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Conditions for Coverage

ESRD Conditions for Coverage (2008)
Conditions for Coverage Frequently Asked Questions (FAQs)
Interpretive Guidance
CMS Waivers & Phase-In Time Extensions for Implementation
Network 5 Conditions for Coverage Resource List
Quick Tips
Implementation Timeline
SubPart U Regulations (2003)


ESRD Conditions for Coverage

On April 15, 2008, the Centers for Medicare & Medicaid Services (CMS) released the revised Conditions for Coverage for ESRD Facilities (PDF 1.3MB) (formerly Subpart U Regulations). This final rule reflects the advances in dialysis technology and standard care practices since the requirements were last revised in their entirety in 1976. The provisions of the final rule are effective October 14, 2008.

Conditions for Coverage Frequently Asked Questions (FAQs)

The Centers for Medicare and Medicaid Services (CMS) and the Network 5 staff have developed listings of Frequently Asked Questions (FAQs) in an effort to assist facility staff with the many questions they have regarding the Conditions for Coverage.
CMS Frequently Asked Questions: Wave One (9/4/09)
CMS Frequently Asked Questions (8/28/08)
Network Frequently Asked Questions


ESRD Conditions for Coverage Interpretive Guidance

In October 2008, CMS released Interpretive Guidance for the ESRD Conditions for Coverage.


CMS Waivers & Phase-In Time Extensions for Implementation

On November 21, 2008, CMS released information regarding waivers and phase-in time extensions for implementation of the new ESRD Conditions for Coverage. Some of the highlights from the CMS Waivers and Phase-In Time Extensions for the Implementation of the New End-Stage Renal Disease (ESRD) Conditions for Coverage memorandum include:

  • Effective Dates, New Regulation: The new ESRD Conditions for Coverage were effective on October 14, 2008. However, there are separate effective dates for
    • The construction of a seperate isolation room for hepatitis B+ patients,
    • Code compliance for National Fire Protections Association's (NFPA) 2000 Life Safety Code (LSC),
    • Certification of patient care dialysis technicians, and
    • Mandatory electronic submission of data and information.
  • Waivers or Time Extensions: In addition to the scheduled effective dates for the above aspects of the new ESRD Conditions, waivers and/or phase-in time extensions may be granted for some requirements.
  • Model letters that facilities may wish to use in providing information for waiver requests.

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Conditions for Coverage Resource List

Network 5 has developed a Conditions for Coverage Resource List which includes resources specifically referenced in the Conditions, as well as recommended resources to assist you in meeting the new Conditions.

Conditions for Coverage Quick Tips

In September 2008, the Network developed a weekly electronic newsletter, entitled Quick Tips, to provide information to dialysis providers, regarding the new conditions.

Implementation Timeline

In the August 2008 issue of Renal Business Today, author Jack Ahern, MBA, provided an implementation timeline to help dialysis facilities implement the Conditions' changes and meet the new requirements. It is presented here with permission from the author.

Subpart U Regulations (2003)

Subpart U Regulations (2003) (PDF 816KB) preceeded the latest Conditions for Coverage, setting forth the requirements dialysis providers were to meet for Medicare health and safety standards, prior to October 14, 2008. See pages 138-158 of these regulations.

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