Policy & Compliance

  • July 25, 2024

    Mich. Jury Awards $8.5M For Missed Cancer Diagnosis

    A Michigan federal jury awarded more than $8.5 million in damages Wednesday to a man who died of kidney cancer, finding that a doctor at a cancer clinic missed an opportunity to diagnose the cancer before it spread to his brain.

  • July 25, 2024

    'AntiVaxMomma' Gets Jail Time, Despite Duress Claim

    A Manhattan judge sentenced a woman to at least 1½ years in jail Thursday for selling fake COVID-19 immunization credentials under the Instagram handle "AntiVaxMomma," rejecting the defendant's claim that she didn't have enough time to weigh a plea offer before admitting her guilt.

  • July 24, 2024

    Native Hawaiian Midwives Gain Relief From Licensing Law

    A Hawaii judge blocked parts of a state law regulating midwives Tuesday, ruling it violates the constitutional rights of Native Hawaiians by denying them a reasonable pathway to securing approval for traditional prenatal care.

  • July 24, 2024

    DC Circ. Nixes Medicare Hospital Inpatient Payment Rule

    The D.C. Circuit has vacated a U.S. Department of Health and Human Services rule that inflated Medicare reimbursements for inpatient care at low-wage hospitals, saying the agency made an "unprecedented, expensive, broad, and possibly never-ending" change to a policy articulated by Congress.

  • July 24, 2024

    GOP States Still Can't Intervene In Wash. Abortion Pill Suit

    The Ninth Circuit rejected a bid by Idaho and other Republican-led states to intervene in Washington's lawsuit seeking to expand access to the abortion pill mifepristone, ruling Wednesday the states lacked standing and only speculated about how they were injured.

  • 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

    Dead Or Not Quite: Hospitals Weigh Shared Definition Of DOA

    What does it mean to be dead on arrival? Standardizing the definition is vital to the nation's hospital emergency departments, which are partly evaluated on patient mortality rates. In New York, the push to define DOA ignited a debate touching on how hospitals are reimbursed, risk-adjusted mortality figures, and the use of emergency procedures intended to save patients without a pulse.

  • 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.

Expert Analysis

  • Steps Toward A Unified Health Financing System For Calif.

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    A new law authorizes the secretary of the California Health and Human Services Agency to move forward with designing a unified healthcare financing system, though the notable absence of healthcare payers in the law's list of specified stakeholders raises questions about the state's position regarding private payer options, says Ima Nsien at Squire Patton.

  • Writing Thriller Novels Makes Me A Better Lawyer

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    Authoring several thriller novels has enriched my work by providing a fresh perspective on my privacy practice, expanding my knowledge, and keeping me alert to the next wave of issues in an increasingly complex space — a reminder to all lawyers that extracurricular activities can help sharpen professional instincts, says Reece Hirsch at Morgan Lewis.

  • What Lawyers Must Know About Calif. State Bar's AI Guidance

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    Initial recommendations from the State Bar of California regarding use of generative artificial intelligence by lawyers have the potential to become a useful set of guidelines in the industry, covering confidentiality, supervision and training, communications, discrimination and more, say attorneys at Debevoise.

  • Industry Must Elevate Native American Women Attys' Stories

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    The American Bar Association's recent research study into Native American women attorneys' experiences in the legal industry reveals the glacial pace of progress, and should inform efforts to amplify Native voices in the field, says Mary Smith, president of the ABA.

  • White House Activity Is A Band-Aid For Regulating AI In Health

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    In the medium term, recent White House actions will have a greater impact on AI in the health care industry than Congress' sluggish efforts to regulate it, but ultimately legislation of AI's development and use in the health space will fall to Congress, say Wendell Bartnick and Vanessa Perumal at Reed Smith.

  • Understanding Discovery Obligations In Era Of Generative AI

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    Attorneys and businesses must adapt to the unique discovery challenges presented by generative artificial intelligence, such as chatbot content and prompts, while upholding the principles of fairness, transparency and compliance with legal obligations in federal civil litigation, say attorneys at King & Spalding.

  • How Mental Health Ruling Paves Road For Equal Coverage

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    The Tenth Circuit’s recent ruling in E.W. v. Health Net, which clarified the pleading requirements necessary to establish a Mental Health Parity and Addiction Equity Act violation, is a win for plaintiffs as it opens the door to those who have been denied coverage for behavioral health treatment to prove a mental health parity violation, says Mark DeBofsky at DeBofsky Law.

  • ESG Around The World: Mexico

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    ESG has yet to become part of the DNA of the Mexican business model, but huge strides are being made in that direction, as more stakeholders demand that companies adopt, at the least, a modicum of sustainability commitments and demonstrate how they will meet them, says Carlos Escoto at Galicia Abogados.

  • The Case For Post-Bar Clerk Training Programs At Law Firms

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    In today's competitive legal hiring market, an intentionally designed training program for law school graduates awaiting bar admission can be an effective way of creating a pipeline of qualified candidates, says Brent Daub at Gilson Daub.

  • 10 Takeaways From New HHS Federal Compliance Guidelines

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    The U.S. Department of Health and Human Services' recently issued general compliance program guidance is the first of its kind that would apply across all health care stakeholders, and signals the agency’s first step to improve and update existing compliance guidance, says Melissa Wong at Holland & Knight.

  • 2 HHS Warnings Highlight Anti-Kickback Risks For Physicians

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    Two recent advisory opinions issued by the U.S. Department of Health and Human Services' Office of Inspector General involve different scenarios and rationales, but together they illustrate the OIG's focus on and disapproval of contractual joint ventures and other revenue-maximizing physician arrangements, say Robert Threlkeld and Elliott Coward at Morris Manning.

  • Attorneys Have An Ethical Duty To Protect The Judiciary

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    The tenor of public disagreement and debate has become increasingly hostile against judges, and though the legislative branch is trying to ameliorate this safety gap, lawyers have a moral imperative and professional requirement to stand with judges in defusing attacks against them and their rulings, says Deborah Winokur at Cozen O'Connor.

  • Cross-Market Implications In FTC's Anesthesia Complaint

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    The Federal Trade Commission's recent complaint against a private equity firm's acquisition of anesthesiology practices highlights the controversial issue of cross-market harm in health care provider mergers, and could provide important insights into how a court may view such theories of harm, say Christopher Lau and Dina Older Aguilar at Cornerstone Research.