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Sunshine Act and Beyond: Improving Compliance Processes and Strategies

 Product Management   Regulatory/Clinical Affairs    Research/Development/Design
 Supply Chain Management    Executive Management  

As global legislative and enforcement bodies increase regulation, investigation and prosecution of medical device companies, it has become critical for these entities to improve compliance strategies to meet enhanced expectations for an effective corporate compliance program. A crucial component of this new regulatory environment is adherence to the Physician Payment Sunshine Act (now referred to as “Open Payments”), requiring applicable manufacturers of drugs, devices and medical supplies to report the majority of payments or transfers of value made to health care professionals (HCPs) and teaching hospitals.


Deadlines for submitting required data pursuant to Open Payments have all but passed; however, companies continue to struggle with designing or enhancing their reporting process and systems in preparation for future submission dates because of ambiguity and evolution in guidance, as well as technical challenges. Further, concerns continue to linger regarding impact on customer relationships and other downstream compliance issues arising from the disclosure of required data. This presentation will provide an overview of current challenges and key strategies for enhancing compliance with Open Payments, as well as other implicated state, Federal and global regulations governing interactions with HCPs.


Session Takeaways:

- Brief overview, with the latest updates to guidance, of Open Payments and analogous state laws/regulations applicable to medical device manufacturers
- Key challenges for manufacturers in capturing, tracking and reporting required data prior to submission, and addressing broader compliance implications related to the disclosure of data
- Best practices and actionable strategies for enhancing compliance with Open Payments and analogous laws/regulations pre- and post-submission of required data
- A survey of the current and forthcoming foreign "Sunshine" laws and industry codes


 

 

Vahan-Minassian WEBVahan Minassian
Manager, Compliance and Ethics
Compliance Implementation Services

Vahan Minassian, Manager, Compliance & Ethics (CIS), is a licensed attorney with experience advising pharmaceutical and medical device manufacturers on legal and operational issues related to the Physician Payment Sunshine Act and state aggregate spend laws, lobbying disclosure laws, the Anti-Kickback Statute, the False Claims Act, off-label promotion, the Foreign Corrupt Practices Act and the U.K. Anti-Bribery Act of 2010.