HR5139-119

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 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: 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— apply any deductible; or impose any cost sharing in excess of $60 per package of 2 delivery systems (or the equivalent). 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. 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. 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. 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: 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— apply any deductible; or impose any cost sharing in excess of $60 per package of 2 delivery systems (or the equivalent). 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. 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. 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. 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: Subchapter B of chapter 100 of the Internal Revenue Code of 1986 is amended by adding at the end the following new section: A group health plan shall provide coverage of epinephrine delivery systems, and with respect to such delivery systems, may not— apply any deductible; or impose any cost sharing in excess of $60 per package of 2 delivery systems (or the equivalent). 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. 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. 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. 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: The amendments made by this section shall apply with respect to plan years beginning on or after January 1, 2026. 2799A–11.Requirements with respect to cost sharing for epinephrine delivery systems (a)In generalA 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 definedIn 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.. 726.Requirements with respect to cost sharing for epinephrine delivery systems (a)In generalA 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 providersNothing 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 definedIn 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.. Sec. 726. Requirements with respect to cost sharing for epinephrine delivery systems.. 9826.Requirements with respect to cost sharing for epinephrine delivery systems (a)In generalA 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 providersNothing 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 definedIn 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.. Sec. 9826. Requirements with respect to cost sharing for epinephrine delivery systems..

2799A–11. Requirements with respect to cost sharing for epinephrine delivery systems 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— apply any deductible; or impose any cost sharing in excess of $60 per package of 2 delivery systems (or the equivalent). 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. 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. 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.

726. Requirements with respect to cost sharing for epinephrine delivery systems 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— apply any deductible; or impose any cost sharing in excess of $60 per package of 2 delivery systems (or the equivalent). 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. 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. 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.

9826. Requirements with respect to cost sharing for epinephrine delivery systems A group health plan shall provide coverage of epinephrine delivery systems, and with respect to such delivery systems, may not— apply any deductible; or impose any cost sharing in excess of $60 per package of 2 delivery systems (or the equivalent). 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. 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. 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.