Policy & Compliance

  • June 10, 2024

    Drugmakers Look To Nix Non-Insulin Claims From AG Suit

    Novo Nordisk, Eli Lilly and Sanofi-Aventis asked the federal judge overseeing a diabetes drug price-fixing multidistrict litigation to rule for drugmakers on Mississippi's claims the pricing for GLP-1s is illegal, saying in a brief that the drugs are under patent and too new to be included in the insulin-pricing suit.

  • June 10, 2024

    'Four Tops' Singer Sues ER Staff Who Ordered Psych Test

    The lead singer of Motown group The Four Tops has sued a hospital in Michigan federal court, claiming in a complaint filed Monday that hospital staff treated him as if he was mentally ill when he said he was a famous singer.

  • June 10, 2024

    3 Takeaways From Cigna's Win In 9th Circ. Rehab Claim Fight

    The Ninth Circuit's recent decision finding Cigna is off the hook for $8.6 million in out-of-network mental health and substance use disorder treatment claims against employee benefit plans administered by the insurer could discourage similar litigation, benefits attorneys say. Here are three key takeaways from the decision.

  • June 10, 2024

    FTC To Fight Go-Ahead Order On Novant $320M Hospital Deal

    Just days after a district court loss, the Federal Trade Commission said Monday it will ask the Fourth Circuit to step in and block Novant Health from buying two North Carolina hospitals in a $320 million deal the agency contends would harm competition.

  • June 10, 2024

    Mass. Nursing Home To Pay Record $4M Over Neglect Claims

    A Massachusetts nursing home operator has agreed to pay a total of $4 million and hire an independent monitor to settle allegations that understaffing at its 16 facilities led to substandard care and patients being harmed, the attorney general’s office announced Monday. Next Step Healthcare LLC has agreed pay $750,000 directly to the state and dedicate the remaining $3.25 million toward increasing staffing levels.

  • June 10, 2024

    High Court To Review HHS Hospital Pay Formula

    The U.S. Supreme Court on Monday agreed to review a D.C. Circuit decision siding with the Department of Health and Human Services over how the agency applies a formula for calculating disproportionate share hospital payments for Supplemental Security Income benefits.

  • June 07, 2024

    Conn. Judge Pushes State For Proof In $11M Kickback Case

    The Connecticut state judge presiding over an $11 million false claims and kickbacks case against a compounding pharmacy appeared unconvinced Friday that the defendants submitted false claims for payment, peppering the government's counsel with requests to support assertions with case law and evidence that was put on at trial.

  • June 07, 2024

    Chicago-Area Man Charged With $60M COVID Test Fraud

    A suburban Chicago man is facing healthcare fraud and money laundering charges over more than $60 million in Medicare reimbursement claims for over-the-counter COVID-19 test kits that were allegedly never provided, including thousands of tests for dead people.

  • June 07, 2024

    7 Health Insurers Eye Rate Hikes In Connecticut

    Seven health insurers have asked Connecticut state regulators to approve rate hikes of 7.4% to 12.5% for individual market plans and 5.1% to 13.6% for small groups, averaging out to a lesser increase than last year's, according to an announcement Friday.

  • June 06, 2024

    Chronic Care Co. To Pay $14.9M To End DOJ False Claims Suit

    A provider of chronic disease management services across several states has reached a $14.9 million settlement with the U.S. Department of Justice, resolving a False Claims Act suit alleging it defrauded Medicare and Medicaid by "upcoding" healthcare claims.

  • June 06, 2024

    Justices Say Feds Liable For Tribes' Healthcare Admin Costs

    A split U.S. Supreme Court on Thursday held that the federal government is required to reimburse two Native American tribes millions of dollars in administrative healthcare costs, saying the spending is necessary for the communities to operate programs assumed from the Indian Health Service.

  • June 05, 2024

    House Votes To Block Vets' Access To Gender-Affirming Care

    The U.S. House of Representatives on Wednesday passed a $147.5 billion spending bill along mostly party lines funding military construction and the U.S. Department of Veterans Affairs, which would block veterans' access to gender-affirming care and which the White House has already threatened to veto.

  • June 05, 2024

    Calif. Wage Hike To Cover Nearly All Healthcare Workplaces

    Nearly all workers at healthcare facilities in California will be entitled to a higher minimum wage beginning July 1 regardless of whether they're involved in patient care. One expert called the increase a sweeping change, partly due to broad definitions of what employees and facilities are covered.

  • June 04, 2024

    Divided 9th Circ. Reverses Sutter Health Antitrust Trial Victory

    A split Ninth Circuit panel on Tuesday overturned Sutter Health's win in insurance plan purchasers' $400 million antitrust suit, ruling that the lower court wrongly excluded "highly relevant" evidence — including admissions by Sutter executives — that would've helped the purchasers potentially prove claims they overpaid thanks to Sutter's anticompetitive conduct.

  • June 04, 2024

    Texas Justices Fuel Confusion Over Abortion Ban Exceptions

    The Texas Supreme Court recently ruled that doctors may perform abortions only when "reasonable medical judgment" says a patient's life is in danger — a decision attorneys say puts doctors in the position of weighing the lives of their patients against the risk of criminal prosecution.

  • June 04, 2024

    FDA Advisers Rebuff Bid To Treat PTSD With MDMA

    A panel of public health experts on Tuesday dealt a blow to a historic effort to regulate MDMA therapy for post-traumatic stress disorder, saying although the positive effects shown in clinical trials are promising, the proposal was hindered by too many confounding factors.

  • June 04, 2024

    HHS Guidance, Feud Over FCA Evidence, And A Deposed AG

    States sue the Biden administration over nondiscrimination guidance. A False Claims Act case sees a tussle over evidence. A Connecticut federal judge allows drugmakers to depose the office of D.C.'s attorney general. Here, Law360 Healthcare Authority looks at notable developments in healthcare litigation over the past week.

  • June 04, 2024

    Ga. County Wants 11th Circ. To Rethink Trans Care Ban Ruling

    A Georgia county that lost a legal challenge to a provision of its health plan that bars coverage for gender-affirming surgery has asked the full Eleventh Circuit to revisit the decision, arguing that an opinion last month wrongly found the policy discriminates against transgender people, rather than being isolated to a single procedure.

  • June 04, 2024

    2nd Circ. Says ERISA Blocks Cigna Bill Backpedaling Suit

    The Second Circuit affirmed the dismissal of a podiatric medicine provider's suit alleging Cigna illegally backtracked on covering a patient's $200,000 bill, ruling that a lower court was right to find that federal benefits law blocks the healthcare provider's breach of contract claims.

  • June 04, 2024

    5th Circ. Medical 'Disinformation' Decision: 5 Things To Know

    A divided 5th Circuit gave a conservative medical group that says it was hurt by a campaign to suppress criticism of Dr. Anthony Fauci another shot at its free-speech claims. Here are five things you should know about the case.

  • June 04, 2024

    Benefits Plan Inks Deal To End Mental Health Coverage Suit

    The employee benefits plan at Mountain Area Health Education Center became the last remaining defendant to reach a settlement in a North Carolina district court lawsuit accusing an insurer and others of refusing to cover the cost of a patient's stay at a residential treatment center.

  • June 04, 2024

    What Clinical Trial Attys Want From FDA Diversity Guidance

    Impending federal guidance on diversifying clinical trial participation marks the latest push to address the historic homogeneity of clinical research. Here, clinical trial attorneys share with Law360 Healthcare Authority the questions they hope the FDA will answer.

  • June 04, 2024

    White House Threatens Veto Over Policy Riders In VA Bill

    The White House has threatened to veto a $147.5 billion bill funding military construction and the U.S. Department of Veterans Affairs, citing partisan policy proposals it said would harm minority groups and risk patient safety at VA medical facilities.

  • June 04, 2024

    Ex-Keller & Heckman Scientist Joins K&L Gates In DC

    K&L Gates LLP announced Tuesday that a longtime scientist at Keller and Heckman LLP joined its Washington, D.C., office as the firm's first senior scientific adviser.

  • June 04, 2024

    NM Cannabis Co. Says Insurers Can't Toss Medical Weed Row

    A group of insurers can't escape a proposed class action demanding they cover medical marijuana costs, a cannabis company and several of its patients said, telling a New Mexico federal court that medical cannabis is a medically necessary behavioral health service that must be covered.

Expert Analysis

  • The State Of CFPB Focus On Credit Reporting Of Medical Debt

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    An increase in credit reporting complaints and the Consumer Financial Protection Bureau's recent annual report on the Fair Debt Collection Practices Act — which focuses on medical debt in credit reporting — are both evidence of the fact that the bureau will continue to prioritize oversight of credit reporting of medical debt, says Kristen Watson at Burr & Forman.

  • FDA's Recent Litigation Records Are Strong, But Imperfect

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    The U.S. Food and Drug Administration has notched its share of litigation wins in recent years thanks to a number of key advantages, but the FDA has been less successful in certain highly visible arenas, Jonathan Berman and Colleen Heisey at Jones Day.

  • 5 Steps For Healthcare Companies After Biden's AI Order

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    Rather than simply monitoring for the issuance of agency guidelines on artificial intelligence in the wake of President Joe Biden's October executive order, health and life sciences companies should take action now and begin building internal operational and technical infrastructures designed to govern the use of AI, says Joy Sharp at Faegre Drinker.

  • Giving The Gov't Drug Patent March-In Authority Is Bad Policy

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    The Biden administration's recent proposal to allow government seizure of certain taxpayer-funded drug patents is a terrible idea that would negate the benefits of government-funded research, to the detriment of patients and the wider economy, says Wayne Winegarden at Pacific Research Institute.

  • How Clients May Use AI To Monitor Attorneys

    Excerpt from Practical Guidance
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    Artificial intelligence tools will increasingly enable clients to monitor and evaluate their counsel’s activities, so attorneys must clearly define the terms of engagement and likewise take advantage of the efficiencies offered by AI, says Ronald Levine at Herrick Feinstein.

  • When Patients Have Standing For Hospital Antitrust Suits

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    Brown v. Hartford Healthcare Corp., recently decided by a Connecticut state court, provides a useful examination of how antitrust standing issues may be analyzed when patients directly sue a healthcare system for anti-competitive conduct, says Charles Honart at Stevens & Lee.

  • ESG Around The World: Singapore

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    Singapore is keen to establish itself as a leading international financial center and a key player in the sustainable finance ecosystem, and key initiatives led by its government and other regulatory bodies have helped the Asian nation progress from its initially guarded attitude toward ESG investment and reporting, say attorneys at Morgan Lewis.

  • The Pop Culture Docket: Judge D'Emic On Moby Grape

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    The 1968 Moby Grape song "Murder in My Heart for the Judge" tells the tale of a fictional defendant treated with scorn by the judge, illustrating how much the legal system has evolved in the past 50 years, largely due to problem-solving courts and the principles of procedural justice, says Kings County Supreme Court Administrative Judge Matthew D'Emic.

  • Performing Music Makes Me A Better Lawyer

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    The discipline of performing live music has directly and positively influenced my effectiveness as a litigator — serving as a reminder that practice, intuition and team building are all important elements of a successful law practice, says Jeff Wakolbinger at Bryan Cave.

  • 'Patient' Definition Ruling Raises Discount Drug Questions

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    A South Carolina federal court's recent decision in Genesis Health Care v. Becerra supports a broader definition of a "patient" eligible to receive discounted drugs under the Section 340B program, but raises a host of novel questions regarding how the decision will affect covered entities and enforcement actions, say attorneys at McDermott.

  • Breaking Down High Court's New Code Of Conduct

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    The U.S. Supreme Court recently adopted its first-ever code of conduct, and counsel will need to work closely with clients in navigating its provisions, from gift-giving to recusal bids, say Phillip Gordon and Mateo Forero at Holtzman Vogel.

  • Legal Profession Gender Parity Requires Equal Parental Leave

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    To truly foster equity in the legal profession and to promote attorney retention, workplaces need to better support all parents, regardless of gender — starting by offering equal and robust parental leave to both birthing and non-birthing parents, says Ali Spindler at Irwin Fritchie.

  • Activist Short-Sellers Are The Dark Knights Of Wall Street

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    While so-called activist short-sellers have been subject to increased scrutiny in recent years, these investors work in the shadows like Batman to expose fraud on Wall Street, often generating leads that may move regulators to take action, say attorneys at Labaton Sucharow.