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<bill bill-type="olc" bill-stage="Introduced-in-Senate" dms-id="A1" public-private="public" slc-id="S1-KEL21735-7NX-0J-YV2">
<metadata xmlns:dc="http://purl.org/dc/elements/1.1/">
<dublinCore>
<dc:title>117 S2149 IS: Donald Payne, Sr., Colorectal Cancer Detection Act of 2021</dc:title>
<dc:publisher>U.S. Senate</dc:publisher>
<dc:date>2021-06-21</dc:date>
<dc:format>text/xml</dc:format>
<dc:language>EN</dc:language>
<dc:rights>Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.</dc:rights>
</dublinCore>
</metadata>
<form>
<distribution-code display="yes">II</distribution-code>
<congress>117th CONGRESS</congress><session>1st Session</session>
<legis-num>S. 2149</legis-num>
<current-chamber>IN THE SENATE OF THE UNITED STATES</current-chamber>
<action>
<action-date date="20210621">June 21, 2021</action-date>
<action-desc><sponsor name-id="S359">Mr. Heinrich</sponsor> (for himself, <cosponsor name-id="S318">Mr. Wicker</cosponsor>, and <cosponsor name-id="S413">Mr. Padilla</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 provide coverage under the Medicare program for FDA-approved qualifying colorectal cancer screening blood-based tests, to increase participation in colorectal cancer screening in under-screened communities of color, to offset the COVID–19 pandemic driven declines in colorectal cancer screening, and for other purposes.</official-title>
</form>
<legis-body style="OLC" display-enacting-clause="yes-display-enacting-clause" id="HCCEE4112D6CE4549B82524BBBE70341B">
<section commented="no" section-type="section-one" id="H7258FD13B4AB4A43949824B0CD6097E2"><enum>1.</enum><header>Short title</header><text display-inline="no-display-inline">This Act may be cited as the <quote><short-title>Donald Payne, Sr., Colorectal Cancer Detection Act of 2021</short-title></quote>.</text></section> <section id="H28A2DEC8CF86495B8173E5695E7E7145"><enum>2.</enum><header>Medicare coverage for FDA-approved qualifying colorectal cancer screening blood-based tests</header> <subsection id="HEFC972B62CBE498B94EDA9C3AD9B3D20"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Section 1861(pp) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395x">42 U.S.C. 1395x(pp)</external-xref>) is amended—</text>
<paragraph id="H82B347991C9940DDB07AE0FCFEF12C8C"><enum>(1)</enum><text>in paragraph (1)—</text> <subparagraph id="HB8D34C135A06468A8FCB7E54ED792553"><enum>(A)</enum><text>by redesignating subparagraph (D) as subparagraph (E); and</text></subparagraph>
<subparagraph id="H04E9EBB0EBEB433096F78EFD515F6A9E"><enum>(B)</enum><text>by inserting after subparagraph (C) the following new subparagraph:</text> <quoted-block style="OLC" display-inline="no-display-inline" id="H3DDDB5FEF09B4A058AB360E717CC8E57"> <subparagraph id="HDB764263955C401CA8A1D75F31F42EA2" indent="up1"><enum>(D)</enum><text display-inline="yes-display-inline">Qualifying colorectal cancer screening blood-based test.</text></subparagraph><after-quoted-block>; and</after-quoted-block></quoted-block></subparagraph></paragraph>
<paragraph id="HD06751E537F64EC1B152B26029FBCD28"><enum>(2)</enum><text>by adding at the end the following new paragraph:</text> <quoted-block style="OLC" display-inline="no-display-inline" id="H337A4249B70B42CFA0AEDC5ECED404C8"> <paragraph id="HB90BAFCF779246AFB80223D4830BFB09" indent="up1"><enum>(3)</enum><text display-inline="yes-display-inline">The term <term>qualifying colorectal cancer screening blood-based test</term> means, with respect to a year, a screening blood-based test for the early detection of colorectal cancer furnished in the year that was marketed or used, as applicable, in accordance with the relevant provisions of section 353 of the Public Health Service Act or the Federal Food, Drug, and Cosmetic Act more than 6 months before the beginning of the year.</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection>
<subsection id="HD28E52BDFE4E4775941ABFCDB7A1A200"><enum>(b)</enum><header>Frequency limits for colorectal cancer screening tests and payment amount for qualifying colorectal cancer screening blood-Based tests</header><text display-inline="yes-display-inline">Section 1834(d) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395m">42 U.S.C. 1395m(d)</external-xref>) is amended—</text> <paragraph id="HCC35318AA4404311BCFBEED7E8D2F53E"><enum>(1)</enum><text>by amending clause (ii) of paragraph (1)(B) to read as follows:</text>
<quoted-block style="OLC" display-inline="no-display-inline" id="H74875E52785D4C4EA95A93259034DE8E">
<clause id="H934BFE470F154F49B96404C42ED9114C"><enum>(ii)</enum><text display-inline="yes-display-inline">if the test is performed within—</text> <subclause commented="no" id="H7CE3269DE0044D729CB3AACDB65103BE"><enum>(I)</enum><text>the 11 months after a previous screening fecal-occult blood test or a previous qualifying colorectal cancer screening blood-based test;</text></subclause>
<subclause id="H5AC3B4C9DE074659BA83C8770B82E5C0"><enum>(II)</enum><text>the 35 months after a previous screening flexible sigmoidoscopy or a previous screening colonoscopy with adenoma findings;</text></subclause> <subclause commented="no" id="HBF66CAAC4C574C379BBBC063452520DA"><enum>(III)</enum><text>the 59 months after a previous screening colonoscopy with small polyp findings; or</text></subclause>
<subclause commented="no" id="H435CE65A2E664E4D86B9A3543E5AB5E8"><enum>(IV)</enum><text>the 119 months after a previous screening colonoscopy without adenoma findings or small polyp findings.</text></subclause></clause><after-quoted-block>;</after-quoted-block></quoted-block></paragraph> <paragraph id="H083CAC7AD54A45E9872AC462F2E473BE"><enum>(2)</enum><text>in paragraph (2)(E)(ii), by inserting <quote>or within the 35 months after a previous screening fecal-occult blood test or previous qualifying colorectal cancer screening blood-based test</quote> after <quote>sigmoidoscopy</quote>;</text></paragraph>
<paragraph id="H693B7BD4177B49B4BF0209C8125E358E"><enum>(3)</enum><text display-inline="yes-display-inline">by amending subparagraph (E) of paragraph (3) to read as follows:</text> <quoted-block style="OLC" display-inline="no-display-inline" id="H5948AC82D3A54A16A6245D6418DC2BB6"> <subparagraph id="HEDF25D25360F487694EEA3C4DBB9BC1B"><enum>(E)</enum><header>Frequency limit</header><text display-inline="yes-display-inline">No payment may be made under this part for a colorectal cancer screening test consisting of a screening colonoscopy—</text>
<clause id="H3184B455B00E47B0A78FBF261E241C9C"><enum>(i)</enum><text>if the procedure is performed within the 11 months after a previous screening fecal-occult blood test or previous qualifying colorectal cancer screening blood-based test;</text></clause> <clause id="HCF85937CC22D4B3881F4FEE278BDF42D"><enum>(ii)</enum><text>for individuals at high risk for colorectal cancer if the procedure is performed within the 23 months after a previous screening colonoscopy; or</text></clause>
<clause id="H00AB4AB8D1F24F77A4193A0DCCD5ABF8"><enum>(iii)</enum><text>for individuals not at high risk for colorectal cancer if the procedure is performed within the 119 months after a previous screening colonoscopy or within the 47 months after a previous screening flexible sigmoidoscopy.</text></clause></subparagraph><after-quoted-block>; and</after-quoted-block></quoted-block></paragraph> <paragraph id="HD8826F86CC6F4B65A11FC6381B33387C"><enum>(4)</enum><text>by adding at the end the following new paragraph:</text>
<quoted-block style="OLC" display-inline="no-display-inline" id="H8D5CF437B94644AC827BBCAD347548FE">
<paragraph commented="no" id="H561F718B0E794C7CBDD3E0E2AAF342DF"><enum>(4)</enum><header>Qualifying colorectal cancer screening blood-based tests</header>
<subparagraph commented="no" id="H81FB6E0ACC7E40AA9716F3E9958BB49B"><enum>(A)</enum><header>Payment amount</header><text display-inline="yes-display-inline">The payment amount for colorectal cancer screening tests consisting of qualifying colorectal cancer screening blood-based tests shall be established by the Secretary.</text></subparagraph> <subparagraph id="H517B9DF755DD4AF695C7FE300054E181"><enum>(B)</enum><header>Frequency limit</header><text>Paragraph (1)(B) shall apply to colorectal cancer screening tests consisting of qualifying colorectal cancer screening blood-based tests in the same manner as such paragraph applies to colorectal cancer screening tests consisting of fecal-occult blood tests.</text></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection>
<subsection id="H5BCEFA8B324D4D9DB92B42B16B5C7CB1"><enum>(c)</enum><header>Effective date</header><text display-inline="yes-display-inline">The amendments made by this section shall apply to colorectal cancer screening tests furnished in a year beginning more than 6 months after the date of the enactment of this Act.</text></subsection></section> </legis-body> </bill> 

