Policy & Compliance

  • 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.

  • June 04, 2024

    Sens. Offer Stark Takes On Abortion Two Years Post-Dobbs

    Republican and Democratic members of the Senate health committee on Tuesday offered two different views of abortion in America two years after the Dobbs Decision overturned the federal right to the procedure.

  • June 04, 2024

    Recent Foley Hoag Addition Tapped As Life Sciences Co-Chair

    Boston-based Foley Hoag LLP announced the appointment of a recently hired patent partner as co-chair of its life sciences industry group, the largest industry sector it services.

  • June 04, 2024

    A Lawsuit 'Field Day' Over Calif. Healthcare Worker Wage Hike

    Even before going into effect, California's new healthcare worker minimum wage is generating complex legal questions about its scope and predictions of legal clashes to come.

  • June 03, 2024

    Colo. Gov Signs Compromise Bill Raising Damages Caps

    Colorado Gov. Jared Polis on Monday signed a law that will increase statutory caps on noneconomic damages for wrongful death and injury claims, as part of a deal to avoid a ballot-box fight between medical providers and personal injury lawyers.

  • June 03, 2024

    House COVID Panel Questions Fauci Over Pandemic Origins

    Anthony Fauci, the former director of the National Institute of Allergy and Infectious Disease responsible for overseeing the pandemic response, was pressed by a U.S. House COVID-19 panel Monday about recent allegations that a senior official tried to evade open records laws regarding the origins of the pandemic.

  • June 03, 2024

    Senate To Vote On Right To Contraception

    The Senate will vote later this week on a bill to codify a statutory right to contraception, ahead of the two-year anniversary of the U.S. Supreme Court's overturning of Roe v. Wade.

  • June 01, 2024

    Blockbuster Summer: 10 Big Issues Justices Still Must Decide

    As the calendar flips over to June, the U.S. Supreme Court still has heaps of cases to decide on issues ranging from trademark registration rules to judicial deference and presidential immunity. Here, Law360 looks at 10 of the most important topics the court has yet to decide.

  • May 31, 2024

    Final Defendant Gets 2 Years In Prison For DC Clinic Blockade

    An anti-abortion activist was sentenced to two years incarceration in D.C. federal court Friday, the final defendant to be sentenced among nine others charged in a 2020 blockade at a reproductive health clinic.

  • May 31, 2024

    Judge Doubts Okla. Can Stop Title X Cut Over Abortion Stance

    A Tenth Circuit judge appeared skeptical Friday that Oklahoma could prevent federal officials from stripping $4.5 million in funding over the state's refusal to provide abortion referrals, suggesting the state's claim of anti-abortion discrimination is better suited to an attack on Title X writ large.

  • May 31, 2024

    Judge Wonders If Wash. Social Media Ban Blocks Free Speech

    A Washington appellate judge on Friday questioned the constitutionality of a state law barring injured workers from posting video of their state workers' compensation medical exams on social media, saying it could be cutting off someone's only way of communicating with the outside world.

  • May 31, 2024

    15 States Sue To Block Biden's ACA Trans Discrimination Rule

    The Biden administration was hit with a lawsuit on Friday over its rule clarifying the application of the Affordable Care Act's nondiscrimination protections to gender identity, with a group of 15 states claiming the guidance is an effort "to enshrine sweeping gender-identity mandates without congressional consent."

  • May 31, 2024

    Texas Supreme Court Rejects Challenge To Abortion Ban

    The Texas Supreme Court unanimously rejected a petition Friday that challenged the state's near-total ban on abortion, ruling the law's narrow exceptions for pregnant women in life-threatening emergencies are broad enough to withstand a constitutional challenge.

  • May 30, 2024

    Physician, Health Cos. Spar Over Docs In Fla. Qui Tam Suit

    A doctor and several healthcare businesses accused each other of withholding evidence in a Florida federal False Claims Act lawsuit, with the doctor saying several key Zoom meeting records were destroyed, although the businesses have alleged the doctor refused to provide a financial agreement she made with a cohort.

  • May 30, 2024

    Ozempic Maker Says Texas Pharmacy Selling Knockoff Drug

    The manufacturer behind the Ozempic weight loss drug has asked a federal court to prohibit a Houston-area pharmacy from selling compounded, non-FDA-approved medications that claim to contain the drug's key ingredient.

  • May 30, 2024

    Sen. Warren Pushes CMS On 'Medical Loss Ratio' Data

    Sen. Elizabeth Warren, D-Mass., is urging the Centers for Medicare & Medicaid Services to collect more data to determine whether private healthcare insurers in Medicare Advantage that employ vertical integration are evading a statutory requirement that they spend the bulk of their earnings on medical claims.

  • May 30, 2024

    Dental Co., Ex-Worker Agree To Arbitrate OT Spat

    A New York federal judge granted a former dental assistant's request to arbitrate her claims accusing a dental company of failing to pay hourly workers all their overtime wages owed or on a weekly basis as state law mandates for manual laborers.

  • May 29, 2024

    FDA Sued Over Controversial Lab Test Rule

    A clinical lab trade group that has been highly critical of the U.S. Food and Drug Administration's new final rule on laboratory-developed tests filed a lawsuit late Wednesday, saying the agency doesn't have the authority to regulate the tests as medical devices.

  • May 29, 2024

    Acting Boston US Atty Says Fraud Cases Still High Priority

    Prosecuting a range of fraud cases despite finite resources will remain a priority for Massachusetts acting U.S. Attorney Joshua Levy as he enters his second year in the job, he told reporters on Wednesday in a question and answer session at his office.

  • May 29, 2024

    Whistleblower Counsel Can't Get 'Exorbitant' $11.5M Fee

    A Boston federal judge slashed an "exorbitant" $11.5 million fee request made by counsel for a False Claims Act whistleblower in a case involving lab testing company Fresenius Medical Care, hammering the attorneys for inflated hourly rates, inflated time entries and a host of questionable billing practices.

Expert Analysis

  • 2 Recent Suits Show Resiliency Of Medicare Drug Price Law

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    Though pharmaceutical companies continue to file lawsuits challenging the Inflation Reduction Act, which enables the federal government to negotiate for lower prescription drug prices, recent decisions suggest that the reduced drug prices are likely here to stay, says Jose Vela Jr. at Clark Hill.

  • Defense Attys Must Prep For Imminent AI Crime Enforcement

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    Given recent statements by U.S. Department of Justice officials, white collar practitioners should expect to encounter artificial intelligence in federal criminal enforcement in the near term, even in pending cases, say Jarrod Schaeffer and Scott Glicksman at Abell Eskew.

  • Lessons For Nursing Facilities From DOJ Fraud Settlement

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    The U.S. Department of Justice's recent settlement with the owner of skilled nursing and assisted living facilities in Florida provides a cautionary tale of potential fraud risks, and lessons on how facilities can mitigate government enforcement actions, say Callan Stein and Rebecca Younker at Troutman Pepper.

  • HHS' Updated Tracking Tech Guidance Offers Little Clarity

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    The U.S. Department of Health and Human Services' Office for Civil Rights' updated guidance on the use of online tracking technologies appears more focused on legal issues raised in ongoing litigation with the American Hospital Association and less on practical guidance for covered entities, say attorneys at Sheppard Mullin.

  • Takeaways From The 2023 DOJ Fraud Section Report

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    Attorneys at Wiley discuss notable trends from the U.S. Department of Justice's recently reported Fraud Section activity last year and highlight areas of enforcement to watch for in the future, including healthcare fraud and Foreign Corrupt Practices Act violations.

  • NIST March-In Framework Is As Problematic As 2021 Proposal

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    While the National Institute of Standards and Technology's proposed march-in framework on when the government can seize patents has been regarded as a radical departure that will support lowering prescription drug costs, the language at the heart of it is identical to a failed 2021 notice of proposed rulemaking, says attorney Kelly Morron.

  • Spartan Arbitration Tactics Against Well-Funded Opponents

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    Like the ancient Spartans who held off a numerically superior Persian army at the Battle of Thermopylae, trial attorneys and clients faced with arbitration against an opponent with a bigger war chest can take a strategic approach to create a pass to victory, say Kostas Katsiris and Benjamin Argyle at Venable.

  • The Road Ahead For Florida's Drug Importation Program

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    Though the U.S. Food and Drug Administration approved Florida's drug importation program in January, a series of hurdles — including requisite buy-in from Canada — and potential legal challenges must be addressed before importation can begin, say attorneys at Ropes & Gray.

  • Assessing CDC's Revised Guideline On Opioid Prescriptions

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    Kenneth Weinstein, Nicholas Van Niel and Kate Uthe at Analysis Group look at newly available data to evaluate the impact that the Centers for Disease Control and Prevention's revised opioid monitoring guideline have had on prescription trends in recent years, highlighting both specific and overall decreases.

  • Valeant Ruling May Pave Way For Patent-Based FCA Suits

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    The Ninth Circuit’s recent ruling in Silbersher v. Valeant marks a significant development in False Claims Act jurisprudence, opens new avenues for litigation and potentially raises the stakes for patent applicants who intend to do business with the government, say Joshua Robbins and Rick Taché at Buchalter.

  • Suits Against Insulin Pricing Are Driven By Rebate Addiction

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    A growing wave of lawsuits filed by states, cities and counties against insulin manufacturers and pharmacy benefit managers improperly allocate the blame for rising insulin costs, when in actuality the plaintiffs are partially responsible, says Dan Leonard at Granite Capitol Consulting.

  • When Physician Retirement Arrangements May Be Legal

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    A recent advisory opinion from the Office of Inspector General regarding physician retirement arrangements sheds light on key considerations and mitigating factors that may be useful when attempting to balance healthcare operational needs with statutory conformity, says Magda Rodriguez at Day Pitney.

  • ESG Around The World: Gulf Cooperation Council

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    The Gulf Cooperation Council is in the early stages of ESG policy implementation, but recent commitments by both states and corporations — including increases in sustainable finance transactions, environmental commitments, female representation on boards and human rights enforcement — show continuing progress toward broader ESG goals, say attorneys at Cleary.