It has recently been brought to our attention that changes made in PC 430 this past session could be misinterpreted to require some addiction specialists who also treat pain patients secondarily to be required to register as pain clinics. The unintended consequence was created when the legislature, at our behest, eliminated the exclusion of suboxone from the list of opioids which would be counted toward the threshold for determining if a practice would need to register. For your information, when we brought the original legislation to the General Assembly in 2011 (PC 340), we, like other states that had decided that pain clinics needed tighter regulation, chose not to include suboxone in the calculation, believing that the drug is used to treat addiction and not pain management. Since we have learned that a number of practices have been prescribing suboxone for off-label uses such as pain management.
With the pending October 1, 2013 change in the definition of pain management clinics, we believe it is possible to interpret the revision in a way that far differed from the reason for the change. As such we would urge you to consider adopting the following policy statement that permits addiction specialists to continue to ply their needed trade in the state without the necessity of becoming registered as pain clinics:
“Pharmaceutical products containing buprenorphine shall not be considered, and are specifically exempted from consideration, in the determination of whether a facility is designated as a pain clinic requiring registration as such with the state, if and only if the buprenorphine product is used in accordance with its FDA indication for the treatment of opioid dependency and in the context of an opioid dependence treatment program. Use of buprenorphine products solely to treat pain, whether transdermal (e.g. Butrans) or sublingual (e.g. Suboxone), shall constitute the use of an opiate for purposes of pain management and shall count toward determination of a facility being designated as a pain clinic requiring registration as such with the state.”
We greatly appreciate your consideration of this request and are prepared to respond to any questions or concerns you may have.
Yarnell Beatty, JD
Vice President, Advocacy
cc: The Honorable Ken Yager
The Honorable Bill Dunn
David Reagan, MD
Mitch Mutter, MD