The Health Care Financing Administration (HCFA) has maintained that some patient care in clinical trials is not reimbursable under Medicare.But HCFA has not issued an explicit policy setting out exactly what should and should not be reimbursed, which has led to varying interpretations of HCFA's intent by its fiscal intermediaries and carriers who process claims, as well as by providers submitting claims.I would like to emphasize that HCFA was clear from the start about its policy regarding both coverage of investigational devices as well as any related services.To provide an example of how the policy was designed to work—if a hospital admission was solely for the purpose of implanting an investigational device, no payment would be made for the hospital stay.Some money is included to cover special tests and procedures, but this varies.There is an expectation in most cases—more prominent for government-sponsored trials—that at least some, and in many cases most, costs of "routine patient care" will be paid for through the usual mechanism, health insurance.
Under HCFA's current policy, any reimbursement for care associated with a cancer clinical trial would be made in error" (GAO, 1997).* HCFA has not issued any new language to change clinical trial reimbursement policy since the 1995 change for trials of medical devices, and no HCFA statements contradictory to what is presented here were found in the course of this study.
HCFA can and does make explicit exceptions to its general prohibition against paying for patient care costs in clinical trials.
The most far-reaching exception is payment for routine care in a large number of medical device trials conducted under FDA-approved Investigational Device Exemption (IDE) protocols.
On the other hand, if a patient was admitted for chest pain, but it was decided during the visit to implant an investigational device, Medicare would pay for a medical admission recognizing the chest pain, but Medicare would not pay the much higher rate applicable to a surgical stay.
No payment would be made for services associated with the surgical procedure to implant the investigational device.