Policy & Compliance

  • June 12, 2024

    32 AGs Urge Justices Take Up Okla. PBM Law Fight

    Thirty-two attorneys general urged the U.S. Supreme Court to take up Oklahoma's petition for review of a Tenth Circuit decision holding that federal law preempted portions of a state law regulating pharmacy benefit managers, arguing the justices needed to intervene to resolve a circuit split.

  • June 12, 2024

    Sen. Dems Seek Criminal Penalties For PE Hospital 'Looters'

    A pair of Democratic senators are targeting private equity's role in the healthcare industry, introducing new legislation Tuesday that would give federal and state enforcers new tools to go after firms they say are "looting" hospital systems and other providers, including possibly jailing executives if patient deaths result.

  • June 11, 2024

    6th Circ. Judge Doubts Clinic's Standing To Block Bias Law

    During Sixth Circuit arguments Tuesday probing whether a Christian medical clinic can block Michigan from targeting it for refusing to facilitate gender transitions, one judge searched for evidence that the clinic is actually at risk of being prosecuted under the state's civil rights law.

  • June 11, 2024

    Doc-Patient Privilege, The Four Tops, And A Win For Humana

    Humana wins a round in a Medicare Advantage lawsuit. The high court takes up hospital "dish" payment case. A Motown legend sues a Michigan hospital. Law360 looks at those and other legal cases from the past week.

  • June 11, 2024

    Texas, Mont. Sue HHS Over ACA Trans Discrimination Rule

    Texas and Montana filed suit against the Biden administration seeking to halt its rule clarifying the application of the Affordable Care Act's nondiscrimination protections to gender identity, saying the new regulations infringe on states' autonomy and force them to violate their own laws.

  • June 11, 2024

    Judge Says Fla. Trans Medical Care Ban Is Unconstitutional

    A Florida federal judge on Tuesday declared that a state law banning gender-affirming care for transgender minors and restricting it for adults is unconstitutional because it was motivated by animus for a specific group of people and serves no legitimate state interest.

  • June 11, 2024

    Fast Appeal In Hospital Merger Row A Sign Of Determined FTC

    The Federal Trade Commission's quick appeal of its failed challenge to a North Carolina hospital merger suggests the agency remains committed to aggressive scrutiny of healthcare consolidation.

  • June 11, 2024

    High Court On Familiar Ground In Hospital Pay Row

    Two years ago, the U.S. Supreme Court decided a case about federal formula for calculating disproportionate share hospital payments — commonly called "dish" payments — under Medicare Part A. A similar case set for high court review puts the justices back on familiar ground.

  • June 11, 2024

    10 Firms Seek $13M Fee For Effexor Antitrust Deal

    Ten law firms asked a New Jersey federal judge on Monday to award $13 million in counsel fees and an additional $2.1 million in costs for representing direct buyers in a $39 million settlement with Pfizer Inc. unit Wyeth over an alleged scheme to delay generic competition for the antidepressant drug Effexor XR.

  • June 11, 2024

    CFPB Floats Rule To Take Medical Debt Off Credit Reports

    The Consumer Financial Protection Bureau on Tuesday proposed a rule that would restrict how lenders and credit reporting companies can use consumers' medical debt information, a measure that the agency said could remove up to $49 billion in outstanding medical bills from millions of credit reports.

  • June 11, 2024

    Pivotal ERISA Case Stalls Amid Mental Health Crisis

    A nationwide mental health crisis has emerged while a landmark case involving thousands of insurance claims denied by United Behavioral Health has wound its way through the courts. The dispute is hitting new headwinds at the Ninth Circuit.

  • June 11, 2024

    WilmerHale Lands Latham Atty To Help Lead Life Sciences

    WilmerHale has added a partner in Palo Alto, California, who is an expert in complex strategic collaboration and licensing transactions, to co-chair its life sciences practice group, the firm said Tuesday.

  • June 11, 2024

    Rao Tracks His Journey From Stay-At-Home Dad To FTC

    Rahul Rao said that every role he's taken on — from BigLaw attorney to stay-at-home dad to overseeing healthcare mergers at the Federal Trade Commission — has helped shape him into the lawyer he is today.

  • June 11, 2024

    FDA Urges 11th Circ. To Back E-Cig Ban Over High Nicotine

    The U.S. Food and Drug Administration is urging the Eleventh Circuit to not let Bidi Vapor market an e-cigarette product that the agency claimed would expose users to nearly twice as much nicotine as a typical combustible cigarette.

  • 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.

Expert Analysis

  • Short-Term Takeaways From CMS' New Long-Term Care Rules

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    The Centers for Medicare & Medicaid Services' new final rule on nursing home staffing minimums imposes controversial regulatory challenges that will likely face significant litigation, but for now, stakeholders will need to prepare for increased staffing expectations and more specialized facility assessments without meaningful funding, say attorneys at Morgan Lewis.

  • FDA's Data Monitoring Guidance Reveals Future Expectations

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    As the world of clinical research grows increasingly complex, the U.S. Food and Drug Administration's recent draft guidance on the use of data monitoring committees in clinical trials reveals how the agency expects such committees to develop, say Melissa Markey and Carolina Wirth at Hall Render.

  • FDA Warning Indicates Scrutiny Of Regenerative Health Cos.

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    The U.S. Food and Drug Administration's recent warning letter to Akan Biosciences is a quintessential example of the agency's enforcement priorities for certain products involving human cells and tissues, and highlights ongoing scrutiny placed on manufacturers, say Dominick DiSabatino and Cortney Inman at Sheppard Mullin.

  • 2 Regulatory Approaches To Psychedelic Clinical Trials

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    Comparing the U.S. and Canada's regulatory frameworks for clinical trials of psychedelic drugs can be useful for designing trial protocols that meet both countries' requirements, which can in turn help diversify patient populations, bolster data robustness and expedite market access, say Kimberly Chew at Husch Blackwell and Sabrina Ramkellawan at AxialBridge.

  • 'Food As Health' Serves Up Fresh Legal Considerations

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    The growth of food as medicine presents a significant opportunity for healthcare organizations and nontraditional healthcare players to improve patient outcomes and reduce costs, though these innovative programs also bring compliance considerations that must be carefully navigated, say attorneys at McDermott.

  • DC Circ. Ruling Heightens HHS Contract Pharmacy Challenges

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    The D.C. Circuit's recent ruling that the Section 340B program does not bar manufacturers from restricting deliveries of discounted drugs to contract pharmacies represents a second strike against the U.S. Department of Health and Human Services' current contract pharmacy policy and raises the stakes surrounding an upcoming Seventh Circuit ruling on the same issue, say attorneys at Foley Hoag.

  • FTC Focus: Exploring The Meaning Of Orange Book Letters

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    The Federal Trade Commission recently announced an expansion of its campaign to promote competition by targeting pharmaceutical manufacturers' improper Orange Book patent listings, but there is a question of whether and how this helps generic entrants, say Colin Kass and David Munkittrick at Proskauer.

  • 3rd Circ.'s Geico Ruling May Encourage Healthcare Arbitration

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    The Third Circuit's recent decision in Geico v. Mount Prospect, finding that claims under New Jersey's Insurance Fraud Prevention Act can be arbitrated, strengthens arbitration as a viable alternative to litigation, even though it is not necessarily always a more favorable forum, say Khaled Klele and Jessica Osterlof at McCarter & English.

  • Proposed Cannabis Reschedule Sidesteps State Law Effects

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    The U.S. Department of Justice's recent proposal to move cannabis to Schedule III of the Controlled Substances Act provides certain benefits, but its failure to address how the rescheduling would interact with existing state cannabis laws disappointed industry participants hoping for clarity on this crucial question, says Ian Stewart at Wilson Elser.

  • A Changing Regulatory Landscape For Weight Loss Drugs

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    As drugs originally approved to treat diabetes become increasingly popular for weight loss purposes, federal and state regulators and payors are increasing their focus on how these drugs are prescribed, and industry participants should pay close attention to rapidly evolving compliance requirements, say attorneys at Goodwin.

  • Opioid Suits Offer Case Study In Abatement Expert Testimony

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    Settlements in the opioid multidistrict litigation provide useful insight into leveraging expert discovery on abatement in public nuisance cases, and would not have been successful without testimony on the costs necessary to lessen the harms of the opioid crisis, says David Burnett at DiCello Levitt.

  • 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.