The U.S. Department of Justice (DOJ) recently announced a new initiative to enhance its working relationship with data miners who bring cases as whistleblowers under the False Claims Act (FCA). The initiative is dubbed “FOCUS,” an acronym for Fraud Oversight through Careful Use of Statistics. 

There has been a sharp increase in qui tam complaints…

The No Surprises Act (NSA), enacted in 2020, was designed to protect patients from unexpected medical bills in certain healthcare settings. The law primarily applies when a patient receives emergency care at either an in-network or out-of-network facility, or receives services from an out-of-network provider while being treated at an in-network facility. In these situations…

On Thursday, May 28, in the next installment of Rivkin Radler’s Health Law Executive Briefings, Ashley Algazi and Tim Gonzalez will present “Examining AI in Health Care: A Review of Key Strategic, Legal, and Regulatory Considerations.”

As AI technologies become more integrated into clinical, operational, and administrative functions, health care providers and their advisors face…

The U.S. Food and Drug Administration (FDA) recently approved Eli Lilly and Company’s oral GLP-1 receptor agonist, Foundayo (orforglipron), for chronic weight management in adults with obesity or those who are overweight with at least one weight-related condition.

The approval introduces a new oral treatment option in a space that has been largely dominated by…

On April 21, in a “Hearing on Protecting Patients and Taxpayers: Cracking down on Medicare Fraud,” the House Ways & Means Committee received testimony on hospice and home health fraud from Sheila Clark, President and Chief Executive Officer of the California Hospice and Palliative Care Association,[1] and Chris Deery, the Director of Corporate Fraud…

In accordance with 42 C.F.R. § 424.515, all healthcare providers participating in Medicare are required to periodically revalidate their enrollment records with the Centers for Medicare & Medicaid Services (CMS) in order to maintain Medicare billing privileges. This routine process requires providers to confirm and, if necessary, update their enrollment information.

Revalidation generally occurs every…

The federal government is escalating its crackdown on Medicaid fraud and every state has been placed on notice.

On April 21, Centers for Medicare & Medicaid Services (CMS) Administrator Mehmet Oz announced that all 50 states will be required to submit provider revalidation plans within 30 days. Speaking during Politico’s Public Health Care Summit, Oz…

Medical spas continue to expand beyond traditional aesthetic services, and peptides have quickly become one of the more heavily marketed offerings in this space. While these products are often positioned as part of a broader “wellness” model, the legal framework that governs them is far less flexible.

At the federal level, the key issue is…

On April 1, the U.S. Food and Drug Administration (FDA) clarified its policies on compounded drugs, including compounded versions of GLP-1 products. Compounders are permitted to produce copies of approved drugs only while those drugs are listed in FDA’s ​shortage database.

GLP-1 products are used primarily for weight loss and diabetes. They include semaglutide (used…