Policy & Compliance

  • May 21, 2024

    Paul Hastings' FDA Chair Departs For Arnold & Porter

    The chair of the U.S. Food and Drug Administration practice at Paul Hastings LLP has left for Arnold & Porter Kaye Scholer LLP just a few months after joining Paul Hastings, the firm said Tuesday.

  • May 20, 2024

    Texas Atty Chided For 'Crappy Strategy' Of Ducking Subpoena

    A transplant surgeon at Memorial Hermann Texas Medical Center accused of tampering with patients' donor acceptance criteria failed to show up to a Houston court hearing — partly thanks to his attorney — in three families' wrongful death case after being subpoenaed, in what a Harris County judge told his attorney was "a crappy strategy."

  • May 20, 2024

    EEOC Says Red States Can't Block PWFA Rule On Abortion

    The U.S. Equal Employment Opportunity Commission urged an Arkansas federal judge to reject a bid by 17 Republican state attorneys general to block recently finalized regulations that guide the Pregnant Workers Fairness Act, arguing that concerns about its abortion accommodations are merely hypothetical.

  • May 20, 2024

    iRhythm Brass Face Suit Over FDA's Heart Monitor Inquiry

    Several current and former directors and executives of medical technology company iRhythm are named in a shareholder derivative suit alleging they failed to disclose an inquiry by the Food and Drug Administration that found iRhythm's heavily touted and high-cost real-time heart monitoring device failed to meet the company's claims.

  • May 20, 2024

    Latham Hires 2 Skadden Healthcare Partners In DC

    Latham & Watkins LLP has picked up two healthcare and life sciences partners from Skadden Arps Slate Meagher & Flom LLP in Washington, D.C., the firm announced Monday.

  • May 20, 2024

    Patients Urge 9th Circ. To Deny UBH Petition In Claim Fight

    Patients alleging United Behavioral Health mismanaged their mental health and substance use disorder treatment claims urged the Ninth Circuit not to grant the insurance company's petition for appellate court intervention in the consolidated action, arguing the effort was inappropriate and unjustified.

  • May 20, 2024

    Northshore Unit Beats Employee's Vaccine Exemption Suit

    A nurse working for a Northshore Health unit in Illinois cannot pursue employment deprivation claims over the hospital's initial rejection of her COVID-19 vaccine religious exemption request since she was granted the exemption on appeal, a federal judge said Friday.

  • May 17, 2024

    Allergan Says Deserted Drug Rule Weakens $680M Fraud Suit

    Allergan drew a Maryland federal court's attention to the Centers for Medicare & Medicaid Services' abandonment of a regulation clarifying drug pricing, arguing the move undermined a whistleblower's claims that it overcharged Medicaid by over $680 million.

  • May 17, 2024

    Steward Health Ch. 11 Lifts Lid On PE In Healthcare

    Steward Health's $9 billion Chapter 11 has come under scrutiny from state attorneys general seeking to uncover why a once-rapidly growing hospital network ended up buried in debt, with authorities taking the unusual tack of turning a special eye toward its former private equity owner Cerberus Capital Management, experts told Law360.

  • May 17, 2024

    OB-GYN Enough Like GYN Oncologist For Expert Witness Law

    A Florida state appeals court on Friday revived a suit accusing a gynecological oncologist of performing an unnecessary surgery, saying the credentials of the patient's medical expert — an OB-GYN — satisfied the state's "same specialty" requirement.

  • May 17, 2024

    Jury Convicts NC Provider In Medicaid, COVID Fraud Scheme

    A clinical social worker in North Carolina was found guilty Friday of defrauding South Carolina's Medicaid program and falsely obtaining COVID-19 relief checks following a nine-day trial in Charlotte's federal courthouse, prosecutors said.

  • May 17, 2024

    Hinshaw Bolsters Healthcare Team In NY With New Partner

    Hinshaw & Culbertson LLP has added a healthcare-focused partner from New York healthcare and business firm Weiss Zarett Brofman Sonnenklar & Levy PC.

  • May 17, 2024

    Mass. Hospital Pays $24.3M To Settle Heart-Surgery FCA Case

    Cape Cod Hospital will pay $24.3 million to settle claims it flouted Medicare billing rules for hundreds of heart-valve replacement surgeries in what's understood to be the largest recovery under the False Claims Act from a Massachusetts hospital.

  • May 17, 2024

    Many Plans Already In Front Of 11th Circ. Trans Health Ruling

    The Eleventh Circuit's recent decision that a county health plan's coverage exclusion for gender transition surgery violated federal anti-discrimination law likely won't have a big impact on plans because they have already made adjustments for the U.S. Supreme Court ruling the appeals court applied, experts say.

  • May 16, 2024

    Ointment Scheme Conned Gov't Out Of Millions, Fla. Suit Says

    Two Florida brothers and one of their former employees are accused of running a years-long fraudulent scheme billing government healthcare programs and receiving millions of dollars after paying kickbacks to generate prescriptions for ointments that were not needed, according to a False Claims Act lawsuit.

  • May 16, 2024

    3rd Circ. Shuns Teva's 'Novel' Appeal On Israeli Investor Class

    The Third Circuit on Thursday turned away an appeal brought by Teva Pharmaceutical Industries Ltd., saying the class certification stage was not the right time to hear arguments over the "novel" question of the applicability of U.S. securities laws to Israeli-listed shares.

  • May 16, 2024

    FTC Deputy Director Rao On Healthcare Antitrust Agenda

    The reason behind the Federal Trade Commission's changed attitude toward antitrust in healthcare in recent years isn't simple, according to Rahul Rao, deputy director of the FTC's Bureau of Competition.

  • May 16, 2024

    EPA Doctor Not A Whistleblower For Slamming Lead Plan

    A former U.S. Environmental Protection Agency pediatrician and epidemiologist who publicly criticized the EPA's plan to reduce lead in drinking water as inadequate is not protected by federal whistleblower law, the Federal Circuit said Thursday.

  • May 16, 2024

    Fla. Seeks To Halt Biden's ACA Trans Discrimination Rule

    Florida urged a federal court to stop recently finalized regulations clarifying gender identity-based discrimination under the Affordable Care Act from taking effect, saying the new rules would force the state to abandon its health and safety laws or lose funding from the federal government.

  • May 15, 2024

    Feds Urge Prison For Convicted Baby Formula Fraudster

    Urging the judge to communicate the gravity of white collar crime, federal prosecutors in New York asked Wednesday that a Staten Island man get at least 2.25 years in prison after he pled guilty to forging baby formula prescriptions as part of a scheme to defraud insurers of $1.9 million.

  • May 15, 2024

    Anti-Trans Groups Fail To Block Wash. Youth Shelter Law

    A federal judge on Wednesday threw out a lawsuit filed by two anti-transgender groups challenging a Washington state law intended to ensure shelter for teens seeking gender-affirming care or reproductive health services, ruling that speculating on possible injury was not enough to clear a standing hurdle.

  • May 15, 2024

    AstraZeneca Sales Reps Win Early Cert. In Gender Bias Suit

    An Illinois federal judge on Tuesday granted a bid by workers to conditionally certify a collective in a lawsuit alleging AstraZeneca paid women less than men, giving the green light for notices to be sent out to female sales representatives who have worked at the pharmaceutical giant since late 2018.

  • May 14, 2024

    Hospitals Liable For Failing To Admit Killer, Pa. Justices Told

    The Pennsylvania Supreme Court was reminded Tuesday, during oral arguments over whether someone can be officially treated at a hospital without filling out an application, that the case before them concerned a man who killed his girlfriend after he was turned away despite claiming homicidal and suicidal impulses.

  • May 14, 2024

    Vein Tech Maker Faces Investor Suit Over DOJ Kickback Probe

    Vein disease device maker Inari Medical Inc. and three of its current and former executives face a proposed investor class action over claims that the company's share price fell after it disclosed an investigation into its compliance with federal anti-kickback laws.

  • May 14, 2024

    States Accuse EEOC Of 'Smuggling' Abortion Into PWFA Rule

    Louisiana and Mississippi have sued the U.S. Equal Employment Opportunity Commission seeking to invalidate regulations implementing the Pregnant Workers Fairness Act, claiming the agency's stance that employers must provide workers accommodations if they get an abortion flouts U.S. Supreme Court precedent and the PWFA itself.

Expert Analysis

  • How HHS Discrimination Rule Affects Gender-Affirming Care

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    The U.S. Department of Health and Human Services' new final rule, which reinterprets the Affordable Care Act's anti-discrimination provision, greatly clarifies protections for gender-affirming care and will require compliance considerations from sponsors and administrators of most group health plans, say attorneys at McDermott.

  • FTC Noncompete Rule's Impact On Healthcare Nonprofits

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    Healthcare entities that are nonprofit or tax-exempt and thus outside of the pending Federal Trade Commission noncompete rule's reach should evaluate a number of potential risk factors and impacts, starting by assessing their own status, say Ben Shook and Tania Archer at Moore & Van Allen.

  • Key Takeaways From FDA Final Rule On Lab-Developed Tests

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    Michele Buenafe and Dennis Gucciardo at Morgan Lewis discuss potential consequences of the U.S. Food and Drug Administration's recently finalized rule regulating lab-developed tests as medical devices, and explain the rule's phaseout policy for enforcement discretion.

  • Assessing HHS' Stance On Rare Disease Patient Assistance

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    The U.S. Department of Health and Human Services' recent advisory opinion, temporarily blessing manufacturer-supported copay funds for rare disease patients, carves a narrow path for single-donor funds, but charities and their donors may require additional assistance to navigate programs for such patients, says Mary Kohler at Kohler Health Law.

  • Are Concessions In FDA's Lab-Developed Tests Rule Enough?

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    Although the U.S. Food and Drug Administration's new policy for laboratory-developed tests included major strategic concessions to help balance patient safety, access and diagnostic innovation, the new rule may well face significant legal challenges in court, say Dominick DiSabatino and Audrey Mercer at Sheppard Mullin.

  • 8 Questions To Ask Before Final CISA Breach Reporting Rule

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    The Cybersecurity and Infrastructure Security Agency’s recently proposed cyber incident reporting requirements for critical infrastructure entities represent the overall approach CISA will take in its final rule, so companies should be asking key compliance questions now and preparing for a more complicated reporting regime, say Arianna Evers and Shannon Mercer at WilmerHale.

  • Mid-2024 FCA Enforcement And Litigation Trends To Watch

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    Reviewing notable False Claims Act trends and enforcement efforts in the last year and a half reveals that healthcare is a key enforcement priority for the U.S. Department of Justice, and the road ahead may bring clarification on Anti-Kickback Statute causation and willfulness standards, along with increased focus on private equity, cybersecurity and self-disclosure, say attorneys at Epstein Becker.

  • Online Portal Helps Fortify Feds' Unfair Health Practices Fight

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    The Federal Trade Commission, U.S. Justice Department and the U.S. Department of Health and Human Services recently launched an online portal where the public can report potentially unfair healthcare practices, effectively maximizing enforcers' abilities to police anti-competitive actions that can drive up healthcare costs and chill innovation, say attorneys at Seyfarth.

  • McKesson May Change How AKS-Based FCA Claims Are Pled

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    The Second Circuit’s analysis in U.S. v. McKesson, an Anti-Kickback Statute-based False Claims Act case, provides guidance for both relators and defendants parsing scienter-related allegations, say Li Yu at Dicello Levitt, Ellen London at London & Stout, and Erica Hitchings at Whistleblower Law.

  • 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.