In my November 2025 blog post, I discussed the uncertainty surrounding the DEA’s then-pending telemedicine rule and its implications for ketamine clinics. At that time, the future of pandemic-era telehealth prescribing flexibilities was unclear, and clinics across the country were bracing for the possibility of a significant regulatory shift at the end of 2025.
The legal and regulatory landscape for ketamine clinics is shifting once again, as the Drug Enforcement Administration (DEA) prepares to release its “Fourth Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications.” While the full text of this rule is not yet public, its very existence signals that the DEA may continue the pandemic-era telehealth flexibilities that have proven vital for many clinics and patients. For owners and operators of ketamine clinics, understanding what’s at stake and how to prepare is more important than ever.
In June 2025, the Department of Justice (DOJ) announced its 2025 National Health Care Fraud Takedown, marking the largest coordinated healthcare fraud enforcement action in DOJ history. The sweep included charges against a range of actors including alleged transnational criminal organizations, providers of allegedly fraudulent wound care, alleged prescription opioid traffickers, alleged telemedicine, and genetic testing fraudsters, among others. DOJ also introduced the creation of a Health Care Fraud Data Fusion Center, designed to enhance the detection, investigation, and prosecution of healthcare fraud.
On June 13, 2024, the Justice Department announced arrests in what it called the nation’s first criminal case against digital health company executives over allegations that those executives caused illegal prescriptions for controlled substances to be ordered by way of telehealth visits.
While the Justice Department has previously brought charges in telehealth cases involving things like orthotic braces or genetic testing, a case against digital health executives involving telehealth-prescribed controlled substances is a first.
Ketamine clinics have been on the rise in the U.S. in recent years. As a byproduct of the common practice of prescribing drugs “off-label,” these clinics are not necessarily new in their operating model. Off-label use is the utilization of pharmaceutical drugs for, among other factors, unapproved indications. An approved indication occurs when the Food and Drug Administration (FDA) formally approves a given drug for a named medical condition.
The Department of Health and Human Services (HHS) has announced its plan to end the Federal Public Health Emergency (PHE) for COVID-19 on May 11, 2023. Due to the COVID-19 pandemic, emergency declarations, legislation, and regulatory waivers across government agencies, including the Centers for Medicare & Medicaid Services (CMS), allowed for flexibility in the delivery of care to patients, including the expanded use of telehealth. Originally intended to conserve healthcare resources and prevent unnecessary exposure to COVID-19, the use of virtual care has exploded since the beginning of the pandemic to become an intrinsic, essential part of the healthcare delivery system. Now, at the end of the PHE, we examine the path forward for telehealth and the extent to which providers may continue to offer it to patients.
Recent legislative changes indicate that Congress is committed to continuing to allow patients to access telehealth services after the COVID-19 public health emergency (PHE) ends, but it is gathering more information before making such changes permanent. Comments from the U.S. Department of Health & Human Services (“HHS”) Secretary Xavier Becerra and the HHS Office of Inspector General (“OIG”) indicate that HHS is committed to expanding telehealth beyond the end of the PHE and that the OIG recognizes the long-term benefits of access to these services.
The Centers for Medicare and Medicaid (CMS) expanded Medicare reimbursement for telehealth within the annual Physician Fee Schedule (PFS) final rule for 2021. During the pandemic Public Health Emergency (PHE), CMS has temporarily reimbursed many telehealth services. In light of the success of unprecedented telehealth utilization during the PHE, more than 60 services have been formally added to the Medicare telehealth list which will endure beyond the end of the PHE.
On October 29, 2020, HHS extended the effective date of compliance for the “Information Blocking” final rule promulgated as part of the 21st Century Cures Act (Information Blocking Rule). The Information Blocking Rule, which was set to take effect on November 2, 2020, prohibits health care providers, IT developers, and health information exchanges from unreasonably interfering with the access, exchange, or use of electronic health information (EHI). We previously discussed the practice of information blocking and the eight exceptions in our blog post Information Blocking: Ready or Not, Here it Comes!.
Centers for Medicare & Medicaid Services (CMS) has further expanded the list of telehealth services that Medicare Fee-For-Service will pay for during the COVID-19 public health emergency (PHE) as of October 14, 2020. CMS is adding 11 new services to the Medicare telehealth services list and will begin paying eligible practitioners who furnish these services immediately and through the end of the PHE. The new telehealth services include neurostimulator analysis and programming services, and cardiac and pulmonary rehabilitation services.