Samantha Kingsbury at Mintz

Landmark AseraCare Case Finally Ends in Settlement

As many of our readers know, the AseraCare case was closely watched over the last several years because of its significance to efforts by the Department of Justice (DOJ) to allege that submission of claims for services...more

3/2/2020 / Bifurcation , False Claims Act (FCA) , Healthcare Fraud , Medical Necessity , Objective Falsity , Qui Tam , Sua Sponte

Eleventh Circuit Rules in AseraCare Case that Disagreements in Clinical Judgment, Without Objective Falsity, Do Not Prove Fraud...

On Monday, the U.S. Court of Appeals for the Eleventh Circuit issued its long-awaited and closely watched decision in United States v. AseraCare Inc.. The court ruled that a claim cannot be deemed false under the False Claims...more

9/12/2019 / Defense Strategies , Department of Justice (DOJ) , False Claims Act (FCA) , Health Care Providers , Healthcare Fraud , Hospice , Medical Necessity , Motion for Summary Judgment , Physicians , Qui Tam , Relators , Remand , Sua Sponte

Insys Bankruptcy Filing Immediately After Global Settlement Triggers Powerful Remedies

Over the last two years, much of the healthcare world has been watching the government’s prosecution of Insys Therapeutics for its sales and marketing practices related to its Subsys spray. Subsys is powerful and highly...more

6/26/2019 / Chapter 11 , Commercial Bankruptcy , Corporate Integrity Agreement , Deferred Prosecution Agreements , Department of Health and Human Services (HHS) , Department of Justice (DOJ) , Executive Compensation , False Claims Act (FCA) , Guilty Pleas , Healthcare , Kickbacks , OIG , Qui Tam , Racketeering

FCA Relator and U.S. Weigh in on Defendants' Argument that the FCA is Unconstitutional

As part of our ongoing discussion of the Polukoff False Claims Act (FCA) qui tam case (involving allegations that certain heart procedures performed by a cardiologist, and billed for by two hospital defendants, were not...more

5/10/2019 / Appeals , Appointments Clause , Article II , Constitutional Challenges , False Claims Act (FCA) , FRCP 9(b) , Motion to Dismiss , Petition for Writ of Certiorari , Pleading Standards , Qui Tam , Relators , Reversal

Health Care Fraud Investigations and Litigation Offer Unexpected Lessons for Bankruptcy Counsel

WHAT’S INSIDE - Who Decides How Bankruptcy Laws Are Applied? PROMESA: An Experiment Doomed to Fail - The Role of Alter Ego in Restructuring - SPECIAL FRAUD SECTION - Don’t Depend on a Handshake - Health...more

4/25/2019 / Department of Justice (DOJ) , False Claims Act (FCA) , FRCP 9(b) , Government Investigations , Health Care Providers , Healthcare Fraud , Medicaid , Medicare , Motion to Dismiss , Petition for Writ of Certiorari , Qui Tam , Relators

FCA Defendant Petitions Supreme Court, Argues Statute is Unconstitutional

As many of our readers know, we have been closely following the Polukoff False Claims Act (FCA) qui tam case, which is based on allegations that certain heart procedures performed by a cardiologist were not medically...more

2/8/2019 / Appointments Clause , Article II , Denial of Rehearing , Failure to Comply , False Claims Act (FCA) , FRCP 9(b) , Health Care Providers , Healthcare Fraud , Medicare , Petition for Writ of Certiorari , Split of Authority , Whistleblowers

DOJ Updates its Justice Manual to Include Section Limiting Use of Guidance Documents in Litigation

Nearly one year ago, on January 25, 2018, the Department of Justice’s (DOJ) Regulatory Reform Task Force issued a memorandum entitled “Limiting Use of Agency Guidance Documents In Affirmative Civil Enforcement Cases.” Many...more

1/8/2019 / Centers for Medicare & Medicaid Services (CMS) , Controlled Substances Act , Department of Health and Human Services (HHS) , Department of Justice (DOJ) , Enforcement Actions , Enforcement Guidance , False Claims Act (FCA) , Litigation Strategies , OIG , Opioid , Physicians , Regulatory Requirements

Tenth Circuit Rejects Request for Rehearing in Closely Watched FCA Medical Necessity Case

In a three-sentence order issued on October 29th, the Tenth Circuit Court of Appeals declined to grant a Request for Rehearing in the closely watched Polukoff case. One of the questions raised in the Request was whether, by...more

11/14/2018 / Denial of Rehearing , Department of Justice (DOJ) , Failure to Comply , False Billing , False Claims Act (FCA) , Health Care Providers , Healthcare Fraud , Medicare , Physicians

Fifth Circuit Decision is Rare Victory Permitting District Court to Enjoin Recoupment Before Provider Exhausts Administrative...

The all-too-common story of a healthcare company declaring bankruptcy in the face of aggressive Medicare recoupment actions before the company even has a hearing before an Administrative Law Judge (ALJ) may get a new ending –...more

4/17/2018 / Administrative Law Judge (ALJ) , Department of Health and Human Services (HHS) , Health Care Providers , Irreparable Harm , Medicare , Medicare Administrative Contractors (MAC) , Overpayment , Physician Medicare Reimbursements , Recoupment

Recent FCA Settlement Shows That What’s Old Is New in Health Care Fraud Enforcement

Last week, the U.S. Attorney’s Office for the District of Massachusetts announced that it had entered into an agreement with a Massachusetts-based medical device manufacturer to settle allegations that the Company had...more

3/14/2018 / Civil Monetary Penalty , Enforcement Actions , False Claims Act (FCA) , Health Care Providers , Healthcare Fraud , Inducements , Medical Devices , Physicians

Federal Enforcement Actions Continue to Focus on Opioid-Related Misconduct

As we predicted in our year-end post on civil and criminal enforcement trends, 2018 is already off to strong start in opioid-related enforcement against individual providers and associated practices. Earlier this month, the...more

2/20/2018 / Controlled Substances Act , Criminal Prosecution , Department of Justice (DOJ) , Enforcement Actions , Health Care Providers , Healthcare Fraud , Medicare , Opioid , Pharmaceutical Industry , Pharmacies , Physicians

Fifth Circuit Decision in Highway Guardrails Case Provides Important Guidance on Materiality in False Claims Act Cases

The U.S. Court of Appeals for the Fifth Circuit recently decided a case that could have a substantial impact on False Claims Act (“FCA”) jurisprudence with respect to the element of “materiality.” In U.S. ex rel. Joshua...more

11/30/2017 / Attorney's Fees , Department of Justice (DOJ) , Department of Transportation (DOT) , Disclosure Requirements , False Claims Act (FCA) , False-Certification of Conformance , Federal Highway Administration , Federal Rule 12(b)(6) , Material Misstatements , Materiality , Qui Tam , Reimbursements , Universal Health Services Inc v United States ex rel Escobar , Whistleblowers , Writ of Mandamus

Federal Trade Commission Announces Workshop on Competition in the Prescription Drug Market

On November 8, 2017, the Federal Trade Commission (FTC) will hold a workshop entitled, “Understanding Competition in Prescription Drug Markets: Entry and Supply Chain Dynamics.” Acting FTC Chairman Maureen K. Ohlhausen and...more

10/9/2017 / Biosimilars , Competition , Federal Trade Commission (FTC) , Food and Drug Administration (FDA) , Generic Drugs , Hatch-Waxman , Prescription Drugs , Public Meetings , Trade Policy

OIG Releases FY 2016 Statistical Data About Medicaid Fraud Control Units

Earlier this week, the Office of Inspector General for the Department of Health and Human Services (“OIG”) posted its fiscal year (“FY”) 2016 data about Medicaid Fraud Control Units (“MFCUs”) across the country....more

3/9/2017 / False Claims Act (FCA) , Fraud , Health Care Providers , Investigations , Medicaid , OIG

Another Court Agrees That A Difference Of Opinion On Medical Necessity Is Insufficient to Show Falsity Under the False Claims Act

Last month, the U.S. District Court for the District of Utah joined the AseraCare court and others in finding that a relator cannot successfully allege violations of the False Claims Act (“FCA”) based on a purported lack of...more

2/14/2017 / False Claims Act (FCA) , Fraud , Health Care Providers , Hospitals , Medicare , Objective Falsity , Prejudice

Another Jury Acquits in One of the First Few Prosecutions of Health Care Executives Following DOJ’s Yates Memo

Last month, we reported on a Massachusetts federal court jury’s decision to acquit the former CEO of Warner Chilcott in one of the first prosecutions of a health care executive following the Department of Justice’s (“DOJ”)...more

7/27/2016 / Acquittals , CEOs , Corporate Executives , Department of Justice (DOJ) , False Claims Act (FCA) , Federal Food Drug and Cosmetic Act (FFDCA) , Felonies , Food and Drug Administration (FDA) , Fraud , Health Care Providers , Medical Devices , Misdemeanors , Off-Label Promotion , Personal Liability , Yates Memorandum

DOJ Announces Dramatic Increase in False Claims Act Penalties

On May 6th, we posted about the possibility that the Department of Justice (“DOJ”) might dramatically increase False Claims Act (“FCA”) penalties after the Railroad Retirement Board (“RRB”) nearly doubled the per-claim...more

7/1/2016 / Civil Monetary Penalty , Department of Justice (DOJ) , False Claims Act (FCA) , Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 , Final Rules , Health Care Providers , Interim Rule , Public Comment , Railroad Retirement Board (RRB)

Jury Acquits Former Pharma Exec in One of the First Post-Yates Memo Health Care Fraud Prosecutions

Like many before it, this year has been one to watch in government health care fraud enforcement efforts. In September 2015, the Department of Justice (DOJ) released the “Yates Memo,” which reaffirmed the government’s...more

6/28/2016 / Acquittals , Affirmative Defenses , Anti-Kickback Statute , Corporate Counsel , Criminal Prosecution , Department of Justice (DOJ) , Good Faith , Healthcare Fraud , Jury Instructions , Kickbacks , Pharmaceutical Industry , Popular , Yates Memorandum

Already Enormous False Claims Act Penalties Set to Increase

The already enormous per-claim penalties under the federal False Claims Act (“FCA”) may nearly double by August 1, 2016, ratcheting up the stakes of FCA cases for health care providers, pharmaceutical and medical device...more

5/9/2016 / Department of Justice (DOJ) , False Claims Act (FCA) , Health Care Providers , Legislative Committees , Medicaid , Statutory Penalties

Mintz Levin Health Care Qui Tam Update - Recently Unsealed Whistleblower Cases: April 2016

Trends & Analysis - ..We have identified 42 health care–related qui tam cases that have been unsealed in whole or in part since the cases covered in our last Qui Tam Update. Included in that count is one proceeding (the...more

4/12/2016 / Class Action , Corporate Integrity Agreement , Fraud , Health Insurance Portability and Accountability Act (HIPAA) , Qui Tam , Whistleblowers

Judge Sides with AseraCare, Grants Summary Judgment in $200 Million FCA Case

Much like the rest of the health care world, we have been following the AseraCare case since May of last year when the Alabama federal district court granted AseraCare’s motion to bifurcate its False Claims Act (FCA) trial...more

4/4/2016 / Corporate Counsel , Department of Justice (DOJ) , False Billing , False Claims Act (FCA) , Hospice , Medicare , Physicians

Laboratories – 2015 Year in Review [VIDEO]

Over the past year, significant regulatory changes began to take shape that will have lasting effects on the laboratory industry for years to come. After publishing draft guidance regarding the regulation of laboratory...more

12/31/2015 / Aetna , Anti-Kickback Statute , Centers for Medicare & Medicaid Services (CMS) , CIGNA , CLIA , Department of Health and Human Services (HHS) , Enforcement Actions , False Claims Act (FCA) , Food and Drug Administration (FDA) , Laboratory Developed Tests , OIG , PAMA , Stark Law

Samantha Kingsbury

Mintz

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