42 U.S.C. § 1395rr — End stage renal disease program

(a) Type, duration, and scope of benefits. Parts A and B must include benefits for people determined to have end-stage renal disease under section 426–1 and benefits for kidney donors under (d). For people with end-stage renal disease who qualify without section 426–1, their benefit type, duration, and scope may never be less than those provided to people who qualify only because of section 426–1.

(b) Payments for services and dialysis.

(b)(1) Payments for ESRD services must include (A) payments to providers and renal dialysis facilities meeting the Secretary’s regulatory requirements for institutional dialysis services and supplies, self-dialysis in a unit maintained by the provider or facility, transplantation, self-care home-dialysis support furnished by the provider or facility, and routine physician^* services during a maintenance-dialysis episode when the physician’s other services are paid under (3)(A)(i); (B) payments to or for patients for home-dialysis supplies and equipment; and (C) payments to a home-dialysis supplier^* that is not a provider, facility, or physician for self-administered erythropoietin described in section 1395x(s)(2)(P), if the Secretary^* finds the patient can safely and effectively administer it using the Secretary’s methods and standards. Requirements under (A) must include a minimum transplantation-use rate. Beginning 180 days after February 9, 2018, an initial survey must begin within 90 days after the enrollment form is complete and enrollment approval is pending the survey.

(b)(2)(A) Part B payment for covered dialysis by providers and facilities is generally 80 percent of the amount under (B), while part A payment is determined under section 1395x(v) or, when applicable, section 1395ww. Organ-procurement amounts may not exceed the agency’s or laboratory’s costs. A facility receives payment only if it accepts it as payment in full, except for the patient’s 20 percent share of the estimated amount calculated under (B) and the deductible under section 1395l(b). (B) The Secretary must regulate methods to determine provider and facility costs and to set part B payments on a cost-related, economical, or fair basis, including a basis authorized by section 1395x(v), consistent with (7). (C) For proprietary providers and facilities other than hospital outpatient departments, regulations^* may recognize a reasonable return on equity if feasible and appropriate, not exceeding the rate in section 1395x(v)(1)(B). (D) For section 1395oo, a renal dialysis facility is treated as a provider of services.

(b)(3)(A) The Secretary pays 80 percent of physician-service amounts calculated either (i) on a reasonable-charge basis, including comparable physicians’ prevailing charges or, for services on or after January 1, 1992, the basis in section 1395w–4, but not routine services during a maintenance-dialysis episode; or (ii) subject to (B), through a comprehensive monthly fee or other time-based method that encourages efficient dialysis and more home dialysis. (B)(i) Subject to (ii) and (iii), a home-dialysis patient may choose telehealth for monthly ESRD clinical assessments furnished on or after January 1, 2019. (ii) The patient must also have an in-person^* assessment at least monthly during the first 3 months and at least once every 3 consecutive months afterward. (iii) The Secretary may waive (ii) during the emergency period in section 1320b–5(g)(1)(B).

(b)(4) Under agreements, the Secretary may pay approved providers and facilities for home supplies, equipment, and support for patients under their direct supervision, using the target rate in (6) or a method in (7). For unsupervised home dialysis, a supplier may be paid only under a written agreement requiring (i) the patient to certify it is the sole supplier, (ii) the supplier to accept assignment-related payment only, and (iii) the supplier to certify an agreement with an approved provider or facility to furnish all support and other necessary dialysis services and supplies, including institutional and emergency services.

(b)(5) An agreement must require the provider or facility to (A) obtain or arrange (i) physician-prescribed medically necessary equipment, (ii) maintenance and repair, (iii) all needed medical supplies, and (iv) trained home aides when needed; (B) perform administrative functions and keep records needed to verify those arrangements; (C) submit required cost reports, data, and information about its home patients; and (D) give the Secretary full access to required records, data, and information.

(b)(6) For each calendar year beginning January 1, 1979, the Secretary must set a regionally adjusted home-dialysis target rate including (A) estimated medically necessary supply and equipment costs, (B) an allowance for helping personnel, and (C) an allowance for administration^* and efficient delivery. Except under regulations in (7), it may not exceed 75 percent of the regionally adjusted national average payment for the preceding fiscal year’s maintenance dialysis. It applies all year without renegotiation. During the last quarter, the Secretary sets the next year’s rate using the newest available data and may use competitive bidding, a pre-negotiated rate, or another feasible and appropriate method.

(b)(7) Subject to (12), regulations must prospectively set payment methods and rates for each mode of facility and home dialysis. The methods must use composite weighted formulas for hospital-based and other facilities, accounting for patient mix and relative costs, or another method that distinguishes those facilities and more effectively encourages efficient and home dialysis. Another method cannot exceed the hospital-based formula’s median payment, except continuous cycling peritoneal dialysis may reach 130 percent. The Secretary must allow warranted unusual-circumstance exceptions, including sole isolated-rural and pediatric facilities; an application is approved unless denied within 60 working days. The method may replace the target rate. Each composite payment must be reduced by 50 cents per treatment^*, with non-hemodialysis adjustments, and paid to network organizations under (c)(1)(A) for proper administrative costs under (c)(2). Distribution must be equitable and consider (A) geographic size, (B) number of ESRD providers, (C) number of entitled people, and (D) the network’s share of collected administrative funds. Composite payments increase 1.2 percent for 2000 over December 31, 1999, 2.4 percent for January 1, 2001–December 31, 2004 over December 31, 2000, and 1.6 percent on and after January 1, 2005 over December 31, 2004.

(b)(8) “Home dialysis supplies and equipment” means medically necessary supplies and equipment, including supportive equipment, required for home renal dialysis, as “home” is defined by regulation. It includes obtaining, installing, and maintaining the equipment. This section does not define “home.”

(b)(9) To the extent regulations permit, “self-care home dialysis support services” means (A) periodic monitoring of home adaptation, including qualified personnel visits, under a plan prepared and periodically reviewed by a professional team including the physician; (B) equipment installation and maintenance; (C) water testing and appropriate treatment; and (D) other support the Secretary finds appropriate and desirable. This section does not define “qualified,” “professional team,” or “appropriate and desirable.”

(b)(10) “Self-care dialysis unit” means an approved renal dialysis facility, or distinct part of one or of a provider, that makes Secretary-defined self-dialysis services available to trained patients. It must at least provide needed services, equipment, and supplies; use patient-staff ratios appropriate for self-dialysis, with less continuing supervision and ancillary help than full-care maintenance dialysis; and meet the Secretary’s quality and cost-effectiveness requirements.

(b)(11) (A) Hepatitis B vaccine and administration for an ESRD patient are not dialysis services under a prospective amount or comprehensive fee and are paid separately under section 1395l. (B) Erythropoietin is likewise excluded and, subject to (12) and (13), is paid separately: physician-provided erythropoietin under section 1395l; other provider, facility, or supplier erythropoietin at $10 per thousand units in 1994, rounded to the nearest 100 units, and later at a Secretary-set amount that cannot exceed the prior amount increased by the applicable gross-national-product implicit-price-deflator percentage. (C) A non-provider, non-facility, non-physician supplier is paid for erythropoietin as a facility is.

(b)(12) (A) Subject to (14), beginning January 1, 2005, the Secretary must replace (7) with a basic case-mix-adjusted prospective system for facility and home dialysis using a limited number of patient characteristics. On and after January 1, 2009, provider rates equal facility rates calculated without that sentence, and the provider labor share uses the facility labor share. (B) It includes (i) the (7) composite-rate services and (ii) the difference between separate drug^* and biological payments, including erythropoietin, and acquisition costs, based on required Inspector General reports: from 2005 for drugs with pre-2004 billing codes and from 2007 for those without, with appropriate adjustment. (C) 2005 uses (13)(A)(i); 2006 adjusts for the estimated difference between that method and (13)(A)(iii). (D) Rates use an appropriate geographic index, phased in over years if different from (7). (E) Estimated 2005 spending, and the relevant 2006 or 2007 spending after the no-code adjustment, must equal what it would have been without this paragraph. (F) From 2006, annual increases apply estimated growth in separately billable drugs to the drug component and convert it into an increase to the basic amounts; the composite component is not updated except under (G). (G) That component increases 1.6 percent for January 1, 2006–March 31, 2007; 1.6 percent for April 1, 2007–December 31, 2008; 1.0 percent for January 1–December 31, 2009; and 1.0 percent on and after January 1, 2010, each compared with the specified prior date. (H) There is no administrative or judicial review of this system, weights, amounts, geographic factor, update, or drug payment/acquisition-cost determination.

(b)(13) (A) Subject to (14), separately billed drugs and biologicals are paid (i) in 2004, other than erythropoietin, at the section 1395u(o)(1)(A)(v) amount; (ii) in 2005, at Inspector-General-determined acquisition cost, or a Secretary-determined amount if unavailable; and (iii) in 2006 and later, at acquisition cost or the section 1395w–3a amount, as the Secretary specifies. (B) Drugs and biologicals, including erythropoietin, separately billed the day before December 8, 2003, remain separately billed afterward, subject to (14).

(b)(14) (A) Subject to (E), for services on and after January 1, 2011, one payment replaces other payments for “renal dialysis services” and (4) items. For 2011, estimated payments must equal 98 percent of estimated payments without this system, using the lowest per-patient utilization from 2007–2009. (B) “Renal dialysis services” include the December 31, 2010 composite-rate items; erythropoiesis-stimulating agents and oral forms; separately paid ESRD drugs and biologicals and oral equivalents; and diagnostic laboratory tests and other ESRD-treatment items not in the composite rate. Vaccines are excluded. (C) Payment may use a week, month, or another Secretary-specified unit. (D) The system must adjust for case mix, high-cost outliers including anemia drugs, and low-volume facilities; the low-volume adjustment is at least 10 percent for January 1, 2011–December 31, 2013. It may adjust for pediatric, geographic, and rural factors, and must consider children’s and young adults’ unique needs. (E) The amount phases in equally over 4 years and is fully effective January 1, 2014. A provider or facility could make one final election before January 1, 2011 to skip phase-in; it is final. Phase-in payments must preserve estimated aggregate spending. (F) From 2012, payments receive the ESRD market-basket increase, with the stated 2016–2018 reductions, productivity adjustment from section 1395ww(b)(3)(B)(xi)(II), and 0 percent for 2015 under the cited regulation; the productivity adjustment may make the factor and rates lower than the prior year. During phase-in, the update does not apply to the composite portion, which receives the market-basket factor subject to the productivity rule. (G) No review is available for amounts, payment unit, included services, adjustments, phase-in, or market-basket factors. (H) Included erythropoiesis-stimulating agents and other drugs and biologicals are treated as part B items. (I) For January 1–December 31, 2014, the Secretary must reduce the payment based on 2007-versus-2012 per-patient utilization changes for specified drugs and biologicals, excluding oral-only ESRD drugs as described in the cited 2010 rule, while considering current sales-price and price-change data.

(c) Renal-disease networks. (1)(A) The Secretary must establish at least 17 ESRD network areas and an administrative organization for each. Each must create a council of local dialysis and transplant facilities and a medical review board including a patient representative, physicians, nurses, and social workers. The Secretary must publish areas and selection criteria. Before entering, continuing, or ending an agreement, the Secretary must publish and apply standards evaluating capability and performance under (2); quality and scope must predominate and price may be no more than 20 percent. An agreement may end only after an effectiveness and efficiency failure, followed by competitive selection and orderly transition. (B) At least one patient representative must serve on every council and board. (C) Regulations must address ownership, control, remuneration, disclosure, and prevention of financial or professional conflicts involving providers, facilities, and relatives.

(c)(2) Networks must (A) encourage medically sound settings supporting rehabilitation and vocational rehabilitation; (B) develop care-quality and appropriateness standards, help with vocational rehabilitation, and set self-care and transplantation goals; (C) evaluate modality-appropriateness procedures; (D) resolve grievances; (E) conduct needed on-site reviews; (F) collect, validate, and analyze registry and report data; (G) identify uncooperative facilities and help correct them, reporting improper care; and (H) report every July 1 to the Secretary on goals, performance, comparative placement and rehabilitation data, uncooperative facilities, and needed services or facilities including training, transplantation, and organ procurement.

(c)(3) If a facility or provider consistently fails to cooperate with network plans or board recommendations, the Secretary may withhold or end certification until reasonable correction. If the failure does not jeopardize the health or safety of patients or justify terminating the facility’s or provider’s certification, the Secretary may instead impose sanctions after notice, including denying reimbursement for patients admitted later or gradually reducing reimbursement for all patients. (c)(4) Certification or expansion decisions must consider network goals and performance. (c)(5) After consultation, the Secretary must issue planning and delivery guidelines promoting self-dialysis and transplantation. (c)(6) Congress intends the maximum practical number of suitable patients receive home dialysis or transplantation and suitable patients receive vocational rehabilitation and encouragement to work; the Secretary must consult and consider research, treatment, and technology evidence.

(c)(7) The Secretary must establish a national ESRD registry to analyze data from networks, transplant centers, and others for (A) the subsection (g) report to Congress, (B) economic, cost-effectiveness, and medical-effectiveness analysis, (C) resource-allocation and cause research, (D) mortality, morbidity, trends, and quality measures, and (E) other analyses useful to Congress. The Secretary must coordinate collection, consolidate systems, choose the location, and appoint a professional advisory group. (c)(8) Sections 1320c–6 and 1320c–9 apply to contracted network administrative organizations, including medical review boards.

(d) Kidney donors. Despite section 426, anyone who donates a kidney for transplant surgery is entitled to parts A and B benefits for the donation. Regulations must provide reimbursement, without deductibles, premiums, or coinsurance, for all reasonable preparation, operation, and recovery expenses incurred during the actual period of recovery, including expenses that could be paid for an otherwise eligible person.

(e) Home-dialysis machines. (1) The Secretary may, under agreements, reimburse approved providers, facilities, and economical nonprofit entities without deductibles or coinsurance for reasonable purchase, installation, maintenance, and reconditioning costs of artificial kidneys and automated peritoneal-dialysis machines, including supportive equipment, used only by entitled home-dialysis patients. (2) Agreements must require exclusive availability to such patients, reconditioning and technology-consistent modification throughout useful life, full Secretary access to records, and required cost, management, and use reports. (3) “Supportive equipment” includes blood pumps, heparin pumps, bubble detectors, other alarms, and other Secretary-determined medically necessary items. This section does not define the term exhaustively.

(f) Experiments, studies, and pilots. (1) The Secretary must run selected-location projects helping people buy new or used durable dialysis equipment when home dialysis begins, with a trial period first. (2) The Secretary must test cost reduction, including payment for nurses, technicians, and assisting family members. (3) The Secretary must test dietary control, including protein-controlled products to delay or reduce dialysis. (4) The Secretary must study ways to increase kidney and other organ donation. (5) The Secretary must study physician reimbursement, payment ranges and averages, and time spent serving patients at home, facilities, hospitals, and elsewhere. (6) The Secretary must study ESRD patients ineligible for benefits and the economic effect, including actuarially sound coverage mechanisms. (7)(A) The Secretary must establish voluntary dialyzer-filter reuse protocols. (B) From January 1, 1988, or July 1, 1988 for bloodlines, facilities may not reuse other supplies without a Secretary protocol and compliance. (C) Protocols and this requirement become facility requirements; violation can cause denial of participation and payment. (8) By October 1, 1979, the Secretary must report fully to Congress on these experiments and studies and recommend needed or desirable legislative changes.

(g) Conditional approval and restricted payments. (1) If a facility is not substantially compliant with (b)(1)(A), its deficiencies do not immediately threaten health or safety, and it had a reasonable chance to correct them, the Secretary may restrict payment instead of ending approval to services for patients who were there before notice took effect. (2) After regulatory notice, restriction continues until substantial compliance or termination of the agreement. (3) The facility receives a hearing and judicial review to the same extent as sections 405(b) and 405(g), with the Secretary and Department of Health and Human Services substituted for the Social Security Commissioner and Administration.

(h) Quality incentives. (1) For services on or after January 1, 2012, a provider or facility failing the year’s total-performance requirement may have its (b)(14) payment reduced by up to 2 percent; the reduction applies only that year. (2) Measures include FDA-label-consistent anemia management, dialysis adequacy, feasible patient satisfaction, oral-only-drug-condition measures from 2016, and other measures including iron, bone-mineral, and vascular-access measures. Measures generally must be endorsed by the section 1395aaa(a) entity, except that an appropriate feasible measure may be used when none is endorsed, considering consensus organizations; the Secretary must update measures with interested parties and consider children’s and young adults’ needs. Oral-only-drug measures should be outcomes-based and use kidney-guideline consensus measures when applicable. (3) The Secretary must calculate total and individual-measure scores, weight them for quality priorities, and give the largest reductions to the lowest total scores. (4) Standards must include achievement and improvement levels, be set before the performance period, and use the specified initial lesser-of historical or national standard for anemia and adequacy. (5) No administrative or judicial review is available for the reduction, standards or period, measures, or scoring method. (6) The Secretary must publish total scores, national comparisons, and individual scores; allow provider review first; give and require display of score certificates; and post an understandable CMS website list.