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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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.

GAO surveys found: (1) prescribing of off-label cancer drugs to treat other types of cancer is widespread, and off-label use has generally increased in treating the more difficult cases including cases in which the cancer has advanced to the point where it is no longer curable or chemotherapy is relatively ineffective; (2) more than half of the surveyed reported reimbursement problems for the use of drugs off-label as well as for the setting where they were administered; (3) reimbursement problems varied significantly across the 11 states reviewed; (4) there was no relationship between drug regimen costs and the likelihood that payment would be denied; and (5) oncologists reported that reimbursement policies and cost of certain drugs have altered their preferred treatment and forced them to change the setting in which they treat patients, by admitting patients to the hospital solely to circumvent restrictions imposed by reimbursement policies.

Recommendations for Executive Action

  1. Status: Closed - Not Implemented

    Comments: 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.

    Recommendation: 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.

    Agency Affected: Department of Health and Human Services

  2. Status: Closed - Not Implemented

    Comments: If policy is not changed, there is no need for an evaluation.

    Recommendation: 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.

    Agency Affected: Department of Health and Human Services

  3. Status: Closed - Not Implemented

    Comments: If policy is not changed, there is no need for evaluation.

    Recommendation: 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.

    Agency Affected: Department of Health and Human Services

 

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