KYSAM is supporting an effort, originated by Dr. James Patrick Murphy, our ASAM Area X Representative, to have the special Suboxone regulation repealed. Suboxone is a Schedule III drug, not Schedule II, a fact that is often lost on those who are not addiction specialists. As a matter of fact, Suboxone is a much safer drug that many of the other drugs in Schedule III, such as benzodiazepines. We are one of only 16 states that have a special regulation above and beyond Schedule III guidelines for Suboxone. The Federation of State Medical Boards has asked that all state boards follow the Federal guidelines which means that they don’t have regulations that are more restrictive than Federal guidelines. Kentucky has not followed that recommendation. We have attempted to work through KBML; however, their process is slow and inflexible as we have seen with the newly released proposed regulations which do not improve upon the previous ones.

The most rational approach to make suboxone more available and incentivize doctors to prescribe it would be to simply drop the special regulation for Suboxone and treat it as a Schedule III drug. Dr. Murphy and other Board members have discussed this with various legislators. Will this result in any action? We aren’t sure, but we believe that it is worth trying. We have attempted to communicate with the Governor. We have not been able to schedule a meeting with him, but we have composed a letter outlining our concerns about the limitations on suboxone prescribing. The letter reads:

RE: Support the Repeal of 201 KAR 9:270

Dear Governor Beshear:

On behalf of the Kentucky Society of Addiction Medicine (KYSAM), the leading medical specialty society representing physicians and other clinicians in Kentucky specializing in the prevention and treatment of addiction, thank you for your attention to this important matter. Today, we write to respectfully request your support for the repeal of 201 KAR § 9:270 – Professional Standards for Prescribing, Dispensing, or Administering Buprenorphine-Mono-Product or Buprenorphine- Combined-with-Naloxone. While perhaps well-intentioned, the regulation is deeply flawed in its current state and serves as a substantial barrier to treatment. Specifically, the regulation contains several onerous provisions that when combined serve as disincentive for practitioners to prescribe buprenorphine, an evidence-based the treatment of opioid use disorder. Simply put, if we are to meet the needs of Kentuckians with addiction and continue to see declines in our state’s fatal overdose rate, antiquated regulations like 201 KAR 9:270 must be repealed to enhance access to treatment for OUD.

On multiple occasions, KYSAM shared specific suggestions to improve 201 KAR 9:270 with the Kentucky Board of Medical Licensure (KBML), including a detailed letter sent in December of 2023. Earlier this year, we called for the formation of a new workgroup to review proposed changes to the regulation. Unfortunately, we have not received constructive engagement from KBML at any point. As a result of this process, we have concluded that any proposals to amend 201 KAR 9:270 are wholly insufficient. Instead, the regulation is fundamentally flawed and should be removed in its entirety.

Indeed, Kentucky is one of only a handful of states maintaining a separate set of regulations restricting the utilization of buprenorphine. Kentucky maintains these regulations despite recent federal policy changes to enhance the accessibility of MOUD. Notably, President Biden signed legislation in 2022 to remove the federal x-waiver from the books, easing the regulatory burden for practitioners to prescribe buprenorphine. Additionally, recent recommendations from the Federation of State Medical Boards (FSMB) state that non-evidence-based barriers to treatment be removed. If Kentucky continues to be out of step with federal policymakers and an outlier among our peers in strictly regulating buprenorphine, individuals with OUD in our state will continue to suffer needlessly. Especially, at a time when these proven treatments for addiction are already underutilized, 201 KAR 9:270 should not serve as another obstacle to treatment.

A common refrain among supporters of 201 KAR 9:270 is that this level of strict regulation protects against diversion and misuse of buprenorphine. However, research shows that stricter regulation does not reduce diversion or overdose. In fact, there is a case to be made that stricter regulation of buprenorphine may facilitate more diversion by artificially reducing the medication’s accessibility to patients. Under the current scheme, if a person encounters difficulty accessing buprenorphine to treat their OUD from legitimate means, there is more likelihood that they will turn to the illicit market. Additionally, creating a separate set of regulations to govern the treatment of OUD perpetuates stigma against individuals with the disease of addiction, causing more harms in the long run. In turn, we must enhance access to buprenorphine treatment and allow practitioners to provide individualized, patient-centered care to Kentuckians without delay.

Kentucky has made great progress under your leadership in accomplishing a reduction in overdose deaths in 2023. However, there is still work to be done to deliver on our shared goals of ensuring that every patient in our great commonwealth has access to the treatment for the disease of addiction that they need. Kentucky should follow the lead of the federal government and prioritize removing burdensome regulations that inhibit access to crucial medications like buprenorphine. As such, we respectfully request your support for the repeal of 201 KAR 9:270 in its entirety.

Thank you again for your consideration of this urgent matter. And please do not hesitate to contact us should you have any questions or concerns. We stand ready to assist and consult as needed.

Sincerely,

Colleen Ryan, MD, FASAM

President Kentucky Society of Addiction Medicine

We understand that clinics are concerned about reimbursement. However, having rigid guidelines around Suboxone prescribing will not guarantee Medicaid reimbursement. That is a separate issue. Recently KYSAM received a letter from CHFS requesting our input on the possibility of resuming PAs for some addiction and behavioral health services. Though the letter stated that they were not looking to resume PAs for medication, we made it clear in our response that resuming PAs for any medication used to treat addiction, including the long acting injectables, should be off the table. We noted that although money is being spent on addiction services, it isn’t always spent in the right places. Clinics are not being reimbursed as they should be, and some are going out of business. We suggested that they increase oversight of the MCOs and how they are spending the money they are given by the state. We recommended that the focus be on increased efficiency, accountability, and delivery of evidence-based care. We suggested increased clarity regarding criteria for different levels of care as well as increased reliance on ASAM criteria for this. We agree that it is reasonable to have some PAs for higher levels of care, but there should be a grace period before the PA is required. We also suggested that they have a panel of experts to advise the MCOs on what is evidence-based care and to provide oversight on how the MCOs handle denials. To read our response, click here.