Clinical Trials and Medicare Secondary Payer Rules: Best Practices for Compliance

Navigating Complex MSP Rules and Reporting Requirements for Research Sponsors and Clinical Sites, and Structuring Agreements

Recording of a 90-minute CLE webinar with Q&A

Conducted on Tuesday, October 29, 2013

Recorded event now available

or call 1-800-926-7926

This CLE course will prepare healthcare counsel to apply Medicare Secondary Payer (MSP) rules to research sponsors and clinical sites. The panel will also provide guidance on MSP reporting requirements as well as practical contracting approaches.


The Medicare Secondary Payer law sets the requirements for coordination of benefits between insurance and Medicare. Research sponsors and clinical sites need to understand the MSP rules and their application to clinical trials to appropriately allocate responsibility for coverage of subject injuries.

Reporting requirements under Sec. 111 of MMSEA require clinical trial sponsors that agree to pay for injuries arising from a clinical trial in their Clinical Trial Agreement or Informed Consent to report those injuries on a quarterly basis to CMS. Failure to report may result in significant fines and action under the Medicare Secondary Payer statute for double damages.

MSP and Sec. 111 requirements are complex and guidance is limited. Compliance is a never-ending challenge for research sponsors and clinical sites. Counsel must carefully structure language addressing the MSP and reporting requirements for clinical trial agreements, informed consent and HIPAA authorization.

Listen as our authoritative panel of healthcare attorneys examines how the MSP rules and the challenging MSP reporting requirements apply to research sponsors and clinical sites. The panel will also offer best practices for contracting.



  1. Application of MSP rules to clinical trials
    1. Historical interpretation
    2. Current guidance
    3. Open issues
  2. MSP reporting requirements
    1. Overview
    2. Application to research sponsors
    3. Impact on clinical sites
    4. Open issues
  3. Best practices for contracting
    1. Clinical trial agreements
    2. Informed consent
    3. HIPAA authorization


The panel will review these and other key questions:

  • What are the MSP reporting requirements under Sec. 111 of the MMSEA?
  • How do the MSP rules apply to research sponsors and clinical sites?
  • How should counsel structure language for clinical trial agreements, informed consent and HIPAA authorization?

Following the speaker presentations, you'll have an opportunity to get answers to your specific questions during the interactive Q&A.


David Piatt
David Piatt
Managing Partner
Piatt Consulting and Medicare Consul Services

He is the former Program Director of the Medicare Secondary Payer Recovery Contract where he managed Medicare's...  |  Read More

Eve M. Brunts
Eve M. Brunts

Ropes & Gray

She regularly advises clients on Medicare and Medicaid coverage, claims and payment requirements for a variety of...  |  Read More

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