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such payments) with respect to 
covered part D drugs dispensed 
to the enrollee; and 
‘‘(gg) shall have in place a 
financial reconciliation process to 
correct inaccuracies in payments 
made by an enrollee under this 
subparagraph with respect to 
covered part D drugs during the 
plan year. 
‘‘(IV) FAILURE TO PAY AMOUNT 
BILLED.—If an enrollee fails to pay 
the amount billed for a month as re-
quired under this subparagraph, the 
election of the enrollee pursuant to 
clause (i) shall be terminated and the 
enrollee shall pay the cost sharing 
otherwise applicable for any covered 
part D drugs subsequently dispensed 
to the enrollee up to the annual out- 
of-pocket threshold specified in para-
graph (4)(B). 
‘‘(V) CLARIFICATION REGARDING 
PAST DUE AMOUNTS.—Nothing in this 
subparagraph shall be construed as 
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prohibiting a PDP sponsor or an MA 
organization from billing an enrollee 
for an amount owed under this sub-
paragraph. 
‘‘(VI) TREATMENT
OF
UNSET-
TLED BALANCES.—Any unsettled bal-
ances with respect to amounts owed 
under this subparagraph shall be 
treated as plan losses and the Sec-
retary shall not be liable for any such 
balances outside of those assumed as 
losses estimated in plan bids.’’; and 
(2) in paragraph (4)— 
(A) in subparagraph (C), by striking ‘‘in 
subparagraph (E)’’ and inserting ‘‘in subpara-
graph (E) and subject to subparagraph (F)’’; 
and 
(B) by adding at the end the following new 
subparagraph: 
‘‘(F) INCLUSION OF COSTS PAID UNDER 
MAXIMUM MONTHLY CAP OPTION.—In applying 
subparagraph (A), with respect to an enrollee 
who has made an election pursuant to clause (i) 
of paragraph (2)(E), costs shall be treated as 
incurred if such costs are paid by a PDP spon-
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sor or an MA organization under the option 
provided under such paragraph.’’. 
(b) APPLICATION TO ALTERNATIVE PRESCRIPTION 
DRUG COVERAGE.—Section 1860D–2(c) of the Social Se-
curity Act (42 U.S.C. 1395w–102(c)) is amended by add-
ing at the end the following new paragraph: 
‘‘(4) SAME MAXIMUM MONTHLY CAP ON COST 
SHARING.—For plan years beginning on or after 
January 1, 2025, the maximum monthly cap on cost 
sharing payments under the option provided under 
subsection (b)(2)(E) shall apply to such coverage.’’. 
(c) IMPLEMENTATION
FOR 2025.—The Secretary 
shall implement this section, including the amendments 
made by this section, for 2025 by program instruction or 
otherwise. 
(d) FUNDING.—In addition to amounts otherwise 
available, there are appropriated to the Centers for Medi-
care & Medicaid Services, out of any money in the Treas-
ury not otherwise appropriated, $1,000,000 for each of fis-
cal years 2022 through 2031, to remain available until ex-
pended, to carry out the provisions of, including the 
amendments made by, this section. 
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PART 4—REPEAL OF CERTAIN PRESCRIPTION 
DRUG REBATE RULE 
SEC. 139301. PROHIBITING IMPLEMENTATION OF RULE RE-
LATING TO ELIMINATING THE ANTI-KICK-
BACK STATUTE SAFE HARBOR PROTECTION 
FOR PRESCRIPTION DRUG REBATES. 
Beginning January 1, 2026, the Secretary of Health 
and Human Services shall not implement, administer, or 
enforce the provisions of the final rule published by the 
Office of the Inspector General of the Department of 
Health and Human Services on November 30, 2020, and 
titled ‘‘Fraud and Abuse; Removal of Safe Harbor Protec-
tion for Rebates Involving Prescription Pharmaceuticals 
and Creation of New Safe Harbor Protection for Certain 
Point-of-Sale Reductions in Price on Prescription Phar-
maceuticals and Certain Pharmacy Benefit Manager Serv-
ice Fees’’ (85 Fed. Reg. 76666). 
PART 5—MISCELLANEOUS 
SEC. 139401. APPROPRIATE COST-SHARING FOR CERTAIN 
INSULIN PRODUCTS UNDER MEDICARE PART 
D. 
(a) IN GENERAL.—Section 1860D–2 of the Social 
Security Act (42 U.S.C. 1395w–102) is amended— 
(1) in subsection (b)— 
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(A) in paragraph (1)(A), by striking ‘‘The 
coverage’’ and inserting ‘‘Subject to paragraph 
(8), the coverage’’; 
(B) in paragraph (2)(A), by striking ‘‘and 
(D)’’ and inserting ‘‘and (D) and paragraph 
(8)’’; 
(C) in paragraph (3)(A), by striking ‘‘and 
(4)’’ and inserting ‘‘(4), and (8)’’; 
(D) in paragraph (4)(A)(i), by striking 
‘‘The coverage’’ and inserting ‘‘Subject to para-
graph (8), the coverage’’; and 
(E) by adding at the end the following new 
paragraph: 
‘‘(8) TREATMENT OF COST-SHARING FOR CER-
TAIN INSULIN PRODUCTS.— 
‘‘(A) IN GENERAL.—For plan years begin-
ning on or after January 1, 2023, the following 
shall apply with respect to insulin products (as 
defined in subparagraph (B)): 
‘‘(i) NO
APPLICATION
OF
DEDUCT-
IBLE.—The deductible under paragraph 
(1) shall not apply with respect to such in-
sulin products. 
‘‘(ii) APPLICATION
OF
COST-SHAR-
ING.— 
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‘‘(I) PLAN YEAR 2023.—For plan 
year 2023, the coverage provides ben-
efits for such insulin products, regard-
less of whether an individual has 
reached the initial coverage limit 
under paragraph (3) or the out-of- 
pocket threshold under paragraph (4), 
with cost-sharing that is equal to the 
applicable copayment amount. 
‘‘(II) PLAN YEAR 2024 AND SUB-
SEQUENT
PLAN
YEARS.—For plan 
year 2024 and subsequent plan years, 
the coverage provides benefits for 
such insulin products, prior to an in-
dividual reaching the out-of-pocket 
threshold under paragraph (4), with 
cost-sharing that is equal to the appli-
cable copayment amount. 
‘‘(III) APPLICABLE
COPAYMENT 
AMOUNT.—For 
purposes 
of 
this 
clause, the term ‘applicable copayment 
amount’ means, with respect to an in-
sulin product under a prescription 
drug plan or an MA–PD plan, an 
amount that is not more than $35. 
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‘‘(B) INSULIN PRODUCT.—For purposes of 
this paragraph, the term ‘insulin product’ 
means an insulin product that is approved 
under section 505 of the Federal Food, Drug, 
and Cosmetic Act or licensed under section 351 
of the Public Health Service Act and marketed 
pursuant to such approval or licensure, includ-
ing any insulin product that has been deemed 
to be licensed under section 351 of the Public 
Health 
Service 
Act 
pursuant 
to 
section 
7002(e)(4) of the Biologics Price Competition 
and Innovation Act of 2009 and marketed pur-
suant to such section.’’; and 
(2) in subsection (c), by adding at the end the 
following new paragraph: 
‘‘(4) TREATMENT OF COST-SHARING FOR INSU-
LIN PRODUCTS.—The coverage is provided in accord-
ance with subsection (b)(8).’’. 
(b) CONFORMING AMENDMENTS TO COST-SHARING 
FOR LOW-INCOME INDIVIDUALS.—Section 1860D–14(a) 
of the Social Security Act (42 U.S.C. 1395w–114(a)) is 
amended— 
(1) in paragraph (1)— 
(A) in subparagraph (D)(iii), by adding at 
the end the following new sentence: ‘‘For plan 
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year 2023 and subsequent plan years, the co-
payment amount applicable under the preceding 
sentence to an insulin product (as defined in 
section 1860D–2(b)(8)(B)) furnished to the in-
dividual may not exceed the applicable copay-
ment amount for the product under the pre-
scription drug plan or MA–PD plan in which 
the individual is enrolled.’’; and 
(B) in subparagraph (E), by inserting the 
following before the period at the end ‘‘or under 
section 1860D–2(b)(8) in the case of an insulin 
product (as defined in subparagraph (B) of 
such section)’’; and 
(2) in paragraph (2)— 
(A) in subparagraph (D), by adding at the 
end the following new sentence: ‘‘For plan year 
2023 and subsequent plan years, the amount of 
the coinsurance applicable under the preceding 
sentence to an insulin product (as defined in 
section 1860D–2(b)(8)(B)) furnished to the in-
dividual may not exceed the applicable copay-
ment amount for the product under the pre-
scription drug plan or MA–PD plan in which 
the individual is enrolled.’’; and 
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(B) in subparagraph (E), by adding at the 
end the following new sentence: ‘‘For plan year 
2023, the amount of the copayment or coinsur-
ance applicable under the preceding sentence to 
an insulin product (as defined in section 
1860D–2(b)(8)(B)) furnished to the individual 
may not exceed the applicable copayment 
amount for the product under the prescription 
drug plan or MA–PD plan in which the indi-
vidual is enrolled.’’ 
(c) IMPLEMENTATION.—The Secretary shall imple-
ment this section for plan years 2023 and 2024 by pro-
gram instruction or otherwise. 
SEC. 
139402. 
COVERAGE 
OF 
ADULT 
VACCINES 
REC-
OMMENDED BY THE ADVISORY COMMITTEE 
ON IMMUNIZATION PRACTICES UNDER MEDI-
CARE PART D. 
(a) ENSURING TREATMENT OF COST SHARING IS 
CONSISTENT WITH TREATMENT OF VACCINES UNDER 
MEDICARE PART B.—Section 1860D–2 of the Social Se-
curity Act (42 U.S.C. 1395w–102), as amended by section 
139401, is further amended— 
(1) in subsection (b)— 
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(A) in paragraph (1)(A), by striking 
‘‘paragraph (8)’’ and inserting ‘‘paragraphs (8) 
and (9)’’; 
(B) in paragraph (2)(A), by striking 
‘‘paragraph (8)’’ and inserting ‘‘paragraphs (8) 
and (9)’’; 
(C) in paragraph (3)(A), by striking ‘‘and 
(8)’’ and inserting ‘‘(8), and (9)’’; 
(D) in paragraph (4)(A)(i), by striking 
‘‘paragraph (8)’’ and inserting ‘‘paragraphs (8) 
and (9)’’; and 
(E) by adding at the end the following new 
paragraph: 
‘‘(9) TREATMENT
OF
COST
SHARING
FOR 
ADULT VACCINES RECOMMENDED BY THE ADVISORY 
COMMITTEE
ON
IMMUNIZATION
PRACTICES
CON-
SISTENT
WITH
TREATMENT
OF
VACCINES
UNDER 
PART B.— 
‘‘(A) IN GENERAL.—For plan years begin-
ning on or after January 1, 2024 , the fol-
lowing shall apply with respect to an adult vac-
cine recommended by the Advisory Committee 
on Immunization Practices (as defined in sub-
paragraph (B)): 
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‘‘(i) NO
APPLICATION
OF
DEDUCT-
IBLE.—The deductible under paragraph 
(1) shall not apply with respect to such 
vaccine. 
‘‘(ii) NO
APPLICATION
OF
COINSUR-
ANCE
OR
ANY
OTHER
COST-SHARING.— 
There shall be no coinsurance or other 
cost-sharing under this part with respect 
to such vaccine, regardless of whether for 
costs below, at, or above the initial cov-
erage limit under paragraph (3) or the 
out-of-pocket threshold under paragraph 
(4). 
‘‘(B) ADULT VACCINES RECOMMENDED BY 
THE ADVISORY COMMITTEE ON IMMUNIZATION 
PRACTICES.—For purposes of this paragraph, 
the term ‘adult vaccine recommended by the 
Advisory Committee on Immunization Prac-
tices’ means a covered part D drug that is a 
vaccine licensed under section 351 of the Public 
Health Service Act for use by adult populations 
and administered in accordance with rec-
ommendations of the Advisory Committee on 
Immunization Practices of the Centers for Dis-
ease Control and Prevention.’’; and 
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(2) in subsection (c), by adding at the end the 
following new paragraph: 
‘‘(5) TREATMENT
OF
COST
SHARING
FOR 
ADULT VACCINES RECOMMENDED BY THE ADVISORY 
COMMITTEE
ON
IMMUNIZATION
PRACTICES.—The 
coverage is in accordance with subsection (b)(9).’’. 
(b) CONFORMING AMENDMENTS TO COST SHARING 
FOR LOW-INCOME INDIVIDUALS.—Section 1860D–14(a) 
of the Social Security Act (42 U.S.C. 1395w–114(a)), as 
amended by section 139401, is further amended— 
(1) in paragraph (1)(D), in each of clauses (ii) 
and (iii), by striking ‘‘In the case’’ and inserting 
‘‘Subject to paragraph (6), in the case’’; 
(2) in paragraph (2)— 
(A) in subparagraph (B), by striking ‘‘A 
reduction’’ and inserting ‘‘Subject to paragraph 
(6), a reduction’’ 
(B) in subparagraph (D), by striking ‘‘The 
substitution’’ and inserting ‘‘Subject to para-
graph (6), the substitution’’; and 
(C) in subparagraph (E), by striking ‘‘sub-
section (c)’’ and inserting ‘‘paragraph (6) and 
subsection (c)’’; and 
(3) by adding at the end the following new 
paragraph: 
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Calendar No. 464 
117TH CONGRESS 
2D SESSION 
H. R. 5376 
AN ACT 
To provide for reconciliation pursuant to title II of 
S. Con. Res. 14. 
AUGUST 3, 2022 
Read the second time and placed on the calendar 
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