<?xml version="1.0"?>
<?xml-stylesheet type="text/xsl" href="billres.xsl"?>
<!DOCTYPE bill PUBLIC "-//US Congress//DTDs/bill.dtd//EN" "bill.dtd">
<bill bill-stage="Introduced-in-House" dms-id="H34B838A6B79440089CD70ACE342E8382" public-private="public" key="H" bill-type="olc"><metadata xmlns:dc="http://purl.org/dc/elements/1.1/">
<dublinCore>
<dc:title>119 HR 5139 IH: Epinephrine’s Pharma Inflated Price Ends Now Act</dc:title>
<dc:publisher>U.S. House of Representatives</dc:publisher>
<dc:date>2025-09-04</dc:date>
<dc:format>text/xml</dc:format>
<dc:language>EN</dc:language>
<dc:rights>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.</dc:rights>
</dublinCore>
</metadata>
<form>
<distribution-code display="yes">I</distribution-code><congress display="yes">119th CONGRESS</congress><session display="yes">1st Session</session><legis-num display="yes">H. R. 5139</legis-num><current-chamber>IN THE HOUSE OF REPRESENTATIVES</current-chamber><action display="yes"><action-date date="20250904">September 4, 2025</action-date><action-desc><sponsor name-id="F000476">Mr. Frost</sponsor> (for himself and <cosponsor name-id="M001163">Ms. Matsui</cosponsor>) introduced the following bill; which was referred to the <committee-name committee-id="HIF00">Committee on Energy and Commerce</committee-name>, and in addition to the Committees on <committee-name committee-id="HED00">Education and Workforce</committee-name>, and <committee-name committee-id="HWM00">Ways and Means</committee-name>, 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</action-desc></action><legis-type>A BILL</legis-type><official-title display="yes">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.</official-title></form><legis-body id="H64D7E1C785E2448D8585E3573B47CC38" style="OLC"> 
<section id="HDA985B2C3DA0414991198938CDE8F0D2" section-type="section-one"><enum>1.</enum><header>Short title</header><text display-inline="no-display-inline">This Act may be cited as the <quote><short-title>Epinephrine’s Pharma Inflated Price Ends Now Act</short-title></quote> or the <quote><short-title>EPIPEN Act</short-title></quote>.</text></section> <section id="HB04253E42B1546679E70DB160143511E"><enum>2.</enum><header>Requirements with respect to cost sharing for epinephrine delivery systems</header> <subsection id="H6D0CB0A909274467BB39E29A92C0CD75"><enum>(a)</enum><header>PHSA</header><text display-inline="yes-display-inline">Part D of title XXVII of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300gg-111">42 U.S.C. 300gg–111 et seq.</external-xref>) is amended by adding at the end the following new section:</text> 
<quoted-block style="OLC" id="HF74AAB6CC9904E28811660303B214252" display-inline="no-display-inline"> 
<section id="H6138CB1090344FF9989CE7BA0B4717FA"><enum>2799A–11.</enum><header>Requirements with respect to cost sharing for epinephrine delivery systems</header> 
<subsection id="H89A9060C3FA24A8FA9FAB9C65EF7C237"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">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—</text> <paragraph id="H3871710C73D54AEFA09B0946F2F05E43"><enum>(1)</enum><text>apply any deductible; or</text></paragraph> 
<paragraph id="H45D652872F0940AA9B0C9CC1584AE7C0"><enum>(2)</enum><text display-inline="yes-display-inline">impose any cost sharing in excess of $60 per package of 2 delivery systems (or the equivalent).</text></paragraph></subsection> <subsection id="H1530522BCE1049E48C28046A0BB43E2A" commented="no"> <enum>(b)</enum> <header>Application of cost sharing toward deductibles and out-of-Pocket maximums</header> <text>Any cost-sharing payments made pursuant to <internal-xref idref="H45D652872F0940AA9B0C9CC1584AE7C0" legis-path="2730.(a)(2)">subsection (a)(2)</internal-xref> shall be counted toward any deductible or out-of-pocket maximum that applies under the plan or coverage.</text>
            </subsection> 
<subsection id="H032BFB27958241DE9714D4FBD439CA66" commented="no">
              <enum>(c)</enum>
              <header>Out-of-Network providers</header>
 <text display-inline="yes-display-inline">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 <internal-xref idref="H45D652872F0940AA9B0C9CC1584AE7C0" legis-path="2730.(a)(2)">subsection (a)(2)</internal-xref> for an epinephrine delivery system described in this section that is delivered by an out-of-network provider.</text>
            </subsection> 
<subsection id="HA50E8A99364F4E4DA936CCFD1558E3C9"><enum>(d)</enum><header>Epinephrine delivery system defined</header><text display-inline="yes-display-inline">In this section, the term <term>epinephrine delivery system</term> 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.</text></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></subsection> <subsection id="HD4674672482B4555BD912C9A037F5943"><enum>(b)</enum><header>ERISA</header> <paragraph id="H1DA8011683104B898138945F160EC2A8"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">Subpart B of part 7 of subtitle B of title I of the Employee Retirement Income Security Act of 1974 (<external-xref legal-doc="usc" parsable-cite="usc/29/1185">29 U.S.C. 1185 et seq.</external-xref>) is amended by adding at the end the following new section:</text> 
<quoted-block style="OLC" id="H74B8F7F7BC044C4D9DFFB2365B1B983E" display-inline="no-display-inline"> 
<section id="HDA25AA9377F842DB966C1BA080D19954"><enum>726.</enum><header>Requirements with respect to cost sharing for epinephrine delivery systems</header> 
<subsection id="H612DCE59C82C4B42BD51CBA7A9FB895B"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">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—</text> <paragraph id="H2A51EB3920F347319A1C255F24C3C6F5"><enum>(1)</enum><text>apply any deductible; or</text></paragraph> 
<paragraph id="H2EAFB3CAD33349498C5F3F7C9CA0CCC1"><enum>(2)</enum><text display-inline="yes-display-inline">impose any cost sharing in excess of $60 per package of 2 delivery systems (or the equivalent).</text></paragraph></subsection> <subsection id="H06BF5315FE4A4D618A76EF349A6555DD" commented="no"> <enum>(b)</enum> <header>Application of cost sharing toward deductibles and out-of-Pocket maximums</header> <text>Any cost-sharing payments made pursuant to <internal-xref idref="H2EAFB3CAD33349498C5F3F7C9CA0CCC1" legis-path="2730.(a)(2)">subsection (a)(2)</internal-xref> shall be counted toward any deductible or out-of-pocket maximum that applies under the plan or coverage.</text>
              </subsection> 
<subsection id="H57D7B2AF249F4B01965FB1F71BD40DBD" commented="no"><enum>(c)</enum><header>Out-of-Network providers</header><text display-inline="yes-display-inline">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 <internal-xref idref="H2EAFB3CAD33349498C5F3F7C9CA0CCC1" legis-path="2730.(a)(2)">subsection (a)(2)</internal-xref> for an epinephrine delivery system described in this section that is delivered by an out-of-network provider.</text></subsection> <subsection id="HBA3C390574064DE18E4A20A134F0D3C1"><enum>(d)</enum><header>Epinephrine delivery system defined</header><text display-inline="yes-display-inline">In this section, the term <term>epinephrine delivery system</term> 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.</text></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></paragraph> 
<paragraph id="H6DAD937BB22440F7B37F8B1806E91DA3"><enum>(2)</enum><header>Clerical amendment</header><text>The table of contents in section 1 of the Employee Retirement Income Security Act of 1974 (<external-xref legal-doc="usc" parsable-cite="usc/29/1001">29 U.S.C. 1001 et seq.</external-xref>) is amended by inserting after the item relating to section 725 the following:</text> <quoted-block style="OLC" id="HF93782B01B6D47B284A24FC8CBC4A0AE" display-inline="no-display-inline"> <toc regeneration="no-regeneration"> <toc-entry level="section">Sec. 726. Requirements with respect to cost sharing for epinephrine delivery systems.</toc-entry></toc><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection> <subsection id="H64273148ADAF4D4F98460CE37C5BD3F1"><enum>(c)</enum><header>IRC</header> <paragraph id="HF0B1AA27F0B64A90A691911234A3740E"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">Subchapter B of <external-xref legal-doc="usc-chapter" parsable-cite="usc-chapter/26/100">chapter 100</external-xref> of the Internal Revenue Code of 1986 is amended by adding at the end the following new section:</text> 
<quoted-block style="OLC" id="HACCA5054834A4879A9B08E9E0C4CC094" display-inline="no-display-inline"> 
<section id="HBC5C7F8ACE4F4FD881057C6FF3C64484"><enum>9826.</enum><header>Requirements with respect to cost sharing for epinephrine delivery systems</header> 
<subsection id="H89B5767C5EB247D2A818F88B5E84B9E7"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">A group health plan shall provide coverage of epinephrine delivery systems, and with respect to such delivery systems, may not—</text> <paragraph id="H30F8347D585B4BF3818F9BBF661D9528"><enum>(1)</enum><text>apply any deductible; or</text></paragraph> 
<paragraph id="HD263B0ECD2E4438CA1CDF0C7DB3AE454"><enum>(2)</enum><text display-inline="yes-display-inline">impose any cost sharing in excess of $60 per package of 2 delivery systems (or the equivalent).</text></paragraph></subsection> <subsection id="H2402445CAAF74C41B9F167D516416C7B" commented="no"> <enum>(b)</enum> <header>Application of cost sharing toward deductibles and out-of-Pocket maximums</header> <text>Any cost-sharing payments made pursuant to <internal-xref idref="HD263B0ECD2E4438CA1CDF0C7DB3AE454" legis-path="2730.(a)(2)">subsection (a)(2)</internal-xref> shall be counted toward any deductible or out-of-pocket maximum that applies under the plan.</text>
              </subsection> 
<subsection id="H41E0DF0B194748E2B5C583B7633BAAA7" commented="no"><enum>(c)</enum><header>Out-of-Network providers</header><text display-inline="yes-display-inline">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 <internal-xref idref="HD263B0ECD2E4438CA1CDF0C7DB3AE454" legis-path="2730.(a)(2)">subsection (a)(2)</internal-xref> for an epinephrine delivery system described in this section that is delivered by an out-of-network provider.</text></subsection> <subsection id="H2B71B360D1F84E5EB0B10119CA878A03"><enum>(d)</enum><header>Epinephrine delivery system defined</header><text display-inline="yes-display-inline">In this section, the term <term>epinephrine delivery system</term> 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.</text></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></paragraph> 
<paragraph id="H0D7107FAB3DA432391C77036F8665310"><enum>(2)</enum><header>Clerical amendment</header><text display-inline="yes-display-inline">The table of sections for subchapter B of <external-xref legal-doc="usc-chapter" parsable-cite="usc-chapter/26/100">chapter 100</external-xref> of the Internal Revenue Code of 1986 is amended by adding at the end the following new item:</text> <quoted-block style="OLC" id="H05767FA3A5BE484AB1E7A0A13BEF7327" display-inline="no-display-inline"> <toc regeneration="no-regeneration"> <toc-entry level="section">Sec. 9826. Requirements with respect to cost sharing for epinephrine delivery systems.</toc-entry></toc><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection> <subsection id="H3EB0545E835A49D79BD74B4B17E6EC38"><enum>(d)</enum><header>Effective date</header><text>The amendments made by this section shall apply with respect to plan years beginning on or after January 1, 2026.</text></subsection></section> 
</legis-body></bill>

