IOM Addresses Medicare Screening, Clinical Coverage Issues

WASHINGTON—Insufficient evidence exists to support or reject the inclusion of routine skin cancer screenings in Medicare coverage, according to a new report by the Institute of Medicine (IOM). A second IOM report urges the Health Care Financing Administration (HCFA) to end uncertainties about whether it will cover routine care for patients taking part in clinical trials by stating that it will.

Medicare already covers skin examinations sought by beneficiaries who are concerned about changes in a mole or some other skin feature, an IOM committee noted in the report “Extending Medicare Coverage for Preventive and Other Services.” However, according to the report, there is currently no evidence for or against the effectiveness of screening patients who have no symptoms.

The report also favored preventive dental care for head and neck cancer patients, which reduced serious damage to the jaw caused by radiation therapy. Currently, Medicare only covers extractions for these patients, although extractions may result in worse health outcomes for some patients, it said.

The committee also concluded that treating leukemia patients with acute dental infections before chemotherapy may reduce life-threatening infections later, but said it lacked evidence to make a recommendation for dental coverage of lymphoma patients.

Covering Clinical Trials

A second IOM committee addressed the uncertainty and controversy surrounding Medicare’s policy on reimbursing for routine care needed by its beneficiaries who participate in clinical trials. Many people have interpreted the Medicare statute as excluding coverage for such care, although much of this care would be necessary whether a patient was part of a clinical study or receiving a standard treatment.

HCFA has never issued explicit guidance regarding reimbursement in clinical trials, except in the case of medical-device studies, the committee stated in the report “Extending Medicare Reimbursement in Clinical Trials.” And in spite of concerns that Medicare will not reimburse for routine care, health care providers frequently submit claims for beneficiaries taking part in trials, and usually the claims are paid.

The committee recommended that HCFA end all uncertainty about reimbursement for coverage in routine care in clinical trials because it is to the agency’s advantage to ensure that the medical interventions for which it pays are effective. Medicare patients enrolled in managed care plans should receive the same reimbursement in clinical trials as those in the traditional Medicare fee-for-service program, the panel said, but this coverage should not exceed the managed care contract’s limits.