171 
‘‘(3) FORMAT.—The educational materials pro-
vided under paragraph (1) may be— 
‘‘(A) in formats such as webinars, con-
tinuing medical education modules, videos, fact 
sheets, infographics, stakeholder toolkits, or 
other formats as appropriate and applicable; 
and 
‘‘(B) tailored for the unique needs of 
health care providers, patients, caregivers, and 
other audiences, as the Secretary determines 
appropriate. 
‘‘(4) OTHER INFORMATION.—In addition to the 
information described in paragraph (2), the Sec-
retary shall continue to publish the following infor-
mation: 
‘‘(A) The action package of each biological 
product licensed under subsection (a) or (k). 
‘‘(B) The summary review of each biologi-
cal product licensed under subsection (a) or (k). 
‘‘(5) CONFIDENTIAL AND TRADE SECRET IN-
FORMATION.—This subsection does not authorize 
the disclosure of any trade secret, confidential com-
mercial or financial information, or other matter de-
scribed in section 552(b) of title 5. 
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‘‘(b) CONTINUING EDUCATION.—The Secretary shall 
advance education and awareness among health care pro-
viders regarding biological products, including biosimilar 
biological products and interchangeable biosimilar biologi-
cal products, as appropriate, including by developing or 
improving continuing education programs that advance 
the education of such providers on the prescribing of, and 
relevant clinical considerations with respect to, biological 
products, including biosimilar biological products and 
interchangeable biosimilar biological products.’’. 
(b) APPLICATION UNDER THE MEDICARE MERIT- 
BASED
INCENTIVE
PAYMENT
SYSTEM.—Section 
1848(q)(5)(C) of the Social Security Act (42 U.S.C. 
1395w–4(q)(5)(C)) is amended by adding at the end the 
following new clause: 
‘‘(iv) CLINICAL MEDICAL EDUCATION 
PROGRAM
ON
BIOSIMILAR
BIOLOGICAL 
PRODUCTS.—Completion of a clinical med-
ical education program developed or im-
proved under section 352A(b) of the Public 
Health Service Act by a MIPS eligible pro-
fessional during a performance period shall 
earn such eligible professional one-half of 
the highest potential score for the perform-
ance category described in paragraph 
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(2)(A)(iii) for such performance period. A 
MIPS eligible professional may only count 
the completion of such a program for pur-
poses of such category one time during the 
eligible professional’s lifetime.’’. 
Subtitle C—Other Provisions 
SEC. 331. CLARIFYING THE MEANING OF NEW CHEMICAL 
ENTITY. 
Chapter V of the Federal Food, Drug, and Cosmetic 
Act is amended— 
(1) in section 505 (21 U.S.C. 355)— 
(A) in subsection (c)(3)(E)— 
(i) in clause (ii), by striking ‘‘active 
ingredient (including any ester or salt of 
the active ingredient)’’ and inserting ‘‘ac-
tive moiety (as defined by the Secretary in 
section 314.3 of title 21, Code of Federal 
Regulations (or any successor regula-
tions))’’; and 
(ii) in clause (iii), by striking ‘‘active 
ingredient (including any ester or salt of 
the active ingredient)’’ and inserting ‘‘ac-
tive moiety (as defined by the Secretary in 
section 314.3 of title 21, Code of Federal 
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174 
Regulations (or any successor regula-
tions))’’; 
(B) in subsection (j)(5)(F)— 
(i) in clause (ii), by striking ‘‘active 
ingredient (including any ester or salt of 
the active ingredient)’’ and inserting ‘‘ac-
tive moiety (as defined by the Secretary in 
section 314.3 of title 21, Code of Federal 
Regulations (or any successor regula-
tions))’’; and 
(ii) in clause (iii), by striking ‘‘active 
ingredient (including any ester or salt of 
the active ingredient)’’ and inserting ‘‘ac-
tive moiety (as defined by the Secretary in 
section 314.3 of title 21, Code of Federal 
Regulations (or any successor regula-
tions))’’; 
(C) in subsection (l)(2)(A)(i), by striking 
‘‘active ingredient (including any ester or salt of 
the active ingredient)’’ and inserting ‘‘active 
moiety (as defined by the Secretary in section 
314.3 of title 21, Code of Federal Regulations 
(or any successor regulations))’’; 
(D) in subsection (s), in the matter pre-
ceding paragraph (1), by striking ‘‘active ingre-
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dient (including any ester or salt of the active 
ingredient)’’ and inserting ‘‘active moiety (as 
defined by the Secretary in section 314.3 of 
title 21, Code of Federal Regulations (or any 
successor regulations))’’; and 
(E) in subsection (u)(1), in the matter pre-
ceding subparagraph (A)— 
(i) by striking ‘‘active ingredient (in-
cluding any ester or salt of the active in-
gredient)’’ and inserting ‘‘active moiety (as 
defined by the Secretary in section 314.3 
of title 21, Code of Federal Regulations (or 
any successor regulations))’’; and 
(ii) by striking ‘‘same active ingre-
dient’’ and inserting ‘‘same active moiety’’; 
(2) 
in 
section 
512(c)(2)(F) 
(21 
U.S.C. 
360b(c)(2)(F))— 
(A) in clause (i), by striking ‘‘active ingre-
dient (including any ester or salt of the active 
ingredient)’’ and inserting ‘‘active moiety (as 
defined by the Secretary in section 314.3 of 
title 21, Code of Federal Regulations (or any 
successor regulations))’’; 
(B) in clause (ii), by striking ‘‘active ingre-
dient (including any ester or salt of the active 
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ingredient)’’ and inserting ‘‘active moiety (as 
defined by the Secretary in section 314.3 of 
title 21, Code of Federal Regulations (or any 
successor regulations))’’; and 
(C) in clause (v), by striking ‘‘active ingre-
dient (including any ester or salt of the active 
ingredient)’’ and inserting ‘‘active moiety (as 
defined by the Secretary in section 314.3 of 
title 21, Code of Federal Regulations (or any 
successor regulations))’’; 
(3) 
in 
section 
524(a)(4)(C) 
(21 
U.S.C. 
360n(a)(4)(C)), by striking ‘‘active ingredient (in-
cluding any ester or salt of the active ingredient)’’ 
and inserting ‘‘active moiety (as defined by the Sec-
retary in section 314.3 of title 21, Code of Federal 
Regulations (or any successor regulations))’’; 
(4) in section 529(a)(4)(A)(ii) (21 U.S.C. 
360ff(a)(4)(A)(ii)), by striking ‘‘active ingredient 
(including any ester or salt of the active ingredient)’’ 
and inserting ‘‘active moiety (as defined by the Sec-
retary in section 314.3 of title 21, Code of Federal 
Regulations (or any successor regulations))’’; and 
(5) in section 565A(a)(4)(D) (21 U.S.C. 
360bbb–4a(a)(4)(D)), by striking ‘‘active ingredient 
(including any ester or salt of the active ingredient)’’ 
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and inserting ‘‘active moiety (as defined by the Sec-
retary in section 314.3 of title 21, Code of Federal 
Regulations (or any successor regulations))’’. 
TITLE IV—REVENUE PROVISION 
SEC. 401. SAFE HARBOR FOR HIGH DEDUCTIBLE HEALTH 
PLANS WITHOUT DEDUCTIBLE FOR INSULIN. 
(a) IN GENERAL.—Section 223(c)(2)(C) of the Inter-
nal Revenue Code of 1986 is amended by inserting ‘‘or 
for insulin or any device for the delivery of insulin’’ before 
the period at the end. 
(b) EFFECTIVE DATE.—The amendment made by 
this section shall apply to months beginning after the date 
of the enactment of this Act. 
TITLE V—MISCELLANEOUS 
SEC. 501. 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) 
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; 
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(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, in lieu of applying subparagraph 
(A) during the initial period described in such 
subparagraph with respect to the biosimilar bio-
logical 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. 
‘‘(ii) The amount determined under 
subsection (b)(1)(B) for the reference bio-
logical product.’’. 
SEC. 502. GAO STUDY AND REPORT ON AVERAGE SALES 
PRICE. 
(a) STUDY.— 
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(1) IN GENERAL.—The Comptroller General of 
the United States (in this section referred to as the 
‘‘Comptroller General’’) shall conduct a study on 
spending for applicable drugs under part B of title 
XVIII of the Social Security Act. 
(2) APPLICABLE DRUGS DEFINED.—In this sec-
tion, the term ‘‘applicable drugs’’ means drugs and 
biologicals— 
(A) for which reimbursement under such 
part B is based on the average sales price of 
the drug or biological; and 
(B) that account for the largest percentage 
of total spending on drugs and biologicals under 
such part B (as determined by the Comptroller 
General, but in no case less than 25 drugs or 
biologicals). 
(3) REQUIREMENTS.—The study under para-
graph (1) shall include an analysis of the following: 
(A) The extent to which each applicable 
drug is paid for— 
(i) under such part B for Medicare 
beneficiaries; or 
(ii) by private payers in the commer-
cial market. 
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(B) Any change in Medicare spending or 
Medicare beneficiary cost-sharing that would 
occur if the average sales price of an applicable 
drug was based solely on payments by private 
payers in the commercial market. 
(C) The extent to which drug manufactur-
ers provide rebates, discounts, or other price 
concessions to private payers in the commercial 
market for applicable drugs, which the manu-
facturer includes in its average sales price cal-
culation, for— 
(i) formulary placement; 
(ii) utilization management consider-
ations; or 
(iii) other purposes. 
(D) Barriers to drug manufacturers pro-
viding such price concessions for applicable 
drugs. 
(E) Other areas determined appropriate by 
the Comptroller General. 
(b) REPORT.—Not later than 2 years after the date 
of the enactment of this Act, the Comptroller General shall 
submit to Congress a report on the study conducted under 
subsection (a), together with recommendations for such 
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