Policy & Compliance
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July 17, 2025
Ex-CEO Agrees To $27.5M Judgment In Medicare Fraud Case
A day before his trial was set to begin, the former CEO and owner of the now-defunct laboratory Premier Medical Inc. agreed to a $27.5 million consent judgment, acknowledging he was likely to be found liable in the suit brought against him by the federal government and three states.
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July 17, 2025
Fla. AG, Sandoz Clash With Other Enforcers Over 'Done' Deal
Sandoz and Florida's attorney general pressed a Connecticut federal judge Wednesday to let them settle out of sweeping price-fixing litigation against generic-drug makers, contending that federal civil procedure rules give no room for objections from other state enforcers worried the Sunshine State deal interferes with their own ability to negotiate settlements.
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July 17, 2025
4th Circ. Orders New Trial After Doc Acquitted In Fraud Case
A Fourth Circuit panel ordered a new trial for a doctor who received a judge's acquittal after a jury found him guilty of alleged healthcare fraud, finding that the jury had sufficient evidence to convict, but the case was "close," and the district court was correct in hedging and allowing another shot at the case.
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July 17, 2025
PE Firm Is Denied FDA Docs For Defense In Deal Challenge
An Illinois federal court on Wednesday denied a request from private equity firm GTCR BC Holdings LLC to force the U.S. Food and Drug Administration to produce more than a decade's worth of medical device approval applications as the firm fights a merger challenge from enforcers.
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July 17, 2025
6th Circ. Says Axed Expert Reports Doom Hip Implant Suit
The Sixth Circuit has sided with a medical device maker in a lawsuit brought by a man who alleged a component of his hip implant was faulty due to a manufacturing defect, saying the lower court correctly excluded his experts for their lack of knowledge about the surgery or the company's manufacturing processes.
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July 16, 2025
8th Circ. Sends Part Of OptumRx Pricing Fight To Arbitration
The Eighth Circuit partially reversed a ruling Wednesday that denied pharmacy benefits manager OptumRx's bid to send a drugstore's proposed class action over generics prescription reimbursements to arbitration, finding that OptumRx waived arbitration as to three claims, but an arbitrator must decide the fate of two recently pleaded claims.
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July 16, 2025
Pharmacy Benefit Managers Say Ohio Can't Recast Suit
The state of Ohio can't "recast its complaint on appeal" in order to convince the Sixth Circuit that its enforcement suit accusing two pharmacy benefit managers of working to raise the cost of prescription drugs belongs in state court, those managers have told the appellate court.
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July 16, 2025
Maine Clinics Sue Over Medicaid Ban On Abortion Providers
A Maine family planning organization sued the U.S. Department of Health and Human Services on Wednesday over abortion-related Medicaid restrictions outlined in President Donald Trump's budget act, saying they violate constitutional equal protection rights.
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July 16, 2025
Charity Care Is Not Unconstitutional Taking, NJ Justices Rule
The New Jersey Supreme Court on Wednesday held that a state requirement to treat patients regardless of the patient's ability to pay does not amount to unconstitutional per se or regulatory taking, backing a lower court's decision that dismissed a group of Garden State hospitals' challenge to the requirement.
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July 15, 2025
GTCR Seeks Rival's Sales Data To Counter FTC Challenge
The private equity firm looking to buy medical device coating company Surmodics is seeking Salesforce data from another competitor in the space, saying the information is crucial to showing that the industry will still be competitive if its acquisition is cleared.
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July 15, 2025
Trump Admin Seeks Win In Harvard $2B Funding Freeze Case
The Trump administration urged a Massachusetts federal judge Monday to grant it summary judgment in Harvard University's lawsuit challenging the government's effort to freeze $2.2 billion in funding, arguing the dispute is a contract fight that belongs in the Federal Claims Court and the allegations fail on the merits.
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July 15, 2025
Split 4th Circ. Rejects GenBioPro Abortion Ban Challenge
A split Fourth Circuit panel on Tuesday rejected GenBioPro's challenge to a West Virginia law banning medication abortion with narrow exceptions, with the majority finding the ban does not conflict with federal regulators' statutory authority to impose safety requirements on drug manufacturers.
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July 15, 2025
Medicaid Cuts Pose 'Frontal Assault,' Penn Law Prof Says
Allison K. Hoffman, a health insurance regulation expert at the University of Pennsylvania Carey Law School, talks about the wide-ranging impacts of the cuts coming to Medicaid funding.
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July 15, 2025
Decades After Autism Omnibus, CDC Back In Thimerosal Fight
An unusual legal proceeding two decades ago tested claims that childhood vaccines caused autism. The "omnibus" proceeding found no such link, cutting off the primary legal path for such claims. Today, a CDC advisory panel reconstituted by HHS Secretary Robert F. Kennedy Jr. is reopening the debate.
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July 15, 2025
Wash. Court Doubts Hospitals' Bid To Nix $230M Judgment
A Washington state appellate judge criticized a hospital system's attempt to undo a $230 million loss in a class wage and hour suit on Tuesday, suggesting the employer's arguments about meal break waivers and timekeeping practices are at odds with its own records.
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July 15, 2025
Workers Seek Class Status In United Pricing Scheme Suit
A group of workers urged a California federal judge to award them class certification in their suit alleging United Behavioral Health and a billing contractor shorted them on coverage for out-of-network substance use disorder treatments, arguing they put forward new detail that clears class status requirements.
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July 15, 2025
Amid Budget Woe, New Hampshire Shutters Drug Price Board
Bucking a trend of state efforts to rein in prescription drug prices, New Hampshire lawmakers have dissolved a state drug affordability board launched just five years ago.
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July 15, 2025
Wisconsin Health Co. Faces Trimmed 403(b) Fee Suit
A federal judge agreed to trim a federal benefits lawsuit against a Wisconsin health system from a proposed class of employees who said their 403(b) retirement plan was mismanaged, refusing to dismiss recordkeeping fee claims but agreeing to toss allegations of excessive investment management fees.
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July 15, 2025
A Legal 'Green Light' For FDA Abortion Drug Review
A case brought by Democratic attorneys general led to a "green light" federal court decision for the Trump administration as it considers new regulations on the abortion drug mifepristone.
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July 14, 2025
BCBS Defends $2.8B Provider Antitrust Deal Amid Objections
Blue Cross Blue Shield asked an Alabama federal judge on Friday to approve a $2.8 billion antitrust settlement with hospitals and other healthcare providers over its territorial policies, arguing that recent objections to the deal's release provision are meritless and the settlement preserves "key, procompetitive features" of the insurance system.
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July 14, 2025
CFPB Deal To Put Medical Debt Back On Reports OK'd
A Texas federal court has reversed a Biden-era rule that kept an estimated $49 billion in medical debt from credit reports after the Consumer Financial Protection Bureau and lender trade groups struck a deal to axe the rule.
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July 14, 2025
DOJ Drops Vax Card Case Against Plastic Surgeon Mid-Trial
The Justice Department dismissed charges against a Utah plastic surgeon accused of leading a conspiracy to forge COVID-19 vaccination cards for over 1,500 people, ending the case less than a week after trial began in Salt Lake City federal court.
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July 14, 2025
Cigna Denies Responsibility For Alleged Health Data Breach
Cigna has asked a Pennsylvania federal judge to throw out class claims by health plan members alleging it failed to protect their private data, arguing they didn't show how their sensitive information was intercepted from the insurer's websites.
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July 14, 2025
Court Says Insider Trading Rules Unscathed By Loper Bright
A U.S. Supreme Court ruling that curtailed deference to agency interpretations of law did not undermine the U.S. Securities and Exchange Commission's rules against insider trading, a Pennsylvania federal court ruled Friday.
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July 14, 2025
Judge Says Med Device 401(k) Fee Suit Should Get A Trim
A Massachusetts federal magistrate judge recommended narrowing a proposed class action claiming a medical technology company saddled its retirement plan with excessive fees and abused forfeited funds, ruling the workers failed to show the business violated the plan's terms.
Expert Analysis
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Plan Sponsors Must Prep For New Mental Health, Drug Rules
To comply with newly published health insurance rules requiring parity between access to mental health and substance use services compared to medical and surgical services, employers with self-insured plans will need to update third-party administrator agreements and collect data, among other compliance steps, say attorneys at Kilpatrick.
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A Primer On Navigating The Conrad 30 Immigration Program
As the Conrad 30 program opens its annual window to help place immigrant physicians in medically underserved areas, employers and physicians engaged in the process must carefully understand the program's nuanced requirements, say Andrew Desposito and Greg Berk at Sheppard Mullin.
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Class Actions At The Circuit Courts: September Lessons
In this month's review of class action appeals, Mitchell Engel at Shook Hardy identifies practice tips from four recent class certification rulings involving denial of Medicare reimbursements, automobile insurance disputes, veterans' rights and automobile defects.
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Proposed Legislation May Crack Down On Online Drug Ads
A bill recently proposed in Congress could serve as a sea change in how the U.S. Food and Drug Administration regulates drug-related speech, with significant trickle-down effects on various corners of not only the drug industry but also on consumers and providers themselves, say Dominick DiSabatino and Arushi Pandya at Sheppard Mullin.
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What To Expect From Calif. Bill Regulating PE In Healthcare
A California bill currently awaiting Gov. Gavin Newsom's approval, intended to increase oversight over private equity and hedge fund investments in healthcare, is emblematic of recent increased scrutiny of investments in the space, and may affect transactions and operations in California in a number of ways, say attorneys at Ropes & Gray.
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Vertex Suit Highlights Issues For Pharma Fertility Support
Vertex Pharmaceuticals' recent lawsuit challenging the U.S. Department of Health and Human Services' interpretation of the Anti-Kickback Statute is influenced by a number of reproductive rights and health equity issues that the Office of Inspector General should address more concretely, including in vitro fertilization and fertility preservation programs, says Mary Kohler at Kohler Health Law.
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CMS' New 'Breakthrough' Device Policy Shows Little Promise
The Centers for Medicare & Medicaid Services’ recent procedural notice outlining a new Medicare coverage pathway for breakthrough medical devices will, at best, be a failed experiment and, at worst, result in Medicare beneficiaries denied access to innovative treatments, say attorneys at King & Spalding.
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A Preview Of AI Priorities Under The Next President
For the first time in a presidential election, both of the leading candidates and their parties have been vocal about artificial intelligence policy, offering clues on the future of regulation as AI continues to advance and congressional action continues to stall, say attorneys at Mintz.
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Managing Community Health Needs Assessments: A Checklist
Excerpt from Practical Guidance
To guide nonprofit hospitals and health systems through their required community health needs assessment every three years, this checklist outlines the steps for 12 phases of the process.
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Pa. Health Employers Must Prep For Noncompete Restrictions
Newly enacted legislation in Pennsylvania prohibits certain noncompete covenants for healthcare practitioners in the state beginning next year, creating compliance challenges that both employers and employees should be aware of, say attorneys at Buchanan Ingersoll.
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FTC Focus: What Access To Patent Settlements Would Mean
Settling parties should adopt a series of practice tips, including specifying rationales to support specific terms, as the Federal Trade Commission seeks to expand its access to settlements before the Patent Trial and Appeal Board, say Shannon McGowan and David Munkittrick at Proskauer.
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Agencies Should Reward Corporate Cyber Victim Cooperation
The increased regulatory scrutiny on corporate victims of cyberattacks — exemplified by the U.S. Securities and Exchange Commission's case against SolarWinds — should be replaced with a new model that provides adequate incentives for companies to come forward proactively and collaborate with law enforcement, say attorneys at McDermott.
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Strategies To Defend Against Healthcare Nuclear Verdicts
The healthcare industry is increasingly the target of megaclaims, particularly those alleging medical malpractice, but attorneys representing providers can use a few tools to push back on flimsy litigation and reduce the likelihood of a nuclear verdict, says LaMar Jost at Wheeler Trigg.