In June 2010, CMS issued guidance regarding the Medicare Secondary Payer (MSP) reporting obligations that apply to clinical research studies under Section 111 of the Medicare, Medicaid, and SCHIP Extension Act of 2007 (Section 111) . In the guidance, CMS stated that payments by sponsors of clinical trials for injuries or complications arising out of clinical trials are considered to be “self-insurance,” which must be reported pursuant to the Section 111 requirements. Failure to comply with such reporting requirements may result in civil monetary penalties of $1,000 per day.

During this 90-minute webinar, the presenters will discuss recent CMS guidance regarding MSP reporting obligations that apply under Section 111 in the context of clinical research studies and specifically:

• Provide an overview of the CMS Clinical Trial Billing Policy and MSP laws, including the Section 111 reporting requirements;
• Discuss issues that may arise in sponsor and site contracting related to payment for routine care, research injuries, etc.;
• Explain CMS' position on Sponsor obligations, and CMS recovery rights under the MSP laws; and
• Discuss sample contract language and compliance strategies.

Who Should Attend

• Chief Compliance Officer
• Legal/Regulatory Counsel
• Director of Regulatory Affairs
• Chief Financial Officer
• Director of Internal Audit
• Chief Risk Officer

About the Presenters

F. Lisa Murtha, J.D., CHC, is a partner in SNR Denton’s health care practice. Lisa has over 22 years of experience in working with provider organizations, universities and life sciences organizations in a variety of compliance areas, including clinical research compliance, corporate governance, compliance program design and effectiveness and much more. Lisa speaks at national events frequently on compliance and clinical research topics and she has published numerous articles, book chapters and books on these topics.

Janice Ziegler, J.D., is also a partner in SNR Denton’s Health Care Group. She focuses on providing strategic, regulatory and legislative counseling to clients regarding the Medicare Secondary Payer laws, the Medicare Advantage and Medicare Part D programs, and federal and state health care privacy matters. With over 20 years of litigation and health care experience, Ms. Ziegler advises a broad range of health care businesses on MSP matters, including. Section 111 reporting, compliance and regulatory matters, litigation, training and risk management issues. She is a frequent author and speaker on this topic.