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Advisory Committee on Blood Safety and Availability Recommendations - April 2004

DATE: June 28, 2004

TO: Interested Parties

FROM: Jerry A. Holmberg, PhD, Executive Secretary for Advisory Committee on Blood Safety and Availability

SUBJECT: Advisory Committee on Blood Safety and Availability Recommendations - April 7&8, 2004

The Advisory Committee unanimously made four Recommendations to Secretary Thompson on April 8, 2004. Minutes, transcripts and presentations are posted on the Committee's web site (http://www.hhs.gov/bloodsafety).

1.)Whereas a safe, available and affordable blood supply is an essential National resource; and whereas the committee applauds Secretary Thompson recognition of the importance of sound policy or reimbursement, the DHHS ACBSA:

1) reiterates the recommendations of their January 28 & 29, 2004, meeting relevant to blood and blood products, including plasma-derived therapeutics and their recombinant analogs.

2) endorses the MMA Conference report statement, "The Secretary is directed to compile and clarify the procedures and policies for billing for blood and blood cost in the hospital inpatient and outpatient setting as well as the operation of the collection of the blood deductibles"; and ,

3) urges timely action in response to the above directive and the aforementioned recommendations of the committee.

Vote: 9 affirmative, 0 nay, 0 abstention (1 member left the room)

2.) Whereas blood clotting factors are life saving biologic therapies; and whereas it is crucial that individuals with hemophilia have access to and choice of the full range of blood clotting factors available on the market; and whereas inappropriate reimbursement methodologies can have a significant and detrimental impact on Medicare beneficiary access to these therapies; and whereas a competitive bidding process under Medicare Part B (Sec1842 (o)(1)(c) of the Medicare Prescription Drug, Improvement, and Modernization Act of2003 (MMA) would not assure access to blood clotting factor, and whereas Congress has recognized the unique challenges facing beneficiaries who rely upon life sustaining plasma protein therapies through an exclusion of intravenous immune globulins (IVIG) therapies from competitive acquisition provisions of the MMA, the Committee recommends that the Secretary exclude blood clotting factors from competitive acquisition under the Exclusion Authority granted in Sec. 1847B(a)(1)(D).

Vote: 10 affirmative, 0 nay, 0 abstention

3.)Whereas a competitive acquisition section of the MMA (section 302) contains language that may require an establishment of quality standards and accreditation bodies for blood products and transfusion medicine services; and whereas adequate federal regulatory controls and public and private standard setting and accreditation bodies exist and are effective, the committee requests that the Secretary should use his authority contained in the MMA to exclude all blood products and transfusion medicine services from the establishment of quality standards and competitive acquisition provisions of the MMA.

Vote: 10 affirmative, 0 nay, 0 abstention

4.)Whereas the DHHS ACBSA recognizes the importance of methods to reduce the risk of bacterial contamination in both apheresis and whole blood derived platelets; and whereas the committee also recognizes the potential for limited availability of platelets, particularly whole blood derived platelets and whereas the current five-day shelf life of apheresis and whole blood derived platelets and restrictions on whole derived platelets pre storage pooling has been identified as barriers to the optimal implementation of bacterial detection in platelets, the committee encourages dialog among the DHHS agencies, blood programs, and manufacturers to ensure strategies for:

? Facilitation of prompt development of technologies;

? The design and completion of feasible studies; and

? The satisfaction of licensing requirements to permit both the pre storage pooling of whole blood derived platelets and extension of platelet dating.

Vote: 7 affirmative, 0 nay, 2 abstention (1 member left the room)