I 119THCONGRESS 1 STSESSION H. R. 2636 To provide for appropriate cost-sharing for individuals 26 years of age or younger for insulin products covered under private health plans. IN THE HOUSE OF REPRESENTATIVES APRIL3, 2025 Mr. L ANDSMAN(for himself, Ms. NORTON, Ms. DEANof Pennsylvania, Mr. M CGARVEY, Mr. THOMPSONof Mississippi, and Mr. GOTTHEIMER) intro- duced 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 Workforce, for a period to be subsequently deter- mined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned A BILL To provide for appropriate cost-sharing for individuals 26 years of age or younger for insulin products covered under private health plans. 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. 3 This Act may be cited as the ‘‘Making Insulin Afford-4 able for All Children Act’’. 5 VerDate Sep 11 2014 08:47 Apr 09, 2025 Jkt 000000 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H2636.IH H2636 mprince on LAP1J3WLY3PROD with $$_JOB 2 •HR 2636 IH SEC. 2. APPROPRIATE COST-SHARING FOR INDIVIDUALS 26 1 YEARS OF AGE OR YOUNGER FOR INSULIN 2 PRODUCTS COVERED UNDER PRIVATE 3 HEALTH PLANS. 4 (a) I NGENERAL.—Part D of title XXVII of the Pub-5 lic Health Service Act (42 U.S.C. 300gg–111 et seq.) is 6 amended by adding at the end the following: 7 ‘‘SEC. 2799A–11. REQUIREMENTS WITH RESPECT TO COST- 8 SHARING FOR CERTAIN INSULIN PRODUCTS. 9 ‘‘(a) I NGENERAL.—For plan years beginning on or 10 after January 1, 2026, a group health plan or health in-11 surance issuer offering group or individual health insur-12 ance coverage shall, with respect to enrolled individuals 13 26 years of age or younger, provide coverage of selected 14 insulin products, and with respect to such products, shall 15 not— 16 ‘‘(1) apply any deductible; or 17 ‘‘(2) impose any cost-sharing in excess of the 18 lesser of, per 30-day supply— 19 ‘‘(A) $35; or 20 ‘‘(B) the amount equal to 25 percent of 21 the negotiated price of the selected insulin prod-22 uct net of all price concessions received by or on 23 behalf of the plan or coverage, including price 24 concessions received by or on behalf of third- 25 party entities providing services to the plan or 26 VerDate Sep 11 2014 08:47 Apr 09, 2025 Jkt 000000 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H2636.IH H2636 mprince on LAP1J3WLY3PROD with $$_JOB 3 •HR 2636 IH coverage, such as pharmacy benefit manage-1 ment services. 2 ‘‘(b) D EFINITIONS.—In this section: 3 ‘‘(1) S ELECTED INSULIN PRODUCTS .—The term 4 ‘selected insulin products’ means at least one of each 5 dosage form (such as vial, pump, or inhaler dosage 6 forms) of each different type (such as rapid-acting, 7 short-acting, intermediate-acting, long-acting, ultra 8 long-acting, and premixed) of insulin (as defined 9 below), when available, as selected by the group 10 health plan or health insurance issuer. 11 ‘‘(2) I NSULIN DEFINED.—The term ‘insulin’ 12 means insulin that is licensed under subsection (a) 13 or (k) of section 351 and continues to be marketed 14 under such section, including any insulin product 15 that has been deemed to be licensed under section 16 351(a) pursuant to section 7002(e)(4) of the Bio-17 logics Price Competition and Innovation Act of 2009 18 and continues to be marketed pursuant to such li-19 censure. 20 ‘‘(c) R ULE OFCONSTRUCTION.—Subsection (a) shall 21 not be construed to require coverage of, or prevent a group 22 health plan or health insurance coverage from imposing 23 cost-sharing other than the levels specified in subsection 24 (a) on, insulin products that are not selected insulin prod-25 VerDate Sep 11 2014 08:47 Apr 09, 2025 Jkt 000000 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H2636.IH H2636 mprince on LAP1J3WLY3PROD with $$_JOB 4 •HR 2636 IH ucts or insulin products for an individual not described 1 in subsection (a), to the extent that such coverage is not 2 otherwise required and such cost-sharing is otherwise per-3 mitted under Federal and applicable State law. 4 ‘‘(d) A PPLICATION OF COST-SHARINGTOWARDS 5 D EDUCTIBLES AND OUT-OF-POCKETMAXIMUMS.—Any 6 cost-sharing payments made pursuant to subsection (a)(2) 7 shall be counted toward any deductible or out-of-pocket 8 maximum that applies under the plan or coverage.’’. 9 (b) N OEFFECT ONOTHERCOST-SHARING.—Section 10 1302(d)(2) of the Patient Protection and Affordable Care 11 Act (42 U.S.C. 18022(d)(2)) is amended by adding at the 12 end the following new subparagraph: 13 ‘‘(D) S PECIAL RULE RELATING TO INSU -14 LIN COVERAGE.—The exemption of coverage of 15 selected insulin products (as defined in section 16 2799A–11(b) of the Public Health Service Act) 17 from the application of any deductible pursuant 18 to section 2799A–11(a)(1) of such Act, section 19 726(a)(1) of the Employee Retirement Income 20 Security Act of 1974, or section 9826(a)(1) of 21 the Internal Revenue Code of 1986 shall not be 22 considered when determining the actuarial value 23 of a qualified health plan under this sub-24 section.’’. 25 VerDate Sep 11 2014 08:47 Apr 09, 2025 Jkt 000000 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H2636.IH H2636 mprince on LAP1J3WLY3PROD with $$_JOB 5 •HR 2636 IH (c) COVERAGE OF CERTAININSULINPRODUCTS 1 U NDERCATASTROPHICPLANS.—Section 1302(e) of the 2 Patient Protection and Affordable Care Act (42 U.S.C. 3 18022(e)) is amended by adding at the end the following: 4 ‘‘(4) C OVERAGE OF CERTAIN INSULIN PROD -5 UCTS.— 6 ‘‘(A) I N GENERAL.—Notwithstanding para-7 graph (1)(B)(i), a health plan described in 8 paragraph (1) shall provide coverage of selected 9 insulin products, with respect to an enrolled in-10 dividual who is 26 years of age or younger, in 11 accordance with section 2799A–11 of the Public 12 Health Service Act, before the enrolled indi-13 vidual has incurred, during the plan year, cost- 14 sharing expenses in an amount equal to the an-15 nual limitation in effect under subsection (c)(1) 16 for the plan year. 17 ‘‘(B) T ERMINOLOGY.—For purposes of 18 subparagraph (A)— 19 ‘‘(i) the term ‘selected insulin prod-20 ucts’ has the meaning given such term in 21 section 2799A–11(b) of the Public Health 22 Service Act; and 23 ‘‘(ii) the requirements of section 24 2799A–11 of such Act shall be applied by 25 VerDate Sep 11 2014 08:47 Apr 09, 2025 Jkt 000000 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H2636.IH H2636 mprince on LAP1J3WLY3PROD with $$_JOB 6 •HR 2636 IH deeming each reference in such section to 1 ‘individual health insurance coverage’ to be 2 a reference to a plan described in para-3 graph (1).’’. 4 (d) ERISA.— 5 (1) I N GENERAL.—Subpart B of part 7 of sub-6 title B of title I of the Employee Retirement Income 7 Security Act of 1974 (29 U.S.C. 1185 et seq.) is 8 amended by adding at the end the following: 9 ‘‘SEC. 726. REQUIREMENTS WITH RESPECT TO COST-SHAR-10 ING FOR CERTAIN INSULIN PRODUCTS. 11 ‘‘(a) I NGENERAL.—For plan years beginning on or 12 after January 1, 2026, a group health plan or health in-13 surance issuer offering group health insurance coverage 14 shall, with respect to enrolled individuals 26 years of age 15 or younger, provide coverage of selected insulin products, 16 and with respect to such products, shall not— 17 ‘‘(1) apply any deductible; or 18 ‘‘(2) impose any cost-sharing in excess of the 19 lesser of, per 30-day supply— 20 ‘‘(A) $35; or 21 ‘‘(B) the amount equal to 25 percent of 22 the negotiated price of the selected insulin prod-23 uct net of all price concessions received by or on 24 behalf of the plan or coverage, including price 25 VerDate Sep 11 2014 08:47 Apr 09, 2025 Jkt 000000 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H2636.IH H2636 mprince on LAP1J3WLY3PROD with $$_JOB 7 •HR 2636 IH concessions received by or on behalf of third- 1 party entities providing services to the plan or 2 coverage, such as pharmacy benefit manage-3 ment services. 4 ‘‘(b) D EFINITIONS.—In this section: 5 ‘‘(1) S ELECTED INSULIN PRODUCTS .—The term 6 ‘selected insulin products’ means at least one of each 7 dosage form (such as vial, pump, or inhaler dosage 8 forms) of each different type (such as rapid-acting, 9 short-acting, intermediate-acting, long-acting, ultra 10 long-acting, and premixed) of insulin (as defined 11 below), when available, as selected by the group 12 health plan or health insurance issuer. 13 ‘‘(2) I NSULIN DEFINED.—The term ‘insulin’ 14 means insulin that is licensed under subsection (a) 15 or (k) of section 351 of the Public Health Service 16 Act (42 U.S.C. 262) and continues to be marketed 17 under such section, including any insulin product 18 that has been deemed to be licensed under section 19 351(a) of such Act pursuant to section 7002(e)(4) 20 of the Biologics Price Competition and Innovation 21 Act of 2009 (Public Law 111–148) and continues to 22 be marketed pursuant to such licensure. 23 ‘‘(c) R ULE OFCONSTRUCTION.—Subsection (a) shall 24 not be construed to require coverage of, or prevent a group 25 VerDate Sep 11 2014 08:47 Apr 09, 2025 Jkt 000000 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H2636.IH H2636 mprince on LAP1J3WLY3PROD with $$_JOB 8 •HR 2636 IH health plan or health insurance coverage from imposing 1 cost-sharing other than the levels specified in subsection 2 (a) on, insulin products that are not selected insulin prod-3 ucts or insulin products for an individual not described 4 in subsection (a), to the extent that such coverage is not 5 otherwise required and such cost-sharing is otherwise per-6 mitted under Federal and applicable State law. 7 ‘‘(d) A PPLICATION OF COST-SHARINGTOWARDS 8 D EDUCTIBLES AND OUT-OF-POCKETMAXIMUMS.—Any 9 cost-sharing payments made pursuant to subsection (a)(2) 10 shall be counted toward any deductible or out-of-pocket 11 maximum that applies under the plan or coverage.’’. 12 (2) C LERICAL AMENDMENT .—The table of con-13 tents in section 1 of the Employee Retirement In-14 come Security Act of 1974 (29 U.S.C. 1001 et seq.) 15 is amended by inserting after the item relating to 16 section 725 the following: 17 ‘‘Sec. 726. Requirements with respect to cost-sharing for certain insulin prod- ucts.’’. (e) INTERNALREVENUECODE.— 18 (1) I N GENERAL.—Subchapter B of chapter 19 100 of the Internal Revenue Code of 1986 is amend-20 ed by adding at the end the following new section: 21 VerDate Sep 11 2014 08:47 Apr 09, 2025 Jkt 000000 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H2636.IH H2636 mprince on LAP1J3WLY3PROD with $$_JOB 9 •HR 2636 IH ‘‘SEC. 9826. REQUIREMENTS WITH RESPECT TO COST-SHAR-1 ING FOR CERTAIN INSULIN PRODUCTS. 2 ‘‘(a) I NGENERAL.—For plan years beginning on or 3 after January 1, 2026, a group health plan shall, with re-4 spect to enrolled individuals 26 years of age or younger, 5 provide coverage of selected insulin products, and with re-6 spect to such products, shall not— 7 ‘‘(1) apply any deductible; or 8 ‘‘(2) impose any cost-sharing in excess of the 9 lesser of, per 30-day supply— 10 ‘‘(A) $35; or 11 ‘‘(B) the amount equal to 25 percent of 12 the negotiated price of the selected insulin prod-13 uct net of all price concessions received by or on 14 behalf of the plan, including price concessions 15 received by or on behalf of third-party entities 16 providing services to the plan, such as phar-17 macy benefit management services. 18 ‘‘(b) D EFINITIONS.—In this section: 19 ‘‘(1) S ELECTED INSULIN PRODUCTS .—The term 20 ‘selected insulin products’ means at least one of each 21 dosage form (such as vial, pump, or inhaler dosage 22 forms) of each different type (such as rapid-acting, 23 short-acting, intermediate-acting, long-acting, ultra 24 long-acting, and premixed) of insulin (as defined 25 VerDate Sep 11 2014 08:47 Apr 09, 2025 Jkt 000000 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H2636.IH H2636 mprince on LAP1J3WLY3PROD with $$_JOB 10 •HR 2636 IH below), when available, as selected by the group 1 health plan. 2 ‘‘(2) I NSULIN DEFINED.—The term ‘insulin’ 3 means insulin that is licensed under subsection (a) 4 or (k) of section 351 of the Public Health Service 5 Act (42 U.S.C. 262) and continues to be marketed 6 under such section, including any insulin product 7 that has been deemed to be licensed under section 8 351(a) of such Act pursuant to section 7002(e)(4) 9 of the Biologics Price Competition and Innovation 10 Act of 2009 (Public Law 111–148) and continues to 11 be marketed pursuant to such licensure. 12 ‘‘(c) R ULE OFCONSTRUCTION.—Subsection (a) shall 13 not be construed to require coverage of, or prevent a group 14 health plan from imposing cost-sharing other than the lev-15 els specified in subsection (a) on, insulin products that are 16 not selected insulin products or insulin products for an 17 individual not described in subsection (a), to the extent 18 that such coverage is not otherwise required and such 19 cost-sharing is otherwise permitted under Federal and ap-20 plicable State law. 21 ‘‘(d) A PPLICATION OF COST-SHARINGTOWARDS 22 D EDUCTIBLES AND OUT-OF-POCKETMAXIMUMS.—Any 23 cost-sharing payments made pursuant to subsection (a)(2) 24 VerDate Sep 11 2014 08:47 Apr 09, 2025 Jkt 000000 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H2636.IH H2636 mprince on LAP1J3WLY3PROD with $$_JOB 11 •HR 2636 IH shall be counted toward any deductible or out-of-pocket 1 maximum that applies under the plan.’’. 2 (2) C LERICAL AMENDMENT .—The table of sec-3 tions for subchapter B of chapter 100 of such Code 4 is amended by adding at the end the following new 5 item: 6 ‘‘Sec. 9826. Requirements with respect to cost-sharing for certain insulin prod- ucts.’’. (f) IMPLEMENTATION.—The Secretary of Health and 7 Human Services, the Secretary of Labor, and the Sec-8 retary of the Treasury may implement the provisions of, 9 including the amendments made by, this subsection 10 through sub-regulatory guidance, program instruction or 11 otherwise. 12 Æ VerDate Sep 11 2014 08:47 Apr 09, 2025 Jkt 000000 PO 00000 Frm 00011 Fmt 6652 Sfmt 6301 E:\BILLS\H2636.IH H2636 mprince on LAP1J3WLY3PROD with $$_JOB