Congress Eliminates the NADEAN Requirement
With the Consolidated Appropriations Act of 2023, Congress eliminated the Drug Addiction Treatment Act (DATA) Waiver Program. This program required prescribers to obtain a D.A.T.A. waiver number, also known as the Narcotics Addiction DEA Number (NADEAN), to prescribe medications for drug addiction treatment.
Per a January 12th announcement from the DEA, the following changes are in effect.
- A DATA-Waiver registration is not required to treat patients with buprenorphine for opioid use disorder.
- All prescriptions for buprenorphine only require a standard DEA registration number. The previously used DATA-Waiver registration numbers are not needed for any prescription.
- There are no limits or patient caps on the number of patients a prescriber may treat for opioid use disorder with buprenorphine.
EPCS prescribing applications are now free to remove the requirements for NADEAN registration for Buprenorphine prescriptions such as Suboxone, and no longer transmit the NADEAN in the DATA2000WaiverID message field.
Because this change touches on EPCS requirements, vendors making this alteration will need to submit an audit attestation form. In the form, they must describe the alterations being made to the application, and attest no other aspects of the EPCS functionality are modified.
If the changes described in the attestation are limited to the NADEAN criteria, a live demonstration test is not required. There is no fee for submitting this attestation. You can download the attestation form here, and submit it to firstname.lastname@example.org.
Vendors are not required to implement this change immediately; however, they may soon see complaints from providers if the NADEAN requirement remains in place. Please see https://www.deadiversion.usdoj.gov/pubs/docs/A-23-0020-Dear-Registrant-Letter-Signed.pdf for more information.
EPCS Final Rule Delayed to March
The DEA regulatory agenda published last year indicated that the EPCS Final Rule would be published in December 2022; however, the DEA has delayed that publication until March 2023.
As indicated in our previous newsletter, Drummond has plans to update all vendors once the Final Rule is published. We will review in detail all of the changes via webinar shortly after the rule is published.
Please keep an eye out for our March newsletter which will summarize the Final Rule changes and include webinar details.
You can review the EPCS regulatory timeline and agenda at https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202210&RIN=1117-AA61