Policy & Compliance

  • February 28, 2024

    AdaptHealth, Ex-CEO Cut $51M Deal To End Investor Fight

    AdaptHealth and its former CEO have agreed to pay $51 million to resolve a shareholder suit alleging the medical equipment company misled investors by retroactively inflating growth numbers ahead of a merger with special acquisition firm DFB Healthcare Acquisitions Corp., according to court documents filed in Pennsylvania federal court Tuesday.

  • February 28, 2024

    Novant In-House Attys Want Access To Confidential FTC Info

    Novant Health has asked to tweak a protective order in the Federal Trade Commission's merger challenge regarding its $320 million plan to buy two hospitals in North Carolina, saying the current order designates nearly the entire investigative file confidential and is "unworkable."

  • February 27, 2024

    Mich. AG Backs Abortion Challenge, But Urges Narrow Block

    The Michigan attorney general on Tuesday backed a challenge from a group of reproductive healthcare clinics to abortion policies they argue violate the state's constitution, but told a state court that the injunction they requested could have collateral damage and advised a narrow block of the provisions. 

  • February 27, 2024

    Hospital Groups Allege Opioid Crisis Damaged Their Finances

    More than 20 hospitals and related companies have joined multidistrict litigation over the opioid epidemic, alleging in a massive new complaint that pharmacies, drug distributors and others contributed to a crisis that damaged hospitals' finances and strained their ability to help patients.

  • February 26, 2024

    Teva Tells 1st Circ. Feds Must Clear High Bar In FCA Case

    Teva Pharmaceuticals told the First Circuit on Monday that the federal government should be held to — and cannot meet — a strict causation standard in a False Claims Act kickback case, asking the court to settle a matter of first impression in the circuit.

  • February 26, 2024

    Stimwave Prosecutors Accused Of Brady Violation Mid-Trial

    The former CEO of Stimwave Technologies has alleged in the middle of her criminal fraud trial that the Manhattan U.S. Attorney's Office withheld key evidence about proffer meetings, teeing up a potential Brady fight before a skeptical judge.

  • February 26, 2024

    Texas Nursing Home Must Face Suit Over Resident's Uri Death

    A Texas appellate court says the daughter of a woman who died of hypothermia during Winter Storm Uri can go ahead with a lawsuit against the nursing home where she died, affirming a lower court's decision that the daughter's expert witnesses were qualified to weigh in on the case.

  • February 26, 2024

    Paul Hastings Adds FDA Practice Chair From King & Spalding

    Paul Hastings LLP announced Monday that a King & Spalding partner specializing in the U.S. Food and Drug Administration and life sciences has joined the firm as chair of its new FDA practice in Washington, D.C.

  • February 23, 2024

    State Farm Alleges Health Co. Violated Deal To Drop 366 Suits

    Two State Farm units are accusing an automobile accident-focused healthcare center of wrongly pursuing 366 lawsuits against the insurer despite a settlement agreement State Farm said requires the facility to drop those suits.

  • February 23, 2024

    Fla. Doctor Says T-Mobile Let Hacker Steal Her SIM Card

    A Tampa, Florida, doctor has sued T-Mobile for allegedly failing to stop a "SIM swap" hacker from transferring her personal phone account and then doing little to address the identity theft that followed, which involved the hacker trying to steal thousands from her retirement account and using her medical credentials to write more than 700 fraudulent prescriptions.

  • February 23, 2024

    Health REIT Hid Halted $375M Equity Stake Deal, Suit Says

    A Medical Properties Trust Inc. shareholder accused the hospital-focused real estate investment trust in Maryland federal court of hiding the California government's halting of a $375 million equity stake transaction with a healthcare management services company.

  • February 23, 2024

    Idaho Blasts 'Abortion Mandate' In High Court State Ban Fight

    The Idaho attorney general has accused the federal government of transforming an emergency medical care law into an "abortion mandate" in a U.S. Supreme Court case pitting the state's criminal ban against the Biden administration's efforts to maintain abortion access post-Dobbs.

  • February 23, 2024

    8th Circ. Says Nursing Home Fraudster Owes Supplier $7.6M

    A nursing home company whose owner pled guilty in January to employment tax fraud in a New Jersey federal case must shoulder a $5 million judgment plus interest and fees for bills it failed to pay a medical supply company, an Eighth Circuit panel affirmed Friday.

  • February 23, 2024

    J&J Unit Assails Knee Replacement IP Verdict At Fed. Circ.

    Johnson & Johnson subsidiary DePuy Synthes wants the Federal Circuit to undo a $20 million jury verdict against it for infringing an orthopedic surgeon's knee replacement patent.

  • February 23, 2024

    VA Nixes Trans Vets' Request For Gender-Affirming Surgery

    The Department of Veterans Affairs said Thursday that it had formally rejected an 8-year-old petition for rulemaking by the Transgender American Veterans Association that sought to add gender-affirming surgery as part of VA-covered medical services, urging the Federal Circuit to toss TAVA's mandamus petition as moot.

  • February 23, 2024

    Christian Clinic Says Trans Surgery Suit Bolsters Mich. Fears

    A Michigan clinic fighting to show it can challenge a state civil rights law it claims would force it to care for transgender patients told the Sixth Circuit that a suit targeting a Colorado children's hospital that stopped providing surgeries for transgender patients underscores how it could come under fire as well. 

  • February 23, 2024

    Holland & Knight Product Liability Ace Rejoins Reed Smith

    Reed Smith LLP has rehired a former partner who, in his first stint with the firm, spent a little over nine years representing pharmaceutical and medical device companies in product liability and other litigation, the firm announced Thursday.

  • February 22, 2024

    Wash. AG Seeks $1.2M In Damages For Debt Collector's Errors

    A debt collection company should pay more than $1.2 million after it "didn't even come close to complying with the law" while recovering medical debt payments for a hospital in Washington, the state attorney general's office told a judge during a bench trial Thursday.

  • February 22, 2024

    Justices Urged To Affirm Limits On Mifepristone Access

    The Alliance for Hippocratic Medicine filed a brief in its U.S. Supreme Court case over the abortion medication mifepristone on Thursday, saying the U.S. Food and Drug Administration unlawfully rolled back various safeguards for accessing the pill, such as an in-person doctor's visit requirement.

  • February 22, 2024

    5th Circ. Affirms Medicare Kickback Convictions

    The Fifth Circuit upheld two Texas group-home owners' convictions and sentences for their role in a Medicare kickback scheme, rejecting their argument that a trial court judge wrongly admitted audio recordings at trial and incorrectly calculated the scheme's returns.

  • February 22, 2024

    NYC Doc Charged Over $20M Lab-Fraud Kickback Scheme

    A federal grand jury in New Jersey has returned an indictment charging a medical doctor with receiving kickbacks in exchange for ordering medically unnecessary tests from lab companies that submitted roughly $20.7 million in false Medicare claims, the U.S. Department of Justice announced.

  • February 22, 2024

    DOJ Reports $2.7B False Claims Act Haul In 2023

    The U.S. Department of Justice on Thursday released its latest data on recoveries under the False Claims Act, saying there were nearly $2.7 billion in settlements and judgments in the 2023 fiscal year, an increase from the prior year's haul. 

  • February 22, 2024

    Mass. Medical Regulator Seeks Pregnancy Center Records

    A group of pregnancy crisis centers in Massachusetts and their medical director have been hit with a civil investigative demand by the state's medical board, which says it is looking into allegations the clinics "may be engaging in deceptive practices" and allowing unlicensed employees to perform ultrasounds and other procedures.

  • February 22, 2024

    Lawmakers Urge Biden To Nix March-In Plan Over Drug Prices

    Twenty-eight members of Congress have written a letter urging President Joe Biden to reconsider a National Institute of Standards proposal to use march-in rights under the Bayh-Dole Act to reduce prescription drug prices, arguing the draft guidance won't achieve lower drug costs and will "hamstring" U.S. innovation.

  • February 22, 2024

    Texas Pharmacists Paid Doctors Kickbacks, Prosecutors Say

    Dallas federal prosecutors have accused about a dozen doctors and pharmacists of a patient referral scheme, saying in an indictment entered Thursday that the pharmacists gave the doctors kickbacks in exchange for expensive prescriptions fillable at specific pharmacies.

Expert Analysis

  • 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.

  • Navigating ACA Reporting Nuances As Deadlines Loom

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    Stephanie Lowe at Liebert Cassidy walks employers through need-to-know elements of Affordable Care Act reporting, including two quickly approaching deadlines, the updated affordability threshold, strategies for choosing an affordability safe harbor, and common coding pitfalls.

  • Lessons From Rare Post-Verdict Healthcare Fraud Acquittal

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    A Maryland federal court recently overturned a jury verdict that found a doctor guilty of healthcare fraud related to billing levels for COVID-19 tests, providing defense attorneys with potential strategies for obtaining acquittals in similar prosecutions, says attorney Andrew Feldman.

  • ChristianaCare Settlement Reveals FCA Pitfalls For Hospitals

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    ChristianaCare's False Claims Act settlement in December is the first one based on a hospital allegedly providing private physicians with free services in the form of hospital-employed clinicians and provides important compliance lessons as the government ramps up scrutiny of compensation arrangements, say attorneys at Sheppard Mullin.

  • Patent Waiver For COVID Meds Would Harm US Biopharma

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    If the Biden administration backs the World Trade Organization in waiving patent rights on COVID-19 treatments, it would negatively affect the U.S. biopharmaceutical industry and help foreign competitors, without necessarily expanding global access to COVID-19 care, says clinical pathologist Wolfgang Klietmann.

  • New CMS Rule Will Change Nursing Facility Disclosures

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    A new rule from the Centers for Medicare & Medicaid Services significantly expands disclosure requirements for nursing facilities backed by private equity companies or real estate investment trusts, likely foreshadowing increased oversight that could include more targeted audits, say Janice Davis and Christopher Ronne at Morgan Lewis.

  • Skirting Anti-Kickback Causation Standard Amid Circuit Split

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    Amid the federal circuit court split over the causation standard applicable to False Claims Act cases involving Anti-Kickback Statute violations, which the First Circuit will soon consider in U.S. v. Regeneron, litigators aiming to circumvent the heightened standard should contemplate certain strategies, say Matthew Modafferi and Terence Park at Frier Levitt.

  • Gilead Ruling Signals That Innovating Can Lead To Liability

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    A California appeals court's ruling last month in Gilead Life Sciences v. Superior Court of San Francisco that a drug manufacturer can be held liable for delaying the introduction of an improved version of its medication raises concerns about the chilling effects that expansive product liability claims may have on innovation, says Gary Myers at the University of Missouri School of Law.

  • Health Policy Legislative Landscape May Remain Frozen

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    With Congress again delaying the full resolution of fiscal year 2024 federal spending legislation, there is now an additional window in which Congress could work through several priority issues for healthcare stakeholders, though these issues are unlikely to be resolved in time, say attorneys at Faegre Drinker.

  • Despite HHS Opinion, Gift Card Giveaways Require Caution

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    Though the U.S. Department of Health and Human Services' Office of Inspector General recently determined that a healthcare consulting firm's gift card plans do not violate the Anti-Kickback Statute, the opinion does not suggest blanket approval for providing gift cards in exchange for referrals, say Ragini Acharya and Matthew Deutsch at Husch Blackwell.

  • DOJ's Biopharma Settlement Raises Anti-Kickback Questions

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    In the aftermath of the U.S. Department of Justice's settlement with Ultragenyx over genetic testing programs, it may be prudent to reevaluate genetic tests through the lens of the Anti-Kickback Statute and reconsider whether it is proper for free testing programs to be treated like patient assistance programs, says Mary Kohler at Kohler Health Law.

  • Where Justices Stand On Chevron Doctrine Post-Argument

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    Following recent oral argument at the U.S. Supreme Court, at least four justices appear to be in favor of overturning the long-standing Chevron deference, and three justices seem ready to uphold it, which means the ultimate decision may rest on Chief Justice John Roberts' vote, say Wayne D'Angelo and Zachary Lee at Kelley Drye.

  • Bracing For Calif.'s New Health Transaction Framework

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    As California's new cost and market impact review regulations' April 1 date for its updated notice and review process approaches, healthcare entities should ready themselves for dramatic changes to the state's regulatory landscape and prepare for potentially substantial transaction delays, say Jordan Grushkin and Matthew Goldman at Sheppard Mullin.