America Living With AIDS

A M E R I C A Living

Third-party payers rely on a few
specific sources for coverage decisions:
FDA approval for drugs under treatment INDs, National Cancer Institute
approval of Group C cancer drugs, or
a few authoritative medical compendia (three are specifically cited in the
Medicare Catastrophic Coverage Act
of 1988). Relying only on such
sources will greatly restrict the coverage of many potentially useful drugs,
as specific approvals are sometimes
not sought by the manufacturer; for
some drugs and some uses approval
may never be sought.
In most cases thus far, expanded
access drugs for treating HIV disease
have been provided by pharmaceutical
companies free of charge to eligible
patients, but only if patients are participating in protocols in which physicians report on the drug's effectiveness
and provide the results of laboratory
tests. It should be noted that, even in
these special circumstances, neither the
physician's time nor laboratory services are covered by the drug company.
In addition, third-party payers have
often been reluctant to reimburse for
so-called "off label" use of drugs, that
is, use for other than indications specifically covered on the FDA-approved
labeling. As treatments for HIV disease
move quickly through the drug
approval process, in some cases bypassing some traditional phases, the benchmarks usually relied upon by third
party payers (public and private) will
have to be reconsidered. The Health
Insurance Association of America, Blue
Cross and Blue Shield, and HCFA are
all reexamining processes for determining which experimental drugs are eligible for coverage and looking at new
technology assessment procedures.
This reexamination is essential for
many HIV-related drugs.
The difficulties in deciding who
pays for health care associated with
research vividly reveals the discontinuity in federal health programs.
NIH-based researchers claim no jurisdiction over health care provision, and
the federal agencies responsible for the
reimbursement and delivery of health
care, HCFA and HRSA, are not
designing program strategies that
would take these research-related
issues into account. As discussed
above in this chapter, the Secretary of
Health and Human Services should
direct NIH, HCFA, and HRSA to work
together to address the health care
needs of clinical trial participants.
This effort should include the full support and participation of the NIH
Director of AIDS Research, the
Administrator of HCFA, and the
Administrator of HRSA.
It is important to note that the issue
of who should pay the associated hospital costs when patients are taking
combinations of licensed and experimental drugs is another serious problem. The NIH Reauthorization Bill
that passed the House of Representatives on July 25, 1991 calls for the
Department of Health and Human Services to conduct a study to determine

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