1 of 19

Review of the Professional Standards for Prescribing Buprenorphine

Danielle Anderson, MD

Department of Psychiatry

University of Kentucky

College of Medicine

2 of 19

Before we begin:

The purpose of today’s talk is to review key points of the KAR regulations pertaining to outpatient prescribing of buprenorphine and buprenorphine-naloxone to aid providers in recognizing requirements and identifying areas for improvement within their practices
This review is based on available KAR regulations that current as of today and may change at anytime without notification
I cannot interpret the regulations. Questions regarding the interpretation of these regulations should be directed to the Kentucky Board of Medical Licensure or the Kentucky Board of Nursing

3 of 19

Todays talk will review:

201 KAR 9:270 Pertains to Physicians and PAs

Professional standards for prescribing, dispensing, or administering Buprenorphine-Mono-Product or Buprenorphine-Combined-with-Naloxone. Expiration date 1/22/2033

201 KAR 20:065 Pertains to APRNs

Professional standards for prescribing Buprenorphine-Mono-Product or Buprenorphine-Combined-with-Naloxone by APRNs for medication assisted treatment for opioid use disorder. Expiration date 3/21/2031

4 of 19

Regulation of Buprenorphine (Federal)

Consolidated Appropriations Act 2023:

Section 1262-Elminated X-Waiver

-eliminated limits on patients

Section 1263-as of 2023 practitioners applying for DEA

need to attest to 8 hours of OUD/SUD

education

Regulations for prescribing buprenorphine resides with the states

Consolidated Appropriations Act does not supersede state law

5 of 19

2 Kentucky Administrative Regulations Guide Buprenorphine prescribing

Physicians and PAs

201 KAR 9:270

APRNs

201 KAR 20:065

Color Coding:

Physicians and PAs

APRNs

Pertains to everyone

6 of 19

*Exceptions to the following can be found in:

KAR 9:270 Section 1 (3)
KAR 20:065 Section (3)

Exceptions exist for hospitalized patients, palliative care, patients undergoing surgery..etc

7 of 19

Initiation of Buprenorphine

In office induction shall be performed (document if unable to do this)

Initial dose shall not exceed 4mg

First day dosing shall not exceed 16 mg (there are extenuating circumstances hospitalized patients)

8 of 19

Frequency of Visits same for both regulations

1^st month: Patient is seen no more than ten days after induction and at frequency of no less than 10 days during first month

2^nd month: No more than 14 days intervals

3^rd month and beyond: at least monthly (up to 2 years)

2 years+: every 3 months

9 of 19

Document Necessity of the Dose

Must be evaluated Every 3 months and document necessity in the chart

KASPER must be obtained every 3 months

Requirement for Behavioral Modification

Counseling or 12 Step Facilitation

10 of 19

SAMSHA Guidance on Counseling Requirement

inability to provide these services {counseling}, or patient refusal of such interventions, should not prevent practitioners from prescribing buprenorphine. The decision as to when counseling and other services, such as case management and peer support, should be made in conjunction with the individual patient.

* Counseling and mutual support groups are an important part of recovery for many. The pharmacology that makes buprenorphine a life saving treatment does not depend behavioral modification.
Kentucky providers are required to include behavioral modifications

SAMSHA FAQs 2024

11 of 19

Co-prescribing BZDs KAR 20:065

Section (3)a

Except as provided in paragraph (b), buprenorphine shalls not be prescribed to a patient who is also being prescribed BZDs, other sedative hypnotics, other stimulants or other opioids without consultation from:

physician certified in addiction medicine or psychiatry
An APRN Certified by Addictions Nursing Certification Board, American Academy of Health Care Providers in the Addictive Disorders, National Certification Commission for Addiction Professionals or a Psychiatric mental health nurse practitioner

*may document extraordinary exception for 30 days

12 of 19

Co-prescribing of Controlled Substances KAR 9:270

If buprenorphine is dispensed or administered to a patient who is also being prescribed another controlled substance or other substance subject to abuse or misuse beyond 3 months, the licensee shall obtain and document a formal provider to provider or patient to provider consult with
Physician certified by ABAM, ABPM, the ABMS in Addiction Medicine
AOA certifying board in Addiction Medicine
Or physician who has completed an addiction psychiatry fellowship

(this version removed board certified psychiatrists from providing this

consultation)

13 of 19

Prescribing Doses > 16mg

Every 12 months

Refer patient to APRN or physician as previously stated

If > 12 months or every 12 months

Refer patient to for formal consultation:

Physician certified by ABAM, ABPM, the ABMS in Addiction Medicine or psychiatry

AOA certifying board in Addiction Medicine

***must document consultation, if you don’t document, it didn’t happen

14 of 19

Prescribing Buprenorphine Mono-product

Exceptions

Pregnant patient
Hypersensitivity to naloxone
*certain healthcare settings
To a patient transitioning from methadone to buprenorphine

for 1 week (APRN) or 30 days (Physician/PA)

15 of 19

Pregnant or Breastfeeding

Pregnancy test/document refusal
Counsel on Neonatal Opioid Withdrawal Syndrome
Obtain and document consultation with obstetrical provider

16 of 19

Urine Drug Screen Requirements

APRN

Minimum of 8 urine drug screens/12 months

2 of those should be random

At least 1 should be confirmed by GC/MS, LC/MS

Must include: buprenorphine, methadone, opioids, THC, BZDs, amphetamines, EtOH and cocaine

Physicians and PAs

Early stages of treatment test once weekly

Stable-once per month

Sustained remission-less frequent

On intake and once per year, randomly comprehensive UDS that also screens for gabapentin

17 of 19

State Regulations

Notably, as of September 1, 2024

• 12 states and the District of Columbia required counseling for patients prescribed buprenorphine for OUD, with three states establishing a minimum frequency of counseling

• 13 states and the District of Columbia required drug testing when prescribing buprenorphine for OUD, with six of these states specifying the frequency of required testing

• 6 states regulated both buprenorphine initiation dosages and buprenorphine maintenance dosages

• 11 states regulated how a practitioner responds to patient “non-compliance.”

Temple University Policy Brief 2025