181 
legislation and administrative action as the Secretary de-
termines appropriate. 
SEC. 503. REQUIRING PRESCRIPTION DRUG PLANS AND 
MA–PD 
PLANS 
TO 
REPORT 
POTENTIAL 
FRAUD, WASTE, AND ABUSE TO THE SEC-
RETARY OF HHS. 
Section 1860D–4 of the Social Security Act (42 
U.S.C. 1395w–104) is amended by adding at the end the 
following new subsection: 
‘‘(p) REPORTING POTENTIAL FRAUD, WASTE, AND 
ABUSE.—Beginning January 1, 2022, the PDP sponsor 
of a prescription drug plan shall report to the Secretary, 
as specified by the Secretary— 
‘‘(1) any substantiated or suspicious activities 
(as defined by the Secretary) with respect to the 
program under this part as it relates to fraud, 
waste, and abuse; and 
‘‘(2) any steps made by the PDP sponsor after 
identifying such activities to take corrective ac-
tions.’’. 
SEC. 504. ESTABLISHMENT OF PHARMACY QUALITY MEAS-
URES UNDER MEDICARE PART D. 
Section 1860D–4(c) of the Social Security Act (42 
U.S.C. 1395w–104(c)) is amended by adding at the end 
the following new paragraph: 
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‘‘(8) APPLICATION
OF
PHARMACY
QUALITY 
MEASURES.— 
‘‘(A) IN GENERAL.—A PDP sponsor that 
implements incentive payments to a pharmacy 
or price concessions paid by a pharmacy based 
on quality measures shall use measures estab-
lished or approved by the Secretary under sub-
paragraph (B) with respect to payment for cov-
ered part D drugs dispensed by such pharmacy. 
‘‘(B) 
STANDARD
PHARMACY
QUALITY 
MEASURES.—The Secretary shall establish or 
approve standard quality measures from a con-
sensus and evidence-based organization for pay-
ments described in subparagraph (A). Such 
measures shall focus on patient health outcomes 
and be based on proven criteria measuring 
pharmacy performance. 
‘‘(C) EFFECTIVE DATE.—The requirement 
under subparagraph (A) shall take effect for 
plan years beginning on or after January 1, 
2023, or such earlier date specified by the Sec-
retary if the Secretary determines there are suf-
ficient measures established or approved under 
subparagraph (B) to meet the requirement 
under subparagraph (A).’’. 
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SEC. 505. IMPROVING COORDINATION BETWEEN THE FOOD 
AND DRUG ADMINISTRATION AND THE CEN-
TERS FOR MEDICARE & MEDICAID SERVICES. 
(a) IN GENERAL.— 
(1) PUBLIC MEETING.— 
(A) IN
GENERAL.—Not later than 12 
months after the date of the enactment of this 
Act, the Secretary of Health and Human Serv-
ices (referred to in this section as the ‘‘Sec-
retary’’) shall convene a public meeting for the 
purposes of discussing and providing input on 
improvements to coordination between the Food 
and Drug Administration and the Centers for 
Medicare & Medicaid Services in preparing for 
the availability of novel medical products de-
scribed in subsection (c) on the market in the 
United States. 
(B) ATTENDEES.—The public meeting 
shall include— 
(i) representatives of relevant Federal 
agencies, including representatives from 
each of the medical product centers within 
the Food and Drug Administration and 
representatives from the coding, coverage, 
and payment offices within the Centers for 
Medicare & Medicaid Services; 
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(ii) stakeholders with expertise in the 
research and development of novel medical 
products, including manufacturers of such 
products; 
(iii) representatives of commercial 
health insurance payers; 
(iv) stakeholders with expertise in the 
administration and use of novel medical 
products, including physicians; and 
(v) stakeholders representing patients 
and with expertise in the utilization of pa-
tient experience data in medical product 
development. 
(C) TOPICS.—The public meeting shall in-
clude a discussion of— 
(i) the status of the drug and medical 
device development pipeline related to the 
availability of novel medical products; 
(ii) the anticipated expertise necessary 
to review the safety and effectiveness of 
such products at the Food and Drug Ad-
ministration and current gaps in such ex-
pertise, if any; 
(iii) the expertise necessary to make 
coding, coverage, and payment decisions 
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with respect to such products within the 
Centers for Medicare & Medicaid Services, 
and current gaps in such expertise, if any; 
(iv) trends in the differences in the 
data necessary to determine the safety and 
effectiveness of a novel medical product 
and the data necessary to determine 
whether a novel medical product meets the 
reasonable and necessary requirements for 
coverage and payment under title XVIII of 
the Social Security Act pursuant to section 
1862(a)(1)(A) of such Act (42 U.S.C. 
1395y(a)(1)(A)); 
(v) the availability of information for 
sponsors of such novel medical products to 
meet each of those requirements; and 
(vi) the coordination of information 
related to significant clinical improvement 
over existing therapies for patients between 
the Food and Drug Administration and the 
Centers for Medicare & Medicaid Services 
with respect to novel medical products. 
(D) TRADE SECRETS AND CONFIDENTIAL 
INFORMATION.—No information discussed as a 
part of the public meeting under this paragraph 
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186 
shall be construed as authorizing the Secretary 
to disclose any information that is a trade se-
cret or confidential information subject to sec-
tion 552(b)(4) of title 5, United States Code. 
(2) IMPROVING
TRANSPARENCY
OF
CRITERIA 
FOR MEDICARE COVERAGE.— 
(A) DRAFT GUIDANCE.—Not later than 18 
months after the public meeting under para-
graph (1), the Secretary shall update the final 
guidance titled ‘‘National Coverage Determina-
tions with Data Collection as a Condition of 
Coverage: Coverage with Evidence Develop-
ment’’ to address any opportunities to improve 
the availability and coordination of information 
as described in clauses (iv) through (vi) of para-
graph (1)(C). 
(B) FINAL GUIDANCE.—Not later than 12 
months after issuing draft guidance under sub-
paragraph (A), the Secretary shall finalize the 
updated guidance to address any such opportu-
nities. 
(b) REPORT ON CODING, COVERAGE, AND PAYMENT 
PROCESSES UNDER MEDICARE
FOR NOVEL MEDICAL 
PRODUCTS.—Not later than 12 months after the date of 
the enactment of this Act, the Secretary shall publish a 
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report on the internet website of the Department of 
Health and Human Services regarding processes under 
the Medicare program under title XVIII of the Social Se-
curity Act (42 U.S.C. 1395 et seq.) with respect to the 
coding, coverage, and payment of novel medical products 
described in subsection (c). Such report shall include the 
following: 
(1) A description of challenges in the coding, 
coverage, and payment processes under the Medicare 
program for novel medical products. 
(2) Recommendations to— 
(A) incorporate patient experience data 
(such as the impact of a disease or condition on 
the lives of patients and patient treatment pref-
erences) into the coverage and payment proc-
esses within the Centers for Medicare & Med-
icaid Services; 
(B) decrease the length of time to make 
national and local coverage determinations 
under the Medicare program (as those terms 
are defined in subparagraph (A) and (B), re-
spectively, of section 1862(l)(6) of the Social 
Security Act (42 U.S.C. 1395y(l)(6))); 
(C) streamline the coverage process under 
the Medicare program and incorporate input 
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from relevant stakeholders into such coverage 
determinations; and 
(D) identify potential mechanisms to incor-
porate novel payment designs similar to those 
in development in commercial insurance plans 
and State plans under title XIX of such Act 
(42 U.S.C. 1396 et seq.) into the Medicare pro-
gram. 
(c) NOVEL MEDICAL PRODUCTS DESCRIBED.—For 
purposes of this section, a novel medical product described 
in this subsection is a medical product, including a drug, 
biological (including gene and cell therapy), or medical de-
vice, that has been designated as a breakthrough therapy 
under section 506(a) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 356(a)), a breakthrough device 
under section 515B of such Act (21 U.S.C. 360e–3), or 
a regenerative advanced therapy under section 506(g) of 
such Act (21 U.S.C. 356(g)). 
SEC. 506. PATIENT CONSULTATION IN MEDICARE NA-
TIONAL AND LOCAL COVERAGE DETERMINA-
TIONS IN ORDER TO MITIGATE BARRIERS TO 
INCLUSION OF SUCH PERSPECTIVES. 
Section 1862(l) of the Social Security Act (42 U.S.C. 
1395y(l)) is amended by adding at the end the following 
new paragraph: 
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‘‘(7) PATIENT
CONSULTATION
IN
NATIONAL 
AND LOCAL COVERAGE DETERMINATIONS.—The Sec-
retary may consult with patients and organizations 
representing patients in making national and local 
coverage determinations.’’. 
SEC. 507. MEDPAC REPORT ON SHIFTING COVERAGE OF 
CERTAIN MEDICARE PART B DRUGS TO MEDI-
CARE PART D. 
(a) STUDY.—The Medicare Payment Advisory Com-
mission (in this section referred to as the ‘‘Commission’’) 
shall conduct a study on shifting coverage of certain drugs 
and biologicals for which payment is currently made under 
part B of title XVIII of the Social Security Act (42 U.S.C. 
1395j et seq.) to part D of such title (42 U.S.C. 1395w– 
21 et seq.). Such study shall include an analysis of— 
(1) differences in program structures and pay-
ment methods for drugs and biologicals covered 
under such parts B and D, including effects of such 
a shift on program spending, beneficiary cost-shar-
ing liability, and utilization management techniques 
for such drugs and biologicals; and 
(2) the feasibility and policy implications of 
shifting coverage of drugs and biologicals for which 
payment is currently made under such part B to 
such part D. 
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(b) REPORT.— 
(1) IN
GENERAL.—Not later than June 30, 
2023, the Commission shall submit to Congress a re-
port containing the results of the study conducted 
under subsection (a). 
(2) CONTENTS.—The report under paragraph 
(1) shall include information, and recommendations 
as the Commission deems appropriate, regarding— 
(A) formulary design under such part D; 
(B) the ability of the benefit structure 
under such part D to control total spending on 
drugs and biologicals for which payment is cur-
rently made under such part B; 
(C) changes to the bid process under such 
part D, if any, that may be necessary to inte-
grate coverage of such drugs and biologicals 
into such part D; 
(D) any other changes to the program that 
Congress should consider in determining wheth-
er to shift coverage of such drugs and 
biologicals from such part B to such part D; 
and 
(E) the feasibility and policy implications 
of creating a methodology to preserve the 
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healthcare provider’s ability to take title of the 
drug, including a methodology under which— 
(i) prescription drug plans negotiate 
reimbursement rates and other arrange-
ments with drug manufacturers on behalf 
of a wholesaler; 
(ii) wholesalers purchase the drugs 
from the manufacturers at the negotiated 
rate and ship them through distributors to 
physicians to administer to patients; 
(iii) physicians and hospitals purchase 
the drug from the wholesaler via the dis-
tributor; 
(iv) after administering the drug, the 
physician submits a claim to the MAC for 
their drug administration fee; 
(v) to be reimbursed for the purchase 
of the drug from the distributor, the physi-
cian furnishes the claim for the drug itself 
to the wholesaler and the wholesaler would 
refund the cost of the drug to the physi-
cian; and 
(vi) the wholesaler passes this claim to 
the PDP to receive reimbursement. 
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