<?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-Senate" dms-id="A1" public-private="public"><metadata xmlns:dc="http://purl.org/dc/elements/1.1/">
<dublinCore>
<dc:title>114 S1455 IS: TREAT Act</dc:title>
<dc:publisher>U.S. Senate</dc:publisher>
<dc:date>2015-05-22</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>114th CONGRESS</congress><session>1st Session</session><legis-num>S. 1455</legis-num><current-chamber>IN THE SENATE OF THE UNITED STATES</current-chamber><action><action-date date="20150522">May 22, 2015</action-date><action-desc><sponsor name-id="S369">Mr. Markey</sponsor> (for himself, <cosponsor name-id="S348">Mr. Paul</cosponsor>, <cosponsor name-id="S221">Mrs. Feinstein</cosponsor>, <cosponsor name-id="S253">Mr. Durbin</cosponsor>, <cosponsor name-id="S361">Ms. Hirono</cosponsor>, <cosponsor name-id="S307">Mr. Brown</cosponsor>, and <cosponsor name-id="S354">Ms. Baldwin</cosponsor>) introduced the following bill; which was read twice and referred to the <committee-name committee-id="SSHR00">Committee on Health, Education, Labor, and Pensions</committee-name></action-desc></action><legis-type>A BILL</legis-type><official-title>To provide access to medication-assisted therapy, and for other purposes.</official-title></form>
	<legis-body>
 <section id="S1" 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>Recovery Enhancement for Addiction Treatment Act</short-title></quote> or the <quote>TREAT Act</quote>.</text>
 </section><section id="id2f389d28114840cea82c9a68aec6e2ee"><enum>2.</enum><header>Findings</header><text display-inline="no-display-inline">Congress finds the following:</text> <paragraph id="id59e8149eee5c4ea7a9955fba964201f2"><enum>(1)</enum><text>Overdoses from opioids have increased dramatically in the United States.</text>
 </paragraph><paragraph id="id62042d8e55014162b67c973dd4e4a0be"><enum>(2)</enum><text>Deaths from drug overdose, largely from prescription pain relievers, have tripled among men and increased five-fold among women over the past decade.</text>
 </paragraph><paragraph id="id3499fbe223f3458b8972a07d97d77a72"><enum>(3)</enum><text>Nationwide, drug overdoses now claim more lives than car accidents.</text> </paragraph><paragraph id="idfc80d4b2020a4346b19230bc6be311ab"><enum>(4)</enum><text>Opioid addiction is a chronic disease that, untreated, places a large burden on the healthcare system. Roughly 475,000 emergency room visits each year are attributable to the misuse and abuse of opioid pain medication.</text>
 </paragraph><paragraph id="id53b1cea0517f429598c00e12fea8d62d"><enum>(5)</enum><text>Effective medication-assisted treatment for opioid addiction, in combination with counseling and behavioral therapies, can decrease overdose deaths, be cost-effective, reduce transmissions of HIV and viral hepatitis, and reduce other social harms such as criminal activity.</text>
 </paragraph><paragraph id="id3006bfee5f174b819c918397432165be"><enum>(6)</enum><text>Effective medication-assisted treatment programs for opioid addiction should include multiple components, including medications, cognitive and behavioral supports and interventions, and drug testing.</text>
 </paragraph><paragraph id="idA97B94154B6F4E3390EEB58346BC2BD8"><enum>(7)</enum><text>Effective medication-assisted treatment programs for opioid addiction may use a team of staff members, in addition to a prescribing provider, to deliver comprehensive care.</text>
 </paragraph><paragraph id="id8c02762f803249a39961a68810001932"><enum>(8)</enum><text>Access to medication-assisted treatments, including office-based buprenorphine opioid treatment, remains limited in part due to current practice regulations and an insufficient number of providers.</text>
 </paragraph><paragraph id="id0cdfa82d928448d79cb8fe20158f5a35"><enum>(9)</enum><text>More than 10 years of experience in the United States with office-based buprenorphine opioid treatment has informed best practices for delivering successful, high quality care.</text>
 </paragraph></section><section id="id3d123a5bab544c7fb641214ed34e3590"><enum>3.</enum><header>Expansion of patient limits under waiver</header><text display-inline="no-display-inline">Section 303(g)(2)(B) of the Controlled Substances Act (<external-xref legal-doc="usc" parsable-cite="usc/21/823">21 U.S.C. 823(g)(2)(B)</external-xref>) is amended—</text> <paragraph id="idcbb4920bd9b948598e70ccce5f89b518"><enum>(1)</enum><text>in clause (i), by striking <term>physician</term> and inserting <term>practitioner</term>;</text>
 </paragraph><paragraph id="id3c8bd7de8bf74016a0fd1e6ba6468cd9"><enum>(2)</enum><text>in clause (iii)—</text> <subparagraph id="idFD1661D7D73143B6B6DD94F6DCE3E44E"><enum>(A)</enum><text>by striking <quote>30</quote> and inserting <quote>100</quote>; and</text>
 </subparagraph><subparagraph id="id7BC48357C70847788D087CB1DC4CA5F8"><enum>(B)</enum><text>by striking <quote>, unless, not sooner</quote> and all that follows through the end and inserting a period; and</text> </subparagraph></paragraph><paragraph id="id26448ce924134d678990b32842b79fcd"><enum>(3)</enum><text>by inserting at the end the following new clause:</text>
				<quoted-block display-inline="no-display-inline" id="id8ca14fc5c97f467487db76e3318e05c7" style="OLC">
 <clause id="id6592a3e7d7fb49c1bfb20f56d6c31d16" indent="up1"><enum>(iv)</enum><text>Not earlier than 1 year after the date on which a qualifying practitioner obtained an initial waiver pursuant to clause (iii), the qualifying practitioner may submit a second notification to the Secretary of the need and intent of the qualifying practitioner to treat an unlimited number of patients, if the qualifying practitioner—</text>
 <subclause id="id83ffb943d4be4437891911c30f7b5766"><enum>(I)</enum><item commented="no" display-inline="yes-display-inline" id="id5CB857F2EDF346F49903F666E7A2F386"><enum>(aa)</enum><text>satisfies the requirements of item (aa), (bb), (cc), or (dd) of subparagraph (G)(ii)(I); and</text> </item><item id="idf3285b936318497996280629933197df" indent="up1"><enum>(bb)</enum><text>agrees to fully participate in the Prescription Drug Monitoring Program of the State in which the qualifying practitioner is licensed, pursuant to applicable State guidelines; or</text>
 </item></subclause><subclause id="id14ec281f95144bc89c0ee46ebb92d50b"><enum>(II)</enum><item commented="no" display-inline="yes-display-inline" id="id170D7A1D0A2345678B33D35AFF957F03"><enum>(aa)</enum><text>satisfies the requirements of item (ee), (ff), or (gg) of subparagraph (G)(ii)(I);</text> </item><item id="id2729603758f742c49f62af886a3070cc" indent="up1"><enum>(bb)</enum><text>agrees to fully participate in the Prescription Drug Monitoring Program of the State in which the qualifying practitioner is licensed, pursuant to applicable State guidelines;</text>
 </item><item id="id583b4ab5361745cf89f10e3fd31ec141" indent="up1"><enum>(cc)</enum><text>practices in a qualified practice setting; and</text> </item><item id="id44FD06DB3ED6472282ADE68C65859397" indent="up1"><enum>(dd)</enum><text>has completed not less than 24 hours of training (through classroom situations, seminars at professional society meetings, electronic communications, or otherwise) with respect to the treatment and management of opiate-dependent patients for substance use disorders provided by the American Society of Addiction Medicine, the American Academy of Addiction Psychiatry, the American Medical Association, the American Osteopathic Association, the American Psychiatric Association, or any other organization that the Secretary determines is appropriate for purposes of this subclause.</text></item></subclause></clause><after-quoted-block>.</after-quoted-block></quoted-block>
 </paragraph></section><section id="id48764625c37a4611942372465a1d45a9"><enum>4.</enum><header>Definitions</header><text display-inline="no-display-inline">Section 303(g)(2)(G) of the Controlled Substances Act (<external-xref legal-doc="usc" parsable-cite="usc/21/823">21 U.S.C. 823(g)(2)(G)</external-xref>) is amended—</text> <paragraph id="id5333DFFCFC174F43A1EDBDB7D012B6F1"><enum>(1)</enum><text display-inline="yes-display-inline">by striking clause (ii) and inserting the following:</text>
				<quoted-block display-inline="no-display-inline" id="id9F77D4FC3C1A4D4DB937712DD479E576" style="OLC">
 <clause id="idca301b394f5e4002976257ac78ba4fc9" indent="up1"><enum>(ii)</enum><text>The term <term>qualifying practitioner</term> means the following:</text> <subclause id="id7343ee8db9434ee7bf067065f65a21ce"><enum>(I)</enum><text>A physician who is licensed under State law and who meets 1 or more of the following conditions:</text>
 <item id="idaeb6c7b58d7d4dd184d807a49e8ad335"><enum>(aa)</enum><text>The physician holds a board certification in addiction psychiatry from the American Board of Medical Specialties.</text>
 </item><item id="id83840ebe7fbe415b8026d75619cc961c"><enum>(bb)</enum><text>The physician holds an addiction certification from the American Society of Addiction Medicine.</text> </item><item id="id5229649fac634ed6bc43df8fe13bbb0f"><enum>(cc)</enum><text>The physician holds a board certification in addiction medicine from the American Osteopathic Association.</text>
 </item><item id="id4a408f3b6d4548a9a70ecd25c53e1ddd"><enum>(dd)</enum><text>The physician holds a board certification from the American Board of Addiction Medicine.</text>
 </item><item id="ida3f59fa9fd2e4b63a0fc7f702def88c4"><enum>(ee)</enum><text>The physician has completed not less than 8 hours of training (through classroom situations, seminars at professional society meetings, electronic communications, or otherwise) with respect to the treatment and management of opiate-dependent patients for substance use disorders provided by the American Society of Addiction Medicine, the American Academy of Addiction Psychiatry, the American Medical Association, the American Osteopathic Association, the American Psychiatric Association, or any other organization that the Secretary determines is appropriate for purposes of this subclause.</text>
 </item><item id="id742a9e6274b448879cc18b5749f387e6"><enum>(ff)</enum><text>The physician has participated as an investigator in 1 or more clinical trials leading to the approval of a narcotic drug in schedule III, IV, or V for maintenance or detoxification treatment, as demonstrated by a statement submitted to the Secretary by this sponsor of such approved drug.</text>
 </item><item id="idda0b59fdbc734051bf6a91ad06c14100"><enum>(gg)</enum><text>The physician has such other training or experience as the Secretary determines will demonstrate the ability of the physician to treat and manage opiate-dependent patients.</text>
 </item></subclause><subclause id="idf3e6653dd2a444308c0b3f441011125e"><enum>(II)</enum><text>A nurse practitioner or physician assistant who is licensed under State law and meets all of the following conditions:</text>
 <item id="id4a2a432bce1f4c1e9a369d6c1cb9dd33"><enum>(aa)</enum><text>The nurse practitioner or physician assistant is licensed under State law to prescribe schedule III, IV, or V medications for pain.</text>
 </item><item id="ide839ef0cfcb247a9aab5a8045bfba826"><enum>(bb)</enum><text>The nurse practitioner or physician assistant satisfies 1 or more of the following:</text> <subitem id="id2af3bfacd8664c30819bf11665605b3c"><enum>(AA)</enum><text>Has completed not fewer than 24 hours of training (through classroom situations, seminars at professional society meetings, electronic communications, or otherwise) with respect to the treatment and management of opiate-dependent patients for substance use disorders provided by the American Society of Addiction Medicine, the American Academy of Addiction Psychiatry, the American Medical Association, the American Osteopathic Association, the American Psychiatric Association, or any other organization that the Secretary determines is appropriate for purposes of this subclause.</text>
 </subitem><subitem id="id801c88d287c7446da023ddab36bc32ff"><enum>(BB)</enum><text>Has such other training or experience as the Secretary determines will demonstrate the ability of the nurse practitioner or physician assistant to treat and manage opiate-dependent patients.</text>
 </subitem></item><item id="idd6d75299f75a444385e13cec585339a0"><enum>(cc)</enum><text>The nurse practitioner or physician assistant practices under the supervision of a licensed physician who holds an active waiver to prescribe schedule III, IV, or V narcotic medications for opioid addiction therapy, and—</text>
 <subitem id="idd17eaae068cb4315b6be83a6dc4a7dce"><enum>(AA)</enum><text>the supervising physician satisfies the conditions of item (aa), (bb), (cc), or (dd) of subclause (I); or</text>
 </subitem><subitem id="id09a7def18fea4de3822e6f18b828c8fa"><enum>(BB)</enum><text>both the supervising physician and the nurse practitioner or physician assistant practice in a qualified practice setting.</text>
 </subitem></item></subclause><subclause id="id69e1b8a1086e49a5b83e93808c75bcee"><enum>(III)</enum><text>A nurse practitioner who is licensed under State law and meets all of the following conditions:</text> <item id="idaac3982466c74f6ab4e5d6c6dfdb4119"><enum>(aa)</enum><text>The nurse practitioner is licensed under State law to prescribe schedule III, IV, or V medications for pain.</text>
 </item><item id="id23e7976183d045b092ca81fb4493e13d"><enum>(bb)</enum><text>The nurse practitioner has training or experience that the Secretary determines demonstrates specialization in the ability to treat opiate-dependent patients, such as a certification in addiction specialty accredited by the American Board of Nursing Specialties or the National Commission for Certifying Agencies, or a certification in addiction nursing as a Certified Addiction Registered Nurse—Advanced Practice.</text>
 </item><item id="ide668e06648184a1f90b67db7ac1b61bb"><enum>(cc)</enum><text>In accordance with State law, the nurse practitioner prescribes opioid addiction therapy in collaboration with a physician who holds an active waiver to prescribe schedule III, IV, or V narcotic medications for opioid addiction therapy.</text>
 </item><item id="id66e4007f038d412b979d911784caa19e"><enum>(dd)</enum><text>The nurse practitioner practices in a qualified practice setting.</text></item></subclause></clause><after-quoted-block>; and</after-quoted-block></quoted-block> </paragraph><paragraph id="id1df1998b07824ee1b1477886cfb1ce3d"><enum>(2)</enum><text>by adding at the end the following:</text>
				<quoted-block display-inline="no-display-inline" id="id131824DD20CB4AFAB984CC8044C0D22C" style="OLC">
 <clause id="ide0ddee510edd41f3b566ae42eae343ca" indent="up1"><enum>(iii)</enum><text>The term <term>qualified practice setting</term> means 1 or more of the following treatment settings:</text> <subclause id="id8e922219552843c38489ac4a99cc84be"><enum>(I)</enum><text>A National Committee for Quality Assurance-recognized Patient-Centered Medical Home or Patient-Centered Specialty Practice.</text>
 </subclause><subclause id="id70bdc5df4dfe428fa6f3235c45ddcc35"><enum>(II)</enum><text>A Centers for Medicaid &amp; Medicare Services-recognized Accountable Care Organization.</text> </subclause><subclause id="id1be92665fcd844b5a3154ca3dc52a1fb"><enum>(III)</enum><text>A clinical facility administered by the Department of Veterans Affairs, Department of Defense, or Indian Health Service.</text>
 </subclause><subclause id="idC21A44D879824EE6A64373E819DC7EF9"><enum>(IV)</enum><text>A Behavioral Health Home accredited by the Joint Commission.</text> </subclause><subclause id="id596cec151a65401ba1ef50e3a92e406d"><enum>(V)</enum><text>A Federally-qualified health center (as defined in section 1905(l)(2)(B) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396d">42 U.S.C. 1396d(l)(2)(B)</external-xref>)) or a Federally-qualified health center look-alike.</text>
 </subclause><subclause id="id4144c5708c98441f988b650986dbc7cf"><enum>(VI)</enum><text>A Substance Abuse and Mental Health Services-certified Opioid Treatment Program.</text> </subclause><subclause id="idf66615e3f6414ba3881378101e568e71"><enum>(VII)</enum><text>A clinical program of a State or Federal jail, prison, or other facility where individuals are incarcerated.</text>
 </subclause><subclause id="idc83f5fe03d4545c1a8aabef9211e5ff5"><enum>(VIII)</enum><text>A clinic that demonstrates compliance with the Model Policy on DATA 2000 and Treatment of Opioid Addiction in the Medical Office issued by the Federation of State Medical Boards.</text>
 </subclause><subclause id="id6e5104c9f20849dcab42c7cf832d6956"><enum>(IX)</enum><text>A treatment setting that is part of an Accreditation Council for Graduate Medical Education, American Association of Colleges of Osteopathic Medicine, or American Osteopathic Association-accredited residency or fellowship training program.</text>
 </subclause><subclause id="id9b41d686fbd945a98cc76f84953935ce"><enum>(X)</enum><text>Any other practice setting approved by a State regulatory board or State Medicaid Plan to provide addiction treatment services.</text>
 </subclause><subclause id="idecf8e30390a44624b4666448931c1b6b"><enum>(XI)</enum><text>Any other practice setting approved by the Secretary.</text></subclause></clause><after-quoted-block>.</after-quoted-block></quoted-block> </paragraph></section><section id="id6CEB1E7954C6400B99164C31C1D6A2D7"><enum>5.</enum><header>GAO Evaluation</header><text display-inline="no-display-inline">Two years after the date on which the first notification under clause (iv) of section 303(g)(2)(B) of the Controlled Substances Act (<external-xref legal-doc="usc" parsable-cite="usc/21/823">21 U.S.C. 823(g)(2)(B)</external-xref>), as added by this Act, is received by the Secretary of Health and Human Services, the Comptroller General of the United States shall initiate an evaluation of the effectiveness of the amendments made by this Act, which shall include an evaluation of—</text>
 <paragraph id="id33BA2A803D8B4F19998B293D125BF0E5"><enum>(1)</enum><text>any changes in the availability and use of medication-assisted treatment for opioid addiction;</text> </paragraph><paragraph id="id29A0097F24134C1CA660F6B9DB4DFED1"><enum>(2)</enum><text>the quality of medication-assisted treatment programs;</text>
 </paragraph><paragraph id="idEAFA93BC7CC5449D89F6FE2D10DB351C"><enum>(3)</enum><text>the integration of medication-assisted treatment with routine healthcare services;</text> </paragraph><paragraph id="id1FD57B2D785E41E3922159EBE33738D1"><enum>(4)</enum><text>diversion of opioid addiction treatment medication;</text>
 </paragraph><paragraph id="id91B3E29699E244CF9A767D53B080FE7E"><enum>(5)</enum><text>changes in State or local policies and legislation relating to opioid addiction treatment;</text> </paragraph><paragraph id="id2E686C8573E2481F907C5A9F0DB05929"><enum>(6)</enum><text>the use of nurse practitioners and physician assistants who prescribe opioid addiction medication;</text>
 </paragraph><paragraph id="id2a8b5709bfa84e9389e44b0cd1becbf9"><enum>(7)</enum><text>the use of Prescription Drug Monitoring Programs by waived practitioners to maximize safety of patient care and prevent diversion of opioid addiction medication;</text>
 </paragraph><paragraph id="id2f09752bf92c474bab4baec5682fafc2"><enum>(8)</enum><text>the findings of Drug Enforcement Administration inspections of waived practitioners, including the frequency with which the Drug Enforcement Administration finds no documentation of access to behavioral health services; and</text>
 </paragraph><paragraph id="id2551f05351554cc2a0742a3f2c729915"><enum>(9)</enum><text>the effectiveness of cross-agency collaboration between Department of Health and Human Services and the Drug Enforcement Administration for expanding effective opioid addiction treatment.</text></paragraph></section></legis-body></bill>


