The Patient Protection and Affordable Care Act and “Applicable Laws” in clinical trial agreements

We are recommending that sponsors include The Patient Protection and Affordable Care Act in any listing of “Applicable Laws” in clinical trial agreements. As the PPACA includes, among other additional duties and obligations for health care providers and industry alike, reporting requirements for reporting certain payments to CMS, under what was formerly known as the Physician Payment Sunshine Act, it is not enough to refer only to the CFRs, ICH GCP and FDA guidance documents.

While it is common practice for some in our industry to agree to a vague and general obligation to conduct clinical trials in accordance with “all applicable laws and guidelines”, we at Contracts Associates interpret the OIG statement, in the HIPAA/HITECH legislation, to mean that applicable laws need to be clearly spelled out. Listing each applicable law and guideline ensures a meeting of the minds and clarifies the assumptions of the parties, at the time the contract was entered into.

For example, if a contract was signed before CMS designated industry sponsors as “Secondary Payors” under Medicare and required reporting of payments for treatment of a Medicare subject’s study-related injury, it could be argued that the study site did not intend to provide subjects social security numbers upon sponsor request.

As always, we are here to guide your company on matters such as this. Call us at 617.275.8080 if you would like further clarification on the impact of agreeing to adhere to “applicable laws” in your contracts.