Advisory Committee on Blood Safety and Availability Recommendations - May 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 - May 1&2, 2003

The Advisory Committee unanimously made four Recommendations to Secretary Thompson on May 2, 2003. Minutes, transcripts and presentations are posted on the Committee's web site (http://www.hhs.gov/bloodsafety).

1. The recommendations of the committee were as follows:

   1. Instruct CMS to identify specific costs of blood products and services within the "market basket".

   2. Instruct CMS to consolidate, simplify, and review reimbursement policy for all blood and blood derived products.

   3. Develop timely and adequate reimbursements mechanisms within and without the CMS appropriation system to assure that improvements in blood safety can be concurrently implemented without sacrificing the financial stability of the nation's blood supply.

   4. Identify contingency funding for unanticipated blood safety initiatives that require immediate implementation.

2. In addition, the Advisory Committee recognized that Intravenous Immune Globulin (IGIV) is derived from pooled human plasma; IGIV is used to treat chronic diseases; and IGIV is fractionated from the same source material used to produce human derived clotting factor for the treatment of hemophilia

3. Therefore; the Advisory Committee recommended that with regard to the Medicare Hospital Outpatient Prospective Payment System (HOPPS) CMS amend the definition of blood and blood products to include all plasma derived products for which there is a need to provide continuing access for therapies used to treat chronic diseases and life threatening conditions, specifically including IGIV.

4. The Advisory Committee further recommends that CMS establish parity of payment rates across different billing dosages.