Policy & Compliance
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May 13, 2025
Michigan Judge Strikes Down State's Abortion Restrictions
A Michigan judge struck down several of the state's abortion restrictions Tuesday, including a mandatory waiting period, required counseling materials and a rule that only doctors may perform abortions, finding the laws make it harder for people to access abortion and don't protect patients' health.
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May 13, 2025
PBMs Get Bipartisan Bashing At Hearing On Drug Costs
Senators across party lines slammed pharmacy benefit managers on Tuesday, sometimes in coarse language, as they wrestled with how to reduce drug prices for patients while also preventing the closure of rural pharmacies.
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May 13, 2025
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."
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May 13, 2025
Feldesman Grants Atty On 'Chaos' Of HHS Funding Cuts
Massive cuts in federal funding for healthcare programs are testing the avenues of recourse for safety-net hospitals and others that depend on grants to keep their doors open.
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May 13, 2025
Ind. Tells Nonprofit Hospitals To Curb Prices, Or Else
A new Indiana law gives charitable hospitals a stark choice: Lower prices or face the loss of their nonprofit status.
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May 13, 2025
Attys Push 11th Circ. To Weigh Judge Shopping Sanctions
The Eleventh Circuit can hear three attorneys' appeal of sanctions against them for judge shopping during their legal challenge to an Alabama law criminalizing gender-affirming care, because the underlying case was dismissed, making the jurisdictional question moot, two of those lawyers told the appellate court.
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May 13, 2025
Associate GC Of University Hospital In NJ Joins Frier Levitt
New Jersey-based national healthcare boutique Frier Levitt has hired a former in-house counsel at University Hospital in Newark this week as a partner in the firm's healthcare practice group.
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May 13, 2025
Express Scripts, FTC Say Defamation Suit 'Should Proceed'
The Federal Trade Commission's new Republican leadership is ready to defend against an Express Scripts defamation lawsuit targeting an agency report excoriating it and other pharmacy benefit managers for allegedly inflating drug costs, the agency and the PBM told a Missouri federal judge Monday.
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May 13, 2025
Canada Drug Import Plan On The Rocks Amid Tension With US
In his first turn through the White House, President Donald Trump said a plan to import cheap prescription drugs from Canada would be a "game-changer." Five years later, the roadblocks to the program have only gotten higher.
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May 12, 2025
W.Va. High Court Declines 4th Circ. Request For Opioid Input
The West Virginia Supreme Court of Appeals on Monday declined the Fourth Circuit's request to answer whether the state's public nuisance law applies to the distribution of opioids, saying disputed facts in litigation between local governments and drug distribution companies must first be resolved.
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May 12, 2025
Pa. Mental Health Rejection Suits Could Rise, Atty Says
The Pennsylvania Supreme Court's recent decision to greenlight a suit accusing two hospitals of negligently rejecting a man seeking mental health treatment who later murdered his girlfriend could spark a rise in such lawsuits, one attorney warned.
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May 12, 2025
Missouri Hit With Sanctions In Generics Price-Fixing Fight
A Connecticut federal judge Monday agreed to sanction and potentially dismiss for good the state of Missouri from antitrust litigation by state enforcers accusing generic-drug makers of conspiring to raise drug prices, finding Missouri violated a court order by ignoring the drugmakers' repeated discovery requests.
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May 12, 2025
Mass. Court Says NIH Grant Disruption Suit Is In The Right Place
A Massachusetts federal court ruled Monday that it has jurisdiction over several states' lawsuit challenging delays and cancellations of federal grant programs linked to issues they say are "disfavored" by the Trump administration, rejecting the federal government's contention that the claims instead belonged in the U.S. Court of Federal Claims.
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May 12, 2025
AGs Call Sandoz Deal's Consumer-Side Benefits 'Illusory'
Dozens of state attorneys general asked a Pennsylvania federal judge to permit intervention into a $275 million settlement resolving generic-drug price-fixing claims from end-payor plaintiffs against Sandoz, arguing the deal threatens relief for consumers and warning that the agreement favors insurers over individuals.
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May 12, 2025
Fla. Pharmacy Beats Novo Nordisk Suit Over Ozempic 'Copies'
A Florida federal judge on Monday granted a compounding pharmacy a win in Novo Nordisk Inc.'s suit claiming it violated a state statute by selling "essentially copies" of Novo Nordisk's blockbuster Ozempic and Wegovy weight loss drugs, ruling that the claims are moot, preempted and nonviable.
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May 12, 2025
20 AGs Suing HHS Move to Halt Cuts At 4 Affected Agencies
States challenging the Trump administration's plans for massive cuts to the U.S. Department of Health and Human Services are asking a Rhode Island federal court to block any planned terminations at four of the department's agencies and programs.
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May 12, 2025
Will Justices Finally Rein In Universal Injunctions?
The U.S. Supreme Court is expected to address for the first time Thursday the propriety of universal injunctions, a tool federal judges have increasingly used to broadly halt presidential orders and policy initiatives, and whose validity has haunted the high court's merits and emergency dockets for more than a decade.
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May 12, 2025
Agencies Win Stay Of Mental Health Parity Rule Suit
A D.C. federal court on Monday agreed to stay a suit from a benefits-focused employer trade group seeking to block a recently finalized mental health parity rule, after the DOL and other federal agencies told the court they plan to rescind or modify the rule.
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May 12, 2025
King & Spalding Taps Fresenius Medical Care Leader In DC
King & Spalding LLP has rehired Patrick Murphy, a life sciences and healthcare regulatory compliance attorney, who told Law360 Pulse in an interview on Monday that he never lost contact with his former colleagues even after spending a quarter-century working as an in-house attorney.
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May 09, 2025
CFPB's Vought Set To Ditch Dozens Of Guidance Docs
The Consumer Financial Protection Bureau's acting Director Russell Vought is withdrawing dozens of the agency's interpretive rules, policy statements and other guidance documents dating back to 2011, according to a Federal Register draft notice filed Friday.
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May 08, 2025
Panel Says Colo. Hospitals Need Notice Of Retaliation Claims
A Colorado appeals court on Thursday sided with a Denver health system in a precedential ruling, finding healthcare workers who sue public hospitals under a state anti-retaliation statute must warn hospitals about their claims.
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May 08, 2025
Albertsons Says Counties Have 'Paradoxical Status' In MDL
A group of pharmacies led by Albertsons Cos. Inc. have told the Texas Supreme Court that two counties can't assert claims against them in the state's opioid multidistrict litigation while simultaneously denying they qualify as claimants.
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May 08, 2025
3rd Circ. Rejects Challenge To Medicare Drug Price Program
The Third Circuit on Thursday rejected AstraZeneca's challenge to the Medicare drug price negotiation program, ruling that the pharmaceutical giant was unable to show how it is injured by the program's guidance or how it violates its due process rights.
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May 08, 2025
Judge Asks DOJ To Define DEI In Health Grant Case
A Massachusetts federal judge on Thursday ordered U.S. Department of Justice lawyers to provide the Trump administration's definitions of diversity, equity and inclusion, saying he needs to know so he can consider whether that is a valid basis for pausing federal health research grants.
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May 08, 2025
Conn. High Court Snapshot: Rehab Permit And Towing Tiff
The Connecticut Supreme Court, in its upcoming term, will consider whether an existing substance abuse treatment center has the right to challenge the opening of a competitor nearby, and determine if a murder suspect is owed a new trial over an allegedly botched jury poll.
Expert Analysis
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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.
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In The CFPB Playbook: Making Good On Bold Promises
The U.S. Supreme Court's decision upholding the Consumer Financial Protection Bureau's funding structure in the second quarter cleared the way for the bureau to resume a number of high-priority initiatives, and it appears poised to charge ahead in working toward its aggressive preelection agenda, say Andrew Arculin and Paula Vigo Marqués at Blank Rome.
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Critical Questions Remain After High Court's Abortion Rulings
The U.S. Supreme Court's decisions in two major abortion-related cases this term largely preserve the status quo for now, but leave federal preemption, the Comstock Act and in vitro fertilization in limbo, say attorneys at Jenner & Block.