Policy & Compliance

  • April 29, 2025

    HHS Legal Staff Cuts Will Impair Abuse, Neglect Enforcement

    A massive overhaul underway at the U.S. Department of Health and Human Services will wipe out the roles filled by more than 100 attorneys and other staff at offices in six states. Among the enforcement areas being hit are federal efforts led by regional HHS legal teams combating elder abuse and neglect at nursing homes.

  • April 29, 2025

    Companies Are Increasing Security Coverage For GCs, Execs

    UnitedHealth Group has disclosed it spent nearly $1.9 million on security for its executives and their families in 2024, including over $213,000 for chief legal officer Christopher Zaetta, and a new study shows more corporations are following suit.

  • April 29, 2025

    Opioid MDL Judge Won't Recuse Over Ex Parte Allegations

    An Ohio federal judge will not step aside from multidistrict opioid litigation after the plaintiffs' attorney, who had alleged the judge "regularly communicates" with other lawyers involved in the litigation, testified that there was no such communication after all, the judge ruled Tuesday.

  • April 29, 2025

    BCBS Wants Hospital Sanctioned For 'Cat-And-Mouse' Tactics

    Blue Cross Blue Shield of North Carolina asked a federal judge to sanction a hospital company and its related entities for their purported "evasion, obfuscation, misdirection and outright misrepresentation" during discovery in a $32 million billing dispute that has gone on for seven years.

  • April 29, 2025

    High Court Backs HHS In Hospital Pay Formula Dispute

    The U.S. Supreme Court on Tuesday sided with federal health officials in a challenge over a formula used to calculate billions of dollars in annual payments to hospitals treating indigent patients, saying that those entitled to Supplemental Security Income should be collecting cash payments before they're counted in the formula.

  • April 28, 2025

    Gov't Reverses Position On Surgery For Trans Prisoners

    The Trump administration is rejecting the federal government's previous stance that prison officials are constitutionally required to provide gender confirmation surgery to incarcerated people with gender dysphoria who request the treatment, noting the shift in recent statements to a Georgia federal court.

  • April 28, 2025

    NC Dentist Acquitted Of $3M Fraud, Tax Evasion Charges

    A North Carolina dentist was acquitted of wire fraud and tax evasion charges on the fourth day of a federal jury trial in which prosecutors had alleged the dentist submitted false loan applications to the Small Business Administration and failed to pay income taxes.

  • April 28, 2025

    Mich. Nurses Quit Claims Of Pay Withheld For Breaks Untaken

    Two registered nurses agreed to drop their claims of unpaid wages against the two locations of a Michigan healthcare system they had accused in federal court of requiring them to work through meal breaks without pay, ending the case Monday in federal court.

  • April 28, 2025

    2nd Circ. Upholds Clinic Manager's Repeat Charges For Fraud

    A decision that allowed the federal government to reindict a health clinic manager for a Medicare and tax fraud scheme can stand, a Second Circuit panel found Monday, agreeing with the lower court that his offenses were serious enough to permit it.

  • April 28, 2025

    Red States Want ACA Trans Health Rule Permanently Off Books

    A group of 15 red states that successfully got a Biden-era rule frozen that protected gender-affirming care under the Affordable Care Act have urged a Mississippi federal judge to rule the U.S. Department of Health and Human Services overstepped its authority and cannot require states to allow gender-affirming care for transgender people.

  • April 25, 2025

    HHS Sued Over Withholding Of $65.8M In Title X Funding

    The U.S. Department of Health and Human Services unlawfully withheld $65.8 million in federal grants for critically needed family planning services, a nonprofit alleged in a suit filed Thursday in D.C. federal court, saying the withholding seemed to be based, in part, on grantees' support for diversity, equity and inclusion.

  • April 25, 2025

    Justices Want More Info On HHS Authority In Task Force Row

    The U.S. Supreme Court on Friday ordered the federal government and a group of Texas businesses and individuals to compile more information as to whether the U.S. Department of Health and Human Services secretary has the authority to appoint members of a task force under the Affordable Care Act.

  • April 25, 2025

    Sutter Health To Pay $228M In Years-Old Antitrust Suit

    A class of millions of health insurance premium payors asked a California federal judge Friday to greenlight an eleventh-hour $228.5 million settlement resolving their long-running claims that hospital chain Sutter Health drives up costs by pushing all-or-nothing network deals on insurers.

  • April 25, 2025

    Refusing Mental Healthcare Means Liability, Pa. Justices Rule

    Physicians in Pennsylvania can be held liable for turning away a mental health patient who goes on to harm someone if that patient came to the hospital asking for help, the state Supreme Court ruled Friday.

  • April 25, 2025

    HHS Says Cuts Target Excess After Judge Seeks More Info

    The U.S. Department of Health and Human Services told a Rhode Island federal judge that a group of states has no basis to challenge the cancellation of billions in grants supporting public health programs because they already received the funds appropriated to them by Congress.

  • April 25, 2025

    Trans Prisoners Fight For Care Over New White House Hurdles

    After staff at a New Jersey federal prison told Alishea Sophia Kingdom that, due to an executive order by President Donald Trump, she would no longer be receiving hormone therapy to treat gender dysphoria, Kingdom lodged the latest in a series of suits against the Federal Bureau of Prisons that contend following the executive order violates the Eighth Amendment's prohibition of cruel and unusual punishment.

  • April 25, 2025

    Organ Donor Network Wants Veteran's Waitlist Bias Suit Axed

    The United Network for Organ Sharing asked a Georgia federal court to toss a lawsuit filed against it and several university medical schools over allegations that they delayed a Black military veteran's ability to receive a kidney transplant by artificially inflating his kidney function scores.

  • April 25, 2025

    DOD To Assess Tricare Program Competition In Ga. And Fla.

    The U.S. Department of Defense has awarded contracts to CareSource Military and Veterans to compete with managed care support contractors in delivering health, medical and administrative support services to eligible Tricare beneficiaries in the Atlanta and Tampa markets. 

  • April 25, 2025

    2nd Circ. Says Withdrawn Application Dooms Age Bias Suit

    The Second Circuit refused to reopen a sleep doctor's lawsuit claiming a hospital refused to consider him for a job because he was 66 years old, saying his decision to turn down an interview after receiving a misaddressed email doomed his case.

  • April 25, 2025

    5 Issues Benefits Attys Want The Gov't To Shed Light On

    The first three months of President Donald Trump's administration have left lawyers who represent employers and benefit plans hungry for clarity on issues like cryptocurrency as a 401(k) investment and coverage for gender-affirming care. Here, Law360 looks at five areas where attorneys are hoping for guidance or regulations.

  • April 24, 2025

    Ex-Pain Clinic Owner Gets 3½ Years For Drug Test Scheme

    The former owner of a Pennsylvania pain management practice has been sentenced to three-and-a-half years in prison for conspiring with others to defraud Medicare by submitting unnecessary urine drug tests for chronic opioid patients at his medical clinics.

  • April 24, 2025

    'Egregious' Delays Wipe Out Ga. Health Fraud Case

    A Georgia federal judge on Thursday dismissed an eight-year-old case over alleged Medicaid fraud, calling the government's delays in bringing three healthcare executives to trial "egregious" and noting that the alleged criminal conduct took place between 12 and 25 years ago.

  • April 24, 2025

    No Greece Trip For Ex-Conn. Official Facing Corruption Cases

    A Connecticut federal judge on Thursday denied a former state official's request to take a trip to Greece amid two indictments, an order that came the day after the government opposed the plan.

  • April 24, 2025

    Polsinelli Gains 2 Healthcare Shareholders In Denver

    Polsinelli PC announced this week that it has brought two Denver-based attorneys from Husch Blackwell LLP and the U.S. Food and Drug Administration to its healthcare practice, which the firm says gained six new shareholders in the past 12 months, not including these most recent additions.

  • April 24, 2025

    Harvard Seeks To Move 'Swiftly' In $2B Fund Freeze Suit

    Harvard University is seeking to move as quickly as possible to get to the merits of its suit challenging the Trump administration's $2.2 billion funding freeze, asking a Massachusetts federal judge to expedite discovery and briefing.

Expert Analysis

  • DOJ Innovasis Settlement Offers Lessons On Self-Disclosure

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    The recent $12 million settlement with Innovasis and two of its executives demonstrates the U.S. Department of Justice's continued prioritization of Anti-Kickback Statute enforcement amid the growing circuit split over causation, and illustrates important nuances surrounding self-disclosure, say Denise Barnes and Scott Gallisdorfer at Bass Berry.

  • How Orange Book Antitrust Scrutiny Is Intensifying

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    Pharmaceutical patent holders should be reviewing Orange Book listing practices, as the Federal Trade Commission takes a more aggressive antitrust approach with actions such as the Teva listing probe, and the U.S. Food and Drug Administration calls attention to potentially improper listings, say attorneys at McDermott.

  • After Chevron: Slowing Down AI In Medical Research

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    The U.S. Supreme Court's recent decision overturning the Chevron doctrine may inhibit agencies' regulatory efforts, potentially slowing down the approval and implementation of artificial intelligence-driven methodologies in medical research, as well as regulators' responses to public health emergencies, say Ragini Acharya and Matthew Deutsch at Husch Blackwell.

  • FDA's Multifaceted Role On Display In MDMA Therapy Scrutiny

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    Ongoing deliberations at the U.S. Food and Drug Administration regarding MDMA-assisted therapy for post-traumatic stress disorder serves as a window into the intricate balance of scientific innovation and patient safety oversight, and offers crucial insights into regulatory nuances, say Kimberly Chew at Husch Blackwell and Kevin Lanzo at Pharmaka Clinical Consulting.

  • Analyzing FDA Draft Guidance On Clinical Trial Diversity

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    In light of the U.S. Food and Drug Administration's draft guidance on clinical trial diversity action plans, there are several important considerations for sponsors and clinical researchers to keep in mind to prevent delay in a drug or device application, say attorneys at Crowell & Moring.

  • In The CFPB Playbook: Making Good On Bold Promises

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    The U.S. Supreme Court's decision upholding the Consumer Financial Protection Bureau's funding structure in the second quarter cleared the way for the bureau to resume a number of high-priority initiatives, and it appears poised to charge ahead in working toward its aggressive preelection agenda, say Andrew Arculin and Paula Vigo Marqués at Blank Rome.

  • Critical Questions Remain After High Court's Abortion Rulings

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    The U.S. Supreme Court's decisions in two major abortion-related cases this term largely preserve the status quo for now, but leave federal preemption, the Comstock Act and in vitro fertilization in limbo, say attorneys at Jenner & Block.

  • Navigating FDA Supply Rule Leeway For Small Dispensers

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    As the November compliance deadline for the U.S. Food and Drug Administration's new pharmaceutical distribution supply chain rules draws closer, small dispensers should understand the narrow flexibilities that are available, and the questions to consider before taking advantage of them, say attorneys at Faegre Drinker.

  • 1st Gender Care Ban Provides Context For High Court Case

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    The history of Arkansas' ban on gender-affirming medical care — the first such legislation in the U.S. — provides important insight into the far-reaching ramifications that the U.S. Supreme Court's decision in U.S. v. Skrmetti next term will have on transgender healthcare, says Tyler Saenz at Baker Donelson.

  • 6 Lessons From DOJ's 1st Controlled Drug Case In Telehealth

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    Following the U.S. Department of Justice’s first-ever criminal prosecution over telehealth-prescribed controlled substances in U.S. v. Ruthia He, healthcare providers should be mindful of the risks associated with restricting the physician-patient relationship when crafting new business models, says Jonathan Porter at Husch Blackwell.

  • After Chevron: Scale Tips Favor Away From HHS Agencies

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    The loss of Chevron deference may indirectly aid parties in challenging the U.S. Department of Health and Human Services' interpretations of regulations and could immediately influence several pending cases challenging HHS on technical questions and agency authority, say attorneys at Ropes & Gray.

  • After Chevron: FDA Regulations In The Crosshairs

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    The U.S. Supreme Court's overturning of the Chevron doctrine is likely to unleash an array of challenges against the U.S. Food and Drug Administration, focusing on areas of potential overreach such as the FDA's authority under the Federal Food, Drug and Cosmetic Act, say attorneys at Debevoise.

  • USPTO Disclaimer Rule Would Complicate Patent Prosecution

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    The U.S. Patent and Trademark Office's proposed changes to terminal disclaimer practice could lead to a patent owner being unable to enforce a valid patent simply because it is indirectly tied to a patent in which a single claim is found anticipated or obvious in view of the prior art, say attorneys at Sterne Kessler.