Policy & Compliance

  • May 23, 2024

    UBH Urges 9th Circ. To Take Up Petition In Health Claim Fight

    United Behavioral Health implored the Ninth Circuit to grant the insurance company's petition for appellate court intervention in a consolidated action alleging mismanagement of mental health and substance use disorder treatment claims, arguing a California federal court clearly erred by allowing further pleadings on a denial of benefits claim.

  • May 23, 2024

    Ambulance Co. Owner Accused Of $1M Pandemic Loan Fraud

    The owner of a California ambulance company who was charged last year with tax evasion and filing false returns has been further accused of fraudulently securing $1 million from federal pandemic relief loan programs, according to the U.S. Department of Justice.

  • May 23, 2024

    Cancer Society Strategist Starts 'New Adventure' With Venable

    Venable LLP has hired the former strategic director for the American Cancer Society's Cancer Action Network as a senior policy adviser for its legislative and government affairs practice group and its health policy team.

  • May 22, 2024

    Wash. Health System Wants $230M Worker Class Win Axed

    A Washington hospital system is seeking to derail a nearly $230 million judgement in favor of workers in a class wage case, contending the plaintiffs' key expert who testified at a state court trial recommended that jurors calculate damages based on a flawed equation that didn't account for differences in pay classifications.

  • May 22, 2024

    NC Panel Revives Retention Claim In Faulty Back Surgery Suit

    A North Carolina appeals court has revived a family's negligent retention claim against a clinic over a doctor who was ousted from the profession for unnecessary and faulty surgeries, finding the claim does not fall under the state's four-year statute of repose for medical malpractice claims.

  • May 22, 2024

    Anti-Abortion Activist Gets Two Years For DC Clinic Blockade

    An anti-abortion activist convicted of invading and blockading a Washington, D.C., reproductive health clinic was sentenced to two years of incarceration Wednesday, becoming the ninth defendant to get prison time in the D.C. federal court case.

  • May 21, 2024

    FTC Noncompete Ban Raises Stakes For Nonprofit Hospitals

    The Federal Trade Commission seems eager to apply its employee noncompete ban to healthcare, with a key target in mind: nonprofit healthcare providers that, in the agency's view, act more like for-profit businesses.

  • May 21, 2024

    Judge Shopping Row, Henrietta Lacks And SC Abortion Clock

    BigLaw lawyers get deeper into sanction spat, a case over profits from harvested cancer cells, and a Texas Supreme Court decision in a Fen-Phen malpractice suit. Law360 Healthcare Authority looks at those and other developments from the week in healthcare litigation.

  • May 21, 2024

    DC Circ. Says Drugmakers Can Limit Pharmacy Discounts

    The D.C. Circuit held Tuesday that a federal drug discount program does not bar manufacturers from restricting deliveries of discounted drugs to contract pharmacies, rejecting the U.S. Department of Health and Human Services' expansive interpretation of the 340B drug pricing program.

  • May 21, 2024

    Mich. Judge Doubts Abortion Laws Pass Constitutional Muster

    A Michigan state judge on Tuesday was skeptical state regulators could impose a waiting period and other requirements on people seeking abortions without violating a state constitutional amendment enshrining the right to abortion.

  • May 21, 2024

    NY High Court Upholds State Abortion Coverage Mandate

    New York's highest court on Tuesday upheld a state law requiring employee health plans to cover medically necessary abortions, finding a 2021 U.S. Supreme Court decision didn't change the state court's determination that an exemption process in the law was constitutional.

  • May 21, 2024

    Counties Not 'Persons' In Texas Opioid MDL Appeal

    A Texas appeals panel found Tuesday that counties are not considered "persons" under the state's common law and therefore are not subject to the Texas Medical Liability Act's requirement that they serve expert reports to pharmacy defendants in the state's opioid multidistrict litigation.

  • May 21, 2024

    Custom Drug Makers Stay On DOJ Radar In Fla. Fraud Case

    Federal law enforcement's stake in a recent whistleblower lawsuit focused on expensive skin creams shows the agency's focus on pharmacies providing custom medications — long recognized as a lucrative avenue for Medicare fraudsters — hasn't waned.

  • May 21, 2024

    Ga. Says Feds Shouldn't Prevail In Medicaid Expansion Suit

    Georgia urged a federal judge on Monday not to rule in favor of the Biden administration in its suit attempting to keep its Medicaid program for low-income residents running until 2028, arguing the government has "no authority" to make it apply for a program extension when "illegal acts" delayed the program's launch.

  • May 21, 2024

    Baker Donelson Lands Health Law Pair From Nelson Mullins

    Baker Donelson Bearman Caldwell & Berkowitz PC has added to its health law group and data protection, privacy and cybersecurity team two attorneys who previously worked at Nelson Mullins Riley & Scarborough LLP.

  • May 21, 2024

    Strategic Hiring Was The New Normal For BigLaw In 2023

    The 400 largest law firms by headcount in the U.S. grew more slowly in 2023 than in the previous two years, while Kirkland & Ellis LLP surpassed the 3,000-attorney threshold, according to the latest Law360 ranking.

  • May 21, 2024

    The Law360 400: Tracking The Largest US Law Firms

    The legal market expanded more tentatively in 2023 than in previous years amid a slowdown in demand for legal services, especially in transactions, an area that has been sluggish but is expected to quicken in the near future.

  • 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.

Expert Analysis

  • How HHS Discrimination Rule Affects Gender-Affirming Care

    Author Photo

    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

    Author Photo

    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

    Author Photo

    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

    Author Photo

    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?

    Author Photo

    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

    Author Photo

    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

    Author Photo

    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

    Author Photo

    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

    Author Photo

    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

    Author Photo

    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

    Author Photo

    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

    Author Photo

    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

    Author Photo

    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.