Followup
DATE: May 1, 2000
TO: Interested Parties
FROM: Stephen D. Nightingale, M. D., Executive
Secretary
Advisory Committee on Blood Safety and Availability
SUBJECT: Recommendations of Advisory Committee
on April 26, 2000 - Follow-up 8/3/00
1. The Advisory Committee on Blood Safety and
Availability recommends the establishment and implementation of a national
reporting and analysis system for transfusion medicine as a basis for action
to reduce and prevent morbidity and mortality due to human and system error.
The Advisory Committee is favorably impressed
with the accomplishments of the error reporting and correction systems that
have been developed to improve the safety of air travel by the aviation industry,
and by the interaction of federal regulatory agencies with this system.
The Advisory Committee acknowledges the efforts
of the FDA working with the blood and plasma collection industries in reducing
errors and accidents, and is favorably impressed with the results to date
of the MERS-TM error management system. While a great deal has been accomplished
in blood collection and processing, the Committee now believes that the opportunity
exists to apply these principles to transfusion practice.
Error management systems should acknowledge
the right of patients to know of any risk or harm suffered as a consequence
of any error or accident related to blood products received. At the same time,
there should be statutory protection from disclosure for voluntarily reported
information and of quality assurance activities that are not associated with
potential or actual harm, provided that the information is also not associated
with reckless or intentionally harmful acts. These error management systems
should complement, and not replace, current regulatory activities, notably
but not exclusively in the area of product safety. All analyses of collected
data should be made available in a timely manner to regulatory agencies, national
transfusion medicine surveillance programs, and other participants in a reporting
system.
Congress should appropriate sufficient funds
to develop these systems and for an infrastructure sufficient to support and
maintain them in the FY 2001 budget. Congress should stipulate that these
funds should not be reallocated for other purposes and that no
other funding should be reduced because of the availability of these funds.
Funds necessary to maintain these systems should be appropriated annually.
The President's budget requests funds
to develop and maintain a reporting and analysis system for error management
in transfusion medicine at the Food and Drug Administration.
2. There is a small but non-zero risk associated
with the use of blood products or plasma derivatives that cannot be eliminated
with current technologies. The Advisory Committee therefore supports the prior
recommendation of the Institute of Medicine, and of others, that a prospective
national system to compensate recipients for injuries or death caused by blood
products or plasma derivatives and not associated with a reckless or intentionally
harmful act should be enacted and funded by Congress.
The Department continues to feel that
compensation issues are the responsibility of Congress. The Administration stands
ready to assist Congress as it considers such recommendations in the future.
3. Whereas the Advisory Committee on Blood Safety
and Availability is dedicated to insuring patient access to safe blood products
and services, and whereas the Committee recognizes that fair, accurate, and
timely reimbursement, including Medicare, for blood-related therapies is critical
to insuring patient access to the safest possible blood, the Advisory Committee,
consistent with its prior recommendations, recommends that the Secretary and
Congress support legislation to insure fair and accurate reimbursement for
inpatient blood-related products and services. Such legislation should provide
sufficient funding to account for increased blood-related costs, including
those associated with new blood safety measures, and require that these costs
be reflected in annual updates of inpatient diagnosis related groups.
The Department has recently responded
to Advisory Committee recommendations about reimbursement for outpatient blood
and blood product use, and initial reaction to this new policy appears favorable.
However, it is our current view that a comparable policy on reimbursement for
inpatient blood and blood product use would require some Congressional action.
4. The Advisory Committee recommends that HCFA
promptly distribute guidelines for coding and billing of blood and plasma
products to all entities covered by the outpatient prospective payment rule.
Furthermore, the Advisory Committee urges HCFA to work with stakeholders,
including consumers, outpatient departments and manufacturers to capture actual
utilization and billing data to be used to establish a permanent payment system
for blood derivatives administered in outpatient settings.
HCFA will do so.
5. Recognizing the significant economic issues
currently affecting the blood system, the Advisory Committee seeks to review
the role of various considerations in decision making related to new and existing
blood safety measures.
The Advisory Committee will meet on August
24, 2000 to consider this issue.
SDN August 3, 2000
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