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<bill bill-stage="Reported-in-House" bill-type="olc" dms-id="HE86C801F00C0420281CCFC6FFFAEF143" key="H" public-private="public">
	<metadata xmlns:dc="http://purl.org/dc/elements/1.1/">
<dublinCore>
<dc:title>115 HR 5799 RH: Medicaid DRUG Improvement Act</dc:title>
<dc:publisher>U.S. House of Representatives</dc:publisher>
<dc:date>2018-05-15</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">IB</distribution-code>
		<calendar display="yes">Union Calendar No. 563</calendar>
		<congress display="yes">115th CONGRESS</congress><session display="yes">2d Session</session>
		<legis-num display="yes">H. R. 5799</legis-num>
		<associated-doc display="yes" role="report">[Report No. 115–728]</associated-doc>
		<current-chamber display="yes">IN THE HOUSE OF REPRESENTATIVES</current-chamber>
		<action display="yes">
			<action-date date="20180515">May 15, 2018</action-date>
			<action-desc><sponsor name-id="B001243">Mrs. Blackburn</sponsor> (for herself, <cosponsor name-id="B001282">Mr. Barr</cosponsor>, and <cosponsor name-id="K000387">Mr. Knight</cosponsor>) introduced the following bill; which was referred to the <committee-name added-display-style="italic" committee-id="HIF00" deleted-display-style="strikethrough">Committee on Energy and Commerce</committee-name></action-desc>
		</action>
		<action><action-date>June 12, 2018</action-date><action-desc>Additional sponsor: <cosponsor name-id="W000791">Mr. Walden</cosponsor></action-desc></action><action>
			<action-date>June 12, 2018</action-date>
			<action-desc>Reported with amendments, committed to the Committee of the Whole House on the State of the Union,
			 and ordered to be printed</action-desc>
			<action-instruction>Strike out all after the enacting clause and insert the part printed in italic</action-instruction>
			<action-instruction>For text of introduced bill, see copy of bill as introduced on May 15, 2018</action-instruction>
		</action>
		<action display="yes">
			<action-desc display="yes"><pagebreak></pagebreak></action-desc>
		</action>
		<legis-type>A BILL</legis-type>
		<official-title display="yes">To amend title XIX of the Social Security Act to require as a condition of receipt of full Federal
			 medical assistance percentage under Medicaid that State Medicaid plans
			 have in place certain drug utilization review activities.<pagebreak></pagebreak></official-title>
	</form>
	<legis-body changed="added" committee-id="HIF00" display-enacting-clause="yes-display-enacting-clause" id="HA7D72F063A904D46A704B71D7AE3D314" reported-display-style="italic" style="OLC">
 <section id="H2B6FB6F59C664840BFE529BF3F69EBE2" 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>Medicaid Drug Review, Utilization, Good Governance Improvement Act</short-title></quote> or the <quote>Medicaid DRUG Improvement Act</quote>.</text> </section><section id="H917131BE2A21480DA43A5CB8A4D25064"><enum>2.</enum><header>Medicaid drug utilization review</header> <subsection id="HB688EDA2589346A1B0A2C5AA8A065F98"><enum>(a)</enum><header>State plan requirement</header><text display-inline="yes-display-inline">Section 1902(a) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396a">42 U.S.C. 1396a(a)</external-xref>) is amended—</text>
 <paragraph id="HB3FA98FE973940DA80C1FCD8575327D5"><enum>(1)</enum><text>in paragraph (82), at the end, by striking <quote>and</quote>;</text> </paragraph><paragraph id="H8E84269B9F134EE3AE38A0DB3E2CE1E9"><enum>(2)</enum><text>in paragraph (83), at the end, by striking the period and inserting <quote>; and</quote>; and</text>
 </paragraph><paragraph id="H489217A928174F109365DF29675D7317"><enum>(3)</enum><text>by inserting after paragraph (83) the following new paragraph:</text> <quoted-block changed="added" committee-id="HIF00" display-inline="no-display-inline" id="HB675CC8E7D7F4ADEBB6854EAC893C18B" reported-display-style="italic" style="OLC"> <paragraph id="HDFDA2E73A47A4F7CB345318A67DDDF10"><enum>(84)</enum><text display-inline="yes-display-inline">provide that the State is in compliance with the drug review and utilization requirements under subsection (nn)(1).</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
 </paragraph></subsection><subsection id="HDB623D0277F1475AA83D896050F849F7"><enum>(b)</enum><header>Drug review and utilization requirements</header><text>Section 1902 of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396a">42 U.S.C. 1396a</external-xref>) is amended by adding at the end the following new subsection:</text>
				<quoted-block changed="added" committee-id="HIF00" display-inline="no-display-inline" id="HF3D4F78A982741B38762F59B426D2634" reported-display-style="italic" style="OLC">
					<subsection id="H45BC1C939B47437FBEE5CE3B23313552"><enum>(nn)</enum><header>Drug review and utilization requirements</header>
 <paragraph id="H8CF50CE821DC47FFA8B308540B6491AC"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">For purposes of subsection (a)(84), the drug review and utilization requirements under this subsection are, subject to paragraph (3) and beginning October 1, 2019, the following:</text>
							<subparagraph id="H2AE053CFCB794F90900348B7ECBB2A69"><enum>(A)</enum><header>Claims review limitations</header>
 <clause id="H8695E7837F564198AA7962C945B33D82"><enum>(i)</enum><header>In general</header><text display-inline="yes-display-inline">The State has in place—</text> <subclause id="H5747ED41CAEC46E88809A87027598D42"><enum>(I)</enum><text>safety edits (as specified by the State) for subsequent fills for opioids and a claims review automated process (as designed and implemented by the State) that indicates when an individual enrolled under the State plan (or under a waiver of the State plan) is prescribed a subsequent fill of opioids in excess of any limitation that may be identified by the State;</text>
 </subclause><subclause id="H3852ED4B7CF9463391A25F26B99C4A96"><enum>(II)</enum><text display-inline="yes-display-inline">safety edits (as specified by the State) on the maximum daily morphine equivalent that can be prescribed to an individual enrolled under the State plan (or under a waiver of the State plan) for treatment of chronic pain and a claims review automated process (as designed and implemented by the State) that indicates when an individual enrolled under the plan (or waiver) is prescribed the morphine equivalent for such treatment in excess of any limitation that may be identified by the State; and</text>
 </subclause><subclause id="H595B908C53C34571AAE2E7511FBB8FE4"><enum>(III)</enum><text display-inline="yes-display-inline">a claims review automated process (as designed and implemented by the State) that monitors when an individual enrolled under the State plan (or under a waiver of the State plan) is concurrently prescribed opioids and—</text>
 <item id="HA6C774EE2B884A2AAB3AD1F4AEF238A3"><enum>(aa)</enum><text>benzodiazepines; or</text> </item><item id="H42A5BF2617544C66875C0E9A4D490AAE"><enum>(bb)</enum><text>antipsychotics.</text>
 </item></subclause></clause><clause id="H745E121E81AD46AF82947F2B6FBFE279"><enum>(ii)</enum><header>Managed care entities</header><text display-inline="yes-display-inline">The State requires each managed care entity (as defined in section 1932(a)(1)(B)) with respect to which the State has a contract under section 1903(m) or under section 1905(t)(3) to have in place, subject to paragraph (3), with respect to individuals who are eligible for medical assistance under the State plan (or under a waiver of the State plan) and who are enrolled with the entity, the limitations described in subclauses (I) and (II) of clause (i) and a claims review automated process described in subclause (III) of such clause.</text>
 </clause><clause id="HE0403E2BC93C49039B67E2EBD281DC11"><enum>(iii)</enum><header>Rules of construction</header><text display-inline="yes-display-inline">Nothing in this subparagraph may be construed as prohibiting a State or managed care entity from designing and implementing a claims review automated process under this subparagraph that provides for prospective or retrospective reviews of claims. Nothing in this subparagraph shall be understood as prohibiting the exercise of clinical judgment from a provider enrolled as a participating provider in a State plan (or waiver of the State plan) or contracting with a managed care entity regarding the best items and services for an individual enrolled under such State plan (or waiver).</text>
 </clause></subparagraph><subparagraph id="H9AAC54E5445F482A83EC0854E22DF563"><enum>(B)</enum><header>Program to monitor antipsychotic medications by children</header><text display-inline="yes-display-inline">The State has in place a program (as designed and implemented by the State), including such a program that the State had in place before the date of the enactment of this subsection, to monitor and manage the appropriate use of antipsychotic medications by children enrolled under the State plan (or under a waiver of the State plan) and submits annually to the Secretary such information as the Secretary may require on activities carried out under such program for individuals not more than the age of 18 years generally and children in foster care specifically.</text>
 </subparagraph><subparagraph id="H92E7E3D9CA6A45F0B6D0A6AF019EB8D6"><enum>(C)</enum><header>Fraud and abuse identification</header><text display-inline="yes-display-inline">The State has in place a process (as designed and implemented by the State), including such a process that the State had in place before the date of the enactment of this subsection, that identifies potential fraud or abuse of controlled substances by individuals enrolled under the State plan (or under a waiver of the State plan), health care providers prescribing drugs to individuals so enrolled, and pharmacies dispensing drugs to individuals so enrolled.</text>
 </subparagraph><subparagraph id="HC7061AB0AD774DF7942D9C70FF665438"><enum>(D)</enum><header>Reports</header><text>The State shall include in the annual report submitted to the Secretary under section 1927(g)(3)(D) information on the limitations, requirement, program, and processes applied by the State under subparagraphs (A) through (C) in accordance with such manner and time as specified by the Secretary.</text>
 </subparagraph></paragraph><paragraph id="HE5B9A57B3E2A4FA392A44D96E2DDFAF4"><enum>(2)</enum><header>Annual report by Secretary</header><text>For each fiscal year beginning with fiscal year 2020, the Secretary shall submit to Congress a report on the most recent information submitted by States under paragraph (1)(D).</text>
						</paragraph><paragraph commented="no" id="H628B169BE2B84A75BB37C5D0FF438A6B"><enum>(3)</enum><header>Exceptions</header>
 <subparagraph commented="no" id="HA04C6E46A8C5472694973ED039C95A5D"><enum>(A)</enum><header>Certain individuals exempted</header><text display-inline="yes-display-inline">The drug review and utilization requirements under this subsection shall not apply with respect to an individual who—</text>
 <clause commented="no" id="HED59E71B3F4E4D3B98A0E92B1EE9454D"><enum>(i)</enum><text>is receiving—</text> <subclause commented="no" id="H18B672B472FF48F18C545C22E74EFC27"><enum>(I)</enum><text>hospice or palliative care; or</text>
 </subclause><subclause commented="no" id="H0AF6BFBD957240D8AB476541E3F53399"><enum>(II)</enum><text>treatment for cancer;</text> </subclause></clause><clause commented="no" id="H4670B49680414C9FBAD79F7767A49267"><enum>(ii)</enum><text>is a resident of a long-term care facility, of a facility described in section 1905(d), or of another facility for which frequently abused drugs are dispensed for residents through a contract with a single pharmacy; or</text>
 </clause><clause commented="no" id="H1466D89B504148C5B7F38D675539830D"><enum>(iii)</enum><text>the State elects to treat as exempted from such requirements.</text> </clause></subparagraph><subparagraph commented="no" id="H30B9B3819A57417A86D4C47453AE2E44"><enum>(B)</enum><header> Exception relating to ensuring access</header><text display-inline="yes-display-inline">In order to ensure reasonable access to health care, the Secretary may waive the drug review and utilization requirements under this subsection, with respect to a State, in the case of natural disasters and similar situations, and in the case of the provision of emergency services (as defined for purposes of section 1860D–4(c)(5)(D)(ii)(II)).</text></subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
 </subsection><subsection commented="no" id="H14208F2E9E954492BFB334C94FC8711D"><enum>(c)</enum><header>Managed care entities</header><text>Section 1932 of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396u-2">42 U.S.C. 1396u–2</external-xref>) is amended by adding at the end the following new subsection:</text>
				<quoted-block changed="added" committee-id="HIF00" display-inline="no-display-inline" id="HD83D12F9B3F945B286154AFCF8A96F9C" reported-display-style="italic" style="OLC">
 <subsection commented="no" id="H57383C3AC52D46FEB15405997136F71A"><enum>(i)</enum><header>Drug utilization review activities and requirements</header><text display-inline="yes-display-inline">Beginning not later than October 1, 2019, each contract under a State plan with a managed care entity (other than a primary care case manager) under section 1903(m) shall provide that the entity is in compliance with the applicable provisions of section 438.3(s)(2) of title 42 of the Code of Federal Regulations, section 483.3(s)(4)) of such title, and section 483.3(s)(5) of such title, as such provisions were in effect on March 31, 2018.</text></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
			</subsection></section><section id="H587BA83592834E0685F3D2DA14E7119D"><enum>3.</enum><header>Identifying and addressing inappropriate prescribing and billing practices under Medicaid</header>
 <subsection id="H8A76747BF21E4332B962D28008FDFCEB"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Section 1927(g) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396r-8">42 U.S.C. 1396r–8(g)</external-xref>) is amended—</text> <paragraph id="H0EEC181DC3984B7986EC8E0467D369D3"><enum>(1)</enum><text display-inline="yes-display-inline">in paragraph (1)(A)—</text>
 <subparagraph id="H4390B2734405499F8179C0E47A6B98E2"><enum>(A)</enum><text>by striking <quote>of section 1903(i)(10)(B)</quote> and inserting <quote>of section 1902(a)(54)</quote>;</text> </subparagraph><subparagraph id="HFCEB06E27073490EB54F846E2DCFC14D"><enum>(B)</enum><text>by striking <quote>, by not later than January 1, 1993,</quote>;</text>
 </subparagraph><subparagraph id="H0E697DD162A34AE0865BC9A55D14962F"><enum>(C)</enum><text>by inserting after <quote>gross overuse,</quote> the following: <quote>excessive utilization,</quote>; and</text> </subparagraph><subparagraph id="H614B0E06BA9B4258BF471974D03407D0"><enum>(D)</enum><text>by striking <quote>or inappropriate or medically unnecessary care</quote> and inserting <quote>inappropriate or medically unnecessary care, or prescribing or billing practices that indicate abuse or excessive utilization</quote>; and</text>
 </subparagraph></paragraph><paragraph id="H92DB291AC6D5437EA1E72C8B1915299A"><enum>(2)</enum><text>in paragraph (2)(B)—</text> <subparagraph id="H3B2F07BCEC174134A3EF9CECC452AB62"><enum>(A)</enum><text>by inserting after <quote>gross overuse,</quote> the following: <quote>excessive utilization,</quote>;</text>
 </subparagraph><subparagraph commented="no" id="HF3975CC4E53743BD92F5E0B123984699"><enum>(B)</enum><text>by striking <quote>or inappropriate or medically unnecessary care</quote> and inserting <quote>inappropriate or medically unnecessary care, or prescribing or billing practices that indicate abuse or excessive utilization</quote>; and</text>
 </subparagraph><subparagraph id="HBDE1DF99A59548F0B4599DE32CB5B9B8"><enum>(C)</enum><text>by adding at the end the following new sentence: <quote>In the case that the program identifies a pattern described in the previous sentence, the State shall take such remedial actions as determined necessary to address such pattern.</quote>.</text>
 </subparagraph></paragraph></subsection><subsection id="HD1A7CD9378604DFD88B85F5C5BC69911"><enum>(b)</enum><header>Effective date</header><text display-inline="yes-display-inline">The amendments made by subsection (a) shall take effect with respect to retrospective drug use reviews conducted on or after October 1, 2020.</text>
			</subsection></section></legis-body><official-title-amendment>Amend the title so as to read: <quote>A bill to amend title XIX of the Social Security Act to require under Medicaid that State Medicaid
			 plans have in place certain drug utilization review activities, and to
			 require States to identify and address inappropriate prescribing and
			 billing practices under Medicaid.</quote>.</official-title-amendment>
	<endorsement display="yes">
		<action-date>June 12, 2018</action-date>
		<action-desc>Reported with amendments, committed to the Committee of the Whole House on the State of the Union,
			 and ordered to be printed</action-desc></endorsement>
</bill>


