Saturday 15 October 2016

End-Stage Renal Disease Facilities (ESRDs)

A. Types of ESRD Facilities

ESRD facilities are entities that perform renal services for patients with irreversible and permanent kidney failure. There are several types of ESRD facilities:
• Renal Transplantation Center (RTC) – An RTC is a hospital unit approved to furnish – directly - transplantation and other medical and surgical specialty services required for the care of ESRD transplant patients, including inpatient dialysis furnished directly or under arrangement. An RTC must be a member of the Organ Procurement and Transplantation Network (OPTN).
• Renal Dialysis Center (RDC) – An RDC is a hospital unit approved to furnish the full spectrum of diagnostic, therapeutic, and rehabilitative services required for the care of ESRD dialysis patients (including inpatient dialysis furnished directly or under arrangement and outpatient dialysis). Also:
• The RDC need not furnish transplantation services.
• An RTC can also be an RDC.
• The RDC must be hospital-owned and operated, and the hospital must be enrolled in Medicare.
A separate, independent dialysis unit located in a Medicare-approved hospital cannot be approved as an RTC or RDC. (See Pub. 100-07, State Operations Manual, chapter 2, section 2280.1.)
• Renal Dialysis Facility (RDF) – This is a unit (but not necessarily a hospital unit) approved to furnish dialysis services directly to ESRD patients. A hospital (whether enrolled or not) can be an RDF if it is an outpatient provider of dialysis services that will not be furnishing inpatient dialysis services. A hospital-based RDF
“satellite” is one that is hospital-owned and administered but is not located on the hospital’s premises. A hospital can have multiple RDF satellites.
• Self-Dialysis Unit (SDU) – An SDU is a unit of an approved RTC, RDC or RDF that provides self-dialysis services.
• Special Purpose Renal Dialysis Facility (SPRDF) – SPRDFs are entities that perform ESRD services on a short-term basis in special situations for patients who cannot otherwise receive treatment in the geographical area. SPRDFs can be approved to serve vacation areas and in emergency situations. (See Pub. 100-07, State Operations Manual, chapter 2, section 2280D for more information on SPRDFs.) Like RTCs, RDCs, RDFs, and SDUs, SPRDFs must submit a Form CMS-855A to the contractor.

B. ESRD Survey and Certification

 The standard CMS survey and certification form used for ESRDs is the Form CMS-3427. Part I of this form must be completed, as must the Form CMS-855A, when the ESRD is initially enrolling, changing or adding a location, or undergoing a change of ownership (CHOW). Part I must also be completed for: (1) a change in service and (2) an expansion or addition of ESRD stations. However, the Form CMS-855A need not be furnished in these two latter instances (e.g., an ESRD station does not qualify as a practice location on the Form CMS-855A), though the RO may issue a tie-in notice or approval letter to the contractor as notification of the change. Also, because the “End-Stage Renal Disease Facility” category on the Form CMS-855A encompasses all five ESRD categories, it is not necessary for the facility to submit a Form CMS-855A if it is changing from one ESRD type to another, though it must complete the Form CMS-3427. (See Pub. 100-07, State Operations Manual, chapter 2, sections 2274 – 2276 and 2278 – 227, for more information on the Form CMS-3427 requirement.)
If the RO approves the station/service change or addition, it may send a tie-in notice or approval letter to the contractor updating the number of stations or types of services.

C. Miscellaneous ESRD Policies

• The ESRD Network is a group of organizations under contract with CMS that serve as liaisons between the agency and ESRD providers. (There are currently 18 Network organizations.) The organizations oversee the care that ESRD patients receive, collect data, and furnish technical assistance to ESRD providers and patients.
• The provider-based rules for ESRD facilities are outlined in 42 CFR §413.174 and are slightly different than those in the main provider-based regulation (42 CFR §413.65). (§413.174 uses the term “hospital-based” as opposed to “provider-based.”)
• As ESRD facilities are technically “suppliers,” they sign a supplier agreement rather than a provider agreement. Even if the ESRD facility is a hospital unit, it signs an agreement that is separate and distinct from the hospital’s agreement.
• ESRDs entities/facilities cannot be mobile.

D. ESRD Enrollment

Each type of ESRD facility must enroll as an ESRD facility via the Form CMS-855A. Since the Form CMS-855A does not distinguish between the different types of ESRD facilities, the following principles apply:
• If an enrolled RTC also wants to become an RDC, the provider must submit a new, complete Form CMS-855A for the RDC. For enrollment purposes, the RTC and the RDC will be treated as two separate ESRD facilities.
• If an enrolled ESRD wants to change to another type of ESRD, the provider need not submit a Form CMS-855A change of information (assuming that this is the only change to the provider’s enrollment data).
• ESRD facilities can have multiple practice locations if the RO approves it, though this typically only occurs with RDFs.

E. Additional Information on ESRD Facilities

For further data on ESRD facilities, refer to:
• Section §1881 of the Social Security Act
• 42 CFR Part 405, Subpart U
• Pub. 100-07, State Operations Manual, chapter 2, section 2270 – 2287B
• Pub. 100-02, Benefit Policy Manual, chapter 11
• Pub. 100-04, Claims Processing Manual, chapter 8

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