Policy & Compliance
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July 02, 2025
9th Circ. Upholds Sutter Health's Win In Doc's Kickback Suit
The Ninth Circuit refused to revive a gastroenterologist's constitutional challenge against Sutter Health alleging the nonprofit paid kickbacks to its physicians to refer low-income patients to other hospitals, ruling Wednesday the appellant lacks evidence of purported kickbacks and doesn't address how the alleged injury to those patients harmed him.
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July 02, 2025
ACA Changes Will Result In Mass Coverage Loss, Suit Claims
Doctors for America, the Main Street Alliance and a trio of cities urged a Maryland federal court to vacate recently finalized changes to Affordable Care Act regulations, arguing they will cause at least 1.8 million people to lose their healthcare coverage.
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July 02, 2025
Veterans Sue Air Force For Disability Review Failures
Three former service members hit the U.S. Air Force with a proposed class action challenging the lawfulness of a screening process used to determine if people should be retained or referred to a formal disability evaluation process.
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July 02, 2025
DOJ, HHS Form New False Claims Act Enforcement Group
Lead attorneys at the U.S. Department of Health and Human Services and the Justice Department will head a working group focused on enforcement of the False Claims Act, government officials announced Wednesday.
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July 02, 2025
Pa. Hospital Co. To Pay $2.75M Over Drug Theft Suit
Pennsylvania healthcare company Lehigh Valley Hospital Network Inc. has agreed to pay the federal government $2.75 million to settle claims that it ran afoul of controlled substance laws when one of its pharmacy technicians allegedly stole medication on multiple occasions.
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July 02, 2025
6th Circ. Backs Cigna's Win In Emergency Room Billing Suit
The Sixth Circuit has ruled that Cigna did not have to face an unjust enrichment lawsuit brought against it by two Tennessee hospitals alleging the insurer underpaid them for out-of-network emergency services, backing a lower court's dismissal order.
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July 02, 2025
Wisconsin High Court Narrowly Blocks 1849 Abortion Ban
The Wisconsin Supreme Court on Wednesday narrowly struck down an 1849 statute criminalizing abortion, finding that the law has been effectively replaced by more modern legislation regulating the procedure.
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July 01, 2025
5 Healthcare Enforcement Actions You Don't Want To Miss
A healthcare fraud operation announced by the Justice Department targeting $14.6 billion in potential false claims wasn't the only enforcement action making waves in the industry this past week.
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July 01, 2025
Texas Goes Big On New Healthcare Laws
It may be mid-summer, but Texas lawmakers are sending doctors and lawyers back to school for a course on what constitutes a "medical emergency" for the purpose of a legal abortion. Law360 Healthcare Authority looks at that statute and other legislation becoming law in the Lone Star State.
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July 01, 2025
State AGs Sue Gov't To Halt Medicaid Data Sharing With ICE
A California-led coalition of nearly two dozen state attorneys general is pushing a federal court to stop the U.S. Department of Health and Human Services from giving immigration officials "unfettered access" to Medicaid recipients' personal health information, arguing that the sharing flouts decades of policy and practice.
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July 01, 2025
Iowa Judge Halts Law Targeting Pharmacy Benefit Managers
A federal judge in Des Moines has temporarily blocked an Iowa law regulating pharmacy benefit managers, delivering a significant victory to a coalition of local businesses that argued the statute overstepped federal authority and infringed on free speech.
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July 01, 2025
Lighting Co. Can't Escape 401(k) Forfeiture, Health Fee Suit
An Illinois federal judge narrowed a proposed federal benefits class action against an automotive lighting company from an ex-worker, but allowed allegations to proceed to discovery alleging the company misspent 401(k) forfeitures and failed to properly notify workers about a health plan tobacco surcharge.
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July 01, 2025
High Court Ruling Puts Limits On Medicaid Enforcement
The U.S. Supreme Court ruling that bars a Medicaid beneficiary from suing over her right to choose a medical provider could make more states comfortable following South Carolina’s lead and cutting off Medicaid funding for disfavored providers.
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July 01, 2025
Rural Clinics Win Reprieve For Telehealth Funds At High Court
Thousands of rural healthcare clinics that rely on federal subsidies to provide telehealth services to millions of patients secured a major win when the U.S. Supreme Court ruled that the funding for a key Federal Communications Commission program is not unconstitutional.
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July 01, 2025
Top Personal Injury, Med Mal News: 2025 Midyear Report
A U.S. Supreme Court ruling over whether personal injury claims can be brought under a RICO statute and a $7.4 billion settlement reached with the Sackler family and Purdue Pharma are among Law360's top personal injury and medical malpractice cases from the first six months of 2025.
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July 01, 2025
Dentons Adds Career Arnold & Porter Litigator In DC
A career Arnold & Porter LLP attorney who spent more than 20 years with his former firm representing clients in False Claims Act litigation and other forms of commercial litigation has joined Dentons' Washington, D.C., office as a partner, the firm announced Tuesday.
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July 01, 2025
Anthem Inks $13M Deal To End Mental Health Class Action
Anthem has agreed to pay about $12.9 million to end a proposed class action alleging the insurer's coverage denials for inpatient mental health and substance use disorder treatments violated federal benefits and mental health parity laws, according to New York federal court filings.
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July 01, 2025
RI Judge Orders Halt To HHS Layoffs, Reorganization
A Rhode Island federal judge on Tuesday blocked the Trump administration from carrying out mass layoffs at the U.S. Department of Health and Human Services, finding the reorganization usurped congressional spending authority and likely violated the Administrative Procedure Act.
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June 30, 2025
Texas Panel Says Suit Challenging Abortion Travel Is Unripe
A split Texas appeals court panel found Monday that several anti-abortion groups lack standing to sue the city of San Antonio for allegedly earmarking money to pay for out-of-state abortion travel, saying the money had not gone out yet and the groups' claims were not ripe.
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June 30, 2025
Justices Won't Disturb 10th Circ. Oklahoma PBM Law Ruling
The U.S. Supreme Court on Monday declined to hear the state of Oklahoma's challenge to a Tenth Circuit decision that found parts of a recently enacted law regulating pharmacy benefit managers were preempted by federal benefits laws and Medicare Part D, cementing an industry group's win in the case.
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June 30, 2025
DOJ Says Over 300 Charged In $14.6B Healthcare Fraud Sting
A healthcare fraud operation conducted by federal and state law enforcement groups netted more than 300 defendants in a slew of schemes amounting to $14.6 billion in potential false claims, the Justice Department announced Monday.
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June 30, 2025
High Court Turns Away Fired Christian Workers' Vax Bias Case
The U.S. Supreme Court on Monday declined to review a Third Circuit ruling that shuttered Christian workers' suits claiming a healthcare system illegally fired them for opposing its COVID-19 vaccine mandate, despite the workers' assertions that the opinion improperly constricted their religious rights.
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June 30, 2025
Trump Administration Says Harvard Violated Civil Rights Law
The Trump administration on Monday informed Harvard University that it had run afoul of federal civil rights law by failing to protect Jewish and Israeli students on campus from harassment, and threatened to cut all funding from the nation's oldest university.
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June 30, 2025
Justices Undo Patients' Win In Gender-Affirming Care Fight
The U.S. Supreme Court on Monday struck down a Fourth Circuit decision that preserved access to gender-affirming care under two state-run health plans, telling the lower court to consider a recent decision by the justices that upheld a Tennessee law limiting treatments for young transgender people.
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June 27, 2025
Feds Prevail Over J&J In Another 340B Rebate Dispute
A D.C. federal judge granted a summary judgment win Friday to the U.S. Health Resources and Services Administration over Johnson & Johnson, finding the agency acted within its discretion when it rejected the company's program to offer rebates instead of discounts in a decades-old drug pricing program.
Expert Analysis
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A Primer On EU's Updated Human Substance Regulations
The European Union's updated standards regarding quality and safety of substances of human origin meant for human application carry significant implications for companies that work with cells and tissues, and U.S. companies active in the EU market should pay particular attention to the import and export rules, say Geneviève Michaux and Georgios Symeonidis at King & Spalding.
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CFPB's Medical Debt Proposal May Have Side Effects
The Consumer Financial Protection Bureau’s recent proposal to prevent medical debt information from appearing on consumer reports and creditors from basing lending decisions on such information may have initial benefits for some consumers, but there are potential negative consequences that should also be considered, say attorneys at Cooley.
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15 Areas That Would Change Under Health Data Rule Proposal
If finalized, the Office of the National Coordinator for Health Information Technology's proposed rule will significantly progress its efforts to advance interoperability, respond to stakeholder concerns and clarify compliance with the health IT certification program, say attorneys at Ropes & Gray.
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3 Healthcare FCA Deals Provide Self-Disclosure Takeaways
Several civil False Claims Act settlements of alleged healthcare fraud violations over the past year demonstrate that healthcare providers may benefit substantially from voluntarily disclosing potential misconduct to both the U.S. Department of Justice and the U.S. Department of Health and Human Services, say Brian Albritton and Raquel Ramirez Jefferson at Phelps Dunbar.
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Takeaways From High Court's Tribal Health Admin Cost Ruling
The U.S. Supreme Court's recent determination that the government must reimburse two Native American tribes for administrative healthcare costs will help tribes maintain equal footing with the Indian Health Service when administering programs, and continues a pattern of how the current court aligns on tribal concerns, say attorneys at Lewis Roca.
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FTC Focus: Private Equity Investments In Healthcare
As the Federal Trade Commission is tightening its scrutiny of private equity investment in healthcare, the agency is finding novel grounds to challenge key focus areas, including rollup acquisitions, the flip-and-strip approach and minority investments in rival providers, say attorneys at Proskauer.
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High Court's Expert Ruling May Help Health Fraud Defendants
The U.S. Supreme Court's decision in Diaz v. U.S. appears to give the government a powerful new tool in calling its own agents as expert witnesses, but it could also benefit defense counsel in criminal healthcare fraud and other white collar criminal cases that arise in complex legal or regulatory environments, say attorneys at Holland & Knight.
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Unpacking HHS' Opinion On Cell Therapy Refund Programs
A recent advisory opinion from the U.S. Department of Health and Human Services, determining that a biopharma company's refund program for its cell therapy will not be penalized, indicates an encouraging willingness to engage, but the regulator's assumptions about the program's limited term warrant a closer look, says Mary Kohler at Kohler Health.
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DOJ Innovasis Settlement Offers Lessons On Self-Disclosure
The recent $12 million settlement with Innovasis and two of its executives demonstrates the U.S. Department of Justice's continued prioritization of Anti-Kickback Statute enforcement amid the growing circuit split over causation, and illustrates important nuances surrounding self-disclosure, say Denise Barnes and Scott Gallisdorfer at Bass Berry.
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How Orange Book Antitrust Scrutiny Is Intensifying
Pharmaceutical patent holders should be reviewing Orange Book listing practices, as the Federal Trade Commission takes a more aggressive antitrust approach with actions such as the Teva listing probe, and the U.S. Food and Drug Administration calls attention to potentially improper listings, say attorneys at McDermott.
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After Chevron: Slowing Down AI In Medical Research
The U.S. Supreme Court's recent decision overturning the Chevron doctrine may inhibit agencies' regulatory efforts, potentially slowing down the approval and implementation of artificial intelligence-driven methodologies in medical research, as well as regulators' responses to public health emergencies, say Ragini Acharya and Matthew Deutsch at Husch Blackwell.
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FDA's Multifaceted Role On Display In MDMA Therapy Scrutiny
Ongoing deliberations at the U.S. Food and Drug Administration regarding MDMA-assisted therapy for post-traumatic stress disorder serves as a window into the intricate balance of scientific innovation and patient safety oversight, and offers crucial insights into regulatory nuances, say Kimberly Chew at Husch Blackwell and Kevin Lanzo at Pharmaka Clinical Consulting.
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Analyzing FDA Draft Guidance On Clinical Trial Diversity
In light of the U.S. Food and Drug Administration's draft guidance on clinical trial diversity action plans, there are several important considerations for sponsors and clinical researchers to keep in mind to prevent delay in a drug or device application, say attorneys at Crowell & Moring.