The Centers for Medicare & Medicaid Services (CMS) recently released data on its 2024 settlements of voluntary self-disclosures related to past violations or potential violations of the physician self-referral law (the Stark Law). In 2024, CMS settled an agency record 314 self-disclosures (an amount that the following chart shows towering over other years), with settlement amounts totaling over $24,700,000 in the aggregate.

On January 23, 2025, the United States Court of Appeals for the Fourth Circuit rejected a challenge to Advisory Opinion 22-19 (the “Advisory Opinion”) issued by the United States Department of Health and Human Services, Office of Inspector General (“OIG”). The case, Pharmaceutical Coalition for Patient Access v. United States, centered on whether the Advisory Opinion was appropriate when it found a proposed patient assistance program for Medicare Part D beneficiaries by the Pharmaceutical Coalition for Patient Access (the “Coalition”) could violate the Anti-Kickback Statute (“AKS”). In rejecting this challenge to the Advisory Opinion, the Fourth Circuit signaled the judiciary’s continued respect afforded to government agencies, including OIG’s issuing of advisory opinions, even in a post-Chevron world.

On February 20, 2025, during a speech to the Federal Bar Association’s annual qui tam conference, Michael Granston, Deputy Assistant Attorney General for the Commercial Litigation Branch at the U.S. Department of Justice (DOJ), said that the Trump Administration will seek to “aggressively” enforce the False Claims Act (FCA). In particular, Granston stated that active FCA enforcement is consistent with the Trump Administration’s priorities of increasing government efficiency and “rooting out waste, fraud and abuse.”