Medicare Documentation Requirements for Clinical Trials

Clinical trials test new treatment methods before their approval by the FDA. They can be lifesaving for patients with few alternatives. Medicare pays for participation in clinical trials if the requirements in its National Coverage Determinations Manual are met.

Purpose

• The clinical trial must test a treatment that falls within an existing Medicare category. For example, cosmetic surgery is excluded. The trial must be for therapeutic purposes; it can't only be testing toxicity. Only diagnostic trials are permitted to enroll healthy participants.

Trial Design

• In order for Medicare to pay for clinical trials, the trial must be supported by scientific or medical information. The trial must comply with all federal regulations regarding human subjects for medical experiments. It must be designed so that it can find an answer to the question raised in the trial. The trial must be conducted with scientific integrity.

Automatic Qualification

• Medicare automatically qualifies some clinical trials without further documentation. Trials under an FDA application for an investigational new drug meet Medicare criteria by default. Trials by the National Institutes of Health, the Centers for Disease Control and the Veterans Administration are also eligible for Medicare payment.