Policy & Compliance

  • August 12, 2025

    Loper Bright Neutered In 6th Circ., Tenn. Tells Supreme Court

    There is "growing confusion among the circuits" regarding the U.S. Supreme Court's rejection of judicial deference to regulators, as evidenced by a Sixth Circuit ruling that negates much of the high court's Loper Bright ruling, Tennessee told the justices in a new petition.

  • August 12, 2025

    States Push Anti-mRNA Bills Amid Growing Public Distrust

    Public distrust was a key motivator for the federal government's decision to cut contracts developing messenger RNA vaccines. The sentiment is apparent in state legislatures considering a slew of vaccine-related bills.

  • August 12, 2025

    Docs Take NJ Telemedicine Restrictions Fight To 3rd Circ.

    A group of doctors and patients have appealed the dismissal of their challenge to a New Jersey law that says out-of-state doctors can't practice telemedicine with Garden State patients unless they're licensed there, telling the Third Circuit that the rule deprives people of potentially life-saving consultation.

  • August 12, 2025

    New Barriers To Health Safety Net Spark Questions, Litigation

    Federal health officials' reinterpretation of a decades-old social welfare law is expected to boot thousands of noncitizens from safety net programs. It has also prompted a wave of enforcement questions from healthcare providers and legal pushback.

  • August 12, 2025

    Worker's Flu Shot Ruling Goes Too Far, 5th Circ. Dissent Says

    A Fifth Circuit judge on Monday said a woman briefly suspended from Texas Children's Hospital over her refusal to get a flu vaccine should be able to pursue her religious discrimination suit even though the hospital ultimately accommodated her beliefs.

  • August 12, 2025

    Sentara Health Must Face Trimmed Stable Value Fund Suit

    A Virginia federal court refused to toss a proposed class action alleging healthcare not-for-profit Sentara Health mismanaged an employee retirement plan, finding workers had sufficiently backed up claims that a stable value fund in the plan underperformed and their employer's investment management process was lacking.

  • August 12, 2025

    Antitrust Actions, Drug Pricing And More

    A federal appeals court revived an antitrust suit against drugmakers, the Federal Trade Commission challenged a heart valve company acquisition, a patient's privacy lawsuit against an urgent care clinic was allowed to proceed, and a Texas federal court upheld Medicare's drug price negotiation program. Here, Law360 Healthcare Authority looks at those and other healthcare litigation developments you may have missed over the past week.

  • August 12, 2025

    NJ Is Key Battleground In Fight Over Newborn Blood Tests

    Newborn blood screening, a cornerstone of modern public health, is the focus of a debate over patient privacy, parental consent and what happens to the samples after initial tests are complete. A New Jersey court recently weighed in.

  • August 12, 2025

    340B Rebate Plan Sparks Questions On Enforcement, Appeals

    The drug industry, long critical of the 340B discount program, appeared to score a win when the Trump administration announced a post-sale rebate model. Hospitals and other buyers have some notes on a potentially deficient appeal process and other uncertainties.

  • August 11, 2025

    Aetna, CVS Want Lab's $21M Payment Suit Tossed For Good

    Aetna and its parent company, CVS Health Corp., said a medical laboratory can't stand in the shoes of patients who were allegedly denied coverage by the insurer for lab tests, and they have asked a Connecticut federal judge to toss the lab's lawsuit for good.

  • August 11, 2025

    Rural Health Providers Say FCC Subsidy Rules Unclear

    Rural healthcare providers still don't know what is and isn't covered by the Universal Service Fund and could use some clarification and guidance from the Federal Communications Commission, a group has told the agency.

  • August 11, 2025

    Proskauer Hires Epstein Becker Lawyer For DC, LA Practices

    A healthcare litigator with experience in-house, at the U.S. government and in private practice, has joined Proskauer Rose LLP as a partner to continue working on healthcare, white collar defense and investigation, the firm announced Monday.

  • August 08, 2025

    Trump EO Requires Appointee Oversight Of US Grantmaking

    President Donald Trump has issued an executive order requiring that all funding opportunity announcements and grant awards be reviewed by his political appointees and allowing for grants to be terminated that fall outside the administration's priorities. 

  • August 08, 2025

    DC Medicaid Recipients Win Class Cert. For Notice Row

    A D.C. federal judge granted a class certification motion lodged by a group of Medicaid beneficiaries who allege the district has violated their due process rights by failing to provide individualized written notices explaining prescription coverage denials and appeal rights.

  • August 08, 2025

    Administration Says States Can't Second-Guess ACA Changes

    The Trump administration urged a Massachusetts federal court to reject a request by a group of states seeking to stay implementation of new rules that will reduce Affordable Care Act healthcare marketplace subsidies and enforce certain enrollment restrictions.

  • August 08, 2025

    Iowa PBM Law Challengers Seek Wider Block At 8th Circ.

    Employers and benefit plans challenging an Iowa law aiming to limit pharmacy benefit managers' power to set drug prices will seek Eighth Circuit review of a district court judge's decision from July that temporarily blocked parts of the new policy as preempted by federal benefits law.

  • August 08, 2025

    Attys Seek Final OK Of $100M Walgreens Rx Cost Settlement

    An Illinois federal judge should greenlight a $100 million settlement to claims that Walgreens overcharged insured customers for generic prescription drugs, the plaintiffs' attorneys said, asking the judge to wrap up the 8-year-old consumer protection litigation.

  • August 07, 2025

    Health Insurance Telemarketers Cough Up $145M In FTC Suits

    Two telemarketing companies will pay $145 million to settle Federal Trade Commission claims that they misled millions of consumers into buying phony health insurance plans, the FTC said in a Thursday announcement accusing the telemarketers of making false promises that didn't provide what they offered.

  • August 07, 2025

    HHS Wins Another Round In Medicare Drug Negotiation Battle

    A Texas federal court dealt another blow to the pharmaceutical industry Thursday when it ruled in favor of Medicare's Drug Price Negotiation Program, turning away arguments that the program is unconstitutional — the third such decision in two days.

  • August 07, 2025

    BioPharma Co.'s $15M Deal Over Ruined J&J Vaccines OK'd

    A Maryland federal judge on Thursday granted final approval to a $15 million settlement to close out a stockholder derivative suit claiming Emergent BioSolutions Inc. and its top brass made a mint selling stock before their allegedly lax oversight led to the contamination of over 15 million Johnson & Johnson COVID-19 vaccine doses.

  • August 07, 2025

    Michigan AG Fights Bid To Pause PBM Price-Fixing Suit

    Michigan's attorney general has said there is no reason to pause her price-fixing suit against pharmacy benefit managers Express Scripts and Prime Therapeutics for a pending dismissal motion, urging a federal judge not to put discovery on ice. 

  • August 07, 2025

    10th Circ. Upholds Okla. Law Banning Trans Care For Minors

    The Tenth Circuit declined to block an Oklahoma law banning gender-affirming care for transgender minors, ruling that a recent U.S. Supreme Court opinion backing a similar law from Tennessee undermines state residents' claims that the statute is discriminatory.

  • August 07, 2025

    2nd Circ. Axes Challenge To Medicare Drug Price Negotiations

    In a published opinion Thursday, the Second Circuit turned away Boehringer Ingelheim's constitutional and administrative challenge to the Medicare Drug Price Negotiation Program, finding that the program is voluntary and it was lawfully implemented under the Inflation Reduction Act.

  • August 07, 2025

    Mich. Agency Can't Shake Suit Over Fights At Psych Hospital

    The Michigan claims court has ruled that the state's health department must face a lawsuit over the beating of a child at a state-run psychiatric facility because the complaint adequately alleged hospital staff took intentional steps that "directly and predictably" led to the fight. 

  • August 06, 2025

    6th Circ. Rips 'Stalking Horse' Ploy In Drug Negotiation Suit

    The pharmaceutical industry will feel the sting of a Wednesday loss in a wide-ranging war over Medicare's power to negotiate drug prices, as the Sixth Circuit tossed a suit and accused one major company of utilizing a "stalking horse" to sue in a more favorable forum.

Expert Analysis

  • AG Watch: Texas Embraces The MAHA Movement

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    Attorneys at Kelley Drye examine Texas Attorney General Ken Paxton's actions related to the federal Make America Healthy Again movement, and how these actions hinge on representations or omissions by the target companies as opposed to specific analyses of the potential health risks.

  • How States Are Regulating Health Insurers' AI Usage

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    The absence of a federal artificial intelligence framework positions states as key regulators of health insurers’ AI use, making it important for payors and service providers to understand the range of state AI legislation being passed in California and elsewhere, and consider implementing an AI-focused compliance infrastructure, say attorneys at Ropes & Gray.

  • HHS Plan To Cut Immigrant Benefits Spurs Provider Questions

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    A recent notice from the U.S. Department of Health and Human Services identifying new federal public benefit programs for which nonqualified aliens are not eligible may have a major impact on entities that participate in these programs — but many questions remain unanswered, say attorneys at Foley.

  • Noncompete Forecast Shows Tough Weather For Employers

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    Several new state noncompete laws signal rough conditions for employers, particularly in the healthcare sector, so employers must account for employees' geographic circumstances as they cannot rely solely on choice-of-law clauses, say lawyers at McDermott.

  • Previewing State Efforts To Regulate Mental Health Chatbots

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    New York, Nevada and Utah have all recently enacted laws regulating the use of artificial intelligence to deliver mental health services, offering early insights into how other states may regulate this area, say attorneys at Goodwin.

  • How DOJ's New Data Security Rules Leave HIPAA In The Dust

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    The U.S. Department of Justice's recently effective data security requirements carry profound implications for how healthcare providers collect, store, share and use data — and approach vendor oversight — that go far beyond the Health Insurance Portability and Accountability Act, say attorneys at Nelson Mullins.

  • Texas Med Spas Must Prepare For 2 New State Laws

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    Two new laws in Texas — regulating elective intravenous therapy and reforming healthcare noncompetes — mark a pivotal shift in the regulatory framework for medical spas in the state, which must proactively adapt their operations and contractual practices, says Brad Cook at Munsch Hardt.

  • DOJ-HHS Collab Crystallizes Focus On Health Enforcement

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    The recently announced partnership between the U.S. Department of Justice and U.S. Department of Health and Human Services to combat False Claims Act violations, following a multiyear trend of high-dollar DOJ recoveries, signals a long-term enforcement horizon with major implications for healthcare entities and whistleblowers, say attorneys at RJO.

  • How The Healthline Privacy Settlement Redefines Ad Tech Use

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    The Healthline settlement is the first time California has drawn a clear line in the sand around how website tracking must function in practice, so if your site uses tracking technologies, especially around sensitive content like health or finance, regulators are inspecting your website's back end, not just its banner, say attorneys at Baker Donelson.

  • How Sweeping Budget Bill Shakes Up Health Industry

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    With the recently passed One Big Beautiful Bill Act marking one of the most significant overhauls of federal health policy since the passage of the Affordable Care Act, providers, managed care organizations and life sciences companies must now shift focus from policy review to implementation planning, say advisers at Holland & Knight.

  • New DOJ Penalty Policy Could Spell Trouble For Cos.

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    In light of the U.S. Department of Justice’s recently published guidance making victim relief a core condition of coordinated resolution crediting, companies facing parallel investigations must carefully calibrate their negotiation strategies to minimize the risk of duplicative penalties, say attorneys at Debevoise.

  • A Look At Key 5th Circ. White Collar Rulings So Far This Year

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    In the first half of 2025, the Fifth Circuit has decided numerous cases of particular import to white collar practitioners, which collectively underscore the critical importance of meticulous recordbuilding, procedural compliance and strategic litigation choices at every stage of a case, says Joe Magliolo at Jackson Walker.

  • What US Medicine Onshoring Means For Indian Life Sciences

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    Despite the Trump administration's latest moves to onshore essential medicine manufacturing, India will likely remain an indispensable component of the U.S. drug supply chain, but Indian manufacturers should prepare for stricter compliance checks, says Jashaswi Ghosh at Holon Law Partners.