News & Analysis as of

Dept. of Justice Dept. of Health and Human Services

The United States Department of Justice is a federal executive department established in 1870 by federal statute. The Department is headed by the Attorney General and is responsible for administering and... more +
The United States Department of Justice is a federal executive department established in 1870 by federal statute. The Department is headed by the Attorney General and is responsible for administering and enforcing federal law. The Department is compromised of many different divisions which handle a wide variety of civil and criminal issues.    less -

"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

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

Eyes on Washington: FY 2018 Budget Request

by Holland & Knight LLP on

The Trump Administration on May 23, 2017, released a full budget blueprint for FY 2018, titled A New Foundation for American Greatness. The full FY 2018 budget proposal is based on the March 2017 "skinny" budget outline. The...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

DOJ vs. OIG: Analysis of Recently Issued Federal Compliance Documents

by Polsinelli on

Within just weeks of each other, the U.S. Department of Justice (DOJ) and the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) issued separate documents that health care organizations may use to...more

New Guidance Offers Deep Dive Into Compliance Issues

Following up on DOJ’s recent memo on “Evaluation of Corporate Compliance Programs,” the Office of Inspector General at the U.S. Department of Health and Human Services released its own compliance program evaluation memo last...more

"Trends in Corporate Integrity Agreements Reflect New HHS OIG Guidance on Use of Exclusion Authority"

2016 was a year of change for the Department of Health and Human Service's Office of Inspector General's (OIG) approach to corporate integrity agreements (CIA). The OIG began to use its new model CIA format and applied its...more

DOJ Issues New, Practical Guidance on Effective Corporate Compliance Programs

by Dorsey & Whitney LLP on

On February 8th, the Department of Justice (DOJ) Criminal Division, Fraud Section issued new guidance on how it evaluates the effectiveness of a corporate compliance program when conducting an investigation of a corporation....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

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

AGG Food and Drug Newsletter - January 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

DOJ False Claims Act recoveries – implications for the health industry

by DLA Piper on

The US Department of Justice Civil Division released its False Claims Act (FCA) recovery statistics for Fiscal Year 2016 on December 13, 2016, announcing that it had recovered $4.76 billion. This represents an increase of...more

The Federal Government Holds Individuals Responsible for Involvement in Corporate Healthcare Fraud and Abuse

by Sherman & Howard L.L.C. on

In September 2016, three corporate officers in two healthcare fraud and abuse cases settled allegations that they were personally liable for violations of federal fraud and abuse laws. These settlements come one year after...more

Risk Corridors Update: DOJ Says US Does Not Have to Pay – House Agrees

by Freeborn & Peters LLP on

Readers of this blog may recall that on September 9, 2016, the federal Department of Health and Human Services (HHS) – through its Centers for Medicare and Medicaid Services (CMS) – announced that it is open to discussing...more

Five Things to Know About the Mylan EpiPen “Settlement” – What It Is and What It Isn’t

Our eyebrows were raised by Mylan’s October 7, 2016 announcement that it had reached a $465 million “settlement” with the United States Department of Justice (DOJ) and “other government agencies” over its Medicaid Drug Rebate...more

Washington Healthcare Update

by McGuireWoods LLP on

This Week: Congress remains in recess, but members write letters on Mylan’s EpiPen…CBO says repealing Part B Demo would cost $395 million…CMS releases data on hospice utilization and finds spending and utilization vary in...more

Now, About Those Settlements? – House Committee Asks

by Freeborn & Peters LLP on

The U.S. House of Representatives Committee on Energy and Commerce (Committee), which oversees the Department of Health and Human Services (HHS), recently sent a strong letter to HHS Secretary Sylvia Matthews Burwell after...more

One Year Later: The Yates Memo, False Claims Act and Director & Executive Liability

by McDermott Will & Emery on

On September 19 and 27, 2016, the US Department of Justice announced two False Claims Act settlements that required corporate executives to make substantial monetary payments to resolve their liability. How will director and...more

Penalties For Health Care Law Violations Surge

The civil monetary penalties for violations of myriad health care laws continue to rise. In June, we discussed the enormous increase in penalties under the federal False Claims Act (“FCA”). Through an interim final rule, the...more

Federal Agencies Forced to Implement Huge Increases in Civil Monetary Penalties for Health Care Fraud

by Baker Ober Health Law on

Thanks to section 701 of the Bipartisan Budget Act of 2015, Public Law 114–74, federal agencies have been forced to implement huge increases in penalties intended to deter health care fraud. The Federal Civil Penalties...more

Former Home Health Agency Owner Sentenced to 20 Years for $57MM Medicare Fraud

The US Department of Justice announced that Khaled Elbeblaswy, the former owner and manager three Miami-area home health agencies, was sentenced to 20 years in prison and ordered to pay $36.4 million in restitution for his...more

HHS Inflation Adjustment Rule Hikes CMPs Across Department Programs

by Reed Smith on

The Department of Health and Human Services (HHS) is increasing maximum civil monetary penalty (CMP) amounts applicable to HHS agencies and programs, in compliance with the Federal Civil Penalties Inflation Adjustment Act...more

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