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.
