Dept. of Justice Centers for Medicare & Medicaid 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 -
News & Analysis as of

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

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

It’s Hunting Season. For Unicorns? Lawsuit Against Theranos Signals Trend In Investors Going After Late-Stage Start-ups

Last week brought more bad news for private blood testing company Theranos Inc., as San Francisco-based Partner Fund Management L.P. (“PFM”) launched a suit claiming that it was duped into making a $96.1 million investment in...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

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

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

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

60-Day Overpayment FCA Enforcement Action Results in $2.95 Million Settlement

On August 23, 2016, a New York hospital system settled False Claims Act (FCA) allegations that it violated the 60-day overpayment rule by improperly retaining Medicaid overpayments. The whistleblower alleged that three of the...more

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

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

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

OIG Issues New Exclusion and CIA Guidance

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

A&B Healthcare Week in Review

I. REGULATIONS, NOTICES, & GUIDANCE - On March 24, 2016, the Food and Drug Administration (FDA) issued a guidance entitled, “Draft Guidance for Industry: General Principles for Evaluating the Abuse Deterrence of Generic...more

Washington Healthcare Update

This Week: The President took a victory lap in Wisconsin, announcing that 20 million people have gained health insurance through the Affordable Care Act... That figure includes people newly covered through insurance...more

Health Care E-Note - February 2016

The U.S. Department of Justice (“DOJ”) has a new view in cases involving corporate wrongdoing (including fraud and abuse, qui tam, and similar matters). And its gaze is focused squarely on rooting out and punishing the...more

Washington Healthcare Update

This Week: Congress and the administration focus on the opioid addiction epidemic... Override of the president’s veto of legislation that would have repealed the Affordable Care Act fails, to no one’s surprise... Senate...more

Washington Healthcare Update

This Week: Because of the Blizzard of 2016—also known as “Snowzilla”—in Washington, D.C., and other parts of the East Coast, this is a combined issue... The House of Representatives opted not to come back to town until next...more

The Pharmacy Industry – 2015 Year In Review

With 2015 coming to a close, we wanted to provide a recap of the major updates impacting the pharmacy industry and what pharmaceutical manufacturers, pharmacy benefit managers (“PBMs”), and pharmacies might expect in 2016. ...more

Health Care Update - November 2015

Ways & Means Leadership Changes – Health Policy Implications Looming: As Congress pushes forward with a two-year budget deal, and new Speaker Paul Ryan begins his tenure as the top Republican in the House of...more

Record-breaking FCA settlements underscore importance of Stark Law compliance

In September and October, the Department of Justice (DOJ) announced four record-breaking False Claims Act settlements – ranging from $25 million to $115 million – involving health care systems that allegedly made improper...more

Skeletons in the Closet? Beware of Potential Enforcement Actions

With Halloween looming, a discussion of skeletons that may be lurking in a health care provider’s closet is timely. Many of our previous posts, as well as the monthly Qui Tam Updates published by our Health Care Enforcement...more

OMB Receives Final Medicare Parts A and B 60-Day Overpayment Rule from CMS

On October 21, 2015, the Office of Management and Budget (OMB) received the Medicare Parts A and B overpayment final rule from CMS which is the last phase before the rule is issued in the Federal Register. While the text of...more

Millennium Health and DOJ Settle False Claims Act Allegations for $256 Million

On October 19, 2015, the Department of Justice (DOJ), through the United States Attorney’s Office for the District of Massachusetts, announced that Millennium Health (formerly Millennium Laboratories) had agreed to resolve...more

Health Law Pulse - October 2015

The Health Resources and Services Administration (HRSA) recently issued proposed omnibus guidance (Omnibus Guidance) interpreting various provisions of the 340B Drug Pricing Program (340B Program). The 340B Program allows...more

Fast Alert: OIG Calls For Reevaluation Of Medicare Therapy Billing

On September 30, 2015, the Office of Inspector General (OIG) published a report titled, "The Medicare System For Skilled Nursing Facilities Needs To Be Evaluated" in response to growing concerns over Medicare's payment system...more

Huge Stark Law Hospital Settlements and Physician Culpability - The New Normal Post-Tuomey?

After the federal government’s victory against Tuomey Hospital, we have seen an increasing number of large False Claims Act (FCA) settlements with hospitals involving Stark Law allegations. Relators are even citing, as...more

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