EPIPEN Act

119 HR 5139 IH: Epinephrine’s Pharma Inflated Price Ends Now Act U.S. House of Representatives 2025-09-04 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. I 119th CONGRESS 1st Session H. R. 5139 IN THE HOUSE OF REPRESENTATIVES September 4, 2025 Mr. Frost (for himself and Ms. Matsui ) introduced the following bill; which was referred to the Committee on Energy and Commerce , and in addition to the Committees on Education and Workforce , and Ways and Means , 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 Employee Retirement Income Security Act of 1974, and the Internal Revenue Code of 1986 to establish requirements with respect to cost sharing for epinephrine delivery systems under group health plans and group and individual health insurance coverage. 1. Short title This Act may be cited as the Epinephrine’s Pharma Inflated Price Ends Now Act or the EPIPEN Act . 2. Requirements with respect to cost sharing for epinephrine delivery systems (a) PHSA Part D of title XXVII of the Public Health Service Act ( 42 U.S.C. 300gg–111 et seq. ) is amended by adding at the end the following new section: 2799A–11. Requirements with respect to cost sharing for epinephrine delivery systems (a) In general A group health plan, and a health insurance issuer offering group or individual health insurance coverage, shall provide coverage of epinephrine delivery systems, and with respect to such delivery systems, may not— (1) apply any deductible; or (2) impose any cost sharing in excess of $60 per package of 2 delivery systems (or the equivalent). (b) Application of cost sharing toward deductibles and out-of-Pocket maximums Any cost-sharing payments made pursuant to subsection (a)(2) shall be counted toward any deductible or out-of-pocket maximum that applies under the plan or coverage. (c) Out-of-Network providers Nothing in this section requires a plan or issuer that has a network of providers to provide benefits for an epinephrine delivery system described in this section that is delivered by an out-of-network provider, or precludes a plan or issuer that has a network of providers from imposing higher cost sharing than the levels specified in subsection (a)(2) for an epinephrine delivery system described in this section that is delivered by an out-of-network provider. (d) Epinephrine delivery system defined In this section, the term epinephrine delivery system means a delivery system approved by the Food and Drug Administration for the administration of epinephrine, including any auto-injector, nasal spray, or sublingual delivery system that is so approved. . (b) ERISA (1) In general Subpart B of part 7 of subtitle B of title I of the Employee Retirement Income Security Act of 1974 ( 29 U.S.C. 1185 et seq. ) is amended by adding at the end the following new section: 726. Requirements with respect to cost sharing for epinephrine delivery systems (a) In general A group health plan, and a health insurance issuer offering group health insurance coverage, shall provide coverage of epinephrine delivery systems, and with respect to such delivery systems, may not— (1) apply any deductible; or (2) impose any cost sharing in excess of $60 per package of 2 delivery systems (or the equivalent). (b) Application of cost sharing toward deductibles and out-of-Pocket maximums Any cost-sharing payments made pursuant to subsection (a)(2) shall be counted toward any deductible or out-of-pocket maximum that applies under the plan or coverage. (c) Out-of-Network providers Nothing in this section requires a plan or issuer that has a network of providers to provide benefits for an epinephrine delivery system described in this section that is delivered by an out-of-network provider, or precludes a plan or issuer that has a network of providers from imposing higher cost sharing than the levels specified in subsection (a)(2) for an epinephrine delivery system described in this section that is delivered by an out-of-network provider. (d) Epinephrine delivery system defined In this section, the term epinephrine delivery system means a delivery system approved by the Food and Drug Administration for the administration of epinephrine, including any auto-injector, nasal spray, or sublingual delivery system that is so approved. . (2) Clerical amendment The table of contents in section 1 of the Employee Retirement Income Security Act of 1974 ( 29 U.S.C. 1001 et seq. ) is amended by inserting after the item relating to section 725 the following: Sec. 726. Requirements with respect to cost sharing for epinephrine delivery systems. . (c) IRC (1) In general Subchapter B of chapter 100 of the Internal Revenue Code of 1986 is amended by adding at the end the following new section: 9826. Requirements with respect to cost sharing for epinephrine delivery systems (a) In general A group health plan shall provide coverage of epinephrine delivery systems, and with respect to such delivery systems, may not— (1) apply any deductible; or (2) impose any cost sharing in excess of $60 per package of 2 delivery systems (or the equivalent). (b) Application of cost sharing toward deductibles and out-of-Pocket maximums Any cost-sharing payments made pursuant to subsection (a)(2) shall be counted toward any deductible or out-of-pocket maximum that applies under the plan. (c) Out-of-Network providers Nothing in this section requires a plan that has a network of providers to provide benefits for an epinephrine delivery system described in this section that is delivered by an out-of-network provider, or precludes a plan that has a network of providers from imposing higher cost sharing than the levels specified in subsection (a)(2) for an epinephrine delivery system described in this section that is delivered by an out-of-network provider. (d) Epinephrine delivery system defined In this section, the term epinephrine delivery system means a delivery system approved by the Food and Drug Administration for the administration of epinephrine, including any auto-injector, nasal spray, or sublingual delivery system that is so approved. . (2) Clerical amendment The table of sections for subchapter B of chapter 100 of the Internal Revenue Code of 1986 is amended by adding at the end the following new item: Sec. 9826. Requirements with respect to cost sharing for epinephrine delivery systems. . (d) Effective date The amendments made by this section shall apply with respect to plan years beginning on or after January 1, 2026.