OTP FAQ

Federal law requires a complete physical evaluation before admission to an OTP. Under 42 C.F.R. § 8.12(f)(2):

(f) Required services— . . .

(2) Initial medical examination services. OTPs shall require each patient to undergo a complete, fully documented physical evaluation by a program physician or a primary care physician, or an authorized healthcare professional under the supervision of a program physician, before admission to the OTP. The full medical examination, including the results of serology and other tests, must be completed within 14 days following admission.

However, under 42 C.F.R. § 8.11(h), SAMHSA has the authority to grant exemptions to OTPs from certain requirements of the OTP regulations.

With respect to new patients treated with buprenorphine, SAMHSA has made the decision to pre-emptively exercise its authority to exempt OTPs from the requirement to perform an in-person physical evaluation (under 42 C.F.R. § 8.12(f)(2)) for any patient who will be treated by the OTP with buprenorphine if a program physician, primary care physician, or an authorized healthcare professional under the supervision of a program physician, determines that an adequate evaluation of the patient can be accomplished via telehealth. This exemption will continue for the period of the national emergency declared in response to the COVID-19 pandemic, and applies exclusively to OTP patients treated with buprenorphine. This exemption does not apply to new OTP patients treated with methadone. The OTP provider caring for the buprenorphine patient under these circumstances must be a licensed healthcare practitioner who can, in his or her scope of practice prescribe or dispense medications and have a current, valid DEA registration permitting prescribing or dispensing of medications in the appropriate Controlled Substances Schedule.

For new OTP patients that are treated with methadone, the requirements of an in-person medical evaluation will remain in force. SAMHSA has made this determination on the basis that eliminating the in-person physical examination requirement for new methadone patients could present significant issues for a patient with OUD. Patients with OUD starting methadone are not permitted to receive escalating doses for induction as take home medication. This means that a person starting methadone for OUD would get a maximum dose of 30 mg/d and may be on this dose, which for most people with OUD would be a low dose that will potentially be inadequate, for extended periods (up to 14 days if the clinic is using a blanket exception during the current medical emergency). The methadone dose could only be increased by a small amount (e.g., 5 mg/d) meaning that the person would be on what are considered to be subtherapeutic doses of methadone to treat OUD for an extended period. An initial in-person physical evaluation is needed in order for OTP providers to address such risks in each newly admitted methadone patient.

Yes, a practitioner may continue treating an existing patient of the OTP with methadone via telehealth and in accordance with SAMHSA’s OTP guidance issued on March 16, 2020, assuming applicable standards of care are met. The OTP provider caring for the methadone patient under these circumstances must be a licensed healthcare practitioner who can, in his or her scope of practice prescribe or dispense medications and have a current, valid DEA registration permitting prescribing or dispensing of medications in the appropriate Controlled Substances Schedule.

Yes, a practitioner may continue treating an existing patient of the OTP with buprenorphine via telehealth assuming applicable standards of care are met, and the patient’s buprenorphine treatment is in accordance with SAMHSA’s OTP guidance issued on March 16, 2020. The OTP provider caring for the methadone patient under these circumstances must be a licensed healthcare practitioner who can, in his or her scope of practice prescribe or dispense medications and have a current, valid DEA registration permitting prescribing or dispensing of medications in the appropriate Controlled Substances Schedule.

Yes, if a practitioner, has a DATA 2000 waiver, the practitioner may prescribe buprenorphine under the practitioner’s DATA 2000 waiver while complying with all applicable standards of care. In such a case, the patient will count against the practitioner’s patient limit and must treat the patient in accordance with any rules that apply to practicing with a waiver under 21 U.S.C. § 823(g)(2), and 42 C.F.R. Part 8, as applicable.

Yes. Under the current national health emergency, OTPs can provide medication under blanket exception: up to 14 doses for clinically less stable patients and 28 doses for clinically stable patients (clinical stability and ability to safely manage medication must be determined by the clinical team and documented in the patient’s medical record).

OTPs must ensure that opioid agonist treatment medications are administered or dispensed only by a practitioner licensed under the appropriate State law and registered under the appropriate State and Federal laws to administer or dispense opioid drugs, or by an agent of such a practitioner, supervised by and under the order of the licensed practitioner. This agent is required to be a pharmacist, registered nurse, or licensed practical nurse, or any other healthcare professional authorized by Federal and State law to administer or dispense opioid drugs.

Therefore, a mid-level practitioner can administer and dispense MAT medication within an OTP, absent the direct supervision of an OTP physician, if the mid-level practitioner is “licensed under the appropriate State law and registered under the appropriate State and Federal laws to administer or dispense opioid drugs.” Please note, however, that this flexibility does not negate the OTP medical director’s obligation to “assume responsibility for administering all medical services performed by the OTP.” See 42 C.F.R. § 8.12(b).

SAMHSA recommends the following:

1. Document that the patient is medically ordered to be under isolation or quarantine. When possible confirm source of information- e.g.: doctor’s order, medical record. Ensure the documentation is maintained in the patient’s OTP record.

2. Identify a trustworthy, patient designated, uninfected 3rd party, i.e. family member, neighbor, to deliver the medications using the OTP’s established chain of custody protocol for take home medication. This protocol should already be in place and in compliance with respective state and DEA regulations. OTPs should obtain documentation now for each patient as to who is designated permission to pick up medication for them and maintain this process of determining a designee for any new patients.

3. If a trustworthy 3rd party is not available or unable to come to the OTP, then the OTP should prepare a “doorstep” delivery of take home medications. Any medication taken out of the OTP must be in an approved lock box.

4. The OTP should always communicate with the patient prior to delivery to reduce risk of diversion. This may involve, but is not limited to:

   1. Call placed to the patient prior to staff departure to deliver the medication ensuring that the patient or their approved designee is available to receive the medication at the address provided by the patient and recorded in the patient’s OTP medical record.

   2. Upon arrival, medication is delivered to the patient’s residence door and another call is made to the patient/designee notifying that the medications are at the door.

   3. The OTP staff is to retreat a minimum of 6 feet to observe that the medications are picked up by the patient or the designated person to receive the medications. The OTP staff person must ask the person who is retrieving the medication to identify themselves. Staff should determine that the person appearing to retrieve the medication is the patient or the person named by the patient as having permission to do so. The OTP staff who deliver the medication remain until observed retrieval of the medication by the designated person takes place, and then documents confirmation that medications were received by the individual identified as permitted to pick up the medication.

   4. Do not leave medication in an unsecured area. OTP staff must remain with the medication until the designated individual arrives and retrieves the medication.

   5. If the person who is to receive the medication is not at the designated location, an attempt should be made to reach the person. If the person does not arrive timely (this wait period will need to be determined by OTP staff), then the staff person must bring the medication back to the OTP where it will be stored in the pharmacy area until a determination is made as to whether another attempt will be made to deliver medication. Any medication returned to the OTP must be logged in. The medication delivery and pick up by the designated person or return of medications to the OTP must be documented in the patient’s OTP record and appropriate pharmacy records.

DSAMH has requested and received a blanket exception for all for all stable patients in an OTP to receive 28 days of Take-Home doses of the patient’s medication for opioid use disorder from SAMHSA. Additionally, DSAMH has requested and received a blanket exception for up to 14 days of Take-Home medication for those patients who are less stable but who the OTP believes can safely handle this level of Take-Home medication from SAMHSA.

For OTP patients that do not meet the criteria described above SAMHSA will consider approving COVID-19 exceptions to permit dispensing of Take-Home Division of Pharmacologic Therapies opioid pharmacotherapy for up to 14 days for those with exposure to COVID-19 or symptomatic for infection when documented by the patient’s healthcare provider. SAMHSA DPT will only consider exception renewals for up to 14 days that are medically indicated and requested by the individual’s healthcare provider. Every exception request for up to 14 days of opioid pharmacotherapy and related to COVID-19 exposure or infection must be presented to the SOTA who will be required to verify that the exception is necessary.