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Amanda Zablocki

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Amanda is a partner in the Corporate Practice Group in the firm’s New York office and is a member of the firm’s healthcare industry team.

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In a decision joined by all nine justices, the Supreme Court preserved the Food and Drug Administration’s (“FDA’s”) regulatory approval of mifepristone, ensuring continued access to the widely-used abortion medication across the country. Food and Drug Administration, et al. v. Alliance for Hippocratic Medicine et al., No. 23-235 and Danco Laboratories, L.L.C. v. Alliance for Hippocratic Medicine, et al., No. 23-236. The Court ultimately decided the case on procedural grounds, holding that the plaintiffs lacked standing to bring suit.Continue Reading Supreme Court Unanimously Preserves Access to Mifepristone

I. Alabama Legislation Following LePage

On March 7th, the Alabama Legislature passed SB159 (“SB159” or the “bill”), as a means of granting certain protections to IVF clinics and providers in the wake of the LePage v. Center for Reproductive Medicine decision. The bill among other things, grants civil and criminal immunity to any individual or entity in connection with death or damage to an embryo when providing or receiving services related to in vitro fertilization (“IVF”). The protections afforded by SB159 apply to (i) manufacturers of goods used to facilitate the IVF treatments and (ii) individuals engaged in the transportation of the stored embryos. Once enacted, the new law would take retroactive effect to shelter providers and suppliers engaged in providing IVF treatments as of the LePage ruling. Continue Reading IVF Caught in the Crosshairs: The Aftermath of the LePage Decision

At HLTH 2023, we saw a focus on certain themes, including the shift in investments and M&A activity, hospital and health system innovation and transformation, the implementation of AI, and healthcare management. Below are our top 10 takeaways from what we heard, and did not hear, at HLTH 2023.Continue Reading Sheppard Mullin’s Top 10 Takeaways from HLTH 2023

The digital health market, as represented by the HLTH showroom floor, is packed with companies focused on care coordination and care management for various health and wellness specialties, diseases, and chronic conditions, as well as organizations focused on increasing consumer access to various types of healthcare. Despite the growth of data analytics and interoperability, the constellation of companies and points of access are decentralized and disconnected. While the abundance of choice and options enhancing accessibility for healthcare consumers are positive indicators of progress in this space, the lack of holistic care coordination across this fragmented landscape affects patient outcomes, causes patient confusion and decision fatigue, and leads to potential care and resource duplication and waste.Continue Reading At HLTH 2023: The Digital Health Symphony, A Care Coordination Orchestra with No Maestro

At the heart of our healthcare system lies two core, yet competing, philosophies: (1) clinical decisions must not be driven by profit, and (2) dollars drive behavior and, by harnessing this revenue, clinical outcomes can be vastly improved while the costs to the system of unnecessary care can be dramatically reduced. Here at HLTH, venture capital firm General Catalyst announced it is seeking to change that paradigm with the launch of its Health Assurance Transformation Corporation (HATCo), seeking to transform healthcare with global risk arrangements while leveraging data and technology. Continue Reading At HLTH 2023: General Catalyst’s HATCo Introduces a Radically Ambitious and Transformative Model for Healthcare

Nearly three months after hearing oral arguments, a divided Fifth Circuit panel issued its decision in Alliance for Hippocratic Medicine v. FDA, upholding the U.S. Food and Drug Administration’s (“FDA”) underlying approval of Mifepristone in 2000, but reinstating the limitations and restrictions under the pre-2016 protocol. Despite rejecting Judge Matthew Kacsmaryk’s blanket suspension of the drug’s approval, the federal appeals court found that the FDA overstepped its authority in expanding access and loosening restrictions on the drug in 2016 and 2021. Specifically, the Fifth Circuit agreed with the lower court’s ruling to invalidate the FDA’s modifications that increased the gestational age and relaxed dispensing requirements such as allowing the drug to be dispensed through the mail and ordered by a non-physician. The 96-page ruling issued by the conservative three-judge panel will likely not have any immediate legal effect, and Mifepristone will remain broadly available due to the Supreme Court’s stay implemented earlier this year.Continue Reading Fifth Circuit Rules to Reinstate Abortion Pill Restrictions

For a brief moment in time last April, the U.S. Food and Drug Administration’s (“FDA”) approval of the commonly-used abortion medication, Mifepristone, was curtailed. Just days after a Texas federal judge’s ruling suspended the FDA’s approval of the drug, the U.S. Department of Justice (the “DOJ”) asked the Fifth Circuit to grant an emergency or administrative stay of that decision. On review, the Fifth Circuit held that Mifepristone could only be prescribed in the first seven weeks of pregnancy, under a physician’s supervision, and the drug cannot be sent by mail, temporarily suspending more recent modifications to the FDA’s approval. Continue Reading Access to Abortion Pill on the Precipice: A Deep Dive into the Federal Court Rulings that will Decide the Fate of Mifepristone 

The U.S. Food and Drug Administration’s (“FDA”) approval of the commonly-used abortion medication, Mifepristone, has been curtailed following dueling federal court decisions in Texas and Washington. Just days after a Texas federal judge’s ruling suspended the FDA’s approval of the drug, the U.S. Department of Justice (the “DOJ”) asked the Fifth Circuit to grant an emergency or administrative stay of that decision. Although the Fifth Circuit did grant temporary, albeit limited, relief, the court maintained that Mifepristone could only be prescribed in the first seven weeks of pregnancy, under a physician’s supervision, and the drug cannot be sent by mail. Continue Reading Access to Abortion Pill in Limbo: Navigating the Intricacies of Conflicting Federal Court Rulings in Texas and Washington State

The Centers for Medicare & Medicaid Services (CMS) recently announced that it has several “prevailing concerns” regarding the accuracy of the 2017 Merit-Based Incentive Payment System (MIPS) scoring data that was used to set the 2019 MIPS payment adjustments.  According to CMS, the concerns at issue relate to problems in the scoring logic used by CMS to generate the MIPS final scores for 2017.  In light of these “prevailing concerns” and the identified errors, CMS went about the task of “addressing and correcting” the 2017 MIPS data.  As a result, on September 13, 2018, CMS posted to the CMS Quality Payment Program (“QPP”) website the CMS revisions to the 2017 MIPS final scores and their associated 2019 MIPS payment adjustments.
Continue Reading The Merit-Based Incentive Payment System’s Targeted Review Deadline is Upon Us: Physicians, Groups, and other Clinicians have until October 15, 2018 to Identify and Report Errors in the Calculation of their 2017 MIPS Final Scores

On April 4, 2018, the Centers for Medicare & Medicaid Services (“CMS”) finalized guidance and policies for the Medicare Advantage program that will expand the supplemental benefits afforded to beneficiaries to include items and services that address certain “social determinants of health” (“SDOH”). SDOH refers to a wide range of factors and conditions that are known to have an impact on healthcare, ranging from socioeconomic status, education and employment, to one’s physical environment and access to healthcare. Previously, CMS did not allow an item or service to be eligible as a supplemental benefit if the primary purpose was for daily maintenance. CMS’ reinterpretation of the statute to expand the scope of the primarily health-related supplemental benefit standard is an important step in encouraging value-based care.
Continue Reading Medicare Advantage to Address Social Determinants of Health: An Important Step for Value-Based Care

Update. We described in a previous blog post major changes that tax-exempt hospitals and other tax-exempt organizations in the healthcare industry face in the tax reform proposals working their way through Congress. In the early hours of Saturday, December 2, 2017, the Senate narrowly passed its tax reform bill. Although the Senate’s bill has much in common with the bill passed by the House of Representatives, there are significant differences. Accordingly, the House voted yesterday, December 4, 2017, to proceed with a conference committee to reconcile the two bills. A reconciled bill would still need to be approved by both the House and Senate. The Republicans are pushing hard to enact a final bill before year end.
Continue Reading Tax-Exempt Healthcare Organizations Brace for Impact as Senate Tax Reform Bill Passes