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 jurisdiction 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 insulin supply chain, and for other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Affordable Insulin for 

5 All Act’’. 


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1 SEC. 2. PROVIDING FOR LOWER PRICES FOR INSULIN 

2 DRUGS. 

3 Part A of title XI of the Social Security Act (42 

4 U.S.C. 1301) is amended by adding at the end the fol5 lowing new section: 

6 ‘‘SEC. 1150C. ESTABLISHMENT OF PROGRAM. 

7 ‘‘(a) IN GENERAL.—The Secretary shall establish an 

8 American Insulin Program (in this section referred to as 

9 the ‘program’) by not later than 30 days after the date 

10 of the enactment of this section. Under the program, the 

11 Secretary shall enter into agreements described in sub12 section (b) with manufacturers and provide for the per13 formance of duties described in subsection (c). The Sec14 retary shall establish a model agreement for use under the 

15 program by not later than 20 days after the date of the 

16 enactment of this section, in consultation with manufac17 turers, and allow for comment on such model agreement. 

18 ‘‘(b) TERMS OF AGREEMENT.— 

19 ‘‘(1) IN GENERAL.— 

20 ‘‘(A) AGREEMENT.—An agreement under 

21 this section shall require the manufacturer to 

22 provide applicable individuals access to Med23 icaid prices for insulin drugs of the manufac24 turer. 

25 ‘‘(B) PROVISION OF DISCOUNTED PRICES

26 AS THE POINT-OF-SALE.— 


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1 ‘‘(i) IN GENERAL.—Subject to clause 

2 (ii), such Medicaid prices shall be provided 

3 to the applicable beneficiary at the phar4 macy or by the mail order service at the 

5 point-of-sale of an insulin drug. 

6 ‘‘(ii) CERTIFICATION OF

7 UNSUSTAINABLE REVENUES.— 

8 ‘‘(I) IN GENERAL.—In the case 

9 the Secretary submits to Congress a 

10 certification that net revenues from 

11 the sale of insulin drugs by manufac12 turers with an agreement under this 

13 section is unsustainable because such 

14 manufactures will be unable to meet 

15 the demand for insulin drugs in the 

16 United States, subject to subclause 

17 (II), the Secretary may increase the 

18 Medicaid price by 5 percent. 

19 ‘‘(II) LIMITATION.—The Sec20 retary may not increase the Medicaid 

21 price in accordance with subclause (I) 

22 more than 3 times. 

23 ‘‘(III) APPLICABILITY OF PRICE

24 INCREASE.—An increase to the Med25 icaid price of insulin drugs described 


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1 in subclause (I) shall apply to the sale 

2 of insulin drugs 90 days after the 

3 date of a certification described in 

4 such subclause. 

5 ‘‘(C) TIMING OF AGREEMENT.— 

6 ‘‘(i) SPECIAL RULE FOR 2021.—In 

7 order for an agreement with a manufac8 turer to be in effect under this section with 

9 respect to the period beginning on January 

10 1, 2021, and ending on December 31, 

11 2021, the manufacturer shall enter into 

12 such agreement not later than 30 days 

13 after the date of the establishment of a 

14 model agreement under subsection (a). 

15 ‘‘(ii) 2022 AND SUBSEQUENT

16 YEARS.—In order for an agreement with a 

17 manufacturer to be in effect under this 

18 section with respect to plan year 2022 or 

19 a subsequent plan year, the manufacturer 

20 shall enter into such agreement (or such 

21 agreement shall be renewed under para22 graph (4)(A)) not later than January 30 of 

23 the preceding year. 

24 ‘‘(2) PROVISION OF APPROPRIATE DATA.—Each 

25 manufacturer with an agreement in effect under this 


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1 section shall collect and have available appropriate 

2 data, as determined by the Secretary, to ensure that 

3 it can demonstrate to the Secretary compliance with 

4 the requirements under the program. 

5 ‘‘(3) COMPLIANCE WITH REQUIREMENTS FOR

6 ADMINISTRATION OF PROGRAM.—Each manufac7 turer with an agreement in effect under this section 

8 shall comply with requirements imposed by the Sec9 retary or a third party with a contract under sub10 section (d)(3), as applicable, for purposes of admin11 istering the program, including any determination 

12 under clause (i) of subsection (c)(1)(A) or proce13 dures established under such subsection (c)(1)(A). 

14 ‘‘(4) LENGTH OF AGREEMENT.— 

15 ‘‘(A) IN GENERAL.—An agreement under 

16 this section shall be effective for an initial pe17 riod of not less than 18 months and shall be 

18 automatically renewed for a period of not less 

19 than 1 year unless terminated under subpara20 graph (B). 

21 ‘‘(B) TERMINATION.— 

22 ‘‘(i) BY THE SECRETARY.—The Sec23 retary may provide for termination of an 

24 agreement under this section for a knowing 

25 and willful violation of the requirements of 


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1 the agreement or other good cause shown. 

2 Such termination shall not be effective ear3 lier than 30 days after the date of notice 

4 to the manufacturer of such termination. 

5 The Secretary shall provide, upon request, 

6 a manufacturer with a hearing concerning 

7 such a termination, and such hearing shall 

8 take place prior to the effective date of the 

9 termination with sufficient time for such 

10 effective date to be repealed if the Sec11 retary determines appropriate. 

12 ‘‘(ii) BY A MANUFACTURER.—A man13 ufacturer may terminate an agreement 

14 under this section for any reason. Any 

15 such termination shall be effective, with re16 spect to a plan year— 

17 ‘‘(I) if the termination occurs be18 fore January 30 of a plan year, as of 

19 the day after the end of the plan year; 

20 and 

21 ‘‘(II) if the termination occurs on 

22 or after January 30 of a plan year, as 

23 of the day after the end of the suc24 ceeding plan year. 


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1 ‘‘(iii) EFFECTIVENESS OF TERMI2 NATION.—Any termination under this sub3 paragraph shall not affect discounts for in4 sulin drugs of the manufacturer that are 

5 due under the agreement before the effec6 tive date of its termination. 

7 ‘‘(iv) NOTICE TO THIRD PARTY.—The 

8 Secretary shall provide notice of such ter9 mination to a third party with a contract 

10 under subsection (d)(3) within not less 

11 than 30 days before the effective date of 

12 such termination. 

13 ‘‘(c) DUTIES DESCRIBED.—The duties described in 

14 this subsection are the following: 

15 ‘‘(1) ADMINISTRATION OF PROGRAM.—Admin16 istering the program, including— 

17 ‘‘(A) the determination of the amount of 

18 the Medicaid price of an insulin drug of a man19 ufacturer for applicable individuals in each 

20 State; 

21 ‘‘(B) except as provided in subparagraph 

22 (C), the establishment of procedures under 

23 which Medicaid prices are provided to applica24 ble individuals at pharmacies or by mail order 

25 service at the point-of-sale of an insulin drug; 


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1 ‘‘(C) in the case where, during the period 

2 beginning on January 1, 2022, and ending on 

3 December 31, 2022, it is not practicable to pro4 vide such Medicaid prices at the point-of-sale 

5 (as described in subparagraph (B)), the estab6 lishment of procedures to provide such Medicaid 

7 prices as soon as practicable after the point-of8 sale; 

9 ‘‘(D) the establishment of procedures to 

10 ensure that, not later than the applicable num11 ber of calendar days after the dispensing of an 

12 insulin drug by a pharmacy or mail order serv13 ice, the pharmacy or mail order service is reim14 bursed for an amount equal to the difference 

15 between— 

16 ‘‘(i) the negotiated price of the insulin 

17 drug; and 

18 ‘‘(ii) the Medicaid price of the insulin 

19 drug; and 

20 ‘‘(E) providing a reasonable dispute resolu21 tion mechanism to resolve disagreements be22 tween manufacturers, applicable individuals, 

23 and the third party with a contract under sub24 section (d)(3). 

25 ‘‘(2) MONITORING COMPLIANCE.— 


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1 ‘‘(A) IN GENERAL.—The Secretary shall 

2 monitor compliance by a manufacturer with the 

3 terms of an agreement under this section. 

4 ‘‘(B) NOTIFICATION.—If a third party 

5 with a contract under subsection (d)(3) deter6 mines that the manufacturer is not in compli7 ance with such agreement, the third party shall 

8 notify the Secretary of such noncompliance for 

9 appropriate enforcement under subsection (e). 

10 ‘‘(3) COLLECTION OF DATA FROM STATE MED11 ICAID PROGRAMS.—The Secretary may collect appro12 priate data from each State Medicaid program under 

13 title XIX in a timeframe that allows for Medicaid 

14 prices to be provided for applicable drugs under this 

15 section. 

16 ‘‘(d) ADMINISTRATION.— 

17 ‘‘(1) IN GENERAL.—Subject to paragraph (2), 

18 the Secretary shall provide for the implementation of 

19 this section, including the performance of the duties 

20 described in subsection (c). 

21 ‘‘(2) LIMITATION.— 

22 ‘‘(A) IN GENERAL.—Subject to subpara23 graph (B), in providing for such implementa24 tion, the Secretary shall not receive or disVerDate Sep 11 2014 03:14 Feb 05, 2020 Jkt 099200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H5749.IH H5749

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1 tribute any funds of a manufacturer under the 

2 program. 

3 ‘‘(B) EXCEPTION.—The limitation under 

4 subparagraph (A) shall not apply to the Sec5 retary with respect to insulin drugs dispensed 

6 during the period beginning on January 1, 

7 2022, and ending on December 31, 2022, but 

8 only if the Secretary determines that the excep9 tion to such limitation under this subparagraph 

10 is necessary in order for the Secretary to begin 

11 implementation of this section and provide ap12 plicable beneficiaries timely access to Medicaid 

13 prices during such period. 

14 ‘‘(3) CONTRACT WITH THIRD PARTIES.—The 

15 Secretary shall enter into a contract with 1 or more 

16 third parties to administer the requirements estab17 lished by the Secretary in order to carry out this 

18 section. At a minimum, the contract with a third 

19 party under the preceding sentence shall require 

20 that the third party— 

21 ‘‘(A) receive and transmit information be22 tween the Secretary, manufacturers, and other 

23 individuals or entities the Secretary determines 

24 appropriate; 


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1 ‘‘(B) receive, distribute, or facilitate the 

2 distribution of funds of manufacturers to ap3 propriate individuals or entities in order to 

4 meet the obligations of manufacturers under 

5 agreements under this section; 

6 ‘‘(C) provide adequate and timely informa7 tion to manufacturers, consistent with the 

8 agreement with the manufacturer under this 

9 section, as necessary for the manufacturer to 

10 fulfill its obligations under this section; and 

11 ‘‘(D) permit manufacturers to conduct 

12 periodic audits, directly or through contracts, of 

13 the data and information used by the third 

14 party to determine discounts for insulin drugs 

15 of the manufacturer under the program. 

16 ‘‘(4) PERFORMANCE REQUIREMENTS.—The 

17 Secretary shall establish performance requirements 

18 for a third party with a contract under paragraph 

19 (3) and safeguards to protect the independence and 

20 integrity of the activities carried out by the third 

21 party under the program under this section. 

22 ‘‘(5) IMPLEMENTATION.—The Secretary may 

23 implement the program under this section by pro24 gram instruction or otherwise. 


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1 ‘‘(6) ADMINISTRATION.—Chapter 35 of title 44, 

2 United States Code, shall not apply to the program 

3 under this section. 

4 ‘‘(e) ENFORCEMENT.— 

5 ‘‘(1) AUDITS.—Each manufacturer with an 

6 agreement in effect under this section shall be sub7 ject to periodic audit by the Secretary. 

8 ‘‘(2) CIVIL MONETARY PENALTY.— 

9 ‘‘(A) IN GENERAL.—The Secretary shall 

10 impose a civil money penalty on a manufacturer 

11 that fails to provide individuals Medicaid prices 

12 for insulin drugs of the manufacturer in accord13 ance with such agreement for each such failure 

14 in an amount the Secretary determines is com15 mensurate with the sum of— 

16 ‘‘(i) the amount that the manufac17 turer would have paid with respect to such 

18 discounts under the agreement, which will 

19 then be used to pay the discounts which 

20 the manufacturer had failed to provide; 

21 and 

22 ‘‘(ii) 25 percent of such amount. 

23 ‘‘(B) APPLICATION.—The provisions of 

24 section 1128A (other than subsections (a) and 

25 (b)) shall apply to a civil money penalty under 


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1 this paragraph in the same manner as such 

2 provisions apply to a penalty or proceeding 

3 under section 1128A(a). 

4 ‘‘(f) DEFINITIONS.—In this section: 

5 ‘‘(1) APPLICABLE INDIVIDUAL.—The term ‘ap6 plicable individual’ means an individual who has re7 ceived a diagnosis of diabetes. 

8 ‘‘(2) APPLICABLE NUMBER OF CALENDAR

9 DAYS.—The term ‘applicable number of calendar 

10 days’ means— 

11 ‘‘(A) with respect to claims for reimburse12 ment submitted electronically, 14 days; and 

13 ‘‘(B) with respect to claims for reimburse14 ment submitted otherwise, 30 days. 

15 ‘‘(3) INSULIN DRUG.—The term ‘insulin drug’ 

16 means a medication approved by the Food and Drug 

17 Administration to treat high blood glucose. 

18 ‘‘(4) MANUFACTURER.—The term ‘manufac19 turer’ means, with respect to insulin drugs, any enti20 ty which is engaged in the production, preparation, 

21 propagation, compounding, conversion, or processing 

22 of prescription drug products, either directly or indi23 rectly by extraction from substances of natural ori24 gin, or independently by means of chemical syn25 thesis, or by a combination of extraction and chemVerDate Sep 11 2014 03:14 Feb 05, 2020 Jkt 099200 PO 00000 Frm 00013 Fmt 6652 Sfmt 6201 E:\BILLS\H5749.IH H5749

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1 ical synthesis. Such term does not include a whole2 sale distributor of insulin drugs or a retail pharmacy 

3 licensed under State law. 

4 ‘‘(5) MEDICAID PRICE.— 

5 ‘‘(A) IN GENERAL.—The term ‘Medicaid 

6 price’ means, with respect to an individual enti7 tled to medical assistance under title XIX, the 

8 net receipt specified in subparagraph (B) for 

9 the dosage form and strength of an insulin drug 

10 and any increase due to a certification de11 scribed in subsection (b)(1)(B)(ii)(I). 

12 ‘‘(B) NET RECEIPT SPECIFIED.—For pur13 poses of subparagraph (A), the net receipt spec14 ified in this subparagraph shall be equal to the 

15 product of— 

16 ‘‘(i) the total number of units of each 

17 dosage form and strength purchased under 

18 the program in the rebate period (as deter19 mined by the Secretary), and 

20 ‘‘(ii) the amount that is the list price 

21 of such drug during such rebate period, 

22 less, the total amount of rebates that the manu23 facturer paid with respect to such drug during 

24 such rebate period. 


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1 ‘‘(6) NEGOTIATED PRICE.—The term ‘nego2 tiated price’ has the meaning given such term in sec3 tion 423.100 of title 42, Code of Federal Regula4 tions (as in effect on the date of enactment of this 

5 section), except that such negotiated price shall not 

6 include any dispensing fee for the applicable drug.’’. 

7 SEC. 3. MAINTENANCE OF EFFORT THROUGHOUT THE IN8 SULIN SUPPLY CHAIN. 

9 (a) ELIMINATION OF PBM REBATES.—Section 

10 1128B(b)(3) of the Social Security Act (42 U.S.C. 1320a– 

11 7b(b)(3)) is amended— 

12 (1) in subparagraph (E), by inserting ‘‘(except 

13 for a payment practice that permits rebates, dis14 counts, or price concessions for insulin drugs (as de15 fined in section 1150C(f)(3)) to be paid by a manu16 facturer to a PBM (as defined in section 1150A(a))’’ 

17 before the semicolon at the end; and 

18 (2) in subparagraph (J)— 

19 (A) by moving the margin two ems to the 

20 left; and 

21 (B) by inserting ‘‘(except for an insulin 

22 drug)’’ after ‘‘section 1860D–14A(g)’’. 

23 (b) EXCLUSION OF INSULIN PAYMENTS FROM

24 MLR.—Not later than 90 days after the date of the enact25 ment of this Act, the Secretary of Health and Human 


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1 Services shall exclude, beginning with plan years begin2 ning on or after January 1, 2021, from the denominator 

3 (as defined in section 158.221(c) of title 45, Code of Fed4 eral Regulations) section of a medical loss ratio (as cal5 culated under section 158.221(a) of such title) of a health 

6 insurance issuer (as defined in section 144.103 of such 

7 title) the amount of payments that such issuer paid during 

8 a MLR reporting year (as defined in section 144.103 of 

9 such title) for insulin drugs through the promulgation of 

10 a regulation. 

11 (c) MAXIMUM COST SHARING AND COINSURANCE

12 FOR INSULIN DRUGS IN CERTAIN PRIVATE PLANS AND

13 MEDICARE.— 

14 (1) PHSA AMENDMENT.—Subpart II of part A 

15 of title XXVII of the Public Health Service Act (42 

16 U.S.C. 300gg–11 et seq.) is amended by inserting 

17 after section 2713 the following new section: 

18 ‘‘SEC. 2713A. COVERAGE OF INSULIN DRUGS. 

19 ‘‘(a) IN GENERAL.—Beginning with plan years begin20 ning 90 days after the date of the enactment of this sec21 tion, a group health plan and a health insurance issuer 

22 offering group or individual health insurance coverage 

23 shall, at a minimum provide coverage and may impose cost 

24 sharing for an insulin drug in accordance with subsection 


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1 (b) for an individual that is provided a prescription for 

2 such drug. 

3 ‘‘(b) COST SHARING.—Beginning with plan years be4 ginning 90 days after the date of the enactment of this 

5 section, the cost sharing incurred under a plan or coverage 

6 described in subsection (a) for an insulin drug may not 

7 exceed $10 for each 1-month period of coverage. 

8 ‘‘(c) INSULIN DRUG DEFINED.—In this section, the 

9 term ‘insulin drug’ has the meaning given such term in 

10 section 1150C(f)(3) of the Social Security Act.’’. 

11 (2) MEDICARE AMENDMENTS.— 

12 (A) COINSURANCE LIMITATION.—Section 

13 1860D–2(b)(2) of the Social Security Act (42 

14 U.S.C. 1395w–102(b)(2)) is amended— 

15 (i) in subparagraph (A), by striking 

16 ‘‘Subject to subparagraphs (C) and (D)’’ 

17 and inserting ‘‘Subject to subparagraphs 

18 (C), (D), and (E)’’; and 

19 (ii) by adding at the end, the fol20 lowing new subparagraph: 

21 ‘‘(E) COVERAGE FOR INSULIN DRUGS.— 

22 Beginning with plan years beginning 90 days 

23 after the date of the enactment of this subpara24 graph, the coverage has coinsurance (for costs 

25 above the annual deductible specified in paraVerDate Sep 11 2014 03:14 Feb 05, 2020 Jkt 099200 PO 00000 Frm 00017 Fmt 6652 Sfmt 6201 E:\BILLS\H5749.IH H5749

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1 graph (1) and up to the initial coverage limit 

2 under paragraph (3)) for an insulin drug (as 

3 defined in section 1861(kkk)) is not more than 

4 $10 for each 1-month period of coverage.’’. 

5 (B) INSULIN DRUG DEFINED.—Section 

6 1861 of the Social Security Act (42 U.S.C. 

7 1395x) is amended by adding at the end the 

8 following new subsection: 

9 ‘‘(kkk) INSULIN DRUG.—The term ‘insulin drug’ has 

10 the meaning given such term in section 1150C(f)(3) fur11 nished on or after 90 days after the date of the enactment 

12 of this subsection.’’. 

13 (d) FREEZING OF SUPPLEMENTAL REBATES IN

14 MEDICAID.—Section 1902(a) of the Social Security Act 

15 (42 U.S.C. 1396a(a)) is amended— 

16 (1) in paragraph (85), by striking at the end 

17 ‘‘and’’; 

18 (2) in paragraph (86), by striking the period at 

19 the end and inserting ‘‘; and’’; and 

20 (3) by inserting after paragraph (86), the fol21 lowing new paragraph: 

22 ‘‘(87) provide that the State may not— 

23 ‘‘(A) secure from the manufacturer of a 

24 drug payable under this title a supplemental re25 bate that is not a rebate under section 1927 


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1 that exceeds the amount of the supplemental re2 bate on the date of the enactment of this para3 graph; or 

4 ‘‘(B) secure any other supplemental re5 bates.’’. 

6 (e) ELIMINATION OF SPREAD PRICING AND RE7 LATED PRACTICES IN MEDICAID.— 

8 (1) IN GENERAL.—Section 1927(e) of the So9 cial Security Act (42 U.S.C. 1396r–8(e)) is amended 

10 by adding at the end the following: 

11 ‘‘(6) PASS-THROUGH PRICING REQUIRED.—A 

12 contract between the State and a pharmacy benefit 

13 manager (referred to in this paragraph as a ‘PBM’), 

14 or a contract between the State and a managed care 

15 entity or other specified entity (as such terms are 

16 defined in section 1903(m)(9)(D)) that includes pro17 visions making the entity responsible for coverage of 

18 covered outpatient drugs dispensed to individuals en19 rolled with the entity, shall require that payment for 

20 such drugs and related administrative services (as 

21 applicable), including payments made by a PBM on 

22 behalf of the State or entity, is based on a pass23 through pricing model under which— 

24 ‘‘(A) any payment made by the entity or 

25 the PBM (as applicable) for such a drug— 


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1 ‘‘(i) is limited to— 

2 ‘‘(I) ingredient cost; and 

3 ‘‘(II) a professional dispensing 

4 fee that is not less than the profes5 sional dispensing fee that the State 

6 plan or waiver would pay if the plan 

7 or waiver was making the payment di8 rectly; 

9 ‘‘(ii) is passed through in its entirety 

10 by the entity or PBM to the pharmacy 

11 that dispenses the drug; and 

12 ‘‘(iii) is made in a manner that is con13 sistent with section 1902(a)(30)(A) and 

14 sections 447.512, 447.514, and 447.518 of 

15 title 42, Code of Federal Regulations (or 

16 any successor regulation) as if such re17 quirements applied directly to the entity or 

18 the PBM; 

19 ‘‘(B) payment to the entity or the PBM 

20 (as applicable) for administrative services per21 formed by the entity or PBM is limited to a 

22 reasonable administrative fee that covers the 

23 reasonable cost of providing such services; 

24 ‘‘(C) the entity or the PBM (as applicable) 

25 shall make available to the State, and the SecVerDate Sep 11 2014 03:14 Feb 05, 2020 Jkt 099200 PO 00000 Frm 00020 Fmt 6652 Sfmt 6201 E:\BILLS\H5749.IH H5749

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1 retary upon request, all costs and payments re2 lated to covered outpatient drugs and accom3 panying administrative services incurred, re4 ceived, or made by the entity or the PBM, in5 cluding ingredient costs, professional dispensing 

6 fees, administrative fees, post-sale and post-in7 voice fees. Discounts, or related adjustments 

8 such as direct and indirect remuneration fees, 

9 and any and all remuneration; and 

10 ‘‘(D) any form of spread pricing whereby 

11 any amount charged or claimed by the entity or 

12 the PBM (as applicable) that is in excess of the 

13 amount paid to the pharmacies on behalf of the 

14 entity, including any post-sale or post-invoice 

15 fees, discounts, or related adjustments such as 

16 direct and indirect remuneration fees or assess17 ments (after allowing for a reasonable adminis18 trative fee as described in subparagraph (B)), is 

19 not allowable for purposes of claiming Federal 

20 matching payments under this title.’’. 

21 (2) CONFORMING AMENDMENT.—Clause (xiii) 

22 of section 1903(m)(2)(A) of such Act (42 U.S.C. 

23 1396b(m)(2)(A)) is amended— 

24 (A) by striking ‘‘and (III)’’ and inserting 

25 ‘‘(III)’’; and 


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1 (B) by inserting before the period at the 

2 end the following: ‘‘, and (IV) pharmacy benefit 

3 management services provided by the entity, or 

4 provided by a pharmacy benefit manager on be5 half of the entity under a contract or other ar6 rangement between the entity and the phar7 macy benefit manager, shall comply with the re8 quirements of section 1927(e)(6)’’. 

9 (3) EFFECTIVE DATE.—The amendments made 

10 by this subsection apply to contracts between States 

11 and managed care entities, other specified entities, 

12 or pharmacy benefits managers that are entered into 

13 or renewed on or after the date that is 90 days after 

14 the date of enactment of this Act. 

15 SEC. 4. GAO REPORT. 

16 Not later than 180 days after the date of the enact17 ment of this Act, the Comptroller General of the United 

18 States shall submit to Congress a report on the feasibility 

19 and affordability of direct manufacturing by the Federal 

20 Government. 

Æ 


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