HHS Ups Buprenorphine Patient Limit, Raising 3 Important Questions

Kolmac Co-Founder and Medical Director George Kolodner, M.D., had this to say about HHS issuing a final rule increasing the number of patients to whom a physician can prescribe buprenorphine:

“We are fortunate that at a time when the opioid addiction epidemic has surged to crisis proportions, buprenorphine – a safe and effective medication for the treatment of opioid use disorders – may be even more readily available,” he said. “In the 13 years that buprenorphine has actually been available for general clinical use, the evidence has accumulated that it is living up to the optimistic expectations that preceded its approval.”

While Kolodner is optimistic about the potential benefits of this latest development, he is also cautious and acknowledges that it raises some important questions, which he addresses below.

#1- Modern Addiction Recovery: For how many patients should a physician be allowed to prescribe buprenorphine?

Kolodner: The limit in the original 2000 legislation was 30, which was raised a few years later to 100. Under newly approved regulations, as of August 5, the number will be raised to 275 — if certain conditions are met. Either the physician must be certified as an addiction specialist, or the treatment center must contain certain clinical and administrative elements. With the opioid addiction problem continuing to ruin the lives of so many people, expanding access to buprenorphine to more patients would clearly be a good idea.

#2- Modern Addiction Recovery: How can access to buprenorphine be expanded without opening the door to parallel expansion of misuses?

Kolodner:  Previous experience with methadone had demonstrated that the public health impact of this medication was substantially limited by the regulatory environment surrounding its use. Many of us believe that the regulations regarding methadone were overly restrictive, thus limiting its usefulness. This awareness guided the decision when buprenorphine was initially released, to make possible its use in office-based settings rather than restricting it to a few specialized treatment centers.

The new buprenorphine regulations attempt to do this with an eye toward some of the misuses that have accompanied the clinical success — thus the restrictions that accompany the increased limit. Of particular concern has been the emergence of places where buprenorphine is prescribed 1) without accompanying psychosocial interventions and 2) on a “cash only” basis (health insurance not accepted). No medication is fully effective on its own. Buprenorphine is akin to a local surgical anesthetic — a useful intervention for physiological support, but only in that it facilitates the primary work of recovery, which is a psychosocial process.

#3- Modern Addiction Recovery: Will the new regulations accomplish what they are setting out to achieve?

How many more patients will actually receive buprenorphine? Will enterprising physicians manage to subvert the new restrictions and establish high volume, low quality “buprenorphine mills”? We don’t yet know but check back here. In future posts, I and our guests will be monitoring this issue locally and nationally to provide updates. For those interested in the full details, you can review the final rule as published on July 8 in the Federal Register.