News & Analysis as of

False Claims Act (FCA) Dept. of Health and Human Services

Healthcare Law Update: September 2017

by Holland & Knight LLP on

OIG Advisory Opinions - Manufacturer's Free Replacement of Spoiled Pharmaceutical Products Authorized - On Aug. 25, 2017, the U.S. Department of Health and Human Services' (HHS) Office of Inspector General (OIG)...more

The Four Things That Surprised Us in the EpiPen False Claims Settlement

On August 17, 2017, the U.S. Department of Justice (DOJ) announced that it had reached a $465 million false claims settlement with Mylan, the manufacturer of EpiPen, over the company’s alleged underpayment of Medicaid Drug...more

Electronic Health Records Vendor Agrees to $155 Million Settlement to Resolve FCA Allegations, Required to Make Free Upgrades to...

by King & Spalding on

On May 31, 2017, the DOJ announced a $155 million settlement with eClinicalWorks (ECW), one of the nation’s largest electronic health records (EHR) vendors, to resolve a False Claims Act lawsuit brought by a whistleblower. ...more

Genesis Healthcare Enters $53.6 Million Settlement

by King & Spalding on

On June 16, 2017, the Department of Justice announced that Genesis Healthcare paid $53.6 million to resolve six False Claims Act whistleblower lawsuits filed by seven of Genesis’ former employees. The lawsuits alleged that...more

"Meaningfully Useful" Risk Mitigation Strategies for Providers Following the eClinicalWorks Settlement

by Jones Day on

The Health Information Technology for Economic and Clinical Health Act ("HITECH Act") established financial incentives under Medicare and Medicaid for eligible health care providers that adopt, implement, and demonstrate use...more

EHR Vendors Beware: eClinicalWorks Settles with DOJ for $155 Million

by Dorsey & Whitney LLP on

The Department of Justice (“DOJ”) announced on May 31, 2017, a $155 million settlement of its lawsuit alleging False Claims Act (“FCA”) and Anti-Kickback Statute (“AKS”) violations committed by eClinicalWorks (“eCW”), one of...more

The Latest in the Epipen Medicaid Drug Rebate Saga – Where Are We Now?

The latest installment in the ongoing saga over EpiPen Medicaid Drug Rebates came on May 31, 2017, when Senator Charles Grassley issued a press release stating that between 2006-2016 taxpayers may have overpaid for EpiPen by...more

Healthcare Law Update: June 2017

by Holland & Knight LLP on

Medicaid - Florida's Medicaid Third-Party Liability Act Pre-empted by Federal Law - By Eddie Williams - In Gallardo v. Dudek, Sec. of Florida Agency for Health Care Administration, No. 4:16cv116-MW/CAS, 2017 WL...more

FCA Issues to Watch: Intersection of the FCA and the Anti-Kickback Statute

by Bass, Berry & Sims PLC on

In the recent past, the government has racked up a number of FCA settlements based on alleged violations of the Anti-Kickback Statute (AKS). This focus undoubtedly will remain a high enforcement priority....more

Seven Takeaways from the ABA National Institute On Health Care Fraud

On May 17, 2017 the American Bar Association convened its 27th National Institute on Health Care Fraud. I have attended many of the past annual meetings, and always enjoy the presentations and the opportunity to network with...more

AGG Food and Drug Newsletter - May 2017

by Arnall Golden Gregory LLP on

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

Why Healthcare and Life Sciences Companies Need to Step Up Their Compliance Efforts in Advance of a U.S. Government Investigation

by Hogan Lovells on

In this hoganlovells.com interview, Hogan Lovells partner Gejaa Gobena discusses how the perception of compliance, remediation, and self-disclosure has evolved in the eyes of government prosecutors from how they factor at...more

The OIG 2017 Work Plan Includes Focus on Hospitals - Corridors Newsletter April 2017

by Poyner Spruill LLP on

The U.S. Department of Health and Human Services (DHHS) Office of Inspector General (OIG) has issued its Work Plan for Fiscal Year 2017. The annual Work Plan provides a summary of new, revised, and continuing reviews for DHHS...more

When to Use the OIG’s Self Disclosure Protocols

by Ruder Ware on

The HHS Office of Inspector General offers providers an opportunity to self-disclose certain violations in exchange for avoiding some of the more draconian penalties that may otherwise apply under applicable regulations. ...more

Health Update - March 2017

The Future of Essential Health Benefits - Editor's Note: The Essential Health Benefits (EHB) rule may be among the many parts of the Affordable Care Act (ACA) that are on the chopping block as the Trump Administration and...more

New OIG Exclusion Authority Rule Set To Go Into Effect on March 21, 2017

On January 12, 2017, just a week prior to President Trump’s Inauguration, the Department of Health and Human Service (HHS) Office of Inspector General (OIG) published a final Rule (Rule) regarding one of its most important...more

What’s in Your Local Transportation Policy?

by Nossaman LLP on

Those in the business of providing healthcare services to Medicare and Medicaid beneficiaries are all too familiar with the federal Anti-kickback Statute (AKS). Among other dreadful sanctions, it imposes criminal penalties on...more

New OIG Exclusion Regulations About to Go into Effect

by McDermott Will & Emery on

The Office of Inspector General (OIG) recently published a final rule regarding its exclusion authorities. The final rule goes into effect March 21, 2017, and expands OIG’s authority to exclude certain individuals and...more

Fraud and Abuse Investigations Should be Taken Very Seriously

by Burr & Forman on

According to the United States Government, fraud and abuse recovery has an excellent return for each investment dollar spent. According to the Health Care Fraud and Abuse Control (HCFAC) Program Report,released by the...more

Stretching the Rules: HHS-OIG Expands its Exclusionary Authority

by Arnall Golden Gregory LLP on

On January 12, 2017, the Department of Health and Human Services’ Office of Inspector General (OIG) published a final rule expanding its authority to exclude providers from participation in federal healthcare programs. This...more

District Court Dismisses FCA Allegations Based Upon Difference of Medical Opinion

by King & Spalding on

This month, the United States District Court for the District of Utah dismissed a relator’s allegations that a cardiac surgeon and two hospitals based in Utah violated the federal False Claims Act (FCA) by billing Medicare...more

First Circuit Tells False Claims Act Relators To “Put Up or Shut Up”

The U.S. Court of Appeals for the First Circuit recently called summary judgment “the put up or shut up moment in litigation.” On January 30, 2017, the relators in U.S. ex rel. Booker v. Pfizer – a long-running False Claims...more

Final Rule Expands OIG Exclusion Authority

by BakerHostetler on

On January 12, 2017, less than a week before the official transition from one administration to the next, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a rule finalizing...more

Regulatory Freeze Notwithstanding, Trump Administration Increases Health Fraud CMPs

by Reed Smith on

The Department of Health and Human Services (HHS) is once again applying an inflation increase to maximum civil monetary penalty (CMP) amounts for HHS agencies and programs – less than five months after the last inflation...more

OIG Expands Exclusionary Authority

The Department of Health and Human Services, Office of Inspector General (OIG) published a final rule on January 12, 2017, expanding the OIG’s authority to exclude providers from participation in federal healthcare programs....more

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