The penalties for fraudulent billing are severe and not to be taken lightly. In a 2004 landmark settlement, for example, Rush
University Medical Center in Chicago paid the United States $1 million after inappropriately obtaining Medicare reimbursement
for cancer trial services not covered under the NCD. These are large fines for any organization. But these penalties are nearly
impossible for private physician investigators and community hospitals to pay. In those cases, it's not unusual for physician
investigators to turn to the sponsoring pharma company for help—as was the case in 2002, when the University of Alabama–Birmingham
subcontracted lymphoma research from Biocryst Pharmaceuticals to an independent PI, who was subsequently convicted of falsifying
research data. (See "Clinical Trials Gone Bad")
Indeed, while cases of fraud and abuse are often intentional, many physician investigators in private practice or community
hospitals violate the NCD through lack of detailed knowledge. And when a revised NCD policy—with potentially even more stringent
limitations—comes out in July 2007, that challenge may grow even greater.
Most physicians already find it difficult to distinguish between services provided for treatment and services provided for
data collection. In particular, certain treatment areas, like cancer, are particularly confusing because most treatment modalities
are experimental to begin with, and payers very often won't reimburse a therapy for unapproved uses. It is here that pharma
companies can help physicians avoid costly billing errors by clearly identifying the services that are reimbursable under
the NCD versus those that must be borne by the sponsoring organizations.
To address this liability, companies should make it a part of study protocol development to create a checklist of which services
and procedures are needed strictly for the collection of data and which shouldn't be billed to payers. This checklist should
be sent to the company's internal regulatory-affairs division when it reviews the study protocol for accuracy.
Sponsors should disseminate the checklist to physicians to ensure accurate and appropriate claim-form completion and submission
to payers, especially with respect to the correct use of modifier codes identifying services or items provided in conjunction
with a trial—an area of weakness within many provider organizations. A checklist is necessary even when investigators use
billing companies that code and submit bills to payers based on medical records. In reality, many billing companies are less
than accurate when it comes to modifier codes. They are also at the mercy of the physician's office—without a checklist, if
the PI fails to note that a patient's visit was for a clinical trial, the billing company won't know how to obtain proper
Even if PIs or third-party billing companies assume the responsibility of following the NCD requirements, sponsoring organizations
must be aware of and monitor adherence to such regulations. After all, while the responsibility to bill appropriately rests
with PIs, at the end of the day, these private physicians don't have the expertise and knowledge that pharma companies do
with respect to what services are part of the clinical trial. And when push comes to shove, companies are responsible for
providing this education and oversight.
Conflict of Interest
Back in February 2006, the Journal of the American Medical Association published an article by 13 psychiatrists that found that pregnant women who stopped taking antidepressants during pregnancy
fell into depressive relapses. It contradicted other credible studies that advised pregnant women not to take these drugs
late in pregnancy because of the risk to the fetus.
While the results were widely publicized, one aspect didn't receive as much attention—at first. But a few months later, the
news broke: The study authors all had financial ties to the pharma industry but had not disclosed them to JAMA.
Payment to physicians, and other conflicts of interest, is a ripe area of concern, particularly when it raises doubt over
the integrity of research findings. Because many PIs are not as sophisticated as pharma companies about the issue of conflict
of interest, companies should educate PIs on full disclosure, and its importance to research integrity.