Title: Improving Access to Home Dialysis Act of 2021
Policy area: Health

Summary:
Improving Access to Home Dialysis Act of 2021
This bill provides for Medicare coverage of staff-assisted home dialysis services for certain individuals with end-stage renal disease (ESRD).
Specifically, the bill provides for coverage of services for ESRD individuals who are either initiating peritoneal or home hemodialysis or receiving home dialysis and are unable to self-dialyze due to illness, injury, caregiver issues, or other temporary circumstances. The Centers for Medicare & Medicaid Services must develop a payment system for such services.
The bill also requires the development of a patient-centered decision tool that includes home dialysis as an option, as well as a report on racial disparities with respect to the use of staff-assisted home dialysis services.

[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5426 Introduced in House (IH)]

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117th CONGRESS
  1st Session
                                H. R. 5426

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.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           September 29, 2021

    Mr. Rush (for himself and Mr. Smith of Missouri) 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.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Improving Access to Home Dialysis 
Act of 2021''.

SEC. 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) 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.
                    ``(ii)(I) Subject to subclause (II), staff-assisted 
                home dialysis may only be furnished during--
                            ``(aa) 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
                            ``(bb) 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.
                    ``(II) 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--
                            ``(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, or any other illness or 
                        injury determined by the Secretary).
                    ``(iii) 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--
                            ``(I) the costs of furnishing staff-
                        assisted home dialysis;
                            ``(II) consultations with dialysis 
                        providers, dialysis patients, private payers, 
                        and MA plans;
                            ``(III) payment amounts for similar items 
                        and services under parts A and B; and
                            ``(IV) payment amounts established by MA 
                        plans under part C, group health plans, and 
                        health insurance coverage offered by health 
                        insurance issuers.
                    ``(iv) In this subparagraph:
                            ``(I) The term `new and respite individual' 
                        means an individual described in subsection (a) 
                        who is either--
                                    ``(aa) initiating either peritoneal 
                                or home hemodialysis; or
                                    ``(bb) receiving home dialysis and 
                                is unable to self-dialyze due to 
                                illness, injury, caregiver issues, or 
                                other temporary circumstances.
                            ``(II) The term `qualified provider' means 
                        a trained professional (as determined by the 
                        Secretary, including nurses and certified 
                        patient technicians) who furnishes renal 
                        dialysis services and--
                                    ``(aa) meets requirements (as 
                                determined by the Secretary) that 
                                ensures competency in patient care and 
                                modality usage; and
                                    ``(bb) 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).
                            ``(III)(aa) The term `staff-assisted home 
                        dialysis' 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.
                            ``(bb) In this subclause, the term `care 
                        partner' means anyone who is designated by the 
                        patient who assists 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.''.
    (b) Patient Education and Training Relating to Staff-Assisted Home 
Dialysis.--Section 1881(b)(5) of the Social Security Act (42 U.S.C. 
1395rr(b)(5)) is amended--
            (1) in subparagraph (C), by striking at the end ``and'';
            (2) in subparagraph (D), by striking the period at the end 
        and inserting a semicolon; and
            (3) by adding at the end the following new subparagraphs:
                    ``(D) 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
                    ``(E) 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--
                            ``(i) regularly and independently;
                            ``(ii) through telehealth services or 
                        through group 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)) 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
                            ``(iii) 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.''.
    (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) in subparagraph (J), by striking at the end 
                ``and'';
                    (B) in subparagraph (K), by striking the period at 
                the end and inserting ``; and''; and
                    (C) by adding at the end the following new 
                subparagraph:
                    ``(L) any remuneration relating to the furnishing 
                of staff-assisted home dialysis (as defined in section 
                1881(b)(14)(J)(iv)(III)).''.
            (2) CMI model.--Section 1115A(b)(2)(B) of the Social 
        Security Act (42 U.S.C. 1320b-(b)(2)(B)) is amended by adding 
        at the end the following new clause:
                            ``(xxviii) 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.''.
            (3) Study.--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 (42 U.S.C. 
        1395rr(b)(14)(J)(iv)(III)) and make recommendations on how to 
        improve access to such dialysis for communities of color.
            (4) Patient decision tool.--Not later than December 31, 
        2023, for the purpose of section 1881(b)(14)(J) of the Social 
        Security Act (42 U.S.C. 1395rr(b)(14)(J)), 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.
            (5) Patient quality of life metric.--Section 1115A(b)(2)(B) 
        of the Social Security Act (42 U.S.C. 1315a(b)(2)(B)) is 
        amended by adding at the end the following new subparagraph:
                            ``(i) 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.''.
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