As of Jan. 10, 2025, the Kentucky Board of Medical Licensure posted proposed updated guidelines for KAR 9:270, the Suboxone prescribing regulation, on its website. While there are a few changes, most of our requested updates are not included. The regulation does not allow physicians to make decisions which are individualized to each patient. It requires a frequency of visits and urine testing that may not be needed for every patient. It does not address the use of long acting injectables. It does not acknowledge the increased research supporting higher doses of suboxone. It requires “certification” of the need for continued care each year. We encourage continued care. Why do we need to justify it? In short, these regulations are not evidence based. KYSAM will be reviewing these regulations in detail. There is a public comment period at KBML offices on March 26 and written comments are accepted until March 31. If you scroll to the end of the proposed regulation, you can see the procedure for signing up for the public comment or submitting written comments. Let us know your opinion about the regulations by emailing admin@kysam.org. To read the proposed regulation, click here.
You may also be aware that HHS and DEA issued a final rule for telemedicine this week. The final rule says that practitioners utilizing telemedicine (video or audio) must review the prescription database for the patient in that state and then can issue up to 6 months of medication (split among several prescriptions) before an in-person visit is required. At the six-month period, the prescriber has 2 options: 1. Conduct an in-person evaluation, or if that is not possible, the practitioner can engage in other forms of the practice of telemedicine as defined in 21 U.S.C.802(54). You can review that rule here. It states that if an in- person evaluation is not possible, the evaluation can take place if the patient is in a DEA registered hospital or clinic and the prescriber has a DEA license in the state where the patient is located, or 2. The patient is being treated by and is in the physical presence of a DEA registered practitioner who is licensed in the state in which the patient is located. The pharmacist has to verify the patient’s identity before releasing the prescription.
In response to concerns about diversion, the final rule says the following:
Though, as with all transactions involving controlled substances, there is an inherent risk of diversion, DEA and HHS believe these regulatory provisions have been narrowly tailored to enable DEA and HHS to mitigate the risk of diversion associated with buprenorphine prescriptions issued pursuant to these new regulations. Moreover, considering the efficacy of treating OUD with buprenorphine when taken appropriately and subject to the additional safeguards in this rule, DEA and HHS believe that expanding access to buprenorphine through audio-only telemedicine outweighs the relatively lower risk of misuse and diversion of buprenorphine.
To read about the final rule, click here: