CLINICAL TRIALS COVERAGE
For many cancer patients,
the best treatment option is care in a clinical trial, but no more than
2-3 percent of people with cancer enroll in clinical trials. A survey
of researchers, conducted by the American Society of Clinical Oncology
(ASCO), found that denials of reimbursement for routine patient care costs
are among the obstacles to enrollment in clinical trials. Routine patient
care costs include those charges that insurance should be expected to
cover, such as physician charges, hospital charges, and routine tests,
but do not include research costs or the cost of investigational new drugs.
A number of states
have enacted legislation requiring insurers to cover routine patient care
costs for clinical trials, and none of those initiatives has resulted
in an explosion of costs due to clinical trials enrollment. However, a
state-by-state approach is not an adequate solution because it leaves
many individuals at risk.
To address this situation,
advocates for people with cancer recommend the following:
- Include a
clinical trials coverage provision in the Patients' Bill of Rights:
The Conference Committee on the Patients' Bill of Rights should approve
strong patient protection measures that will ensure individuals the
right to enroll in clinical trials.
- Broaden clinical
trial coverage to include private FDA-approved clinical trials:
Coverage provisions (whether state or federal) should be broad-based
and inclusive, covering private, FDA-approved clinical trials as well
as NIH-sponsored clinical trials. Much of the cutting-edge cancer research
is conducted in the private sector, and cancer patients should have
access to these important clinical trial opportunities.
- Enact the
Medicare Cancer Clinical Trials Coverage Act: The Medicare Cancer
Clinical Trials Coverage Act (S. 784/H.R. 1388) has strong bipartisan
support, but until it is enacted, Medicare beneficiaries will face uncertainty
regarding their ability to enroll in clinical trials. The Institute
of Medicine (IOM), noting that senior citizens are underrepresented
in cancer trials, recently recommended to Congress that Medicare provide
coverage for cancer trials.
to Clinical TrialsMedicare Index
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