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End Stage Renal Disease Facility Providers

This page provides basic information about being certified as a Medicare and/or Medicaid End Stage Renal Disease (ESRD) provider and includes links to applicable laws, regulations, and compliance information.

ESRD is that stage of renal impairment that appears irreversible and permanent, and requires a regular course of dialysis or kidney transplant to maintain life.

Types of ESRD Facilities:

  • Renal Transplantation Center

A hospital unit which is 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.  A renal transplantation center may also be a renal dialysis center.

  • Renal Dialysis Center

A renal dialysis center is a hospital unit that is 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).  A hospital need not provide renal transplantation to qualify as a renal dialysis center.

  • Renal Dialysis Facility

A renal dialysis facility is a unit that is approved to furnish dialysis service(s) directly to ESRD patients.

  • Self Dialysis Unit

A self-dialysis unit is a unit that is part of an approved renal transplantation center, renal dialysis center, or renal dialysis facility, and which furnishes self-dialysis services.

 

ESRD Application Requirement

Filing of Application

To establish eligibility to provide ESRD services under Medicare, an applicant must complete Part I of the End Stage Renal Disease Application and Survey and Certification Report, Form CMS-3427.

Application must be made: 

  • To request initial approval;
  • To request expansion or addition of stations; 
  • For change in location; 
  • For change of ownership (CHOW).  Ownership means the responsibility and liability for operational decisions of a health care enterprise.  A CHOW only occurs when there is a change in the identity of the governing body having ultimate operational responsibility for carrying out ESRD care in the facility; and/or
  • For change in service(s) provided, including reuse.

The State Survey Agency certifies compliance with health and safety standards, using the Survey Procedures and Interpretive Guidelines for End Stage Renal Disease Facilities.  Additional statutory and regulatory requirements include furnishing data and information for ESRD program administration, and participation in network activities.  The State Survey Agency assists the CMS Regional Office in gathering specified information relating to these regulations.