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<dc:title>114 S1013 IS: Ensuring Access to Quality Complex Rehabilitation Technology Act of 2015</dc:title>
<dc:publisher>U.S. Senate</dc:publisher>
<dc:date>2015-04-20</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>114th CONGRESS</congress><session>1st Session</session><legis-num>S. 1013</legis-num><current-chamber>IN THE SENATE OF THE UNITED STATES</current-chamber><action><action-date date="20150420">April 20, 2015</action-date><action-desc><sponsor name-id="S136">Mr. Cochran</sponsor> (for himself and <cosponsor name-id="S270">Mr. Schumer</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 for coverage and payment for complex
			 rehabilitation technology items under the Medicare program, and for other
			 purposes.</official-title></form>
	<legis-body id="H89BFFE260D6944708A835AF73D674DB2" style="OLC">
 <section id="H92CC6F41FB9C4602A3F427216646FEB6" 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>Ensuring Access to Quality Complex Rehabilitation Technology Act of 2015</short-title></quote>.</text> </section><section display-inline="no-display-inline" id="HAC3B05738C0C4996B766BD4233280E7E"><enum>2.</enum><header>Findings</header><text display-inline="no-display-inline">Congress finds the following:</text>
 <paragraph id="HD3D61A5A48774EE78D6A278B8C821CF3"><enum>(1)</enum><text>Individuals with disabilities and significant medical conditions such as Cerebral Palsy, Muscular Dystrophy, Multiple Sclerosis, Spinal Cord Injury, Amyotrophic Lateral Sclerosis, and Spina Bifida experience physical, functional, and cognitive challenges every day.</text>
 </paragraph><paragraph id="HA7881F96F7244C2394E66B5FEA252C60"><enum>(2)</enum><text>Complex rehabilitation technology items (in this Act referred to as <term>CRT items</term>), including products such as complex rehabilitation power wheelchairs, highly configurable manual wheelchairs, adaptive seating and positioning systems, and other specialized equipment, such as standing frames and gait trainers, enable individuals to maximize their function and minimize the extent and costs of their medical care.</text>
 </paragraph><paragraph id="H4B955AB734B646B7831B920CE2952876"><enum>(3)</enum><text>Access to CRT items and related services can be threatened by inadequate coding, coverage, and payment policies for such items and services. These policies have restricted access to existing complex rehabilitation technology and stifled innovation. Access challenges have increased over the past several years and, without meaningful change to these policies, will only become greater in the future.</text>
 </paragraph><paragraph id="HEA9A4F87C4484F35914157852B3F276B"><enum>(4)</enum><text display-inline="yes-display-inline">Current Medicare policies often fail to adequately address the needs of individuals with disabilities, to consider the range of services furnished by complex rehabilitation technology suppliers, and to recognize and account for the complexity and unique nature of the equipment itself.</text>
 </paragraph><paragraph id="H9EEDC178C4514AF987F9002744FE6907"><enum>(5)</enum><text>A significant factor responsible for such access challenges is that individually-configurable CRT items do not have a distinct payment category under the Medicare program, but instead are classified within the broad category of durable medical equipment (DME). CRT items serve patients with serious medical conditions that require a broader range of services and specialized personnel than what is required for standard DME. Individually-configured CRT items also require more resources in the areas of configuring, training, and education to ensure appropriate use and to optimize results.</text>
 </paragraph><paragraph id="H2FD70AD47F7C4EACA302BE64AE57814E"><enum>(6)</enum><text>Unlike most DME, a medical model incorporating an interdisciplinary team approach is necessary to ensure proper individual configuration and use of a CRT item. This team typically includes a physician, a licensed physical or licensed occupational therapist (with no financial relationship with the CRT supplier), a qualified CRT professional, the individual using such item, and sometimes a caregiver for such individual.</text>
 </paragraph><paragraph id="HC187687499E8441D9FFA46C5DC4D5CF5"><enum>(7)</enum><text>The Medicare program should recognize the specialized nature of the CRT service delivery model, the required supporting processes and technology-related CRT services, the credentials and competencies needed by the providing suppliers and critical staff, and the related costs involved. A separate benefit category for CRT items would allow for unique coding, coverage, and payment rules and policies that address the unique needs of persons with disabilities and acknowledge the extensive service component.</text>
 </paragraph><paragraph id="H6F8C0E3DB9B6453D8834C7CB64CC42B0"><enum>(8)</enum><text>Congress and the Centers for Medicare &amp; Medicaid Services have previously recognized the benefits of a separate classification for unique, individually-configured products. In 2008, Congress exempted certain CRT items from inclusion in the Medicare DME competitive bidding program, and Congress has created a separate and distinct benefit category for orthotics and prosthetics (custom braces and artificial limbs), which have their own medical policies, accreditation standards, and payment calculations.</text>
			</paragraph></section><section id="H0056EE023C764EF3B0EEAC1AC12DA413"><enum>3.</enum><header>Establishing separate benefit category for complex rehabilitation technologies within Medicare</header>
 <subsection id="H2CE3DF098CE242CD809EB04F494EFC2A"><enum>(a)</enum><header>New category</header><text display-inline="yes-display-inline">Section 1861 of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395x">42 U.S.C. 1395x</external-xref>) is amended—</text> <paragraph id="H4D165788F9274D6E8CFEBEAE94B01777"><enum>(1)</enum><text>in subsection (s)(2)—</text>
 <subparagraph id="H2DB2718C7E6B4E1E8105F9EFACBFE6EB"><enum>(A)</enum><text>in subparagraph (EE), by striking <quote>and</quote> at the end;</text> </subparagraph><subparagraph id="HCDE73F640F7349ACBEF4D83DAB556579"><enum>(B)</enum><text>in subparagraph (FF), by inserting <quote>and</quote> at the end; and</text>
 </subparagraph><subparagraph id="HE6CF3CC635CC425CB7BBE515F88B0B5D"><enum>(C)</enum><text>by inserting after subparagraph (FF) the following new paragraph:</text> <quoted-block id="H17135CC8D4984CA7AB16865A23173F65" style="OLC"> <subparagraph id="H9F468EF2B8C343F2BA55A9B374B4D426"><enum>(GG)</enum><text>complex rehabilitation technology items (as defined in subsection (iii));</text></subparagraph><after-quoted-block>; and</after-quoted-block></quoted-block>
 </subparagraph></paragraph><paragraph id="H95B38D74940A416CB241F4DB056A2185"><enum>(2)</enum><text>by adding at the end the following new subsection:</text> <quoted-block id="HF4BF351664FC4162931CBBBE87784426" other-style="archaic" style="other"><subsection id="H50F1B16BF32E431197C25319A4C47FA8"><enum>(iii)</enum><header>Complex rehabilitation technology item</header><paragraph commented="no" display-inline="yes-display-inline" id="HD80351F70F344F5C824CB8CCCFA0FC54"><enum>(1)</enum><text>The terms <term>complex rehabilitation technology item</term> and <term>CRT item</term> mean an item that—</text>
 <subparagraph id="H185943409B394F959AA799849CF3B707" indent="up1"><enum>(A)</enum><text>is designed or individually configured for a specific qualified individual to meet the individual’s unique—</text>
 <clause id="H8B9DCF72413E4E1EA521FCE69F96D71C"><enum>(i)</enum><text>medical, physical, or functional needs related to a medical condition; and</text> </clause><clause id="H079010CA346E48A9AEBF2FC67856A25D"><enum>(ii)</enum><text>capacities for basic activities of daily living or instrumental activities of daily living;</text>
 </clause></subparagraph><subparagraph id="HD3055E3A9F694DD39C2D4D51E00E7A13" indent="up1"><enum>(B)</enum><text>is primarily used to serve a medical or functional purpose and is generally not useful to a person in the absence of illness or injury; and</text>
 </subparagraph><subparagraph id="HFABBEC38F2294873ADD1DE67A6B92079" indent="up1"><enum>(C)</enum><text>requires certain services to ensure appropriate design, configuration, and use of such item, including—</text>
 <clause id="HF2354122DB9645369269DE0CD9E7E357"><enum>(i)</enum><text>an evaluation of needs and capacities and matching of the features and functions of CRT items to the qualified individual who will use such an item; and</text>
 </clause><clause id="H84EE074F823F4DE2BE3F8008B16B597A"><enum>(ii)</enum><text>configuring, fitting, programming, adjusting, or adapting the particular complex rehabilitation technology item for use by such individual.</text>
 </clause></subparagraph></paragraph><paragraph id="HACC6D326BD424A86B8791D3CA500162F" indent="up1"><enum>(2)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="H8A3298B715CF43A3BC5BE7B41586E580"><enum>(A)</enum><text>The Secretary, in consultation with the Director of Office on Disability, the Chairman of the National Council on Disability, the Executive Director on the Interagency Committee on Disability, the Director of the National Institute on Disability and Rehabilitation Research of the Department of Education, and the Co-Chairmen of the Senior Oversight Committee’s Care Management Reform Team of the Department of Defense and the Veterans Administration, shall, by regulation—</text>
 <clause id="HD4F0C0AEFC5C46DFA3198520D4B6E016" indent="up1"><enum>(i)</enum><text>designate items as complex rehabilitation technology items; and</text> </clause><clause id="H81FA4C61961445929E21DD6F8D2ECCA0" indent="up1"><enum>(ii)</enum><text>establish eligibility criteria to determine if an individual is a qualified individual based on the level of physical and functional needs and capacities related to a medical condition or conditions described in <internal-xref idref="H4E3C1172795C48C8A8C66A22AACCA0AB" legis-path="(iii)(2)(E)">subparagraph (F)</internal-xref>.</text>
 </clause></subparagraph><subparagraph commented="no" id="H0910C7A741114E04B44819B66488C603" indent="up1"><enum>(B)</enum><text display-inline="yes-display-inline">The items designated as complex rehabilitation technology items under <internal-xref idref="HD9BEA66B09D34523B1B8A4289D6CA77E" legis-path="(iii)(3)(A)(i)">subparagraph (A)(i)</internal-xref> shall include items which, as of January 1, 2015 , were classified within the following HCPCS codes: E0637, E0638, E0641, E0642, E0986, E1002, E1003, E1004, E1005, E1006, E1007, E1008, E1009, E1010, E1011, E1014, E1037, E1161, E1220, E1228, E1229, E1231, E1232, E1233, E1234, E1235, E1236, E1237, E1238, E1239 E2209, E2291, E2292, E2293, E2294, E2295, E2300, E2301, E2310, E2311, E2312, E2313, E2321, E2322, E2323, E2324, E2325, E2326, E2327, E2328, E2329, E2330, E2331, E2351, E2373, E2374, E2376, E2377, E2609, E2610, E2617, E8000, E8001, E8002, K0005, K0835, K0836, K0837, K0838, K0839, K0840, K0841, K0842, K0843, K0848, K0849, K0850, K0851, K0852, K0853, K0854, K0855, K0856, K0857, K0858, K0859, K0860, K0861, K0862, K0863, K0864, K0868, K0869, K0870, K0871, K0877, K0878, K0879, K0880, K0884, K0885, K0886, K0890, K0891, and K0898.</text>
 </subparagraph><subparagraph id="HEABB62C1D219439C975E72EDD4B9BAE4" indent="up1"><enum>(C)</enum><clause commented="no" display-inline="yes-display-inline" id="H7356880574FA4BB89EDA4BC3473485D6"><enum>(i)</enum><text>The items designated as complex rehabilitation technology items under <internal-xref idref="HD9BEA66B09D34523B1B8A4289D6CA77E" legis-path="(iii)(3)(A)(i)">subparagraph (A)(i)</internal-xref> shall include each item that—</text> <subclause id="H018D82534929421299BE075713893FBC" indent="up1"><enum>(I)</enum><text>as of January 1, 2015, was classified within the HCPCS codes under clause (ii); and</text>
 </subclause><subclause id="HFFC8439CDD7B402CA4B5E0B98ADADA98" indent="up1"><enum>(II)</enum><text>the Secretary, acting in consultation with suppliers and manufacturers of CRT items, determines which items should be removed from such code and assigned a new HCPCS code because such item is a complex rehabilitation technology item.</text>
 </subclause></clause><clause id="H42B405060A794347AF96B5C68B28B7C0" indent="up1"><enum>(ii)</enum><text>The HCPCS codes under this clause are the following: E0143, E0950, E0951, E0952, E0955, E0956, E0957, E0960, E0967, E0978, E0990, E1015, E1016, E1028, E01029, E1030, E2205, E2208, E2231, E2368, E2369, E2370, E2605, E2606, E2607, E2608, E2613, E2614, E2615, E2616, E2620, E2621, E2624, E2625, K0004, K0009, K0040, K0108, and K0669.</text>
 </clause></subparagraph><subparagraph id="HD517815018E24439BDBB6D6FF400749A" indent="up1"><enum>(D)</enum><text display-inline="yes-display-inline">The Secretary may not designate as a complex rehabilitation technology item—</text> <clause id="HDD9F1C2B77E94D3EA4DDF47F3E1FB769"><enum>(i)</enum><text>adaptive equipment to operate motor vehicles;</text>
 </clause><clause id="HC22B14495E25425DA5878DE636DC24B8"><enum>(ii)</enum><text>prosthetic devices described in subsection (s)(8); or</text> </clause><clause id="H4A9C32AAC3634024A87F35FEBD8E1C73"><enum>(iii)</enum><text>orthotics and prosthetics described in subsection (s)(9).</text>
 </clause></subparagraph><subparagraph id="H8DD46CE909674D0BA447E0B3BCEF5489" indent="up1"><enum>(E)</enum><text display-inline="yes-display-inline">The Secretary shall publish guidelines and implement a process to facilitate the submission of comprehensive coding proposals addressing CRT items to be submitted to the CMS HCPCS Work Group and included in the HCPCS Work Group public meetings.</text>
 </subparagraph><subparagraph id="H4E3C1172795C48C8A8C66A22AACCA0AB" indent="up1"><enum>(F)</enum><text>In establishing the eligibility criteria under <internal-xref idref="HD9BEA66B09D34523B1B8A4289D6CA77E" legis-path="(iii)(3)(A)(ii)">subparagraph (A)(ii)</internal-xref>, the Secretary shall include appropriate physical and functional needs and capacities arising from any of the following medical conditions:</text>
 <clause id="H5C82E60F7D5E4D9BB8A016A64D6C1514"><enum>(i)</enum><text>Congenital disorders, progressive or degenerative neuromuscular diseases, or injuries or trauma that result in significant physical or functional needs and capacities.</text>
 </clause><clause id="HA9C5B8A6676B48F7ADF96E603C7CBB24"><enum>(ii)</enum><text>Spinal cord injury, traumatic brain injury, cerebral palsy, muscular dystrophy, spina bifida, osteogenesis imperfecta, arthrogryposis, amyotrophic lateral sclerosis, multiple sclerosis, demyelinating disease, myelopathy, myopathy, progressive muscular atrophy, anterior horn cell disease, post-polio syndrome, cerebellar degeneration, dystonia, Huntington’s disease, or spinocerebellar disease.</text>
 </clause><clause id="H4170F4DF038E4E6FBE9916D6F757AF82"><enum>(iii)</enum><text>Certain types of amputation, paralysis, or paresis that result in significant physical or functional needs and capacities.</text>
 </clause></subparagraph><subparagraph id="HE6D322B9F3004D7B941001A30056AC42" indent="up1"><enum>(G)</enum><clause commented="no" display-inline="yes-display-inline" id="H32885B7CFA3F49749FA96DF2A74F010D"><enum>(i)</enum><text>For 2016, the Secretary shall publish—</text> <subclause id="HA0F9691580EA49AB8B7B8ABA4E948E24" indent="up1"><enum>(I)</enum><text>a list of items designated under <internal-xref idref="HD9BEA66B09D34523B1B8A4289D6CA77E" legis-path="(iii)(3)(A)(i)">subparagraph (A)(i)</internal-xref> and the HCPCS codes for such items; and</text>
 </subclause><subclause id="H5562D0BFDD0F4A4380B0B48C1330A2F4" indent="up1"><enum>(II)</enum><text>the eligibility criteria established under <internal-xref idref="HD9BEA66B09D34523B1B8A4289D6CA77E" legis-path="(iii)(3)(A)(ii)">subparagraph (A)(ii)</internal-xref>.</text> </subclause></clause><clause id="H12C55EAEDF724ECFB55FB3D8EFABC78D" indent="up1"><enum>(ii)</enum><text>For 2017 and each subsequent year, the Secretary shall publish any necessary updates to such list (including additions of new CRT items and any changes in applicable HCPCS codes) and to such eligibility criteria.</text>
 </clause></subparagraph><subparagraph id="H8CC80D24D450456D949B64B96109EA1B" indent="up1"><enum>(H)</enum><text>The Secretary shall make available, on a public Web site, the process by which the Secretary will consider requests from members of the public that the Secretary—</text>
 <clause id="H1DE511BC94304CEE95ECFE56A9935B28"><enum>(i)</enum><text>designate an item as a CRT item under <internal-xref idref="HD4F0C0AEFC5C46DFA3198520D4B6E016" legis-path="(iii)(2)(A)(i)">subparagraph (A)(i)</internal-xref>; or</text> </clause><clause id="H3CB8FD17FB784A7E983755B1C6F60679"><enum>(ii)</enum><text>amend the eligibility criteria established under <internal-xref idref="HD9BEA66B09D34523B1B8A4289D6CA77E" legis-path="(iii)(3)(A)(ii)">subparagraph (A)(ii)</internal-xref>.</text>
 </clause></subparagraph></paragraph><paragraph id="HBCBA1B365F25466CA5688EA6098CBA27" indent="up1"><enum>(3)</enum><text>For purposes of this subsection:</text> <subparagraph id="HFF0046921952442C93E74D3AA9D8B954"><enum>(A)</enum><text>The term <term>capacity for basic activities of daily living</term> means an individual’s capacity to safely participate in mobility and self-care activities including—</text>
 <clause id="H4B4FDB495E37418CBF410820DB05648D"><enum>(i)</enum><text>maintaining and changing body position;</text> </clause><clause id="HCDCC9C5C85DC414FA6AD93D69B8807C9"><enum>(ii)</enum><text>transferring to or from one surface to another;</text>
 </clause><clause id="H2D82EF3CF5B34FB7BF1FC82D6E66DA97"><enum>(iii)</enum><text>walking;</text> </clause><clause id="H65E24EBED08E4E63ACB8EBD0D6C07B82"><enum>(iv)</enum><text>moving from place to place using mobility equipment, in a safe and timely manner;</text>
 </clause><clause id="H766205859BBA41BC8CD7766B11A2BEC6"><enum>(v)</enum><text>washing one’s self;</text> </clause><clause id="HC28BBA9C359F4C84A8B0C8C0E4E0FCB0"><enum>(vi)</enum><text>caring for the body;</text>
 </clause><clause id="H8E3FE779BE4F471C81E312F2707E5E30"><enum>(vii)</enum><text>toileting;</text> </clause><clause id="H62CB4638EFBF41DFBD049B9ABD575FE1"><enum>(viii)</enum><text>dressing;</text>
 </clause><clause id="HFB29BF68D3924CC3862C0FFA877A9B96"><enum>(ix)</enum><text>eating;</text> </clause><clause id="H5C8D6A57F0374C5B9825133BE7C25DBC"><enum>(x)</enum><text>drinking;</text>
 </clause><clause id="H62DBAB01DE554AAF927AFE2707191F14"><enum>(xi)</enum><text>looking after one’s health; and</text> </clause><clause id="HAA0E7C2AA32B4FEF8BFC732434805595"><enum>(xii)</enum><text>carrying, moving, and handling objects to perform and participate in other activities under this subparagraph and <internal-xref idref="HD9BEA66B09D34523B1B8A4289D6CA77E" legis-path="(iii)(4)(C)">subparagraph (B)</internal-xref>.</text>
 </clause></subparagraph><subparagraph id="H8566000BADEF4A119C5BF34D2850E417"><enum>(B)</enum><text display-inline="yes-display-inline">The term <term>capacity for instrumental activities of daily living</term> means an individual’s capacity to safely participate in life situations in the home and community, including—</text>
 <clause id="H4189AC1B0E1245A6B347FDA7E18DA9BD"><enum>(i)</enum><text>communicating;</text> </clause><clause id="HAB668F7D39EC47ADA069A73D54323417"><enum>(ii)</enum><text>moving around using transportation;</text>
 </clause><clause id="HD9BEA66B09D34523B1B8A4289D6CA77E"><enum>(iii)</enum><text>acquiring necessities, goods, and services;</text> </clause><clause id="H8517FD6A3C38433C8C2E2461AA471DBE"><enum>(iv)</enum><text>performing household tasks;</text>
 </clause><clause commented="no" id="H5B52FF9E78674957868FC12D28296068"><enum>(v)</enum><text>caring for household members and family members;</text> </clause><clause id="HDBE72E571A354F11B50D51A178FC2B00"><enum>(vi)</enum><text>caring for household objects;</text>
 </clause><clause id="H0DB0A905CE364245B74F9453259E52D1"><enum>(vii)</enum><text>engaging in education, work, employment and economic life; and</text> </clause><clause id="H0BB3BA7AF4C24E90802AFD0D52530CE7"><enum>(viii)</enum><text>participating in community, social, and civic activities.</text>
 </clause></subparagraph><subparagraph display-inline="no-display-inline" id="HCC845BBFC92440FCAD7D9A55154C21C6"><enum>(C)</enum><text>The term <term>HCPCS</term> refers to the Health Care Procedure Coding System.</text> </subparagraph><subparagraph id="H11A6D9F31B5449CB8A155F9FF3A350F9"><enum>(D)</enum><text>The term <term>individually-configured</term> means, with respect to an item, that—</text>
 <clause id="HC3D5B26FA2704F43B449C07ACBC8A2C1"><enum>(i)</enum><text>the item has features, adjustments, or modifications specific to the individual who uses such item or the item is used in combination with other CRT items specific to the individual's needs; and</text>
 </clause><clause id="HBB90B0E5B204454ABDB3770CE4C31BB2"><enum>(ii)</enum><text>the supplier of such item must measure the individual and configure, fit, program, adjust, or adapt the item, as appropriate, so that the item is consistent with—</text>
 <subclause id="H4156246FE0DC444DAC2A09557B8C50B9"><enum>(I)</enum><text>an assessment or evaluation of the individual by an appropriate licensed clinician;</text> </subclause><subclause id="H0C4DE0EE09DB40D2923FB978CC3F4F0E"><enum>(II)</enum><text>the written order required under section 1834(r)(2)(B)(i); and</text>
 </subclause><subclause id="H6A068D8E2AC841AEAC291B43EB1B2C54"><enum>(III)</enum><text>medical condition, physical and functional needs and capacities, and body size of the individual who will use the item, the period for which such individual will need such item, and the intended use of such item by such individual.</text>
 </subclause></clause></subparagraph><subparagraph id="H1C5EE010B8B847819565C5CEB75E4C8B"><enum>(E)</enum><text display-inline="yes-display-inline">The term <term>qualified individual</term> means an individual who—</text> <clause id="H83EB29A35EC04D19B18F82D72767AC1E"><enum>(i)</enum><text>is enrolled under part B; and</text>
 </clause><clause id="HF00702DB45DF44798B9491282B076D4D"><enum>(ii)</enum><text>has physical and functional needs and capacities that arise from a medical condition that meet the eligibility criteria established by the Secretary under <internal-xref idref="H81FA4C61961445929E21DD6F8D2ECCA0" legis-path="(iii)(2)(A)(ii)">paragraph (2)(A)(ii)</internal-xref>.</text></clause></subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
 </paragraph></subsection></section><section id="HF30C24683A11445685C6FA72D46388C3"><enum>4.</enum><header>Payment rules</header><text display-inline="no-display-inline">Section 1834 of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395m">42 U.S.C. 1395m</external-xref>) is amended by adding at the end the following:</text>
			<quoted-block display-inline="no-display-inline" id="HF4FC9FBDE0A147608C6983C7C8703860" style="OLC">
				<subsection id="HACB83B0A3EAA4F55AD27E9AA91CD38F0"><enum>(r)</enum><header>Coverage and payment for CRT items</header>
					<paragraph id="HD1100EDD32E3473295C74FA8A69C9403"><enum>(1)</enum><header>General rule for payment</header>
 <subparagraph id="HB2AFC9BA41AC4128BE1CA13E9710F9BC"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">Not later than the date that is one year after the date of the enactment of this subsection, subject to <internal-xref idref="HBE4E4FBEB22C41FC9DF8A348B2BB9B7F" legis-path="(p)(1)(B)">subparagraph (B)</internal-xref>, the Secretary shall determine a payment system that shall apply to CRT items—</text>
 <clause id="H75C6F9BD723C45029C6F2E25CF94ADBC"><enum>(i)</enum><text>with HCPCS codes that were assigned to the item under section 1861(iii)(2)(C)(i)(II);</text> </clause><clause id="H3262A1D8389C41ED81952B247CA24EEE"><enum>(ii)</enum><text>for which no HCPCS code was assigned prior to such date; or</text>
 </clause><clause id="H902FD02AA8E14245803C30FDEF99DCF0"><enum>(iii)</enum><text>which, prior to such date, was classified under a miscellaneous HCPCS code.</text> </clause></subparagraph><subparagraph id="HBE4E4FBEB22C41FC9DF8A348B2BB9B7F"><enum>(B)</enum><header>Considerations</header><text display-inline="yes-display-inline">In determining the payment system under <internal-xref idref="HB2AFC9BA41AC4128BE1CA13E9710F9BC" legis-path="(p)(1)(A)">subparagraph (A)</internal-xref>, the Secretary—</text>
 <clause id="HC357B930FFB74C4FA9C8E4C57CA1E146"><enum>(i)</enum><text>may disregard the freezes on CPI increases to the payment amounts for durable medical equipment that occurred before the date of the enactment of this subsection, when determining the payment amount for CRT items;</text>
 </clause><clause id="HB360A5A4C04C4E92A338508B0CFC936D"><enum>(ii)</enum><text>shall ensure that the payment amounts for CRT items under such system are adequate to provide qualified individuals with access to such items and to encourage innovation, taking into account—</text>
 <subclause id="HC925ED3CA45D4EBFA8A8ACB8B083D5FF"><enum>(I)</enum><text display-inline="yes-display-inline">the unique needs of qualified individuals for access to CRT items;</text> </subclause><subclause id="HB5A2880ECF0A4DA8983CE62B95440EC2"><enum>(II)</enum><text>the unique complexity of CRT items; and</text>
 </subclause><subclause id="H15A44F3EDCDF45E0B08F9AF76A7EB3EC"><enum>(III)</enum><text>the resources and staff needed to provide appropriate individual configuration of CRT items for a qualified individual; and</text>
 </subclause></clause><clause id="H7AE87E87E9964ACB9540F9F38F816932"><enum>(iii)</enum><text display-inline="yes-display-inline">shall provide that CRT codes will be paid on a purchase basis with a beneficiary rental basis option.</text>
 </clause></subparagraph><subparagraph commented="no" id="HC468D51DBE0A4EF0867F2B47E0DBA7BD"><enum>(C)</enum><header>Exclusive payment rule</header><text display-inline="yes-display-inline">This subsection shall constitute the exclusive provision of this title for payment for CRT items under this part or under part A to a home health agency.</text>
 </subparagraph><subparagraph id="H72E95BBCEFE3479089E9E8BA449E2A3E"><enum>(D)</enum><header>Limitation on payment</header><text>No payment shall be made under this subsection for a CRT item unless such CRT item—</text> <clause id="HF050F2296D4645E3A9190F0CBCB0EE1B"><enum>(i)</enum><text>is provided to a qualified individual;</text>
 </clause><clause id="H4458414733854891886E19CB9319812B"><enum>(ii)</enum><text>meets the clinical conditions for coverage established under <internal-xref idref="HE12D81F9490E4442AF01E3CBF8C69252" legis-path="(__)(2)">paragraph (2)</internal-xref>; and</text> </clause><clause id="H76F2DB3565344942B7C7A1E6BDA6A884"><enum>(iii)</enum><text>is furnished by a supplier accredited pursuant to <internal-xref idref="H3341E37C0DF64A818AA7A4DEBB65AF96" legis-path="(p)(3)">paragraph (3)</internal-xref>.</text>
							</clause></subparagraph></paragraph><paragraph id="HE12D81F9490E4442AF01E3CBF8C69252"><enum>(2)</enum><header>Clinical conditions for coverage</header>
 <subparagraph id="H52854EE59ECE44F398B16028690A8C2A"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">The Secretary shall establish standards for clinical conditions for payment for CRT items under this subsection.</text>
 </subparagraph><subparagraph id="H809229552C7C43E7B5C4550F3561E127"><enum>(B)</enum><header>Requirements</header><text>The standards established under <internal-xref idref="H52854EE59ECE44F398B16028690A8C2A" legis-path="(p)(2)(A)">subparagraph (A)</internal-xref> shall require the following:</text> <clause id="H722584CB0D9B43EABB5A7D088C75CF8A"><enum>(i)</enum><header>Written order</header> <subclause id="H27F41F002D3D4FA8AA0AB9B18A96B6D7"><enum>(I)</enum><header>In general</header><text>A qualified ordering practitioner shall provide a written order for a CRT item for a qualified individual before the Secretary may provide payment for such item for such individual under this subsection.</text>
 </subclause><subclause id="HFFAF54C86DE841BAA04A29C05AE31E2C"><enum>(II)</enum><header>CRT evaluation</header><text display-inline="yes-display-inline">In the case of a CRT item that is categorized by the Secretary, for purposes of the program under this title, as a manual wheelchair or a power wheelchair, and is to be provided to a qualified individual who has a diagnosis specified under <internal-xref idref="HDED0D64CCA924A5C9E50633282BA3B8A" legis-path="(p)(2)(C)">subparagraph (C)</internal-xref>, the qualified ordering practitioner may not provide a written order under <internal-xref idref="H27F41F002D3D4FA8AA0AB9B18A96B6D7" legis-path="(p)(2)(B)(i)(I)">subclause (I)</internal-xref> unless the qualified individual has undergone a CRT evaluation conducted by a licensed physical therapist or occupational therapist who has no financial relationship with the CRT supplier. The performance of such a CRT evaluation by a licensed physical or occupational therapist shall not be subject (or counted towards) the limitation on certain therapy services under section 1833(g).</text>
 </subclause></clause><clause id="HF55C1E2827AC4FB2BE90F758DB2CF9C2"><enum>(ii)</enum><header>Documentation of medical necessity</header><text display-inline="yes-display-inline">A qualified ordering practitioner who provides a written order under <internal-xref idref="H89BFFE260D6944708A835AF73D674DB2" legis-path="(__)(2)(B)(i)">clause (i)</internal-xref> shall maintain documentation of the medical necessity of such order for a period of seven years and shall make such documentation available to the Secretary upon request. The documentation of medical necessity under this clause shall include—</text>
 <subclause display-inline="no-display-inline" id="H75992EDDF92A4EA190D9A1C6D73DC0E3"><enum>(I)</enum><text>evidence that the individual for whom the order was written has physical and functional needs and capacities related to a medical condition that meet the eligibility criteria established under section 1861(iii)(2)(A)(ii); and</text>
 </subclause><subclause id="H4FBB009BED5044418B2A3649863B11D4"><enum>(II)</enum><text>evidence of any CRT evaluation required under <internal-xref idref="HFFAF54C86DE841BAA04A29C05AE31E2C" legis-path="(p)(2)(B)(i)(II)">clause (i)(II)</internal-xref>.</text> </subclause></clause></subparagraph><subparagraph id="HDED0D64CCA924A5C9E50633282BA3B8A"><enum>(C)</enum><header>Specification of diagnosis for CRT evaluation</header><text display-inline="yes-display-inline">The Secretary, in consultation with relevant parties (including the agencies listed in section 1861(iii)(2)(A), physicians, licensed physical therapists, licensed occupational therapists, and suppliers of complex rehabilitation technologies) shall specify the diagnoses and other medical presentations for which the requirement for a CRT evaluation under <internal-xref idref="HFFAF54C86DE841BAA04A29C05AE31E2C" legis-path="(p)(2)(B)(i)(II)">subparagraph (B)(i)(II)</internal-xref> shall apply.</text>
 </subparagraph><subparagraph id="HCF30232C6057428BA2B4F8CDBAE2410D"><enum>(D)</enum><header>Coverage determinations</header><text display-inline="yes-display-inline">In developing the standards under <internal-xref idref="H52854EE59ECE44F398B16028690A8C2A" legis-path="(__)(2)(A)">subparagraph (A)</internal-xref>, the coverage of CRT items with respect to an individual shall be based on—</text> <clause id="H6A35DD95973540129B375390B1F36315"><enum>(i)</enum><text>the specific medical, physical, and functional needs of the individual;</text>
 </clause><clause id="H2687F53A060542DC95F1603211CB0323"><enum>(ii)</enum><text display-inline="yes-display-inline">the individual’s capacities for safe participation in basic activities of daily living and instrumental activities of daily living in all routinely encountered environments (as such terms are defined in section 1861(iii)(3)); and</text>
 </clause><clause id="H47290083189E439DBF5C5AF9F0B9350F"><enum>(iii)</enum><text>the individual’s expected progression of such needs and capacities.</text> </clause></subparagraph><subparagraph commented="no" id="HBD9047D77CF04661A62B12C747C91347"><enum>(E)</enum><header>Contractor individualized consideration</header><text display-inline="yes-display-inline">The Secretary shall instruct Medicare contractors to provide individual consideration in cases that may lack one of the diagnoses identified, but that exhibit comparable functional presentations or deficits (or both) and where the need for CRT items has been documented by the qualified clinical professional.</text>
 </subparagraph><subparagraph display-inline="no-display-inline" id="H6213AF98E5BF4E4982246C3E5B33D13C"><enum>(F)</enum><header>Payment for residents of skilled nursing facilities</header><text>In the case of a qualified individual who is a resident of a skilled nursing facility, payment may only be made under this subsection for a CRT item for such individual if such CRT item is required as part of a plan of care to allow the transition of such individual from the skilled nursing facility to a home or community setting.</text>
						</subparagraph></paragraph><paragraph id="H3341E37C0DF64A818AA7A4DEBB65AF96"><enum>(3)</enum><header>Establishment of quality standards</header>
 <subparagraph id="H37E4F3DFBDFB40749CC5885D5E470518"><enum>(A)</enum><header>Establishment</header><text display-inline="yes-display-inline">The Secretary shall establish, through regulation, quality standards for suppliers of CRT items. Such standards shall be applied prospectively and shall be published on the Internet Web site of the Centers for Medicare and Medicaid Services.</text>
 </subparagraph><subparagraph id="H74BE98A805814A6A8AE97FE76604A404"><enum>(B)</enum><header>Consultation</header><text display-inline="yes-display-inline">In establishing the quality standards under <internal-xref idref="H218CD01D7A024034BD55C89A231B2996" legis-path="(p)(3)(A)">subparagraph (A)</internal-xref>, the Secretary shall consult with relevant parties (including clinicians, consumer groups, suppliers, and manufacturers).</text>
 </subparagraph><subparagraph id="H7AE9D5DD87324DE88AC4F266949082EA"><enum>(C)</enum><header>Requirements of standards</header><text display-inline="yes-display-inline">In establishing the quality standards under <internal-xref idref="H218CD01D7A024034BD55C89A231B2996" legis-path="(p)(3)(A)">subparagraph (A)</internal-xref>, the Secretary shall require that the suppliers of CRT items meet the following requirements:</text> <clause id="H5FC2981A669F46F39E27612D802D47B3"><enum>(i)</enum><header>DME standards</header><text display-inline="yes-display-inline">The supplier complies with all of the standards that are applicable to suppliers of durable medical equipment under subsection (a)(20) and suppliers of medical equipment and supplies under subsection (j).</text>
 </clause><clause id="H6B1EEACDB0F64DC484286D28D7046DFE"><enum>(ii)</enum><header>Qualified CRT professional</header><text>The supplier of a CRT item makes available, in each service area served by such supplier, at least one qualified CRT professional to—</text>
 <subclause display-inline="no-display-inline" id="H2BDDC35E89804DE4AEBBF497E3035A12"><enum>(I)</enum><text display-inline="yes-display-inline">analyze the needs and capacities of individuals for a CRT item in collaboration with the clinical team;</text>
 </subclause><subclause id="H47E9E388B2174AA2B799030DF651C8D8"><enum>(II)</enum><text>assist in selecting an appropriate CRT item for such individual, given such needs and capacities; and</text>
 </subclause><subclause id="H81D9A8CB3E74443BADF817C4D4A88CB8"><enum>(III)</enum><text>provide technology-related training to such individual in the proper use and maintenance of the CRT items.</text>
 </subclause></clause><clause id="HF73175D5DB9C4BAEBD4A2F51795B06EE"><enum>(iii)</enum><header>Trial equipment</header><text display-inline="yes-display-inline">The supplier of the CRT item provides the qualified individual with appropriate equipment for trial and simulation, if a physician, licensed physical therapist, or licensed occupational therapist determines that the provision of such equipment is necessary.</text>
 </clause><clause id="H72CD958F23FE456988D8667BA82B54A9"><enum>(iv)</enum><header>Information on service and repair</header><text>The supplier of the CRT item provides the qualified individual with written information on accessing service and repair for the CRT item before the CRT item is ordered for the individual.</text>
 </clause><clause id="HE7C3D5A598534C539C7D85AF18099269"><enum>(v)</enum><header>Repair</header><text display-inline="yes-display-inline">The supplier of a CRT item—</text> <subclause id="H31984C9F1CF34B7398468D82363EB2A7"><enum>(I)</enum><text>makes available, in each service area served by such supplier, at least one qualified CRT service technician to service and repair CRT items that—</text>
 <item id="HE356B5D28D1943A3AE2CFA5E51F6D420"><enum>(aa)</enum><text>are furnished by such supplier; and</text> </item><item id="HBB6C175845DB4DF598979B7B8F1BAEEF"><enum>(bb)</enum><text>at the time of the need for repair, are located in a service area of the supplier; or</text>
 </item></subclause><subclause id="H3836B5ECA3E443CB99806C85681F7530"><enum>(II)</enum><text>if the qualified individual lives outside the service area served by such supplier at the time of order of the CRT item, the supplier shall disclose in writing to the qualified individual that the supplier does not provide repair service for such item and provide contact information for entities that do provide such repair service.</text>
 </subclause></clause><clause id="HD273C310B29B49EA88E0A6E29D21FEB2"><enum>(vi)</enum><header>Rental equipment</header><text>If payment is allowed under paragraph (6), the supplier of the CRT item provides temporary rental equipment to the qualified individual when the supplier is repairing a qualified individual’s CRT item that was paid for under this subsection.</text>
							</clause></subparagraph></paragraph><paragraph id="HB14CDB2997A94DD79322C4906D2F5575"><enum>(4)</enum><header>Application of standards and accreditation program for suppliers of CRT items</header>
						<subparagraph id="H218CD01D7A024034BD55C89A231B2996"><enum>(A)</enum><header>In general</header>
 <clause id="HFE75326E68644399BB8DD3FFD06E49CA"><enum>(i)</enum><header>Requirement for provider or supplier number</header><text>The Secretary shall not provide a supplier of CRT items with a provider or supplier number to submit claims for payment under this title unless the supplier is in compliance with the standards under paragraph (3).</text>
 </clause><clause id="HD52A8C1FF49240A4BED297EDCD512D0E"><enum>(ii)</enum><header>Requirement for payment</header><text>Payment shall not be made under this part for CRT items furnished by a supplier unless the supplier is in compliance with the standards under paragraph (3).</text>
 </clause></subparagraph><subparagraph display-inline="no-display-inline" id="H8387DC104C744F0F8A4D38733308340A"><enum>(B)</enum><header>Application of accreditation requirement</header><text>In implementing quality standards under <internal-xref idref="H3341E37C0DF64A818AA7A4DEBB65AF96" legis-path="(p)(3)">paragraph (3)</internal-xref>, the Secretary shall require suppliers furnishing CRT items, on or after one year after the standards are published under such paragraph, directly or as a subcontractor for another entity—</text>
 <clause id="H0EDE321FE94549FEB8A74D746A7DABC2"><enum>(i)</enum><text>to comply with such standards; and</text> </clause><clause id="H23E937118CB84594909A13CFD01F7A78"><enum>(ii)</enum><text>to have submitted to the Secretary evidence of accreditation by an accreditation organization designated under <internal-xref idref="HA4FC1C9158D94B35BD04A1160766B2DC" legis-path="(p)(4)(D)">subparagraph (C)</internal-xref> demonstrating that the supplier is complying with such standards.</text>
 </clause></subparagraph><subparagraph id="HA4FC1C9158D94B35BD04A1160766B2DC"><enum>(C)</enum><header>Designation of independent accreditation organizations</header><text>Not later than the date that is one year after the date on which the Secretary implements the quality standards under <internal-xref idref="H3341E37C0DF64A818AA7A4DEBB65AF96" legis-path="(p)(3)">paragraph (3)</internal-xref>, the Secretary shall designate and approve one or more independent accreditation organizations that—</text>
 <clause id="H2F561FBF983F4A11AEEFDEB5ED721EB3"><enum>(i)</enum><text>are approved under subsection (a)(20)(B); and</text> </clause><clause id="HD1D2EF90B6B6446BAD5F3EA7FAF87169"><enum>(ii)</enum><text>the Secretary has determined have the capability to assess whether suppliers of CRT items meet the quality standards established under <internal-xref idref="H3341E37C0DF64A818AA7A4DEBB65AF96" legis-path="(p)(3)">paragraph (3)</internal-xref>.</text>
							</clause></subparagraph></paragraph><paragraph id="HD69BC8A2B6B74A66A3108462FE97492B"><enum>(5)</enum><header>Coding system for complex rehabilitation technologies</header>
 <subparagraph id="H0B2DCC0A7B38433BB2E4DC3FDEBC4BDC"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">The Secretary shall, in consultation with suppliers and manufacturers of CRT items, establish a formal process to allow submission of CRT code set modification requests by stakeholder groups for comprehensive coding changes related to entire policy groups. This process shall include a specific application, public meeting participation and an appeals process. The Secretary shall then, in consultation with suppliers and manufacturers of CRT items, establish a HCPCS coding subset that shall utilize and include HCPCS codes described in section 1861(iii)(2) for CRT items for which payment may be made under this subsection.</text>
						</subparagraph><subparagraph id="H7FD35C30C0B548B4A7779FB755D428F6"><enum>(B)</enum><header>Treatment of existing products</header>
 <clause id="H98FC9AA7F8B748649CA88D8B316FFDAB"><enum>(i)</enum><header>In general</header><text>With respect to CRT items for which payment was available under this title before the effective date of the amendments made by the <short-title>Ensuring Access to Quality Complex Rehabilitation Technology Act of 2015</short-title>, the Secretary shall assign such items to a code in the coding subset established under <internal-xref idref="H0B2DCC0A7B38433BB2E4DC3FDEBC4BDC" legis-path="(p)(4)(A)">subparagraph (A)</internal-xref>.</text>
 </clause><clause id="HB686FD09F6F14A1EA55D67458FBEF7EF"><enum>(ii)</enum><header>Updates</header><text display-inline="yes-display-inline">After the initial assignment under <internal-xref idref="H98FC9AA7F8B748649CA88D8B316FFDAB" legis-path="(__)(3)(C)(i)">clause (i)</internal-xref>, the Secretary may decide to reassign additional product categories, or items within those categories, that exist before the date of the enactment of this subsection to the CRT coding subset.</text>
 </clause><clause id="H7AFC699DB50841C9AB57B9372E9C1B17"><enum>(iii)</enum><header>Consultation</header><text display-inline="yes-display-inline">Before making reassignments of CRT items under <internal-xref idref="H98FC9AA7F8B748649CA88D8B316FFDAB" legis-path="(p)(4)(B)(i)">clause (ii)</internal-xref>, the Secretary shall consult with suppliers and manufacturers of such items. The Secretary shall not require manufacturers of CRT items for which payment was available under this title before the effective date of the amendments made by the <short-title>Ensuring Access to Quality Complex Rehabilitation Technology Act of 2015</short-title> to submit requests for reassignment of the code for such product to the coding subset under <internal-xref idref="H0B2DCC0A7B38433BB2E4DC3FDEBC4BDC" legis-path="(p)(4)(A)">subparagraph (A) </internal-xref>as long as—</text>
 <subclause id="HDAFE4938D00F400BB1ABEACD20AC8766"><enum>(I)</enum><text>no changes have been made to the code definitions, required code characteristics or test requirements; and</text>
 </subclause><subclause id="HB48CD67386634C5EA500DBD8E407218F"><enum>(II)</enum><text>the item was previously verified to meet the code requirements.</text> </subclause></clause></subparagraph><subparagraph id="HEF1E9651BCE14195A685DD114C0C8EE5"><enum>(C)</enum><header>Removing complex rehabilitation technology from DME codes</header><text>The Secretary shall, in consultation with suppliers and manufacturers of CRT items—</text>
 <clause id="H1B7D8BD5C6A5433CB70EBD105DD2C327"><enum>(i)</enum><text>remove from the coding subset for durable medical equipment any CRT items that are included in the coding subset under <internal-xref idref="H0B2DCC0A7B38433BB2E4DC3FDEBC4BDC" legis-path="(__)(3)(A)">subparagraph (A)</internal-xref>; and</text>
 </clause><clause id="HD7CFA52A5A6745B5ABCF6CBECE72E5DE"><enum>(ii)</enum><text>assign new codes to such CRT items based on technological differences to support adequate access to meet clinical outcomes and for purposes of including such items in the subset under <internal-xref idref="H0B2DCC0A7B38433BB2E4DC3FDEBC4BDC" legis-path="(p)(4)(A)">subparagraph (A)</internal-xref>.</text>
							</clause></subparagraph><subparagraph id="HA4BE4AF3E2B94C9685B28F881342C860"><enum>(D)</enum><header>New technology</header>
 <clause id="H6A096311E6E94B3FA5F595E6FC68E949"><enum>(i)</enum><header>In general</header><text display-inline="yes-display-inline">The Secretary shall update as needed the HCPCS level II process used to modify the code set to include CRT items for the purposes of establishing new codes and determining products to be classified as CRT items. In determining if a product is a CRT item, the Secretary shall consider—</text>
 <subclause id="H41B10F08A986444188CF55BC8B80A12E"><enum>(I)</enum><text>if the product is novel;</text> </subclause><subclause id="H027B28AD9E8E43F295D39D1C2D1D0533"><enum>(II)</enum><text>the clinical application of the product; and</text>
 </subclause><subclause id="H843EA950914340ED8872D6EC0470A7E7"><enum>(III)</enum><text>the ability of the product to address the unique needs and capacities of a qualified individual.</text> </subclause></clause><clause id="HDC80F873F5394C03A9A488D996BB3D71"><enum>(ii)</enum><header>Inclusion of codes in list</header><text>The Secretary shall include the codes established in <internal-xref idref="H6A096311E6E94B3FA5F595E6FC68E949" legis-path="(__)(3)(E)(i)">clause (i)</internal-xref> in the list under section 1861(iii)(2)(F).</text>
 </clause></subparagraph><subparagraph id="H0790CCD255E94596BCF559C7E66F1EFE"><enum>(E)</enum><header>Miscellaneous code for innovation and local coverage determinations</header><text>The coding subset established under <internal-xref idref="H0B2DCC0A7B38433BB2E4DC3FDEBC4BDC" legis-path="(__)(3)(A)">subparagraph (A)</internal-xref> shall include at least one miscellaneous code for items not otherwise classified.</text> </subparagraph><subparagraph id="H15F8B43057684AB6A8CA667327188DD1"><enum>(F)</enum><header>Establishment of adequate HCPCS codes to reflect specialized nature of CRT</header><text display-inline="yes-display-inline">The Secretary shall ensure that HCPCS codes exist (or are developed) to represent the specialized nature of CRT, including codes to represent custom CRT manual and power wheelchairs and modifications to CRT manual and power wheelchair frames, and miscellaneous codes for CRT manual and power wheelchairs that are otherwise classified.</text>
						</subparagraph></paragraph><paragraph commented="no" id="H3C29BEBEF0CE4AD3B52DB2E3892A7663"><enum>(6)</enum><header>Replacement of CRT items</header>
 <subparagraph commented="no" id="H69D22D0F66C84725A262B5E67A0EEE50"><enum>(A)</enum><header>In general</header><text>Payment shall be made for the replacement of a CRT item (or for the replacement of any part of such item) without regard to continuous use or useful lifetime restrictions established under section 1834(a)(7)(C) for items of durable medical equipment if a qualified ordering practitioner determines that the provision of a replacement item (or a replacement part of such an item) is necessary because—</text>
 <clause commented="no" id="H9AD780B78FCC440C81C1C1E78193F327"><enum>(i)</enum><text>there was a change in the physiological condition of the qualified individual to whom such item was provided;</text>
 </clause><clause id="H49EAD85B614B477582266A02AB630FA5"><enum>(ii)</enum><text>there was an irreparable change in the condition of the CRT item (or, in the case of the replacement of a part, in the part of the CRT item); or</text>
 </clause><clause id="H499257AE00A347BE979FD351BD25FD46"><enum>(iii)</enum><text display-inline="yes-display-inline">the CRT item requires repairs and the cost of such repairs would be more than 50 percent of the cost of a replacement of the CRT item.</text>
							</clause></subparagraph><subparagraph commented="no" id="H3983DD7C89A24971B5F290CB7DAB4D66"><enum>(B)</enum><header>Deferral to providers</header>
 <clause id="H54550C950D384E2599E59DE79BA0BC10"><enum>(i)</enum><header>In general</header><text>Subject to <internal-xref idref="HDCA2547BAF5E4A5880C1AAE20026B7DE" legis-path="(__)(3)(B)(ii)">clause (ii)</internal-xref>, if a qualified ordering practitioner determines that a replacement of the CRT item, or the replacement of a part of a CRT item, is necessary pursuant to subparagraph (A), the replacement item or part is deemed to be reasonable and necessary for purposes of section 1862(a)(1)(A).</text>
 </clause><clause id="HDCA2547BAF5E4A5880C1AAE20026B7DE"><enum>(ii)</enum><header>Exception for items under 3 years old</header><text display-inline="yes-display-inline">If the CRT item that is being replaced (or the part of the CRT item that is being replaced) under <internal-xref idref="H69D22D0F66C84725A262B5E67A0EEE50" legis-path="(__)(3)(A)">subparagraph (A)</internal-xref> is less than 3 years old (calculated from the date on which the qualified individual began to use the CRT item or part), the Secretary may require the qualified ordering practitioner to provide confirmation of necessity of the replacement item or replacement part, as the case may be.</text>
							</clause></subparagraph></paragraph><paragraph id="HDCCB53544CF04DC791EFAD2D5B256121"><enum>(7)</enum><header>Payment for temporary rental</header>
 <subparagraph id="H1CA259B308D24B86A24DE9551AF1B7F7"><enum>(A)</enum><header>In general</header><text>If a CRT item owned by a qualified individual needs to be repaired, payment may be made under this subsection for the temporary rental of a CRT item while the CRT item owned by such individual is being repaired.</text>
 </subparagraph><subparagraph id="HE66A2831555F4EFBA047B59EEF1DCA11"><enum>(B)</enum><header>Basis; limitation</header><text>Payment permitted under <internal-xref idref="H1CA259B308D24B86A24DE9551AF1B7F7" legis-path="(__)(3)(A)">subparagraph (A)</internal-xref> shall be made on a monthly basis, and the period of rental may not exceed two months.</text> </subparagraph><subparagraph id="HEFB049FA8C364F92BEF6D1861A0655BB"><enum>(C)</enum><header>Payment amount</header><text>The amount of payment allowed under <internal-xref idref="H1CA259B308D24B86A24DE9551AF1B7F7" legis-path="(__)(3)(A)">subparagraph (A)</internal-xref> for a month for the rental of a CRT item shall be 10 percent of the purchase price for the CRT item.</text>
 </subparagraph></paragraph><paragraph id="H785ACE93431D4CA9BBDB8ECEB0F83316"><enum>(8)</enum><header>Definitions</header><text>For purposes of this subsection:</text> <subparagraph id="HB77BEC238EEF4693887666B3532C1BDA"><enum>(A)</enum><header>HCPCS</header><text>The term <term>HCPCS</term> refers to the Health Care Procedure Coding System.</text>
						</subparagraph><subparagraph id="H9723E41358304774B4086A2800E982E8"><enum>(B)</enum><header>Qualified CRT professional</header>
 <clause id="H2E4FB4D6B18E4BCFA1B186ABA6612F9E"><enum>(i)</enum><header>In general</header><text>The term <term>qualified CRT professional</term> means an individual who—</text> <subclause id="H6A18AEC7C6464A718B4B081C9238A11E"><enum>(I)</enum><text>is certified by the Rehabilitation Engineering and Assistive Technology Society of North America as an assistive technology professional or is certified by another organization designated by the Secretary (acting in consultation with relevant parties) as providing a certification that is equivalent to, or more stringent than, the assistive technology professional certification; and</text>
 </subclause><subclause id="HFC0F8BC0B94D4DA79A8640F226D93F1E"><enum>(II)</enum><text>beginning two years after the establishment of the designation under <internal-xref idref="H8D140AA0880745B190C69FFE0B9DA36F" legis-path="(p)(8)(C)(ii)">clause (ii)</internal-xref>, achieves an additional designation that demonstrates the individual’s competencies and experience in supplying CRT items.</text>
 </subclause></clause><clause id="H8D140AA0880745B190C69FFE0B9DA36F"><enum>(ii)</enum><header>Establishment</header><text>Not later than one year after the date of the enactment of this subsection, the Secretary, acting in consultation with relevant parties, shall establish the additional designation under <internal-xref idref="HFC0F8BC0B94D4DA79A8640F226D93F1E" legis-path="(p)(8)(C)(i)(II)">clause (i)(II).</internal-xref></text>
 </clause><clause id="HD0095EEFEABF41D493516992FD4A9D35"><enum>(iii)</enum><header>Relevant parties</header><text display-inline="yes-display-inline">For purposes of this subparagraph, the term <term>relevant parties</term> includes clinicians, consumer groups, CRT suppliers, and CRT manufacturers.</text> </clause></subparagraph><subparagraph id="HBE37475CDF794D8B841332F31C0E434D"><enum>(C)</enum><header>Qualified CRT service technician</header><text>The term <term>qualified CRT service technician</term> means an individual who—</text>
 <clause id="H9147CF9565154C6D8E473202487E1AC1"><enum>(i)</enum><text>is factory-trained by the manufacturers of the CRT items being offered by the suppler of such items;</text>
 </clause><clause id="H749FC698C4AD43A6BF8809E5470F0327"><enum>(ii)</enum><text>is trained and educated (including through on-the-job training) to assemble, fit, program, service, and repair CRT items; and</text>
 </clause><clause id="HC50334EAE4184464984A999AA589B1A9"><enum>(iii)</enum><text>on an annual basis, completes at least 10 hours of continuing education specific to the assembly, fitting, programming, service, and repair of CRT items.</text>
 </clause></subparagraph><subparagraph id="H1E10D5D73920498D930132DC15C0A987"><enum>(D)</enum><header>Qualified individual</header><text>The term <term>qualified individual</term> has the meaning given such term in section 1861(iii)(3)(E).</text> </subparagraph><subparagraph id="HF0633CB55E694156890B1971311BB4AC"><enum>(E)</enum><header>Qualified ordering practitioner</header><text>The term <term>qualified ordering practitioner</term> means a physician (as defined in section 1861(r)), a physician assistant, nurse practitioner, or a clinical nurse specialist (as those terms are defined in section 1861(aa)(5)).</text>
 </subparagraph><subparagraph id="HC15A25665F7B4D48B9B550C30B7CCDAE"><enum>(F)</enum><header>Qualified licensed clinician</header><text>The term <quote>qualified licensed clinician</quote> means a licensed physical therapist or occupational therapist or physician who possesses specialized training and experience in providing seating and mobility services and the skills to perform all aspects of the evaluation described in paragraph (2)(B)(i)(II).</text></subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
		</section><section commented="no" id="H6959D60CE7FA4791938CDB469438C4EF"><enum>5.</enum><header>Conforming amendments</header>
 <subsection commented="no" id="H2DB8B207238A410C9685792D0FFCF055"><enum>(a)</enum><header>Exclusion from the in-Home use limitation for DME</header><text display-inline="yes-display-inline">Section 1861(n) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395x">42 U.S.C. 1395x(n)</external-xref>) is amended by adding at the end the following: <quote>For 2016 and subsequent years, such term does not include complex rehabilitation technologies (as defined in subsection (iii)).</quote>.</text>
 </subsection><subsection commented="no" id="H02AE3F83C78540C3ACE874161B92CEAB"><enum>(b)</enum><header>Exemption from competitive acquisition</header><text display-inline="yes-display-inline">Section 1847(a)(7) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-3">42 U.S.C. 1395w–3(a)(7)</external-xref>) is amended by adding at the end the following new subparagraph:</text>
				<quoted-block display-inline="no-display-inline" id="H33C465C59F7F4F7D9B4FEC3664E4947F" style="OLC">
 <subparagraph id="HC808BB49F52E4DA49985B30FEB8AF6F7"><enum>(C)</enum><header> CRT items</header><text display-inline="yes-display-inline">For 2016 and subsequent years, complex rehabilitation technology items (as defined in section 1861(iii)).</text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block>
 </subsection><subsection id="H9D1427E5CCBF47239346C0855D2C1AC1"><enum>(c)</enum><header>Exemption from SNF consolidated billing</header><text>Section 1888(e)(2)(A)(iii) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395yy">42 U.S.C. 1395yy(e)(2)(A)(iii)</external-xref>) is amended by adding at the end the following:</text>
				<quoted-block display-inline="no-display-inline" id="H63801E77AC7E41DDB46B3B7528E03D52" style="OLC">
 <subclause id="H7956711FDAA840A9B3F45D41A6783C3B"><enum>(VI)</enum><text display-inline="yes-display-inline">Complex rehabilitation technology items (as defined in section 1861(iii)) if delivered to an inpatient for use during the stay in the skilled nursing facility as part of the plan of care to allow the transition of such qualified individuals from the skilled nursing facility setting to the home and community.</text></subclause><after-quoted-block>.</after-quoted-block></quoted-block>
 </subsection><subsection id="H71904A80C4154C19ACEEDEC9DAFC92E9"><enum>(d)</enum><header>Payment exclusions</header><text>Section 1834(a) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395m">42 U.S.C. 1395m(a)</external-xref>) is amended—</text> <paragraph id="HD11A0ACE456748A3895FA68745C546B5"><enum>(1)</enum><text>in paragraph (4), by adding at the end the following sentence <quote>For 2016 and subsequent years, the items covered by this paragraph shall not include complex rehabilitation technology items (as defined in section 1861(iii)).</quote>;</text>
 </paragraph><paragraph id="H31DC013661564A15997EEACFBCF8B666"><enum>(2)</enum><text>in paragraph (7)(A), by adding at the end the following: <quote>For fiscal year 2016 and subsequent years, the previous sentence shall not apply to power-driven wheelchairs that are designated as CRT items under section 1861(iii).</quote>; and</text>
 </paragraph><paragraph id="HC21B7D8808DF44A6B39E0E051463FE17"><enum>(3)</enum><text>in paragraph (16), by inserting at the end the following: <quote>The Secretary shall impose (and, may, as allowed by the second sentence of this paragraph, waive) the requirements of the first sentence of this paragraph to suppliers of complex rehabilitation technology items, except that, in order to avoid duplicate bonds, the Secretary shall not impose such requirements with respect to suppliers of complex rehabilitation technology items if such suppliers also participate in the Medicare program as suppliers of durable medical equipment.</quote>.</text>
 </paragraph></subsection><subsection id="HEC080FEFA83849D8B89BFDFF507A5669"><enum>(e)</enum><header>Requirements for suppliers of medical equipment and supplies</header><text>Section 1834(j)(5) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395m">42 U.S.C. 1395m(j)(5)</external-xref>) is amended—</text> <paragraph id="H8DE2D53DD0734092A356A7DB596F70C1"><enum>(1)</enum><text>by redesignating subparagraphs (E) and (F) as subparagraphs (F) and (G), respectively;</text>
 </paragraph><paragraph id="HB2746D103BDF4C438B961B397A3D15F1"><enum>(2)</enum><text>by inserting after subparagraph (D) the following new subparagraph:</text> <quoted-block display-inline="no-display-inline" id="H23501177CD694A0AAC0278CEB8F1E038" style="OLC"> <subparagraph id="H028A7DA65A454D24965BE2005FB5FF15"><enum>(E)</enum><text display-inline="yes-display-inline">complex rehabilitation technology items (as defined in section 1861(iii));</text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block>
 </paragraph></subsection></section><section id="H2E05648F5CF5439EB34B45DAD059330E"><enum>6.</enum><header>Effective date</header><text display-inline="no-display-inline">The amendments made by this Act shall apply to items and services furnished on or after January 1, 2016.</text></section></legis-body></bill>


