Health Law Advisor

On May 18, 2023, the Federal Trade Commission (FTC) filed a Notice of Proposed Rulemaking and Request for Public Comment (“NPRM”) seeking to amend the Health Breach Notification Rule (“HBNR”). We previously wrote about the FTC’s policy statement, in which the FTC took the position that mobile health applications that are not covered by the Health Insurance Portability and Accountability Act (“HIPAA”) are covered by the HBNR. In our post, we highlighted concerns raised in dissent by commissioner Noah Joshua Phillips that the FTC’s interpretation of “breach of security” was too broad. Commissioner Phillips has since resigned.

In the absence of a comprehensive federal data privacy law, state legislators continue to add to the often-contradictory array of laws aimed at protecting the security and privacy of their residents’ data. Very recently, Washington State’s My Health My Data Act was signed into law by Governor Jay Inslee in late April, Florida lawmakers passed Senate Bill 262 in early May, and the Tennessee Information Protection Act was signed into law earlier this month as well. While preparing this update, Montana’s enacted its Consumer Data Privacy Act on May 19^th, which we will address in subsequent guidance due to its recency. These newly enacted state laws build upon the growing patchwork of laws enacted in California, Connecticut, Colorado, Virginia, and Utah, all of which we previously discussed here and here. Yet, among these state laws there is significant variety, including inconsistencies as to whether the laws allow for private rights of action, and whether the laws provide affirmative defenses and other incentives based on compliance with relevant best practices.

On May 11, the U.S.  Senate Committee on Health, Education, Labor and Pensions (the “HELP Committee” or the “Committee”) passed a bipartisan bill to expand federal regulation of pharmacy benefit managers (“PBMs”) for group health plans.[1]  As a compromise by Health Sub-Committee Chair Bernie Sanders (I-VT) and ranking Republican Bill Cassidy (LA), the Pharmacy Benefit Manager Act (S. 1339) reflects the overarching legislative push by members from both sides of the aisle and chambers of Congress to address drug pricing issues through federal fixes to the PBM framework . Further, Congress’ efforts build on the momentum from the enactment of the high-profile Medicare prescription drug pricing provisions of the Inflation Reduction Act (the “IRA”) in 2022. [2]

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.