Policy & Compliance

  • June 11, 2024

    Beveridge & Diamond Hires DOJ Jan. 6 Litigator In DC

    Beveridge & Diamond PC's new white collar principal, Louis Manzo, has worked on some of the highest-profile cases in the nation for the Justice Department, helping secure convictions for several January 6 insurrectionists charged with seditious conspiracy.

  • June 10, 2024

    Rehab Clinics Add To MultiPlan Insurance Fixing Pile-On

    Addiction treatment providers sued MultiPlan, Aetna, Cigna, UnitedHealth and Elevance Friday and Saturday in 14 separate New York federal court complaints that appear to be the first to add substance abuse disorder-specific allegations to the cases pegging MultiPlan at the center of a scheme to suppress insurer payouts.

  • June 10, 2024

    IHS Urges Budget Shift After High Court Healthcare Ruling

    The Indian Health Service, following a divided U.S. Supreme Court decision affirming that the federal government is liable for the reimbursement of millions in administrative healthcare costs for two Native American tribes, is urging Congress to shift its budget appropriations for fiscal year 2026 to protect the agency's overall health.

  • June 10, 2024

    SoCal Workers Want Class Cert. In Union Healthcare Fee Suit

    A group of union-represented Southern California hospitality workers who say they're getting charged much higher health insurance rates than their counterparts in Las Vegas are seeking class certification in their lawsuit challenging the rates, according to a filing in Illinois federal court.

  • June 10, 2024

    Baltimore Lands $45M Deal With Allergan In Opioid Litigation

    Baltimore has put to rest its claims that Allergan played a part in the opioid crisis, reaching a $45 million settlement with the pharmaceutical company, an amount the city called "unprecedented" in an announcement on Monday.

  • June 10, 2024

    Colo. Justices Say Doc-Patient Privilege Mirrors Atty-Client

    The Colorado Supreme Court held Monday that doctor-patient privilege does persist after a patient dies but that a "testamentary exception" exists for when a late patient's medical records become necessary information to execute their estate, similar to how attorney-client privilege works.

  • June 10, 2024

    Drugmakers Look To Nix Non-Insulin Claims From AG Suit

    Novo Nordisk, Eli Lilly and Sanofi-Aventis asked the federal judge overseeing a diabetes drug price-fixing multidistrict litigation to rule for drugmakers on Mississippi's claims the pricing for GLP-1s is illegal, saying in a brief that the drugs are under patent and too new to be included in the insulin-pricing suit.

  • June 10, 2024

    'Four Tops' Singer Sues ER Staff Who Ordered Psych Test

    The lead singer of Motown group The Four Tops has sued a hospital in Michigan federal court, claiming in a complaint filed Monday that hospital staff treated him as if he was mentally ill when he said he was a famous singer.

  • June 10, 2024

    3 Takeaways From Cigna's Win In 9th Circ. Rehab Claim Fight

    The Ninth Circuit's recent decision finding Cigna is off the hook for $8.6 million in out-of-network mental health and substance use disorder treatment claims against employee benefit plans administered by the insurer could discourage similar litigation, benefits attorneys say. Here are three key takeaways from the decision.

  • June 10, 2024

    FTC To Fight Go-Ahead Order On Novant $320M Hospital Deal

    Just days after a district court loss, the Federal Trade Commission said Monday it will ask the Fourth Circuit to step in and block Novant Health from buying two North Carolina hospitals in a $320 million deal the agency contends would harm competition.

  • June 10, 2024

    Mass. Nursing Home To Pay Record $4M Over Neglect Claims

    A Massachusetts nursing home operator has agreed to pay a total of $4 million and hire an independent monitor to settle allegations that understaffing at its 16 facilities led to substandard care and patients being harmed, the attorney general’s office announced Monday. Next Step Healthcare LLC has agreed pay $750,000 directly to the state and dedicate the remaining $3.25 million toward increasing staffing levels.

  • June 10, 2024

    High Court To Review HHS Hospital Pay Formula

    The U.S. Supreme Court on Monday agreed to review a D.C. Circuit decision siding with the Department of Health and Human Services over how the agency applies a formula for calculating disproportionate share hospital payments for Supplemental Security Income benefits.

  • June 07, 2024

    Conn. Judge Pushes State For Proof In $11M Kickback Case

    The Connecticut state judge presiding over an $11 million false claims and kickbacks case against a compounding pharmacy appeared unconvinced Friday that the defendants submitted false claims for payment, peppering the government's counsel with requests to support assertions with case law and evidence that was put on at trial.

  • June 07, 2024

    Chicago-Area Man Charged With $60M COVID Test Fraud

    A suburban Chicago man is facing healthcare fraud and money laundering charges over more than $60 million in Medicare reimbursement claims for over-the-counter COVID-19 test kits that were allegedly never provided, including thousands of tests for dead people.

  • June 07, 2024

    7 Health Insurers Eye Rate Hikes In Connecticut

    Seven health insurers have asked Connecticut state regulators to approve rate hikes of 7.4% to 12.5% for individual market plans and 5.1% to 13.6% for small groups, averaging out to a lesser increase than last year's, according to an announcement Friday.

  • June 06, 2024

    Chronic Care Co. To Pay $14.9M To End DOJ False Claims Suit

    A provider of chronic disease management services across several states has reached a $14.9 million settlement with the U.S. Department of Justice, resolving a False Claims Act suit alleging it defrauded Medicare and Medicaid by "upcoding" healthcare claims.

  • June 06, 2024

    Justices Say Feds Liable For Tribes' Healthcare Admin Costs

    A split U.S. Supreme Court on Thursday held that the federal government is required to reimburse two Native American tribes millions of dollars in administrative healthcare costs, saying the spending is necessary for the communities to operate programs assumed from the Indian Health Service.

  • June 05, 2024

    House Votes To Block Vets' Access To Gender-Affirming Care

    The U.S. House of Representatives on Wednesday passed a $147.5 billion spending bill along mostly party lines funding military construction and the U.S. Department of Veterans Affairs, which would block veterans' access to gender-affirming care and which the White House has already threatened to veto.

  • June 05, 2024

    Calif. Wage Hike To Cover Nearly All Healthcare Workplaces

    Nearly all workers at healthcare facilities in California will be entitled to a higher minimum wage beginning July 1 regardless of whether they're involved in patient care. One expert called the increase a sweeping change, partly due to broad definitions of what employees and facilities are covered.

  • June 04, 2024

    Divided 9th Circ. Reverses Sutter Health Antitrust Trial Victory

    A split Ninth Circuit panel on Tuesday overturned Sutter Health's win in insurance plan purchasers' $400 million antitrust suit, ruling that the lower court wrongly excluded "highly relevant" evidence — including admissions by Sutter executives — that would've helped the purchasers potentially prove claims they overpaid thanks to Sutter's anticompetitive conduct.

  • June 04, 2024

    Texas Justices Fuel Confusion Over Abortion Ban Exceptions

    The Texas Supreme Court recently ruled that doctors may perform abortions only when "reasonable medical judgment" says a patient's life is in danger — a decision attorneys say puts doctors in the position of weighing the lives of their patients against the risk of criminal prosecution.

  • June 04, 2024

    FDA Advisers Rebuff Bid To Treat PTSD With MDMA

    A panel of public health experts on Tuesday dealt a blow to a historic effort to regulate MDMA therapy for post-traumatic stress disorder, saying although the positive effects shown in clinical trials are promising, the proposal was hindered by too many confounding factors.

  • June 04, 2024

    HHS Guidance, Feud Over FCA Evidence, And A Deposed AG

    States sue the Biden administration over nondiscrimination guidance. A False Claims Act case sees a tussle over evidence. A Connecticut federal judge allows drugmakers to depose the office of D.C.'s attorney general. Here, Law360 Healthcare Authority looks at notable developments in healthcare litigation over the past week.

  • June 04, 2024

    Ga. County Wants 11th Circ. To Rethink Trans Care Ban Ruling

    A Georgia county that lost a legal challenge to a provision of its health plan that bars coverage for gender-affirming surgery has asked the full Eleventh Circuit to revisit the decision, arguing that an opinion last month wrongly found the policy discriminates against transgender people, rather than being isolated to a single procedure.

  • June 04, 2024

    2nd Circ. Says ERISA Blocks Cigna Bill Backpedaling Suit

    The Second Circuit affirmed the dismissal of a podiatric medicine provider's suit alleging Cigna illegally backtracked on covering a patient's $200,000 bill, ruling that a lower court was right to find that federal benefits law blocks the healthcare provider's breach of contract claims.

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.