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Basics
What costs do trials involve, and who is usually responsible for them?
What criteria do health plans use to make decisions about coverage for trials?
Medicare coverage
There are two types of costs associated with a clinical trial: patient care costs and research
costs.
Patient care costs fall into two categories:
Usual care costs, such as doctor visits, hospital stays, clinical
laboratory tests, x-rays, etc., which occur whether you are participating
in a trial or receiving standard treatment. These costs have usually been
covered by a third-party health plan, such as Medicare or private insurance.
Extra care costs associated with clinical trial participation, such
as the additional tests that may or may not be fully covered by the clinical
trial sponsor and/or research institution. The sponsor and the participant's
health plan need to resolve coverage of these costs for particular trials.
Research costs are those associated with conducting the trial, such
as data collection and management, research physician and nurse time, analysis
of results, and tests purely performed for research purposes. Such costs are
usually covered by the sponsoring organization, such as the National Cancer Institute (NCI) or a pharmaceutical
company.
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Health insurance companies and managed care companies decide which health care
services they will pay for by developing a coverage policy regarding the specific
services. In general, the most important factor determining whether something
is covered is a health plan's judgment as to whether the service is established
or investigational. Health plans usually designate a service as established
if there is a certain amount of scientific data to show that it is safe and
effective. If the health plan does not think that such data exist in sufficient
quantity, the plan may label the service as investigational.
Health care services delivered within the setting of a clinical trial are very
often categorized as investigational and not covered. This is because the health
plan thinks that the major reason to perform the clinical trial is that there
is not enough data to establish the safety and effectiveness of the service
being studied. Thus, for some health plans, any mention of the fact that the
patient is involved in a clinical trial results in a denial of payment.
Your health plan may define specific criteria that a trial must meet before
extending coverage, such as:
Trial phase and type:
Some plans may cover patient care costs only for the clinical trials they
judge to be "medically necessary" on a case-by-case basis. Trial
phase may also affect coverage; for example, while a plan may be willing to
cover costs associated with phase III trials, which include treatments that
have already been successful with a certain number of people, the plan may
require some documentation of effectiveness before covering a phase I or phase II
trial.
While health plans are interested in efforts to improve prevention and
screening, they currently seem less likely to have a review process in place
for these trials. Therefore, it may be more difficult to get coverage for
the care costs associated with them. See
What is a Clinical Trial?
for a description of the phases of cancer clinical trials.
Some plans, especially smaller ones, will not cover any costs associated
with a clinical trial. Policies vary widely, but in most cases your best bet
is to have your doctor start discussions with the health plan.
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For up-to-date information about Medicare coverage of clinical trials, go to
the Web site for the Centers for
Medicaid & Medicare (formerly the Health Care Financing Administration).
As of January 2001, the following information was accurate:
If I'm in a clinical trial, what will Medicare pay?
Anything normally covered is still covered when it is part of a clinical
trial. This includes test, procedures, and doctor visits that are ordinarily
covered. Anything normally covered even if it is a service or item associated with
the experimental treatment. For example, Medicare will pay for the intravenous
administration of a new chemotherapy drug being tested in a trial, including
any therapy to prevent side effects from the new drug. Anything normally covered even if it resulted from your being in the clinical
trial. For example, a test or hospitalization resulting from a side effect
of the new treatment that Medicare would ordinarily cover.
What costs are not covered?
Investigational items or services being tested in a trial. Sponsors of clinical
trials often provide the new drug free, but make sure you ask your doctor
before you begin. Items or services used solely for the data collection needs of the
trial. Anything being provided free by the sponsor of the trial.
What kinds of clinical trials are covered?
The National Cancer Institute's Cancer Information Service has provided a fact sheet for Medicare beneficiaries
(see More Choices in Cancer Care: Information for Beneficiaries on Medicare Coverage of Cancer Clinical Trials). In general, cancer treatment and
diagnosis trials are covered if:
They are funded by the National Cancer Institute (NCI), NCI-Designated Cancer
Centers, NCI-Sponsored Clinical Trials Cooperative Groups and all other federal
agencies that fund cancer research. Other trials may be eligible for coverage
and doctors can ask Medicare to pay the patients' costs. Ask your doctor about
this before you begin. They are designed to treat or diagnose your cancer. The purpose or subject of the trial is within a Medicare benefit category.
For example, cancer diagnosis and treatment are Medicare benefits, so these
trials are covered. Cancer prevention trials are not currently covered.
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