Meenakshi Datta

A Prediction on the Louisiana #ContractPharmacy Law? Last Thursday, a US District Court heard oral argument on the constitutional challenges brought by PhRMA AstraZeneca, and AbbVie to the LA CP law. Although it’s always hard to predict an outcome from an argument, I’m going to tempt fate. The judge is still finding his legs in what he described as a “complicated case”. Even so, he showed little interest in all but one claim—a subset of the “#preemption” issues. But I think he’s leaning in the state’s direction, even on those claims. Limited Questions: The judge showed little interest in most of the claims. Pretty much zippo questions on the argument that the state law was an unconstitutional taking of #drug makers’ property without just compensation (an argument I like) or that the law is too vaguely drafted (not a great argument), for instance. Preemption: Where the court did show some interest was the issue of whether the state law is preempted because it conflicts with the #340B statute. Even here, though, the court seemed disinterested in some versions of the preemption challenge; the court did not really engage on the (pretty sound) argument that the state law conflicts with the federal patent laws, impeding the value of #patents by imposing #pricecontrols. And though the court showed a little more interest re: the argument that the 340B statute laid out a comprehensive balance of benefits and obligations that the state is disturbing, he didn’t seem likely to bite there, either. He wondered out loud a few times why a CP law would conflict with the federal law so long as the “link to a [legitimate] #coveredentity” was present. The court showed the most interest in the question of whether the 340B statute’s enforcement mechanisms would be undermined by the state law. The court seemed to telegraph that its ultimate view of the “enforcement preemption” issue would boil down to the question of whether the state statute was a “pricing” or a “delivery” provision. P vs. D: If the state law is a “pricing” statute, the court suggested, it would likely be preempted. The 340B statute and the Supremes’ decision in the Santa Clara case really do seem to frame federal mechanisms, including #HRSA’s Administrative Dispute Resolution, as the exclusive means for addressing “pricing” or “overcharge” issues. But, if the state law is only about “delivery”, the court’s working hypothesis seemed to be that the 3rd and DC Circuit opinions hold that the 340B statute is “silent” on those issues. If so, the court appeared to reason, “silence” can’t be the basis for a state-federal conflict. Where Is the Court Headed?: Good question! Please see the comments below for my prediction. #lifescienses #healthcare #pharmaceuticals #drugpricing

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Listen Here: https://lnkd.in/gwQysAEE Kendra Calhoun, Senior Vice President of Marketing, Communications & Digital Experience at Avera Health joins the podcast to share insights into her background & Avera Health, the biggest issues in healthcare she is keeping an eye on today, her excitement and nerves surrounding AI, and more. For more information about Becker's Healthcare, please contact Jessica Calzaretta or Scott Becker. #podcast #healthcare #womensleadership

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The DOJ's formation of a new healthcare task force signals an even stronger emphasis on addressing competition issues in the healthcare industry. Learn more from a recent Antitrust Alert article my colleagues and I authored.

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Looking at the new TEAM mandatory model in a lot more detail and why even if you participate in another CMMI model you may want to pay attention

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New DOJ Task Force Targets Health Care Antitrust Violations The DOJ's Antitrust Division has launched the new Task Force on Health Care Monopolies and Collusions (HCMC) to address antitrust violations in the healthcare sector. The focus will be on vertically integrated “payviders” and entities rapidly acquiring healthcare assets. In light of these developments, companies are urged to carefully assess their recent M&A activities, books and records, and overall compliance with best practices to align with the increased DOJ scrutiny. Thanks to co-authors Lee Van Voorhis and Matthew Hickman for this alert. Womble Bond Dickinson (US) LLP Womble Bond Dickinson (UK) LLP #DOJ #AntitrustDivision #Healthcare #Compliance #TaskForce #MandA #HealthcareIndustry #LegalCompliance

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Listen Here: https://lnkd.in/gz5MCGPm Recorded live at the 11th Annual Becker's Healthcare CEO + CFO Roundtable, this episode features Sara Vaezy, Chief Strategy and Digital Officer at Providence. Here, she shares insights into her background & Providence, how healthcare providers are changing the consumer experience amid rising expectations, how her organization is looking at surveys as a way to collect & use patient data to better the patient experience, and more. This episode is brought to you by R1 RCM, a leading provider of technology-driven solutions that transform the financial performance of hospitals, health systems, and medical groups. R1 delivers proven, scalable operating models that power sustainable improvements to net patient revenue, while reducing operating costs. To learn how you can build a future-ready revenue cycle today, visit us at www.r1rcm.com/beckers (https://lnkd.in/grdk6GtT) For more information about Becker's Healthcare, please contact Jessica Cole or Scott Becker. #podcast #healthcare #womensleadership

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In this thoughtful piece my colleagues explore application of the Supreme Court's opinion in Jarkesy (invalidating the SEC's non-remedial penalty scheme as violating the 7th Amendment's jury trial guarantee) to the healthcare space. Many similar agency penalty schemes are now similarly suspect.

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Eric is an amazing attorney who gets great results. You should take a look at the article

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Wanted to share our first corporate governance podcast of 2024! #ahla

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How will health systems be impacted by the #SCOTUS decision overturning #Chevron deference? Join our upcoming webinar to explore new opportunities for health systems to advance policy and fiscal goals via regulatory litigation. We'll dive into Loper Bright and hot topics including 340B, LDTs, the IRA and more. Register today! https://lnkd.in/eggTyyvY

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Listen Here: https://lnkd.in/e4-baq6f Discover the nuances of pharmaceutical expenses in healthcare systems with Amy Gutierrez, PharmD, CPEL, VP and Chief Pharmacy Officer at UCHealth. Amy shares insights on the overlooked rise in drug costs versus labor expenses and discusses current focuses, including GLP-1 medications' promising aspects and challenges. Tune in for a concise exploration of these crucial topics. For more information about Becker's Healthcare, please contact Jessica Cole or Scott Becker. #podcast #healthcare #womensleadership

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Interesting analysis that my colleagues (Ryan Murr, Karen Alexandra Spindler, Marina Szteinbok, and Artin Au-Yeung) and I drafted of the Delaware Chancery Court’s recent decision on whether a buyer, in the context of a pharmaceutical earnout, used “commercially reasonable efforts” (“CRE”) to achieve certain milestones, and the implications for drafting CRE definitions in the context of license agreements, royalty financings, and merger agreements. #CRE #CommerciallyReasonableEfforts #Earnout #M&A #Licensing #RoyaltyFinance #Royalty #MileStones

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