Health Law Advisor

On January 18^th, the Centers for Medicare & Medicaid Services (CMS) announced a new demonstration model called the Innovation in Behavioral Health (IBH) Model, which is designed to improve outcomes for adults with mental health and substance use disorders (MH/SUD) by enhancing behavioral health provider capacity to integrate physical health care into their practice settings and services. The new demonstration model will be run out of the Centers for Medicare and Medicaid Innovation (CMMI) under the funding authority of Section 3021 of the Affordable Care Act and demonstration ...

On January 16, 2024, New Jersey Governor Phil Murphy signed into law Senate Bill No. 332, “An Act concerning online services, consumers, and personal data” (“SB 332”).  New Jersey is the fourteenth state to pass a comprehensive consumer privacy bill, and the obligations and rights created by SB 332 follow the format used in a growing number of states that have passed comprehensive consumer privacy laws.

Scope and Exemptions

SB 332 imposes obligations on “controllers”  – entities or individuals that determine the purpose and means of processing personal data – that ...

On January 9, 2024, the Center for Medicare and Medicaid Services (CMS) sent a letter to New York’s Medicaid director approving New York’s Section 1115 Waiver amendment, which the state submitted for approval on September 2, 2022. During the term of the amendment (January 9, 2024 through March 31, 2027), New York aims to fundamentally reform the way health care services are delivered through its Medicaid program by:   

1. Investing in Health Related Social Needs (HRSN) via providers working with Social Care Networks (SCNs) which in turn contract with existing Medicaid managed care ...

Introduction

Frequently, I am asked by clients to predict how long it will take for FDA to review and clear a 510(k).  At a high level, I observe that on average clearance can take 160 days according to the data.  Then, beyond that, I observe that review times are highly variable among differing product codes, and the very first Unpacking Averages post I wrote in October 2021 provided a graphic to show just how much variation there was depending on the technology.  Here, though, I want to dive into yet another separate factor that should be taken into account, the seasonality of FDA ...

On December 6, 2023, Senate Budget Committee Ranking Member Chuck Grassley (R-Iowa) and Chair Sheldon Whitehouse (D.-R.I.) announced a new bipartisan investigation into private equity ownership in hospitals—just ahead of a new plan by the Biden-Harris Administration to crack down on anticompetitive practices in health care.

Under the Biden plan, announced December 7, the Department of Justice (DOJ), the Federal Trade Commission (FTC), and Department of Health and Human Services (HHS) will seek input on how private equity is affecting the health care of Americans and the ...

As previously noted, the Illinois Biometric Information Privacy Act (BIPA) has invited a great deal of litigation, often resulting in interpretations favorable toward plaintiffs. As a result, we advise employers who use biometric technology in Illinois workplaces to adhere carefully to their obligations under BIPA. While that advice won’t change, employers operating in the health care sector can take some – though not too much – comfort in a recent ruling that limits their exposure under this law.

In Mosby v. Ingalls Memorial Hospital, the Illinois Supreme Court delved ...

In this episode of the Diagnosing Health Care Podcast: Under the Biden administration, the Centers for Medicare & Medicaid Services published a health equity framework that drastically changed the playing field for health plans and other risk-bearing entities.

In the wake of these changes, how can health plans, accountable care organizations, and other similar stakeholders successfully create and administer social determinants of health interventions as a means to advance health equity?

On this episode, Epstein Becker Green attorneys Jackie Selby, Kevin Malone, and Marjorie Scher discuss the recent national focus on health equity, the actionable interventions behind the concept, and the responsibility of stakeholders in making care delivery more equitable.

In this episode of the Diagnosing Health Care Podcast: What trends in state laws and regulations have emerged in the post-public health emergency (PHE) era, and how do these changes impact telehealth stakeholders?

At the federal level, many telehealth-related flexibilities have been extended through December 31, 2024, whereas, at the state level, there are wide variations in approach. Many states have continued to push the boundaries of existing telehealth policies, yet no two states are exactly alike in their approach to defining and regulating telehealth.

On this episode ...

Those who have been reading this blog know that I like to analyze collections of documents at FDA to discern, using natural language processing, whether, for example, the agency takes more time to address certain topics than others. This month, continuing the analysis I started in my October post regarding device-related citizens petitions, I used topic modeling on the citizens petitions to see which topics are most frequent, and whether there are significant differences in the amount of time it takes for FDA to make a decision based on the topic.

Discerning the Topics

As you probably ...

An increasing number of states are requiring advance notice of health care transactions.  These requirements may delay transactions or result in confidential information becoming accessible to the public. Effective August 1, 2023, New York[1] enacted legislation that requires health care entities involved in material transaction(s) to provide written notice to the New York Department of Health at least 30 days prior to the closing of the transaction. In enacting the legislation, New York joined Connecticut[2], Massachusetts[3], Nevada[4], Oregon[5], Rhode Island[6], and ...