II 

117TH CONGRESS 

2D SESSION S. 3700 

To provide for appropriate cost-sharing for insulin products covered under 

Medicare part D and private health plans. 

IN THE SENATE OF THE UNITED STATES 

FEBRUARY 17, 2022 

Mr. WARNOCK (for himself, Mr. SCHUMER, Mr. DURBIN, Mr. WYDEN, Mr. 

BENNET, Mr. BLUMENTHAL, Ms. BALDWIN, Mr. KELLY, Ms. STABENOW, 

Mr. REED, Mr. VAN HOLLEN, Ms. HIRONO, Ms. KLOBUCHAR, Mr. MURPHY, Ms. HASSAN, Mrs. SHAHEEN, Mr. BOOKER, Mr. KING, Ms. SMITH, 

and Mr. PADILLA) introduced the following bill; which was read twice and 

referred to the Committee on Finance 

A BILL 

To provide for appropriate cost-sharing for insulin products 

covered under Medicare part D and private health plans. 

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 Now 

5 Act’’. 


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1 SEC. 2. APPROPRIATE COST-SHARING FOR INSULIN PROD2 UCTS COVERED UNDER MEDICARE PART D 

3 AND PRIVATE HEALTH PLANS. 

4 (a) MEDICARE PART D.— 

5 (1) IN GENERAL.—Section 1860D–2 of the So6 cial Security Act (42 U.S.C. 1395w–102) is amend7 ed— 

8 (A) in subsection (b)— 

9 (i) in paragraph (1)(A), in the matter 

10 preceding clause (i), by striking ‘‘The cov11 erage’’ and inserting ‘‘Subject to para12 graph (8), the coverage’’; 

13 (ii) in paragraph (2)— 

14 (I) in subparagraph (A), in the 

15 matter preceding clause (i), by strik16 ing ‘‘and (D)’’ and inserting ‘‘and (D) 

17 and paragraph (8)’’; 

18 (II) in subparagraph (C)(i), in 

19 the matter preceding subclause (I), by 

20 striking ‘‘paragraph (4)’’ and insert21 ing ‘‘paragraphs (4) and (8)’’; and 

22 (III) in subparagraph (D)(i), in 

23 the matter preceding subclause (I), by 

24 striking ‘‘paragraph (4)’’ and insert25 ing ‘‘paragraphs (4) and (8)’’; 


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1 (iii) in paragraph (3)(A), in the mat2 ter preceding clause (i), by striking ‘‘and 

3 (4)’’ and inserting ‘‘(4), and (8)’’; 

4 (iv) in paragraph (4)(A)(i), in the 

5 matter preceding subclause (I), by striking 

6 ‘‘The coverage’’ and inserting ‘‘Subject to 

7 paragraph (8), the coverage’’; and 

8 (v) by adding at the end the following 

9 new paragraph: 

10 ‘‘(8) TREATMENT OF COST-SHARING FOR COV11 ERED INSULIN PRODUCTS.— 

12 ‘‘(A) IN GENERAL.—For the portion of 

13 plan year 2022 beginning on October 1, 2022, 

14 and ending on December 31, 2022, and for 

15 plan year 2023 and subsequent plan years, the 

16 following rules shall apply with respect to cost17 sharing for a month’s supply of any covered in18 sulin product (as defined in subparagraph (B)) 

19 that is covered under the prescription drug plan 

20 or MA–PD plan: 

21 ‘‘(i) NO APPLICATION OF DEDUCT22 IBLE.—The deductible under paragraph 

23 (1) shall not apply with respect to any 

24 such covered insulin product. 

25 ‘‘(ii) MAXIMUM COST-SHARING.— 


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1 ‘‘(I) IN GENERAL.—The coverage 

2 shall provide benefits for such any 

3 covered insulin product, regardless of 

4 whether an individual has reached the 

5 initial coverage limit under paragraph 

6 (3) or the annual out-of-pocket 

7 threshold under paragraph (4), with 

8 cost-sharing for a month’s supply that 

9 does not exceed the maximum cost10 sharing amount. 

11 ‘‘(II) MAXIMUM COST-SHARING

12 AMOUNT.—For purposes of subclause 

13 (I), the term ‘maximum cost-sharing 

14 amount’ means, with respect to a cov15 ered insulin product under a prescrip16 tion drug plan or an MA–PD plan 

17 dispensed— 

18 ‘‘(aa) on or after October 1, 

19 2022, and before January 1, 

20 2024, $35; and 

21 ‘‘(bb) during plan year 2024 

22 or subsequent plan year, the less23 er of— 

24 ‘‘(AA) $35; or 


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1 ‘‘(BB) an amount equal 

2 to 25 percent of the nego3 tiated price of the covered 

4 insulin product under the 

5 prescription drug plan or 

6 MA–PD plan. 

7 ‘‘(B) COVERED INSULIN PRODUCT.—For 

8 purposes of this paragraph, the term ‘covered 

9 insulin product’ means a covered part D drug 

10 that is an insulin product that is approved 

11 under section 505 of the Federal Food, Drug, 

12 and Cosmetic Act or licensed under section 351 

13 of the Public Health Service Act and continues 

14 to be marketed, including any insulin product 

15 that has been deemed to be licensed under sec16 tion 351 of the Public Health Service Act pur17 suant to section 7002(e)(4) of the Biologics 

18 Price Competition and Innovation Act of 2009 

19 and continues to be marketed.’’; and 

20 (B) in subsection (c), by adding at the end 

21 the following new paragraph: 

22 ‘‘(4) TREATMENT OF COST-SHARING FOR INSU23 LIN PRODUCTS.—The coverage is provided in accord24 ance with subsection (b)(8).’’. 


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1 (2) CONFORMING AMENDMENTS TO COST-SHAR2 ING FOR LOW-INCOME INDIVIDUALS.—Section 

3 1860D–14(a) of the Social Security Act (42 U.S.C. 

4 1395w–114(a)) is amended— 

5 (A) in paragraph (1)— 

6 (i) in subparagraph (D)(iii), by add7 ing at the end the following new sentence: 

8 ‘‘For the portion of plan year 2022 begin9 ning on October 1, 2022, and ending on 

10 December 31, 2022, and for plan year 

11 2023 and subsequent plan years, the co12 payment amount applicable under the pre13 ceding sentence to a month’s supply of a 

14 covered insulin product (as described in 

15 section 1860D–2(b)(8)) dispensed to the 

16 individual may not exceed the applicable 

17 copayment or coinsurance amount for the 

18 product under the prescription drug plan 

19 or MA–PD plan in which the individual is 

20 enrolled.’’; and 

21 (ii) in subparagraph (E), by inserting 

22 the following before the period at the end: 

23 ‘‘or under section 1860D–2(b)(8) in the 

24 case of a covered insulin product (as de25 scribed in such section)’’; and 


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1 (B) in paragraph (2)— 

2 (i) in subparagraph (D), by adding at 

3 the end the following new sentence: ‘‘For 

4 the portion of plan year 2022 beginning on 

5 October 1, 2022, and ending on December 

6 31, 2022, and for plan year 2023 and sub7 sequent plan years, the amount of the co8 insurance applicable under the preceding 

9 sentence to a month’s supply of a covered 

10 insulin product (as described in section 

11 1860D–2(b)(8)) dispensed to the indi12 vidual may not exceed the applicable co13 payment or coinsurance amount for the 

14 product under the prescription drug plan 

15 or MA–PD plan in which the individual is 

16 enrolled.’’; and 

17 (ii) in subparagraph (E), by adding at 

18 the end the following new sentence: ‘‘For 

19 the portion of plan year 2022 beginning on 

20 October 1, 2022, and ending on December 

21 31, 2022, and for plan year 2023 and sub22 sequent plan years, the amount of the co23 payment or coinsurance applicable under 

24 the preceding sentence to a month’s supply 

25 of a covered insulin product (as described 


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1 in section 1860D–2(b)(8)) dispensed to the 

2 individual may not exceed the applicable 

3 copayment or coinsurance amount for the 

4 product under the prescription drug plan 

5 or MA–PD plan in which the individual is 

6 enrolled.’’. 

7 (3) IMPLEMENTATION.—Notwithstanding any 

8 other provision of law, the Secretary of Health and 

9 Human Services may implement the provisions of, 

10 including the amendments made by, this subsection 

11 for plan years 2022, 2023, and 2024 by program in12 struction or otherwise. 

13 (4) FUNDING.—In addition to amounts other14 wise available, there is appropriated to the Centers 

15 for Medicare & Medicaid Services, out of any money 

16 in the Treasury not otherwise appropriated, 

17 $1,500,000 for fiscal year 2022, to remain available 

18 until expended, to carry out the provisions of, in19 cluding the amendments made by, this subsection. 

20 (b) PRIVATE HEALTH PLANS.— 

21 (1) IN GENERAL.—Part D of title XXVII of the 

22 Public Health Service Act (42 U.S.C. 300gg–111 et 

23 seq.) is amended by adding at the end the following: 


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1 ‘‘SEC. 2799A–11. REQUIREMENTS WITH RESPECT TO COST2 SHARING FOR CERTAIN INSULIN PRODUCTS. 

3 ‘‘(a) IN GENERAL.—For plan years beginning on or 

4 after January 1, 2023, a group health plan or health in5 surance issuer offering group or individual health insur6 ance coverage shall provide coverage of selected insulin 

7 products, and with respect to such products, shall not— 

8 ‘‘(1) apply any deductible; or 

9 ‘‘(2) impose any cost-sharing in excess of the 

10 lesser of, per 30-day supply— 

11 ‘‘(A) $35; or 

12 ‘‘(B) the amount equal to 25 percent of 

13 the negotiated price of the selected insulin prod14 uct net of all price concessions received by or on 

15 behalf of the plan or coverage, including price 

16 concessions received by or on behalf of third17 party entities providing services to the plan or 

18 coverage, such as pharmacy benefit manage19 ment services. 

20 ‘‘(b) DEFINITIONS.—In this section: 

21 ‘‘(1) SELECTED INSULIN PRODUCTS.—The term 

22 ‘selected insulin products’ means at least one of each 

23 dosage form (such as vial, pump, or inhaler dosage 

24 forms) of each different type (such as rapid-acting, 

25 short-acting, intermediate-acting, long-acting, ultra 

26 long-acting, and premixed) of insulin (as defined 


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1 below), when available, as selected by the group 

2 health plan or health insurance issuer. 

3 ‘‘(2) INSULIN DEFINED.—The term ‘insulin’ 

4 means insulin that is licensed under subsection (a) 

5 or (k) of section 351 and continues to be marketed 

6 under such section, including any insulin product 

7 that has been deemed to be licensed under section 

8 351(a) pursuant to section 7002(e)(4) of the Bio9 logics Price Competition and Innovation Act of 2009 

10 and continues to be marketed pursuant to such li11 censure. 

12 ‘‘(c) OUT-OF-NETWORK PROVIDERS.—Nothing in 

13 this section requires a plan or issuer that has a network 

14 of providers to provide benefits for selected insulin prod15 ucts described in this section that are delivered by an out16 of-network provider, or precludes a plan or issuer that has 

17 a network of providers from imposing higher cost-sharing 

18 than the levels specified in subsection (a) for selected insu19 lin products described in this section that are delivered 

20 by an out-of-network provider. 

21 ‘‘(d) RULE OF CONSTRUCTION.—Subsection (a) shall 

22 not be construed to require coverage of, or prevent a group 

23 health plan or health insurance coverage from imposing 

24 cost-sharing other than the levels specified in subsection 

25 (a) on, insulin products that are not selected insulin prodVerDate Sep 11 2014 01:23 Feb 25, 2022 Jkt 029200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\S3700.IS S3700

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1 ucts, to the extent that such coverage is not otherwise re2 quired and such cost-sharing is otherwise permitted under 

3 Federal and applicable State law. 

4 ‘‘(e) APPLICATION OF COST-SHARING TOWARDS

5 DEDUCTIBLES AND OUT-OF-POCKET MAXIMUMS.—Any 

6 cost-sharing payments made pursuant to subsection (a)(2) 

7 shall be counted toward any deductible or out-of-pocket 

8 maximum that applies under the plan or coverage.’’. 

9 (2) NO EFFECT ON OTHER COST-SHARING.— 

10 Section 1302(d)(2) of the Patient Protection and Af11 fordable Care Act (42 U.S.C. 18022(d)(2)) is 

12 amended by adding at the end the following new 

13 subparagraph: 

14 ‘‘(D) SPECIAL RULE RELATING TO INSU15 LIN COVERAGE.—The exemption of coverage of 

16 selected insulin products (as defined in section 

17 2799A–11(b) of the Public Health Service Act) 

18 from the application of any deductible pursuant 

19 to section 2799A–11(a)(1) of such Act, section 

20 726(a)(1) of the Employee Retirement Income 

21 Security Act of 1974, or section 9826(a)(1) of 

22 the Internal Revenue Code of 1986 shall not be 

23 considered when determining the actuarial value 

24 of a qualified health plan under this sub25 section.’’. 


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1 (3) COVERAGE OF CERTAIN INSULIN PRODUCTS

2 UNDER CATASTROPHIC PLANS.—Section 1302(e) of 

3 the Patient Protection and Affordable Care Act (42 

4 U.S.C. 18022(e)) is amended by adding at the end 

5 the following: 

6 ‘‘(4) COVERAGE OF CERTAIN INSULIN PROD7 UCTS.— 

8 ‘‘(A) IN GENERAL.—Notwithstanding para9 graph (1)(B)(i), a health plan described in 

10 paragraph (1) shall provide coverage of selected 

11 insulin products, in accordance with section 

12 2799A–11 of the Public Health Service Act, be13 fore an enrolled individual has incurred, during 

14 the plan year, cost-sharing expenses in an 

15 amount equal to the annual limitation in effect 

16 under subsection (c)(1) for the plan year. 

17 ‘‘(B) TERMINOLOGY.—For purposes of 

18 subparagraph (A)— 

19 ‘‘(i) the term ‘selected insulin prod20 ucts’ has the meaning given such term in 

21 section 2799A–11(b) of the Public Health 

22 Service Act; and 

23 ‘‘(ii) the requirements of section 

24 2799A–11 of such Act shall be applied by 

25 deeming each reference in such section to 


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1 ‘individual health insurance coverage’ to be 

2 a reference to a plan described in para3 graph (1).’’. 

4 (4) ERISA.— 

5 (A) IN GENERAL.—Subpart B of part 7 of 

6 subtitle B of title I of the Employee Retirement 

7 Income Security Act of 1974 (29 U.S.C. 1185 

8 et seq.) is amended by adding at the end the 

9 following: 

10 ‘‘SEC. 726. REQUIREMENTS WITH RESPECT TO COST-SHAR11 ING FOR CERTAIN INSULIN PRODUCTS. 

12 ‘‘(a) IN GENERAL.—For plan years beginning on or 

13 after January 1, 2023, a group health plan or health in14 surance issuer offering group health insurance coverage 

15 shall provide coverage of selected insulin products, and 

16 with respect to such products, shall not— 

17 ‘‘(1) apply any deductible; or 

18 ‘‘(2) impose any cost-sharing in excess of the 

19 lesser of, per 30-day supply— 

20 ‘‘(A) $35; or 

21 ‘‘(B) the amount equal to 25 percent of 

22 the negotiated price of the selected insulin prod23 uct net of all price concessions received by or on 

24 behalf of the plan or coverage, including price 

25 concessions received by or on behalf of thirdVerDate Sep 11 2014 01:23 Feb 25, 2022 Jkt 029200 PO 00000 Frm 00013 Fmt 6652 Sfmt 6201 E:\BILLS\S3700.IS S3700

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1 party entities providing services to the plan or 

2 coverage, such as pharmacy benefit manage3 ment services. 

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

5 ‘‘(1) SELECTED INSULIN PRODUCTS.—The term 

6 ‘selected insulin products’ means at least one of each 

7 dosage form (such as vial, pump, or inhaler dosage 

8 forms) of each different type (such as rapid-acting, 

9 short-acting, intermediate-acting, long-acting, ultra 

10 long-acting, and premixed) of insulin (as defined 

11 below), when available, as selected by the group 

12 health plan or health insurance issuer. 

13 ‘‘(2) INSULIN DEFINED.—The term ‘insulin’ 

14 means insulin that is licensed under subsection (a) 

15 or (k) of section 351 of the Public Health Service 

16 Act (42 U.S.C. 262) and continues to be marketed 

17 under such section, including any insulin product 

18 that has been deemed to be licensed under section 

19 351(a) of such Act pursuant to section 7002(e)(4) 

20 of the Biologics Price Competition and Innovation 

21 Act of 2009 (Public Law 111–148) and continues to 

22 be marketed pursuant to such licensure. 

23 ‘‘(c) OUT-OF-NETWORK PROVIDERS.—Nothing in 

24 this section requires a plan or issuer that has a network 

25 of providers to provide benefits for selected insulin prodVerDate Sep 11 2014 01:23 Feb 25, 2022 Jkt 029200 PO 00000 Frm 00014 Fmt 6652 Sfmt 6201 E:\BILLS\S3700.IS S3700

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1 ucts described in this section that are delivered by an out2 of-network provider, or precludes a plan or issuer that has 

3 a network of providers from imposing higher cost-sharing 

4 than the levels specified in subsection (a) for selected insu5 lin products described in this section that are delivered 

6 by an out-of-network provider. 

7 ‘‘(d) RULE OF CONSTRUCTION.—Subsection (a) shall 

8 not be construed to require coverage of, or prevent a group 

9 health plan or health insurance coverage from imposing 

10 cost-sharing other than the levels specified in subsection 

11 (a) on, insulin products that are not selected insulin prod12 ucts, to the extent that such coverage is not otherwise re13 quired and such cost-sharing is otherwise permitted under 

14 Federal and applicable State law. 

15 ‘‘(e) APPLICATION OF COST-SHARING TOWARDS

16 DEDUCTIBLES AND OUT-OF-POCKET MAXIMUMS.—Any 

17 cost-sharing payments made pursuant to subsection (a)(2) 

18 shall be counted toward any deductible or out-of-pocket 

19 maximum that applies under the plan or coverage.’’. 

20 (B) CLERICAL AMENDMENT.—The table of 

21 contents in section 1 of the Employee Retire22 ment Income Security Act of 1974 (29 U.S.C. 

23 1001 et seq.) is amended by inserting after the 

24 item relating to section 725 the following: 

‘‘Sec. 726. Requirements with respect to cost-sharing for certain insulin products.’’. 


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1 (5) INTERNAL REVENUE CODE.— 

2 (A) IN GENERAL.—Subchapter B of chap3 ter 100 of the Internal Revenue Code of 1986 

4 is amended by adding at the end the following 

5 new section: 

6 ‘‘SEC. 9826. REQUIREMENTS WITH RESPECT TO COST-SHAR7 ING FOR CERTAIN INSULIN PRODUCTS. 

8 ‘‘(a) IN GENERAL.—For plan years beginning on or 

9 after January 1, 2023, a group health plan shall provide 

10 coverage of selected insulin products, and with respect to 

11 such products, shall not— 

12 ‘‘(1) apply any deductible; or 

13 ‘‘(2) impose any cost-sharing in excess of the 

14 lesser of, per 30-day supply— 

15 ‘‘(A) $35; or 

16 ‘‘(B) the amount equal to 25 percent of 

17 the negotiated price of the selected insulin prod18 uct net of all price concessions received by or on 

19 behalf of the plan, including price concessions 

20 received by or on behalf of third-party entities 

21 providing services to the plan, such as phar22 macy benefit management services. 

23 ‘‘(b) DEFINITIONS.—In this section: 

24 ‘‘(1) SELECTED INSULIN PRODUCTS.—The term 

25 ‘selected insulin products’ means at least one of each 


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1 dosage form (such as vial, pump, or inhaler dosage 

2 forms) of each different type (such as rapid-acting, 

3 short-acting, intermediate-acting, long-acting, ultra 

4 long-acting, and premixed) of insulin (as defined 

5 below), when available, as selected by the group 

6 health plan. 

7 ‘‘(2) INSULIN DEFINED.—The term ‘insulin’ 

8 means insulin that is licensed under subsection (a) 

9 or (k) of section 351 of the Public Health Service 

10 Act (42 U.S.C. 262) and continues to be marketed 

11 under such section, including any insulin product 

12 that has been deemed to be licensed under section 

13 351(a) of such Act pursuant to section 7002(e)(4) 

14 of the Biologics Price Competition and Innovation 

15 Act of 2009 (Public Law 111–148) and continues to 

16 be marketed pursuant to such licensure. 

17 ‘‘(c) OUT-OF-NETWORK PROVIDERS.—Nothing in 

18 this section requires a plan that has a network of providers 

19 to provide benefits for selected insulin products described 

20 in this section that are delivered by an out-of-network pro21 vider, or precludes a plan that has a network of providers 

22 from imposing higher cost-sharing than the levels specified 

23 in subsection (a) for selected insulin products described 

24 in this section that are delivered by an out-of-network pro25 vider. 


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1 ‘‘(d) RULE OF CONSTRUCTION.—Subsection (a) shall 

2 not be construed to require coverage of, or prevent a group 

3 health plan from imposing cost-sharing other than the lev4 els specified in subsection (a) on, insulin products that are 

5 not selected insulin products, to the extent that such cov6 erage is not otherwise required and such cost-sharing is 

7 otherwise permitted under Federal and applicable State 

8 law. 

9 ‘‘(e) APPLICATION OF COST-SHARING TOWARDS

10 DEDUCTIBLES AND OUT-OF-POCKET MAXIMUMS.—Any 

11 cost-sharing payments made pursuant to subsection (a)(2) 

12 shall be counted toward any deductible or out-of-pocket 

13 maximum that applies under the plan.’’. 

14 (B) CLERICAL AMENDMENT.—The table of 

15 sections for subchapter B of chapter 100 of 

16 such Code is amended by adding at the end the 

17 following new item: 

‘‘Sec. 9826. Requirements with respect to cost-sharing for certain insulin products.’’. 

18 (6) IMPLEMENTATION.—The Secretary of 

19 Health and Human Services, the Secretary of Labor, 

20 and the Secretary of the Treasury may implement 

21 the provisions of, including the amendments made 

22 by, this subsection through sub-regulatory guidance, 

23 program instruction or otherwise. 

Æ 


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