Policy & Compliance
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March 14, 2025
Md. Judge Joins Calif. In Reversing Federal Workers' Firing
A Maryland federal judge has ordered the reinstatement of thousands of probationary employees who were abruptly fired from 18 federal agencies, saying the Trump administration's lack of required notice left states "scrambling" to pick up the pieces.
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March 14, 2025
NC Ex-Doctor Gets 2.5 Years For Drug Test Billing Scheme
A 72-year-old doctor in North Carolina was sentenced Friday to two and a half years in prison and ordered to hand over $2 million in restitution for a fraudulent billing scheme involving medically unnecessary drug tests, prosecutors said.
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March 14, 2025
FTC Urges 8th Circ. Not To Pause Insulin Pricing Case
The Federal Trade Commission has urged the Eighth Circuit not to pause its in-house case accusing Caremark Rx, Express Scripts and OptumRx of artificially inflating insulin prices, telling the appeals court the pharmacy benefit managers have no chance of winning on their constitutional claims.
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March 14, 2025
Dr. Oz Pledges 'Upcoding' Crackdown If Confirmed At CMS
Dr. Mehmet Oz told lawmakers he would combat rising healthcare costs by showing there's a "new sheriff in town" opposed to so-called upcoding by Medicare Advantage plans, as he sought support Friday for his nomination to lead the U.S. Centers for Medicare and Medicaid Services.
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March 14, 2025
Sutter Health Reaches $4.3M Deal To End Retirement Suit
Nonprofit healthcare system Sutter Health will pay $4.3 million to settle a class action from workers alleging their employee retirement plan was saddled with excessive fees and poorly performing investments, according to filings in California federal court.
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March 14, 2025
Feds Say North Carolina Cardiologist Owes $7.9M In Taxes
A North Carolina cardiologist owes the federal government $7.9 million in taxes, fees and interest, according to a new civil complaint brought against him by the tax division of the U.S. Department of Justice seeking to hold him liable for the purportedly unpaid sum.
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March 13, 2025
Colo. Says Its Abortion 'Reversal' Ban Doesn't Discriminate
The Colorado Medical Board and Colorado Board of Nursing have urged a federal court to leave in place a state law banning the use of medication to "reverse" the abortion pill, arguing that it merely regulates "substandard ineffective medical practices" and doesn't discriminate against religious health providers.
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March 13, 2025
Ohio Health Insurer Wins $24M Verdict ln Racketeering Case
An Ohio jury has awarded Medical Mutual of Ohio more than $24 million in damages, after the insurer accused its rivals FrontPath Health Coalition and HealthScope Benefits of undercutting the bidding process for healthcare contracts with the city of Toledo.
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March 13, 2025
NY AG James Pitches Bill To Expand Consumer Protection Law
New York Attorney General Letitia James on Thursday announced legislation that would expand the state's ban on deceptive business practices to also protect against unfair and abusive practices, an idea backed by Biden-era Federal Trade Commission and Consumer Financial Protection Bureau heads.
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March 13, 2025
Calif. AG Appealing State Limits On Pay-For-Delay Ban
California enforcers are appealing to the Ninth Circuit after a lower court found that a new state law restricting "reverse payment" settlements between brand-name and generic-drug makers cannot be used to regulate deals that were struck outside the state.
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March 13, 2025
PBMs Tell FTC 5-Month Delay Too Long For In-House Insulin Trial
The nation's "Big Three" pharmacy benefit managers say they want to get to trial in the Federal Trade Commission's administrative suit against them sooner rather than later, arguing that the agency's request for a five-month delay would be too long, but they're open to a three-week postponement.
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March 13, 2025
HHS Calls Back Terminated Attys Clearing Medicare Appeals
The U.S. Department of Health and Human Services on Thursday moved to reinstate about 15 attorneys who were cut loose in recent weeks, restoring staff many in the agency saw as critical to clearing a backlog of Medicare appeals.
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March 13, 2025
9th Circ. Ends Idaho Abortion Law Row After Mutual Dismissal
A Ninth Circuit panel has dropped an appeal from Idaho claiming the state's strict abortion ban doesn't conflict with a federal law protecting emergency abortions, after the Trump administration announced its decision to drop the Biden-era legal challenge.
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March 13, 2025
Days Into New Role, FDA's Top Lawyer Is Out
The top lawyer of the U.S. Food and Drug Administration resigned just two days after she was selected for the role, according to a Thursday announcement by the agency on social media site X.
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March 13, 2025
Lacking Votes, White House Pulls Weldon Nomination At CDC
The White House pulled Dr. Dave Weldon's nomination to lead the Centers for Disease Control and Prevention on Thursday after support among GOP lawmakers wavered, and it became clear he didn't have the votes to clear a Senate committee.
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March 12, 2025
GOP Senators Take Aim At CFPB Medical Debt Rule
Republican senators have introduced a measure to overturn the Consumer Financial Protection Bureau's recent rule banning medical debt from credit reports, one of the latest Biden-era regulations to be targeted for legislative repeal.
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March 12, 2025
Cancer Cause Or Red Herring? Jury Weighs Plant Bellwether
A medical sterilization company told a Colorado jury Wednesday that four women can't get millions in damages based on the "possibility" that emissions from a sterilization plant caused their cancer, at the close of a six-week trial in which the plaintiffs argued the company should be punished for its negligence.
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March 12, 2025
Law360 Cheat Sheet: Novartis' Fight Over Generic Entresto
Novartis has led a wide-ranging litigation campaign to block generic versions of its bestselling cardiovascular drug Entresto that has involved multidistrict litigation, trips to several circuit courts and cases against the federal government. Here, Law360 breaks down how the various cases intersect and what's still playing out.
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March 12, 2025
Women Attys, AGs Urge Justices To Protect Provider Choice
Women attorney groups and a group of state attorneys general urged the U.S. Supreme Court to reject South Carolina's attempt to stop Medicaid patients from seeing Planned Parenthood healthcare providers, saying in an amicus brief Wednesday that patients have a right to choose their healthcare providers and have a private right of action to enforce that right.
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March 12, 2025
SEC Says Ex-Allarity Execs Concealed Doomed FDA Approval
The U.S. Securities and Exchange Commission sued three former executives of clinical-stage pharmaceutical company Allarity Therapeutics Inc. in Massachusetts federal court, alleging Wednesday that they schemed to conceal from the public that the company's new drug application for its flagship drug had no chance of gaining regulatory approval.
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March 12, 2025
Trump Admin Seeks To End ACA Access For 'Dreamers'
The U.S. Department of Health and Human Services on Wednesday proposed a regulation that would do away with the Biden administration's rule allowing recipients of Deferred Action for Childhood Arrivals to qualify for Affordable Care Act coverage.
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March 12, 2025
Judge Says Hospital Orgs.' Input Not Needed In Multiplan MDL
The Illinois federal judge handling multidistrict litigation targeting Multiplan's out-of-network reimbursement rates has rejected two hospital organizations' bid to weigh in as he considers whether he should dismiss the case.
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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."
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.