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May 18, 2013

Final Sunshine Act Arrives: Now the Hard Part

Morgan, Lewis & Bockius LLP.
Kathleen McDermott
Albert W. Shay
Michele L. Buenafe
Jonathan A. Havens
Rebecca L. Osowski
Morgan, Lewis & Bockius LLP
Saturday, March 9, 2013
Administrative & Regulatory / Health Law & Managed Care
All Federal
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Final U.S. Sunshine statute significantly clarifies the types of entities that meet the definition of an “applicable manufacturer” and further specifies requirements related to deadlines, notification, payment, and many other provisions.

Download this memorandum as a PDF.

Copyright © 2013 by Morgan, Lewis & Bockius LLP. All Rights Reserved.

About the Author

Kathleen McDermott
Partner

Kathleen McDermott is a partner in the Washington, D.C. office of Morgan Lewis and has been involved in health industry government enforcement and compliance matters for 19 years. She has served as an Assistant U.S. Attorney and DOJ Health Care Fraud Coordinator, and is a recipient of the HHS-OIG Inspector General’s Integrity Award for her work in government healthcare fraud matters.

kmcdermott@morganlewis.com
202-739-5458
www.morganlewis.com

About the Author

Albert W. Shay
Partner

Albert W. Shay is a partner in Morgan Lewis's FDA and Healthcare Practice. Mr. Shay's practice includes the representation of hospitals, integrated health systems, academic medical centers, (including entities developing accountable care organizations (ACOs)), large single- and multispecialty physician group practices, and other healthcare providers on a wide range of regulatory, compliance, and transactional matters. He advises hospitals, physician groups, and other healthcare providers on the application of the federal fraud and abuse and self-referral...

ashay@morganlewis.com
202-739-5291
www.MorganLewis.com

Contributors

Michele L. Buenafe
Associate

Michele L. Buenafe is an associate in Morgan Lewis's FDA and Healthcare Practice. Her practice focuses on FDA regulatory, compliance, and enforcement issues pertaining to medical devices and pharmaceuticals. As part of her practice, Ms. Buenafe regularly advises clients on issues related to the development, manufacturing, and marketing of medical devices, pharmaceuticals, biologics, and combination products; labeling and advertising; post-market requirements; and compliance with FDA's bioterrorism regulations. In addition, Ms. Buenafe has assisted clients in navigating the state...

mbuenafe@morganlewis.com
202-739-6326
www.morganlewis.com

About the Author

Jonathan A. Havens
Associate

Jonathan A. Havens is an associate in Morgan Lewis's FDA and Healthcare Practice. His practice focuses on FDA and healthcare regulatory, compliance, and enforcement issues. In this capacity, Mr. Havens assists in the representation of clients in matters relating to FDA regulatory compliance, including marketing, promotion, and advertisement.

Prior to joining Morgan Lewis, Mr. Havens was a regulatory counsel with the U.S. Food and Drug Administration. While at the FDA, Mr. Havens received an FDA Group Recognition Award for Compliance and Enforcement of Tobacco...

jhavens@morganlewis.com
202.739.5952
www.morganlewis.com

About the Author

Rebecca L. Osowski
Director of Health Care Compliance

Rebecca L. Osowski is the director of healthcare compliance for Morgan Lewis's FDA and Healthcare Practice. Morgan Lewis's compliance representations encompass HHS OIG corporate integrity agreements for CIA implementation; Board and IRO compliance resources; DOJ deferred prosecution agreements; voluntary corporate compliance effectiveness reviews; healthcare professional arrangement reviews; corporate compliance policy development; and federal and state transparency and marketing compliance.

Ms. Osowski's corporate compliance engagements focus on...

rosowski@morganlewis.com
202.739.5009
www.morganlewis.com

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