Why Your Institution Should Conduct a Coverage Analysis
A coverage analysis, or a Medicare coverage analysis, is an integral part of clinical research compliance programs. Yet properly preparing for a coverage analysis is a highly involved and technical process, and many institutions lack the talent, training, and speed needed for execution.
In the following Q&A, Leah Guidry, a Huron managing director, provides her expert insight on why an institution should conduct a coverage analysis, and some of the best practices and common pitfalls when doing so.
Q: For those who may be new to research billing compliance, could you explain, at a high-level, what exactly a coverage analysis entails?
A: It is the evaluation of a clinical research study to assist with budgeting process, as well as with the billing process. The evaluation entails reviewing various study documents to determine whether or not the study qualifies for Medicare billing.
It is a process that enables the research site, be it a university, hospital or an academic medical system, to determine which elements of the research study they can bill. A coverage analysis does two main things for a research site:
First, it helps them with their research finances to make sure that they are covering all the costs of conducting a clinical trial. Second, it makes sure they are compliantly billing the government and other third-party payers for services provided to research subjects.
“Healthcare providers have an obligation to ensure their claims are accurate before they submit them to Medicare, Medicaid or commercial insurance payers, and this is a process that a research site needs to go through in order to ensure they are doing their due diligence before pushing their claims out the door.”
— Leah Guidry, Managing Director, Huron
Q: In general, how has the Medicare Clinical Trial Policy impacted Medicare billing?
A: It’s been very positive for research sites. It clarified what the rules are in terms of billing Medicare for clinical trial services. In many ways, it has opened up another avenue of payment for research sites.
Prior to the clarity the government provided in the 2000 National Coverage Decision, and then the clinical trial policy in 2007, research sites either didn’t bill for the services provided to research participants, billed only the sponsor, or billed both and ran the risk of double billing.
But the policy also provided a significant hurdle because it is a complicated process, and many organizations aren’t able to do it well. It’s a process that requires an understanding of two very disparate areas — one being clinical research and the other being healthcare billing.
It’s very difficult to find a person with expertise in both bodies of knowledge. Thus, people need significant training and oversight — at a high cost to an institution. That high cost and the significant oversight needed means that many people conducting the coverage analysis do not get the training and support they need to do an effective job.
Have questions about coverage analyses? To learn more about the process, Huron, and how our experts can help your organization, visit our Research Enterprise Solutions website and our Coverage Analysis website. You can also contact Leah Guidry.Read More