Policy & Compliance

  • January 16, 2025

    Initial Green Light Given to UnitedHealth's Deal In TCPA Suit

    A Washington federal judge gave a $2.5 million settlement between UnitedHealthcare and a class of Telephone Consumer Protection Act claimants preliminary approval, signing off on a deal that class counsel says would net each class member over $90, if all applied.

  • January 16, 2025

    Merck Defends 3rd Circ. Win In Mumps Vaccine Antitrust Case

    Merck urged the Third Circuit not to reconsider a ruling that immunized the company from antitrust claims over submissions it made to federal regulators for its mumps vaccine, arguing the appeals court was right to find the submissions were protected.

  • January 16, 2025

    Chamber Slams Opioid Judge's PBM Audit Privilege Ruling

    The Sixth Circuit must step in to prevent a pharmacy benefit manager from being forced to turn over internal compliance audit documents, the U.S. Chamber of Commerce has said, arguing a lower court's decision threatens to undermine the existence of in-house counsel's attorney-client privilege. 

  • January 15, 2025

    Gilead, Feds Resolve HIV Drug Patent Dispute Amid Appeal

    Gilead Sciences and the federal government have agreed to dismiss all claims and counterclaims in a yearslong intellectual property and contract battle over HIV prevention drugs Truvada and Descovy, according to stipulations of voluntary dismissal filed Wednesday in both the Federal Circuit and Delaware federal court.

  • January 15, 2025

    FTC Won't Disqualify Commissioners From PBM Insulin Case

    The Federal Trade Commission denied bids from Caremark Rx, Express Scripts and OptumRx that sought to bar the commission's Democratic members from participating in a case accusing the pharmacy benefit managers of inflating insulin prices.

  • January 15, 2025

    Ruling On Fla. Gender Law Animus Is Flawed, 11th Circ. Told

    Florida urged an Eleventh Circuit panel on Wednesday to overturn an order declaring the state's ban on certain types of medical treatment for gender dysphoria unconstitutional, arguing the lower court wrongly used the condition as a proxy for transgender individuals in ruling that the prohibition was proof of discriminatory animus.

  • January 15, 2025

    9th Circ. Eyes Undoing Trans Patients' Win In ACA Bias Suit

    The Ninth Circuit seemed inclined Wednesday to strike down a trial court win for patients who challenged Blue Cross Blue Shield of Illinois' administration of their employer-provided health plans containing gender-affirming care exclusions, with two judges questioning why those employers weren't part of the case. 

  • January 15, 2025

    DOJ Reports $2.9B Haul Under FCA, Largest In 3 Years

    Litigation under the False Claims Act generated a little over $2.9 billion in settlements and judgments in the most recent fiscal year, a 5% bump over 2023's total and the most in three years, according to data released Wednesday by the U.S. Department of Justice.

  • January 15, 2025

    Former FDA Official Joins King & Spalding Life Sciences Team

    King & Spalding on Wednesday announced that a former U.S. Food and Drug Administration official has joined the firm's government matters and regulation practice group after an eight-year stint at the agency.

  • January 15, 2025

    Holland & Knight Adds Ex-GOP Rep. To Policy Advisory Team

    Holland & Knight LLP has hired seven-term Indiana Republican Congressman Larry Bucshon as a senior policy adviser.

  • January 14, 2025

    New EMTALA Suit in Idaho Seeks To Keep Injunction

    An Idaho health system filed a lawsuit Tuesday alleging that Idaho's strict abortion ban conflicts with an emergency stabilization law and is seeking to keep the ban blocked while it prepares to take up the legal battle once fought by the Biden administration.

  • January 14, 2025

    Dispute Over Eli Lilly Weight Loss Drug Reignited

    Compounding pharmacies have reignited a suit against the U.S. Food and Drug Administration over the removal of a lucrative weight loss drug from the shortage list, with a Texas federal judge ordering both sides to turn in briefing on injunctive relief during a Tuesday hearing.

  • January 14, 2025

    FTC Issues Second Report On PBMs, Expanding Study Scope

    The Federal Trade Commission released a second "interim" report on pharmacy benefit managers and their effects on specialty drug prices Tuesday, claiming that the companies have driven up prices well over acquisition costs and continue to squeeze independent pharmacies out of the market through low reimbursement rates.

  • January 14, 2025

    Both Michigan US Attys Resign Ahead Of Inauguration

    Michigan's U.S. attorneys, Dawn Ison in the Eastern District and Mark Totten in the Western District, announced their departures this week ahead of President-elect Donald Trump's inauguration.

  • January 14, 2025

    Healthcare Laws Taking Effect In 2025

    This year, the healthcare industry will see a host of new laws touching on everything from private equity transactions and oversight to drug price caps and medical leave policies.

  • January 14, 2025

    Whistleblowing Compliance Pro Secures 4th FCA Settlement

    A repeat whistleblower has cost hospitals more than $43 million in federal settlements over the last 18 years, illustrating the increased use of data analysis and other trends in False Claims Act litigation.

  • January 14, 2025

    2nd Circ. Rules Prison Docs Can't Escape Indifference Claims

    A Second Circuit panel on Monday ruled two New York prison doctors must face a former inmate's deliberate indifference claims for allegedly overlooking his cancer symptoms despite medical exam results, while also finding the inmate's claims were not time-barred, though the court said the state and facility are protected by sovereign immunity. 

  • January 14, 2025

    Mass. AG Says Insulin Makers, Middlemen Colluded On Costs

    Insulin makers Eli Lilly, Sanofi and Novo Nordisk conspired with pharmacy benefit managers OptumRX, Express Scripts and CVS Caremark to jack up prices by as much as 1,000%, the Massachusetts attorney general alleged in a suit.

  • January 14, 2025

    Assisted Living Co., Ex-Worker End Race-Based Pay Bias Suit

    An assisted living facility and a former employee have agreed to close her suit claiming she was paid less than colleagues and belittled by her supervisor because she is Indian American, according to a New York federal court filing.

  • January 13, 2025

    Lincare Pays $1.15M To End Wash. Medicaid Fraud Probe

    Lincare Inc. agreed to pay $1.15 million to resolve a Washington probe into allegations the medical equipment supplier overbilled Medicaid for rental payments for patients' oxygen equipment over a six-year period, the Washington State Office of the Attorney General announced Monday.

  • January 13, 2025

    Blue Cross Can't Skirt NC Hospital's Defamation Claims

    A local hospital can pursue some of its defamation claims against Blue Cross and Blue Shield of North Carolina in a suit alleging the health insurer wrongly denied millions of dollars in reimbursements and falsely accused the facility of fraud, a federal judge ruled Monday.

  • January 13, 2025

    Duke Health Worker Agrees To Arbitrate Bias Suit, For Now

    A former Duke University Health System Inc. radiology technologist who accused the healthcare network of firing her for being pregnant with her second child told a North Carolina federal judge Monday she is all right with her former employer's request to take the matter to arbitration.

  • January 13, 2025

    RFK Jr.'s Wash. Anti-Vax Suit Can't Get High Court Save

    The U.S. Supreme Court on Monday rejected Robert F. Kennedy Jr.'s bid for an emergency order to temporarily block a state of Washington medical board investigation into alleged anti-vaccine statements made by retired doctors.

  • January 13, 2025

    Feds Say NC Medical Biz Owner Overbilled For Nutrient Drinks

    A North Carolina businessman who ran a durable medical equipment business under multiple names overbilled the state's Medicaid program $1.85 million for special enteral nutritional formulas used to treat inherited metabolic disorders when he was actually just providing people common nutritional shakes like Ensure, the federal government said.

  • January 13, 2025

    Supreme Court Turns Away IP Safe Harbor Dispute

    The U.S. Supreme Court on Monday said it won't consider whether the Federal Circuit has overexpanded a safe harbor for drug development, in litigation where Meril Life Sciences escaped allegations that it infringed Edwards Lifesciences' heart valve patents.

Expert Analysis

  • Key Healthcare Issues That Hinge On The Election Outcome

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    The 2024 presidential race, while not heavily dominated by healthcare issues compared to past elections, holds significant implications for the direction of healthcare policy in a potential Harris or Trump administration, encompassing issues ranging from Medicare to artificial intelligence, says Miranda Franco at Holland & Knight.

  • The Key To Solving High Drug Costs Is Understanding Causes

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    One-sided views on who or what contributes to the high cost of pharmaceuticals render possible solutions much harder to discover and implement, and a better approach would be to examine history and learn why costs have increased and what legislation has and hasn't helped, says Nancy Linck at NJ Linck Consulting.

  • Next Steps For FCA Defendants After Fla. Qui Tam Ruling

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    Because a Florida federal court's recent decision in Zafirov v. Florida Medical Associates could eventually prove to be a watershed event for False Claims Act suits, defendants should consider potential next steps to ensure that their litigation benefits from the court's reasoning and further developments, says Scott Gallisdorfer at Bass Berry.

  • A Look At Calif.'s New AI Law For Health Insurers

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    A newly enacted California law prohibits artificial intelligence tools from making medical necessity determinations for healthcare service plans or disability insurers, addressing core questions that have arisen around AI's role in coverage decisions, say attorneys at DLA Piper.

  • New HHS Research Misconduct Rules Bring Seismic Changes

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    The U.S. Department of Health and Human Services' new rule regarding research misconduct investigations brings significant changes that focus on remediation, appeals and confidentiality, while other changes could result in institutions causing undue harm to scientists accused of such misconduct, say attorneys at Cohen Seglias.

  • Fla. Ruling May Undermine FCA Whistleblowers' Authority

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    A Florida federal court's decision in Zafirov v. Florida Medical Associates last month will deprive relators of their ability to bring suits under the False Claims Act, limiting their capability to expose and rectify wrongdoings and potentially affecting billions in FCA recoveries, say Matthew Nielsen and Lily Johnson at Bracewell.

  • 11th Circ. Kickback Ruling May Widen Hearsay Exception

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    In a $400 million fraud case, U.S. v. Holland, the Eleventh Circuit recently held that a conspiracy need not have an unlawful object to introduce co-conspirator statements under federal evidence rules, potentially broadening the application of the so-called co-conspirator hearsay exception, say attorneys at ArentFox Schiff.

  • Navigating Complex Regulatory Terrain Amid State AG Races

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    This year's 10 attorney general elections could usher in a wave of new enforcement priorities and regulatory uncertainty, but companies can stay ahead of the shifts by building strong relationships with AG offices, participating in industry coalitions and more, say Ketan Bhirud and Dustin McDaniel at Cozen O’Connor.

  • Navigating HHS' New Reproductive Healthcare Privacy Rule

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    The U.S. Department of Health and Human Services' new final rule regarding protections for the privacy of reproductive health information will require regulated entities to grapple with difficult questions about whether to comply with state law requirements or federal privacy prohibitions, says Christine Chasse at Spencer Fane.

  • Mental Health Parity Rules: Tips For Plans And Issuers

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    Following federal agencies' release of final mental health parity rules, plan sponsors and health insurance issuers should develop protocols for preparing compliant nonquantitative treatment limitation comparative analyses, say attorneys at Ropes & Gray.

  • FTC's Report Criticizing Drug Middlemen Is Flawed

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    The Federal Trade Commission's July report, which claims that pharmacy benefit managers are inflating drug costs, does not offer a credible analysis of PBMs, and its methodology lacks rigor, says Jay Ezrielev at Elevecon.

  • Plan Sponsors Must Prep For New Mental Health, Drug Rules

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    To comply with newly published health insurance rules requiring parity between access to mental health and substance use services compared to medical and surgical services, employers with self-insured plans will need to update third-party administrator agreements and collect data, among other compliance steps, say attorneys at Kilpatrick.

  • A Primer On Navigating The Conrad 30 Immigration Program

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    As the Conrad 30 program opens its annual window to help place immigrant physicians in medically underserved areas, employers and physicians engaged in the process must carefully understand the program's nuanced requirements, say Andrew Desposito and Greg Berk at Sheppard Mullin.