[Code of Federal Regulations]
[Title 42, Volume 3]
[Revised as of October 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR488.60]

[Page 652]
 
                         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 Contents
 
                     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.
    (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]