140 
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-
VerDate Sep 11 2014 
17:03 Apr 19, 2022
Jkt 029200
PO 00000
Frm 00140
Fmt 6652
Sfmt 6201
E:\BILLS\H7497.IH
H7497
pamtmann on DSKBC07HB2PROD with BILLS
141 
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 cov-
erage.’’. 
(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. 
VerDate Sep 11 2014 
17:03 Apr 19, 2022
Jkt 029200
PO 00000
Frm 00141
Fmt 6652
Sfmt 6201
E:\BILLS\H7497.IH
H7497
pamtmann on DSKBC07HB2PROD with BILLS
142 
TITLE IV—REPEAL OF CERTAIN 
PRESCRIPTION 
DRUG 
RE-
BATE RULE 
SEC. 401. PROHIBITING IMPLEMENTATION OF RULE RELAT-
ING TO ELIMINATING THE ANTI-KICKBACK 
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). 
TITLE V—MISCELLANEOUS 
SEC. 501. APPROPRIATE COST-SHARING FOR CERTAIN IN-
SULIN 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)— 
VerDate Sep 11 2014 
17:03 Apr 19, 2022
Jkt 029200
PO 00000
Frm 00142
Fmt 6652
Sfmt 6201
E:\BILLS\H7497.IH
H7497
pamtmann on DSKBC07HB2PROD with BILLS
143 
(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.— 
VerDate Sep 11 2014 
17:03 Apr 19, 2022
Jkt 029200
PO 00000
Frm 00143
Fmt 6652
Sfmt 6201
E:\BILLS\H7497.IH
H7497
pamtmann on DSKBC07HB2PROD with BILLS
144 
‘‘(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. 
VerDate Sep 11 2014 
17:03 Apr 19, 2022
Jkt 029200
PO 00000
Frm 00144
Fmt 6652
Sfmt 6201
E:\BILLS\H7497.IH
H7497
pamtmann on DSKBC07HB2PROD with BILLS
145 
‘‘(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 
VerDate Sep 11 2014 
17:03 Apr 19, 2022
Jkt 029200
PO 00000
Frm 00145
Fmt 6652
Sfmt 6201
E:\BILLS\H7497.IH
H7497
pamtmann on DSKBC07HB2PROD with BILLS
146 
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 
VerDate Sep 11 2014 
17:03 Apr 19, 2022
Jkt 029200
PO 00000
Frm 00146
Fmt 6652
Sfmt 6201
E:\BILLS\H7497.IH
H7497
pamtmann on DSKBC07HB2PROD with BILLS
147 
(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. 502. COVERAGE OF ADULT VACCINES RECOMMENDED 
BY THE ADVISORY COMMITTEE ON IMMUNI-
ZATION PRACTICES UNDER MEDICARE 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 
501, is further amended— 
(1) in subsection (b)— 
VerDate Sep 11 2014 
17:03 Apr 19, 2022
Jkt 029200
PO 00000
Frm 00147
Fmt 6652
Sfmt 6201
E:\BILLS\H7497.IH
H7497
pamtmann on DSKBC07HB2PROD with BILLS
148 
(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 following 
shall apply with respect to an adult vaccine rec-
ommended by the Advisory Committee on Im-
munization Practices (as defined in subpara-
graph (B)): 
VerDate Sep 11 2014 
17:03 Apr 19, 2022
Jkt 029200
PO 00000
Frm 00148
Fmt 6652
Sfmt 6201
E:\BILLS\H7497.IH
H7497
pamtmann on DSKBC07HB2PROD with BILLS
149 
‘‘(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 
VerDate Sep 11 2014 
17:03 Apr 19, 2022
Jkt 029200
PO 00000
Frm 00149
Fmt 6652
Sfmt 6201
E:\BILLS\H7497.IH
H7497
pamtmann on DSKBC07HB2PROD with BILLS
150 
(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 501, 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: 
VerDate Sep 11 2014 
17:03 Apr 19, 2022
Jkt 029200
PO 00000
Frm 00150
Fmt 6652
Sfmt 6201
E:\BILLS\H7497.IH
H7497
pamtmann on DSKBC07HB2PROD with BILLS
151 
‘‘(6) NO APPLICATION OF COST-SHARING FOR 
ADULT VACCINES RECOMMENDED BY THE ADVISORY 
COMMITTEE
ON
IMMUNIZATION
PRACTICES.—For 
plan years beginning on or after January 1, 2024, 
there shall be no cost-sharing under this section, in-
cluding no annual deductible applicable under this 
section, with respect to an adult vaccine rec-
ommended by the Advisory Committee on Immuniza-
tion Practices (as defined in subparagraph (B) of 
such section).’’. 
(c) RULE OF CONSTRUCTION.—Nothing in this sec-
tion shall be construed as limiting coverage under part D 
of title XVIII of the Social Security Act for vaccines that 
are not recommended by the Advisory Committee on Im-
munization Practices. 
(d) IMPLEMENTATION
FOR 2024.—The Secretary 
shall implement this section, including the amendments 
made by this section, for 2024 by program instruction or 
otherwise. 
SEC. 503. PAYMENT FOR BIOSIMILAR BIOLOGICAL PROD-
UCTS DURING INITIAL PERIOD. 
Section 1847A(c)(4) of the Social Security Act (42 
U.S.C. 1395w–3a(c)(4)) is amended— 
(1) in each of subparagraphs (A) and (B), by 
redesignating clauses (i) and (ii) as subclauses (I) 
VerDate Sep 11 2014 
17:03 Apr 19, 2022
Jkt 029200
PO 00000
Frm 00151
Fmt 6652
Sfmt 6201
E:\BILLS\H7497.IH
H7497
pamtmann on DSKBC07HB2PROD with BILLS
152 
and (II), respectively, and moving such subclauses 2 
ems to the right; 
(2) by redesignating subparagraphs (A) and 
(B) as clauses (i) and (ii) and moving such clauses 
2 ems to the right; 
(3) by striking ‘‘UNAVAILABLE.—In the case’’ 
and inserting ‘‘UNAVAILABLE.— 
‘‘(A) IN
GENERAL.—Subject to subpara-
graph (B), in the case’’; and 
(4) by adding at the end the following new sub-
paragraph: 
‘‘(B) LIMITATION
ON
PAYMENT
AMOUNT 
FOR BIOSIMILAR BIOLOGICAL PRODUCTS DUR-
ING
INITIAL
PERIOD.—In the case of a bio-
similar biological product furnished on or after 
July 1, 2023, during the initial period described 
in subparagraph (A) with respect to the bio-
similar biological product, the amount payable 
under this section for the biosimilar biological 
product is the lesser of the following: 
‘‘(i) The amount determined under 
clause (ii) of such subparagraph for the 
biosimilar biological product. 
VerDate Sep 11 2014 
17:03 Apr 19, 2022
Jkt 029200
PO 00000
Frm 00152
Fmt 6652
Sfmt 6201
E:\BILLS\H7497.IH
H7497
pamtmann on DSKBC07HB2PROD with BILLS
153 
‘‘(ii) The amount determined under 
subsection (b)(1)(B) for the reference bio-
logical product.’’. 
SEC. 504. TEMPORARY INCREASE IN MEDICARE PART B 
PAYMENT FOR CERTAIN BIOSIMILAR BIO-
LOGICAL PRODUCTS. 
Section 1847A(b)(8) of the Social Security Act (42 
U.S.C. 1395w–3a(b)(8)) is amended— 
(1) by redesignating subparagraphs (A) and 
(B) as clauses (i) and (ii), respectively, and moving 
the margin of each such redesignated clause 2 ems 
to the right; 
(2) by striking ‘‘PRODUCT.—The amount’’ and 
inserting the following: ‘‘PRODUCT.— 
‘‘(A) IN
GENERAL.—Subject to subpara-
graph (B), the amount’’; and 
(3) by adding at the end the following new sub-
paragraph: 
‘‘(B) TEMPORARY PAYMENT INCREASE.— 
‘‘(i) IN GENERAL.—In the case of a 
qualifying biosimilar biological product 
that is furnished during the applicable 5- 
year period for such product, the amount 
specified in this paragraph for such prod-
uct with respect to such period is the sum 
VerDate Sep 11 2014 
17:03 Apr 19, 2022
Jkt 029200
PO 00000
Frm 00153
Fmt 6652
Sfmt 6201
E:\BILLS\H7497.IH
H7497
pamtmann on DSKBC07HB2PROD with BILLS
154 
determined under subparagraph (A), ex-
cept that clause (ii) of such subparagraph 
shall be applied by substituting ‘8 percent’ 
for ‘6 percent’. 
‘‘(ii) APPLICABLE 5-YEAR PERIOD.— 
For purposes of clause (i), the applicable 
5-year period for a qualifying biosimilar bi-
ological product is— 
‘‘(I) in the case of such a product 
for which payment was made under 
this paragraph as of March 31, 2022, 
the 5-year period beginning on April 
1, 2022; and 
‘‘(II) in the case of such a prod-
uct for which payment is first made 
under this paragraph during a cal-
endar quarter during the period be-
ginning April 1, 2022, and ending 
March 31, 2027, the 5-year period be-
ginning on the first day of such cal-
endar quarter during which such pay-
ment is first made. 
‘‘(iii) QUALIFYING
BIOSIMILAR
BIO-
LOGICAL
PRODUCT
DEFINED.—For pur-
poses of this subparagraph, the term 
VerDate Sep 11 2014 
17:03 Apr 19, 2022
Jkt 029200
PO 00000
Frm 00154
Fmt 6652
Sfmt 6201
E:\BILLS\H7497.IH
H7497
pamtmann on DSKBC07HB2PROD with BILLS
155 
‘qualifying biosimilar biological product’ 
means a biosimilar biological product de-
scribed in paragraph (1)(C) with respect to 
which— 
‘‘(I) in the case of a product de-
scribed in clause (ii)(I), the average 
sales price under paragraph (8)(A)(i) 
for a calendar quarter during the 5- 
year period described in such clause is 
not more than the average sales price 
under paragraph (4)(A) for such 
quarter for the reference biological 
product; and 
‘‘(II) in the case of a product de-
scribed in clause (ii)(II), the average 
sales price under paragraph (8)(A)(i) 
for a calendar quarter during the 5- 
year period described in such clause is 
not more than the average sales price 
under paragraph (4)(A) for such 
quarter for the reference biological 
product.’’. 
SEC. 505. IMPROVING ACCESS TO ADULT VACCINES UNDER 
MEDICAID AND CHIP. 
(a) MEDICAID.— 
VerDate Sep 11 2014 
17:03 Apr 19, 2022
Jkt 029200
PO 00000
Frm 00155
Fmt 6652
Sfmt 6201
E:\BILLS\H7497.IH
H7497
pamtmann on DSKBC07HB2PROD with BILLS
156 
(1) REQUIRING COVERAGE OF ADULT VACCINA-
TIONS.— 
(A) IN GENERAL.—Section 1902(a)(10)(A) 
of 
the 
Social 
Security 
Act 
(42 
U.S.C. 
1396a(a)(10)(A)) is amended in the matter pre-
ceding clause (i) by inserting ‘‘(13)(B),’’ after 
‘‘(5),’’. 
(B) 
MEDICALLY
NEEDY.—Section 
1902(a)(10)(C)(iv) of such Act (42 U.S.C. 
1396a(a)(10)(C)(iv)) is amended by inserting ‘‘, 
(13)(B),’’ after ‘‘(5)’’. 
(2) NO COST-SHARING FOR VACCINATIONS.— 
(A) 
GENERAL
COST-SHARING
LIMITA-
TIONS.—Section 1916 of the Social Security 
Act (42 U.S.C. 1396o) is amended— 
(i) in subsection (a)(2)— 
(I) in subparagraph (G), by in-
serting a comma after ‘‘State plan’’; 
(II) in subparagraph (H), by 
striking ‘‘; or’’ and inserting a 
comma; 
(III) in subparagraph (I), by 
striking ‘‘; and’’ and inserting ‘‘, or’’; 
and 
VerDate Sep 11 2014 
17:03 Apr 19, 2022
Jkt 029200
PO 00000
Frm 00156
Fmt 6652
Sfmt 6201
E:\BILLS\H7497.IH
H7497
pamtmann on DSKBC07HB2PROD with BILLS
157 
(IV) by adding at the end the fol-
lowing new subparagraph: 
‘‘(J) 
vaccines 
described 
in 
section 
1905(a)(13)(B) and the administration of such 
vaccines; and’’; and 
(ii) in subsection (b)(2)— 
(I) in subparagraph (G), by in-
serting a comma after ‘‘State plan’’; 
(II) in subparagraph (H), by 
striking ‘‘; or’’ and inserting a 
comma; 
(III) in subparagraph (I), by 
striking ‘‘; and’’ and inserting ‘‘, or’’; 
and 
(IV) by adding at the end the fol-
lowing new subparagraph: 
‘‘(J) 
vaccines 
described 
in 
section 
1905(a)(13)(B) and the administration of such 
vaccines; and’’. 
(B) APPLICATION TO ALTERNATIVE COST- 
SHARING.—Section 1916A(b)(3)(B) of the So-
cial Security Act (42 U.S.C. 1396o–1(b)(3)(B)) 
is amended by adding at the end the following 
new clause: 
VerDate Sep 11 2014 
17:03 Apr 19, 2022
Jkt 029200
PO 00000
Frm 00157
Fmt 6652
Sfmt 6201
E:\BILLS\H7497.IH
H7497
pamtmann on DSKBC07HB2PROD with BILLS
158 
‘‘(xiv) Vaccines described in section 
1905(a)(13)(B) and the administration of 
such vaccines.’’. 
(3) INCREASED FMAP FOR ADULT VACCINES.— 
Section 1905(b) of the Social Security Act (42 
U.S.C. 1396d(b)) is amended— 
(A) by striking ‘‘and (5)’’ and inserting 
‘‘(5)’’; 
(B) by striking ‘‘services and vaccines de-
scribed in subparagraphs (A) and (B) of sub-
section (a)(13), and prohibits cost-sharing for 
such services and vaccines’’ and inserting ‘‘serv-
ices described in subsection (a)(13)(A), and 
prohibits cost-sharing for such services’’; 
(C) by striking ‘‘medical assistance for 
such services and vaccines’’ and inserting ‘‘med-
ical assistance for such services’’; and 
(D) by inserting ‘‘, and (6) during the first 
8 fiscal quarters beginning on or after the effec-
tive date of this clause, in the case of a State 
which, as of the date of enactment of the Act 
titled ‘An Act to provide for reconciliation pur-
suant to title II of S. Con. Res. 14’, provides 
medical assistance for vaccines described in 
subsection (a)(13)(B) and their administration 
VerDate Sep 11 2014 
17:03 Apr 19, 2022
Jkt 029200
PO 00000
Frm 00158
Fmt 6652
Sfmt 6201
E:\BILLS\H7497.IH
H7497
pamtmann on DSKBC07HB2PROD with BILLS
159 
and prohibits cost-sharing for such vaccines, the 
Federal medical assistance percentage, as deter-
mined under this subsection and subsection (y), 
shall be increased by 1 percentage point with 
respect to medical assistance for such vaccines’’ 
before the first period. 
(b) CHIP.— 
(1) REQUIRING COVERAGE OF ADULT VACCINA-
TIONS.—Section 2103(c) of the Social Security Act 
(42 U.S.C. 1397cc(c)) is amended by adding at the 
end the following paragraph: 
‘‘(12) REQUIRED
COVERAGE
OF
APPROVED, 
RECOMMENDED ADULT VACCINES AND THEIR AD-
MINISTRATION.—Regardless of the type of coverage 
elected by a State under subsection (a), if the State 
child health plan or a waiver of such plan provides 
child health assistance or pregnancy-related assist-
ance (as defined in section 2112) to an individual 
who is 19 years of age or older, such assistance shall 
include coverage of vaccines described in section 
1905(a)(13)(B) and their administration.’’. 
(2) NO
COST-SHARING
FOR
VACCINATIONS.— 
Section 
2103(e)(2) 
of 
such 
Act 
(42 
U.S.C. 
1397cc(e)(2)) is amended by inserting ‘‘vaccines de-
scribed in subsection (c)(12) (and the administration 
VerDate Sep 11 2014 
17:03 Apr 19, 2022
Jkt 029200
PO 00000
Frm 00159
Fmt 6652
Sfmt 6201
E:\BILLS\H7497.IH
H7497
pamtmann on DSKBC07HB2PROD with BILLS
160 
of such vaccines),’’ after ‘‘in vitro diagnostic prod-
ucts described in subsection (c)(10) (and administra-
tion of such products),’’. 
(c) EFFECTIVE DATE.—The amendments made by 
this section take effect on the 1st day of the 1st fiscal 
quarter that begins on or after the date that is 1 year 
after the date of enactment of this Act and shall apply 
to expenditures made under a State plan or waiver of such 
plan under title XIX of the Social Security Act (42 U.S.C. 
1396 through 1396w–6) or under a State child health plan 
or waiver of such plan under title XXI of such Act (42 
U.S.C. 1397aa through 1397mm) on or after such effec-
tive date. 
TITLE VI—ADDITIONAL INSULIN 
POLICIES 
SEC. 601. ERISA REQUIREMENTS WITH RESPECT TO COST- 
SHARING FOR CERTAIN INSULIN PRODUCTS. 
(a) IN GENERAL.—Subpart B of part 7 of subtitle 
B of title I of the Employee Retirement Income Security 
Act of 1974 (29 U.S.C. 1185 et seq.) is amended by add-
ing at the end the following: 
‘‘SEC. 726. REQUIREMENTS WITH RESPECT TO COST-SHAR-
ING FOR CERTAIN INSULIN PRODUCTS. 
‘‘(a) IN GENERAL.—For plan years beginning on or 
after January 1, 2023, a group health plan or health in-
VerDate Sep 11 2014 
17:03 Apr 19, 2022
Jkt 029200
PO 00000
Frm 00160
Fmt 6652
Sfmt 6201
E:\BILLS\H7497.IH
H7497
pamtmann on DSKBC07HB2PROD with BILLS
161 
surance issuer offering group health insurance coverage 
shall provide coverage of selected insulin products, and 
with respect to such products, shall not— 
‘‘(1) apply any deductible; or 
‘‘(2) impose any cost-sharing in excess of the 
lesser of, per 30-day supply— 
‘‘(A) $35; or 
‘‘(B) the amount equal to 25 percent of 
the negotiated price of the selected insulin prod-
uct net of all price concessions received by or on 
behalf of the plan or coverage, including price 
concessions received by or on behalf of third- 
party entities providing services to the plan or 
coverage, such as pharmacy benefit manage-
ment services. 
‘‘(b) DEFINITIONS.—In this section: 
‘‘(1) SELECTED INSULIN PRODUCTS.—The term 
‘selected insulin products’ means at least one of each 
dosage form (such as vial, pump, or inhaler dosage 
forms) of each different type (such as rapid-acting, 
short-acting, intermediate-acting, long-acting, ultra 
long-acting, and premixed) of insulin (as defined 
below), when available, as selected by the group 
health plan or health insurance issuer. 
VerDate Sep 11 2014 
17:03 Apr 19, 2022
Jkt 029200
PO 00000
Frm 00161
Fmt 6652
Sfmt 6201
E:\BILLS\H7497.IH
H7497
pamtmann on DSKBC07HB2PROD with BILLS
162 
‘‘(2) INSULIN
DEFINED.—The term ‘insulin’ 
means insulin that is licensed under subsection (a) 
or (k) of section 351 of the Public Health Service 
Act (42 U.S.C. 262) and continues to be marketed 
under such section, including any insulin product 
that has been deemed to be licensed under section 
351(a) of such Act pursuant to section 7002(e)(4) 
of the Biologics Price Competition and Innovation 
Act of 2009 (Public Law 111–148) and continues to 
be marketed pursuant to such licensure. 
‘‘(c) OUT-OF-NETWORK
PROVIDERS.—Nothing in 
this section requires a plan or issuer that has a network 
of providers to provide benefits for selected insulin prod-
ucts described in this section that are delivered by an out- 
of-network provider, or precludes a plan or issuer that has 
a network of providers from imposing higher cost-sharing 
than the levels specified in subsection (a) for selected insu-
lin products described in this section that are delivered 
by an out-of-network provider. 
‘‘(d) RULE OF CONSTRUCTION.—Subsection (a) shall 
not be construed to require coverage of, or prevent a group 
health plan or health insurance coverage from imposing 
cost-sharing other than the levels specified in subsection 
(a) on, insulin products that are not selected insulin prod-
ucts, to the extent that such coverage is not otherwise re-
VerDate Sep 11 2014 
17:03 Apr 19, 2022
Jkt 029200
PO 00000
Frm 00162
Fmt 6652
Sfmt 6201
E:\BILLS\H7497.IH
H7497
pamtmann on DSKBC07HB2PROD with BILLS
163 
quired and such cost-sharing is otherwise permitted under 
Federal and applicable State law. 
‘‘(e) APPLICATION
OF
COST-SHARING
TOWARDS 
DEDUCTIBLES
AND OUT-OF-POCKET MAXIMUMS.—Any 
cost-sharing payments made pursuant to subsection (a)(2) 
shall be counted toward any deductible or out-of-pocket 
maximum that applies under the plan or coverage.’’. 
(b) CLERICAL AMENDMENT.—The table of contents 
in section 1 of the Employee Retirement Income Security 
Act of 1974 (29 U.S.C. 1001 et seq.) is amended by in-
serting after the item relating to section 725 the following: 
‘‘Sec. 726. Requirements with respect to cost-sharing for certain insulin prod-
ucts.’’. 
SEC. 602. PUBLIC HEALTH SERVICE ACT REQUIREMENTS 
WITH RESPECT TO COST-SHARING FOR INSU-
LIN PRODUCTS. 
(a) IN GENERAL.—Part D of title XXVII of the Pub-
lic Health Service Act (42 U.S.C. 300gg–111 et seq.) is 
amended by adding at the end the following: 
‘‘SEC. 2799A–11. REQUIREMENTS WITH RESPECT TO COST- 
SHARING FOR CERTAIN INSULIN PRODUCTS. 
‘‘(a) IN GENERAL.—For plan years beginning on or 
after January 1, 2023, a group health plan or health in-
surance issuer offering group or individual health insur-
ance coverage shall provide coverage of selected insulin 
products, and with respect to such products, shall not— 
VerDate Sep 11 2014 
17:03 Apr 19, 2022
Jkt 029200
PO 00000
Frm 00163
Fmt 6652
Sfmt 6201
E:\BILLS\H7497.IH
H7497
pamtmann on DSKBC07HB2PROD with BILLS
164 
‘‘(1) apply any deductible; or 
‘‘(2) impose any cost-sharing in excess of the 
lesser of, per 30-day supply— 
‘‘(A) $35; or 
‘‘(B) the amount equal to 25 percent of 
the negotiated price of the selected insulin prod-
uct net of all price concessions received by or on 
behalf of the plan or coverage, including price 
concessions received by or on behalf of third- 
party entities providing services to the plan or 
coverage, such as pharmacy benefit manage-
ment services. 
‘‘(b) DEFINITIONS.—In this section: 
‘‘(1) SELECTED INSULIN PRODUCTS.—The term 
‘selected insulin products’ means at least one of each 
dosage form (such as vial, pump, or inhaler dosage 
forms) of each different type (such as rapid-acting, 
short-acting, intermediate-acting, long-acting, ultra 
long-acting, and premixed) of insulin (as defined 
below), when available, as selected by the group 
health plan or health insurance issuer. 
‘‘(2) INSULIN
DEFINED.—The term ‘insulin’ 
means insulin that is licensed under subsection (a) 
or (k) of section 351 and continues to be marketed 
under such section, including any insulin product 
VerDate Sep 11 2014 
17:03 Apr 19, 2022
Jkt 029200
PO 00000
Frm 00164
Fmt 6652
Sfmt 6201
E:\BILLS\H7497.IH
H7497
pamtmann on DSKBC07HB2PROD with BILLS
165 
that has been deemed to be licensed under section 
351(a) pursuant to section 7002(e)(4) of the Bio-
logics Price Competition and Innovation Act of 2009 
and continues to be marketed pursuant to such li-
censure. 
‘‘(c) OUT-OF-NETWORK
PROVIDERS.—Nothing in 
this section requires a plan or issuer that has a network 
of providers to provide benefits for selected insulin prod-
ucts described in this section that are delivered by an out- 
of-network provider, or precludes a plan or issuer that has 
a network of providers from imposing higher cost-sharing 
than the levels specified in subsection (a) for selected insu-
lin products described in this section that are delivered 
by an out-of-network provider. 
‘‘(d) RULE OF CONSTRUCTION.—Subsection (a) shall 
not be construed to require coverage of, or prevent a group 
health plan or health insurance coverage from imposing 
cost-sharing other than the levels specified in subsection 
(a) on, insulin products that are not selected insulin prod-
ucts, to the extent that such coverage is not otherwise re-
quired and such cost-sharing is otherwise permitted under 
Federal and applicable State law. 
‘‘(e) APPLICATION
OF
COST-SHARING
TOWARDS 
DEDUCTIBLES
AND OUT-OF-POCKET MAXIMUMS.—Any 
cost-sharing payments made pursuant to subsection (a)(2) 
VerDate Sep 11 2014 
17:03 Apr 19, 2022
Jkt 029200
PO 00000
Frm 00165
Fmt 6652
Sfmt 6201
E:\BILLS\H7497.IH
H7497
pamtmann on DSKBC07HB2PROD with BILLS
166 
shall be counted toward any deductible or out-of-pocket 
maximum that applies under the plan or coverage.’’. 
(b) NO EFFECT ON OTHER COST-SHARING.—Section 
1302(d)(2) of the Patient Protection and Affordable Care 
Act (42 U.S.C. 18022(d)(2)) is amended by adding at the 
end the following new subparagraph: 
‘‘(D) SPECIAL RULE RELATING TO INSU-
LIN COVERAGE.—The exemption of coverage of 
selected insulin products (as defined in section 
2799A–11(b) of the Public Health Service Act) 
from the application of any deductible pursuant 
to section 2799A–11(a)(1) of such Act, section 
726(a)(1) of the Employee Retirement Income 
Security Act of 1974, or section 9826(a)(1) of 
the Internal Revenue Code of 1986 shall not be 
considered when determining the actuarial value 
of a qualified health plan under this sub-
section.’’. 
(c) COVERAGE
OF CERTAIN INSULIN PRODUCTS 
UNDER CATASTROPHIC PLANS.—Section 1302(e) of the 
Patient Protection and Affordable Care Act (42 U.S.C. 
18022(e)) is amended by adding at the end the following: 
‘‘(4) COVERAGE
OF
CERTAIN
INSULIN
PROD-
UCTS.— 
VerDate Sep 11 2014 
17:03 Apr 19, 2022
Jkt 029200
PO 00000
Frm 00166
Fmt 6652
Sfmt 6201
E:\BILLS\H7497.IH
H7497
pamtmann on DSKBC07HB2PROD with BILLS
167 
‘‘(A) IN GENERAL.—Notwithstanding para-
graph (1)(B)(i), a health plan described in 
paragraph (1) shall provide coverage of selected 
insulin products, in accordance with section 
2799A–11 of the Public Health Service Act, for 
a plan year before an enrolled individual has in-
curred cost-sharing expenses in an amount 
equal to the annual limitation in effect under 
subsection (c)(1) for the plan year. 
‘‘(B) TERMINOLOGY.—For purposes of 
subparagraph (A)— 
‘‘(i) the term ‘selected insulin prod-
ucts’ has the meaning given such term in 
section 2799A–11(b) of the Public Health 
Service Act; and 
‘‘(ii) the requirements of section 
2799A–11 of such Act shall be applied by 
deeming each reference in such section to 
‘individual health insurance coverage’ to be 
a reference to a plan described in para-
graph (1).’’. 
SEC. 603. IRC REQUIREMENTS WITH RESPECT TO COST- 
SHARING FOR CERTAIN INSULIN PRODUCTS. 
(a) IN GENERAL.—Subchapter B of chapter 100 is 
amended by adding at the end the following new section: 
VerDate Sep 11 2014 
17:03 Apr 19, 2022
Jkt 029200
PO 00000
Frm 00167
Fmt 6652
Sfmt 6201
E:\BILLS\H7497.IH
H7497
pamtmann on DSKBC07HB2PROD with BILLS
168 
‘‘SEC. 9826. REQUIREMENTS WITH RESPECT TO COST-SHAR-
ING FOR CERTAIN INSULIN PRODUCTS. 
‘‘(a) IN GENERAL.—For plan years beginning on or 
after January 1, 2023, a group health plan shall provide 
coverage of selected insulin products, and with respect to 
such products, shall not— 
‘‘(1) apply any deductible; or 
‘‘(2) impose any cost-sharing in excess of the 
lesser of, per 30-day supply— 
‘‘(A) $35; or 
‘‘(B) the amount equal to 25 percent of 
the negotiated price of the selected insulin prod-
uct net of all price concessions received by or on 
behalf of the plan, including price concessions 
received by or on behalf of third-party entities 
providing services to the plan, such as phar-
macy benefit management services. 
‘‘(b) DEFINITIONS.—In this section: 
‘‘(1) SELECTED INSULIN PRODUCTS.—The term 
‘selected insulin products’ means at least one of each 
dosage form (such as vial, pump, or inhaler dosage 
forms) of each different type (such as rapid-acting, 
short-acting, intermediate-acting, long-acting, ultra 
long-acting, and premixed) of insulin (as defined 
below), when available, as selected by the group 
health plan. 
VerDate Sep 11 2014 
17:03 Apr 19, 2022
Jkt 029200
PO 00000
Frm 00168
Fmt 6652
Sfmt 6201
E:\BILLS\H7497.IH
H7497
pamtmann on DSKBC07HB2PROD with BILLS