Policy & Compliance

  • April 18, 2024

    Would-Be Whistleblowers Drop ER Service Overbilling Claims

    A North Carolina federal judge has granted two whistleblowers' request to drop their suit accusing a pair of healthcare companies and their affiliates of overcharging both state and federal Medicare and Medicaid programs for emergency services provided at multiple regional hospitals, dismissing the case without prejudice.

  • April 18, 2024

    FDA Head Gets GOP Rep.'s Rebuke Over Pot Rescheduling

    The Republican chair of a U.S. House of Representatives Appropriations subcommittee on Thursday chided the commissioner of the U.S. Food and Drug Administration for the agency's recommendation last year to loosen restrictions on marijuana.

  • April 17, 2024

    Lab Whistleblower Drops COVID Test Suit After Feds Pass

    An ex-lab director has dropped his False Claims Act lawsuit alleging he was ousted from a diagnostic testing firm for raising concerns about regulatory violations and improper billing of federal health care programs, closing his Washington federal court case just days after the government declined to intervene.

  • April 17, 2024

    FDA's Foot-Dragging On Menthol Ban Sparks Frustration

    The U.S. Food and Drug Administration's yearslong delay to ban menthol has left public health groups frustrated over why the agency has failed to act on what the groups see as an obvious way to improve public health and prevent needless deaths, prompting a second lawsuit over taking menthol off store shelves.

  • April 17, 2024

    'Ringleader' Of Black Market HIV Drug Scam Gets 9 Years

    A New York federal judge on Wednesday sentenced a pharmacy operator to nine years in prison for spearheading a $13 million scheme to sell black market HIV medication and collect fraudulent reimbursements from Medicaid and Medicare.

  • April 16, 2024

    Eli Lilly's Insulin Price Cap Deal Collapses After Cert. Denial

    Eli Lilly & Co. and insulin buyers have called off a proposed nationwide settlement that would've capped insulin prices and been worth up to $500 million over several years, a decision that was made after the buyers lost a class certification bid early this year, according to the buyers' counsel.

  • April 16, 2024

    Healthcare Industry Sees Spate Of New Data Sharing Suits

    A $7 million-plus settlement between a federal regulator and a mental healthcare provider accused of improperly sharing patient data highlights the ubiquitous ties between health systems and tech giants like Facebook — and the growing legal and regulatory scrutiny over those relationships.

  • April 16, 2024

    Ohio Bans On Transgender Care, Youth Sports Halted By Judge

    An Ohio state court on Tuesday blocked a law that bans gender-affirming healthcare for children and prohibits transgender girls from competing in girls' school sports, issuing a temporary restraining order more than a week before the statute was to go into effect.

  • April 16, 2024

    NY High Court Zeroes In On Abortion Coverage Exemptions

    New York's highest court grappled Tuesday with whether a state regulation's exemption process shielding religious groups from a requirement that employee health plans cover abortions conflicted with a 2021 U.S. Supreme Court decision, with multiple judges questioning the constitutionality of the carveout procedure.

  • April 16, 2024

    Ex-NBA Guard Gets 18 Months In Healthcare Scheme

    A former Detroit Pistons point guard was sentenced to 18 months in prison Tuesday after being convicted of one of two counts over an alleged scheme to defraud the NBA's healthcare plan, with a Manhattan federal judge saying his proceeds were "not chump change" and faulting his behavior on pretrial release.

  • April 16, 2024

    As Hospitals Hire Outside Help, Who's Liable If Patients Sue?

    A medical malpractice case that’s triggered repeated disagreement in Michigan courts underscores the complexity of hospital "agent" liability amid increasing healthcare industry reliance on contractor nurses and doctors.

  • April 16, 2024

    Knotty Preemption Inquiry Awaits High Court In Abortion Case

    The U.S. Supreme Court next week will hear a dispute over an Idaho abortion ban and a federal emergency care law. The case promises to challenge the court to decide whether the two vastly different statutes actually conflict.

  • April 16, 2024

    Va. Hospital System Beats COVID Vaccine Bias Suit

    A Virginia healthcare system defeated a suit claiming it unlawfully refused to excuse two Christian employees from its COVID-19 vaccination requirement, with a federal judge finding they could have taken a version of the vaccine that didn't conflict with their religious beliefs.

  • April 16, 2024

    Ex-FDA Chief On Election Year Healthcare Policy

    Former FDA chief counsel Stacy Cline Amin of Morrison Foerster LLP talks to Law360 about march-in rights, the Inflation Reduction Act and healthcare policy issues in a presidential election year.

  • April 15, 2024

    Justices Face Off Over Shadow Docket Procedures

    The U.S. Supreme Court's internal disagreements over how to manage its emergency docket were on full display Monday in its decision allowing Idaho to enforce a ban on gender-affirming care for minors — a case the court's liberals said wasn't worthy of their intervention, but its conservatives touted as a win in the fight against universal injunctions.

  • April 15, 2024

    Mental Health Co. Cerebral To Pay $7M Over Data Failures

    Mental health service provider Cerebral Inc. will pay more than $7 million to settle claims from the Federal Trade Commission, saying it failed to protect users' sensitive health data and made it difficult for patients to cancel services and stop recurring charges, according to a Monday court filing.

  • April 15, 2024

    Justices Allow Idaho To Enforce Gender Care Ban, Sans Plaintiffs

    The U.S. Supreme Court allowed the state of Idaho on Monday to begin enforcing its ban on gender-affirming care for minors, reshaping a preliminary injunction the majority said was far too broad to keep in place as the litigation plays out, perhaps for years.

  • April 15, 2024

    Feds Seek Prison For Group That Invaded Abortion Clinic

    Prosecutors are seeking prison sentences for six anti-abortion activists convicted of storming a Washington, D.C., abortion clinic, including a six-year term for the alleged "criminal mastermind" behind this and other blockades.

  • April 12, 2024

    Ex-Biotech CEO Gets 7 Years In Fake COVID Test Case

    A former biotech CEO accused of defrauding investors by touting a phony rapid finger-prick COVID test was sentenced to seven years in prison in D.C. federal court Friday.

  • April 12, 2024

    NY Health Network To Pay $1M For Deceptive COVID Test Bills

    Long Island, New York-based hospital network Northwell Health will pay $1 million over allegations that it fraudulently billed patients for a hospital visit after they came for what they thought was a free COVID-19 test, the state's attorney general said Friday.

  • April 12, 2024

    Trade Groups Urge Senators To Advance Patent Reform Bills

    Groups representing inventors, startups and medical technology companies are putting pressure on U.S. senators to pass bills that would prospectively limit the ability of courts to throw out patent lawsuits, a month after tech industry groups argued the legislation would trigger an onslaught of patent litigation.

  • April 11, 2024

    Sandoz Says Feds Misclassified Generics As 'Innovator Drugs'

    Pharmaceutical company Sandoz Inc. sued the Centers for Medicare & Medicaid Services in Washington, D.C., federal court on Wednesday, alleging the agency ignored the company's objection to classifying two of its generics as "innovator drugs," which could impact Sandoz's rebate obligations under Medicaid.

  • April 11, 2024

    UnitedHealth Patients' Addiction Coverage Suit Revived, Again

    The Ninth Circuit on Thursday revived for the second time a proposed class action accusing UnitedHealth of wrongly rejecting coverage for outpatient substance use disorder treatments in violation of federal benefits law, finding the plaintiff plausibly alleged the insurer employed an excessively strict review process for those claims.

  • April 11, 2024

    Full 8th Circ. Hears Ark. Bid To Revive Youth Trans Care Ban

    An en banc panel of the Eighth Circuit weighing whether to revive an Arkansas state law that banned gender-affirming care for children and teens heard oral arguments Thursday, as Arkansas officials sought to demonstrate that the law does not unconstitutionally discriminate based on sex.

  • April 11, 2024

    Medtronic Can't Ditch Ex-Sales Rep's Retaliation Claim

    Medical device maker Medtronic can't avoid a whistleblower retaliation claim by a former sales rep who says he was pushed out after reporting what he suspected to be a kickback scheme to the U.S. Food and Drug Administration, a federal judge said Wednesday.

Expert Analysis

  • What The Law Firm Of The Future Will Look Like

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    As the legal landscape shifts, it’s become increasingly clear that the BigLaw business model must adapt in four key ways to remain viable, from fostering workplace flexibility to embracing technology, say Kevin Henderson and Eric Pacifici at SMB Law Group.

  • 4 PR Pointers When Your Case Is In The News

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    Media coverage of new lawsuits exploded last year, demonstrating why defense attorneys should devise a public relations plan that complements their legal strategy, incorporating several objectives to balance ethical obligations and advocacy, say Nathan Burchfiel at Pinkston and Ryan June at Castañeda + Heidelman.

  • Digging Into The Debate On FDA's Proposed Lab Test Rule

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    A proposed 10-word amendment from the U.S. Food and Drug Administration represents a sea change in device regulation as it would summarily end decades of FDA enforcement discretion for laboratory developed tests, and the public comments offer some insight into the future of this long-running saga, say attorneys at Mintz.

  • Law Firm Strategies For Successfully Navigating 2024 Trends

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    Though law firms face the dual challenge of external and internal pressures as they enter 2024, firms willing to pivot will be able to stand out by adapting to stakeholder needs and reimagining their infrastructure, says Shireen Hilal at Maior Consultants.

  • AI In Health Law: The Top Guest Articles Of 2023

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    As the use of artificial intelligence accelerated this year, Expert Analysis writers examined AI's significant impact on the healthcare sector, ranging from key compliance considerations for companies utilizing AI tools to regulators' efforts to keep up with rapidly evolving technologies.

  • The Most-Read Legal Industry Law360 Guest Articles Of 2023

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    A range of legal industry topics drew readers' attention in Law360's Expert Analysis section this year, from associate retention strategies to ethical billing practices.

  • Inside Higher Education's New FCA Liability Challenges

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    As the educational sector expands its use of government funding, schools are at increased risk under the False Claims Act, but recent settlements offer valuable lessons about new theories of liability they may face and specific procedures to reduce their exposure, say James Zelenay and Jeremy Ochsenbein at Gibson Dunn.

  • AI Executive Order's Life Science, Healthcare Industry Effects

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    The recent White House executive order to manage risks associated with artificial intelligence includes provisions specific to healthcare and life sciences that merit special attention, including transparency, human oversight of AI output, and real world performance monitoring, say attorneys at Ropes & Gray.

  • HHS Advisory Highlights Free Product Inducement Risks

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    A recent U.S. Department of Health and Human Services advisory opinion highlights concerns that valuable free products and other inducements may influence patients and providers to choose one manufacturer’s product over another, notwithstanding that such free healthcare products may be a benefit, say attorneys at Morgan Lewis.

  • Attorneys' Busiest Times Can Be Business Opportunities

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    Attorneys who resolve to grow their revenue and client base in 2024 should be careful not to abandon their goals when they get too busy with client work, because these periods of zero bandwidth can actually be a catalyst for future growth, says Amy Drysdale at Alchemy Consulting.

  • In The World Of Legal Ethics, 10 Trends To Note From 2023

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    Lucian Pera at Adams and Reese and Trisha Rich at Holland & Knight identify the top legal ethics trends from 2023 — including issues related to hot documents, artificial intelligence and cybersecurity — that lawyers should be aware of to put their best foot forward.

  • How Attorneys Can Be More Efficient This Holiday Season

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    Attorneys should consider a few key tips to speed up their work during the holidays so they can join the festivities — from streamlining the document review process to creating similar folder structures, says Bennett Rawicki at Hilgers Graben.

  • Top 10 Whistleblowing And Retaliation Events Of 2023

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    The U.S. Securities and Exchange Commission and federal and state courts made 2023 another groundbreaking year for whistleblower litigation and retaliation developments, including the SEC’s massive whistleblower awards, which are likely to continue into 2024 and further incentivize individuals to submit tips, say attorneys at Proskauer.