Expanding Access to Investigational Therapies for HIV Infection and AIDS (1991) / Chapter Skim
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6 THIRD-PARTY PAYERS
6 THIRD-PARTY PAYERS
Pages 53-62
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From page 53... ...
At the same time, government policymakers have been bombarded by studies showing a severe shortage of basic health care services for major segments of the population, particularly low-income minorities in urban centers. This environment provides a particularly difficult setting in which to resolve questions about payment for health care services related to investigational drugs.
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From page 54... ...
Some patient advocates claim that worsening economic conditions in health care have caused third-party payers to become increasingly restrictive in their reimbursement policies. In certain situations, they say, a patient's decision to enter a clinical trial has led insurers to refuse reimbursement for hospitalization, physician fees, and patient care costs that would have been required even if the patient had not been involved in a research protocol.
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From page 55... ...
(Some patient advocates say that this new position is actually a retreat because many plans paid for off-label indication as part of standard patient care costs in the absence of an official policy.) The Blue Cross and Blue Shield Association has a mixed record with respect to expanded access programs for investigational drugs.
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From page 56... ...
The companies it represents underwrite about 85 percent of all commercial health insurance in the United States. Recently, HIAA convened a task force to make recommendations to member companies about off-label uses of approved drugs, treatment IND drugs, Group C drugs, and related issues.
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From page 57... ...
With regard to investigational drugs, the task force recommended that drugs for immediately life-threatening or serious conditions be considered for coverage or at least not categorically denied-by health insurers. This includes treatment IND drugs and Group C cancer drugs.
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From page 58... ...
Medicaid Drug coverage under Medicaid varies tremendously among states because it is considered an optional service; the only statutory guideline is that states may not receive federal payment for drugs that have not been determined effective by the FDA Coverage of investigational drugs and of unlabeled indications of approved drugs is usually at the discretion of the state.) 1In a 1989 decision, the U.S.
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From page 59... ...
For thousands of patients, the only remaining therapeutic alternative is an investigational drug. Drug sponsors or research grants usually pay drug-related patient care costs for individuals enrolled in traditional clinical trials, but there are no similar arrangements for patients receiving drugs through treatment IND or parallel track protocols.
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From page 60... ...
HCFA is in the process of establishing regulations to govern the Medicare coverage process. A HCFA spokesman says that when the notice of proposed rulemaking was published in the Federal Register, the agency received numerous letters from the public urging Medicare coverage of treatment INDs.
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From page 61... ...
61 these cases, {he committee said, thi[d-par~ pars should pay the standard patient ore ~S1S while ~S1S related lo i~esligalional inclusions should be borne by the drug sponsor pharma~ulio1 impala NIH, or a ~undadon.
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