I 

117TH CONGRESS 

2D SESSION H. R. 6833 

To amend title XXVII of the Public Health Service Act, the Internal Revenue 

Code of 1986, and the Employee Retirement Income Security Act of 

1974 to establish requirements with respect to cost-sharing for certain 

insulin products, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

FEBRUARY 25, 2022 

Ms. CRAIG (for herself, Mr. KILDEE, and Mrs. MCBATH) introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, and Education and Labor, 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 XXVII of the Public Health Service Act, 

the Internal Revenue Code of 1986, and the Employee 

Retirement Income Security Act of 1974 to establish 

requirements with respect to cost-sharing for certain insulin products, 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 Now 

5 Act’’. 


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1 SEC. 2. REQUIREMENTS WITH RESPECT TO COST-SHARING 

2 FOR INSULIN PRODUCTS. 

3 (a) PHSA.—Part D of title XXVII of the Public 

4 Health Service Act (42 U.S.C. 300gg–111 et seq.) is 

5 amended by adding at the end the following new section: 

6 ‘‘SEC. 2799A–11. REQUIREMENTS WITH RESPECT TO COST7 SHARING FOR CERTAIN INSULIN PRODUCTS. 

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

9 after January 1, 2023, a group health plan or health in10 surance issuer offering group or individual health insur11 ance coverage shall provide coverage of selected insulin 

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

13 ‘‘(1) apply any deductible; or 

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

15 lesser of, per 30-day supply— 

16 ‘‘(A) $35; or 

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

18 the negotiated price of the selected insulin prod19 uct net of all price concessions received by or on 

20 behalf of the plan or coverage, including price 

21 concessions received by or on behalf of third22 party entities providing services to the plan or 

23 coverage, such as pharmacy benefit manage24 ment services. 

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


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

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

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

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

5 short-acting, intermediate-acting, long-acting, ultra 

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

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

8 health plan or health insurance issuer. 

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

10 means insulin that is licensed under subsection (a) 

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

12 under such section, including any insulin product 

13 that has been deemed to be licensed under section 

14 351(a) pursuant to section 7002(e)(4) of the Bio15 logics Price Competition and Innovation Act of 2009 

16 and continues to be marketed pursuant to such li17 censure. 

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

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

20 of providers to provide benefits for selected insulin prod21 ucts described in this section that are delivered by an out22 of-network provider, or precludes a plan or issuer that has 

23 a network of providers from imposing higher cost-sharing 

24 than the levels specified in subsection (a) for selected insuVerDate Sep 11 2014 23:20 Mar 02, 2022 Jkt 029200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H6833.IH H6833

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1 lin products described in this section that are delivered 

2 by an out-of-network provider. 

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

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

5 health plan or health insurance coverage from imposing 

6 cost-sharing other than the levels specified in subsection 

7 (a) on, insulin products that are not selected insulin prod8 ucts, to the extent that such coverage is not otherwise re9 quired and such cost-sharing is otherwise permitted under 

10 Federal and applicable State law. 

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

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

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

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

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

16 (b) IRC.— 

17 (1) IN GENERAL.—Subchapter B of chapter 

18 100 of the Internal Revenue Code of 1986 is amend19 ed by adding at the end the following new section: 

20 ‘‘SEC. 9826. REQUIREMENTS WITH RESPECT TO COST-SHAR21 ING FOR CERTAIN INSULIN PRODUCTS. 

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

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

24 coverage of selected insulin products, and with respect to 

25 such products, shall not— 


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1 ‘‘(1) apply any deductible; or 

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

3 lesser of, per 30-day supply— 

4 ‘‘(A) $35; or 

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

6 the negotiated price of the selected insulin prod7 uct net of all price concessions received by or on 

8 behalf of the plan, including price concessions 

9 received by or on behalf of third-party entities 

10 providing services to the plan, such as phar11 macy benefit management services. 

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

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

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

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

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

17 short-acting, intermediate-acting, long-acting, ultra 

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

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

20 health plan. 

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

22 means insulin that is licensed under subsection (a) 

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

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

25 under such section, including any insulin product 


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1 that has been deemed to be licensed under section 

2 351(a) of such Act pursuant to section 7002(e)(4) 

3 of the Biologics Price Competition and Innovation 

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

5 be marketed pursuant to such licensure. 

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

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

8 to provide benefits for selected insulin products described 

9 in this section that are delivered by an out-of-network pro10 vider, or precludes a plan that has a network of providers 

11 from imposing higher cost-sharing than the levels specified 

12 in subsection (a) for selected insulin products described 

13 in this section that are delivered by an out-of-network pro14 vider. 

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

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

17 health plan from imposing cost-sharing other than the lev18 els specified in subsection (a) on, insulin products that are 

19 not selected insulin products, to the extent that such cov20 erage is not otherwise required and such cost-sharing is 

21 otherwise permitted under Federal and applicable State 

22 law. 

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

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

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


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

2 maximum that applies under the plan.’’. 

3 (2) CLERICAL AMENDMENT.—The table of sec4 tions for subchapter B of chapter 100 of the Inter5 nal Revenue Code of 1986 is amended by adding at 

6 the end the following new item: 

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

7 (c) ERISA.— 

8 (1) IN GENERAL.—Subpart B of part 7 of sub9 title B of title I of the Employee Retirement Income 

10 Security Act of 1974 (29 U.S.C. 1185 et seq.) is 

11 amended by adding at the end the following: 

12 ‘‘SEC. 726. REQUIREMENTS WITH RESPECT TO COST-SHAR13 ING FOR CERTAIN INSULIN PRODUCTS. 

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

15 after January 1, 2023, a group health plan or health in16 surance issuer offering group health insurance coverage 

17 shall provide coverage of selected insulin products, and 

18 with respect to such products, shall not— 

19 ‘‘(1) apply any deductible; or 

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

21 lesser of, per 30-day supply— 

22 ‘‘(A) $35; or 

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

24 the negotiated price of the selected insulin prodVerDate Sep 11 2014 23:20 Mar 02, 2022 Jkt 029200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H6833.IH H6833

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1 uct net of all price concessions received by or on 

2 behalf of the plan or coverage, including price 

3 concessions received by or on behalf of third4 party entities providing services to the plan or 

5 coverage, such as pharmacy benefit manage6 ment services. 

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

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

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

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

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

12 short-acting, intermediate-acting, long-acting, ultra 

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

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

15 health plan or health insurance issuer. 

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

17 means insulin that is licensed under subsection (a) 

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

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

20 under such section, including any insulin product 

21 that has been deemed to be licensed under section 

22 351(a) of such Act pursuant to section 7002(e)(4) 

23 of the Biologics Price Competition and Innovation 

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

25 be marketed pursuant to such licensure. 


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

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

3 of providers to provide benefits for selected insulin prod4 ucts described in this section that are delivered by an out5 of-network provider, or precludes a plan or issuer that has 

6 a network of providers from imposing higher cost-sharing 

7 than the levels specified in subsection (a) for selected insu8 lin products described in this section that are delivered 

9 by an out-of-network provider. 

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

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

12 health plan or health insurance coverage from imposing 

13 cost-sharing other than the levels specified in subsection 

14 (a) on, insulin products that are not selected insulin prod15 ucts, to the extent that such coverage is not otherwise re16 quired and such cost-sharing is otherwise permitted under 

17 Federal and applicable State law. 

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

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

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

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

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

23 (2) CLERICAL AMENDMENT.—The table of con24 tents in section 1 of the Employee Retirement In25 come Security Act of 1974 (29 U.S.C. 1001 et seq.) 


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1 is amended by inserting after the item relating to 

2 section 725 the following: 

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

3 (d) NO EFFECT ON OTHER COST-SHARING.—Section 

4 1302(d)(2) of the Patient Protection and Affordable Care 

5 Act (42 U.S.C. 18022(d)(2)) is amended by adding at the 

6 end the following new subparagraph: 

7 ‘‘(D) SPECIAL RULE RELATING TO INSU8 LIN COVERAGE.—The exemption of coverage of 

9 selected insulin products (as defined in section 

10 2799A–11(b) of the Public Health Service Act) 

11 from the application of any deductible pursuant 

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

13 726(a)(1) of the Employee Retirement Income 

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

15 the Internal Revenue Code of 1986 shall not be 

16 considered when determining the actuarial value 

17 of a qualified health plan under this sub18 section.’’. 

19 (e) COVERAGE OF CERTAIN INSULIN PRODUCTS

20 UNDER CATASTROPHIC PLANS.—Section 1302(e) of the 

21 Patient Protection and Affordable Care Act (42 U.S.C. 

22 18022(e)) is amended by adding at the end the following: 

23 ‘‘(4) COVERAGE OF CERTAIN INSULIN PROD24 UCTS.— 


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1 ‘‘(A) IN GENERAL.—Notwithstanding para2 graph (1)(B)(i), a health plan described in 

3 paragraph (1) shall provide coverage of selected 

4 insulin products, in accordance with section 

5 2799A–11 of the Public Health Service Act, for 

6 a plan year before an enrolled individual has in7 curred cost-sharing expenses in an amount 

8 equal to the annual limitation in effect under 

9 subsection (c)(1) for the plan year. 

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

11 subparagraph (A)— 

12 ‘‘(i) the term ‘selected insulin prod13 ucts’ has the meaning given such term in 

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

15 Service Act; and 

16 ‘‘(ii) the requirements of section 

17 2799A–11 of such Act shall be applied by 

18 deeming each reference in such section to 

19 ‘individual health insurance coverage’ to be 

20 a reference to a plan described in para21 graph (1).’’. 

22 SEC. 3. APPROPRIATE COST-SHARING FOR CERTAIN INSU23 LIN PRODUCTS UNDER MEDICARE PART D. 

24 (a) IN GENERAL.—Section 1860D–2 of the Social 

25 Security Act (42 U.S.C. 1395w–102) is amended— 


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1 (1) in subsection (b)— 

2 (A) in paragraph (1)(A), by striking ‘‘The 

3 coverage’’ and inserting ‘‘Subject to paragraph 

4 (8), the coverage’’; 

5 (B) in paragraph (2)(A), by striking ‘‘and 

6 (D)’’ and inserting ‘‘and (D) and paragraph 

7 (8)’’; 

8 (C) in paragraph (3)(A), by striking ‘‘and 

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

10 (D) in paragraph (4)(A)(i), by striking 

11 ‘‘The coverage’’ and inserting ‘‘Subject to para12 graph (8), the coverage’’; and 

13 (E) by adding at the end the following new 

14 paragraph: 

15 ‘‘(8) TREATMENT OF COST-SHARING FOR CER16 TAIN INSULIN PRODUCTS.— 

17 ‘‘(A) IN GENERAL.—For plan years begin18 ning on or after January 1, 2023, the following 

19 shall apply with respect to insulin products (as 

20 defined in subparagraph (B)): 

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

23 (1) shall not apply with respect to such in24 sulin products. 


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1 ‘‘(ii) APPLICATION OF COST-SHAR2 ING.— 

3 ‘‘(I) PLAN YEAR 2023.—For plan 

4 year 2023, the coverage provides ben5 efits for such insulin products, regard6 less of whether an individual has 

7 reached the initial coverage limit 

8 under paragraph (3) or the out-of9 pocket threshold under paragraph (4), 

10 with cost-sharing that is equal to the 

11 applicable copayment amount. 

12 ‘‘(II) PLAN YEAR 2024 AND SUB13 SEQUENT PLAN YEARS.—For plan 

14 year 2024 and subsequent plan years, 

15 the coverage provides benefits for 

16 such insulin products, prior to an in17 dividual reaching the out-of-pocket 

18 threshold under paragraph (4), with 

19 cost-sharing that is equal to the appli20 cable copayment amount. 

21 ‘‘(III) APPLICABLE COPAYMENT

22 AMOUNT.—For purposes of this 

23 clause, the term ‘applicable copayment 

24 amount’ means, with respect to an in25 sulin product under a prescription 


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1 drug plan or an MA–PD plan, an 

2 amount that is not more than $35. 

3 ‘‘(B) INSULIN PRODUCT.—For purposes of 

4 this paragraph, the term ‘insulin product’ 

5 means an insulin product that is approved 

6 under section 505 of the Federal Food, Drug, 

7 and Cosmetic Act or licensed under section 351 

8 of the Public Health Service Act and marketed 

9 pursuant to such approval or licensure, includ10 ing any insulin product that has been deemed 

11 to be licensed under section 351 of the Public 

12 Health Service Act pursuant to section 

13 7002(e)(4) of the Biologics Price Competition 

14 and Innovation Act of 2009 and marketed pur15 suant to such section.’’; and 

16 (2) in subsection (c), by adding at the end the 

17 following new paragraph: 

18 ‘‘(4) TREATMENT OF COST-SHARING FOR INSU19 LIN PRODUCTS.—The coverage is provided in accord20 ance with subsection (b)(8).’’. 

21 (b) CONFORMING AMENDMENTS TO COST-SHARING

22 FOR LOW-INCOME INDIVIDUALS.—Section 1860D–14(a) 

23 of the Social Security Act (42 U.S.C. 1395w–114(a)) is 

24 amended— 

25 (1) in paragraph (1)— 


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1 (A) in subparagraph (D)(iii), by adding at 

2 the end the following new sentence: ‘‘For plan 

3 year 2023 and subsequent plan years, the co4 payment amount applicable under the preceding 

5 sentence to an insulin product (as defined in 

6 section 1860D–2(b)(8)(B)) furnished to the in7 dividual may not exceed the applicable copay8 ment amount for the product under the pre9 scription drug plan or MA–PD plan in which 

10 the individual is enrolled.’’; and 

11 (B) in subparagraph (E), by inserting the 

12 following before the period at the end ‘‘or under 

13 section 1860D–2(b)(8) in the case of an insulin 

14 product (as defined in subparagraph (B) of 

15 such section)’’; and 

16 (2) in paragraph (2)— 

17 (A) in subparagraph (D), by adding at the 

18 end the following new sentence: ‘‘For plan year 

19 2023 and subsequent plan years, the amount of 

20 the coinsurance applicable under the preceding 

21 sentence to an insulin product (as defined in 

22 section 1860D–2(b)(8)(B)) furnished to the in23 dividual may not exceed the applicable copay24 ment amount for the product under the preVerDate Sep 11 2014 23:20 Mar 02, 2022 Jkt 029200 PO 00000 Frm 00015 Fmt 6652 Sfmt 6201 E:\BILLS\H6833.IH H6833

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1 scription drug plan or MA–PD plan in which 

2 the individual is enrolled.’’; and 

3 (B) in subparagraph (E), by adding at the 

4 end the following new sentence: ‘‘For plan year 

5 2023, the amount of the copayment or coinsur6 ance applicable under the preceding sentence to 

7 an insulin product (as defined in section 

8 1860D–2(b)(8)(B)) furnished to the individual 

9 may not exceed the applicable copayment 

10 amount for the product under the prescription 

11 drug plan or MA–PD plan in which the indi12 vidual is enrolled.’’ 

13 (c) IMPLEMENTATION.—The Secretary shall imple14 ment this section for plan years 2023 and 2024 by pro15 gram instruction or otherwise. 

Æ 


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