Latest News

The Federal Government eliminated the “DATA-Waiver Program” as part of the Consolidated Appropriations Act of 2023, effective December 29, 2022. The relaxation of regulatory control signaled another step in the DEA’s stated goal of wanting: “medication for opioid use disorder to be readily and safely available to anyone in the country who needs it.”  The new Federal changes include:

• Elimination of the DATA-Waiver registration to treat patients with buprenorphine for opioid use disorder.
• All prescriptions for buprenorphine only require a standard DEA registration number.
• The elimination of limits or patient caps on the number of patients a prescriber may treat for opioid use disorder with buprenorphine.
• The introduction of new training requirements for all prescribers (these requirements will not go into effect until June 21, 2023).

The Act does not impact existing applicable state laws or regulations. More information on the Federal changes is available here.  In response, the State of Ohio Board of Pharmacy updated its published guidance for Office-Based Opioid Treatment (OBOT) clinics. Beginning January 23, 2023, the Pharmacy Board will no longer enforce the requirement that a Responsible Person hold a DATA2000 waiver. The State Medical Board of Ohio, which regulates the delivery of medication-assisted treatment for opioid use disorder, has not yet signaled if it will revise its rules that currently require a DATA2000 waiver.

If you are a medical provider treating patients for opioid use disorder and you have questions regarding regulatory compliance, you should consider contacting the attorneys at Graff & McGovern, LPA. Our attorneys have decades of experience representing licensed professionals, including representation of Physicians, Pharmacists, and Certified Registered Nurse Practitioners. Attorney Levi Tkach can be reached at levi@grafflaw.com.