News & Analysis as of

Office of the Inspector General Dept. of Justice

OIG Reports More Than $731 Million in Inappropriate Medicare Meaningful Use Payments

by McDermott Will & Emery on

The Electronic Health Records (EHR) Incentive Program run by Centers for Medicare and Medicaid Services (CMS) garnered attention again last week following the release of a report by the Office of Inspector General of the US...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

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

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

Hospital and its Clinic Agree to $34 Million Settlement to False Claims Act Allegation that Compensation to Oncologists Violated...

Last week, the Department of Justice (DOJ) entered into a $34 million settlement with Mercy Hospital Springfield (“Hospital”) of Springfield, Missouri, and its affiliate Mercy Clinic (“Clinic”). The settlement resolves an...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

How Effective Is Your Compliance Program? New OIG and DOJ Guidance for Measuring the Effectiveness of Your Corporate Compliance...

by Dorsey & Whitney LLP on

Compliance programs are an important tool for health care providers. Compliance programs help to prevent fraud, waste and abuse, create a mechanism for catching problems early, and effective compliance programs can also...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

Civil Forfeiture Under Fire – Part II

by Ballard Spahr LLP on

In this post, we consider the Department of Justice’s (DOJ) Office of the Inspector General report (OIG Report), released on March 29, 2017, evaluating the DOJ’s oversight of its cash seizure and forfeiture operations. This...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

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

DOJ/OIG Update on FY 2016 Health Care Fraud and Abuse Control (HCFAC) Program Recoveries

by Reed Smith on

Federal health fraud recoveries for FY 2016 totaled $3.3 billion, according to the latest HCFAC program annual report. The HCFAC program is credited with more than $31.0 billion in Medicare Trust Funds recoveries since it...more

Compliance Expertise Needed on the Board

by Thomas Fox on

This week I have been exploring the different types compliance committee’s which an organization can utilize to help effect a best practices compliance program. I have written about compliance committee’s at the Board of...more

Key Takeaways: Fourth Annual Seminar for Pharmaceutical, Biotechnology and Medical Device Companies

On October 5, 2016, Skadden hosted its Fourth Annual Seminar for Pharmaceutical, Biotechnology and Medical Device Companies. The seminar focused on the current and developing challenges facing such companies and included...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

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

Insights Conversations: How Government Health Care Investigations May Be Shifting

The Department of Justice (DOJ) has long had the advantage when investigating False Claims Act (FCA) cases against health care companies. However, recent changes in the courts, including a unanimous U.S. Supreme Court...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

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

AGG Food and Drug Newsletter - May 2016

by Arnall Golden Gregory LLP on

Arnall Golden Gregory LLP's (AGG) 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...more

Physician-Owned Distributor (POD) Update

by Reed Smith on

For some time, we have been reporting on issues involving federal government scrutiny of physician-owned distributors ("PODs"). From the Department of Health and Human Services Office of Inspector General’s ("OIG") issuance...more

U.S. Department of Health and Human Services Updates Criteria for Permissive Exclusion Under Section 1128(b)(7) of the Social...

by Saul Ewing LLP on

The HHS-OIG issued new guidelines on April 18, 2016 regarding the Secretary's exercise of the Department's permissive exclusion authority pursuant to Section 1128(b)(7) of the Social Security Act. The HHS-OIG's new guidance...more

OIG Issues New Exclusion and CIA Guidance

by McDermott Will & Emery on

On April 18, 2016, Inspector General Daniel R. Levinson announced the publication of updated guidance on how the Office of Inspector General (OIG) makes decisions about using its permissive exclusion authority and requiring...more

"New HHS OIG Criteria to Guide Resolution of Health Care Investigations"

The Office of Inspector General of the Department of Health and Human Services (OIG) has issued updated guidance on the use of its so-called permissive exclusion authority under Section 1128(b)(7) of the Social Security Act...more

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