Policy & Compliance
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July 08, 2025
Omnicare, CVS Tab In FCA Case Increases To $949M
A New York federal judge on Monday raised a False Claims Act judgment against Omnicare and CVS to a combined $949 million following a jury's finding that they submitted millions of false prescription claims for long-term care patients.
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July 08, 2025
Calif.'s PE Healthcare Oversight Bill: 3 Things To Know
A California bill expanding the power of a state healthcare affordability board is moving through the Legislature amid opposition from key industry organizations. Here, Law360 Healthcare Authority examines three key aspects of the legislation.
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July 08, 2025
Utah Doc Heads To Trial Over Bogus Vax Card Claims
A Utah plastic surgeon accused in a fake COVID vaccine card conspiracy headed to trial in Salt Lake City this week. Dr. Michael Kirk Moore won't be able to argue his actions were necessary to protect patients who feared taking the vaccine after the court foreclosed a "necessity" defense.
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July 08, 2025
Sweeping Medicaid Cuts Leave Health Attys With Questions
Healthcare attorneys coming back to their offices after the long weekend have had a busy few days fielding phone calls from clients looking for help digesting the One Big Beautiful Bill Act, the sweeping legislation recently signed into law by President Donald Trump that would have far-reaching ramifications for the healthcare industry.
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July 08, 2025
HHS Conscience Probes Face Post-Chevron Hurdles
As the Trump administration promotes the rights of healthcare providers to deny gender-affirming care on religious or moral grounds, legal experts say the effort may be frustrated by a U.S. Supreme Court decision that undercuts judicial deference to agencies' statutory interpretations.
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July 08, 2025
Biosimilars Industry Group Backs Interchangeability Bill
The current law on how biosimilars are deemed interchangeable or not with their name-brand biologic equivalents has led to public confusion over how safe biosimilars are, a coalition of healthcare industry groups told lawmakers in a letter Monday.
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July 08, 2025
Pa. Panel Grants Immunity To Nursing Board In Exam Dispute
A Pennsylvania appellate court on Tuesday narrowly rejected a lawsuit filed by an ex-nurse who contends a state board violated her rights by ordering her to undergo a mental health exam, finding instead that the board members are entitled to quasi-judicial immunity.
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July 08, 2025
HHS Can't Dodge Suit Over Nixed LGBTQ Bias Protections
A New York federal judge declined Tuesday to toss a transgender woman's suit challenging President Donald Trump's decision to roll back anti-discrimination regulations for LGBTQ patients during his first term, rejecting arguments from the government that the case is moot given that a Biden-era rule restored the protections.
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July 08, 2025
High Court Allows Trump's Gov't Cuts And Restructuring
The U.S. Supreme Court on Tuesday ruled the Trump administration can move forward with its plans for large-scale layoffs and reorganizations at various federal departments and agencies, lifting a California federal judge's order that had paused the efforts while a legal challenge continues.
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July 08, 2025
Merits Not At Issue For Health Co. Wage Collective, Court Told
A healthcare facility operator is focusing too much on the merits of unpaid wages claims rather than whether it had common policies that detracted from employees' pay, a respiratory therapist told a North Carolina federal court, saying collective status is appropriate.
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July 08, 2025
Ore. Weighs Tough New Requirements For Long-Term Care
Two years ago, an Oregon woman died in the cold after leaving, unseen, from a memory care facility. Today, state lawmakers are moving to strengthen oversight of long-term care facilities that serve older adults, including those with dementia.
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July 07, 2025
Pregnant Doc, Medical Orgs. Sue To Block RFK's Vax Directive
A pregnant doctor who fears she will be denied a COVID-19 vaccination, along with a coalition of medical associations, sued Health and Human Services Secretary Robert F. Kennedy Jr. in Massachusetts federal court on Monday challenging his directive recommending against the shot for pregnant women and children.
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July 07, 2025
Planned Parenthood Wins Block of 'Catastrophic' Defunding
A Massachusetts federal judge late Monday agreed to temporarily block the Trump administration's plans to prohibit Planned Parenthood health centers from receiving Medicaid reimbursements, issuing a temporary restraining order just hours after Planned Parenthood sued, saying the consequences would be "catastrophic."
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July 07, 2025
Mich. Top Court Won't Hear COVID-19 Immunity Appeal
A split Michigan Supreme Court has decided to leave in place an appellate panel's ruling that a state pandemic-response law shields a hospital from malpractice and negligence claims brought by a woman who was admitted for COVID-19-related stress, with dissenting justices saying they have concerns with the lower court's rationale.
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July 07, 2025
Atty-Client Shield Null In HIV Drug Fraud Case Docs, Feds Say
Two alleged distributors of sham HIV drugs can't shield more than 1,000 documents related to legal advice from discovery, U.S. prosecutors told a Florida federal judge Monday, asserting that any attorney-client privilege is invalidated because the advice was used to facilitate a $90 million fraud.
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July 07, 2025
Ex-Leerink Banker Can't Get Redo On Unpaid Bonuses Claim
A Massachusetts federal judge declined on Monday to rethink partially tossing a former Leerink Partners employee's suit alleging she was cheated out of millions of dollars in bonuses, rejecting the worker's argument that new evidence should change the court's mind.
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July 07, 2025
J&J Unit Looks To Wipe Out $442M Catheter Antitrust Loss
Johnson & Johnson health tech unit Biosense Webster has asked a California federal court to throw out Innovative Health's $442 million trial win in a case accusing Biosense of conditioning product support for its cardiac mapping systems on the purchase of cardiac catheters.
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July 03, 2025
States Still Oppose Florida's Generic Drug Deal With Sandoz
States accusing generic-drug makers of fixing prices are continuing to object to a $10 million settlement struck between Florida and Sandoz, arguing that it limits their ability to negotiate deals while letting the Sunshine State benefit without participating in the litigation.
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July 03, 2025
Natera Inks $8.25M Deal To End Prenatal Tests Suit
A proposed class of buyers of Natera Inc.'s noninvasive prenatal tests has asked a California federal court to give preliminary approval to an $8.25 million settlement to resolve claims that the company knew the tests were unreliable but failed to tell buyers.
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July 03, 2025
High Court Passes On Mont. Abortion, Parental Consent Case
The U.S. Supreme Court declined Thursday to hear a case focused on parental consent and abortion in Montana, as two conservative justices said the decision shouldn't be seen as a rejection by the justices of the parental-rights question itself.
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July 03, 2025
HHS Ordered To Restore Data Axed Under 'Gender Ideology' EO
The U.S. Department of Health and Human Services must restore a swath of webpages and datasets it took down following a Trump administration executive order seeking to root out references to so-called gender ideology, a D.C. federal judge ruled.
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July 03, 2025
Mich. Justices Turn Down Challenge To Med Mal Damage Cap
Michigan's highest court won't weigh in on the constitutionality of the state's caps on medical malpractice awards, rejecting a federal district court's certified question Thursday.
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July 03, 2025
The Firms That Won Big At The Supreme Court
The number of law firms juggling three or more arguments before the U.S. Supreme Court this past term nearly doubled from the number of firms that could make that claim last term.
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July 03, 2025
Breaking Down The Vote: The High Court Term In Review
The U.S. Supreme Court once again waited until the term's closing weeks — and even hours — to issue some of its most anticipated and divided decisions.
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July 03, 2025
Supreme Court Takes Up Transgender Sports Bans
The U.S. Supreme Court agreed Thursday to hear challenges to West Virginia and Idaho laws barring transgender athletes from competing on sports teams consistent with their gender identity, putting yet more anti-trans legislation to the test after upholding Tennessee's ban on gender-affirming care for minors this term.
Expert Analysis
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What Drug Cos. Must Know About NY Price Transparency Law
Drug manufacturers must understand the contours of New York's recently implemented law requiring self-reporting of drug price increases, as well as best practices for compliance and challenges against similar laws in other states, say Elizabeth Bierut and Angie Garcia at Friedman Kaplan.
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Whistleblowers Must Note 5 Key Differences Of DOJ Program
The U.S. Department of Justice’s recently unveiled whistleblower awards program diverges in key ways from similar programs at other agencies, and individuals must weigh these differences and look first to programs with stronger, proven protections before blowing the whistle, say Stephen Kohn and Geoff Schweller at Kohn Kohn.
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The Licensure Landscape For Psychedelics Manufacturers
As the need for bulk manufacturing of psychedelic substances grows, organizations aiming to support clinical trials or become commercial suppliers must navigate a rigorous and multifaceted journey to obtaining a license from the U.S. Drug Enforcement Administration, say Kimberly Chew at Husch Blackwell and Jaime Dwight at Promega Corp.
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OSHA Workplace Violence Citation Highlights Mitigation Steps
The Occupational Safety and Health Administration's recent citation against behavioral health company Circles of Care sheds light on the enforcement risks companies may face for failing to prevent workplace violence, and is a reminder of the concrete steps that can help improve workplace safety, say attorneys at Benesch.
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When Banks Unknowingly Become HIPAA Biz Associates
There appears to be significant confusion regarding the application of the Health Insurance Portability and Accountability Act to financial institutions when serving healthcare-related clients, so these institutions should consider undertaking several steps as a starting point in the effort to achieve compliance, say attorneys at Vorys.
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The Regulatory Headwinds Facing Lab-Developed Tests
Though the U.S. Food and Drug Administration's final rule regarding regulation of laboratory-developed tests outlines a four-year plan for ending enforcement discretion, and though this rule is currently being challenged in courts, manufacturers should heed compliance opportunities immediately as enforcement actions are already on the horizon, say attorneys at Kirkland & Ellis.
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3 High Court Rulings May Shape Health Org. Litigation Tactics
Three separate decisions from the U.S. Supreme Court's most recent term — Loper Bright, Corner Post and Jarkesy — will likely strengthen healthcare organizations' ability to affirmatively sue executive agencies to challenge regulations governing operations and enforcement actions, say attorneys at McDermott.
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A New Way Forward For COVID Vaccine Lawsuit Immunity
As Public Readiness and Emergency Preparedness Act protections for COVID-19 vaccines wane, adding those vaccines to coverage by the National Vaccine Injury Compensation Program would bolster defenses for administrators and manufacturers while also providing stronger remedies for those injured by vaccines, says Altom Maglio at MCT Law.
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Why DOJ's Whistleblower Program May Have Limited Impact
The U.S. Department of Justice’s new whistleblower pilot program aims to incentivize individuals to report corporate misconduct, but the program's effectiveness may be undercut by its differences from other federal agencies’ whistleblower programs and its interplay with other DOJ policies, say attorneys at Milbank.
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How Cos. With Chinese Suppliers Should Prep For Biotech Bill
A proposed bill to prohibit government-affiliated life sciences companies from contracting with Chinese biotech companies of concern may necessitate switching to other sources for research and supplies, meaning they should begin evaluating supply chains now due to the long lead times of drug development, say John O'Loughlin and Christina Carone at Weil Gotshal.
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FTC's Drug Middlemen Probe Highlights Ongoing Scrutiny
The Federal Trade Commission's interim staff report on its inquiry into pharmacy benefit managers suggests that the industry will remain under an enforcement microscope for the foreseeable future due to concerns about how PBMs affect drug costs and accessibility, say attorneys at Arnold & Porter.
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What Cos. Should Note In DOJ's New Whistleblower Pilot
After the U.S. Department of Justice unveiled a new whistleblower pilot program last week — continuing its efforts to incentivize individual reporting of misconduct — companies should review the eligibility criteria, update their compliance programs and consider the risks and benefits of making their own self-disclosures, say attorneys at Skadden.
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Motion To Transfer Venue Considerations For FCA Cases
Several recent decisions highlight the importance for practitioners of analyzing as early as possible whether a False Claims Act case warrants a change of venue, and understanding how courts weigh certain factors for defendants versus whistleblowers, say Ellen London at London & Stout, and Li Yu and Corey Lipton at DiCello Levitt.