Policy & Compliance
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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August 12, 2025
Religious Liberty Claims Spread In Abortion Ban Challenges
With the U.S. Supreme Court expanding religious protections, a groundswell of lawsuits challenging state abortion bans on free-exercise grounds has emerged.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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
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Considering The Future Of AI Regulation On Health Sector
As Texas looks to become the next state to pass a comprehensive law regulating artificial intelligence, the healthcare industry should consider how AI regulation will continue to evolve in the U.S. and how industry members can keep up with compliance considerations, say attorneys at Kirkland & Ellis.
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What To Expect From 'Make America Healthy Again' Actions
The Make America Healthy Again Commission recently established by President Donald Trump and chaired by Robert F. Kennedy Jr. will potentially bring energy and attention to important public health topics, and stakeholders should be aware of pathways for sharing their input and proactively informing proceedings, says Nicholas Manetto at Faegre Drinker.
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How Citizen Petitions Have Affected Drug Competition
In light of recent citizen petitions and proposed legislation regulating such petitions, Omar Robles at Managing Health analyzes the statistics of the extent to which citizen petitions have been filed, and to what extent they have delayed competition in prescription pharmaceuticals.
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Drug Kickback Ruling Will Make FCA Liability Harder To Prove
The First Circuit's ruling in U.S. v. Regeneron Pharmaceuticals, requiring the government to prove but-for causation to establish False Claims Act liability based on violations of the Anti-Kickback Statute, raises the bar for FCA enforcement and deepens a circuit split that the U.S. Supreme Court may need to resolve, say attorneys at Baker Donelson.
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Assessing PE Risk After Mass. False Claims Act Amendments
A law recently passed in Massachusetts amends the commonwealth's False Claims Act by dramatically expanding potential liability for private equity firms and investors, underscoring the importance of robust diligence and risk assessments for private equity firms conducting transactions in the commonwealth, say attorneys at Gibson Dunn.
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What Trump Actions Mean For Federal Research Funding
New guidance from the National Institutes of Health represents a massive policy shift regarding federal funding for researchers at institutions of higher education, contributing to a perfect storm of significant resource shortfalls in upcoming years, say attorneys at Arnold & Porter.
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A Look At Healthcare Transaction Oversight In Oregon
Understanding Oregon's enforcement authority and its impact on proposed transactions last year provides a road map to the state's plans to strengthen its processes this year, though enforcement could be challenged by ongoing litigation, say attorneys at Ropes & Gray.
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Rethinking 'No Comment' For Clients Facing Public Crises
“No comment” is no longer a cost-free or even a viable public communications strategy for companies in crisis, and counsel must tailor their guidance based on a variety of competing factors to help clients emerge successfully, says Robert Bowers at Moore & Van Allen.
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High Court Must Acknowledge US History Of Anti-Trans Laws
Despite Justice Amy Coney Barrett's claim to the contrary during oral arguments in U.S. v. Skrmetti, U.S. governments at every level have systematically discriminated against transgender people, and the U.S. Supreme Court must consider this historical context in upcoming cases about transgender issues, says Paisley Currah at the City University of New York.
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The Fate Of Biden-Era Clinical Study Guidance Under Trump
Draft guidance about the study of sex and gender differences in medical product development issued by the outgoing Biden administration currently faces significant uncertainty and litigation potential due to the Trump administration's executive orders and other actions, say attorneys at Arnold & Porter.
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10 Issues To Watch In Aerospace And Defense Contracting
This year, in addition to evergreen developments driven by national security priorities, disruptive new technologies and competition with rival powers, federal contractors will see significant disruptions driven by the new administration’s efforts to reduce government spending, regulation and the size of the federal workforce, say attorneys at Thompson Hine.
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Dispelling 10 Myths About Health Provider-Based Compliance
Congress appears intent on requiring hospitals to submit provider-based attestations for all off-campus outpatient hospital locations, so now is the time for hospitals to prepare for this change by understanding common misconceptions about provider-based status and proactively correct noncompliance, say attorneys at McDermott.
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A Look At HHS' New Opinion On Patient Assistance Programs
A recent advisory opinion from the U.S. Department of Health and Human Services' Office of Inspector General follows a recent trend of blessing patient assistance program arrangements that implicate the Anti-Kickback Statute, as long as they are structured with appropriate safeguards to minimize the risk of fraud and abuse, say attorneys at Sheppard Mullin.