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Off-Label Drugs: Reimbursement Policies Constrain Physicians in Their Choice of Cancer Therapies

PEMD-91-14 Published: Sep 27, 1991. Publicly Released: Sep 27, 1991.
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Highlights

Pursuant to a congressional request, GAO examined the prevalence of the off-label use of anticancer drugs, focusing on: (1) the extent to which approved anticancer drugs are being prescribed for off-label uses, and how patient characteristics, therapeutic intent, and type of cancer influence their use; (2) third party reimbursements to physicians that prescribe anticancer drugs for off-label uses; and (3) ways in which physicians alter the way they treat cancer patients because of difficulties in obtaining reimbursement for off-label drug use.

Recommendations

Recommendations for Executive Action

Agency Affected Recommendation Status
Department of Health and Human Services The Secretary of Health and Human Services should issue a policy that states specifically the circumstances under which the Health Care Financing Administration will reimburse for the administration of drugs off-label in the treatment of cancer patients.
Closed – Not Implemented
The Department of Health and Human Services (HHS) is in the process of establishing reimbursement policy for the administration of drugs off-label. The Department has a physician reimbursement policy under revision. Relevance of recommendation is no longer clear.
Department of Health and Human Services The Secretary of Health and Human Services should conduct an evaluation of the policy within the first 2 years of its introduction to determine what modifications, if any, are needed. This recommendation is based whether reliance on the drug compendia for reimbursement decision will influence the processes by which information is entered in those documents.
Closed – Not Implemented
If policy is not changed, there is no need for an evaluation.
Department of Health and Human Services The Secretary of Health and Human Services should conduct an evaluation of the policy within the first 2 years of its introduction to determine what modifications, if any are needed. This recommendation is based on whether the likely advent of new and expensive forms of therapy for cancer argues for a timely review of coverage and reimbursement policy.
Closed – Not Implemented
If policy is not changed, there is no need for evaluation.

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Topics

CancerCancer researchSubstance abuse treatmentHealth care costsHealth insuranceInsurance claimsMedical expense claimsMedicarePharmacological researchPhysiciansTherapyChemotherapy