Health Law Advisor

In this episode of the Diagnosing Health Care Podcast:  Like the diversity of the industry itself, merger and acquisition (M&A) transactions in health care take many forms, varying in size and complexity.

While buyers tend to focus on several things as part of those transactions, securing key employees post-closing is an important but sometimes overlooked issue.

What are some important factors to consider when entering a transaction in a human capital-intensive industry like health care?

In the absence of a federal law directly aimed at regulating artificial intelligence (AI), the Federal Trade Commission (FTC) is seeking to position itself as one of the primary regulators of this emergent technology through existing laws under the FTC’s ambit. As we recently wrote, the FTC announced the establishment of an Office of Technology, designed to provide technology expertise and support the FTC in enforcement actions. In a May 3, 2023 opinion piece published in the New York Times entitled “We Must Regulate A.I. Here’s How,” Lina Khan, the Chairperson of the FTC, outlined at least three potential avenues for FTC enforcement and oversight of artificial intelligence technology.

In this episode of the Diagnosing Health Care Podcast:  On April 21, 2023, the U.S. Supreme Court ruled to preserve access to the prescription abortion drug mifepristone.

However, while the case continues in the U.S. Court of Appeals for the Fifth Circuit, the future of mifepristone—and the U.S. Food and Drug Administration’s authority to approve new drugs—will continue to be debated on appeal.

As health care entities around the country face staffing shortages, hospitals have started to turn to apps to fill nursing shifts. New apps allow hospitals to engage nurses as independent contractors to fill open shifts, allowing nurses to bid on shifts and select hours that match their schedule. Apps allow nurses to work as independent contractors and engage directly with the hospital as opposed to employees of the hospital or a nursing staffing agency that then engages on their behalf to staff the hospital. The Wall Street Journal recently reported on these apps, crediting their rise to nurses retiring or leaving the field after burn out from the COVID-19 pandemic, from which hospitals are still struggling to recover. But, these apps have existed for several years, and employment issues such as correct calculation of wages and tracking work time are something Epstein Becker Green has previously spotted.

In this episode of the Diagnosing Health Care Podcast:  The Inflation Reduction Act (IRA), signed into law in August 2022, included significant and controversial drug-pricing provisions.

What key compliance issues must industry stakeholders consider as these provisions are put into effect?

On this episode, Epstein Becker Green attorneys Leslie Norwalk, Connie Wilkinson, and Alexis Boaz discuss key considerations for the health care and life sciences industry as the Centers for Medicare & Medicaid Services works its way through the initial stages of ...

The Centers for Medicare & Medicaid Services (“CMS”) is using its annual rulemaking process to update the CMS payment system rules for fiscal year (“FY”) 2024 as a mechanism to advance health equity systematically across various CMS payment programs. Specifically, CMS is incorporating proposals to advance health equity in its proposed payment rules for inpatient hospitals and long-term care hospitals, skilled nursing facilities, inpatient psychiatric facilities, and hospices, and in the final rate announcement for the Medicare Part C and Part D programs for FY 2024. Significantly, in several instances, CMS is requesting comments, which opens the door for providers to share their input about relevant considerations. This CMS initiative is consistent with key components that were detailed in CMS’s “Framework for Health Equity,” the agency’s 10-year plan to “remedy systemic barriers to equity so that every one [CMS] serve[s] has a fair and just opportunity to attain their optimal health regardless of race, ethnicity, disability, sexual orientation, gender identity, socioeconomic status, geography, preferred language, or other factors that affect access to care and health outcomes.”[1] This post outlines the changes being proposed by CMS, as well as highlights opportunities where providers should consider preparing and submitting comments.

In prior posts here and here, I analyzed new data obtained from FDA through the Freedom of Information Act about FOIA requests.  I looked at response times and then started to dive into the topics that requesters were asking about.  This is the third and final post on this data set, and it builds on the last post by taking the topics identified there to explore success rates by topic.  From there, I look at who is asking about those topics and how successful those individual companies are in their requests.

During the past several turbulent weeks for the U.S. health care system, rulings in the case Alliance for Hippocratic Medicine v. FDA have called into question the U.S. Food and Drug Administration’s (“FDA’s”) scientific review process to approve new drug applications. While the U.S. Supreme Court acted on the afternoon of Friday, April 21, 2023 to preserve access to the drug mifepristone while the case continues in the United States Court of Appeals for the  Fifth Circuit, the future of mifepristone—and the FDA’s authority to approve new drugs—will continue to be debated on appeal.

In this episode of the Diagnosing Health Care Podcast:  A complex landscape of state laws overlays the direct access testing model, ranging from physician order requirements, such as telemedicine standards and the corporate practice of medicine doctrine, to specimen collection considerations, including how the varying options for collection could impact a model.

How do these factors combine to create a roadmap for companies navigating the direct access testing industry?

In this episode of the Diagnosing Health Care Podcast:  Renewed interest in the potential benefits of psychedelic treatments has led to an upsurge in research. Is the first FDA approval of a psychedelic for therapeutic use on the horizon?