Legal Insights

The regulatory environment surrounding ketamine therapy is entering a new phase of maturity and enforcement. Recently, the Texas Medical Board published proposed regulations governing ketamine therapy, one of the first comprehensive regulatory frameworks in the country.

California’s hospice fraud crackdown is only the beginning of what CMS and Medi-Cal regulators have claimed will be many more cases brought against hospice facilities and home health agencies. Providers who do not timely respond to a suspension or revocation may waive important rights. Act now to protect your business and reputation from governmental overreach based on data mining and other unreliable sources.

On Saturday, April 18, President Trump signed an executive order designed to accelerate federal drug approvals for psychedelic drugs, a move experts are calling a significant win for patient access. But for ketamine providers and practices offering ketamine-assisted psychotherapy (KAP), increased coordination among regulators means increased scrutiny is inevitable. In this article, we break down what this executive order means for the future of regulatory enforcement.

On January 1, 2026, the Centers for Medicare & Medicaid Services (CMS) officially launched the Wasteful and Inappropriate Service Reduction (WISeR) Model. This initiative is not just another administrative hurdle; it is a technology-driven enforcement overhaul aimed directly at the wound care industry.

Every year, the New York Office of the Medicaid Inspector General (OMIG) releases its Work Plan outlining enforcement priorities. The 2026 plan sends a clear signal that Medicaid providers in New York are entering a far more aggressive enforcement environment.

Pharmacies undergoing a Pharmacy Benefit Manager (PBM) audit are typically prepared to address inventory discrepancies and documentation issues. What many are not prepared for, however, is the increasing use of PBM member denial findings, allegations that a patient claims they did not receive and/or did not authorize the dispensing of a medication for which a claim was submitted.

Pharmacies often approach a PBM audit with the understanding that small discrepancies and modest recoupments are simply part of doing business. In today’s enforcement landscape, that assumption is no longer safe.

Inventory discrepancies are one of the first things PBMs look for during an audit. Even minor clerical errors like entering the incorrect NDC or failing to return a medication to stock can snowball, creating major financial risks that could place your pharmacy in jeopardy.

Health Law Alliance helped n independent pharmacy in Florida reverse over $45,000 in clawbacks.