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Keeping you afloat admidst the rising sea of regulations

Not Just for Health Care Providers Anymore: Health IT Vendor Pays $155 Million to Settle False Claims Act Case

Last week, eClinicalWorks (ECW)—an electronic health records (EHR) vendor—settled an intervened False Claims Act case with the Department of Justice for $155 million.

Recent Drug Company Settlement Highlights Unique Theory of False Claims Act Liability: Failure to Follow Current Good Manufacturing Practices

Last month, Baxter International Inc. and Baxter Healthcare Corporation (collectively “Baxter”) settled a qui tam False Claims Act (FCA) case with the Department of Justice (DOJ) for $18 million. The settlement is not monumental in terms of the amount, but does highlight the unique theory of FCA liability.

Supreme Court Declines to Adopt Automatic-Dismissal Rule for Violations of False Claims Act’s Seal Requirement

On December 6, 2016, the Supreme Court determined in State Farm Fire & Casualty Co. v. United States ex rel. Rigsby that violation of the statutorily mandated seal requirement, 31 U.S.C. § 3730(b)(2), in a qui tam False Claims Act case does not automatically require dismissal, but instead the district court has discretion to determine the appropriate sanction under the circumstances – whether it be dismissal or a less severe sanction.

OIG 2017 Work Plan Lists New Enforcement Priorities

The Department of Health and Human Services (HHS) Office of Inspector General (OIG) recently published its Work Plan for fiscal year 2017 (2017 Work Plan), which furnishes key guidance to providers and suppliers (collectively referred to here as “providers”) and others doing business in the health care industry on the agency’s enforcement priorities for the upcoming year.

US Attorney Announces Kickback and False Claims Act Settlement with Device Manufacturer BioTelmetry/MedNet

The US Attorney’s Office for the District of New Jersey recently announced an agreement with BioTelemetry Inc. to settle allegations that its recently-acquired subsidiary, MedNet, Inc., violated the Anti-Kickback Statue and False Claims Act by improperly inducing health care providers to use the company’s cardiac monitoring services.  

Supreme Court Unlikely to Adopt Automatic-Dismissal Rule for Violations of False Claims Act’s Seal Requirement

On November 1, 2016, the Supreme Court heard argument in State Farm Fire & Casualty Co. v. United States ex rel. Rigsby, a False Claims Act case in which the defendant sought dismissal of a qui tam action after the whistleblower violated the FCA’s seal requirement, 31 U.S.C. § 3730(b)(2), and publicly disclosed the complaint. See the oral-argument transcript here.  

Mylan Agrees to $465 Million Settlement with DOJ Over EpiPen Medicaid Drug Rebate Reporting Classification

Mylan recently announced a $465 million settlement with the US Department of Justice and other government agencies regarding the company’s covered outpatient drug (COD) classification of its EpiPen (and EpiPen, Jr.),  an epinephrine auto-injector, under the Medicaid Drug Rebate Program (MDRP).  

Needing to Adjust: DOJ and HHS Announce Steep Increases to FCA, Stark Law, Anti-Kickback Statute, and EMTALA Penalties

Life science companies, health care providers, and government contractors will be at risk for significantly larger penalties due to substantial increases to False Claims Act (FCA) penalties and civil monetary penalties (CMPs). These penalty increases cover a broad range of health care violations, including the Stark Law, the Anti-Kickback Statute, the Emergency Medical Treatment and Labor Act (EMTALA) and the Health Insurance Portability and Accountability Act (HIPAA).

AHLA Educational Call: Implications of Escobar - Credentialing and Peer Review Compliance Issues and Risks

Please join Arent Fox partner Erin Muellenberg on Friday, September 16, from 1:30-2:30 PM Eastern for an AHLA educational call on the Implications of Escobar: Credentialing and Peer Review Compliance Issues and Risks. 

Don't Have a Heart Attack...but Enforcement Scrutiny Increasing Against Some Cardiac Care Providers

* The following alert was originally published in California Healthcare News (CHN). To read it on the CHN website, click here.