Navigating the Physician Payment Sunshine Act: Significant Implications to Healthcare and Medical Industries
With increasing scrutiny of interactions between health care providers and life sciences manufacturers, the enactment of the Physician Payments Sunshine Act was intended to shed light on industry-provider relationships. Under the Act, drug, biological, medical device and medical supply manufacturers are required to annually report certain information about payments and other transfers of value that they provide directly or indirectly to U.S. physicians and teaching hospitals, as well as certain ownership or investment interests that physicians hold in such manufacturers, to the Centers for Medicare and Medicaid Services (“CMS”). CMS is required to annually publish the data on its website.
For the 2014 Sunshine reporting period, CMS published data on over 11 million transactions representing more than $6 billion in value. Though the Act's focus is on increasing transparency of industry-health care provider relationships, some are wary of how these collected and disclosed data could more broadly affect the health care and medical industries. Thus, it is with great importance for companies to maintain a robust compliance program to help avoid potential enforcement actions and penalties arising from the Sunshine Act data and reporting requirements.
In this two-hour LIVE Webcast, a panel of distinguished professionals and thought leaders assembled by the Knowledge Group will help the audience navigate the Physician Payment Sunshine Act and will provide an in-depth discussion of its significant implications to healthcare and medical industries. Speakers will also offer best practices in developing and implementing an effective and efficient Sunshine compliance program.
Key topics include:
- Physician Payments Sunshine Act - An Overview
- Sunshine Reporting Requirements and Exclusions to Reporting
- Penalties for Non-compliance and the Current Enforcement Environment
- Key Implications for Stakeholders
- Practical Implementation Issues and Hurdles
- Best Practices
Andrew S. Furlow, Attorney
Hogan Lovells US LLP
Brian A. Bohnenkamp, Attorney
King & Spalding LLP
- Provide high level overview of the Sunshine Act requirements, including which entities must file reports (applicable manufacturers), who will be reported on (covered recipients), what is required to be reported and excluded from reporting, and reporting deadlines. Key practical considerations will be highlighted.
- Discuss the process for filing reports with the Centers for Medicare and Medicaid Services, including covered recipients’ opportunities to review reported data and, if desired, dispute data that they believe to be inaccurate.
- Briefly discuss the effects of increased transparency, including possible scrutiny from enforcement authorities, media outlets, competitors, patients, and others who review the data.
- Highlight penalties for failing to comply with the Sunshine Act requirements and the current enforcement environment.
- Discuss common issues that manufacturers face in their efforts to comply with the Sunshine requirements.
- Discuss common issues that covered recipients (physicians and teaching hospitals) have experienced in relation to the Sunshine requirements.
Who Should Attend:
- Biotech/Pharma Industry Lawyers
- Life Sciences and Health Care Practice Consultants/Advisors
- General Counsel
- Senior Management
- Financial Reporting Officers
- Medical Supply Manufacturers
- Professionals coming from Biotech and Pharmaceutical Firms
- Consultants & Clients in the Biotech and Pharmaceutical Industries
- And other Related/Interested Professionals
Andrew Furlow advises pharmaceutical and device manufacturers, healthcare providers, and a range of other clients on a wide variety of health regulatory issues. Andrew is an expert on the federal Open Payments (Sunshine) law and related state laws and has guided dozens of drug and device manufacturers, from one-product start-ups to top-5 multi-national companies, through the many complex issues raised by these laws. In addition, Andrew regularly assists clients in complying with federal and state fraud and abuse laws, including prospective guidance on structuring operations and customer relationships as well as assistance in responding to enforcement actions. He has considerable experience in helping clients to maximize business opportunities by navigating complex Medicare and Medicaid rules on pricing, coverage, and reimbursement. Andrew also frequently works with health care companies to shape and respond to new legislation and regulation in areas of strategic importance.
Andrew Furlow advises pharmaceutical and device manufacturers, healthcare providers, and a range of other clients on a wide variety of …
Brian Bohnenkamp is a Senior Associate in the Washington, D.C. office and a member of the FDA & Life Sciences Practice Group. He regularly counsels manufacturers of drugs and medical devices on a variety of regulatory compliance issues, including those involving compliance with federal and state transparency laws, fraud and abuse laws (including the federal Anti-Kickback Statute), and government ethics restrictions, as well as compliance with industry codes, including the AdvaMed and PhRMA Codes, and the development and implementation of comprehensive compliance programs. Mr. Bohnenkamp provides counsel to the Ad Hoc Sunshine and State Law Compliance Group (a coalition of medical device and pharmaceutical manufacturers) on a variety of laws and regulations, including state marketing code of conduct laws, gift prohibition laws, and marketing costs disclosure laws, as well as the federal Physician Payments Sunshine provisions. He also has experience representing manufacturers before government enforcement authorities to resolve allegations of non-compliance with gift restrictions/bans and transparency requirements.
Brian Bohnenkamp is a Senior Associate in the Washington, D.C. office and a member of the FDA & Life Sciences …
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About Hogan Lovells US LLP
Hogan Lovells is a global legal powerhouse that helps corporations, financial institutions, and governments across the spectrum of their business and legal issues globally and locally. We have around 2,500 lawyers operating out of more than 40 offices in the United States, Europe, Latin America, the Middle East, and Asia. Hogan Lovells’ Health practice is grounded in an in-depth understanding of the relationship between the global healthcare marketplace and government. Many of the lawyers serving our health industry clients have had experience in government, industry, or both. From this foundation of knowledge we are uniquely positioned to serve providers and suppliers of healthcare products and services not only as their regulatory lawyers, but also as their strategic advisers, lobbyists, litigators, and dealmakers.
About King & Spalding LLP
Celebrating more than 130 years of service, King & Spalding is an international law firm that represents a broad array of clients, including half of the Fortune Global 100, with 900 lawyers in 18 offices in the United States, Europe, the Middle East and Asia. The firm has handled matters in over 160 countries on six continents and is consistently recognized for the results it obtains, for uncompromising commitment to quality and for dedication to understanding the business and culture of its clients. King & Spalding was recently chosen by U.S. News & World Report and Best Lawyers as the “Law Firm of the Year” for FDA law and LMG Life Sciences selected the firm as one of the finalists for “Regulatory Firm of the Year” in 2015.