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The Nuts and Bolts of the Sunshine Act and Enforcement Implications


The Nuts and Bolts of the Sunshine Act and Enforcement Implications
$224
Webinar
Product Code - LGA102
Speaker(s): Thomas S. Crane, Mintz, Levin, Cohn, Ferris, Glovsky and Pope, P.C.; Karen S. Lovitch, Mintz, Levin, Cohn, Ferris, Glovsky and Pope, P.C.; Clarice McCauley, Roche Diagnostics Corporation
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The Physician Payments Sunshine Act is one of the most closely watched regulations in the pharmaceutical and medical device industry. The Act’s just-released final rule, published in the February 8, 2013 Federal Register, will require manufacturers to start collecting data as of August 1, 2013 for annually reporting to the Centers for Medicare and Medicaid Services (CMS), which will be due on March 31, 2014, of all payments or transfers of value (including gifts, consulting fees, research activities, speaking fees, meals, and travel) made to physicians and teaching hospitals. The payment information will be posted on CMS’s website later in 2014 with data aggregated, downloadable and searchable. In an industry already under intense scrutiny, it is critical for companies to understand the type of information they need to disclose, how soon they will be required to start collecting data, ways to collect and report this information, and its possible uses by federal health officials and other enforcement agencies.

This program aims to help manufacturers and providers identify best practices for achieving compliance and highlight the Act’s implications for government enforcement activity. The faculty will review the Act’s reporting obligations; CMS guidelines for interactions between providers and manufacturers, key terms and exceptions; discuss key issues addressed in the regulation and remaining open questions; and identify practical compliance implementation issues.

Educational Objectives

• Understand the legal framework of the Sunshine Act.
• Review of key terms and exceptions.
• Identify principal reporting obligations.
• Review of key terms and exceptions.
• Understand key issues in the regulation and open questions.
• Learn practical compliance implementation problems.

Who would benefit most from attending the program?

• Device and pharma compliance officers
• Device and pharma in-house counsel
• Community and academic medical center compliance officers
• Community and academic medical center in-house counsel
• Outside counsel

Program Level: Intermediate.

Credit Available: CLE. For more information, please click on the “CLE Credit” tab.

Thomas S. Crane, Mintz, Levin, Cohn, Ferris, Glovsky and Pope, P.C.; Karen S. Lovitch, Mintz, Levin, Cohn, Ferris, Glovsky and Pope, P.C.; Clarice McCauley, Roche Diagnostics Corporation

Thomas S. Crane, Mintz, Levin, Cohn, Ferris, Glovsky and Pope, P.C.
Tom Crane is a member with Mintz Levin and works in the firm’s Health Care Section and Health Care Enforcement Defense practice group. He is a nationally recognized authority on fraud and abuse. He advises national and local clients on structuring complex strategic affiliation arrangements and transactions to comply with the applicable fraud and abuse laws as well as the variety of other regulatory requirements to meet today’s health reform challenges. In addition, he defends clients against anti-kickback, false claims, and whistleblower allegations includes litigation, internal investigations, voluntary disclosures, negotiating settlements and Corporate Integrity Agreements (CIAs).

Mr. Crane has appeared before numerous offices of U.S. Attorneys, the FBI and OIG around the country. Recent engagements include serving as lead counsel in Colorado Heart Institute, LLC v. Leavitt (D.D.C. No. 1:08-cv-01626-RMC), a suit challenging CMS’s Stark Law regulations, and as counsel to a hospital executive and his management company in United States v. Jones (5th Cir. Jan. 16, 2007), a criminal related party cost report fraud case reversing District Court’s sentencing and restitution order based on a failure of the government’s proof.

Mr. Crane earned a J.D. from Antioch College, an M.H.A. from the University of Michigan, and a B.A. from Harvard University.

Karen S. Lovitch, Mintz, Levin, Cohn, Ferris, Glovsky and Pope, P.C.
Karen Lovitch is the Practice Leader of Mintz Levin’s Health Law Practice. She counsels health care clients on regulatory, transactional, and operational issues, including Medicare coverage and reimbursement, the development and implementation of health care compliance programs, and licensure and certification matters. In addition, Karen advises clients on the legal, practical, and fraud and abuse implications of business arrangements. Her experience includes matters related to the anti-kickback statute, the Stark law, and state statutes prohibiting kickbacks and self-referrals.

Ms. Lovitch earned a J.D., magna cum laude, from American University and a B.A., summa cum laude, from West Virginia University.

Clarice McCauley, Roche Diagnostics Corporation
Clarice McCauley is an attorney and the Director of Ethics & Compliance at Roche, where she provides guidance on conflicts of interest, structuring appropriate transactions with health care organizations, anti-kickback and false claim matters and state and federal reporting requirements. Ms. McCauley also manages internal ethical investigations and compliance audits. She has been with Roche for more than eight years supporting various business units.

Ms. McCauley earned a J.D. from DePaul University College of Law.

This program is CLE-credit eligible.

If you have further questions regarding a specific state or how to file for CLE credit, please contact Bloomberg BNA customer service at 800-372-1033 and ask to speak to the Legal and Business CLE Accreditation Coordinator.

Hardship Policy
Bloomberg BNA offers a hardship policy for attorneys earning less than $50,000 per year. If an attorney wishes to take advantage of this option, he or she must contact Bloomberg BNA directly. For attorneys who are unemployed or earning less than $35,000 per year, a full discount off the price of the program will be awarded upon written proof of hardship. Attorneys earning between $35,000 and $50,000 per year will receive a 50% discount off the price of the program. Any attorney working in the public service sector also qualifies for a special price. If you have further questions regarding the hardship policy or seek additional information, please contact Bloomberg BNA customer service at 800-372-1033 and ask to speak to Lindsey Pace, CLE Accreditations Coordinator, or email us at accreditations@bna.com.

Questions
For more information about Mandatory or Minimum Continuing Legal Education (MCLE) requirements, visit the American Bar Association website at http://www.abanet.org/cle/mandatory.html.