Today, on April 29, 2024, following more than a decade of discourse, the U.S. Food and Drug Administration (“FDA” or the “Agency”) released its long-awaited “Medical Devices; Laboratory Developed Tests” Final Rule (the “Final Rule”) formalizing the Agency’s authority to regulate laboratory developed tests (“LDTs”) as medical devices. Since FDA issued its Proposed Rule (the “Proposed Rule”) in the Fall of 2023, Epstein Becker Green (EBG) and other industry stakeholders have eagerly awaited FDA’s issuance of the Final Rule and have speculated as  ..read more

Turns out, ignorance really is bliss, at least according to the Office of Civil Rights (“OCR”) within the Department of Health and Human Services (“HHS”), in publishing its final rule on algorithmic discrimination by payers and providers. Our concern is that the final rule,  based on section 1557 of the Affordable Care Act, creates a double standard where more sophisticated organizations are held to a higher level of compliance.  Set to become effective 300 days after publication, health care providers and payers will have a lot of work to do in that time. In this post, we will lay&n ..read more

Late last year, the case Shannon MacDonald, MD, et al v. Otto Sabando was filed in the U.S. District Court for the District of New Jersey. The plaintiffs claimed that New Jersey’s licensure restrictions on the use of telehealth were unconstitutional as they infringe on basic civil rights everyone has and therefore should be struck down. However, the defendants argued that the licensure of physicians is within the jurisdiction of states to decide and regulate such that New Jersey’s licensure laws do not violate the U.S. Constitution. EBG discussed the initial arguments in this  ..read more

Aesthetic services and the medical spa industry have continued to grow over the past few years as clients continue to demand the availability of such cosmetic services. In response, many providers and investors in the health care industry are seeing opportunities to open or invest in a medical spa. Before opening or investing in a medical spa there are several key elements to be considered: Corporate Structure One of the first elements to consider when opening a medical spa is the corporate structure and ownership of the medical spa. Many jurisdictions have “Corporate Practice of  ..read more

“Master Files” are not just for PowerPoints. On April 4, 2024, the Food and Drug Administration (FDA) issued its “New Dietary Ingredient Notification Master Files for Dietary Supplements: Guidance for Industry” (“Draft Guidance”). These latest recommendations build upon the agency’s Final Guidance issued in March—the subject of our prior blog post—regarding procedures and timeframes for industry stakeholders to submit NDINs. The new recommendations also replace and expand upon those portions of a 2016 Revised Draft Guidance, called “Dietary  ..read more

On April 1, 2024, the U.S. Department of Health and Human Services (“HHS”) released new guidance which requires hospitals to obtain informed consent from patients before practitioners, or medical or other students, perform important surgical tasks or sensitive or invasive procedures or examinations (“Guidance”). The Guidance aims to address increasing concerns over patient privacy, in particular the performance of sensitive examinations and invasive procedures on anesthetized patients. The Guidance both revises the Hospital Interpretive Guidelines regarding  ..read more

In our ongoing series of blog posts, we examine key negotiating points for tenants in triple net health care leases. We also offer 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 first two blog posts, we considered the importance of negotiating initial terms and renewal  ..read more

Combination products present a tremendous opportunity to improve health outcomes, because they leverage multiple disciplines.  If we were, for example, to focus on drugs alone with little thought to how they might be delivered, we would be surely missing a chance to enhance safety or effectiveness.  Likewise, many devices can be made more effective or safer if paired with a drug. At the end of 2016, FDA finalized a rule covering Postmarket Safety Reporting for Combination Products that now can be found at 21 C.F.R. Subpart B.[1]  A few years later, in July 2019, FDA finalized a ..read more

We recently wrote about proposed Oregon legislation that would have addressed workplace violence in healthcare settings but failed to move forward in the legislature due to concerns about a provision that would have made assault on a hospital worker punishable as a felony. This was not a concern that troubled the Kentucky legislature, which on March 27, 2024, signed and delivered to the state governor a bill relating to workplace violence against healthcare workers. The Kentucky legislation expands the offense of assault in the third degree perpetrated against a variety of  ..read more

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