Governor Signs Pain Clinic Licensure Bill

Governor John Kasich signed HB 93, May 20th, warning "pill mill" operators "if you overprescribe, we're going to come and get you." 

HB 93, sponsored by State Reps. David Burke (R-Marysville) and Terry A. Johnson, DO (R-McDermott), has been a top priority of the Kasich administration since January.  Because the bill carries an emergency clause, the legislation will become effective immediately upon signing and will impact physicians in three significant ways by: (1) requiring licensure of pain management clinics; (2) mandating that physicians review the Ohio Automated Rx Reporting Systems (OARRS) according to standards set by the Ohio State Medical Board; and (3) limiting the amount of controlled substances which can be dispensed from physician offices.

“Ohio’s prescription drug abuse epidemic is quickly spreading throughout our homes and our communities,” said Johnson, who served as Scioto County coroner prior to being elected to the Ohio House of Represenatives. “Southern Ohio in particular has suffered a drastic rise in the number of fatalities as a result of prescription drug overdoses. I’m very pleased that this measure passed from the House with strong bipartisan support. Today saw a great step forward in the ongoing effort to rid Ohio of this scourge.”

Under the new law, a "pain management clinic" is defined as a facility where (1) the primary component of the practice is treatment of pain or chronic pain; and (2) the majority of patients of the prescribers at the facility are treated for pain or chronic pain that includes the use of controlled substances, tramadol, carisoprodol, or other drugs.

The term “majority of patients” is based on the number of patients treated in a one-month time period.  Patients receiving controlled substances, tramadol, carisoprodol or other drugs for treatment of an injury or illness that lasts thirty days or less are not considered in the calculation of the majority.  Hospitals, hospice, ambulatory surgery centers, academic medical centers and medical schools are specifically exempted from the definition.

The legislation traces its roots back to more than a year of activities, starting with the appointment of the Ohio Prescription Drug Abuse Task Force appointed by Gov. Ted Strickland.  Both Johnson and Aaron Adams, DO, who were respectively the coroner and health commissioner of Scioto County at the time, were advocates for legislation to give state regulatory boards the authority they need to shut down “pill mills” that have questionable standards of care and have been traced to drug diversion and addition problems in southern Ohio. 

Because the law goes into effect immediately upon signing, the Ohio State Medical Board has been drafting emergency rules for nearly a month in anticipation of the bill’s passage.  The third set of draft rules was submitted to the Joint Committee on Agency Rule Review last week in order to comply with statutory rule-making requirements.  The OOA, OSMA and an ad hoc expert pain committee of the Medical Board have been debating and revising the proposed rules for several weeks.  They include:

• Rule 4731-11-11, Standards and Procedures for Review of OARRS.  Sets forth a series of circumstances or “red flags” that should prompt a physician to review an OARRS report when prescribing controlled substances.  When a physician is treating a patient in excess of twelve weeks with controlled substances, the physician would be required to review an OARRS report upon commencement of treatment, at least every twelve weeks thereafter, and upon the appearance of any “red flags” listed within the rule.

• Rule 4731-29-01, Standards and Procedures for Operation of a Pain Management Clinic.  Requires each physician providing care at a pain management clinic to hold staff membership at a local hospital with admitting or consulting privileges and to hold board certification or meet one of the equivalencies set forth.  The rule requires the physician owner of a pain management clinic to maintain a log of all patients, develop a quality assurance system, verify staff credentials on an annual basis, maintain billing records for a period of seven years, and maintain patient records for a period of seven years.  Training or subspecialty board certification in pain medicine (ABMS, AOA, ABPM or ABIPPP) or hospital and palliative medicine (ABMS or AOA) or practicing in pain medicine, hospice and palliative care for the last three years with a hospital or clinical professor with a medical school.

Pain management clinics will need to obtain a new category of Terminal Distributor License from the Ohio Board of Pharmacy and must be owned and operated only by physicians.  Owners and employees must submit to criminal records checks and send the results to the Board of Pharmacy.  The OOA will continue to provide updated information from the Ohio State Medical Board and the Ohio Board of Pharmacy as it becomes available. 

To see a copy of the bill as signed by the governor click here.  For a copy of the current proposed rules and information concerning the June 24^th rules hearing, click here