Policy & Compliance

  • November 15, 2024

    Eli Lilly Says HHS Ignores Drug Discount Double-Dipping

    Eli Lilly & Co. claims the U.S. Department of Health and Human Services is unlawfully blocking its efforts to crack down on hospitals the company alleges are double-dipping on medication discounts that are meant to benefit low-income patients, according to a lawsuit filed in D.C. federal court.

  • November 15, 2024

    HHS Likely To Limit Migrant Data After Flores Deal Ends

    A California federal judge indicated Friday that she can't force the U.S. Department of Health and Human Services to provide human rights groups with regular data about children in low-security detention facilities now that the long-running Flores settlement has been replaced with a government regulation.

  • November 15, 2024

    PBMs Denied Breakup Of Combined FTC Insulin Price Trial

    The Federal Trade Commission's allegations that pharmacy benefit manager giants Caremark Rx, Express Scripts and OptumRx are artificially inflating insulin prices through unfair rebate schemes will forge ahead as a single case following an in-house agency judge's refusal to break them into separate proceedings.

  • November 15, 2024

    Despite Vaccine Spotlight, RFK Jr. A Health Policy 'Unknown'

    Robert F. Kennedy Jr., President-elect Donald Trump's pick to be the nation's top health official, has made clear his unorthodox and often false views on public health issues like vaccines. But there's still plenty of policy under his potential control where his stance remains opaque, attorneys say, which could stymie their efforts to prepare for the next four years.

  • November 15, 2024

    Telehealth Cos. Misclassified Managers, Ex-Worker Says

    Two telehealth companies misclassified account managers and client relations directors as overtime-exempt despite their job duties not qualifying for any of the exemptions under the Fair Labor Standards Act, a proposed collective action filed in Florida federal court said.

  • November 15, 2024

    Teva Defends Mifepristone Antitrust Case Against Corcept

    Teva Pharmaceuticals has asked a California federal judge to reject a bid to dismiss its lawsuit against the maker of a brand-name drug used to treat a rare cortisol disorder, contending its complaint plausibly alleges an illegal scheme to suppress generic competition.

  • November 15, 2024

    Attys Get 'Final Warning' In Tepezza Hearing Loss MDL

    A magistrate judge has chastised attorneys on both sides of multidistrict litigation involving claims that a thyroid eye disease treatment manufactured by Horizon Pharmaceuticals Inc. causes hearing loss, calling for an end to their "improper" conduct during depositions.

  • November 15, 2024

    Orrick Trial Partner Joins Morgan Lewis In Boston

    Morgan Lewis & Bockius LLP announced that an experienced litigator from Orrick Herrington & Sutcliffe LLP joined the firm's Boston office as a partner, enhancing its capacity in areas such as life sciences and regulatory compliance.

  • November 15, 2024

    Pharma Biz To Pay $47M To Settle Feds' Kickback Claims

    A Florida pharmaceutical company and its chief executive have agreed to pay $47 million to settle claims that their practice of paying for certain patient tests crossed the line into being an illegal kickback to increase prescriptions of an enzyme replacement therapy, Boston federal prosecutors said on Friday.

  • November 15, 2024

    Hospital Workers' 2nd Circ. Appeal May Wait For Deloitte Case

    Workers for Montefiore Medical Center seeking to revive retirement plan mismanagement allegations may see a delayed ruling in their case until another Second Circuit panel rules on similar claims against Deloitte, a panel judge said Friday during proceedings.

  • November 14, 2024

    Ex-Ga. Rep. Doug Collins To Head Trump's Veterans Affairs

    President-elect Donald Trump announced Thursday that his administration's U.S. Department of Veterans Affairs will be led by former Rep. Doug Collins, a Republican from Georgia and an attorney who steered Trump's defense during his impeachment by the House.

  • November 14, 2024

    NY Nursing Homes Ink $45M Deal To End AG's Fraud Suit

    Four New York nursing homes have agreed to a $45 million deal that will end a civil lawsuit brought by the state accusing them of neglecting residents and defrauding Medicare and Medicaid, according to a Friday announcement by New York Attorney General Letitia James.

  • November 14, 2024

    Trump Picks RFK Jr. To Lead Health & Human Services

    President-elect Donald Trump announced Thursday that Robert F. Kennedy Jr., a prominent anti-vaccination activist and former presidential candidate, is his nominee to lead the U.S. Department of Health and Human Services.

  • November 13, 2024

    7th Circ. Won't Halt Ind. Gender-Affirming Care For Minors Ban

    A split Seventh Circuit reversed a lower court's preliminary injunction order Tuesday that stopped an Indiana law prohibiting its physicians from providing gender-affirming care through medication to minors, finding the plaintiff's view on the law would result in allowing parents to decline to take a seriously injured child to the hospital.

  • November 13, 2024

    TikTok Asks To Keep NC AG's Addiction Complaint Redacted

    TikTok Inc. is asking a North Carolina state court to keep redacted portions of a complaint by the state alleging that it targets youth to make them compulsive and addicted users, saying parts of the complaint include information from confidential documents and trade secrets.

  • November 13, 2024

    Outgoing DOJ Antitrust Head Wants To Unstack Healthcare

    The U.S. Department of Justice's top antitrust official looked to the future Tuesday, of both healthcare and his own exit with the change in presidential administration, as he defended the Biden era's more aggressive, nuanced approach to merger enforcement that wouldn't allow massive insurers and others to stack up the industry like Tetris.

  • November 13, 2024

    Biotech Brass Misled Investors About Cancer Drugs, Suit Says

    Executives and directors of biotechnology company Agenus Inc. have been hit with a shareholder derivative suit in Massachusetts federal court alleging that the company misled investors about the effectiveness of its mainstay cancer treatments.

  • November 13, 2024

    Mass. AG Ready To Reprise Office's Role As Trump Foil

    Taking a page from her predecessor's book, Massachusetts Attorney General Andrea Joy Campbell told Law360 she is hoping to work with the incoming Trump administration, but the Democrat said she is nevertheless prepared to use her office's "significant tools and power" to challenge actions she feels are at odds with her constituents' interests.

  • November 12, 2024

    Trump Taps Elon Musk To Head New 'Gov't Efficiency' Dept.

    President-elect Donald Trump announced Tuesday that billionaire Elon Musk and former presidential candidate Vivek Ramaswamy will lead a newly created "Department in Government Efficiency" for his administration come January.

  • November 12, 2024

    Idaho Says Any Health Risk Could Be Used To Justify Abortion

    In his opening statement Tuesday in a trial weighing whether Idaho's abortion bans are forcing women to carry dangerous, nonviable pregnancies to term, a state attorney hypothetically quipped that to abortion rights advocates, even stepping on a "rusty nail" could be considered a health risk that could require an abortion.

  • November 12, 2024

    Judge Sends Malpractice Cap Question To Mich. High Court

    A Michigan federal judge has certified questions to the state's Supreme Court asking if caps on noneconomic medical malpractice damages are constitutional, in a case in which a cancer patient's estate was awarded $8.6 million for a missed diagnosis.

  • November 12, 2024

    J&J Says HHS Is Thwarting Transparency Of Drug Discounts

    Johnson & Johnson claims the U.S. Department of Health and Human Services is thwarting its efforts to crack down on hospitals the company alleges are "reaping immense profits" on reduced-price medications without passing those discounts on to patients, according to a lawsuit filed Tuesday in D.C. federal court.

  • November 12, 2024

    GOP Reps. Propose Another Bill On TRIPS Waivers

    A new bill from Republicans in the U.S. House of Representatives seeks to force the Office of the U.S. Trade Representative to file a report "before the negotiation of any international agreement relating to an intellectual property right."

  • November 12, 2024

    University Of Washington Scores Worker Vax Suit Dismissal

    A Washington federal judge has thrown out a lawsuit by a group of healthcare workers who alleged the University of Washington denied their religious exemptions from a COVID-19 vaccination requirement, saying the university was justified in firing the workers to prevent patients and employees from being exposed to the virus.

  • November 08, 2024

    Cigna Agrees To End Behavioral Health Underpayment Suit

    Cigna and a billing contractor have agreed to resolve claims that they violated federal benefits law by colluding to underpay out-of-network claims for substance use disorder treatments, according to a filing in California federal court.

Expert Analysis

  • Expect More State-Level Scrutiny Of Noncompetes Ahead

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    Despite the nationwide injunction against the Federal Trade Commission’s noncompete ban, and the incoming Republican administration, employers should anticipate that state legislatures will continue to focus on laws that limit or ban noncompetes, including those that target certain salary thresholds or industries, says Benjamin Fryer at FordHarrison.

  • Cos. Should Inventory Issues To Prep For New Congress

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    As the legislative and oversight agendas of the 119th Congress come into sharper focus, corporate counsel should assess and plan for areas of potential oversight risk — from tax policy changes to supply chain integrity — even as much uncertainty remains, say attorneys at WilmerHale.

  • Incoming Admin May Shake Up Life Sciences Regulation

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    Though President-elect Donald Trump has not yet articulated policy priorities regarding the life sciences industry, the sector is positioned to see significant changes that could affect everything from drug exclusivity and generic drug approvals, to the availability of over-the-counter drugs, to laboratory-developed tests and digital health, say attorneys at Morgan Lewis.

  • Navigating DOJ's Patchwork Whistleblower Regime

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    In the past few months, the U.S. Department of Justice and several individual U.S. attorney’s offices have issued different pilot programs aimed at incentivizing individuals to blow the whistle on misconduct, but this piecemeal approach may create confusion and suboptimal outcomes, say attorneys at BakerHostetler.

  • What To Expect Next From Federal Health Tech Regulation

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    Healthcare organizations should pay close attention to federal health information technology regulators' recent guidance concerning barriers to accessing electronic health information, which signals that more enforcement in this area is likely forthcoming, say attorneys at Ropes & Gray.

  • 5 Areas Congress May Investigate After GOP Election Wins

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    With Republicans poised to take control of Congress in addition to the executive branch next year, private companies can expect an unprecedented uptick in congressional investigations focused on five key areas, including cryptocurrency and healthcare, say attorneys at Cahill Gordon.

  • Takeaways From State Votes On Abortion In The 2024 Election

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    Attorneys at Epstein Becker discuss how 10 states voted on ballot initiatives to either protect or restrict access to abortion in the 2024 general election, and analyze overarching trends.

  • Loper Bright Offers New Materiality Defense To FCA Liability

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    The U.S. Supreme Court's decision in Loper Bight Enterprises v. Raimondo, ending Chevron deference, may have created a new defense to False Claims Act liability by providing the opportunity to argue that a given regulation is not material to the government's payment decision, says Tanner Cook at Husch Blackwell.

  • How Expanded Birth Control Coverage May Affect Employers

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    Employers should consider the potential impact of recently proposed regulations that would expand group health plans' required coverage of preventive services and contraceptives, including questions about how the agencies would implement their plans to eliminate the prescription requirement and alter the exceptions process, says Jennifer Rigterink at Proskauer.

  • Legislation Most Likely To Pass In Lame Duck Session

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    As Congress begins its five-week post-election lame duck session, attorneys at Greenberg Traurig break down the legislative priorities and which proposals can be expected to pass.

  • Preserving The FCA Is Crucial In Trump's 2nd Term

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    While the Trump administration may pursue weaker False Claims Act enforcement, it remains an essential tool in safeguarding public funds and maintaining corporate accountability, so now is not the time to undermine ethical behavior, or reduce protections and incentives for whistleblowers, says Adam Pollock at Pollock Cohen.

  • PREVAIL Bill Is Another Misguided Attempt To Restrict PTAB

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    The decade-long campaign against the U.S. Patent and Trademark Office's Patent Trial and Appeal Board — currently focused on the PREVAIL Act that's slated for markup in the Senate — is not really about procedural issues, and it is not aimed at securing more accurate patentability decisions, says Clear IP's Joseph Matal, former acting director at the USPTO.

  • Justices Face Tough Question On HHS Hospital Pay Formula

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    In Advocate Christ Medical Center v. Becerra, the U.S. Supreme Court will determine whether the U.S. Department of Health and Human Services properly applied certain Medicare reimbursement adjustments to hospitals — a decision that could significantly affect hospitals' ability to seek higher Medicare reimbursement for low-income patients, say attorneys at Sheppard Mullin.