Perspectives on Government Investigations

In a surprising move that could dramatically impact government enforcement actions against life science companies, the health care industry, and government contractors, a federal board has increased federal False Claims Act penalties by more than 100 percent. 

The Department of Justice recently announced it has reached a more than $780 million settlement with Pfizer Inc. and its subsidiary Wyeth to resolve reported false pricing allegations.

Partners Jacques Smith and David Greenberg spoke with AHLA Weekly after the US Supreme Court heard oral argument on April 19 in a major False Claims Act case that has far-reaching implications for the health care industry and other highly-regulated sectors reliant on government funding.

The US Supreme Court is set to hear oral arguments on April 19 in Universal Health Services, Inc. v. United States ex rel. Escobar, a key case addressing the implied certification theory of liability under the False Claims Act. 

Federal prosecutors appearing at the American Conference Institute’s 16th Annual Forum on Fraud and Abuse in the Sales and Marketing of Medical Devices earlier this month outlined recent enforcement trends that should catch the attention of the health care industry.

In a recent decision, a US Department of Health and Human Services (HHS) Administrative Law Judge (ALJ) agreed with the HHS Office of Civil Rights (OCR) that Lincare, Inc. d/b/a United Medical had violated HIPAA.

As part of the federal government’s multi-front attack on opioid abuse, the Department of Justice announced on Friday, February 12 that CVS Pharmacy, Inc. has agreed to pay $8 million to settle allegations that it violated the Controlled Substances Act (CSA).

The federal government has focused on compounding pharmacies and pharmacists for fraud and abuse investigations in recent years, and now the great state of Texas has joined in.

In an important development, the Centers for Medicare and Medicaid Services (CMS) has issued additional final regulations implementing the Stark Law as part of the Physician Fee Schedule for calendar year 2016 (see 80 Fed. Reg. 70,886 (Nov. 16, 2015)).

The Department of Justice recently announced that Tuomey Healthcare System has agreed to pay $72.4 million and enter into a five-year Corporate Integrity Agreement to finally resolve the long-running U.S. ex rel., Drakeford v. Tuomey Healthcare System, Inc. False Claims Act/Stark Law litigation.

US Department of Health and Human Services Office of Inspector General released an OIG Alert reminding the public that electronic health records furnished to referral sources may not meet the federal anti-kickback statute’s EHR safe harbor if EHR system has limited or restricted interoperability.

Health care providers and their contractors have been put on notice by the Office for Civil Rights (OCR) that the next round of HIPAA compliance audits will begin in early 2016.  The previous round of HIPAA audits was completed in 2014.

On September 21, 2015, the US DOJ and whistleblowers’ counsel announced that Florida-headquartered Adventist Health System (Adventist) had agreed to pay $118.7 million to resolve allegations that it violated the FCA by submitting claims in violation of the Stark law and by miscoding claims.

Joyce Branda, the Deputy Assistant Attorney General for the Commercial Litigation Branch of the DOJ, gave the keynote address on September 28, 2015, at the American Health Lawyers Association Fraud and Compliance Forum in Baltimore, providing conference attendees with an update from DOJ.

The US Department of Justice (DOJ) recently announced that Columbus Regional Healthcare System (Columbus Regional) has agreed to pay up to $35 million and enter into a Corporate Integrity Agreement with the U.S. Department of Health and Human Services Office of Inspector General.

On September 15, the US Department of Justice announced that it reached a $69.5 million settlement with the North Broward Hospital District to resolve False Claims Act allegations that originated in 2010.

On August 5, 2015, the Department of Health and Human Services Office of Inspector General (OIG) issued Advisory Opinion No. 15-11.

On Monday, a federal district court judge in New York issued a ruling that, if adopted broadly, will have a significant – and potentially nightmarish – impact on any provider who receives an overpayment from Medicare or Medicaid.  Kane v. Healthfirst, Inc. and U.S. v. Continuum Health Partners Inc. 

In an unexpected development, the Centers for Medicare and Medicaid Services recently proposed several changes that will generally add greater flexibility to Stark Law regulations in the proposed physician fee schedule for calendar year 2016, which was published on July 15, 2015.

In an unexpected development, the Centers for Medicare and Medicaid Services recently proposed several changes that will generally add greater flexibility to Stark Law regulations in the proposed physician fee schedule for calendar year 2016, which was published on July 15, 2015.

On July 7, 2015, the US Court of Appeals for the Ninth Circuit overruled a 23-year-old False Claims Act precedent, relaxing its test for deciding when a whistleblower can overcome a motion to dismiss because the allegations in the complaint were publicly disclosed. 

Health care partner Tom Jeffry was interviewed by Law360 to discuss the implications of the Ninth Circuit’s recent ruling in a False Claims Act litigation against Kinetic Concepts Inc.

Last week, the U.S. Department of Health and Human Services Office of Inspector General (OIG) announced the creation of a new litigation team focused solely on using the OIG’s authority to impose civil monetary penalties and exclude individuals and businesses from Medicare and Medicaid.

King v. Burwell understandably took the attention of the health care industry a couple of weeks ago when it upheld a key component of the ACA. A day later, the Supreme Court released another decision that may have a more significant going-forward impact on the health care industry: Obergefell.

The United States Court of Appeals for the District of Columbia Circuit released a decision requiring the Department of Health and Human Services to reconsider a 2008 rule prohibiting certain per-click leasing arrangements under the Stark Law.