Policy & Compliance

  • June 18, 2024

    Healthcare Tensions Equal Business For Litigation Funders

    As rampant consolidation collides with inflation-squeezed margins in the American healthcare system, tensions between service providers and insurers are at the breaking point and increasingly boiling "over into litigation," providing opportunities for litigation funders, according to a new article by Burford Capital LLC.

  • June 18, 2024

    High Court Petition Asks Justices: What's A 'Willful' Kickback?

    Does a "willful" act under federal anti-kickback law require a defendant to know that the conduct violates the law? That's the question a whistleblower is asking the U.S. Supreme Court to answer in order to resolve what the petition calls a circuit split on a key question of federal fraud prosecutions.

  • June 18, 2024

    Adderall Indictment Shows DOJ Focus On Telehealth Drugs

    The arrest of two digital health executives accused of conspiring to illegally distribute Adderall online is a "shot across the bow" from federal prosecutors ramping up enforcement of telehealth fraud.

  • June 18, 2024

    Company, States Battle In Court Over At-Home Rape Kits

    A fight is brewing in federal and state courts between a company that purports to be the nation's only purveyor of self-administered sexual assault DNA collection kits and state attorneys general who believe it is misleading sexual assault victims.

  • June 18, 2024

    Prelogar's Mifepristone Win Is 'A Master Class,' Advocates Say

    U.S. Solicitor General Elizabeth Prelogar's recent victory for abortion advocates at the conservative-led U.S. Supreme Court won widespread praise from practitioners, particularly for her decision to focus on the procedural defects of the case seeking to limit access to mifepristone.

  • June 18, 2024

    Insurer Countersues In Penile Implant Coverage Dispute

    An insurer has no duty to defend or indemnify a urologist, his medical device company or his practice in a proposed class action over a penile enlargement implant and procedure, the company told a California federal court, saying the underlying suit doesn't seek bodily injury damages that would trigger coverage.

  • June 18, 2024

    Ex-Pharmacist Faces Rare Murder Trial In Meningitis Outbreak

    Twelve years after a deadly outbreak of fungal meningitis, an unusual legal question is set to be decided this fall: Was it murder?

  • June 18, 2024

    'Historic' Medicaid Disenrollment Sparks Suits Over Notice

    With millions of Americans losing healthcare coverage upon the expiration of COVID-era protections, two states are facing new legal challenges targeting allegedly flawed state notices.

  • June 17, 2024

    Teva, DOJ Signal Key Kickback Case May Fizzle At 1st Circ.

    A U.S. Department of Justice kickback case against Teva Pharmaceuticals — closely watched by False Claims Act lawyers because of its multibillion-dollar stakes and its link to a major circuit split — is poised for settlement, according to a new First Circuit filing ahead of eagerly awaited oral arguments.

  • June 17, 2024

    Teamsters Plan Says Health Network Has Monopoly In Conn.

    A Teamsters healthcare benefits plan and a Connecticut public transit provider have sued the healthcare network Hartford Healthcare Corp., accusing it of having a monopoly over healthcare in a half-dozen regions of the state.

  • June 17, 2024

    Pharmacy Groups Urge High Court To Hear Okla. PBM Case

    Pharmacy industry groups asked the U.S. Supreme Court to reverse a Tenth Circuit decision that overturned portions of an Oklahoma law regulating pharmacy benefit managers, saying these intermediaries have driven up costs for patients while raising their own bottom lines, and states should be allowed to keep them in check.

  • June 17, 2024

    Attys Accused Of Judge Shopping Must Turn Over Q&A Doc

    Attorneys accused of a coordinated effort to "judge shop" amid federal suits challenging an Alabama law banning certain medical procedures for transgender youth must supply a document the court believes displays the attorneys' preparations for a panel hearing in which one of the attorneys allegedly committed perjury.

  • June 14, 2024

    Janssen Hit With $150M Verdict In HIV Drug False Claims Suit

    A New Jersey federal jury hit Janssen with a $150 million False Claims Act verdict in a 12-year-old whistleblower suit, finding that the drugmaker violated the federal law as well as 27 related state FCA statutes by illegally profiting from the off-label marketing of two popular Janssen HIV medications.

  • June 14, 2024

    3rd Circ. Merges 3 Challenges To Medicare Drug Price Talks

    The Third Circuit will hear three separate appeals challenging Medicare's drug price negotiations together, according to a new order consolidating cases brought by AstraZeneca, Bristol-Myers Squibb and Janssen Pharmaceuticals in New Jersey and Delaware federal courts.

  • June 13, 2024

    Justices Hand Abortion Advocates An Incomplete Win

    The U.S. Supreme Court's rejection Thursday of a challenge to the abortion drug mifepristone will do little to safeguard long-term access to the medication while suggesting that it will be up to voters, not judges, to settle some of the nation's abortion debates, attorneys say.

  • June 13, 2024

    Thomas Targets Group Standing In Mifepristone Ruling

    U.S. Supreme Court Justice Clarence Thomas joined his colleagues Thursday to unanimously uphold broad access to the abortion medication mifepristone for now, but he wrote separately to challenge a standing rule that often serves as the key to the courthouse doors for litigants of all varieties.

  • June 13, 2024

    Feds Get $4.6M In Deal Over Telehealth Billing Fraud Probe

    A multi-state network of behavioral health companies and their CEO have agreed to pay nearly $4.6 million to settle allegations that they submitted fraudulent claims for payment to Medicare and Connecticut's Medicaid program for telehealth services for nursing home residents, federal investigators said Thursday.

  • June 13, 2024

    Teva Wins Pause Of Order Ousting Patents From Orange Book

    A New Jersey federal judge ordered on Thursday a 30-day stay of his Monday ruling that a handful of patents covering Teva-brand asthma inhalers were improperly listed in the federal Orange Book, saying he wanted the matter to reach the Federal Circuit in the most orderly way possible.

  • June 13, 2024

    CVS Dodges Discovery Audit In Generic Drug Collusion Suit

    A federal judge declined to make CVS hire a forensic auditor to evaluate its compliance with information demands in a lawsuit alleging it colluded with drugmakers to keep Medicare beneficiaries from accessing certain generic drugs, despite a whistleblower bemoaning "woefully deficient" discovery on the pharmacy chain's part.

  • June 13, 2024

    Health Co. Execs Charged In $100M Adderall Sales Scheme

    Two California digital healthcare company executives were charged in a first-of-its-kind case Thursday with scheming to sell Adderall through deceptive advertising, allegedly bringing in $100 million in illicit profits.

  • June 13, 2024

    EU Makes First Ever Formal Pharma Price-Fixing Complaint

    European Union antitrust authorities issued their first ever price-fixing complaint in the pharmaceutical industry Thursday, going after the only company that did not agree to a €13.4 million ($14.4 million) settlement in October.

  • June 13, 2024

    Abortion Medication Case Ends 'With A Whimper' At High Court

    A case that threatened to cut off access to a widely used abortion medication while disrupting the U.S. Food and Drug Administration's authority over drugs and medical devices ended Thursday at the U.S. Supreme Court with a decision concerned solely with challengers' right to sue.

  • June 12, 2024

    32 AGs Urge Justices Take Up Okla. PBM Law Fight

    Thirty-two attorneys general urged the U.S. Supreme Court to take up Oklahoma's petition for review of a Tenth Circuit decision holding that federal law preempted portions of a state law regulating pharmacy benefit managers, arguing the justices needed to intervene to resolve a circuit split.

  • June 12, 2024

    Sen. Dems Seek Criminal Penalties For PE Hospital 'Looters'

    A pair of Democratic senators are targeting private equity's role in the healthcare industry, introducing new legislation Tuesday that would give federal and state enforcers new tools to go after firms they say are "looting" hospital systems and other providers, including possibly jailing executives if patient deaths result.

  • June 11, 2024

    6th Circ. Judge Doubts Clinic's Standing To Block Bias Law

    During Sixth Circuit arguments Tuesday probing whether a Christian medical clinic can block Michigan from targeting it for refusing to facilitate gender transitions, one judge searched for evidence that the clinic is actually at risk of being prosecuted under the state's civil rights law.

Expert Analysis

  • 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.

  • 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.