CMS — SafeBlood: Interim Response, January 14, 2003

08/01/2004

January 14, 2003

Debby Thetford Nye, Esq. 
Mitchell, Williams, Selig, Gates, and Woodward, P.L.L.C. 
5414 Pinnacle Point Drive, Suite 500 
Rogers, Arkansas 72758-8131

Dear Ms. Nye:

This letter is in response to your November 14 letter transmitting an Information Quality Request for Correction (the "Request") on behalf of SafeBlood® Technologies, Inc. The Centers for Medicare & Medicaid Services (CMS) received your Request on November 18, 2002.

While your Request purportedly seeks correction of information under the Federal Data Health Quality Act (the "Act") (P. L. 106-554, enacting into law § 515 of Title V of H.R. 5658 (114 Stat. 2763A-153)), the prayers for relief far exceed the scope of the Act and CMS's "Guidelines for Ensuring the Quality of Information Disseminated to the Public" ("CMS Guidelines," available at http://www.dhhs.gov/infoquality). The relief sought by your Request instead seeks the reversal of a local medical review policy (LMRP) decision regarding treatments associated with chronic wound care. As such, we suggest that you follow the established administrative procedures for appealing LMRP determinations. The procedures to request formally a reconsideration of an LMRP decision can be found in Section I 1 of the Medicare Program Integrity Manual (MPIM)(Chapter 13 - Local Medical Review Policy)(located at http://www.cms.gov/manuals/108_pim/pim83cl3.asp).

In response to the limited relief sought in your Request relating specifically to correction of allegedly erroneous information in the draft LMRP, we draw your attention to Section VI of the CMS Guidelines for Ensuring the Quality of Information Disseminated to the Public (CMS Guidelines) and the MPIM. Section VI indicates that CMS will use existing public comment procedures to respond to information quality complaints that arise during agency actions. Section 11 of the MPIM provides for an LMRP reconsideration process, whereby interested parties can request a revision to an LMRP, in whole or in partWe note that because the LMRP in question has recently been finalized, the reconsideration process is now available to your client.

To avoid duplicating the reconsideration process of the LMRP decision, CMS will forward your Request to the Arkansas Contractor Medical Director (CMD) for the limited purpose of reviewing the allegedly erroneous information. If you wish other portions of the LMRP to be reconsidered, you should immediately inform the CMD directly. You can expect a decision on whether a correction of the allegedly erroneous information is warranted and an explanation of the actions that will be taken, if any, within the next thirty (30) days. In the meantime, should you have any questions regarding this process, you may contact Dr. Sydney Hayes, the Contractor Medical Director for the Arkansas Blue Cross I Shield, who can be reached at the following:

Sydney P Hayes, MD
Arkansas Blue Cross Blue Shield
601 Gaines Street
Little Rock, AR 72203

In addition, we also recognize that part of the relief sought in your Request may seek the reversal of a national noncoverage decision issued by CMS regarding treatments associated with chronic wound care. If you are in fact seeking that relief, we suggest that you follow the established administrative procedures for appealing coverage determinations. The procedures to request formally a reconsideration of a noncoverage decision can be found at http://www.cms.hhs.gov/coverage/8a1.asp or http:www.access.gpo.gov/nara/index.html.

If you. have any other questions, feel free to contact me at the address in our letterhead or at telephone number 410.786.7932.

Sincerely,

Dan I R. Waldo 
Director, Information and Methods Group 
Office of Research, Development, and Information

Last Revised:  August, 2004