Policy & Compliance

  • March 04, 2025

    Congress' Plan To Cut Medicaid Budget: 3 Things To Know

    As Congress grapples with potential Medicaid cuts after passage of the House budget last week, experts are concerned that lawmakers will slash the program by $880 billion, leading to fresh lawsuits and legal obstacles.

  • March 04, 2025

    Hospitals Risk Penalties As Trump Pushes Price Transparency

    President Donald Trump's executive order to sharpen enforcement of healthcare price transparency regulations is a "warning bell" that hospitals and health plans may face stiffer fines and tighter deadlines as they evaluate how to disclose complex data.

  • March 04, 2025

    HHS Cuts Hit Attys Tackling Medicare Appeals Backlog

    The Department of Health and Human Services is terminating more than a dozen attorneys charged with reducing a massive backlog of Medicare appeals at an internal administrative board. The cuts may slow an already cumbersome administrative process.

  • March 04, 2025

    Lead Testing Operations Chief To Admit Misbranding Charge

    The former chief operating officer of Magellan Diagnostics will admit to defrauding the public by hiding flaws in the company's lead testing devices for years, according to a filing in Massachusetts federal court.

  • March 03, 2025

    Ultragenyx Loses Bid To Toss Suit Over Henrietta Lacks' Cells

    A Maryland federal judge on Monday refused to toss a lawsuit lodged by the family of the late Henrietta Lacks against biotechnology company Ultragenyx for allegedly profiting off her stolen "immortal" cells, saying proof Ultragenyx engaged in intrastate business in Maryland would thwart its contention the lawsuit was filed too late.

  • March 03, 2025

    Sandoz Settles Florida's Generic Drug Price-Fixing Claims

    Sandoz AG reached a settlement with Florida that ends federal antitrust claims the Sunshine State lodged against the drugmaker within wider litigation claiming numerous pharmaceutical companies and individuals participated in a conspiracy to fix generic drug prices, according to a Friday court filing.

  • March 03, 2025

    Teva Should Face Key Copaxone Antitrust Claims, Court Told

    Mylan and pharmaceutical wholesalers should be allowed to proceed with some, but not all, parallel claims accusing Teva of using regulatory deception, false advertising, improper rebates and more to delay generic competition to its Copaxone multiple sclerosis treatment, a special master has recommended in New Jersey federal court.

  • March 03, 2025

    Trump Admin Defends Right To Send DOGE Into Agencies

    A group of unions is trying to limit the president's right to oversee the executive branch by claiming that Elon Musk's Department of Government Efficiency can't access agencies' computer systems, the Trump administration told a D.C. federal judge, asking him to nix the unions' injunction bid.

  • March 03, 2025

    Sutter Settles Years-Old Antitrust Suit On Courthouse Steps

    Attorneys for a class of millions of health insurance premium payors announced an eleventh hour deal staving off a new antitrust trial Monday in California federal court over claims that hospital chain Sutter Health drives up costs by pushing all-or-nothing network deals on insurers.

  • March 03, 2025

    2nd Circ. Denies Amish Schools' Vaccine Rule Challenge

    The Second Circuit on Monday denied a religious challenge to New York's immunization law from three Amish schools and two Amish parents, saying both the appellate court and the U.S. Supreme Court have a history of upholding school immunization requirements implemented by states.

  • February 28, 2025

    Group Blasts Judge's Call For Women In Contraception MDL

    A judicial organization dedicated to fighting "leftist lawfare" filed a complaint Thursday against the Florida federal judge overseeing multidistrict litigation over the hormonal contraceptive drug Depo-Provera, claiming that her comments about women needing to be represented in the MDL leadership show an impermissible bias.

  • February 28, 2025

    Wash. Judge Picks Apart Parents' Hospital Data Privacy Suit

    A Washington appellate judge on Friday grilled parents seeking to revive their proposed privacy class action against a Seattle hospital, expressing frustration with their argument that state wiretapping law could apply to an individual's queries to a public-facing website.

  • February 28, 2025

    Ex-Conn. Official Hit With New Corruption Charges

    A federal grand jury has indicted former Connecticut budget official Konstantinos Diamantis and Christopher Ziogas, a suspended attorney and former lawmaker, for allegedly accepting bribes to end a state audit targeting Ziogas' fiancée, an optometrist who separately admitted to healthcare fraud, prosecutors said Friday.

  • February 28, 2025

    SuperValu Complains About Falsity Question In FCA Case

    Whistleblowers claiming SuperValu overcharged the government by $123 million for prescriptions can ask witnesses a single question alluding to a bitterly contested legal finding in the False Claims Act case in Illinois federal court, the grocer revealed in a motion objecting to the judge allowing that question.

  • February 28, 2025

    Aetna, Optum To Pay $8.3M To End ERISA Fee Suit

    Aetna Inc. and OptumHealth Care Solutions LLC will pay $8.3 million to settle 88,000 patients' claims that they were overcharged in a scheme to hide administrative fees as medical expenses, nearly three months after OptumHealth said it was pulling out of the deal.

  • February 27, 2025

    FTC Asks To Delay In-House PBM Insulin Case

    Arguing that pharmacy benefit managers accused of artificially inflating insulin prices have already "unreasonably delayed" discovery, the Federal Trade Commission is asking an in-house judge to push back an evidentiary trial in the case, saying it would allow the administrative court more time to accommodate up to 17 expert witnesses.

  • February 27, 2025

    Unions Can Depose DOGE In Agency Access Suit, Judge Says

    The Department of Government Efficiency must tell a group of unions whom it's sent into the Department of Labor, the Department of Health & Human Services and the Consumer Financial Protection Bureau and what computer systems they've accessed, a D.C. federal judge ruled Thursday.

  • February 27, 2025

    CooperSurgical Says Unique IVF Claims Require Separate Trials

    Fertility company CooperSurgical Inc. is pushing back against the suggestion that four lawsuits accusing the company of negligently destroying embryos with its recalled culture media could be consolidated into one trial, saying the couples' varied location and unique IVF situations preclude joining them.

  • February 27, 2025

    CVS Freed From Hospital's Suit Over Drug Pricing Program

    A Pennsylvania hospital's antitrust lawsuit claiming CVS forced healthcare providers participating in a federal discount drug program to go through the pharmacy chain's administrator has been tossed, with a federal judge ruling the hospital fell short in its allegations of anticompetitive behavior.

  • February 27, 2025

    Cedars-Sinai Strikes Deal To End Retirement Plan Suit

    Cedars-Sinai Medical Center Inc. and a group of retirement plan participants agreed to settle a proposed class action alleging the healthcare system loaded the plan with excessive recordkeeping fees and underperforming investment options, according to a California federal court filing.

  • February 27, 2025

    Polsinelli Blocked From Repping BCBS Settlement Opt-Outs

    An Alabama federal judge has disqualified Polsinelli PC from representing hospitals that opt out of a landmark $2.8 billion Blue Cross Blue Shield antitrust settlement, even as other firms are licking their lips at the prospect of a multibillion-dollar bonanza of opt-out litigation.

  • February 27, 2025

    NC Pharmacy Settles Feds' Suit Over Opioid Records

    A North Carolina pharmacy has agreed to pay $204,000 to resolve allegations that it violated federal recordkeeping requirements for controlled substances, the U.S. Attorney's Office for the Western District of North Carolina announced Thursday.

  • February 26, 2025

    Merck, Glenmark Trim United Healthcare's Zetia Antitrust Suit

    A Minnesota federal judge has trimmed a United Healthcare unit's antitrust suit claiming that Merck and Glenmark conspired to delay a generic version of the anti-cholesterol drug Zetia, throwing out non-Minnesota state-law claims he called a "bare and conclusory pleading."

  • February 26, 2025

    Planned Parenthood Immune From FCA Suit, 5th Circ. Says

    Planned Parenthood is entitled to attorney immunity, the Fifth Circuit said Wednesday in a case that had accused the organization of improperly billing Medicaid programs for millions after losing its Medicaid credentials.

  • February 26, 2025

    CVS Ordered To Comply With FTC's PBM Subpoena

    A D.C. federal judge is ordering CVS to turn over new materials in the Federal Trade Commission's investigation into its pharmacy benefit manager Caremark Rx, saying that just because producing updated documents would cost the company more doesn't mean it faces an "undue burden."

Expert Analysis

  • 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.

  • 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.