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<dc:title>118 HR 3248 IH: Diagnostic Lab Testing Transparency Act</dc:title>
<dc:publisher>U.S. House of Representatives</dc:publisher>
<dc:date>2023-05-11</dc:date>
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<dc:language>EN</dc:language>
<dc:rights>Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.</dc:rights>
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<distribution-code display="yes">I</distribution-code><congress display="yes">118th CONGRESS</congress><session display="yes">1st Session</session><legis-num display="yes">H. R. 3248</legis-num><current-chamber>IN THE HOUSE OF REPRESENTATIVES</current-chamber><action display="yes"><action-date date="20230511">May 11, 2023</action-date><action-desc><sponsor name-id="M001215">Mrs. Miller-Meeks</sponsor> (for herself and <cosponsor name-id="D000197">Ms. DeGette</cosponsor>) introduced the following bill; which was referred to the <committee-name committee-id="HIF00">Committee on Energy and Commerce</committee-name>, and in addition to the Committee on <committee-name committee-id="HWM00">Ways and Means</committee-name>, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned</action-desc></action><legis-type>A BILL</legis-type><official-title display="yes">To amend title XVIII of the Social Security Act to increase price transparency of clinical diagnostic laboratory tests under the Medicare program.</official-title></form><legis-body id="H5538185C0DFF4CCA9785EFD7527C164C" style="OLC"><section id="HB529C35C738244B18A38ADF8F2C773A5" section-type="section-one"><enum>1.</enum><header>Short title</header><text display-inline="no-display-inline">This Act may be cited as the <quote><short-title>Diagnostic Lab Testing Transparency Act</short-title></quote>. </text></section><section id="H42A9B095C4D34353AD178BBB0F6FFC4A" section-type="subsequent-section"><enum>2.</enum><header>Increasing price transparency of clinical diagnostic laboratory tests under the Medicare program</header><text display-inline="no-display-inline">Section 1846 of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-2">42 U.S.C. 1395w–2</external-xref>) is amended—</text><paragraph id="H33556367716849D38C86DAC36D9E8342"><enum>(1)</enum><text>in the header, by inserting <quote><header-in-text level="section" style="OLC">and additional requirements</header-in-text></quote> after <quote><header-in-text level="section" style="OLC">sanctions</header-in-text></quote>; and</text></paragraph><paragraph id="H4C7CEEFAEDBC42C7B5B54CB296AFCC48"><enum>(2)</enum><text>by adding at the end the following new subsection:</text><quoted-block style="OLC" id="HB4D8399C38044E688D9721B33FDDAEEE" display-inline="no-display-inline"><subsection id="H51D64674EC57486A94F5F25A441A8E22"><enum>(c)</enum><header>Price transparency requirement</header><paragraph id="H232177A4CE9945BC855ECE28C0E7B948"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">Beginning January 1, 2025, each provider of services or supplier that is available to furnish any specified clinical diagnostic laboratory test under this title shall—</text><subparagraph id="H84B85776EFC940A48A42EF17FC47E3A0"><enum>(A)</enum><text display-inline="yes-display-inline">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 provider or supplier is so available to furnish; and</text></subparagraph><subparagraph id="HC9744CDBD2784F4282CF179CC679CF3E"><enum>(B)</enum><text>ensure that such information is updated not less frequently than annually.</text></subparagraph></paragraph><paragraph id="HF70FE7EDB9B7479083A6965751BDC565"><enum>(2)</enum><header>Information described</header><text display-inline="yes-display-inline">For purposes of paragraph (1), the information described in this paragraph is, with respect to a provider of services or supplier and a specified clinical diagnostic laboratory test, the following:</text><subparagraph id="H692C7F088D534F7D958B355C923765BE"><enum>(A)</enum><text display-inline="yes-display-inline">The discounted cash price for such test (or, if no such price exists, the gross charge for such test).</text></subparagraph><subparagraph id="H391C5E2D223B412EB794173997BD6618"><enum>(B)</enum><text display-inline="yes-display-inline">The deidentified minimum negotiated rate in effect between such provider or supplier and any group health plan or group or individual health insurance coverage for such test.</text></subparagraph><subparagraph id="H0F9A6058A26043AA8A624DBE1A911B60"><enum>(C)</enum><text display-inline="yes-display-inline">The deidentified maximum negotiated rate in effect between such provider or supplier and any such plan or coverage for such test.</text></subparagraph></paragraph><paragraph id="H16EEC1DB06B543D8978D5A696E586D0E"><enum>(3)</enum><header>Inclusion of ancillary services</header><text display-inline="yes-display-inline">Any price or rate for a specified clinical diagnostic laboratory test available to be furnished by a provider of services or supplier made publicly available in accordance with paragraph (1) shall include the price or rate (as applicable) for any ancillary item or service (such as specimen collection services) that would normally be furnished by such provider or supplier as part of such test, as specified by the Secretary.</text></paragraph><paragraph id="H08BEEFD2DE884CD488E60F3D9A58BFA8"><enum>(4)</enum><header>Enforcement</header><subparagraph id="H14DBDA4960054B6FA0591AE530BAE010"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">In the case that the Secretary determines that a provider of services or supplier is not in compliance with paragraph (1)—</text><clause id="H8F353E66E9A040EE9BFF64CEF317B118"><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="H46D92844740E451E86DBE74FB2CFBB2D"><enum>(ii)</enum><text>not later than 90 days after such notification is sent, such provider or supplier shall complete a corrective action plan to comply with such paragraph and submit such plan to the Secretary; and</text></clause><clause id="HE35CC1A5027C47A08EFE0768F13E3A0C"><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, the Secretary may impose a civil monetary penalty in an amount not to exceed $300 for each day (beginning with the date that is 91 days after such notification was sent) during which such failure is ongoing.</text></clause></subparagraph><subparagraph id="H424BDB7E6A9C4A18BB91E23410F25984"><enum>(B)</enum><header>Application of certain provisions</header><text display-inline="yes-display-inline">The provisions of section 1128A (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="HB0CACD7B0EE94641B16E870F60C209D1"><enum>(5)</enum><header>Definitions</header><text display-inline="yes-display-inline">In this subsection:</text><subparagraph id="H875E46E8CE1948E6B3191C9DA37D78AB"><enum>(A)</enum><header>Group health plan; group health insurance coverage; individual health insurance coverage</header><text>The terms <quote>group health plan</quote>, <quote>group health insurance coverage</quote>, and <quote>individual health insurance coverage</quote> have the meaning given such terms in section 2791 of the Public Health Service Act.</text></subparagraph><subparagraph id="H0A88D6130FB44D3A80A4BB80FE8DBAF8"><enum>(B)</enum><header>Specified clinical diagnostic laboratory test</header><text>The term <quote>specified clinical diagnostic laboratory test</quote> means a clinical diagnostic laboratory test that is included on the list of shoppable services specified by the Centers for Medicare &amp; Medicaid Services (as described in section 180.60 of title 42, Code of Federal Regulations (or a successor regulation)).</text></subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></section></legis-body></bill> 

