Policy & Compliance

  • June 18, 2024

    Prelogar's Mifepristone Win Is 'A Master Class,' Advocates Say

    U.S. Solicitor General Elizabeth Prelogar's recent victory for abortion advocates at the conservative-led U.S. Supreme Court won widespread praise from practitioners, particularly for her decision to focus on the procedural defects of the case seeking to limit access to mifepristone.

  • June 18, 2024

    Insurer Countersues In Penile Implant Coverage Dispute

    An insurer has no duty to defend or indemnify a urologist, his medical device company or his practice in a proposed class action over a penile enlargement implant and procedure, the company told a California federal court, saying the underlying suit doesn't seek bodily injury damages that would trigger coverage.

  • June 18, 2024

    Ex-Pharmacist Faces Rare Murder Trial In Meningitis Outbreak

    Twelve years after a deadly outbreak of fungal meningitis, an unusual legal question is set to be decided this fall: Was it murder?

  • June 18, 2024

    'Historic' Medicaid Disenrollment Sparks Suits Over Notice

    With millions of Americans losing healthcare coverage upon the expiration of COVID-era protections, two states are facing new legal challenges targeting allegedly flawed state notices.

  • June 17, 2024

    Teva, DOJ Signal Key Kickback Case May Fizzle At 1st Circ.

    A U.S. Department of Justice kickback case against Teva Pharmaceuticals — closely watched by False Claims Act lawyers because of its multibillion-dollar stakes and its link to a major circuit split — is poised for settlement, according to a new First Circuit filing ahead of eagerly awaited oral arguments.

  • June 17, 2024

    Teamsters Plan Says Health Network Has Monopoly In Conn.

    A Teamsters healthcare benefits plan and a Connecticut public transit provider have sued the healthcare network Hartford Healthcare Corp., accusing it of having a monopoly over healthcare in a half-dozen regions of the state.

  • June 17, 2024

    Pharmacy Groups Urge High Court To Hear Okla. PBM Case

    Pharmacy industry groups asked the U.S. Supreme Court to reverse a Tenth Circuit decision that overturned portions of an Oklahoma law regulating pharmacy benefit managers, saying these intermediaries have driven up costs for patients while raising their own bottom lines, and states should be allowed to keep them in check.

  • June 17, 2024

    Attys Accused Of Judge Shopping Must Turn Over Q&A Doc

    Attorneys accused of a coordinated effort to "judge shop" amid federal suits challenging an Alabama law banning certain medical procedures for transgender youth must supply a document the court believes displays the attorneys' preparations for a panel hearing in which one of the attorneys allegedly committed perjury.

  • June 14, 2024

    Janssen Hit With $150M Verdict In HIV Drug False Claims Suit

    A New Jersey federal jury hit Janssen with a $150 million False Claims Act verdict in a 12-year-old whistleblower suit, finding that the drugmaker violated the federal law as well as 27 related state FCA statutes by illegally profiting from the off-label marketing of two popular Janssen HIV medications.

  • June 14, 2024

    3rd Circ. Merges 3 Challenges To Medicare Drug Price Talks

    The Third Circuit will hear three separate appeals challenging Medicare's drug price negotiations together, according to a new order consolidating cases brought by AstraZeneca, Bristol-Myers Squibb and Janssen Pharmaceuticals in New Jersey and Delaware federal courts.

  • June 13, 2024

    Justices Hand Abortion Advocates An Incomplete Win

    The U.S. Supreme Court's rejection Thursday of a challenge to the abortion drug mifepristone will do little to safeguard long-term access to the medication while suggesting that it will be up to voters, not judges, to settle some of the nation's abortion debates, attorneys say.

  • June 13, 2024

    Thomas Targets Group Standing In Mifepristone Ruling

    U.S. Supreme Court Justice Clarence Thomas joined his colleagues Thursday to unanimously uphold broad access to the abortion medication mifepristone for now, but he wrote separately to challenge a standing rule that often serves as the key to the courthouse doors for litigants of all varieties.

  • June 13, 2024

    Feds Get $4.6M In Deal Over Telehealth Billing Fraud Probe

    A multi-state network of behavioral health companies and their CEO have agreed to pay nearly $4.6 million to settle allegations that they submitted fraudulent claims for payment to Medicare and Connecticut's Medicaid program for telehealth services for nursing home residents, federal investigators said Thursday.

  • June 13, 2024

    Teva Wins Pause Of Order Ousting Patents From Orange Book

    A New Jersey federal judge ordered on Thursday a 30-day stay of his Monday ruling that a handful of patents covering Teva-brand asthma inhalers were improperly listed in the federal Orange Book, saying he wanted the matter to reach the Federal Circuit in the most orderly way possible.

  • June 13, 2024

    CVS Dodges Discovery Audit In Generic Drug Collusion Suit

    A federal judge declined to make CVS hire a forensic auditor to evaluate its compliance with information demands in a lawsuit alleging it colluded with drugmakers to keep Medicare beneficiaries from accessing certain generic drugs, despite a whistleblower bemoaning "woefully deficient" discovery on the pharmacy chain's part.

  • June 13, 2024

    Health Co. Execs Charged In $100M Adderall Sales Scheme

    Two California digital healthcare company executives were charged in a first-of-its-kind case Thursday with scheming to sell Adderall through deceptive advertising, allegedly bringing in $100 million in illicit profits.

  • June 13, 2024

    EU Makes First Ever Formal Pharma Price-Fixing Complaint

    European Union antitrust authorities issued their first ever price-fixing complaint in the pharmaceutical industry Thursday, going after the only company that did not agree to a €13.4 million ($14.4 million) settlement in October.

  • June 13, 2024

    Abortion Medication Case Ends 'With A Whimper' At High Court

    A case that threatened to cut off access to a widely used abortion medication while disrupting the U.S. Food and Drug Administration's authority over drugs and medical devices ended Thursday at the U.S. Supreme Court with a decision concerned solely with challengers' right to sue.

  • June 12, 2024

    32 AGs Urge Justices Take Up Okla. PBM Law Fight

    Thirty-two attorneys general urged the U.S. Supreme Court to take up Oklahoma's petition for review of a Tenth Circuit decision holding that federal law preempted portions of a state law regulating pharmacy benefit managers, arguing the justices needed to intervene to resolve a circuit split.

  • June 12, 2024

    Sen. Dems Seek Criminal Penalties For PE Hospital 'Looters'

    A pair of Democratic senators are targeting private equity's role in the healthcare industry, introducing new legislation Tuesday that would give federal and state enforcers new tools to go after firms they say are "looting" hospital systems and other providers, including possibly jailing executives if patient deaths result.

  • June 11, 2024

    6th Circ. Judge Doubts Clinic's Standing To Block Bias Law

    During Sixth Circuit arguments Tuesday probing whether a Christian medical clinic can block Michigan from targeting it for refusing to facilitate gender transitions, one judge searched for evidence that the clinic is actually at risk of being prosecuted under the state's civil rights law.

  • June 11, 2024

    Doc-Patient Privilege, The Four Tops, And A Win For Humana

    Humana wins a round in a Medicare Advantage lawsuit. The high court takes up hospital "dish" payment case. A Motown legend sues a Michigan hospital. Law360 looks at those and other legal cases from the past week.

  • June 11, 2024

    Texas, Mont. Sue HHS Over ACA Trans Discrimination Rule

    Texas and Montana filed suit against the Biden administration seeking to halt its rule clarifying the application of the Affordable Care Act's nondiscrimination protections to gender identity, saying the new regulations infringe on states' autonomy and force them to violate their own laws.

  • June 11, 2024

    Judge Says Fla. Trans Medical Care Ban Is Unconstitutional

    A Florida federal judge on Tuesday declared that a state law banning gender-affirming care for transgender minors and restricting it for adults is unconstitutional because it was motivated by animus for a specific group of people and serves no legitimate state interest.

  • June 11, 2024

    Fast Appeal In Hospital Merger Row A Sign Of Determined FTC

    The Federal Trade Commission's quick appeal of its failed challenge to a North Carolina hospital merger suggests the agency remains committed to aggressive scrutiny of healthcare consolidation.

Expert Analysis

  • Gilead Ruling Signals That Innovating Can Lead To Liability

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    A California appeals court's ruling last month in Gilead Life Sciences v. Superior Court of San Francisco that a drug manufacturer can be held liable for delaying the introduction of an improved version of its medication raises concerns about the chilling effects that expansive product liability claims may have on innovation, says Gary Myers at the University of Missouri School of Law.

  • Health Policy Legislative Landscape May Remain Frozen

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    With Congress again delaying the full resolution of fiscal year 2024 federal spending legislation, there is now an additional window in which Congress could work through several priority issues for healthcare stakeholders, though these issues are unlikely to be resolved in time, say attorneys at Faegre Drinker.

  • Despite HHS Opinion, Gift Card Giveaways Require Caution

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    Though the U.S. Department of Health and Human Services' Office of Inspector General recently determined that a healthcare consulting firm's gift card plans do not violate the Anti-Kickback Statute, the opinion does not suggest blanket approval for providing gift cards in exchange for referrals, say Ragini Acharya and Matthew Deutsch at Husch Blackwell.

  • DOJ's Biopharma Settlement Raises Anti-Kickback Questions

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    In the aftermath of the U.S. Department of Justice's settlement with Ultragenyx over genetic testing programs, it may be prudent to reevaluate genetic tests through the lens of the Anti-Kickback Statute and reconsider whether it is proper for free testing programs to be treated like patient assistance programs, says Mary Kohler at Kohler Health Law.

  • Where Justices Stand On Chevron Doctrine Post-Argument

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    Following recent oral argument at the U.S. Supreme Court, at least four justices appear to be in favor of overturning the long-standing Chevron deference, and three justices seem ready to uphold it, which means the ultimate decision may rest on Chief Justice John Roberts' vote, say Wayne D'Angelo and Zachary Lee at Kelley Drye.

  • Bracing For Calif.'s New Health Transaction Framework

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    As California's new cost and market impact review regulations' April 1 date for its updated notice and review process approaches, healthcare entities should ready themselves for dramatic changes to the state's regulatory landscape and prepare for potentially substantial transaction delays, say Jordan Grushkin and Matthew Goldman at Sheppard Mullin.

  • Uncharted Waters Ahead For FCA Litigation In 2024

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    Following a year of significant court decisions, settlements, recoveries and proposed amendments, 2024 promises to be a lively year for False Claims Act actions and litigation, and one that will hopefully provide more clarity as FCA jurisprudence evolves, say attorneys at Crowell & Moring.

  • OIG Report Has Clues For 2024 Healthcare Fraud Enforcement

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    A recent report from the Health Department's Office of the Inspector General reveals healthcare fraud and abuse enforcement trends that will continue in 2024, from increased telehealth oversight to enhanced policing of managed care, say attorneys at Sheppard Mullin.

  • FOIA Exemption Questions On Redacted HHS Cannabis Letter

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    The U.S. Department of Health and Human Services' recent recommendation letter concerning the rescheduling of cannabis was heavily redacted, and based on an analysis on the applicability of Freedom of Information Act Exemption 5 to the letter, it's likely that we will see successful legal challenges to those redactions, say attorneys at Troutman Pepper.

  • A Primer On New Calif. Health Transaction Reporting Rules

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    New California regulations regarding the reporting of certain transactions involving healthcare entities, which took effect on Jan. 1, address some industry feedback about overly broad requirements but still leave several areas of concern, says Andrew Demetriou at Husch Blackwell.

  • In The CFPB Playbook: Rulemaking Rush Before Election Year

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    In this quarterly Consumer Financial Protection Bureau activity recap by former bureau personnel, attorneys at McGuireWoods explain the regulator's recent push to finalize new rules about data aggregators, digital payment apps and more before the election-year Congressional Review Act window opens.

  • What The Law Firm Of The Future Will Look Like

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    As the legal landscape shifts, it’s become increasingly clear that the BigLaw business model must adapt in four key ways to remain viable, from fostering workplace flexibility to embracing technology, say Kevin Henderson and Eric Pacifici at SMB Law Group.

  • 4 PR Pointers When Your Case Is In The News

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    Media coverage of new lawsuits exploded last year, demonstrating why defense attorneys should devise a public relations plan that complements their legal strategy, incorporating several objectives to balance ethical obligations and advocacy, say Nathan Burchfiel at Pinkston and Ryan June at Castañeda + Heidelman.