Policy & Compliance

  • July 15, 2026

    Albertsons Slow To Review Wash. Opioid Sales, Judge Told

    Albertsons conducted few reviews of opioid dispensing by its Washington pharmacies for years after establishing a controlled substances compliance team, according to testimony played on Day 3 of a bench trial in the state's lawsuit accusing the company and its Safeway subsidiary of exacerbating Washington's opioid epidemic.

  • July 15, 2026

    Acorda Can't Add $66M To Award In Ampyra Royalty Fight

    The Second Circuit on Wednesday refused to alter an arbitral award issued to Acorda Therapeutics to include nearly $66 million beyond the $16.6 million it won in a multiple sclerosis drug dispute, saying the company "slept on its rights" and couldn't change the result now.

  • July 15, 2026

    2nd Circ. Revives NY Provider's BCBS Underpayment Suit

    The Second Circuit on Wednesday revived a New York healthcare provider's suit accusing out-of-state Blue Cross Blue Shield licensees of underpaying insurance claims, saying the carriers' long-standing business relationship with a New York licensee to obtain preferential prices in the state supports jurisdiction there.

  • July 15, 2026

    Local Gov'ts Seek To Bar HHS Teen Health Program Changes

    A group of local governments and health nonprofits urged a D.C. federal court Wednesday to block recent federal mandates requiring Teen Pregnancy Prevention Program grant recipients to incorporate abstinence education and other changes to their reproductive health programming, arguing the changes are arbitrary and capricious.

  • July 15, 2026

    NC Panel Nixes Nurse Noncompetes For Being 'Too Broad'

    A medical clinic provider couldn't convince a North Carolina state appeals court to overturn a ruling that noncompete agreements for two former nurses were unenforceable, after a split panel ruled Wednesday that the terms were overly broad and voidable under public policy.

  • July 15, 2026

    United Owes $630K In Fight Over Teen's Mental Health Care

    United Healthcare must pay $630,000 to a mother who challenged the insurance company's decision to deny coverage for her son's residential mental health treatment, a Utah federal judge ordered, after rejecting the company's bid to slim her requests for interest and attorney fees.

  • July 15, 2026

    Mass. Says UnitedHealth FCA Case Belongs In State Court

    Massachusetts asked a federal judge to send its $100 million state False Claims Act lawsuit alleging overbilling by UnitedHealthcare back to state court, accusing the insurer of forum shopping with a theoretical defense touching on federal law.

  • July 15, 2026

    DC Circ. Affirms Ratings For Alignment Medicare Plans

    The D.C. Circuit sided with the Centers for Medicare & Medicaid Services regarding its decision not to discard certain unfavorable surveys for Alignment Healthcare's Medicare Advantage plans, saying there is no indication of an administrative error.

  • July 14, 2026

    Albertsons Probed On Pharmacy Compliance Staffing At Trial

    Two former Albertsons pharmacy compliance executives testified in video depositions played Tuesday before a Washington judge considering whether Albertsons failed to prevent the diversion of opioids in the state, acknowledging the nationwide compliance team consisted of just six staffers between 2015 and 2020 despite heightened scrutiny amid the opioid epidemic.

  • July 14, 2026

    3rd Circ. Revives Providers' Underpayment Suit Against Cigna

    The Third Circuit partially revived several New Jersey-based healthcare practices' Employee Retirement Income Security Act suit alleging Cigna improperly underreimbursed them for covered healthcare services provided to Cigna's subscribers, ruling Monday the plaintiffs sufficiently alleged they were underpaid for some out-of-network services when compared to their normal charges for similar services.

  • July 14, 2026

    Patent Eligibility Bill Divides Senators Over Health Costs

    Several U.S. senators expressed strong support at a hearing Tuesday for a bill aimed at expanding which inventions are eligible for patents, while others appeared to have reservations about the potential effect of the proposed changes on healthcare costs.

  • July 14, 2026

    Medical Device Co. Settles FCA Claims

    A company that sells compression devices to reduce swelling in patients with certain medical conditions will pay $551,000 to settle allegations that it obtained Medicare reimbursement with falsified medical records, the U.S. attorney's office in Massachusetts announced Tuesday.

  • July 14, 2026

    FDA Resumes Drug Denial Letters Amid Secrecy Clash

    Drugmakers are examining a new batch of drug application rejection letters released by the U.S. Food and Drug Administration this month — the first disclosure since regulators paused the releases amid industry outcry.

  • July 14, 2026

    CVS Caremark Settles Out Of FTC Suit Over Insulin Pricing

    The Federal Trade Commission reached a settlement on Tuesday with CVS Caremark that includes a number of changes to its business practices, the second deal in a case accusing the country's largest pharmacy benefit managers of inflating insulin prices through unfair rebate schemes.

  • July 14, 2026

    The Latest Medicare Star Lawsuits: What You Need To Know

    Following a win in a Georgia federal court for a health plan challenging a Medicare Advantage Star Ratings calculation, Law360 Healthcare Authority looks at a recent batch of insurer lawsuits seeking to capitalize on the ruling.

  • July 14, 2026

    1st Circ. Backs CDC Ban On Importing Dogs Under 6 Months

    The First Circuit has upheld a rule requiring all dogs imported into the U.S. to be at least six months of age, saying the federal Centers for Disease Control and Prevention had shown it was a reasonable measure to fight rabies.

  • July 14, 2026

    DOJ Asks 9th Circ. Undo Trans Health Ruling Against Premera

    The federal government has backed Premera Blue Cross in its bid at the Ninth Circuit to overturn a Washington federal court's judgment that held the insurance company's coverage policy for gender dysphoria surgery is discriminatory, arguing the decision is out of line with U.S. Supreme Court precedent.

  • July 14, 2026

    Clinics Want Medicaid Abortion Stay Lifted After Pa. Court Win

    Allegheny Reproductive Health Center and other healthcare providers on Tuesday asked a Commonwealth Court judge to unfreeze money for Medicaid-funded abortions in Pennsylvania following the court's landmark ruling that the state's coverage exclusions for such abortions were unconstitutional.

  • July 14, 2026

    Kroger Says Flimsy Claims Doom Tobacco Fee Suit

    Grocery giant Kroger urged an Ohio federal judge to toss a suit challenging the legality of an extra health plan fee it charged tobacco users, stating it complied with federal benefits law by giving workers a 90-day window each year to dodge the fee by enrolling in a wellness program.

  • July 14, 2026

    HHS Wields Checkbook To Pressure State Fraud Units

    Cutting off federal funding to Medicaid fraud units in New York and Hawaii could reshape the enforcement priorities of similar units across the country. The HHS watchdog has made clear the agency wants states to lean in on criminal Medicaid fraud cases.

  • July 14, 2026

    Amgen Colo. Win May Chill States' Push To Cap Drug Prices

    A Colorado injunction blocking a prescription drug pricing statute may have thrown a wrench into efforts in other states to limit drug costs for consumers through a new crop of state oversight boards.

  • July 13, 2026

    Albertsons, Safeway Face Trial Over Wash.'s Opioid Epidemic

    Albertsons and Safeway ignored signs of problematic opioid prescriptions in Washington for years, an attorney for the state told a Seattle judge Monday during opening statements in a bench trial over allegations that the pharmacy chains failed to prevent the diversion of opioids that fueled the state's long-running overdose crisis.

  • July 13, 2026

    2nd Circ. Says Tylenol Maker Must Face Autism, ADHD Suits

    The Second Circuit said Monday that a lower court had wrongly excluded plaintiffs experts from testifying about an alleged relationship between using Tylenol during pregnancy and autism spectrum disorder and attention-deficit/hyperactivity disorder, although the panel cautioned that the decision was not political or scientific.

  • July 13, 2026

    J&J Asks 3rd Circ. To Block Return Of Ex-Worker's Fee Claims

    Johnson & Johnson has asked the Third Circuit to keep dismissed excessive fee claims out of a proposed class action alleging the company charged employees too much for a prescription drug benefits program, arguing that the lower court correctly tossed that portion of the suit for lack of standing.

  • July 13, 2026

    Northwell Escapes Suit Over Pension Plan Conversion

    Northwell Health defeated a proposed class action alleging it hid cuts to workers' pension plans when converting to a cash-balance plan in the late 1990s, with a New York federal judge finding the hospital system adequately disclosed how the change could impact participants' benefits.

Expert Analysis

  • Fraud Enforcement, Sentencing Face Unusual Convergence

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    The Trump administration’s newly created task force to eliminate fraud and the U.S. Sentencing Commission’s recent proposals to scale back certain elements of the federal sentencing framework seem to point in opposite directions, creating a collision of policy priorities that may reshape how fraud cases are charged, negotiated and sentenced for years to come, says David Tarras at Tarras Defense.

  • Peptide Policy Is Shifting Toward Sanctioned Compounding

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    The policy landscape for peptides is undergoing a significant shift under the Trump administration, moving toward a complex system of verified compounding and complementary enforcement that will likely bring peptides firmly back into the sphere of legitimate consumer products, say attorneys at Sheppard.

  • Trump Order Signals Tougher Benefits Fraud Probes

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    A recent order from President Donald Trump establishing a federal taskforce for addressing fraud in federally funded benefit programs emphasizes interagency information sharing, potentially affecting a broad range of areas including government contracts, administrative law considerations and False Claims Act cases, say attorneys at Morgan Lewis.

  • The Evolution Of States' Workplace Violence Prevention Laws

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    Utah's new law requiring hospitals to implement comprehensive workplace violence reporting systems continues a broader trend of state efforts to expand workplace protections in the absence of sufficient federal regulations, say attorneys at Ogletree.

  • FDA Guidance May Move Goalposts For Form 483 Responses

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    New draft guidance from the U.S. Food and Drug Administration provides formal insight on how drug manufacturers are expected to respond to Form 483s, raising some concerns about the agency's timelines and expectations, say attorneys at Cooley.

  • 2 Strands Of Patent Law In High Court's 'Skinny Label' Case

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    Amarin v. Hikma, which is set for oral argument in the U.S. Supreme Court this month, highlights the distinction between two different strands of intellectual property law — analogizing a patent to either a property deed or a home, says Jonas McDavit at Spencer West.

  • A Check-Up On HHS' Push To Implement AI Infrastructure

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    The U.S. Department of Health and Human Services has made some headway in its efforts to implement artificial intelligence across its agencies, but will have to overcome a number of near-term tests in order to be successful, says Theodore Thompson at Stinson.

  • Mich. Banking Brief: All The Notable Legal Updates In Q1

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    Michigan's financial services sector saw several significant developments in 2026's first quarter, including the state Department of Insurance and Financial Services' issuance of a bulletin on the use of artificial intelligence and the Michigan House's introduction of a bill based on the Model Money Transmission Modernization Act, say attorneys at Dykema.

  • The Road Ahead For Drug Development In The US

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    Against the backdrop of drug manufacturers potentially looking to move development efforts overseas, the U.S. Food and Drug Administration's latest guidance on new approach methodologies signals the FDA is likely to be receptive to industry innovation that makes U.S.-based drug development faster or less expensive, creating opportunities and compliance risks for tech companies, say attorneys at Morgan Lewis.

  • FDA's Crackdown On Drug Ads Conflicts With Precedent

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    Recent U.S. Food and Drug Administration warning letters to drug manufacturers targeting direct-to-consumer advertising raise significant constitutional concerns, and directly clash with prior FDA stances, say attorneys at Sidley.

  • Informal Announcements Are Reshaping FDA Regulations

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    The U.S. Food and Drug Administration's recent shift toward using press releases, podcasts and other informal channels to announce major policy changes reflects a valid desire to modernize and accelerate regulatory efforts, but it could lead to diminished transparency, increased industry burden and reduced policy durability, says Rachel Turow at Skadden.

  • A Shift In Fed. Circ.'s Approach To Patent Summary Judgment

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    The Federal Circuit's recent decision in Range of Motion v. Armaid may come to be seen as a seminal opinion for potentially exposing and entrenching the Federal Circuit's movement away from its previous framework for identifying obvious noninfringement cases, says Nicholas Nowak at Nowak IP Group.

  • DOJ Actions Suggest Expansion Of Healthcare Enforcement

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    Recent actions by the U.S. Department of Justice and U.S. Food and Drug Administration suggest that federal healthcare enforcement efforts are moving away from traditional program-based fraud and toward cases centered on product integrity, regulatory transparency and telehealth marketing, effectively widening the government's enforcement playbook, say attorneys at MoFo.