I 
116TH CONGRESS 
2D SESSION 
H. R. 5749 
To amend title XI of the Social Security Act to establish the American 
Insulin Program to provide for lower prices for insulin drugs, to maintain 
effort throughout the insulin supply chain, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
FEBRUARY 4, 2020 
Mr. CRIST introduced the following bill; which was referred to the Committee 
on Energy and Commerce, and in addition to the Committee on Ways 
and Means, for a period to be subsequently determined by the Speaker, 
in each case for consideration of such provisions as fall within the juris-
diction of the committee concerned 
A BILL 
To amend title XI of the Social Security Act to establish 
the American Insulin Program to provide for lower prices 
for insulin drugs, to maintain effort throughout the insu-
lin supply chain, and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Affordable Insulin for 
All Act’’. 
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SEC. 2. PROVIDING FOR LOWER PRICES FOR INSULIN 
DRUGS. 
Part A of title XI of the Social Security Act (42 
U.S.C. 1301) is amended by adding at the end the fol-
lowing new section: 
‘‘SEC. 1150C. ESTABLISHMENT OF PROGRAM. 
‘‘(a) IN GENERAL.—The Secretary shall establish an 
American Insulin Program (in this section referred to as 
the ‘program’) by not later than 30 days after the date 
of the enactment of this section. Under the program, the 
Secretary shall enter into agreements described in sub-
section (b) with manufacturers and provide for the per-
formance of duties described in subsection (c). The Sec-
retary shall establish a model agreement for use under the 
program by not later than 20 days after the date of the 
enactment of this section, in consultation with manufac-
turers, and allow for comment on such model agreement. 
‘‘(b) TERMS OF AGREEMENT.— 
‘‘(1) IN GENERAL.— 
‘‘(A) AGREEMENT.—An agreement under 
this section shall require the manufacturer to 
provide applicable individuals access to Med-
icaid prices for insulin drugs of the manufac-
turer. 
‘‘(B) PROVISION OF DISCOUNTED PRICES 
AS THE POINT-OF-SALE.— 
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‘‘(i) IN GENERAL.—Subject to clause 
(ii), such Medicaid prices shall be provided 
to the applicable beneficiary at the phar-
macy or by the mail order service at the 
point-of-sale of an insulin drug. 
‘‘(ii) 
CERTIFICATION
OF 
UNSUSTAINABLE REVENUES.— 
‘‘(I) IN GENERAL.—In the case 
the Secretary submits to Congress a 
certification that net revenues from 
the sale of insulin drugs by manufac-
turers with an agreement under this 
section is unsustainable because such 
manufactures will be unable to meet 
the demand for insulin drugs in the 
United States, subject to subclause 
(II), the Secretary may increase the 
Medicaid price by 5 percent. 
‘‘(II) 
LIMITATION.—The 
Sec-
retary may not increase the Medicaid 
price in accordance with subclause (I) 
more than 3 times. 
‘‘(III) APPLICABILITY OF PRICE 
INCREASE.—An increase to the Med-
icaid price of insulin drugs described 
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in subclause (I) shall apply to the sale 
of insulin drugs 90 days after the 
date of a certification described in 
such subclause. 
‘‘(C) TIMING OF AGREEMENT.— 
‘‘(i) SPECIAL
RULE
FOR
2021.—In 
order for an agreement with a manufac-
turer to be in effect under this section with 
respect to the period beginning on January 
1, 2021, and ending on December 31, 
2021, the manufacturer shall enter into 
such agreement not later than 30 days 
after the date of the establishment of a 
model agreement under subsection (a). 
‘‘(ii) 
2022 
AND
SUBSEQUENT 
YEARS.—In order for an agreement with a 
manufacturer to be in effect under this 
section with respect to plan year 2022 or 
a subsequent plan year, the manufacturer 
shall enter into such agreement (or such 
agreement shall be renewed under para-
graph (4)(A)) not later than January 30 of 
the preceding year. 
‘‘(2) PROVISION OF APPROPRIATE DATA.—Each 
manufacturer with an agreement in effect under this 
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section shall collect and have available appropriate 
data, as determined by the Secretary, to ensure that 
it can demonstrate to the Secretary compliance with 
the requirements under the program. 
‘‘(3) COMPLIANCE
WITH
REQUIREMENTS
FOR 
ADMINISTRATION
OF
PROGRAM.—Each manufac-
turer with an agreement in effect under this section 
shall comply with requirements imposed by the Sec-
retary or a third party with a contract under sub-
section (d)(3), as applicable, for purposes of admin-
istering the program, including any determination 
under clause (i) of subsection (c)(1)(A) or proce-
dures established under such subsection (c)(1)(A). 
‘‘(4) LENGTH OF AGREEMENT.— 
‘‘(A) IN GENERAL.—An agreement under 
this section shall be effective for an initial pe-
riod of not less than 18 months and shall be 
automatically renewed for a period of not less 
than 1 year unless terminated under subpara-
graph (B). 
‘‘(B) TERMINATION.— 
‘‘(i) BY THE SECRETARY.—The Sec-
retary may provide for termination of an 
agreement under this section for a knowing 
and willful violation of the requirements of 
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the agreement or other good cause shown. 
Such termination shall not be effective ear-
lier than 30 days after the date of notice 
to the manufacturer of such termination. 
The Secretary shall provide, upon request, 
a manufacturer with a hearing concerning 
such a termination, and such hearing shall 
take place prior to the effective date of the 
termination with sufficient time for such 
effective date to be repealed if the Sec-
retary determines appropriate. 
‘‘(ii) BY A MANUFACTURER.—A man-
ufacturer may terminate an agreement 
under this section for any reason. Any 
such termination shall be effective, with re-
spect to a plan year— 
‘‘(I) if the termination occurs be-
fore January 30 of a plan year, as of 
the day after the end of the plan year; 
and 
‘‘(II) if the termination occurs on 
or after January 30 of a plan year, as 
of the day after the end of the suc-
ceeding plan year. 
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‘‘(iii) EFFECTIVENESS
OF
TERMI-
NATION.—Any termination under this sub-
paragraph shall not affect discounts for in-
sulin drugs of the manufacturer that are 
due under the agreement before the effec-
tive date of its termination. 
‘‘(iv) NOTICE TO THIRD PARTY.—The 
Secretary shall provide notice of such ter-
mination to a third party with a contract 
under subsection (d)(3) within not less 
than 30 days before the effective date of 
such termination. 
‘‘(c) DUTIES DESCRIBED.—The duties described in 
this subsection are the following: 
‘‘(1) ADMINISTRATION OF PROGRAM.—Admin-
istering the program, including— 
‘‘(A) the determination of the amount of 
the Medicaid price of an insulin drug of a man-
ufacturer for applicable individuals in each 
State; 
‘‘(B) except as provided in subparagraph 
(C), the establishment of procedures under 
which Medicaid prices are provided to applica-
ble individuals at pharmacies or by mail order 
service at the point-of-sale of an insulin drug; 
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‘‘(C) in the case where, during the period 
beginning on January 1, 2022, and ending on 
December 31, 2022, it is not practicable to pro-
vide such Medicaid prices at the point-of-sale 
(as described in subparagraph (B)), the estab-
lishment of procedures to provide such Medicaid 
prices as soon as practicable after the point-of- 
sale; 
‘‘(D) the establishment of procedures to 
ensure that, not later than the applicable num-
ber of calendar days after the dispensing of an 
insulin drug by a pharmacy or mail order serv-
ice, the pharmacy or mail order service is reim-
bursed for an amount equal to the difference 
between— 
‘‘(i) the negotiated price of the insulin 
drug; and 
‘‘(ii) the Medicaid price of the insulin 
drug; and 
‘‘(E) providing a reasonable dispute resolu-
tion mechanism to resolve disagreements be-
tween manufacturers, applicable individuals, 
and the third party with a contract under sub-
section (d)(3). 
‘‘(2) MONITORING COMPLIANCE.— 
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‘‘(A) IN
GENERAL.—The Secretary shall 
monitor compliance by a manufacturer with the 
terms of an agreement under this section. 
‘‘(B) NOTIFICATION.—If a third party 
with a contract under subsection (d)(3) deter-
mines that the manufacturer is not in compli-
ance with such agreement, the third party shall 
notify the Secretary of such noncompliance for 
appropriate enforcement under subsection (e). 
‘‘(3) COLLECTION OF DATA FROM STATE MED-
ICAID PROGRAMS.—The Secretary may collect appro-
priate data from each State Medicaid program under 
title XIX in a timeframe that allows for Medicaid 
prices to be provided for applicable drugs under this 
section. 
‘‘(d) ADMINISTRATION.— 
‘‘(1) IN GENERAL.—Subject to paragraph (2), 
the Secretary shall provide for the implementation of 
this section, including the performance of the duties 
described in subsection (c). 
‘‘(2) LIMITATION.— 
‘‘(A) IN
GENERAL.—Subject to subpara-
graph (B), in providing for such implementa-
tion, the Secretary shall not receive or dis-
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tribute any funds of a manufacturer under the 
program. 
‘‘(B) EXCEPTION.—The limitation under 
subparagraph (A) shall not apply to the Sec-
retary with respect to insulin drugs dispensed 
during the period beginning on January 1, 
2022, and ending on December 31, 2022, but 
only if the Secretary determines that the excep-
tion to such limitation under this subparagraph 
is necessary in order for the Secretary to begin 
implementation of this section and provide ap-
plicable beneficiaries timely access to Medicaid 
prices during such period. 
‘‘(3) CONTRACT
WITH
THIRD
PARTIES.—The 
Secretary shall enter into a contract with 1 or more 
third parties to administer the requirements estab-
lished by the Secretary in order to carry out this 
section. At a minimum, the contract with a third 
party under the preceding sentence shall require 
that the third party— 
‘‘(A) receive and transmit information be-
tween the Secretary, manufacturers, and other 
individuals or entities the Secretary determines 
appropriate; 
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‘‘(6) ADMINISTRATION.—Chapter 35 of title 44, 
United States Code, shall not apply to the program 
under this section. 
‘‘(e) ENFORCEMENT.— 
‘‘(1) AUDITS.—Each manufacturer with an 
agreement in effect under this section shall be sub-
ject to periodic audit by the Secretary. 
‘‘(2) CIVIL MONETARY PENALTY.— 
‘‘(A) IN
GENERAL.—The Secretary shall 
impose a civil money penalty on a manufacturer 
that fails to provide individuals Medicaid prices 
for insulin drugs of the manufacturer in accord-
ance with such agreement for each such failure 
in an amount the Secretary determines is com-
mensurate with the sum of— 
‘‘(i) the amount that the manufac-
turer would have paid with respect to such 
discounts under the agreement, which will 
then be used to pay the discounts which 
the manufacturer had failed to provide; 
and 
‘‘(ii) 25 percent of such amount. 
‘‘(B) APPLICATION.—The provisions of 
section 1128A (other than subsections (a) and 
(b)) shall apply to a civil money penalty under 
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this paragraph in the same manner as such 
provisions apply to a penalty or proceeding 
under section 1128A(a). 
‘‘(f) DEFINITIONS.—In this section: 
‘‘(1) APPLICABLE INDIVIDUAL.—The term ‘ap-
plicable individual’ means an individual who has re-
ceived a diagnosis of diabetes. 
‘‘(2) APPLICABLE
NUMBER
OF
CALENDAR 
DAYS.—The term ‘applicable number of calendar 
days’ means— 
‘‘(A) with respect to claims for reimburse-
ment submitted electronically, 14 days; and 
‘‘(B) with respect to claims for reimburse-
ment submitted otherwise, 30 days. 
‘‘(3) INSULIN DRUG.—The term ‘insulin drug’ 
means a medication approved by the Food and Drug 
Administration to treat high blood glucose. 
‘‘(4) MANUFACTURER.—The term ‘manufac-
turer’ means, with respect to insulin drugs, any enti-
ty which is engaged in the production, preparation, 
propagation, compounding, conversion, or processing 
of prescription drug products, either directly or indi-
rectly by extraction from substances of natural ori-
gin, or independently by means of chemical syn-
thesis, or by a combination of extraction and chem-
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ical synthesis. Such term does not include a whole-
sale distributor of insulin drugs or a retail pharmacy 
licensed under State law. 
‘‘(5) MEDICAID PRICE.— 
‘‘(A) IN
GENERAL.—The term ‘Medicaid 
price’ means, with respect to an individual enti-
tled to medical assistance under title XIX, the 
net receipt specified in subparagraph (B) for 
the dosage form and strength of an insulin drug 
and any increase due to a certification de-
scribed in subsection (b)(1)(B)(ii)(I). 
‘‘(B) NET RECEIPT SPECIFIED.—For pur-
poses of subparagraph (A), the net receipt spec-
ified in this subparagraph shall be equal to the 
product of— 
‘‘(i) the total number of units of each 
dosage form and strength purchased under 
the program in the rebate period (as deter-
mined by the Secretary), and 
‘‘(ii) the amount that is the list price 
of such drug during such rebate period, 
less, the total amount of rebates that the manu-
facturer paid with respect to such drug during 
such rebate period. 
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‘‘(6) NEGOTIATED
PRICE.—The term ‘nego-
tiated price’ has the meaning given such term in sec-
tion 423.100 of title 42, Code of Federal Regula-
tions (as in effect on the date of enactment of this 
section), except that such negotiated price shall not 
include any dispensing fee for the applicable drug.’’. 
SEC. 3. MAINTENANCE OF EFFORT THROUGHOUT THE IN-
SULIN SUPPLY CHAIN. 
(a) ELIMINATION
OF
PBM REBATES.—Section 
1128B(b)(3) of the Social Security Act (42 U.S.C. 1320a– 
7b(b)(3)) is amended— 
(1) in subparagraph (E), by inserting ‘‘(except 
for a payment practice that permits rebates, dis-
counts, or price concessions for insulin drugs (as de-
fined in section 1150C(f)(3)) to be paid by a manu-
facturer to a PBM (as defined in section 1150A(a))’’ 
before the semicolon at the end; and 
(2) in subparagraph (J)— 
(A) by moving the margin two ems to the 
left; and 
(B) by inserting ‘‘(except for an insulin 
drug)’’ after ‘‘section 1860D–14A(g)’’. 
(b) EXCLUSION
OF
INSULIN
PAYMENTS
FROM 
MLR.—Not later than 90 days after the date of the enact-
ment of this Act, the Secretary of Health and Human 
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Services shall exclude, beginning with plan years begin-
ning on or after January 1, 2021, from the denominator 
(as defined in section 158.221(c) of title 45, Code of Fed-
eral Regulations) section of a medical loss ratio (as cal-
culated under section 158.221(a) of such title) of a health 
insurance issuer (as defined in section 144.103 of such 
title) the amount of payments that such issuer paid during 
a MLR reporting year (as defined in section 144.103 of 
such title) for insulin drugs through the promulgation of 
a regulation. 
(c) MAXIMUM COST SHARING
AND COINSURANCE 
FOR INSULIN DRUGS IN CERTAIN PRIVATE PLANS AND 
MEDICARE.— 
(1) PHSA AMENDMENT.—Subpart II of part A 
of title XXVII of the Public Health Service Act (42 
U.S.C. 300gg–11 et seq.) is amended by inserting 
after section 2713 the following new section: 
‘‘SEC. 2713A. COVERAGE OF INSULIN DRUGS. 
‘‘(a) IN GENERAL.—Beginning with plan years begin-
ning 90 days after the date of the enactment of this sec-
tion, a group health plan and a health insurance issuer 
offering group or individual health insurance coverage 
shall, at a minimum provide coverage and may impose cost 
sharing for an insulin drug in accordance with subsection 
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