Policy & Compliance
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August 22, 2025
Judge Blocks Most ACA Rule Changes, Lets Others Proceed
A Maryland federal judge Friday largely froze the Trump administration's changes to Affordable Care Act regulations, handing a win to three cities, a coalition of doctors and a small business advocacy group that contend the changes would cause at least 1.8 million people to lose their healthcare coverage.
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August 21, 2025
CVS, Drugmakers Illegally Inflated Insulin Prices, City Claims
Drugmakers Eli Lilly and Co., Novo Nordisk Inc. and Sanofi-Aventis US LLC, pharmacy benefit managers CVS Caremark, Express Scripts and Optum Rx, and others have been hit with civil racketeering and state unfair trade practices law claims by the city of Torrington, Connecticut, over an alleged scheme to inflate insulin prices.
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August 21, 2025
DOJ Gets Backing In Fight Over Public Benefits
A group that fights to restrict immigration into the U.S. is urging a Rhode Island federal court to let the Trump administration narrow noncitizens' access to programs like Head Start, homeless shelters and food banks, arguing Thursday that a coalition of 20 states is trying to obstruct immigration enforcement and give benefits to "illegal aliens."
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August 21, 2025
High Court Allows Trump Admin To Cancel $783M In NIH Grants
The U.S. Supreme Court on Thursday allowed the Trump administration to resume the mass termination of scientific grants, overturning rulings by lower courts that had kept the funds flowing to universities and other recipients.
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August 21, 2025
Feds Claim Fla. Billing Co. Aided $15M Medicare Fraud
The U.S. government urged a Florida federal judge to deny an outsourcing company's motion to toss a $15 million False Claims Act lawsuit, saying the business aided a Miami-based laboratory to fraudulently bill Medicare for genetic tests that weren't used to treat patients.
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August 21, 2025
11th Circ. Backs Health System In Black Worker's Bias Suit
The Eleventh Circuit ruled Thursday that a fired Black worker can't revive her race and disability bias suit against a Georgia health system, saying her failure to provide a proposed date to return from medical time off amounted to an unreasonable request for indefinite leave.
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August 21, 2025
Seton Hall Gets COVID-19 Death Suit Tossed For Good
A New Jersey federal judge wasn't swayed by new arguments brought by parents of a Seton Hall University sophomore who died during a COVID-19 isolation period, saying their contract-related claims failed to establish one existed at all.
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August 21, 2025
Employer Plans In Limbo As Courts Grapple With Trans Care
Despite appellate courts' apparent willingness to allow states to ban gender-affirming care for minors, employers are still waiting for clarity on whether federal anti-discrimination laws require health plans to cover transgender healthcare access, experts say.
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August 20, 2025
17 States, DC Urge FDA To Lift Mifepristone Restrictions
Seventeen states and the District of Columbia Wednesday joined four others in urging the U.S. Food and Drug Administration to lift restrictions on the abortion drug mifepristone, saying that data their health departments collected overwhelmingly back the drug's safety.
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August 20, 2025
Judge Grills Feds On Upending 30-Year Noncitizen Benefits
A Rhode Island federal judge seemed perplexed Wednesday by a government attorney's contention that for nearly 30 years, various administrations across the political spectrum have wrongly interpreted a law the Trump administration now says requires immigration status checks for additional federal benefits.
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August 20, 2025
Ohio Justices Free Bank From $77M Guaranty Disclosure Duty
The Ohio Supreme Court on Wednesday ruled that nothing in state law required Huntington Bank to inform a co-signer of a $77 million loan guaranty about the risks associated with signing the deal with two other partners, one of whom later pled guilty to a check-kiting scheme.
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August 20, 2025
Northwell Health Inks $2.75M Deal In 403(B) Suit
New York healthcare giant Northwell Health Inc. has agreed to pay $2.75 million to end a former employee's claims it breached its fiduciary duties to participants and beneficiaries in its retirement plan by allegedly saddling workers with excessive recordkeeping fees and offering an underperforming fund.
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August 20, 2025
TikTok Can't Dodge NC Claims Over Addictive App Design
Chinese internet behemoth ByteDance Inc. and its social media subsidiary TikTok Inc. can be sued in the Tar Heel State, North Carolina's business court ruled Tuesday, preserving a lawsuit that accuses the companies of exploiting minors through addictive app design.
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August 20, 2025
NC's Cap On Med Mal Damages Is Constitutional, Panel Rules
The North Carolina state appeals court ruled Wednesday that a state law capping compensatory damages in certain medical malpractice lawsuits at $500,000 is constitutional, handing a defeat to a woman seeking to recoup her full $7.5 million jury verdict stemming from the loss of her unborn baby.
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August 20, 2025
Texas AG Threatens Suit Over Orgs. Mailing Abortion Pills
Texas Attorney General Ken Paxton has sent cease-and-desist letters to three organizations he's accused of shipping abortion drugs to women in the state in violation of state and federal laws.
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August 20, 2025
State AGs Sidelined From Sandoz Price-Fixing Deal
A group of over 40 states and territories cannot intervene in a $275 million settlement resolving generic-drug price-fixing claims against Sandoz because they only have a nominal interest in the suit that fails to confer standing, a Pennsylvania federal judge said.
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August 20, 2025
$2.8B BCBS Antitrust Deal Approved With $759M For Attys
An Alabama federal judge has approved a $2.8 billion settlement between Blue Cross Blue Shield and a class of medical providers in a landmark antitrust case, with $759 million going to Whatley Kallas LLP and other law firms for attorney fees and costs.
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August 20, 2025
Insurers Say Gov't Misusing FCA To Get Medicare Cost Cap
Insurers accused of paying brokers to steer customers to their Medicare Advantage plans asked a Massachusetts federal judge to dismiss a False Claims Act lawsuit, saying the government is mischaracterizing legal payments for marketing as kickbacks in an attempt to impose caps it has thus far been unable to obtain.
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August 20, 2025
CVS PBM Overbilling Judgment Trebled To $289M
A Pennsylvania federal judge has increased threefold a judgment against CVS Caremark from $95 million to $289 million for overbilling Medicare Part D-sponsored drugs.
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August 19, 2025
Tenn. Judge Trims Healthcare Contract TRAP Suit
A Tennessee federal judge dismissed Fair Labor Standards Act claims brought by operating room technicians claiming their ex-employer, SpecialtyCare, unlawfully required them to repay tens of thousands of dollars for specialty training, plus interest, if they quit within three years, but the judge greenlit their Truth in Lending Act claims.
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August 19, 2025
Losses Mount For Medicare Drug Negotiation Challengers
Big Pharma's losses in challenges to Medicare drug price negotiations are piling up. But don't think the industry is ready to wave the white flag.
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August 19, 2025
High Court Interest In Health Sharing Ministry Case
The U.S. Supreme Court is showing interest in a challenge to state regulatory authority over health care sharing ministries. The nonprofit groups, which offer a cheaper alternative to traditional insurance, are expected to see more demand under major changes coming to the insurance marketplace.
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August 19, 2025
Novo Nordisk Gets Forfeiture Claims Cut From 401(k) Suit
A New Jersey federal judge on Tuesday dismissed workers' allegations that Novo Nordisk unlawfully used forfeited funds in its $2.3 billion 401(k) plan for its own benefit and kept a shoddy fund on its investment roster, leaving an excessive fee claim in play.
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August 19, 2025
Panel Weighs Ga. High Court Ruling In Sham Donor Suit
Customers who accused a sperm bank of selling sperm without disclosing the true medical and criminal histories of donors urged the Georgia Court of Appeals to revive their lawsuits Tuesday, arguing the dismissals were based on a misreading of a 2020 decision from the state's high court.
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August 19, 2025
CMS Defeats 'Hair's Breadth' Star Rating Challenge
Insurance companies challenging the "star" system for rating Medicare Advantage organizations have lost another round in court, with a Texas federal judge saying Elevance Health failed to show federal officials violated the law when rounding down scores.
Expert Analysis
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Takeaways From DOJ's 1st Wage-Fixing Jury Conviction
U.S. v. Lopez marked the U.S. Department of Justice's first labor market conviction at trial as a Nevada federal jury found a home healthcare staffing executive guilty of wage-fixing and wire fraud, signaling that improper agreements risk facing successful criminal prosecution, say attorneys at McGuireWoods.
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Deregulation Memo Presents Risks, Opportunities For Cos.
A recent Trump administration memo providing direction to agencies tasked with rescinding regulations under an earlier executive order — without undergoing the typical notice-and-review process — will likely create much uncertainty for businesses, though they may be able to engage with agencies to shape the regulatory agenda, say attorneys at Blank Rome.
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The IRS Shouldn't Go To War Over Harvard's Tax Exemption
If the Internal Revenue Service revokes Harvard's tax-exempt status for violating established public policy — a position unsupported by currently available information — the precedent set by surviving the inevitable court challenge could undercut the autonomy and distinctiveness of the charitable sector, says Johnny Rex Buckles at Houston Law Center.
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New Hospice Regulations Should Enforce Core Principles
As the U.S. Department of Health and Human Services' Office of Inspector General prepares to research and expand on oversight of Medicare hospice care, the OIG should keep in mind certain core principles, such as an emphasis on preventing the entry of hospices that raise red flags, says Bill Dombi at Arnall Golden.
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7 Considerations For Conducting Drug Clinical Trials Abroad
With continuing cuts to U.S. Food and Drug Administration staffing motivating some pharmaceutical companies to consider developing drugs abroad, it's important to understand the additional risks and compliance requirements associated with conducting clinical studies in other countries, say attorneys at Morgan Lewis.
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Compliance Lessons From Warby Parker's HIPAA Fine
The U.S. Department of Health and Human Services' civil money penalty against Warby Parker highlights the emerging challenges that consumer-facing brands encounter when expanding into healthcare-adjacent sectors, with Health Insurance Portability and Accountability Act compliance being a potential focus of regulatory attention, say attorneys at Saul Ewing.
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5th Circ. Ruling Is Latest Signal Of Shaky Qui Tam Landscape
In his recent concurring opinion in U.S. v. Peripheral Vascular Associates, a Fifth Circuit judge joined a growing list of jurists suggesting that the False Claims Act's whistleblower provisions are unconstitutional, underscoring that acceptance of qui tam relators can no longer be taken for granted, say attorneys at Miller & Chevalier.
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Medicare Advantage Enforcement Strong Amid Agency Cuts
The second Trump administration's actions thus far suggest that Medicare Advantage enforcement remains a bipartisan focus despite challenges presented by evolving trends in federal agency staffing and resources, say attorneys at Ropes & Gray.
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A New Tool For Assessing Kickback Risks In Health Marketing
The Seventh Circuit's recent decision in U.S. v. Sorensen, reversing a conviction after trial of a durable medical equipment distributor, highlights two principle considerations for determining whether payments to marketers in healthcare are unlawful under the Anti-Kickback Statute, says Elisha Kobre at Sheppard Mullin.
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How Trump Orders Affect Health Orgs.' Care For Trans Minors
Two recent executive orders issued by President Donald Trump regarding gender-affirming care for minors have put healthcare organizations in a precarious situation, and these institutions should prepare for various implications and potential scenarios, say attorneys at ArentFox.
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Reproductive Health Under Trump So Far, And What's Next
Based on priorities stated so far, the Trump administration will likely continue to weaken Biden-era policies that protect reproductive health, with abortion, in vitro fertilization and contraception all being issues to watch closely amid a post-Dobbs shift, say attorneys at McDermott.
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What's Next For Lab Test Regulation Without FDA Authority
A recent Texas federal court decision vacating the U.S. Food and Drug Administration's final rule that would apply FDA regulations to laboratory-developed tests signals potential positive impacts in the diagnostic space, and could inspire more healthcare entities to litigate against the government, say attorneys at Hooper Lundy.
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6 Criteria Can Help Assess Executive Branch Actions
With new executive policy changes announced seemingly every day, several questions can help courts, policymakers and businesses determine whether such actions are proper, effective and in keeping with our democratic norms, say Marc Levin and Khalil Cumberbatch at the Council on Criminal Justice.