Policy & Compliance
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January 17, 2025
1st Circ. Revives Biotech Worker's COVID-19 Vax Challenge
The First Circuit on Thursday resuscitated religious discrimination claims brought by a former pharmaceutical company employee who alleged her employer's COVID-19 vaccination mandate during the pandemic was in conflict with her sincerely held religious beliefs.
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January 16, 2025
Texas Judge Says 3 States Can Pursue Mifepristone Suit
A Texas federal judge said Thursday that Idaho, Missouri and Kansas can continue to challenge federal approvals for the abortion medication mifepristone in Texas federal court after private plaintiffs dropped their claims.
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January 16, 2025
NC Gov. Boosts Abortion Safeguards Amid 'Alarming Attacks'
North Carolina's newly minted Gov. Josh Stein on Thursday in one of his first official acts rolled out an executive order that shores up abortion protections in the Tar Heel state, joining the ranks of other Democratic politicians seeking to cement progressive priorities ahead of a second Trump administration.
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January 16, 2025
Initial Green Light Given to UnitedHealth's Deal In TCPA Suit
A Washington federal judge gave a $2.5 million settlement between UnitedHealthcare and a class of Telephone Consumer Protection Act claimants preliminary approval, signing off on a deal that class counsel says would net each class member over $90, if all applied.
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January 16, 2025
Merck Defends 3rd Circ. Win In Mumps Vaccine Antitrust Case
Merck urged the Third Circuit not to reconsider a ruling that immunized the company from antitrust claims over submissions it made to federal regulators for its mumps vaccine, arguing the appeals court was right to find the submissions were protected.
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January 16, 2025
Chamber Slams Opioid Judge's PBM Audit Privilege Ruling
The Sixth Circuit must step in to prevent a pharmacy benefit manager from being forced to turn over internal compliance audit documents, the U.S. Chamber of Commerce has said, arguing a lower court's decision threatens to undermine the existence of in-house counsel's attorney-client privilege.
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January 15, 2025
Gilead, Feds Resolve HIV Drug Patent Dispute Amid Appeal
Gilead Sciences and the federal government have agreed to dismiss all claims and counterclaims in a yearslong intellectual property and contract battle over HIV prevention drugs Truvada and Descovy, according to stipulations of voluntary dismissal filed Wednesday in both the Federal Circuit and Delaware federal court.
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January 15, 2025
FTC Won't Disqualify Commissioners From PBM Insulin Case
The Federal Trade Commission denied bids from Caremark Rx, Express Scripts and OptumRx that sought to bar the commission's Democratic members from participating in a case accusing the pharmacy benefit managers of inflating insulin prices.
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January 15, 2025
Ruling On Fla. Gender Law Animus Is Flawed, 11th Circ. Told
Florida urged an Eleventh Circuit panel on Wednesday to overturn an order declaring the state's ban on certain types of medical treatment for gender dysphoria unconstitutional, arguing the lower court wrongly used the condition as a proxy for transgender individuals in ruling that the prohibition was proof of discriminatory animus.
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January 15, 2025
9th Circ. Eyes Undoing Trans Patients' Win In ACA Bias Suit
The Ninth Circuit seemed inclined Wednesday to strike down a trial court win for patients who challenged Blue Cross Blue Shield of Illinois' administration of their employer-provided health plans containing gender-affirming care exclusions, with two judges questioning why those employers weren't part of the case.
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January 15, 2025
DOJ Reports $2.9B Haul Under FCA, Largest In 3 Years
Litigation under the False Claims Act generated a little over $2.9 billion in settlements and judgments in the most recent fiscal year, a 5% bump over 2023's total and the most in three years, according to data released Wednesday by the U.S. Department of Justice.
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January 15, 2025
Former FDA Official Joins King & Spalding Life Sciences Team
King & Spalding on Wednesday announced that a former U.S. Food and Drug Administration official has joined the firm's government matters and regulation practice group after an eight-year stint at the agency.
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January 15, 2025
Holland & Knight Adds Ex-GOP Rep. To Policy Advisory Team
Holland & Knight LLP has hired seven-term Indiana Republican Congressman Larry Bucshon as a senior policy adviser.
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January 14, 2025
New EMTALA Suit in Idaho Seeks To Keep Injunction
An Idaho health system filed a lawsuit Tuesday alleging that Idaho's strict abortion ban conflicts with an emergency stabilization law and is seeking to keep the ban blocked while it prepares to take up the legal battle once fought by the Biden administration.
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January 14, 2025
Dispute Over Eli Lilly Weight Loss Drug Reignited
Compounding pharmacies have reignited a suit against the U.S. Food and Drug Administration over the removal of a lucrative weight loss drug from the shortage list, with a Texas federal judge ordering both sides to turn in briefing on injunctive relief during a Tuesday hearing.
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January 14, 2025
FTC Issues Second Report On PBMs, Expanding Study Scope
The Federal Trade Commission released a second "interim" report on pharmacy benefit managers and their effects on specialty drug prices Tuesday, claiming that the companies have driven up prices well over acquisition costs and continue to squeeze independent pharmacies out of the market through low reimbursement rates.
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January 14, 2025
Both Michigan US Attys Resign Ahead Of Inauguration
Michigan's U.S. attorneys, Dawn Ison in the Eastern District and Mark Totten in the Western District, announced their departures this week ahead of President-elect Donald Trump's inauguration.
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January 14, 2025
Healthcare Laws Taking Effect In 2025
This year, the healthcare industry will see a host of new laws touching on everything from private equity transactions and oversight to drug price caps and medical leave policies.
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January 14, 2025
Whistleblowing Compliance Pro Secures 4th FCA Settlement
A repeat whistleblower has cost hospitals more than $43 million in federal settlements over the last 18 years, illustrating the increased use of data analysis and other trends in False Claims Act litigation.
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January 14, 2025
2nd Circ. Rules Prison Docs Can't Escape Indifference Claims
A Second Circuit panel on Monday ruled two New York prison doctors must face a former inmate's deliberate indifference claims for allegedly overlooking his cancer symptoms despite medical exam results, while also finding the inmate's claims were not time-barred, though the court said the state and facility are protected by sovereign immunity.
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January 14, 2025
Mass. AG Says Insulin Makers, Middlemen Colluded On Costs
Insulin makers Eli Lilly, Sanofi and Novo Nordisk conspired with pharmacy benefit managers OptumRX, Express Scripts and CVS Caremark to jack up prices by as much as 1,000%, the Massachusetts attorney general alleged in a suit.
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January 14, 2025
Assisted Living Co., Ex-Worker End Race-Based Pay Bias Suit
An assisted living facility and a former employee have agreed to close her suit claiming she was paid less than colleagues and belittled by her supervisor because she is Indian American, according to a New York federal court filing.
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January 13, 2025
Lincare Pays $1.15M To End Wash. Medicaid Fraud Probe
Lincare Inc. agreed to pay $1.15 million to resolve a Washington probe into allegations the medical equipment supplier overbilled Medicaid for rental payments for patients' oxygen equipment over a six-year period, the Washington State Office of the Attorney General announced Monday.
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January 13, 2025
Blue Cross Can't Skirt NC Hospital's Defamation Claims
A local hospital can pursue some of its defamation claims against Blue Cross and Blue Shield of North Carolina in a suit alleging the health insurer wrongly denied millions of dollars in reimbursements and falsely accused the facility of fraud, a federal judge ruled Monday.
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January 13, 2025
Duke Health Worker Agrees To Arbitrate Bias Suit, For Now
A former Duke University Health System Inc. radiology technologist who accused the healthcare network of firing her for being pregnant with her second child told a North Carolina federal judge Monday she is all right with her former employer's request to take the matter to arbitration.
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.