On September 30, 2024, a federal district court judge held that the qui tam provisions of the False Claims Act (FCA) violate the Appointments Clause of Article II of the Constitution.  U.S. ex rel. Zafirov v. Fla. Med. Assocs., LLC, C.A. No. 8:19-cv-01236-KKM, 2024 U.S. Dist. LEXIS 176626 (M.D. Fla. Sept. 30, 2024) (“Zafirov”).  While Zafirov’s holding is novel, the constitutional issue raised in that decision is not.

Acting U.S. Attorney Joshua Levy discussed the enforcement priorities for the Massachusetts U.S. Attorney’s Office (USAO) during a Q&A session on May 29, 2024, and made clear that the historical focus of the office remains the top priority: detecting and combating health care fraud, waste, and abuse. 

The government’s continued dedication of resources to investigating and prosecuting fraud against COVID-19 pandemic relief programs appears to have borne fruit according to the results of the COVID-19 Fraud Enforcement Task Force’s (CFETF) report released on April 9, 2024. The CFETF, which represents a concerted effort across numerous federal agencies to investigate pandemic-related fraud, has, according to its 2024 report, succeeded in prosecuting over 3,500 defendants in criminal enforcement matters, in bringing civil enforcement actions resulting in more than 400 civil settlements and judgments, and in securing more than $1.4 billion in seizures and forfeitures. The report itself is a showcase of the CFETF’s COVID-19 fraud enforcement efforts to date.

Lawyers for Good Government, in partnership with the American College of Obstetricians and Gynecologists, initiated a vital project known as The Policy Resource Hub in 2022.

The government continued to dedicate enormous resources to investigating and prosecuting fraud against COVID-19 pandemic relief programs in 2023. In addition to civil False Claims Act settlements, there were a number of criminal enforcement matters, including some involving politicians, government employees, and those with connections to gangs and transnational crime networks.

As the Mintz Health Law team welcomes the beginning of 2024, many of its members take a moment to reflect on the exciting growth of the Health Law Practice, opportunities to partner with clients on complex legal issues, and the celebration of numerous milestones.

The Department of Health and Human Services’ Office of Inspector General (OIG) published a General Compliance Program Guidance (GCPG) on November 6, 2023, marking the first update to OIG’s compliance program guidance documents (CPGs) since 2008 and advancing OIG’s Modernization Initiative first announced in a September 2021 Request for Information. 

The Federal Trade Commission’s (FTC) recent press release marks a continuation in government action against manufacturers of products infused with delta-8 tetrahydrocannabinol (delta-8).  In May 2022, the U.S. Food and Drug Administration (FDA) issued warning letters to companies advertising delta-8 products as treatments for various medical conditions (see our prior post here).  The more recent action came on July 3, 2023, when the FTC and FDA announced that they had jointly issued warning letters to manufacturers marketing products infused with delta-8 that appear similar to Cheetos, Doritos, Nerds, and other snacks and treats popular with children.

The Department of Health and Human Services’ Office of Inspector General (OIG) announced on April 24, 2023 that it will soon issue long overdue updates to its compliance program guidance documents (CPGs).  First introduced in 1998, the CPGs are a series of voluntary guidance documents, each tailored to a specific segment of the health care industry. While the CPGs include important insights on specific risk areas and how to apply the seven elements of an effective compliance program to particular types of health care entities, they are ripe for modernizing. OIG will publish a General CPG (GCPG) applicable to all individuals and entities involved in the health care industry by the end of 2023, followed by industry-specific CPGs (ICPGs) in 2024. Of note, the OIG announced that its first two ICPGs will address Medicare Advantage and Skilled Nursing Facilities (SNFs), perhaps signaling the OIG’s priorities. The OIG’s updates to the CPGs are part of the OIG’s Modernization Initiative first announced in September 2022.

On March 9, 2023, the Food and Drug Administration (FDA) published a final rule to update the Mammography Quality Standards Act (MQSA) to reflect advances in mammography technology and, among other requirements, standardize aspects of mammography reports patients receive. Most notably, the final rule requires informing patients about whether they have "dense" or "not dense" breast tissue and establishes a new mandatory timeframe for facilities to send those reports to the referring health care provider (i.e., within 30 days). The final rule, which takes effect on September 10, 2024, modernizes the MQSA by addressing changes in mammography technology and making improvements that enhance enforcement of quality standards as well as the way mammography results are provided to patients and health care providers.