U.S. Code of Federal Regulations
Regulations most recently checked for updates: Aug 11, 2020
The total number of patients that a practitioner may dispense or prescribe covered medications to at any one time for purposes of 21 U.S.C. 823(g)(2)(B)(iii) is 275 if:
(a) The practitioner possesses a current waiver to treat up to 100 patients under section 303(g)(2) of the Controlled Substances Act (21 U.S.C. 823(g)(2)) and has maintained the waiver in accordance with applicable statutory requirements without interruption for at least one year since the practitioner's notification of intent (NOI) under section 303(g)(2)(B) to treat up to 100 patients was approved;
(b) The practitioner:
(1) Holds additional credentialing as defined in § 8.2; or
(2) Provides medication-assisted treatment (MAT) utilizing covered medications in a qualified practice setting as defined in § 8.615;
(c) The practitioner has not had his or her enrollment and billing privileges in the Medicare program revoked under § 424.535 of this title; and
(d) The practitioner has not been found to have violated the Controlled Substances Act pursuant to 21 U.S.C. 824(a).
A qualified practice setting is a practice setting that:
(a) Provides professional coverage for patient medical emergencies during hours when the practitioner's practice is closed;
(b) Provides access to case-management services for patients including referral and follow-up services for programs that provide, or financially support, the provision of services such as medical, behavioral, social, housing, employment, educational, or other related services;
(c) Uses health information technology (health IT) systems such as electronic health records, if otherwise required to use these systems in the practice setting. Health IT means the electronic systems that health care professionals and patients use to store, share, and analyze health information;
(d) Is registered for their State prescription drug monitoring program (PDMP) where operational and in accordance with Federal and State law. PDMP means a statewide electronic database that collects designated data on substances dispensed in the State. For practitioners providing care in their capacity as employees or contractors of a Federal government agency, participation in a PDMP is required only when such participation is not restricted based on their State of licensure and is in accordance with Federal statutes and regulations;
(e) Accepts third-party payment for costs in providing health services, including written billing, credit, and collection policies and procedures, or Federal health benefits.
In order for a practitioner to receive approval for a patient limit of 275, a practitioner must meet all of the requirements specified in § 8.610 and submit a Request for Patient Limit Increase to SAMHSA that includes all of the following:
(a) Completed Request for Patient Limit Increase form;
(b) Statement certifying that the practitioner:
(1) Will adhere to nationally recognized evidence-based guidelines for the treatment of patients with opioid use disorders;
(2) Will provide patients with necessary behavioral health services as defined in § 8.2 or through an established formal agreement with another entity to provide behavioral health services;
(3) Will provide appropriate releases of information, in accordance with Federal and State laws and regulations, including the Health Information Portability and Accountability Act Privacy Rule (45 CFR part 160 and 45 CFR part 164, subparts A and E) and 42 CFR part 2, if applicable, to permit the coordination of care with behavioral health, medical, and other service practitioners;
(4) Will use patient data to inform the improvement of outcomes;
(5) Will adhere to a diversion control plan to manage the covered medications and reduce the possibility of diversion of covered medications from legitimate treatment use;
(6) Has considered how to assure continuous access to care in the event of practitioner incapacity or an emergency situation that would impact a patient's access to care as defined in § 8.2; and
(7) Will notify all patients above the 100 patient level, in the event that the request for the higher patient limit is not renewed or the renewal request is denied, that the practitioner will no longer be able to provide MAT services using buprenorphine to them and make every effort to transfer patients to other addiction treatment;
(c) Any additional documentation to demonstrate compliance with § 8.610 as requested by SAMHSA.
(a) Not later than 45 days after the date on which SAMHSA receives a practitioner's Request for Patient Limit Increase as described in § 8.620, or renewal Request for Patient Limit Increase as described in § 8.640, SAMHSA shall approve or deny the request.
(1) A practitioner's Request for Patient Limit Increase will be approved if the practitioner satisfies all applicable requirements under §§ 8.610 and 8.620. SAMHSA will thereafter notify the practitioner who requested the patient limit increase, and the Drug Enforcement Administration (DEA), that the practitioner has been approved to treat up to 275 patients using covered medications. A practitioner's approval to treat up to 275 patients under this section will extend for a term not to exceed 3 years.
(2) SAMHSA may deny a practitioner's Request for Patient Limit Increase if SAMHSA determines that:
(i) The Request for Patient Limit Increase is deficient in any respect; or
(ii) The practitioner has knowingly submitted false statements or made misrepresentations of fact in the practitioner's Request for Patient Limit Increase.
(b) If SAMHSA denies a practitioner's Request for Patient Limit Increase (or renewal), SAMHSA shall notify the practitioner of the reasons for the denial.
(c) If SAMHSA denies a practitioner's Request for Patient Limit Increase (or renewal) based solely on deficiencies that can be resolved, and the deficiencies are resolved to the satisfaction of SAMHSA in a manner and time period approved by SAMHSA, the practitioner's Request for Patient Limit Increase will be approved. If the deficiencies have not been resolved to the satisfaction of SAMHSA within the designated time period, the Request for Patient Limit Increase may be denied.
§ 8.630 - What must practitioners do in order to maintain their approval to treat up to 275 patients?
(a) A practitioner whose Request for Patient Limit Increase is approved in accordance with § 8.625 shall maintain all eligibility requirements specified in § 8.610, and all attestations made in accordance with § 8.620(b), during the practitioner's 3-year approval term. Failure to do so may result in SAMHSA withdrawing its approval of a practitioner's Request for Patient Limit Increase.
(b) All practitioners whose Request for Patient Limit Increase has been approved under § 8.625 must provide reports to SAMHSA as specified in § 8.635.
§ 8.635 - What are the reporting requirements for practitioners whose Request for Patient Limit Increase is approved?
(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.
§ 8.640 - What is the process for renewing a practitioner's Request for Patient Limit Increase approval?
(a) Practitioners who intend to continue to treat up to 275 patients beyond their current 3 year approval term must submit a renewal Request for Patient Limit Increase in accordance with the procedures outlined under § 8.620 at least 90 days before the expiration of their approval term.
(b) If SAMHSA does not reach a final decision on a renewal Request for Patient Limit Increase before the expiration of a practitioner's approval term, the practitioner's existing approval term will be deemed extended until SAMHSA reaches a final decision.
§ 8.645 - What are the responsibilities of practitioners who do not submit a renewal Request for Patient Limit Increase, or whose renewal request is denied?
Practitioners who are approved to treat up to 275 patients in accordance with § 8.625, but who do not renew their Request for Patient Limit Increase, or whose renewal request is denied, shall notify, under § 8.620(b)(7) in a time period specified by SAMHSA, all patients affected above the 100 patient limit, that the practitioner will no longer be able to provide MAT services using covered medications and make every effort to transfer patients to other addiction treatment.
§ 8.650 - Can SAMHSA's approval of a practitioner's Request for Patient Limit Increase be suspended or revoked?
(a) SAMHSA, at any time during a practitioner's 3 year approval term, may suspend or revoke its approval of a practitioner's Request for Patient Limit Increase under § 8.625 if it is determined that:
(1) Immediate action is necessary to protect public health or safety;
(2) The practitioner made misrepresentations in the practitioner's Request for Patient Limit Increase;
(3) The practitioner no longer satisfies the requirements of this subpart; or
(4) The practitioner has been found to have violated the CSA pursuant to 21 U.S.C. 824(a).
§ 8.655 - Can a practitioner request to temporarily treat up to 275 patients in emergency situations?
(a) Practitioners with a current waiver to prescribe up to 100 patients and who are not otherwise eligible to treat up to 275 patients under § 8.610 may request a temporary increase to treat up to 275 patients in order to address emergency situations as defined in § 8.2 if the practitioner provides information and documentation that:
(1) Describes the emergency situation in sufficient detail so as to allow a determination to be made regarding whether the situation qualifies as an emergency situation as defined in § 8.2, and that provides a justification for an immediate increase in that practitioner's patient limit;
(2) Identifies a period of time, not longer than 6 months, in which the higher patient limit should apply, and provides a rationale for the period of time requested; and
(3) Describes an explicit and feasible plan to meet the public and individual health needs of the impacted persons once the practitioner's approval to treat up to 275 patients expires.
(b) Prior to taking action on a practitioner's request under this section, SAMHSA shall consult, to the extent practicable, with the appropriate governmental authorities in order to determine whether the emergency situation that a practitioner describes justifies an immediate increase in the higher patient limit.
(c) If SAMHSA determines that a practitioner's request under this section should be granted, SAMHSA will notify the practitioner that his or her request has been approved. The period of such approval shall not exceed six months.
(d) If a practitioner wishes to receive an extension of the approval period granted under this section, he or she must submit a request to SAMHSA at least 30 days before the expiration of the six month period, and certify that the emergency situation as defined in § 8.2 necessitating an increased patient limit continues. Prior to taking action on a practitioner's extension request under this section, SAMHSA shall consult, to the extent practicable, with the appropriate governmental authorities in order to determine whether the emergency situation that a practitioner describes justifies an extension of an increase in the higher patient limit.
(e) Except as provided in this section and § 8.650, requirements in other sections under subpart F of this part do not apply to practitioners receiving waivers in this section.