Policy & Compliance

  • December 18, 2024

    Patent Limits For Biosimilar Litigation Lands In Spending Bill

    Congress' spending package to keep the government open through March would also limit how many patents a biologics maker can assert when trying to prevent a competitor from getting on the market.

  • December 18, 2024

    FDA's Gastro Drug Fast-Track Denial Survives DC Circ.

    A D.C. Circuit panel upheld federal regulators' refusal to streamline approval of a drug to treat nausea in patients with a chronic gastric condition, ruling that the U.S. Food and Drug Administration was right to consider the drug's development plan when deciding whether it qualified for fast tracking.

  • December 18, 2024

    Destroyed Docs Merit Harsher Sanctions, Mich. Panel Says

    A Michigan appellate panel on Tuesday said fees awarded to the estate of a man who died after choking in an adult foster care facility were likely too low, finding a lower court erred by limiting the scope of available sanctions over the destruction of "copious amounts" of digital evidence.

  • December 18, 2024

    Philip Morris Sues FDA Over New Cigarette Warning Labels

    Tobacco giant Philip Morris and a group of Georgia convenience store interests have sued the U.S. Food and Drug Administration over a rule that would add graphic warnings to cigarette labels, alleging the agency is exceeding its statutory authority in a move that would mark a "sea change" for the industry.

  • December 18, 2024

    CVS Fueled Opioid Epidemic In Rush For Profits, Feds Say

    The U.S. Department of Justice unveiled a suit Wednesday accusing CVS, the nation's largest pharmacy chain, of knowingly filling invalid prescriptions for powerful opioids and ignoring internal pleas from its pharmacists as it allegedly put profits over safety. 

  • December 18, 2024

    FTC Wants Express Scripts' Defamation Suit Tossed

    The Federal Trade Commission told a Missouri federal court that Express Scripts Inc. has no basis to challenge an interim agency report that only offered "qualified conclusions" from an ongoing study about how pharmacy benefit managers affect prescription drug prices.

  • December 18, 2024

    Senate Sends $895B Defense Bill To Biden's Desk

    The U.S. Senate on Wednesday easily passed an $895.2 billion defense policy and budget bill for 2025, despite criticism over a contentious clause effectively barring gender-affirming healthcare coverage for service members' transgender children.

  • December 18, 2024

    Top Conn. Cases Of 2024: Kickbacks, Paybacks And Bribes

    Judges and juries in Connecticut awarded several multimillion-dollar verdicts against companies big and small in 2024, socking Johnson & Johnson in a talc case in which the already substantial damages could multiply and ordering a pharmacy that paid kickbacks to cough up nearly four times the money it cost the state.

  • December 18, 2024

    Justices Will Decide If Medicaid Recipients Can Pick Providers

    The U.S. Supreme Court on Wednesday partially granted the state of South Carolina's petition to review a Fourth Circuit decision blocking its Medicaid program from ending its provider agreement with Planned Parenthood, agreeing to determine if the Medicaid Act allows a beneficiary to choose a specific provider. 

  • December 17, 2024

    NC Panel Revives Negligence Suit Against State Health Dept.

    An adult care center's constitutional claims accusing the North Carolina Department of Health and Human Services of negligently asserting bogus penalties and unfairly suspending admissions at the facility are timely, a North Carolina state appellate panel ruled Tuesday, reviving a case that previously landed before the North Carolina Supreme Court.

  • December 17, 2024

    3 Healthcare Decisions This Week You Don't Want To Miss

    The Third Circuit issued a precedential ruling allowing Pennsylvania to dip into the $300 million budget surplus of an insurance fund for doctors facing medical malpractice claims. Meanwhile in Texas, a split appellate panel found that a member of a national hospital chain can enforce an arbitration agreement with an employee. 

  • December 17, 2024

    Express Scripts, OptumRx Can't Ditch LA County Opioid Suit

    A California judge ruled Tuesday that Los Angeles County can keep pursuing a lawsuit claiming pharmacy benefit managers Express Scripts and OptumRx colluded with drugmakers to fuel the opioid epidemic, though the county must rework its complaint to specify how regulators were allegedly deceived.

  • December 17, 2024

    House GOP Asks CVS How Its PBM Treats Smaller Pharmacies

    Lawmakers on Capitol Hill are demanding documents from CVS on its pharmacy benefit manager's treatment of independent pharmacies, continuing to press the healthcare giant over potentially anticompetitive conduct.

  • December 17, 2024

    Feds Intervene In $200M FCA Case Against CVS

    The federal government has intervened in a whistleblower case accusing CVS and its subsidiaries of pocketing more than $200 million in overpayments, in order to defend the constitutionality of the False Claims Act's whistleblower provisions.

  • December 17, 2024

    5th Circ. Preserves Feds' ACA Trans Health Policy

    The Fifth Circuit upended a Texas court decision that invalidated a federal agency interpretation of the Affordable Care Act's provision on nondiscrimination in healthcare, keeping intact federal policy that prohibits insurers from discriminating against individuals seeking treatment for gender dysphoria.

  • December 17, 2024

    Nurse Survey Rule Case Sheds Light On Loper At 2nd Circ.

    A legal challenge over a federal rule saying registered nurses aren’t required at Medicaid compliance inspections is at the center of a Second Circuit case that promises to shed light on how courts could use the Loper Bright decision.

  • December 16, 2024

    Pa. Malpractice Fund Belongs To State, 3rd Circ. Rules

    The Third Circuit said Monday in a precedential ruling that Pennsylvania's medical malpractice insurance fund is an agency of the state and that it can dip into the fund's $300 million budget surplus.

  • December 16, 2024

    11th Circ. Appears Wary Of Doc's New Trial Bid In $27.5M Case

    The Eleventh Circuit on Monday questioned whether a Georgia doctor and his medical practice should get a new trial in a $27.5 million False Claims Act case on the basis that he and an expert who wasn't allowed to testify at trial believed the thousands of treatments he billed for were medically necessary and could be covered by Medicare, saying that contention seems to contradict the doctor's prior statements. 

  • December 13, 2024

    UnitedHealthcare Owes $900K For Services, Provider Says

    A national healthcare provider and two affiliated entities told a Minnesota federal court that UnitedHealthcare owes over $900,000 in independent dispute resolution awards entered against the carrier, accusing it of devising a scheme of denying, delaying and underpaying out-of-network providers.

  • December 13, 2024

    Texas AG Sues NY Doctor Over Telehealth Abortion Script

    Texas Attorney General Ken Paxton sued a New York doctor who founded the Abortion Coalition for Telemedicine in the Lone Star State Friday, accusing the physician of violating Texas state abortion laws by providing abortion-inducing prescription drugs to a Texas resident via telehealth.

  • December 13, 2024

    McKinsey To Pay $650M For Work With Opioid Maker Purdue

    Consulting giant McKinsey & Co. will pay $650 million to resolve charges related to its work helping Purdue Pharma market and boost sales of OxyContin, federal prosecutors announced Friday.

  • December 12, 2024

    3rd Circ. Backs Dismissal Of Anti-Abortion Group's Suit

    The Third Circuit on Thursday affirmed the dismissal of an anti-abortion pregnancy center's bid to block the enforcement of a subpoena seeking information about its donors, ruling its constitutional claims are not yet ripe.

  • December 12, 2024

    Wash. Justices OK Tax Break For Pharmacy Benefits Manager

    A Washington pharmacy benefits manager is exempt from a state business tax on its services for Medicaid patients because its corporate sibling paid premium taxes in connection with the same services, the state's high court affirmed Thursday.

  • December 12, 2024

    Lawmaker Sues Over Firing For Remarks On Jewish Rival

    Outgoing Connecticut State Rep. Anabel Figueroa, a Democrat representing Stamford, is suing her ex-employer Nuvance Health Inc. claiming it wrongly fired her over purportedly antisemitic comments she made in a radio interview about her successful primary challenger that she said were taken out of context.

  • December 11, 2024

    Montana Justices Uphold Temporary Block On Trans Care Ban

    Montana's highest court delivered a key victory for transgender youths and healthcare practitioners on Wednesday in a decision finding that privacy rights afforded by Montana's constitution favor a halt to the state's ban on gender-affirming care while litigation against it proceeds.

Expert Analysis

  • White House Activity Is A Band-Aid For Regulating AI In Health

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    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.

  • Understanding Discovery Obligations In Era Of Generative AI

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    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.

  • How Mental Health Ruling Paves Road For Equal Coverage

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    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.

  • ESG Around The World: Mexico

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    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.

  • The Case For Post-Bar Clerk Training Programs At Law Firms

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    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.

  • 10 Takeaways From New HHS Federal Compliance Guidelines

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    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.

  • 2 HHS Warnings Highlight Anti-Kickback Risks For Physicians

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    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.

  • Attorneys Have An Ethical Duty To Protect The Judiciary

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    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.

  • Cross-Market Implications In FTC's Anesthesia Complaint

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    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.

  • AI Can Help Lawyers Overcome The Programming Barrier

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    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.

  • Preparing Law Students For A New, AI-Assisted Legal World

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    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.

  • ESG Around The World: South Korea

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    Numerous ESG trends have materialized in South Korea in the past three years, with impacts ranging from greenwashing prevention and carbon neutrality measures to workplace harassment and board diversity initiatives, say Chang Wook Min and Hyun Chan Jung at Jipyong.

  • General Counsel Need Data Literacy To Keep Up With AI

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    With the rise of accessible and powerful generative artificial intelligence solutions, it is imperative for general counsel to understand the use and application of data for myriad important activities, from evaluating the e-discovery process to monitoring compliance analytics and more, says Colin Levy at Malbek.