I 118th CONGRESS 2d Session H. R. 8075 IN THE HOUSE OF REPRESENTATIVES April 18, 2024 Mrs. Miller of West Virginia (for herself, Mrs. Miller-Meeks , Ms. Strickland , and Mr. Blumenauer ) introduced the following bill; which was referred to the Committee on Energy and Commerce , and in addition to the Committee on Ways and Means , 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 A BILL 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.

1. Short title This Act may be cited as the Improving Access to Home Dialysis Act of 2024 . 2. Providing for staff-assisted home dialysis for certain hemodialysis and peritoneal dialysis patients (a) In general Section 1881(b)(14) of the Social Security Act ( 42 U.S.C. 1395rr(b)(14) ) is amended by adding at the end the following new subparagraph: (J) (i) With respect to staff-assisted home dialysis (as defined in clause (iv)(IV)) furnished on or after the date that is 1 year after the date of the enactment of this subparagraph, subject to the succeeding provisions of this subparagraph, the Secretary shall increase the single payment that would otherwise apply under this paragraph for renal dialysis services by the add-on payment amount established pursuant to clause (iii). (ii) (I) Subject to subclause (II), staff-assisted home dialysis may only be furnished— (aa) with respect to an initializing patient (as defined in clause (iv)(I)) or a returning patient (as defined in clause (iv)(III)), for a period of up to 90 days, referred to as the initial period , which may be extended as determined necessary by the care team of the individual in not more than 2 intervals of up to 30 days each, each of which is referred to as an extended interval ; and (bb) with respect to a temporary assistance patient (as defined in clause (iv)(V)), for any 30-day period as determined necessary by the care team of the individual, notwithstanding whether such an individual receives any routine dialysis respite care during such period. (II) Notwithstanding subclause (I), staff-assisted home dialysis may be furnished for as long as the Secretary determines appropriate to an individual who— (aa) is blind; (bb) has a cognitive or neurological impairment (including a stroke, Alzheimer’s, dementia, amyotrophic lateral sclerosis, or any other impairment determined by the Secretary); or (cc) has any other illness or injury that reduces mobility (including cerebral palsy, spinal cord injuries, patients on a ventilator, or any other illness or injury determined by the Secretary). (iii) The Secretary shall, by regulation, establish an add-on payment amount for staff-assisted home dialysis to determine the amounts payable to a qualified provider for assisting in the furnishing of staff-assisted home dialysis on a frequency as determined by the Secretary and in consultation with clinicians, patients, and care partners to ensure maximum patient choice, access, and flexibility. In establishing the add-on payment under this clause, the Secretary shall consult with stakeholders, including providers of renal dialysis services, individuals receiving home dialysis, qualified providers (as defined in clause (iv)(II)), private insurance payers, and Medicare Advantage plans under part C. (iv) In this subparagraph: (I) The term initializing patient means an individual who initiates a home dialysis modality, including home hemodialysis and peritoneal dialysis. (II) The term qualified provider means a trained professional (as determined by the Secretary, including a registered or licensed practical nurse and a certified patient care technician) who— (aa) furnishes renal dialysis services; (bb) meets requirements (as determined by the Secretary) that ensure competency in patient care and modality usage; and (cc) during a period described in clause (ii)(I), provides in-person assistance to an individual for an appropriate number of dialysis sessions, as determined by the care team of the individual based on the needs of the individual, caregiver availability, prescription, and mode of home dialysis. (III) The term returning patient means an individual who is returning to home dialysis after a period of hospitalization or other non-home dialysis modality. (IV) (aa) The term staff-assisted home dialysis means dialysis furnished by the individual in a home, residence, or other approved setting with the assistance of a qualified provider, the frequency of which is determined by the qualified provider in coordination with the individual, the care partner, and the care team of the individual and outlined in a patient plan of care. (bb) In this subclause, the term care partner means a friend or family member who is designated by the individual who is trained to assist the individual with the furnishing of home dialysis. (cc) In this subclause, the term patient plan of care has the meaning given such term in section 494.90 of title 42, Code of Federal Regulations (or any successor regulations). (V) The term temporary assistance patient means an individual who is receiving home dialysis and is temporarily unable to perform functions necessary to home dialysis due to illness, injury, caregiver unavailability, or other temporary circumstances not to exceed 30 days. . (b) Patient education and training relating to staff-Assisted home dialysis (1) In general Section 1881(b)(5) of the Social Security Act ( 42 U.S.C. 1395rr(b)(5) ) is amended— (A) in subparagraph (C), by striking at the end and ; (B) in subparagraph (D), by striking the period at the end and inserting a semicolon; and (C) by adding at the end the following new subparagraphs: (E) educate individuals on the opportunity to receive staff-assisted home dialysis (as defined in paragraph (14)(J)(iv)(IV)) during the periods described in paragraph (14)(J)(ii); and (F) provide for registered or licensed nurses, certified patient care technicians, or other qualified providers (as determined by a physician) to train individuals and their care partners in skills and procedures needed to furnish staff-assisted home dialysis, including— (i) in a group-training environment with other individuals and their care partners when appropriate and 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; (ii) via telehealth (following an initial period of in-person competency training, in accordance with standards specified by the Secretary); (iii) through interdisciplinary team training (as described in the interpretive guidance relating to tag number V590 of Advance Copy—End Stage Renal Disease (ESRD) Program Interpretive Guidance Version 1.1 (published on October 3, 2008)); and (iv) in the home or residence of an individual, in a dialysis facility, in a stand-alone training facility, or the place in which the individual has been approved to perform home dialysis by the care team. . (2) Effective date The amendments made by this subsection shall take effect on the date that is one year after the date of the enactment of this Act. (c) Other provisions (1) Anti-kickback statute Section 1128B(b)(3) of the Social Security Act (42 U.S.C. 1320a–7b(b)(3)) is amended— (A) by moving subparagraphs (J) and (K) 2 ems to the left; (B) in subparagraph (K), by striking and at the end; (C) in subparagraph (L), by striking the period at the end and inserting ; and ; and (D) by adding at the end the following new subparagraph: (M) any remuneration relating to the furnishing of staff-assisted home dialysis (as defined in section 1881(b)(14)(J)(iv)(IV)). . (2) Study Not later than 2 years after the date of the enactment of this Act, the Secretary of Health and Human Services (in this section referred to as the Secretary ) shall submit, to the Committee on Finance of the Senate and the Committees on Energy and Commerce and Ways and Means of the House of Representatives, a report that— (A) examines racial disparities in the utilization of home dialysis (as defined in section 1881(b)(14)(J)(iv)(IV) of the Social Security Act ( 42 U.S.C. 1395rr(b)(14)(J)(iv)(IV) ), as added by subsection (a)), and makes recommendations on how to improve access to home dialysis for communities of color; (B) examines coverage for, and utilization of, home dialysis in rural communities, and makes recommendations on how to improve access to home dialysis for such rural communities; and (C) analyzes clinical and quality of life outcomes for patients, disaggregated by geographic and demographic indicators, who receive different dialysis modalities, including staff-assisted home dialysis, unassisted home dialysis, and dialysis furnished in a facility. (3) Patient decision tool Not later than December 31, 2025, for the purposes of section 1881(b)(14)(J)) of the Social Security Act ( 42 U.S.C. 1395rr(b)(14)(J) ), as added by subsection (a), the Secretary shall convene a patient panel to develop a patient-centered decision tool to assist dialysis patients in evaluating their lifestyle and goals and in choosing the dialysis setting and modality. Such tool shall include an acknowledgment that the patient is capable of home dialysis and wants home dialysis, if that is the modality such patient chooses. (4) Patient quality of life metric Section 1881(h)(2)(A)(iv) of the Social Security Act ( 42 U.S.C. 1395rr(h)(2)(A)(iv) ) is amended— (A) in subclause (II), by striking and at the end; (B) in subclause (III), by striking the period at the end and inserting ; and ; and (C) by adding at the end the following new subclause: (IV) patient quality of life for all individuals utilizing dialysis regardless of modality, with the intent of measuring and improving patient quality of life on dialysis. .