Policy & Compliance
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March 12, 2025
NC Organ Procurer Sues CMS Over Hospital Waiver
A North Carolina-based organ procurement organization told a federal court Wednesday that the Centers for Medicare & Medicaid Services has violated federal law by giving a waiver to a hospital to work with another organ procurement service from a different region.
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March 12, 2025
HHS To Eliminate 6 Regional Offices For Legal Staff
The U.S. Department of Health and Human Services said Tuesday it will close six out of 10 regional offices where attorneys for the agency work.
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March 12, 2025
Harvard Docs Say Gov't Censored Articles With Gender Terms
A pair of Harvard Medical School researchers sued the Trump administration in Massachusetts federal court on Wednesday, claiming their work was erased from a government-run patient safety website because their articles contained terms like "LGBTQ" and "transgender."
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March 11, 2025
FTC Merger Suit, Hospital DEI Probe And Qui Tam At 11th Circ.
The Federal Trade Commission initiated its first merger challenge since the start of President Donald Trump's current term, arguing that a private equity firm's plans to buy a medical device company would lead to an unlawful level of market concentration.
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March 11, 2025
'Paucity' Of Proof Thwarts NC State Law Claims In Gardasil MDL
A North Carolina federal judge has found that Merck did not violate state law by not including warnings about its Human Papillomavirus vaccine Gardasil, saying there was a "paucity" of evidence that the vaccines cause certain injuries to recipients.
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March 11, 2025
Conversion Therapy Ban At High Court: 5 Cases To Know
The U.S. Supreme Court is set to hear a First Amendment challenge to a Colorado ban on mental health professionals using "conversion" therapy intended to help change minors' gender identity or sexual orientation.
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March 11, 2025
Zydus Cuts Deal With States, Tribes In Opioid Nuisance Suit
Zydus Pharmaceuticals Inc. has reached a deal in principle with states and Native American tribes that should quash claims related to the company's alleged role in exasperating the opioid crisis.
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March 11, 2025
Hospital Orgs. Say MultiPlan Must Not Duck Price-Fix Claims
Hundreds of American hospitals are "on the brink of collapse" and letting MultiPlan and a host of insurers who have been accused of conspiring to underpay out-of-network providers off the hook will not improve matters, two groups that represent thousands of hospitals have told the court.
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March 11, 2025
Alaska's RICO Claims Advance Against PBM In Opioid Suit
An Alaska federal judge has allowed most of the state's Racketeer Influenced and Corrupt Organization Act claims to move forward against pharmacy benefits manager Express Scripts for its alleged role in the opioid epidemic.
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March 11, 2025
Feds Turn To FCA As Enforcement Weapon In Opioid Crisis
Federal prosecutors are expanding their use of the False Claims Act to target pharmacies accused of contributing to the opioid crisis, a legal strategy that exposes the defendants to hefty penalties.
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March 11, 2025
Trump Admin Drops Suit Over COVID Nasal Spray Ads Claims
The U.S. Department of Justice quietly moved Monday to drop a Utah federal court lawsuit filed on behalf of the Federal Trade Commission accusing a sinus nasal spray company of falsely claiming its products could help prevent and treat COVID-19.
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March 11, 2025
HHS Comment Reversal Sets Stage For Quick Policy Changes
The sudden reversal at the U.S. Department of Health and Human Services of a longstanding commitment to robust public engagement clears the way for fast-paced changes to Medicaid and other massive programs, putting more pressure on compliance officers and sending more lobbying work behind closed doors.
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March 11, 2025
CEO, Staff Charged After Fatal Oxygen Chamber Explosion
Three people, including the CEO of a treatment center, have been charged with murder in connection with a hyperbaric oxygen chamber explosion that killed a 5-year-old boy, Michigan's attorney general announced Tuesday.
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March 11, 2025
Advocates Fear Abortion Drug U-Turn Under FDA Nominee
Ahead of a key Senate confirmation vote on Thursday, abortion rights advocates are sounding alarms about Marty Makary and indications that he may roll back expanded access to abortion medications as commissioner of the U.S. Food and Drug Administration.
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March 10, 2025
Justices Seen Resolving Circuit Split Over Med Mal Law
The U.S. Supreme Court said Monday it will decide whether a Delaware medical malpractice statute requiring an expert affidavit can apply in federal court, which experts said will give the justices the opportunity to reassess the so-called Erie doctrine and the relationship between state and federal courts.
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March 10, 2025
11th Circ. Urged To Find Qui Tam Cases Unconstitutional
A group of defendants accused of Medicare Advantage fraud urged the Eleventh Circuit on Monday to uphold a decision finding the False Claims Act's whistleblower provision unconstitutional, saying the statutory clause violates the Constitution in multiple ways.
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March 10, 2025
Medtronic Compliance Officer's Journey To State Senate Seat
A Medtronic compliance officer is taking on a role making different kinds of policies at the Minnesota State Capitol, following his successful bid for a state senate seat in late January. He told Law360 his compliance background is a natural fit for his new role in the public sector.
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March 10, 2025
Ga. Health System Says 'Vague,' 'Disorganized' Bias Suit Fails
A Georgia urologists' practice group on Monday hit back at a civil rights lawsuit from three doctors who said they were the victims of anti-Indian discrimination, arguing that their "shoot first and aim later" complaint fails to tie the company at all to their allegations.
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March 10, 2025
CVS PBM Caused Up To $330M In Part D Damages, Judge Told
A CVS-owned pharmacy benefits manager caused anywhere from $240 million to $330 million in damages by overbilling the government for Medicare Part D sponsored drugs, counsel for a whistleblower told a Pennsylvania federal judge at the beginning of a False Claims Act bench trial on Monday.
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March 10, 2025
AFL-CIO, Unions Defend Fight Against DOGE Access
The AFL-CIO and a group of unions sought to keep alive their claims that Elon Musk's Department of Government Efficiency can't legally access data from the U.S. Department of Labor and other federal agencies, telling a D.C. federal judge they have standing to file their suit.
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March 10, 2025
DOJ Defends Musk's Influence Against States' Challenge
The U.S. Department of Justice is defending Elon Musk's influence in the federal government against a constitutional challenge brought by 14 states, telling D.C. federal court that the "special government employee" does not occupy an official office that would be subject to the Constitution's appointments clause.
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March 10, 2025
High Court Will Review Colo.'s Conversion Therapy Ban
The U.S. Supreme Court announced Monday that it will review a challenge to Colorado's ban on licensed therapists providing conversion therapy to transgender minors, in a case that asks whether the state's law is a permissible regulation of professional conduct or an unconstitutional restriction of speech.
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March 10, 2025
Ex-Magellan CEO Pleads Guilty Over Faulty Lead Tests
The former CEO of Magellan Diagnostics Inc. admitted Monday to selling faulty devices that tested blood lead levels, the final of three defendants to plead guilty ahead of a jury trial scheduled for April.
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March 10, 2025
Justices To Weigh If Del. Expert Law Applies In Federal Court
The U.S. Supreme Court on Monday agreed to review whether federal courts must apply a Delaware state law requiring an expert affidavit for all medical malpractice complaints.
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March 07, 2025
AGs Say Anti-Trans Admin Puts $367M Hospital Grants At Risk
Attorneys general from Washington and three other states told a federal court that the Trump administration has canceled thousands of dollars in grant funding for gender-affirming care — and threatened to strip up to nearly $370 million more — in violation of court injunctions.
Expert Analysis
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5 Steps For Healthcare Companies After Biden's AI Order
Rather than simply monitoring for the issuance of agency guidelines on artificial intelligence in the wake of President Joe Biden's October executive order, health and life sciences companies should take action now and begin building internal operational and technical infrastructures designed to govern the use of AI, says Joy Sharp at Faegre Drinker.
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Giving The Gov't Drug Patent March-In Authority Is Bad Policy
The Biden administration's recent proposal to allow government seizure of certain taxpayer-funded drug patents is a terrible idea that would negate the benefits of government-funded research, to the detriment of patients and the wider economy, says Wayne Winegarden at Pacific Research Institute.
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How Clients May Use AI To Monitor Attorneys
Excerpt from Practical Guidance
Artificial intelligence tools will increasingly enable clients to monitor and evaluate their counsel’s activities, so attorneys must clearly define the terms of engagement and likewise take advantage of the efficiencies offered by AI, says Ronald Levine at Herrick Feinstein.
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When Patients Have Standing For Hospital Antitrust Suits
Brown v. Hartford Healthcare Corp., recently decided by a Connecticut state court, provides a useful examination of how antitrust standing issues may be analyzed when patients directly sue a healthcare system for anti-competitive conduct, says Charles Honart at Stevens & Lee.
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ESG Around The World: Singapore
Singapore is keen to establish itself as a leading international financial center and a key player in the sustainable finance ecosystem, and key initiatives led by its government and other regulatory bodies have helped the Asian nation progress from its initially guarded attitude toward ESG investment and reporting, say attorneys at Morgan Lewis.
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The Pop Culture Docket: Judge D'Emic On Moby Grape
The 1968 Moby Grape song "Murder in My Heart for the Judge" tells the tale of a fictional defendant treated with scorn by the judge, illustrating how much the legal system has evolved in the past 50 years, largely due to problem-solving courts and the principles of procedural justice, says Kings County Supreme Court Administrative Judge Matthew D'Emic.
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Performing Music Makes Me A Better Lawyer
The discipline of performing live music has directly and positively influenced my effectiveness as a litigator — serving as a reminder that practice, intuition and team building are all important elements of a successful law practice, says Jeff Wakolbinger at Bryan Cave.
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'Patient' Definition Ruling Raises Discount Drug Questions
A South Carolina federal court's recent decision in Genesis Health Care v. Becerra supports a broader definition of a "patient" eligible to receive discounted drugs under the Section 340B program, but raises a host of novel questions regarding how the decision will affect covered entities and enforcement actions, say attorneys at McDermott.
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Breaking Down High Court's New Code Of Conduct
The U.S. Supreme Court recently adopted its first-ever code of conduct, and counsel will need to work closely with clients in navigating its provisions, from gift-giving to recusal bids, say Phillip Gordon and Mateo Forero at Holtzman Vogel.
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Legal Profession Gender Parity Requires Equal Parental Leave
To truly foster equity in the legal profession and to promote attorney retention, workplaces need to better support all parents, regardless of gender — starting by offering equal and robust parental leave to both birthing and non-birthing parents, says Ali Spindler at Irwin Fritchie.
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Activist Short-Sellers Are The Dark Knights Of Wall Street
While so-called activist short-sellers have been subject to increased scrutiny in recent years, these investors work in the shadows like Batman to expose fraud on Wall Street, often generating leads that may move regulators to take action, say attorneys at Labaton Sucharow.
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Steps Toward A Unified Health Financing System For Calif.
A new law authorizes the secretary of the California Health and Human Services Agency to move forward with designing a unified healthcare financing system, though the notable absence of healthcare payers in the law's list of specified stakeholders raises questions about the state's position regarding private payer options, says Ima Nsien at Squire Patton.
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Writing Thriller Novels Makes Me A Better Lawyer
Authoring several thriller novels has enriched my work by providing a fresh perspective on my privacy practice, expanding my knowledge, and keeping me alert to the next wave of issues in an increasingly complex space — a reminder to all lawyers that extracurricular activities can help sharpen professional instincts, says Reece Hirsch at Morgan Lewis.