I 

116TH CONGRESS 

1ST SESSION H. R. 4906 

To provide patient protections with respect to the cost of insulin. 

IN THE HOUSE OF REPRESENTATIVES 

OCTOBER 29, 2019 

Ms. DEGETTE (for herself and Mr. REED) 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 provide patient protections with respect to the cost of 

insulin. 

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 ‘‘Insulin Price Reduc5 tion Act’’. 

6 SEC. 2. INSULIN PRICE PROTECTIONS. 

7 (a) IN GENERAL.—Subpart II of part A of title 

8 XXVII of the Public Health Service Act (42 U.S.C. 


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1 300gg–11 et seq.) is amended by adding at the end the 

2 following: 

3 ‘‘SEC. 2729A. INSULIN PRICE PROTECTIONS. 

4 ‘‘(a) CONTRACTING REQUIREMENTS.— 

5 ‘‘(1) IN GENERAL.— 

6 ‘‘(A) REQUIREMENT.—Except as provided 

7 in subparagraph (B), a group health plan or a 

8 health insurance issuer offering group or indi9 vidual health insurance coverage shall not, and 

10 shall ensure that any entity that provides phar11 macy benefits management services under a 

12 contract with any such health plan or health in13 surance coverage does not, directly or indirectly, 

14 receive from a manufacturer of certified insulin 

15 a rebate, reduction in price, or other remunera16 tion with respect to such insulin received by an 

17 enrollee in the plan or coverage and covered by 

18 the plan or coverage. 

19 ‘‘(B) EXCEPTION.—The requirement under 

20 subparagraph (A) shall not apply to— 

21 ‘‘(i) any such reduction in price that 

22 is reflected at the point of sale to the en23 rollee; or 

24 ‘‘(ii) any remuneration that is a flat 

25 fee-based service fee that a manufacturer 


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1 of such insulin pays to a pharmacy benefit 

2 manager for services rendered to the man3 ufacturer that relate to arrangements by 

4 the pharmacy benefit manager to provide 

5 pharmacy benefit management services to 

6 a health plan or health insurance issuer, if 

7 certain conditions established by the Sec8 retary are met, including requirements 

9 that the fees are transparent to the health 

10 plan or health insurance issuer. 

11 ‘‘(2) APPLICABILITY.—The restriction under 

12 paragraph (1) shall apply with respect to insulin de13 scribed in paragraph (1), for which the manufac14 turer has certified the list price in accordance with 

15 section 5(b) of the Insulin Price Reduction Act with 

16 respect to— 

17 ‘‘(A) any plan year in which the list price 

18 for insulin is certified under section 5(b)(2)(A) 

19 of the Insulin Price Reduction Act; and 

20 ‘‘(B) each subsequent plan year during 

21 which the manufacturer limits any increase in 

22 the list price to the price that gave rise to the 

23 restriction under paragraph (1), adjusted by 

24 not more than the price change in the medical 

25 care component of the consumer price index for 


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1 all urban consumers (U.S. city average), as cer2 tified under section 5(b)(2)(B) of the Insulin 

3 Price Reduction Act. 

4 ‘‘(b) DEDUCTIBLE LIMITATION.—A group health 

5 plan or a health insurance issuer offering group or indi6 vidual health insurance coverage shall not apply any de7 ductible amount that otherwise is applicable to prescrip8 tion drugs with respect to coverage of certified insulin 

9 under such plan or coverage, during the period described 

10 in subsection (a)(2). 

11 ‘‘(c) HOLD HARMLESS.—During the period begin12 ning on the date a certification is first made under section 

13 5(b)(2)(A) of the Insulin Price Reduction Act and ending 

14 on the last day of the second plan year beginning on or 

15 after such date, a group health plan or a health insurance 

16 issuer offering group or individual health insurance cov17 erage shall not, and shall ensure that any entity that pro18 vides pharmacy benefits management services under a 

19 contract with such health plan or health insurance cov20 erage does not— 

21 ‘‘(1) restrict or disadvantage such insulin from 

22 the formulary applicable to the plan or coverage rel23 ative to any other insulin or similar formulation; 

24 ‘‘(2) impose higher cost-sharing with respect to 

25 such insulin than the cost-sharing that applied with 


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1 respect to the insulin in the year in which the list 

2 price reduction certification was provided under sec3 tion 5(b)(2)(A) of the Insulin Price Reduction Act; 

4 ‘‘(3) impose any prior authorization require5 ments for coverage of such insulin that were not ap6 plied during the year in which the list price reduc7 tion certification was provided under such section 

8 5(b)(2)(A); or 

9 ‘‘(4) establish a step therapy requirement for 

10 such insulin that was not applied during the year in 

11 which the list price reduction certification was pro12 vided under such section 5(b)(2)(A). 

13 ‘‘(d) DEFINITIONS.—In this section— 

14 ‘‘(1) the term ‘certified insulin’ means, with re15 spect to a year, insulin that has been certified under 

16 section 5(b) of the Insulin Price Reduction Act for 

17 the year; 

18 ‘‘(2) the term ‘insulin’ means any insulin prod19 uct approved by the Food and Drug Administration 

20 to improve glycemic control in patients with diabetes 

21 mellitus; 

22 ‘‘(3) the term ‘list price’ has the meaning given 

23 the term ‘wholesale acquisition cost’ in section 

24 1847A(c)(6)(B) of the Social Security Act; and 


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1 ‘‘(4) the term ‘rebate’ means any discount, 

2 price concession, or fee, other than the fee described 

3 in section (a)(1)(B), the terms of which are fixed at 

4 the time of the sale and disclosed, but which is not 

5 received at the time of the sale.’’. 

6 (b) CONFORMING AMENDMENT.—Paragraph (2) of 

7 section 223(d) of the Internal Revenue Code of 1986 is 

8 amended by redesignating subparagraph (D) as subpara9 graph (E) and by inserting after subparagraph (C) the 

10 following new subparagraph: 

11 ‘‘(D) SAFE HARBOR FOR ABSENCE OF DE12 DUCTIBLE FOR INSULIN.—A plan shall not fail 

13 to be treated as a high deductible health plan 

14 by reason of exempting insulin from any de15 ductible pursuant to section 2729A(b) of the 

16 Public Health Service Act during the period de17 scribed in section 2729A(a)(2) of such Act.’’. 

18 (c) EFFECTIVE DATE.—The amendments made by 

19 subsections (a) and (b) shall take effect with respect to 

20 plan years beginning on or after January 1, 2022. 

21 SEC. 3. INSULIN PRICE PROTECTIONS UNDER MEDICARE 

22 PART D. 

23 Section 1860D–4 of the Social Security Act (42 

24 U.S.C. 1395w–104) is amended— 


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1 (1) by redesignating the subsection (m) as 

2 added by section 6063(c) of the SUPPORT for Pa3 tients and Communities Act (Public Law 115–271) 

4 as subsection (n); and 

5 (2) by adding at the end the following new sub6 section: 

7 ‘‘(o) LIMITATION ON REBATES, PRICE REDUCTIONS, 

8 OR OTHER REMUNERATION FOR CERTIFIED INSULIN.— 

9 ‘‘(1) LIMITATION.— 

10 ‘‘(A) IN GENERAL.—Subject to subpara11 graphs (B) and (C), for plan year 2022 and 

12 subsequent plan years, a PDP sponsor and a 

13 Medicare Advantage organization shall ensure 

14 that each prescription drug plan or MA–PD 

15 plan offered by the sponsor or organization, and 

16 any entity that provides pharmacy benefits 

17 management services under a contract with the 

18 prescription drug plan or MA–PD plan offered 

19 by the sponsor or organization, does not, di20 rectly or indirectly, receive from a manufacturer 

21 of certified insulin a rebate, reduction in price, 

22 or other remuneration with respect to certified 

23 insulin that is covered by the plan. 

24 ‘‘(B) EXCEPTION.—The requirement under 

25 subparagraph (A) shall not apply to— 


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1 ‘‘(i) any such reduction in price that 

2 is reflected at the point of sale to the bene3 ficiary; or 

4 ‘‘(ii) any remuneration that is a flat 

5 fee-based service fee that a manufacturer 

6 of such certified insulin pays to a phar7 macy benefit manager for services rendered 

8 to the manufacturer that relate to arrange9 ments by the pharmacy benefit manager to 

10 provide pharmacy benefit management 

11 services to a prescription drug plan or 

12 MA–PD plan, if certain conditions estab13 lished by the Secretary are met, including 

14 requirements that the fees are transparent 

15 to the prescription drug plan or MA–PD 

16 plan. 

17 ‘‘(C) HOLD HARMLESS FOR FIRST 2 YEARS

18 THAT AN INSULIN IS CERTIFIED.—In the first 

19 2 plan years during which paragraph (2) ap20 plies with respect to a certified insulin, a PDP 

21 sponsor and a Medicare Advantage organization 

22 shall not, and shall ensure that any entity that 

23 provides pharmacy benefits management serv24 ices under a contract with such sponsor or or25 ganization does not— 


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1 ‘‘(i) remove such insulin from the for2 mulary applicable to the prescription drug 

3 plan or MA–PD plan; 

4 ‘‘(ii) impose higher cost-sharing with 

5 respect to such insulin than the cost-shar6 ing that applied with respect to the cer7 tified insulin in the year in which the list 

8 price reduction certification was provided 

9 under section 5(b)(2)(A) of the Insulin 

10 Price Reduction Act; 

11 ‘‘(iii) impose any prior authorization 

12 requirements for coverage of the certified 

13 insulin that were not applied during the 

14 year in which the list price reduction cer15 tification was provided under such section 

16 5(b)(2)(A); or 

17 ‘‘(iv) establish a step therapy require18 ment for the certified insulin that was not 

19 applied during the year in which the list 

20 price reduction certification was provided 

21 under such section 5(b)(2)(A). 

22 ‘‘(2) DEFINITIONS.—In this section: 

23 ‘‘(A) CERTIFIED INSULIN.—The term ‘cer24 tified insulin’ means, with respect to a year, inVerDate Sep 11 2014 15:51 Nov 02, 2019 Jkt 099200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H4906.IH H4906

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1 sulin that has been certified under section 5(b) 

2 of the Insulin Price Reduction Act for the year. 

3 ‘‘(B) INSULIN.—The term ‘insulin’ means 

4 any insulin product approved by the Food and 

5 Drug Administration to improve glycemic con6 trol in patients with diabetes mellitus. 

7 ‘‘(C) LIST PRICE.—The term ‘list price’ 

8 has the meaning given the term ‘wholesale ac9 quisition cost’ in section 1847A(c)(6)(B). 

10 ‘‘(D) REBATE.—The term ‘rebate’ means 

11 any discount, price concession, or fee, other 

12 than the fee described in paragraph (1)(B), the 

13 terms of which are fixed at the time of the sale 

14 and disclosed, but which is not received at the 

15 time of the sale.’’. 

16 SEC. 4. APPLICABILITY OF PRE-LIST PRICE REDUCTION 

17 AMP TO MEDICAID MINIMUM REBATE 

18 AMOUNTS. 

19 Section 1927(c) of the Social Security Act (42 U.S.C. 

20 1396r–8(c)) is amended— 

21 (1) in paragraph (1)(A), in the matter pre22 ceding clause (i), by inserting ‘‘and paragraph (5)’’ 

23 after ‘‘paragraph (2)’’; 


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1 (2) in paragraph (3)(A), in the matter pre2 ceding clause (i), by inserting ‘‘and paragraph (5)’’ 

3 after ‘‘subparagraph (C)’’; and 

4 (3) by adding at the end the following new 

5 paragraph: 

6 ‘‘(5) SPECIAL RULE FOR DETERMINING MIN7 IMUM BASIC REBATES FOR INSULIN.— 

8 ‘‘(A) IN GENERAL.—In determining the 

9 amount of the rebate specified in this sub10 section for a dosage form and strength of a cov11 ered outpatient drug described in subparagraph 

12 (B) for any rebate period occurring after April 

13 30, 2020, paragraph (1)(A)(ii)(II) or paragraph 

14 (3)(A)(i) (as applicable) shall be applied by sub15 stituting— 

16 ‘‘(i) the pre-reduction average manu17 facturer price (as defined in subparagraph 

18 (C)) for the dosage form and strength of 

19 the drug for the rebate period; for 

20 ‘‘(ii) the average manufacturer price 

21 for the dosage form and strength of the 

22 drug for the rebate period. 

23 ‘‘(B) DRUGS DESCRIBED.—A covered out24 patient drug is described in this subparagraph 

25 for a rebate period if the drug is insulin for 


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1 which, throughout such rebate period, the man2 ufacturer has certified the list price for each 

3 dosage form and strength of such drug in ac4 cordance with section 5(b) of the Insulin Price 

5 Reduction Act. 

6 ‘‘(C) PRE-REDUCTION AVERAGE MANUFAC7 TURER PRICE.—For purposes of this para8 graph, the term ‘pre-reduction average manu9 facturer price’ means, with respect to each dos10 age form and strength of a covered outpatient 

11 drug described in subparagraph (B) and a re12 bate period— 

13 ‘‘(i) the average manufacturer price 

14 for such drug for the calendar quarter be15 ginning July 1, 2019; increased by 

16 ‘‘(ii) the percentage by which the con17 sumer price index for all urban consumers 

18 (United States city average) for the month 

19 before the month in which the rebate pe20 riod begins exceeds such index for Sep21 tember 2019.’’. 

22 SEC. 5. LIST PRICE DATA SUBMISSIONS. 

23 (a) INITIAL SUBMISSION.— 

24 (1) IN GENERAL.—Not later than April 30, 

25 2020, any manufacturer of insulin wishing to receive 


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1 certification under this section shall submit to the 

2 Secretary— 

3 (A) data on the list price of any insulin 

4 manufactured by the manufacturer during the 

5 period beginning on January 1, 2000 (or the 

6 first date on which such manufacturer begins 

7 manufacturing such insulin), through the list 

8 price applicable at the time of the report; and 

9 (B) a certification that such data is accu10 rate. 

11 (2) LATER SUBMISSIONS.—Any manufacturer 

12 of insulin that does not submit the information de13 scribed in paragraph (1) by the date described in 

14 such paragraph may later submit the information 

15 described in subparagraphs (A) and (B) of para16 graph (1) to the Secretary. Such a manufacturer 

17 who submits such information pursuant to this para18 graph is eligible to certify its list price for the appli19 cable insulin under subsection (b)(2)(A)(ii) with re20 spect to the first plan year that begins at least 15 

21 months after the date of submission under this para22 graph. 

23 (b) ANNUAL PRICE CERTIFICATION.— 

24 (1) IN GENERAL.—Any manufacturer of insulin 

25 who submits information in accordance with subVerDate Sep 11 2014 02:08 Nov 05, 2019 Jkt 099200 PO 00000 Frm 00013 Fmt 6652 Sfmt 6201 E:\BILLS\H4906.IH H4906

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1 section (a) is eligible for certification under this sub2 section. 

3 (2) REQUIREMENTS.— 

4 (A) FIRST CERTIFICATION.— 

5 (i) INITIAL ELIGIBILITY FOR CERTIFI6 CATION.—A manufacturer of insulin who 

7 submits information under subsection 

8 (a)(1) is considered certified under this 

9 subsection for plan year 2022 if such man10 ufacturer, not later than September 30, 

11 2020, submits to the Secretary a certifi12 cation that the manufacturer reduced its 

13 list price for insulin to an amount that is 

14 no greater than the list price for the same 

15 insulin that applied as of July 1, 2006. 

16 (ii) LATER CERTIFICATION.—A manu17 facturer of insulin that submitted informa18 tion under subsection (a)(2) not later than 

19 September 30 of the calendar year that is 

20 2 years prior to the applicable plan year, 

21 is considered certified under this sub22 section for the applicable plan year if such 

23 manufacturer submits to the Secretary a 

24 certification, not later than September 30 

25 of such calendar year, that the manufacVerDate Sep 11 2014 15:51 Nov 02, 2019 Jkt 099200 PO 00000 Frm 00014 Fmt 6652 Sfmt 6201 E:\BILLS\H4906.IH H4906

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1 turer reduced its list price for insulin to 

2 the amount that is no greater than the list 

3 price for the same insulin that applied as 

4 of July 1, 2006, increased by not more 

5 than the rate by which the medical care 

6 component of the consumer price index for 

7 all urban consumers (U.S. city average) in8 creased between September 30, 2020, and 

9 the date on which the certification is sub10 mitted. 

11 (B) SUBSEQUENT CERTIFICATION.—For 

12 plan year 2023 and each plan year thereafter, 

13 a manufacturer of insulin who previously sub14 mitted a certification under clause (i) or (ii) of 

15 subparagraph (A) is considered certified under 

16 this subsection for the applicable plan year if 

17 such manufacturer submits, not later than Sep18 tember 30 of the calendar year that is 2 years 

19 prior to the applicable plan year, a certification 

20 that the manufacturer did not increase the list 

21 price for insulin previously certified under 

22 clause (i) or (ii) of subparagraph (A), by more 

23 than the rate by which the medical care compo24 nent of the consumer price index for all urban 

25 consumers (U.S. city average) increased since 


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1 the initial certification under such clause (i) or 

2 (ii). 

3 (3) SPECIAL RULE FOR CERTAIN INSULIN.— 

4 (A) IN GENERAL.—In the case of a manu5 facturer of insulin that did not manufacture a 

6 particular insulin in 2006, such manufacturer 

7 may be certified under this subsection with re8 spect to such insulin by submitting information 

9 under paragraph (2)(A) certifying that the list 

10 price of such insulin is no greater than the 

11 weighted average list price, in 2006, of, as ap12 plicable— 

13 (i)(I) all short-acting insulins; 

14 (II) all rapid-acting insulins; or 

15 (III) all long-acting insulins; or 

16 (ii) such other insulin categories, as 

17 the Secretary determines appropriate. 

18 (B) INCREASE.—The weighted averages 

19 under subparagraph (A) shall be increased in 

20 accordance with paragraph (2)(A)(ii), as appli21 cable. 

22 (4) APPLICATION TO AUTHORIZED GENERIC IN23 SULIN.—In the case of an insulin that is classified 

24 as an authorized generic drug, as defined in section 

25 505(t)(3) of the Federal Food, Drug, and Cosmetic 


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1 Act (21 U.S.C. 355(t)(3)), the manufacturer of such 

2 insulin may be certified under this section by sub3 mitting information under paragraph (1)(A) certi4 fying that the list price of such authorized generic 

5 insulin is no greater than the list price, as of July 

6 1, 2006, of the listed drug insulin product upon 

7 which the authorized generic drug was based under 

8 section 505(t) of the Federal Food, Drug, and Cos9 metic Act. The certification pursuant to this para10 graph applies only to the authorized generic drug in11 sulin, and does not apply with respect to the applica12 ble listed drug insulin. 

13 (c) AUDITS AND PENALTIES.—The Inspector General 

14 of the Department of Health and Human Services may 

15 audit the financial records and other relevant records of 

16 any manufacturer submitting data under subsections (a) 

17 and (b), and any manufacturer or officer, director, agent, 

18 or managing employee of such manufacturer that know19 ingly submits false or incomplete data shall be subject to 

20 a civil penalty for each insulin for which false or incom21 plete data are submitted in an amount not to exceed the 

22 greater of— 

23 (1) an amount equal to 2 times the total 

24 amount of rebates paid by the manufacturer to 

25 State Medicaid plans for the insulin for rebate periVerDate Sep 11 2014 02:08 Nov 05, 2019 Jkt 099200 PO 00000 Frm 00017 Fmt 6652 Sfmt 6201 E:\BILLS\H4906.IH H4906

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1 ods occurring in calendar year 2018 under section 

2 1927 of the Social Security Act (42 U.S.C. 1396r– 

3 8); or 

4 (2) an alternative amount to be determined by 

5 the Secretary. 

6 (d) DEFINITIONS.—In this section— 

7 (1) the term ‘‘insulin’’ means any insulin prod8 uct approved by the Food and Drug Administration 

9 to improve glycemic control in patients with diabetes 

10 mellitus; 

11 (2) the term ‘‘list price’’ has the meaning given 

12 the term ‘‘wholesale acquisition cost’’ in section 

13 1847A(c)(6)(B) of the Social Security Act (42 

14 U.S.C. 1395w–3a(c)(6)(B)); and 

15 (3) the term ‘‘Secretary’’ means the Secretary 

16 of Health and Human Services. 

Æ 


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