On June 5, 2016 we posted a blog (here) outlining Congressional support for an increase in the number of patients that practitioners can treat for substance abuse with designated medications. Tomorrow, HHS will publish a 112-page Final Rule (here) outlining how the phase in of an increase in the number of patients that a provider will be able to treat and monitor will be accomplished.
Background information in the Final Rule States:
“Section 303(g)(2) of the CSA (21 U.S.C. 823(g)(2)) allows individual practitioners to dispense or prescribe Schedule III, IV, or V controlled substances that have been approved by the Food and Drug Administration (FDA) for use in maintenance and detoxification treatment without registering as an opioid treatment program (OTP). Buprenorphine is a schedule III controlled substance under the CSA. To qualify to treat any patients with buprenorphine, the practitioner must be a physician, possess a valid license to practice medicine, be a registrant of the Drug Enforcement Administration (DEA), have the capacity to refer patients for appropriate counseling and other necessary ancillary services, and have completed required training.
The CSA also imposes a limit on the number of patients a practitioner may treat with certain types of FDA-approved narcotic drugs, such as buprenorphine, at any one time. Specifically, Section 303(g)(2)(B)(iii) of the CSA allows qualified practitioners who file an initial notification of intent (NOI) to treat a maximum of 30 patients at a time. After 1 year, the practitioner may file a second NOI indicating his/her intent to treat up to 100 patients at a time. Pursuant to 21 U.S.C. 823(g)(2)(B)(iii), the Secretary is authorized to change the patient limit by regulation.”
The Final Rule also notes that “[G]iven the evidence supporting buprenorphine-based MAT as an effective treatment for opioid use disorder and the magnitude of the opioid crisis, this rule is intended to increase access to buprenorphine-based MAT, prevent diversion, and ensure quality services are provided. With respect to the comment specifically related to the issues of subspecialty board certification and unclear criteria for a qualified practice setting, the final rule addresses these issues by replacing the “board certification” definition with an “additional credentialing” definition and also provides further clarity regarding the criteria for a qualified practice setting.”
With appropriate documentation and credentialing for certain practitioners, the limit can increase to 275 patients up from a previous maximum of 200 with special circumstances. This will mean a significant increase in the availability of MAT resources for patients and will also likely mean an increase in the use of the common drugs used in the MAT program. Hopefully, this will be another advance in the treatment of addicted patients and shorten the wait time for entry into MAT programs.
There are lots of details in the Final Rule and there is a companion Supplemental Notice of Proposed Rule Making relative to new Reporting requirements for MAT that can be found here.