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<bill bill-stage="Introduced-in-House" dms-id="H71B04DBD3A83464896729852D49EFC6F" public-private="public" key="H" bill-type="olc"><metadata xmlns:dc="http://purl.org/dc/elements/1.1/">
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<dc:title>117 HR 5426 IH: Improving Access to Home Dialysis Act of 2021</dc:title>
<dc:publisher>U.S. House of Representatives</dc:publisher>
<dc:date>2021-09-29</dc:date>
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<dc:language>EN</dc:language>
<dc:rights>Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.</dc:rights>
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<distribution-code display="yes">I</distribution-code><congress display="yes">117th CONGRESS</congress><session display="yes">1st Session</session><legis-num display="yes">H. R. 5426</legis-num><current-chamber>IN THE HOUSE OF REPRESENTATIVES</current-chamber><action display="yes"><action-date date="20210929">September 29, 2021</action-date><action-desc><sponsor name-id="R000515">Mr. Rush</sponsor> (for himself and <cosponsor name-id="S001195">Mr. Smith of Missouri</cosponsor>) introduced the following bill; which was referred to the <committee-name committee-id="HIF00">Committee on Energy and Commerce</committee-name>, and in addition to the Committee on <committee-name committee-id="HWM00">Ways and Means</committee-name>, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned</action-desc></action><legis-type>A BILL</legis-type><official-title display="yes">To amend title XVIII of the Social Security Act to provide for Medicare coverage of staff-assisted home dialysis for certain hemodialysis and peritoneal dialysis patients and to ensure all patients are educated on modality options and receive the resources, information, and support to succeed on the modality of their choice, and for other purposes.</official-title></form><legis-body id="H92E3E960969F44E285711BCE13AFA210" style="OLC"><section id="H1622F07241314FBD82B8D1C58D08F150" section-type="section-one"><enum>1.</enum><header>Short title</header><text display-inline="no-display-inline">This Act may be cited as the <quote><short-title>Improving Access to Home Dialysis Act of 2021</short-title></quote>. </text></section><section id="H3E58489DC113436C8C991733DFB028D1"><enum>2.</enum><header>Providing for staff-assisted home dialysis for certain hemodialysis and peritoneal dialysis patients</header><subsection id="H2E60EC31A20845C99C8C4C21981DCE52"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Section 1881(b)(14) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395rr">42 U.S.C. 1395rr(b)(14)</external-xref>) is amended by adding at the end the following new subparagraph:</text><quoted-block style="OLC" id="HBAD63D40F2D648C3AA14FB6BF4D4553C" display-inline="no-display-inline"><subparagraph id="HFDDFDBBA378C46A1AA94860E9FEFD883"><enum>(J)</enum><clause commented="no" display-inline="yes-display-inline" id="H2AA53EA2CA1142A88A4CC1B522E35FAA"><enum>(i)</enum><text>For services furnished on or after the date which is 1 year after the date of the enactment of this subparagraph which are staff-assisted home dialysis (as defined in clause (iv)(III)), the Secretary shall increase the single payment that would otherwise apply under this paragraph for renal dialysis services furnished to new and respite individuals in accordance with the payment system established under clause (iii) by qualified providers.</text></clause><clause id="H9E6290BA95BB41FB89FBD974B63A5C64" indent="up1"><enum>(ii)</enum><subclause commented="no" display-inline="yes-display-inline" id="H9B28824D6289453DB55D0FB541226AD6"><enum>(I)</enum><text>Subject to subclause (II), staff-assisted home dialysis may only be furnished during—</text><item id="HFE82BB5571414A91B58CBB00A2776BD4" indent="up1"><enum>(aa)</enum><text>with respect to an individual described in subclause (iv)(I)(aa), one 90-day period which may be renewed up to two 30-day periods; and</text></item><item id="H7F68C52140014951B0F207849793F29C" indent="up1"><enum>(bb)</enum><text display-inline="yes-display-inline">with respect to an individual described in subclause (iv)(I)(bb) and notwithstanding whether such an individual receives any respite care under part A, any 30-day period.</text></item></subclause><subclause id="H08BE1728B41B4ED994175E44067D7722" indent="up1"><enum>(II)</enum><text>Notwithstanding the limits described in subclause (I), staff-assisted home dialysis may be furnished for as long as the Secretary determines appropriate to an individual who—</text><item id="H1EF36134930B4523A6E06B0D6EB5B2B1"><enum>(aa)</enum><text>is blind;</text></item><item id="H87E9F457490143609D612ABA1BAD08A9"><enum>(bb)</enum><text display-inline="yes-display-inline">has a cognitive or neurological impairment (including a stroke, Alzheimer's, dementia amyotrophic lateral sclerosis, or any other impairment determined by the Secretary); or</text></item><item id="H3744E19D4C714569A2FDA14721667607"><enum>(cc)</enum><text>has any other illness or injury that reduces mobility (including cerebral palsy, spinal cord injuries, or any other illness or injury determined by the Secretary).</text></item></subclause></clause><clause id="H8B3E38D66F184A1F8F59997A9CAECE4A" indent="up1"><enum>(iii)</enum><text display-inline="yes-display-inline">The Secretary shall establish a prospective payment system through regulations to determine the amounts payable to qualified providers for staff-assisted home dialysis. In establishing such system, the Secretary may consider—</text><subclause id="H4B20CF728F9A438EA5E4DD8304BDF112"><enum>(I)</enum><text>the costs of furnishing staff-assisted home dialysis;</text></subclause><subclause id="HD6F8017204274927887C8A9BFFFA1B30"><enum>(II)</enum><text>consultations with dialysis providers, dialysis patients, private payers, and MA plans;</text></subclause><subclause id="H0E72090E2D174B9C8E93925690F1E387"><enum>(III)</enum><text>payment amounts for similar items and services under parts A and B; and</text></subclause><subclause id="HADDC73E24D764FE6BBAD65CEAC414DEF"><enum>(IV)</enum><text>payment amounts established by MA plans under part C, group health plans, and health insurance coverage offered by health insurance issuers.</text></subclause></clause><clause id="H3EA9847840EC4C4D9A6DED88A79A8DD2" indent="up1"><enum>(iv)</enum><text>In this subparagraph:</text><subclause id="H0A470259D62B47D5AB4D7AFC5DB02969" display-inline="no-display-inline"><enum>(I)</enum><text>The term <quote>new and respite individual</quote> means an individual described in subsection (a) who is either—</text><item id="H509E86F94F1B4BA3AE56C938E68354B0"><enum>(aa)</enum><text display-inline="yes-display-inline">initiating either peritoneal or home hemodialysis; or</text></item><item id="H29B688122AE84C72B62172D25952B1C5"><enum>(bb)</enum><text display-inline="yes-display-inline">receiving home dialysis and is unable to self-dialyze due to illness, injury, caregiver issues, or other temporary circumstances.</text></item></subclause><subclause id="H048DC22BCA644BAD8970B70C7FCC664B"><enum>(II)</enum><text display-inline="yes-display-inline">The term <quote>qualified provider</quote> means a trained professional (as determined by the Secretary, including nurses and certified patient technicians) who furnishes renal dialysis services and—</text><item id="HD8020BB8E1BC45E3AEE924A91088E924"><enum>(aa)</enum><text display-inline="yes-display-inline">meets requirements (as determined by the Secretary) that ensures competency in patient care and modality usage; and</text></item><item id="H4F02344BCD024248B32C4AAE3304BC4F"><enum>(bb)</enum><text display-inline="yes-display-inline">provides in-person assistance to a patient for at least 75 percent of staff-assisted home dialysis sessions during a period described in clause (ii)(i).</text></item></subclause><subclause id="HE57D579617754C468A4D7A9F0099C9E6" display-inline="no-display-inline"><enum>(III)</enum><item commented="no" display-inline="yes-display-inline" id="HC5D9B99535704778BE19064124A2E4E0"><enum>(aa)</enum><text>The term <quote>staff-assisted home dialysis</quote> means home dialysis using trained professionals to assist individuals who have been determined to have end stage renal disease, and the frequency of such home dialysis is determined by such professionals in coordination with the patient and his or her care partner, and outlined in a patient plan of care.</text></item><item id="HECF3BD6E540F401798DDBD2D956311FA" indent="up1"><enum>(bb)</enum><text>In this subclause, the term <quote>care partner</quote> means anyone who is designated by the patient who assists the individual with the furnishing of home dialysis.</text></item><item id="HAD967D2FBED94083887C705BF493D7B8" indent="up1"><enum>(cc)</enum><text>In this subclause, the term <quote>patient plan of care</quote> has the meaning given such term in section 494.90 of title 42, Code of Federal Regulations. </text></item></subclause></clause></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></subsection><subsection id="HBFEF066B71314CA0A2E9CEDFEF7320E0"><enum>(b)</enum><header>Patient education and training relating to staff-Assisted home dialysis</header><text>Section 1881(b)(5) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395rr">42 U.S.C. 1395rr(b)(5)</external-xref>) is amended—</text><paragraph id="H7FA9AF4B940C49C08540791990F7435C"><enum>(1)</enum><text>in subparagraph (C), by striking at the end <quote>and</quote>;</text></paragraph><paragraph id="HD534382D711E4DD0A4B973764E23BE2B"><enum>(2)</enum><text>in subparagraph (D), by striking the period at the end and inserting a semicolon; and</text></paragraph><paragraph id="HB6E3992C293846C682F182080174D531"><enum>(3)</enum><text>by adding at the end the following new subparagraphs:</text><quoted-block style="OLC" id="HBE445E2F0AE0449FA187CF5F51133BF1" display-inline="no-display-inline"><subparagraph id="HB657ED84B0784D50B70A7348511160F7"><enum>(D)</enum><text display-inline="yes-display-inline">educate patients of the opportunity to receive staff-assisted home dialysis (as defined in paragraph (14)(J)(iv)(III)) during the period beginning 30 days after the first day such facility furnishes renal dialysis services to an individual and ending 60 days after such day; and</text></subparagraph><subparagraph id="H5B697C1D17B946B09C3062D08C51AC76"><enum>(E)</enum><text display-inline="yes-display-inline">provide for nurses, certified patient technicians, or other professionals to train patients and their care partners in skills and procedures needed to perform home dialysis (as defined in paragraph (14)(J)(iv)(III)) treatment—</text><clause id="H8CA2A02ACD33412C894683F3E6CFBCCE"><enum>(i)</enum><text>regularly and independently;</text></clause><clause id="H4F7D9EBB302141C9BCA648FFD7F8DDFC"><enum>(ii)</enum><text display-inline="yes-display-inline">through telehealth services or through group training (as described in the interpretive guidance relating to tag number V590 of <quote>Advance Copy—End Stage Renal Disease (ESRD) Program Interpretive Guidance Version 1.1</quote> (published on October 3, 2008)) in accordance with the Federal regulations (concerning the privacy of individually identifiable health information) promulgated under section 264(c) of the Health Insurance Portability and Accountability Act of 1996; and</text></clause><clause id="HA565BA48F0BC4FBFADFC79B834AFBA99"><enum>(iii)</enum><text display-inline="yes-display-inline">in the home or resident of a patient, in a dialysis facility, or the place in which the patient intends to receive staff-assisted home dialysis.</text></clause></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection><subsection id="H7CC013807C4F448984F582BCFFE3271A"><enum>(c)</enum><header>Other provisions</header><paragraph id="HA44888F341C14967BCA1354ACCF9E772"><enum>(1)</enum><header>Anti-kickback statute</header><text display-inline="yes-display-inline">Section 1128B(b)(3) of the Social Security Act (42 U.S.C. 1320a–7b(b)(3)) is amended—</text><subparagraph id="H93B0952474A94920A2478CD822B5007F"><enum>(A)</enum><text>in subparagraph (J), by striking at the end <quote>and</quote>;</text></subparagraph><subparagraph id="H2B050D2D6A2B4C59A8E479831844ADC4"><enum>(B)</enum><text>in subparagraph (K), by striking the period at the end and inserting <quote>; and</quote>; and</text></subparagraph><subparagraph id="H5A3E4A7180C943CCB0E17DEBC93B8F5B"><enum>(C)</enum><text>by adding at the end the following new subparagraph:</text><quoted-block style="OLC" id="H32FE4493EC5C4CFBA1DAA50CA5CA637B" display-inline="no-display-inline"><subparagraph id="H8BFDC8C214084552A14B3FA623A3D56E"><enum>(L)</enum><text display-inline="yes-display-inline">any remuneration relating to the furnishing of staff-assisted home dialysis (as defined in section 1881(b)(14)(J)(iv)(III)).</text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></subparagraph></paragraph><paragraph id="H045EF544E0AC4F4DAD6726AFF0650254"><enum>(2)</enum><header>CMI model</header><text>Section 1115A(b)(2)(B) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1320b–">42 U.S.C. 1320b–(b)(2)(B)</external-xref>) is amended by adding at the end the following new clause:</text><quoted-block style="OLC" id="HD35C4B0156F14D0FB47C9F02D7D2C4F2" display-inline="no-display-inline"><clause id="HB55EB314E4C54F0A91E097A438808B28"><enum>(xxviii)</enum><text display-inline="yes-display-inline">Making payment to anyone who is designated by a patient who receives staff-assisted home dialysis (as defined in section 1881(b)(14)(J)(iv)(III)) and otherwise meets the requirements (as determined by the Secretary), notwithstanding whether an individual is a qualified provider (as defined in section 1881(b)(14)(J)(iv)(II)) or otherwise eligible for reimbursement under title XVIII.</text></clause><after-quoted-block>.</after-quoted-block></quoted-block></paragraph><paragraph id="HDEF4E65C61F44DEF98D6E05920EC50D0"><enum>(3)</enum><header>Study</header><text display-inline="yes-display-inline">Not later than 2 years after the date of the enactment of this Act, the Secretary of Health and Human Services shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Finance of the Senate a report that examines racial disparities in the utilization of the home dialysis defined in section 1881(b)(14)(J)(iv)(III) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395rr">42 U.S.C. 1395rr(b)(14)(J)(iv)(III)</external-xref>) and make recommendations on how to improve access to such dialysis for communities of color.</text></paragraph><paragraph id="H3239560820324BC597229510BB9B4A28"><enum>(4)</enum><header>Patient decision tool</header><text display-inline="yes-display-inline">Not later than December 31, 2023, for the purpose of section 1881(b)(14)(J) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395rr">42 U.S.C. 1395rr(b)(14)(J)</external-xref>), the Secretary of Health and Human Services shall convene a patient panel to create a patient-centered decision tool for dialysis patients to evaluate their lifestyle and goals and be assisted in choosing the dialysis modality that best suits them. This tool should include an acknowledgment that they are capable of home dialysis and want home dialysis, if that is the modality they choose.</text></paragraph><paragraph id="H9D92BC8897174B4AA612149583FB34F6"><enum>(5)</enum><header>Patient quality of life metric</header><text>Section 1115A(b)(2)(B) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1315a">42 U.S.C. 1315a(b)(2)(B)</external-xref>) is amended by adding at the end the following new subparagraph: </text><quoted-block style="OLC" id="H16DFFBB68402419A80F25A0D3BAFF0A4" display-inline="no-display-inline"><clause id="H4C6147944E934E3CBEE00C4C6F695A9A"><enum>(i)</enum><text display-inline="yes-display-inline">A patient quality of life metric for all patients utilizing dialysis regardless of modality with the intent of measuring and improving patient quality of life on dialysis.</text></clause><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection></section></legis-body></bill> 

