Policy & Compliance
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January 28, 2025
Trump's CMS Suit U-Turn, Sacklers Settle, And Trans Suit Stay
Law360 Healthcare Authority recaps the significant cases and decisions that shaped the healthcare industry over the past week, including the Trump administration’s reversal on a case challenging the Medicare Advantage star rating system, a freeze on a lawsuit over a Biden-era gender dysphoria rule, and the Sackler family’s $7.4 billion opioid settlement.
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January 28, 2025
Hospitals Brace For Immigration Agents, Legal Clashes
The Trump administration’s move to allow immigration enforcement at "sensitive" locations is pushing hospitals to scrutinize their legal obligations under HIPAA and other state and federal laws.
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January 28, 2025
CFPB's Medical Debt Rule In Peril Under Trump
A last-minute effort by the Biden administration to ease the burden of medical debt could face a perfect storm of regulatory and legal challenges under President Donald Trump, potentially quashing momentum to achieve relief for those saddled with unpaid healthcare bills.
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January 27, 2025
VA To Nix $6.1M In Contracts Under Trump's DEI Order
The U.S. Department of Veterans Affairs announced Monday that it has placed dozens of employees on paid leave and will cancel $6.1 million worth of contracts as part of efforts to root out diversity, equity and inclusion activities.
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January 25, 2025
Trump Revives Federal Anti-Abortion Policies
President Donald Trump issued two executive orders Friday targeting abortion inside and outside the United States, reinstating a ban on federal funding for certain international family planning groups and revoking a pair of Biden-era directives supporting abortion access.
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January 24, 2025
Anti-Abortion Group Seeks High Court Review Of NJ Probe
An anti-abortion pregnancy center operator wants the U.S. Supreme Court to revive its federal court challenge to a subpoena from the New Jersey attorney general that seeks information about its donors, urging the court in a petition for certiorari to resolve a legal "Catch-22."
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January 24, 2025
J&J Escapes Part Of Worker's Drug Benefits Suit, For Now
A suit alleging Johnson & Johnson overcharged employees through a prescription drug benefits program was partially tossed Friday, with a New Jersey federal judge ruling the suing worker failed to show the court could provide any remedies on her claims that plan members overpaid for medicine.
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January 24, 2025
Feds Drop HIPAA Charges Against Houston Surgeon
The federal government has dropped criminal charges against a Texas surgeon accused of improperly accessing patient information and sharing information about the hospital's gender-affirming care practices with the press.
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January 24, 2025
Employer Groups Back Tossing Pension Annuity Suit In NY
Three employer trade groups are backing Bristol-Myers Squibb and investment manager State Street as they fight claims brought by retirees of the pharmaceutical giant that the companies violated federal benefits law by converting workers' pension benefits into annuity insurance contracts.
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January 24, 2025
5th Circ. Upholds Tossing Medicare Rate Policy Challenge
A Fifth Circuit panel said it agrees with a Texas federal judge that a lawsuit brought by four anesthesia practices claiming a Centers for Medicare and Medicaid Services policy will cost them $4 million in reduced reimbursements is statutorily barred.
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January 24, 2025
Greenberg Traurig Health Ace Joins Polsinelli In LA
Polsinelli PC is expanding its California team, bringing in a Greenberg Traurig LLP healthcare corporate attorney as a principal in its Los Angeles office.
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January 24, 2025
Dentons Adds 2 Healthcare Attys From Katten In NY
Dentons announced that it has added two attorneys with extensive experience in Medicare and Medicaid reimbursement, regulatory compliance and False Claims Act defense as New York-based partners in its healthcare practice.
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January 23, 2025
Marlboro Smoker Was Target Of Deception, Jury Hears
Philip Morris targeted a Massachusetts preteen as a "replacement" customer for others who were dying of lung disease, a Springfield jury heard Thursday, though the company's lawyer said the woman had free will and knew enough to stop smoking.
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January 23, 2025
4th Circ. Reads Kickback Law Broadly In Loss For Big Pharma
The Fourth Circuit on Thursday affirmed a Virginia federal judge's ruling against a pharmaceuticals industry-backed charity looking to weaken the Anti-Kickback Statute, holding that a proposed program for helping patients cover the cost of drugs could indeed constitute a quid pro quo.
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January 23, 2025
Georgia Pain Doctor To Pay Feds $3.5M In FCA Settlement
A Georgia doctor and his pain management clinic have agreed to pay $3.5 million to end a yearslong civil probe into False Claims Act allegations of billing fraud and violations of opioid prescription protocols, the U.S. Department of Justice said Thursday.
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January 23, 2025
Conn. Lawmakers Target Healthcare After Hospital's Ch. 11
In the lead-up to and aftermath of California hospital operator Prospect Medical Holdings Inc.'s $1 billion bankruptcy, Connecticut lawmakers are considering new regulatory powers, promising and penning oversight bills for hospitals owned by private equity firms and real estate trusts while seeking to stabilize the state's healthcare markets.
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January 23, 2025
UnitedHealthcare Settles Proton Beam Coverage Suit
UnitedHealthcare has agreed to resolve a proposed class action claiming it unlawfully denied coverage of a proton beam cancer treatment after wrongly labeling it as experimental, the insurance company and plan participants told a Massachusetts federal court.
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January 23, 2025
15 States Reach $7.4B Settlement With Sackler Family
A bipartisan coalition of states on Thursday announced a $7.4 billion settlement in principle with the Sackler family and their company Purdue Pharma Inc., representing the largest settlement to date with the family accused of contributing significantly to the opioid epidemic.
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January 22, 2025
RFK Filings Show Biopharma Stakes, Millions In Firm Income
Robert F. Kennedy Jr. plans to sell off his stakes in two biopharmaceutical companies and step back from lucrative roles at a handful of law firms if he is confirmed to lead the U.S. Department of Health and Human Services, according to new financial disclosures.
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January 22, 2025
Med Mal Experts Need Only 1 Specialty, NJ Justices Rule
When a doctor accused of malpractice has more than one specialty, the plaintiff needs only to produce an affidavit of merit from a physician who is certified in one of the specialties, the New Jersey Supreme Court ruled Wednesday, overturning a state appellate court ruling.
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January 22, 2025
Wash. City Beats Fired Workers' Suit Targeting Vax Mandate
A Washington federal judge tossed a suit brought by city workers claiming they were illegally fired for opposing a COVID-19 vaccine mandate, ruling that the city they worked for didn't violate any of their rights by requiring them to get immunized or lose their jobs.
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January 22, 2025
Feds Trim Spine-Implant Kickback Case Ahead Of Trial
A Massachusetts federal judge has granted a motion by prosecutors to drop bribery charges against a maker of spinal implant devices and whittle down the case against two of its former executives.
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January 22, 2025
Logistics Cos. Say Workers' Tobacco Fee Suit Filed Too Late
A pair of logistics companies are asking a Connecticut federal court to throw out a proposed class action alleging they violated federal law by not fully reimbursing employees who paid an additional tobacco-use fee on their healthcare, saying all the claims in the suit are barred by statutes of limitation.
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January 21, 2025
The Legal And Practical Questions Around Trump's WHO Exit
President Donald Trump’s first-day order setting in motion the United States’ withdrawal from the World Health Organization could leave the nation less prepared for global health threats and trigger legal clashes over the president’s authority to act unilaterally.
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January 21, 2025
4th Circ. Won't Undo Doctor's Conviction For Reusing Devices
A former North Carolina ear, nose and throat doctor staring down 25 years in prison for healthcare fraud lost an appeal Tuesday seeking to overturn her conviction, with the Fourth Circuit finding that the lower court did not commit any reversible error that would favor a shot at redemption.
Expert Analysis
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How White Collar Defense Attys Can Use Summary Witnesses
Few criminal defense attorneys have successfully utilized summary witnesses in the past, but several recent success stories show that it can be a worthwhile trial tactic to help juries understand the complex decision-making at issue, says Jonathan Porter at Husch Blackwell.
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Nutraceutical Patent Insights As Market Heats Up
Companies entering the expanding nutraceutical market and seeking patents to protect their innovations should evaluate successful nutraceutical claim language and common patent challenges in this field, say attorneys at Sterne Kessler.
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How White Collar Attys Can Use Mythic Archetypes At Trial
A careful reading of a classic screenwriting guide shows that fairy tales and white collar trials actually have a lot in common, and defense attorneys would do well to tell a hero’s journey at trial, relying on universal character archetypes to connect with the jury, says Jack Sharman at Lightfoot Franklin.
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What 2024 Election Means For Drugs, Medicare And Medicaid
With Republicans running the White House, U.S. House of Representatives and U.S. Senate, the incoming administration is likely to provide pathways — through new initiatives and others returning from Trump's previous presidency — for a range of potential changes to drug pricing, Medicare and Medicaid, say attorneys at Morgan Lewis.
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Justices Mull Sex-Based Classification In Trans Law Case
After the U.S. Supreme Court heard oral argument in U.S. v. Skrmetti this week, it appears that the fate of the Tennessee law at the center of the case — a law banning gender-affirming healthcare for transgender adolescents — will hinge on whether the majority read the statute as imposing a sex-based classification, says Alexandra Crandall at Dickinson Wright.
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Key Takeaways From FDA's Latest Social Media Warnings
The U.S. Food and Drug Administration's latest untitled letter concerning a drug company's social media promotion provides lessons for how companies should navigate risk presentation, FDA labeling requirements and superiority claims, say attorneys at Sheppard Mullin.
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Rank-And-File DOJ Attorneys Will Keep Calm And Carry On
Career prosecutors at the U.S. Department of Justice often pride themselves on their ability to remain apolitical in order to ensure consistency and keep the department’s mission afloat, and the incoming Trump administration is unlikely to upend this tradition, says Michael Landman at Bird Marella.
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Unpacking Arguments From High Court's Rural Hospital Case
During oral arguments in Advocate v. Becerra, the U.S. Supreme Court justices focused questions on the meaning of being "entitled to" supplementary security income assistance, and there's reason for optimism that the likely split decision will break in favor of hospitals, say attorneys at King & Spalding.
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Health Policy Predictions For Trump's Second Administration
As President-elect Donald Trump's nominations for health policy and enforcement heads work their way through the confirmation process, healthcare organizations can look at nominee backgrounds, campaign statements and actions from Trump's previous presidency to predict incoming priorities, say attorneys at McDermott.
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What Trump's Next Term May Mean For Biz Immigration
Leonard D'Arrigo at Harris Beach discusses the employment-based immigration policies businesses can potentially expect during President-elect Donald Trump’s second term, based on policies enacted during his first administration, statements made during his campaign and proposals in Project 2025.
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Weak Reasoning Underlies Fla. Judge's Bold Qui Tam Ruling
U.S. District Judge Kathryn Mizelle's groundbreaking decision in U.S. ex rel. Zafirov v. Florida Medical Associates LLC, holding that qui tam provisions of the False Claims Act are unconstitutional, relies on weak logic to reach a conclusion that differs from every other court that has ruled on the issue, says Ethan Greenberg at Anderson Kill.
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Medicare Overpayment Rules Are A Mixed Bag For Providers
The Centers for Medicare & Medicaid Services' updated rules for handling agency overpayments adopt a more reasonable definition of what it means to have "identified" an overpayment, which is a win for providers, but their new time frame for investigating related overpayments is unrealistic, says Susan Banks at Holland & Knight.
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Expect More State-Level Scrutiny Of Noncompetes Ahead
Despite the nationwide injunction against the Federal Trade Commission’s noncompete ban, and the incoming Republican administration, employers should anticipate that state legislatures will continue to focus on laws that limit or ban noncompetes, including those that target certain salary thresholds or industries, says Benjamin Fryer at FordHarrison.