INSULIN Act of 2023

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, Edu- cation, Labor, and Pensions A BILL To reduce the price of insulin and provide for patient protections with respect to the cost of insulin. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 3 (a) SHORT TITLE.—This Act may be cited as the 4 ‘‘Improving Needed Safeguards for Users of Lifesaving 5 Insulin Now Act of 2023’’ or the ‘‘INSULIN Act of 6 2023’’. 7 (b) TABLE OF CONTENTS.—The table of contents for 8 this Act is as follows: 9 Sec. 1. Short title; table of contents. VerDate Sep 11 2014 02:13 Apr 28, 2023 Jkt 039200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6211 E:\BILLS\S1269.IS S1269 pbinns on DSKJLVW7X2PROD with $$_JOB 2 •S 1269 IS TITLE I—COMMERCIAL MARKET PATIENT PROTECTIONS Sec. 101. Requirements with respect to cost-sharing for certain insulin prod- ucts. Sec. 102. Application to retiree and certain small group plans. Sec. 103. Administration. TITLE II—PHARMACY BENEFIT MANAGER TRANSPARENCY AND REBATE REFORM Sec. 201. Full rebate on insulin pass-through to plan. TITLE III—BIOSIMILAR BIOLOGICAL PRODUCT AND GENERIC DRUG COMPETITION AND AFFORDABILITY Sec. 301. Ensuring timely access to generics. Sec. 302. Permitted mid-year changes in Medicare part D plan formularies for certain biosimilar biological products and the reference product of such biosimilars. Sec. 303. Expediting competitive biosimilar competition. Sec. 304. Insulin competition report. TITLE I—COMMERCIAL MARKET 1 PATIENT PROTECTIONS 2 SEC. 101. REQUIREMENTS WITH RESPECT TO COST-SHAR- 3 ING FOR CERTAIN INSULIN PRODUCTS. 4 (a) IN GENERAL.—Part D of title XXVII of the Pub- 5 lic Health Service Act (42 U.S.C. 300gg–111 et seq.) is 6 amended by adding at the end the following: 7 ‘‘SEC. 2799A–11. REQUIREMENTS WITH RESPECT TO COST- 8 SHARING FOR CERTAIN INSULIN PRODUCTS. 9 ‘‘(a) IN GENERAL.—For plan years beginning on or 10 after January 1, 2024, a group health plan or health in- 11 surance issuer offering group or individual health insur- 12 ance coverage shall provide coverage of selected insulin 13 products, and with respect to such products, shall not— 14 ‘‘(1) apply any deductible; or 15 VerDate Sep 11 2014 02:13 Apr 28, 2023 Jkt 039200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S1269.IS S1269 pbinns on DSKJLVW7X2PROD with $$_JOB 3 •S 1269 IS ‘‘(2) impose any cost-sharing requirements in 1 excess of, per 30-day supply— 2 ‘‘(A) for any applicable plan year begin- 3 ning before January 1, 2025, $35; or 4 ‘‘(B) for any plan year beginning on or 5 after January 1, 2025, the lesser of— 6 ‘‘(i) $35; or 7 ‘‘(ii) the amount equal to 25 percent 8 of the negotiated price of the selected insu- 9 lin product net of all price concessions re- 10 ceived by or on behalf of the plan or issuer, 11 including price concessions received by or 12 on behalf of third-party entities providing 13 services to the plan or issuer, such as 14 pharmacy benefit management services or 15 third party administrators. 16 ‘‘(b) DEFINITIONS.—In this section: 17 ‘‘(1) SELECTED INSULIN PRODUCTS.—The term 18 ‘selected insulin products’ means, for any plan year 19 beginning on or after January 1, 2024, at least one 20 of each dosage form (such as vial, pen, or inhaler 21 dosage forms) of each different type (such as rapid- 22 acting, short-acting, intermediate-acting, long-acting, 23 and pre-mixed) of insulin, when such form is li- 24 VerDate Sep 11 2014 02:13 Apr 28, 2023 Jkt 039200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S1269.IS S1269 pbinns on DSKJLVW7X2PROD with $$_JOB 4 •S 1269 IS censed and marketed, as selected by the group 1 health plan or health insurance issuer. 2 ‘‘(2) INSULIN.—The term ‘insulin’ means insu- 3 lin that is licensed under subsection (a) or (k) of 4 section 351 and continues to be marketed pursuant 5 to such licensure. 6 ‘‘(c) OUT-OF-NETWORK PROVIDERS.—Nothing in 7 this section requires a plan or issuer that has a network 8 of providers to provide benefits for selected insulin prod- 9 ucts described in this section that are delivered by an out- 10 of-network provider, or precludes a plan or issuer that has 11 a network of providers from imposing higher cost-sharing 12 than the levels specified in subsection (a) for selected insu- 13 lin products described in this section that are delivered 14 by an out-of-network provider. 15 ‘‘(d) RULE OF CONSTRUCTION.—Subsection (a) shall 16 not be construed to require coverage of, or prevent a group 17 health plan or health insurance coverage from imposing 18 cost-sharing other than the levels specified in subsection 19 (a) on, insulin products that are not selected insulin prod- 20 ucts, to the extent that such coverage is not otherwise re- 21 quired and such cost-sharing is otherwise permitted under 22 Federal and applicable State law. 23 ‘‘(e) APPLICATION OF COST-SHARING TOWARDS 24 DEDUCTIBLES AND OUT-OF-POCKET MAXIMUMS.—Any 25 VerDate Sep 11 2014 02:13 Apr 28, 2023 Jkt 039200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S1269.IS S1269 pbinns on DSKJLVW7X2PROD with $$_JOB 5 •S 1269 IS cost-sharing payments made pursuant to subsection (a)(2) 1 shall be counted toward any deductible or out-of-pocket 2 maximum that applies under the plan or coverage. 3 ‘‘(f) OTHER REQUIREMENTS.—A group health plan 4 or health insurance issuer offering group or individual 5 health insurance coverage shall not impose, directly or 6 through an entity providing pharmacy benefit manage- 7 ment services, any prior authorization or other medical 8 management requirement, or other similar conditions, on 9 selected insulin products, except as clinically justified for 10 safety reasons, to ensure reasonable quantity limits and 11 as specified by the Secretary.’’. 12 (b) NO EFFECT ON OTHER COST-SHARING.—Section 13 1302(d)(2) of the Patient Protection and Affordable Care 14 Act (42 U.S.C. 18022(d)(2)) is amended by adding at the 15 end the following new subparagraph: 16 ‘‘(D) SPECIAL RULE RELATING TO INSU- 17 LIN COVERAGE.—For plans years beginning on 18 or after January 1, 2025, the exemption of cov- 19 erage of selected insulin products (as defined in 20 section 2799A–11(b) of the Public Health Serv- 21 ice Act) from the application of any deductible 22 pursuant to section 2799A–11(a)(1) of such 23 Act, section 726(a)(1) of the Employee Retire- 24 ment Income Security Act of 1974, or section 25 VerDate Sep 11 2014 02:13 Apr 28, 2023 Jkt 039200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S1269.IS S1269 pbinns on DSKJLVW7X2PROD with $$_JOB 6 •S 1269 IS 9826(a)(1) of the Internal Revenue Code of 1 1986 shall not be considered when determining 2 the actuarial value of a qualified health plan 3 under this subsection.’’. 4 (c) COVERAGE OF CERTAIN INSULIN PRODUCTS 5 UNDER CATASTROPHIC PLANS.—Section 1302(e) of the 6 Patient Protection and Affordable Care Act (42 U.S.C. 7 18022(e)) is amended by adding at the end the following: 8 ‘‘(4) COVERAGE OF CERTAIN INSULIN PROD- 9 UCTS.— 10 ‘‘(A) IN GENERAL.—Notwithstanding para- 11 graph (1)(B)(i), a health plan described in 12 paragraph (1) shall provide coverage of selected 13 insulin products, in accordance with section 14 2799A–11 of the Public Health Service Act, be- 15 fore an enrolled individual has incurred, during 16 the plan year, cost-sharing expenses in an 17 amount equal to the annual limitation in effect 18 under subsection (c)(1) for the plan year. 19 ‘‘(B) TERMINOLOGY.—For purposes of 20 subparagraph (A)— 21 ‘‘(i) the term ‘selected insulin prod- 22 ucts’ has the meaning given such term in 23 section 2799A–11(b) of the Public Health 24 Service Act; and 25 VerDate Sep 11 2014 02:13 Apr 28, 2023 Jkt 039200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S1269.IS S1269 pbinns on DSKJLVW7X2PROD with $$_JOB 7 •S 1269 IS ‘‘(ii) the requirements of section 1 2799A–11 of such Act shall be applied by 2 deeming each reference in such section to 3 ‘individual health insurance coverage’ to be 4 a reference to a plan described in para- 5 graph (1).’’. 6 (d) ERISA.— 7 (1) IN GENERAL.—Subpart B of part 7 of sub- 8 title B of title I of the Employee Retirement Income 9 Security Act of 1974 (29 U.S.C. 1185 et seq.) is 10 amended by adding at the end the following: 11 ‘‘SEC. 726. REQUIREMENTS WITH RESPECT TO COST-SHAR- 12 ING FOR CERTAIN INSULIN PRODUCTS. 13 ‘‘(a) IN GENERAL.—For plan years beginning on or 14 after January 1, 2024, a group health plan or health in- 15 surance issuer offering group health insurance coverage 16 shall provide coverage of selected insulin products, and 17 with respect to such products, shall not— 18 ‘‘(1) apply any deductible; or 19 ‘‘(2) impose any cost-sharing requirements in 20 excess of, per 30-day supply— 21 ‘‘(A) for any applicable plan year begin- 22 ning before January 1, 2025, $35; or 23 ‘‘(B) for any plan year beginning on or 24 after January 1, 2025, the lesser of— 25 VerDate Sep 11 2014 02:13 Apr 28, 2023 Jkt 039200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S1269.IS S1269 pbinns on DSKJLVW7X2PROD with $$_JOB 8 •S 1269 IS ‘‘(i) $35; or 1 ‘‘(ii) the amount equal to 25 percent 2 of the negotiated price of the selected insu- 3 lin product net of all price concessions re- 4 ceived by or on behalf of the plan or issuer, 5 including price concessions received by or 6 on behalf of third-party entities providing 7 services to the plan or issuer, such as 8 pharmacy benefit management services or 9 third party administrators. 10 ‘‘(b) DEFINITIONS.—In this section: 11 ‘‘(1) SELECTED INSULIN PRODUCTS.—The term 12 ‘selected insulin products’ means, for any plan year 13 beginning on or after January 1, 2024, at least one 14 of each dosage form (such as vial, pen, or inhaler 15 dosage forms) of each different type (such as rapid- 16 acting, short-acting, intermediate-acting, long-acting, 17 and pre-mixed) of insulin, when such form is li- 18 censed and marketed, as selected by the group 19 health plan or health insurance issuer. 20 ‘‘(2) INSULIN.—The term ‘insulin’ means insu- 21 lin that is licensed under subsection (a) or (k) of 22 section 351 of the Public Health Service Act (42 23 U.S.C. 262) and continues to be marketed pursuant 24 to such licensure. 25 VerDate Sep 11 2014 02:13 Apr 28, 2023 Jkt 039200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S1269.IS S1269 pbinns on DSKJLVW7X2PROD with $$_JOB 9 •S 1269 IS ‘‘(c) OUT-OF-NETWORK PROVIDERS.—Nothing in 1 this section requires a plan or issuer that has a network 2 of providers to provide benefits for selected insulin prod- 3 ucts described in this section that are delivered by an out- 4 of-network provider, or precludes a plan or issuer that has 5 a network of providers from imposing higher cost-sharing 6 than the levels specified in subsection (a) for selected insu- 7 lin products described in this section that are delivered 8 by an out-of-network provider. 9 ‘‘(d) RULE OF CONSTRUCTION.—Subsection (a) shall 10 not be construed to require coverage of, or prevent a group 11 health plan or health insurance coverage from imposing 12 cost-sharing other than the levels specified in subsection 13 (a) on, insulin products that are not selected insulin prod- 14 ucts, to the extent that such coverage is not otherwise re- 15 quired and such cost-sharing is otherwise permitted under 16 Federal and applicable State law. 17 ‘‘(e) APPLICATION OF COST-SHARING TOWARDS 18 DEDUCTIBLES AND OUT-OF-POCKET MAXIMUMS.—Any 19 cost-sharing payments made pursuant to subsection (a)(2) 20 shall be counted toward any deductible or out-of-pocket 21 maximum that applies under the plan or coverage. 22 ‘‘(f) OTHER REQUIREMENTS.—A group health plan 23 or health insurance issuer offering group health insurance 24 coverage shall not impose, directly or through an entity 25 VerDate Sep 11 2014 02:13 Apr 28, 2023 Jkt 039200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\S1269.IS S1269 pbinns on DSKJLVW7X2PROD with $$_JOB 10 •S 1269 IS providing pharmacy benefit management services, any 1 prior authorization or other medical management require- 2 ment, or other similar conditions, on selected insulin prod- 3 ucts, except as clinically justified for safety reasons, to en- 4 sure reasonable quantity limits and as specified by the 5 Secretary.’’. 6 (2) CLERICAL AMENDMENT.—The table of con- 7 tents in section 1 of the Employee Retirement In- 8 come Security Act of 1974 (29 U.S.C. 1001 et seq.) 9 is amended by inserting after the item relating to 10 section 725 the following: 11 ‘‘Sec. 726. Requirements with respect to cost-sharing for certain insulin prod- ucts.’’. (e) INTERNAL REVENUE CODE.— 12 (1) IN GENERAL.—Subchapter B of chapter 13 100 of the Internal Revenue Code of 1986 is amend- 14 ed by adding at the end the following new section: 15 ‘‘SEC. 9826. REQUIREMENTS WITH RESPECT TO COST-SHAR- 16 ING FOR CERTAIN INSULIN PRODUCTS. 17 ‘‘(a) IN GENERAL.—For plan years beginning on or 18 after January 1, 2024, a group health plan shall provide 19 coverage of selected insulin products, and with respect to 20 such products, shall not— 21 ‘‘(1) apply any deductible; or 22 ‘‘(2) impose any cost-sharing requirements in 23 excess of, per 30-day supply— 24 VerDate Sep 11 2014 02:13 Apr 28, 2023 Jkt 039200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\S1269.IS S1269 pbinns on DSKJLVW7X2PROD with $$_JOB 11 •S 1269 IS ‘‘(A) for any applicable plan year begin- 1 ning before January 1, 2025, $35; or 2 ‘‘(B) for any plan year beginning on or 3 after January 1, 2025, the lesser of— 4 ‘‘(i) $35; or 5 ‘‘(ii) the amount equal to 25 percent 6 of the negotiated price of the selected insu- 7 lin product net of all price concessions re- 8 ceived by or on behalf of the plan, includ- 9 ing price concessions received by or on be- 10 half of third-party entities providing serv- 11 ices to the plan, such as pharmacy benefit 12 management services or third party admin- 13 istrators. 14 ‘‘(b) DEFINITIONS.—In this section: 15 ‘‘(1) SELECTED INSULIN PRODUCTS.—The term 16 ‘selected insulin products’ means, for any plan year 17 beginning on or after January 1, 2024, at least one 18 of each dosage form (such as vial, pen, or inhaler 19 dosage forms) of each different type (such as rapid- 20 acting, short-acting, intermediate-acting, long-acting, 21 and pre-mixed) of insulin, when such form is li- 22 censed and marketed, as selected by the group 23 health plan. 24 VerDate Sep 11 2014 02:13 Apr 28, 2023 Jkt 039200 PO 00000 Frm 00 [Text truncated for display. Full text available on Congress.gov.]