CMS Requests Public Comment on DRAFT Interpretive Guidelines for ESRD

October 11, 2007

The proposed End Stage Renal Disease (ESRD) Conditions for Coverage were published in the Federal Register on February 4, 2005. Final rules have been drafted and are in the approval process. The final rule must be published by February 4, 2008. These new rules will require changes in the survey process, including the interpretive guidelines which help surveyors assure patient health and safety.

In preparation for implementation of the final rule, CMS has prepared DRAFT interpretive guidelines based on the proposed ESRD Conditions for Coverage. CMS plans to revise these DRAFT interpretive guidelines after the final rule is published.

In the meantime, CMS is giving the public an opportunity to comment on the DRAFT interpretive guidelines. We wish to make clear, however, that this document is based on the proposed rule and will need to be revised to conform to any changes that might be made in the final rule. We also wish to stress that while we welcome comments on these DRAFT interpretive guidelines, this opportunity to comment does not extend to comments that might be made on the proposed rule. This is not an opportunity for further comment on the regulation language. It is an opportunity for input for the surrogate "Draft Interpretive Guidelines" column. CMS intends to consider suggestions offered as this document is adapted to the final rule once the final rule is published.

Instructions:

Download or print the DRAFT ESRD Interpretive Guidelines document at http://www.cms.hhs.gov/GuidanceforLawsAndRegulations/05_Dialysis.asp . This document has three columns:

* ID#: Each row is labeled with a red "ID#" for ease of reference.
* Proposed Regulation: The content in the "Proposed Regulation" column is from the proposed regulation published for comment February 4, 2005 and includes the language from the AAMI and CDC documents proposed to be adopted by reference. The proposed regulatory language is included to remind commenters of wording in the proposed regulation. This is NOT an opportunity for further comments on the proposed regulations. That comment period closed May 5, 2005.
* Draft Interpretive Guidelines: This column includes draft interpretive guidelines based on the proposed regulations.

To make comments on the Draft Interpretive Guidelines:

Download the DRAFT ESRD Interpretive Guidelines Comment Form at http://www.cms.hhs.gov/GuidanceforLawsAndRegulations/05_Dialysis.asp . This form has two columns:

* In the first column labeled "ID#," type the red ID number of the row about which you intend to provide comments.
* In the "Comment on Draft Interpretive Guidelines" column, you have the opportunity to comment on current draft recommendations. Type any edits or suggestions to the "Draft Interpretive Guidelines" text in this row. Type as much as you wish; the size of the space will expand to fit the text. If you have comments on more sections than the number of rows provided, tab until a new row appears.

Mail or email your comment no later than 5 p.m. ET on October 22, 2007 to:

Center for Medicare & Medicaid Services

Survey and Certification Group - IG Comments

Attention: Debbie Davis

Mail Stop S2-12-25

7500 Security Blvd.

Baltimore, Maryland 21244-1850

Email: esrd@cms.hhs.gov