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The development of new drugs and devices is one of the highest compliance risk areas for the health care industry. A lot is at stake for the developers, the providers who perform the research and the patients waiting for help from industry innovation. We understand the stakes from all perspectives.

The industry has seen increased enforcement of clinical trials research regulatory rules, particularly in billing compliance. Meade Roach & Annulis represented Rush University Medical Center in its recent settlement with the government on cancer clinical trials. The settlement was one of the first involving the National Coverage Decision on Clinical Trials. In the course of the settlement, CMS provided clarification on a number of ambiguities in the NCD. Upon completion of the settlement, HHS/OIG commented that Rush's response and action was a model resolution to a compliance issue.

Meade Roach & Annulis has been the national leader in helping providers develop structures and tools to comply with the complex rules involved in billing for clinical trial services. Not only has the law firm negotiated and settled matters on behalf of clients, but the firm has also provided extensive counsel in developing comments for clients on proposed revisions to the Medicare policy. In collaboration with a client, a partner of the firm recently provided testimony before the CMS committee tasked with revising proposed changes to the Medicare policy for clinical trial coverage.

Healthcare providers with contracts from research sponsors face a minefield of legal obstacles to performing the research and staying within the bounds of the law. Successful legal compliance during research helps to ensure that the investigational drugs, items or procedures ultimately receive government approval and patients are helped.

A track record of successful compliance also aids a provider in receiving more grants and sponsorships.

The main issues to navigate in a clinical trial are:

  • IRB rules

  • Contracting process with the sponsors

  • Analysis of what can be appropriately billed to Medicare and other third-party payors

  • Drafting the patient's informed consent document in a way that protects the patient and the provider, as well as being consistent with the protocol and sponsor contract

  • Compliance with Medicare's national coverage decision allowing for billing during clinical trials (the "Clinical Trial NCD").

After more than six years of the Clinical Trial NCD, the government is stepping up its audits, reviews and investigations of non-compliance. Healthcare providers are quickly learning that they need to put in place processes as soon as possible to identify the appropriate billing compliance rules for each clinical trial.