Policy & Compliance
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April 24, 2025
Workplace Screening Co. To Pay $8M For False Billing Claims
Vault Medical Services will pay $8 million to resolve allegations that it knowingly submitted false reimbursement claims for providing COVID-19 testing and other pandemic-related services to a federal program designated for uninsured patients.
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April 23, 2025
11th Circ. Considers Timeliness Of J&J Pelvic Mesh Claims
An Alabama couple urged the Eleventh Circuit on Wednesday to revive their lawsuit over injuries allegedly caused by pelvic mesh manufactured by Ethicon Inc. and its parent Johnson & Johnson, arguing that a district court wrongly found their claims were time-barred.
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April 23, 2025
Feds Oppose Ex-Conn. Official's 'Troubling' Greece Trip Plan
Federal prosecutors on Wednesday opposed a twice-indicted ex-Connecticut budget official's request to spend six weeks in Greece visiting family as he awaits twin corruption trials, citing a skipped deadline to relinquish guns and the risk that he might use Greek citizenship to evade justice.
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April 23, 2025
Genetic Testing Co., Marketer Settle FCA Case For $6M
A genetic testing company, marketing firm, and their top executives have agreed to pay $6 million to resolve the government's allegations that they billed Medicare for unnecessary medical tests, in violation of the False Claims Act.
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April 23, 2025
Eli Lilly Sues 4 Telehealth Cos. For Weight Loss Drug Copies
Eli Lilly filed a new round of lawsuits Wednesday over the compounding of its popular weight loss drugs Mounjaro and Zepbound, accusing four telehealth companies of making copies of the medications while alleging that two companies violated laws requiring doctors to make medical decisions, not corporations.
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April 22, 2025
Free Speech Experts Question DOJ Letter To Medical Journal
A federal prosecutor's letter to a medical journal skeptically asking about its commitment to nonpartisan debate is an unusual intrusion into editorial decision-making and may interfere with the publication's First Amendment rights, free speech experts say.
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April 22, 2025
'Fetal Personhood' Animates Neb. Aborted-Remains Debate
Nebraska lawmakers are sparring over a bill that would require healthcare facilities to bury or cremate fetal remains following an elective abortion. Supporters envision a "dignified" disposition. Opponents decry a requirement targeting providers while advancing the “fetal personhood” doctrine.
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April 22, 2025
Hogan Lovells Adds Ex-HHS Atty To Health Practice
Hogan Lovells on Tuesday announced the arrival of a former U.S. Department of Health and Human Services attorney to the firm's global regulatory and intellectual property practice group.
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April 22, 2025
Trump's Healthcare Order A Mixed Bag For Big Pharma
While Trump's executive order last week is more of a general road map than a clear plan for cutting prices, experts say it signals key policy priorities for the administration — including on a point of serious contention between drug companies and federal regulators.
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April 22, 2025
Pharma Co. Owner Cops To Selling $60M Of Sham HIV Drugs
An owner of a pharmaceutical company has pled guilty in Florida to participating in a $60 million nationwide scheme to illegally distribute misbranded and adulterated HIV drugs to patients.
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April 22, 2025
MoFo Adds Perkins Coie FDA Regulatory Leader In DC
Morrison Foerster LLP has hired a former Perkins Coie LLP leader who focuses his practice on a range of regulatory matters involving the U.S. Food and Drug Administration as its new head of food and regulatory, the firm announced Tuesday.
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April 22, 2025
Trump Deregulation Order Puts Target On Nurse Survey Rule
The Trump administration's push for mass deregulation is raising the hopes of nursing facilities that have spent years pushing back on a controversial rule limiting when a registered nurse must be present during facility safety inspections.
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April 22, 2025
State Legislatures Pull Back On Certificate-Of-Need Laws
Lawmakers in a handful of states are considering a fresh round of repeals and rollbacks to certificate-of-need laws, an often divisive tool designed to control healthcare costs by limiting duplication of services. That means more changes to a legal landscape that has evolved significantly since the advent of the statutes in the 1970s.
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April 22, 2025
Save Mart Reaches $20.5M Deal On Nonunion Retiree Benefits
California-based Save Mart Supermarkets will pay about $20.5 million to escape a suit from workers who alleged the company unlawfully revoked a monthly health reimbursement that it promised to nonunion retirees and their spouses for life, according to a proposed deal filed in federal court.
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April 22, 2025
Nossaman Health Atty Talks Staffing, Evolving Calif. Law
A former Procopio Health attorney has made the jump to Nossaman LLP at a time when California law around peer and judicial review processes for medical staff is evolving.
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April 21, 2025
Premera's Teen Trans Policy 'Textbook' Sex Bias, Judge Says
Premera Blue Cross discriminated based on sex against transgender teens at the center of a lawsuit alleging the insurer and health plan administrator illegally denied coverage for gender-affirming chest surgery, according to a Washington federal judge who also denied class certification because the teens' claims are not typical of class members.
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April 21, 2025
Harvard Sues Trump Admin Over $2B Funding Freeze
Harvard University on Monday hit the Trump administration with a suit in Massachusetts federal court, escalating a high-profile battle after the government slashed more than $2 billion in funding amid allegations the elite school has failed to properly address antisemitism on its campus.
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April 21, 2025
NJ Panel Revives Ex-Group Home Worker's Whistleblower Suit
A New Jersey appeals court reinstated a group home worker's lawsuit alleging she was fired for raising concerns about staffing levels and training, reasoning Monday that she met the pleading standards for the state's whistleblower law.
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April 21, 2025
Unions Demand Halt To DOGE's Info Access At DOL, HHS
A D.C. federal judge must block Elon Musk's Department of Government Efficiency from accessing sensitive systems in the U.S. Department of Labor and Department of Health and Human Services, unions argued in a preliminary injunction bid, saying the government's search for "waste, fraud and abuse" doesn't warrant access.
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April 21, 2025
HCA, Workers Eye Mediation in Wage Suit
HCA Healthcare Inc. asked a North Carolina federal court to press pause on a respiratory therapist's class and collective action accusing the company of manipulating workers' time sheets to pay them less overtime wages, saying the parties are planning to attend mediation in July.
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April 21, 2025
Justices Mull 5th Circ. Redo In ACA Preventive Care Fight
The U.S. Supreme Court on Monday appeared skeptical of a Fifth Circuit ruling that found members of a task force setting preventive services coverage requirements under the Affordable Care Act were unconstitutionally appointed, with multiple justices suggesting kicking the case back down to the circuit court for additional arguments.
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April 21, 2025
Justices Kick Flavored-Vape Dispute Back To 5th Circ.
After the U.S. Supreme Court affirmed the U.S. Food and Drug Administration's authority to reject an e-cigarette company's application to market flavored vapes, the high court on Monday granted summary disposition on one other pending case on the same subject, while denying certiorari to three others.
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April 19, 2025
Up Next At High Court: Preventive Healthcare, LGBTQ Books
The U.S. Supreme Court will hear arguments in five cases this week, including disputes over the constitutionality of a task force that sets preventive healthcare coverage requirements, a school district's introduction of LGBTQ-themed storybooks and whether parties can establish standing based on harms affecting third parties.
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April 18, 2025
Walgreens To Pay DOJ $300M Over Invalid Prescriptions
Walgreens revealed in a U.S. Securities and Exchange Commission filing Friday that it will pay upward of $300 million to resolve U.S. Department of Justice allegations that it knowingly filed millions of prescriptions for opioids and other drugs that didn't have a legitimate medical purpose or weren't valid.
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April 18, 2025
Lilly Blasts Compounders' 'Scattershot' Bid To Reverse FDA
Eli Lilly urged a Texas federal judge to deny a request from pharmacies that produce copycat doses of its popular weight loss drug to have the court reverse an FDA decision taking the drug off a national shortage list, saying the bid was filled with unreliable "scattershot" arguments.
Expert Analysis
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Navigating Scrutiny Of Friendly Professional Corps. In Calif.
In light of ongoing scrutiny and challenges to private equity participation in the California healthcare marketplace, particularly surrounding the use of the friendly professional corporation model, management services organizations should consider implementing four best practices, say attorneys at Holland & Knight.
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Takeaways From New HHS Substance Use Disorder Info Rules
A new U.S. Department of Health and Human Services rule continues the agency's efforts to harmonize complex rules surrounding confidentiality provisions for substance use disorder patient records, though healthcare providers will need to remain mindful of different potentially applicable requirements and changes that their compliance structures may require, say attorneys at Ropes & Gray.
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Calif. Banking Brief: All The Notable Legal Updates In Q2
The second quarter of 2024 in California, which saw efforts to expand consumer protection legislation and enforcement actions in areas of federal focus like medical debt and student loans, demonstrated that the state's role as a trendsetter in consumer financial protection will continue for the foreseeable future, say attorneys at Sheppard Mullin.
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How Cannabis Rescheduling May Affect Current Operators
The U.S. Drug Enforcement Agency's proposal to reschedule marijuana to Schedule III provides relief in the form of federal policy from the stigma and burdens of Schedule I, but commercial cannabis operations will remain unchanged until the federal-state cannabis policy gap is remedied by Congress, say Meital Manzuri and Alexis Lazzeri at Manzuri Law.
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Air Ambulance Ruling Severely Undermines No Surprises Act
A Texas federal court's recent decision in Guardian Flight v. Health Care Service — that the No Surprises Act lacks a judicial remedy when a health insurer refuses to pay the amount established through an independent review — likely throws a huge monkey wrench into the elaborate protections the NSA was enacted to provide, says Mark DeBofsky at DeBofsky Law.
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Class Actions At The Circuit Courts: June Lessons
In this month's review of class action appeals, Mitchell Engel at Shook Hardy considers two recent decisions from the Third and Tenth Circuits, and identifies practice tips around class action settlements and standing in securities litigation.
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How Congress Is Tackling The US Healthcare Shortage
With healthcare shortages continuing across the U.S. despite industry efforts to improve patient access to care, increased Medicare support for graduate medical education could be a crucial component of the solution, say Sarah Crossan and Miranda Franco at Holland & Knight.
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The Current State Of Healthcare Transaction Reviews In Calif.
As of April, certain healthcare transactions in California have been subject to additional notification compliance requirements, and complying with these new rules could significantly delay and discourage some deals, says Andrew Demetriou at Husch Blackwell.
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High Court's Abortion Pill Ruling Shuts Out Future Challenges
The U.S. Supreme Court's unanimous ruling in U.S. Food and Drug Administration v. Alliance for Hippocratic Medicine maintains the status quo for mifepristone access and rejects the plaintiffs' standing theories so thoroughly that future challenges from states or other plaintiffs are unlikely to be viable, say Jaime Santos and Annaka Nava at Goodwin.
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Orange Book Warnings Highlight FTC's Drug Price Focus
In light of heightened regulatory scrutiny surrounding drug pricing and the Federal Trade Commission's activity in the recent Teva v. Amneal case, branded drug manufacturers should expect the FTC's campaign against allegedly improper Orange Book listings to continue, say attorneys at Ropes & Gray.
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A Plaintiffs-Side Approach To Cochlear Implant Cases
As the number of cochlear implants in the U.S. continues to grow, some will inevitably fail — especially considering that many recalled implants remain in use — plaintiffs attorneys should proactively prepare for litigation over defective implants, says David Shoop at Shoop.
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Inside Antitrust Agencies' Rollup And Serial Acquisition Moves
The recent request for public comments on serial acquisitions and rollup strategies from the Federal Trade Commission and U.S. Justice Department mark the antitrust agencies' continued focus on actions that fall below premerger reporting thresholds, say attorneys at Paul Weiss.
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Short-Term Takeaways From CMS' New Long-Term Care Rules
The Centers for Medicare & Medicaid Services' new final rule on nursing home staffing minimums imposes controversial regulatory challenges that will likely face significant litigation, but for now, stakeholders will need to prepare for increased staffing expectations and more specialized facility assessments without meaningful funding, say attorneys at Morgan Lewis.