II 

118TH CONGRESS 

1ST SESSION S. 1269 

To reduce the price of insulin and provide for patient protections with respect 

to the cost of insulin. 

IN THE SENATE OF THE UNITED STATES 

APRIL 25, 2023 

Mrs. SHAHEEN (for herself and Ms. COLLINS) introduced the following bill; 

which was read twice and referred to the Committee on Health, Education, Labor, and Pensions 

A BILL 

To reduce the price of insulin and provide for 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; TABLE OF CONTENTS. 

4 (a) SHORT TITLE.—This Act may be cited as the 

5 ‘‘Improving Needed Safeguards for Users of Lifesaving 

6 Insulin Now Act of 2023’’ or the ‘‘INSULIN Act of 

7 2023’’. 

8 (b) TABLE OF CONTENTS.—The table of contents for 

9 this Act is as follows: 

Sec. 1. Short title; table of contents. 


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TITLE I—COMMERCIAL MARKET PATIENT PROTECTIONS 

Sec. 101. Requirements with respect to cost-sharing for certain insulin products. 

Sec. 102. Application to retiree and certain small group plans. 

Sec. 103. Administration. 

TITLE II—PHARMACY BENEFIT MANAGER TRANSPARENCY AND 

REBATE REFORM 

Sec. 201. Full rebate on insulin pass-through to plan. 

TITLE III—BIOSIMILAR BIOLOGICAL PRODUCT AND GENERIC 

DRUG COMPETITION AND AFFORDABILITY 

Sec. 301. Ensuring timely access to generics. 

Sec. 302. Permitted mid-year changes in Medicare part D plan formularies for 

certain biosimilar biological products and the reference product 

of such biosimilars. 

Sec. 303. Expediting competitive biosimilar competition. 

Sec. 304. Insulin competition report. 

1 TITLE I—COMMERCIAL MARKET 

2 PATIENT PROTECTIONS 

3 SEC. 101. REQUIREMENTS WITH RESPECT TO COST-SHAR4 ING FOR CERTAIN INSULIN PRODUCTS. 

5 (a) IN GENERAL.—Part D of title XXVII of the Pub6 lic Health Service Act (42 U.S.C. 300gg–111 et seq.) is 

7 amended by adding at the end the following: 

8 ‘‘SEC. 2799A–11. REQUIREMENTS WITH RESPECT TO COST9 SHARING FOR CERTAIN INSULIN PRODUCTS. 

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

11 after January 1, 2024, a group health plan or health in12 surance issuer offering group or individual health insur13 ance coverage shall provide coverage of selected insulin 

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

15 ‘‘(1) apply any deductible; or 


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1 ‘‘(2) impose any cost-sharing requirements in 

2 excess of, per 30-day supply— 

3 ‘‘(A) for any applicable plan year begin4 ning before January 1, 2025, $35; or 

5 ‘‘(B) for any plan year beginning on or 

6 after January 1, 2025, the lesser of— 

7 ‘‘(i) $35; or 

8 ‘‘(ii) the amount equal to 25 percent 

9 of the negotiated price of the selected insu10 lin product net of all price concessions re11 ceived by or on behalf of the plan or issuer, 

12 including price concessions received by or 

13 on behalf of third-party entities providing 

14 services to the plan or issuer, such as 

15 pharmacy benefit management services or 

16 third party administrators. 

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

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

19 ‘selected insulin products’ means, for any plan year 

20 beginning on or after January 1, 2024, at least one 

21 of each dosage form (such as vial, pen, or inhaler 

22 dosage forms) of each different type (such as rapid23 acting, short-acting, intermediate-acting, long-acting, 

24 and pre-mixed) of insulin, when such form is liVerDate Sep 11 2014 02:13 Apr 28, 2023 Jkt 039200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S1269.IS S1269

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1 censed and marketed, as selected by the group 

2 health plan or health insurance issuer. 

3 ‘‘(2) INSULIN.—The term ‘insulin’ means insu4 lin that is licensed under subsection (a) or (k) of 

5 section 351 and continues to be marketed pursuant 

6 to such licensure. 

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

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

9 of providers to provide benefits for selected insulin prod10 ucts described in this section that are delivered by an out11 of-network provider, or precludes a plan or issuer that has 

12 a network of providers from imposing higher cost-sharing 

13 than the levels specified in subsection (a) for selected insu14 lin products described in this section that are delivered 

15 by an out-of-network provider. 

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

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

18 health plan or health insurance coverage from imposing 

19 cost-sharing other than the levels specified in subsection 

20 (a) on, insulin products that are not selected insulin prod21 ucts, to the extent that such coverage is not otherwise re22 quired and such cost-sharing is otherwise permitted under 

23 Federal and applicable State law. 

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

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


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

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

3 maximum that applies under the plan or coverage. 

4 ‘‘(f) OTHER REQUIREMENTS.—A group health plan 

5 or health insurance issuer offering group or individual 

6 health insurance coverage shall not impose, directly or 

7 through an entity providing pharmacy benefit manage8 ment services, any prior authorization or other medical 

9 management requirement, or other similar conditions, on 

10 selected insulin products, except as clinically justified for 

11 safety reasons, to ensure reasonable quantity limits and 

12 as specified by the Secretary.’’. 

13 (b) NO EFFECT ON OTHER COST-SHARING.—Section 

14 1302(d)(2) of the Patient Protection and Affordable Care 

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

16 end the following new subparagraph: 

17 ‘‘(D) SPECIAL RULE RELATING TO INSU18 LIN COVERAGE.—For plans years beginning on 

19 or after January 1, 2025, the exemption of cov20 erage of selected insulin products (as defined in 

21 section 2799A–11(b) of the Public Health Serv22 ice Act) from the application of any deductible 

23 pursuant to section 2799A–11(a)(1) of such 

24 Act, section 726(a)(1) of the Employee Retire25 ment Income Security Act of 1974, or section 


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1 9826(a)(1) of the Internal Revenue Code of 

2 1986 shall not be considered when determining 

3 the actuarial value of a qualified health plan 

4 under this subsection.’’. 

5 (c) COVERAGE OF CERTAIN INSULIN PRODUCTS

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

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

8 18022(e)) is amended by adding at the end the following: 

9 ‘‘(4) COVERAGE OF CERTAIN INSULIN PROD10 UCTS.— 

11 ‘‘(A) IN GENERAL.—Notwithstanding para12 graph (1)(B)(i), a health plan described in 

13 paragraph (1) shall provide coverage of selected 

14 insulin products, in accordance with section 

15 2799A–11 of the Public Health Service Act, be16 fore an enrolled individual has incurred, during 

17 the plan year, cost-sharing expenses in an 

18 amount equal to the annual limitation in effect 

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

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

21 subparagraph (A)— 

22 ‘‘(i) the term ‘selected insulin prod23 ucts’ has the meaning given such term in 

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

25 Service Act; and 


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1 ‘‘(ii) the requirements of section 

2 2799A–11 of such Act shall be applied by 

3 deeming each reference in such section to 

4 ‘individual health insurance coverage’ to be 

5 a reference to a plan described in para6 graph (1).’’. 

7 (d) 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, 2024, 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 requirements in 

21 excess of, per 30-day supply— 

22 ‘‘(A) for any applicable plan year begin23 ning before January 1, 2025, $35; or 

24 ‘‘(B) for any plan year beginning on or 

25 after January 1, 2025, the lesser of— 


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1 ‘‘(i) $35; or 

2 ‘‘(ii) the amount equal to 25 percent 

3 of the negotiated price of the selected insu4 lin product net of all price concessions re5 ceived by or on behalf of the plan or issuer, 

6 including price concessions received by or 

7 on behalf of third-party entities providing 

8 services to the plan or issuer, such as 

9 pharmacy benefit management services or 

10 third party administrators. 

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

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

13 ‘selected insulin products’ means, for any plan year 

14 beginning on or after January 1, 2024, at least one 

15 of each dosage form (such as vial, pen, or inhaler 

16 dosage forms) of each different type (such as rapid17 acting, short-acting, intermediate-acting, long-acting, 

18 and pre-mixed) of insulin, when such form is li19 censed and marketed, as selected by the group 

20 health plan or health insurance issuer. 

21 ‘‘(2) INSULIN.—The term ‘insulin’ means insu22 lin that is licensed under subsection (a) or (k) of 

23 section 351 of the Public Health Service Act (42 

24 U.S.C. 262) and continues to be marketed pursuant 

25 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 ‘‘(f) OTHER REQUIREMENTS.—A group health plan 

24 or health insurance issuer offering group health insurance 

25 coverage shall not impose, directly or through an entity 


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1 providing pharmacy benefit management services, any 

2 prior authorization or other medical management require3 ment, or other similar conditions, on selected insulin prod4 ucts, except as clinically justified for safety reasons, to en5 sure reasonable quantity limits and as specified by the 

6 Secretary.’’. 

7 (2) CLERICAL AMENDMENT.—The table of con8 tents in section 1 of the Employee Retirement In9 come Security Act of 1974 (29 U.S.C. 1001 et seq.) 

10 is amended by inserting after the item relating to 

11 section 725 the following: 

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

12 (e) INTERNAL REVENUE CODE.— 

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

14 100 of the Internal Revenue Code of 1986 is amend15 ed by adding at the end the following new section: 

16 ‘‘SEC. 9826. REQUIREMENTS WITH RESPECT TO COST-SHAR17 ING FOR CERTAIN INSULIN PRODUCTS. 

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

19 after January 1, 2024, a group health plan shall provide 

20 coverage of selected insulin products, and with respect to 

21 such products, shall not— 

22 ‘‘(1) apply any deductible; or 

23 ‘‘(2) impose any cost-sharing requirements in 

24 excess of, per 30-day supply— 


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1 ‘‘(A) for any applicable plan year begin2 ning before January 1, 2025, $35; or 

3 ‘‘(B) for any plan year beginning on or 

4 after January 1, 2025, the lesser of— 

5 ‘‘(i) $35; or 

6 ‘‘(ii) the amount equal to 25 percent 

7 of the negotiated price of the selected insu8 lin product net of all price concessions re9 ceived by or on behalf of the plan, includ10 ing price concessions received by or on be11 half of third-party entities providing serv12 ices to the plan, such as pharmacy benefit 

13 management services or third party admin14 istrators. 

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

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

17 ‘selected insulin products’ means, for any plan year 

18 beginning on or after January 1, 2024, at least one 

19 of each dosage form (such as vial, pen, or inhaler 

20 dosage forms) of each different type (such as rapid21 acting, short-acting, intermediate-acting, long-acting, 

22 and pre-mixed) of insulin, when such form is li23 censed and marketed, as selected by the group 

24 health plan. 


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1 ‘‘(2) INSULIN.—The term ‘insulin’ means insu2 lin that is licensed under subsection (a) or (k) of 

3 section 351 of the Public Health Service Act (42 

4 U.S.C. 262) and continues to be marketed pursuant 

5 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 ‘‘(f) OTHER REQUIREMENTS.—A group health plan 

4 shall not impose, directly or through an entity providing 

5 pharmacy benefit management services, any prior author6 ization or other medical management requirement, or 

7 other similar conditions, on selected insulin products, ex8 cept as clinically justified for safety reasons, to ensure rea9 sonable quantity limits and as specified by the Secretary’’. 

10 (2) CLERICAL AMENDMENT.—The table of sec11 tions for subchapter B of chapter 100 of such Code, 

12 as amended by section 102(c)(2), is further amended 

13 by adding at the end the following new item: 

‘‘Sec. 9827. Requirements with respect to cost-sharing for certain insulin products.’’. 

14 SEC. 102. APPLICATION TO RETIREE AND CERTAIN SMALL 

15 GROUP PLANS. 

16 (a) ERISA.—Section 732(a) of the Employee Retire17 ment Income Security Act of 1974 (29 U.S.C. 1191a(a)) 

18 is amended by striking ‘‘section 711’’ and inserting ‘‘sec19 tions 711 and 726’’. 

20 (b) IRC.—The Internal Revenue Code of 1986 is 

21 amended— 

22 (1) in section 9831(a), by adding at the end the 

23 following flush text: 


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1 ‘‘Paragraph (2) shall not apply to the requirements under 

2 sections 9811 and 9826.’’; and 

3 (2) in section 4980D(d)(1), by striking ‘‘section 

4 9811’’ and inserting ‘‘sections 9811 and 9826’’. 

5 SEC. 103. ADMINISTRATION. 

6 (a) IMPLEMENTATION.—Notwithstanding any other 

7 provision of law, the Secretary of Health and Human 

8 Services, the Secretary of Labor, and the Secretary of the 

9 Treasury may implement the provisions of, including the 

10 amendments made by, this title for plan years that begin 

11 on or after January 1, 2024, and end not later than Janu12 ary 1, 2027, by subregulatory guidance, program instruc13 tion, or otherwise. 

14 (b) NON-APPLICATION OF THE PAPERWORK REDUC15 TION ACT.—Chapter 35 of title 44, United States Code 

16 (commonly referred to as the ‘‘Paperwork Reduction Act 

17 of 1995’’), shall not apply to the provisions of, including 

18 the amendments made by, this title. 


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1 TITLE II—PHARMACY BENEFIT 

2 MANAGER TRANSPARENCY 

3 AND REBATE REFORM 

4 SEC. 201. FULL REBATE ON INSULIN PASS-THROUGH TO 

5 PLAN. 

6 Part A of title XXVII of the Public Health Service 

7 Act (42 U.S.C. 300gg et seq.) is further amended by add8 ing at the end the following: 

9 ‘‘SEC. 2729A. FULL REBATE ON INSULIN PASS-THROUGH TO 

10 PLAN. 

11 ‘‘(a) IN GENERAL.—A pharmacy benefits manager, 

12 a third-party administrator of a group health plan, a 

13 health insurance issuer offering group health insurance 

14 coverage, or an entity providing pharmacy benefits man15 agement services under such health plan or health insur16 ance coverage shall remit 100 percent of rebates, fees, al17 ternative discounts, and all other remuneration received 

18 from a pharmaceutical manufacturer, distributor or any 

19 other third party, that are related to utilization of insulin 

20 under such health plan or health insurance coverage, to 

21 the group health plan. 

22 ‘‘(b) FORM AND MANNER OF REMITTANCE.—Such 

23 rebates, fees, alternative discounts, and other remunera24 tion shall be— 


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1 ‘‘(1) remitted to the group health plan in a 

2 timely fashion after the period for which such re3 bates, fees, or other remuneration is calculated, and 

4 in no case later than 90 days after the end of such 

5 period; 

6 ‘‘(2) fully disclosed and enumerated to the 

7 group health plan sponsor; and 

8 ‘‘(3) available for audit by the plan sponsor, or 

9 a third-party designated by a plan sponsor no less 

10 than once per plan year.’’. 

11 TITLE III—BIOSIMILAR BIOLOGI12 CAL PRODUCT AND GENERIC 

13 DRUG COMPETITION AND AF14 FORDABILITY 

15 SEC. 301. ENSURING TIMELY ACCESS TO GENERICS. 

16 Section 505(q) of the Federal Food, Drug, and Cos17 metic Act (21 U.S.C. 355(q)) is amended— 

18 (1) in paragraph (1)— 

19 (A) in subparagraph (A)(i), by inserting ‘‘, 

20 10.31,’’ after ‘‘10.30’’; 

21 (B) in subparagraph (E)— 

22 (i) by striking ‘‘application and’’ and 

23 inserting ‘‘application or’’; 

24 (ii) by striking ‘‘If the Secretary’’ and 

25 inserting the following: 


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1 ‘‘(i) IN GENERAL.—If the Secretary’’; 

2 and 

3 (iii) by striking the second sentence 

4 and inserting the following: 

5 ‘‘(ii) PRIMARY PURPOSE OF DELAY6 ING.— 

7 ‘‘(I) IN GENERAL.—In deter8 mining whether a petition was sub9 mitted with the primary purpose of 

10 delaying an application, the Secretary 

11 may consider the following factors: 

12 ‘‘(aa) Whether the petition 

13 was submitted in accordance with 

14 paragraph (2)(B), based on when 

15 the petitioner knew or reasonably 

16 should have known the relevant 

17 information relied upon to form 

18 the basis of such petition. 

19 ‘‘(bb) Whether the petitioner 

20 has submitted multiple or serial 

21 petitions or supplements to peti22 tions raising issues that reason23 ably could have been known to 

24 the petitioner at the time of subVerDate Sep 11 2014 02:13 Apr 28, 2023 Jkt 039200 PO 00000 Frm 00017 Fmt 6652 Sfmt 6201 E:\BILLS\S1269.IS S1269

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1 mission of the earlier petition or 

2 petitions. 

3 ‘‘(cc) Whether the petition 

4 was submitted close in time to a 

5 known, first date upon which an 

6 application under subsection 

7 (b)(2) or (j) of this section or 

8 section 351(k) of the Public 

9 Health Service Act could be ap10 proved. 

11 ‘‘(dd) Whether the petition 

12 was submitted without relevant 

13 data or information in support of 

14 the scientific positions forming 

15 the basis of such petition. 

16 ‘‘(ee) Whether the petition 

17 raises the same or substantially 

18 similar issues as a prior petition 

19 to which the Secretary has re20 sponded substantively already, in21 cluding if the subsequent submis22 sion follows such response from 

23 the Secretary closely in time. 

24 ‘‘(ff) Whether the petition 

25 requests changing the applicable 


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1 standards that other applicants 

2 are required to meet, including 

3 requesting testing, data, or label4 ing standards that are more on5 erous or rigorous than the stand6 ards the Secretary has deter7 mined to be applicable to the list8 ed drug, reference product, or pe9 titioner’s version of the same 

10 drug. 

11 ‘‘(gg) The petitioner’s record 

12 of submitting petitions to the 

13 Food and Drug Administration 

14 that have been determined by the 

15 Secretary to have been submitted 

16 with the primary purpose of 

17 delay. 

18 ‘‘(hh) Other relevant and 

19 appropriate factors, which the 

20 Secretary shall describe in guid21 ance. 

22 ‘‘(II) GUIDANCE.—The Secretary 

23 may issue or update guidance, as ap24 propriate, to describe factors the SecVerDate Sep 11 2014 02:13 Apr 28, 2023 Jkt 039200 PO 00000 Frm 00019 Fmt 6652 Sfmt 6201 E:\BILLS\S1269.IS S1269

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1 retary considers in accordance with 

2 subclause (I).’’; 

3 (C) by adding at the end the following: 

4 ‘‘(iii) REFERRAL TO THE FEDERAL

5 TRADE COMMISSION.—The Secretary shall 

6 establish procedures for referring to the 

7 Federal Trade Commission any petition or 

8 supplement to a petition that the Secretary 

9 determines was submitted with the primary 

10 purpose of delaying approval of an applica11 tion. Such procedures shall include notifi12 cation to the petitioner by the Secretary.’’; 

13 (D) by striking subparagraph (F); 

14 (E) by redesignating subparagraphs (G) 

15 through (I) as subparagraphs (F) through (H), 

16 respectively; and 

17 (F) in subparagraph (H), as so redesig18 nated, by striking ‘‘submission of this petition’’ 

19 and inserting ‘‘submission of this document’’; 

20 (2) in paragraph (2)— 

21 (A) by redesignating subparagraphs (A) 

22 through (C) as subparagraphs (C) through (E), 

23 respectively; 

24 (B) by inserting before subparagraph (C), 

25 as so redesignated, the following: 


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1 ‘‘(A) IN GENERAL.—A person shall submit 

2 a petition to the Secretary under paragraph (1) 

3 before filing a civil action in which the person 

4 seeks to set aside, delay, rescind, withdraw, or 

5 prevent submission, review, or approval of an 

6 application submitted under subsection (b)(2) 

7 or (j) of this section or section 351(k) of the 

8 Public Health Service Act. Such petition and 

9 any supplement to such a petition shall describe 

10 all information and arguments that form the 

11 basis of the relief requested in any civil action 

12 described in the previous sentence. 

13 ‘‘(B) TIMELY SUBMISSION OF CITIZEN PE14 TITION.—A petition and any supplement to a 

15 petition shall be submitted within 60 days after 

16 the person knew, or reasonably should have 

17 known, the information that forms the basis of 

18 the request made in the petition or supple19 ment.’’; 

20 (C) in subparagraph (C), as so redesig21 nated— 

22 (i) in the heading, by striking ‘‘WITH23 IN 150 DAYS’’; 


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1 (ii) in clause (i), by striking ‘‘during 

2 the 150-day period referred to in para3 graph (1)(F),’’; and 

4 (iii) by amending clause (ii) to read as 

5 follows: 

6 ‘‘(ii) on or after the date that is 151 

7 days after the date of submission of the 

8 petition, the Secretary approves or has ap9 proved the application that is the subject 

10 of the petition without having made such a 

11 final decision.’’; 

12 (D) by amending subparagraph (D), as so 

13 redesignated, to read as follows: 

14 ‘‘(D) DISMISSAL OF CERTAIN CIVIL AC15 TIONS.— 

16 ‘‘(i) PETITION.—If a person files a 

17 civil action against the Secretary in which 

18 a person seeks to set aside, delay, rescind, 

19 withdraw, or prevent submission, review, or 

20 approval of an application submitted under 

21 subsection (b)(2) or (j) of this section or 

22 section 351(k) of the Public Health Service 

23 Act without complying with the require24 ments of subparagraph (A), the court shall 


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1 dismiss without prejudice the action for 

2 failure to exhaust administrative remedies. 

3 ‘‘(ii) TIMELINESS.—If a person files a 

4 civil action against the Secretary in which 

5 a person seeks to set aside, delay, rescind, 

6 withdraw, or prevent submission, review, or 

7 approval of an application submitted under 

8 subsection (b)(2) or (j) of this section or 

9 section 351(k) of the Public Health Service 

10 Act without complying with the require11 ments of subparagraph (B), the court shall 

12 dismiss with prejudice the action for fail13 ure to timely file a petition. 

14 ‘‘(iii) FINAL RESPONSE.—If a civil ac15 tion is filed against the Secretary with re16 spect to any issue raised in a petition time17 ly filed under paragraph (1) in which the 

18 petitioner requests that the Secretary take 

19 any form of action that could, if taken, set 

20 aside, delay, rescind, withdraw, or prevent 

21 submission, review, or approval of an appli22 cation submitted under subsection (b)(2) 

23 or (j) of this section or section 351(k) of 

24 the Public Health Service Act before the 

25 Secretary has taken final agency action on 


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1 the petition within the meaning of sub2 paragraph (C), the court shall dismiss 

3 without prejudice the action for failure to 

4 exhaust administrative remedies.’’; and 

5 (E) in clause (iii) of subparagraph (E), as 

6 so redesignated, by striking ‘‘as defined under 

7 subparagraph (2)(A)’’ and inserting ‘‘within the 

8 meaning of subparagraph (C)’’; and 

9 (3) in paragraph (4)— 

10 (A) by striking ‘‘EXCEPTIONS’’ and all that 

11 follows through ‘‘This subsection does’’ and in12 serting ‘‘EXCEPTIONS.—This subsection does’’; 

13 (B) by striking subparagraph (B); and 

14 (C) by redesignating clauses (i) and (ii) as 

15 subparagraphs (A) and (B), respectively, and 

16 adjusting the margins accordingly. 

17 SEC. 302. PERMITTED MID-YEAR CHANGES IN MEDICARE 

18 PART D PLAN FORMULARIES FOR CERTAIN 

19 BIOSIMILAR BIOLOGICAL PRODUCTS AND 

20 THE REFERENCE PRODUCT OF SUCH 

21 BIOSIMILARS. 

22 (a) IN GENERAL.—Section 1860D–4(b) of the Social 

23 Security Act (42 5 U.S.C. 1395w–104(b)) is amended by 

24 adding at the end the following new paragraph: 


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1 ‘‘(5) MID-YEAR CHANGES IN FORMULARIES

2 PERMITTED FOR CERTAIN BIOSIMILAR BIOLOGICAL

3 PRODUCTS AND THE REFERENCE PRODUCT OF SUCH

4 BIOSIMILARS.—If a PDP sponsor of a prescription 

5 drug plan uses a formulary (including the use of 

6 tiered cost-sharing), the following shall apply: 

7 ‘‘(A) IN GENERAL.—For plan year 2024, 

8 and subsequent plan years, in the case of a cov9 ered part D drug that is the reference biological 

10 product (as defined in section 1847A(c)(6)(I)) 

11 with respect to a biosimilar biological product 

12 (as defined in section 1847A(c)(6)(H)), the 

13 PDP sponsor may, with respect to a formulary, 

14 at any time after the first 60 days of the plan 

15 year, subject to paragraph (3)(E), change the 

16 preferred or tiered cost-sharing status of such 

17 reference biological product if such PDP spon18 sor adds, at the same time, to such formulary 

19 such biosimilar biological product at the same 

20 or a higher preferred status, or to the same or 

21 lower cost-sharing tier, as that of such ref22 erence biological product immediately prior to 

23 such change. 

24 ‘‘(B) REQUEST FOR APPROVAL OF

25 CHANGE.—Prior to making a change described 


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1 in clause (i), the PDP sponsor shall submit to 

2 the Secretary a request to make such change. 

3 If the Secretary approves the request or has not 

4 provided a decision to the PDP sponsor regard5 ing such request within 30 days of receiving 

6 such request, such PDP sponsor may make 

7 such change.’’. 

8 (b) ADMINISTRATION.— 

9 (1) IMPLEMENTATION.—Notwithstanding any 

10 other provision of law, the Secretary of Health and 

11 Human Services may implement the amendment 

12 made by subsection (a) by subregulatory guidance, 

13 program instruction, or otherwise. 

14 (2) NON-APPLICATION OF THE PAPERWORK RE15 DUCTION ACT.—Chapter 35 of title 44, United 

16 States Code (commonly referred to as the ‘‘Paper17 work Reduction Act of 1995’’), shall not apply to the 

18 implementation of the amendment made by sub19 section (a). 

20 SEC. 303. EXPEDITING COMPETITIVE BIOSIMILAR COM21 PETITION. 

22 (a) IN GENERAL.—Section 351(k) of the Public 

23 Health Service Act (42 U.S.C. 262(k)) is amended by add24 ing at the end the following: 


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1 ‘‘(10) EXPEDITING COMPETITIVE BIOSIMILAR

2 COMPETITION.— 

3 ‘‘(A) IN GENERAL.—The Secretary may, at 

4 the request of the sponsor of an application 

5 under this subsection for a biosimilar biological 

6 product that is designated as a competitive bio7 similar therapy pursuant to subsection (b), ex8 pedite the development and review of such ap9 plication under this subsection. 

10 ‘‘(B) DESIGNATION PROCESS.— 

11 ‘‘(i) REQUEST.—The sponsor of an 

12 application under this subsection may re13 quest the Secretary to designate the drug 

14 as a competitive biosimilar therapy. A re15 quest for such designation may be made 

16 concurrently with, or at any time prior to, 

17 the submission of a biosimilar biological 

18 product license application under this sub19 section. 

20 ‘‘(ii) CRITERIA.—A biological product 

21 is eligible for designation as a competitive 

22 biosimilar therapy under this paragraph if 

23 the Secretary determines that there is in24 adequate biosimilar competition. 


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1 ‘‘(iii) DESIGNATION.—Not later than 

2 60 calendar days after the receipt of a re3 quest under clause (i), the Secretary 

4 may— 

5 ‘‘(I) determine whether the bio6 similar biological product that is the 

7 subject of the request meets the cri8 teria described in clause (ii); and 

9 ‘‘(II) if the Secretary finds that 

10 such product meets such criteria, des11 ignate the biosimilar biological prod12 uct as a competitive biosimilar ther13 apy. 

14 ‘‘(C) ACTIONS.—In expediting the develop15 ment and review of an application under sub16 paragraph (A), the Secretary may, as requested 

17 by the applicant, take actions including the fol18 lowing: 

19 ‘‘(i) Hold meetings with the sponsor 

20 and the review team throughout the devel21 opment of the biosimilar biological product 

22 prior to submission of the application 

23 under this subsection. 

24 ‘‘(ii) Provide timely advice to, and 

25 interactive communication with, the sponVerDate Sep 11 2014 02:13 Apr 28, 2023 Jkt 039200 PO 00000 Frm 00028 Fmt 6652 Sfmt 6201 E:\BILLS\S1269.IS S1269

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1 sor regarding the development of the drug 

2 to ensure that the development program to 

3 gather the data necessary for approval is 

4 as efficient as practicable. 

5 ‘‘(iii) Involve senior managers and ex6 perienced review staff, as appropriate, in a 

7 collaborative, coordinated review of such 

8 application, including with respect to bio9 logical product-device combination prod10 ucts and other complex products. 

11 ‘‘(iv) Assign a cross-disciplinary 

12 project lead— 

13 ‘‘(I) to facilitate an efficient re14 view of the development program and 

15 application, including manufacturing 

16 inspections; and 

17 ‘‘(II) to serve as a scientific liai18 son between the review team and the 

19 applicant. 

20 ‘‘(D) INSPECTIONS.—With respect to an 

21 application described in subparagraph (A), in 

22 the case of an inspection report that finds ap23 proval of such biological product is dependent 

24 upon remediation of a facility, if the applicant 

25 attests that necessary changes have been made 


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1 to the facility, the Secretary shall expedite rein2 spection of such facility, including establishing 

3 a set timeline to reinspect the facility or make 

4 a determination about the response of the appli5 cant and whether to approve the application. 

6 ‘‘(E) REPORTING REQUIREMENT.—Not 

7 later than 1 year after the date of licensure 

8 under this subsection with respect to a bio9 similar biological product for which the develop10 ment and review is expedited under this para11 graph, the holder of the license of such bio12 similar biological product shall report to the 

13 Secretary on whether the biosimilar biological 

14 product has been marketed in interstate com15 merce since the date of such licensure. 

16 ‘‘(F) INADEQUATE BIOSIMILAR COMPETI17 TION.—In this paragraph, the term ‘inadequate 

18 biosimilar competition’ means, with respect to a 

19 biological product, there are fewer than 3 li20 censed biological products on the list published 

21 under paragraph (9)(A) (not including biologi22 cal products on the discontinued section of such 

23 list) that are biosimilar biological products with 

24 the same reference product.’’. 


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1 SEC. 304. INSULIN COMPETITION REPORT. 

2 Not later than 1 year after the date of the enactment 

3 of this Act, the Secretary of Health and Human Services, 

4 in collaboration with the Administrator for the Centers for 

5 Medicare & Medicaid Services and the Commissioner of 

6 Food and Drugs, shall— 

7 (1) complete a study to determine the extent of, 

8 and causes of, delays in getting insulin products to 

9 market, and the market dynamics and extent bio10 similar biological product development and competi11 tion could increase, or is increasing, the number of 

12 biological products approved and available to pa13 tients, including by examining barriers to— 

14 (A) placement of biosimilar biological prod15 ucts on health insurance formularies; 

16 (B) market entry of insulin product in the 

17 United States, as compared to other highly de18 veloped nations; and 

19 (C) patient and provider education around 

20 biosimilar biological products; and 

21 (2) submit a report to Congress that describes 

22 the results of the study conducted pursuant to para23 graph (1) and recommended policy solutions. 

Æ 


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