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CMS — Safeblood: HHS Response to Rfc

April 17, 2003

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

Dear Ms. Nye:

We have reviewed your letter transmitting an Information Quality Request for Correction (the "Request") dated November 14, 2002, the Request itself, the accompanying materials, your January 23, 2003 letter, and additional information your client has submitted in further support of the Request.

In previous communications we have explained that the prayers for relief and the requests made in your original request and in your subsequent January 23, 2003 letter far exceed the scope of the Federal Data Health Quality Act (the "Act") and all implementing Guidelines arising from the Act. As you know, the Act seeks to ensure and maximize the quality, objectivity, utility and integrity of information (including statistical information) disseminated by Federal agencies. The Act moreover seeks only the correction of information that fails to meet these objectives. Neither the Act nor the OMB Guidelines require that coverage determination procedures be modified, that Federal agencies in any way alter their policies, or that Federal agencies duplicate currently existing review mechanisms to respond to information correction requests.

Under the provisions of the Act, we can therefore address that portion of your request concerning posting of information regarding Autologous Tissue Grafting™, now termed SafeBlood Graft™, and platelet-derived wound healing formula (e.g. Procuren™) in the Arkansas Fiscal Intermediary draft LMRP titled "Chronic Would Care - Draft" (the "LMRP").

Upon reviewing the materials submitted, we have determined that sufficient clinical differences exist between Safeblood and Procuren to justify correction of the information contained in the LMRP on the Arkansas Blue Cross and Blue Shield website. We consequently have requested Arkansas Blue Cross and Blue Shield to remove immediately the incorrect information from their website, which they have done.

If your client does not agree with this decision (including the corrective action), you may send a written hard copy or electronic request for reconsideration within 30 days of receipt of this letter. The appeal must state the reasons why you consider our decision or correction within the scope of the Act to be insufficient or inadequate. You must also attach a copy of your original request and our response to it, clearly mark the appeal with the words, "Information Quality Appeal," and send the appeal to the following address:

Daniel Waldo C3-16-27 
Information Quality 
Centers for Medicare & Medicaid Services 
7500 Security Boulevard 
Baltimore, MD 21244-1850

Alternatively, your appeal can be e-mailed to Please note that appeals should contain the word "appeal" on the envelope or in the subject line.

If you have any questions regarding this matter, please contact me at 410.786.7932 or at the address in the letterhead. If you have any further questions specifically concerning the LMRP, feel free to contact Beth Giebelhaus at 410.786.4283.


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

Last Revised:  August, 2004