Policy & Compliance
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May 20, 2025
Trump Admin Rationale For HHS Firings Challenged By Judge
A Rhode Island federal judge expressed skepticism Tuesday about the Trump administration's assertion that mass firings at the U.S. Department of Health and Human Services were lawful and intended to improve national health, saying during a preliminary injunction hearing that nothing in the record demonstrates "thoughtful work" behind these decisions.
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May 20, 2025
Medical Organizations Sue Feds For Removing Health Data
The U.S. Department of Health and Human Services and several constituent agencies are accused of violating the Administrative Procedure Act by illegally purging websites containing critical public health information related to trans and HIV care, vaccines and the prevention of outbreaks of communicable diseases, according to a lawsuit filed Tuesday in Washington federal court.
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May 20, 2025
Mont. Wraps Anti-DEI Medical Board Row: 3 Things To Know
A recent decision by Montana lawmakers to eliminate rules supporting gender and racial balance in state government brought an early end to a legal challenge by an anti-DEI medical advocacy group.
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May 20, 2025
4th Circ. Won't Revive Md. Retirees' Drug Benefits Case
The Fourth Circuit backed Maryland's defeat of a proposed class action alleging it broke promises made to retirees when it transitioned their prescription drug benefits to Medicare Part D, saying Tuesday that a lower court was right to toss the case.
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May 20, 2025
J&J Workers Reassert Drug Costs Resulted In Concrete Harm
Johnson & Johnson workers are urging a New Jersey federal court to maintain their proposed class claims that the company botched the management of prescription drug costs in its employee healthcare plan by allowing excessive pharmacy costs, asserting that company mismanagement resulted in concrete harm.
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May 20, 2025
Doctor's Disability Bias Claim Too Late, Mass. Court Says
A former Brigham and Women's Hospital anesthesiologist and Harvard Medical School faculty member is time-barred from pursuing disability bias claims for actions by the hospital that he was aware of as early as 2006, an intermediate Massachusetts appellate court has concluded.
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May 20, 2025
Genital Mutilation Expert On DOJ Anti-Trans Care Enforcement
A recent memo from the U.S. Department of Justice marks a turning point as the first time U.S. government officials, publicly and at the national level, have conflated female genital mutilation with gender-affirming therapies and surgeries.
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May 20, 2025
Manners, Experts And A Plan: Immigration Agents In Hospitals
As the Trump administration increases deportation efforts, hospitals and medical staff may find themselves caught between federal immigration agents pressing pointed questions about patients or medical records and privacy laws designed to prevent probing eyes.
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May 19, 2025
Feds Get Early Win In Drugmakers' Suit Over 340B Rebates
A D.C. federal judge awarded an early win to the U.S. Department of Health and Human Services on Friday on claims it illegally blocked drugmakers' efforts to implement rebates instead of discounts in a decades-old drug pricing program, finding the agency has the authority to pre-approve the price reduction models.
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May 19, 2025
9th Circ. Backs Family's Win In Suit Over Denied Benefits
The Ninth Circuit declined to upend a guild member's win in his lawsuit challenging his healthcare plan's decision to deny coverage for his son's mental health treatments, but said a lower court was wrong to award the family additional damages on their breach of fiduciary duty claim.
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May 19, 2025
Doc Loses 4th Circ. Fight Over $5.5M Order After FCA Deal
A North Carolina district court was right to reject a doctor and his wife's request to overturn or modify a $5.5 million judgment against them for allegedly hiding assets after settling a previous False Claims Act case with the government, the Fourth Circuit ruled Monday.
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May 19, 2025
5th Circ. Affirms Masculinity Gibe Can't Sustain Gay Bias Suit
The Fifth Circuit backed a hospice company's win over a former nurse who said a supervisor failed to take action when a colleague insulted him for being gay, saying the coworker's offensive comment wasn't enough to sustain a bias case.
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May 16, 2025
Fla. Gov. Says He Will Veto Bill To Expand Death Damages
Florida Gov. Ron DeSantis has said he will veto a bill recently passed by Florida lawmakers to repeal a statute limiting pain-and-suffering damages in fatal medical malpractice cases, saying a veto will prevent a flood of lawsuits against healthcare providers.
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May 16, 2025
Biotech Co. Hit With Investor Suits Over Cancer Drug Launch
Cancer treatment company Iovance Biotherapeutics has been hit with two proposed shareholder class actions accusing the company of misleading the public about the success of its commercial rollout of an FDA-approved skin cancer treatment.
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May 16, 2025
HHS Says Pain Clinic's Delay Hurts $11M Bill Challenge
The U.S. Department of Health and Human Services on Friday fought a pain clinic's bid in North Carolina federal court for a pretrial win in the clinic's suit challenging $11 million in overpayments for urine drug screening tests, saying the clinic waited too long to bring evidence that the testing was justified.
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May 16, 2025
Feds Want Ex-McKinsey Exec To Serve Time For Obstruction
Prosecutors urged a Virginia federal judge Thursday to sentence a disbarred, former senior McKinsey & Co. partner to one year in prison for obstructing an investigation into the consulting giant's work with opioid-manufacturer Purdue Pharma, while defense counsel pushed for probation so that he can return to his home in Thailand.
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May 16, 2025
23 States Win Order Halting Billions In HHS Public Health Cuts
A Rhode Island federal judge on Friday barred the Trump administration from cutting off billions of dollars in funding to state public health programs, determining the abrupt grant terminations likely violated congressional authority over spending.
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May 16, 2025
Trucking Co. Worker Says Tobacco Surcharge Violates ERISA
An employee of Marten Transport Ltd. is suing the trucking company in Wisconsin federal court, alleging that a tobacco surcharge in its health plan violates federal antidiscrimination law.
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May 16, 2025
Surgical Center Operator Inks $15M Deal Over Data Breach
Shields Health Group Inc., which runs dozens of MRI and surgical centers around New England, has agreed to pay around $15 million to resolve claims in a proposed class action stemming from a data breach that compromised the personal information of over 2 million people.
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May 16, 2025
Trump Admin Settles Vaccine Contract Info Suit For $10K
The Trump administration has reached a $10,000 settlement with a consumer advocacy group over allegedly withholding information about the government's billion-dollar contracts with companies that developed and manufactured the COVID-19 vaccine, including Pfizer and Moderna.
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May 15, 2025
Ex-CEO Cops To Conspiracy Charge In $212M Fraud Case
A New Jersey-based former CEO of a medical billing company has pled guilty to conspiring to commit securities fraud in connection with government claims he was part of a $212.5 million scheme to inflate the value of his company to defraud potential investors in a go-private transaction.
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May 15, 2025
Feds Freeze Parity Enforcement As Agencies Rethink Regs
Federal agencies said Thursday they will hold off on enforcing a rule requiring employer group health plans to analyze how they restrict coverage for mental health and substance use disorder treatments, citing ongoing litigation aimed at blocking the policy and broader plans to reevaluate enforcement priorities.
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May 14, 2025
Mont. Court Blocks 'Ideological' Transgender Youth Care Ban
A Montana judge on Tuesday struck down a state statute that banned gender-affirming care for minors, holding that the state's interest is "ideological rather than medical" and violates the constitutional rights of transgender youth seeking gender-affirming care and of healthcare professionals who provide it.
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May 14, 2025
9th Circ. Doubts Wash. Anti-Vaxxers' Stance In Med Board Suit
A Ninth Circuit judge expressed skepticism on Wednesday that the federal appellate court could revive Robert F. Kennedy Jr.'s suit against the Washington Medical Commission for initiating disciplinary proceedings against physicians who publicly aired anti-vaccination views, pointing out that federal courts generally "don't interfere" with ongoing state litigation.
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May 14, 2025
Sage Therapeutics Brass Sued Over Drug Candidate Claims
The top brass of Sage Therapeutics Inc. have been hit with a shareholder derivative suit in New York federal court alleging they misled investors about the safety, efficacy, durability and commercial prospects of three of the company's drug candidates and overstated their likelihood to be approved by the U.S. Food and Drug Administration.

As Trump Pushes Coal, Miners Fear Health Protection Erosion
A court order restoring a coal miner "black lung" screening program hasn't ended concerns among health and legal advocates that the Trump administration is neglecting miners as it pushes coal production.

DOJ Puts New Target On Medicare Advantage 'Steering'
U.S. Department of Justice officials' decision to back whistleblower claims that major health insurance companies paid millions in illegal kickbacks to brokers marks a dramatic escalation of an effort to crack down on Medicare Advantage "steering."

New AG, Same DOJ Stance On Whistleblower Law
The Trump administration's forceful defense of the qui tam provisions of the False Claims Act is significant but not surprising, given the government's increasing reliance on whistleblowers to thwart fraud and abuse.
Expert Analysis
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How NY's FAIR Act Mirrors ÃÛÌÒÊÓÆµ State Recommendations
New York's proposed FAIR Business Practices Act, which targets predatory lending and junk fees, reflects the Rohit Chopra-era Consumer Financial Protection Bureau's recommendations to states in a number of ways, including by defining "abusive" conduct and adding a new right to file class actions, says Christian Hancock at Bradley Arant.
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A Breakdown Of Trump's Order On Drug Pricing
The Trump administration may attempt to effectuate through rulemaking a recently issued executive order on lowering drug prices, which would likely have an adverse effect on stakeholders and trigger litigation, say attorneys at Debevoise.
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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.