Policy & Compliance

  • June 24, 2024

    NYC Pharmacy Owners Get Jail Time For $18M Med Fraud

    Two brothers who own several New York pharmacies will each have to pay over $18 million in restitution in addition to serving jail time for submitting fraudulent claims to Medicare for pricey cancer medication and funneling illicit proceeds through several shell companies, the U.S. Department of Justice announced Monday.

  • June 24, 2024

    Health Co. Narrows Doctor's Reneged Benefits Suit

    An Arizona federal judge trimmed a doctor's suit claiming her healthcare system employer refused to let her use her benefits to take time off to undergo cancer treatments, but kept alive claims that the company violated state and federal law by misleading her about paid leave.

  • June 24, 2024

    LA Schools Says Pseudoscience Infected 9th Circ. Vax Ruling

    The Los Angeles Unified School District said Friday that a split Ninth Circuit panel leaned on pseudoscience when ruling that a rescinded employee COVID-19 vaccination mandate implicated the right of district employees to refuse medical treatment, urging an en banc panel to correct the "fatally flawed" decision.

  • June 24, 2024

    Ark. AG Sues Pharmacy Benefit Managers Over Opioids

    The Arkansas attorney general said Monday that he had sued pharmacy benefit managers Optum Inc. and Express Scripts Inc. in state court, claiming they contributed to the opioid crisis and profited from the drug epidemic.

  • June 24, 2024

    Justices Pass On Conn. School Vaccine Mandate Fight

    The U.S. Supreme Court on Monday declined to review a Second Circuit decision that largely upheld the dismissal of a suit challenging a Connecticut law passed during the COVID-19 pandemic that revoked religious exemptions to student vaccine mandates.

  • June 24, 2024

    Justices Pass On Rutgers COVID-19 Vax Mandate Case

    The U.S. Supreme Court declined on Monday to review a split Third Circuit ruling that Rutgers University students cannot challenge the school's COVID-19 vaccine policy because, under the high court's 1905 precedent in Jacobson v. Massachusetts, there is no fundamental right to refuse vaccinations.

  • 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

    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

    '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.

Expert Analysis

  • High Court's Abortion Pill Ruling Shuts Out Future Challenges

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    The U.S. Supreme Court's unanimous ruling in U.S. Food and Drug Administration v. Alliance for Hippocratic Medicine maintains the status quo for mifepristone access and rejects the plaintiffs' standing theories so thoroughly that future challenges from states or other plaintiffs are unlikely to be viable, say Jaime Santos and Annaka Nava at Goodwin.

  • Orange Book Warnings Highlight FTC's Drug Price Focus

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    In light of heightened regulatory scrutiny surrounding drug pricing and the Federal Trade Commission's activity in the recent Teva v. Amneal case, branded drug manufacturers should expect the FTC's campaign against allegedly improper Orange Book listings to continue, say attorneys at Ropes & Gray.

  • A Plaintiffs-Side Approach To Cochlear Implant Cases

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    As the number of cochlear implants in the U.S. continues to grow, some will inevitably fail — especially considering that many recalled implants remain in use — plaintiffs attorneys should proactively prepare for litigation over defective implants, says David Shoop at Shoop.

  • Inside Antitrust Agencies' Rollup And Serial Acquisition Moves

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    The recent request for public comments on serial acquisitions and rollup strategies from the Federal Trade Commission and U.S. Justice Department mark the antitrust agencies' continued focus on actions that fall below premerger reporting thresholds, say attorneys at Paul Weiss.

  • Short-Term Takeaways From CMS' New Long-Term Care Rules

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    The Centers for Medicare & Medicaid Services' new final rule on nursing home staffing minimums imposes controversial regulatory challenges that will likely face significant litigation, but for now, stakeholders will need to prepare for increased staffing expectations and more specialized facility assessments without meaningful funding, say attorneys at Morgan Lewis.

  • FDA's Data Monitoring Guidance Reveals Future Expectations

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    As the world of clinical research grows increasingly complex, the U.S. Food and Drug Administration's recent draft guidance on the use of data monitoring committees in clinical trials reveals how the agency expects such committees to develop, say Melissa Markey and Carolina Wirth at Hall Render.

  • FDA Warning Indicates Scrutiny Of Regenerative Health Cos.

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    The U.S. Food and Drug Administration's recent warning letter to Akan Biosciences is a quintessential example of the agency's enforcement priorities for certain products involving human cells and tissues, and highlights ongoing scrutiny placed on manufacturers, say Dominick DiSabatino and Cortney Inman at Sheppard Mullin.

  • 2 Regulatory Approaches To Psychedelic Clinical Trials

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    Comparing the U.S. and Canada's regulatory frameworks for clinical trials of psychedelic drugs can be useful for designing trial protocols that meet both countries' requirements, which can in turn help diversify patient populations, bolster data robustness and expedite market access, say Kimberly Chew at Husch Blackwell and Sabrina Ramkellawan at AxialBridge.

  • 'Food As Health' Serves Up Fresh Legal Considerations

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    The growth of food as medicine presents a significant opportunity for healthcare organizations and nontraditional healthcare players to improve patient outcomes and reduce costs, though these innovative programs also bring compliance considerations that must be carefully navigated, say attorneys at McDermott.

  • DC Circ. Ruling Heightens HHS Contract Pharmacy Challenges

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    The D.C. Circuit's recent ruling that the Section 340B program does not bar manufacturers from restricting deliveries of discounted drugs to contract pharmacies represents a second strike against the U.S. Department of Health and Human Services' current contract pharmacy policy and raises the stakes surrounding an upcoming Seventh Circuit ruling on the same issue, say attorneys at Foley Hoag.

  • FTC Focus: Exploring The Meaning Of Orange Book Letters

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    The Federal Trade Commission recently announced an expansion of its campaign to promote competition by targeting pharmaceutical manufacturers' improper Orange Book patent listings, but there is a question of whether and how this helps generic entrants, say Colin Kass and David Munkittrick at Proskauer.

  • 3rd Circ.'s Geico Ruling May Encourage Healthcare Arbitration

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    The Third Circuit's recent decision in Geico v. Mount Prospect, finding that claims under New Jersey's Insurance Fraud Prevention Act can be arbitrated, strengthens arbitration as a viable alternative to litigation, even though it is not necessarily always a more favorable forum, say Khaled Klele and Jessica Osterlof at McCarter & English.

  • Proposed Cannabis Reschedule Sidesteps State Law Effects

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    The U.S. Department of Justice's recent proposal to move cannabis to Schedule III of the Controlled Substances Act provides certain benefits, but its failure to address how the rescheduling would interact with existing state cannabis laws disappointed industry participants hoping for clarity on this crucial question, says Ian Stewart at Wilson Elser.