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<bill bill-stage="Introduced-in-Senate" dms-id="A1" public-private="public" slc-id="S1-KEL23156-S8T-X7-54S"><metadata xmlns:dc="http://purl.org/dc/elements/1.1/">
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<dc:title>118 S1000 IS: Saving Access to Laboratory Services Act</dc:title>
<dc:publisher>U.S. Senate</dc:publisher>
<dc:date>2023-03-28</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">II</distribution-code><congress>118th CONGRESS</congress><session>1st Session</session><legis-num>S. 1000</legis-num><current-chamber>IN THE SENATE OF THE UNITED STATES</current-chamber><action><action-date date="20230328">March 28, 2023</action-date><action-desc><sponsor name-id="S307">Mr. Brown</sponsor> (for himself and <cosponsor name-id="S384">Mr. Tillis</cosponsor>) introduced the following bill; which was read twice and referred to the <committee-name committee-id="SSFI00">Committee on Finance</committee-name></action-desc></action><legis-type>A BILL</legis-type><official-title>To amend title XVIII of the Social Security Act to improve the accuracy of market-based Medicare payment for clinical diagnostic laboratory services, to reduce administrative burdens in the collection of data, and for other purposes.</official-title></form><legis-body display-enacting-clause="yes-display-enacting-clause"><section section-type="section-one" id="S1"><enum>1.</enum><header>Short title</header><text display-inline="no-display-inline">This Act may be cited as the <quote><short-title>Saving Access to Laboratory Services Act</short-title></quote>.</text></section><section id="id44ef1adfdb05405ea15a948766a66040"><enum>2.</enum><header>Modification of requirements for medicare clinical diagnostic laboratory tests</header><subsection id="idcc162617344d4c5996cc969fc7a3002a"><enum>(a)</enum><header>Use of statistical sampling for widely available clinical diagnostic laboratory tests</header><paragraph id="id03529f9b5e374696b18c39a5c4d359dd"><enum>(1)</enum><header>In general</header><text>Section 1834A(a)(1) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395m-1">42 U.S.C. 1395m–1(a)(1)</external-xref>) is amended—</text><subparagraph id="iddadac1c8acc444c6ad8f94a23227dbad"><enum>(A)</enum><text>in subparagraph (A), by striking <quote>Subject to subparagraph (B)</quote> and inserting <quote>Subject to subparagraphs (B) and (C)</quote>; and</text></subparagraph><subparagraph id="id5cbc9ef0f61c4d33906b53326aa2f4ee"><enum>(B)</enum><text>by adding at the end the following new subparagraph:</text><quoted-block style="OLC" display-inline="no-display-inline" id="id62c04e527c0e4132aec99f1e79a5acaa"><subparagraph id="id71db57630c6b4c0198302990cf810acb"><enum>(C)</enum><header>Use of statistical sampling for widely available clinical diagnostic laboratory tests</header><clause id="id8e6d863aa6bc4bfe86427c10b24ba52c"><enum>(i)</enum><header>In general</header><text>Subject to clause (ii), with respect to data collection periods for reporting periods beginning on or after January 1, 2026, in the case of a widely available clinical diagnostic laboratory test (as defined in clause (iii)), in lieu of requiring the reporting of applicable information from each applicable laboratory, the Secretary shall require the collection and reporting of applicable information from a statistically valid sample of applicable laboratories for each such widely available clinical diagnostic laboratory test.</text></clause><clause id="id5e25aedb72514212af6f5ada6c7b9c81"><enum>(ii)</enum><header>Requirements for statistical sampling</header><subclause id="id5ce8c476ae154009a9d8868ed45d4902"><enum>(I)</enum><header>In general</header><text>The Secretary, in consultation with stakeholders, shall develop a methodology for a statistically valid sample under clause (i), using the maximal brewer selection method, as described in the June 2021 Medicare Payment Access Commission Report to the Congress, to establish the payment amount for a widely available clinical diagnostic laboratory test under paragraph (2) of subsection (b) for each applicable HCPCS code for a widely available clinical diagnostic laboratory test.</text></subclause><subclause id="id313712589b694c9ba9b4695df7d93319"><enum>(II)</enum><header>Representative sampling</header><text>The methodology under subclause (I) for a statistically valid sample under clause (i) shall, for each applicable HCPCS code for a widely available clinical diagnostic laboratory test—</text><item id="id4fb05497a3034422b1c0246976bc0a4d"><enum>(aa)</enum><text>provide for a sample that allows for the payment amounts established under paragraph (2) of subsection (b) for such a test to be representative of rates paid by private payors to applicable laboratories receiving payment under this section, including independent laboratories, hospital laboratories, hospital outreach laboratories, and physician office laboratories that furnish the widely available clinical diagnostic laboratory test;</text></item><item id="id3c94776f96be4da78626cda2633a1600"><enum>(bb)</enum><text>include applicable information (as defined in paragraph (3)) with respect to such widely available clinical diagnostic laboratory test from such different types of applicable laboratories; and</text></item><item id="idcb7e7a77aa424acea8e9f8a3ae908abf"><enum>(cc)</enum><text>be of sufficient size to accurately and proportionally represent the range of private payor payment rates received by each such type of applicable laboratory weighted according to the utilization rates of each type of applicable laboratory for the widely available clinical diagnostic laboratory test during the first 6 months of the calendar year immediately preceding the data collection period applicable to the sample to be collected.</text></item></subclause><subclause id="id5e8f2315a9364fc2a8b2cd054581724c"><enum>(III)</enum><header>Least burdensome data collection and reporting processes</header><text>The methodology developed by the Secretary shall be designed to reduce administrative burdens of data collection and reporting on applicable laboratories and the Centers for Medicare &amp; Medicaid Services to the greatest extent practicable.</text></subclause><subclause id="ide996d3e1936c4f78ac2b3f5b6507ec66"><enum>(IV)</enum><header>Publication of list of widely available clinical diagnostic laboratory tests and notification to applicable laboratories required to report applicable information</header><text>Not later than September 30 of the year immediately preceding each data collection period (as defined in paragraph (4)), the Secretary shall publish in the Federal Register a list of widely available clinical diagnostic laboratory tests and shall directly notify applicable laboratories required to report applicable information under this subsection.</text></subclause></clause><clause id="ideacbabdd4b044edabe5acebb1df1d6e6"><enum>(iii)</enum><header>Definition of widely available clinical diagnostic laboratory test</header><text>In this subparagraph, the term <term>widely available clinical diagnostic laboratory test</term> means a clinical diagnostic laboratory test that meets both of the following criteria during the first 6 months of the calendar year immediately preceding the data collection period applicable to the sample to be collected:</text><subclause id="idb8c41655af79444ca709df032736d33b"><enum>(I)</enum><header>Payment rate</header><text>The payment amount determined for the clinical diagnostic laboratory test under this section is less than $1,000 per test.</text></subclause><subclause id="id122105c454784bbc97a638e27df4d687"><enum>(II)</enum><header>Number of laboratories performing the test</header><text>The number of applicable laboratories receiving payments under this section for the clinical diagnostic laboratory test (as determined by the Secretary using the national provider identifier of the provider of services or supplier on the claim submitted for payment under this part for such test) exceeds 100.</text></subclause></clause></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></subparagraph></paragraph><paragraph id="id7efd111e4afd486683c360cdac5a4cab"><enum>(2)</enum><header>Delays to revised reporting periods and reporting period frequency</header><subparagraph id="id017ae828684540b8aae5dbe594f9dbe2"><enum>(A)</enum><header>In general</header><text>Section 1834A(a)(1)(B) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395m-1">42 U.S.C. 1395m–1(a)(1)(B)</external-xref>) is amended—</text><clause id="ida69800af2e76417495dffc3508741148"><enum>(i)</enum><text>in clause (i), by striking <quote>December 31, 2023</quote> and inserting <quote>December 31, 2026</quote>;</text></clause><clause id="id3f96cb97cf2f46f2b0d1ad3f3fd15f8a"><enum>(ii)</enum><text>in clause (ii), by striking <quote>beginning January 1, 2024, and ending March 31, 2024</quote> and inserting <quote>beginning January 1, 2027, and ending March 31, 2027</quote>; and</text></clause><clause id="id614e8e6bb2634b57995fd8561e0ae77e"><enum>(iii)</enum><text>in clause (iii) by striking <quote>every three years</quote> and inserting <quote>every four years</quote>. </text></clause></subparagraph><subparagraph id="ideb545d25bad54725b0449c96b529f8b3"><enum>(B)</enum><header>Conforming change to definition of data collection period</header><text>Section 1834A(a)(4)(B) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395m-1">42 U.S.C. 1395m–1(a)(4)(B)</external-xref>) is amended by striking <quote>January 1, 2019, and ending June 30, 2019</quote> and inserting <quote>January 1, 2026, and ending June 30, 2026</quote>.</text></subparagraph></paragraph></subsection><subsection id="id8c5455b27e224b0aba6dc51ac6fd07eb"><enum>(b)</enum><header>Elimination of majority of Medicare revenues test</header><text>The first sentence of section 1834A(a)(2) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395m-1">42 U.S.C. 1395m–1(a)(2)</external-xref>) is amended by striking <quote>In this section</quote> and all that follows through the period and inserting the following: <quote>Notwithstanding determinations of applicable laboratories made prior to January 1, 2025, the term <term>applicable laboratory</term> means a laboratory that receives at least $12,500 in payments under this section during the first 6 months of the calendar year immediately preceding the applicable data collection period.</quote>.</text></subsection><subsection id="id6736f1d32d4e4db89bd0ed74a95f24e8"><enum>(c)</enum><header>Modifications to applicable information reported</header><paragraph id="id4623d77d06074ffeb660e1dd2e18cfd8"><enum>(1)</enum><header>Medicaid managed care rates</header><text>Section 1834A(a)(8)(C) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395m-1">42 U.S.C. 1395m–1(a)(8)(C)</external-xref>) is amended by striking <quote>A medicaid managed care organization</quote> and inserting <quote>With respect to data collection periods for reporting periods beginning before January 1, 2027, a medicaid managed care organization (as defined in section 1903(m))</quote>.</text></paragraph><paragraph id="idbdfa5f90d61841069a2320d5af96bbcd"><enum>(2)</enum><header>Authority to exclude manual remittances</header><text>Section 1834A(a)(3) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395m-1">42 U.S.C. 1395m–1(a)(3)</external-xref>) is amended—</text><subparagraph id="id8ecb9b5e07294ebe90219e4c29547c42"><enum>(A)</enum><text>in subparagraph (A), by striking <quote>subject to subparagraph (B),</quote> and inserting <quote>subject to subparagraphs (B) and (C)</quote>; and</text></subparagraph><subparagraph id="id04e8db450aae4daea1c34249b41511ee"><enum>(B)</enum><text>by adding at the end the following new subparagraph:</text><quoted-block style="OLC" display-inline="no-display-inline" id="idD2354404AE2147C49F0C50B01A4534D4"><subparagraph id="idd74aefc400fb45648b8cc24e0ebd7092"><enum>(C)</enum><header>Exclusion of manual remittances</header><text>An applicable laboratory for which less than 10 percent of its total paid claims during a data collection period are paid by private payors by means other than an electronic standard transaction (as defined in section 162.103 of title 45, Code of Federal Regulations (or any successor regulation)) may exclude from the definition of applicable information under this paragraph payments made by private payors that are not made through an electronic standard transaction.</text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></subparagraph></paragraph></subsection><subsection id="id8fe27ca3d5f64de5aeb018bff3faf4d4"><enum>(d)</enum><header>Modification to limits on payment reductions; imposition of annual cap on payment increases</header><paragraph id="id3c682b79ad234b148157301a9f813268"><enum>(1)</enum><header>Payment reduction limits</header><text>Section 1834A(b)(3) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395m-1">42 U.S.C. 1395m–1(b)(3)</external-xref>) is amended—</text><subparagraph id="id29bf40d84716496ba0b5608af4b752f6"><enum>(A)</enum><text>in subparagraph (A), by striking <quote>for each of 2017 through 2026</quote> and inserting <quote>for 2017 and each succeeding year</quote>; and</text></subparagraph><subparagraph id="idc0524a0138a1424d9bdc8975367b6c06"><enum>(B)</enum><text>in subparagraph (B)—</text><clause id="id7E866508FFA44D31B21F46AAE2D61D4D"><enum>(i)</enum><text>in clause (ii)—</text><subclause commented="no" display-inline="no-display-inline" id="idb00746aac90f4f24b26697008c12caf7"><enum>(I)</enum><text display-inline="yes-display-inline">by striking <quote>through 2023</quote> and inserting <quote>through 2024</quote>; and</text></subclause><subclause commented="no" display-inline="no-display-inline" id="id3e0e0da0ccf24ee6a544b87157229cd3"><enum>(II)</enum><text display-inline="yes-display-inline">by striking <quote>and</quote> at the end; and</text></subclause></clause><clause id="id61BFB3E54973431DB9648EEF8E721645"><enum>(ii)</enum><text>by striking clause (iii) and inserting the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="idB214ED2684D646158187A04339AA4D49"><clause commented="no" display-inline="no-display-inline" id="id05bc5cd7967145e0a17f908ee9d5c23e"><enum>(iii)</enum><text display-inline="yes-display-inline">for 2025, 2.5 percent; and </text></clause><clause id="id4294284F07134CFA8E9A08A700AFC975"><enum>(iv)</enum><text>for 2026 and each subsequent year, 5 percent.</text></clause><after-quoted-block>.</after-quoted-block></quoted-block></clause></subparagraph></paragraph><paragraph id="id00bde6a13c8c4baba19271e5e63f98f0"><enum>(2)</enum><header>Annual cap on payment rate increases</header><text>Section 1834A(b)(3) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395m-1">42 U.S.C. 1395m–1(b)(3)</external-xref>), as amended by paragraph (1), is amended—</text><subparagraph commented="no" id="idca08b414103b42b09dd1d825173a1d8f"><enum>(A)</enum><text>in subparagraph (A)—</text><clause commented="no" id="idA0837EB0767E445E9A2FE575CCDF7664"><enum>(i)</enum><text>by striking <quote>test for 2017 and each succeeding year—</quote> and inserting </text><quoted-block style="OLC" display-inline="yes-display-inline" id="idDFD8D48AE8B446CBA1C097B9225A94C4"><text>test—</text><clause commented="no" id="idD7765764CDFE471E8B9C6C49A37EEC79"><enum>(i)</enum><text>for 2017 and each succeeding year</text></clause><after-quoted-block>;</after-quoted-block></quoted-block></clause><clause id="id8f7cc7a9e2734c8680fceb2b8d633147"><enum>(ii)</enum><text>in clause (i), as added by clause (i) of this subparagraph, by striking the period and inserting <quote>; and</quote>; and</text></clause><clause id="id67e1e89e2d184725b635c2422790674a"><enum>(iii)</enum><text>by adding at the end the following new clause:</text><quoted-block style="OLC" display-inline="no-display-inline" id="ide5e82e03cf2043059edc16a5710a0590"><clause id="id4a57252420c44556b7215d24fef4d4b9"><enum>(ii)</enum><text>for 2024 and each succeeding year, shall not result in an increase in payments for a clinical diagnostic laboratory test for the year of greater than the applicable percent (as defined in subparagraph (D)) of the amount of payment for the test for the preceding year.</text></clause><after-quoted-block>;</after-quoted-block></quoted-block></clause></subparagraph><subparagraph id="ida9ab3f589dda46c7b7d1e620de299f2e"><enum>(B)</enum><text>in subparagraph (B), in the matter preceding clause (i), by striking <quote>In this paragraph</quote> and inserting <quote>In clause (i) of subparagraph (A)</quote>; and</text></subparagraph><subparagraph id="id45de28a61aa747039225e36a80a6df86"><enum>(C)</enum><text>by adding at the end the following new subparagraph:</text><quoted-block style="OLC" display-inline="no-display-inline" id="id8E3ACDFE9D38409AAEBF9F1197D773DB"><subparagraph id="iddd910c4fa1ce4833a538b84a5c92facf"><enum>(D)</enum><header>Definition of applicable percent for purposes of annual cap on payment increases</header><text>In clause (ii) of subparagraph (A), the term <term>applicable percent</term> means the following:</text><clause id="id1134E3E9722B401AB016D62C3FA85C4D"><enum>(i)</enum><header>Widely available clinical diagnostic laboratory tests</header><text>With respect to a widely available clinical diagnostic laboratory test—</text><subclause id="id2221ed3b1a864eebbf511a82de8cefc1"><enum>(I)</enum><text>for each of 2024 and 2025, 2.5 percent;</text></subclause><subclause id="id27ca89e1f2f74d51964af57ddf707a8f"><enum>(II)</enum><text>for each of 2026 and 2027, 3.75 percent; and</text></subclause><subclause id="id55ea684d7e4b4a0687a4bbd24213db6a"><enum>(III)</enum><text>for 2028 and each subsequent year, 5 percent.</text></subclause></clause><clause id="id7E72795F853E4DB7B41F73124809BD7C"><enum>(ii)</enum><header>Other clinical diagnostic laboratory tests</header><text>With respect to a clinical diagnostic laboratory test not described in clause (i), 5 percent.</text></clause></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></subparagraph></paragraph><paragraph id="ide04204b0c6c84a5586f86dc73192d40c"><enum>(3)</enum><header>Conforming amendment</header><text>Section 1834A(b)(3) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395m-1">42 U.S.C. 1395m–1(b)(3)</external-xref>) is amended in the heading by striking <quote><header-in-text level="paragraph" style="OLC">reductions</header-in-text></quote> and inserting <quote><header-in-text level="paragraph" style="OLC">medicare payment changes</header-in-text></quote>.</text></paragraph></subsection><subsection id="id61366efe7ef745d494edc68a3be107af"><enum>(e)</enum><header>Regulations</header><paragraph commented="no" display-inline="yes-display-inline" id="id080A840CA6074269844A980E031688FD"><enum>(1)</enum><text>Not later than December 31, 2024, the Secretary of Health and Human Services shall implement the amendments made by this section (other than subsection (d)) through notice and comment rulemaking.</text></paragraph><paragraph id="id0668a5ec048f4ed89403c7d7daab1b0e" indent="up1"><enum>(2)</enum><text>The Secretary of Health and Human Services may implement the amendments made by subsection (d) through interim final rulemaking, program instruction, or otherwise. </text></paragraph></subsection></section></legis-body></bill>