NASHVILLE, Tenn.--(EON: Enhanced Online News)--Bass, Berry & Sims PLC announced the release of its annual “Healthcare Fraud and Abuse Review 2016,” an in-depth and comprehensive review of enforcement settlements, court decisions and developments affecting the healthcare industry.
“Pharmaceutical and medical device companies must remain vigilant regarding their compliance programs, especially in areas of enforcement priority, such as product promotion and physician speaker programs”
The fifth annual Review is compiled by the firm’s Healthcare Fraud Task Force and is organized by industry sector, including hospitals and health systems, skilled nursing facilities, hospice, home health, and pharmaceutical and device. In addition to reviewing all settlements, the Review also includes updates on enforcement-related litigation involving the Stark Law and Anti-Kickback Statute, and looks at the unfolding implications from the Yates Memo, which DOJ released in late 2015, which should be of particular interest to individuals and entities facing civil and criminal healthcare fraud investigations.
“The federal government’s healthcare fraud enforcement efforts have always enjoyed wide bi-partisan political support and we see no likelihood of that changing,” said Brian D. Roark, head of the firm’s Healthcare Fraud Task Force. “Healthcare providers will continue to see a robust enforcement environment and the government’s encouragement of whistleblower activity will remain at the forefront of those enforcement efforts.”
Qui tam complaints – initially brought by whistleblowers and filed under seal – continued to account for the vast majority of new civil fraud matters, with 702 new whistleblower lawsuits filed last year – a nearly 10% increase over the previous year. Also of note, however, was the fact that federal enforcement agencies initiated a record-setting 69 new cases against healthcare providers without the help of whistleblowers, far surpassing the 26 cases brought by the government in the prior year.
The Review also highlights many of the legal developments under the FCA, which garnered significant attention last year. “One of the most significant legal developments concerning the FCA was the Supreme Court’s June 2016 decision in Escobar, which confirmed the viability of the implied certification theory of liability. The healthcare industry should closely watch how lower courts interpret the scope of this theory of FCA liability and whether and to what extent those courts apply the FCA’s ‘demanding’ materiality requirement,” said Matthew M. Curley, a Healthcare Fraud Task Force member and former Civil Chief at the U.S. Attorney’s Office in Nashville, Tennessee.
Enforcement efforts against pharmaceutical and medical device manufacturers remained a key initiative in the government’s healthcare fraud enforcement efforts. The federal government racked up a number of large settlements within this industry sector involving a wide range of issues, including off-label promotion and violations of the Anti-Kickback Statute.
“Pharmaceutical and medical device companies must remain vigilant regarding their compliance programs, especially in areas of enforcement priority, such as product promotion and physician speaker programs,” said John E. Kelly, managing partner of the firm’s Washington, D.C., office and former Assistant Chief for Healthcare Fraud with DOJ's Fraud Section. “The consequences go beyond large dollar settlements and include administrative scrutiny and potential individual liability in connection with civil and criminal enforcement efforts.”
“The evolving legal landscape requires healthcare leaders to be more vigilant than ever before when it comes to compliance issues,” said Lisa S. Rivera, a Healthcare Fraud Task Force Member and former federal civil and criminal healthcare Assistant U.S. Attorney. “While the healthcare system may be facing unprecedented uncertainty, it remains critical for healthcare providers to monitor government enforcement activity and legal developments that will shape the healthcare fraud landscape during the coming year.”
To download the “Healthcare Fraud and Abuse Review 2016” click here.
About the Bass, Berry & Sims Healthcare Fraud Task Force
The Bass, Berry & Sims Healthcare Fraud Task Force represents healthcare providers in connection with fraud and abuse matters, including responding to governmental inquiries by the U.S. Department of Justice, U.S. Attorneys’ Offices, the Office of Inspector General of the U.S. Department of Health and Human Services, federal program safeguard contractors, and various states’ Attorneys General offices.
About Bass, Berry & Sims PLC
With more than 270 attorneys representing numerous publicly traded companies and Fortune 500 businesses, Bass, Berry & Sims PLC has been involved in some of the largest and most significant business transactions, investigations and litigation matters in the country. The firm has distinguished itself for service to national healthcare clients, including hospitals, pharmaceutical companies and outpatient service providers. Ranked as one of the largest healthcare law firms in the United States, Bass, Berry & Sims provides unsurpassed depth in mergers and acquisitions, investigations, compliance, regulatory and operational matters. For more information, visit www.bassberry.com.