Followup
DATE: November 30, 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 November 24, 1998 - Followup 8/3/00
1. The Secretary of Health and Human Services should recommend legislation that would lower barriers to the use of federal data bases for locating individuals at risk of hepatitis C infection.
Recommendation received by the Department.
2. The Department of Health and Human Services
should allocate sufficient additional resources to permit the Centers for
Disease Control and Prevention to work with state and local health departments
to facilitate education, testing, and referral programs for individuals at
risk of hepatitis C infection.
The current CDC budget for Hepatitis C Activities is $12.9 Million/year.
3. The Department of Health and Human Services
should investigate supplemental sources of financial support to facilitate
prompt completion of targeted lookback for individuals at risk of transfusion-transmitted
hepatitis C infection.
Discussion 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.
4. The Health Care Financing Administration
should remove financial barriers to testing of individuals identified by current
government standards as being at risk of hepatitis C infection.
On March 18, 1999, HCFA issued Program Memorandum #804, which clarifies its coverage policies on HCV testing.
5. The Secretary of Health and Human Services
should take all necessary steps to insure completion of current lookback programs
within currently recommended time frames.
On March 30, 2000, FDA Commissioner Henney reaffirmed her agency's commitment to enforcement on this issue.
6. The Advisory Committee on Blood Safety and
Availability supports Recommendation 1A and 3 of the Seventh Report of the
House Committee on Government Reform and Oversight.
Noted by the Department.
7. The current targeted lookback program should
be expanded to include recipients of blood from donors subsequently identified
as repeat reactive by the single antigen (EIA-1) screening test for hepatitis
C infection that was licensed in 1990.
See following recommendation.
8. Implementation of the prior motion should
be deferred until the Public Health Service has had an opportunity to review
it and to present options for its implementation and evaluation to the Advisory
Committee at its next meeting.
Noted by the Department.
SDN August 3, 2000
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