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.
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