Policy & Compliance

  • April 30, 2024

    Biden Rocks Healthcare Space With Rule After Rule

    Using federal agencies as its instrument, the Biden administration pumped out numerous healthcare and life sciences rules in the past week, ranging from addressing discrimination in healthcare to requiring health apps to report data breaches to consumers.

  • April 30, 2024

    FTC Continues To Target 'Junk' Drug Patents

    Federal trade officials told a series of pharmaceutical companies — including the makers of the controversial diabetes and weight loss drug Ozempic — that they may have listed faulty patents in a key register of a federal drug database.

  • April 30, 2024

    High Court's Conscience Concerns Offer Docs Little Guidance

    At oral arguments in both abortion cases to reach the nation's top court this term, justices parried with the federal government over the knotty topic of doctors raising a personal objection to providing an abortion to a patient suffering a medical crisis.

  • April 30, 2024

    'Global' Budgets May Fix Hospital Spending. Will States Try It?

    An ambitious experiment is underway that could shake up healthcare spending by moving providers away from a traditional fee-for-service model in favor of "global" hospital budgets. But with deadlines looming, the voluntary, "total cost of care" model can't deliver without state buy-in.

  • April 30, 2024

    6th Circ. Weighs Merits, Procedure In NLRB Severance Case

    The Sixth Circuit grappled Tuesday with a hospital's challenge to the National Labor Relations Board's ruling that it unlawfully offered severance agreements that muzzled workers, with one judge questioning how the agreements interfered with workers' rights and another whether the hospital was even entitled to oppose the new standard.

  • April 30, 2024

    New Staffing Minimums Rattle Nursing Home Industry

    A new Biden administration rule that sets minimum staffing standards for nursing homes could reshape the industry, intensifying the competition to hire nurses and exposing the facilities to new litigation and financial risks, healthcare attorneys say.

  • April 30, 2024

    Tougher Privacy Rule Won't End Abortion Data Fight

    Healthcare attorneys welcomed enhanced federal protections for patient abortion records. But the new rule likely won't release providers from the bind of complying with federal privacy law while potentially facing out-of-state probes into sensitive patient information.

  • April 30, 2024

    Texas, Washington Spar In Rare Interstate Gender Care Clash

    An investigation launched by the Texas attorney general into medical care 1,700 miles away in Washington triggered an unusual burst of litigation and a settlement, illustrating a potential new front in the legal fight over transgender rights.

  • April 29, 2024

    ReNew Health To Pay $7M To Settle COVID-19 FCA Claims

    ReNew Health Group LLC has agreed to pay the federal government and California $7 million to settle whistleblower allegations that the healthcare provider misused a COVID-19 waiver intended to free up hospital beds by submitting fraudulent claims for nursing home residents, the U.S. Department of Justice announced Friday.

  • April 29, 2024

    Pfizer Inks $25M Deal Ending Leftover Effexor Antitrust Claims

    A proposed class of indirect buyers have asked a New Jersey federal judge to greenlight a $25.5 million settlement to end allegations that Pfizer unit Wyeth engaged in a scheme with Teva Pharmaceuticals to delay generic competition for the antidepressant Effexor XR.

  • April 29, 2024

    Judge Rejects 2 Challenges To Medicare Drug Price Talks

    A New Jersey federal judge on Monday shot down a pair of challenges to the Medicare drug price negotiations, extending a string of court victories for the Biden administration as it defends the talks as entirely voluntary.

  • April 29, 2024

    9th Circ. Scraps Trans Law Opinion After High Court Ruling

    The Ninth Circuit on Monday scrapped its 2023 opinion blocking an Idaho law that would have banned transgender women from competing in sports following the U.S. Supreme Court's recent decision allowing enforcement of another Idaho law permitting a ban on gender-affirming care for minors, explaining that a revised opinion is needed.

  • April 29, 2024

    UnitedHealth's Cyberattack Response Is 'Inadequate,' AGs Say

    Nearly two dozen state attorneys general urged UnitedHealth Group and its subsidiary Change Healthcare "to do more" to address the fallout from a February cyberattack by Russian ransomware group Blackcat that breached their systems and services, noting their response efforts to the outage "have been inadequate."

  • April 29, 2024

    Trans Patients In NC, W.Va. Prevail In 4th Circ. Health Fight

    The Fourth Circuit on Monday affirmed two lower court decisions ordering North Carolina and West Virginia to end discriminatory exclusions for coverage of gender-affirming medical care for transgender people in both states, finding the lower courts properly struck down the policies as "textbook sex discrimination."

  • April 29, 2024

    Judge Rejects Class Certification Of Seizure Drug Customers

    An Illinois federal judge has rejected a class certification bid in a suit against drugmaker Mallinckrodt and prescription delivery platform Express Scripts, ruling that the plaintiffs were unable to meet their predominance burden as a class.

  • April 29, 2024

    DOL Finalizes Rescission Of ACA-Skirting Health Plan Rule

    The U.S. Department of Labor on Monday finalized its rescission of an association health plan rule that allowed small businesses to band together to create healthcare plans that skirt certain Affordable Care Act requirements, which a D.C. federal court largely invalidated in 2019.

  • April 26, 2024

    HHS Finalizes Bolstered Sexual Orientation Bias Protections

    The U.S. Department of Health and Human Services on Friday unveiled a final rule designed to beef up protections against discrimination in healthcare, in particular protecting access to healthcare for the LGBTQ+ community as well as for other vulnerable populations.

  • April 26, 2024

    Gov't Wants Ex-Boston Celtic Imprisoned For Health Plan Scheme

    Prosecutors asked a Manhattan federal judge to sentence former Boston Celtics player Glen "Big Baby" Davis to roughly three years in prison after he was convicted of scheming with a group of ex-pros to submit fraudulent invoices to the NBA's healthcare plan.

  • April 25, 2024

    Benefytt Successor Pursues Del.'s Bankruptcy Alternative

    Three affiliates of Benefytt Technologies have asked Delaware's Chancery Court for assignment for the benefit of creditors, a state-administered restructuring option, with $41 million in unsecured debt and $20 million worth of liens, saying the ripple effects of the health technology company's Chapter 11 drove them under.

  • April 25, 2024

    Houston Surgeon OKs Order For Docs In Wrongful Death Suit

    A transplant surgeon at Memorial Hermann Texas Medical Center in Houston and the families of three patients who died while on the hospital's liver transplant waiting list told a judge Thursday that they had agreed to a temporary restraining order preventing the doctor from deleting or altering any documents related to the families' wrongful death claims.

  • April 25, 2024

    5th Circ. May Ponder If Threats Are Claims In Healthcare Suit

    The Fifth Circuit will review Monday if a healthcare company is covered for a more than $200,000 settlement over mistakenly approving out-of-state treatment for a Florida Medicaid patient, with the case potentially hinging on whether a letter threatening litigation against another party constitutes a claim. Here, Law360 breaks down the case in advance of oral arguments.

  • April 25, 2024

    DOJ Still Owes Victims After $139M Nassar Settlement

    The federal government's $139 million settlement for victims of convicted sexual abuser Larry Nassar goes a long way toward holding the FBI responsible for its egregious mishandling of the victims' allegations, but gives no assurance that such complaints in the future will be handled properly, legal experts say.

  • April 25, 2024

    Jury Rejects Ex-Medical Co. GC's Suit Against Loeb & Loeb

    A Colorado federal jury has rejected a former in-house attorney's claim that Loeb & Loeb LLP and one of its ex-partners acted outrageously when they filed a lawsuit on behalf of a medical device company accusing him of stealing trade secrets.

  • April 25, 2024

    EEOC Pregnant Worker Rule Draws Suit From Red State AGs

    A group of 17 Republican state attorneys general hit the U.S. Equal Employment Opportunity Commission with a lawsuit Thursday over the agency's recently finalized Pregnant Workers Fairness Act regulations, saying the EEOC's stance that the PWFA encompasses abortion-related workplace accommodations is unconstitutional. 

  • April 24, 2024

    Motley Rice, Morgan & Morgan Among Ozempic MDL Leaders

    The Pennsylvania federal judge overseeing multidistrict litigation over alleged risks associated with Ozempic and similar drugs has appointed lawyers from Motley Rice LLC, Morgan & Morgan PA and six other firms to leadership roles, according to an order issued Tuesday.

Expert Analysis

  • A Look At Healthcare Timelines Set By Biden's AI Order

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    President Joe Biden's artificial intelligence executive order establishes standards for using AI in the healthcare industry, including a number of staggered deadlines that should help coordinate a more unified federal approach to AI governance, say attorneys at Holland & Knight.

  • A Look At Successful Bid Protests In FY 2023

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    Attorneys at Sheppard Mullin look beyond the statistics in the U.S. Government Accountability Office’s recent annual report on bid protests, sharing their insights about nine categories of sustained protests, gained from reading every fiscal year 2023 decision in which the protester had a positive result.

  • Navigating Discovery Of Generative AI Information

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    As generative artificial intelligence tools become increasingly ubiquitous, companies must make sure to preserve generative AI data when there is reasonable expectation of litigation, and to include transcripts in litigation hold notices, as they may be relevant to discovery requests, say Nick Peterson and Corey Hauser at Wiley.

  • FDA's Lab-Developed Test Rule May Bring Historic Challenges

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    If finalized, the U.S. Food and Drug Administration's proposed rule for regulating laboratory-developed tests will provoke some of the most interesting legal challenges that the agency has faced in decades, with outcomes that will likely reverberate across the agency's product centers, says Stacy Amin at MoFo.

  • Finding Focus: Strategies For Attorneys With ADHD

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    Given the prevalence of ADHD among attorneys, it is imperative that the legal community gain a better understanding of how ADHD affects well-being, and that resources and strategies exist for attorneys with this disability to manage their symptoms and achieve success, say Casey Dixon at Dixon Life Coaching and Krista Larson at Stinson.

  • AI Use May Trigger False Claims Act's Public Disclosure Bar

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    The likely use of publicly available artificial intelligence tools to detect government fraud by combing through large data sets will raise complex questions about a False Claims Act provision that prohibits the filing of claims based on previously disclosed information, say Nick Peterson and Spencer Brooks at Wiley Rein.

  • Beware Privacy Risks In Training AI Models With Health Data

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    Because data used to train artificial intelligence models may be protected by the Health Insurance Portability and Accountability Act or other regulations, users of these models should conduct proper diligence to avoid costly compliance failures, say Neha Matta and Barbara Bennett at Frost Brown.

  • Unpacking GAO's FY 2023 Bid Protest Report

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    The U.S. Government Accountability Office's recent bid protest report reflects an increase in sustained protests, illustrating that disappointed offerors may see little reason to refrain from seeking corrective action — but there is more to the story, say Aron Beezley and Patrick Quigley at Bradley Arant.

  • White House AI Order Balances Innovation And Regulation

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    President Joe Biden’s recently issued executive order on artificial intelligence lays out a sprawling list of directives aimed at establishing standards for safety, security and privacy protection, and may help strike the balance between the freedom to innovate and the need to impose regulation in this rapidly evolving space, say Kristen Logan and Martin Zoltick at Rothwell Figg.

  • Reading Between The Lines Of HHS' National Lab Opinion

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    The U.S. Department of Health and Human Services' Office of Inspector General recently rejected a national laboratory's request to pay a referring lab to process specimens, but the request might have been an attempt to exploit the OIG's advisory opinion process for a competitive advantage, says Mary Kohler at Kohler Health Law.

  • A Closer Look At Proposed HHS Research Misconduct Rule

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    The U.S. Department of Health and Human Services' proposed updates to its policies on research misconduct codify many well-known best practices, but also contain some potential surprises for the research community and counsel, say attorneys at Hogan Lovells.

  • Handling Religious Objections To Abortion-Related Job Duties

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    While health care and pharmacy employee religious exemption requests concerning abortion-related procedures or drugs are not new, recent cases demonstrate why employer accommodation considerations should factor in the Title VII standard set forth by the U.S. Supreme Court’s 2023 Groff v. DeJoy ruling, as well as applicable federal, state and local laws, say attorneys at Epstein Becker.

  • Why Hemp-Synthesized Intoxicants Need Uniform Regs

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    State laws regulating hemp-synthesized intoxicants are a patchwork with little consistency between any given state, and without the adoption of a uniform regulatory framework, producers and consumers alike will need to be very cautious, say Dylan Anderson and Seth Goldberg at Duane Morris.