Policy & Compliance

  • April 18, 2024

    Clinic Head Gets 9 Years For Medicare Kickback, Tax Scheme

    A health clinic manager was sentenced to nine years in prison and ordered to pay $40 million in restitution to the government for participating in a multimillion-dollar healthcare kickback scheme that involved tax fraud, according to documents in a New York federal court.

  • April 18, 2024

    Endo Pleads Guilty To Marketing Opioids As 'Crush Proof'

    Endo Health Solutions Inc. pled guilty Thursday in Michigan federal court to putting out a drug it falsely advertised as being "crush proof" and "abuse deterrent," part of its larger agreement with the government to resolve nearly $2 billion in civil and criminal claims against the company.

  • 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.

Expert Analysis

  • Compliance Takeaways From HHS Information Blocking Rule

    Author Photo

    A recently finalized rule from the U.S. Department of Health and Human Services' Office of Inspector General demonstrates a renewed focus on investigating practices that may interfere with patients' access to their electronic health information, and should encourage renewed compliance efforts across a range of processes, say attorneys at Ropes & Gray.

  • Immigration Program Pitfalls Exacerbate Physician Shortages

    Author Photo

    Eliminating shortcomings from U.S. immigration regulations and policies could help mitigate the national shortage of physicians by encouraging foreign physicians to work in medically underserved areas, but progress has been halted by partisan gridlock, say Alison Hitz and Dana Schwarz at Clark Hill.

  • Mallory Gives Plaintiffs A Better Shot At Justice

    Author Photo

    Critics of the U.S. Supreme Court's recent decision in Mallory v. Norfolk Southern claim it opens the door to litigation tourism, but the ruling simply gives plaintiffs more options — enabling them to seek justice against major corporations in the best possible court, say Rayna Kessler and Ethan Seidenberg at Robins Kaplan.

  • Why Justices' SuperValu Ruling Wasn't Quite A 'Seismic Shift'

    Author Photo

    Notwithstanding an early victory lap by the relators' bar, the U.S. Supreme Court’s decision in U.S. v. SuperValu Inc. was a win for both whistleblowers and sophisticated companies, but unfortunately left “subjective belief” to be interpreted by lower courts and future litigants, say attorneys at Baker Donelson.

  • A Glimpse Into HHS' Digital App Enforcement Priorities

    Author Photo

    A recent opinion from the U.S. Department of Health and Human Services' Office of Inspector General sheds helpful light on the evolving intersection between health care regulation and digital apps, revealing some of the agency's key priorities and concerns in overseeing how federal program patients choose providers, says Mary Kohler at Kohler Health Law.

  • Courts Can Overturn Deficient State Regulations, Too

    Author Photo

    While suits challenging federal regulations have become commonplace, such cases against state agencies are virtually nonexistent, but many states have provisions that allow litigants to bring suit for regulations with inadequate cost-benefit analyses, says Reeve Bull at the Virginia Office of Regulatory Management.

  • Tales From The Trenches Of Remote Depositions

    Author Photo

    As practitioners continue to conduct depositions remotely in the post-pandemic world, these virtual environments are rife with opportunities for improper behavior such as witness coaching, scripted testimony and a general lack of civility — but there are methods to prevent and combat these behaviors, say Jennifer Gibbs and Bennett Moss at Zelle.

  • The Double-Edged Sword Of Using ChatGPT In Health Care

    Author Photo

    While ChatGPT has shown promising potential in health care, one of the key challenges for players in this space is balancing patient privacy and data protection with the benefits of utilizing this technology, say attorneys at Sheppard Mullin.

  • Level Up Lawyers' Business Development With Gamification

    Author Photo

    With employee engagement at a 10-year low in the U.S., there are several gamification techniques marketing and business development teams at law firms can use to make generating new clients and matters more appealing to lawyers, says Heather McCullough at Society 54.

  • Addressing Legal Issues Raised By AI Use In Health Care

    Excerpt from Practical Guidance
    Author Photo

    With the usage of artificial intelligence and machine learning in health care likely to be governed by a patchwork of state laws for the near future, industry actors should build flexibility into products to meet evolving regulatory concerns, including monetization of patient data and professional licensing questions, say Sara Shanti and Phil Kim at Sheppard Mullin.

  • Mallory Ruling Leaves Personal Jurisdiction Deeply Unsettled

    Author Photo

    In Mallory v. Norfolk Southern Railway, a closely divided U.S. Supreme Court recently rolled back key aspects of its 2017 opinion in Daimler AG v. Bauman that limited personal jurisdiction, leaving as many questions for businesses as it answers, say John Cerreta and James Rotondo at Day Pitney.

  • Recent Provider Relief Fund Audits Are Just The Beginning

    Author Photo

    Though the Health Resources and Services Administration's initial audits of the Provider Relief Fund program appear to be limited in scope, fund recipients should prepare for additional oversight, scrutiny and disallowances as the HRSA ramps up its efforts, say Brian Lee and Christopher Frisina at Alston & Bird.

  • 5 Ways Firms Can Rethink Office Design In A Hybrid World

    Author Photo

    As workplaces across the country adapt to flexible work, law firms must prioritize individuality, amenities and technology in office design, says Kristin Cerutti at Nelson Worldwide.