The Supreme Court will hear argument next week in two consolidated cases that will decide what standard applies when a doctor asserts a good faith defense to a criminal prosecution for unlawful drug distribution. The argument on Tuesday, March 1, will address the convictions of two doctors accused of running “pill mills” and seeking to profit in the midst of
Northwell Loses Bid For COVID-19 Insurance Coverage
SDNY Judge Jed Rakoff rejected Northwell Health’s bid for insurance coverage for its increased costs and business losses related to the COVID-19 pandemic in a recent decision. As the COVID-19 pandemic unfolded, Northwell was inundated with new patients, had increased cleaning costs, and stopped offering outpatient care services and elective procedures. In the ruling, Judge Rakoff held that Northwell
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Second Circuit Holds Case Challenging Marijuana Classification As Schedule I Drug In Abeyance Pending Agency Exhaustion
Last week, in Washington v. Barr, the Second Circuit addressed a case seeking to strike down the federal government’s classification of marijuana as a Schedule I drug under the Controlled Substances Act (CSA). The Court held that plaintiffs had failed to exhaust their administrative remedies before the Drug Enforcement Administration (DEA). Rather than dismissing the case, however, the Court
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Home Health Care Aides Working Twenty-Four Hour Shifts Can Be Paid For Thirteen Hours If Employer Meets Sleep and Meal Time Requirements
Home health care aides working twenty-four hour shifts can be paid for as little as thirteen hours under certain conditions, according to a March ruling from the New York Court of Appeals in Andryeyeva v. New York Health Care, Inc. The Court of Appeals remanded, however, for lower courts to consider whether employers were adhering to the sleep and
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EDNY False Claims Act Overfill Decision Highlights Importance of Timely Naming All Defendants
EDNY Judge Nina Gershon analyzed several False Claims Act issues in United States ex rel. Omni Healthcare Inc. v. McKesson Corp., ruling on first-to-file, Rule 9(b), and statute of limitations issues.
Relator Omni Healthcare alleged that defendants improperly used “overfill” in vials of injectable drugs. “Overfill” is the amount of a drug in excess of the amount indicated on
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Need For Discretion In Civil DOJ Cases Drives Rosenstein To Modify Yates Memorandum Individual Accountability Policy
In federal criminal investigations, corporate health care providers have faced a Department of Justice increasingly focused on individuals, one that has limited or foreclosed cooperation credit for corporations not providing complete information on all individual involvement. At a conference in late November, Deputy Attorney General Rod Rosenstein outlined a modification of these stringent guidelines, to some extent for criminal prosecutions
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NY Court of Appeals Strikes Down DOH Limits On Use Of Private Funds For Executive Compensation And Upholds Limits On Use Of Public Funds
Last week, in LeadingAge New York, Inc. v. Shah, the New York Court of Appeals addressed Department of Health regulations limiting executive compensation and administrative expenditures by healthcare providers receiving state funds. The Court upheld limits related to state funding, but struck down a limit that applied regardless of the source of funding.
In 2012, Governor Cuomo directed agencies
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Second Circuit Answers First-To-File Question: Amended Complaint Cannot Save Later-Filed FCA Action
In United States ex rel. Wood v. Allergan, Inc., the Second Circuit addressed the issue of whether a violation of the False Claims Act’s “first-to-file” rule compels dismissal of an action or whether it can be cured by the filing of an amended or supplemental pleading. The Court’s acceptance of the interlocutory appeal was addressed here in a post
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NY Court of Appeals Rejects Hospital’s Bid To Cloak Allegedly Defamatory FDA Investigation Statements With Absolute Immunity
The recent New York Court of Appeals decision in Stega v. New York Downtown Hospital provides strong support for defamation claims arising out of witness testimony in investigations and quasi-judicial hearings. In Stega, the Court held that statements made in administrative proceedings that allegedly defame a person are not absolutely immune where the person has no recourse to challenge
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Congressional Appropriations Riders Suspended Affordable Care Act Mandates On Risk Corridors Program
In a decision last week that could affect $12 billion that insurers assert is owed by the federal government, the Federal Circuit decided that HHS was not required to pay amounts required by statute because Congress had repealed or suspended those obligations through riders to appropriations bills. In Moda Health Plan, Inc. v. United States, the Federal Circuit rejected
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