This program, presented by healthcare attorney Hillary Stemple, will provide an overview of the health care compliance considerations applicable to pharmaceutical and device manufacturers.
The program will include (1) an overview of compliance program basics, including the OIG’s 7 elements of an effective compliance program; (2) an overview of the healthcare laws applicable to manufacturers, including state-specific laws; (3) a discussion of high-risk areas applicable to manufacturers and how manufacturers can avoid falling into such compliance traps; and (4) a discussion of resources and guidance available to manufacturers to help avoid compliance pitfalls.
Discuss the basic requirements for an effective compliance program
Identify both federal and state health care laws governing pharmaceutical and device manufacturers and the implications of non-compliance with these laws
Determine high-risk areas for manufacturers and how these risk areas can be addressed by an effective compliance program
Explore resources and guidance available for manufacturers in order to help guide their interactions with healthcare professionals and avoid compliance pitfalls
Hillary Stemple is an associate in Arent Fox’s Health Care group where she represents health care providers, including hospitals and health care systems, long term care facilities, and hospice and home care agencies.
Hillary regularly advises clients on compliance with health care fraud and abuse laws, with an emphasis on the Stark law and anti-kickback statute. She also counsels clients on internal and external investigations, particularly investigations related to the False Claims Act, as well as on reimbursement issues, licensing requirements, and other compliance matters.