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 in-patient or out-p ..read more

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 had received the ..read more

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 This update follows FDA’s draft guidance, which was issued in July 2014, and supersedes the FDA’s “A Guide to Informed Consent,” which was issued in September 1998.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 investigations. The Final Guidance: (i) summarizes the informed ..read more

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 the de ..read more

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 selected drug between Oct ..read more

In this episode of the Diagnosing Health Care Podcast:  The impacts of climate volatility, cybersecurity threats, artificial intelligence, and building information modeling and construction technology have increased pressure on major construction projects on top of labor availability and supply chain adversity.  If your approach to delivering construction is the same as it was in early 2020, you’re probably inviting more risk to your project than you want. As part of our Owner’s Outlook series, special guest Alanna Klein, Product Director of Construction and ..read more

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 for the provider plaintiffs ..read more

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 amending the mandatory com ..read more

On June 1, 2023, the U.S. Supreme Court unanimously settled a long-standing dispute over a subjective versus objective standard for scienter under the False Claims Act (FCA), holding that a defendant’s own subjective belief is relevant to scienter, rather than what an “objectively reasonable” person may have known or believed. The case in question, U.S. ex rel. Schutte v. SuperValu Inc., consolidated from two lower court decisions, involved allegations that the defendants, two retail pharmacy chains, overcharged the government for prescription drugs in violation of the FCA. The FCA provides fo ..read more

Due diligence is a standard phase of any corporate transaction, whether structured as an asset or stock sale or joint venture, and sellers are often surprised, and even overwhelmed, by the comprehensiveness of the diligence investigation.  Preparing prior to soliciting bids or looking for a buyer can ease the burden of diligence and allow the seller to focus on other areas of the transaction, such as negotiating important terms and documents. The Two Phases of Diligence             There are usually two phases of diligence—one after s ..read more