Followup
DATE: September 5, 1998
TO: Interested Parties
FROM: Stephen D. Nightingale, M.D., Executive Secretary
Advisory Committee on Blood Safety and Availability
SUBJECT: Recommendations of Advisory Committee
on August 28, 1998 - Followup 8/3/00
1. The Advisory Committee recommends that the
Department of Health and Human Services take steps to accelerate the transition
from plasma derivatives to their recombinant analogs where medically appropriate.
This appears to have been accomplished.
2. The Advisory Committee recommends that the
Department of Health and Human Services support research to develop alternatives
to plasma-based technologies for diseases such as the immunodeficiencies,
alpha-one antitrypsin deficiency, and von Willenbrand's disease, where these
alternative technologies have not yet matured.
This research continues to be supported.
3. The Advisory Committee recommends that the
Department of Health and Human Services maintain and as necessary expand or
intensify surveillance of blood donors and recipients for existing and emerging
transmissible diseases.
A meeting on this issue sponsored by the
Immune Deficiency Foundation and attended by government officials was held May
4, 2000.
4. The Advisory Committee directs its staff
to develop options to be presented to the Blood Safety Director for the creation
of a sentinel system to monitor production, demand, and utilization of blood
products and to create projections for future demand.
A surveillance system for blood products
similar to the system developed for plasma derivatives by PPTA has been funded
by NHLBI and is now operational.
5. The Advisory Committee recommends that the
Secretary of Health and Human Services direct the Health Care Financing Administration
and other appropriate agencies to explore strategies to ensure that all patients
have access to adequate reimbursement for recombinant technologies, and to
report to this Committee in a timely manner.
Discussions over reimbursement issues
continue on many levels. Reimbursement for outpatient use of plasma derivatives
is specified in the April 7, 2000 HCFA Final Rule on Hospital Outpatient Prospective
Payment Systems.
6. The Advisory Committee recommends that the
Secretary examine innovative responses, including regulating the import and
export of plasma and finished products, in order to ensure a safe and adequate
supply of plasma derivatives and recombinant products for American user communities.
The Department remains receptive to such
initiatives.
7. The Advisory Committee encourages further
efforts to develop and communicate standards for the prophylactic and therapeutic
use of clotting factors and other blood derivatives.
Clinical trials needed for this effort
are expected to occur as more product becomes available.
8. The Advisory Committee urges the Secretary
to convene a meeting of manufacturers of plasma derivatives and their recombinant
analogs to discuss strategies for distribution in light of shortages.
The objectives of this recommendation
are being met without actions that might be construed as anticompetitive.
SDN August 3, 2000
|
Download Reader 
