Policy & Compliance

  • July 23, 2024

    Meet The Lead Ozempic Lawyers

    The recently deceased U.S. District Judge Gene E.K. Pratter this past spring appointed plaintiff leadership in litigation over Ozempic and similar drugs over allegations that the medications cause gastrointestinal issues. Here's who's who in the list of plaintiffs' leaders.

  • July 23, 2024

    Kickback Risk Remains For Gene Therapy Fertility Programs

    Federal health officials this week declined to relieve two companies of potential liability under the Anti-Kickback Statute concerning their fertility support programs for patients receiving gene therapies.

  • July 23, 2024

    Wash. AG Says 'Abortion Reversal' Clinic's Suit Still Deficient

    Washington state's attorney general said Monday an anti-abortion clinic group being investigated for marketing an "abortion reversal pill" cannot blame his two-year-old document demands for a recent insurance rate hike, pushing a Tacoma federal judge to reject the group's legal effort to shield itself from future consumer protection enforcement.

  • July 23, 2024

    Healthcare Dealmaking Trends Of 2024: A Midyear Review

    While each deal is unique, transactions don't occur in a vacuum. Here, Law360 Healthcare Authority reviews five trends that helped shape some of those deals and the wider healthcare industry so far this year.

  • July 23, 2024

    $680M Allergan FCA Suit Tossed After High Court Revival

    A Maryland federal judge on Tuesday again tossed a False Claims Act suit accusing an Allergan unit of overcharging Medicaid, previously revived by the U.S. Supreme Court, saying a whistleblower still hadn't shown any deliberate wrongdoing by the company.

  • July 23, 2024

    6th Circ. Vows Careful Immunity Take In Prof's Retaliation Suit

    The Sixth Circuit wrestled Tuesday with whether six University of Louisville officials were each rightly denied immunity from a former professor's suit alleging he was unconstitutionally pushed out because of his views on treating childhood gender dysphoria, with one judge promising meticulous assessments of each defendant.

  • July 23, 2024

    On Capitol Hill, PBM Execs Deny Role In High Drug Costs

    Executives from the nation's three largest pharmacy benefit managers told members of a U.S. House committee on Tuesday that they lower drug costs while pointing the finger at pharmaceutical manufacturers.

  • July 23, 2024

    Hospital Cites Rare Doctrine In Colo. Trans Care Clash

    A Colorado hospital accused of illegally refusing to provide gender-affirming surgery is turning to an unusual defense employed more often in foreign policy than healthcare litigation. While it's a rare effort to apply the "political question" doctrine to a healthcare dispute involving two private parties, it could influence other cases if employed successfully.

  • July 23, 2024

    PBMs Seek Safe Harbor Under Anti-Kickback Law

    Pharmacy benefit managers are trying to stay one step ahead of federal regulators and lawmakers, undertaking aggressive restructuring and relying on the protection of safe harbor provisions under the anti-kickback statute.

  • July 22, 2024

    AbbVie Challenges Mo. Drug Discount Program Requirements

    AbbVie Inc. on Monday asked a Missouri federal court to block a state law that adds requirements to participate in the federal drug discount program, claiming that the measure violates both the federal and Missouri constitutions.

  • July 22, 2024

    Groups Ask 3rd Circ. To Reverse Medicare Drug Price Rulings

    A conservative group was one of several organizations to file amicus curiae briefs with the Third Circuit on Friday urging it to reverse a lower court's finding that Medicare's ability to negotiate drug prices with pharmaceutical companies does not run contrary to the companies' constitutional rights.

  • July 22, 2024

    1st Circ. Hints At Higher Bar For Feds In Anti-Kickback Cases

    The First Circuit on Monday questioned the government's assertion that Congress intended to broaden the standard for liability in False Claims Act kickback cases when it passed a key amendment in 2010.

  • July 19, 2024

    House IP Committee Heads Unveil Drug Pricing Bill

    Reps. Darrell Issa, R-Calif., and Hank Johnson, D-Ga., respectively the chair and top Democrat of the House intellectual property subcommittee, on Friday introduced a new bill that would change patent law to increase competition in the prescription drug market in order to lower patient costs.

  • July 19, 2024

    Ex-Pharma Sales Exec Denies Fake Prescription Scheme

    The former vice president of sales for pharmaceutical company U.S. Compounding Inc. pled not guilty in Manhattan federal court Friday to forging fake horse drug prescriptions in order to juice revenues.

  • July 19, 2024

    Regeneron Rips DOJ's FCA Suit As 'Divorced From Reality'

    Regeneron Pharmaceuticals Inc. has told a Massachusetts federal judge that a False Claims Act suit brought by the U.S. Department of Justice claiming the company withheld information about a drug's average sales price was "divorced from reality" and the practice the government was complaining about was commonplace.

  • July 18, 2024

    DaVita To Pay $34M In Medicare Kickback Whistleblower Suit

    Dialysis company DaVita will pay more than $34 million to settle a Medicare fraud case over alleged kickbacks doctors received in exchange for patient referrals, after a whistleblower from the company's C-suite came forward, the U.S. Attorney's Office for the District of Colorado announced Thursday.

  • July 18, 2024

    6th Circ. Sees 'Fundamental' Shift Post-Chevron In Title X Row

    The toppling of Chevron deference set the tone for a Sixth Circuit hearing on Thursday as the court contemplated Tennessee's arguments that the U.S. Department of Health and Human Services went beyond its statutory power when it introduced new requirements for family planning funding.

  • July 18, 2024

    9th Circ. Revives Fired Doctor's COVID Vax Religious Bias Suit

    The Ninth Circuit revived a doctor's claims that Washington State University failed to accommodate his religious beliefs when it fired him from his residency for refusing the COVID-19 vaccine, ruling Thursday that U.S. Supreme Court precedent necessitates another look at his case.

  • July 18, 2024

    Feds Say Loper Bright Not Relevant In IVF Policy Suit

    The U.S. Department of Defense urged a New York federal court Thursday to throw out a nonprofit's lawsuit challenging its in vitro fertilization coverage policy for service members, countering the group's argument that the agency can't shake the suit because the U.S. Supreme Court upended Chevron deference.

  • July 18, 2024

    PharMerica Inks $100M Deal In 13-Year-Old Whistleblower Suit

    PharMerica Corp. has agreed to pay $100 million to settle a former New Jersey nursing home owner's long-running whistleblower litigation over an alleged drug kickback scheme, according to the plaintiff's law firm.

  • July 17, 2024

    Judge Warns HHS It's Not In 'Reasonable Compliance'

    The Department of Health and Human Services appears not to be in "reasonable compliance" of an injunction ordering it to develop an avenue for Medicare beneficiaries to appeal their hospitalization status, a Connecticut federal judge said in a Tuesday notice.

  • July 17, 2024

    U. Miami Climate Leader Sees Chance For Innovation

    With Miami often called the "ground zero" of the climate change crisis, the University of Miami in 2022 launched a Climate Resilience Academy to coordinate an interdisciplinary response. Nearly a year into his tenure, its leader reflects on the opportunity for midsize city innovation in infrastructure in the face of climate challenges.

  • July 17, 2024

    Burr & Forman Accused Of Aiding Health Insurance Fraud

    Burr & Forman LLP has been hit with a malpractice suit in Georgia federal court by the liquidating trustees of two purported health insurance companies after the firm allegedly aided in a scheme to defraud customers by charging exorbitant fees and denying promised coverage, saying the attorneys helped create a web of LLCs to which it siphoned off millions.

  • July 16, 2024

    No Let-Up On DOJ Medicare Advantage Fraud Probes

    Federal scrutiny of Medicare Advantage fraud is showing no signs of abating.

  • July 16, 2024

    Sanford-Marshfield Tie-Up Portends More Cross-Market Deals

    A merger between two Midwest health systems is evidence of hospitals' desire to strike deals with players in other markets, according to experts in the space, who say the trend may be influenced by a tough antitrust environment and larger industry shift to value-based care.

Expert Analysis

  • FDA's Multifaceted Role On Display In MDMA Therapy Scrutiny

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    Ongoing deliberations at the U.S. Food and Drug Administration regarding MDMA-assisted therapy for post-traumatic stress disorder serves as a window into the intricate balance of scientific innovation and patient safety oversight, and offers crucial insights into regulatory nuances, say Kimberly Chew at Husch Blackwell and Kevin Lanzo at Pharmaka Clinical Consulting.

  • Analyzing FDA Draft Guidance On Clinical Trial Diversity

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    In light of the U.S. Food and Drug Administration's draft guidance on clinical trial diversity action plans, there are several important considerations for sponsors and clinical researchers to keep in mind to prevent delay in a drug or device application, say attorneys at Crowell & Moring.

  • In The CFPB Playbook: Making Good On Bold Promises

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    The U.S. Supreme Court's decision upholding the Consumer Financial Protection Bureau's funding structure in the second quarter cleared the way for the bureau to resume a number of high-priority initiatives, and it appears poised to charge ahead in working toward its aggressive preelection agenda, say Andrew Arculin and Paula Vigo Marqués at Blank Rome.

  • Critical Questions Remain After High Court's Abortion Rulings

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    The U.S. Supreme Court's decisions in two major abortion-related cases this term largely preserve the status quo for now, but leave federal preemption, the Comstock Act and in vitro fertilization in limbo, say attorneys at Jenner & Block.

  • Navigating FDA Supply Rule Leeway For Small Dispensers

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    As the November compliance deadline for the U.S. Food and Drug Administration's new pharmaceutical distribution supply chain rules draws closer, small dispensers should understand the narrow flexibilities that are available, and the questions to consider before taking advantage of them, say attorneys at Faegre Drinker.

  • 1st Gender Care Ban Provides Context For High Court Case

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    The history of Arkansas' ban on gender-affirming medical care — the first such legislation in the U.S. — provides important insight into the far-reaching ramifications that the U.S. Supreme Court's decision in U.S. v. Skrmetti next term will have on transgender healthcare, says Tyler Saenz at Baker Donelson.

  • 6 Lessons From DOJ's 1st Controlled Drug Case In Telehealth

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    Following the U.S. Department of Justice’s first-ever criminal prosecution over telehealth-prescribed controlled substances in U.S. v. Ruthia He, healthcare providers should be mindful of the risks associated with restricting the physician-patient relationship when crafting new business models, says Jonathan Porter at Husch Blackwell.

  • After Chevron: Scale Tips Favor Away From HHS Agencies

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    The loss of Chevron deference may indirectly aid parties in challenging the U.S. Department of Health and Human Services' interpretations of regulations and could immediately influence several pending cases challenging HHS on technical questions and agency authority, say attorneys at Ropes & Gray.

  • After Chevron: FDA Regulations In The Crosshairs

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    The U.S. Supreme Court's overturning of the Chevron doctrine is likely to unleash an array of challenges against the U.S. Food and Drug Administration, focusing on areas of potential overreach such as the FDA's authority under the Federal Food, Drug and Cosmetic Act, say attorneys at Debevoise.

  • USPTO Disclaimer Rule Would Complicate Patent Prosecution

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    The U.S. Patent and Trademark Office's proposed changes to terminal disclaimer practice could lead to a patent owner being unable to enforce a valid patent simply because it is indirectly tied to a patent in which a single claim is found anticipated or obvious in view of the prior art, say attorneys at Sterne Kessler.

  • Navigating Scrutiny Of Friendly Professional Corps. In Calif.

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    In light of ongoing scrutiny and challenges to private equity participation in the California healthcare marketplace, particularly surrounding the use of the friendly professional corporation model, management services organizations should consider implementing four best practices, say attorneys at Holland & Knight.

  • Takeaways From New HHS Substance Use Disorder Info Rules

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    A new U.S. Department of Health and Human Services rule continues the agency's efforts to harmonize complex rules surrounding confidentiality provisions for substance use disorder patient records, though healthcare providers will need to remain mindful of different potentially applicable requirements and changes that their compliance structures may require, say attorneys at Ropes & Gray.

  • Calif. Banking Brief: All The Notable Legal Updates In Q2

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    The second quarter of 2024 in California, which saw efforts to expand consumer protection legislation and enforcement actions in areas of federal focus like medical debt and student loans, demonstrated that the state's role as a trendsetter in consumer financial protection will continue for the foreseeable future, say attorneys at Sheppard Mullin.