(a) General. All practitioners whose Request for Patient Limit Increase is approved under §8.625 must submit to SAMHSA annually a report along with documentation and data, as requested by SAMHSA, to demonstrate compliance with applicable provisions in §§8.610, 8.620, and 8.630.

(b) Schedule. The report must be submitted within 30 days following the anniversary date of a practitioner's Request for Patient Limit Increase approval under §8.625, and during this period on an annual basis thereafter or on another annual schedule as determined by SAMHSA.

(c) Content of the Annual Report. The report shall include information concerning the following, as further detailed in report form instructions issued by the Secretary:

(1) The annual caseload of patients by month.

(2) Numbers of patients provided behavioral health services and referred to behavioral health services.

(3) Features of the practitioner's diversion control plan.

(d) Discrepancies. SAMHSA may check reports from practitioners prescribing under the higher patient limit against other data sources to the extent allowable under applicable law. If discrepancies between reported information and other data are identified, SAMHSA may require additional documentation from the practitioner.

(e) Noncompliance. Failure to submit reports under this section, or deficient reports, may be deemed a failure to satisfy the requirements for a patient limit increase, and may result in the withdrawal of SAMHSA's approval of the practitioner's Request for Patient Limit Increase.

[81 FR 66196, Sept. 27, 2016]