Policy & Compliance

  • June 13, 2024

    Justices Hand Abortion Advocates An Incomplete Win

    The U.S. Supreme Court's rejection Thursday of a challenge to the abortion drug mifepristone will do little to safeguard long-term access to the medication while suggesting that it will be up to voters, not judges, to settle some of the nation's abortion debates, attorneys say.

  • June 13, 2024

    Thomas Targets Group Standing In Mifepristone Ruling

    U.S. Supreme Court Justice Clarence Thomas joined his colleagues Thursday to unanimously uphold broad access to the abortion medication mifepristone for now, but he wrote separately to challenge a standing rule that often serves as the key to the courthouse doors for litigants of all varieties.

  • June 13, 2024

    Feds Get $4.6M In Deal Over Telehealth Billing Fraud Probe

    A multi-state network of behavioral health companies and their CEO have agreed to pay nearly $4.6 million to settle allegations that they submitted fraudulent claims for payment to Medicare and Connecticut's Medicaid program for telehealth services for nursing home residents, federal investigators said Thursday.

  • June 13, 2024

    Teva Wins Pause Of Order Ousting Patents From Orange Book

    A New Jersey federal judge ordered on Thursday a 30-day stay of his Monday ruling that a handful of patents covering Teva-brand asthma inhalers were improperly listed in the federal Orange Book, saying he wanted the matter to reach the Federal Circuit in the most orderly way possible.

  • June 13, 2024

    CVS Dodges Discovery Audit In Generic Drug Collusion Suit

    A federal judge declined to make CVS hire a forensic auditor to evaluate its compliance with information demands in a lawsuit alleging it colluded with drugmakers to keep Medicare beneficiaries from accessing certain generic drugs, despite a whistleblower bemoaning "woefully deficient" discovery on the pharmacy chain's part.

  • June 13, 2024

    Health Co. Execs Charged In $100M Adderall Sales Scheme

    Two California digital healthcare company executives were charged in a first-of-its-kind case Thursday with scheming to sell Adderall through deceptive advertising, allegedly bringing in $100 million in illicit profits.

  • June 13, 2024

    EU Makes First Ever Formal Pharma Price-Fixing Complaint

    European Union antitrust authorities issued their first ever price-fixing complaint in the pharmaceutical industry Thursday, going after the only company that did not agree to a €13.4 million ($14.4 million) settlement in October.

  • June 13, 2024

    Abortion Medication Case Ends 'With A Whimper' At High Court

    A case that threatened to cut off access to a widely used abortion medication while disrupting the U.S. Food and Drug Administration's authority over drugs and medical devices ended Thursday at the U.S. Supreme Court with a decision concerned solely with challengers' right to sue.

  • 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.

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.