Policy & Compliance

  • June 25, 2024

    The Federal Judge At The Center Of NC Abortion Battles

    A lone federal judge in North Carolina is playing an outsize role in abortion access cases critical to women seeking the procedures across much of the American South.

  • June 25, 2024

    Longtime Pediatrix Atty Joins Envision Healthcare As GC

    The longtime top attorney for Pediatrix Medical Group Inc. has joined Nashville, Tennessee-based national medical group Envision Healthcare as its new general counsel.

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Unified School District said Friday that a split Ninth Circuit panel leaned on pseudoscience when ruling that a rescinded employee COVID-19 vaccination mandate implicated the right of district employees to refuse medical treatment, urging an en banc panel to correct the "fatally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

    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?

Expert Analysis

  • 9th Circ. Ruling Puts Teeth Into Mental Health Parity Claims

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    In its recent finding that UnitedHealth applied an excessively strict review process for substance use disorder treatment claims, the Ninth Circuit provided guidance on how to plead a Mental Health Parity and Addiction Equity Act violation and took a step toward achieving mental health parity in healthcare, says Mark DeBofsky at DeBofsky Law.

  • Breaking Down DOJ's Individual Self-Disclosure Pilot Program

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    The U.S. Department of Justice’s recently announced pilot program aims to incentivize individuals to voluntarily self-disclose corporate misconduct they were personally involved in, complementing a new whistleblower pilot program for individuals not involved in misconduct as well as the government's broader corporate enforcement approach, say attorneys at Paul Weiss.

  • 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.