WASHINGTONUnder proposed new Medicare rules, routine care costs for beneficiaries participating in clinical trials funded by a number of federal agencies would be automatically covered. Trials conducted under investigational new drug applications (INDs) or that are exempt from an IND would also receive automatic coverage status. Other trials that meet eligibility requirements (to be established) would also be covered.
The Health Care Financing Administration (HCFA) drafted the proposed rules in response to an executive memorandum signed by President Clinton on June 7. It directed the Department of Health and Social Services to authorize Medicare payments for patient care costs and costs due to medical complications associated with participation in trials.
Previously, Medicare regarded clinical trials as experimental and the agencys policy was not to pay for patient care.
In its proposed national coverage decision, HCFA defines routine care costs as all items and services that are otherwise generally available to Medicare beneficiaries (for example, hospital services, physicians services, diagnostic tests) that are provided in a clinical trial. Among these, the agency specifically lists:
Items or services that are typically provided outside a clinical trial, such as conventional care.
Items or services required solely to provide the intervention under investigation (such as the administration of a noncovered chemotherapeutic agent); clinically appropriate monitoring of the effects of the test drug, material, or device; and the prevention of complications.
Items or services needed for reasonable and necessary care arising from the provision of an investigational item or servicein particular, for the diagnosis or treatment of complications.
Costs that would be excluded from Medicare coverage are the investigational item or service itself, items and ser-vices provided solely to satisfy data collection needs, and those provided by the trial sponsor without charge.
HCFA noted that a recent report by the Institute of Medicine (IOM) had defined routine care for clinical trials as care that would be received by a patient undergoing standard treatment. This would include such items as room and board for patients who are hospitalized, diagnostic and laboratory tests and monitoring appropriate to the patients condition, postsurgical care when indicated, office visits, and so on.
The IOM committee also recommended against providing Medicare coverage for the investigational item or service and protocol-induced costs. Thus, our proposed policy is consistent with the IOMs definitions, HCFA said.
The draft rules propose requirements that clinical trials must meet to qualify for Medicare coverage of routine patient costs.
The subject of the trial must evaluate an item or service that falls within a Medicare benefit category (eg, physicians service, durable medical equipment, diagnostic test) and is not statutorily excluded from coverage (eg, cosmetic surgery, hearing aids), the HCFA proposal states. Trials that are designed exclusively to test such things as toxicity levels or basic disease biology are excluded from coverage of routine costs. Trials of therapeutic interventions must enroll patients with diagnosed disease rather than healthy volunteers.
HCFA would grant automatic coverage to Medicare patients participating in clinical trials funded by the National Institutes of Health, the Centers for Disease Control and Prevention, the Agency for Healthcare Research and Quality, HCFA, and the Departments of Defense and Veterans Affairs. Trials conducted at National Cancer Institute-supported cancer centers and those conducted under, or exempt from, an IND would also receive automatic coverage.
The agency said that studies other than those deemed automatically covered would receive Medicare coverage for routine care if they meet criteria to be established by a federal interagency group. Principal investigators will certify that their trials meet the criteria, which will be based on seven desirable characteristics of a clinical trial listed by HCFA (see Table).
The criteria for investigator self-certification, to be developed by the federal panel, should be easily verifiable and, where possible, dichotomous (that is, objective yes/no responses), HCFA said. Some examples might be: Is the trial approved by an investigational review board? Does the trial have a written protocol? Has the trial been approved by a federal agency?
Under this system, principal investigators will submit a copy of the trial protocol to a Medicare clinical trials registry, along with a certification form indicating which of the qualifying criteria the trial meets. Once a trial is certified, the registry will issue a trial identifier that will allow the routine cost of the trial to be billed to Medicare. HCFA said, This approach of automatically including certain trials and establishing a self-certification approval process for others will avoid the administrative burden that a trial-by-trial review would impose on the federal government and trial investigators. A significant percentage of trials have already gone through an intensive peer-review process to obtain approval or funding by other entities.