Policy & Compliance

  • May 01, 2024

    J&J Unit Cuts Deal To End Cancer Drug Trade Secret Fight

    A New Jersey federal judge has signed off on a consent judgment that permanently bars Chinese drugmaker Jiangsu Hengrui Pharmaceuticals Co. from misappropriating Johnson and Johnson's pharmaceutical subsidiary Janssen's trade secrets for its popular chemotherapy drug Yondelis.

  • May 01, 2024

    5th Circ. Judge Skeptical Of Medicare Drug 'Price-Setting'

    A Fifth Circuit judge on Wednesday sharply criticized the Biden administration's Medicare drug pricing program, characterizing it as government "price-setting" and questioning "what possible procompetitive justification" there can be for penalizing companies that don't participate.

  • April 30, 2024

    Ex-Olympus Exec Says He Was Fired For Flagging FDA Issue

    The former global head of product development at medical manufacturer Olympus Corp. said he was fired earlier this year after he reported multiple compliance concerns regarding the company's practices and related to nearly 100 products, according to a suit filed Monday in Pennsylvania federal court.

  • April 30, 2024

    Judge Strikes Parts Of NC Law Restricting Abortion Drug

    A North Carolina federal judge struck down parts of a state law Tuesday that restricts access to the abortion medication mifepristone, finding some provisions violate the U.S. Constitution's supremacy clause by enacting safety regulations already considered by the U.S. Food and Drug Administration, such as requiring in-person prescribing, dispensing and scheduling around the drug.

  • April 30, 2024

    BCBS Says Federal Drug Law Preempts NM Medical Weed Row

    A group of insurers, including Blue Cross and Blue Shield of New Mexico, urged a New Mexico federal judge to reject a proposed class action seeking to compel them to cover their policyholders' medical marijuana costs, arguing that state law doesn't require it and federal law forbids it.

  • April 30, 2024

    Aetna Resists State Court Remand In Provider Payment Suit

    A lawsuit alleging Aetna units have underpaid emergency healthcare workers' benefit claims should be heard in an Ohio federal court, the insurer said in opposing a remand to the state level, based in part on the argument that two of the corporate defendants don't belong in the case.

  • 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.

Expert Analysis

  • What Circuit Split May Mean For FCA Kickback Liability

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    The recent circuit split on the meaning of the resulting-from provision in False Claims Act kickback cases could have significant ramifications for FCA liability, as it could affect the standard of causation that plaintiffs must meet to establish liability, say former federal prosecutors Li Yu, Ellen London and Gregg Shapiro.

  • More States Should Join Effort To Close Legal Services Gap

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    Colorado is the most recent state to allow other types of legal providers, not just attorneys, to offer specific services in certain circumstances — and more states should rethink the century-old assumptions that shape our current regulatory rules, say Natalie Anne Knowlton and Janet Drobinske at the University of Denver.

  • How Health Cos. Can Brace For Tracking Tech Scrutiny

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    A joint letter sent by the U.S. Department of Health and Human Services Office for Civil Rights and Federal Trade Commission last month highlights the agencies' concerns about tracking technologies, and may foreshadow a spike in enforcement actions, say attorneys at Moses Singer.

  • Identifying Trends And Tips In Litigation Financing Disclosure

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    Growing interest and controversy in litigation financing raise several salient concerns, but exploring recent compelled disclosure trends from courts around the country can help practitioners further their clients' interests, say Sean Callagy and Samuel Sokolsky at Arnold & Porter.

  • What's Next For Adult-Use Marijuana In Ohio

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    After Ohio voters defeated a proposal that would have made it harder to pass any citizen-initiated constitutional amendment, a state ballot measure to legalize adult-use marijuana has fairly good chances of passing — but advocates still face a long road ahead, say Perry Salzhauer and David Waxman at McGlinchey Stafford.

  • Unpacking CMS' Latest Proposals For Telehealth Flexibilities

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    The Centers for Medicare and Medicaid Services' calendar year 2024 proposed rule includes a number of important extensions to telehealth flexibilities, acknowledging the importance of these temporary policies, but permanent certainty will require further legislative action and agency rulemaking, say attorneys at Baker Donelson.

  • Congress Needs Better Health Care Fraud Data From DOD

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    The U.S. Department of Defense does not collect enough data to prevent health care and service contractor fraud and waste, so Congress should enact benchmarks that the DOD must meet when gathering and reporting data, enabling lawmakers to make better-informed decisions about defense appropriations, says Jessica Lehman at Verizon.

  • The Pop Culture Docket: Judge Elrod On 'Jury Duty'

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    Though the mockumentary series “Jury Duty” features purposely outrageous characters, it offers a solemn lesson about the simple but brilliant design of the right to trial by jury, with an unwitting protagonist who even John Adams may have welcomed as an impartial foreperson, says Fifth Circuit Judge Jennifer Elrod.

  • 4 Business-Building Strategies For Introvert Attorneys

    Excerpt from Practical Guidance
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    Introverted lawyers can build client bases to rival their extroverted peers’ by adapting time-tested strategies for business development that can work for any personality — such as claiming a niche, networking for maximum impact, drawing on existing contacts and more, says Ronald Levine at Herrick Feinstein.

  • No Surprises Act Creates Payment Challenges For Providers

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    Since the implementation of the No Surprises Act last year, flaws in the federal Independent Dispute Resolution process — particularly enforceability issues — have left providers struggling to get paid for out-of-network emergency services, say Carrie Douglas and Julia Kowalsky at Bracewell.

  • 3 Ways Justices' Disclosure Defenses Miss The Ethical Point

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    The rule-bound interpretation of financial disclosures preferred by U.S. Supreme Court Justices Samuel Alito and Clarence Thomas — demonstrated in their respective statements defending their failure to disclose gifts from billionaires — show that they do not understand the ethical aspects of the public's concern, says Jim Moliterno at the Washington and Lee University School of Law.

  • Preparing For New Scrutiny Of Consumer Medical Financing

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    With U.S. health and consumer credit watchdogs soliciting feedback on medical credit cards and related loans, financial institutions and fintech companies that offer these payment products should prepare for potential increased regulatory scrutiny by taking steps to confirm their business practices prioritize patient well-being and financial security, say Benjamin Saul and Tarrian Ellis at Greenberg Traurig.

  • Breaking Down The Long-Awaited HHS Info Blocking Rule

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    Although the U.S. Department of Health and Human Services' Office of Inspector General's final information-blocking enforcement rule is a step toward regulating conduct, there is still no rule for appropriate disincentives for provider-actors, leaving a significant enforcement gap, say attorneys at Sheppard Mullin.