II 

Calendar No. 389 

117TH CONGRESS 

2D SESSION H. R. 6833 

IN THE SENATE OF THE UNITED STATES 

APRIL 4 (legislative day, MARCH 31), 2022 

Received 

MAY 24, 2022 

Read the first time 

MAY 25, 2022 

Read the second time and placed on the calendar 

AN ACT 

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 03:20 May 26, 2022 Jkt 029200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H6833.PCS 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 and continues to be marketed under such sec25 tion, including any insulin product that has been 


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1 deemed to be licensed under section 351(a) of such 

2 Act pursuant to section 7002(e)(4) of the Biologics 

3 Price Competition and Innovation Act of 2009 and 

4 continues to be marketed pursuant to such licensure. 

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

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

7 to provide benefits for selected insulin products described 

8 in this section that are delivered by an out-of-network pro9 vider, or precludes a plan that has a network of providers 

10 from imposing higher cost-sharing than the levels specified 

11 in subsection (a) for selected insulin products described 

12 in this section that are delivered by an out-of-network pro13 vider. 

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

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

16 health plan from imposing cost-sharing other than the lev17 els specified in subsection (a) on, insulin products that are 

18 not selected insulin products, to the extent that such cov19 erage is not otherwise required and such cost-sharing is 

20 otherwise permitted under Federal and applicable State 

21 law. 

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

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

24 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 03:20 May 26, 2022 Jkt 029200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H6833.PCS 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 and continues to be marketed under such sec20 tion, including any insulin product that has been 

21 deemed to be licensed under section 351(a) of such 

22 Act pursuant to section 7002(e)(4) of the Biologics 

23 Price Competition and Innovation Act of 2009 and 

24 continues to 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, be6 fore an enrolled individual has incurred, during 

7 a plan year, 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 (f) IMPLEMENTATION.—The Secretary of Health and 

23 Human Services, the Secretary of Labor, and the Sec24 retary of the Treasury may implement the provisions of, 

25 including the amendments made by, this section through 


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1 sub-regulatory guidance, program instruction, or other2 wise. 

3 SEC. 3. APPROPRIATE COST-SHARING FOR CERTAIN INSU4 LIN PRODUCTS UNDER MEDICARE PART D. 

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

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

7 (1) in subsection (b)— 

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

9 coverage’’ and inserting ‘‘Subject to paragraph 

10 (8), the coverage’’; 

11 (B) in paragraph (2)— 

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

13 ‘‘and (D)’’ and inserting ‘‘and (D) and 

14 paragraph (8)’’; 

15 (ii) in subparagraph (B), by striking 

16 ‘‘and (D)’’ and inserting ‘‘and (D) and 

17 paragraph (8)’’; 

18 (iii) in subparagraph (C)(i), by strik19 ing ‘‘paragraph (4)’’ and inserting ‘‘para20 graphs (4) and (8)’’; and 

21 (iv) in subparagraph (D)(i), by strik22 ing ‘‘paragraph (4)’’ and inserting ‘‘para23 graphs (4) and (8)’’; 

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

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


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

2 ‘‘The coverage’’ and inserting ‘‘Subject to para3 graph (8), the coverage’’; and 

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

5 paragraph: 

6 ‘‘(8) TREATMENT OF COST-SHARING FOR CER7 TAIN INSULIN PRODUCTS.— 

8 ‘‘(A) IN GENERAL.—For plan years begin9 ning on or after January 1, 2023, with respect 

10 to an individual, the following shall apply with 

11 respect to any insulin product (as defined in 

12 subparagraph (B)) that is covered under the 

13 prescription drug plan or MA–PD plan in which 

14 the individual is enrolled: 

15 ‘‘(i) NO APPLICATION OF DEDUCT16 IBLE.—The deductible under paragraph 

17 (1) shall not apply with respect to such in18 sulin product. 

19 ‘‘(ii) APPLICATION OF COST-SHAR20 ING.— 

21 ‘‘(I) IN GENERAL.—The coverage 

22 provides benefits for such insulin 

23 product, regardless of whether an in24 dividual has reached the initial cov25 erage limit under paragraph (3) or 


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1 the out-of-pocket threshold under 

2 paragraph (4), with cost-sharing for a 

3 one-month supply that is equal to the 

4 applicable copayment amount. 

5 ‘‘(II) APPLICABLE COPAYMENT

6 AMOUNT.—For purposes of this 

7 clause, the term ‘applicable copayment 

8 amount’ means, with respect to an in9 sulin product under a prescription 

10 drug plan or an MA–PD plan, an 

11 amount that is not more than $35. 

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

13 this paragraph, the term ‘insulin product’ 

14 means a covered part D drug that is an insulin 

15 product that is approved under section 505 of 

16 the Federal Food, Drug, and Cosmetic Act or 

17 licensed under section 351 of the Public Health 

18 Service Act and marketed pursuant to such ap19 proval or licensure, including any insulin prod20 uct that has been deemed to be licensed under 

21 section 351 of the Public Health Service Act 

22 pursuant to section 7002(e)(4) of the Biologics 

23 Price Competition and Innovation Act of 2009 

24 and marketed pursuant to such section.’’; and 


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

2 following new paragraph: 

3 ‘‘(4) TREATMENT OF COST-SHARING FOR INSU4 LIN PRODUCTS.—The coverage is provided in accord5 ance with subsection (b)(8).’’. 

6 (b) CONFORMING AMENDMENTS TO COST-SHARING

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

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

9 amended— 

10 (1) in paragraph (1)— 

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

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

13 year 2023 and subsequent plan years, the co14 payment amount applicable under the preceding 

15 sentence for a one-month supply of an insulin 

16 product (as defined in subparagraph (B) of sec17 tion 1860D–2(b)(8)) dispensed to the individual 

18 may not exceed the applicable copayment 

19 amount (as defined in subparagraph (A)(ii)(II) 

20 of such section) for the product under the pre21 scription drug plan or MA–PD plan in which 

22 the individual is enrolled.’’; and 

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

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

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


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1 product (as defined in subparagraph (B) of 

2 such section)’’; and 

3 (2) in paragraph (2)— 

4 (A) in subparagraph (B), by adding at the 

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

6 2023 and subsequent plan years, the annual de7 ductible applicable under such section, including 

8 as reduced under the preceding sentence, shall 

9 not apply with respect to an insulin product (as 

10 defined in subparagraph (B) of section 1860D– 

11 2(b)(8)) dispensed to the individual.’’; 

12 (B) in subparagraph (D), by adding at the 

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

14 2023 and subsequent plan years, the amount of 

15 the coinsurance applicable under the preceding 

16 sentence for a one-month supply of an insulin 

17 product (as defined in subparagraph (B) of sec18 tion 1860D–2(b)(8)) dispensed to the individual 

19 may not exceed the applicable copayment 

20 amount (as defined in subparagraph (A)(ii)(II) 

21 of such section) for the product under the pre22 scription drug plan or MA–PD plan in which 

23 the individual is enrolled.’’; and 

24 (C) in subparagraph (E), by adding at the 

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


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1 2023 and subsequent plan years, the amount of 

2 the copayment or coinsurance applicable under 

3 the preceding sentence for a one-month supply 

4 of an insulin product (as defined in subpara5 graph (B) of section 1860D–2(b)(8)) dispensed 

6 to the individual may not exceed the applicable 

7 copayment amount (as defined in subparagraph 

8 (A)(ii)(II) of such section) for the product 

9 under the prescription drug plan or MA–PD 

10 plan in which the individual is enrolled.’’ 

11 (c) IMPLEMENTATION.—Notwithstanding any other 

12 provision of law, the Secretary of Health and Human 

13 Services shall implement this section for plan years 2023 

14 and 2024 by program instruction or otherwise. 

15 SEC. 4. ONE YEAR-EXTENSION ON MORATORIUM ON IMPLE16 MENTATION OF RULE RELATING TO ELIMI17 NATING THE ANTI-KICKBACK STATUTE SAFE 

18 HARBOR PROTECTION FOR PRESCRIPTION 

19 DRUG REBATES. 

20 Section 90006 of the Infrastructure Investment and 

21 Jobs Act (P.L. 117–58) is amended by striking ‘‘January 

22 1, 2026’’ and inserting ‘‘January 1, 2027’’. 

23 SEC. 5. MEDICARE IMPROVEMENT FUND. 

24 Section 1898(b)(1) of the Social Security Act (42 

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1 sion P of the Consolidated Appropriations Act, 2022, is 

2 amended by striking ‘‘$5,000,000’’ and inserting 

3 ‘‘$9,046,500,000’’. 

Passed the House of Representatives March 31, 

2022. 

Attest: CHERYL L. JOHNSON, 

Clerk. 


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Calendar No. 389 

117TH CONGRESS 

2D SESSION H. R. 6833 

AN ACT 

To amend title XXVII of the Public Health Service 

other purposes. cost-sharing for certain insulin products, and for 1974 to establish requirements with respect to Employee Retirement Income Security Act of Act, the Internal Revenue Code of 1986, and the 

MAY 25, 2022 

Read the second time and placed on the calendar 


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