Health Law Advisor

Six months from the date of closing. That’s how long acquiring companies have under the newly announced Department of Justice (DOJ) Mergers and Acquisitions (M&A) Safe Harbor Policy to disclose misconduct discovered in the context of a merger or acquisition – whether discovered pre or post-acquisition.  And the acquiring company has one year from the date of closing to remediate, as well as provide restitution to any victims and disgorge  any profits.

Over the last two years, the DOJ has made clear its priority to encourage companies to self-disclose misconduct aiming to ...

From our Thought Leaders in Health Law video series: The Inflation Reduction Act (IRA) introduces significant changes in prescription drug pricing, including the establishment of the Medicare Drug Price Negotiation Program and the Medicare Prescription Drug Inflation Rebate Program to control drug prices.

The IRA includes a redesign of the Medicare Part D benefit, which began with the announcement of 10 Medicare Part D drugs open for negotiation. This video highlights the challenges and complexities during the multi-year IRA implementation and emphasizes the penalties for ...

What is the 8 and 80 overtime system?

The Fair Labor Standards Act (“FLSA”) generally requires covered employers to pay non-exempt employees overtime for all hours worked over 40 hours in a work week. However, the FLSA provides an exception for certain employers in the health care industry, who are instead permitted to adopt a fixed work period of 14 consecutive days and pay overtime for all hours worked: (a) over 8 hours in a single day, or (b) over 80 hours in a 14-day work period.

Under the 8 and 80 overtime system, for example, an employee who works a 12-hour shift would be entitled ...

This month I wanted to take a data-driven look at FDA’s treatment of citizen petitions, and specifically as a starting point how quickly the agency resolves those petitions.  Make no mistake, I have an interest in this topic.  Over the more than 35 years I have been practicing law, I have filed multiple petitions including a 1995 petition that successfully caused FDA to adopt Good Guidance Practices.  But more recently, specifically on February 6, 2023, I filed a citizen petition asking FDA to rescind its final guidance on Clinical Decision Support Software.[1]  On August 5, 2023, when we ...

In a last minute push before an anticipated government shutdown, FDA put down its marker for moving forward toward regulation of lab developed tests (“LDTs”). Unlike past proposals from FDA and Capitol Hill, FDA has taken a simple approach: laboratories that make LDTs for clinical use are manufacturing in vitro diagnostic medical devices (“IVDs”) for commercial distribution, and as such must eventually comply with FDA’s already-established IVD requirements. The FDA zeitgeist boils down to this: It doesn’t matter if the lab is large or small, for profit or ...

In this episode of the Diagnosing Health Care Podcast:  Throughout this series, we've talked about the growth of the direct access testing industry and the types of models developed to support the businesses that are using that type of testing.

We've covered reimbursement considerations and physician ordering and specimen collection regulations. How does all of this come together to shape the future of the lab testing industry?

On the final episode of our four-part series on direct access laboratory testing, Epstein Becker Green attorneys Bob Hearn, James ...

Beginning June 21, 2023, New York State (NYS) Public Health Law (PHL) Section 2830 requires hospitals and healthcare professionals to provide written notice to patients before the patient is charged a facility fee.

Overview of Hospital Billing

Billing by hospitals and certain medical facilities typically involves a combination of a facility fee and a professional fee. Facility fees account for the overhead costs of maintaining a hospital, or other health care facility, and refer to the payments for services provided by the hospital, or other health care facility, for either ...

On August 30, an official at the United States Department of Health and Human Services (HHS) released one of the most significant announcements made at the federal level concerning marijuana reclassification. In a letter dated August 29, 2023, Rachel Levine (HHS Assistant Secretary for Health), provided a formal recommendation to Anne Milgrim (Agency Administrator) at the United States Drug Enforcement Agency (DEA) to reclassify cannabis from a Schedule I drug to a Schedule III drug under the Federal Controlled Substances Act (CSA).

A DEA spokesperson confirmed the department ...

On August 15, 2023, the U.S. Food and Drug Administration (“FDA”) released final guidance on informed consent for clinical investigations (“Final Guidance”). This update follows FDA’s draft guidance, which was issued in July 2014, and supersedes the FDA’s “A Guide to Informed Consent,” which was issued in September 1998. The Final Guidance is intended to assist clinical research stakeholders, such as institutional review boards (“IRBs”), investigators, and sponsors, in complying with FDA’s informed consent regulations for clinical ...

It’s common for a client to show up at my door and explain that they have performance data on a medical device they have been testing, and for the client to ask me if the performance they found is adequate to obtain FDA clearance through the 510(k) process. I often respond, very helpfully, “it depends.” But for some reason clients aren’t completely satisfied by that.

I then volunteer that a general rule of thumb is 95%, but that this is just a rule of thumb. For Class II medical devices undergoing review through the 510(k) process, the legal standard is that the applicant must show that ...