Top 3 Myths about Clinical Research Billing Compliance

By Ryan Meade | Managing Director, Aegis Compliance & Ethics Center
April 7th, 2013

Summary: Ryan Meade, JD from Aegis Compliance & Ethics Center, LLP discusses the top myths of Clinical Research Billing Compliance.

Estimated reading time: 2 minutes

Many people think that Medicare has a binary approach for all research studies —merely dividing the services between standard of care and research. In reality, the term “standard of care” is not used in the Medicare billing rules. This is among one of the most common myths surrounding Clinical Research Billing (CRB) Compliance.

MYTH #1: The Medicare program’s CRB rule simply divides services between “Standard of Care” and “Research.”

Under the Medicare Clinical Trial Policy (National Coverage Determination 310.1), Medicare covers items and services which meet the definition of a “routine cost” during a “qualifying clinical trial.” For most device studies, the qualifying status involves an approval process by the local Medicare Contractor. The Medicare term “routine costs” comes close to being what the research community means by “standard of care,” but it’s not a one-for-one interchangeable concept.

MYTH #2: All services not reimbursed by the cooperative group are billable.

While many cancer cooperative group studies are designed so everything is billable, not all of them are. Just because a service is not reimbursed by a cooperative group, does not necessarily mean that the service is billable to insurance.

For CRB purposes, cooperative group studies must be assessed just like any other research study.

MYTH #3: If NIH does not fund a service through a grant, then that means it is billable to insurance.

If a research study is sponsored by the NIH or is funded with funds from a federal agency, it does not follow that whatever the grant does not pay for is billable to the subject’s insurance. There could be many reasons why the agency is not funding a certain service, but non-funding should not be taken as a signal that the service is billable. All government-funded studies need to be assessed for CRB proposes just like any other research study.

Want to learn more?

To learn more facts about Clinical Billing Compliance and how to develop a successful compliance process, download the free eBook, “Building a Successful Clinical Research Billing Initiative.” This resource, by Aegis Compliance & Ethics Center and Forte Research Systems, provides an introduction to the importance of CRB and provide starting points for developing an effective CRB initiative.

About the Author

Ryan is a partner in the law firm of Meade, Roach & Annulis, and also a managing director of Aegis Compliance & Ethics Center. Ryan focuses his legal practice and consulting work on regulatory compliance matters for health care organizations, concentrating principally on Medicare/Medicaid billing compliance and clinical research regulatory laws. Ryan was recently appointed to the faculty of Loyola University Chicago School of Law as the Director of Regulatory Compliance Studies. In Ryan's new role he is responsible not only for developing and teaching a new curriculum for law students in health care compliance but is also overseeing Loyola's online masters program in health care compliance and launching its online masters in research regulatory compliance.

Website: Aegis Compliance & Ethics Center

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