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
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.
Outline
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Application of MSP rules to clinical trials
- Historical interpretation
- Current guidance
- Open issues
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MSP reporting requirements
- Overview
- Application to research sponsors
- Impact on clinical sites
- Open issues
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Best practices for contracting
- Clinical trial agreements
- Informed consent
- HIPAA authorization
Benefits
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.
Faculty
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
He is the former Program Director of the Medicare Secondary Payer Recovery Contract where he managed Medicare's national recovery efforts and participated in the development of the Mandatory Insurer Reporting requirements. He has been on the forefront of this issue and recently brokered a meeting between CMS and two major Clinical Trials Sponsors.
CloseEve M. Brunts
Partner
Ropes & Gray
She regularly advises clients on Medicare and Medicaid coverage, claims and payment requirements for a variety of... | Read More
She regularly advises clients on Medicare and Medicaid coverage, claims and payment requirements for a variety of services; Medicare and Medicaid managed care programs; the Medicaid drug rebate program; Medicaid state plan requirements; reimbursement for health care services in clinical trials; managed care contracting and state managed care laws; and federal and state fraud and abuse laws.
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