Host Jonathan Porter welcomes Brett McNeal and David Traskey to the show to discuss challenges associated with interpreting agency guidance—particularly advisory opinions from the Department of Health and Human Services’ Office of Inspector General (HHS-OIG)—as it relates to regulatory compliance in the healthcare industry. The conversation begins with a review of “first things,” or the short list of fundamentals that figure prominently in the regulatory setting, such as the origination and generation of business and whether federal money is involved in a service or product area. Advisory opinions often speak to these fundamentals, but the opinions are not always crystal clear. The conversation discusses how HHS-OIG advisory opinions are constructed, the statutory mandates that call them into existence, and the purposes they serve. While the opinions are legally binding on HHS and the parties that request them, their publication (in redacted form) can create issues owing to their highly qualified nature. Advisory opinions sometimes only hint broadly at how healthcare law might apply to any given situation, generating as many questions as they answer. So how should healthcare providers approach HHS-OIG advisory opinions? The short answer is Very Carefully. Healthcare industry entities should consider their options fully prior to requesting advisory opinions and think through why it is they want the opinion and what the implications of the opinion could be. Jonathan, Brett, and David impart some practical tips on how to lead that conversation and analysis, offer thoughts on how the regulatory framework could be improved, and predict where healthcare fraud and abuse regulation could be heading.
Host Jonathan Porter welcomes Brett McNeal and David Traskey to the show to discuss challenges associated with interpreting agency guidance—particularly advisory opinions from the Department of Health and Human Services’ Office of Inspector General (HHS-OIG)—as it relates to regulatory compliance in the healthcare industry. The conversation begins with a review of “first things,” or the short list of fundamentals that figure prominently in the regulatory setting, such as the origination and generation of business and whether federal money is involved in a service or product area.
Advisory opinions often speak to these fundamentals, but the opinions are not always crystal clear. The conversation discusses how HHS-OIG advisory opinions are constructed, the statutory mandates that call them into existence, and the purposes they serve. While the opinions are legally binding on HHS and the parties that request them, their publication (in redacted form) can create issues owing to their highly qualified nature. Advisory opinions sometimes only hint broadly at how healthcare law might apply to any given situation, generating as many questions as they answer.
So how should healthcare providers approach HHS-OIG advisory opinions? The short answer is Very Carefully. Healthcare industry entities should consider their options fully prior to requesting advisory opinions and think through why it is they want the opinion and what the implications of the opinion could be. Jonathan, Brett, and David impart some practical tips on how to lead that conversation and analysis, offer thoughts on how the regulatory framework could be improved, and predict where healthcare fraud and abuse regulation could be heading.
Jonathan Porter | Full Biography
Jonathan focuses on white collar criminal defense, federal investigations brought under the False Claims Act, and litigation against the government and whistleblowers, where he uses his experience as a former federal prosecutor to guide clients in sensitive and enterprise-threatening litigation. At the Department of Justice, Jonathan earned a reputation as a top white-collar prosecutor and trial lawyer and was a key member of multiple international healthcare fraud takedowns and high-profile financial crime prosecution teams. He serves as a vice chair of the American Health Law Association’s Fraud and Abuse Practice Group and teaches white collar crime as an adjunct professor of law at Mercer University School of Law.
Brett McNeal | Full Biography
Brett serves as the Chief Legal Officer of CAN Community Health, a leading operator of healthcare clinics. His deep experience with healthcare law is principally in the area of fraud and abuse, including the Stark Law, the Anti-Kickback Statute, and the False Claims Act. He also regularly provides advice and guidance on a range of regulatory issues and matters impacting the healthcare industry, including Medicare and Medicaid program and reimbursement requirements, the 340B Drug Pricing Program, HIPAA, and provider scope of practice issues.
David Traskey | Full Biography
David co-leads the Washington, DC office of the law firm Garfunkel Wild and advises individuals and entities involved in government investigations, guides clients on corporate compliance and governance matters, and litigates civil and white-collar health care fraud cases. Prior to entering private practice, David served as Senior Counsel with the United States Department of Health and Human Services (HHS), Office of Inspector General (OIG).