Health Law Advisor

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 federal courts would defer to federal agencies’ interpretation of their own statutes if the underlying statute was ambiguous and the interpretation was reasonable. The Court determined that this Chevron deference was inconsistent with the Administrative Procedure Act’s (APA) tasking to federal courts the duty to interpret federal statutes. Although the Court overruled the original decision in Chevron, the Court went out of its way to state that it “does not call into question prior cases that relied on the Chevron framework. The holdings of those cases that specific agency actions are lawful—including the Clean Air Act holding of Chevron itself—are still subject to statutory stare decisis despite the Court’s change in interpretive methodology.”

As stated in an amicus brief authored by prominent advocates, and as discussed at oral arguments, health care, as one of the most regulated industries, will be significantly impacted by the end of Chevron deference.

Federal regulatory agencies may have to alter their use of existing statutes to address new concerns under the post-Chevron landscape. Federal agencies also may have to go back to Congress to address new, emerging regulatory concerns not yet considered by statute.

In response to the recent turmoil caused by the Alabama Supreme Court’s February 16th ruling in LePage et al., v. The Center for Reproductive Medicine et al. and Burdick-Aysenne et al., v. The Center for Reproductive Medicine et al.  that pre-embryos are human children for the purposes of advancing a wrongful death claim, the Alabama legislature enacted a law intended to shield those who “provide or receive goods or services related to in vitro fertilization [(“IVF”)]” from any “action, suit, or criminal prosecution for the damage to or death of an embryo[.]” AL SB ...

Background

On February 16, 2024, the Alabama Supreme Court issued an opinion in the consolidated cases LePage et al., v. The Center for Reproductive Medicine et al. and Burdick-Aysenne et al., v. The Center for Reproductive Medicine et al., SC-2022-0579, in which the Court reversed a trial court’s dismissal of the plaintiffs’ civil wrongful-death claims and allowed the plaintiffs to move forward with a cause of action under the Alabama Wrongful Death of a Minor Act (the “Act”).[1] In so holding, the Alabama Supreme Court found that fertilized pre-embryos stored outside of ...

On October 30, 2023, President Joe Biden signed the first ever Executive Order (EO) that specifically directs federal agencies on the use and regulation of Artificial Intelligence (AI). A Fact Sheet for this EO is also available.

This EO is a significant milestone as companies and other organizations globally grapple with the trustworthy use and creation of AI.  Previous Biden-Harris Administration action on AI have been guidance of principles (e.g., the AI Bill of Rights) or have been targeted guidance on a particular aspect of AI such as the Executive Order Addressing Racial ...

Introduction

Hardly a day goes by when we don’t see some media report of health care providers experimenting with machine learning, and more recently with generative AI, in the context of patient care. The allure is obvious. But the question is, to what extent do health care providers need to worry about FDA requirements as they use AI?

Based on their extensive experience advising health care industry clients, Epstein Becker Green attorneys and strategic advisors from EBG Advisors are predicting the “hot” health care sectors for investment, growth, and consolidation in 2020.  These predictions for 2020 are largely based on the increasing confluence of the following three key “drivers” of health industry transformation that is substantially underway:

1. The ongoing national imperative of reducing the cost of health care, via disease prevention and detection, and cost-effective, quality treatment, including more efficient care in ambulatory and retail settings;
2. Extraordinary advances in technologies which enhance disease prevention, detection and cost-effective treatment (e.g., artificial intelligence (AI)-driven diagnosis and treatment, virtual care, electronic medical record (EMR) systems, medical devices, gene therapy, and precision medicine); and
3. The aging baby-boomer population, with tens of millions of Americans entering into their 70s, 80s, and above.

On October 24, 2018, President Trump signed sweeping bipartisan legislation to combat the opioid epidemic. The Substance Use–Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act, or the SUPPORT for Patients and Communities Act (“H.R. 6” or “the Law”), aims to “reduce access to the supply of opioids by expanding access to prevention, treatment, and recovery services.”[1] Congress has already appropriated $8.5 billion to implement this “landmark legislation” in 2018 and 2019.

In a series of Client Alerts, Epstein ...

On October 10, 2018, President Donald Trump signed into law the “Know the Lowest Price Act” and the “Patients’ Right to Know Drug Prices Act,” which aim to improve consumer access to drug price information by banning gag clauses. The Trump administration previously announced its intention to enact this legislation in its May 2018 Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs and will likely point to these new federal laws as affirmation of its commitment to drug pricing reform that favors patients and consumers.

These bills—one of which applies to ...

In its recent decision in U.S. House of Representatives v. Burwell,[1] the U.S. District Court for the District of Columbia ruled that the Obama administration's payment of cost-sharing subsidies for enrollees in plans offered through the Affordable Care Act's Exchanges is unauthorized for lack of Congressional appropriation. The decision would affect future cost-sharing subsidies, though the court immediately stayed the decision pending its outcome on appeal.[2]

In its decision, the court found in favor of the members of the House of Representatives, based upon its ...