<enum>I</enum><header>ACE Kids</header> <section display-inline="no-display-inline" id="H86D43B4234EA465ABB623A1FE191E196"><enum>101.</enum><header>State option to provide coordinated care through a health home for children with medically complex conditions</header><text display-inline="no-display-inline">Title XIX of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396">42 U.S.C. 1396</external-xref> et seq.) is amended by inserting after section 1945 the following new section:</text> <quoted-block display-inline="no-display-inline" id="H6E122586114749B0A871A6BF1E0D6DAB" style="OLC"> <section id="H5FC701313DFA4F169D7573B9C54694C3"><enum>1945A.</enum><header>State option to provide coordinated care through a health home for children with medically complex conditions</header> <subsection id="H3062D8B5B07248EC9D9C9A03A5C9A50B"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Notwithstanding section 1902(a)(1) (relating to statewideness) and section 1902(a)(10)(B) (relating to comparability), beginning October 1, 2022, a State, at its option as a State plan amendment, may provide for medical assistance under this title to children with medically complex conditions who choose to enroll in a health home under this section by selecting a designated provider, a team of health care professionals operating with such a provider, or a health team as the child’s health home for purposes of providing the child with health home services.</text> </subsection> <subsection commented="no" id="H4CF06163EB674AFD9F121874406BF6EA"><enum>(b)</enum><header>Health home qualification standards</header><text>The Secretary shall establish standards for qualification as a health home for purposes of this section. Such standards shall include requiring designated providers, teams of health care professionals operating with such providers, and health teams to demonstrate to the State the ability to do the following:</text> <paragraph commented="no" id="H687C0B058C354AF48F7F2B33FFD0FC3D"><enum>(1)</enum><text display-inline="yes-display-inline">Coordinate prompt care for children with medically complex conditions, including access to pediatric emergency services at all times.</text> </paragraph> <paragraph commented="no" id="H50F972617773491BA955D56F55E308E8"><enum>(2)</enum><text display-inline="yes-display-inline">Develop an individualized comprehensive pediatric family-centered care plan for children with medically complex conditions that accommodates patient preferences.</text> </paragraph> <paragraph commented="no" id="H689B42567EBB4708BF74BD8C8154CE3B"><enum>(3)</enum><text display-inline="yes-display-inline">Work in a culturally and linguistically appropriate manner with the family of a child with medically complex conditions to develop and incorporate into such child’s care plan, in a manner consistent with the needs of the child and the choices of the child’s family, ongoing home care, community-based pediatric primary care, pediatric inpatient care, social support services, and local hospital pediatric emergency care.</text> </paragraph> <paragraph commented="no" id="HD313DA6B1A0A4DB787E16F7E0E74D1A4"><enum>(4)</enum><text display-inline="yes-display-inline">Coordinate access to—</text> <subparagraph commented="no" id="H6E2FF6977D93416D920228EAF469EE78"><enum>(A)</enum><text>subspecialized pediatric services and programs for children with medically complex conditions, including the most intensive diagnostic, treatment, and critical care levels as medically necessary; and</text> </subparagraph> <subparagraph commented="no" id="HDF4D5AB1B3CD4C46BB578CA90C62847B"><enum>(B)</enum><text>palliative services if the State provides such services under the State plan (or a waiver of such plan).</text> </subparagraph></paragraph> <paragraph commented="no" id="HE84A502B5B5F49BFBA3F010919A914B8"><enum>(5)</enum><text display-inline="yes-display-inline">Coordinate care for children with medically complex conditions with out-of-State providers furnishing care to such children to the maximum extent practicable for the families of such children and where medically necessary, in accordance with guidance issued under subsection (e)(1) and section 431.52 of title 42, Code of Federal Regulations.</text> </paragraph> <paragraph commented="no" id="H630FAF31C8FB4EFC9246F6688635B8A1"><enum>(6)</enum><text display-inline="yes-display-inline">Collect and report information under subsection (g)(1).</text> </paragraph></subsection> <subsection id="H6992BCF8978A4E81ACC85B131D27428A"><enum>(c)</enum><header>Payments</header> <paragraph id="HCA6F74DB00A04CAD853CFF19BDB7E8DB"><enum>(1)</enum><header>In general</header><text>A State shall provide a designated provider, a team of health care professionals operating with such a provider, or a health team with payments for the provision of health home services to each child with medically complex conditions that selects such provider, team of health care professionals, or health team as the child’s health home. Payments made to a designated provider, a team of health care professionals operating with such a provider, or a health team for such services shall be treated as medical assistance for purposes of section 1903(a), except that, during the first 2 fiscal year quarters that the State plan amendment is in effect, the Federal medical assistance percentage applicable to such payments shall be increased by 15 percentage points, but in no case may exceed 90 percent.</text> </paragraph> <paragraph id="HA81D9508C1654740A5B1E0A20B0D4E94"><enum>(2)</enum><header>Methodology</header> <subparagraph id="H5B6315C43ADB49C5B028EF5ACF3A4A04"><enum>(A)</enum><header>In general</header><text>The State shall specify in the State plan amendment the methodology the State will use for determining payment for the provision of health home services. Such methodology for determining payment—</text> <clause id="HDC0EA47DA5F24D9F8FECEB50898E067A"><enum>(i)</enum><text>may be tiered to reflect, with respect to each child with medically complex conditions provided such services by a designated provider, a team of health care professionals operating with such a provider, or a health team, the severity or number of each such child’s chronic conditions, life-threatening illnesses, disabilities, or rare diseases, or the specific capabilities of the provider, team of health care professionals, or health team; and</text> </clause> <clause id="HF05A32CFF38241129C2E5A6981692C9D"><enum>(ii)</enum><text>shall be established consistent with section 1902(a)(30)(A).</text> </clause></subparagraph> <subparagraph id="H08561437EBF54D83A2450E7CF79F4B00"><enum>(B)</enum><header>Alternate models of payment</header><text>The methodology for determining payment for provision of health home services under this section shall not be limited to a per-member per-month basis and may provide (as proposed by the State and subject to approval by the Secretary) for alternate models of payment.</text> </subparagraph></paragraph> <paragraph commented="no" id="H25FABFF49D354FA5956A87D5FE24D729"><enum>(3)</enum><header>Planning grants</header> <subparagraph commented="no" id="HEF4104E789F14716A9A4B7DECFCF34C6"><enum>(A)</enum><header>In general</header><text>Beginning October 1, 2022, the Secretary may award planning grants to States for purposes of developing a State plan amendment under this section. A planning grant awarded to a State under this paragraph shall remain available until expended.</text> </subparagraph> <subparagraph commented="no" id="H6AD2F9FFC55F45C78BB764874A0A5DC4"><enum>(B)</enum><header>State contribution</header><text>A State awarded a planning grant shall contribute an amount equal to the State percentage determined under section 1905(b) (without regard to section 5001 of <external-xref legal-doc="public-law" parsable-cite="pl/111/5">Public Law 111–5</external-xref>) for each fiscal year for which the grant is awarded.</text> </subparagraph> <subparagraph commented="no" id="H7582292146204A9BA56AB825C4089343"><enum>(C)</enum><header>Limitation</header><text>The total amount of payments made to States under this paragraph shall not exceed $5,000,000.</text> </subparagraph></paragraph></subsection> <subsection commented="no" id="H7FE751D30F8F48D28242F8AC2E2C1D86"><enum>(d)</enum><header>Coordinating care</header> <paragraph id="H575926B521E444058A721A9D8076B649"><enum>(1)</enum><header>Hospital notification</header><text display-inline="yes-display-inline">A State with a State plan amendment approved under this section shall require each hospital that is a participating provider under the State plan (or a waiver of such plan) to establish procedures for, in the case of a child with medically complex conditions who is enrolled in a health home pursuant to this section and seeks treatment in the emergency department of such hospital, notifying the health home of such child of such treatment.</text> </paragraph> <paragraph commented="no" id="H528CD1E9EC9A4786B16CE1EC5B73FC37"><enum>(2)</enum><header>Education with respect to availability of health home services</header><text display-inline="yes-display-inline">In order for a State plan amendment to be approved under this section, a State shall include in the State plan amendment a description of the State’s process for educating providers participating in the State plan (or a waiver of such plan) on the availability of health home services for children with medically complex conditions, including the process by which such providers can refer such children to a designated provider, team of health care professionals operating such a provider, or health team for the purpose of establishing a health home through which such children may receive such services.</text> </paragraph> <paragraph commented="no" id="H5C6563C5EFC7445CA860639893BF0465"><enum>(3)</enum><header>Family education</header><text display-inline="yes-display-inline">In order for a State plan amendment to be approved under this section, a State shall include in the State plan amendment a description of the State’s process for educating families with children eligible to receive health home services pursuant to this section of the availability of such services. Such process shall include the participation of family-to-family entities or other public or private organizations or entities who provide outreach and information on the availability of health care items and services to families of individuals eligible to receive medical assistance under the State plan (or a waiver of such plan).</text> </paragraph> <paragraph commented="no" id="H95D0762A4F2E4440AEF7516F88BEA20C"><enum>(4)</enum><header>Mental health coordination</header><text display-inline="yes-display-inline">A State with a State plan amendment approved under this section shall consult and coordinate, as appropriate, with the Secretary in addressing issues regarding the prevention and treatment of mental illness and substance use among children with medically complex conditions receiving health home services under this section.</text> </paragraph></subsection> <subsection commented="no" id="H3B47E9447B5A440F89AFC69D09244A1E"><enum>(e)</enum><header>Guidance on coordinating care from out-of-State providers</header> <paragraph commented="no" display-inline="no-display-inline" id="H4A0640E59C56408B8FA0B858402906D6"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">Not later than October 1, 2020, the Secretary shall issue (and update as the Secretary determines necessary) guidance to State Medicaid directors on—</text> <subparagraph commented="no" id="H572A79CD39B246E9A23C8D9D8F32FD86"><enum>(A)</enum><text>best practices for using out-of-State providers to provide care to children with medically complex conditions;</text> </subparagraph> <subparagraph commented="no" id="H587E501FE0B34E8DAE046F91127A2849"><enum>(B)</enum><text display-inline="yes-display-inline">coordinating care for such children provided by such out-of-State providers (including when provided in emergency and non-emergency situations);</text> </subparagraph> <subparagraph commented="no" id="H475767A6037C4D3CA056AAE54192F67C"><enum>(C)</enum><text display-inline="yes-display-inline">reducing barriers for such children receiving care from such providers in a timely fashion; and</text> </subparagraph> <subparagraph commented="no" id="H0B9256D545804AA0A7C77A93E2BD1B8D"><enum>(D)</enum><text>processes for screening and enrolling such providers in the respective State plan (or a waiver of such plan), including efforts to streamline such processes or reduce the burden of such processes on such providers.</text> </subparagraph></paragraph> <paragraph commented="no" display-inline="no-display-inline" id="H143269211E6242409631127A5E669504"><enum>(2)</enum><header>Stakeholder input</header><text display-inline="yes-display-inline">In carrying out paragraph (1), the Secretary shall issue a request for information to seek input from children with medically complex conditions and their families, States, providers (including children’s hospitals, hospitals, pediatricians, and other providers), managed care plans, children’s health groups, family and beneficiary advocates, and other stakeholders with respect to coordinating the care for such children provided by out-of-State providers.</text> </paragraph></subsection> <subsection id="H7F46AEDD71EC433BB1D2E6E3F4669B17"><enum>(f)</enum><header>Monitoring</header><text>A State shall include in the State plan amendment—</text> <paragraph id="H66445540EC914899B5D3F4898CAA6F2A"><enum>(1)</enum><text>a methodology for tracking avoidable hospital readmissions and calculating savings that result from improved care coordination and management under this section;</text> </paragraph> <paragraph id="HCE58F01C040F4D36BF2BCE112EBAD0FD"><enum>(2)</enum><text>a proposal for use of health information technology in providing health home services under this section and improving service delivery and coordination across the care continuum (including the use of wireless patient technology to improve coordination and management of care and patient adherence to recommendations made by their provider); and</text> </paragraph> <paragraph commented="no" id="H3D9BD891708344FD83A454E99AA82BA8"><enum>(3)</enum><text>a methodology for tracking prompt and timely access to medically necessary care for children with medically complex conditions from out-of-State providers.</text> </paragraph></subsection> <subsection commented="no" id="HBB99EA9E11314ADAB4869B9147F340CF"><enum>(g)</enum><header>Data collection</header> <paragraph commented="no" id="H9451307B353E42828E9E149B6CEF0578"><enum>(1)</enum><header>Provider reporting requirements</header><text display-inline="yes-display-inline">In order to receive payments from a State under subsection (c), a designated provider, a team of health care professionals operating with such a provider, or a health team shall report to the State, at such time and in such form and manner as may be required by the State, the following information:</text> <subparagraph commented="no" id="HFBDFB2D8D7154A79808FF0D08BE444E0"><enum>(A)</enum><text>With respect to each such provider, team of health care professionals, or health team, the name, National Provider Identification number, address, and specific health care services offered to be provided to children with medically complex conditions who have selected such provider, team of health care professionals, or health team as the health home of such children.</text> </subparagraph> <subparagraph commented="no" id="H17C520FE35584A05B9B401F7DCFA9A3E"><enum>(B)</enum><text display-inline="yes-display-inline">Information on all applicable measures for determining the quality of health home services provided by such provider, team of health care professionals, or health team, including, to the extent applicable, child health quality measures and measures for centers of excellence for children with complex needs developed under this title, title XXI, and section 1139A.</text> </subparagraph> <subparagraph commented="no" id="HFFDD09B3A84546679ECC07B4480D97B2"><enum>(C)</enum><text display-inline="yes-display-inline">Such other information as the Secretary shall specify in guidance.</text> </subparagraph><continuation-text continuation-text-level="paragraph">When appropriate and feasible, such provider, team of health care professionals, or health team, as the case may be, shall use health information technology in providing the State with such information.</continuation-text></paragraph> <paragraph commented="no" id="H2833B41394634B21B65162D8782DE2F9"><enum>(2)</enum><header>State reporting requirements</header> <subparagraph commented="no" id="HA6A58064231341868083C84694E9005F"><enum>(A)</enum><header>Comprehensive report</header><text display-inline="yes-display-inline">A State with a State plan amendment approved under this section shall report to the Secretary (and, upon request, to the Medicaid and CHIP Payment and Access Commission), at such time and in such form and manner determined by the Secretary to be reasonable and minimally burdensome, the following information:</text> <clause commented="no" id="HAB0767E3486B4501BD7585C6250C74B6"><enum>(i)</enum><text>Information reported under paragraph (1).</text> </clause> <clause commented="no" id="HDE0874C813C442ACBB8EA131A0ADFF89"><enum>(ii)</enum><text>The number of children with medically complex conditions who have selected a health home pursuant to this section.</text> </clause> <clause commented="no" id="H3B21E1F0853F46278B3D910CA32DF9F8"><enum>(iii)</enum><text display-inline="yes-display-inline">The nature, number, and prevalence of chronic conditions, life-threatening illnesses, disabilities, or rare diseases that such children have.</text> </clause> <clause commented="no" id="HA381EC84F9024C3F93EBEDCDD748F397"><enum>(iv)</enum><text>The type of delivery systems and payment models used to provide services to such children under this section.</text> </clause> <clause commented="no" id="H342EE4E55D454B2E9530C2727CAE4B46"><enum>(v)</enum><text display-inline="yes-display-inline">The number and characteristics of designated providers, teams of health care professionals operating with such providers, and health teams selected as health homes pursuant to this section, including the number and characteristics of out-of-State providers, teams of health care professionals operating with such providers, and health teams who have provided health care items and services to such children.</text> </clause> <clause commented="no" id="H3D13B6C98DB347BD87230A13BCD41085"><enum>(vi)</enum><text>The extent to which such children receive health care items and services under the State plan.</text> </clause> <clause commented="no" id="H8B0783F4B2F54AEE8D0571AB9004D6FD"><enum>(vii)</enum><text>Quality measures developed specifically with respect to health care items and services provided to children with medically complex conditions.</text> </clause></subparagraph> <subparagraph commented="no" id="HEDBF57FBA1854B62A969FB1876326906"><enum>(B)</enum><header>Report on best practices</header><text display-inline="yes-display-inline">Not later than 90 days after a State has a State plan amendment approved under this section, such State shall submit to the Secretary, and make publicly available on the appropriate State website, a report on how the State is implementing guidance issued under subsection (e)(1), including through any best practices adopted by the State.</text> </subparagraph></paragraph></subsection> <subsection id="H4CD307B807A74536B794C2C7E720BE75"><enum>(h)</enum><header>Rule of construction</header><text display-inline="yes-display-inline">Nothing in this section may be construed—</text> <paragraph id="HED06E38B1E91446A93FE7BA7FCB176F7"><enum>(1)</enum><text>to require a child with medically complex conditions to enroll in a health home under this section;</text> </paragraph> <paragraph id="HCDBD2E01089E4FC4A3E39A32ADF39043"><enum>(2)</enum><text display-inline="yes-display-inline">to limit the choice of a child with medically complex conditions in selecting a designated provider, team of health care professionals operating with such a provider, or health team that meets the health home qualification standards established under subsection (b) as the child’s health home; or</text> </paragraph> <paragraph id="H9B3D93FF22704F42BD2FCCE18D5D9C4C"><enum>(3)</enum><text display-inline="yes-display-inline">to reduce or otherwise modify—</text> <subparagraph id="HD4A0CB6C51EB4B16A0122150720ED726"><enum>(A)</enum><text>the entitlement of children with medically complex conditions to early and periodic screening, diagnostic, and treatment services (as defined in section 1905(r)); or</text> </subparagraph> <subparagraph id="HC6CEF76E22424F9084B867CED7B6690F"><enum>(B)</enum><text display-inline="yes-display-inline">the informing, providing, arranging, and reporting requirements of a State under section 1902(a)(43).</text> </subparagraph></paragraph></subsection> <subsection id="HA9ADA72AD9F74A7BBF797C9C7EAEC1EB"><enum>(i)</enum><header>Definitions</header><text>In this section:</text> <paragraph id="HEFD47BD7A1A44DD9AD174145986CBEB3"><enum>(1)</enum><header>Child with medically complex conditions</header> <subparagraph commented="no" id="H8CEAEF3E6C8A42A48215692BF5E09A9E"><enum>(A)</enum><header>In general</header><text>Subject to subparagraph (B), the term <term>child with medically complex conditions</term> means an individual under 21 years of age who—</text> <clause commented="no" id="H9EB91034CB034E9C99D9D92A032C04B3"><enum>(i)</enum><text>is eligible for medical assistance under the State plan (or under a waiver of such plan); and</text> </clause> <clause commented="no" id="H060FA535255A4CCDA3EC2E5760A46678"><enum>(ii)</enum><text>has at least—</text> <subclause commented="no" id="H67984BFF603449028D3487483800F349"><enum>(I)</enum><text display-inline="yes-display-inline">one or more chronic conditions that cumulatively affect three or more organ systems and severely reduces cognitive or physical functioning (such as the ability to eat, drink, or breathe independently) and that also requires the use of medication, durable medical equipment, therapy, surgery, or other treatments; or</text> </subclause> <subclause commented="no" id="H06D93D6A05834CCC80859ABACF526E6F"><enum>(II)</enum><text display-inline="yes-display-inline">one life-limiting illness or rare pediatric disease (as defined in section 529(a)(3) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/360ff">21 U.S.C. 360ff(a)(3)</external-xref>)).</text> </subclause></clause></subparagraph> <subparagraph id="HE5A1D811C4854207866F822045FC736D"><enum>(B)</enum><header>Rule of construction</header><text>Nothing in this paragraph shall prevent the Secretary from establishing higher levels as to the number or severity of chronic, life threatening illnesses, disabilities, rare diseases or mental health conditions for purposes of determining eligibility for receipt of health home services under this section.</text> </subparagraph></paragraph> <paragraph commented="no" id="H9C7E0BF84EFD48158C47E832BDD6EC77"><enum>(2)</enum><header>Chronic condition</header><text display-inline="yes-display-inline">The term <term>chronic condition</term> means a serious, long-term physical, mental, or developmental disability or disease, including the following:</text> <subparagraph commented="no" id="H3964BC256BF145E2BBF41B3306E7ACE9"><enum>(A)</enum><text>Cerebral palsy.</text> </subparagraph> <subparagraph commented="no" id="H22DEEEBD86174F8DB506A4820D7EA8B6"><enum>(B)</enum><text>Cystic fibrosis.</text> </subparagraph> <subparagraph commented="no" id="HF8CC0406D361405581E05E7466FC461C"><enum>(C)</enum><text>HIV/AIDS.</text> </subparagraph> <subparagraph commented="no" id="H27EADFE27B244B66BA9348AD589FF8C3"><enum>(D)</enum><text>Blood diseases, such as anemia or sickle cell disease.</text> </subparagraph> <subparagraph commented="no" id="H51F6C48CCF4A44B1B507E7B787FA0C6F"><enum>(E)</enum><text>Muscular dystrophy.</text> </subparagraph> <subparagraph commented="no" id="H3692642FC86C4D69B7FC91D13A1CA24B"><enum>(F)</enum><text>Spina bifida.</text> </subparagraph> <subparagraph commented="no" id="HF954EAA804EE4551A653237A9140716A"><enum>(G)</enum><text>Epilepsy.</text> </subparagraph> <subparagraph commented="no" id="HFCD1F81B178E4CD9ADB1CF4039380E4C"><enum>(H)</enum><text>Severe autism spectrum disorder.</text> </subparagraph> <subparagraph commented="no" id="H6904ED2459484C89AFCC7AECA97385B9"><enum>(I)</enum><text>Serious emotional disturbance or serious mental health illness.</text> </subparagraph></paragraph> <paragraph id="HBE3A82BB1AE5469690B436DDF49575E2"><enum>(3)</enum><header>Health home</header><text>The term <term>health home</term> means a designated provider (including a provider that operates in coordination with a team of health care professionals) or a health team selected by a child with medically complex conditions (or the family of such child) to provide health home services.</text> </paragraph> <paragraph id="H8F57D8E122714B29B5E610857C8D6873"><enum>(4)</enum><header>Health home services</header> <subparagraph id="HE7655D8A16374E02A76645A744A6A58C"><enum>(A)</enum><header>In general</header><text>The term <term>health home services</term> means comprehensive and timely high-quality services described in subparagraph (B) that are provided by a designated provider, a team of health care professionals operating with such a provider, or a health team.</text> </subparagraph> <subparagraph commented="no" id="H28CB78418D494C628BCABC4E97B769C4"><enum>(B)</enum><header>Services described</header><text>The services described in this subparagraph shall include—</text> <clause commented="no" id="HC4DDD2AF46B0477E9DD149AB43889093"><enum>(i)</enum><text display-inline="yes-display-inline">comprehensive care management;</text> </clause> <clause commented="no" id="H21C1B0AA0B224FF1AD0AB52554AAD7F2"><enum>(ii)</enum><text>care coordination, health promotion, and providing access to the full range of pediatric specialty and subspecialty medical services, including services from out-of-State providers, as medically necessary;</text> </clause> <clause commented="no" id="HD651EFAE919541F894E469B112DDFBD2"><enum>(iii)</enum><text>comprehensive transitional care, including appropriate follow-up, from inpatient to other settings;</text> </clause> <clause commented="no" id="H305EA345F5C94243869EAF5436E973D4"><enum>(iv)</enum><text>patient and family support (including authorized representatives);</text> </clause> <clause commented="no" id="HF3B6525CBA2648A2BB42806357E198B7"><enum>(v)</enum><text>referrals to community and social support services, if relevant; and</text> </clause> <clause commented="no" id="H42672F20890A424E92ACB5D187711C4C"><enum>(vi)</enum><text>use of health information technology to link services, as feasible and appropriate.</text> </clause></subparagraph></paragraph> <paragraph commented="no" id="HDCA2C867294C4B5B8703F520449684E5"><enum>(5)</enum><header>Designated provider</header><text display-inline="yes-display-inline">The term <term>designated provider</term> means a physician (including a pediatrician or a pediatric specialty or subspecialty provider), children’s hospital, clinical practice or clinical group practice, prepaid inpatient health plan or prepaid ambulatory health plan (as defined by the Secretary), rural clinic, community health center, community mental health center, home health agency, or any other entity or provider that is determined by the State and approved by the Secretary to be qualified to be a health home for children with medically complex conditions on the basis of documentation evidencing that the entity has the systems, expertise, and infrastructure in place to provide health home services. Such term may include providers who are employed by, or affiliated with, a children’s hospital.</text> </paragraph> <paragraph commented="no" id="H29C91CD0224A44638C386AB23B312568"><enum>(6)</enum><header>Team of health care professionals</header><text display-inline="yes-display-inline">The term <term>team of health care professionals</term> means a team of health care professionals (as described in the State plan amendment under this section) that may—</text> <subparagraph commented="no" id="H68A78DB892954DB6A869AB7F97325AEA"><enum>(A)</enum><text display-inline="yes-display-inline">include—</text> <clause id="H4F2015EC842E4F938113B18B22828CBA"><enum>(i)</enum><text>physicians and other professionals, such as pediatricians or pediatric specialty or subspecialty providers, nurse care coordinators, dietitians, nutritionists, social workers, behavioral health professionals, physical therapists, occupational therapists, speech pathologists, nurses, individuals with experience in medical supportive technologies, or any professionals determined to be appropriate by the State and approved by the Secretary;</text> </clause> <clause id="HC231FDBA725148D2834F86CF49DDCFB0"><enum>(ii)</enum><text>an entity or individual who is designated to coordinate such a team; and</text> </clause> <clause id="H889AE8E58BE84B0EA3568ED34C1D82D0"><enum>(iii)</enum><text>community health workers, translators, and other individuals with culturally-appropriate expertise; and</text> </clause></subparagraph> <subparagraph commented="no" id="H3E3DF691C6C24E91856A3292741B782F"><enum>(B)</enum><text display-inline="yes-display-inline">be freestanding, virtual, or based at a children’s hospital, hospital, community health center, community mental health center, rural clinic, clinical practice or clinical group practice, academic health center, or any entity determined to be appropriate by the State and approved by the Secretary.</text> </subparagraph></paragraph> <paragraph id="HD382C4BD4B29466EA03194F8C0929B90"><enum>(7)</enum><header>Health team</header><text>The term <term>health team</term> has the meaning given such term for purposes of section 3502 of <external-xref legal-doc="public-law" parsable-cite="pl/111/148">Public Law 111–148</external-xref>.</text></paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block> </section>

115 HR 7217 EH: Improving Medicaid Programs and Opportunities for Eligible Beneficiaries Act U.S. House of Representatives text/xml EN 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.

Short title

This Act may be cited as the

Improving Medicaid Programs and Opportunities for Eligible Beneficiaries Act

or the

IMPROVE Act

<enum>I</enum><header>ACE Kids</header> <section display-inline="no-display-inline" id="H86D43B4234EA465ABB623A1FE191E196"><enum>101.</enum><header>State option to provide coordinated care through a health home for children with medically complex conditions</header><text display-inline="no-display-inline">Title XIX of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396">42 U.S.C. 1396</external-xref> et seq.) is amended by inserting after section 1945 the following new section:</text> <quoted-block display-inline="no-display-inline" id="H6E122586114749B0A871A6BF1E0D6DAB" style="OLC"> <section id="H5FC701313DFA4F169D7573B9C54694C3"><enum>1945A.</enum><header>State option to provide coordinated care through a health home for children with medically complex conditions</header> <subsection id="H3062D8B5B07248EC9D9C9A03A5C9A50B"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Notwithstanding section 1902(a)(1) (relating to statewideness) and section 1902(a)(10)(B) (relating to comparability), beginning October 1, 2022, a State, at its option as a State plan amendment, may provide for medical assistance under this title to children with medically complex conditions who choose to enroll in a health home under this section by selecting a designated provider, a team of health care professionals operating with such a provider, or a health team as the child’s health home for purposes of providing the child with health home services.</text> </subsection> <subsection commented="no" id="H4CF06163EB674AFD9F121874406BF6EA"><enum>(b)</enum><header>Health home qualification standards</header><text>The Secretary shall establish standards for qualification as a health home for purposes of this section. Such standards shall include requiring designated providers, teams of health care professionals operating with such providers, and health teams to demonstrate to the State the ability to do the following:</text> <paragraph commented="no" id="H687C0B058C354AF48F7F2B33FFD0FC3D"><enum>(1)</enum><text display-inline="yes-display-inline">Coordinate prompt care for children with medically complex conditions, including access to pediatric emergency services at all times.</text> </paragraph> <paragraph commented="no" id="H50F972617773491BA955D56F55E308E8"><enum>(2)</enum><text display-inline="yes-display-inline">Develop an individualized comprehensive pediatric family-centered care plan for children with medically complex conditions that accommodates patient preferences.</text> </paragraph> <paragraph commented="no" id="H689B42567EBB4708BF74BD8C8154CE3B"><enum>(3)</enum><text display-inline="yes-display-inline">Work in a culturally and linguistically appropriate manner with the family of a child with medically complex conditions to develop and incorporate into such child’s care plan, in a manner consistent with the needs of the child and the choices of the child’s family, ongoing home care, community-based pediatric primary care, pediatric inpatient care, social support services, and local hospital pediatric emergency care.</text> </paragraph> <paragraph commented="no" id="HD313DA6B1A0A4DB787E16F7E0E74D1A4"><enum>(4)</enum><text display-inline="yes-display-inline">Coordinate access to—</text> <subparagraph commented="no" id="H6E2FF6977D93416D920228EAF469EE78"><enum>(A)</enum><text>subspecialized pediatric services and programs for children with medically complex conditions, including the most intensive diagnostic, treatment, and critical care levels as medically necessary; and</text> </subparagraph> <subparagraph commented="no" id="HDF4D5AB1B3CD4C46BB578CA90C62847B"><enum>(B)</enum><text>palliative services if the State provides such services under the State plan (or a waiver of such plan).</text> </subparagraph></paragraph> <paragraph commented="no" id="HE84A502B5B5F49BFBA3F010919A914B8"><enum>(5)</enum><text display-inline="yes-display-inline">Coordinate care for children with medically complex conditions with out-of-State providers furnishing care to such children to the maximum extent practicable for the families of such children and where medically necessary, in accordance with guidance issued under subsection (e)(1) and section 431.52 of title 42, Code of Federal Regulations.</text> </paragraph> <paragraph commented="no" id="H630FAF31C8FB4EFC9246F6688635B8A1"><enum>(6)</enum><text display-inline="yes-display-inline">Collect and report information under subsection (g)(1).</text> </paragraph></subsection> <subsection id="H6992BCF8978A4E81ACC85B131D27428A"><enum>(c)</enum><header>Payments</header> <paragraph id="HCA6F74DB00A04CAD853CFF19BDB7E8DB"><enum>(1)</enum><header>In general</header><text>A State shall provide a designated provider, a team of health care professionals operating with such a provider, or a health team with payments for the provision of health home services to each child with medically complex conditions that selects such provider, team of health care professionals, or health team as the child’s health home. Payments made to a designated provider, a team of health care professionals operating with such a provider, or a health team for such services shall be treated as medical assistance for purposes of section 1903(a), except that, during the first 2 fiscal year quarters that the State plan amendment is in effect, the Federal medical assistance percentage applicable to such payments shall be increased by 15 percentage points, but in no case may exceed 90 percent.</text> </paragraph> <paragraph id="HA81D9508C1654740A5B1E0A20B0D4E94"><enum>(2)</enum><header>Methodology</header> <subparagraph id="H5B6315C43ADB49C5B028EF5ACF3A4A04"><enum>(A)</enum><header>In general</header><text>The State shall specify in the State plan amendment the methodology the State will use for determining payment for the provision of health home services. Such methodology for determining payment—</text> <clause id="HDC0EA47DA5F24D9F8FECEB50898E067A"><enum>(i)</enum><text>may be tiered to reflect, with respect to each child with medically complex conditions provided such services by a designated provider, a team of health care professionals operating with such a provider, or a health team, the severity or number of each such child’s chronic conditions, life-threatening illnesses, disabilities, or rare diseases, or the specific capabilities of the provider, team of health care professionals, or health team; and</text> </clause> <clause id="HF05A32CFF38241129C2E5A6981692C9D"><enum>(ii)</enum><text>shall be established consistent with section 1902(a)(30)(A).</text> </clause></subparagraph> <subparagraph id="H08561437EBF54D83A2450E7CF79F4B00"><enum>(B)</enum><header>Alternate models of payment</header><text>The methodology for determining payment for provision of health home services under this section shall not be limited to a per-member per-month basis and may provide (as proposed by the State and subject to approval by the Secretary) for alternate models of payment.</text> </subparagraph></paragraph> <paragraph commented="no" id="H25FABFF49D354FA5956A87D5FE24D729"><enum>(3)</enum><header>Planning grants</header> <subparagraph commented="no" id="HEF4104E789F14716A9A4B7DECFCF34C6"><enum>(A)</enum><header>In general</header><text>Beginning October 1, 2022, the Secretary may award planning grants to States for purposes of developing a State plan amendment under this section. A planning grant awarded to a State under this paragraph shall remain available until expended.</text> </subparagraph> <subparagraph commented="no" id="H6AD2F9FFC55F45C78BB764874A0A5DC4"><enum>(B)</enum><header>State contribution</header><text>A State awarded a planning grant shall contribute an amount equal to the State percentage determined under section 1905(b) (without regard to section 5001 of <external-xref legal-doc="public-law" parsable-cite="pl/111/5">Public Law 111–5</external-xref>) for each fiscal year for which the grant is awarded.</text> </subparagraph> <subparagraph commented="no" id="H7582292146204A9BA56AB825C4089343"><enum>(C)</enum><header>Limitation</header><text>The total amount of payments made to States under this paragraph shall not exceed $5,000,000.</text> </subparagraph></paragraph></subsection> <subsection commented="no" id="H7FE751D30F8F48D28242F8AC2E2C1D86"><enum>(d)</enum><header>Coordinating care</header> <paragraph id="H575926B521E444058A721A9D8076B649"><enum>(1)</enum><header>Hospital notification</header><text display-inline="yes-display-inline">A State with a State plan amendment approved under this section shall require each hospital that is a participating provider under the State plan (or a waiver of such plan) to establish procedures for, in the case of a child with medically complex conditions who is enrolled in a health home pursuant to this section and seeks treatment in the emergency department of such hospital, notifying the health home of such child of such treatment.</text> </paragraph> <paragraph commented="no" id="H528CD1E9EC9A4786B16CE1EC5B73FC37"><enum>(2)</enum><header>Education with respect to availability of health home services</header><text display-inline="yes-display-inline">In order for a State plan amendment to be approved under this section, a State shall include in the State plan amendment a description of the State’s process for educating providers participating in the State plan (or a waiver of such plan) on the availability of health home services for children with medically complex conditions, including the process by which such providers can refer such children to a designated provider, team of health care professionals operating such a provider, or health team for the purpose of establishing a health home through which such children may receive such services.</text> </paragraph> <paragraph commented="no" id="H5C6563C5EFC7445CA860639893BF0465"><enum>(3)</enum><header>Family education</header><text display-inline="yes-display-inline">In order for a State plan amendment to be approved under this section, a State shall include in the State plan amendment a description of the State’s process for educating families with children eligible to receive health home services pursuant to this section of the availability of such services. Such process shall include the participation of family-to-family entities or other public or private organizations or entities who provide outreach and information on the availability of health care items and services to families of individuals eligible to receive medical assistance under the State plan (or a waiver of such plan).</text> </paragraph> <paragraph commented="no" id="H95D0762A4F2E4440AEF7516F88BEA20C"><enum>(4)</enum><header>Mental health coordination</header><text display-inline="yes-display-inline">A State with a State plan amendment approved under this section shall consult and coordinate, as appropriate, with the Secretary in addressing issues regarding the prevention and treatment of mental illness and substance use among children with medically complex conditions receiving health home services under this section.</text> </paragraph></subsection> <subsection commented="no" id="H3B47E9447B5A440F89AFC69D09244A1E"><enum>(e)</enum><header>Guidance on coordinating care from out-of-State providers</header> <paragraph commented="no" display-inline="no-display-inline" id="H4A0640E59C56408B8FA0B858402906D6"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">Not later than October 1, 2020, the Secretary shall issue (and update as the Secretary determines necessary) guidance to State Medicaid directors on—</text> <subparagraph commented="no" id="H572A79CD39B246E9A23C8D9D8F32FD86"><enum>(A)</enum><text>best practices for using out-of-State providers to provide care to children with medically complex conditions;</text> </subparagraph> <subparagraph commented="no" id="H587E501FE0B34E8DAE046F91127A2849"><enum>(B)</enum><text display-inline="yes-display-inline">coordinating care for such children provided by such out-of-State providers (including when provided in emergency and non-emergency situations);</text> </subparagraph> <subparagraph commented="no" id="H475767A6037C4D3CA056AAE54192F67C"><enum>(C)</enum><text display-inline="yes-display-inline">reducing barriers for such children receiving care from such providers in a timely fashion; and</text> </subparagraph> <subparagraph commented="no" id="H0B9256D545804AA0A7C77A93E2BD1B8D"><enum>(D)</enum><text>processes for screening and enrolling such providers in the respective State plan (or a waiver of such plan), including efforts to streamline such processes or reduce the burden of such processes on such providers.</text> </subparagraph></paragraph> <paragraph commented="no" display-inline="no-display-inline" id="H143269211E6242409631127A5E669504"><enum>(2)</enum><header>Stakeholder input</header><text display-inline="yes-display-inline">In carrying out paragraph (1), the Secretary shall issue a request for information to seek input from children with medically complex conditions and their families, States, providers (including children’s hospitals, hospitals, pediatricians, and other providers), managed care plans, children’s health groups, family and beneficiary advocates, and other stakeholders with respect to coordinating the care for such children provided by out-of-State providers.</text> </paragraph></subsection> <subsection id="H7F46AEDD71EC433BB1D2E6E3F4669B17"><enum>(f)</enum><header>Monitoring</header><text>A State shall include in the State plan amendment—</text> <paragraph id="H66445540EC914899B5D3F4898CAA6F2A"><enum>(1)</enum><text>a methodology for tracking avoidable hospital readmissions and calculating savings that result from improved care coordination and management under this section;</text> </paragraph> <paragraph id="HCE58F01C040F4D36BF2BCE112EBAD0FD"><enum>(2)</enum><text>a proposal for use of health information technology in providing health home services under this section and improving service delivery and coordination across the care continuum (including the use of wireless patient technology to improve coordination and management of care and patient adherence to recommendations made by their provider); and</text> </paragraph> <paragraph commented="no" id="H3D9BD891708344FD83A454E99AA82BA8"><enum>(3)</enum><text>a methodology for tracking prompt and timely access to medically necessary care for children with medically complex conditions from out-of-State providers.</text> </paragraph></subsection> <subsection commented="no" id="HBB99EA9E11314ADAB4869B9147F340CF"><enum>(g)</enum><header>Data collection</header> <paragraph commented="no" id="H9451307B353E42828E9E149B6CEF0578"><enum>(1)</enum><header>Provider reporting requirements</header><text display-inline="yes-display-inline">In order to receive payments from a State under subsection (c), a designated provider, a team of health care professionals operating with such a provider, or a health team shall report to the State, at such time and in such form and manner as may be required by the State, the following information:</text> <subparagraph commented="no" id="HFBDFB2D8D7154A79808FF0D08BE444E0"><enum>(A)</enum><text>With respect to each such provider, team of health care professionals, or health team, the name, National Provider Identification number, address, and specific health care services offered to be provided to children with medically complex conditions who have selected such provider, team of health care professionals, or health team as the health home of such children.</text> </subparagraph> <subparagraph commented="no" id="H17C520FE35584A05B9B401F7DCFA9A3E"><enum>(B)</enum><text display-inline="yes-display-inline">Information on all applicable measures for determining the quality of health home services provided by such provider, team of health care professionals, or health team, including, to the extent applicable, child health quality measures and measures for centers of excellence for children with complex needs developed under this title, title XXI, and section 1139A.</text> </subparagraph> <subparagraph commented="no" id="HFFDD09B3A84546679ECC07B4480D97B2"><enum>(C)</enum><text display-inline="yes-display-inline">Such other information as the Secretary shall specify in guidance.</text> </subparagraph><continuation-text continuation-text-level="paragraph">When appropriate and feasible, such provider, team of health care professionals, or health team, as the case may be, shall use health information technology in providing the State with such information.</continuation-text></paragraph> <paragraph commented="no" id="H2833B41394634B21B65162D8782DE2F9"><enum>(2)</enum><header>State reporting requirements</header> <subparagraph commented="no" id="HA6A58064231341868083C84694E9005F"><enum>(A)</enum><header>Comprehensive report</header><text display-inline="yes-display-inline">A State with a State plan amendment approved under this section shall report to the Secretary (and, upon request, to the Medicaid and CHIP Payment and Access Commission), at such time and in such form and manner determined by the Secretary to be reasonable and minimally burdensome, the following information:</text> <clause commented="no" id="HAB0767E3486B4501BD7585C6250C74B6"><enum>(i)</enum><text>Information reported under paragraph (1).</text> </clause> <clause commented="no" id="HDE0874C813C442ACBB8EA131A0ADFF89"><enum>(ii)</enum><text>The number of children with medically complex conditions who have selected a health home pursuant to this section.</text> </clause> <clause commented="no" id="H3B21E1F0853F46278B3D910CA32DF9F8"><enum>(iii)</enum><text display-inline="yes-display-inline">The nature, number, and prevalence of chronic conditions, life-threatening illnesses, disabilities, or rare diseases that such children have.</text> </clause> <clause commented="no" id="HA381EC84F9024C3F93EBEDCDD748F397"><enum>(iv)</enum><text>The type of delivery systems and payment models used to provide services to such children under this section.</text> </clause> <clause commented="no" id="H342EE4E55D454B2E9530C2727CAE4B46"><enum>(v)</enum><text display-inline="yes-display-inline">The number and characteristics of designated providers, teams of health care professionals operating with such providers, and health teams selected as health homes pursuant to this section, including the number and characteristics of out-of-State providers, teams of health care professionals operating with such providers, and health teams who have provided health care items and services to such children.</text> </clause> <clause commented="no" id="H3D13B6C98DB347BD87230A13BCD41085"><enum>(vi)</enum><text>The extent to which such children receive health care items and services under the State plan.</text> </clause> <clause commented="no" id="H8B0783F4B2F54AEE8D0571AB9004D6FD"><enum>(vii)</enum><text>Quality measures developed specifically with respect to health care items and services provided to children with medically complex conditions.</text> </clause></subparagraph> <subparagraph commented="no" id="HEDBF57FBA1854B62A969FB1876326906"><enum>(B)</enum><header>Report on best practices</header><text display-inline="yes-display-inline">Not later than 90 days after a State has a State plan amendment approved under this section, such State shall submit to the Secretary, and make publicly available on the appropriate State website, a report on how the State is implementing guidance issued under subsection (e)(1), including through any best practices adopted by the State.</text> </subparagraph></paragraph></subsection> <subsection id="H4CD307B807A74536B794C2C7E720BE75"><enum>(h)</enum><header>Rule of construction</header><text display-inline="yes-display-inline">Nothing in this section may be construed—</text> <paragraph id="HED06E38B1E91446A93FE7BA7FCB176F7"><enum>(1)</enum><text>to require a child with medically complex conditions to enroll in a health home under this section;</text> </paragraph> <paragraph id="HCDBD2E01089E4FC4A3E39A32ADF39043"><enum>(2)</enum><text display-inline="yes-display-inline">to limit the choice of a child with medically complex conditions in selecting a designated provider, team of health care professionals operating with such a provider, or health team that meets the health home qualification standards established under subsection (b) as the child’s health home; or</text> </paragraph> <paragraph id="H9B3D93FF22704F42BD2FCCE18D5D9C4C"><enum>(3)</enum><text display-inline="yes-display-inline">to reduce or otherwise modify—</text> <subparagraph id="HD4A0CB6C51EB4B16A0122150720ED726"><enum>(A)</enum><text>the entitlement of children with medically complex conditions to early and periodic screening, diagnostic, and treatment services (as defined in section 1905(r)); or</text> </subparagraph> <subparagraph id="HC6CEF76E22424F9084B867CED7B6690F"><enum>(B)</enum><text display-inline="yes-display-inline">the informing, providing, arranging, and reporting requirements of a State under section 1902(a)(43).</text> </subparagraph></paragraph></subsection> <subsection id="HA9ADA72AD9F74A7BBF797C9C7EAEC1EB"><enum>(i)</enum><header>Definitions</header><text>In this section:</text> <paragraph id="HEFD47BD7A1A44DD9AD174145986CBEB3"><enum>(1)</enum><header>Child with medically complex conditions</header> <subparagraph commented="no" id="H8CEAEF3E6C8A42A48215692BF5E09A9E"><enum>(A)</enum><header>In general</header><text>Subject to subparagraph (B), the term <term>child with medically complex conditions</term> means an individual under 21 years of age who—</text> <clause commented="no" id="H9EB91034CB034E9C99D9D92A032C04B3"><enum>(i)</enum><text>is eligible for medical assistance under the State plan (or under a waiver of such plan); and</text> </clause> <clause commented="no" id="H060FA535255A4CCDA3EC2E5760A46678"><enum>(ii)</enum><text>has at least—</text> <subclause commented="no" id="H67984BFF603449028D3487483800F349"><enum>(I)</enum><text display-inline="yes-display-inline">one or more chronic conditions that cumulatively affect three or more organ systems and severely reduces cognitive or physical functioning (such as the ability to eat, drink, or breathe independently) and that also requires the use of medication, durable medical equipment, therapy, surgery, or other treatments; or</text> </subclause> <subclause commented="no" id="H06D93D6A05834CCC80859ABACF526E6F"><enum>(II)</enum><text display-inline="yes-display-inline">one life-limiting illness or rare pediatric disease (as defined in section 529(a)(3) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/360ff">21 U.S.C. 360ff(a)(3)</external-xref>)).</text> </subclause></clause></subparagraph> <subparagraph id="HE5A1D811C4854207866F822045FC736D"><enum>(B)</enum><header>Rule of construction</header><text>Nothing in this paragraph shall prevent the Secretary from establishing higher levels as to the number or severity of chronic, life threatening illnesses, disabilities, rare diseases or mental health conditions for purposes of determining eligibility for receipt of health home services under this section.</text> </subparagraph></paragraph> <paragraph commented="no" id="H9C7E0BF84EFD48158C47E832BDD6EC77"><enum>(2)</enum><header>Chronic condition</header><text display-inline="yes-display-inline">The term <term>chronic condition</term> means a serious, long-term physical, mental, or developmental disability or disease, including the following:</text> <subparagraph commented="no" id="H3964BC256BF145E2BBF41B3306E7ACE9"><enum>(A)</enum><text>Cerebral palsy.</text> </subparagraph> <subparagraph commented="no" id="H22DEEEBD86174F8DB506A4820D7EA8B6"><enum>(B)</enum><text>Cystic fibrosis.</text> </subparagraph> <subparagraph commented="no" id="HF8CC0406D361405581E05E7466FC461C"><enum>(C)</enum><text>HIV/AIDS.</text> </subparagraph> <subparagraph commented="no" id="H27EADFE27B244B66BA9348AD589FF8C3"><enum>(D)</enum><text>Blood diseases, such as anemia or sickle cell disease.</text> </subparagraph> <subparagraph commented="no" id="H51F6C48CCF4A44B1B507E7B787FA0C6F"><enum>(E)</enum><text>Muscular dystrophy.</text> </subparagraph> <subparagraph commented="no" id="H3692642FC86C4D69B7FC91D13A1CA24B"><enum>(F)</enum><text>Spina bifida.</text> </subparagraph> <subparagraph commented="no" id="HF954EAA804EE4551A653237A9140716A"><enum>(G)</enum><text>Epilepsy.</text> </subparagraph> <subparagraph commented="no" id="HFCD1F81B178E4CD9ADB1CF4039380E4C"><enum>(H)</enum><text>Severe autism spectrum disorder.</text> </subparagraph> <subparagraph commented="no" id="H6904ED2459484C89AFCC7AECA97385B9"><enum>(I)</enum><text>Serious emotional disturbance or serious mental health illness.</text> </subparagraph></paragraph> <paragraph id="HBE3A82BB1AE5469690B436DDF49575E2"><enum>(3)</enum><header>Health home</header><text>The term <term>health home</term> means a designated provider (including a provider that operates in coordination with a team of health care professionals) or a health team selected by a child with medically complex conditions (or the family of such child) to provide health home services.</text> </paragraph> <paragraph id="H8F57D8E122714B29B5E610857C8D6873"><enum>(4)</enum><header>Health home services</header> <subparagraph id="HE7655D8A16374E02A76645A744A6A58C"><enum>(A)</enum><header>In general</header><text>The term <term>health home services</term> means comprehensive and timely high-quality services described in subparagraph (B) that are provided by a designated provider, a team of health care professionals operating with such a provider, or a health team.</text> </subparagraph> <subparagraph commented="no" id="H28CB78418D494C628BCABC4E97B769C4"><enum>(B)</enum><header>Services described</header><text>The services described in this subparagraph shall include—</text> <clause commented="no" id="HC4DDD2AF46B0477E9DD149AB43889093"><enum>(i)</enum><text display-inline="yes-display-inline">comprehensive care management;</text> </clause> <clause commented="no" id="H21C1B0AA0B224FF1AD0AB52554AAD7F2"><enum>(ii)</enum><text>care coordination, health promotion, and providing access to the full range of pediatric specialty and subspecialty medical services, including services from out-of-State providers, as medically necessary;</text> </clause> <clause commented="no" id="HD651EFAE919541F894E469B112DDFBD2"><enum>(iii)</enum><text>comprehensive transitional care, including appropriate follow-up, from inpatient to other settings;</text> </clause> <clause commented="no" id="H305EA345F5C94243869EAF5436E973D4"><enum>(iv)</enum><text>patient and family support (including authorized representatives);</text> </clause> <clause commented="no" id="HF3B6525CBA2648A2BB42806357E198B7"><enum>(v)</enum><text>referrals to community and social support services, if relevant; and</text> </clause> <clause commented="no" id="H42672F20890A424E92ACB5D187711C4C"><enum>(vi)</enum><text>use of health information technology to link services, as feasible and appropriate.</text> </clause></subparagraph></paragraph> <paragraph commented="no" id="HDCA2C867294C4B5B8703F520449684E5"><enum>(5)</enum><header>Designated provider</header><text display-inline="yes-display-inline">The term <term>designated provider</term> means a physician (including a pediatrician or a pediatric specialty or subspecialty provider), children’s hospital, clinical practice or clinical group practice, prepaid inpatient health plan or prepaid ambulatory health plan (as defined by the Secretary), rural clinic, community health center, community mental health center, home health agency, or any other entity or provider that is determined by the State and approved by the Secretary to be qualified to be a health home for children with medically complex conditions on the basis of documentation evidencing that the entity has the systems, expertise, and infrastructure in place to provide health home services. Such term may include providers who are employed by, or affiliated with, a children’s hospital.</text> </paragraph> <paragraph commented="no" id="H29C91CD0224A44638C386AB23B312568"><enum>(6)</enum><header>Team of health care professionals</header><text display-inline="yes-display-inline">The term <term>team of health care professionals</term> means a team of health care professionals (as described in the State plan amendment under this section) that may—</text> <subparagraph commented="no" id="H68A78DB892954DB6A869AB7F97325AEA"><enum>(A)</enum><text display-inline="yes-display-inline">include—</text> <clause id="H4F2015EC842E4F938113B18B22828CBA"><enum>(i)</enum><text>physicians and other professionals, such as pediatricians or pediatric specialty or subspecialty providers, nurse care coordinators, dietitians, nutritionists, social workers, behavioral health professionals, physical therapists, occupational therapists, speech pathologists, nurses, individuals with experience in medical supportive technologies, or any professionals determined to be appropriate by the State and approved by the Secretary;</text> </clause> <clause id="HC231FDBA725148D2834F86CF49DDCFB0"><enum>(ii)</enum><text>an entity or individual who is designated to coordinate such a team; and</text> </clause> <clause id="H889AE8E58BE84B0EA3568ED34C1D82D0"><enum>(iii)</enum><text>community health workers, translators, and other individuals with culturally-appropriate expertise; and</text> </clause></subparagraph> <subparagraph commented="no" id="H3E3DF691C6C24E91856A3292741B782F"><enum>(B)</enum><text display-inline="yes-display-inline">be freestanding, virtual, or based at a children’s hospital, hospital, community health center, community mental health center, rural clinic, clinical practice or clinical group practice, academic health center, or any entity determined to be appropriate by the State and approved by the Secretary.</text> </subparagraph></paragraph> <paragraph id="HD382C4BD4B29466EA03194F8C0929B90"><enum>(7)</enum><header>Health team</header><text>The term <term>health team</term> has the meaning given such term for purposes of section 3502 of <external-xref legal-doc="public-law" parsable-cite="pl/111/148">Public Law 111–148</external-xref>.</text></paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block> </section> <enum>II</enum><header>Other Medicaid</header> <section id="H4C5A7F353EE943EABAE3F31B56B86207"><enum>201.</enum><header>Extension of Money Follows the Person Rebalancing demonstration</header> <subsection id="H6C9E1AC2D30E4C3B8C40732C479C4338"><enum>(a)</enum><header>General Funding</header><text display-inline="yes-display-inline">Section 6071(h) of the Deficit Reduction Act of 2005 (<external-xref legal-doc="usc" parsable-cite="usc/42/1396a">42 U.S.C. 1396a</external-xref> note) is amended—</text> <paragraph id="H3C7B0660335A46839552D4E3D15D7C20"><enum>(1)</enum><text>in paragraph (1)—</text> <subparagraph id="H10160D46F46D40419AEF53CD37775C94"><enum>(A)</enum><text>in subparagraph (D), by striking <quote>and</quote> after the semicolon;</text> </subparagraph> <subparagraph id="HE0B964356FD64127867D55743F0790E8"><enum>(B)</enum><text>in subparagraph (E), by striking the period at the end and inserting <quote>; and</quote>; and</text> </subparagraph> <subparagraph id="H19E2D60DDAE44AB686C1EEE741628502"><enum>(C)</enum><text>by adding at the end the following:</text> <quoted-block display-inline="no-display-inline" id="HEA9053BA4BEB427DA050EFAFF67C8192" style="OLC"> <subparagraph id="H2C3B78F8A5B642D08164B1489E04D21E"><enum>(F)</enum><text>subject to paragraph (3), $112,000,000 for fiscal year 2019.</text></subparagraph><after-quoted-block>; </after-quoted-block></quoted-block> </subparagraph></paragraph> <paragraph commented="no" id="H39EC8DAD541144A8A85127274606E97D"><enum>(2)</enum><text>in paragraph (2)—</text> <subparagraph commented="no" id="H068DA0886918451DB9008F4915B81F4C"><enum>(A)</enum><text>by striking <quote>Amounts made</quote> and inserting <quote>Subject to paragraph (3), amounts made</quote>; and</text> </subparagraph> <subparagraph commented="no" id="HB9F4D8A50A8B45428D989217D2BCBBB4"><enum>(B)</enum><text>by striking <quote>September 30, 2016</quote> and inserting <quote>September 30, 2021</quote>; and</text> </subparagraph></paragraph> <paragraph id="H81259F797658417EBA37E5E5E328EAFE"><enum>(3)</enum><text>by adding at the end the following new paragraph:</text> <quoted-block display-inline="no-display-inline" id="H65661397BE1D4657BC18C624177B73CB" style="OLC"> <paragraph id="H596F74514A18439EBCDCDB096D7449FB"><enum>(3)</enum><header>Special rule for FY <enum-in-header>2019</enum-in-header></header><text display-inline="yes-display-inline">Funds appropriated under paragraph (1)(F) shall be made available for grants to States only if such States have an approved MFP demonstration project under this section as of December 31, 2018.</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block> </paragraph></subsection> <subsection commented="no" id="H54F3CB77BC404E6781A7930F52FB7C0E"><enum>(b)</enum><header>Funding for quality assurance and improvement; technical assistance; oversight</header><text>Section 6071(f) of the Deficit Reduction Act of 2005 (<external-xref legal-doc="usc" parsable-cite="usc/42/1396a">42 U.S.C. 1396a</external-xref> note) is amended by striking paragraph (2) and inserting the following:</text> <quoted-block display-inline="no-display-inline" id="H5D1A609D26CD42BD9BCD008281D5E3FC" style="OLC"> <paragraph commented="no" id="HC4CE0B55BF6543729EF53C88409A6E45"><enum>(2)</enum><header>Funding</header><text>From the amounts appropriated under subsection (h)(1)(F) for fiscal year 2019, $500,000 shall be available to the Secretary for such fiscal year to carry out this subsection.</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block> </subsection> <subsection id="HEDC02753694A4883AE87DFD95AC09C2E"><enum>(c)</enum><header>Technical amendment</header><text>Section 6071(b) of the Deficit Reduction Act of 2005 (<external-xref legal-doc="usc" parsable-cite="usc/42/1396a">42 U.S.C. 1396a</external-xref> note) is amended by adding at the end the following:</text> <quoted-block display-inline="no-display-inline" id="H3EE9648B07464691B5C04D7529C0C845" style="OLC"> <paragraph id="HD82730CB059047FDB1405D93B7FF353B"><enum>(10)</enum><header>Secretary</header><text>The term <term>Secretary</term> means the Secretary of Health and Human Services.</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block> </subsection></section> <section id="HEF465F17175A43DDB769D4E21B1671CE"><enum>202.</enum><header>Extension of protection for Medicaid recipients of home and community-based services against spousal impoverishment</header> <subsection id="H062E88FD88784F5E9FFCDD922B0CEF27"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Section 2404 of <external-xref legal-doc="public-law" parsable-cite="pl/111/148">Public Law 111–148</external-xref> (<external-xref legal-doc="usc" parsable-cite="usc/42/1396r-5">42 U.S.C. 1396r–5</external-xref> note) is amended by striking <quote>the 5-year period that begins on January 1, 2014,</quote> and inserting <quote>the period beginning on January 1, 2014, and ending on March 31, 2019,</quote>.</text> </subsection> <subsection commented="no" id="HC0CC7B10AE674371847F6A710795D271"><enum>(b)</enum><header>Rule of construction</header> <paragraph commented="no" id="HA48919F9814D479A8D4416F30D3C6735"><enum>(1)</enum><header>Protecting State spousal income and asset disregard flexibility under waivers and plan amendments</header><text>Nothing in section 2404 of <external-xref legal-doc="public-law" parsable-cite="pl/111/148">Public Law 111–148</external-xref> (<external-xref legal-doc="usc" parsable-cite="usc/42/1396r-5">42 U.S.C. 1396r–5</external-xref> note) or section 1924 of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396r-5">42 U.S.C. 1396r–5</external-xref>) shall be construed as prohibiting a State from disregarding an individual’s spousal income and assets under a State waiver or plan amendment described in paragraph (2) for purposes of making determinations of eligibility for home and community-based services or home and community-based attendant services and supports under such waiver or plan amendment.</text> </paragraph> <paragraph commented="no" id="HE30AEE428A544182A77EB21ADA965D60"><enum>(2)</enum><header>State waiver or plan amendment described</header><text display-inline="yes-display-inline">A State waiver or plan amendment described in this paragraph is any of the following:</text> <subparagraph commented="no" id="HCF413483343B4452A98096565A9F4765"><enum>(A)</enum><text>A waiver or plan amendment to provide medical assistance for home and community-based services under a waiver or plan amendment under subsection (c), (d), or (i) of section 1915 of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396n">42 U.S.C. 1396n</external-xref>) or under section 1115 of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1315">42 U.S.C. 1315</external-xref>).</text> </subparagraph> <subparagraph commented="no" id="H6653ADE23ABA482AAED7908EE649C0D3"><enum>(B)</enum><text>A plan amendment to provide medical assistance for home and community-based services for individuals by reason of being determined eligible under section 1902(a)(10)(C) of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396a">42 U.S.C. 1396a(a)(10)(C)</external-xref>) or by reason of section 1902(f) of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396a">42 U.S.C. 1396a(f)</external-xref>) or otherwise on the basis of a reduction of income based on costs incurred for medical or other remedial care under which the State disregarded the income and assets of the individual’s spouse in determining the initial and ongoing financial eligibility of an individual for such services in place of the spousal impoverishment provisions applied under section 1924 of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396r-5">42 U.S.C. 1396r–5</external-xref>).</text> </subparagraph> <subparagraph commented="no" id="H360528FA0946455AB8F5876515B629D8"><enum>(C)</enum><text>A plan amendment to provide medical assistance for home and community-based attendant services and supports under section 1915(k) of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396n">42 U.S.C. 1396n(k)</external-xref>).</text> </subparagraph></paragraph></subsection></section> <section id="H468BE715E7624C9D9D7F463F2A4091A9"><enum>203.</enum><header>Reduction in FMAP after <enum-in-header>2020 </enum-in-header>for States without asset verification program</header><text display-inline="no-display-inline">Section 1940 of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396w">42 U.S.C. 1396w</external-xref>) is amended by adding at the end the following new subsection:</text> <quoted-block display-inline="no-display-inline" id="HCE71DBFBD5624B96A3115CFE42063948" style="OLC"> <subsection id="H5C96F9FBDD814288B1334C09CA3B618A"><enum>(k)</enum><header>Reduction in FMAP after <enum-in-header>2020 </enum-in-header>for non-Compliant States</header> <paragraph id="H56E16930081348DA883A80675A4BBC54"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">With respect to a calendar quarter beginning on or after January 1, 2021, the Federal medical assistance percentage otherwise determined under section 1905(b) for a non-compliant State shall be reduced—</text> <subparagraph id="H51AB5E5307774F62BB3AC26F4E28014D"><enum>(A)</enum><text>for calendar quarters in 2021 and 2022, by 0.12 percentage points;</text> </subparagraph> <subparagraph id="H2BABE9203BC242DC91A994DAAF9EEDCC"><enum>(B)</enum><text>for calendar quarters in 2023, by 0.25 percentage points;</text> </subparagraph> <subparagraph id="H5C6321DCD7B14FC4B760819ECFAEA8F6"><enum>(C)</enum><text>for calendar quarters in 2024, by 0.35 percentage points; and</text> </subparagraph> <subparagraph id="H0E4913AA1A87427C8112392C61C5B535"><enum>(D)</enum><text>for calendar quarters in 2025 and each year thereafter, by 0.5 percentage points.</text> </subparagraph></paragraph> <paragraph id="HBCE9C7826EFE48BBA9AF5DF03A958E65"><enum>(2)</enum><header>Non-compliant State defined</header><text>For purposes of this subsection, the term <term>non-compliant State</term> means a State—</text> <subparagraph id="HB7A5D35EB41A4E6F981B7EDD98F8A4ED"><enum>(A)</enum><text>that is one of the 50 States or the District of Columbia;</text> </subparagraph> <subparagraph id="H18A86459486C49B5A21A08349C99E51D"><enum>(B)</enum><text>with respect to which the Secretary has not approved a State plan amendment submitted under subsection (a)(2); and</text> </subparagraph> <subparagraph commented="no" id="H4A07F11A94FA4004A687A1A0D11DB0FF"><enum>(C)</enum><text>that is not operating, on an ongoing basis, an asset verification program in accordance with this section.</text></subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block> </section> <section id="H379742415C0A4A3F8024BF96F0A8EA76"><enum>204.</enum><header>Denial of FFP for certain expenditures relating to vacuum erection systems and penile prosthetic implants</header> <subsection id="HF92C822A131D49AEA0AB4974C2B01B1B"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Section 1903(i) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396b">42 U.S.C. 1396b(i)</external-xref>) is amended by inserting after paragraph (11) the following:</text> <quoted-block display-inline="no-display-inline" id="H45B0B76DBD944991B9887A855EDE168A" style="OLC"> <paragraph id="HCA64291EEE9D4687AAB0DDD95967FA0F"><enum>(12)</enum><text display-inline="yes-display-inline">with respect to any amounts expended for—</text> <subparagraph id="H19E85B6197234D1DA8FE3AF07BA8976B"><enum>(A)</enum><text display-inline="yes-display-inline">a vacuum erection system that is not medically necessary; or</text> </subparagraph> <subparagraph id="HAD49257E4B4E4FFAAA386B760AB48FAA"><enum>(B)</enum><text>the insertion, repair, or removal and replacement of a penile prosthetic implant (unless such insertion, repair, or removal and replacement is medically necessary); or</text></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block> </subsection> <subsection id="HDB39B035018A47D5A13BFD658EF3DA6F"><enum>(b)</enum><header>Effective date</header><text>The amendment made by subsection (a) shall apply with respect to items and services furnished on or after January 1, 2019.</text> </subsection></section> <section commented="no" id="HF313363CB7A44E8C89C59DD66E7B505E"><enum>205.</enum><header>Medicaid Improvement Fund</header><text display-inline="no-display-inline">Section 1941(b)(1) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396w-1">42 U.S.C. 1396w–1(b)(1)</external-xref>) is amended by striking <quote>$31,000,000</quote> and inserting <quote>$9,000,000</quote>.</text> </section> <section id="HE244396066AC45229A4DBF54E477E929"><enum>206.</enum><header>Preventing the misclassification of drugs under the Medicaid drug rebate program</header> <subsection id="H3E9779915B59405ABDDB7314350A9305"><enum>(a)</enum><header>Application of civil money penalty for misclassification of covered outpatient drugs</header> <paragraph id="HB599185EBD0D459DA774D646551A98BC"><enum>(1)</enum><header>In general</header><text>Section 1927(b)(3) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396r-8">42 U.S.C. 1396r–8(b)(3)</external-xref>) is amended—</text> <subparagraph id="H502958E95072476CA89CFA10A9A2686C"><enum>(A)</enum><text>in the paragraph heading, by inserting <quote><header-in-text level="paragraph" style="traditional">and drug product</header-in-text></quote> after <quote><header-in-text level="paragraph" style="traditional">price</header-in-text></quote>;</text> </subparagraph> <subparagraph id="H89E8DD7501C947F6B16DB8488C2B8F34"><enum>(B)</enum><text>in subparagraph (A)—</text> <clause id="HE9BA25CDE4544A339530EE58B857575F"><enum>(i)</enum><text>in clause (ii), by striking <quote>; and</quote> at the end and inserting a semicolon;</text> </clause> <clause id="H2B21D3943CF544BC8E7D0C512DB3BC52"><enum>(ii)</enum><text>in clause (iii), by striking the period at the end and inserting a semicolon;</text> </clause> <clause id="H43ABF58B472643E89DCFD4CF8FE324A1"><enum>(iii)</enum><text>in clause (iv), by striking the semicolon at the end and inserting <quote>; and</quote>; and</text> </clause> <clause id="HEA076EB80C0342089F12005C6058AD6C"><enum>(iv)</enum><text>by inserting after clause (iv) the following new clause:</text> <quoted-block act-name="" id="H3A0EDBE9791541BFB4C307B739557784" style="traditional"> <clause id="HC14AB0C9A75841ABABA8C896830D5405"><enum>(v)</enum><text display-inline="yes-display-inline">not later than 30 days after the last day of each month of a rebate period under the agreement, such drug product information as the Secretary shall require for each of the manufacturer’s covered outpatient drugs.</text></clause><after-quoted-block>; and</after-quoted-block></quoted-block> </clause></subparagraph> <subparagraph id="H3DB6361974B348ED8F8CF9F2A59C2866"><enum>(C)</enum><text>in subparagraph (C)—</text> <clause id="H6DFD5A07780444A79C3384119464B3B6"><enum>(i)</enum><text>in clause (ii), by inserting <quote>, including information related to drug pricing, drug product information, and data related to drug pricing or drug product information,</quote> after <quote>provides false information</quote>; and</text> </clause> <clause id="HA162AB579492434492735970BC5A53A5"><enum>(ii)</enum><text>by adding at the end the following new clauses:</text> <quoted-block act-name="" id="H0C682264EA3C491793B0710B84F1C35D" style="traditional"> <clause id="HC88109153DEC4935A56DB47835596400"><enum>(iii)</enum><header>Misclassified or misreported information</header> <subclause id="HA394713892574CDDBE3B28DFDDEA180A"><enum>(I)</enum><header>In general</header><text display-inline="yes-display-inline">Any manufacturer with an agreement under this section that knowingly (as defined in section 1003.110 of title 42, Code of Federal Regulations (or any successor regulation)) misclassifies a covered outpatient drug, such as by knowingly submitting incorrect drug category information, is subject to a civil money penalty for each covered outpatient drug that is misclassified in an amount not to exceed 2 times the amount of the difference, as determined by the Secretary, between—</text> <item commented="no" id="HD0B884D879A1482BBFF860CF2825B70A"><enum>(aa)</enum><text display-inline="yes-display-inline">the total amount of rebates that the manufacturer paid with respect to the drug to all States for all rebate periods during which the drug was misclassified; and</text> </item> <item commented="no" id="H4313BE2C46634AD59D9653FB9B3EAD96"><enum>(bb)</enum><text>the total amount of rebates that the manufacturer would have been required to pay, as determined by the Secretary, with respect to the drug to all States for all rebate periods during which the drug was misclassified if the drug had been correctly classified.</text> </item></subclause> <subclause commented="no" id="H93F3D88B0763483EB463A9879415900D"><enum>(II)</enum><header>Other penalties and recovery of underpaid rebates</header><text>The civil money penalties described in subclause (I) are in addition to other penalties as may be prescribed by law and any other recovery of the underlying underpayment for rebates due under this section or the terms of the rebate agreement as determined by the Secretary.</text> </subclause></clause> <clause id="H2D3EF7EC20E5454289A194499580A6A2"><enum>(iv)</enum><header>Increasing oversight and enforcement</header><text>Each year the Secretary shall retain, in addition to any amount retained by the Secretary to recoup investigation and litigation costs related to the enforcement of the civil money penalties under this subparagraph and subsection (c)(4)(B)(ii)(III), an amount equal to 25 percent of the total amount of civil money penalties collected under this subparagraph and subsection (c)(4)(B)(ii)(III) for the year, and such retained amount shall be available to the Secretary, without further appropriation and until expended, for activities related to the oversight and enforcement of this section and agreements under this section, including—</text> <subclause id="H6A801D428A8E4DDCA10E650F642B77B3"><enum>(I)</enum><text>improving drug data reporting systems;</text> </subclause> <subclause id="H0951B10BF0D1412F9B89AD367258DE10"><enum>(II)</enum><text>evaluating and ensuring manufacturer compliance with rebate obligations; and</text> </subclause> <subclause id="H90EDD312A1714647B2AFAB227377B22A"><enum>(III)</enum><text>oversight and enforcement related to ensuring that manufacturers accurately and fully report drug information, including data related to drug classification.</text></subclause></clause><after-quoted-block>; and</after-quoted-block></quoted-block> </clause> <clause id="H48BD1AB0FF414E64A37A89E27F50D927"><enum>(iii)</enum><text>in subparagraph (D)—</text> <subclause id="H7AE7213900DC4EACA38F036D916ABBE3"><enum>(I)</enum><text>in clause (iv), by striking <quote>, and</quote> and inserting a comma;</text> </subclause> <subclause id="H1D1A01BC41FC4376814F644B32861E1C"><enum>(II)</enum><text>in clause (v), by striking <quote>subsection (f).</quote> and inserting <quote>subsection (f), and</quote>; and</text> </subclause> <subclause id="HF698A6A282BC49DFB1FE7AB59997CBED"><enum>(III)</enum><text>by inserting after clause (v) the following new clause:</text> <quoted-block act-name="" id="HBBB7B88E890A47F7BE6B5F65B49B8757" style="traditional"> <clause id="H1C1EBF5D9BD04D35AE530E9C6D093D8C"><enum>(vi)</enum><text display-inline="yes-display-inline">in the case of categories of drug product or classification information that were not considered confidential by the Secretary on the day before the date of the enactment of the IMPROVE Act.</text></clause><after-quoted-block>.</after-quoted-block></quoted-block> </subclause></clause></subparagraph></paragraph> <paragraph id="HEA1C47D213004AA7B3AAB0FA2221BFC8"><enum>(2)</enum><header>Technical amendments</header> <subparagraph id="H60E99D4E4A7D4875A7A185A2A6319DDC"><enum>(A)</enum><text>Section 1903(i)(10) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396b">42 U.S.C. 1396b(i)(10)</external-xref>) is amended—</text> <clause id="HE0DA04D884DA4B16B335FA5FA25E027F"><enum>(i)</enum><text>in subparagraph (C)—</text> <subclause id="HCE6A615A9D554D30849B4541F44527D5"><enum>(I)</enum><text>by adjusting the left margin so as to align with the left margin of subparagraph (B); and</text> </subclause> <subclause id="H5E50CEBF969848D3866B9FA6EBFCDB14"><enum>(II)</enum><text>by striking <quote>, and</quote> and inserting a semicolon;</text> </subclause></clause> <clause id="H30006165578D44298D666B24DC413670"><enum>(ii)</enum><text>in subparagraph (D), by striking <quote>; or</quote> and inserting <quote>; and</quote>; and</text> </clause> <clause id="H8332BF5DA87545F1B913C3EDD5D6BBF9"><enum>(iii)</enum><text>by adding at the end the following new subparagraph:</text> <quoted-block act-name="" id="H105F5247900140C18629A488C0B12214" style="traditional"> <subparagraph id="HA91482772F5C46448C449D948D8DBC79"><enum>(E)</enum><text display-inline="yes-display-inline">with respect to any amount expended for a covered outpatient drug for which a suspension under section 1927(c)(4)(B)(ii)(II) is in effect; or</text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block> </clause></subparagraph> <subparagraph id="H3240CB1661714ADBA7946BD3B07F0CF8"><enum>(B)</enum><text>Section 1927(b)(3)(C)(ii) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396r-8">42 U.S.C. 1396r–8(b)(3)(C)(ii)</external-xref>) is amended by striking <quote>subsections (a) and (b)</quote> and inserting <quote>subsections (a), (b), (f)(3), and (f)(4)</quote>.</text> </subparagraph></paragraph></subsection> <subsection id="H7DD5DA14E2FC482AAC5CF6E1B797B9D4"><enum>(b)</enum><header>Recovery of unpaid rebate amounts due to misclassification of covered outpatient drugs</header> <paragraph id="H71E4A1D4D7254BEBA4D8508D2341B5AA"><enum>(1)</enum><header>In general</header><text>Section 1927(c) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396r-8">42 U.S.C. 1396r–8(c)</external-xref>) is amended by adding at the end the following new paragraph:</text> <quoted-block act-name="" id="H02108772147E4FD4A43909ED8FC09D3B" style="traditional"> <paragraph id="HA455B06A46D942FCAD4620D7988D994E"><enum>(4)</enum><header>Recovery of unpaid rebate amounts due to misclassification of covered outpatient drugs</header> <subparagraph commented="no" id="H7F861E902A1A4953A3191AF212E38EB2"><enum>(A)</enum><header>In general</header><text>If the Secretary determines that a manufacturer with an agreement under this section paid a lower per-unit rebate amount to a State for a rebate period as a result of the misclassification by the manufacturer of a covered outpatient drug (without regard to whether the manufacturer knowingly made the misclassification or should have known that the misclassification would be made) than the per-unit rebate amount that the manufacturer would have paid to the State if the drug had been correctly classified, the manufacturer shall pay to the State an amount equal to the product of—</text> <clause commented="no" id="H9DAFB85428AA4383B4D472E4AA17C21E"><enum>(i)</enum><text>the difference between—</text> <subclause commented="no" id="HAAA0A46F3D264798A7F5E2C988058D32"><enum>(I)</enum><text>the per-unit rebate amount paid to the State for the period; and</text> </subclause> <subclause commented="no" id="H61A363434C9D45A5BA858AFBF836DB97"><enum>(II)</enum><text>the per-unit rebate amount that the manufacturer would have paid to the State for the period, as determined by the Secretary, if the drug had been correctly classified; and</text> </subclause></clause> <clause commented="no" id="H97166139FCC84188A83811320A73999A"><enum>(ii)</enum><text>the total units of the drug paid for under the State plan in the period.</text> </clause></subparagraph> <subparagraph id="H18393A8D2D2B4322BD94059AA8B64D5E"><enum>(B)</enum><header>Authority to correct misclassifications</header> <clause id="HDF6A99105B1F4F0B966CDBFF9C615CD6"><enum>(i)</enum><header>In general</header><text>If the Secretary determines that a manufacturer with an agreement under this section has misclassified a covered outpatient drug (without regard to whether the manufacturer knowingly made the misclassification or should have known that the misclassification would be made), the Secretary shall notify the manufacturer of the misclassification and require the manufacturer to correct the misclassification in a timely manner.</text> </clause> <clause id="H9349D8F549154E378F82614054A92024"><enum>(ii)</enum><header>Enforcement</header><text>If, after receiving notice of a misclassification from the Secretary under clause (i), a manufacturer fails to correct the misclassification by such time as the Secretary shall require, until the manufacturer makes such correction, the Secretary may—</text> <subclause id="H8E4BE7DDEF194E80B37F1023411E6B0A"><enum>(I)</enum><text>correct the misclassification on behalf of the manufacturer;</text> </subclause> <subclause id="HB0C3B916C0554471AE1594EC23EDDA33"><enum>(II)</enum><text>suspend the misclassified drug and the drug’s status as a covered outpatient drug under the manufacturer’s national rebate agreement; or</text> </subclause> <subclause id="HE552F8B880FC48EF90F051803C732573"><enum>(III)</enum><text>impose a civil money penalty (which shall be in addition to any other recovery or penalty which may be available under this section or any other provision of law) for each rebate period during which the drug is misclassified not to exceed an amount equal to the product of—</text> <item id="H41DB6FF6D6FE46AF9EE6DDEFDF428493"><enum>(aa)</enum><text>the total number of units of each dosage form and strength of such misclassified drug paid for under any State plan during such a rebate period; and</text> </item> <item id="H1D9F63A980B24DEBA5C8349F7BDAB8DF"><enum>(bb)</enum><text>23.1 percent of the average manufacturer price for the dosage form and strength of such misclassified drug.</text> </item></subclause></clause></subparagraph> <subparagraph id="HC7EE87608AF14ABEA2CA4965BAD6D98F"><enum>(C)</enum><header>Reporting and transparency</header> <clause id="HDB4179970DE24822982641DA09DE703A"><enum>(i)</enum><header>In general</header><text>The Secretary shall submit a report to Congress on at least an annual basis that includes information on the covered outpatient drugs that have been identified as misclassified, the steps taken to reclassify such drugs, the actions the Secretary has taken to ensure the payment of any rebate amounts which were unpaid as a result of such misclassification, and a disclosure of expenditures from the fund created in subsection (b)(3)(C)(iv), including an accounting of how such funds have been allocated and spent in accordance with such subsection.</text> </clause> <clause id="HCF91E0FEE4804093913C748EFB03D38D"><enum>(ii)</enum><header>Public access</header><text>The Secretary shall make the information contained in the report required under clause (i) available to the public on a timely basis.</text> </clause></subparagraph> <subparagraph id="H599AE7691BBE4E84B5ED932BDFDE60AD"><enum>(D)</enum><header>Other penalties and actions</header><text>Actions taken and penalties imposed under this paragraph shall be in addition to other remedies available to the Secretary including terminating the manufacturer’s rebate agreement for noncompliance with the terms of such agreement and shall not exempt a manufacturer from, or preclude the Secretary from pursuing, any civil money penalty under this title or title XI, or any other penalty or action as may be prescribed by law.</text></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block> </paragraph> <paragraph id="HC9D1CCB4A60449A1BA39A1BF2A751237"><enum>(2)</enum><header>Offset of recovered amounts against medical assistance</header><text>Section 1927(b)(1)(B) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396r-8">42 U.S.C. 1396r–8(b)(1)(B)</external-xref>) is amended by inserting <quote>, including amounts received by a State under subsection (c)(4),</quote> after <quote>in any quarter</quote>.</text> </paragraph></subsection> <subsection commented="no" id="H0EC9828B89314C358E6AD0C9D3967C60"><enum>(c)</enum><header>Clarifying definitions</header><text>Section 1927(k)(7)(A) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396r-8">42 U.S.C. 1396r–8(k)(7)(A)</external-xref>) is amended—</text> <paragraph commented="no" id="H05DFD7937B7642A38C05E4F3C3C626C5"><enum>(1)</enum><text>by striking <quote>an original new drug application</quote> and inserting <quote>a new drug application</quote> each place it appears;</text> </paragraph> <paragraph commented="no" id="H9ED0CC4FB7EC4380AF992B0B6D4A0A85"><enum>(2)</enum><text>in clause (i), by inserting <quote>but including a drug product approved for marketing as a non-prescription drug that is regarded as a covered outpatient drug under paragraph (4)</quote> after <quote>drug described in paragraph (5)</quote>;</text> </paragraph> <paragraph commented="no" id="H0306EB81D4A74C399A8AD92D2CBF317B"><enum>(3)</enum><text>in clause (ii), by striking <quote>was originally marketed</quote> and inserting <quote>is marketed</quote>; and</text> </paragraph> <paragraph commented="no" id="H3A8E00CB0203435DB04952E747CC5F72"><enum>(4)</enum><text>in clause (iv)—</text> <subparagraph commented="no" id="H69F02A8CD95248F398BFFCCF7E504A25"><enum>(A)</enum><text>by inserting <quote>, including a drug product approved for marketing as a non-prescription drug that is regarded as a covered outpatient drug under paragraph (4),</quote> after <quote>covered outpatient drug</quote>; and</text> </subparagraph> <subparagraph commented="no" id="H90FD5296C6DE448D867B087E6AB66966"><enum>(B)</enum><text>by adding at the end the following new sentence: <quote>Such term also includes a covered outpatient drug that is a biological product licensed, produced, or distributed under a biologics license application approved by the Food and Drug Administration.</quote>.</text> </subparagraph></paragraph></subsection> <subsection commented="no" id="HE7808385CF5B47598E1CFA8EB56FAB14"><enum>(d)</enum><header>Exclusion of manufacturers for knowing misclassification of covered outpatient drugs</header><text>Section 1128(b) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1320a-7">42 U.S.C. 1320a–7(b)</external-xref>) is amended by adding at the end the following new paragraph:</text> <quoted-block act-name="" id="H4BE6D34940A740A18374AE131FEDCD65" style="traditional"> <paragraph commented="no" id="H3D6B1B63085F484D9CCFF604EF8841AE"><enum>(17)</enum><header>Knowingly misclassifying covered outpatient drugs</header><text>Any manufacturer or officer, director, agent, or managing employee of such manufacturer that knowingly misclassifies a covered outpatient drug under an agreement under section 1927, knowingly fails to correct such misclassification, or knowingly provides false information related to drug pricing, drug product information, or data related to drug pricing or drug product information.</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block> </subsection> <subsection id="HF16ABDB626074B2CA273DAC2B920EC91"><enum>(e)</enum><header>Effective date</header><text>The amendments made by this section shall take effect on the date of the enactment of this Act, and shall apply to covered outpatient drugs supplied by manufacturers under agreements under section 1927 of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1396r-8">42 U.S.C. 1396r–8</external-xref>) on or after such date.</text> </subsection></section> <enum>III</enum><header>Medicare</header> <section id="HCF2941B3A6F0428589E4A0B78A12868F" section-type="subsequent-section"><enum>301.</enum><header>Exclusion of complex rehabilitative manual wheelchairs from Medicare competitive acquisition program; Non-application of Medicare fee-schedule adjustments for certain wheelchair accessories and cushions</header> <subsection id="H1646E05B6D9249D0A20304BF02A3E41D"><enum>(a)</enum><header>Exclusion of complex rehabilitative manual wheelchairs from competitive acquisition program</header><text display-inline="yes-display-inline">Section 1847(a)(2)(A) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-3">42 U.S.C. 1395w–3(a)(2)(A)</external-xref>) is amended—</text> <paragraph id="H3954E0492511460FAB7D90163D9C207E"><enum>(1)</enum><text>by inserting <quote>, complex rehabilitative manual wheelchairs (as determined by the Secretary), and certain manual wheelchairs (identified, as of October 1, 2018, by HCPCS codes E1235, E1236, E1237, E1238, and K0008 or any successor to such codes)</quote> after <quote>group 3 or higher</quote>; and</text> </paragraph> <paragraph id="H0FD6B68A56AC44B5A5673394A3018B5F"><enum>(2)</enum><text display-inline="yes-display-inline">by striking <quote>such wheelchairs</quote> and inserting <quote>such complex rehabilitative power wheelchairs, complex rehabilitative manual wheelchairs, and certain manual wheelchairs</quote>.</text> </paragraph></subsection> <subsection id="HF86BCC6C60C3408CAF3FF3C023236BB1"><enum>(b)</enum><header>Non-Application of Medicare fee schedule adjustments for wheelchair accessories and seat and back cushions when furnished in connection with complex rehabilitative manual wheelchairs</header> <paragraph id="HBD6BB2E044F54ACCA2C6A486847D65DF"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">Notwithstanding any other provision of law, the Secretary of Health and Human Services shall not, during the period beginning on January 1, 2019, and ending on June 30, 2020, use information on the payment determined under the competitive acquisition programs under section 1847 of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-3">42 U.S.C. 1395w–3</external-xref>) to adjust the payment amount that would otherwise be recognized under section 1834(a)(1)(B)(ii) of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395m">42 U.S.C. 1395m(a)(1)(B)(ii)</external-xref>) for wheelchair accessories (including seating systems) and seat and back cushions when furnished in connection with complex rehabilitative manual wheelchairs (as determined by the Secretary), and certain manual wheelchairs (identified, as of October 1, 2018, by HCPCS codes E1235, E1236, E1237, E1238, and K0008 or any successor to such codes).</text> </paragraph> <paragraph id="H368660B3155C4229B31EE66A6F0D1529"><enum>(2)</enum><header>Implementation</header><text display-inline="yes-display-inline">Notwithstanding any other provision of law, the Secretary may implement this subsection by program instruction or otherwise.</text> </paragraph></subsection></section>

Passed the House of Representatives December 11, 2018.

Karen L. Haas,Clerk.