CMS — SafeBlood: Amended RFC

08/01/2004

January 23, 2003

Mr. Daniel R. Waldo 
Director, Information and Methods Group 
Office of Research, Development and Information 
Centers for Medicare and Medicaid Services 
C3-16-27 7500 Security Boulevard 
Baltimore, Maryland 21244-1850

Re:Information Quality Request for Correction Safeblood Technologies, Inc.

Dear Mr. Waldo:

On January 16, 2003 I received The Centers for Medicare and Medicaid Services' Response to a Request submitted on behalf of Safeblood Technologies, Inc. made pursuant to the provisions of the Federal Data Health Quality Act. Please accept this letter as a Request to Appeal the determination made by The Centers for Medicare and Medicaid Services ("CMS") in its letter of January 14, 2003.

The Request to Appeal is made specifically to address the following points. First, the Complaint initiated on behalf of Safeblood Technologies did not seek to request a review of a national non-covered service restriction (§ 45-26). Rather, the Complaint set forth a position that asserted the physician-assisted treatment was distinguishable from the reimbursement prohibition for the product as identified in the § 45-26 limitation. The Response received on January 14, 2003 does not address the accuracy of the Safeblood Technologies contention that the physicianassisted treatment was, in fact, not a treatment limited by § 45-26. In other words, Safeblood Technologies, Inc. does not seek a review of the non-covered service, nor does it challenge the appropriateness of such service limitation, but rather, it seeks to have a finding by CMS that § 45-26 does not apply to the physician-assisted treatment as described in its Complaint. If the provisions of the Local Medical Review Policy, which is the subject of the Complaint, are in fact a restatement of the national non-coverage service provision, then it would follow that there was no reason to implement a local medical policy. The position of the Contractor Medical Director for the Arkansas Blue Cross/Blue Shield is inconsistent, and should be declared void.

Secondly, the Appeal requests a review of the clinical information relied upon by the Arkansas Contractor Medical Director that served as the underlying basis for the validity of local medical review policy. The January 14, 2003 Response letter appears to indicate that the use of the public comment procedures should in fact have allowed for this review. The Appeal requested is specifically aimed at the erroneous procedural and noncompliant steps utilized by the Contractor Medical Director for the Arkansas Blue Cross/Blue Shield in its attempt to finalize the local medical review policy. This request is again made as a part of the Appeal.

It is further requested that the Appeal not be resubmitted to the Contractor Medical Director for Arkansas Blue Cross/Blue Shield inasmuch as that exercise would be not a fair review. It is clear from the documents and interaction with the Contractor Medical Director that she is predisposed on all points. Therefore, it is requested that the Appeal be forwarded to the appropriate officials at CMS to assure full compliance with the provisions of the Federal Data Health Quality Act (P.L. 106-554). Once again, on behalf of Safeblood Technologies, Inc., I thank you for your attention to this very important matter and if it raises questions or if further information is required to process this Appeal, please do not hesitate to contact me.

Sincerely,

MITCHELL, WILLIAMS, SELIG, 
GATES & WOODYARD, P.L.L.C.

By: Debby Thetford Nye

DTN: aa

cc: Mr. Jim Limbird, President Safeblood Technologies, Inc.

Last Revised:  August, 2004