To Do or Not To Do: Appending MCAs in CTAs

Ryan Meade
Managing Director, Aegis Compliance & Ethics Center
July 30th, 2015

In one of Ryan Meade’s recent webinars with Forte, the question below was was asked. It’s a question that has surfaced several times in his career, so here, Ryan provides his thoughts on this practice.

Is it a good idea to attach the Medicare Coverage Analysis (MCA) as an appendix to the budget?

Ultimately, it’s entirely up to you if you want to include the MCA as an appendix to the clinical trial agreement (CTA). There’s nothing right or wrong with doing it this way. The most important thing is that the Budget Exhibit to the CTA is very clear about what the sponsor is paying for and not paying for. Some organizations append the MCA as a way to show this. However, if you do this, be careful that the language in the main body of the contract matches what is in the MCA or is at least neutral to allow the MCA to speak for itself. Problems occur when there is contradiction or ambiguity. For tips on how to avoid ambiguity, read “8 Tips to Ensure Clarity in Your Clinical Trial Agreement.”

What matters most is that there’s consistency and alignment between all pieces of the contract.

Achieving consistency in contracts is important, and it’s also important with MCAs. Often, the MCA has some pretty detailed comments. Consider who’s writing it and who the audience is. Similar to other parts of the CTA and budget, if multiple people are working on it, understand that terms may mean different things to different people, so it’s important to be clear. Perhaps the comments from the analyst seem obvious from a billing perspective, but may not make sense in reference to the rest of the contract. Ensure that everyone working on any aspect of the contract is aware of terminology and terms used throughout.

In the end, it doesn’t really matter if the MCA is attached as an appendix or not. What matters is that there’s consistency and alignment between all pieces of the contract.

On-Demand Webinar: Clinical Trial Agreements – FAQs

To view Ryan’s other webinars on Clinical Trial Agreements and Clinical Research Billing Compliance, please visit our Educational Resources for Clinical Research.


Billing Compliance Budgeting

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