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.
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