Conditions for Coverage (2008)

On April 15, 2008, the Centers for Medicare & Medicaid Services (CMS) released the revised Conditions for Coverage for ESRD Facilities (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 took effect on October 14, 2008.


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 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 separate 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.   

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.


In June 2010, CMS released the CMS Dialysis Survey & Certification webpage for further guidance on laws & regulations related to dialysis facility certification surveys.

In April 2010, CMS released Frequently Asked Questions about Patient Care Technicians.

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

A Measures Assessment Tool (MAT) was also released, listing measures, values, references and source information for certain conditions/standards listed in the new Conditions for Coverage. This includes water and dialysate quality, reuse of hemodialyzers and patient blood lines, patient assessment, plan of care and QAPI. V-tags are also listed for each condition.

Frequently Asked Questions (FAQS)

CMS FAQ Resources

Frequently Asked Questions: Wave One (9/4/2009)
CMS Frequently Asked Questions (8/28/08)