Policy & Compliance
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January 17, 2025
Trade Group Sues To Stop Federal Mental Health Parity Regs
A benefits-focused employer trade group sued the U.S. Department of Labor and other federal agencies in D.C. federal court Friday, seeking to block recently finalized mental health parity regulations the group alleges are unconstitutional and violate administrative procedure laws.
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January 17, 2025
4 Battles Over Gender-Affirming Care To Watch In 2025
The U.S. Supreme Court will rule on the federal government's challenge to Tennessee's ban on gender-affirming care for minors, and the Eleventh Circuit is considering a bid to upend federal rules extending the Affordable Care Act's nondiscrimination protections to transgender patients. Here, Law360 looks at four cases that could have ramifications for benefits law in 2025.
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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.
Expert Analysis
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What Lawyers Must Know About Calif. State Bar's AI Guidance
Initial recommendations from the State Bar of California regarding use of generative artificial intelligence by lawyers have the potential to become a useful set of guidelines in the industry, covering confidentiality, supervision and training, communications, discrimination and more, say attorneys at Debevoise.
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Industry Must Elevate Native American Women Attys' Stories
The American Bar Association's recent research study into Native American women attorneys' experiences in the legal industry reveals the glacial pace of progress, and should inform efforts to amplify Native voices in the field, says Mary Smith, president of the ABA.
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White House Activity Is A Band-Aid For Regulating AI In Health
In the medium term, recent White House actions will have a greater impact on AI in the health care industry than Congress' sluggish efforts to regulate it, but ultimately legislation of AI's development and use in the health space will fall to Congress, say Wendell Bartnick and Vanessa Perumal at Reed Smith.
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Understanding Discovery Obligations In Era Of Generative AI
Excerpt from Practical Guidance
Attorneys and businesses must adapt to the unique discovery challenges presented by generative artificial intelligence, such as chatbot content and prompts, while upholding the principles of fairness, transparency and compliance with legal obligations in federal civil litigation, say attorneys at King & Spalding.
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How Mental Health Ruling Paves Road For Equal Coverage
The Tenth Circuit’s recent ruling in E.W. v. Health Net, which clarified the pleading requirements necessary to establish a Mental Health Parity and Addiction Equity Act violation, is a win for plaintiffs as it opens the door to those who have been denied coverage for behavioral health treatment to prove a mental health parity violation, says Mark DeBofsky at DeBofsky Law.
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ESG Around The World: Mexico
ESG has yet to become part of the DNA of the Mexican business model, but huge strides are being made in that direction, as more stakeholders demand that companies adopt, at the least, a modicum of sustainability commitments and demonstrate how they will meet them, says Carlos Escoto at Galicia Abogados.
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The Case For Post-Bar Clerk Training Programs At Law Firms
In today's competitive legal hiring market, an intentionally designed training program for law school graduates awaiting bar admission can be an effective way of creating a pipeline of qualified candidates, says Brent Daub at Gilson Daub.
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10 Takeaways From New HHS Federal Compliance Guidelines
The U.S. Department of Health and Human Services' recently issued general compliance program guidance is the first of its kind that would apply across all health care stakeholders, and signals the agency’s first step to improve and update existing compliance guidance, says Melissa Wong at Holland & Knight.
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2 HHS Warnings Highlight Anti-Kickback Risks For Physicians
Two recent advisory opinions issued by the U.S. Department of Health and Human Services' Office of Inspector General involve different scenarios and rationales, but together they illustrate the OIG's focus on and disapproval of contractual joint ventures and other revenue-maximizing physician arrangements, say Robert Threlkeld and Elliott Coward at Morris Manning.
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Attorneys Have An Ethical Duty To Protect The Judiciary
The tenor of public disagreement and debate has become increasingly hostile against judges, and though the legislative branch is trying to ameliorate this safety gap, lawyers have a moral imperative and professional requirement to stand with judges in defusing attacks against them and their rulings, says Deborah Winokur at Cozen O'Connor.
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Cross-Market Implications In FTC's Anesthesia Complaint
The Federal Trade Commission's recent complaint against a private equity firm's acquisition of anesthesiology practices highlights the controversial issue of cross-market harm in health care provider mergers, and could provide important insights into how a court may view such theories of harm, say Christopher Lau and Dina Older Aguilar at Cornerstone Research.
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AI Can Help Lawyers Overcome The Programming Barrier
Legal professionals without programming expertise can use generative artificial intelligence to harness the power of automation and other technology solutions to streamline their work, without the steep learning curve traditionally associated with coding, says George Zalepa at Greenberg Traurig.
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Preparing Law Students For A New, AI-Assisted Legal World
As artificial intelligence rapidly transforms the legal landscape, law schools must integrate technology and curricula that address AI’s innate challenges — from ethics to data security — to help students stay ahead of the curve, say Daniel Garrie at Law & Forensics, Ryan Abbott at JAMS and Karen Silverman at Cantellus Group.