Sunshine Act: The Final Rule
As The Centers for Medicare & Medicaid Services (CMS) implement the Final Rule of Section 6002 of the Affordable Care Act, commonly known as “Sunshine Act.” The industry continues to craft the best compliance policies for their organizations. The provision aims to increase transparency of financial relationships between the industry, healthcare providers and patients though as with any new regulations, there will be significant implementations costs and potentially hazardous pitfalls during the adoption phase.
More specifically, the Sunshine Act requires drug, biological and medical supply manufacturers (including group purchasing organizations (GPOs)) to report, in significant detail, payments made to physicians and other medical institutions to the Federal Government on an annual basis. It also the affected organizations, to report certain ownership or investment interest held by physicians and their immediate family members. Furthermore, the information that will be disclosed will be posted on a public website.
Group Purchasing Organizations, Device Manufacturers, Biotech Companies and Pharmaceutical Companies must have a complete understanding of the Final Rule to avoid penalties and fines.
Join us for this two-hour live webcast as our panel of key thought leaders and professionals discuss the issues and concerns surrounding the Final Sunshine Rule. They will explain the substantive provisions of the rule as well its impact on the healthcare industry. The panel will also share their best strategy to ensure compliance. A live interaction with the audience in a question and answer format is also included in this event.
John Patrick Oroho, Executive Vice President and Chief Strategy Officer,
Porzio Life Sciences
- Why there is a need for transparency.
- Who’s required to report.
- Manner of reporting payments & important dates.
- How to dispute reports.
Sushiel Keswani , Executive Director ,
Ernst & Young LLP
- Importance of a well defined taxonomy of spend types and recipient types
- Importance of allocation rules to accurately reflect spend on each recipient
- Need for cross reference tables to aggregate spend on each physician stored in disparate systems
- Importance of governance around master data management and integration with 3rd party vendor systems
Gail Rodgers, Partner ,
- Understand the Key Principles of the Sunshine Act
- Identify Those Impacted and General Reporting Requirements
- Understand Legal Implications
- Identify Proactive Strategies to Avoid or Respond to Litigation
Jen Johnson, Partner,
- Physician Payments – In the News
- Keys to Compliance
- Determining Fair Market Value
William Lit, Manager,
- Compliance Assessments
- Data testing to review Sunshine solution operations
- Procedures to test for spend capture completeness
- Next Steps
- Key indicators of potential compliance risks in aggregate spend datasets
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
JOHN PATRICK OROHO, Executive Vice President and Chief Strategy Officer of Porzio Life Sciences, LLC, meets regularly with companies to identify sales and marketing issues and to propose solutions that streamline their understanding of acceptable practices and conduct in meeting compliance requirements of all 50 states and the District of Columbia.
Mr. Oroho is also a principal of the law firm, Porzio, Bromberg & Newman P.C., and practices in the Pharmaceutical Marketing and Sales Compliance department. He concentrates his law practice in regulatory compliance with respect to the Prescription Drug Marketing Act (PDMA), Anti kickback statute, False Claim Act, and Medicare and Medicaid fraud and abuse.
Mr. Oroho previously served as Senior Vice President and General Counsel for the PDMA Alliance, a national trade association focused on sample distribution and pharmaceutical marketing and sales compliance.
Mr. Oroho has an extensive pharmaceutical regulatory and compliance background. He spent three years as General Counsel for Integrated Pharma Technologies and Computer Systems Services & Consulting, Inc.
Mr. Oroho received a J.D. from the University of Notre Dame School of Law in 1985 and a B.S. from the United States Merchant Marine Academy, where he graduated with honors in 1978.
JOHN PATRICK OROHO, Executive Vice President and Chief Strategy Officer of Porzio Life Sciences, LLC, meets regularly with companies to …
Sushiel is an Executive Director in Ernst & Young’s Americas Advisory Life Sciences practice and leads the Customer Domain services for Life Sciences clients. Sushiel brings over 8 years of basic research (synthesis of chemical entities), 4 years of manufacturing of packaging for pharmaceuticals and the last 19 years of consulting experience in upstream R&D and downstream Commercial operations of pharmaceutical manufacturers
Sushiel’s areas of focus, both at the country level and global, have been business strategy & transformation, new commercial model design and implementation, customer experience engineering, clinical trial operations optimization, Medical information management, Commercial Agility, enabling technology implementation, complex project management and deployment of solutions for Fortune 100 companies. Sushiel has experience in the following therapeutic areas: Inhalation anaesthetics, Hypoxic Respiratory Failure, Rheumatoid Arthritis, Urinary Incontinence, CV/Metabolics, Neuroscience, Virology and Oncology. Hel leads the Totality of HCP/O/A Spend and PPSA reporting related service offerings for EY in the US for all pharmaceutical clients ranging from readiness assessment to implementation of complete technology enabled solutions.
Sushiel is an Executive Director in Ernst & Young’s Americas Advisory Life Sciences practice and leads the Customer Domain services …
GAIL RODGERS is a Partner with the law firm of DLA Piper LLP in New York, NY. Her global litigation practice concentrates on products liability, mass torts and pharmaceutical and medical device litigation.
Ms. Rodgers has extensive experience in a wide variety of state and federal litigation, including managing discovery, depositions, motions practice and alternative dispute resolution. She has represented a significant number of DLA Piper’s Fortune 100 clients, including some of the largest pharmaceutical companies in the world.
Ms. Rodgers acts as litigator and litigation manager, handling individual matters in a lead capacity while also supervising and coordinating the work of attorneys drawn from multiple outside law firms. She also has significant experience as resolution counsel and has coordinated a team of medical specialists in the evaluation of individual and class action claims, resulting in the resolution of thousands of claims. Relevant engagements include litigation relating to the prescription medications Celebrex and Bextra, Omniscan, Phen-Fen and Propulsid as well as medical devices. Before her legal career, Ms. Rodgers practiced as a Registered Nurse in the Critical Care department of one of the world’s leading cancer hospitals, M.D. Anderson Cancer Center. Her medical experience provides her and her clients a distinct advantage, as it gives her particular insight into complex medical issues, scientific evidence, expert development, depositions of medical fact witnesses and case valuation.
Ms. Rodgers graduated with honors from the University of Texas Health Science Center at Houston, with honors from Baptist Hospital School of Nursing in Memphis and graduated cum laude from the University of Houston Law School.
GAIL RODGERS is a Partner with the law firm of DLA Piper LLP in New York, NY. Her global litigation …
Jen Johnson is a Partner with VMG Health and oversees the Professional Services Agreements division. Her expertise is related to the in-depth knowledge required to understand the Fair Market Value challenges, market data and regulatory guidelines associated with valuing professional service arrangements associated with both healthcare systems and life sciences companies.
Mrs. Johnson has experience with valuing a multitude of professional services including call coverage, medical directorships, subsidies, clinical coverage, physician consulting, co-management and management, billing, development, intellectual property and quality initiatives. In addition, she has been published and presented numerous times on Fair Market Value and physician compensation. These publications and organizations include Compliance Today, the American Bar Association, the American Health Lawyers Association and the Healthcare Financial Management Association.
Mrs. Johnson is a member of the American Health Lawyers Association and the Chartered Financial Analyst Institute.
Jen Johnson is a Partner with VMG Health and oversees the Professional Services Agreements division. Her expertise is related to …
William Lit is a manager in KPMG’s Forensic Advisory practice in the United States. During his 8 years, he has focused on analyzing large and complex datasets in order to detect key patterns and metrics. William uses insights gained from these datasets to identify risks and recommend business solutions.
During the past 4 years, William has specialized in the life sciences industry. He has advised manufacturers on government pricing strategies such as unbundling, smoothing, rebate allocation, and general calculation methodologies. In addition, William has advised manufacturers on aggregate spend methodology, IT strategy, and led teams which have completed extensive data testing on aggregate spend systems.
William Lit is a manager in KPMG’s Forensic Advisory practice in the United States. During his 8 years, he has …
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About Porzio Life Sciences
Porzio Life Sciences, LLC (PorzioLS) provides the life science industry with Internet-based products enabling companies to comply with marketing and sales federal and state laws and regulations, as well as, distribution, licensing, sampling and a growing body of state pharmaceutical compliance requirements. PorzioLS provides compliance tools and customized services, related to the PDMA, anti-kickback statutes, aggregate spend reporting, OIG and CMS guidances, False Claims Act and FDA regulations, such as the Porzio Compliance Digest and Porzio AggregateSpendID, a best in class aggregate spend system capable of handling state and federal transparency reporting, in addition to sample transparency reporting to FDA and Vermont. These compliance tools and customized services facilitate companies’ compliance with federal and state marketing and sales regulations, which has propelled PorzioLS into an industry leader in life science marketing and sales compliance.
About Ernst & Young LLP
The relationship between risk and performance improvement is an increasingly complex and central business challenge, with business performance directly connected to the effective management of risk. Whether your focus is on business transformation or sustaining achievement, having the right advisors can make all the difference. Our 25,000 advisory professionals form one of the broadest global advisory networks of any professional organization, delivering seasoned multidisciplinary teams that work with clients to deliver a powerful and superior client experience. We use proven, integrated methodologies to help you achieve your strategic priorities and make improvements that are sustainable for the longer term.
About DLA Piper
About VMG Health
With deep industry experience, insight, and technical support, KPMG LLP is one of the largest providers of audit, tax, and advisory services to pharmaceutical and life sciences companies. We help clients gain practical insight into emerging issues, consider approaches to balance risk and controls, improve performance, and explore the accelerating transformation of this industry, both domestically and globally. For more information about KPMG, please call the KPMG Hotline at 1-877-679-KPMG (5764) or visit us at www.us.kpmg.com.