Strategic Review of Pending Sunshine Regulations for the Pharmaceutical, Biotech, Medical Device and GPO Industry LIVE Webcast
Group Purchasing Organizations, Device Manufacturers, Biotech Companies and Pharmaceutical Companies have been closely tracking CMS’s development of regulations to implement the so-called Sunshine Provisions of the Affordable Care Act. These Provisions will require more robust reporting and disclosure of payments to physicians and institutional providers, and certain types of physician investments and ownership interests. CMS issued a proposed rule in December 2012 and announced on May 3rd that it intends to issue the Final Rule in 2012 with data collection to begin in January 2013. Despite the lack of certainty in how CMS will craft regulations, companies need to anticipate what’s coming down the pipeline or risk being unprepared.
Group Purchasing Organizations, Device Manufacturers, Biotech Companies and Pharmaceutical Companies should have a thorough understanding of what this provision can offer as well as its potential impact on their business relations. Legal Series: Sunshine Laws for Bio and Pharmaceuticals in 2012 LIVE Webcast will analyze Sunshine Act laws from a 360 degree perspective providing attendees with a best practices guide to help avoid the many pitfalls.
The Knowledge Group has assembled a panel of key thought leaders and authorities to help you more thoroughly understand the Sunshine Act Law.
They will address the following key issues:
– Updates to the Proposed Rule
– Scope of Sunshine Laws
– Compliance with Sunshine Laws and its cost
– What the Industry has to Say
– The Impact of the Rule
Jennifer S. Geetter, Partner,
McDermott Will & Emery
- Although GPOs and life sciences industry entities may already have robust fraud and abuse compliance programs, these programs may not be sufficient to comply with the Sunshine provisions in light of the specific requirements set forth in the Act and the proposed rule. Correspondingly, even entities with well-established fraud and abuse compliance programs will need to take significant steps to comply with the Final Rule. Smaller biotech companies and start-ups may not have established programs to serve as a foundation for compliance with the Sunshine Rules and may face a more significant uphill battle to comply.
- Given the agency’s May 3rd announcement that it expects release a Final Rule in 2012 with data collection beginning in January 2013, regulated entities may have a compressed timeframe in which to built compliance programs. Accordingly, regulated entities may want to begin the process of developing a draft compliance program based on the provisions in the Act with the proposed rule serving as a guidepost for where the agency may be heading.
- The Proposed Rule contains a number of ambiguities and uncertainties that could be important to regulated parties. Given the detail and breadth of the Proposed Rule, some of these finer details — which could have a big impact — might get lost.
- Complying with the Sunshine Provisions is not just a concern of industry and the GPO community. Institutional providers, physicians, and physician family members will all be affected. Institutional providers and physicians should be considering potential necessary updates to existing conflict of interest programs to position themselves to comply with the rule.
Jen Johnson, Partner,
- It is now imperative for all life science company executives to understand the Fair Market Value (FMV) requirement and appropriate methodologies for determining payments to physicians.
- The analytical process and documentation to justify the payment is FMV will be essential in defending the compensation level
- The presentation will include tips for determining FMV, use of internal calculators and a compliance checklist for selecting and compensating physicians.
Who Should Attend:
- Biotech/Pharma Industry Lawyers
- Life Sciences and Health Care Practice Consultants/Advisors
- General Counsel
- Senior Management
- Senior Executives
- Professionals coming from Biotech and Pharmaceutical Firms
- Consultants & Clients in the Biotech and Pharmaceutical Industries
Jennifer S. Geetter is a partner in the law firm of McDermott Will & Emery LLP and is based in Firm’s Washington, D.C., office. She focuses her practice on emerging biotechnology and safety issues, advising hospital, industry, insurance and provider clients on matters relating to research, drug and device development, off-label use, personalized medicine, formulary compliance, privacy and security, electronic health records and data strategy initiatives, patient safety, conflicts of interest, scientific review and research misconduct, internal hospital disciplinary proceedings, and emerging issues in secondary research concerning biological samples and data warehousing. Jennifer also assists health care clients in implementing research strategies, structuring research operational and compliance infrastructure, and in developing guidelines for the appropriate relationships between providers and industry.
Jennifer S. Geetter is a partner in the law firm of McDermott Will & Emery LLP and is based in …
Jen Johnson, CFA, is a Partner with VMG Health and is dedicated to the valuation of professional service arrangements. Her expertise is related to the in-depth knowledge required to understand the FMV challenges, market data and regulatory guidelines associated with valuing any type of arrangement between organizations and healthcare providers.
Mrs. Johnson began her valuation career with KPMG, LLP in its Forensic and Litigation Services Department in 1998, where she worked directly under experts in the field of finance, accounting and economics. She has worked at University of North Texas as a finance professor, where she taught Liquidity & Capital Management and Investments. Prior to that, she earned her MBA in Finance and the Chartered Financial Analyst designation, while working for several companies in a consulting capacity.
Mrs. Johnson has been published and presented on the topic of fair market value and physician compensation numerous times with nationally recognized organizations such as the American Bar Association, the American Health Lawyers Association, RX Compliance and Pharma Congress.
Jen Johnson, CFA, is a Partner with VMG Health and is dedicated to the valuation of professional service arrangements. Her …
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Method of Presentation:
On-demand Webcast (CLE)
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About McDermott Will & Emery
McDermott Will & Emery has one of the largest and most prestigious Health law practices in the world, counseling leading organizations in every major sector of the health and life sciences industry on legal, regulatory and business transaction issues. For the second consecutive year Chambers USA ranked the Firm’s Health practice as the only Tier 1 Health Practice in the United States. The Firm’s Life Sciences Industry Group is also nationally ranked by Chambers USA, and this group of 135+ lawyers, patent agents and scientific advisors provides the full range of legal services required by life sciences companies, regardless of their stage of development.
About VMG Health
Pharmaceutical, medical device and biotechnology companies are facing increased scrutiny regarding payments to thought leaders for consulting arrangements and must ensure these payments are set at fair market value. VMG Health offers a unique expertise of the regulatory environment for organizations seeking to maintain compliant with the evolving disclosure requirements for physician and other thought leaders relationships.