Health Law Advisor

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 ...

On August 29, 2023, the Centers for Medicare & Medicaid Services (CMS) announced the ten (10) Medicare Part D drugs selected for the first round of negotiations of the Medicare Drug Price Negotiation Program (Program)—a few days before the September 1, 2023, statutory deadline imposed by the Inflation Reduction Act (IRA). The negotiated pricing will go into effect in 2026.

In its announcement, CMS included details about upcoming opportunities for public input regarding the Program, including a series of patient-focused listening sessions CMS plans to hold for each ...

On August 24, 2023, the U.S. District Court for the Eastern District of Texas issued an opinion and order in Texas Medical Association, et al. v. United States Department of Health and Human Services(“HHS”)(“TMA III”). TMA III challenged certain portions of the July 2021 No Surprises Act (“NSA”) interim final rules proposed by the U.S. Departments of Health and Human Services, Labor, and Treasury, along with the Office of Personnel Management (the “Departments”).  In a decision that significantly levels the field for providers, the District Court ruled in part ...

It is axiomatic that New York State requires every Medicaid provider to have an “effective” compliance program.  New York Social Services Law § 363-d.  In July 2022, the New York State Office of the Medicaid Inspector General (“OMIG”) proposed extensive modifications to the regulatory requirements governing compliance programs for entities receiving “significant” Medicaid revenue (increased by these regulations from a threshold of $500,000 to $1 million).  These regulations were proposed to implement portions of the New York State 2020-2021 Budget Bill ...

New York State cannabis agencies and related individuals were served with a lawsuit from four New York veterans (Carmine Fiore, William Norgard, Steve Mejia, and Dominic Spaccio, collectively, the “Plaintiffs”) related to the cannabis market and licensing structure on August 2, 2023. The Plaintiffs are alleging that under the Conditional Adult-Use Retail Dispensary (“CAURD”) licenses, state officials have been favoring “Justice Involved” individuals over disabled veterans in the application process. Their lawsuit has thus far led to the issuance of a ...