119 HR 8324 IH: Great American Healthcare Plan
U.S. House of Representatives
2026-04-16
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.
1.Short title; table of contents
(a)This Act may be cited as the Great American Healthcare Plan
. (b)The table of contents for this Act is as follows:
Sec. 1. Short title; table of contents.
Title I—Health Savings Accounts
Sec. 101. Short title.
Sec. 102. Increase in contribution limitations.
Sec. 103. Freedom from mandate.
Sec. 104. Amounts paid for health insurance or direct primary care service arrangement.
Sec. 105. Special rule for certain medical expenses incurred before establishment of account.
Sec. 106. Administrative error correction before due date of return.
Sec. 107. Allowing HSA rollover to child or parent of account holder.
Sec. 108. Coverage for amounts paid for healthy food, vitamins, dietary supplements, and sports and fitness expenses.
Sec. 109. Equivalent bankruptcy protections for health savings accounts as retirement funds.
Sec. 110. Satisfaction of employer mandate through health savings account contributions.
Sec. 111. Rollovers from health care FSAs and HRAs permitted.
Sec. 112. Qualified general contributions to health savings accounts.
Sec. 113. Charitable contributions to health savings accounts.
Sec. 114. Amounts paid for health care sharing ministry.
Title II—Health Marketplace for All
Sec. 201. Short title.
Sec. 202. Health marketplace pools deemed an employer
for purposes of offering group health plans or group health insurance coverage.
Sec. 203. Conforming amendments.
Title III—Strengthening Hospital and Insurer Price Transparency
Sec. 301. Short title.
Sec. 302. Strengthening hospital price transparency requirements.
Sec. 303. Increasing price transparency of clinical diagnostic laboratory tests.
Sec. 304. Imaging transparency.
Sec. 305. Ambulatory surgical center price transparency requirements.
Sec. 306. Strengthening health coverage transparency requirements.
Sec. 307. Increasing group health plan access to health data.
Sec. 308. Oversight of administrative service providers.
Sec. 309. State preemption only in event of conflict.
Sec. 310. Requirement for explanation of benefits.
Sec. 311. Provision of itemized bills.
Title IV—Protecting Patient Access to Cancer and Complex Therapies
Sec. 401. Short title.
Sec. 402. Rebate by manufacturers for selected drugs and biological products subject to maximum fair price negotiation.
Title V—Expanded-access Prescription Drugs
Sec. 501. Expanded-access prescription drugs.
Sec. 502. Government sponsored programs.
<enum>I</enum><header>Health Savings Accounts</header>
<section id="H4E57FD1708AB445D9C7B781D54257C8D"><enum>101.</enum><header>Short title</header><text display-inline="no-display-inline">This title may be cited as the <quote><short-title>Health Savings Accounts For All Act of 2026</short-title></quote>.</text></section> <section id="HC8DA4F812BC94E28ACCA8A6290A0EFB7"><enum>102.</enum><header>Increase in contribution limitations</header> <subsection id="H31BDA6CB977D437992967874CB4F0786"><enum>(a)</enum><header>In general</header><text>Subsection (b) of <external-xref legal-doc="usc" parsable-cite="usc/26/223">section 223</external-xref> of the Internal Revenue Code of 1986 is amended—</text>
<paragraph id="H54A407371C4B474D9295A30EAD8C2DD9"><enum>(1)</enum><text>in paragraph (1), by striking <quote>the sum of</quote> and all that follows through the period and inserting <quote>an amount equal to the applicable dollar amount under paragraph (1)(B) of section 402(g) (as adjusted pursuant to paragraph (4) of such section) with respect to such taxable year.</quote>,</text></paragraph> <paragraph id="H7E1315F104184FE183144C04002CE7DC"><enum>(2)</enum><text>by striking paragraphs (2), (3), (5), (7), and (8),</text></paragraph>
<paragraph id="H1F574581EC034C77BF0F22E871924300"><enum>(3)</enum><text>by inserting after paragraph (1) the following:</text> <quoted-block style="OLC" display-inline="no-display-inline" id="H6B921B71553C4E9C8E8521193C767962"> <paragraph id="HC7B323251CFF42D4985641E536FE92A9"><enum>(2)</enum><header>Additional contributions for individuals 50 or older</header><text>In the case of an individual who has attained age 50 before the close of the taxable year, the amount of the limitation under paragraph (1) shall be increased by an amount equal to the applicable dollar amount under subparagraph (B)(i) of section 414(v)(2) (as adjusted pursuant to subparagraph (C) of such section).</text></paragraph><after-quoted-block>,</after-quoted-block></quoted-block></paragraph>
<paragraph id="H989E547040484E96AD9FDF7AA5891DBE"><enum>(4)</enum><text>in paragraph (4), by striking the flush matter following subparagraph (C), and</text></paragraph> <paragraph id="H0917AE3AE0D7474D8F3FBD68A57477AC"><enum>(5)</enum><text>by redesignating paragraphs (4) and (6) as paragraphs (3) and (4), respectively.</text></paragraph></subsection>
<subsection id="HF83BAC8D2C6942D085684C1DF947ECF7"><enum>(b)</enum><header>Conforming amendments</header>
<paragraph id="HA9981EAD57984922AF6B154857D61499"><enum>(1)</enum><text>Subparagraph (A) of <external-xref legal-doc="usc" parsable-cite="usc/26/223">section 223(d)(1)</external-xref> of the Internal Revenue Code of 1986 is amended by striking <quote>the sum of—</quote> and all that follows through the period and inserting <quote>the amount determined under subsection (b)(1).</quote>.</text></paragraph> <paragraph id="H599C4568B1C74BB5B4A89FC06CC1AB53"><enum>(2)</enum><text>Subsection (g)(1) of section 223 of such Code is amended—</text>
<subparagraph id="HBCEE43272A834EA9B57D7189F4D7CE78"><enum>(A)</enum><text>by striking <quote>(b)(2), (c)(2)(A), and</quote> and inserting <quote>(c)(2)(A) and,</quote>,</text></subparagraph> <subparagraph id="H186ADDE8269D474C95E6E9ED5EE3FDC3"><enum>(B)</enum><text>by amending subparagraph (B) to read as follows:</text>
<quoted-block style="OLC" display-inline="no-display-inline" id="H83F1E57A7CC440B4ABC48EEBFACEDB92">
<subparagraph commented="no" display-inline="no-display-inline" id="H0E8BD3864A684C0B8DF22823E8114A4B"><enum>(B)</enum><text display-inline="yes-display-inline">the cost-of-living adjustment determined under section 1(f)(3) for the calendar year in which such taxable year begins determined by substituting <quote>calendar year 2003</quote> for <quote>calendar year 2016</quote> in subparagraph (A)(ii) thereof.</text></subparagraph><after-quoted-block>, and</after-quoted-block></quoted-block></subparagraph> <subparagraph commented="no" display-inline="no-display-inline" id="H46C52F9C6E6D4CC8B677F88BAE539CA8"><enum>(C)</enum><text>by striking <quote>(b)(2), (c)(1)(E)(ii)(II),</quote> and inserting <quote>(c)(1)(E)(ii)(II)</quote>.</text></subparagraph></paragraph>
<paragraph commented="no" id="HAD32A7307F91490C8B9A80715F518A73"><enum>(3)</enum><text>Section 26(b)(2)(S) of such Code is amended by striking <quote>, 223(b)(8)(B)(i)(II),</quote>.</text></paragraph> <paragraph id="H121C8AC779FF43D5BB8942A30A38221B"><enum>(4)</enum><text>Section 408(d)(9)(C)(i)(I) of such Code is amended by striking <quote>computed on the basis of the type of coverage under the high deductible health plan covering the individual</quote>.</text></paragraph></subsection>
<subsection commented="no" display-inline="no-display-inline" id="H48218ED7D7994A80B2B966B2F57837A6"><enum>(c)</enum><header display-inline="yes-display-inline">Effective date</header><text display-inline="yes-display-inline">The amendments made by this section shall apply to taxable years beginning after the date of the enactment of this Act.</text></subsection></section> <section id="H32D56160D9854A1E9C08C6FA7B66F243"><enum>103.</enum><header>Freedom from mandate</header> <subsection id="HECF780D98BB744CA9246B4986F8A7504"><enum>(a)</enum><header>In general</header><text><external-xref legal-doc="usc" parsable-cite="usc/26/223">Section 223</external-xref> of the Internal Revenue Code of 1986, as amended by section 102, is further amended by striking subsections (c) and (g) and by redesignating subsections (d), (e), (f), and (h) as subsections (c), (d), (e), and (f), respectively.</text></subsection>
<subsection id="HE3B22FB6BF914CA7A0CA4F89AEE54F8A"><enum>(b)</enum><header>Conforming amendments</header>
<paragraph id="H411717FA61DB4DD1963ED6B708DF6172"><enum>(1)</enum><text>Subsection (a) of <external-xref legal-doc="usc" parsable-cite="usc/26/223">section 223</external-xref> of the Internal Revenue Code of 1986 is amended to read as follows:</text> <quoted-block style="OLC" display-inline="no-display-inline" id="H4B88767D2402459BB9683AE19BCA0C49"> <subsection id="HF4DF1B66A0E743F69D667419C809EEF1"><enum>(a)</enum><header>Deduction allowed</header><text>In the case of an individual, there shall be allowed as a deduction for the taxable year an amount equal to the aggregate amount paid in cash during such taxable year by or on behalf of such individual to a health savings account of such individual.</text></subsection><after-quoted-block>.</after-quoted-block></quoted-block></paragraph>
<paragraph id="H117CFC3125B446DEB554260CFDFE1281"><enum>(2)</enum><text>Subsection (c)(1)(A) of section 223 of such Code, as amended by section 102 and redesignated by subsection (a), is further amended by striking <quote>subsection (f)(4)</quote> and inserting <quote>subsection (e)(4)</quote>.</text></paragraph> <paragraph commented="no" id="H2D8016228A5F4D5CB3C141A73650FC90"><enum>(3)</enum><text>Subparagraph (U) of section 26(b)(2) of such Code, as amended by section 102, is further amended by striking <quote>section 223(f)(4)</quote> and inserting <quote>section 223(e)(4)</quote>.</text></paragraph>
<paragraph id="HBDC0147A46294B3E854B394C4A7E2115" commented="no"><enum>(4)</enum><text>Sections 35(g)(3), 220(f)(5)(A), 848(e)(1)(B)(v), 4973(a)(5), and 6051(a)(12) of such Code are each amended by striking <quote>section 223(d)</quote> each place it appears and inserting <quote>section 223(c)</quote>.</text></paragraph> <paragraph commented="no" id="HB2736958F55743FE8F82A6F4105B0AC2"><enum>(5)</enum><text>Section 106(d)(1) of such Code is amended—</text>
<subparagraph commented="no" id="H552D1136EA1C443EA2199BE9B07A28B6"><enum>(A)</enum><text>by striking <quote>who is an eligible individual (as defined in section 223(c)(1))</quote>, and</text></subparagraph> <subparagraph commented="no" id="HB1D572FDB5494724A0CBAF143589D2A5"><enum>(B)</enum><text>by striking <quote>section 223(d)</quote> and inserting <quote>section 223(c)</quote>.</text></subparagraph></paragraph>
<paragraph commented="no" id="HBEEA508A71D844C2A7C81CA5143DAFE0"><enum>(6)</enum><text>Section 106(e) of such Code is amended—</text> <subparagraph commented="no" id="H56F52050212440ABB4396C608C158789"><enum>(A)</enum><text>by striking paragraphs (3) and (4) and by redesignating paragraph (5) as paragraph (4),</text></subparagraph>
<subparagraph commented="no" id="HAADD9D0C4D094097B6C75D4D650BE4F8"><enum>(B)</enum><text>by inserting after paragraph (2) the following new paragraph:</text> <quoted-block style="OLC" act-name="" id="H12CC3FFD206B4038B65BFEE79A03595F"> <paragraph id="HF87050C22D074578B1681EAA1A701442" commented="no"><enum>(3)</enum><header>Treatment as rollover contribution</header><text>A qualified HSA distribution shall be treated as a rollover contribution described in section 223(e)(5).</text></paragraph><after-quoted-block>, and</after-quoted-block></quoted-block></subparagraph>
<subparagraph commented="no" id="HD4E91F259DEA46C09AB9BC3CFCD19AE2"><enum>(C)</enum><text>by striking <quote>to any eligible individual covered under a high deductible health plan of the employer</quote> in paragraph (4)(B)(ii) (as so redesignated) and inserting <quote>to any employee with respect to whom a health savings account has been established</quote>.</text></subparagraph></paragraph> <paragraph commented="no" id="H8BD86114B7B0493FA395BC389813D17E"><enum>(7)</enum><text>Section 408(d)(9)(A) of such Code is amended by striking <quote>who is an eligible individual (as defined in section 223(c)) and</quote>.</text></paragraph>
<paragraph commented="no" id="HF38F1F4E95D84D6D935F2634545B5113"><enum>(8)</enum><text>Section 877A(g)(6) of such Code is amended by striking <quote>223(f)(4)</quote> and inserting <quote>223(e)(4)</quote>.</text></paragraph> <paragraph commented="no" id="HF14E9A2260CB4B869D230B6D7D401DA9"><enum>(9)</enum><text>Section 4973(g) of such Code is amended—</text>
<subparagraph commented="no" id="H4CF7E7A49BEF46198B36B0C4BC843A66"><enum>(A)</enum><text>by striking <quote>section 223(d)</quote> and inserting <quote>section 223(c)</quote>,</text></subparagraph> <subparagraph commented="no" id="H3BAB7ABE615C4CF2A111205E51D38925"><enum>(B)</enum><text>in paragraph (1), by striking <quote>or 223(f)(5)</quote> and inserting <quote>or 223(e)(5)</quote>,</text></subparagraph>
<subparagraph commented="no" id="HB83327D77B1F4EADB4FD25590F52C890"><enum>(C)</enum><text>in paragraph (2)(A), by striking <quote>section 223(f)(2)</quote> and inserting <quote>section 223(e)(2)</quote>, and</text></subparagraph> <subparagraph commented="no" id="H000B0C633AA74BF2A97C4F71FC8B06DF"><enum>(D)</enum><text>in the flush matter at the end, by striking <quote>section 223(f)(3)</quote> and inserting <quote>section 223(e)(3)</quote>.</text></subparagraph></paragraph>
<paragraph commented="no" id="H821CAB760D9A46A8961F549A3BAC7AB2"><enum>(10)</enum><text>Section 4975 of such Code is amended—</text> <subparagraph commented="no" id="H99763DF633D643C1832BE9D0A0C7D5B9"><enum>(A)</enum><text>in subsection (c)(6)—</text>
<clause commented="no" id="H815682C790B940FBB0F25947CC0C38DD"><enum>(i)</enum><text>by striking <quote>section 223(d)</quote> and inserting <quote>section 223(c)</quote>, and</text></clause> <clause commented="no" id="HBCB2D05834B74116B63243CD36E12D9E"><enum>(ii)</enum><text>by striking <quote>section 223(e)(2)</quote> and inserting <quote>section 223(d)(2)</quote>, and</text></clause></subparagraph>
<subparagraph commented="no" id="H16F708F9902F4361869716C6C57C02CF"><enum>(B)</enum><text>in subsection (e)(1)(E), by striking <quote>section 223(d)</quote> and inserting <quote>section 223(c)</quote>.</text></subparagraph></paragraph> <paragraph commented="no" id="HCA2D949243B74D28AF620A4026C398AB"><enum>(11)</enum><text>Subsection (b) of section 4980G of such Code is amended to read as follows:</text>
<quoted-block style="OLC" display-inline="no-display-inline" id="HA86627758FE64FD9B6B195B87B38FA59">
<subsection commented="no" id="H38BA0F359A024E168EE2304D6191801C"><enum>(b)</enum><header>Rules and requirements</header>
<paragraph id="H27634C93CA31464596339039DB0CB35C"><enum>(1)</enum><header>In general</header><text>An employer meets the requirements of this subsection for any calendar year if the employer makes available comparable contributions to the health savings accounts of all comparable participating employees for each coverage period during such calendar year.</text></paragraph> <paragraph id="HF1F61F770FFC4DB2903579A7EE03FD9B"><enum>(2)</enum><header>Comparable contributions</header> <subparagraph id="H765B126AF48D473B8FE739EAA55A74B2"><enum>(A)</enum><header>In general</header><text>For purposes of paragraph (1), the term <term>comparable contributions</term> means contributions—</text>
<clause id="H678E3836345648608244622D6205BB8F"><enum>(i)</enum><text>which are the same amount, or</text></clause> <clause id="H79E2D301C9EB4187B58186A811A99735"><enum>(ii)</enum><text>if the employees are covered by a health plan, which are the same percentage of the annual deductible limit under the plan covering the employees.</text></clause></subparagraph>
<subparagraph id="HBC7D91D8592C428985A6EE5218CFA5B2"><enum>(B)</enum><header>Part-year employees</header><text>In the case of an employee who is employed by the employer for only a portion of the calendar year, a contribution to the health savings account of such employee shall be treated as comparable if it is an amount which bears the same ratio to the comparable amount (determined without regard to this subparagraph) as such portion bears to the entire calendar year.</text></subparagraph></paragraph> <paragraph id="H25CBB63E53714C9D9489087A307098B2"><enum>(3)</enum><header>Comparable participating employees</header><text>For purposes of paragraph (1), the term <term>comparable participating employees</term> means all employees who are covered (if at all) under the same health plan of the employer and have the same category of coverage. For purposes of the preceding sentence, the categories of coverage are self-only and family coverage.</text></paragraph>
<paragraph id="HE3BEC9A06B934B72AFFDE465F166D471"><enum>(4)</enum><header>Part-time employees</header>
<subparagraph id="H8DD5752E1C7343B0AA90ED1872CF6493"><enum>(A)</enum><header>In general</header><text>Paragraph (3) shall be applied separately with respect to part-time employees and other employees.</text></subparagraph> <subparagraph id="HB0AF0285F16442A088AB4A27086E4F0B"><enum>(B)</enum><header>Part-time employee</header><text>For purposes of subparagraph (A), the term <term>part-time employee</term> means any employee who is customarily employed for fewer than 30 hours per week.</text></subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></paragraph>
<paragraph commented="no" id="H587E74F98EE647C0B24BB5F56B5D6FA4"><enum>(12)</enum><text>Section 4980G(d) of such Code is amended by striking <quote>section 4980E</quote> and inserting <quote>this section</quote>.</text></paragraph> <paragraph commented="no" id="H05D14A25097D48BAB97EC0FEBE12FB93"><enum>(13)</enum><text>Section 6693(a)(2)(C) of such Code is amended by striking <quote>section 223(h)</quote> and inserting <quote>section 223(f)</quote>.</text></paragraph></subsection>
<subsection commented="no" display-inline="no-display-inline" id="H7C3D703009DB4C72A031952189521634"><enum>(c)</enum><header>Effective date</header><text display-inline="yes-display-inline">The amendments made by this section shall apply to taxable years beginning after the date of the enactment of this Act.</text></subsection></section> <section id="HB3E27F55790143B995201E8D44EF993B"><enum>104.</enum><header>Amounts paid for health insurance or direct primary care service arrangement</header> <subsection id="HACC7C9E41B4A4428B42CA7DCD54D75CA"><enum>(a)</enum><header>In general</header><text>Paragraph (2) of <external-xref legal-doc="usc" parsable-cite="usc/26/223">section 223(c)</external-xref> of the Internal Revenue Code of 1986, as redesignated by section 103, is amended—</text>
<paragraph id="H6A8074553A0A4396AFFAE5B0DAD4A79F"><enum>(1)</enum><text>in subparagraph (A), by inserting <quote>or pursuant to an arrangement under which an individual is provided coverage restricted to primary care services in exchange for a fixed periodic fee or payment for primary care services</quote> after <quote>menstrual care products</quote>,</text></paragraph> <paragraph id="HD8B5083B977644DD94FAD07FB0F63327"><enum>(2)</enum><text>by striking subparagraphs (B) and (C), and</text></paragraph>
<paragraph id="H2BD17C1FC52E40A59FDB171694C64FD9"><enum>(3)</enum><text>by redesignating subparagraph (D) as subparagraph (B).</text></paragraph></subsection> <subsection id="HFE12CB5E4CCA4C3FBA33FEC6FB4DCDFF"><enum>(b)</enum><header>Conforming amendment</header><text>Paragraph (2) of <external-xref legal-doc="usc" parsable-cite="usc/26/223">section 223(c)</external-xref> of the Internal Revenue Code of 1986, as amended by the preceding sections of this Act, is further amended by striking <quote>and any dependent (as defined in section 152, determined without regard to subsections (b)(1), (b)(2), and (d)(1)(B) thereof) of such individual</quote> and inserting <quote>any dependent (as defined in section 152, determined without regard to subsections (b)(1), (b)(2), and (d)(1)(B) thereof) of such individual, and any child (as defined in section 152(f)(1)) of such individual who has not attained the age of 27 before the end of such individual’s taxable year</quote>.</text></subsection>
<subsection commented="no" display-inline="no-display-inline" id="HF3D534B25CAE466F9157E85B056106BF"><enum>(c)</enum><header>Technical amendments</header>
<paragraph commented="no" display-inline="no-display-inline" id="HD5017BA469B14732BD569067FC4F3C9F"><enum>(1)</enum><text><external-xref legal-doc="usc" parsable-cite="usc/26/220">Section 220(d)(2)(A)</external-xref> of the Internal Revenue Code of 1986 is amended by striking <quote>section 223(d)(2)(D)</quote> and inserting <quote>section 223(c)(2)(B)</quote>.</text></paragraph> <paragraph commented="no" display-inline="no-display-inline" id="H02023EE7C4034231A477804FF2FECC87"><enum>(2)</enum><text>Subsection (f) of <external-xref legal-doc="usc" parsable-cite="usc/26/106">section 106</external-xref> of the Internal Revenue Code of 1986 is amended by striking <quote>section 223(d)(2)(D)</quote> and inserting <quote>section 223(c)(2)(B)</quote>.</text></paragraph></subsection>
<subsection commented="no" display-inline="no-display-inline" id="H58DA1761CCF6403D921E36935C9C0FB0"><enum>(d)</enum><header>Effective dates</header>
<paragraph commented="no" display-inline="no-display-inline" id="HD3EB436FAB4547BBA834F5696D698A3E"><enum>(1)</enum><header>In general</header><text>The amendments made by subsections (a) and (b) shall apply with respect to amounts paid after the date of the enactment of this Act in taxable years beginning after such date.</text></paragraph> <paragraph commented="no" display-inline="no-display-inline" id="H7AE0EC84631540FA8AB012EE37976249"><enum>(2)</enum><header>Technical amendments</header><text>The amendments made by subsection (c) shall apply with respect to taxable years beginning after the date of enactment of this Act.</text></paragraph></subsection></section>
<section id="H5C1606B1F53F4B47A8E761FAAE0CE616" commented="no"><enum>105.</enum><header>Special rule for certain medical expenses incurred before establishment of account</header>
<subsection id="HB403F99DED54484298110940D50C4256" commented="no"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Paragraph (2) of <external-xref legal-doc="usc" parsable-cite="usc/26/223">section 223(c)</external-xref> of the Internal Revenue Code of 1986, as amended and redesignated by the preceding sections of this Act, is further amended by adding at the end the following new subparagraph:</text> <quoted-block style="OLC" display-inline="no-display-inline" id="HC18D656F96504E1F807D338BB09DA048"> <subparagraph id="H5DB87A4AE63E418F83FB10B0ADBA126C" commented="no"><enum>(C)</enum><header>Certain medical expenses incurred before establishment of account treated as qualified</header><text>An expense shall not fail to be treated as a qualified medical expense solely because such expense was incurred before the establishment of the health savings account if such expense was incurred—</text>
<clause id="H097ED983643047A48DAA6695CE3DC773" commented="no"><enum>(i)</enum><text>during either—</text> <subclause id="HC63E9667D0B04174BDDFDA720CDD22AD" commented="no"><enum>(I)</enum><text>the taxable year in which the health savings account was established, or</text></subclause>
<subclause id="H0B36466EC76245E18A80F5A09A947FC5" commented="no"><enum>(II)</enum><text>the preceding taxable year, in the case of a health savings account established after the taxable year in which such expense was incurred but before the time prescribed by law for filing the return for such taxable year (not including extensions thereof), and</text></subclause></clause> <clause id="HB6BE8A7F6DFC40E4A2D36E4E4969D393" commented="no"><enum>(ii)</enum><text>for medical care which (but for the fact that it was incurred before the establishment of the account) otherwise meets the requirements of the preceding subparagraphs.</text></clause></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></subsection>
<subsection commented="no" display-inline="no-display-inline" id="H6531DF88975842B68D3488764B21B302"><enum>(b)</enum><header>Effective date</header><text>The amendment made by this section shall apply to taxable years beginning after the date of the enactment of this Act.</text></subsection></section> <section id="HA80ADE98B68E41689F640C0A6386764C"><enum>106.</enum><header>Administrative error correction before due date of return</header> <subsection id="H8379500B9ACF468D82CE50B7D21D92A9"><enum>(a)</enum><header>In general</header><text>Paragraph (4) of <external-xref legal-doc="usc" parsable-cite="usc/26/223">section 223(e)</external-xref> of the Internal Revenue Code of 1986, as amended and redesignated by the preceding sections of this Act, is amended by adding at the end the following new subparagraph:</text>
<quoted-block style="OLC" display-inline="no-display-inline" id="H0662D898695F4A069CC278EE39D3FFF0">
<subparagraph id="HA2E59CC28E474138AD698C7865F726CE"><enum>(D)</enum><header>Exception for administrative errors corrected before due date of return</header><text>Subparagraph (A) shall not apply if any payment or distribution is made to correct an administrative, clerical, or payroll contribution error and if—</text> <clause id="HE45876AAD21A4FB1AD19A8A1E841C3AB"><enum>(i)</enum><text>such distribution is received by the individual on or before the last day prescribed by law (including extensions of time) for filing such individual's return for such taxable year, and</text></clause>
<clause id="H19DFE2CC303E48568A2969CADE2B5497"><enum>(ii)</enum><text>such distribution is accompanied by the amount of net income attributable to such contribution.</text></clause><continuation-text continuation-text-level="subparagraph">Any net income described in clause (ii) shall be included in the gross income of the individual for the taxable year in which it is received.</continuation-text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></subsection> <subsection commented="no" display-inline="no-display-inline" id="H47AD717B2F084417A1A7E7F4733E5B3C"><enum>(b)</enum><header>Effective date</header><text>The amendment made by this section shall take effect on the date of the enactment of this Act.</text></subsection></section>
<section id="H27CE7FCDC1A44B8A8B308C75B6AEEAC7"><enum>107.</enum><header>Allowing HSA rollover to child or parent of account holder</header>
<subsection id="H193587AA9E7443A4B2D809568368F78B"><enum>(a)</enum><header>In general</header><text>Paragraph (8)(A) of <external-xref legal-doc="usc" parsable-cite="usc/26/223">section 223(e)</external-xref> of the Internal Revenue Code of 1986, as redesignated by the preceding sections of this Act, is amended—</text> <paragraph id="H3318102CCA154BECAFBC3F9CE8C0C841"><enum>(1)</enum><text>by inserting <quote>, child, parent, or grandparent</quote> after <quote>surviving spouse</quote>,</text></paragraph>
<paragraph id="HC8957CC280B14AD38A5C0E593A13DD47"><enum>(2)</enum><text>by inserting <quote>, child, parent, or grandparent, as the case may be,</quote> after <quote>the spouse</quote>,</text></paragraph> <paragraph id="H055C66D7E0AC4AB4A7C9DABD7EEBF837"><enum>(3)</enum><text>by inserting <quote><header-in-text level="subparagraph" style="OLC">, child, parent, or grandparent</header-in-text></quote> after <quote><header-in-text level="subparagraph" style="OLC">spouse</header-in-text></quote> in the heading thereof, and</text></paragraph>
<paragraph id="H0E0486B9123745E6958EFA9DC44AD23F"><enum>(4)</enum><text>by adding at the end the following: <quote>In the case of a child who acquires such beneficiary’s interest and with respect to whom a deduction under section 151 is allowable to another taxpayer for a taxable year beginning in the calendar year in which such individual’s taxable year begins, such health savings account shall be treated as a health savings account of such child.</quote>.</text></paragraph></subsection> <subsection commented="no" display-inline="no-display-inline" id="HC17F55D7115D413BABB555143A141AD5"><enum>(b)</enum><header>Effective date</header><text>The amendments made by this section shall apply to taxable years beginning after the date of the enactment of this Act.</text></subsection></section>
<section section-type="subsequent-section" id="H9C381245F9D94FD592F21C3D2F389265" commented="no"><enum>108.</enum><header>Coverage for amounts paid for healthy food, vitamins, dietary supplements, and sports and fitness expenses</header>
<subsection id="HBFFC0529F29F4928A60D942A1AFB8772" commented="no"><enum>(a)</enum><header>In general</header><text>Paragraph (2) of <external-xref legal-doc="usc" parsable-cite="usc/26/223">section 223(c)</external-xref> of the Internal Revenue Code of 1986, as amended by the preceding provisions of this Act, is amended—</text> <paragraph id="H2B8BC5C0522D4BA5B19E4D3331A1DE80" commented="no"><enum>(1)</enum><text>in subparagraph (A), by adding at the end the following new sentence: <quote>For purposes of this subparagraph, amounts paid for qualified wellness expenses shall be treated as paid for medical care, but only to the extent that such amounts paid with respect to each individual described in the first sentence of this subparagraph do not exceed $100 per month in the case of a health savings account the balance of which does not exceed $5,000; $150 per month in the case of a health savings account the balance of which exceeds $5,000 but does not exceed $10,000; and $200 per month in the case of a health savings account the balance of which exceeds $10,000.</quote>, and</text></paragraph>
<paragraph id="H81160C2361F14A959500006BCF196ADB" commented="no"><enum>(2)</enum><text>by adding at the end the following:</text> <quoted-block style="OLC" display-inline="no-display-inline" id="H9E171C4A6B184DDAAB39189E645FF7E0"> <subparagraph id="HE8AEBA07ABC546A8B9B1D20A4122F40B" commented="no"><enum>(D)</enum><header>Qualified wellness expenses</header> <clause id="HA2BA43386C5F43FF9EAE9E5A335267FB"><enum>(i)</enum><header>In general</header><text display-inline="yes-display-inline">For purposes of this paragraph, the term <term>qualified wellness expenses</term> means amounts paid for healthy food, vitamins, dietary supplements (as defined in section 201(ff) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/321">21 U.S.C. 321(ff)</external-xref>)), or qualified sports and fitness expenses.</text> </clause>
<clause id="H12E99E933B054A53BD8B3590DC95CFF6" commented="no"><enum>(ii)</enum><header>Healthy food</header><text>The term <term>healthy food</term> means any individual food which meets the criteria of section 101.65(d)(3)(i) of title 21, Code of Federal Regulations (or any successor regulations).</text></clause> <clause id="HEC73BF2E2C304124B5DDDBD7A4224F45"><enum>(iii)</enum><header>Qualified sports and fitness expenses</header> <subclause id="HC1E320FBA29C41F2A4F6021BE7A96041"><enum>(I)</enum><header>In general</header><text display-inline="yes-display-inline">The term <term>qualified sports and fitness expenses</term> means amounts paid exclusively for the sole purpose of participating in a physical activity, including—</text>
<item id="H7516A12B8C9E4782B6814C60EF83391F"><enum>(aa)</enum><text display-inline="yes-display-inline">for membership at a fitness facility,</text></item> <item id="H5037F55C19E74812AEB8DB5386A2790A"><enum>(bb)</enum><text display-inline="yes-display-inline">for participation or instruction in physical exercise or physical activity, or</text></item>
<item id="H5F914DF81C1B4F579B8B5D44D45D9986"><enum>(cc)</enum><text display-inline="yes-display-inline">for equipment used in a program (including a self-directed program) of physical exercise or physical activity, including a wearable fitness tracker.</text></item></subclause> <subclause id="H54361C4D2DB14C718108262B2F0163A0"><enum>(II)</enum><header>Fitness facility</header><text>For purposes of subclause (I)(aa), the term <term>fitness facility</term> means a facility—</text>
<item id="H314BA4B6FC93415386D33D7D7539AEC5"><enum>(aa)</enum><text display-inline="yes-display-inline">which provides instruction in a program of physical exercise, offers facilities for the preservation, maintenance, encouragement, or development of physical fitness, or serves as the site of such a program of a State or local government or an organization described in section 501(c)(3) and exempt from tax under section 501(a),</text></item> <item id="HDC9F342FDC2047AF91C6D4B54979B39C"><enum>(bb)</enum><text display-inline="yes-display-inline">which is not a private club owned and operated by its members,</text></item>
<item id="H878C395A6868439DA6A4E874DBBEF160"><enum>(cc)</enum><text display-inline="yes-display-inline">which does not offer golf, hunting, sailing, or riding facilities,</text></item> <item id="HF82CAC2D4D214473B0D733D29D5FB157"><enum>(dd)</enum><text display-inline="yes-display-inline">the health or fitness component of which is not incidental to its overall function and purpose, and</text></item>
<item id="HC4230E42FA8F48A089CA16C82BD1B3F1"><enum>(ee)</enum><text display-inline="yes-display-inline">which is fully compliant with the State of jurisdiction and Federal anti-discrimination laws.</text></item></subclause> <subclause id="H2A381DDD23FB4A2AAC841CE07F831BEC"><enum>(III)</enum><header>Treatment of exercise videos, etc</header><text display-inline="yes-display-inline">Videos, books, and similar materials shall be treated as described in subclause (I)(bb) if the content of such materials constitutes instruction in a program of physical exercise or physical activity.</text></subclause>
<subclause id="H65422ED982094DB99074A1719C934FBB"><enum>(IV)</enum><header>Limitations related to sports and fitness equipment</header><text display-inline="yes-display-inline">Amounts paid for equipment described in subclause (I)(cc) shall be treated as qualified sports and fitness expenses only—</text> <item id="H42E9F7682F7147509EC01B2517FE9A5F"><enum>(aa)</enum><text display-inline="yes-display-inline">if such equipment is utilized exclusively for participation in fitness, exercise, sport, or other physical activity, and</text></item>
<item id="HE86FED1D65134B34B38BE8B2FFDE8D5F"><enum>(bb)</enum><text display-inline="yes-display-inline">in the case of amounts paid for apparel or footwear, if such apparel or footwear is of a type that is necessary for, and is not used for any purpose other than, a specific physical activity.</text></item></subclause></clause></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection> <subsection id="HB314458A16084C7C9741107B15A76599" commented="no"><enum>(b)</enum><header>Effective date</header><text>The amendments made by this section shall apply to taxable years beginning after the date of the enactment of this Act.</text></subsection></section>
<section section-type="subsequent-section" id="HBAF7A146B2E24F6CB3A65E741ED19419"><enum>109.</enum><header>Equivalent bankruptcy protections for health savings accounts as retirement funds</header>
<subsection id="H6FBD18EAFA0D446287053C56F89C4C16"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Section 522 of title 11, United States Code, is amended by adding at the end the following new subsection:</text> <quoted-block style="OLC" display-inline="no-display-inline" id="HF0E655B6650F4450AE3C7B7A50AE2E0B"> <subsection id="H070F4D0196764CFA96CDBF7BC1AD0211"><enum>(r)</enum><header>Treatment of health savings accounts</header><text>For purposes of this section, any health savings account (as described in <external-xref legal-doc="usc" parsable-cite="usc/26/223">section 223</external-xref> of the Internal Revenue Code of 1986) shall be treated in the same manner as an individual retirement account described in section 408 of such Code.</text></subsection><after-quoted-block>.</after-quoted-block></quoted-block></subsection>
<subsection commented="no" display-inline="no-display-inline" id="H6A7D69BD1ED849FF86E6999D4B676F5B"><enum>(b)</enum><header>Effective date</header><text>The amendment made by this section shall apply to cases commencing under title 11, United States Code, after the date of the enactment of this Act.</text></subsection></section> <section id="HB7A8938089A9418C99E91E8945D53618" commented="no"><enum>110.</enum><header>Satisfaction of employer mandate through health savings account contributions</header> <subsection id="H9967B6A87B8647A6B775DBFC07F2C49B" commented="no"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline"><external-xref legal-doc="usc" parsable-cite="usc/26/4980H">Section 4980H</external-xref> of the Internal Revenue Code of 1986 is amended by adding at the end the following new subsection:</text>
<quoted-block style="OLC" display-inline="no-display-inline" id="H82B28314864F48EABAB3BCA60545085A">
<subsection id="HC905D9E1B63F41BC9096B6C604BA6262" commented="no"><enum>(e)</enum><header>Contributions to health savings accounts</header>
<paragraph id="HF8CD56EFC6704FC2B7CB911A49051C8E" commented="no"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">An offer to make a contribution of $450 per month to an employee’s health savings account shall be treated for purposes of this section as an offer to enroll in minimum essential coverage under an eligible employer-sponsored plan for such month.</text></paragraph> <paragraph id="H8F2170C08610418FA6D03238A1B54F9D" commented="no"><enum>(2)</enum><header>Treatment as affordable coverage</header><text>Any employee offered a contribution described in paragraph (1) by any employer for any month shall not be treated as described in subsection (b)(1)(B) with respect to such employer for such month.</text></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></subsection>
<subsection id="H1B38603AD83A4F94B1758292CAEBA446"><enum>(b)</enum><header>Application of exclusion for employer contributions to health savings accounts</header><text>Section 106(d) of such Code is amended—</text> <paragraph id="H7533735DC52E480390B2C4E02561BC15"><enum>(1)</enum><text>by redesignating paragraphs (2) and (3) as paragraphs (3) and (4), respectively, and</text></paragraph>
<paragraph id="H7E18DF94EB484005A52AE8EC277A3963"><enum>(2)</enum><text>by inserting after paragraph (1) the following new paragraph:</text> <quoted-block style="OLC" id="H84DA65205D5544049B9184960DBE8339" display-inline="no-display-inline"> <paragraph id="HEFC925127CD54D96BD49595C0248F6A3"><enum>(2)</enum><header>Limitation</header><text display-inline="yes-display-inline">In the case of an employee whose employer makes a contribution of at least $450 per month to such employee’s health savings account, paragraph (1) shall apply to such a contribution only if such employee is enrolled in health care coverage for such month.</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection>
<subsection id="H617DFE4F8DD74CF6859D488EE9A6979B" commented="no"><enum>(c)</enum><header>Effective date</header><text display-inline="yes-display-inline">The amendments made by this section shall apply to months beginning in taxable years beginning after the date of the enactment of this Act.</text></subsection></section> <section id="H55CCFA4C9CAC4CD2AA56685940D6BCAC" commented="no"><enum>111.</enum><header>Rollovers from health care FSAs and HRAs permitted</header> <subsection id="H14F774E3F6234EF6B0D42013F3EFCABD" commented="no"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline"><external-xref legal-doc="usc" parsable-cite="usc/26/106">Section 106</external-xref> of the Internal Revenue Code of 1986 is amended by adding at the end the following new subsection:</text>
<quoted-block style="OLC" id="HDC5879A167574331BBDEFB71CD3DD563" display-inline="no-display-inline">
<subsection id="H927F3E9DB1F54E7A994CFC3D20ED32DA" commented="no"><enum>(h)</enum><header>FSA and HRA rollovers to health savings accounts</header>
<paragraph id="H0515FDDF4CF1446F91DA2109F543A199" commented="no"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">A plan shall not fail to be treated as a health flexible spending arrangement or health reimbursement arrangement under this section or section 105 merely because such plan provides for a qualified HSA rollover distribution.</text></paragraph> <paragraph id="H7DAF8A8C1F7E4DCE9E0636CB2211BBC7" commented="no"><enum>(2)</enum><header>Qualified HSA rollover distribution</header><text>For purposes of this subsection, the term <term>qualified HSA rollover distribution</term> means any portion of a beneficiary’s unused balance of a health flexible spending arrangement or health reimbursement arrangement at the end of any plan year (or such other times as the Secretary may provide) which is transferred in a direct trustee-to-trustee transfer to a health savings account of such beneficiary.</text></paragraph>
<paragraph id="H40602134A1B54C2C8B65331919C5DDE9" commented="no"><enum>(3)</enum><header>Treatment as HSA rollover contribution</header><text>For purposes of this title, a qualified HSA rollover distribution shall be treated as a contribution described in section 223(e)(5).</text></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></subsection> <subsection id="HDE7F586B1D17493C919599AE7E828F74" commented="no"><enum>(b)</enum><header>Effective date</header><text display-inline="yes-display-inline">The amendment made by this section shall apply to taxable years beginning after the date of the enactment of this Act.</text></subsection></section>
<section id="HE360653C670B45B2997DBF6830D1E6DC" commented="no"><enum>112.</enum><header>Qualified general contributions to health savings accounts</header>
<subsection id="HCC5836FF4ED24E308BA2F084608A1DF8" commented="no"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline"><external-xref legal-doc="usc" parsable-cite="usc/26/223">Section 223</external-xref> of the Internal Revenue Code of 1986, as amended by the preceding provisions of this Act, is amended—</text> <paragraph id="H026B54A597944EABAF06D1A620605BBA" commented="no"><enum>(1)</enum><text>in subsection (c)(1)(A), by inserting <quote>or a qualified general contribution,</quote> after <quote>section 220(f)(5),</quote>, and</text></paragraph>
<paragraph id="HBE1BC4A8F9A7409DAE8B80AC9995DA0C" commented="no"><enum>(2)</enum><text>in subsection (e)—</text> <subparagraph id="H947D0990069C4E4EBAEBCC41F46F6D14" commented="no"><enum>(A)</enum><text>in paragraph (3)(B), by inserting <quote>, or a qualified general contribution</quote> after <quote>section 220(f)(5)</quote>, and</text></subparagraph>
<subparagraph id="H232C040FA32C426A9B1321B93FDF7E91" commented="no"><enum>(B)</enum><text>by adding at the end the following new paragraph:</text> <quoted-block style="OLC" id="H4E7AB0AF4495471AAE609BE291BE4F34" display-inline="no-display-inline"> <paragraph id="H8CA137EB2E174E9B99529C29F5BC5CCE" commented="no"><enum>(9)</enum><header>Qualified general contribution</header><text display-inline="yes-display-inline">For purposes of this section—</text>
<subparagraph id="HFAB3147535124283A160124F4E849B3A" commented="no"><enum>(A)</enum><header>In general</header><text>The term <term>qualified general contribution</term> means any contribution which—</text> <clause id="HC5EBB7A1733C464B9E463FDB19A76A7C" commented="no"><enum>(i)</enum><text display-inline="yes-display-inline">is made by the Secretary pursuant to a general funding contribution,</text></clause>
<clause id="H334AA65A8C8B4B38951058A3BEAE5AC0" commented="no"><enum>(ii)</enum><text display-inline="yes-display-inline">is made to the health savings account of an account beneficiary in the qualified class of account beneficiaries specified in the general funding contribution, and</text></clause> <clause id="H0D320423C32F4AC49629075A47BF7987" commented="no"><enum>(iii)</enum><text display-inline="yes-display-inline">is in an amount which is equal to the ratio of—</text>
<subclause id="H4D0A6BD017DC495FB23222ED767FF6E3" commented="no"><enum>(I)</enum><text display-inline="yes-display-inline">the amount of such general funding contribution, to</text></subclause> <subclause id="H120DD2A634054A8B9DF919BF884097FE" commented="no"><enum>(II)</enum><text>the number of account beneficiaries in such qualified class.</text></subclause></clause></subparagraph>
<subparagraph id="H43D7262B81864874ADBEA21CAFEC1FD9" commented="no"><enum>(B)</enum><header>General funding contribution</header><text>The term <term>general funding contribution</term> means a contribution which—</text> <clause id="HF6B1A1B04BD649168B67E56B3A010DC9" commented="no"><enum>(i)</enum><text>is made by—</text>
<subclause id="HC35CE46D7FED49D1BF30715DB82C8873" commented="no"><enum>(I)</enum><text display-inline="yes-display-inline">an entity described in section 170(c)(1) (other than a possession of the United States or a political subdivision thereof) or an Indian tribal government, or</text></subclause> <subclause id="H02FD7FF71FD7403783164B7A04225766" commented="no"><enum>(II)</enum><text display-inline="yes-display-inline">an organization described in section 501(c)(3) and exempt from tax under section 501(a), and</text></subclause></clause>
<clause id="H4AE2619CFF134DD18B0E3AA0F54E7C8F" commented="no"><enum>(ii)</enum><text display-inline="yes-display-inline">which specifies a qualified class of account beneficiaries to whom such contribution is to be distributed.</text></clause></subparagraph> <subparagraph id="H877914EE655D413CBE2D692C1CB445F8" commented="no"><enum>(C)</enum><header>Qualified class</header> <clause id="HE78DF0BB4FAD45F481C9E3A4CCB9E964" commented="no"><enum>(i)</enum><header>In general</header><text display-inline="yes-display-inline">The term <term>qualified class</term> means any of the following:</text>
<subclause id="H7D3858CC19154EF2BEA864F15D3D3772" commented="no"><enum>(I)</enum><text>All account beneficiaries.</text></subclause> <subclause id="H51C69393903E4D3CBB9DDFD2E6E8E1DE" commented="no"><enum>(II)</enum><text display-inline="yes-display-inline">All account beneficiaries who reside in one or more States or other qualified geographic areas specified by the terms of the general funding contribution.</text></subclause></clause>
<clause id="HCD8BD29A808444C38CC30B5EE2C1E887" commented="no"><enum>(ii)</enum><header>Qualified geographic area</header><text display-inline="yes-display-inline">The term <term>qualified geographic area</term> means any geographic area in which not less than 5,000 account beneficiaries reside and which is designated by the Secretary as a qualified geographic area under this clause.</text></clause></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></subparagraph></paragraph></subsection> <subsection id="H2F8ECA5A9C8A4570A919B614331776C2" commented="no"><enum>(b)</enum><header>Exclusion from gross income</header> <paragraph id="H51F84E998A734E7C8E3213B3BF77E767" commented="no"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">Part III of subchapter B of chapter 1 of such Code is amended by inserting before section 140 the following new section:</text>
<quoted-block style="OLC" id="HAE9C2B3C27E94319A4013577FF4ED02D" display-inline="no-display-inline">
<section id="H1971F743FDEC4638AF8C0F36F72FB6EB" commented="no"><enum>139M.</enum><header>Qualified general contributions to health savings accounts</header>
<subsection id="H543B35B17C504D2B872D3D48F5DBFC2F" commented="no"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Gross income of an account beneficiary shall not include any qualified general contribution to a health savings account of the account beneficiary.</text></subsection> <subsection id="HF1C3A345E3A64CACAD4E49A3B5AED24C" commented="no"><enum>(b)</enum><header>Definitions</header><text display-inline="yes-display-inline">Any term used in this section which is used in section 223 shall have the meaning given such term under section 223.</text></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></paragraph>
<paragraph id="HD7DC177EF65F4C8FB1792E83E731CCFF" commented="no"><enum>(2)</enum><header>Clerical amendment</header><text display-inline="yes-display-inline">The table of sections for part III of subchapter B of chapter 1 of such Code is amended by inserting before the item relating to section 140 the following new item:</text> <quoted-block style="OLC" id="H125335BA0D094000BBF15C3A45AE7F8D" display-inline="no-display-inline"> <toc regeneration="no-regeneration"> <toc-entry level="section">Sec. 139M. Qualified general contributions to health savings accounts.</toc-entry></toc><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection> <subsection id="H03A0B5339FC843C69C46D64D1699E116" commented="no"><enum>(c)</enum><header>Effective date</header><text display-inline="yes-display-inline">The amendments made by this section shall apply to taxable years beginning after the date of the enactment of this Act.</text></subsection></section>
<section id="HDAE82C0B947247C68CDB7C70E63DC193"><enum>113.</enum><header>Charitable contributions to health savings accounts</header>
<subsection id="HE4E4F81B8553446C802E78111DEA284A"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline"><external-xref legal-doc="usc" parsable-cite="usc/26/223">Section 223(c)(1)</external-xref> of the Internal Revenue Code of 1986, as amended by the preceding provisions of this Act, is amended by adding at the end the following new subparagraph:</text> <quoted-block style="OLC" id="H7CDD9EFF90814FA99E7033B6FAD8C1D0" display-inline="no-display-inline"> <subparagraph id="HF1AD511232274ABA80F98906B4BCFE66"><enum>(F)</enum><text display-inline="yes-display-inline">The trustee provides the account beneficiary with a URL (or other similar shareable link) which allows any organization described in section 501(c)(3) and exempt from tax under section 501(a) to make contributions to the account on the account beneficiary’s behalf. Any such contribution shall be taken into account as a charitable contribution for purposes of section 170 to the extent that the aggregate amount of such contributions from each such organization for any taxable year does not exceed $5,000.</text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></subsection>
<subsection id="HBEB3FBA1A3494537A2633207F15C31F1"><enum>(b)</enum><header>Effective date</header><text>The amendment made by this section shall apply to taxable years beginning after the date of the enactment of this Act.</text></subsection></section> <section id="HD253918DA6F943FEB386A42460CABDCE"><enum>114.</enum><header>Amounts paid for health care sharing ministry</header> <subsection id="H6D68698F2707407EBE80812DAB85271B" commented="no" display-inline="no-display-inline"><enum>(a)</enum><header>In general</header><text><external-xref legal-doc="usc" parsable-cite="usc/26/223">Section 223(c)(2)(A)</external-xref> of the Internal Revenue Code of 1986, as amended by the preceding provisions of this Act, is amended by adding at the end the following new sentence: <quote>For purposes of this subparagraph, amounts paid by a member of a health care sharing ministry (as defined in section 5000A(d)(2)(B)(ii) without regard to subclause (IV) thereof) for the sharing of medical expenses among members, or administrative fees of such ministry, shall be treated as paid for medical care.</quote>.</text> </subsection>
<subsection id="HFC7ECCE008A046D483433DC1DFF0B9B2"><enum>(b)</enum><header>Effective date</header><text>The amendment made by this section shall apply to taxable years beginning after the date of the enactment of this Act.</text></subsection></section> <enum>II</enum><header>Health Marketplace for All</header> <section id="H4E76EF6FEC804CC3A9BF1FA896A1F252"><enum>201.</enum><header>Short title</header><text display-inline="no-display-inline">This title may be cited as the <quote><short-title>Health Marketplace for All Act of 2026</short-title></quote>.</text></section>
<section id="HE6CCFFF08DD444C0B71A51C00DF76373"><enum>202.</enum><header>Health marketplace pools deemed an <quote>employer</quote> for purposes of offering group health plans or group health insurance coverage</header>
<subsection id="H6C34AF298AE8494A86A219E33E3DBA53"><enum>(a)</enum><header>Definition of employer</header><text>Section 3(5) of the Employee Retirement Income Security Act of 1974 (<external-xref legal-doc="usc" parsable-cite="usc/29/1002">29 U.S.C. 1002(5)</external-xref>) is amended by adding at the end the following: <quote>Such term shall be deemed to include, for purposes of offering a group health plan (as defined in section 733(a)(1)) or group health insurance coverage (as defined in section 733(b)(4)) (which, notwithstanding any other provision of law, may include such a plan or coverage covering prescription or nonprescription drugs as the only benefit offered by the plan or coverage in accordance with section 736(b)(5)(B)), any entity that meets the requirements under section 736(b).</quote>.</text></subsection> <subsection id="HA8E89D24C69D4F1885F4BB287316C17C"><enum>(b)</enum><header>Group health plans and group health insurance coverage</header><text>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/29/1181">29 U.S.C. 1181 et seq.</external-xref>) is amended by adding at the end the following:</text>
<quoted-block style="OLC" display-inline="no-display-inline" id="HC4BA63A4B81B4D99BF28653CECC3257D">
<section id="HCF1F462788C64BE2AEC352335AF5DB8B"><enum>736.</enum><header>Health marketplace pools deemed an <quote>employer</quote> for purposes of offering group health plans or group health insurance coverage</header>
<subsection id="H8E009F67E2F04BAABFCA76ACEE1F5E16"><enum>(a)</enum><header>In general</header><text>An entity (referred to in this section as a <quote>health marketplace pool</quote>) that meets the requirements under subsection (b) shall be deemed an employer under section 3(5) for purposes of offering a group health plan or group health insurance coverage (which, notwithstanding any other provision of law, may include such a plan or coverage covering prescription or nonprescription drugs as the only benefit offered by the plan or coverage in accordance with subsection (b)(5)(B)).</text></subsection> <subsection id="H71C13C26F19D49B0AD2DB4422A39CEB2"><enum>(b)</enum><header>Requirements for health marketplace pools</header><text>The requirements under this subsection are each of the following:</text>
<paragraph id="HBAA65115C31A487F9719E83AE56A54EA"><enum>(1)</enum><header>Organization</header><text>The health marketplace pool shall—</text> <subparagraph id="HDED8D678B86947E1ACF1607B6B1AC402"><enum>(A)</enum><text>be formed and maintained in good faith for a purpose that includes the formation of a risk pool in order to offer group health insurance coverage or a group health plan to its members; and</text></subparagraph>
<subparagraph id="H345956244659448A93A9401F924BF217"><enum>(B)</enum><text>not condition membership in the health marketplace pool on any health status-related factor relating to an individual (including an employee of an employer or a dependent of an employee).</text></subparagraph></paragraph> <paragraph id="H831C3ED856534731AF570AA8136E12D1"><enum>(2)</enum><header>Offering group health plans and group health insurance coverage</header> <subparagraph id="HC7102EACD01642DEAA32FFC0217A5A29"><enum>(A)</enum><header>Different groups</header> <clause id="H7FD52F3B143C4E7BB1CB138FE46FA06D"><enum>(i)</enum><header>In general</header><text>The health marketplace pool, which may be in conjunction with a health insurance issuer that offers group health insurance coverage through the health marketplace pool, shall make available a group health plan or group health insurance coverage to all members of the health marketplace pool (and, in the case of members that are employers, employees of the employers) at rates that—</text>
<subclause id="H841E72A228C444DEA6E0584ABECB42D3"><enum>(I)</enum><text>are established by the health marketplace pool, or a health insurance issuer contracting with such health marketplace pool, on a policy or product specific basis; and</text></subclause> <subclause id="HE5B7430910B640CDBD25BE08733B4303"><enum>(II)</enum><text>subject to sections 701 and 702, may vary for individuals covered through the health marketplace pool.</text></subclause></clause>
<clause id="H503734D53B4F42AC92A09BA34AD2D5C9"><enum>(ii)</enum><header>Permissible coverage for dependents</header><text>Such group health plan or group health insurance coverage may be made available under clause (i) to any dependents of members of the health marketplace pool or dependents of employees of employers that are such members.</text></clause></subparagraph> <subparagraph id="HD5B271715BDF406BA8C2E35FE34E4A94"><enum>(B)</enum><header>Nondiscrimination in coverage offered</header> <clause id="HA677FBB9359C493AA6617C8243EAD201"><enum>(i)</enum><header>In general</header><text>Subject to clause (ii), the health marketplace pool may not offer coverage under a group health plan or group health insurance coverage to a member of the health marketplace pool unless the same coverage is offered to all such members of the health marketplace pool.</text></clause>
<clause id="HCE61344DF5564B63B6408F8EC0386AA8"><enum>(ii)</enum><header>Construction</header><text>Nothing in this subsection shall be construed as requiring a health insurance issuer or group health plan to provide coverage outside the service area of the issuer or plan, or preventing a health insurance issuer or group health plan from underwriting or from excluding or limiting the coverage on any individual, subject to the requirements under sections 701 and 702.</text></clause></subparagraph> <subparagraph id="H16A28617AE1F4787933E7806C97964E4"><enum>(C)</enum><header>Assumption of risk</header><text>The health marketplace pool may provide—</text>
<clause id="H343DB0DA39A64D6FA7C5F5E08515ACE4"><enum>(i)</enum><text>group health insurance coverage through a contract with a health insurance issuer; or</text></clause> <clause id="H916E982B0960476D8A9B1B0A11E4BB59"><enum>(ii)</enum><text>a group health plan through self-insurance.</text></clause></subparagraph></paragraph>
<paragraph id="H48E5CE32DFAC4DB68D6962C1EA2EE789"><enum>(3)</enum><header>Geographic areas</header><text>Nothing in this subsection shall be construed as preventing the establishment and operation of more than 1 health marketplace pool in a geographic area or as limiting the number of health marketplace pools that may operate in any area.</text></paragraph> <paragraph id="H621C889B89284A7097041479E0ECFDA4"><enum>(4)</enum><header>Provision of administrative services to purchasers</header><text display-inline="yes-display-inline">The health marketplace pool may provide administrative services for members. Such services may include accounting, billing, and enrollment information.</text></paragraph>
<paragraph id="H18DF636C8D014E0898D8DF072F47D1F1"><enum>(5)</enum><header>Drug coverage</header><text>The group health plan or group health insurance coverage offered by the health marketplace pool may offer—</text> <subparagraph id="HE2A3E874C80B4FC9AD1A1A8FBAB262CE"><enum>(A)</enum><text>drug coverage, including coverage of over-the-counter drugs, in combination with other benefits covered by the group health plan or group health insurance coverage; or</text></subparagraph>
<subparagraph id="H4786354E49C34EB587C820A42938CB00"><enum>(B)</enum><text>notwithstanding any other provision of law, drug coverage, including coverage of over-the-counter drugs, as the only benefit covered by the group health plan or group health insurance coverage.</text></subparagraph></paragraph> <paragraph id="HB065AE186DA84912BA02A058A96017DC"><enum>(6)</enum><header>Members</header> <subparagraph id="H1E778DB5EFEC4B06AA79EC560B826A52"><enum>(A)</enum><header>In general</header><text>With respect to an individual who is a member of the health marketplace pool—</text>
<clause id="H4BC43BE99D5640EBAD18D67A1D84877C"><enum>(i)</enum><text>the individual may enroll for coverage under the group health plan or group health insurance coverage offered by the health marketplace pool (including, if applicable, enrollment for coverage for a dependent of such individual); or</text></clause> <clause id="H69DE1341FFBC4BB99B24530A11090189"><enum>(ii)</enum><text>the employer of the individual may enroll the individual for coverage under the group health plan or group health insurance coverage offered by the health marketplace pool (including, if applicable, enrollment for coverage for a dependent of such individual).</text></clause></subparagraph>
<subparagraph id="HB3FDDC1928804D4CAB3CDD19C667851C"><enum>(B)</enum><header>Eligibility</header><text>An individual shall be eligible to be a member of the health marketplace pool if such individual is—</text> <clause id="HB7C8EAE42E414D49B67908DBD28D5634"><enum>(i)</enum><text>a member of an entity that establishes or joins the health marketplace pool (or a dependent of such a member, as applicable);</text></clause>
<clause id="H5EB384F50D774E6693461B5D885121E3"><enum>(ii)</enum><text>an employee of a member of an entity described in clause (i) (or a dependent of such an employee, as applicable); or</text></clause> <clause id="HA0FAD5593B3D454DA34D414C1E4F14A8"> <enum>(iii)</enum> <text>an employee of an entity (or a dependent of such an employee, as applicable) controlled by a member of an entity described in clause (i).</text>
</clause></subparagraph>
<subparagraph id="HE0B5B86818F74541BBD6F01F532D745E"><enum>(C)</enum><header>Rules for enrollment</header><text>Nothing in this paragraph shall preclude the health marketplace pool from establishing rules of enrollment and reenrollment of members. Such rules shall be applied consistently to all members within the health marketplace pool and shall not be based in any manner on health status-related factors in accordance with sections 701 and 702.</text></subparagraph></paragraph></subsection> <subsection commented="no" id="H9D62154852C5406781D896DD2A9C4EFC"><enum>(c)</enum><header>Determination of employer and joint employer status</header><text>Participating in or facilitating a group health plan or group health insurance coverage under this section shall not be construed as establishing under any Federal or State law—</text>
<paragraph commented="no" id="H99A8AA3202BA4EC184CCA4C4944A29AF"><enum>(1)</enum><text>an employer relationship for any purpose other than offering the group health plan or group health insurance coverage; or</text></paragraph> <paragraph commented="no" id="HD23E85D532D145AC96D3DF6A1266168B"><enum>(2)</enum><text>a joint employer relationship for any purpose.</text></paragraph></subsection>
<subsection id="HEB74949F48424C0CA2291681D8E637F9"><enum>(d)</enum><header>Definition</header><text>In this section, the term <term>dependent</term>, as applied to a group health plan or group health insurance coverage offered in a State, shall have the meaning applied to such term with respect to such plan or coverage under the State law applying to such plan or coverage. Such term may include the spouse and children of the individual involved in accordance with such State law.</text></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></subsection></section> <section id="H8D93FD01D498418BB63E9495740D5745"><enum>203.</enum><header>Conforming amendments</header><text display-inline="no-display-inline">Section 3 of the Employee Retirement Income Security Act of 1974 (<external-xref legal-doc="usc" parsable-cite="usc/29/1002">29 U.S.C. 1002</external-xref>) is amended—</text>
<paragraph id="HFDA5A6C4C9C843E5B297F8B3EDBA0473"><enum>(1)</enum><text>in paragraph (6), by inserting before the period <quote>, except (with respect to an entity meeting the requirements under section 736(b)) such term includes any member of such entity</quote>;</text></paragraph> <paragraph id="HE08F2023C657462E8F4C6481161DD7F1"><enum>(2)</enum><text>in paragraph (21)—</text>
<subparagraph id="HE0E2E42F2D3F4C568112D77D268C025F"><enum>(A)</enum><text>in subparagraph (A), by striking <quote>subparagraph (B)</quote> and inserting <quote>subparagraphs (B) and (C)</quote>; and</text></subparagraph> <subparagraph id="H891F05EAC07845DCB60C9E536135C52D"><enum>(B)</enum><text>by adding at the end the following:</text>
<quoted-block style="OLC" display-inline="no-display-inline" id="HA5B6F4D7113E481B8B848AE366087A56">
<subparagraph id="HDCF05FA92F764A508B309A4FB61DF089" indent="up2"><enum>(C)</enum><text>With respect to a person that is a member of an entity (referred to in section 736 and this subparagraph as a <quote>health marketplace pool</quote>) that meets the requirements of section 736(b) and offers a group health plan (as defined in section 733(a)(1)) or group health insurance coverage (as defined in section 733(b)(4)) (which, notwithstanding any other provision of law, may include such a plan or coverage covering prescription or nonprescription drugs as the only benefit offered by the plan or coverage), membership in the health marketplace pool shall not by itself cause the person to be a fiduciary with respect to the group health plan or group health insurance coverage.</text></subparagraph><after-quoted-block>; and</after-quoted-block></quoted-block></subparagraph></paragraph> <paragraph id="H456DCB3DBE5843ACA7279AA621421AE1"><enum>(3)</enum><text>in paragraph (40)(A)—</text>
<subparagraph id="HBFF865950F1E4A5D84636D77409810AB"><enum>(A)</enum><text>in clause (ii), by striking <quote>, or</quote> and inserting <quote>,</quote>;</text></subparagraph> <subparagraph id="HEEDC4CF532E34644BEBADF5BD96A830A"><enum>(B)</enum><text>in clause (iii), by striking the period and inserting <quote>, or</quote>; and</text></subparagraph>
<subparagraph id="H319AF35A750344C1A01C1C16EFDF1322"><enum>(C)</enum><text>by adding at the end the following:</text> <quoted-block style="OLC" display-inline="no-display-inline" id="HFE7445001DCF4AE5A7A8F96A965BCD9B"> <clause commented="no" display-inline="no-display-inline" id="HD5B742030EBB4AE7AB63398043C30447" indent="up2"><enum>(iv)</enum><text>as a group health plan (as defined in section 733(a)(1)), or group health insurance coverage (as defined in section 733(b)(4)), offered by an entity meeting the requirements under section 736(b) (which, notwithstanding any other provision of law, may include such an entity offering such a plan or coverage covering prescription or nonprescription drugs as the only benefit offered by the plan or coverage).</text></clause><after-quoted-block>.</after-quoted-block></quoted-block></subparagraph></paragraph></section>
<enum>III</enum><header>Strengthening Hospital and Insurer Price Transparency</header>
<section section-type="subsequent-section" id="H82252536B67547F6A76939DBF8C8A6DE"><enum>301.</enum><header>Short title</header><text display-inline="no-display-inline">This title may be cited as the <quote><short-title>Patients Deserve Price Tags Act</short-title></quote>.</text></section> <section id="HDFB66FA8A89249369F89D2851C89437E"><enum>302.</enum><header>Strengthening hospital price transparency requirements</header> <subsection id="H1675BA48CD314BC7873D0213D2FB82CB"><enum>(a)</enum><header>In general</header><text>Section 2718(e) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300gg-18">42 U.S.C. 300gg–18(e)</external-xref>) is amended to read as follows:</text>
<quoted-block style="OLC" display-inline="no-display-inline" id="HD6A9893F6C4A48BB96B2A63E6E83A331">
<subsection id="HC3487A8151F842068DEAFD4CF53DC5F2"><enum>(e)</enum><header>Standard hospital charges</header>
<paragraph id="HB4AB95BD4FCD4FA38725DC8B13E2E775"><enum>(1)</enum><header>In general</header>
<subparagraph id="H4CAAC35B755048509E832EB3C284D629"><enum>(A)</enum><header>Disclosure of standard charges</header><text>Each hospital shall, in accordance with a method and format established by the Secretary under subparagraph (C), on a monthly basis compile and make public (without subscription and free of charge)—</text> <clause id="H9ED1A51D95D5479FAC6FBC0C80D3D123"><enum>(i)</enum><text>all of the hospital’s standard charges (including the information described in subparagraph (B)) for each item and service furnished by such hospital; and</text></clause>
<clause id="H7F730855FC094C46876D2A08FC17759E"><enum>(ii)</enum><text>hospital standard charge information, including the information described in subparagraph (B), in a consumer-friendly format (as specified by the Secretary), that includes—</text> <subclause id="H2FFF0319D03F4A818D5A1B700A454275"><enum>(I)</enum><text>as many of the Centers for Medicare & Medicaid Services-specified shoppable services that are furnished by the hospital, and as many additional hospital-selected shoppable services (or all such additional services, if such hospital furnishes fewer than 300 shoppable services) as may be necessary for a combined total of at least 300 shoppable services through December 31, 2027, after which the hospital’s prices shall include all shoppable services; and</text></subclause>
<subclause id="H1C4CCCF511A14D26A803D8F9DB8813D0"><enum>(II)</enum><text>with respect to each Centers for Medicare & Medicaid Services-specified shoppable service that is not furnished by the hospital, an indication that such service is not so furnished.</text></subclause></clause></subparagraph> <subparagraph id="H4ADC6A48BA824688865D934CE4F79A86"><enum>(B)</enum><header>Standard charges described</header><text>For purposes of subparagraph (A), standard charges means:</text>
<clause id="H5C5E1D584FBA4A51BE389D499D773D1D"><enum>(i)</enum><text>A plain language description of each item or service, accompanied by any applicable billing codes, including modifiers, using commonly recognized billing code sets, including the Current Procedural Terminology code, the Healthcare Common Procedure Coding System code, the diagnosis-related group, the National Drug Code, and other nationally recognized identifier.</text></clause> <clause id="HF2E0C6729743429C897D92D4EE2BA567"><enum>(ii)</enum><text>The gross charge, expressed as a dollar amount, for each such item or service, when provided in, as applicable, the inpatient setting and outpatient department setting.</text></clause>
<clause id="HB8FE8479474949F391B7BCE432C1B417"><enum>(iii)</enum><text>The discounted cash price expressed as a dollar amount, for each such item or service when provided in, as applicable, the inpatient setting and outpatient department setting (or, in the case no discounted cash price is available for an item or service, the minimum cash price accepted by the hospital from self-pay individuals for such item or service, expressed as a dollar amount, as well as, with respect to prices made public pursuant to subparagraph (A)(ii), a link to a consumer-friendly document that clearly explains the hospital’s charity care policy). The hospital shall accept the discounted cash price as payment in full from any patient that chooses to pay in cash without regard to the patient’s coverage.</text></clause> <clause id="HA66047AAFEC144F88D5B4F0AD4F74DAD"><enum>(iv)</enum><text>The payer-specific negotiated charges, expressed as a dollar amount and clearly associated with the name of the applicable third party payer and name of each plan, that apply to each such item or service when provided in, as applicable, the inpatient setting and outpatient department setting. If the charges are based on an algorithm, percentage of another amount, or other formula or criteria, the hospital also shall disclose such algorithm, percentage, formula, or criteria as set forth in its contract and any other terms, schedules, exhibits, data, or other information referenced in any such contract as shall be required to determine and disclose the negotiated charge.</text></clause>
<clause id="HD3F1E129E1A34909A12A247DF5045782"><enum>(v)</enum><text>The de-identified maximum and minimum negotiated charges for each such item or service, expressed as a non-zero dollar amount.</text></clause> <clause id="H0BE66D4C26684AD7B0DDE475C4372FF7"><enum>(vi)</enum><text>Any other additional information the Secretary may require for the purpose of improving the accuracy of, or enabling consumers to easily understand and compare, standard charges and prices for an item or service, except information that is duplicative of any other reporting requirement under this subsection. In the case of standard charges and prices for an item or service included as part of a bundled, per diem, episodic, or other similar arrangement, the information described in this subparagraph shall be made available as determined appropriate by the Secretary.</text></clause></subparagraph>
<subparagraph id="H629F4CF0749A467E9278AD9373928986"><enum>(C)</enum><header>Uniform method and format</header><text>Not later than January 1, 2027, the Secretary shall establish a standard, uniform method and format for hospitals to use in compiling and making public standard charges pursuant to subparagraph (A)(i) and a standard, uniform method and format for such hospitals to use in compiling and making public prices pursuant to subparagraph (A)(ii). Such methods and formats shall—</text> <clause id="HD20385C8BAD346D79F2A295E9761FA64"><enum>(i)</enum><text>in the case of such method and format for making public standard charges pursuant to subparagraph (A)(i), ensure that such charges are made available in a machine-readable spreadsheet format;</text></clause>
<clause id="HE844E6A821D040E0AA283AFF53904384"><enum>(ii)</enum><text>meet such standards as determined appropriate by the Secretary in order to ensure the accessibility and usability of such charges and prices; and</text></clause> <clause id="H89CB67EFA65A4D11A6502B13F8978E31"><enum>(iii)</enum><text>be updated as determined appropriate by the Secretary, in consultation with stakeholders.</text></clause></subparagraph></paragraph>
<paragraph id="H7686A4358F2548778854DFDC6025BDA2">
<enum>(2)</enum>
<header>No deemed compliance</header>
<text>The availability of a price estimator tool shall not be considered to deem compliance with or otherwise vitiate the requirements of paragraph (1)(A)(ii) or any other requirements of this section. Furthermore, the use of an estimator tool shall not be used for purposes of compliance with any provisions in this section.</text>
</paragraph>
<paragraph id="H4C91E961EAD84FC3BA190E47802C5ABB"><enum>(3)</enum><header>Monitoring compliance</header><text>The Secretary shall, in consultation with the Inspector General of the Department of Health and Human Services, establish a process to monitor compliance with this subsection. Such process shall ensure that each hospital’s compliance with this subsection is reviewed not less frequently than once every year.</text></paragraph> <paragraph id="H3C49C92992434559A09510421F4D11BC"><enum>(4)</enum><header>Attestation</header><text>A senior official from each hospital (the Chief Executive Officer, Chief Financial Officer, or an official of equivalent seniority) shall attest to the accuracy and completeness of the disclosures made in accordance with the hospital price transparency requirements set forth in this regulation. Such attestation shall be deemed to be material to payment from the Federal Government to the hospital.</text></paragraph>
<paragraph id="HABD27159EED54F4581DE450581A57083"><enum>(5)</enum><header>Enforcement</header>
<subparagraph id="H742A4C835A9F4DB486CEBC43F87005FC"><enum>(A)</enum><header>In general</header><text>In the case of a hospital that fails to comply with the requirements of this subsection, not later than 30 days after the date on which the Secretary determines such failure exists, the Secretary shall submit to such hospital a notification of such determination, which shall include a request for a corrective action plan to comply with such requirements.</text></subparagraph> <subparagraph id="H6F1966E65F2043F6982BC1328A607CE0"><enum>(B)</enum><header>Civil monetary penalty</header> <clause id="H73107474789748799BFE1D6B4D8075D8"><enum>(i)</enum><header>In general</header><text>In addition to any other enforcement actions or penalties that may apply under another provision of law, a hospital that has received a request for a corrective action plan under subparagraph (A) and fails to comply with the requirements of this subsection by the date that is 45 days after such request is made shall be subject to a civil monetary penalty of an amount specified by the Secretary for each day (beginning with the day on which the Secretary first determined that such hospital was not complying with such requirements) during which such failure was ongoing. Such amount shall not exceed—</text>
<subclause id="H0374ECD723264F3AB13DF1542EE59B7D"><enum>(I)</enum><text>in the case of a hospital with 30 or fewer beds, $300 per day;</text></subclause> <subclause id="H3D4157FC3EE741A4BD3311756BCCED12"><enum>(II)</enum><text>in the case of a hospital with more than 30 beds but fewer than 101 beds, $12.50 per bed per day (or, in the case of such a hospital that has been noncompliant with such requirements for a 1-year period or longer, beginning with the first day following such 1-year period, $15 per bed per day);</text></subclause>
<subclause id="H9237527D85F742598C02D71F72305ED0"><enum>(III)</enum><text>in the case of a hospital with more than 100 beds but fewer than 301 beds, $17.50 per bed per day (or, in the case of such a hospital that has been noncompliant with such requirements for a 1-year period or longer, beginning with the first day following such 1-year period, $20 per bed per day);</text></subclause> <subclause id="HB8896BB3C73B4BC3953D638A1DABABCF"><enum>(IV)</enum><text>in the case of a hospital with more than 300 beds but fewer than 501 beds, $20 per bed per day (or, in the case of such a hospital that has been noncompliant with such requirements for a 1-year period or longer, beginning with the first day following such 1-year period, $25 per bed per day); and</text></subclause>
<subclause id="HEB0611C07C0A426C8A765B61D480876F"><enum>(V)</enum><text>in the case of a hospital with more than 500 beds, $25 per bed per day (or, in the case of such a hospital that has been noncompliant with such requirements for a 1-year period or longer, beginning with the first day following such 1-year period, $35 per bed per day).</text></subclause></clause> <clause id="HD43017AD68B64C22B113FBDADD034A7A"><enum>(ii)</enum><header>Increase authority</header><text>In applying this subparagraph with respect to violations occurring in 2028 or a subsequent year, the Secretary may through notice and comment rulemaking increase—</text>
<subclause id="HD1956FD234CC40BD8FCC338BAE579970"><enum>(I)</enum><text>the limitation on the per day amount of any penalty applicable to a hospital under clause (i)(I);</text></subclause> <subclause id="H0BD57259E55F4377A1757479199E7842"><enum>(II)</enum><text>the limitations on the per bed per day amount of any penalty applicable under any of subclauses (II) through (V) of clause (i); and</text></subclause>
<subclause id="H1301A0B248BB45B4AB3E42971CF8A0DA"><enum>(III)</enum><text>the limitation on the increase of any penalty applied under clause (iii) pursuant to the amounts specified in subclause (II) of such clause.</text></subclause></clause> <clause id="H53A2CAE609AB4ACEBA994114F5C80432"><enum>(iii)</enum><header>Persistent noncompliance</header> <subclause id="H2253B41258DE4A08AEFDECDAFD440D9C"><enum>(I)</enum><header>In general</header><text>In the case of a hospital that the Secretary has determined to be knowingly and willfully noncompliant with the provisions of this subsection two or more times during a 1-year period, the Secretary may increase any penalty otherwise applicable under this subparagraph by the amount specified in subclause (II) with respect to such hospital and may require such hospital to complete such additional corrective actions plans as the Secretary may specify.</text></subclause>
<subclause id="HBCE10B90545C43E190D9382C6E2F1BCB"><enum>(II)</enum><header>Specified amount</header><text>For purposes of subclause (I), the amount specified in this subclause is, with respect to a hospital—</text> <item id="HAB72EADB9AC1410FA6EFFC6C325D7080"><enum>(aa)</enum><text>with more than 30 beds but fewer than 101 beds, an amount that is not less than $500,000 and not more than $1,000,000;</text></item>
<item id="H38351B3FA80C4667B478DC3D837897C2"><enum>(bb)</enum><text>with more than 100 beds but fewer than 301 beds, an amount that is greater than $1,000,000 and not more than $2,000,000;</text></item> <item id="H507715DF9A0C4D84B28E2D17C7D7FBF1"><enum>(cc)</enum><text>with more than 300 beds but fewer than 501 beds, an amount that is greater than $2,000,000 and not more than $4,000,000; and</text></item>
<item id="HCF3D0DF9804346D4B6B0EE0A6D248AD3">
<enum>(dd)</enum>
<text>with more than 500 beds, an amount that is not less than $5,000,000 and not more than $10,000,000.</text>
</item></subclause></clause>
<clause id="HB312E8447C1A41F58B17C6E406E8239C"><enum>(iv)</enum><header>Provision of technical assistance</header><text>The Secretary may, to the extent practicable, provide technical assistance relating to compliance with the provisions of this section to hospitals requesting such assistance.</text></clause> <clause id="H7DB962D872B645FE964D3F27D5B42DAA"><enum>(v)</enum><header>Application of certain provisions</header><text>The provisions of section 1128A (other than subsections (a) and (b) of such section) shall apply to a civil monetary penalty imposed under this subparagraph in the same manner as such provisions apply to a civil monetary penalty imposed under subsection (a) of such section.</text></clause></subparagraph>
<subparagraph id="HFA05D016FEFD40CA88E906A60F781C43"><enum>(C)</enum><header>No waiver</header><text>The Secretary shall not grant or extend any waiver, delay, tolling, or other mitigation of a civil monetary penalty for violation of this subsection.</text></subparagraph></paragraph> <paragraph id="HB0BE33A2B3274E24BDDFBA858B5B5F56"><enum>(6)</enum><header>Definitions</header><text>For purposes of this subsection:</text>
<subparagraph id="H8665C63F8EDB4E2D8D006470AEE0D444"><enum>(A)</enum><header>Discounted cash price</header><text>The term <term>discounted cash price</term> means the minimum charge, exclusive of any hospital or third-party payer assistance, that the hospital accepts from an individual who pays cash, or cash equivalent, for a hospital-furnished item or service, without regard to patient coverage, as payment in full.</text></subparagraph> <subparagraph id="H921C699F5597484DA06A5E605FA8F6F6"><enum>(B)</enum><header>Gross charge</header><text>The term <term>gross charge</term> means the charge for an individual item or service that is reflected on a hospital’s chargemaster, absent any discounts.</text></subparagraph>
<subparagraph id="H84C42B3422AE44E7B91B2003546E887D"><enum>(C)</enum><header>Hospital</header><text>The term <term>hospital</term> means a hospital (as defined in section 1861(e) of the Social Security Act), a critical access hospital (as defined in section 1861(mmm)(1) of the Social Security Act), or a rural emergency hospital (as defined in section 1861(kkk) of the Social Security Act), together with any parent, subsidiary, or other affiliated provider or supplier of health care items and services without regard to whether such parent, subsidiary, or other affiliated provider or supplier operates under separate licensure, certification, or designation.</text></subparagraph> <subparagraph id="HE7B3455FB5064B838F83BAC1B2DE2115"><enum>(D)</enum><header>Payer-specific negotiated charge</header><text>The term <term>payer-specific negotiated charge</term> means the charge that a hospital has negotiated with a third party payer for an item or service.</text></subparagraph>
<subparagraph id="HC09BBE47EBA74637A651C4FD2F7D223C"><enum>(E)</enum><header>Shoppable service</header><text>The term <term>shoppable service</term> means a service that can be scheduled by a health care consumer in advance and includes all ancillary items and services customarily furnished as part of such service.</text></subparagraph> <subparagraph id="HF2C33B36BA5C49DEB2CB63B82DE795DA"><enum>(F)</enum><header>Third party payer</header><text>The term <term>third party payer</term> means an entity that is, by statute, contract, or agreement, legally responsible for payment of a claim for a health care item or service.</text></subparagraph></paragraph>
<paragraph id="H89F2C737B26940C4948C733F2F4CB934"><enum>(7)</enum><header>Rulemaking</header><text>The Secretary shall implement this subsection through notice and comment rulemaking in accordance with section 553 of title 5, United States Code.</text></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></subsection> <subsection id="H90E88947D9954B1184E701566B83F030"><enum>(b)</enum><header>Effective date</header> <paragraph id="H0F4817EB6E9F4F4BAAAE768819CF73CC"><enum>(1)</enum><header>In general</header><text>The amendment made by subsection (a) shall apply beginning January 1, 2027.</text></paragraph>
<paragraph id="H45AD84C4EC364150B64BF3BB616E2A82"><enum>(2)</enum><header>Continued applicability of rules for previous years</header><text>Nothing in the amendment made by this section may be construed as affecting the applicability of the regulations codified at part 180 of title 45, Code of Federal Regulations, before January 1, 2026.</text></paragraph></subsection> <subsection id="H54A0C4D0C0D94D189E21C28C07D9FF16"><enum>(c)</enum><header>Continued applicability of state law</header><text>The provisions of this Act shall not supersede any provision of State law that establishes, implements, or continues in effect any requirement or prohibition related to health care price transparency, except to the extent that such requirement or prohibition prevents the application of a requirement or prohibition of this Act.</text></subsection></section>
<section id="HEBCC3B399D67414DBDEA386C8E1F362A"><enum>303.</enum><header>Increasing price transparency of clinical diagnostic laboratory tests</header><text display-inline="no-display-inline">Section 2718 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300gg-18">42 U.S.C. 300gg–18</external-xref>) is amended by adding at the end the following:</text> <quoted-block style="OLC" display-inline="no-display-inline" id="HC925ADA8B92F4D04BCBD108F1305ABC1"> <subsection commented="no" display-inline="no-display-inline" id="H4498389B90E14EF89A4DF2B89A2ED1EA"><enum>(f)</enum><header>Clinical diagnostic laboratory price transparency</header> <paragraph id="H27E2BCE619844BA9A464CBCBF9BE9613"><enum>(1)</enum><header>In general</header><text>Beginning July 1, 2028, an applicable laboratory shall—</text>
<subparagraph id="HEE66374E0F904439B16CDE2A4A4E2B85"><enum>(A)</enum><text>make publicly available on an internet website the information described in paragraph (2) with respect to each such specified clinical diagnostic laboratory test that such laboratory so furnishes; and</text></subparagraph> <subparagraph id="H4A72101942724DB6931CBE0E7A9DBE36"><enum>(B)</enum><text>ensure that such information is updated not less frequently than monthly, if there have been any changes to such information.</text></subparagraph></paragraph>
<paragraph id="H3A8B683F3B8448D8B6D875D5E26CC504"><enum>(2)</enum><header>Information described</header><text>For purposes of paragraph (1), the information described in this paragraph is, with respect to an applicable laboratory and a specified clinical diagnostic laboratory test, the following:</text> <subparagraph id="H9BBDBB3871764063837310F9BC9E7AAB"><enum>(A)</enum><text>A plain language description of each item or service, accompanied by any applicable billing codes, including modifiers, using commonly recognized billing code sets, including the Current Procedural Terminology code, the Healthcare Common Procedure Coding System code, the diagnosis-related group, the National Drug Code, and other nationally recognized identifier.</text></subparagraph>
<subparagraph id="H39C9F899FB5E47F28DD12F490734D812"><enum>(B)</enum><text>The gross charge expressed as a dollar amount, for each such item or service.</text></subparagraph> <subparagraph id="H5A981239C1F04E0EB75B3A8AD59D6584"><enum>(C)</enum><text>The discounted cash price expressed as a dollar amount, for each such item or service (or, in the case no discounted cash price is available for an item or service, the minimum cash price accepted by the laboratory from self-pay individuals for such item or service when provided in such settings for the previous three years, expressed as a dollar amount, as well as, with respect to prices made public pursuant to subparagraph (A)(ii), a link to a consumer-friendly document that clearly explains the laboratory’s charity care policy). The laboratory shall accept the discounted or minimum cash price as payment in full from any patient that chooses to pay in cash without regard to the patient’s coverage.</text></subparagraph>
<subparagraph id="HCE85894F97AE463CA66D7681623AF10B"><enum>(D)</enum><text>The payer-specific negotiated charges, expressed as a dollar amount and clearly associated with the name of the applicable third party payer and name of each plan, that apply to each such item or service when provided in, as applicable, the inpatient setting and outpatient department setting. If the charges are based on an algorithm, percentage of another amount, or other formula or criteria, the clinical diagnostic laboratory also shall disclose such algorithm, percentage, formula, or criteria as set forth in its contract and any other terms, schedules, exhibits, data, or other information referenced in any such contract as shall be required to determine and disclose the negotiated charge.</text></subparagraph> <subparagraph id="HCA930484E6284760AC96D694BDEEC86D"><enum>(E)</enum><text>The de-identified maximum and minimum negotiated charges for each such item or service, expressed as a non-zero dollar amount.</text></subparagraph>
<subparagraph id="HAB6085CACBF94C9D8B37B930352BBD4D"><enum>(F)</enum><text>Any other additional information the Secretary may require for the purpose of improving the accuracy of, or enabling consumers to easily understand and compare, standard charges and prices for an item or service, except information that is duplicative of any other reporting requirement under this subsection. In the case of standard charges and prices for an item or service included as part of a bundled, per diem, episodic, or other similar arrangement, the information described in this subparagraph shall be made available as determined appropriate by the Secretary.</text></subparagraph></paragraph> <paragraph id="H1A87983F05D1414C9839D7A9DC886B8C"><enum>(3)</enum><header>Uniform method and format</header><text>Not later than January 1, 2028, the Secretary shall establish a standard, uniform method and format for applicable laboratories to use in compiling and making public information pursuant to paragraph (1). Such method and format shall—</text>
<subparagraph id="HE7CD257EE2BD4BEA8027D4F241A15161"><enum>(A)</enum><text>include a machine-readable spreadsheet format containing the information described in paragraph (2) for all items and services furnished by each laboratory;</text></subparagraph> <subparagraph id="HB35A013E7E8847CD9A7E2132B0D946A6"><enum>(B)</enum><text>meet such standards as determined appropriate by the Secretary in order to ensure the accessibility and usability of such information; and</text></subparagraph>
<subparagraph id="HCA477CCA968145568B62C9ED103A643B"><enum>(C)</enum><text>be updated as determined appropriate by the Secretary, in consultation with stakeholders.</text></subparagraph></paragraph> <paragraph id="HCC2510BDBD9340EDBF134332EF9C72A4"><enum>(4)</enum><header>Inclusion of ancillary services</header><text>Any price or rate for a specified clinical diagnostic laboratory test available to be furnished by an applicable laboratory made publicly available in accordance with paragraph (1) shall include the price or rate for any ancillary item or service (including specimen collection services, specimen transport, centrifugation, aliquoting, labeling, requisition processing, and standard result reporting services) that would customarily and routinely be furnished by such laboratory as part of such test, as specified by the Secretary.</text></paragraph>
<paragraph id="H44AA39E9279046C8BDD52C3796AAB6EB"><enum>(5)</enum><header>Enforcement</header>
<subparagraph id="HA24A5514ECCB40369D792D998112138A"><enum>(A)</enum><header>In general</header><text>In the case that the Secretary determines that an applicable laboratory is not in compliance with paragraph (1)—</text> <clause id="H9A221BEC39E5416B9579538B90190A62"><enum>(i)</enum><text>not later than 30 days after such determination, the Secretary shall notify such laboratory of such determination; and</text></clause>
<clause id="H20C6D9F45EDD47BA962F938ECF1217C6"><enum>(ii)</enum><text>if such laboratory continues to fail to comply with such paragraph after the date that is 90 days after such notification is sent, the Secretary may impose a civil monetary penalty in an amount not to exceed $300 for each day (beginning with the day on which the Secretary first determined that such laboratory was failing to comply with such paragraph) during which such failure is ongoing.</text></clause></subparagraph> <subparagraph id="HCBBC93CFB2904774A24A67D64D96B454"><enum>(B)</enum><header>Increase authority</header><text>In applying this paragraph with respect to violations occurring in 2029 or a subsequent year, the Secretary may through notice and comment rulemaking increase the per day limitation on civil monetary penalties under subparagraph (A)(ii).</text></subparagraph>
<subparagraph id="HFA2824DA8A39420CBBFD2780D4834419"><enum>(C)</enum><header>Application of certain provisions</header><text>The provisions of section 1128A of the Social Security Act (other than subsections (a) and (b) of such section) shall apply to a civil monetary penalty imposed under this paragraph in the same manner as such provisions apply to a civil monetary penalty imposed under subsection (a) of such section.</text></subparagraph></paragraph> <paragraph id="H5692D3D396C04A7D85B48F3FCC4E02FC"><enum>(6)</enum><header>Provision of technical assistance</header><text>The Secretary shall, to the extent practicable, provide technical assistance relating to compliance with the provisions of this subsection to applicable laboratories requesting such assistance.</text></paragraph>
<paragraph id="HD24D9BF1DF0D4AACBAF018D124B0586E"><enum>(7)</enum><header>Definitions</header><text>In this subsection:</text> <subparagraph id="H9F378D6A0B2842B6AAFCA86456D053F2"><enum>(A)</enum><header>Applicable laboratory</header><text>The term <term>applicable laboratory</term> means a <term>laboratory</term> as such term is defined in section 493.2, of title 42, Code of Federal Regulations (or a successor regulation), except that such term does not include a laboratory with respect to which standard charges and prices for specified clinical diagnostic laboratory tests furnished by such laboratory are made available by a hospital pursuant to subsection (e) of this section.</text></subparagraph>
<subparagraph id="H4A40804543B54854975BE2B64B4B49D5"><enum>(B)</enum><header>Discounted cash price</header><text>The term <term>discounted cash price</term> means the charge that applies to an individual who pays cash, or cash equivalent, for an item or service.</text></subparagraph> <subparagraph id="H1FA80B7E2593424BA41FDBBB66540742"><enum>(C)</enum><header>Gross charge</header><text>The term <term>gross charge</term> means the charge for an individual item or service that is reflected on an applicable laboratory’s chargemaster, absent any discounts.</text></subparagraph>
<subparagraph id="H07949E34604240B59B079FFCFFFC54BD"><enum>(D)</enum><header>Payer-specific negotiated charge</header><text>The term <term>payer-specific negotiated charge</term> means the charge that an applicable laboratory has negotiated with a third party payer for an item or service.</text></subparagraph> <subparagraph id="HDE401331567C4A48ADE6EA7E4FF289EF"><enum>(E)</enum><header>Specified clinical diagnostic laboratory test</header><text>The term <term>specified clinical diagnostic laboratory test</term> means a clinical diagnostic laboratory test that is included on the list of shoppable services specified by the Centers for Medicare & Medicaid Services (as described in subsection (e) of this section), other than such a test that is only available to be furnished by a single provider of services or supplier.</text></subparagraph>
<subparagraph id="HFC5ABD0AA8A247379A6F7DBE77CA33CC"><enum>(F)</enum><header>Third party payer</header><text>The term <term>third party payer</term> means an entity that is, by statute, contract, or agreement, legally responsible for payment of a claim for a health care item or service.</text></subparagraph></paragraph> <paragraph id="H95D3A08A9E0B4310941269A3F8034279"><enum>(8)</enum><header>Rulemaking</header><text>The Secretary shall implement this subsection through notice and comment rulemaking in accordance with section 553 of title 5, United States Code.</text></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></section>
<section id="HDCBAF1726D10486EB5FACBC53823C597"><enum>304.</enum><header>Imaging transparency</header><text display-inline="no-display-inline">Section 2718 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300gg-18">42 U.S.C. 300gg–18</external-xref>), as amended by section 303, is further amended by adding at the end the following:</text> <quoted-block style="OLC" display-inline="no-display-inline" id="H69673486035740358699263AB5696959"> <subsection commented="no" display-inline="no-display-inline" id="H29BB0509024E4FC5B9EEF9ABB814EDA8"><enum>(g)</enum><header>Imaging services price transparency</header> <paragraph id="HBC7DBC56542141AD8EEEE4ED2DBAEE4B"><enum>(1)</enum><header>In general</header><text>Beginning July 1, 2028, each provider of services or supplier that furnishes a specified imaging service, other than such a provider or supplier with respect to which standard charges and prices for such services furnished by such provider or supplier are made available by a hospital pursuant to subsection (e), shall—</text>
<subparagraph id="H4D952D82805649FFA1FEB087FA4F2F17"><enum>(A)</enum><text>make publicly available (in accordance with paragraph (3)) on an internet website the information described in paragraph (2) with respect to each such service that such provider of services or supplier furnishes; and</text></subparagraph> <subparagraph id="H117DFF51D38E4E2E9E845E2C9456D09B"><enum>(B)</enum><text>ensure that such information is updated not less frequently than annually.</text></subparagraph></paragraph>
<paragraph id="HF9319FDC89BC4998AB408565674797A3"><enum>(2)</enum><header>Information described</header><text>For purposes of paragraph (1), the information described in this paragraph is, with respect to a provider of services or supplier and a specified imaging service, the following:</text> <subparagraph id="H7C18FC40DA09478EAB700009C8CC0662"> <enum>(A)</enum> <text>A plain language description of each item or service, accompanied by any applicable billing codes, including modifiers, using commonly recognized billing code sets, including the Current Procedural Terminology code, the Healthcare Common Procedure Coding System code, the diagnosis-related group, the National Drug Code, and other nationally recognized identifiers.</text>
</subparagraph>
<subparagraph id="H6D25D279168747E58869D5D42DCB2606"><enum>(B)</enum><text>The gross charge expressed as a dollar amount, for each such item or service.</text></subparagraph> <subparagraph id="H72F317D89492427D821EDCAED08CADDE"><enum>(C)</enum><text>The discounted cash price expressed as a dollar amount, for each such item or service (or, in the case no discounted cash price is available for an item or service, the minimum cash price accepted by the provider of services or supplier from self-pay individuals for such item or service when provided in such settings for the previous three years, expressed as a dollar amount, as well as, with respect to prices made public pursuant to subparagraph (A)(ii), a link to a consumer-friendly document that clearly explains the provider of services or supplier’s charity care policy). The provider of services or supplier shall accept the discounted or minimum cash price as payment in full from any patient that chooses to pay in cash without regard to the patient’s coverage.</text></subparagraph>
<subparagraph id="HBBC4B16FA8D5446FA104BF7ACF7D4094"><enum>(D)</enum><text>The payer-specific negotiated charges, expressed as a dollar amount and clearly associated with the name of the applicable third party payer and name of each plan, that apply to each such item or service when provided in, as applicable, the inpatient setting and outpatient department setting. If the charges are based on an algorithm, percentage of another amount, or other formula or criteria, the provider or supplier also shall disclose such algorithm, percentage, formula, or criteria as set forth in its contract and any other terms, schedules, exhibits, data, or other information referenced in any such contract as shall be required to determine and disclose the negotiated charge.</text></subparagraph> <subparagraph id="H612A86FAC9434ED4841C329360218D92"><enum>(E)</enum><text>The de-identified maximum and minimum negotiated charges for each such item or service, expressed as a non-zero dollar amount.</text></subparagraph>
<subparagraph id="H32A64D34178846DD85DF136E5B297673"><enum>(F)</enum><text>Any other additional information the Secretary may require for the purpose of improving the accuracy of, or enabling consumers to easily understand and compare, standard charges and prices for an item or service, except information that is duplicative of any other reporting requirement under this subsection. In the case of standard charges and prices for an item or service included as part of a bundled, per diem, episodic, or other similar arrangement, the information described in this subparagraph shall be made available as determined appropriate by the Secretary.</text></subparagraph></paragraph> <paragraph id="HF4980E70C16748D39685690891E86747"><enum>(3)</enum><header>Uniform method and format</header><text>Not later than January 1, 2028, the Secretary shall establish a standard, uniform method and format for providers of services and suppliers to use in making public information described in paragraph (2). Any such method and format shall—</text>
<subparagraph id="H23B1130453D24DB98B86CA91B429A97D"><enum>(A)</enum><text>include a machine-readable spreadsheet format containing the information described in paragraph (2) for all items and services furnished by each provider of services and supplier described in paragraph (1);</text></subparagraph> <subparagraph id="HD9F7955201B84237BFFF07B3DB41E2E9"><enum>(B)</enum><text>meet such standards as determined appropriate by the Secretary in order to ensure the accessibility and usability of such information; and</text></subparagraph>
<subparagraph id="H2DD7FBB1A2B944E4A187F973938DEFBC"><enum>(C)</enum><text>be updated as determined appropriate by the Secretary, in consultation with stakeholders.</text></subparagraph></paragraph> <paragraph id="H4E27FFC62B5F49AC8038134997763AD8"><enum>(4)</enum><header>Monitoring compliance</header><text>The Secretary shall, through notice and comment rulemaking and in consultation with the Inspector General of the Department of Health and Human Services, establish a process to monitor compliance with this subsection.</text></paragraph>
<paragraph id="H07A753839F6A4272ACE6AEC7EB4CB122"><enum>(5)</enum><header>Enforcement</header>
<subparagraph id="H788B603DEAA1445EAF3DA45CED2C8C52"><enum>(A)</enum><header>In general</header><text>In the case that the Secretary determines that a provider of services or supplier is not in compliance with paragraph (1)—</text> <clause id="H772AA96030DF4690939023CE4D387F87"><enum>(i)</enum><text>not later than 30 days after such determination, the Secretary shall notify such provider or supplier of such determination;</text></clause>
<clause id="H01425D5A51E4468F80554910219420A7"><enum>(ii)</enum><text>upon request of the Secretary, such provider or supplier shall submit to the Secretary, not later than 45 days after the date of such request, a corrective action plan to comply with such paragraph; and</text></clause> <clause id="HFB08F30C39D24EC898B3F8D618DD55A5"><enum>(iii)</enum><text>if such provider or supplier continues to fail to comply with such paragraph after the date that is 90 days after such notification is sent (or, in the case of such a provider or supplier that has submitted a corrective action plan described in clause (ii) in response to a request so described, after the date that is 90 days after such submission), the Secretary may impose a civil monetary penalty in an amount not to exceed $300 for each day (beginning with the day on which the Secretary first determined that such provider or supplier was failing to comply with such paragraph) during which such failure to comply or failure to submit is ongoing.</text></clause></subparagraph>
<subparagraph id="H016B0943DF32456E96BE0780DFD4B962"><enum>(B)</enum><header>Increase authority</header><text>In applying this paragraph with respect to violations occurring in 2028 or a subsequent year, the Secretary may through notice and comment rulemaking increase the amount of the civil monetary penalty under subparagraph (A)(iii).</text></subparagraph> <subparagraph id="HD5B77D9D63A64C4CB8D99B0C5EAC7CFF"><enum>(C)</enum><header>Application of certain provisions</header><text>The provisions of section 1128A of the Social Security Act (other than subsections (a) and (b) of such section) shall apply to a civil monetary penalty imposed under this paragraph in the same manner as such provisions apply to a civil monetary penalty imposed under subsection (a) of such section.</text></subparagraph>
<subparagraph id="HC4DF4294DC2C4E4185519FB158EB0DA9"><enum>(D)</enum><header>No authority to waive or reduce penalty</header><text>The Secretary shall not grant or extend any waiver, delay, tolling, or other mitigation of a civil monetary penalty for violation of this subsection.</text></subparagraph> <subparagraph id="H31DE7FB3B6574A54A6302178B5372D04"><enum>(E)</enum><header>Provision of technical assistance</header><text>The Secretary shall, to the extent practicable, provide technical assistance relating to compliance with the provisions of this subsection to providers of services and suppliers requesting such assistance.</text></subparagraph>
<subparagraph id="H4B49639BEF6543B39060C78ACE4EEB3F"><enum>(F)</enum><header>Clarification of nonapplicability of other enforcement provisions</header><text>Notwithstanding any other provision of this title, this paragraph shall be the sole means of enforcing the provisions of this subsection.</text></subparagraph></paragraph> <paragraph id="HFDF97704BC1940359944C1D9BFEB7D41"> <enum>(6)</enum> <header>Specified imaging service defined</header> <text>The term <term>specified imaging service</term> means an imaging service that is a Centers for Medicare & Medicaid Services-specified shoppable service (as described in subsection (e)).</text>
</paragraph>
<paragraph id="H3EEDF5F555C045958FE70685D3D79613"><enum>(7)</enum><header>Rulemaking</header><text>The Secretary shall implement this subsection through notice and comment rulemaking in accordance with section 553 of title 5, United States Code.</text></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></section> <section id="H7E1F818984EE49A2AD13A997D196BDEF"><enum>305.</enum><header>Ambulatory surgical center price transparency requirements</header><text display-inline="no-display-inline">Section 2718 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300gg-18">42 U.S.C. 300gg–18</external-xref>), as amended by section 304, is further amended by adding at the end the following:</text>
<quoted-block style="OLC" display-inline="no-display-inline" id="HDD1F1ABC18C44CDCAE22880E1C09F0F1">
<subsection commented="no" display-inline="no-display-inline" id="H3AB28121380148C79FBBA666923D6A98"><enum>(h)</enum><header>Ambulatory surgery center transparency</header>
<paragraph id="H6A9EE08AABAF4571A43FC5460833A443"><enum>(1)</enum><header>In general</header><text>Beginning July 1, 2028, each specified ambulatory surgical center shall comply with the price transparency requirement described in paragraph (2).</text></paragraph> <paragraph id="HE8D3A9B9BC064E9B86212196794CFC3B"><enum>(2)</enum><header>Requirement described</header> <subparagraph commented="no" display-inline="no-display-inline" id="H9CD8D89CEDE94231B9AF560E514BDA87"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">A specified ambulatory surgical center, in accordance with a method and format established by the Secretary under subparagraph (C), shall compile and make public (without subscription and free of charge), for each year—</text>
<clause id="H8E17ECC5743E47DBB6BD1DB1C6D7D562"><enum>(i)</enum><text>one or more lists, in a machine-readable format specified by the Secretary, of the ambulatory surgical center’s standard charges (including the information described in subparagraph (B)) for each item and service furnished by such surgical center;</text></clause> <clause id="HEE30592C730C47AB9C3F5F75C55866E0"><enum>(ii)</enum><text>information in a consumer-friendly format (as specified by the Secretary) on the ambulatory surgical center’s prices (including the information described in subparagraph (B)) for as many of the Centers for Medicare & Medicaid Services-specified shoppable services included on the list described in subsection (e) that are furnished by such surgical center, and as many additional ambulatory surgical center-selected shoppable services (or all such additional services, if such surgical center furnishes fewer than 300 shoppable services) as may be necessary for a combined total of at least 300 shoppable services; and</text></clause>
<clause id="H27ACC63424D543188FDC0538045A194F"><enum>(iii)</enum><text>with respect to each Centers for Medicare & Medicaid Services-specified shoppable service (as described in clause (ii)) that is not furnished by the ambulatory surgical center, an indication that such service is not so furnished.</text></clause></subparagraph> <subparagraph id="H70919E2ABBDA4A078D80B1451FD6AF5D"><enum>(B)</enum><header>Information described</header><text>For purposes of subparagraph (A), the information described in this subparagraph is, with respect to standard charges and prices made public by a specified ambulatory surgical center, the following:</text>
<clause id="H125933BDBCAB4DBEBB7B5647DBED764F"><enum>(i)</enum><text>A description of each item or service, accompanied by the Healthcare Common Procedure Coding System code, the national drug code, or other identifier used or approved by the Centers for Medicare & Medicaid Services.</text></clause> <clause id="HA8D81142B99B43F6A0F684D57F7636CC"><enum>(ii)</enum><text>The gross charge, expressed as a dollar amount, for each such item or service.</text></clause>
<clause id="HCE312218ADEE47A4801783BDF291F125"><enum>(iii)</enum><text>The discounted cash price, expressed as a dollar amount, for each such item or service (or, in the case no discounted cash price is available for an item or service, the minimum cash price accepted by the specified ambulatory surgical center from self-pay individuals for such item or service when provided in such settings for the previous three years, expressed as a dollar amount, as well as, with respect to prices made public pursuant to subparagraph (A)(ii), a link to a consumer-friendly document that clearly explains the provider of services or supplier’s charity care policy). The specified ambulatory surgical center shall accept the discounted cash price as payment in full from any patient that chooses to pay in cash without regard to the patient’s coverage.</text></clause> <clause id="H73EFA7632FDB40C3B4F86A3B8C44537D"><enum>(iv)</enum><text>The payer-specific negotiated charges, expressed as a dollar amount and clearly associated with the name of the applicable third party payer and name of each plan, that apply to each such item or service when provided in, as applicable, the inpatient setting and outpatient department setting. If the charges are based on an algorithm, percentage of another amount, or other formula or criteria, the ambulatory surgical center also shall disclose such algorithm, percentage, formula, or criteria as set forth in its contract and any other terms, schedules, exhibits, data, or other information referenced in any such contract as shall be required to determine and disclose the negotiated charge.</text></clause>
<clause id="HD72E05100C4040CFAF284347C736E017"><enum>(v)</enum><text>The de-identified maximum and minimum negotiated charges for each such item or service, expressed as a non-zero dollar amount.</text></clause> <clause id="H263E71F4E04C4E85A1C0C9F9B2EE98DF"><enum>(vi)</enum><text>Any other additional information the Secretary may require for the purpose of improving the accuracy of, or enabling consumers to easily understand and compare, standard charges and prices for an item or service, except information that is duplicative of any other reporting requirement under this subsection.</text></clause></subparagraph>
<subparagraph id="H7048ED806BBB442BAB187799A41D1000"><enum>(C)</enum><header>Uniform method and format</header><text>Not later than January 1, 2028, the Secretary shall establish a standard, uniform method and format for specified ambulatory surgical centers to use in making public standard charges pursuant to subparagraph (A)(i) and a standard, uniform method and format for such centers to use in making public prices pursuant to subparagraph (A)(ii). Any such method and format shall—</text> <clause id="HEBA05CA3772447F0882DBBBD94FD10B9"><enum>(i)</enum><text>in the case of such charges made public by an ambulatory surgical center, ensure that such charges are made available in a machine-readable format;</text></clause>
<clause id="H4D409A60E8364E01BE9533B92E8A91F1"><enum>(ii)</enum><text>meet such standards as determined appropriate by the Secretary in order to ensure the accessibility and usability of such charges and prices; and</text></clause> <clause id="H283D312D35F24D99BDFA96454CA73D7D"><enum>(iii)</enum><text>be updated as determined appropriate by the Secretary, in consultation with stakeholders.</text></clause></subparagraph></paragraph>
<paragraph id="H3D1D121684954A29B73048627C11F76D"><enum>(3)</enum><header>No deemed compliance</header><text>The availability of a price estimator tool shall not be considered to deem compliance with or otherwise vitiate the requirements of this subsection (aa). Furthermore, the use of an estimator tool shall not be used for purposes of compliance with any provisions in this subsection.</text></paragraph> <paragraph id="HF281C01F2B944ED58A361273CA419BD4"><enum>(4)</enum><header>Monitoring compliance</header><text>The Secretary shall, in consultation with the Inspector General of the Department of Health and Human Services, establish a process to monitor compliance with this subsection. Such process shall ensure that each specified ambulatory surgical center’s compliance with this subsection is reviewed not less frequently than once every year.</text></paragraph>
<paragraph id="HBCB3149ED0724355B45EFF453EDD5C7D"><enum>(5)</enum><header>Enforcement</header>
<subparagraph id="H8E5BD907F0074FD3B6A67358444F6E4F"><enum>(A)</enum><header>In general</header><text>In the case of a specified ambulatory surgical center that fails to comply with the requirements of this subsection—</text> <clause id="H81AEB44C70EB42F3B76D7CDCAA062D4B"><enum>(i)</enum><text>the Secretary shall notify such ambulatory surgical center of such failure not later than 30 days after the date on which the Secretary determines such failure exists; and</text></clause>
<clause id="H3C84F04D18244EC5A24163183DD1E197"><enum>(ii)</enum><text>upon request of the Secretary, the ambulatory surgical center shall submit to the Secretary, not later than 45 days after the date of such request, a corrective action plan to comply with such requirements.</text></clause></subparagraph> <subparagraph id="H1E88B56DEE7743ED880FB59BCAF0B84A"><enum>(B)</enum><header>Civil monetary penalty</header> <clause id="H627F373272884FEE833FCD65A92AD9CA"><enum>(i)</enum><header>In general</header><text>A specified ambulatory surgical center that has received a notification under subparagraph (A)(i) and fails to comply with the requirements of this subsection by the date that is 90 days after such notification (or, in the case of an ambulatory surgical center that has submitted a corrective action plan described in subparagraph (A)(ii) in response to a request so described, by the date that is 90 days after such submission) shall be subject to a civil monetary penalty of an amount specified by the Secretary for each day (beginning with the day on which the Secretary first determined that such hospital was not complying with such requirements) during which such failure is ongoing (not to exceed $300 per day).</text></clause>
<clause id="H5F0AD49573BC416790AA1CF797D10342"><enum>(ii)</enum><header>Increase authority</header><text>In applying this subparagraph with respect to violations occurring in 2028 or a subsequent year, the Secretary may through notice and comment rulemaking increase the limitation on the per day amount of any penalty applicable to a specified ambulatory surgical center under clause (i).</text></clause> <clause id="HD1D1435A02894B85925678920FE1E120"><enum>(iii)</enum><header>Application of certain provisions</header><text>The provisions of section 1128A of the Social Security Act (other than subsections (a) and (b) of such section) shall apply to a civil monetary penalty imposed under this subparagraph in the same manner as such provisions apply to a civil monetary penalty imposed under subsection (a) of such section.</text></clause>
<clause id="H4E51F1A05DBF4518BDA8498869F0CCDB"><enum>(iv)</enum><header>No authority to waive or reduce penalty</header><text>The Secretary shall not grant or extend any waiver, delay, tolling, or other mitigation of a civil monetary penalty for violation of this subsection.</text></clause></subparagraph></paragraph> <paragraph id="HC62BBD6E7A574DA1BD055200C75D9442"><enum>(6)</enum><header>Provision of technical assistance</header><text>The Secretary shall, to the extent practicable, provide technical assistance relating to compliance with the provisions of this subsection to specified ambulatory surgical centers requesting such assistance.</text></paragraph>
<paragraph id="HBCEBA19AC91D49F1987943499918478C"><enum>(7)</enum><header>Definitions</header><text>For purposes of this section:</text> <subparagraph id="H1242F3993C04416C9D478F7C1E45ACFE"><enum>(A)</enum><header>Discounted cash price</header><text>The term <term>discounted cash price</term> means the charge that applies to an individual who pays cash, or cash equivalent, for a item or service furnished by an ambulatory surgical center.</text></subparagraph>
<subparagraph id="HAD72BD7CF4984A108B2961D7D481CA86"><enum>(B)</enum><header>Gross charge</header><text>The term <term>gross charge</term> means the charge for an individual item or service that is reflected on a specified surgical center’s chargemaster, absent any discounts.</text></subparagraph> <subparagraph id="H5C69F495881241C8A94E0EC442762743"><enum>(C)</enum><header>Group health plan; group health insurance coverage; individual health insurance coverage</header><text>The terms <term>group health plan</term>, <term>group health insurance coverage</term>, and <term>individual health insurance coverage</term> have the meaning given such terms in section 2791 of the Public Health Service Act.</text></subparagraph>
<subparagraph id="H6D8E66A3D5504ED0926FFDD314749277"><enum>(D)</enum><header>Payer-specific negotiated charge</header><text>The term <term>payer-specific negotiated charge</term> means the charge that a specified surgical center has negotiated with a third party payer for an item or service.</text></subparagraph> <subparagraph id="HF2C46A1D8F2E4837BD51FFBBFA8A4FF3"><enum>(E)</enum><header>Shoppable service</header><text>The term <term>shoppable service</term> means a service that can be scheduled by a health care consumer in advance and includes all ancillary items and services customarily furnished as part of such service.</text></subparagraph>
<subparagraph id="H0681A4B590D84378B6F9CC160446F7A2"><enum>(F)</enum><header>Specified ambulatory surgical center</header><text>The term <term>specified ambulatory surgical center</term> means an ambulatory surgical center with respect to which a hospital (or any person with an ownership or control interest (as defined in section 1124(a)(3) of the Social Security Act) in a hospital) is a person with an ownership or control interest (as so defined).</text></subparagraph> <subparagraph id="H732868A8D8214A6598403C044800AA9A"><enum>(G)</enum><header>Third party payer</header><text>The term <term>third party payer</term> means an entity that is, by statute, contract, or agreement, legally responsible for payment of a claim for a health care item or service.</text></subparagraph></paragraph>
<paragraph id="H7B2F9303444449AC8CBF2DD183417C29"><enum>(8)</enum><header>Rulemaking</header><text>The Secretary shall implement this subsection through notice and comment rulemaking in accordance with section 553 of title 5, United States Code.</text></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></section> <section id="HE9F9D4F2C1014D039FB969324D444BFC"><enum>306.</enum><header>Strengthening health coverage transparency requirements</header> <subsection id="HCD23ACE6ED4F40F3823EDACE4BFB74A6"><enum>(a)</enum><header>Transparency in coverage</header><text>Section 1311(e)(3)(C) of the Patient Protection and Affordable Care Act (<external-xref legal-doc="usc" parsable-cite="usc/42/18031">42 U.S.C. 18031(e)(3)(C)</external-xref>) is amended—</text>
<paragraph id="H9E8A6C87E61545369E247E29FA4D40AD"><enum>(1)</enum><text>by striking <quote>The Exchange</quote> and inserting the following:</text> <quoted-block style="OLC" display-inline="no-display-inline" id="H11C0E3C449274B83AF7188BA0B78CC55"> <clause id="HE03EFBFB00F442DAB9683257C19D6A06"><enum>(i)</enum><header>In general</header><text>The Exchange</text></clause><after-quoted-block>;</after-quoted-block></quoted-block></paragraph>
<paragraph id="HBB37D24EAC9F446D8A0AC5D07E2E0DAD"><enum>(2)</enum><text>in clause (i), as inserted by paragraph (1)—</text> <subparagraph id="HA824A6B65934493E86A3D694B85155B2"><enum>(A)</enum><text>by striking <quote>participating provider</quote> and inserting <quote>provider</quote>;</text></subparagraph>
<subparagraph id="HA0B33BDB950A49AFA842EB99E333D1A2"><enum>(B)</enum><text>by inserting <quote>shall include the information specified in clause (ii) and</quote> after <quote>such information</quote>;</text></subparagraph> <subparagraph id="H9580D3114EA84002ACCD790D53F572AD"><enum>(C)</enum><text>by striking <quote>an Internet website</quote> and inserting <quote>a self-service tool that meets the requirements of clause (iii)</quote>; and</text></subparagraph>
<subparagraph id="H4CC9A8D2BD5D45FE9E7794E49CABF327"><enum>(D)</enum><text>by striking <quote>and such other</quote> and all that follows through the period and inserting <quote>or, at the option such individual, through a paper or phone disclosure (as selected by such individual and provided at no cost to such individual) that meets such requirements as the Secretary may specify.</quote>; and</text></subparagraph></paragraph> <paragraph id="HB61200F8EFA046D792C457E940001ADB"><enum>(3)</enum><text>by adding at the end the following new clauses:</text>
<quoted-block style="OLC" display-inline="no-display-inline" id="H68ABC0F0E56F4621BF3154AC95B3315D">
<clause id="H5059CBC75E724462B0CCE06327D134D8"><enum>(ii)</enum><header>Specified information</header><text>For purposes of clause (i), the information specified in this clause is, with respect to benefits available under a health plan for an item or service furnished by a health care provider, the following:</text> <subclause id="H1320436A85F54532AA8046859EF0EE74"><enum>(I)</enum><text>If such provider is a participating provider with respect to such item or service, the in-network rate (as defined in subparagraph (F)) for such item or service.</text></subclause>
<subclause id="HF11DC67B743049C1B042342851F6591C"><enum>(II)</enum><text>If such provider is not described in subclause (I), the maximum allowed dollar amount for such item or service.</text></subclause> <subclause id="HECC24BA961C94572A9B0079AB291CD15"><enum>(III)</enum><text>The amount of cost sharing (including deductibles, copayments, and coinsurance) that the individual will incur for such item or service (which, in the case such item or service is to be furnished by a provider described in subclause (II), shall be calculated using the maximum amount described in such subclause).</text></subclause>
<subclause id="H73D0006782514B21A6E4D07E80E28C7D">
<enum>(IV)</enum>
<text>The amount the individual has already accumulated with respect to any deductible or out-of-pocket maximum under the plan (broken down, in the case separate deductibles or maximums apply to separate individuals enrolled in the plan, by such separate deductibles or maximums, in addition to any cumulative deductible or maximum).</text>
</subclause>
<subclause id="H41FF4FA91E524374B42F8056EE03D45E"><enum>(V)</enum><text>In the case such plan imposes any frequency or volume limitations with respect to such item or service (excluding medical necessity determinations), the amount that such individual has accrued towards such limitation with respect to such item or service.</text></subclause> <subclause id="HBB413F7E15444D3BBBFD7CAAD2AFB174"><enum>(VI)</enum><text>Any prior authorization, concurrent review, step therapy, fail first, or similar requirements applicable to coverage of such item or service under such plan.</text></subclause></clause>
<clause id="H5C7EB67114B04BD7AFB8E2F0BB82F474"><enum>(iii)</enum><header>Self-service tool</header><text>For purposes of clause (i), a self-service tool established by a health plan meets the requirements of this clause if such tool—</text> <subclause id="HE34F3A76A5AB4F1683401E0CE55B4F71"><enum>(I)</enum><text>is based on an internet website;</text></subclause>
<subclause id="HE325619D67134579A6025F2432A0FB88"><enum>(II)</enum><text>provides for real-time responses to requests described in such clause;</text></subclause> <subclause id="H208DB46159B64615940C378E615B9A23"><enum>(III)</enum><text>is updated in a manner such that information provided through such tool is timely and accurate;</text></subclause>
<subclause id="HC38999F467A348F181031E0F2266979E"><enum>(IV)</enum><text>allows such a request to be made with respect to an item or service furnished by—</text> <item id="HE5DA9DF992C54F8F859C5249CAE37353"><enum>(aa)</enum><text>a specific provider that is a participating provider with respect to such item or service;</text></item>
<item id="H854846316D1147ABB722B55B5784F516"><enum>(bb)</enum><text>all providers that are participating providers with respect to such plan and such item or service; or</text></item> <item id="H82C1EE7C24014A6F8C49F3B0DE94C500"><enum>(cc)</enum><text>a provider that is not described in item (bb);</text></item></subclause>
<subclause id="HB7AD4A0FD15D46D18BD99DBFB04C1E56"><enum>(V)</enum><text>provides that such a request may be made with respect to an item or service through use of—</text> <item commented="no" display-inline="no-display-inline" id="H7D95ECFDDAEB49BDB3D48FD8492118FA"><enum>(aa)</enum><text display-inline="yes-display-inline">the billing code for such item or service; or</text></item>
<item commented="no" display-inline="no-display-inline" id="H7FA5A121DB8E4A5FB32180E1EDA30BC3"><enum>(bb)</enum><text display-inline="yes-display-inline">through use of a descriptive term for such item or service to produce a list of billing code options from which the individual selects to indicate the subject matter items or services; and</text></item></subclause> <subclause id="H30AD4180790D45A8BE24E5F0DF8536BC"><enum>(VI)</enum><text>holds a member harmless for the amount of any difference in excess of the amount of the individual’s responsibility generated by the self-service tool and the amount ultimately billed or charged to the individual.</text></subclause></clause><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection>
<subsection id="H7AC80DD1EAE448EBBE56BDB5C2F3EA09"><enum>(b)</enum><header>Disclosure of additional information</header><text>Section 1311(e)(3) of the Patient Protection and Affordable Care Act (<external-xref legal-doc="usc" parsable-cite="usc/42/18031">42 U.S.C. 18031(e)(3)</external-xref>) is amended by adding at the end the following new subparagraphs:</text> <quoted-block style="OLC" display-inline="no-display-inline" id="H18D86F40ABB74549B38A9DB3A69682CB"> <subparagraph id="H7595E5973CD9426DAE7DCA5279CC3426"><enum>(E)</enum><header>Rate and payment information</header> <clause id="HA8E9604086C6408781ABD48153CC9636"><enum>(i)</enum><header>In general</header><text>Not later than January 1, 2028, and every month thereafter, each health plan shall submit to the Exchange, the Secretary, the State insurance commissioner, and make available to the public, the rate and payment information described in clause (ii) in accordance with clause (iii).</text></clause>
<clause id="HE586BE8808E24098A1461A85A683EB18"><enum>(ii)</enum><header>Rate and payment information described</header><text>For purposes of clause (i), the rate and payment information described in this clause is, with respect to a health plan, the following:</text> <subclause id="HB940574FF45449EA8BE1F3ADAAA218F6"><enum>(I)</enum><text>With respect to each item or service for which benefits are available under such plan (expressed as a dollar amount), including prescription drugs, identified by CPT, HCPCS, DRG, NDC, or other applicable nationally recognized identifier, including any applicable code modifiers, and accompanied by a brief description of the item or service, the in-network rate in effect as of the date of the submission of such information with each provider (identified by national provider identifier) that is a participating provider with respect to such item or service, other than such a rate in effect with a provider—</text>
<item commented="no" display-inline="no-display-inline" id="HA1BC37839AE5411596098202A1A783F6"><enum>(aa)</enum><text display-inline="yes-display-inline">that has submitted no claims; and</text></item> <item commented="no" display-inline="no-display-inline" id="H12D2AD189CD6466F83944B6C6F7CA69A"><enum>(bb)</enum><text display-inline="yes-display-inline">expects to receive no claims in the then applicable calendar year for such item or service to such plan.</text></item></subclause>
<subclause id="HA5A2296113E54CBC91A3973A543821E0"><enum>(II)</enum><text>With respect to each drug (identified by National Drug Code, J-code, or other commonly recognized billing code used for drugs) for which benefits are available under such plan:</text> <item commented="no" display-inline="no-display-inline" id="H81D2432A1BC44681927EE905B26E8BBC"><enum>(aa)</enum><text display-inline="yes-display-inline">The in-network rate (expressed as a dollar amount), including the individual and total amounts for any bundled rates, in effect as of the first day of the month in which such information is made public with each provider that is a participating provider with respect to such drug.</text></item>
<item id="H725EC088C4E44063B9D4DE0F82F28F21"><enum>(bb)</enum><text>The historical net price paid by such plan (net of rebates, discounts, and price concessions) (expressed as a dollar amount) for such drug dispensed or administered during the 90-day period beginning 180 days before such date of submission to each provider that was a participating provider with respect to such drug, broken down by each such provider (identified by national provider identifier), other than such an amount paid to a provider that has submitted no claims for such drug to such plan.</text></item></subclause> <subclause id="HD1972184C49E4D7F83306A0A33908547"><enum>(III)</enum><text>With respect to each item or service for which benefits are available under such plan (expressed as a dollar amount), identified by CPT, DRG, HCPCS, NDC, or other applicable nationally recognized identifier, including any applicable code modifiers, and accompanied by a brief description of the item or service, the amount billed or charged by the provider, and the amount allowed by the plan, for each such item or service furnished during the 90-day period beginning 180 days before such date of submission by each provider that was not a participating provider with respect to such item or service, broken down by each such provider (identified by national provider identifier), other than items and services with respect to which no claims for such item or service were submitted to such plan during such period.</text></subclause></clause>
<clause id="H5BD561C8C7F34FE887BAC7BD0CDA182F"><enum>(iii)</enum><header>Manner of submission</header><text>Rate and payment information required to be submitted and made available under this subparagraph shall be so submitted and so made available as follows:</text> <subclause id="HF2BEE89FB30B4A82B591D71D761A9AA9"><enum>(I)</enum><text>Information shall be contained in 3 separate machine-readable files corresponding to the information described in each of subclauses (I) through (III) of clause (ii) that meet such requirements as specified by the Secretary through rulemaking, in consultation with the Secretaries of Labor and the Treasury to apply comparable requirements to group health plans and to entities providing benefit management or other third-party administration services on a contractual basis with a group health plan.</text></subclause>
<subclause id="H2E24C3A1F8B341CFA3EEE25446114F5B"><enum>(II)</enum><text>Requirements specified by the Secretary through rulemaking shall ensure that:</text> <item id="H3755D834AA884ED29BEC793554173708"><enum>(aa)</enum><text>Such files are limited to an appropriate size, are made available in a widely available format that allows for information contained in such files to be compared across health plans, and are accessible to individuals at no cost and without the need to establish a user account or provider other credentials.</text></item>
<item id="HDD3806D0A0CB47F693C310329FAA6B17"><enum>(bb)</enum><text>The rates, amounts, and prices to be disclosed include contractual terms containing calculation formulae, pricing methodologies, and other information necessary to determine the dollar value of reimbursement.</text></item> <item id="HBD664A8D99EF4B548C9E2B12E270B444"><enum>(cc)</enum><text>Each such file includes each of the following data elements:</text>
<subitem id="H80D8C1A459DF402CB986B1BCD6D8CA1B"><enum>(AA)</enum><text>A numerical identifier for the group health plan and/or health insurance issuer (such as a Health Insurance Oversight System identifier).</text></subitem> <subitem id="H5FE06F2D0B4B49DDB9314027FD9719FF"><enum>(BB)</enum><text>A plain-language description of the item or service (including, for drugs, the proprietary and nonproprietary name assigned).</text></subitem>
<subitem id="H14D2BB8A2F48459E95F4F92BA96BBB2E"><enum>(CC)</enum><text>The billing code, including any applicable modifiers, associated with such item or service, including the Healthcare Common Procedure Coding System code, diagnosis-related group, national drug code, or other commonly recognized code set.</text></subitem> <subitem id="HF31694FC62FC4508875B246EC4C09FC4"><enum>(DD)</enum><text>The place of service code.</text></subitem>
<subitem id="H6A3258FEE4EA4797A88A1892908AEE4F"><enum>(EE)</enum><text>The National Provider Identifier or provider Tax Identification Number.</text></subitem></item></subclause> <subclause id="H372C2D63658346319238F570DE918D9B"><enum>(III)</enum><text>The rate and payment information disclosed under subclauses (I) through (III) of clause (ii) shall be separately delineated for each item or service, regardless of whether such item or service is reimbursed as a part of a bundle, episode, or other grouping of items and services.</text></subclause>
<subclause id="HAE574C2238A442DDBEA3B8DF717CA8F2"><enum>(IV)</enum><text>An officer or executive of competent authority shall attest to the accuracy and completeness of information submitted and made available under this subparagraph. Such attestation shall be subject to enforcement under subparagraph (H) and, where applicable, shall be deemed material to payments from the Federal Government received by the group health plan or health insurance issuer.</text></subclause> <subclause id="H7840C0ADFF614A0D8595158A7B03508A"><enum>(V)</enum><text>Regulations promulgated pursuant to this section shall provide that:</text>
<item id="H498977DFDB644683BFF1C527FF719343"><enum>(aa)</enum><text>The Secretary shall audit the three machine-readable files required by subparagraph (E)(ii) posted by no fewer than 20 group health plans or health insurance issuers.</text></item> <item id="H7CF24B388DC74E909A8CAC0817BBBFD2"><enum>(bb)</enum><text>The Secretary of Labor shall audit the three machine-readable files required by subparagraph (E)(ii) posted by no fewer than 200 group health plans or service providers furnishing third-party administrator services to a group health plan.</text></item>
<item id="HCBA4B16C829D480D983D50777A149311"><enum>(cc)</enum><text>Findings, conclusions, and enforcement actions taken based on audits of the machine-readable files shall be reported annually to Congress no later than July 1 of the calendar year during which the files were audited. Such report to Congress shall be accessible to the public.</text></item></subclause></clause> <clause id="H185C601001E64A9BBF741707C43ABFAF"><enum>(iv)</enum><header>User guide</header><text>Each health plan shall make available to the public instructions written in plain language explaining how individuals may search for information described in clause (ii) in files submitted in accordance with clause (iii).</text></clause></subparagraph>
<subparagraph id="H2F9B00C53E4C46C78048905DE01E6512"><enum>(F)</enum><header>Definitions</header><text>In this paragraph:</text> <clause id="HA73EF58C604B474C9A33780E8A744A63"><enum>(i)</enum><header>Participating provider</header><text>The term <term>participating provider</term> has the meaning given such term in section 2799A–1 of the Public Health Service Act.</text></clause>
<clause id="H72EE5BC34A424933B25AD36E6520AA94"><enum>(ii)</enum><header>In-network rate</header><text>The term <term>in-network rate</term> means, with respect to a health plan and an item or service furnished by a provider that is a participating provider with respect to such plan and item or service, the contracted rate in effect between such plan and such provider for such item or service. If the rate is based on an algorithm, percentage of another amount, or other formula or criteria, the health plan also shall disclose such algorithm, percentage, formula, or criteria as set forth in its contract and any other terms, schedules, exhibits, data, or other information referenced in any such contract as shall be required to determine and disclose the negotiated rate.</text></clause></subparagraph> <subparagraph id="H2DAACB7A1A1C44918ECB702E7219492D"><enum>(G)</enum><header>Applicability to accountable care organizations</header><text>An applicable ACO participating in the Medicare Shared Savings Program, as defined in Section 1899 of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395jjj">42 U.S.C. 1395jjj</external-xref>), shall be subject to the requirements of this paragraph as if such applicable ACO is a group health plan or health insurance issuer.</text></subparagraph>
<subparagraph id="H503A90AE64E84E0C9BEAD48D1B895B2B"><enum>(H)</enum><header>Enforcement</header>
<clause commented="no" display-inline="no-display-inline" id="H20EE2590D190450BAC42BD37D73A7B40"><enum>(i)</enum><header>In general</header><text display-inline="yes-display-inline">Each year, the Secretary shall audit the three machine-readable files required by subparagraph (E)(ii) posted by no fewer than 20 group health plans or health insurance issuers.</text></clause> <clause id="HE5FDCC0233D24A41815D0F5DF6B4B224" commented="no"><enum>(ii)</enum><header>Notification and request for corrective action</header><text>In the case of a health plan that fails to comply with the requirements of this subsection, not later than 30 days after the date on which the Secretary determines such failure exists, the Secretary shall submit to such health plan a notification of such determination, which shall include a request for a corrective action plan to comply with such requirements.</text></clause>
<clause id="HC5B7486473524908B7D3718D125AF3AA" commented="no"><enum>(iii)</enum><header>Civil monetary penalty</header><text>A health plan that has received a request for a corrective action plan under clause (ii) and fails to comply with the requirements of this subsection by the date that is 90 days after such request is made shall be subject to a civil monetary penalty of an amount specified by the Secretary for each day (beginning with the day on which the Secretary first determined that such laboratory was failing to comply with such paragraph) during which such failure was ongoing. Such amount shall not exceed $300 per member per day or $10,000,000, whichever is lesser.</text></clause></subparagraph> <subparagraph id="H75891A08181842F88A0BD478F93436E2"><enum>(I)</enum><header>Rulemaking</header><text>The Secretary shall implement subparagraphs (E) through (H) through notice and comment rulemaking in accordance with section 553 of title 5, United States Code.</text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></subsection>
<subsection id="H377F446B41E64A4E905402CB86CAB347"><enum>(c)</enum><header>Effective date</header>
<paragraph id="HD62E6F452EA6498A99BDC17301C843BC"><enum>(1)</enum><header>In general</header><text>The amendments made by subsections (a) and (b) shall apply beginning January 1, 2027.</text></paragraph> <paragraph id="HF45FBE60C7974C45BA4F55227A0E9E8E"> <enum>(2)</enum> <header>Continued applicability of rules for previous years</header> <text>Nothing in the amendments made by this section may be construed as affecting the applicability of the rule entitled <quote>Transparency in Coverage</quote> published by the Department of the Treasury, the Department of Labor, and the Department of Health and Human Services on November 12, 2020 (85 Fed. Reg. 72158) before January 1, 2027.</text>
</paragraph></subsection></section>
<section id="H381491F473C140558A5B3BC005339193"><enum>307.</enum><header>Increasing group health plan access to health data</header>
<subsection id="HF6BF5A9F4F024C008DD1C93C4AAB66A2"><enum>(a)</enum><header>Group health plan access to information</header>
<paragraph commented="no" display-inline="no-display-inline" id="H2DF466C1C39D4FCB9EB5462F6EB831B1"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text>Paragraph (2) of section 408(b) of the Employee Retirement Income Security Act of 1974 (<external-xref legal-doc="usc" parsable-cite="usc/29/1108">29 U.S.C. 1108(b)</external-xref>) is amended by adding at the end the following new subparagraphs:</text> <quoted-block style="OLC" display-inline="no-display-inline" id="HDAB60AC19BAB4788BCFF60D3132C5275"> <subparagraph id="H3FF5A3029A54441893C1A426328372AD"><enum>(C)</enum><text>No contract or arrangement for services, and no extension or renewal of such contract or arrangement, between a group health plan (as that term is defined in section 733(a) of this title) and party in interest, including a health care provider (which for purposes of this subparagraph, includes a health care facility), network or association of providers, service provider offering access to a network of providers, or third-party administrator (collectively referred to as <quote>Covered Service Providers</quote>), is reasonable within the meaning of this paragraph unless such contract or arrangement—</text>
<clause id="H1AF50AC5262E417DA10B5E00AB23D32A"><enum>(i)</enum><text>allows the responsible plan fiduciary (as that term is defined in subparagraph (B)(ii)(I)(ee)) access to all claims and encounter information or data, and any documentation supporting claim payments, including, but not limited to, medical records and policy documents, or information or data described in section 724(a)(1)(B) to—</text> <subclause id="H7B4B6836487C4A738842FC8B2FAB418D"><enum>(I)</enum><text>enable such entity to comply with the terms of the plan and any applicable law; and</text></subclause>
<subclause id="HE53F45EFEB52403D85555D57BA91DEE0"><enum>(II)</enum><text>determine the accuracy or reasonableness of payment; and</text></subclause></clause> <clause id="H7E17F69F86CF4A52B6A8936DF6D43E32"><enum>(ii)</enum><text>does not—</text>
<subclause id="H7575348EAA63495EB44FC91D94902628"><enum>(I)</enum><text>unreasonably limit or delay access, as determined by the Secretary but in any event not longer than 15 days, to such information or data;</text></subclause> <subclause id="H836891A483824A4DAD088C9B3CC10A0C"><enum>(II)</enum><text>limit the volume of claims and encounter information or data that the group health plan, the plan sponsor, the plan administrator, or a business associate of such plan may access during an audit or pursuant to any request for such information or data;</text></subclause>
<subclause id="H5EEBAE55BA8D4B749A803B39F6B40847"><enum>(III)</enum><text>limit the disclosure of pricing terms for value-based payment arrangements or capitated payment arrangements, including—</text> <item id="HCA7012B811D94351A774BBF6656EF253"><enum>(aa)</enum><text>payment calculations and formulas;</text></item>
<item id="HE32F3936DFE349FBA9AA1FF77E887278"><enum>(bb)</enum><text>quality measures;</text></item> <item id="H674EBBFCCC7D43F48A4C5176E1A381DE"><enum>(cc)</enum><text>contract terms;</text></item>
<item id="HD1359775DBDC4FFB81D22595BAB63AD0"><enum>(dd)</enum><text>payment amounts;</text></item> <item id="H911E11AAB18245C3879529364C03D9DE"><enum>(ee)</enum><text>measurement periods for all incentives; and</text></item>
<item id="HF442C962C10942C8973566083AA1DBA6"><enum>(ff)</enum><text>other payment methodologies used by an entity, including a health care provider (including a health care facility), network or association of providers, service provider offering access to a network of providers, or third-party administrator;</text></item></subclause> <subclause id="H3DD38FBF51554779B92CBA8F33B9A4DE"><enum>(IV)</enum><text>limit the disclosure of overpayments and overpayment recovery terms;</text></subclause>
<subclause id="HDE6C3ECD167F497282FEAAEADE727AB3"><enum>(V)</enum><text>limit the right of the group health plan, the plan sponsor, or the plan administrator of such plan to select an auditor or define audit scope or frequency;</text></subclause> <subclause id="HC0D39AF1233D48EB811676A1BD5CAF67"><enum>(VI)</enum><text>otherwise limit or unduly delay the group health plan, the plan sponsor, the plan administrator, or a business associate of such plan from accessing claims and encounter information or data in a daily batch;</text></subclause>
<subclause id="H1B2C2FB1A3D44FB5BB6484584A8CB0E4"><enum>(VII)</enum><text>limit the disclosure of fees charged to the group health plan related to plan administration and claims processing, including renegotiation fees, access fees, repricing fees, or enhanced review fees;</text></subclause> <subclause id="HB39A856BA557403DBDB998D64B91FFA1"><enum>(VIII)</enum><text>limit the right of the group health plan, the plan sponsor, or the plan administrator to request action on any suspect claim payments; or</text></subclause>
<subclause id="H37B5A4953FF4442BA25766C5F6921E16"><enum>(IX)</enum><text>limit public disclosure of de-identified or aggregate information.</text></subclause></clause></subparagraph> <subparagraph id="H57F47CA062894F73B46061DE8F0C9624"><enum>(D)</enum> <clause commented="no" display-inline="yes-display-inline" id="H81524BE5C47645CAAA23C9C3507D7A2A"><enum>(i)</enum><text display-inline="yes-display-inline">Covered Service Providers shall provide information or data under this paragraph in a manner consistent with the privacy and security regulations promulgated under the Health Insurance Portability and Accountability Act (referred to in this subparagraph as <quote>HIPAA</quote>).</text></clause>
<clause indent="up1" commented="no" display-inline="no-display-inline" id="H19B8E1AA1C744EF684D3CA06C92B8806"><enum>(ii)</enum><text>A group health plan that receives a disclosure from a party in interest pursuant to subparagraph (B) or (C) shall comply with the privacy and security regulations promulgated under HIPAA.</text></clause> <clause indent="up1" commented="no" display-inline="no-display-inline" id="H5423ADF2343741E1B1FEEF66F02D340F"><enum>(iii)</enum><text>Nothing in this subparagraph shall be construed to modify the requirements for the creation, receipt, maintenance, or transmission of protected health information under the HIPAA privacy regulation (as defined in section 1180(b)(3) of the Social Security Act) as they apply directly or indirectly to an entity pursuant to this paragraph.</text></clause>
<clause indent="up1" commented="no" display-inline="no-display-inline" id="HE637F00EF854443FA7CD305E71107383"><enum>(iv)</enum><text>This subparagraph shall not be read to abridge or limit the disclosure requirements under this paragraph or to impose additional privacy or security requirements on Covered Service Providers or plan sponsors.</text></clause></subparagraph> <subparagraph id="HB0546B79F4A5449189020CCE16EF4354"><enum>(E)</enum><text>A group health plan receiving information or data under this paragraph may disclose such information only in a manner that is consistent with the Health Insurance Portability and Accountability Act (HIPAA) and the privacy and security regulations promulgated thereunder, regardless of their direct or indirect applicability to the plan or any entities that could be or are business associates.</text></subparagraph>
<subparagraph id="H656865445364419F92D56C8C2B18752B"><enum>(F)</enum><text>Information made available under this section shall conform to the following standards:</text> <clause id="HB34780F0BFB94EE2AD64EAAC98153782"><enum>(i)</enum><text>All claims from a healthcare provider shall be made to the group health plan in accordance with transaction standards adopted by regulation under HIPAA, as follows:</text>
<subclause id="HE082B77D43784F3984F832068AECE3FC"><enum>(I)</enum><text>Institutional, professional, and dental claims shall be in ASC X12N 837 format or any subsequent standard.</text></subclause> <subclause id="H6E5170D2141A472D826E54C8BB529F87"><enum>(II)</enum><text>Pharmacy claims shall be in the National Council for Prescription Drug Programs (NCPDP) format or any subsequent standard.</text></subclause>
<subclause commented="no" display-inline="no-display-inline" id="H58567A28650E42398F3DCA7A730ABF06"><enum>(III)</enum><text display-inline="yes-display-inline">The files shall be unmodified copies of the files sent from the provider. In the event that paper claims are sent by the provider, they shall be converted to the appropriate standard electronic format. Files shall be accessible to the plan at no cost to the group health plan.</text></subclause></clause> <clause id="HB34E36CD161246C694B675A75C680041"><enum>(ii)</enum><text>All claim payment (or EFT, electronic funds transfer) and electronic remittance advice (ERA) notices sent by a Covered Service Provider shall be made available to the group health plan as ASC X12N 835 files in accordance with standards adopted by regulation under HIPAA. The files shall be unmodified copies of the files sent by the Covered Service Provider to the healthcare provider. Files shall be accessible at no cost to the group health plan.</text></clause>
<clause id="H15A4C7C4B5ED4D1FBFB0A221A37082E8"><enum>(iii)</enum><text>The contractual terms containing calculation formulae, pricing methodologies, and other information used to determine the dollar value of reimbursement.</text></clause> <clause id="H44C7A15EA893459EBEF9AA6517442AA2"><enum>(iv)</enum><text>All non-claim costs shall be itemized and made available to the group health plan in real time through a web-based portal, through an API, and through a downloadable CSV file.</text></clause></subparagraph>
<subparagraph id="H9024B626360C4928B5906923B137C871"><enum>(G)</enum><text>The Secretary shall implement subparagraphs (C) through (F) through notice and comment rulemaking in accordance with section 553 of title 5, United States Code.</text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph> <paragraph commented="no" display-inline="no-display-inline" id="H510ADFE3724A4055B6663A6999BC261F"><enum>(2)</enum><header>Civil enforcement</header><text>Subsection (c) of section 502 of such Act (<external-xref legal-doc="usc" parsable-cite="usc/29/1132">29 U.S.C. 1132</external-xref>) is amended by adding at the end the following new paragraph:</text>
<quoted-block style="OLC" display-inline="no-display-inline" id="H70B2006FD1324C8F965F3CCC27CAAC00">
<paragraph commented="no" display-inline="no-display-inline" id="H3EDE27C1A7644B0C8271BBBA13DDFA2C"><enum>(13)</enum><text display-inline="yes-display-inline">In the case of an agreement between a group health plan (as defined in section 733(a)), the plan sponsor of such plan (as defined in section 3(16)(B)), or the plan administrator of such plan (as defined in section 3(16)(A)) and a health care provider (which, for purposes of this paragraph, includes a health care facility), network or association of providers, service provider offering access to a network or association of providers, or third-party administrator, that violates the provisions of section 724, the Secretary may assess a civil penalty against such provider, network or association, service provider offering access to a network or association of providers, third-party administrator, or other service provider in the amount of $10,000 for each day during which such violation continues. Such penalty shall be in addition to other penalties as may be prescribed by law.</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph> <paragraph id="HCE3EF3E63B5141E08F07BB285476C498"><enum>(3)</enum><header>Existing provisions void</header><text>Section 410 of such Act (<external-xref legal-doc="usc" parsable-cite="usc/29/1110">29 U.S.C. 1110</external-xref>) is amended by adding at the end the following:</text>
<quoted-block style="OLC" display-inline="no-display-inline" id="HD9DE312A31D54D98BD855E52FCFCEABE">
<subsection id="H92D2906D9210463EBB240F5A48D6CE7D"><enum>(c)</enum><text>Any provision in an agreement or instrument shall be void as against public policy if such provision—</text> <paragraph id="H77347FDFFA9644C48ECD0B1123BF927A"><enum>(1)</enum><text>unduly delays or limits a group health plan (as defined in section 733(a)), the plan sponsor of such plan (as defined in section 3(16)(B)), or the plan administrator of such plan (as defined in section 3(16)(A)) from accessing the claims and encounter information or data described in section 724(a)(1)(B); or</text></paragraph>
<paragraph id="HCC0318CAE90248ECBD260380580759E0"><enum>(2)</enum><text>violates the requirements of section 408(b)(2)(C).</text></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></paragraph> <paragraph id="H2B128A23F01D4D8B9121ACA5F707E8B0"><enum>(4)</enum><header>Technical amendment</header><text>Clause (i) of section 408(b)(2)(B) of such Act is amended by striking <quote>this clause</quote> and inserting <quote>this paragraph</quote>.</text></paragraph></subsection>
<subsection id="H6CE7C7AF8F0E4A7DBA1611136ECEADA2"><enum>(b)</enum><header>Updated attestation for price and quality information</header><text>Section 724(a)(3) of the Employee Retirement Income Security Act of 1974 (<external-xref legal-doc="usc" parsable-cite="usc/29/1185m">29 U.S.C. 1185m(a)(3)</external-xref>) is amended to read as follows:</text> <quoted-block style="OLC" display-inline="no-display-inline" id="HAEED96AE612E4F129323A789BAFB48D4"> <paragraph commented="no" display-inline="no-display-inline" id="HAA4A767A432F432E955AAF20B69B6F2E"><enum>(3)</enum><header display-inline="yes-display-inline">Attestation</header> <subparagraph commented="no" display-inline="no-display-inline" id="HD4229C1D78B045F2AF5851CAA5D42E0F"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text>Subject to subparagraph (C), a group health plan or health insurance issuer offering group health insurance coverage shall annually submit to the Secretary an attestation that such plan or issuer of such coverage is in compliance with the requirements of this subsection. Such attestation shall also include a statement verifying that—</text>
<clause id="H4B8685B357904E65BCE72452FFF09D4C"><enum>(i)</enum><text>the information or data described under subparagraphs (A) and (B) of paragraph (1) is available upon request and provided to the group health plan, the plan sponsor, the plan administrator, or the business associate of such plan, or the issuer in a timely manner; and</text></clause> <clause id="H25B342D0338D4F5F945D74A5F3117FD5"><enum>(ii)</enum><text>there are no terms in the agreement under such paragraph (1) that directly or indirectly restrict or unduly delay a group health plan, the plan sponsor, the plan administrator, a business associate of such plan, or the issuer from auditing, reviewing, or otherwise accessing such information.</text></clause></subparagraph>
<subparagraph id="H58E11A7EAA3A410FA09A117191B3C4B9"><enum>(B)</enum><header>Limitation on submission</header><text>Subject to clause (ii), a group health plan or issuer offering group health insurance coverage may not enter into an agreement with a third-party administrator or other service provider to submit the attestation required under subparagraph (A).</text></subparagraph> <subparagraph id="HD6A03929317B4660B150529858F5C994"><enum>(C)</enum><header>Exception</header><text>In the case of a group health plan or issuer offering group health insurance coverage that is unable to obtain the information or data needed to submit the attestation required under subparagraph (A), such plan or issuer may submit a written statement in lieu of such attestation that includes—</text>
<clause id="H74598654ED864379A1E58DE277A608BE"><enum>(i)</enum><text>an explanation of why such plan or issuer was unsuccessful in obtaining such information or data, including whether such plan, the plan sponsor, or the plan administrator or issuer was limited or prevented from auditing, reviewing, or otherwise accessing such information or data;</text></clause> <clause id="HBC17623F83FA4E4FB5092BAD53836042"><enum>(ii)</enum><text>a description of the efforts made by the group health plan, the plan sponsor, or the plan administrator to remove any gag clause provisions from the agreement under paragraph (1); and</text></clause>
<clause id="HC81224974B1E4042A1AAF16E267E9AEB"><enum>(iii)</enum><text>a description of any response by the third-party administrator or other service provider with respect to efforts to comply with the attestation requirement under subparagraph (A), including the name of the third-party administrator or other service provider.</text></clause></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></subsection> <subsection commented="no" display-inline="no-display-inline" id="HC478C0DBA680400BA8588BF15B05E5BF"><enum>(c)</enum><header>Effective date</header><text>The amendments made by subsections (a) and (b) shall apply with respect to a plan beginning with the first plan year that begins on or after the date that is 1 year after the date of enactment of this Act.</text></subsection></section>
<section id="HA7C88ED73A3C4CB38802C7DF9FD4F602"><enum>308.</enum><header>Oversight of administrative service providers</header>
<subsection commented="no" display-inline="no-display-inline" id="HD703F4D8B72741A99F3FDE4C65D05353"><enum>(a)</enum><header display-inline="yes-display-inline">ERISA amendments</header>
<paragraph id="H2380A80FCDDB48C0A2E5C13CBE8FA903"><enum>(1)</enum><header>In general</header><text>Subpart B of part 7 of subtitle B of the Employee Retirement Income Security Act of 1974 (<external-xref legal-doc="usc" parsable-cite="usc/29/1021">29 U.S.C. 1021 et seq.</external-xref>) is amended by adding at the end the following:</text> <quoted-block style="OLC" display-inline="no-display-inline" id="H4860835D62B64EFE97405124CD160AF5"> <section id="H34D89E9656BD447684A6EFB25F3E3672"><enum>727.</enum><header>Oversight of administrative service providers</header> <subsection id="HA98120B2C00D42CB88E7E3EC02B43AC5"><enum>(a)</enum><header>In general</header><text>For plan years beginning on or after the date that is 2 years after the date of enactment of this section, no agreement between a group health plan (as defined in section 733(a)), the plan sponsor of such plan (as defined in section 3(16)(B)), the plan administrator of such plan (as defined in section 3(16)(A)), or a business associate of such plan (as defined in section 160.103 of title 45, Code of Federal Regulations), (or health insurance issuer offering group health insurance coverage in connection with such a plan), and a health care provider, network or association of providers, third-party administrator, service provider offering access to a network of providers, or any other third party (each referred to as a <quote>health plan service provider</quote>) is permissible if such agreement limits (or delays beyond the applicable reporting period described in subsection (b)(1)) the disclosure of information to group health plans in such a manner that prevents such plan, issuer, or entity from providing the information described in subsection (b).</text></subsection>
<subsection id="H71CD3148549A48119E260BC885CFF0C4"><enum>(b)</enum><header>Required disclosures</header>
<paragraph id="HE51503FF49A44680A858A9A1122496BD"><enum>(1)</enum><header>Contents and frequency</header><text>With respect to plan years beginning on or after the date that is 2 years after the date of enactment of this section, not less frequently than quarterly, a health plan service provider shall provide to the group health plan or health insurance issuer the following information at no cost to the group health plan or health insurance issuer:</text> <subparagraph id="H207B6491EBC64FBBBD2C3B23012CD855"><enum>(A)</enum><text>The information described in section 724(a)(1)(B).</text></subparagraph>
<subparagraph id="H6EEFBE2F1FA5418BAA173F6A33C8B10A"><enum>(B)</enum><text>Any contractual and subcontractual calculation methodologies, pricing or fee schedules, or other formulae used to determine reimbursement amounts to providers and subcontractors, including methodologies, schedules, fee structures, and any applied adjustments or modifiers, with such information provided in a manner sufficiently detailed to enable the group health plan or health insurance issuer to accurately assess, verify, and ensure compliance with the terms of any contractual and subcontractual agreement governing the reimbursement amounts.</text></subparagraph> <subparagraph id="H477A5A4181B54F0B9F2479D292B9B635"><enum>(C)</enum><text>The total amount received or expected to be received by the health plan service provider or its subcontractors in provider or supplier rebates, fees, alternative discounts, and all other remuneration including amounts held in escrow or variance accounts that has been paid or is to be paid for claims incurred and administrative services including data sales or network payments.</text></subparagraph>
<subparagraph id="H481D0A0293D747ACA7E3360257D6D365"><enum>(D)</enum><text>The total amount paid or expected to be paid by the health plan service provider or to subcontractors in rebates, fees, contractual arrangements, and all other remuneration that has been paid or is expected to be paid for administrative and other services.</text></subparagraph> <subparagraph id="H4B02D7EC0D484E259F163F0162A81264"><enum>(E)</enum><text>All payment data and reconciliation information related to alternative compensation arrangements including accountable care organizations, value-based programs, shared savings programs, incentive compensation, bundled payments, capitation arrangements, performance payments, and any other reimbursement or payment models, where the group health plan or health insurance issuer paid fees, incurred obligations, or made payments in connection with the group health plan related to such arrangements.</text></subparagraph></paragraph>
<paragraph id="H0E56CB42CF0B4E059DAB75F506E5C695"><enum>(2)</enum><header>Privacy requirements</header>
<subparagraph id="H671C881BFF5B439187AA910545940094"><enum>(A)</enum><header>In general</header><text>Health plan service providers shall provide the information or data under paragraph (1) consistent with the privacy, security, and breach notification regulations at parts 160 and 164 of title 45, Code of Federal Regulations, promulgated under subtitle F of the Health Insurance Portability and Accountability Act of 1996, subtitle D of the Health Information Technology for Clinical Health Act of 2009, and section 1180 of the Social Security Act, and shall restrict the use and disclosure of such information according to such privacy, security, and breach notification regulations. An entity that receives a disclosure from a party in interest pursuant to subparagraph (B) or (C) shall comply with the privacy and security regulations promulgated under HIPAA.</text></subparagraph> <subparagraph id="H9B177B530B7D46E284FB2069FA3E1750"><enum>(B)</enum><header>Restrictions</header><text>A group health plan shall comply with section 164.504(f) of title 45, Code of Federal Regulations (or a successor regulation), and a plan sponsor shall act in accordance with the terms of the agreement described in such section.</text></subparagraph>
<subparagraph id="H0ADC56753091451A9E65515C0EB4AE47">
<enum>(C)</enum>
<header>Rule of construction</header>
<text>Nothing in this section shall be construed to modify the requirements for the creation, receipt, maintenance, or transmission of protected health information under the HIPAA privacy regulations (45 CFR parts 160 and 164, subparts A and E).</text>
</subparagraph></paragraph>
<paragraph id="H34DB329BDD114865B24C62D7FE22D15C"><enum>(3)</enum><header>Disclosure and redisclosure</header>
<subparagraph id="H4993FDAE744447029077106A72248B69"><enum>(A)</enum><header>In general</header><text>A group health plan receiving information under paragraph (1) may disclose such information only—</text> <clause commented="no" display-inline="no-display-inline" id="H59544F1C2B544F9AB827E8DDD1525618"><enum>(i)</enum><text display-inline="yes-display-inline">to the entity from which the information was received or to that entity’s business associates or to the group health plan's business associates as defined in section 160.103 of title 45, Code of Federal Regulations (or successor regulations); or</text></clause>
<clause commented="no" display-inline="no-display-inline" id="H241317B3D1ED41468232BF23579EAAC7">
<enum>(ii)</enum>
<text display-inline="yes-display-inline">as permitted by the HIPAA Privacy Rule (45 CFR parts 160 and 164, subparts A and E).</text>
</clause></subparagraph>
<subparagraph id="HE7981BF7F6D0497EBC3373ABA42FC39A"><enum>(B)</enum><header>Availability of information</header><text>To the extent the information required by this subsection is made available to the health insurance issuer offering group health insurance in connection with a group health plan, the health insurance issuer shall make such information available, at the same time, in the same format, and at no cost, to the group health plan.</text></subparagraph> <subparagraph id="HA2389683479247CB99B26230B39C4164"><enum>(C)</enum><header>Failure to provide</header><text>The obligation to provide information pursuant to this subsection shall exist notwithstanding the presence of any formal data-sharing agreement between the parties. Failure to provide the required information as specified shall constitute a violation of this Act and the Secretary shall initiate enforcement action under section 502 within 90 days of becoming aware of a violation of this section, except that nothing in this section shall be construed to limit the Secretary's existing authority under the Act.</text></subparagraph></paragraph>
<paragraph id="H5FD8DA3270CB4D768428C8D718D5CD2B"><enum>(4)</enum><header>Data format standards</header><text>All data and information provided pursuant to this subsection shall comply with the following standards:</text> <subparagraph id="H8F90E1BC19284E98A82DD105D985054C"><enum>(A)</enum><text>All claims from a healthcare provider shall be made to the group health plan in accordance with transactions standards adopted under HIPAA, as follows:</text>
<clause id="H5E3FCB94E8024A53ABC97C59AA8B3F84"><enum>(i)</enum><text>Institutional, professional, and dental claims and adjustments to these claims shall be in ASC X12N 837 format, as transmitted by the provider, or, in the case of paper claims, converted to the ASC X12N 837 electronic format.</text></clause> <clause id="H1A6ECC108C7A45888EFD6CCCBFF6DC17"><enum>(ii)</enum><text>Prescription drug claims shall be in the National Council for Prescription Drug Programs (NCPDP) format, as transmitted by the provider, or in the case of paper claims, converted to the NCPDP electronic format.</text></clause>
<clause commented="no" display-inline="no-display-inline" id="H0438DFD46F65452498D69E1962A55DCF"><enum>(iii)</enum><text display-inline="yes-display-inline">Such data shall be provided at no cost to the group health plan.</text></clause></subparagraph> <subparagraph id="H073E9AD062884D618EA67F1921D861E2"><enum>(B)</enum><text>All claim payment (or EFT, electronic funds transfer) and electronic remittance advice (ERA) information sent by a health plan service provider shall be provided to the group health plan or health insurance issuer in the ASC X12N 835 format in accordance with transaction standards adopted under HIPAA, unmodified from the form in which it was transmitted to the healthcare provider. Such information shall be provided at no cost to the group health plan or health insurance issuer.</text></subparagraph>
<subparagraph id="HD9B94BFE67B8487CB159F4AC21D666B4"><enum>(C)</enum><text>The Secretary may modify the standards set forth in this paragraph as necessary to align with any changes adopted by the Secretary of Health and Human Services pursuant to the authority provided under section 1173 of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1320d-2">42 U.S.C. 1320d–2</external-xref>).</text></subparagraph></paragraph></subsection> <subsection id="H66D65B214E2143628AFE651E79E8F15A"><enum>(c)</enum><header>Prohibited contractual provisions</header><text>Any provision in an agreement between a group health plan, the plan sponsor, the plan administrator, or a business associate of such plan or a health insurance issuer and a health plan service provider that unduly delays or limits a group health plan’s or health insurance issuer’s access to information described in this section or that restricts the format or timing of the provision of such information in a manner that is inconsistent with the requirements of this section shall be prohibited and, if a group health plan or health insurance issuer enters into such agreement, shall be deemed void as against public policy.</text></subsection>
<subsection id="H19722B88F68C4C6CB761E50500D1D813"><enum>(d)</enum><header>Penalties for non-Compliance</header><text>Any failure by a health plan service provider to comply with the requirements of this section shall result in the imposition of a civil penalty of $100,000 for each day the violation continues, in addition to any other penalties prescribed by law.</text></subsection> <subsection commented="no" display-inline="no-display-inline" id="H408447A6FD7445D5B334265082AFBC13"><enum>(e)</enum><header>Regulations</header><text display-inline="yes-display-inline">The Secretary shall implement this section through notice and comment rulemaking in accordance with section 553 of title 5, United States Code.</text></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></paragraph>
<paragraph id="HE4C35D32C2E84D18B4E16A59E5E32779"><enum>(2)</enum><header>Penalty</header>
<subparagraph commented="no" display-inline="no-display-inline" id="H9F1C85A2DE144B2BB1EA26041FB01B88"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">Section 502(a) of the Employee Retirement Income Security Act of 1974 (<external-xref legal-doc="usc" parsable-cite="usc/29/1132">29 U.S.C. 1132(a)</external-xref>) is amended by adding at the end the following new paragraph:</text> <quoted-block style="OLC" display-inline="no-display-inline" id="HA59C8B45C0B046A59FBB8C34303C6E58"> <paragraph commented="no" display-inline="no-display-inline" id="H45BC8593A0FE4813B4817C5B78344B8D"><enum>(14)</enum><text display-inline="yes-display-inline">The Secretary may assess a civil penalty against any person of $100,000 per day for each violation by any person of section 727.</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></subparagraph>
<subparagraph commented="no" display-inline="no-display-inline" id="H78DFED51534B460EA3F648DCD460BB27"><enum>(B)</enum><header>Technical amendment</header><text>Paragraph (6) of section 502(a) of the Employee Retirement Income Security Act of 1974 (<external-xref legal-doc="usc" parsable-cite="usc/29/1132">29 U.S.C. 1132(a)</external-xref>) is amended by striking <quote>or (9)</quote> and inserting it with the phrase <quote>(9), (13), or (14)</quote>.</text></subparagraph></paragraph></subsection> <subsection id="HC35E094157A84176A62B273B51D62D9C"><enum>(b)</enum><header>PHSA amendments</header> <paragraph commented="no" display-inline="no-display-inline" id="H7AFD608D182846A68BF0DAFB3C46C823"><enum>(1)</enum><header>In general</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:</text>
<quoted-block style="OLC" display-inline="no-display-inline" id="H5F1BA65CD01947B7A1BE37380DE06160">
<section id="H69D625B26FBF44C79EA5A5EE3E33E5E0"><enum>2799A–12.</enum><header>Oversight of administrative service providers</header>
<subsection id="HDD4669ABA88A4DC58FAA792240A4DFCE">
<enum>(a)</enum>
<header>In general</header>
<text>For plan years beginning on or after the date that is 1 year after the date of enactment of this section, no agreement between a group health plan that is a self-funded, non-Federal plan, as defined in section 2791(d)(8)(C) (<external-xref legal-doc="usc" parsable-cite="usc/42/300gg-91">42 U.S.C. 300gg–91(d)(8)(C)</external-xref>), and a health care provider, network or association of providers, third-party administrator, service provider offering access to a network of providers, or any other third party (each referred to in this section as a <quote>health plan service provider</quote>) is permissible if such agreement limits (or delays beyond the applicable reporting period described in subsection (b)(1)) the disclosure of information to group health plans in such a manner that prevents such plan, issuer, or entity from providing the information described in subsection (b).</text>
</subsection>
<subsection id="H5E26A96B51F54A588CD9C3842B1FF54D"><enum>(b)</enum><header>Required disclosures</header>
<paragraph id="HAF7718F775AA4F95B6F4788CA3DB082D">
<enum>(1)</enum>
<header>Contents and frequency</header>
<text>With respect to plan years beginning on or after the date that is 1 year after the date of enactment of this section, not less frequently than quarterly, a health plan service provider shall provide to the group health plan that is a self-funded, non-Federal governmental plan the following information at no cost to the plan:</text>
<subparagraph id="H374CD3F1B26A4060AD46F1787B05CA7E">
<enum>(A)</enum>
<text>The information described in section 2799A–9(a)(1)(B) (<external-xref legal-doc="usc" parsable-cite="usc/42/300gg-119">42 U.S.C. 300gg–119(a)(1)(B)</external-xref>).</text>
</subparagraph>
<subparagraph id="H653A74929D114BF89D04390E5CAB1AE3">
<enum>(B)</enum>
<text>Any contractual and subcontractual calculation methodologies, pricing or fee schedules, or other formulae used to determine reimbursement amounts to providers and subcontractors, including methodologies, schedules, fee structures, and any applied adjustments or modifiers, with such information provided in a manner sufficiently detailed to enable the group health plan to accurately assess, verify, and ensure compliance with the terms of any contractual and subcontractual agreement governing the reimbursement amounts.</text>
</subparagraph>
<subparagraph id="HF4820C4661084D759EB6E788BD582E4C">
<enum>(C)</enum>
<text>The total amount received or expected to be received by the health plan service provider or its subcontractors in provider or supplier rebates, fees, alternative discounts, and all other remuneration including amounts held in escrow or variance accounts that has been paid or is to be paid for claims incurred and administrative services including data sales or network payments.</text>
</subparagraph>
<subparagraph id="HD6A25448BEF24ED7B3247AE087782514">
<enum>(D)</enum>
<text>The total amount paid or expected to be paid by the health plan service provider or to subcontractors in rebates, fees, contractual arrangements, and all other remuneration that has been paid or is expected to be paid for administrative and other services.</text>
</subparagraph>
<subparagraph id="H08E3A3C728F947749644FD2FA1195ABC">
<enum>(E)</enum>
<text>All payment data and reconciliation information related to alternative compensation arrangements including accountable care organizations, value-based programs, shared savings programs, incentive compensation, bundled payments, capitation arrangements, performance payments, and any other reimbursement or payment models, where the group health plan paid fees, incurred obligations, or made payments in connection with the group health plan related to such arrangements.</text>
</subparagraph>
</paragraph>
<paragraph id="H8B8377D6662D44548134A701FFF64807"><enum>(2)</enum><header>Privacy requirements</header>
<subparagraph id="H5912E2AA13254674880A328BE5316993"><enum>(A)</enum><header>In general</header><text>Health plan service providers shall provide the information or data under paragraph (1) consistent with the privacy, security, and breach notification regulations at parts 160 and 164 of title 45, Code of Federal Regulations, promulgated under subtitle F of the Health Insurance Portability and Accountability Act of 1996, subtitle D of the Health Information Technology for Clinical Health Act of 2009, and section 1180 of the Social Security Act, and shall restrict the use and disclosure of such information according to such privacy, security, and breach notification regulations. An entity that receives a disclosure from a party in interest pursuant to subparagraph (B) or (C) shall comply with the privacy and security regulations promulgated under HIPAA.</text></subparagraph> <subparagraph id="HAE7A8A6E7B3D454FBBB31657231D5453"> <enum>(B)</enum> <header>Restrictions</header> <text>A group health plan that is a self-funded, non-Federal governmental plan shall comply with section 164.504(f) of title 45, Code of Federal Regulations (or a successor regulation), and a plan sponsor shall act in accordance with the terms of the agreement described in such section.</text>
</subparagraph>
<subparagraph id="H748560BC24FF4B73ADA2758480C15297">
<enum>(C)</enum>
<header>Rule of construction</header>
<text>Nothing in this section shall be construed to modify the requirements for the creation, receipt, maintenance, or transmission of protected health information under the HIPAA privacy regulations (45 CFR parts 160 and 164, subparts A and E).</text>
</subparagraph></paragraph>
<paragraph id="HF3B2250B75AD4B1F8C4DA69775D53E03"><enum>(3)</enum><header>Disclosure and redisclosure</header>
<subparagraph id="H65DA6F347224472A8A0B2DDB141D23F2">
<enum>(A)</enum>
<header>In general</header>
<text>A group health plan that is a self-funded, non-Federal governmental plan receiving information under paragraph (1) may disclose such information only—</text>
<clause id="H5E12A7ACCF2A48CA869E5DD381B2AE9C">
<enum>(i)</enum>
<text>to the entity from which the information was received or to that entity’s business associates as defined in section 160.103 of title 45, Code of Federal Regulations (or successor regulations); or</text>
</clause>
<clause id="HDE43C7EC1A0F49ACBD6BBEAA15E1B4FF">
<enum>(ii)</enum>
<text>as permitted by the HIPAA Privacy Rule (45 CFR parts 160 and 164, subparts A and E).</text>
</clause>
</subparagraph>
<subparagraph id="H12574E8D9C894A3285D2A493F063B481">
<enum>(B)</enum>
<header>Rule of construction</header>
<text>Nothing in this section shall be construed to prevent a group health plan that is a self-funded, non-Federal governmental plan, or a health plan service provider providing services with respect to such a plan, from placing reasonable restrictions on the public disclosure of the information described in paragraph (1), except that such plan or entity may not restrict disclosure of such information to the Department of Health and Human Services, the Department of Labor, the Department of the Treasury, or the Comptroller General of the United States.</text>
</subparagraph>
<subparagraph id="HB753341F043840FE950F6085F4270DFB"><enum>(C)</enum><header>Failure to provide</header><text>The obligation to provide information pursuant to this subsection shall exist notwithstanding the presence of any formal data-sharing agreement between the parties. Failure to provide the required information as specified shall constitute a violation of this Act and the Secretary shall initiate enforcement action under section 2723(b) (<external-xref legal-doc="usc" parsable-cite="usc/42/300gg-22">42 U.S.C. 300gg–22(b)</external-xref>) within 90 days of becoming aware of a violation of this section, except that nothing in this section shall be construed to limit the Secretary’s existing authority under this Act.</text></subparagraph></paragraph> <paragraph id="H7775E2F14C9E4FC1915B27055B9F175A"><enum>(4)</enum><header>Data format standards</header><text>All data and information provided pursuant to this subsection shall comply with the following standards:</text>
<subparagraph id="H4D6BD35F74CD49118449A7C385EF2C73"><enum>(A)</enum><text>All claims from a healthcare provider shall be made to the group health plan in accordance with standards adopted under HIPAA at section 162.1101 of title 45, Code of Federal Regulations, as follows:</text> <clause id="H0838558D71F647438E3EEED1F08AF1C3"> <enum>(i)</enum> <text>Institutional, professional, and dental claims and adjustments to these claims shall be provided to the group health plan that is a self-funded, non-Federal governmental plan in the ASC X12N 837 format.</text>
</clause>
<clause id="HD92D592F19114459B582AA581CDBEDF8"><enum>(ii)</enum><text>Prescription drug claims shall be in the National Council for Prescription Drug Programs (NCPDP) format.</text></clause> <clause id="H3D956606F5E94309A27F7F837DA15D07"><enum>(iii)</enum><text>The files shall be unmodified copies of the files sent from the provider. In the event that paper claims are sent by the provider, they shall be converted to the appropriate standard electronic format. Such data shall be provided at no cost to the group health plan.</text></clause></subparagraph>
<subparagraph id="H62BBEDED655945C085D40ABBBF544DF9"><enum>(B)</enum><text>All claim payment (or EFT, electronic funds transfer) and electronic remittance advice (ERA) information sent by a health plan service provider shall be provided to the group health plan or health insurance issuer in the ASC X12N 835 format, in accordance with standards adopted under HIPAA at section 162.1602 of title 45, Code of Federal Regulations, unmodified from the form in which it was transmitted to the healthcare provider. Such information shall be provided at no cost to the group health plan.</text></subparagraph> <subparagraph id="HD94852811C204F8BA3AE2F7DB0D21F04"><enum>(C)</enum><text>The Secretary may modify the standards set forth in this paragraph as necessary to align with any changes adopted by the Secretary pursuant to the authority provided under section 1173 of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1320d-2">42 U.S.C. 1320d–2</external-xref>).</text></subparagraph></paragraph></subsection>
<subsection id="H1FB3F1B313D349E0AEE32E3537B785A7">
<enum>(c)</enum>
<header>Prohibited contractual provisions</header>
<text>Any provision in an agreement that unduly delays or limits a group health plan that is a self-funded, non-Federal governmental plan’s access to information described in this section or that restricts the format or timing of the provision of such information in a manner that is inconsistent with the requirements of this section shall be prohibited and, if a self-funded, non-Federal governmental plan enters into such agreement, shall be deemed void as against public policy.</text>
</subsection>
<subsection id="HA408D809E8D1445F960450ABD8FDAF53"><enum>(d)</enum><header>Regulations</header><text>The Secretary shall implement this section through notice and comment rulemaking in accordance with section 553 of title 5, United States Code.</text></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></paragraph> <paragraph id="H3C82657706C14CAE8260EC34B782BAEF"><enum>(2)</enum><header>Penalty</header><text>Section 2723(b) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300gg-22">42 U.S.C. 300gg–22(b)</external-xref>) is amended by adding at the end the following:</text>
<quoted-block style="OLC" display-inline="no-display-inline" id="HD7D84EEE2AEC42F6864D61E5877CE4F7">
<paragraph id="H03211889A74646ABB7542612FBBCC6AD"><enum>(4)</enum><header>Enforcement authority relating to health plan service providers</header><text>Notwithstanding any provisions to the contrary, the Secretary may assess a penalty against a health plan service provider, as defined in section 2799A–12(a) (<external-xref legal-doc="usc" parsable-cite="usc/42/300gg-121">42 U.S.C. 300gg–121(a)</external-xref>), of $100,000 per day for each violation of such section, pursuant to substantially similar processes and procedures as those set forth in section 2723(b)(2)(D) through (G) (<external-xref legal-doc="usc" parsable-cite="usc/42/300gg-121">42 U.S.C. 300gg–121(b)(2)(D)</external-xref> through (G)).</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection></section> <section id="H542B2832210240A884BB985A117AA4B6"><enum>309.</enum><header>State preemption only in event of conflict</header><text display-inline="no-display-inline">The provisions of sections 302 through 305 (including the amendments made by such sections) shall not supersede any provision of State law which establishes, implements, or continues in effect any requirement or prohibition related to health care price transparency, including hospital, clinical diagnostic laboratory tests, imaging services, and ambulatory surgical center, except to the extent that such requirement or prohibition prevents the application of a requirement or prohibition of such sections (or amendment). Nothing in this section shall be construed to affect group health plans established under the Employee Retirement Income Security Act of 1974, or alter the application of section 514 of such Act (<external-xref legal-doc="usc" parsable-cite="usc/29/1144">29 U.S.C. 1144</external-xref>).</text></section>
<section id="H0757B5E6BFFA4D5C9A827844CAC15DEF"><enum>310.</enum><header>Requirement for explanation of benefits</header>
<subsection id="HDAB15468205B4B479A0020A99C980B66"><enum>(a)</enum><header>PHSA Amendments</header>
<paragraph id="HCED866808542462B93A6305AE6324B9D"><enum>(1)</enum><header>Emergency services</header><text>Section 2799A–1(f)(1)(C) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300gg-111">42 U.S.C. 300gg–111(f)(1)(C)</external-xref>) is amended to read as follows:</text> <quoted-block style="OLC" display-inline="no-display-inline" id="HB753DE4B092B4E5CA2866DFD90747A79"> <subparagraph id="H0A2F1CA7740B49DEBD987C6EF14AF163"><enum>(C)</enum><text>A good faith estimate of the amount the plan or coverage is responsible for paying for items and services included in the estimate described in subparagraph (B), including a plain language description of each item or service and all applicable billing codes for each item or service, including modifiers, using standard and commonly recognized billing code sets that are clearly identified.</text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph>
<paragraph id="H373A9F1904AA4643BD0A12853A66894E"><enum>(2)</enum><header>Explanation of benefits</header><text>Section 2799A–1 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300gg-111">42 U.S.C. 300gg–111</external-xref>) is amended by adding at the end the following:</text> <quoted-block style="OLC" display-inline="no-display-inline" id="H08F302FB2F1E47BD8CB605AC52C64D5E"> <subsection id="HF67777B55BD94ABEA7ACA495DDA73880"><enum>(g)</enum><header>Explanation of benefits</header> <paragraph id="H934B1AF231F44A0FA044C9980004DA1A"><enum>(1)</enum><header>In general</header><text>For plan years beginning on or after January 1, 2027, each group health plan, or a health insurance issuer offering group or individual health insurance coverage shall, within 45 days of receiving any request for payment for an item or service under the plan, provide to the participant, beneficiary, or enrollee (through mail or electronic means, as requested by the participant, beneficiary, or enrollee) a notification (in clear and understandable language and utilizing substantially the same format as the advanced explanation of benefits required by subsection (f) to enable comparison) including the following:</text>
<subparagraph id="H41A0EBBC694E40C1B39B55E053A8A3CA"><enum>(A)</enum><text>Whether or not the provider or facility is a participating provider or a participating facility with respect to the plan or coverage with respect to the furnishing of such item or service.</text></subparagraph> <subparagraph id="H68D5DF222BBB4AB0A8B84CB24EF0F283"><enum>(B)</enum><text>An itemized explanation of benefits that includes the following:</text>
<clause id="H19E639F227B248BFB2EB93CA36BFE766"><enum>(i)</enum><text>A plain language description of each item or service.</text></clause> <clause id="H025C450FF7384E5C9EDE0BA3C27C6219"><enum>(ii)</enum><text>All applicable billing codes for each item or service, including modifiers, using standard and commonly recognized billing code sets that are clearly identified.</text></clause>
<clause id="H7F71CD82448C405DBB9EA67729F84D5A"><enum>(iii)</enum><text>The amount the plan or coverage is responsible for paying for each item or service.</text></clause> <clause id="HA14F324C83AA456992A06F01FE44AFB1"><enum>(iv)</enum><text>The amount of any cost-sharing for which the participant, beneficiary, or enrollee is responsible for each item or service (as of the date of such notification).</text></clause>
<clause id="HA3EF4D4B2B9A47A5809FB2FE9408ED8A"><enum>(v)</enum><text>The amount that the participant, beneficiary, or enrollee has incurred toward meeting the limit of the financial responsibility (including with respect to deductibles and out-of-pocket maximums) under the plan or coverage (as of the date of such notification).</text></clause> <clause commented="no" display-inline="no-display-inline" id="H644F2495CEA2485F81B2C5E225FF7B88"><enum>(vi)</enum><text>The site of each item or service.</text></clause></subparagraph></paragraph>
<paragraph id="HE4958E9CEEA1425994655BA7E65B842A"><enum>(2)</enum><header>Format</header><text>If applicable, the notification described in paragraph (1) may be provided in conjunction with, or as part of, a notice of a claim determination or other communication required by section 2719(a) (<external-xref legal-doc="usc" parsable-cite="usc/42/300gg-19">42 U.S.C. 300gg–19(a)</external-xref>), or regulations thereunder.</text></paragraph></subsection> <subsection id="H30CB920697F843EFBB1BF8D10DA4E5A1"><enum>(h)</enum><header>Regulations</header><text>The Secretary shall implement this section through notice and comment rulemaking in accordance with section 553 of title 5, United States Code.</text></subsection><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection>
<subsection id="HC534B768B76E4063A677582A6BC8D670"><enum>(b)</enum><header>IRC amendments</header>
<paragraph id="HD8875F0796FE408688828C9875CEC31D"><enum>(1)</enum><header>Emergency services</header><text><external-xref legal-doc="usc" parsable-cite="usc/26/9816">Section 9816(f)(1)(C)</external-xref> of the Internal Revenue Code of 1986 is amended to read as follows:</text> <quoted-block style="OLC" display-inline="no-display-inline" id="HB447840FCCC84DF4B3F3B00CB6083A46"> <subparagraph id="H91CA6C0BD6E940FA901BAB082302817B"><enum>(C)</enum><text>A good faith estimate of the amount the plan is responsible for paying for items and services included in the estimate described in subparagraph (B), including a plain language description of each item or service and all applicable billing codes for each item or service, including modifiers, using standard and commonly recognized billing code sets that are clearly identified.</text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph>
<paragraph id="HEE179CFA4D704387A75001828D7FAB07"><enum>(2)</enum><header>Explanation of benefits</header><text><external-xref legal-doc="usc" parsable-cite="usc/26/9816">Section 9816</external-xref> of the Internal Revenue Code of 1986 is amended by adding at the end the following:</text> <quoted-block style="OLC" display-inline="no-display-inline" id="H0796BDDF1672461A9A570DCFACFA5852"> <subsection id="H1FB81F07D24F43079E467990097DE405"><enum>(g)</enum><header>Explanation of benefits</header> <paragraph id="HA6C324B2ED8349F5A6594B9521DED316"><enum>(1)</enum><header>In general</header><text>For plan years beginning on or after January 1, 2027, each group health plan shall, within 45 days of receiving any request for payment for an item or service under the plan, provide to the participant or beneficiary (through mail or electronic means, as requested by the participant or beneficiary) a notification (in clear and understandable language and utilizing substantially the same format as the advanced explanation of benefits required by subsection (f) to enable comparison) including the following:</text>
<subparagraph id="H0E6098382DF74BE2AFDA9EC84F86D84F"><enum>(A)</enum><text>Whether or not the provider or facility is a participating provider or a participating facility with respect to the plan with respect to the furnishing of such item or service.</text></subparagraph> <subparagraph id="H8EEEE15201E54FED9E140CF351EA2B69"><enum>(B)</enum><text>An itemized explanation of benefits that includes the following:</text>
<clause id="HA1CB4E8DB78A4532B869483F90F0EC40"><enum>(i)</enum><text>A plain language description of each item or service.</text></clause> <clause id="H861B379594374DC1A7F562B80885536C"><enum>(ii)</enum><text>All applicable billing codes for each item or service, including modifiers, using standard and commonly recognized billing code sets that are clearly identified.</text></clause>
<clause id="H071194F536874E64B4E973306B57B4EC"><enum>(iii)</enum><text>The amount the plan is responsible for paying for each item or service.</text></clause> <clause id="HBB0BA7EA8B4C451584B9FE0A371E9AB0"><enum>(iv)</enum><text>The amount of any cost-sharing for which the participant or beneficiary is responsible for each item or service (as of the date of such notification).</text></clause>
<clause id="HEE8E9A1676EB4A9AB99A3DF099B7DB52"><enum>(v)</enum><text>The amount that the participant or beneficiary has incurred toward meeting the limit of the financial responsibility (including with respect to deductibles and out-of-pocket maximums) under the plan (as of the date of such notification).</text></clause> <clause commented="no" display-inline="no-display-inline" id="H9CDC59AE2F2147838256FD80BFC0962D"><enum>(vi)</enum><text>The site of each item or service.</text></clause></subparagraph></paragraph>
<paragraph id="HB6B5341B5E22456387298E2DF1959223"><enum>(2)</enum><header>Format</header><text>If applicable, the notification described in paragraph (1) may be provided in conjunction with, or as part of, a notice of a claim determination or other communication required by section 503 of the Employee Retirement Income Security Act of 1974 or regulations thereunder.</text></paragraph></subsection> <subsection id="HC17EE665B306424F9F6E72ED35DCA667"><enum>(h)</enum><header>Regulations</header><text>The Secretary shall implement this section through notice and comment rulemaking in accordance with section 553 of title 5, United States Code.</text></subsection><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection>
<subsection id="HA8061475ABC44AA6B2000922BA41743F"><enum>(c)</enum><header>ERISA amendments</header>
<paragraph id="H8558FBB5BCC5434DB5379036685C44FB"><enum>(1)</enum><header>Emergency services</header><text>Section 716(f)(1)(C) of the Employee Retirement Income Security Act of 1974 (<external-xref legal-doc="usc" parsable-cite="usc/29/1185e">29 U.S.C. 1185e(f)(1)(C)</external-xref>) is amended to read as follows:</text> <quoted-block style="OLC" display-inline="no-display-inline" id="HF71CC8A3977346A3B777F290CF23B00C"> <subparagraph id="H5D9FC13ADE3A40569C23BEB63E83AA01"><enum>(C)</enum><text>A good faith estimate of the amount the health plan is responsible for paying for items and services included in the estimate described in subparagraph (B), including a plain language description of each item or service and all applicable billing codes for each item or service, including modifiers, using standard and commonly recognized billing code sets that are clearly identified.</text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph>
<paragraph id="H1AE92E31304A4D5FB3FB2F79BD39C6DB"><enum>(2)</enum><header>Explanation of benefits</header><text>Section 716 of the Employee Retirement Income Security Act of 1974 (<external-xref legal-doc="usc" parsable-cite="usc/29/1185e">29 U.S.C. 1185e</external-xref>) is amended by adding at the end the following:</text> <quoted-block style="OLC" display-inline="no-display-inline" id="HC9D8E0427BDA421CA7424AA291B91B61"> <subsection id="H81761A10188F4E24AF960046CBF5EA21"><enum>(g)</enum><header>Explanation of benefits</header> <paragraph id="HDD40BDF2DB8540CABB5D09AEF7E662C5"><enum>(1)</enum><header>In general</header><text>For plan years beginning on or after January 1, 2027, each group health plan or health insurance issuer offering group health insurance coverage shall, within 45 days of receiving any request for payment for an item or service under the plan, provide to the participant or beneficiary (through mail or electronic means, as requested by the participant or beneficiary) a notification (in clear and understandable language and utilizing substantially the same format as the advanced explanation of benefits required by subsection (f) to enable comparison) including the following:</text>
<subparagraph id="H52FB43BE297C47AF830465E3EE789924"><enum>(A)</enum><text>Whether or not the provider or facility is a participating provider or a participating facility with respect to the plan or coverage with respect to the furnishing of such item or service.</text></subparagraph> <subparagraph id="H858C40603FA94927B9E563DFDE546309"><enum>(B)</enum><text>An itemized explanation of benefits that includes the following:</text>
<clause id="HC3D0055275384A5993A669E12AE61C34"><enum>(i)</enum><text>A plain language description of each item or service.</text></clause> <clause id="H14FCEE6791B244AE9C5F2D70C77C3024"><enum>(ii)</enum><text>All applicable billing codes for each item or service, including modifiers, using standard and commonly recognized billing code sets that are clearly identified.</text></clause>
<clause id="H00FC8FC3EED4445EB6ED9D209F663646"><enum>(iii)</enum><text>The amount the plan or coverage is responsible for paying for each item or service.</text></clause> <clause id="HB5C8F7C57A2F41F98420D74202133443"><enum>(iv)</enum><text>The amount of any cost-sharing for which the participant or beneficiary is responsible for each item or service (as of the date of such notification).</text></clause>
<clause id="HC5223D09E3B24587BF6EC7AB11DD5E06"><enum>(v)</enum><text>The amount that the participant or beneficiary has incurred toward meeting the limit of the financial responsibility (including with respect to deductibles and out-of-pocket maximums) under the plan or coverage (as of the date of such notification).</text></clause> <clause commented="no" display-inline="no-display-inline" id="H40137FEB6A364F62A7E166E0A2F31D1B"><enum>(vi)</enum><text>The site of each item or service.</text></clause></subparagraph></paragraph>
<paragraph id="H9D3BB53F1D9E46F7A25FD384609FB80E"><enum>(2)</enum><header>Format</header><text>If applicable, the notification described in paragraph (1) may be provided in conjunction with, or as part of, a notice of a claim determination or other communication required by section 503 or regulations thereunder.</text></paragraph></subsection> <subsection id="HE91E979401E045F4A831FB8574588612"><enum>(h)</enum><header>Regulations</header><text>The Secretary shall implement this section through notice and comment rulemaking in accordance with section 553 of title 5, United States Code.</text></subsection><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection></section>
<section id="HE4F33B6346BA4914BF08F2D82961A8B3"><enum>311.</enum><header>Provision of itemized bills</header><text display-inline="no-display-inline">Part E of title XXVII of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300gg-131">42 U.S.C. 300gg–131 et seq.</external-xref>) is amended by adding at the end the following:</text> <quoted-block style="OLC" display-inline="no-display-inline" id="HE34EB2EE5426491AB8207EBB095E66FA"> <section id="H85DFA4735280488799045C3A37A1AFB1"><enum>2799B–10.</enum><header>Provider requirements for itemized bills</header> <subsection id="H365EE95413864D26B6ED90ECA47B1A9A"><enum>(a)</enum><header>Requirements</header> <paragraph id="H91EDE8DCFE264A1DADA63BC0816503E9"><enum>(1)</enum><header>Itemized bill and other information required</header> <subparagraph id="HE73D54F2B3D24909AEE58562A77973A0"><enum>(A)</enum><header>In general</header><text>A health care provider or health care facility that requests payment from an individual after providing a health care item or service to the patient shall include with such request a written, itemized bill of the cost of each reasonably expected item or service the health care provider or health care facility provided to the individual, including telehealth visits or visits by other electronic means. The health care provider or health care facility shall provide the itemized bill not later than 30 days after the health care provider or health care facility received a final payment on the provided service or supply from a third party.</text></subparagraph>
<subparagraph id="HD4B53AB0B39B47C8A22820E172A08607"><enum>(B)</enum><header>Required information</header><text>For each item or service provided by the health care provider or facility or for which the health care provider or facility is billing the individual, the itemized bill must include—</text> <clause id="HD061CD0B94584AFCAFFA404326EEB7C9"><enum>(i)</enum><text>a plain language description of each distinct health care item or service;</text></clause>
<clause id="HB58AA4EE18344633AC00AA4A4B12D776"><enum>(ii)</enum><text>all applicable billing codes for each distinct health care item or service, including modifiers, using standard and commonly recognized billing code sets that are clearly identified;</text></clause> <clause id="H5B60AF3A21D543478B544BC59BDA7FF1"><enum>(iii)</enum><text>the price and billed amount, if different, of each distinct health care item or service or if the provider or facility is offering binding, all-in prices for bundled items and services, the total binding price for bundled items and services and billed amount;</text></clause>
<clause id="H856002103A354B42BE5A802FC961AF17"><enum>(iv)</enum><text>any payments made to the health care provider or health care facility by or on behalf of the individual (including payments by any health plan or insurance) for any health care item or service covered in the itemized bill;</text></clause> <clause id="H44DBA15E20754CF695C287528BCD1F37"><enum>(v)</enum><text>information about the availability of language-assistance services for individuals with limited English proficiency (LEP);</text></clause>
<clause id="H557D4D587DBA423BBB4872336B66A1BC"><enum>(vi)</enum><text>the identification of an office or individual at the health care provider or health care facility, including phone number and email address, that shall be able to discuss the specific details of the itemized statement and be authorized to make appropriate changes thereto; and</text></clause> <clause id="H2B8A1955916742BB86AA1297DC217F99"><enum>(vii)</enum><text>information about the health care provider’s or health care facility’s charity care policies and instructions on how to apply for charity care.</text></clause></subparagraph></paragraph>
<paragraph id="H3CAF7010A2C444A192F251414EE63481"><enum>(2)</enum><header>Collections actions</header>
<subparagraph commented="no" display-inline="no-display-inline" id="HAF20F26E9F0D4927A1676FE100A2F86E"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">A health care provider or health care facility shall not take any collections actions against an individual—</text> <clause id="H880C01636B5946E49F5A1FDD9490CE23"><enum>(i)</enum><text>for any provided health care item or service unless the health care provider or health care facility has complied with paragraph (1); or</text></clause>
<clause id="HB229E7E93862416C99588E2857A5C6AB"><enum>(ii)</enum><text>with respect to any items or services for which the amount appearing on an itemized bill described above in paragraph (1) exceeds the amount disclosed pursuant to Federal health care price transparency regulations, including part 180 of title 45, Code of Federal Regulations, or provided in a good faith estimate that complies with section 2799B–6 of this Act and section 149.610 of title 45, Code of Federal Regulations, or another good faith estimate provided by a health care entity covered under this section but not otherwise covered under such section 2799B–6 unless the provider or facility documents that the additional items or services were medically necessary due to unforeseen complications or a patient-initiated change, and could not reasonably have been anticipated.</text></clause></subparagraph> <subparagraph commented="no" display-inline="no-display-inline" id="H0444C2EA887448D7A8FBF2A01FB6DB8D"><enum>(B)</enum><header>Burden of proof</header><text display-inline="yes-display-inline">The burden of proof under subparagraph (A)(ii) shall rest with the provider, and absent the documentation described in such subparagraph, the good faith estimate shall be binding.</text></subparagraph></paragraph></subsection>
<subsection id="H5015727FC9524B079A91F4C0DB91506E"><enum>(b)</enum><header>Failure To comply</header>
<paragraph id="HCA07EF34C1CA454685E5E0042A10E1CA"><enum>(1)</enum><header>Penalties</header><text>The Secretary shall impose penalties on any health care provider or health care facility that fails to comply with the requirements of this section in an amount not to exceed $10,000 for each instance of failure to comply.</text></paragraph> <paragraph id="HAEB7A4EF255D47B09B982712B0994E79"><enum>(2)</enum><header>Presumption in favor of individual</header><text>If a health care provider or health care facility fails to comply with the requirements of this section, the presumption shall be that charges were substantially in excess of the good faith estimate (as set forth in section 2799B–6) for the purpose of any patient-provider dispute, including in accordance with section 2799B–7 and regulations promulgated thereunder.</text></paragraph></subsection>
<subsection id="HC8BB8052B5654B3FA28F1FB4DF32C158"><enum>(c)</enum><header>Regulations</header><text>The Secretary shall implement this section through notice and comment rulemaking in accordance with section 553 of title 5, United States Code.</text></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></section> <enum>IV</enum><header>Protecting Patient Access to Cancer and Complex Therapies</header> <section id="H341580608C294220B20AF9F43B754E30"><enum>401.</enum><header>Short title</header> <text display-inline="no-display-inline">This title may be cited as the <quote><short-title>Protecting Patient Access to Cancer and Complex Therapies Act</short-title></quote>.</text></section>
<section id="H726B22924E24451FBF4C1EBE3AADA806"><enum>402.</enum><header>Rebate by manufacturers for selected drugs and biological products subject to maximum fair price negotiation</header>
<subsection id="H57A2457794A9419AB99DC2529BD84763"><enum>(a)</enum><header>Maintaining payments under part B based on ASP+6</header><text display-inline="yes-display-inline">Section 1847A(b)(1)(B) of the Social Security Act (42 U.S.C. 1395w–3a(b)(1)(B)) is amended by striking <quote>or in the case of such a drug or biological product that is a selected drug</quote> and all that follows through the semicolon and inserting a semicolon.</text></subsection> <subsection id="H70CF5BE644634BB4BC99C0D985BE8264"><enum>(b)</enum><header>Rebate by manufacturers for selected drugs and biological products subject to maximum fair price negotiation</header> <paragraph id="H823BAD54462248D18F44DC71CB6C4DC8"><enum>(1)</enum><header>In general</header><text>Section 1847A of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-3a">42 U.S.C. 1395w–3a</external-xref>) is amended—</text>
<subparagraph id="HB0CFEE9B03DD422BBD43A23E3C11D0FA"><enum>(A)</enum><text>by redesignating subsection (j) as subsection (k); and</text></subparagraph> <subparagraph id="HEAE47C7DEA4146588A07F46C2F69384E"><enum>(B)</enum><text>by inserting after subsection (i) the following new subsection:</text>
<quoted-block style="OLC" display-inline="no-display-inline" id="H6016D48AFB0B41D8AD8F19AD5930CF63">
<subsection id="H7CDF3108677F4760A64A0EF349F99CA0"><enum>(j)</enum><header>Rebate by manufacturers for selected drugs and biological products subject to maximum fair price negotiation</header>
<paragraph id="HD1A1FC6DB5EC47F1AB8D540812DF40B1"><enum>(1)</enum><header>Requirements</header>
<subparagraph id="H4F7E2F677F5B49BFA1350B146DEA3E91"><enum>(A)</enum><header>Secretarial provision of information</header><text>Not later than 6 months after the end of each calendar quarter beginning on or after the first day of the initial price applicability period (as defined in section 1191(b)(2)), the Secretary shall, for each selected drug (as defined in section 1192(c)) of each manufacturer with an agreement under section 1193 for which a maximum fair price is in effect and for which payment may be made under this part, report to each manufacturer of such selected drug the following for such calendar quarter during such price applicability period:</text> <clause id="H5A3A512205E24463AF3F422275F2B966"><enum>(i)</enum><text>Information on the total number of units of the billing and payment code for such selected drug furnished under this part during such calendar quarter.</text></clause>
<clause id="H5BEF7EA01CFA4D1491BF5FC70EF3E5B4"><enum>(ii)</enum><text>Information on the sum of—</text> <subclause id="HC70DEB27D75A4F5D8951BBBD41E9477A"><enum>(I)</enum><text>the amount (if any) by which—</text>
<item id="H6E12185B984547589259C31FDFBD661F"><enum>(aa)</enum><text>the ASP+6 payment amount (as defined in paragraph (5)) for such drug and calendar quarter, less the ASP+6 coinsurance amount for such drug and calendar quarter; exceeds</text></item> <item id="H593377FAFEDC4807ABD3A011021BE66E"><enum>(bb)</enum><text>the MFP+6 payment amount (as so defined) for such drug and calendar quarter, less the MFP+6 coinsurance amount for such drug and calendar quarter; and</text></item></subclause>
<subclause id="H044FBF4C3C524EE889F6117A6FD90F6E"><enum>(II)</enum><text>the amount (if any) by which—</text> <item id="H20BF1D5D2E274380B58177E5670737A3"><enum>(aa)</enum><text>the ASP+6 coinsurance amount (as defined in paragraph (5)) for such drug and calendar quarter; exceeds</text></item>
<item id="HC1A33DF07DCA48E1AB66DCA723BFBFDC"><enum>(bb)</enum><text>the MFP+6 coinsurance amount (as so defined) for such drug and calendar quarter.</text></item></subclause></clause> <clause id="HA8DC7EDD45064FFA84C1FA3A2094AA7B"><enum>(iii)</enum><text>The rebate amount specified under subparagraph (B) for such drug and calendar quarter.</text></clause></subparagraph>
<subparagraph id="H2DAED7CB4E3646DD962B579C823B321D"><enum>(B)</enum><header>Manufacturer requirement</header><text>For each calendar quarter beginning on or after the first day of the initial price applicability period (as defined in section 1191(b)(2)), the manufacturer of a selected drug shall, for such drug, not later than 30 days after the date of receipt from the Secretary of the information described in subparagraph (A) for such calendar quarter, provide to the Secretary a rebate that is equal to the amount specified in subparagraph (A)(ii) multiplied by the number of units specified in subparagraph (A)(i) for such drug for such calendar quarter. The rebate required under this subparagraph shall be in addition to any other rebates required under this title or title XIX, including the payments required under subsections (h) and (i).</text></subparagraph></paragraph> <paragraph id="HCE362F216D2E4B2C9A75D8A006150455"><enum>(2)</enum><header>Calculation of beneficiary coinsurance based on mfp+6</header> <subparagraph id="HB51DF6E066E647F7B7A76DAAD0A8F497"><enum>(A)</enum><header>In general</header><text>Subject to subparagraph (B), in the case of a selected drug with respect to which a rebate is paid under this subsection—</text>
<clause id="HE61D88C721384847B2D78F5F0E3AC9A7"><enum>(i)</enum><text>the amount of any coinsurance applicable under this part to an individual to whom such drug is furnished during a calendar quarter shall be equal to the MFP+6 coinsurance amount; and</text></clause> <clause id="HB3052892FED041AD9CECEBD250E08437"><enum>(ii)</enum><text display-inline="yes-display-inline">the amount of such coinsurance for such calendar quarter shall be applied as a percent, as determined by the Secretary, to the payment amount that would otherwise apply under subsection (b)(1)(B).</text></clause></subparagraph>
<subparagraph commented="no" id="H1BCA15206A1248BBACFC11B7031BCDC5"><enum>(B)</enum><header>Clarification regarding application of inflation rebate</header><text>If a rebate is required under subsection (i) with respect to a selected drug for a calendar quarter, the lesser of the amount of coinsurance computed under subparagraph (A) or the coinsurance computed under subsection (i)(5) shall apply for such drug and calendar quarter.</text></subparagraph></paragraph> <paragraph id="H0DDD72F570C94332BA992C77F9BC3787"><enum>(3)</enum><header>Rebate deposits</header><text>Amounts paid as rebates under paragraph (1)(B) shall be deposited into the Federal Supplementary Medical Insurance Trust Fund established under section 1841.</text></paragraph>
<paragraph id="H1E21E29E20AE4BBDB5B44CAFCECA6034"><enum>(4)</enum><header>Civil money penalty</header><text>The civil money penalty established under paragraph (7) of subsection (i) shall apply to the failure to comply with this subsection in the same manner as such penalty applies to failures to comply with the requirements under paragraph (1)(B) of subsection (i).</text></paragraph> <paragraph id="H771CAE4F5D12493BB8604F7E2125503D"><enum>(5)</enum><header>Definitions</header><text>In this subsection, with respect to a selected drug for a calendar quarter during a price applicability period:</text>
<subparagraph id="H19B423EEE17F41B3923F533AB741228A"><enum>(A)</enum><header>ASP+6 coinsurance amount</header><text>The <term>ASP+6 coinsurance amount</term> is equal to 20 percent of the ASP+6 payment amount.</text></subparagraph> <subparagraph id="H16B39587D7B543F1866AFD23538B18B7"><enum>(B)</enum><header>ASP+6 payment amount</header><text>The <term>ASP+6 payment amount</term> is equal to 106 percent of the amount determined under paragraph (4) of subsection (b) for such drug during such calendar quarter.</text></subparagraph>
<subparagraph id="H2CABB07B3A71496694432B259796CC0D"><enum>(C)</enum><header>MFP+6 coinsurance amount</header><text>The <term>MFP+6 coinsurance amount</term> is equal to 20 percent of the MFP+6 payment amount.</text></subparagraph> <subparagraph id="HBD4812DFDA07439F9C19FB5E228E08FC"><enum>(D)</enum><header>MFP+6 payment amount</header><text>The <term>MFP+6 payment amount</term> is equal to 106 percent of the maximum fair price (as defined in section 1191(c)(2)) applicable for such drug during such calendar quarter.</text></subparagraph></paragraph>
<paragraph id="H3E720A4E1159419B83DF9F2BB719CBE9" commented="no"><enum>(6)</enum><header>Clarification</header><text>Nothing in part E of title XI or this subsection shall be construed to require a manufacturer to provide selected drugs at maximum fair prices other than through the rebate required under this subsection.</text></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></subparagraph></paragraph> <paragraph id="HEECA67F6A0C544FB8260A499A078C460"><enum>(2)</enum><header>Amounts payable; cost-sharing</header><text>Section 1833(a)(1) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395l">42 U.S.C. 1395l(a)(1)</external-xref>) is amended—</text>
<subparagraph id="H30089F26163647D387232B3E9B773B87"><enum>(A)</enum><text>in subparagraph (G), by striking <quote>subsection (i)(9)</quote> and inserting <quote>paragraphs (9) and (10) of subsection (i)</quote>;</text></subparagraph> <subparagraph id="HFA50006745354E96A5078E2CC78861CA"><enum>(B)</enum><text>in subparagraph (S), by striking <quote>subparagraph (EE)</quote> and inserting <quote>subparagraphs (EE) and (II)</quote>;</text></subparagraph>
<subparagraph id="H6EC50D919A78444C9C7CB9DE909042CA"><enum>(C)</enum><text>by striking <quote>and (HH)</quote> and inserting <quote>(HH)</quote>; and</text></subparagraph> <subparagraph id="HEF7AB757D090436D8D724209DED0558C"><enum>(D)</enum><text>by inserting before the semicolon at the end the following: <quote>, and (II) with respect to a selected drug (as defined in section 1192(c)) that is subject to a rebate under section 1847A(j), the amounts paid shall be equal to the percent of the payment amount otherwise determined under section 1847A(b)(1)(B) that equals the difference between (i) 100 percent, and (ii) the percent applied under section 1847A(j)(2)(A)(ii)</quote>.</text></subparagraph></paragraph>
<paragraph id="H3873200B1B9841DF9F9AEFA0C32ED9E8"><enum>(3)</enum><header>ASC conforming amendments</header><text>Section 1833(i) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395l">42 U.S.C. 1395l(i)</external-xref>) is amended by adding at the end the following new paragraph:</text> <quoted-block style="OLC" display-inline="no-display-inline" id="HB9E1C1361605474F8D62E06758409632"> <paragraph id="H5D5F6496CBCA4D4EB91A6268FE9AF2C3"><enum>(11)</enum><text>In the case of a selected drug (as defined in section 1192(c)), subject to a rebate under section 1847A(j) for which payment under this subsection is not packaged into a payment for a service furnished on or after the initial price applicability year for the selected drug under the revised payment system under this subsection, in lieu of calculation of coinsurance and the amount of payment otherwise applicable under this subsection, the provisions of section 1847(j)(2) and paragraph (1)(II) of subsection (a), shall, as determined appropriate by the Secretary, apply under this subsection in the same manner as such provisions of section 1847A(j)(2) and subsection (a) apply under such section and subsection.</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph>
<paragraph id="HF2A5A4839C0B447C8723E20B6B04F2DC">
<enum>(4)</enum>
<header>OPPS conforming amendment</header>
<text>Section 1833(t)(8) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395l">42 U.S.C. 1395l(t)(8)</external-xref>) is amended by adding at the end the following new subparagraph:</text>
<quoted-block style="OLC" display-inline="no-display-inline" id="HFDDDB4C7115749F281D065ADA07161BB">
<subparagraph id="H082E1E7E461A43BCA625DB83E9CA9584">
<enum>(G)</enum>
<header>Selected drugs subject to rebate</header>
<text>In the case of a selected drug (as defined in section 1192(c)), subject to a rebate under section 1847A(j) for which payment under this subsection is not packaged into a payment for a covered OPD service (or group of services) furnished on or after the initial price applicability year for the selected drug, and the payment for such drug is the same as the amount for a calendar quarter under section 1847A(b)(1)(B), under the system under this subsection, in lieu of the calculation of the copayment amount and the amount otherwise applicable under this subsection (other than the application of the limitation described in subparagraph (C)), the provisions of section 1847A(j)(2) and paragraph (1)(II) of subsection (a), shall, as determined by the Secretary apply under this section in the same manner as such provisions of section 1847A(j)(2) and subsection (a) apply under such section and subsection.</text>
</subparagraph>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</paragraph>
<paragraph id="HF14BCE99D151426799E176CF45ED2B90"><enum>(5)</enum><header>Exclusion of selected drug mfp rebates from asp calculation</header><text>Section 1847A(c)(3) of the Social Security Act (42 U.S.C. 1395w–3a(c)(3)) is amended by striking <quote>subsection (i)</quote> and inserting <quote>subsection (i), subsection (j)</quote>.</text></paragraph> <paragraph id="H78B3ECB0FCB84A95963FD80A8F7CA30A"><enum>(6)</enum><header>Coordination with medicaid rebate information disclosures</header><text>Section 1927(b)(3)(D)(i) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396r-8">42 U.S.C. 1396r–8(b)(3)(D)(i)</external-xref>) is amended by striking <quote>and the rebate</quote> and inserting <quote>and the rebates</quote>.</text></paragraph>
<paragraph id="H72292CB5576A4FC3A9997E2C236E8769"><enum>(7)</enum><header>Provision of rebates</header><text>Section 1193(a) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1320f-2">42 U.S.C. 1320f–2(a)</external-xref>) is amended—</text> <subparagraph id="HDDDC826F9278439298C2BEFF6D78478A"><enum>(A)</enum><text>in paragraph (1), by striking subparagraph (B) and inserting the following:</text>
<quoted-block style="OLC" display-inline="no-display-inline" id="H9E39608F2B934F019770CF147AB5EA7B">
<subparagraph id="H8ABE2E75822244899459242B0E0C8314"><enum>(B)</enum><text>by paying rebates in accordance with section 1847A(j);</text></subparagraph><after-quoted-block>;</after-quoted-block></quoted-block></subparagraph> <subparagraph id="HCB5E67A5748D4B59BE467685E8CCBD13"><enum>(B)</enum><text>in paragraph (2), by striking subparagraph (B) and inserting the following:</text>
<quoted-block style="OLC" display-inline="no-display-inline" id="H94D2AB9EA0964D77A263BFD09C1AB77B">
<subparagraph id="HA764C23463FA45779265A487FBCCFF14"><enum>(B)</enum><text>by paying rebates in accordance with section 1847A(j);</text></subparagraph><after-quoted-block>; and</after-quoted-block></quoted-block></subparagraph> <subparagraph id="H0783B013BD9042A192C8A614FE4B25CA"><enum>(C)</enum><text>in paragraph (3), by striking subparagraph (B) and inserting the following:</text>
<quoted-block style="OLC" display-inline="no-display-inline" id="H485D9D7425794C38A6351C89DD1ADD25">
<subparagraph id="HC92222896E674DE2BE8D76DB7A48DFBC"><enum>(B)</enum><text>by paying rebates in accordance with section 1847A(j);</text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></subparagraph></paragraph></subsection> <subsection id="HE53A4A47D81D45F3938AAA2F1C7FF630"><enum>(c)</enum><header>Conforming amendments</header> <paragraph id="HF9C91A460F5846D19F83E6FF2C403510"><enum>(1)</enum><text>Section 1847A(i)(5) of the Social Security Act (42 U.S.C. 1395w–3a(i)(5)) is amended, in the matter preceding subparagraph (A)—</text>
<subparagraph id="H0216B0CC6F6C4C52A064E9D46565BDC3"><enum>(A)</enum><text>by striking <quote>In the case</quote> and inserting <quote>Subsection to subsection (j)(2)(B), in the case</quote>; and</text></subparagraph> <subparagraph id="HFAB540BE20DA4C6986DB1AA323249AE8"><enum>(B)</enum><text>by striking <quote>(or, in the case of a part B rebatable drug that is a selected drug (as defined in section 1192(c)), the payment amount described in subsection (b)(1)(B) for such drug)</quote>; and</text></subparagraph></paragraph>
<paragraph id="HEAF4027605954ACB83FD8FAA875094BD"><enum>(2)</enum><text>Section 1833(a)(1)(EE) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395l">42 U.S.C. 1395l(a)(1)(EE)</external-xref>) is amended—</text> <subparagraph id="HAFD3D852403845B6948F294224619A0F"><enum>(A)</enum><text>by striking <quote>(or, in the case of a part B rebatable drug that is a selected drug (as defined in section 1192(c) for which, the payment amount described in section 1847A(b)(1)(B)) for such drug for such quarter</quote>; and</text></subparagraph>
<subparagraph id="HAB07983B14BC458BB2638A086CB1CC2A"><enum>(B)</enum><text>by striking <quote>or section 1847A(b)(1)(B), as applicable,</quote>.</text></subparagraph></paragraph></subsection></section> <enum>V</enum><header>Expanded-access Prescription Drugs</header> <section id="H620437CCC3E64E1CABAC5D5AE2917AEE" section-type="subsequent-section"><enum>501.</enum><header>Expanded-access prescription drugs</header> <subsection id="H3807C51F13434874AF3D86BC1A4A797E"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Section 503(b) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/353">21 U.S.C. 353(b)</external-xref>) is amended by adding at the end the following:</text>
<quoted-block style="OLC" id="H2B87C142C6014D8FB04CDB4DCD11B9F2" display-inline="no-display-inline">
<paragraph id="H02DE5A939A41452EA886A0471F6C07E4" indent="up1"><enum>(6)</enum><header>Expanded-access prescription drugs</header>
<subparagraph id="HC00A35F3F5AE4A9C86AA2B845A7AB075"><enum>(A)</enum><header>Establishment of list</header><text display-inline="yes-display-inline">The Secretary shall establish and maintain a list of expanded-access prescription drugs.</text></subparagraph> <subparagraph id="H6CD0CD415AB84E0E9B97F356A98EF549"><enum>(B)</enum><header>Designation</header><text display-inline="yes-display-inline">The Secretary shall designate such expanded-access prescription drugs based on safety data, evidence of low risk, and suitability for assessment in a pharmacy or similar setting (such as certain antibiotics for minor infections, antivirals, hormonal therapies, and maintenance drugs for chronic conditions).</text></subparagraph>
<subparagraph id="HF881E335A6BF449B9466668F41A243B2"><enum>(C)</enum><header>Dispensing and administering</header><text display-inline="yes-display-inline">Notwithstanding paragraph (1), an expanded-access prescription drug may be dispensed and administered by a covered individual after conducting an appropriate patient assessment consistent with protocols to be issued by the Secretary.</text></subparagraph> <subparagraph id="H4ED323BDA707466193F3B891D9A92B79"><enum>(D)</enum><header>Rulemaking</header><text display-inline="yes-display-inline">Not later than 120 days after the date of enactment of this paragraph, the Secretary shall issue such regulations through notice-and-comment rulemaking as may be necessary to carry out this paragraph, including—</text>
<clause id="H7AF79816C6774D9ABD651F7F46A79D6C"><enum>(i)</enum><text display-inline="yes-display-inline">to establish and maintain the list under subparagraph (A); and</text></clause> <clause id="H1348E80DFB5C41E8BEB9BB16DBA641C7"><enum>(ii)</enum><text>to issue protocols under subparagraph (C).</text></clause></subparagraph>
<subparagraph id="H59D162ACE7F443A4B612D10BFD67E3DC"><enum>(E)</enum><header>Preemption</header>
<clause id="HB954A7642FA3493AA501472BBF9F1801"><enum>(i)</enum><header>In general</header><text display-inline="yes-display-inline">Except as provided in clause (ii), no State or political subdivision of a State may establish, enforce, or continue in effect with respect to an expanded-access prescription drug any provision of law or legal requirement, including with respect to licensure of a covered individual, that is different from, or is in conflict with, any requirement applicable under this paragraph.</text></clause> <clause id="H8FE6A11D17BA4164B08AD04C035D9382"><enum>(ii)</enum><header>State opt-out authority</header><text display-inline="yes-display-inline">The prohibition in clause (i) shall not apply in the case of a State (excluding a political subdivision thereof) that has in effect a law explicitly prohibiting or limiting the prescribing or dispensing of an expanded-access prescription drug by a covered individual.</text></clause></subparagraph>
<subparagraph id="H081359F9948A4852BF19DDAD43FA5421"><enum>(F)</enum><header>Covered individual defined</header><text display-inline="yes-display-inline">In this paragraph, the term <term>covered individual</term> means an individual who is licensed under applicable State law as—</text> <clause id="H764ADA705B0D481F822036998D7BBAB8"><enum>(i)</enum><text>a pharmacist;</text></clause>
<clause id="H26A4B9430D1F45D1A430C8DA3FB7AD26"><enum>(ii)</enum><text>an advanced practice registered nurse;</text></clause> <clause id="HFC7E08209DEF4CA9A9708D7F6C61A0C9"><enum>(iii)</enum><text>an advanced practice provider;</text></clause>
<clause id="H795032C664604803853201E18DD92E1D"><enum>(iv)</enum><text>a physician assistant; or</text></clause> <clause id="HC77B924701A44F349F7BEDEA4B85F1DA"><enum>(v)</enum><text display-inline="yes-display-inline">such other health care professional, as may be specified by the Secretary.</text></clause></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block> </subsection>
<subsection id="H32FA3716A1E8420581C0FB29F5EA048B"><enum>(b)</enum><header>Congressional report</header><text display-inline="yes-display-inline">Not later than 2 years after the date of enactment of this Act, the Secretary of Health and Human Services shall submit to Congress a report on the implementation of, and State opt-outs under, paragraph (6) of section 503(b) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/353">21 U.S.C. 353(b)</external-xref>) (as added by subsection (a)).</text></subsection></section> <section id="HA4860276F3704DCCA19861BEBB0D117D" commented="no"><enum>502.</enum><header>Government sponsored programs</header> <subsection id="H25868AA1A6764A7B90E68E5D47AFD149" commented="no"><enum>(a)</enum><header>Requirement</header><text display-inline="yes-display-inline">The President shall take such steps as are necessary to ensure that each Government sponsored program includes coverage for expanded-access prescription drugs administered by covered individuals to beneficiaries of the program.</text></subsection>
<subsection id="HE819DCA79C3F4AEEAED19B120953ECD7" commented="no"><enum>(b)</enum><header>Preemption</header><text display-inline="yes-display-inline">A covered individual may administer expanded-access prescription drugs pursuant to subsection (a) regardless of a provision of law or legal requirement in the State of the covered individual regarding the licensure or scope-of-practice of the individual.</text></subsection> <subsection id="H0729815B5976449F8A2311674CE2551C" commented="no"><enum>(c)</enum><header>Definitions</header><text>In this section:</text>
<paragraph id="H05EAF1FE03B148CCBE6AC04E1097AD12" commented="no">
<enum>(1)</enum>
<text display-inline="yes-display-inline">The term <term>covered individual</term> has the meaning given that term in section 503(b)(6) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/353">21 U.S.C. 353(b)(6)</external-xref>), as added by section 501 of this Act.</text>
</paragraph>
<paragraph id="HDBFCB9A5249A428899F93F96D46C9F04" commented="no"><enum>(2)</enum><text display-inline="yes-display-inline">The term <term>expanded-access prescription drugs</term> means drugs covered under such section 503(b)(6).</text></paragraph> <paragraph id="H06CC711A26EB476180460615BC765E6A" commented="no"><enum>(3)</enum><text>The term <term>Government sponsored program</term> means any coverage described in <external-xref legal-doc="usc" parsable-cite="usc/26/5000A">section 5000A(f)(1)(A)</external-xref> of the Internal Revenue Code of 1986.</text></paragraph></subsection></section>