Policy & Compliance

  • September 03, 2025

    Arkansas Insurance Rule Beats Union Plan's ERISA Challenge

    An Illinois federal judge has tossed a Teamsters healthcare plan's challenge to an Arkansas insurance regulation that aims to protect local pharmacies from under-reimbursement for prescription drugs, saying the regulation doesn't tread on the Employee Retirement Income Security Act's territory.

  • September 03, 2025

    BakerHostetler Adds King & Spalding Health Pro In Atlanta

    A longtime King & Spalding LLP attorney has brought her healthcare practice to BakerHostetler in Atlanta, the firm announced Wednesday.

  • September 02, 2025

    DOJ Accuses Nonprofit Nursing Home Chain Of FCA Violations

    The U.S. Department of Justice has intervened in a whistleblower suit against nonprofit nursing home operator ProMedica, alleging a "systematic and pervasive" pattern of understaffing that resulted in "grossly substandard" or non-existent care for Medicare and Medicaid beneficiaries, in violation of the False Claims Act.

  • September 02, 2025

    Pharmacists, Attys Navigate Murky COVID Vaccine Waters

    In recent years, the changing of the season has sent millions of Americans to their local pharmacists for a COVID-19 vaccine with few worries about availability. This year, things aren't so simple. Without a complete federal roadmap, pharmacists are facing new legal uncertainties.

  • September 02, 2025

    Meet The Attys Behind AstraZeneca Suit Over Colo. 340B Law

    An Arnold & Porter Kaye Scholer LLP team is representing AstraZeneca in its challenge of a Colorado law aimed at guarding the ability of providers to contract with pharmacies for discounted drugs under the 340B program.

  • September 02, 2025

    Amid Vaccine Tumult, RFK Jr.'s Liability Threat A 'Red Herring'

    HHS Secretary Robert F. Kennedy Jr. has warned doctors they could lose vaccine liability protections if they stray from agency recommendations. Vaccine law experts say he's misrepresenting a 1980s statute focused largely on drugmakers.

  • September 02, 2025

    Ex-Executive Slaps Novo Nordisk Unit With Sex, Age Bias Suit

    A former finance director for a Novo Nordisk unit hit the company with a sex and age bias lawsuit last week, saying in a North Carolina federal court complaint that her career was cut short after she complained about workplace safety and discrimination.

  • September 02, 2025

    New Insulin Lawsuit, Idaho Antitrust Claim Tossed And More

    Major insulin makers Eli Lilly, Novo Nordisk and Sanofi and the three largest pharmacy benefit managers have been hit with a fresh lawsuit accusing them of artificially inflating the cost of the diabetes medicine. Elsewhere, an Idaho federal judge tossed a group of neurosurgeons' antitrust claims against a healthcare system. 

  • September 02, 2025

    FDA's New Cigarette Warning Label Rule Tossed By Ga. Judge

    A Georgia federal judge has vacated a U.S. Food and Drug Administration rule that would add graphic warnings to cigarette labels, saying that while the rule wasn't in violation of the Family Smoking Prevention and Tobacco Control Act, it was promulgated without "observance of procedure required by law."

  • September 02, 2025

    Defunding Planned Parenthood Is Meant To Punish, Judge Says

    A Massachusetts federal judge on Friday refused to lift an order that keeps Medicaid reimbursements flowing to Planned Parenthood, ruling that legislation intended to halt the organization's federal funding appears to illegally target the group for punishment.

  • September 02, 2025

    Wells Fargo Employee Drug Cost Battle: What To Know

    A group of former Wells Fargo employees is back in federal court this week with allegations the company mismanaged their prescription drug benefits, leading to millions in overpayments. The banking giant says the case is a do-over of allegations already axed by the Minnesota court

  • September 02, 2025

    'Never My Intention' To Defy Justices, Judge In NIH Case Says

    A veteran Massachusetts jurist on Tuesday responded to suggestions by two U.S. Supreme Court justices that he had defied the high court by going ahead with a bench trial on two challenges to the Trump administration's cuts to National Institutes of Health research grants, saying he would never intentionally disregard precedent.

  • September 02, 2025

    HHS Office Of Inspector General Leader Joins Arnold & Porter

    A longtime attorney with the U.S. Department of Health and Human Services' Office of Inspector General, who was nominated to be inspector general of the U.S. Department of Commerce by former President Joe Biden, has joined Arnold & Porter Kaye Scholer LLP, the firm announced Tuesday.

  • August 29, 2025

    Ga. Ban On Trans Prisoner Healthcare 'Troubling,' Judge Says

    A Georgia federal judge signaled Friday that she may soon halt a new state law banning access to gender-affirming healthcare for transgender state prisoners, saying she found it "troubling to me" that lawmakers had substituted their judgment for that of doctors.

  • August 29, 2025

    3rd Circ. Backs Walmart In Opioid Securities Disclosure Suit

    A proposed class action by Walmart investors claiming the company misled them by failing to disclose a federal opioid investigation was rejected Friday by the Third Circuit, which held the retailer's U.S. Securities and Exchange Commission filings were not false or misleading.

  • August 29, 2025

    GardaWorld Can't Avoid Tobacco, Vaccine Health Fee Suit

    A North Carolina federal judge trimmed — but refused to toss — a proposed class action challenging a security company's health plan surcharges to employees who refused COVID-19 vaccinations and who use tobacco, opening discovery on claims that the fees violated nondiscrimination provisions in federal benefits law.

  • August 29, 2025

    Emory Healthcare Taps K&L Gates Partner As Legal Leader

    Emory Healthcare tapped a K&L Gates LLP partner with more than 20 years of experience as a healthcare regulatory attorney as its next chief counsel for health affairs.

  • August 29, 2025

    Ill. Jury Sides With Ex-CTA Worker In Vax Bias Lawsuit

    An Illinois federal jury on Friday awarded a former Chicago Transit Authority employee $425,000 in damages, finding the transit agency liable on his religious discrimination claim after he was terminated following his refusal to take the COVID-19 vaccine and denied an exemption to the agency's vaccine requirement.

  • August 28, 2025

    3rd Circ. Agrees Natera Doesn't Owe $45M In False Ad Fight

    The Third Circuit Thursday affirmed a lower court's decision to take genetic testing company Natera off the hook from paying $45 million in damages to rival CareDx, saying in an unpublished opinion that CareDx failed to prove Natera actually deceived consumers through false statements about a Natera test's superiority.

  • August 28, 2025

    DOJ Right On Anti-Vax Group's AP Boycott Claims, Court Told

    The anti-vaccine group founded by U.S. Department of Health and Human Services Secretary Robert F. Kennedy Jr. on Wednesday latched onto the arguments raised by the Justice Department backing its lawsuit alleging The Associated Press, the Washington Post, Reuters and the BBC colluded with social media platforms to censor rivals.

  • August 28, 2025

    Kimberly-Clark To Pay $40M Over Adulterated Surgical Gowns

    Kimberly-Clark agreed to pay up to $40 million to resolve federal prosecutors' criminal charge that the multinational consumer goods and personal care company sold adulterated surgical gowns and conducted fraudulent testing on the gowns to avoid having to submit a new premarket notification to the FDA.

  • August 28, 2025

    DOJ Seeks Kroger Patient Data In Opioid FCA Probe

    The U.S. Department of Justice urged an Ohio federal court to order The Kroger Co. to turn over patient names and other health information the supermarket chain has redacted in responses to the government throughout a False Claims Act investigation into its opioid dispensing practices.

  • August 28, 2025

    Unions Urge Judgment Blocking DOGE's Agency Access

    Unions and advocacy groups asked a Washington, D.C., federal judge Thursday for a win before trial in their lawsuit claiming agencies unlawfully provided Elon Musk's Department of Government Efficiency access to sensitive data, saying the agencies departed from their usual data access procedures without explanation.

  • August 28, 2025

    AstraZeneca Challenges Colo. Law Over Drug Pricing Rules

    Pharmaceutical giant AstraZeneca told a Colorado federal judge Wednesday that a recently passed state law aiming to extend a federal drug discount program to certain pharmacies is preempted by the same law that created the program.

  • August 28, 2025

    J&J Unit Can't Shake $442M Loss In Catheter Antitrust Suit

    A California federal judge has refused to upend the $442 million trial loss of Johnson & Johnson's Biosense Webster health tech unit to Innovative Health, finding the jury was presented with sufficient evidence to fault Biosense for conditioning product support for its cardiac mapping systems on the purchase of cardiac catheters.

Expert Analysis

  • FDA's Hasty Policymaking Approach Faces APA Challenges

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    Though the U.S. Food and Drug Administration has abandoned its usual notice-and-comment process for implementing new regulatory initiatives, two recent district court decisions make clear that these programs are still susceptible to Administrative Procedure Act challenges, says Rachel Turow at Skadden.

  • The Metamorphosis Of The Major Questions Doctrine

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    The so-called major questions doctrine arose as a counterweight to Chevron deference over the past few decades, but invocations of the doctrine have persisted in the year since Chevron was overturned, suggesting it still has a role to play in reining in agency overreach, say attorneys at Crowell & Moring.

  • A Rapidly Evolving Landscape For Noncompetes In Healthcare

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    A wave of new state laws regulating noncompete agreements in the healthcare sector, varying in scope, approach and enforceability, are shaped by several factors unique to the industry and are likely to distort the market, say attorneys at Seyfarth.

  • Arguing The 8th Amendment For Reduction In FCA Penalties

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    While False Claims Act decisions lack consistency in how high the judgment-to-damages ratio in such cases can be before it becomes unconstitutional, defense counsel should cite the Eighth Amendment's excessive fines clause in pre-trial settlement negotiations, and seek penalty decreases in post-judgment motions and on appeal, says Scott Grubman at Chilivis Grubman.

  • $95M Caremark Verdict Should Put PBMs On Notice

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    A Pennsylvania federal judge’s recent ruling that pharmacy benefits manager CVS Caremark owes the government $95 million for overbilling Medicare Part D-sponsored drugs highlights the effectiveness of the False Claims Act, as scrutiny of PBMs’ outsized role in setting drug prices continues to increase, say attorneys at Duane Morris.

  • DOJ Actions Signal Rising Enforcement Risk For Health Cos.

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    The U.S. Department of Justice's announcement of a new False Claims Act working group, together with the largest healthcare fraud takedown in history, underscore the importance of sophisticated compliance programs that align with the DOJ's data-driven approach, say attorneys at Debevoise.

  • Spotlight On Medicare Marketing Practices Enforcement Trend

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    Recent U.S. Department of Justice actions, including its recent Medicare kickback allegations in Shea v. eHealth, demonstrate increasing enforcement scrutiny on Medicare Advantage marketing practices, say Ellen London at London & Naor, Li Yu at Bernstein Litowitz and Erica Hitchings at the Whistleblower Law Collaborative.

  • Federal Regs Order May Spell Harsher FDCA Enforcement

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    A recent executive order aimed at reducing criminal prosecutions of those who unknowingly violate complex federal regulations may actually lead to more aggressive felony indictments under the Federal Food, Drug and Cosmetic Act, but companies and executives can mitigate risks by following several key principals, say attorneys at McGuireWoods.

  • What High Court's Tenn. Trans Care Ruling Means Nationally

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    The U.S. Supreme Court's decision in U.S. v. Skrmetti, upholding a Tennessee ban on gender-affirming medical care for minors, is fairly limited in scope and closely tailored to the specific language of Tennessee's law, but it may have implications for challenges to similar laws in other states, say attorneys at Hall Render.

  • High Court ACA Ruling May Harm Preventative Care

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    The U.S. Supreme Court's decision in Kennedy v. Braidwood last week, ruling that the U.S. Department of Health and Human Services secretary has authority over an Affordable Care Act preventive care task force, risks harming the credibility of the task force and could open the door to politicians dictating clinical recommendations, says Michael Kolber at Manatt.

  • Rising Enforcement Stakes For Pharma Telehealth Platforms

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    Two pieces of legislation recently introduced in Congress could transform the structure and promotion of telehealth arrangements as legislators increasingly scrutinize direct-to-consumer advertising platforms, potentially paving the way for a new U.S. Food and Drug Administration policy with bipartisan support, say attorneys at Sheppard Mullin.

  • 3 Judicial Approaches To Applying Loper Bright, 1 Year Later

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    In the year since the U.S. Supreme Court overturned Chevron deference in its Loper Bright Enterprises v. Raimondo decision, a few patterns have emerged in lower courts’ application of the precedent to determine whether agency actions are lawful, say attorneys at Husch Blackwell.

  • How Providers Can Brace For Drug Pricing Policy Changes

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    Though it's uncertain which provisions of the Trump administration's executive order aimed at addressing prescription drug costs will eventually be implemented, stakeholders can reduce potential negative outcomes by understanding pathways that could be used to effectuate the order's directives, say attorneys at McDermott.