Policy & Compliance

  • April 22, 2024

    J&J Says Worker's Drug Costs Suit Misses Big Picture

    Johnson & Johnson asked a New Jersey federal judge to toss a worker's suit claiming employees were overcharged for their prescriptions under a drug benefit program because of a contract with a pharmacy benefits manager, saying employees didn't show they could've gotten a better deal elsewhere.

  • April 22, 2024

    5 New State Employment Laws Passed This Year So Far

    State legislatures around the country are winding down legislative sessions that began in January, bringing newly enacted employment laws into effect in the coming months. From child labor to pay inequality to mandatory overtime, Law360 looks at five state laws that employers will have to comply with.

  • April 19, 2024

    Allergan To Face Kickback Claim In Suit Over Child Botox Use

    A Texas federal judge has axed allegations that pharmaceutical company Allergan Inc. defrauded the U.S. government when it promoted the unapproved use of Botox to treat migraines in children but will allow claims that the company bribed doctors to conduct the procedure to move forward.

  • April 19, 2024

    Up Next At High Court: Abortions & Presidential Immunity

    The U.S. Supreme Court will return Monday for the term's final week of oral arguments, during which it will consider several high-stakes disputes, including whether a federal healthcare law can preempt state abortion bans and whether former President Donald Trump is entitled to immunity from criminal charges related to official acts.

  • April 19, 2024

    'Anti-Vax Momma' Admits To Selling Fake Immunization Creds

    A woman who went by the Instagram handle @AntiVaxMomma pled guilty on Friday to selling fake U.S. Centers for Disease Control and Prevention vaccination cards and falsely registering buyers in New York state's immunization database.

  • April 19, 2024

    Feds Want Prison For Ga. Chiropractor In NBA Health Fraud

    Federal prosecutors have asked a New York federal judge to impose a 10- to 16-month prison sentence for a chiropractor who admitted to conspiring with former Celtics forward Glen "Big Baby" Davis to commit healthcare and wire fraud by submitting fake invoices to the NBA health plan.

  • April 18, 2024

    Jury Awards $98M To Wash. Healthcare Workers In Wage Suit

    A Seattle jury said Thursday a Washington-based healthcare system should pay thousands of its employees almost $100 million for its illegal timeclock rounding and meal break practices, an award that's expected to be doubled because a judge has already determined that the company's violations were willful.

  • April 18, 2024

    Clinic Head Gets 9 Years For Medicare Kickback, Tax Scheme

    A health clinic manager was sentenced to nine years in prison and ordered to pay $40 million in restitution to the government for participating in a multimillion-dollar healthcare kickback scheme that involved tax fraud, according to documents in a New York federal court.

  • April 18, 2024

    Endo Pleads Guilty To Marketing Opioids As 'Crush Proof'

    Endo Health Solutions Inc. pled guilty Thursday in Michigan federal court to putting out a drug it falsely advertised as being "crush proof" and "abuse deterrent," part of its larger agreement with the government to resolve nearly $2 billion in civil and criminal claims against the company.

  • April 18, 2024

    Would-Be Whistleblowers Drop ER Service Overbilling Claims

    A North Carolina federal judge has granted two whistleblowers' request to drop their suit accusing a pair of healthcare companies and their affiliates of overcharging both state and federal Medicare and Medicaid programs for emergency services provided at multiple regional hospitals, dismissing the case without prejudice.

  • April 18, 2024

    FDA Head Gets GOP Rep.'s Rebuke Over Pot Rescheduling

    The Republican chair of a U.S. House of Representatives Appropriations subcommittee on Thursday chided the commissioner of the U.S. Food and Drug Administration for the agency's recommendation last year to loosen restrictions on marijuana.

  • April 17, 2024

    Lab Whistleblower Drops COVID Test Suit After Feds Pass

    An ex-lab director has dropped his False Claims Act lawsuit alleging he was ousted from a diagnostic testing firm for raising concerns about regulatory violations and improper billing of federal health care programs, closing his Washington federal court case just days after the government declined to intervene.

  • April 17, 2024

    FDA's Foot-Dragging On Menthol Ban Sparks Frustration

    The U.S. Food and Drug Administration's yearslong delay to ban menthol has left public health groups frustrated over why the agency has failed to act on what the groups see as an obvious way to improve public health and prevent needless deaths, prompting a second lawsuit over taking menthol off store shelves.

  • April 17, 2024

    'Ringleader' Of Black Market HIV Drug Scam Gets 9 Years

    A New York federal judge on Wednesday sentenced a pharmacy operator to nine years in prison for spearheading a $13 million scheme to sell black market HIV medication and collect fraudulent reimbursements from Medicaid and Medicare.

  • April 16, 2024

    Eli Lilly's Insulin Price Cap Deal Collapses After Cert. Denial

    Eli Lilly & Co. and insulin buyers have called off a proposed nationwide settlement that would've capped insulin prices and been worth up to $500 million over several years, a decision that was made after the buyers lost a class certification bid early this year, according to the buyers' counsel.

  • April 16, 2024

    Healthcare Industry Sees Spate Of New Data Sharing Suits

    A $7 million-plus settlement between a federal regulator and a mental healthcare provider accused of improperly sharing patient data highlights the ubiquitous ties between health systems and tech giants like Facebook — and the growing legal and regulatory scrutiny over those relationships.

  • April 16, 2024

    Ohio Bans On Transgender Care, Youth Sports Halted By Judge

    An Ohio state court on Tuesday blocked a law that bans gender-affirming healthcare for children and prohibits transgender girls from competing in girls' school sports, issuing a temporary restraining order more than a week before the statute was to go into effect.

  • April 16, 2024

    NY High Court Zeroes In On Abortion Coverage Exemptions

    New York's highest court grappled Tuesday with whether a state regulation's exemption process shielding religious groups from a requirement that employee health plans cover abortions conflicted with a 2021 U.S. Supreme Court decision, with multiple judges questioning the constitutionality of the carveout procedure.

  • April 16, 2024

    Ex-NBA Guard Gets 18 Months In Healthcare Scheme

    A former Detroit Pistons point guard was sentenced to 18 months in prison Tuesday after being convicted of one of two counts over an alleged scheme to defraud the NBA's healthcare plan, with a Manhattan federal judge saying his proceeds were "not chump change" and faulting his behavior on pretrial release.

  • April 16, 2024

    Knotty Preemption Inquiry Awaits High Court In Abortion Case

    The U.S. Supreme Court next week will hear a dispute over an Idaho abortion ban and a federal emergency care law. The case promises to challenge the court to decide whether the two vastly different statutes actually conflict.

  • April 16, 2024

    Va. Hospital System Beats COVID Vaccine Bias Suit

    A Virginia healthcare system defeated a suit claiming it unlawfully refused to excuse two Christian employees from its COVID-19 vaccination requirement, with a federal judge finding they could have taken a version of the vaccine that didn't conflict with their religious beliefs.

  • April 16, 2024

    Ex-FDA Chief On Election Year Healthcare Policy

    Former FDA chief counsel Stacy Cline Amin of Morrison Foerster LLP talks to Law360 about march-in rights, the Inflation Reduction Act and healthcare policy issues in a presidential election year.

  • April 15, 2024

    Justices Face Off Over Shadow Docket Procedures

    The U.S. Supreme Court's internal disagreements over how to manage its emergency docket were on full display Monday in its decision allowing Idaho to enforce a ban on gender-affirming care for minors — a case the court's liberals said wasn't worthy of their intervention, but its conservatives touted as a win in the fight against universal injunctions.

  • April 15, 2024

    Mental Health Co. Cerebral To Pay $7M Over Data Failures

    Mental health service provider Cerebral Inc. will pay more than $7 million to settle claims from the Federal Trade Commission, saying it failed to protect users' sensitive health data and made it difficult for patients to cancel services and stop recurring charges, according to a Monday court filing.

  • April 15, 2024

    Justices Allow Idaho To Enforce Gender Care Ban, Sans Plaintiffs

    The U.S. Supreme Court allowed the state of Idaho on Monday to begin enforcing its ban on gender-affirming care for minors, reshaping a preliminary injunction the majority said was far too broad to keep in place as the litigation plays out, perhaps for years.

Expert Analysis

  • FDA Warning Letter Tightens Reins On 'Research Only' Labels

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    A recent warning letter from the U.S. Food and Drug Administration to Agena Bioscience alleged the company’s diagnostic devices were labeled for research use only, but improperly promoted for human clinical purposes, signifying a reinforcement — and a potential narrowing — of the agency's policy on products labeled “research only,” say attorneys at Sheppard Mullin.

  • First 10b5-1 Insider Trading Case Raises Compliance Issues

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    The ongoing case against former Ontrak CEO Terren Peizer is the U.S. Department of Justice's first insider trading prosecution based primarily on the filing of 10b5-1 plans, and has important takeaways for attorneys reviewing corporate policies on the possession of material nonpublic information, say attorneys at Cadwalader.

  • Policy Misrepresentations Carry Insurance Rescission Risks

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    The Second Circuit's recent decision in Medical Mutual v. Gnik, finding that material misrepresentation in a clinic's insurance applications warranted policy rescission, is a clear example of the far-reaching effects that misrepresentations can have and provides a reminder that policyholders should employ relatively straightforward steps to decrease risks, say attorneys at Hunton.

  • The Pros And Cons Of NIST's Proposed March-In Framework

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    Recent comments for and against the National Institute of Standards and Technology’s proposed guidance on march-in rights — which permit the government to seize federally funded patents — highlight how the framework may promote competition, but could also pose a risk to contractors and universities, say Nick Lee and Paul Ragusa at Baker Botts.

  • 2 Recent Suits Show Resiliency Of Medicare Drug Price Law

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    Though pharmaceutical companies continue to file lawsuits challenging the Inflation Reduction Act, which enables the federal government to negotiate for lower prescription drug prices, recent decisions suggest that the reduced drug prices are likely here to stay, says Jose Vela Jr. at Clark Hill.

  • Defense Attys Must Prep For Imminent AI Crime Enforcement

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    Given recent statements by U.S. Department of Justice officials, white collar practitioners should expect to encounter artificial intelligence in federal criminal enforcement in the near term, even in pending cases, say Jarrod Schaeffer and Scott Glicksman at Abell Eskew.

  • Lessons For Nursing Facilities From DOJ Fraud Settlement

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    The U.S. Department of Justice's recent settlement with the owner of skilled nursing and assisted living facilities in Florida provides a cautionary tale of potential fraud risks, and lessons on how facilities can mitigate government enforcement actions, say Callan Stein and Rebecca Younker at Troutman Pepper.

  • HHS' Updated Tracking Tech Guidance Offers Little Clarity

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    The U.S. Department of Health and Human Services' Office for Civil Rights' updated guidance on the use of online tracking technologies appears more focused on legal issues raised in ongoing litigation with the American Hospital Association and less on practical guidance for covered entities, say attorneys at Sheppard Mullin.

  • Takeaways From The 2023 DOJ Fraud Section Report

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    Attorneys at Wiley discuss notable trends from the U.S. Department of Justice's recently reported Fraud Section activity last year and highlight areas of enforcement to watch for in the future, including healthcare fraud and Foreign Corrupt Practices Act violations.

  • NIST March-In Framework Is As Problematic As 2021 Proposal

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    While the National Institute of Standards and Technology's proposed march-in framework on when the government can seize patents has been regarded as a radical departure that will support lowering prescription drug costs, the language at the heart of it is identical to a failed 2021 notice of proposed rulemaking, says attorney Kelly Morron.

  • Spartan Arbitration Tactics Against Well-Funded Opponents

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    Like the ancient Spartans who held off a numerically superior Persian army at the Battle of Thermopylae, trial attorneys and clients faced with arbitration against an opponent with a bigger war chest can take a strategic approach to create a pass to victory, say Kostas Katsiris and Benjamin Argyle at Venable.

  • The Road Ahead For Florida's Drug Importation Program

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    Though the U.S. Food and Drug Administration approved Florida's drug importation program in January, a series of hurdles — including requisite buy-in from Canada — and potential legal challenges must be addressed before importation can begin, say attorneys at Ropes & Gray.

  • Assessing CDC's Revised Guideline On Opioid Prescriptions

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    Kenneth Weinstein, Nicholas Van Niel and Kate Uthe at Analysis Group look at newly available data to evaluate the impact that the Centers for Disease Control and Prevention's revised opioid monitoring guideline have had on prescription trends in recent years, highlighting both specific and overall decreases.