 1 year after the 
date of the enactment of this Act, the Secretary of Health 
and Human Services, acting through the Commissioner of 
Food and Drugs, shall promulgate final regulations to im-
plement section 569C(b) of the Federal Food, Drug, and 
Cosmetic Act, as added by this section. 
SEC. 205. ENSURING COVERAGE FOR CLINICAL TRIALS 
UNDER EXISTING STANDARD OF CARE. 
(a) REVISION TO DEFINITION OF APPROVED CLIN-
ICAL TRIAL IN INDIVIDUAL AND GROUP MARKET.— 
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(1) IN GENERAL.—Subsection (d)(1) of the first 
section 2709 of the Public Health Service Act (42 
U.S.C. 300gg–8) (relating to coverage for individ-
uals participating in approved clinical trials) is 
amended by adding at the end the following new 
subparagraph: 
‘‘(D) The study or investigation is ap-
proved or funded (which may include funding 
through in-kind contributions) by the Patient 
Centered Outcomes Research Institute estab-
lished under section 1181 of the Social Security 
Act.’’. 
(2) EFFECTIVE DATE.—The amendment made 
by this paragraph shall apply with respect to plan 
years beginning on or after January 1, 2022. 
(b) MEDICARE COVERAGE OF ROUTINE COSTS ASSO-
CIATED WITH CERTAIN CLINICAL TRIALS.— 
(1) IN GENERAL.—Section 1862(m)(2) of the 
Social Security Act (42 U.S.C.1395y(m)(2)) is 
amended, in the matter preceding subparagraph (A), 
by inserting ‘‘(including a trial funded by the Pa-
tient Centered Outcomes Research Institute estab-
lished under section 1181)’’ after ‘‘means a trial’’. 
(2) EFFECTIVE DATE.—The amendment made 
by this paragraph shall apply with respect to items 
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and services furnished on or after the date of the en-
actment of this Act. 
TITLE III—FOOD AND DRUG 
ADMINISTRATION 
SEC. 301. REPORT ON COLLABORATION AND ALIGNMENT IN 
REGULATING 
DIGITAL 
HEALTH 
TECH-
NOLOGIES. 
(a) IN GENERAL.—Not later than 1 year after the 
date of the enactment of this Act, the Secretary of Health 
and Human Services, acting through the Commissioner of 
Food and Drugs, shall submit a report to the Congress 
on the efforts to ensure collaboration and alignment across 
the centers and offices of the Food and Drug Administra-
tion with respect to the regulation of digital health tech-
nologies. 
(b) CONTENTS.— The report under subsection (a) 
shall include a description of the following: 
(1) How the Commissioner of Food and Drugs 
and the heads of the centers and offices of the Food 
and Drug Administration collaborate in regulating 
digital health technologies, including recommenda-
tions with respect to— 
(A) the use of digital endpoints for regu-
latory review, including the validation and qual-
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ification of digital endpoints and digital bio-
markers; 
(B) the acceptance of decentralized trials; 
(C) the use of digital health technologies in 
patient-focused development of products; and 
(D) the use and validation of digital health 
technology tools; 
(2) How the Food and Drug Administration co-
ordinates with foreign regulators to ensure harmoni-
zation on the regulation and use of digital health 
technologies. 
(c) DEFINITION.—In this section, the term ‘‘digital 
health technologies’’ includes those technologies in health 
care or society that help deliver or provide access to health 
care products and services such as hardware (for example, 
wearable sensors, virtual reality headsets, and digitally-en-
abled drug delivery devices), advanced analytics (for exam-
ple, artificial intelligence, machine learning, and sophisti-
cated computation), cloud services (for example, storage, 
computing, and data processing), and software (for exam-
ple, mobile medical applications, and software as a medical 
device). 
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SEC. 302. GRANTS FOR NOVEL TRIAL DESIGNS AND OTHER 
INNOVATIONS IN DRUG DEVELOPMENT. 
(a) IN GENERAL.—The Secretary of Health and 
Human Services, acting through the Commissioner of 
Food and Drugs, shall award grants for— 
(1) incorporating complex adaptive and other 
novel trial designs into clinical protocols and applica-
tions for drugs pursuant to an exemption for inves-
tigational use under section 505(i) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) or 
section 351(a) of the Public Health Service Act (42 
U.S.C. 262(a)); and 
(2) the collection of patient experience data 
with respect to drugs and the use of such data and 
related information in drug development. 
(b) PRIORITIZATION.—In awarding grants under this 
section, the Secretary shall prioritize the incorporation of 
digital health technologies and real world evidence in drug 
development. 
(c) DEFINITIONS.—In this section: 
(1) The term ‘‘digital health technologies’’ has 
the meaning given to such term in section 301. 
(2) The term ‘‘patient experience data’’ has the 
meaning given to such term by section 569C(d) of 
the Federal Food, Drug, and Cosmetic Act, as re-
designated by section 204 of this Act. 
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(3) The term ‘‘real world evidence’’ has the 
meaning given to that term in section 505F of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355g). 
(d) AUTHORIZATION OF APPROPRIATIONS.—To carry 
out this section, there is authorized to be appropriated 
$25,000,000 for each of fiscal years 2022 through 2024. 
SEC. 303. FDA CELL AND GENE THERAPY. 
Not later than 1 year after the date of the enactment 
of this Act, the Secretary of Health and Human Services, 
acting through the Commissioner of Food and Drugs, 
shall submit a report to the Congress on the following: 
(1) The foreseeable challenges to the Food and 
Drug Administration with respect to cell and gene 
therapies during the next ten years. 
(2) How the Food and Drug Administration 
will address these challenges. 
(3) The additional resources and authorities the 
Food and Drug Administration needs to address 
these challenges. 
(4) The current state of cell and gene therapies 
regulation by the Food and Drug Administration, in-
cluding— 
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(A) the amount and nature of the submis-
sions filed with the Food and Drug Administra-
tion; 
(B) the status of such applications in the 
review process; and 
(C) the therapeutic areas intended to be 
addressed by the products that are subject to 
such applications. 
SEC. 304. INCREASING USE OF REAL WORLD EVIDENCE. 
(a) GUIDANCE.— 
(1) ISSUANCE.—Not later than 6 months after 
the date of the enactment of this Act, the Secretary 
of Health and Human Services (in this section re-
ferred to as the ‘‘Secretary’’) shall issue guidance on 
the use of real world evidence in evaluating the safe-
ty and effectiveness of breakthrough devices (devel-
oped pursuant to section 515B of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360e–3)) and 
breakthrough drugs subsequent to the approval or li-
censing of such drugs pursuant to subsection (a), 
(b), or (c) of section 506 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 356) as a break-
through therapy, a fast track product, or a product 
considered for accelerated approval. 
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(2) CONSIDERATIONS.—The guidance under 
paragraph (1) shall take into consideration each of 
the following: 
(A) Special and underrepresented popu-
lations. 
(B) Acceptable endpoints and outcomes 
measures. 
(C) Data quality standards. 
(D) Data transparency requirements. 
(E) Study design considerations. 
(b) IDENTIFICATION AND IMPLEMENTATION OF AP-
PROACHES.— 
(1) 
IDENTIFICATION.—Consistent 
with 
the 
framework established under 505F of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355g), 
the Secretary of Health and Human Services shall, 
by not later than 1 year after the date of the enact-
ment of this Act— 
(A) identify consistent, clear approaches 
for the Department of Health and Human 
Services to use real world evidence (as defined 
in such section 505F)— 
(i) in conducting and supporting re-
search; and 
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(ii) in regulating, purchasing, and 
supporting the purchase of health care 
products and services; 
(B) include in such approaches rec-
ommendations for any additional statutory au-
thorities needed; 
(C) publish such approaches in the Federal 
Register; and 
(D) submit a report to the Congress on 
such approaches. 
(2) 
IMPLEMENTATION.—Upon 
publication 
under paragraph (1) of the approaches identified 
pursuant to such paragraph, consistent with the au-
thorities vested in the Department of Health and 
Human Services by other provisions of law, the Sec-
retary take such actions as may be appropriate to 
implement the approaches identified pursuant to 
paragraph (1). 
(c) REAL WORLD EVIDENCE TASK FORCE.— 
(1) ESTABLISHMENT.—The Secretary shall es-
tablish a permanent task force, to be known as the 
Real World Evidence Task Force (in this subsection 
referred to as the ‘‘Task Force’’) to coordinate the 
programs and activities of the Department of Health 
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and Human Services with regard to the collection 
and use of real world evidence. 
(2) MEMBERSHIP.—The members of the Task 
Force shall include the following: 
(A) The Secretary (or the Secretary’s des-
ignee), who shall serve as the Chair of the Task 
Force. 
(B) The Administrator of the Centers for 
Medicare & Medicaid Services (or the Adminis-
trator’s designee). 
(C) The Commissioner of Food and Drugs 
(or the Commissioner’s designee). 
(D) The Director of the National Insti-
tutes of Health (or the Director’s designee). 
(E) Such additional Federal officials (or 
their designees) as the Secretary determines ap-
propriate. 
(F) Private sector representatives, includ-
ing patient group representatives, to be ap-
pointed by the Secretary. 
(3) RECOMMENDATIONS.—In carrying para-
graph (1), the Task Force shall— 
(A) develop and periodically update rec-
ommendations on ways to encourage patients 
to— 
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(i) engage in the generation of real 
world evidence; and 
(ii) participate in postapproval clinical 
trials for the collection of real world evi-
dence; and 
(B) not later than 2 years after the date 
of the enactment of this Act, and every 2 years 
thereafter, submit a report to the Congress on 
such recommendations. 
SEC. 305. IMPROVING FDA–CMS COMMUNICATION REGARD-
ING TRANSFORMATIVE NEW THERAPIES. 
(a) IN GENERAL.—Upon the designation of a product 
as a breakthrough therapy, a fast track product, or a 
product eligible for accelerated approval under subsection 
(a), (b), or (c), respectively, of section 506 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 356), the Com-
missioner of Food and Drugs and the Administrator of 
the Centers for Medicare & Medicaid Services shall— 
(1) maintain communication with each other re-
garding approval and coverage decisions with respect 
to such product; and 
(2) share such information with each other as 
may be appropriate to inform and coordinate such 
decisions. 
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(b) SEPARATE AND DISTINCT.—In approving or des-
ignating a product described in subsection (a), the Com-
missioner of Food and Drugs and the Administrator of 
the Centers for Medicare & Medicaid Services shall ensure 
that the process for approval or designation remains sepa-
rate and distinct. 
SEC. 306. ESTABLISHMENT OF ADDITIONAL INTERCENTER 
INSTITUTES AT THE FOOD AND DRUG ADMIN-
ISTRATION. 
(a) ESTABLISHMENT.—Subsection (c) of section 
1014 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 399g(c)) is amended to read as follows: 
‘‘(c) TIMING.—Not later than the date that is one 
year after the date of the enactment of the Cures 2.0 Act 
or the end of the coronavirus disease 2019 (COVID–19) 
pandemic public health emergency under section 319 of 
the Public Health Service Act, whichever is later, the Sec-
retary shall establish, in accordance with this section, at 
least two additional Institutes under subsection (a).’’. 
(b) CRITERIA.—In establishing the focus of the two 
Institutes referenced in the amendment made by sub-
section (a), the Secretary of Health and Human Services 
shall ensure the following: 
(1) One of the Institutes focuses on a group of 
diseases meeting the following criteria: 
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(B) Over 90 percent of such diseases have 
no therapy approved by the Food and Drug Ad-
ministration. 
(C) Affects, in total, over 30,000,000 
Americans. 
(D) Over 50 percent of patients are chil-
dren. 
(c) REPORT
ON INTERCENTER INSTITUTES.—Not 
later than 2 years after the date of the enactment of this 
Act, and annually thereafter, the Secretary of Health and 
Human Services, acting through the Commissioner of 
Food and Drugs, shall submit a report to the Committee 
on Energy and Commerce of the House of Representatives 
and the Committee on Health, Education, Labor, and 
Pensions of the Senate on the activities of the Institutes 
established pursuant to this section. 
SEC. 307. ACCELERATING TIMELINE FOR BREAKTHROUGH 
AND RMAT DESIGNATIONS. 
(a) 
BREAKTHROUGH
THERAPIES.—Section 
506(a)(2) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 356(a)(2)) is amended by striking ‘‘A request 
for the designation may be made concurrently with, or at 
any time after, the submission of an application for the 
investigation of the drug under section 505(i) or section 
351(a)(3) of the Public Health Service Act’’ and inserting 
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‘‘A request for the designation may be made at any point 
before or after submission of an application for approval 
of the drug under section 505(b) of this Act or licensure 
of the drug under section 351(a)(2) of the Public Health 
Service Act and shall include clinical evidence, including 
preliminary clinical evidence from clinical trials conducted 
outside of the United States’’. 
(b) REGENERATIVE ADVANCED THERAPIES.—Sec-
tion 506(g)(3) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 356(g)(3)) is amended by striking ‘‘con-
currently with, or at any time after, submission of an ap-
plication for the investigation of the drug under section 
505(i) of this Act or section 351(a)(3) of the Public 
Health Service Act’’ and inserting ‘‘at any point before 
or after submission of an application for approval of the 
drug under section 505(b) of this Act or licensure of the 
drug under section 351(a)(2) of the Public Health Service 
Act and shall include clinical evidence, including prelimi-
nary clinical evidence from clinical trials conducted outside 
of the United States’’. 
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SEC. 308. GUIDANCE REGARDING DEVELOPMENT AND SUB-
MISSION OF CHEMISTRY, MANUFACTURING, 
AND CONTROLS INFORMATION FOR EXPE-
DITED APPROVAL. 
(a) IN GENERAL.—The Secretary of Health and 
Human Services shall— 
(1) not later than 6 months after the date of 
the enactment of this Act, issue draft revised guid-
ance to provide clarity regarding the development 
and submission of chemistry, manufacturing, and 
controls information for purposes of subsections (a), 
(b), (c), and (g) of section 506 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 356; relating to 
breakthrough therapies, fast track products, acceler-
ated approval, and regenerative advanced therapies); 
and 
(2) not later than 90 days after the close of a 
period of public comment on such draft guidance, fi-
nalize the guidance. 
(b) CONTENTS.—The guidance under subsection (a) 
shall address— 
(1) how the Food and Drug Administration will 
determine how, and by when, chemistry, manufac-
turing, and controls information is required to be 
submitted throughout development and during the 
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pre- and post-approval phases, taking into consider-
ation— 
(A) how such determinations will reflect 
the risks and benefits of such information given 
the seriousness or life-threatening nature of the 
disease the product is intended to diagnose, 
cure, mitigate, treat, or prevent; 
(B) the phase and expedited nature of de-
velopment; and 
(C) the availability of relevant data and in-
formation from nonclinical and clinical studies, 
product applications, and post-approval over-
sight; and 
(2) how the Food and Drug Administration will 
provide ongoing advice and opportunities for spon-
sors to interact with the Food and Drug Administra-
tion on, and how the Food and Drug Administration 
will facilitate, the submission of chemistry, manufac-
turing, and controls information throughout the life 
cycle of the product. 
SEC. 309. POST-APPROVAL STUDY REQUIREMENTS FOR AC-
CELERATED APPROVAL. 
Section 506(c)(2)(A) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 356(c)(2)(A)) is amended after 
‘‘studies’’ by inserting ‘‘, or otherwise submit evidence 
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based on analyses of data in clinical care data repositories, 
patient registries, or other sources of real world evi-
dence,’’. 
SEC. 310. RECOMMENDATIONS TO DECENTRALIZE CLIN-
ICAL TRIALS. 
(a) IN GENERAL.—Not later than the end of fiscal 
year 2022, the Secretary of Health and Human Services, 
acting through the Commissioner of Food and Drugs, 
shall convene a meeting of covered representatives to rec-
ommend to the Secretary innovative approaches and in-
centives to adopt decentralized clinical trials. 
(b) DEFINITIONS.—In this section: 
(1) COVERED
REPRESENTATIVE.—The term 
‘‘covered representative’’ means a representative of 
the following: 
(A) Sponsors of an application for approval 
of a drug under section 505 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 
355). 
(B) A manufacturer of a device (as defined 
in section 201 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321)). 
(C) Clinical research organizations. 
(D) The technology community. 
(E) The patient community. 
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(2) DECENTRALIZED
CLINICAL
TRIAL.—The 
term ‘‘decentralized clinical trial’’ means a clinical 
trial method that includes the use of telemedicine or 
digital technologies to allow for the remote collection 
of clinical trial data from subjects, including in the 
home or office setting. 
TITLE IV—CENTERS FOR MEDI-
CARE & MEDICAID SERVICES 
SEC. 401. GAO STUDY AND REPORT. 
Not later than one year after the date of the enact-
ment of this Act, the Comptroller General of the United 
States shall submit to Congress a report on recommenda-
tions for administrative actions that may be taken by the 
Secretary of Health and Human Services (as well as rec-
ommendations for legislative changes needed) to— 
(1) enhance coverage and reimbursement ap-
proaches under the Medicare program under title 
XVIII of the Social Security Act for innovative tech-
nologies that increase access to health care, improve 
health care quality, decrease expenditures under 
such program, or otherwise improve the Medicare 
program or health care for beneficiaries under such 
program; and 
(2) better harmonize and integrate the oper-
ating structure of the Medicare program (and the 
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Centers for Medicare & Medicaid Services) to im-
prove interagency collaboration and communication. 
SEC. 402. STRATEGIES TO INCREASE ACCESS TO TELE-
HEALTH UNDER MEDICAID AND CHILDREN’S 
HEALTH INSURANCE PROGRAM. 
(a) GUIDANCE.—Not later than one year after the 
date of the enactment of this Act, the Secretary of Health 
and Human Services shall issue and disseminate guidance 
to States to clarify strategies to overcome existing barriers 
and increase access to telehealth under the Medicaid pro-
gram under title XIX of the Social Security Act (42 
U.S.C. 1396 et seq.) and the Children’s Health Insurance 
Program under title XXI of such Act (42 U.S.C. 1397aa 
et seq.). Such guidance shall include technical assistance 
and best practices regarding— 
(1) existing strategies States can use to inte-
grate telehealth and other virtual health care serv-
ices into value-based health care models; and 
(2) examples of States that have used waivers 
under the Medicaid program to test expanded access 
to telehealth, including during the emergency period 
described in section 1135(g)(1)(B) of the Social Se-
curity Act (42 U.S.C. 1320b–5(g)(1)(B)). 
(b) STUDIES.— 
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(1) TELEHEALTH
IMPACT
ON
HEALTH
CARE 
ACCESS.—Not later than one year after the date of 
the enactment of this Act, the Medicaid and CHIP 
Payment and Access Commission shall conduct a 
study, with respect to a minimum of 10 States 
across geographic regions of the United States, and 
submit to Congress a report, on the impact of tele-
health on health care access, utilization, cost, and 
outcomes, broken down by race, ethnicity, sex, age, 
disability status, and zip code. Such report shall— 
(A) evaluate cost, access, utilization, out-
comes, and patient experience data from across 
the health care field, including States, Medicaid 
managed care organizations, provider organiza-
tions, and other organizations that provide or 
pay for telehealth under the Medicaid program 
and Children’s Health Insurance Program; 
(B) identify barriers and potential solu-
tions to provider entry and participation in tele-
health that States are experiencing, as well as 
barriers to providing telehealth across State 
lines, including during times of public health 
crisis or public health emergency; 
(C) determine the frequency at which out- 
of-State telehealth is provided to patients en-
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rolled in the Medicaid program and the poten-
tial impact on access to telehealth if State Med-
icaid policies were more aligned; and 
(D) identify and evaluate opportunities for 
more alignment among such policies to promote 
access to telehealth across all States, State 
Medicaid plans under title XIX of the Social 
Security Act (42 U.S.C. 1396 et seq.), State 
child health plans under title XXI of such Act 
(42 U.S.C. 1397aa et seq.), and Medicaid man-
aged care organizations, including the potential 
for regional compacts or reciprocity agreements. 
(2) FEDERAL AGENCY TELEHEALTH COLLABO-
RATION.—Not later than 1 year after the date of the 
enactment of this Act, the Comptroller General of 
the United States shall conduct a study and submit 
to Congress a report evaluating collaboration be-
tween Federal agencies with respect to telehealth 
services furnished under the Medicaid or CHIP pro-
gram to individuals under the age of 18, including 
such services furnished to such individuals in early 
care and education settings. Such report shall in-
clude recommendations on— 
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(A) opportunities for Federal agencies to 
improve collaboration with respect to such tele-
health services; and 
(B) opportunities for collaboration between 
Federal agencies to expand telehealth access to 
such individuals enrolled under the Medicaid or 
CHIP program, including in early care and 
education settings. 
SEC. 403. EXTENDING MEDICARE TELEHEALTH FLEXIBILI-
TIES. 
(a) EXPANDING ACCESS
TO TELEHEALTH SERV-
ICES.— 
(1) IN
GENERAL.—Section 1834(m)(4)(C) of 
the Social Security Act (42 U.S.C. 1395m(m)(4)(C)) 
is amended by adding at the end the following new 
clause: 
‘‘(iii) EXPANDING ACCESS TO TELE-
HEALTH SERVICES.—With respect to tele-
health services furnished beginning on the 
first day after the end of the emergency 
period described in section 1135(g)(1)(B) 
of this clause, the term ‘originating site’ 
means any site at which the eligible tele-
health individual is located at the time the 
service is furnished via a telecommuni-
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cations system, including the home of an 
individual.’’. 
(2) CONFORMING AMENDMENTS.—Such section 
is amended— 
(A) in paragraph (2)(B)— 
(i) in clause (i), in the matter pre-
ceding subclause (I), by striking ‘‘clause 
(ii)’’ and inserting ‘‘clauses (ii) and (iii)’’; 
and 
(ii) by adding at the end the following 
new clause: 
‘‘(iii) NO
FACILITY
FEE
FOR
NEW 
SITES.—With respect to telehealth services 
furnished on or after the date of the enact-
ment of this clause, a facility fee shall only 
be paid under this subparagraph to an 
originating site that is described in para-
graph (4)(C)(ii) (other than subclause (X) 
of such paragraph).’’; 
(B) in paragraph (4)(C)— 
(i) in clause (i), in the matter pre-
ceding subclause (I), by inserting ‘‘and 
clause (iii)’’ after ‘‘and (7)’’; and 
(ii) in clause (ii)(X), by inserting 
‘‘prior to the first day after the end of the 
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emergency period described in section 
1135(g)(1)(B)’’ before the period; 
(C) in paragraph (5), by inserting ‘‘and 
prior to the first day after the end of the emer-
gency 
period 
described 
in 
section 
1135(g)(1)(B)’’ after ‘‘January 1, 2019,’’; 
(D) in paragraph (6)(A), by inserting ‘‘and 
prior to the first day after the end of the emer-
gency 
period 
described 
in 
section 
1135(g)(1)(B),’’ after ‘‘January 1, 2019,’’; and 
(E) in paragraph (7), by adding at the end 
the following new subparagraph: 
‘‘(C) SUNSET.—The provisions of this 
paragraph shall not apply with respect to serv-
ices furnished on or after the first day after the 
end of the emergency period described in sec-
tion 1135(g)(1)(B).’’. 
(b) EXPANDING PRACTITIONERS ELIGIBLE TO FUR-
NISH TELEHEALTH SERVICES.—Section 1834(m) of the 
Social Security Act (42 U.S.C. 1395m(m)) is amended— 
(1) in paragraph (1), by striking ‘‘(described in 
section 1842(b)(18)(C))’’ and inserting ‘‘(defined in 
paragraph (4)(E))’’; and 
(2) in paragraph (4)(E)— 
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(A) by striking ‘‘PRACTITIONER.—The 
term’’ and inserting ‘‘PRACTITIONER.— 
‘‘(A) IN
GENERAL.—Subject to subpara-
graph (B), the term’’; and 
(B) by adding at the end the following new 
subparagraph: 
‘‘(B) EXPANSION.—The Secretary, after 
consulting with stakeholders regarding services 
that are clinically appropriate, may expand the 
types of practitioners who may furnish tele-
health services to include any health care pro-
fessional that is eligible to bill the program 
under this title for their professional services.’’. 
(c) RETENTION OF ADDITIONAL SERVICES AND SUB-
REGULATORY PROCESS FOR MODIFICATIONS FOLLOWING 
EMERGENCY PERIOD.—Section 1834(m)(4)(F) of the So-
cial Security Act (42 U.S.C. 1395m(m)(4)(F)) is amend-
ed— 
(1) in clause (i), by inserting ‘‘and clause (iii)’’ 
after ‘‘paragraph (8)’’; 
(2) in clause (ii), by striking ‘‘The Secretary’’ 
and inserting ‘‘Subject to clause (iii), the Sec-
retary’’; and 
(3) by adding at the end the following new 
clause: 
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‘‘(iii) RETENTION
OF
ADDITIONAL 
SERVICES AND SUBREGULATORY PROCESS 
FOR
MODIFICATIONS
FOLLOWING
EMER-
GENCY
PERIOD.—With respect to tele-
health services furnished after the last day 
of the emergency period described in sec-
tion 1135(g)(1)(B), the Secretary may— 
‘‘(I) retain as appropriate the ex-
panded list of telehealth services spec-
ified in clause (i) pursuant to the 
waiver 
authority 
under 
section 
1135(b)(8) during such emergency pe-
riod; and 
‘‘(II) retain the subregulatory 
process used to modify the services in-
cluded on the list of such telehealth 
services pursuant to clause (ii) during 
such emergency period.’’. 
(d) ENHANCING TELEHEALTH SERVICES FOR FED-
ERALLY
QUALIFIED
HEALTH
CENTERS
AND
RURAL 
HEALTH CLINICS.—Section 1834(m)(8) of the Social Se-
curity Act (42 U.S.C. 1395m(m)(8)) is amended— 
(1) in the paragraph heading by inserting ‘‘AND 
AFTER’’ after ‘‘DURING’’; 
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(2) in subparagraph (A), in the matter pre-
ceding clause (i), by inserting ‘‘and after’’ after 
‘‘During’’; and 
(3) in the first sentence of subparagraph (B)(i), 
by inserting ‘‘and after’’ after ‘‘during’’. 
(e) USE OF TELEHEALTH, AS CLINICALLY APPRO-
PRIATE, TO CONDUCT FACE-TO-FACE ENCOUNTER FOR 
HOSPICE CARE.—Section 1814(a)(7)(D)(i)(II) of the So-
cial Security Act (42 U.S.C. 1395f(a)(7)(D)(i)(II)) is 
amended by inserting ‘‘and after such emergency period 
as clinically appropriate’’ after ‘‘1135(g)(1)(B)’’. 
(f) USE OF TELEHEALTH, AS CLINICALLY APPRO-
PRIATE, TO CONDUCT FACE-TO-FACE CLINICAL ASSESS-
MENTS
FOR HOME DIALYSIS.—Clause (iii) of section 
1881(b)(3)(B) of the Social Security Act (42 U.S.C. 
1395rr(b)(3)(B)) is amended— 
(1) by moving such clause 4 ems to the left; 
and 
(2) by inserting ‘‘and after such emergency pe-
riod as clinically appropriate’’ before the period. 
(g) IMPLEMENTATION.—Notwithstanding any provi-
sion of law, the Secretary may implement the provisions 
of, and amendments made by, this section by interim final 
rule, program instruction, or otherwise. 
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SEC. 404. COVERAGE AND PAYMENT FOR BREAKTHROUGH 
DEVICES UNDER THE MEDICARE PROGRAM. 
(a) IN GENERAL.—Part E of title XVIII of the Social 
Security Act (42 U.S.C. 1395x et seq.) is amended by add-
ing at the end the following new section: 
‘‘SEC. 1899C. COVERAGE OF BREAKTHROUGH DEVICES. 
‘‘(a) BREAKTHROUGH DEVICES.—For purposes of 
this section, the term ‘breakthrough device’ means a med-
ical device that is a device (as defined in section 201 of 
the Federal Food, Drug, and Cosmetic Act) and that is— 
‘‘(1) provided with review priority by the Sec-
retary under subsection (d)(5) of section 515 of such 
Act; and 
‘‘(2) approved or cleared pursuant to section 
510(k), 513(f), or 515 of such Act for use in treat-
ing an indication on or after March 15, 2021. 
Such term also includes a breakthrough device that is a 
specified breakthrough device (as defined in subsection 
(e)(1)(B)) approved or cleared pursuant to section 510(k), 
513(f), or 515 of such Act for use in treating an indication 
on or after March 15, 2021. 
‘‘(b) COVERAGE.— 
‘‘(1) TRANSITIONAL COVERAGE.— 
‘‘(A) IN
GENERAL.—During the transi-
tional coverage period (as defined in subpara-
graph (B)) a breakthrough device shall be— 
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‘‘(i) deemed to be reasonable and nec-
essary 
for 
purposes 
of 
section 
1862(a)(1)(A); 
‘‘(ii) deemed to be approved for an ad-
ditional 
payment 
under 
section 
1886(d)(5)(K) (other than with respect to 
the cost criterion under clause (ii)(I) of 
such section); 
‘‘(iii) deemed to be approved for pass- 
through payment under section 1833(t)(6) 
and section 1833(i) (other than with re-
spect to the cost criterion under section 
1833(t)(6)(A)(iv)); and 
‘‘(iv) insofar as such breakthrough de-
vice may be furnished in a setting for 
which payment is made under an applica-
ble payment system described in subpara-
graphs (D) through (I) of subsection 
(c)(4), deemed eligible for an additional 
payment or payment adjustment, as the 
case may be, pursuant to subsection (d)(3) 
when furnished in a setting for which pay-
ment is made under such an applicable 
payment system during such transitional 
coverage period. 
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‘‘(B) TRANSITIONAL
COVERAGE
PERIOD 
DEFINED.—As used in this section, the term 
‘transitional coverage period’ means, with re-
spect to a breakthrough device, the period 
that— 
‘‘(i) begins on the date of the approval 
under section 515 of the Federal Food, 
Drug, and Cosmetic Act or of the clear-
ance under section 510(k) of such Act, as 
applicable, of such device by the Secretary 
for the indication described in subsection 
(a)(1); and 
‘‘(ii) ends on the last day of the 4- 
year period that begins on the date that 
the Secretary, pursuant to subsection 
(c)(2), updates the relevant applicable pay-
ment system (as defined in subsection 
(c)(4)) to recognize the unique temporary 
or permanent code or codes assigned under 
subsection (c)(1) to such breakthrough de-
vice, except as provided in subsections 
(d)(1)(B) and (d)(2)(B). 
‘‘(C) DATA USED TO MEET THE NTAP AND 
PASS-THROUGH
COST
CRITERIA.—In 
deter-
mining whether a breakthrough device qualifies 
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system established under this title for such 
items and services when furnished by such pro-
vider of services or supplier. 
‘‘(d) PAYMENT.— 
‘‘(1) INPATIENT HOSPITAL PROSPECTIVE PAY-
MENT SYSTEM: DEEMED ELIGIBILITY FOR BREAK-
THROUGH
PAYMENT.—The Secretary shall deem 
each breakthrough device as approved for an addi-
tional payment under section 1886(d)(5)(K) for the 
4-year period that begins— 
‘‘(A) except as provided in subparagraph 
(B), on the date that the Secretary, pursuant to 
subsection (c)(2)(A), updates the payment sys-
tem under section 1886(d) to recognize the 
unique temporary or permanent code or codes 
assigned under subsection (c)(1) to such break-
through device; or 
‘‘(B) in the case of a device that has not 
received approval or clearance as a break-
through device by the Food and Drug Adminis-
tration before such payment system is updated 
under subsection (c)(2)(A) to recognize the 
unique temporary or permanent code or codes 
assigned under subsection (c)(1) to such device, 
on the date of such approval or clearance. 
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133 
mined by the Secretary) to use claims data. 
Upon the Secretary’s approval of a clinician-led 
clinical data registry’s application described in 
this subparagraph, the Secretary shall provide 
access to a database of claims data to such cli-
nician-led clinical data registry for a period of 
at least 5 years. After the expiration of the time 
period described in this subparagraph, the clini-
cian-led clinical data registry shall reapply to 
access the database of claims data under the 
program established in subsection (a). 
(B) PROCESS.—The Secretary shall estab-
lish a streamlined initial application and recer-
tification application process under which the 
Secretary shall approve or deny the clinician-led 
clinical data registry’s application described in 
subparagraph (2)(A) within 60 calendar days 
after receiving the application unless the Sec-
retary demonstrates a compelling reason for 
needing additional time to complete the process. 
If the clinician-led clinical data registry’s appli-
cation described in subparagraph (2)(A) is de-
nied, the Secretary shall provide the reason(s) 
for denial. 
(3) APPEAL RIGHTS.— 
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