[Code of Federal Regulations]

[Title 42, Volume 4]

[Revised as of October 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 42CFR488.60]



[Page 670-671]

 

                         TITLE 42--PUBLIC HEALTH

 

  CHAPTER IV--CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF 

                  HEALTH AND HUMAN SERVICES (CONTINUED)

 

PART 488_SURVEY, CERTIFICATION, AND ENFORCEMENT PROCEDURES--Table of 

 

                     Subpart B_Special Requirements

 

Sec.  488.60  Special procedures for approving end stage renal disease 



facilities.



    (a) Considerations for approval. An ESRD facility which wishes to be 

approved for coverage, or which wishes any expansion of dialysis 

services to be approved for coverage in accordance with subpart U of 

part 405, must secure the Secretary's determination thereunder. In 

addition to the certification by the State agency referred to in Sec.  

488.12 of this part, data furnished by network organizations and 

recommendations of the Public Health Service, concerning the 

contribution of a facility to the furnishing of end-stage renal disease 

services in its network and concerning the facility's compliance with 

professional norms and standards (see subpart U of part 405), shall be 

considered by the Secretary in determining whether to approve a facility 

for coverage or for any expansion of services under the End-Stage Renal 

Disease Program. The facility will also be required to submit data 

pertaining to its qualifications for approval or for any expansion of 

services, for consideration in the Secretary's determination.

    (b) Determining compliance with minimal utilization rates: Time 

limitations--(1) Unconditional status. A facility which meets minimal 

utilization requirements will be assigned this status as long as it 

continues to meet these requirements.

    (2) Conditional status. A conditional status may be granted to a 

facility for not more than four consecutive calendar years and will not 

be renewable (see Sec.  405.2122(b) of this chapter). Its status may be 

examined each calendar year to ascertain its compliance with Subpart U.

    (3) Exception status. Under unusual circumstances (see Sec.  

405.2122 (b) of this chapter) the Secretary may grant a time-limited 

exception to a facility which is not in compliance with the minimal 

utilization rate(s) for either unconditional status or conditional 

status. This exception status may be granted, and may be renewed on an 

annual basis, under circumstances where rigid application of minimal 

utilization rate requirements would adversely affect the achievement of 

ESRD program objectives.

    (c) New applicant. A facility which has not previously participated 

in the ESRD program must submit a plan detailing how it expects to meet 

the conditional minimal utilization rate status by the end of the second 

calendar year of its operation under the program and meet the 

unconditional minimal utilization rate status by the end of the fourth 

calendar year of its operation under the program.

    (d) Notification. The Secretary will notify each facility and its 

network coordinating council of its initial and its subsequent minimal 

utilization rate classification.



[[Page 671]]



    (e) Failure to meet minimal utilization rate. A facility failing to 

meet standards for unconditional status or conditional status, or if 

applicable, for exception status, will be so notified at the time of 

such classification.

    (f) Interim regulations participant. A facility previously 

participating under the interim regulations will not be approved under 

the program established by subpart U until it has demonstrated that it 

meets all the applicable requirements of this subpart, including the 

appropriate minimal utilization rate. It may continue under the interim 

program only for a period not to exceed 1 year from the effective date 

of these amendments (see Sec.  405.2100(c) of this chapter). During this 

period it may demonstrate its ability to meet the appropriate minimal 

utilization rate. Failure to qualify under this subpart will 

automatically terminate coverage of such facility's services under the 

ESRD program at the end of such year.



[41 FR 22510, June 3, 1976. Redesignated at 42 FR 52826, Sept. 30, 1977, 

and further amended at 45 FR 58124, Sept. 2, 1980. Redesignated and 

amended at 53 FR 23100, June 17, 1988]