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Melinda Campopiano, MDMedical Officer

Center for Substance Abuse TreatmentSubstance Abuse and Mental Health Services Administration

U.S. Department of Health & Human Services

Federal Guidelines for Opioid Treatment Programs

CSAT/SOTA meetingAtlanta GA March 29, 2015

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New Federal Guidelines for OTPs

Offer full range of pharmaceuticals for MAT for medically determined necessary tx of clients

Provide recovery-oriented care• Relapse/overdose

prevention servicesLeverage PDMPs as

clinical support tools

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Federal Opioid Treatment Program Standards

Major change from public comment draft due to language in Part 8.12(h)(4): • OTPs shall maintain current procedures adequate to ensure that

each opioid agonist treatment medication used by the program is administered and dispensed in accordance with its approved product labeling. Dosing and administration decisions shall be made by a program physician familiar with the most up-to-date product labeling. These procedures must ensure that any significant deviations from the approved labeling, including deviations with regard to dose, frequency, or the conditions of use described in the approved labeling, are specifically documented in the patient's record.

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Possible Means to Address the Role of Advanced Practice Nurses and Physician Assistants

Exemptions allowed in Part 8.11(h): An OTP may, at the time of application for certification or any time thereafter, request from SAMHSA exemption from the regulatory requirements set forth under this section and §8.12. • An example of a case in which an exemption might be

granted would be for a private practitioner who wishes to treat a limited number of patients in a non-metropolitan area with few physicians and no rehabilitative services geographically accessible and requests exemption from some of the staffing and service standards.

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OTP Justification for Exemption

The OTP shall support the rationale for the exemption with thorough documentation, to be supplied in an appendix to the initial application for certification or in a separate submission.

SAMHSA will approve or deny such exemptions at the time of application, or any time thereafter, if appropriate. • SAMHSA shall consult with the appropriate

State authority prior to taking action on an exemption request.

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Proposed Exemption Process

What is required in the 42CFR Part 8:OTPs shall support the rationale for the

exemption with thorough documentation.SAMHSA will not approve unless state

supports the request.

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Sample Request for Exemption

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Sent: Tuesday, March 24, 2015 8:36 AM To: Campopiano, Melinda (SAMHSA) Subject: Exception Requestion for Physician's Assistant Good Morning Ms. Campopiano, I met you in January of 2014…. It was a pleasure having you and you mentioned if we ever had any questions we could feel free to reach out to you. I am reaching out to you to find out what type of form there is to complete to request an exception to allow a physician’s assistant to complete admissions to our OTP facilities. Thank you for any assistance or advice you can give me. I appreciate your time. Warm Regards,

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Sample Response to Request for Exemption

From: Campopiano, Melinda (SAMHSA) [mailto:Melinda.Campopiano@samhsa.hhs.gov] Sent: Tuesday, March 24, 2015 9:52 AM To: Subject: RE: Exception request for Physician's Assistant Hi, Nice to hear from you. Hope all is well. There is not a form. The process is spelled out in 42CFR Part8.11(h) and is accomplished via a letter. However, you will need to get permission from the state first. Thanks,

Melinda

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Possible Regulatory Review and Revision

Long-Range Response to Short-Comings of Federal Opioid Treatment Program Standards

Satisfy Executive Order and Request from Congress to update 42 CFR Part 8.

Could include:• Amend 8.12(h)(4) to allow APNs and PAs• Clarify confusion language regarding

provider responsibilities elsewhere.

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THANK YOU,Melinda.Campopiano@samhsa.hhs.gov