End-Stage Renal Disease Facilities (ESRDs)

10.2.1.3 - End-Stage Renal Disease Facilities (ESRDs) (Rev. 12639; Issued: 05-16-24; Effective: 06-17-24; Implementation: 06-17-24) (In this section 10.2.1.3, the terms “ESRD” and “ESRD facility” have the same meaning and will be used interchangeably). A. General Background Information ESRD facilities are entities that provide renal services and related care for patients with irreversible and permanent kidney failure. 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). (For instance, § 413.174 uses the term “hospital-based” as opposed to “provider-based.”) The ESRD Network is a group of organizations under contract with CMS that serve as liaisons between the agency and ESRD providers. The organizations oversee the care that ESRD patients receive, collect data, and furnish technical assistance to ESRD providers and patients. B. Types of ESRD Facilities Pub. 100-07, State Operations Manual, lists several classifications of ESRD facilities. They are summarized as follows: 1. Hospital-Based ESRD Facility A hospital-based ESRD facility is a separately certified ESRD facility that (1) is an outpatient department of a hospital and (2) meets the ESRD conditions of coverage at 42 CFR Part 494. A hospital-based ESRD facility is owned and administered by a hospital or critical access hospital and is physically located on the hospital campus. If a hospital operates multiple separately certified hospital-based ESRD facilities, each separate ESRD facility must have its own CCN and be separately enrolled. A hospital-based ESRD facility is discussed at 42 CFR § 413.174(c) and must meet the criteria listed therein (e.g., ESRD facility and hospital have a common governing body and are financially integrated). Hospital-based ESRD facilities are assigned CCNs from the 2300-2499 series. 2. Satellite Renal Dialysis Facility (Hospital-Based) A satellite renal dialysis facility is a hospital-owned and hospital-administered ESRD facility but is not located on the campus of the hospital. A single hospital may have several satellite renal dialysis facilities. Each satellite facility: (1) is separately certified and surveyed; (2) must independently meet the ESRD conditions of coverage; (3) is assigned its own CCN; and (4) be separately enrolled. Satellite renal dialysis facilities (hospital-based) are assigned CCNs in the 3500-3699 series. 3. Independent Renal Dialysis Facility An independent renal dialysis facility is any outpatient ESRD facility that does not meet the definition of a hospital-based renal dialysis facility or satellite renal dialysis facility as described in the paragraphs above. An independent renal dialysis facility may be physically located on a hospital campus, but it is not owned and/or administered by the hospital. Independent renal dialysis facilities are assigned CCNs in the 2500-2899 series and are individually enrolled. 4. Special Purpose Renal Dialysis Facility (SPRDF) (§ 494.120) This type of renal disease facility is temporarily certified to furnish dialysis at special locations on a short-term basis (i.e., up to 8 months in any 12-month period) to a group of dialysis patients who would otherwise be unable to obtain treatment in the geographical area. The SOG Location must clearly specify the limited nature of the SPRDF certification, the time period covered by the certification, and the automatic termination of payment on the last day of the certification period in its notifications. The special locations for SPRDF fall into two categories: (A) Vacation Camps - Vacation camps serve dialysis patients temporarily residing there. A vacation camp SPRDF would allow campers to receive hemodialysis at the camp site, avoiding interruption of the camping experience. Vacation camps may be approved for the duration of the camp but up to a maximum of 8 months in any 12-month period. (B) Emergency Circumstance SPRDFs - These locations are set up to provide dialysis services to those ESRD patients who would otherwise be unable to obtain such services in their geographical area resulting from a natural or man-made disaster or a need for a greater capacity to dialyze patients who may have been evacuated from another location. The CMS SOG Location may extend the time-period in emergency SPRDF approvals, where necessary, beyond the standard eight-month period based upon the termination of the emergency condition. SPRDFs are assigned CCNs in the 3700-3799 series when owned and administered by a hospital and in the 2900-2999 series for independent facilities. Although they are individually enrolled, they cannot convert to a permanent ESRD facility (i.e., to a non-SPRDF). They must instead reapply as a brand new ESRD facility and receive an initial certification survey. C. Processing Instructions for ESRD Initial Form CMS-855A Applications An ESRD facility is separately and individually certified and does not have any branch, multiple, or parent locations. As such, each type of ESRD facility/location must independently and separately enroll as such via the Form CMS-855A; multiple sites cannot be listed on a single application. Note that the instructions in this section 10.2.1.3(C) apply to all ESRD facility types except for SPRDFs. This ESRD type is not “transitioning” as that term is described in this chapter. Accordingly, the contractor shall continue to process initial applications from SPRDFs consistent with longstanding instructions rather than those described in this section 10.2.1.3(C) (e.g., receiving the final approval from the SOG location rather than the state; no need to send the application to PEOG after final SOG location approval). 1. Receipt of Application Upon receipt of an initial ESRD Form CMS-855A application, the contractor shall undertake the following (in whichever order the contractor prefers unless directed otherwise in this chapter): (A) Perform all data validations otherwise required per this chapter. (B) Ensure that the application(s) is complete consistent with the instructions in this section 10.2.1.3 and this chapter. (C) Ensure that the ESRD facility has submitted all documentation otherwise required per this chapter. For ESRD initial enrollment, this also includes the following: • Part I of the Form CMS-3427A (End Stage Renal Disease Application and Survey and Certification Report) (See Pub. 100-07, chapter 2, section 2274B for more information on this form.) • A certificate of need (CON) if required by state law (though SPRDFs need not submit a CON) (The ESRD must complete and submit Part I of the Form CMS-3427A, though the ESRD need not complete those sections of the form reserved for CMS. For organizational ESRDs, an authorized official (as defined in § 424.502) must sign the form; for sole proprietorships, the sole proprietor must sign. Note that there is no provider agreement for ESRD facilities; the Form CMS-3427A is a survey and certification document, not a provider/supplier agreement.) Notwithstanding the foregoing, if Part I of the Form-CMS-3427A and/or CON evidence is missing, unsigned, undated, or otherwise incomplete, the contractor need not develop for the form(s) or the information thereon. (Nor need the contractor: (1) research individual state laws to ascertain whether the state requires a CON; or (2) review the data on the CON.) The contractor shall instead notify the state in its recommendation letter which document(s) was/were missing or otherwise incomplete. For all other missing or incomplete required documentation, the contractor shall follow the normal development instructions in this chapter. 2. Conclusion of Initial Contractor Review (Nothing in this section 10.2.1.3(C) prohibits the contractor from returning or rejecting the ESRD application if otherwise permitted to do so per this chapter. When returning or rejecting the application, the contractor shall follow this chapter’s procedures for doing so.) (A) Approval Recommendation If, consistent with the instructions in section 10.2.1.3(C) and this chapter, the contractor believes an approval recommendation is warranted, the contractor shall send the recommendation to the state pursuant to existing practice and this chapter’s instructions. The contractor need not copy the SOG Location or PEOG on the recommendation. Unless CMS directs otherwise, the contractor shall also send to the provider the notification letter in section 10.7.5.1(E) of this chapter. The state will: (1) review the recommendation package for completeness; (2) review the contractor’s recommendation for approval; (3) perform any state-specific functions; and (4) contact the contractor with any questions. The contractor shall respond to any state inquiry in Item (4) within 5 business days. If the inquiry involves the need for the contractor to obtain additional data, documentation, or clarification from the ESRD, however, the timeframe is 15 business days; if the provider fails to respond to the contractor within this timeframe, it shall notify the state thereof. The contractor may always contact its PEOG BFL should it need the latter’s assistance with a particular state inquiry. (B) Denial If the contractor determines that a denial is warranted, it shall follow the denial procedures outlined in this chapter. This includes: (1) using the appropriate denial letter format in section 10.7.5.1 of this chapter; and (2) if required under section 10.6.6 (or another CMS directive) of this chapter, referring the matter to PEOG for review prior to denying the application. 3. Completion of State Review The state will notify the contractor once it has completed its review. There are two potential outcomes: (A) Approval Not Recommended If the state does not recommend approval, it will notify the contractor thereof----typically via the Form CMS-1539, although the contractor may accept any notification that is in writing (e-mail is fine). No later than 5 business days after receiving this notification, the contractor shall commence the actions described in section 10.2.1.3(C)(2)(B) above. (B) Approval Recommended If the state recommends approval, it will typically do so via a Form CMS-1539; however, the contractor may accept any documentation from the state signifying that the latter recommends approval. (Note that the contractor will not receive a formal tie-in notice.) No later than 5 business days after receipt of the recommendation from the state, the contractor shall send an e-mail to MedicareProviderEnrollment@cms.hhs.gov with the following information and documents: • The Form CMS-855 application (or PECOS Application Data Report) and all application attachments • A copy of the Form CMS-1539 from the state or similar documentation received from the AO • A copy of the draft approval letter, with the effective date shown on the Form CMS-1539 (or similar documentation) included in the draft letter. (See section 10.7.5.1 for the model approval letter.) (As required per section 10.6.21 of this chapter, the e-mail subject line shall include the following: SUBJECT LINE: S&C: Facility Type; Application Type; Facility Name; National Provider Identifier; CCN; Application Receipt Date (MMDDYY*) (*Date the Contractor Received the Application from the Provider/Supplier). (Note, however, that this data need not be duplicated in the e-mail’s body.)) PEOG will review the documentation. Based on the information received from the contractor, PEOG will also (1) assign an effective date, (2) assign a CCN, and (3) enter the relevant data into the applicable national database, and (4) approve (with possible edits) the approval letter. Within 5 business days of receiving from PEOG the effective date, and CCN the contractor shall: (1) send the approval letter to the ESRD provider, with a copy to the state and/or AO (as applicable); and (2) switch the PECOS record from “approval recommended” to “approved” consistent with existing instructions. D. Additional/Changed Stations If an enrolled ESRD seeks to add/change services or stations (e.g., add ESRD services in SNFs, additional modalities), the ESRD need not submit a Form CMS-855A application to do so, for these services and stations do not constitute practice locations and cannot otherwise be reported on the application. Instead, the ESRD contacts the state or accreditation organization (AO) to request these changes. The ESRD must complete a Form CMS-3427 and submit it to the state or AO (as applicable). A survey may be performed, and the state will update the applicable national database with any administrative changes. The state will also send a CMS-1539 or approval letter to the contractor as notification of the additional/change service(s) or station(s). When the contractor receives such a notice, it shall abide by the following: • As applicable, and consistent with longstanding practice, the contractor shall enter all relevant data into PECOS. No referral to or prior approval from PEOG is necessary. However, the contractor may contact its PEOG BFL if it has questions regarding the Form CMS-1539 or the supplier’s PECOS record. • For situations involving new/expanded/changed ESRD stations, the contractor shall send to the supplier the “ESRD Service Station/Modality Changes” letter identified in section 10.7.19 of this chapter. (The state and, as applicable, the AO shall be copied on said letter.) E. ESRD Location Changes An ESRD facility that is changing its location must submit either a Form CMS-855A change of information application or an initial enrollment application. The specific transaction type involved (change request or initial) will depend on the particular situation. These situations include the following, and they will generally trigger the termination of the ESRD’s existing CCN and the issuance of a new one. (i) A hospital-based ESRD facility is relocating to an off-campus location in the same state. In this situation, the ESRD’s current CCN will be retired. If the off-campus location will still function under a common governing body, operate under the hospital’s policies and practices, continue to serve the same community, and utilize the same staff at this new location, the new CCN will be that of a renal satellite facility. The application can be processed as a change of information pursuant to the instructions in section 10.6.1.2(A). If the off-campus location will no longer be operationally, administratively, or financially integrated with the hospital, the new CCN will be that of an independent dialysis facility. The hospital must voluntarily terminate this location from its enrollment, and the site must enroll as a new ESRD facility. If the contractor has any questions as to whether the relocated location will still be sufficiently integrated with the hospital to permit a change of information application rather than an initial enrollment, the contractor may contact the state for guidance. The processing time clock stops while the contractor awaits the state’s guidance. (ii) An independent ESRD facility is relocating to become a hospital-based facility or a renal satellite facility of a hospital Since the ESRD facility will be serving a different community under different policies, etc., the facility must terminate its existing enrollment and enroll as a new ESRD facility. (iii) An independent ESRD facility is relocating to another location and will remain independent If the ESRD facility will be serving a different community, the facility must terminate its existing enrollment and enroll as a new/initial ESRD facility. If it will serve the same community, the relocation can be processed as a change of information. (iv) ESRD facility relocating out-of-state If an ESRD facility of any type (e.g., independent, satellite) is relocating out-of-state --- and notwithstanding any other instruction to the contrary in this chapter ---- it must terminate its existing enrollment and enroll as an initial/new applicant. F. CHOWs and Changes of Information For ESRD CHOWs, the contractor shall follow the instructions in section 10.6.1.1 of this chapter. For ESRD changes of information, the contractor shall follow the instructions in section 10.6.1.2 of this chapter. G. New ESRD Model Letters Notwithstanding any other instruction to the contrary in this chapter, the contractor shall use the applicable ESRD letters in section 10.7.19 of this chapter for initial enrollments and state- approved changes of ownership. H. Beds and Services A Form CMS-3427 from the state must be included with an initial or CHOW Form CMS-1539 that identifies, as applicable, the services or number of beds at issue. If, nonetheless, this data is not furnished by the state to the contractor for an initial or CHOW application, the contractor may secure it from the state (or, for CHOWs, and as applicable, the AO). I. ESRD Survey, Certification, and Modalities As previously indicated, the standard CMS survey and certification form used for ESRDs is the Form CMS-3427. The modalities listed on the Form CMS-3427 are: • In-center Hemodialysis (HD) • In-center Peritoneal Dialysis (PD) • In-center Nocturnal HD • Home HD Training & Support • HD in LTC • Home PD Training & Support • PD in LTC • Dialyzer Reuse For further information on ESRD facilities, refer to: • Section § 1881 of the Social Security Act • 42 CFR Part 405, Subpart U • Pub. 100-07, chapter 2, section 2270 – 2287B • Pub. 100-02, chapter 11 • Pub. 100-04, Claims Processing Manual, chapter 8