Advisory Committee on Blood Safety and Availability Recommendations - January 2003

DATE: August 24, 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 - January 23&24, 2003

The Advisory Committee unanimously made four Recommendations to Secretary Thompson on January 24, 2003. Minutes, transcripts and presentations are posted on the Committee's web site (http://www.hhs.gov/bloodsafety).

The committee recognizes that the current leading causes of transfusion related fatalities are:

1. bacterial contamination of platelets;

2. hemolysis, primarily due to errors; and

3. transfusion related acute lung injury (TRALI) and that efforts to address these threats have been limited in comparison to other threats.

The committee further recognizes that public attention remains highly focused on residual risks from HIV and hepatitis agents, and on less quantifiable known and theoretical risks.

The committee also finds that technologies already exist that could effectively reduce the risks from bacterial contamination and hemolysis, but there are no currently proven technologies to reduce TRALI.

Therefore, we recommend that:

1. the Secretary take steps to encourage and facilitate implementation of available measures that could:

   1. reduce the risk of bacterial contamination, and

   2. prevent errors that can result in hemolytic transfusion reactions

2. the Secretary encourage research that:

   1. possibly may improve the safety and extend the shelf-life of stored platelets and

   2. may result in technologies/ practices that could reduce the incidence of TRALI.

3. an ad hoc sub-committee be formed to develop a process to identify and evaluate residual, known and unknown risks affecting blood safety and secondarily availability, both in relation to etiological agents and the processes used in transfusion medicine. The subcommittee is tasked to use the process as one tool combined with other relevant data to propose prioritization of efforts by government, industry and the health care system to address these risks for further consideration by the committee.

Whereas the Centers for Medicare and Medicaid Services (CMS) Carrier Manual provisions regarding reimbursement for hemophilia clotting factors¹ include outdated terminology such as "heat treated variety and non-heat treated variety" clotting factors, and

Whereas, the Health and Human Services Advisory Committee on Blood Safety and Availability (Advisory Committee) is very concerned about the potential impact these outdated provisions could have not only on Medicare coverage decisions, but also on the policies of state Medicaid agencies and private insurers, and

Whereas the Advisory Committee has previously recommended that "Every effort should be made to make recombinant clotting factors available to all who would benefit from them, and all barriers to conversion from human to recombinant clotting factors should be removed."², and

Whereas the Advisory Committee has also previously recommended "that the Department of Health and Human Services take steps to accelerate the transition from plasma derivatives to their recombinant analogs where medically appropriate."³, and

Whereas the Medical and Scientific Advisory Council (MASAC) of the National Hemophilia Foundation (NHF) has endorsed these recommendations of the Advisory Committee⁴, and

Whereas MASAC has taken note of the egregious practice of reimbursement denial contrary to the recommendations of MASAC and the Advisory Committee⁵:

The Advisory Committee wishes to reaffirm its previous recommendations regarding recombinant clotting factors, and further recommends that the Secretary of Health and Human Services direct the Centers for Medicare and Medicaid Services to promptly revise the Carrier Manual provisions regarding reimbursement for hemophilia clotting factors to remove all insurance barriers to recombinant technology.

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