Research & Clinical Trials Compliance

Health care providers with contracts or grants from research sponsors face a minefield of regulatory obstacles to performing the research and staying within the bounds of the law. Successful 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 determination allowing for billing during clinical trials (the "Clinical Trial NCD").

After over six years of the Clinical Trial NCD, the government is finally stepping up its audits, reviews and investigations of non-compliance. Health care 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.

Aegis Compliance & Ethics Center, LLP consultants have helped providers analyze clinical trials for billing compliance and have helped them design internal systems to ensure compliance is being met.