In an effort to curb prescription drug abuse throughout Ohio, the Ohio General Assembly unanimously adopted legislation in May 2011 designed to help prevent “pill mill” operations and prescription drug abuse. The State Medical Board of Ohio issued proposed emergency rule 4731-29-01, Standards and Procedures for the Operation of a Pain Management Clinic. The emergency rule became effective on June 20, 2011. This law sets out new mandatory procedures and licensing requirements for pain management clinics in Ohio. Among other things, the new law establishes standards that must be followed by owners such clinics regarding supervision, direction, and control.
The rule defines a “pain management clinic” to be a facility (i.e. a single location) where:
- The primary component of the practice is treating pain or chronic pain; and
- A majority of the patients at the facility are provided treatment for the pain or chronic pain, including the use of controlled substances, tramadol, or carisoprodol.
The law requires physician owners of a pain management clinic to have current subspecialty board certification in pain medicine or hospice and palliative care, or to have board certification by the American Board of Pain Medicine or the American Board of Interventional Pain Physicians. Additionally, any physician who provides care at a pain management clinic must complete at least 20 hours of category I continuing medical education in pain medicine every two years.
Certain physicians failing to meet the certification requirements may be grandfathered. To be eligible, such physicians must meet one of several educational and practice options, including having provided full-time clinical services for the last three years in pain medicine, pain management, hospice and palliative medicine, or certain other specialties. Alternatively, a physician may be grandfathered if he or she has attended an internship, residency program, or clinical fellowship program with post graduate training requirements for board certification in one of the previously mentioned fields. In order to be grandfathered, physicians must have filed an application for a license as a category III terminal distributor of dangerous drugs with a pain management clinic classification with the Board of Pharmacy by June 20, 2011. Physicians who fail to meet this deadline will be required to meet the general ownership certification requirements.
Finally, the new law requires physicians who provide supervision, direction, and control of individuals at a pain management clinic to comply with several recordkeeping procedures. Among other things, they must maintain a log of all patients, develop a quality assurance system, verify staff credentials on an annual basis, and keep billing and patient records for seven years.
Failure to follow the rules of operation or standards for pain management clinics is punishable by the Board of Pharmacy by a fine of up to $5,000. The Medical Board may also impose a fine up to $20,000.