On June 11, 2024, U.S. Senators Ed Markey and Elizabeth Warren from Massachusetts, introduced proposed legislation titled The Corporate Crimes Against Health Care Act (“CCAHCA”), aimed at addressing a perceived “looting” of health care systems by for profit private equity investors. According to Sen. Warren, the bill was introduced to “root out corporate greed and private equity abuse in the health care system,” “prevent exploitative private equity practices,” and to specifically ensure that actions such as “looting” do not happen again by addressing trigger events and targeting real estate in ..read more

Key Takeaways Federal courts are no longer required to defer to federal agencies’ reasonable regulatory interpretation of ambiguous federal statutes under the 1984 Chevron In this new Loper landscape, increased engagement at all points of the federal legislative and federal regulatory process is more important than ever, especially for those in the heavily regulated health care industry. I. What Did the Supreme Court Do? What Changed with the Loper decision? In a 6-3 decision authored by Chief Justice John Roberts, the Supreme Court overruled the longstanding Chevron doctrine—under which fed ..read more

New from the Diagnosing Health Care Podcast: Laboratories in the United States are facing a major regulatory landscape shift. The U.S. Food and Drug Administration (FDA) has finalized a new rule ending its historical blanket enforcement discretion over laboratory developed tests (LDTs). What does this mean for labs going forward? On this episode, Epstein Becker Green attorneys James Boiani, Rob Wanerman, and Megan Robertson lay out the new landscape, analyze existing and potential challenges, and identify key developments to watch for as this new regulatory era unfolds ..read more

New from the Diagnosing Health Care Podcast: In a recent landmark decision, the U.S. Supreme Court overruled the Chevron doctrine in the case of Loper Bright Enterprises v. Raimondo. This ruling has significant implications for employers and other entities in the health care and life sciences industries, as it changes the way courts are likely to interpret and apply regulations issued by federal agencies. On this episode, Epstein Becker Green attorneys George Breen, Stuart Gerson, Rob Wanerman, and Paul DeCamp analyze the fallout of this monumental decision, discuss what it ..read more

Recently, the California Legislature made a series of major revisions to Assembly Bill 3129 (“AB 3129” or “the Bill”), a highly anticipated piece of legislation expected to have a substantial impact on transactions in California’s healthcare space.  Although Epstein Becker Green has previously discussed the Bill (see original post here, as well as a first update here), this blog post will discuss the legislature’s most recent revisions on June 19 and June 27. Why Assembly Bill 3129 Was Introduced The Bill was introduced by Assembly Member Wood and is supported by Attorney General Bonta in ..read more

When I was working on my Masters in data science, one of the projects I did was to create an algorithm that would take an intended use statement for a medical device and predict whether FDA would require a clinical trial.  It worked fairly well, with accuracy of about 95%. Since that’s a dynamic algorithm in which the user inputs an intended use statement and gets a prediction of FDA’s decision, I wanted to go about a similar task this month: create a static word cloud to show what words are most associated with intended use statements where FDA has required a clinical trial.  At lea ..read more

The ability to obtain public records in New Jersey is about to undergo a massive overhaul. A new bill, S2930 (the “Reform Bill”), was signed into law by New Jersey Governor Phil Murphy on June 5, 2024, and has the potential to make it more difficult for requestors to obtain access to certain government records. The controversial move to pass the Reform Bill has been called out by numerous critics for imposing limits on government transparency and inviting corruption to the state. Governor Murphy’s response has remained that the Reform Bill considers these concerns and aims to simplify the ..read more

In this episode of the Diagnosing Health Care Podcast: Will the reclassification of marijuana from a Schedule I to a Schedule III drug disrupt the cannabis marketplace? What consequences must industry stakeholders consider if the Drug Enforcement Administration's proposal becomes a reality? On this episode, special guests Anthony Minniti, a New Jersey-licensed pharmacist, and Stacey Udell, an accountant with expertise in representing cannabis operators across the United States, join Epstein Becker Green attorney Lisa Gora to discuss the regulatory domino effect and tax implications relate ..read more

On June 13, 2024, a unanimous Supreme Court held that physicians and medical associations opposed to abortion lacked standing to challenge the U.S. Food and Drug Administration’s (FDA’s) approval of the drug mifepristone, which is primarily used in terminating pregnancy. The Court’s decision in FDA v. Alliance for Hippocratic Medicine affirms the status quo—mifepristone will remain available to patients without in-person dispensing requirements and for pregnancies up to 10 weeks. In April 2023, the U.S. District Court for the Northern District of Texas ruled that the physicians and medical ass ..read more

In our ongoing series of blog posts, we have examined key negotiating points for tenants in triple net health care leases. We also have offered suggestions for certain lease provisions that will protect tenants from overreaching and unfair expenses, overly burdensome obligations, and ambiguous terms with respect to the rights and responsibilities of the parties. These suggestions are intended to result in efficient lease negotiations and favorable lease terms from a tenant’s perspective. In our previous posts, we considered the importance of negotiating initial terms and renewal terms, operati ..read more