Medicare Secondary Payer Rules and Clinical Trials

Navigating MSP Rules and Reporting Requirements for Research Sponsors and Clinical Sites and Best Practices for Contracting

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

Conducted on Wednesday, August 8, 2012

Recorded event now available

or call 1-800-926-7926

This CLE course will prepare healthcare counsel to apply Medicare secondary payor (MSP) rules to research sponsors and clinical sites, and provide guidance on the new MSP reporting requirements and 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.

New reporting requirements under Sec. 111 of MMSEA include CMS' position that payments for healthcare expenses by clinical trial sponsors constitute liability self-insurance. Such payments, claims or potential claims require reporting by the responsible reporting entity.

The MSP and Sec. 111 requirements are complex and guidance is limited. Compliance presents an ongoing challenge for research sponsors and clinical sites. Language addressing the MSP and reporting requirements for clinical trial agreements, informed consent and HIPAA authorization should be carefully drafted.

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



  1. Application of MSP rules to clinical trials
    1. Historical interpretation
    2. Current guidance
    3. Open issues
  2. New 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 new MSP reporting requirements?
  • How do the MSP rules apply to research sponsors and clinical sites?
  • How should language for clinical trial agreements, informed consent and HIPAA authorization be revised?

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


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

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

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