Policy & Compliance

  • March 14, 2024

    Feds Say Healthcare Ruling Could Upset Tribal Relationships

    The federal government is urging the U.S. Supreme Court to overturn a lower court's ruling that ordered Indian Health Services to reimburse millions in administrative healthcare costs, saying if the two tribes prevail in the litigation, it would upend 35 years of practice between the agency and its contracting tribes.

  • March 14, 2024

    8th Circ. Weighs If No-Bill Agreements Break Minn. Law

    The Eighth Circuit carefully considered arguments Thursday between six Farmers units and a policyholder class as to whether the carriers' agreements with healthcare providers restricted the class's medical expense coverage in violation of Minnesota law, giving little indication of which way it leaned.

  • March 14, 2024

    Extended Workers' Comp Needs High Bar, NC Justices Told

    The North Carolina Department of Public Safety told the state's top court Wednesday that injured workers must clear a higher hurdle to keep collecting disability benefits after their initial workers' compensation runs out, saying an appellate court got it wrong by applying a more lax standard.

  • March 14, 2024

    8th Circ. Questions Patient Standing In ERISA Claims Dispute

    An Eighth Circuit panel appeared skeptical Thursday of reviving a suit from patients insured by UnitedHealth Group alleging a billing practice known as cross-plan offsetting violated federal benefits law, with judges questioning whether the patients sufficiently established injury.

  • March 14, 2024

    Feds Seek 20 Mos. For Aegerion Fraud 'Puppet Master'

    A pharmaceutical sales representative who gloated about being a "puppet master" for false insurance claims for Aegerion's cholesterol drug should serve 20 months in prison, the U.S. government has told a Boston federal judge.

  • March 14, 2024

    Trial Challenging NC Abortion Restrictions Pushed To July

    A July trial date has been set in a closely watched constitutional challenge seeking to dismantle a state law that restricts access to abortions in North Carolina after 12 weeks, marking a pushback from the court's earlier projected spring timetable for the trial.

  • March 13, 2024

    Planned Parenthood Foe Calls Immunity Claim 'Half-Baked'

    Attorneys for a pseudonymous relator who sued Planned Parenthood over allegations that it improperly billed Medicaid programs urged the Fifth Circuit on Wednesday to reject the group's position that it was shielded by attorney immunity, calling the entity's argument "half-baked."

  • March 13, 2024

    Wash. Hospital Workers Sue Kaiser Over Missed Breaks

    A nursing assistant at Seattle's Kaiser Permanente hospital said understaffing compels her and other healthcare employees to work through their meal breaks, but that the hospital system has not been paying them for that time, according to a proposed class action filed in Washington state court.

  • March 12, 2024

    NYC Hospital Signs $17.3M 'Kickback' Deal With Feds, State

    NewYork-Presbyterian/Brooklyn Methodist Hospital has agreed to pay $17.3 million to resolve allegations that it paid unlawful kickbacks to physicians at its chemotherapy infusion clinic, the U.S. Department of Justice announced Tuesday.

  • March 12, 2024

    NY Jury Rules Some Claims About Prevagen Are Misleading

    A New York federal jury said some statements made by Quincy Bioscience about its memory booster Prevagen were misleading to consumers but found that most statements about the supplement were made on solid grounds.

  • March 12, 2024

    2nd Circ. Revives Parts Of McKesson Whistleblower Suit

    The Second Circuit on Tuesday revived parts of a lawsuit brought by a McKesson Corp. whistleblower who accuses the pharmaceutical company of a kickback scheme, finding that the lower court should reconsider the claims that were brought under state anti-kickback laws.

  • March 12, 2024

    Walgreens, Kenvue Unit Sued Over Benzene In Acne Products

    Walgreens, Kenvue unit Johnson & Johnson Consumer Inc. and Genomma Lab face a trio of proposed consumer fraud class actions in California federal court by customers who alleged their acne treatment products contain unsafe levels of benzene, but that each of the companies failed to disclose its presence in their labeling.

  • March 12, 2024

    4th Circ. Revives Navy Surgery Wrongful Death Claims

    The Fourth Circuit on Tuesday reversed an order dismissing claims from the estate of a woman who died after an allegedly botched surgery at a Navy hospital, saying the trial court was wrong to conclude that Navy regulations for implementing Federal Tort Claims Act procedures created jurisdictional requirements beyond what the FTCA's text includes.

  • March 12, 2024

    Pharmacy Calls $11M False Claims Case A 'House Of Cards'

    A compounding pharmacy and its president trashed the Connecticut attorney general's $11 million false claims and kickback allegations against them as a "house of cards" that awarded "a sweetheart cooperation deal" to an alleged co-conspirator and improperly benefited private attorneys, calling instead for a judgment against the state.

  • March 11, 2024

    FDA Seeks $7.2B For Fiscal Year 2025

    The U.S. Food and Drug Administration on Monday said that it is requesting $7.2 billion as part of the Biden administration's proposed budget, an increase of nearly $500 million from fiscal year 2023's funding, with $15 million aimed at protecting food safety and nutrition.

  • March 11, 2024

    NY Man's COVID Loan 'Greed' Merits 10 Years, Feds Say

    Federal prosecutors have asked a New York judge to sentence a Long Island man to 10 years in prison for his role in a scheme to steal more than $10 million from the Paycheck Protection Program and other pandemic-era disaster relief programs.

  • March 11, 2024

    Biden Proposes More Mental Health Expansion In 2025 Budget

    The Biden administration's $7.3 trillion fiscal year 2025 spending blueprint unveiled Monday maintains a pledge to transform the nation's mental health system, but contains the least ambitious discretionary budget ask for the U.S. Department of Labor in four years.

  • March 11, 2024

    Pfizer Slams Ex-Compliance Officer's Whistleblower Claims

    Pfizer has asked a California federal court to again dismiss the bulk of a discrimination and retaliation lawsuit filed by a former compliance officer for the pharmaceutical giant, arguing his latest suit is "largely a regurgitation of his original complaint."

  • March 11, 2024

    Urologist Seeks Coverage For Defective Penile Implants Suit

    A urologist's medical device company told a California federal court that two insurers must cover it, the doctor and his practice in an underlying class action alleging that a silicone implant invented for penile enlargement, and the procedure that went with it, left patients with permanent damage.

  • March 08, 2024

    Trump 'An Existential Threat' To Rule Of Law, Attys Warn

    Former President Donald Trump represents an "existential threat" to democracy and the rule of law, legal experts said Friday at a conference on white collar crime in San Francisco.

  • March 08, 2024

    Judge Keeps Novel Insider Trading Indictment Alive

    A California federal judge has refused to throw out a novel insider trading indictment against a former healthcare CEO, saying that the federal prosecutors provided sufficient information to sustain their allegations that the executive acted criminally by shedding millions of dollars worth of stock at the same time an important client relationship was nearing its end. 

  • March 08, 2024

    FDA Pumps Brakes On Eli Lilly Alzheimer's Drug Approval

    The U.S. Food and Drug Administration is delaying an approval decision on Eli Lilly and Co.'s Alzheimer's drug donanemab, the company said Friday, throwing a wrench in what was expected to be a smooth approval process for the experimental neurodegenerative treatment.

  • March 08, 2024

    7th Circ. Wants 'Roadmap' For Ill. Workplace Disease Law

    The Seventh Circuit has asked the Illinois Supreme Court to weigh in on the state's Workers' Occupational Diseases Act, saying it needs a "roadmap" to handle claims for asbestos and other diseases that manifest belatedly as it considers a widow's suit alleging her husband's exposure to a toxic chemical while working for Goodrich Corp. led to his death.

  • March 07, 2024

    Abortion, Drug Costs Top Health Issues in State Of The Union

    President Joe Biden laid out a forceful healthcare agenda in his State of the Union address on Thursday, promising to ramp up efforts to control drug prices and pledging to reinstate the federal right to an abortion if voters elect a pro-abortion Congress.

  • March 07, 2024

    Judge Doubts Medicare Drug Pricing Amounts To 'Taking'

    A New Jersey federal judge on Thursday bristled at the position by pharmaceutical companies that Medicare's drug price negotiation program is an unconstitutional "taking" that undercuts their bottom line, suggesting that the drug powerhouses needed more numbers to back their argument.

Expert Analysis

  • 4 Employer Action Steps For New Mental Health Parity Rules

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    A recently released guidance under the Mental Health Parity and Addiction Equity Act reiterated that employers contracting with outside service providers to administer their health plans are not relieved of their compliance obligations — so all employers sponsoring a group health plan should consider four action items for success, say attorneys at Ice Miller.

  • Recalling USWNT's Legal PR Playbook Amid World Cup Bid

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    As the U.S. Women's National Soccer Team strives to take home another World Cup trophy, their 2022 pay equity settlement with the U.S. Soccer Federation serves as a good reminder that winning in the court of public opinion can be more powerful than a victory inside the courtroom, says Hector Valle at Vianovo.

  • Parsing Through The FTC's Proposed Health Privacy Updates

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    The Federal Trade Commission's recently proposed updates to its Health Breach Notification Rule contain subtle but significant changes to key terms that help modernize the agency's health app regulation and provide stakeholders an important opportunity to help shape the future of virtual health care, say attorneys at Arnold & Porter.

  • Indivior Ruling May Affect Rebate Wall Litigation

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    A New Jersey federal court's recent decision in Indivior v. Alvogen, in which a claim that an alleged rebate wall anti-competitively blocked generic competition survived summary judgment, may provide a blueprint for successfully challenging other drug rebating practices, say Peter Herrick and Monsura Sirajee at O'Melveny.

  • Compliance Takeaways From HHS Information Blocking Rule

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    A recently finalized rule from the U.S. Department of Health and Human Services' Office of Inspector General demonstrates a renewed focus on investigating practices that may interfere with patients' access to their electronic health information, and should encourage renewed compliance efforts across a range of processes, say attorneys at Ropes & Gray.

  • Immigration Program Pitfalls Exacerbate Physician Shortages

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    Eliminating shortcomings from U.S. immigration regulations and policies could help mitigate the national shortage of physicians by encouraging foreign physicians to work in medically underserved areas, but progress has been halted by partisan gridlock, say Alison Hitz and Dana Schwarz at Clark Hill.

  • Mallory Gives Plaintiffs A Better Shot At Justice

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    Critics of the U.S. Supreme Court's recent decision in Mallory v. Norfolk Southern claim it opens the door to litigation tourism, but the ruling simply gives plaintiffs more options — enabling them to seek justice against major corporations in the best possible court, say Rayna Kessler and Ethan Seidenberg at Robins Kaplan.

  • Why Justices' SuperValu Ruling Wasn't Quite A 'Seismic Shift'

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    Notwithstanding an early victory lap by the relators' bar, the U.S. Supreme Court’s decision in U.S. v. SuperValu Inc. was a win for both whistleblowers and sophisticated companies, but unfortunately left “subjective belief” to be interpreted by lower courts and future litigants, say attorneys at Baker Donelson.

  • A Glimpse Into HHS' Digital App Enforcement Priorities

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    A recent opinion from the U.S. Department of Health and Human Services' Office of Inspector General sheds helpful light on the evolving intersection between health care regulation and digital apps, revealing some of the agency's key priorities and concerns in overseeing how federal program patients choose providers, says Mary Kohler at Kohler Health Law.

  • Courts Can Overturn Deficient State Regulations, Too

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    While suits challenging federal regulations have become commonplace, such cases against state agencies are virtually nonexistent, but many states have provisions that allow litigants to bring suit for regulations with inadequate cost-benefit analyses, says Reeve Bull at the Virginia Office of Regulatory Management.

  • Tales From The Trenches Of Remote Depositions

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    As practitioners continue to conduct depositions remotely in the post-pandemic world, these virtual environments are rife with opportunities for improper behavior such as witness coaching, scripted testimony and a general lack of civility — but there are methods to prevent and combat these behaviors, say Jennifer Gibbs and Bennett Moss at Zelle.

  • The Double-Edged Sword Of Using ChatGPT In Health Care

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    While ChatGPT has shown promising potential in health care, one of the key challenges for players in this space is balancing patient privacy and data protection with the benefits of utilizing this technology, say attorneys at Sheppard Mullin.

  • Level Up Lawyers' Business Development With Gamification

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    With employee engagement at a 10-year low in the U.S., there are several gamification techniques marketing and business development teams at law firms can use to make generating new clients and matters more appealing to lawyers, says Heather McCullough at Society 54.