Kelly M. Willenberg (firstname.lastname@example.org) is President and CEO of Kelly Willenberg, LLC in Chesnee, SC.
In December 2004, the Journal of the Royal Society of Medicine explored the questions around sham procedures. “Trained to perform invasive interventions only for the medical benefit of patients, [clinicians/investigators] find themselves administering fake procedures. Moreover, they must manipulate the performance so as to create a false belief in patient-subjects that a real procedure is being administered—a deception that may have to be maintained in follow-up visits.”
Ethical questions arise on sham procedures that must be explained in the informed consent process. Sponsors need to understand why sites question when they (the sponsor) are not willing to cover the sham procedure when it is part of an investigational device exemption (IDE) trial as one of the arms of the study.
Sham procedures are mostly associated with IDE studies, and placebo controlled studies are more in line with drug clinical trials. Questions arise when a site bills for the sham procedure in a two-arm study where one arm is the IDE with a Category A (experimental) or Category B (nonexperimental/investigational) designation. What is the definition of a sham procedure? According to the Medical Dictionary, 2009, it is treatment that has no known therapeutic effect. Such treatment may be employed by clinical researchers who are trying to determine whether another intervention will be more effective than doing nothing.
In dealing with IDE studies, sham procedures have no known therapeutic effect, so in the Medicare billing world, that would mean “not billable.” When trying to assess proper coding, it gets rather interesting. In many instances, the “sham” procedure does not have a code that can be used to bill it for reimbursement. By coding it incorrectly to receive payment, the site submits a claim that may not have occurred. Dilemma or not?
The other problem with sham procedures is that in many instances, the study is blinded. It is really complex to be able to make a claim to any payer in a way that the patient-subject will not be able to discern what procedure they received. Without a careful review of any claim being released, an Explanation of Benefits (EOB) may disclose what happened during the procedure in regards to the “sham,” which essentially unblinds the study. Dilemma or not?
Understanding the nuances of “sham” IDE arms vs. placebo drug studies from a billing compliance perspective takes knowledge. Medicare will not cover non-therapeutic procedures, so there are dilemmas for billing. Is a “sham” procedure medically necessary? The billing challenges speak loud and clear!