The presentation will provide an overview of the Physician Payments Sunshine Act and corresponding regulations including the history and purpose of these laws. The presenter will provide the background upon which these laws were determined to be necessary and developed. The attendees will be provided with an overview and description of the laws, why they were instituted, what they do and do not cover and who they are and are not applicable to. The law, which was passed on August 1, 2017, requires manufacturers of drugs and medical devices to track and report payments and any items of value given to physician and teaching hospitals. The purpose behind this bill is not to chill these types of transactions, but to ensure they are 100% transparent. All of the information that is reported is often publicly available on the Centers for Medicare and Medicaid Services website. Physicians need to understand what types of payments are reported, how and when they are reported, why they are reported, and what the potential ramifications of these public reports can be.
Physicians have the ability to review and confirm that any information being reported about them is correct and, if it is not, there is an annual review and dispute process that the presenter will educate the attendees on. The webinar will cover tips to make sure that your report, and reporting about you, is accurate and up-to date.
Finally, the webinar will also provide an overview of what types of compensation and payments are exempt from reporting.
- Develop and understand the basics of the federal laws relating to reporting of payments to physicians by drug and medical device manufacturers
- Know what must be reported
- Know what will not be reported
- Take control of your own online reputation – monitor and confirm reports and dispute when appropriate
Areas Covered in the Session:
- Clinical trial financial reporting requirements
- Kind of payments covered and exempted for reporting to CMS
- Format of reporting to CMS
- Dealing with CMS’s inquiries regarding reported information
- Acceptable and Unacceptable practices
- Comparison of Federal reporting requirements with Industry best practices
- Legal and practical implications of reporting financial information for investigators
- Regulatory solutions for most common anticipated issues with reporting.
- Physician Payment Sunshine Act
- Considerations to make when putting an SOP in place
- Registration requirements
- Live Q&A Session
- Health care providers
- Practice managers
- Health care providers
- Compliance officers
About the Presenter:
Ms. Gina L. Campanella focuses on healthcare regulatory and transactional matters federally and in New Jersey, New York, Vermont and Pennsylvania. Ms. Campanella has assisted clients with transactional services and regulatory compliance consulting, as well as general counsel services to small practices and large societies and medical groups alike. Clients seek her expertise when reviewing employment agreements, formation of new practices, separation from and sale of practices, business structuring, related commercial and residential real estate transactions, and surgical center licensing and registration, including preparation for Department of Health, AAAHC and AAAASF surveys of licensed and Medicare deemed facilities, as well as preparation and implementation of resulting plans of correction. Ms. Campanella is a nationally respected regulatory compliance specialist who dedicates herself to educating physicians and healthcare professionals nationwide on issues of healthcare transactions and regulatory compliance.
Ms. Campanella graduated Magna Cum Laude from Seton Hall University with a Masters in Healthcare Administration in 2012 and earned her Juris Doctor from Seton Hall Law in 2005. In 2002, she graduated with Honors from Union College with a Bachelor of Arts in History. She is also a member of the American College of Healthcare Executives (New Jersey Chapter), the American Health Lawyers Association, the New Jersey State Bar Association (Health Law Section), the New York City Bar Association.
Ms. Campanella has been admitted to practice law in New Jersey and United States District Court for the District of New Jersey since 2006, the District of Columbia since 2013, New York since 2013, Pennsylvania since 2017 and Vermont since 2018. Ms. Campanella was recognized by New Jersey Super LawyersTM as a Rising Star in 2014, 2015, 2017, 2018 and 2019, a “Best of Bergen” attorney by Bergen Magazine in 2017 & 2018, and is recognized by AVVO as a Clients’ Choice Attorney in 2016, 2017, 2018 & 2019 with an AVVO rating of “10 out of 10”.* Her additional certifications include earning the status of Certified HIPAA Administrator from the HIPAA Academy and she is a Fellow in the American College of Healthcare Executives. Ms. Campanella is also an Adjunct Professor at the Seton Hall University School of Health and Medical Sciences.
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