As discussed in our article recently published by Law360, 2019 brought yet another year of robust health care enforcement activity, and the False Claims Act (FCA) remains the government’s most powerful civil health care...more
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
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
On June 3, 2019, the U.S. Supreme Court issued a decision in Azar v. Allina Health Services. The case involved a challenge by hospitals over whether the Department of Health and Human Services (“HHS”) was required to proceed...more
6/5/2019
/ Administrative Procedure Act ,
Azar v Allina Health Services ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Hospitals ,
Low-Income Issues ,
Medicare ,
Medicare Advantage ,
Medicare Part A ,
Medicare Part C ,
Notice and Comment ,
Pay Reductions ,
Provider Payments ,
Reaffirmation ,
Retroactive Application ,
SCOTUS ,
Substantive Rule ,
Vacated
The U.S. Department of Justice (DOJ) issued policy guidance on May 6, 2019, about providing credit in False Claims Act (FCA) settlements to corporations for “disclosure, cooperation, and remediation." DOJ has never previously...more
5/13/2019
/ Compliance ,
Cooperation ,
Corporate Misconduct ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Government Agencies ,
Government Investigations ,
New Guidance ,
Remedial Actions ,
Risk Mitigation ,
Voluntary Disclosure
On January 15, 2019, the Supreme Court heard oral arguments in Azar v. Allina Health Services, a prominent case involving a challenge by hospitals over when Medicare’s instructions to its contractors impact a “substantive...more
2/5/2019
/ Administrative Procedure Act ,
Appeals ,
Azar v Allina Health Services ,
Centers for Medicare & Medicaid Services (CMS) ,
Certiorari ,
Department of Health and Human Services (HHS) ,
Disproportionate Share Adjustments ,
Health Care Providers ,
Hospitals ,
Interpretive Rule ,
Medicare ,
Medicare Part C ,
Notice and Comment ,
Petition for Writ of Certiorari ,
Physician Medicare Reimbursements ,
Provider Payments ,
Rulemaking Process ,
SCOTUS
On January 15, 2019, the U.S. Supreme Court will hear arguments in a hotly-contested case involving a challenge by hospitals over when Medicare’s instructions to its contractors impact a “substantive legal standard” and thus...more
1/16/2019
/ Administrative Procedure Act ,
Appeals ,
Azar v Allina Health Services ,
Centers for Medicare & Medicaid Services (CMS) ,
Certiorari ,
Department of Health and Human Services (HHS) ,
Disproportionate Share Adjustments ,
Health Care Providers ,
Hospitals ,
Interpretive Rule ,
Medicare ,
Medicare Part C ,
Notice and Comment ,
Petition for Writ of Certiorari ,
Physician Medicare Reimbursements ,
Provider Payments ,
Rulemaking Process ,
SCOTUS
As in years past, the False Claims Act (FCA) remained a powerful health care enforcement tool in 2018, and FCA investigations and litigation persisted, fueled mainly by hundreds of lawsuits filed annually by relators,...more
1/16/2019
/ Anti-Kickback Statute ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Gilead Sciences Inc v United States ex rel Campie ,
Health Care Providers ,
Healthcare ,
Healthcare Fraud ,
Petition for Writ of Certiorari ,
Solicitor General ,
Universal Health Services Inc v United States ex rel Escobar
Last year, as we previously discussed, there were two significant Department of Justice (DOJ) policy developments that are applicable to False Claims Act (FCA) litigation: (1) the “Granston Memo” (issued by DOJ Civil Fraud...more
1/14/2019
/ Anti-Kickback Statute ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare ,
Healthcare Fraud ,
Hospitals ,
Kickbacks ,
Qui Tam ,
Relators
Along with most of us, last January DOJ set its own goals for 2018: new policies related to False Claims Act (“FCA”) enforcement. One such “resolution” for 2018 was the DOJ Civil Fraud section’s instruction to its attorneys...more
The United States Department of Justice (DOJ) filed an amicus curiae brief with the Supreme Court on November 30, 2018 in a closely watched False Claims Act (FCA) lawsuit, after the Supreme Court asked for the Solicitor...more
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
The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (the “SUPPORT for Patients and Communities Act”) – which is intended to combat the spread and pernicious...more
11/13/2018
/ Anti-Kickback Statute ,
Clinical Laboratories ,
Health Care Providers ,
OIG ,
Opioid ,
Pain Management ,
Patient Referrals ,
Regulatory Oversight ,
Regulatory Requirements ,
Remuneration ,
Safe Harbors ,
Secretary of HHS
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
Two new DOJ policies about False Claims Act enforcement became public last week. First, DOJ’s Associate Attorney General announced a new civil enforcement policy that instructs False Claims Act litigators not to use any...more
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
In this month’s issue of our Qui Tam Update, we review an unusual cluster of five cases alleging that common defendants — a health care provider and its subsidiaries — provided medically unnecessary services to hospice,...more
A court in the Southern District of New York (“SDNY” or the “Court”) recently released an important decision applying the Supreme Court’s landmark Escobar ruling to a qui tam action involving percentage fee arrangements for...more
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
5/25/2017
/ Corporate Integrity Agreement ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Hospitals ,
Kickbacks ,
OIG ,
Patient Referrals ,
Physicians ,
Qui Tam ,
Settlement ,
Stark Law
In a closely watched False Claims Act (“FCA”) case, the Fourth Circuit Court of Appeals decided that the Department of Justice (“DOJ”) has an unreviewable right to object to a proposed settlement agreement between a relator...more
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
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
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
7/8/2016
/ Affordable Care Act ,
Alternative Payment Models (APM) ,
Congressional Investigations & Hearings ,
Congressional Reports ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Exceptions ,
False Claims Act (FCA) ,
Fee-for-Service ,
Fraud and Abuse ,
Medicare Access and CHIP Reauthorization (MACRA) ,
Physician Compensation Arrangements ,
Senate Finance Committee ,
Stark Law ,
Treble Damages ,
Waivers
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
On June 16, 2016, a unanimous Supreme Court issued its long-awaited decision in Universal Health Services v. United States ex rel. Escobar (“Escobar”). The Court ruled that under certain circumstances the theory of “implied...more
6/21/2016
/ Conditions of Payment ,
False Claims Act (FCA) ,
False Implied Certification Theory ,
Federal Contractors ,
Federal Pleading Requirements ,
Fraud ,
Implied Certification ,
Material Misrepresentation ,
Materiality ,
Medicaid ,
SCOTUS ,
Universal Health Services Inc v United States ex rel Escobar ,
Unlicensed Medical Providers