<?xml version="1.0"?>
<?xml-stylesheet type="text/xsl" href="billres.xsl"?>
<!DOCTYPE bill PUBLIC "-//US Congress//DTDs/bill.dtd//EN" "bill.dtd">
<bill bill-stage="Introduced-in-House" dms-id="HAC708F66B2484FFBA82CF11D268D0034" public-private="public" key="H" bill-type="olc">
<metadata xmlns:dc="http://purl.org/dc/elements/1.1/">
<dublinCore>
<dc:title>117 HR 318 IH: Safe Testing at Residence Telehealth Act of 2021</dc:title>
<dc:publisher>U.S. House of Representatives</dc:publisher>
<dc:date>2021-01-13</dc:date>
<dc:format>text/xml</dc:format>
<dc:language>EN</dc:language>
<dc:rights>Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.</dc:rights>
</dublinCore>
</metadata>
<form>
<distribution-code display="yes">I</distribution-code>
<congress display="yes">117th CONGRESS</congress><session display="yes">1st Session</session>
<legis-num display="yes">H. R. 318</legis-num>
<current-chamber>IN THE HOUSE OF REPRESENTATIVES</current-chamber>
<action display="yes">
<action-date date="20210113">January 13, 2021</action-date>
<action-desc><sponsor name-id="S001183">Mr. Schweikert</sponsor> (for himself, <cosponsor name-id="R000515">Mr. Rush</cosponsor>, and <cosponsor name-id="K000376">Mr. Kelly of Pennsylvania</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 to provide coverage and payment for certain tests and assistive telehealth consultations during the COVID–19 emergency period, and for other purposes.</official-title>
</form>
<legis-body id="H691B8919A0FC4799A58F7DAD7AC67328" style="OLC">
<section id="H7F6608B4FB3C485A8C23544E1ED5CCB2" 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>Safe Testing at Residence Telehealth Act of 2021</short-title></quote>.</text></section> <section id="HE03CCB7F28014C4FA8CF2378A51A835B"><enum>2.</enum><header>Coverage and payment for certain tests and assistive telehealth consultations during the COVID–19 emergency period</header> <subsection id="H765C5298B8ED45828C70F053FD0E6B2C"><enum>(a)</enum><header>Coverage and payment rule</header> <paragraph id="H1C134F048B6146139D311E5A2838888F"><enum>(1)</enum><header>In general</header><text>Section 1834(m) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395m">42 U.S.C. 1395m(m)</external-xref>) is amended by adding at the end of the following new paragraph:</text>
<quoted-block style="OLC" id="HE99EAD8D07BC477E83022AEB7FC7D8C8" display-inline="no-display-inline">
<paragraph id="HFC0940F83F24477AA03E9C078684FD9F"><enum>(9)</enum><header>Coverage and payment for certain tests and assistive telehealth consultations during COVID–19 emergency period</header>
<subparagraph id="H7715447F261948A5A4478361C176DB80"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">During the emergency period described in section 1135(g)(1)(B), the Secretary shall pay for a test described in subparagraph (C) that is ordered and an assistive telehealth consultation that is furnished via a telecommunications system by a physician or practitioner to an eligible telehealth individual enrolled under this part notwithstanding that the individual physician or practitioner ordering the test did not furnish the test or that the individual physician or practitioner providing the assistive telehealth consultation is not at the same location as the beneficiary.</text></subparagraph> <subparagraph id="H75DDFE4EE4854D239C1EF1CE3EDD4378" display-inline="no-display-inline"><enum>(B)</enum><header>Payment amount</header><text display-inline="yes-display-inline">During the emergency period described in section 1135(g)(1)(B), the Secretary shall pay to a physician or practitioner located at a distant site that—</text>
<clause id="H1B38EABA180046A39F0B91C233B419AD"><enum>(i)</enum><text display-inline="yes-display-inline">orders a test described in subparagraph (C) to an eligible telehealth individual an amount equal to the amount that such physician or practitioner would have been paid for a diagnostic laboratory test under section 1833(h); and</text></clause> <clause id="H6A14FC60BCF143BFBDB489674BF8B7F0"><enum>(ii)</enum><text>furnishes an assistive telehealth consultation to an eligible telehealth individual an amount equal to the amount that a physician or practitioner would have been paid for such telehealth service under paragraph (2).</text></clause></subparagraph>
<subparagraph id="HA9CEF190DFC74014B078257ED2E46636"><enum>(C)</enum><header>Tests described</header><text display-inline="yes-display-inline">For purposes of subparagraphs (A) and (B), a test described in this subparagraph is a medical device (as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act) or is a test approved under an emergency use authorization under section 564 of such Act and is either—</text> <clause id="HC29668E28B8D426696D187437E129E57"><enum>(i)</enum><text>a diagnostic laboratory test for the diagnosis of influenza or a similar respiratory condition that is required to obtain a final diagnosis of COVID–19 for an individual when such test is ordered by a physician or practitioner in conjunction with a COVID–19 diagnostic laboratory test for purposes of discounting a diagnosis of influenza or a related diagnosis for such individual; or</text></clause>
<clause id="H869914EACC3D4FC2909F22656C085C66"><enum>(ii)</enum><text>a serology test for COVID–19.</text></clause></subparagraph> <subparagraph id="H1A7787BE28234156B332C321126545F6"><enum>(D)</enum><header>Other matters relating to documentation and claims review</header><text>The requirements of paragraphs (2) and (3) of section 410.32(d) of title 42, Code of Federal Regulations (as in effect on the date of the enactment of this paragraph), relating to documentation and claims review, respectively, shall apply to a test described in subparagraph (C) and an assistive telehealth consultation.</text></subparagraph>
<subparagraph id="HB3D70122A7B64858A951D277194E97A3"><enum>(E)</enum><header>Demographic data</header><text display-inline="yes-display-inline">To be eligible for reimbursement under this paragraph, each claim for reimbursement shall include, with respect to such an eligible telehealth individual, the following demographic data:</text> <clause id="H66A2FFFF90C444FA9113B9856977CB46"><enum>(i)</enum><text display-inline="yes-display-inline">Age.</text></clause>
<clause id="HC5B6C24757EC41C5B811C67175C40FD9"><enum>(ii)</enum><text>Race and ethnicity.</text></clause> <clause id="H62D909073BD142D689C33C08BD0A90B2"><enum>(iii)</enum><text>Gender.</text></clause>
<clause id="H35D4077A05A7462F8A1E1C0DA5CB6BC1"><enum>(iv)</enum><text display-inline="yes-display-inline">An affirmative or negative statement of the existence of any chronic condition.</text></clause> <clause id="HC451368361004EE88349DDE78209E1FC"><enum>(v)</enum><text>Any other information the Secretary determines appropriate.</text></clause></subparagraph>
<subparagraph id="HDD79D5B651714435AFDE3117E95B6193"><enum>(F)</enum><header>Assistive telehealth consultation</header><text>In this paragraph, the term <term>assistive telehealth consultation</term> means a telehealth service (as defined in paragraph (4)(F)) that is—</text> <clause id="H2D7139EFD0294DC5AD2509152D0B5253" display-inline="no-display-inline"><enum>(i)</enum><text display-inline="yes-display-inline">an evaluation and management service;</text></clause>
<clause id="H839DDC8CDBD440E69D482D11A0EAAFB5"><enum>(ii)</enum><text display-inline="yes-display-inline">an assessment of any evidence of systems which would make a diagnostic laboratory test necessary to be furnished in the home of an eligible telehealth individual;</text></clause> <clause id="HD2DBD89C70264AC388F09BB401F0FC77"><enum>(iii)</enum><text>the ordering of a diagnostic laboratory test;</text></clause>
<clause id="H581E042C80B54EAFAB8C4F6BE362C95D"><enum>(iv)</enum><text display-inline="yes-display-inline">an assessment of an individual succeeding the delivery of a diagnostic laboratory test;</text></clause> <clause id="H3ACD9319284B458A8AEE9F8AA0FBA286"><enum>(v)</enum><text display-inline="yes-display-inline">any assistance in the collection of a sample necessary for a diagnostic laboratory test and securing the sample for shipping;</text></clause>
<clause id="H1D9A7237D23D47AAA1A4C6B2582242A9"><enum>(vi)</enum><text display-inline="yes-display-inline">the referral of an eligible telehealth individual to a physician or practitioner for in-person treatment; or</text></clause> <clause id="HD84CC68908B14170844C8C9F5CB8A0A0"><enum>(vii)</enum><text>the review of a diagnostic laboratory test by a physician or practitioner.</text></clause></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph>
<paragraph id="HD0D63ACB847B48A4B8B25E0D39C9B2F0"><enum>(2)</enum><header>Report</header>
<subparagraph id="HD8B2B8F662D544C8987F456BC7358985"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">During the period beginning 20 days after the date of the enactment of this Act and ending on the last day of the emergency period, each physician and practitioner, who furnishes a test or an assistive telehealth consultation during such period, shall, on a monthly basis during such period, submit to the Administrator of the Centers for Medicare &amp; Medicaid Services and the appropriate State health agency demographic data specified under section 1834(m)(9)(E) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395m">42 U.S.C. 1395m(m)(9)(E)</external-xref>) with respect to individuals to whom such test or consultation was so furnished (in accordance with the HIPAA privacy regulation).</text></subparagraph> <subparagraph id="H86E0C2CA78714D1EBD63AD8BFD061297"><enum>(B)</enum><header>Definitions</header><text>In this paragraph:</text>
<clause id="H13D102B33C6E401DAFFD8CE5768CD54D"><enum>(i)</enum><header>Assistive telehealth consultation</header><text display-inline="yes-display-inline">The term <term>assistive telehealth consultation</term> has the meaning given such term in section 1834(m)(9)(E) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395m">42 U.S.C. 1395m(m)(9)(F)</external-xref>).</text></clause> <clause id="H07E21E0D194D479F9655A536CA81405F"><enum>(ii)</enum><header>Emergency period</header><text display-inline="yes-display-inline">The term <term>emergency period</term> has the meaning as such term is described in section 1135(g)(1)(B) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1320b-5">42 U.S.C. 1320b–5(g)(1)(B)</external-xref>).</text></clause>
<clause id="HE5EDDE0F96DE4DDDA94F28F53BC77EE6"><enum>(iii)</enum><header>HIPAA privacy regulation</header><text display-inline="yes-display-inline">The term <term>HIPAA privacy regulation</term> has the meaning given such term in section 1180(b)(3) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1320d-9">42 U.S.C. 1320d–9(b)(3)</external-xref>).</text></clause> <clause id="H110F108D2D8545709127996415EC4DE7"><enum>(iv)</enum><header>Test</header><text display-inline="yes-display-inline">The term <term>test</term> has the meaning as such term is described in section 1834(m)(9)(C) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395m">42 U.S.C. 1395m(m)(9)(C)</external-xref>).</text></clause></subparagraph></paragraph></subsection>
<subsection id="HAD8BAEF800C74FD88291E15584BF4C8B"><enum>.(b)</enum><header>No payment for certain in-Person test after telehealth test during the COVID–19 emergency period</header>
<paragraph id="HF1B07895625341F3A31D5F790E0E569F"><enum>(1)</enum><header>In general</header><text>Section 1833(h) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395l">42 U.S.C. 1395l(h)</external-xref>) is amended—</text> <subparagraph id="H15BB04E8C51D40FD85CAFEA3BD04B452"><enum>(A)</enum><text>in paragraph (1)(A), by striking <quote>Subject to section 1834(d)(1)</quote> and inserting <quote>Subject to section 1834(a)(1) and paragraph (10)</quote>; and</text></subparagraph>
<subparagraph id="H14A547BAFE9848E0B9EC4B00E5654F64"><enum>(B)</enum><text>by adding at the end the following new paragraph:</text> <quoted-block style="OLC" id="H41069058189B43ED970A24A22DA5FDFE" display-inline="no-display-inline"> <paragraph id="H3D8B998E65D7428CB5382078E4B63A42" indent="up1"><enum>(10)</enum><text display-inline="yes-display-inline">During the emergency period described in section 1135(g)(1)(B), the Secretary may not make payment for a test described in section 1834(m)(9)(C) that is furnished in-person by a physician or practitioner to an individual if a physician or practitioner has previously ordered such a test via a telecommunications system pursuant to section 1834(m)(9)(A), unless the physician or practitioner determines such a test is medically necessary and appropriate (as determined by the Secretary).</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></subparagraph></paragraph>
<paragraph id="HF563BEEA7B544BF581B701A7BB63A877"><enum>(2)</enum><header>Report</header><text display-inline="yes-display-inline">Not later than 1 year after the termination of the emergency period described in section 1135(g)(1)(B) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1320b-5">42 U.S.C. 1320b–5(g)(1)(B)</external-xref>), the Inspector General of the Department of Health and Human Services shall review claims for payment for tests described in section 1834(m)(9)(C) of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395m">42 U.S.C. 1395m(m)(9)(C)</external-xref>) furnished during such emergency period and submit to Congress a report on any instances of waste, fraud, or abuse identified through such review.</text></paragraph></subsection> <subsection id="H4472EC2C0F974E3485B5940F6E1D93FF"><enum>(c)</enum><header>Conforming amendments</header><text display-inline="yes-display-inline">Section 1834(m) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395m">42 U.S.C. 1395m(m)(4)(C)(ii)(X)</external-xref>), as amended by subsection (a), is further amended—</text>
<paragraph id="HA1E0258953EF4C29A85F4CA9C2021544"><enum>(1)</enum><text>in paragraph (1), by striking <quote>Subject to paragraph (8)</quote> and inserting <quote>Subject to paragraphs (8) and (9)</quote>;</text></paragraph> <paragraph id="HF6C462F10F564813BCAB92C64F4FDB43"><enum>(2)</enum><text>in paragraph (2), by striking <quote>Subject to paragraph (8)</quote> and inserting <quote>Subject to paragraphs (8) and (9)</quote>; and</text></paragraph>
<paragraph id="H7B006FCD4F984C05B243F08EFA0E9B8D"><enum>(3)</enum><text display-inline="yes-display-inline">in paragraph (4)(C)(ii)(X), by striking <quote>telehealth services described in paragraph (7)</quote> and inserting <quote>telehealth services described in paragraph (7) or (9)</quote>.</text></paragraph></subsection></section> </legis-body> </bill> 

