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CMS and OIG Issue Final Fraud and Abuse Waivers for ACOs

On October 29, 2015, the Centers for Medicare & Medicaid Services and the Office of Inspector General of the Department of Health & Human Services (jointly, the “Agencies”) issued a final rule (Final Rule) regarding waivers...more

Up, Up and Away: Penalties and CMPs to be Adjusted for Inflation

As part of the recent bipartisan budget deal, the Federal Civil Penalties Inflation Adjustment Improvements Act of 2015 (the “Improvements Act”) requires that all federal agencies make inflation-based adjustments to all civil...more

CMS Finalizes Revisions to Stark to Ease Burden on Providers, Refines “Incident to” Requirements

In its calendar year 2016 Physician Fee Schedule Final Rule published in the Federal Register on November 16, 2015 (Final Rule), the Centers for Medicare and Medicaid Services (CMS) finalized amendments to the federal...more

Health Care E-Note - November 2015

With medical device related acquisitions at all-time highs, and regulatory interest intense from the Federal Trade Commission, the Food and Drug Administration, the Securities and Exchange Commission, and the Office of...more

District Court Rejects FCA Claim Against Healthcare Provider That Submitted False Claims But Did So Without Necessary Mental State

Healthcare provider Fresenius Medical Care North America claimed victory in a False Claims Act (“FCA”) lawsuit recently when a federal district court ruled that there was no evidence that its practice of billing for...more

OIG Issues HHS Fiscal Year 2016 Work Plan

The Work Plan describes more than 100 initiatives, including 43 new initiatives for the upcoming year. On November 2, the Department of Health and Human Services (HHS) Office of the Inspector General (OIG) issued its...more

U.S. v. AseraCare and the Standard of Falsity Under the False Claims Act

Prosecutors, defense attorneys and health care providers alike have been closely watching the U.S. v. AseraCare (No. 2:12-cv-00245) matter pending in the Northern District of Alabama. The AseraCare case relates to hospice...more

Bipartisan Budget Act Jacks Up Civil Monetary Penalties Under the Social Security Act and False Claims Act Penalties

The Bipartisan Budget Act of 2015 (H.R. 1314), signed into law by President Obama November 2, 2015, will increase the civil monetary penalties (CMPs) imposed under the Social Security Act (SSA) in addition to False Claims Act...more

Bipartisan Budget Act Raises Stakes For FCA Defendants to All-Time High

On November, 2, 2015, President Obama signed into law the Bipartisan Budget Act of 2015 (“BBA”), a two-year budget deal that funds the government through the 2017 fiscal year. A relatively inconspicuous provision of the BBA,...more

Court Rules that Medicare and Medicaid Payments to Nursing Home Must Continue Pending Jurisdictional Dispute

On October 27, 2015, United States District Judge James S. Moody, Jr. extended a stay of proceedings thereby permitting Bayou Shores SNF, LLC (“Bayou Shores”) to remain viable and continue receiving Medicare and Medicaid...more

Identifying Overpayments Under the ACA’s 60-Day Rule Creates Additional Uncertainty in Determining False Claims Act Liability

Under the Affordable Care Act (ACA), healthcare providers that receive an overpayment from Medicare or Medicaid are required to report and return the overpayment to the government within 60 days after the date on which the...more

Final Curtain Call for Tuomey: Long-Running FCA/Stark Case Settled

After 10 years of litigation, including two trials and appeals to the 4th Circuit Court of Appeals, the U.S. Department of Justice (DOJ) and Tuomey Healthcare System (Tuomey) have entered into a settlement of DOJ's action...more

Principal Deputy Assistant Attorney General Mizer on Yates Memo: “No Partial Credit for Cooperation that Doesn’t Include...

Principal Deputy Assistant Attorney General Benjamin C. Mizer’s remarks at the 16th Pharmaceutical Compliance Congress and Best Practices Forum highlighted the Department of Justice’s “renewed commitment to ensuring that...more

Justice Department Charges Pharma President with Kickback Conspiracy

In the public relations battle following the issuance of the Yates Memo, the Justice Department can now cite one example for the new policy – the recent arrest and charging of Carl Reichel, former President of Warner...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

Millennium Health to Pay $256 million in False Claims Act Settlement

Millennium Health, one of the nation’s largest urine drug testing laboratories, has agreed to pay the government $256 million to resolve claims that it violated the Federal False Claims Act (“FCA”). The Settlement...more

Minimizing Exposure to Stark Law Liability in False Claims Act Cases by Isolating Those Who Determine Fair Market Value From Those...

I. Stark Law and False Claims Act - The FCA has become the primary enforcement vehicle for the Ethics in Patient Referrals Act, better known as the Stark Law. There are now more than 150 public cases citing to both the...more

PE-Backed Lab Company Millennium Health to Pay $256 Million Settlement with Government

We’ve discussed in the past certain risks of which investors should be aware with laboratory investments. Last week, TA Associates portfolio company Millennium Health agreed to pay $256 million to resolve claims that it...more

RACs recover $2.39 billion in overpayments in FY 2014

Last week, CMS released its report to Congress regarding the results of the FY 2014 Medicare Recovery Audit Program (the “Report”). Of note, the Report notes that RACs identified and corrected more than 1 million claims for...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

Tuomey Resolves Stark Law and False Claims Act Judgment for $72.4 Million

The Department of Justice announced on October 16, 2015 a settlement agreement with Tuomey Healthcare System that resolves a $237 million judgment against the system involving claims submitted to the Medicare program in...more

Health Alert (Australia) - October 26, 2015

In This Issue: -Judgments; Legislation; and Reports -Excerpt from Judgments Queensland 22 September 2015 - Metro South Hospital and Health Service & Leighton v Luthje [2015] QCATA...more

Tuomey Agrees to Pay $72.4 Million, Join Multi-Hospital System in Settlement

On October 16, 2015, Tuomey Healthcare System announced it had entered into a $72.4 million settlement with the United States Department of Justice (DOJ) to resolve a $237 million False Claims Act and Stark Law judgment...more

Be careful with Resident Rotators: What You Don't Know Might Hurt Your Hospital's Ability to Receive Medicare GME Payments in the...

Residents participating in a graduate medical education (GME) training program are unlikely to spend 100 percent of their time at a single hospital and its affiliated physician practices, and for good reason. Hospitals and...more

PharMerica Corporation Settles Anti-Kickback Allegations by Paying Over $9 Million to Government

On October 7, 2015, the Department of Justice announced that PharMerica Corporation (“PharMerica”), the nation’s second-largest nursing home pharmacy, agreed to pay $9.25 million to resolve allegations that it received...more

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