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Bass, Berry & Sims Releases Annual Healthcare Fraud Report

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Comprehensive Guide to Health Care Fraud Developments of 2017 and
Forecast for 2018

Bass, Berry & Sims announced the release of its annual "Healthcare Fraud
and Abuse Review 2017," an in-depth and comprehensive review of
enforcement settlements, court decisions and developments affecting the
healthcare industry.

The 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
healthcare fraud-related settlements, the Review includes updates on
enforcement-related litigation involving the Stark Law and Anti-Kickback
Statute, and looks at the continued implications from the government's
focus on enforcement efforts involving individual actors in connection
with civil and criminal healthcare fraud investigations.

"The federal government's healthcare fraud enforcement efforts continue
to enjoy wide bi-partisan political support," said Brian
D. Roark
, head of the firm's Healthcare Fraud Task Force. "As a
result, healthcare providers will continue to face a robust enforcement
environment spurred on by the frequent filing of qui tam actions."

Qui tam complaints – initially brought by whistleblowers under
the False Claims Act (FCA) and filed under seal – continued to account
for the vast majority of new civil fraud matters, with 674 new
whistleblower lawsuits filed last year and nearly 3,500 such complaints
filed over the last five years. These lawsuits are largely responsible
for driving the federal government's civil enforcement recoveries, which
have amounted to more than $20 billion during that same time period.

The release of the Review also follows two key announcements made by the
federal government concerning its healthcare fraud enforcement efforts
relevant to the FCA. In early January 2018, a DOJ memorandum set forth
factors for DOJ's evaluation of whether to seek dismissal of FCA cases
where DOJ has declined to intervene in the lawsuit. Then, later that
same month, DOJ's Associate Attorney General released a memorandum that
limited DOJ's use of agency guidance documents to establish liability in
affirmative civil enforcement cases.

"The release of the DOJ memos on dismissal of declined FCA cases and the
prohibition on the use of noncompliance with agency guidance documents
as a means of proving FCA violations are significant developments for
healthcare providers facing government investigations and related
litigation," said Matthew
M. Curley
, a Healthcare Fraud Task Force member and former Civil
Chief at the U.S. Attorney's Office in Nashville, Tennessee. "Along with
the unfolding developments following the Supreme Court's decision in Escobar,
healthcare providers now have even greater tools at their disposal in
pushing back against questionable theories of liability advanced by
whistleblowers and the government in these matters."

Enforcement efforts against pharmaceutical and medical device
manufacturers remained a key initiative in the government's healthcare
fraud enforcement efforts. In particular, the government has directed
significant resources in pursuing healthcare fraud and abuse matters
related to opioid abuse, recently announcing the newly-created position
of Director of Opioid Enforcement and Prevention Efforts and DOJ's
intention to file a statement of interest in multidistrict litigation
involving hundreds of lawsuits against opioid manufacturers and
distributors.

"Pharmaceutical and medical device companies are facing unprecedented
pressure associated with the government's enforcement efforts," 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 of falling short of applicable statutory and
regulatory requirements go far beyond large dollar settlements and
include administrative scrutiny and potential individual liability in
connection with civil and criminal enforcement efforts."

"Healthcare leaders must be more vigilant in proactively identifying and
addressing compliance issues," said Lisa
S. Rivera
, a Healthcare Fraud Task Force member and former federal
prosecutor, who served as Civil and Criminal Healthcare Fraud
Coordinator at the U.S. Attorney's Office in Nashville, Tennessee.
"While the healthcare system continues to face considerable 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."

For more information, download the 2017 "Healthcare
Fraud and Abuse Review
."

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 DOJ, U.S. Attorneys'
Offices, the HHS-OIG, federal program safeguard contractors, and various
states' Attorneys General offices. For more information, visit www.bassberry.com/healthcare-fraud.

About Bass, Berry & Sims PLC

With more than 270 attorneys representing numerous publicly traded
companies and Fortune 500 businesses, Bass, Berry & Sims has been
involved in some of the largest and most significant business
transactions and litigation matters in the country. As one of the
largest healthcare firms in the U.S., Bass, Berry & Sims has a depth of
healthcare experience that ranges from operational and regulatory
compliance to government investigations, litigation, and complex
corporate transactions. The firm has participated in the evolution of
the healthcare industry in Nashville, the capital of entrepreneurial
healthcare and today represents more than 200 healthcare-related
companies, 35 of which are publicly traded. For more information, visit www.bassberry.com.

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