Policy & Compliance
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September 16, 2025
$50B Rural Health Fund: A Primer
The U.S. Centers for Medicare & Medicaid Services will use a newly created $50 billion rural health fund to entice states to take unhealthy foods out of their food-stamp programs, expand telehealth and embrace other Trump administration priorities.
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September 16, 2025
Calif. Healthcare Bills: 4 You Need To Know
Golden State lawmakers passed a flurry of healthcare bills this legislative session, including measures meant to ease prior authorization requirements on providers and increase oversight of PBMs and PE-backed transactions. Healthcare Authority looks at four bills now on the governor's desk.
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September 16, 2025
CVS Caremark Takes $290M Overbilling Judgment To 3rd Circ.
CVS's pharmacy benefits manager will appeal a judgment against the company that was recently increased from $95 million to $290 million in a suit alleging it overbilled Medicare Part D-sponsored drugs, according to a notice of appeal filed in Pennsylvania federal court.
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September 16, 2025
WellSpan Health Elevates Atty To Legal Chief
Regional healthcare provider WellSpan Health has tapped one of the company's in-house attorneys to lead its law department in its south central Pennsylvania headquarters.
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September 16, 2025
For Cahill Atty, Rare Disease Pro Bono Work Is Personal
John MacGregor of Cahill Gordon & Reindel LLP didn't have any experience in healthcare law before taking on a pro bono client that supports people with a rare form of epilepsy. MacGregor's son is one of them.
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September 16, 2025
HHS OIG Senior Counsel Joins Polsinelli As Shareholder
A former senior counsel in the U.S. Department of Health and Human Services' Office of Counsel to the Inspector General, who spent more than a decade in private practice before his most-recent six years in public service, has joined Polsinelli PC.
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September 15, 2025
Mich. Says HHS Can't Justify $195M Medicaid Clawback
The state of Michigan urged a federal judge to find that the U.S. Department of Health and Human Services cannot catch a payday for its yearslong delay in affirming a decision to disallow $195 million in Medicaid payments to two state-operated psychiatric hospitals, arguing that the delay runs afoul of federal law and the department's own policies.
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September 15, 2025
Stewart Says New Policies Seek Fairness For Patent Owners
Acting U.S. Patent and Trademark Office Director Coke Morgan Stewart said Monday the numerous changes to patent reviews she has implemented are intended to provide "more balance and fairness" for patent owners, and bring the reviews "back to how they were originally intended."
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September 15, 2025
Corcept Can't Escape Teva's Mifepristone Antitrust Suit
Corcept Therapeutics must face most of Teva Pharmaceuticals' lawsuit alleging it suppressed generic competition for its brand-name medication used to treat a rare cortisol disorder, a California federal judge ruled, saying the claims are not time-barred and Teva has adequately alleged unlawful monopolization.
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September 15, 2025
Mich. Ordered To Clarify Stance On Clinic's Trans Care Policy
A federal magistrate judge on Monday ordered Michigan civil rights enforcers to clarify in discovery responses whether a Christian medical clinic's opposition to gender-affirming care violates the state's antidiscrimination law.
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September 12, 2025
AbbVie Can't Halt Miss. Discount Drug Law, 5th Circ. Says
AbbVie and other pharmaceutical manufacturers that participate in Medicaid cannot preliminarily block a Mississippi law barring their interference with the distribution of discounted prescriptions to pharmacies serving low-income patients, the Fifth Circuit ruled Friday, saying the drugmakers haven't shown that the statute likely effectuates a taking of their property.
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September 12, 2025
Ex-Conn. Assistant AG Faces DQ Bid In Price-Fixing Case
Drug companies accused of fixing prices for generics are seeking to disqualify former Connecticut Assistant Attorney General Joseph Nielsen and his law firm from representing insurers in a multidistrict litigation, arguing Nielsen had access to confidential information as a government attorney that he could unfairly use against them now.
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September 11, 2025
States Push Conn. Court To Ban Generic Drug Price-Fixing
A court order is necessary to prevent pharmaceutical companies and their executives from illegally fixing the prices of generic drugs, a coalition of state enforcers have told a Connecticut federal judge, arguing there is a "reasonable expectation" that the allegedly anticompetitive behavior at the center of multidistrict litigation will happen again.
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September 11, 2025
Medicare Drug Pricing Plan Survives Novartis' 3rd Circ. Appeal
The Third Circuit ruled Thursday that the Centers for Medicare & Medicaid Services' ability to negotiate "maximum fair prices" with drugmakers doesn't violate their constitutional rights, rejecting an argument by Novartis Pharmaceuticals Corp. that the practice amounted to a raw deal for the pharmaceutical industry.
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September 11, 2025
Expert's AI Hallucinations Blamed On Attys' 'Willful Blindness'
Utah anesthesiologists facing a False Claims Act fraudulent billing suit doubled down Wednesday on their bid to sanction and disqualify the whistleblower's counsel for not catching an expert witness report with numerous AI-generated fabrications, arguing the errors were so obvious that the failure to catch them constitutes "willful blindness."
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September 11, 2025
1st Circ. OKs Freeze Of Planned Parenthood Medicaid Funding
The First Circuit on Thursday allowed the Trump administration to halt Medicaid reimbursements to Planned Parenthood and its affiliates, pausing a pair of lower court rulings that had blocked the funding cut.
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September 11, 2025
7th Circ. Backs $183M FCA Award Over Eli Lilly Drug Rebates
The Seventh Circuit refused on Thursday to unwind a whistleblower's $183 million trial win against Eli Lilly in a false claims case targeting more than a decade of drug rebate miscalculations, saying a jury reasonably found that the company knowingly "hid the truth" about how much it charged for Medicaid-covered drugs.
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September 11, 2025
LifePoint Must Face Workers' 401(k) Mismanagement Suit
A Tennessee federal judge refused to toss a proposed class action against LifePoint Health Inc. from participants in the healthcare company's employee 401(k) plan who alleged their retirement savings were dragged down by excessive recordkeeping and administrative fees, concluding allegations were sufficiently backed up to proceed to discovery.
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September 10, 2025
Feds Barred From Axing 30-Year Noncitizen Services, For Now
A Rhode Island federal judge Wednesday blocked the Trump administration from enacting a policy change requiring immigration status checks for a number of federally funded community services, saying a coalition of Democratic-led states is likely to succeed in its assertion that the move is unconstitutional, as well as arbitrary and capricious.
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September 10, 2025
FTC Urged To Probe Microsoft Over Ascension Data Breach
U.S. Sen. Ron Wyden, D-Ore., is calling on the Federal Trade Commission to open an investigation into Microsoft's "gross cybersecurity negligence" that has allegedly contributed to cyberattacks against critical infrastructure providers, including a 2024 ransomware hack that targeted hospital system Ascension.
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September 10, 2025
FTC Warns Healthcare Employers About Noncompetes
The Federal Trade Commission has sent letters warning healthcare employers and staffing companies not to include overly broad noncompete restrictions in their employment contracts and urged them to conduct a review to ensure they comply with the law.
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September 10, 2025
Medical Equipment Co. Settles County Claims In Opioid MDL
Medical equipment company Henry Schein Inc. and its related entities have settled claims by Virginia counties brought against it in the sprawling national opioid litigation, according to a notice filed Wednesday.
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September 09, 2025
4th Circ. Debates Whether 'Silence' In 340B Empowers States
Two states told a Fourth Circuit panel on Tuesday that "silence" in the law governing the federal government's drug discount program permits state enforcers to step in and regulate the delivery of those drugs to their communities.
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September 09, 2025
Trump Admin Blocked From Boston Hospital Trans Care Docs
A Massachusetts federal judge on Tuesday blocked the Trump administration's bid to gain access to a wide array of documents related to gender-affirming care at Boston Children's Hospital, finding that the request is a veiled attempt to limit such care in the state.
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September 09, 2025
Colo. Justices Rule Interest Not Covered By $1M Med Mal Cap
The Colorado Supreme Court has ruled that the state's $1 million cap on medical malpractice damages doesn't encompass certain interest awards when the so-called good cause exception applies, in a suit accusing a doctor of causing a baby's severe brain injury.
Expert Analysis
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10 Noteworthy CFPB Developments From 2024
In a banner year for consumer finance regulation, the Consumer Financial Protection Bureau made significant strides in its efforts to rein in Big Tech and nonbank financial firms, including via rules regarding open banking, credit card late fees, and buy now, pay later products, say attorneys at Wiley.
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The Future Of GLP-1 Policy After Drug Shortage Ends
If and when the U.S. Food and Drug Administration determines that GLP-1 RA drugs are no longer in short supply, regulators will face questions of how to balance access to GLP-1 RAs with statutory and policy considerations applicable to compounded drugs, say attorneys at Skadden.
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Top 10 Whistleblowing And Retaliation Events Of 2024
From a Florida federal court’s ruling that the False Claims Act’s qui tam provision is unconstitutional to a record-breaking number of whistleblower tips filed with the U.S. Commodity Futures Trading Commission, employers saw significant developments in the federal and state whistleblower landscapes this year, say attorneys at Proskauer.
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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.