Policy & Compliance

  • June 24, 2024

    High Court To Review State Gender Care Bans

    The U.S. Supreme Court on Monday agreed to review a Sixth Circuit decision that allowed Tennessee to keep in place a new ban on gender-affirming care for minors.

  • June 24, 2024

    Justices Won't Hear Objections To $2.67B BCBS Deal

    The U.S. Supreme Court refused on Monday to review Home Depot's challenge of a $2.67 billion settlement in antitrust litigation targeting Blue Cross Blue Shield, along with a separate challenge of the attorney fees awarded for the deal.

  • June 21, 2024

    Texas Medical Board Adopts Abortion Records Requirement

    Texas doctors who determine that an abortion is necessary during a pregnant patient's health crisis will face new recordkeeping requirements under a final rule issued Friday by the state's medical board.

  • June 21, 2024

    Attys Accused Of Judge Shopping Must Share Public Remarks

    Attorneys accused of judge shopping two 2022 suits challenging an Alabama law criminalizing some gender-affirming care for transgender youths have been given 48 hours to turn over any public statements, releases or other information they or their organizations have shared about the disciplinary proceedings, just days ahead of a Monday hearing.

  • June 21, 2024

    5th Circ. Knocks Out National Block On ACA Preventive Care

    The Fifth Circuit on Friday struck down a national injunction against Affordable Care Act requirements forcing insurers to cover a range of preventive treatments, but kept a block in place that prevents its application to the individuals and businesses in Texas that sued.

  • June 21, 2024

    Mount Sinai's Doctor Pacts Violate Labor Law, NLRB GC Says

    New York's Mount Sinai Health System has illegally required part-time physicians to sign employment agreements with provisions that infringe on workers' rights, National Labor Relations Board prosecutors alleged, and the agency is seeking financial damages for affected employees.

  • June 20, 2024

    Web-Tracking Guidance Exceeded HHS' Authority, Judge Says

    A Texas federal judge ordered the Biden administration Thursday to rescind its new guidance restricting hospitals' use of online tracking technology, declaring that federal officials had overstepped their authority by redefining what they consider protected health information.

  • June 20, 2024

    UnitedHealth To Pay $1M To End NY AG Birth Control Probe

    New York Attorney General Letitia James announced Thursday that UnitedHealthcare of New York Inc. will pay $1 million to end allegations that the company violated Empire State law by refusing to fully cover an oral contraceptive.

  • June 20, 2024

    HHS Drug Pricing Program Flouts Constitution, Boehringer Says

    An "unprecedented" new Medicare price negotiation program deprives drugmakers of their constitutional rights and forces them to make declarations on issues of public concern that reflect poorly on them, Boehringer Ingelheim Pharmaceuticals Inc. argued Thursday in Connecticut federal court as it echoed the industry chorus seeking to strike the initiative.

  • June 20, 2024

    Attys Accused Of Judge Shopping Rebut Fraud Allegations

    An Alabama federal judge is conducting an in-camera review of a long-awaited "Q&A document" believed to have circulated among attorneys accused of judge shopping their efforts to fight a 2022 state law preventing transgender youth from accessing gender-affirming care, with the lawyers handing over the document but denying allegations of misconduct.

  • June 18, 2024

    Healthcare Tensions Equal Business For Litigation Funders

    As rampant consolidation collides with inflation-squeezed margins in the American healthcare system, tensions between service providers and insurers are at the breaking point and increasingly boiling "over into litigation," providing opportunities for litigation funders, according to a new article by Burford Capital LLC.

  • June 18, 2024

    High Court Petition Asks Justices: What's A 'Willful' Kickback?

    Does a "willful" act under federal anti-kickback law require a defendant to know that the conduct violates the law? That's the question a whistleblower is asking the U.S. Supreme Court to answer in order to resolve what the petition calls a circuit split on a key question of federal fraud prosecutions.

  • June 18, 2024

    Adderall Indictment Shows DOJ Focus On Telehealth Drugs

    The arrest of two digital health executives accused of conspiring to illegally distribute Adderall online is a "shot across the bow" from federal prosecutors ramping up enforcement of telehealth fraud.

  • June 18, 2024

    Company, States Battle In Court Over At-Home Rape Kits

    A fight is brewing in federal and state courts between a company that purports to be the nation's only purveyor of self-administered sexual assault DNA collection kits and state attorneys general who believe it is misleading sexual assault victims.

  • 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.

Expert Analysis

  • Skirting Anti-Kickback Causation Standard Amid Circuit Split

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    Amid the federal circuit court split over the causation standard applicable to False Claims Act cases involving Anti-Kickback Statute violations, which the First Circuit will soon consider in U.S. v. Regeneron, litigators aiming to circumvent the heightened standard should contemplate certain strategies, say Matthew Modafferi and Terence Park at Frier Levitt.

  • 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.