Policy & Compliance
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September 18, 2025
Mich. Top Court To Weigh Medicare's Role In No-Fault Cases
Michigan's highest court will weigh whether an injured driver who opted out of personal injury protection due to his Medicare coverage must offset his damages by billing the insurance program for accident-related medical expenses in a no-fault dispute.
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September 18, 2025
HHS Shutters Miami Organ Donor Org. For 'Unsafe' Practices
Federal health officials have decertified a Miami-based organ procurement organization that arranges organ donations after an investigation found a pattern of "unsafe" practices, marking the first time the federal government has revoked the certification of such a group, according to an announcement Thursday from Health Secretary Robert F. Kennedy Jr.
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September 18, 2025
Elevance Won't Cover Zepbound To Treat Apnea, Patient Says
Elevance Health, formerly known as Anthem Inc., arbitrarily excludes coverage of FDA-approved Zepbound to treat moderate to severe obstructive sleep apnea and refuses to consider requests for exceptions by maintaining that the medication is for weight loss, alleges a proposed class action filed by an enrollee in Indiana federal court Tuesday.
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September 18, 2025
Senate Confirms Trump's Pick To Lead DOL Benefits Arm
The Senate confirmed fiduciary liability insurance expert Daniel Aronowitz on Thursday to lead the U.S. Department of Labor's employee benefits division, which oversees regulation and enforcement of employer-provided health and retirement plans.
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September 18, 2025
Couple Slam NC Defense Attys In Hospital Negligence Appeal
A couple pursuing negligence claims against a local hospital scoffed at the idea that they were lurking on the sidelines waiting to cash in on a favorable outcome in a similar case, telling the North Carolina appeals court to ignore an amicus brief by defense attorneys arguing as much.
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September 18, 2025
1st Circ. Won't Lift Block On HHS Job, Program Cuts
The First Circuit on Wednesday rejected a bid by the Trump administration to let it move ahead with cutting 10,000 jobs and end a number of programs at the U.S. Department of Health and Human Services while it appeals a Rhode Island federal judge's order temporarily barring the plan.
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September 18, 2025
Withheld Email Not Enough To Revive Doc's Retaliation Suit
A psychiatrist failed to convince the Second Circuit to reinstate his suit claiming a New York City-area hospital system forced him out because he raised patient safety concerns, with the appeals court saying he couldn't show the hospital's omission of an email during discovery was purposeful.
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September 17, 2025
J&J Whistleblowers Defend $1.6B False Claims Act Win
Whistleblowers filed a brief Wednesday in the Third Circuit in a closely watched False Claims Act appeal involving a $1.6 billion judgment against Johnson & Johnson unit Janssen as well as the constitutionality of the FCA's "qui tam" whistleblower provisions, arguing that the act's lawfulness has been settled by its "unbroken 162-year history."
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September 17, 2025
FDA Says Vape Manufacturer Lying About Marketing Approval
The U.S. Food and Drug Administration on Tuesday sued manufacturers of flavored vapes in New Jersey federal court to seek an end to their sales, saying that they are falsely representing that their products had received marketing approval.
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September 17, 2025
3rd Circ. Weighs Limits On NJ Medical Aid In Dying Act
The Third Circuit on Wednesday considered whether a Delaware woman with terminal cancer can challenge New Jersey's residency requirement for medical aid in dying, even though she has yet to be certified as having six months or less to live.
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September 17, 2025
Hospital Agrees To End Retirement Plan Fee, Investment Suit
A New York hospital system told a federal court Wednesday it will end a proposed class action alleging it failed to remove underperforming investment options from its retirement plan and keep an eye on administrative costs, losing millions of dollars of employees' savings.
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September 17, 2025
Ex-CDC Head Says RFK Jr. Urged Vax Schedule Rubber Stamp
Susan Monarez, the former head of the Centers for Disease Control and Prevention, told federal lawmakers on Wednesday she was abruptly fired just weeks into her tenure for "holding the line on scientific integrity."
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September 16, 2025
Dr.'s COVID Falsehoods Are Free Speech, Wash. Panel Says
A Washington state appeals court unanimously ruled Tuesday that the Washington Medical Commission overstepped its authority by punishing a doctor for COVID-19 falsehoods he published to his blog, but affirmed the commission's decision to discipline him for prescribing ivermectin to COVID-19 patients.
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September 16, 2025
Harborview Nurses In Ga. Score Collective Status In OT Suit
A pair of nurses who worked at Harborview Health Systems' facility in Rome, Georgia, brought enough evidence to show they and other similarly situated nurses were subjected to pay practices that shorted them on overtime wages to proceed as a collective action, a New York magistrate judge said Tuesday.
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September 16, 2025
Merck Says Vaccine Case 'Poor Vehicle' For Antitrust Review
Merck & Co. told the U.S. Supreme Court to reject a bid from physicians looking to revive antitrust claims over submissions the pharmaceutical giant made to federal regulators concerning its mumps vaccine, arguing that the case is "an exceptionally poor vehicle" for review.
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September 16, 2025
FTC Ends Director Overlap In Healthcare Space
The Federal Trade Commission said three members of Sevita Health's board of directors resigned after enforcers flagged an overlap with the board of a competing provider of specialty healthcare for people with intellectual and developmental disabilities.
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September 16, 2025
Oregon Joins Expansion Of '5NP' Acupuncture Practice
Oregon has joined a number of states that have enacted laws that make it easier for people to get a "five needle" therapy with a raft of mental health benefits, including reduced substance withdrawal symptoms.
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September 16, 2025
The Limits On Blue States' Push For Vaccine Policy Control
Democratic-run states are changing vaccine policies as HHS Secretary Robert F. Kennedy Jr. and other Trump health officials move to restrict vaccine access, creating a new policy patchwork. Those state efforts can only go so far, healthcare experts say.
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September 16, 2025
Pharma Tests Drug Price Policies In Court: 3 Cases To Know
Two circuit courts issued notable rulings over the past week upholding laws aimed at lowering prescription drug prices. Elsewhere, insulin makers are seeking a panel rehearing in a proposed class action targeting discount programs. Here, Law360 Healthcare Authority looks at three key drug pricing cases you may have missed.
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September 16, 2025
Wash. Justices Scrutinize Minimum Wage 'Live In' Exclusion
Washington Supreme Court justices on Tuesday pushed counsel for an adult family home on the stance that its "live in" workers are adequately protected by existing laws and regulations, pointing to testimony its employees are always on call and sometimes at risk of physical assault by residents.
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September 16, 2025
Ill. Hospital Nonprofit Must Face Tobacco Fee Suit
An Illinois federal judge refused to toss the bulk of a proposed class action from an Illinois hospital worker who claimed a fee on the employee health plans of tobacco users was discriminatory and breached fiduciary duties under benefits law, finding most allegations sufficiently backed up to survive dismissal.
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September 16, 2025
DC Circ. Asked To Look At ADA Injunction In Segregation Case
Washington, D.C., wants the D.C. Circuit to narrow an injunction commanding the district to help people in Medicaid-funded nursing homes move out of those facilities and into less restrictive forms of care, as the litigation approaches its 15th birthday.
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September 16, 2025
$50B Rural Health Fund: A Primer
The U.S. Centers for Medicare & Medicaid Services will use a newly created $50 billion rural health fund to entice states to take unhealthy foods out of their food-stamp programs, expand telehealth and embrace other Trump administration priorities.
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September 16, 2025
Calif. Healthcare Bills: 4 You Need To Know
Golden State lawmakers passed a flurry of healthcare bills this legislative session, including measures meant to ease prior authorization requirements on providers and increase oversight of PBMs and PE-backed transactions. Healthcare Authority looks at four bills now on the governor's desk.
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September 16, 2025
CVS Caremark Takes $290M Overbilling Judgment To 3rd Circ.
CVS's pharmacy benefits manager will appeal a judgment against the company that was recently increased from $95 million to $290 million in a suit alleging it overbilled Medicare Part D-sponsored drugs, according to a notice of appeal filed in Pennsylvania federal court.
Expert Analysis
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How Sweeping Budget Bill Shakes Up Health Industry
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.
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New DOJ Penalty Policy Could Spell Trouble For Cos.
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.
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A Look At Key 5th Circ. White Collar Rulings So Far This Year
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.
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What US Medicine Onshoring Means For Indian Life Sciences
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.
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FCA Working Group Reboot Signals EHR Compliance Risk
The revival of the False Claims Act working group is an aggressive expansion of enforcement efforts by the Justice Department and the U.S. Department of Health and Human Services targeted toward technology-enabled fraud involving electronic health records and other data, say attorneys at ArentFox Schiff.
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FDA's Hasty Policymaking Approach Faces APA Challenges
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.
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The Metamorphosis Of The Major Questions Doctrine
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.
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A Rapidly Evolving Landscape For Noncompetes In Healthcare
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.
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Arguing The 8th Amendment For Reduction In FCA Penalties
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.
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$95M Caremark Verdict Should Put PBMs On Notice
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.
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DOJ Actions Signal Rising Enforcement Risk For Health Cos.
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.
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Spotlight On Medicare Marketing Practices Enforcement Trend
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.
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Federal Regs Order May Spell Harsher FDCA Enforcement
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.