Policy & Compliance

  • June 11, 2024

    Rao Tracks His Journey From Stay-At-Home Dad To FTC

    Rahul Rao said that every role he's taken on — from BigLaw attorney to stay-at-home dad to overseeing healthcare mergers at the Federal Trade Commission — has helped shape him into the lawyer he is today.

  • June 11, 2024

    FDA Urges 11th Circ. To Back E-Cig Ban Over High Nicotine

    The U.S. Food and Drug Administration is urging the Eleventh Circuit to not let Bidi Vapor market an e-cigarette product that the agency claimed would expose users to nearly twice as much nicotine as a typical combustible cigarette.

  • June 11, 2024

    Next Wave Of Opioid Suits Targets Drug Biz 'Middlemen'

    Communities ravaged by opioid addiction have secured billions of dollars in settlements with companies that make, market and dispense the drugs. A new target is now emerging in the next wave of litigation — pharmacy benefit managers.

  • June 11, 2024

    Beveridge & Diamond Hires DOJ Jan. 6 Litigator In DC

    Beveridge & Diamond PC's new white collar principal, Louis Manzo, has worked on some of the highest-profile cases in the nation for the Justice Department, helping secure convictions for several January 6 insurrectionists charged with seditious conspiracy.

  • June 10, 2024

    Rehab Clinics Add To MultiPlan Insurance Fixing Pile-On

    Addiction treatment providers sued MultiPlan, Aetna, Cigna, UnitedHealth and Elevance Friday and Saturday in 14 separate New York federal court complaints that appear to be the first to add substance abuse disorder-specific allegations to the cases pegging MultiPlan at the center of a scheme to suppress insurer payouts.

  • June 10, 2024

    IHS Urges Budget Shift After High Court Healthcare Ruling

    The Indian Health Service, following a divided U.S. Supreme Court decision affirming that the federal government is liable for the reimbursement of millions in administrative healthcare costs for two Native American tribes, is urging Congress to shift its budget appropriations for fiscal year 2026 to protect the agency's overall health.

  • June 10, 2024

    SoCal Workers Want Class Cert. In Union Healthcare Fee Suit

    A group of union-represented Southern California hospitality workers who say they're getting charged much higher health insurance rates than their counterparts in Las Vegas are seeking class certification in their lawsuit challenging the rates, according to a filing in Illinois federal court.

  • June 10, 2024

    Baltimore Lands $45M Deal With Allergan In Opioid Litigation

    Baltimore has put to rest its claims that Allergan played a part in the opioid crisis, reaching a $45 million settlement with the pharmaceutical company, an amount the city called "unprecedented" in an announcement on Monday.

  • June 10, 2024

    Colo. Justices Say Doc-Patient Privilege Mirrors Atty-Client

    The Colorado Supreme Court held Monday that doctor-patient privilege does persist after a patient dies but that a "testamentary exception" exists for when a late patient's medical records become necessary information to execute their estate, similar to how attorney-client privilege works.

  • 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.

Expert Analysis

  • FDA Warning Letter Tightens Reins On 'Research Only' Labels

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    A recent warning letter from the U.S. Food and Drug Administration to Agena Bioscience alleged the company’s diagnostic devices were labeled for research use only, but improperly promoted for human clinical purposes, signifying a reinforcement — and a potential narrowing — of the agency's policy on products labeled “research only,” say attorneys at Sheppard Mullin.

  • First 10b5-1 Insider Trading Case Raises Compliance Issues

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    The ongoing case against former Ontrak CEO Terren Peizer is the U.S. Department of Justice's first insider trading prosecution based primarily on the filing of 10b5-1 plans, and has important takeaways for attorneys reviewing corporate policies on the possession of material nonpublic information, say attorneys at Cadwalader.

  • Policy Misrepresentations Carry Insurance Rescission Risks

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    The Second Circuit's recent decision in Medical Mutual v. Gnik, finding that material misrepresentation in a clinic's insurance applications warranted policy rescission, is a clear example of the far-reaching effects that misrepresentations can have and provides a reminder that policyholders should employ relatively straightforward steps to decrease risks, say attorneys at Hunton.

  • The Pros And Cons Of NIST's Proposed March-In Framework

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    Recent comments for and against the National Institute of Standards and Technology’s proposed guidance on march-in rights — which permit the government to seize federally funded patents — highlight how the framework may promote competition, but could also pose a risk to contractors and universities, say Nick Lee and Paul Ragusa at Baker Botts.

  • 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.