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 -

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

Corporate Investigations and White Collar Defense - August 2016

Spotlight on the False Claims Act - Why it matters: This month, we review a recent Ninth Circuit case that allowed a qui tam relator’s action against various Medicare Advantage organizations to proceed, holding that the...more

Health Update - July 2016

The Vulnerability of Healthcare Information - According to a report the Brookings Institute issued in May 2016, 23% of all data breaches occur in the healthcare industry. Nearly 90% of healthcare organizations had some...more

Health Care Fraud Prosecutions: Strong Seas and High Winds Ahead for Individuals and Corporations

by Baker Ober Health Law on

During the past nine months, the U.S. Department of Justice (DOJ) has made several significant policy pronouncements that impact health care organizations and individual providers. These directives and initiatives reflect...more

New Affordable Care Act and Medicaid Regulations Will Require Covered Entities Providing Healthcare Programs and Services to Have...

There has been a proliferation of ADA lawsuits alleging that websites are not accessible to the blind or deaf. Individuals who are blind or have low vision may require assistive devices and specialized software to access the...more

Senate Committee Releases Report on Potential Stark Law Changes, Hearing Scheduled

On June 30, 2016, the Senate Finance Committee’s Republican staff issued a 20-page report discussing comments made by industry stakeholders after a December 2015 round-table on the future of the physician self-referral law,...more

Health Update - June 2016

Real-Time Data Analytics in Government Investigations and Reducing Exposure - It is not every day that the words “innovative” and “nimble” are used when referring to an agency of the federal government bureaucracy. Yet,...more

Legal Issues Associated with Multi-Provider Alternative Payment Model

Since the passage of the Affordable Care Act (ACA), both federal and state policies have promoted the adoption of alternative payment models (APMs), providing financial incentives for groups of providers to improve care...more

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