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.
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.
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. …
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. …
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
As federal tax reform efforts proceed rapidly in both chambers of Congress, tax-exempt hospitals and other tax-exempt healthcare organizations are facing major potential changes. New tax burdens on tax-exempt organizations are among the ways in which the bills would raise revenue to pay for proposed tax cuts for businesses and individuals. Importantly, it is still early in the legislative process, and much may change as Republicans race to have a bill signed into law before the end of the year.
Continue Reading Tax-Exempt Hospitals & Other Tax-Exempt Healthcare Organizations Not Immune from Federal Tax Reform
Since 2014, there has been a steady increase in mergers and acquisitions in the Rehabilitation sector, with a total of 40 deals announced in 2016. This is almost double the number of deals in 2014 (a total of 21), and includes deals with both publicly traded corporations as well as privately held acquirers. Similarly, after seeing a sharp decline in M&A activity in 2015, the home health and hospice sectors saw an increase of 12% in M&A activity in 2016 with a total of 57 deals announced, including several deals involving private equity investors.
Continue Reading Merger and Acquisition Activity in the Rehabilitation, Home Health and Hospice Sectors Increased in 2016, But Will this Trend Continue?