New Guidelines for Clinical Trial Reimbursement
Published on Wed Aug 01, 2001
Clinical trials are important in the development of new treatments and medications and neurologists can tap into research and grant money for the development of these important studies. Funding for the clinical care given to the subjects of such trials, however, is a different matter. Effective Sept. 19, 2000, and updated and clarified on June 4, 2001, the Centers for Medicare and Medicaid (CMS, formerly HCFA) released guidelines, called the National Coverage Determination (NCD), outlining Medicare coverage of such clinical trials. According to this directive, Medicare covers:
the routine costs of qualifying clinical trials; and
reasonable and necessary items and services used to diagnose and treat complications arising from participation in all clinical trials.
It is important for billing personnel to be aware that not only the routine costs directly involved, but also those incurred as a result of diagnosing or treating complications resulting from a clinical trial are reimbursable under Medicare guidelines. As Carol Pohlig, RN, CPC, a reimbursement analyst for the Office of Clinical Documentation at the University of Pennsylvania, explains, "This directive allows practices to bill and be reimbursed more frequently for those services provided to diagnose and treat complications associated with clinical trials. Even though these reimbursements were possible prior to Sept. 19, 2000, the NCD's clarification lessens the scrutiny of such claims, resulting in fewer denials and, thus, the realization of more dollars."
Meet Established Criteria
The first step to ensure prompt and complete reimbursement involves making sure that the clinical trial meets the criteria established by Medicare. In order to qualify, it must meet all of the following:
The drug or procedure being studied must fall within a benefit category as defined by Medicare.
The intent of the trial must be therapeutic; it cannot be designed to test for toxicity or disease pathology only.
The subjects used in the trials can be of two kinds: trials of therapeutic intervention must use patients diagnosed with the appropriate disease, not healthy volunteers, while trials of diagnostic intervention may use healthy patients as a control group.
The trial must have the following characteristics, deemed desirable by the NCD:
It has the potential to improve the health of the participants.
It is supported by current medical and scientific information, or it clarifies or explains clinical practices currently in use.
It does not duplicate previous trials.
It is designed to answer the research questions posed.
It is sponsored by an organization or individual appropriately able to do so.
It complies with federal regulations.
It is conducted scientific accuracy and integrity.
The NCD directive clarifies this point by indicating that trials funded by the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), the Agency for [...]
