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…

A recent report issued by The NYU Stern Center for Business and Human Rights entitled “Private Equity and Healthcare: Balancing Profit with Wellness” examined the expanding role of private equity in the healthcare sector, concluding that “Private Equity’s combination of legal immunity, public anonymity, and financialized ownership creates a culture that often prioritizes profits over…

On March 26, the U.S. Department of Justice (DOJ) and the U.S. Attorney’s Office for the Southern District of New York filed a civil antitrust lawsuit against The New York and Presbyterian Hospital (NYP). The Complaint alleges that NYP violated Section 1 of the Sherman Act by requiring restrictive anti-competitive language in its commercial contracts…

Last month, Pinnacle MultiCare Nursing and Rehabilitation Center (Pinnacle) filed a federal action to stop the U.S. Department of Health and Human Services (HHS) from recouping tens of millions of dollars in Medicare Part A payments made to Pinnacle during the COVID-19 pandemic. According to its Complaint, Pinnacle received a letter from…

On March 20, the Federal Trade Commission (FTC) issued a memorandum announcing the formation of a Healthcare Task Force dedicated to addressing unlawful business practices within the healthcare sector. The memorandum emphasizes that industry consolidation and anticompetitive conduct have contributed to “higher prices, decreased quality, less access and transparency, and stifled innovation.” According to the FTC…