Important Update on Pain Clinic Licensure and OARRS Reporting/Checking Requirements
In addition to licensing pain management clinics, HB 93 requires all prescribers to periodically review information in the Ohio Automated Rx Reporting System (OARRS). For a complete analysis explaining all provisions in HB 93, click here: HB 93 Analysis.
Any physician (or prescriber) who is not currently registered to access OARRS should do so immediately. For instructions on how to register, see the State Agency Page of this website. HB 93 also allows a prescriber to designate a representative -- who may or may not be a licensed professional -- to consult the database on the prescriber's behalf.
Under HB 93, the Ohio State Medical Board is responsible for developing:
- Standards and procedures for review of the Ohio Automated Rx Reporting System
- Standards and procedures for the operation of pain clinics
- Licensing pain clinics and enforcing standards in consultation with the Ohio State Medical Board
- Enforcing HB 93 as it pertains to in-office dispensing limits and prescribing data that must be submitted to the OARRS database if drugs are personally furnished by the prescriber to a patient (including samples).
Ohio State Medical Board Rule 4731-11-11; Standards and procedures for review of Ohio Automated Rx Reporting System (OARRS)
The proposed OARRS rule - outlining when a prescriber must consult OARRS - is currently under review for additional interested party input. Tentative plans are for the Medical Board to approve changes to the proposed rule during its September meeting. If the board approves the rule, it will move through the standard process with an estimated effective date November 30, 2011. For a copy of the proposed rule, click here.
Ohio State Medical Board Emergency Rule 4731-29-01: Standards and procedures for the operation of a pain management clinic
The emergency (temporary) rule for pain clinic standards expired at midnight on August 30, 2011. Any physician office (which has a patient mix with more than 50 percent of their patients being treated for pain) that applied for licensure under the "grandfathering clause" in the emergency rule must first have his/her office inspected by the Ohio State Medical Board before a license is issued by the Ohio Board of Pharmacy. The Medical Board is developing procedures for inspection, but has not yet begun the inspection process.
Any "pain management clinic" that was not subject to the grandfathering restriction (and otherwise met all the applicable standards in the emergency rule) and applied for licensure by the Board of Pharmacy, should have received its license from the Pharmacy Board. For frequently asked questions about the licenses, consult the Ohio State Pharmacy Board web site.
Ohio State Medical Board Permanent Rule 4731-29-01: Standards and procedures for the operation of a pain management clinic
The permanent rule was effective August 31, 2011. Download a booklet containing a list of Frequently Asked Questions about the new rule by clicking here: Pain Rule Frequently Asked Questions. Permanent rule 4731-29-01 can be found in its entirety at the following link:
Ohio Board of Pharmacy Proposed Rule 4729-37-07 Frequency Requirements for Submitting Drug Database Information
The Ohio Board of Pharmacy conducted a rules hearing, September 12, on prescriber reporting requirements for all controlled substances that are dispensed or personally furnished by an office-based physicians. The draft is being revised based on testimony and will subsequently be approved by the Pharmacy Board for the standard rule-making process within the next thirty days.
HB 93 establishes limits on the amount of controlled substances that may be personally furnished by prescribers on a monthly and 72-hour basis. Although "personally furnish" is not defined in current law or the bill, it is a term that is used to describe the action of a prescriber who provides a whole or partial supply of drugs to a patient for the patient's personal use. This is in contrast to the action of directly administering a drug to a patient.
The bill applies the limits to all types of prescribers, other than veterinarians. In effect, however, the limits apply only to prescribers who are physicians, podiatrists, or dentists. The remaining types of prescribers (i.e., advanced practice nurses, physician assistants, and optometrists) currently do not have authority to personally furnish supplies of controlled substances to patients.
The bill's specific limits on personally furnishing controlled substances are as follows:
- Monthly: In any 30-day period, an amount of all controlled substances combined that exceeds a total of 2,500 dosage units;
- 72-hour period: In any 72-hour period, an amount of a controlled substance provided to or for a patient that exceeds the amount necessary for the patient's use in a 72-hour period.
- Any amount of methadone personally furnished to a patient for the purpose of treating drug addiction does not count toward the limits.
If a prescriber violates the bill's limits, the prescriber is subject to a $5,000 administrative fine. Each instance of a violation is subject to an additional fine.
All prescribers must review information in the OARRS as specified by the Ohio State Medical Board in the OARRS Rule. HB 93 also establishes an OARRS reporting requirement for prescribers who personally furnish to a patient a controlled substance or other dangerous drug specified by the Pharmacy Board. This pertains to all prescribers, not just those practicing in a pain management clinic. Specifically, a prescriber must submit the following information:
- Prescriber identification;
- Patient identification;
- Date drug was personally furnished by the prescriber;
- Indication of whether the drug is new or a refill;
- Name, strength, and national drug code of drug furnished;
- Quantity of drug furnished;
- Number of days' supply of drug furnished.27
Prescribers who fail to report information to OARRS may be subject to disciplinary action.
Bottom line: Under the current draft, if you dispense drugs to a patient to take with them or give them samples, you will have to report what you dispense or give as samples on a weekly basis as the rule now stands. The draft rules require that all of the following be reported:
- All schedule II controlled substances
- All Schedule III controlled substances
- All Schedule IV controlled substances
- All schedule V controlled substances dispense pursuant to a prescription;
- All schedule V controlled substances sold to a prescriber at wholesale;
- All dangerous drug products containing carisoprodol
- All dangerous drug products containing tramadol
The State Medical Board of Ohio considered comments and testimony from its June 24th public hearing and voted to revise the wording of proposed permanent rule 4731-29-01, Standards and Procedures for the Operation of a Pain Management Clinic. The revisions were made during its July monthly meeting and included the following:
- The addition of definitions to clarify certain terms used within the rule;
- The addition of provisions to reflect the changes in the definition of a pain management clinic that were made in the budget bill (HB 153 of the 129th General Assembly);
- The deletion of the requirement that physicians providing care at a pain management clinic hold specified professional credentials;
- The deletion of the requirement that the owners of and the physicians providing medical services at a pain management clinic hold hospital privileges;
- The addition of disciplinary actions involving dangerous drugs to the licensure actions that prohibit a physician from owning or providing care at a pain management clinic;
- The addition of a requirement that physician owners of, and physician providers at, a pain management clinic complete continuing medical education in pain medicine, to include one or more courses addressing the potential for addiction; and
- The addition of a requirement that owners of a pain management clinic hold specified professional credentials.
About 16 witnesses testified at the June 24th Ohio State Medical Board hearing on rules implementing HB 93, which went into effect by executive order of Governor Kasich. The rules specifically deal with standards for operating a pain management clinic and mandatory use of the Ohio Automated Rx Reporting System (OARRS) by all licensed physicians.
The emergency order took effect immediately upon being filed and allowed the Medical Board to adopt the emergency rule while bypassing the normal O.R.C. §119.03 rule-making procedure. However, the emergency order expired on the 91st day after its effective date (August 30).
In order to effectively readopt the rule, the agency must abide by the normally applicable rule-making procedure pursuant to O.R.C. §119.03(A)-(E) through the Joint Committee on Agency Rule Review (JCARR). The Medical Board , alternatively, elected to make changes to the rule and adopt it as it would any other rule through JCARR.
Among those testifying were:
- OOA Executive Director Jon F. Wills, who presented testimony on behalf of the American Osteopathic Association;
- OOA Legal Counsel Eric Jones, who presented testimony on behalf of the Ohio Osteopathic Association;
- Cleanne Cass , DO, OOA's representative on the Ohio Prescription Abuse Task Force, who spoke on her own behalf; and
- Three other DOs who testified as interested parties, including two family physicians and a former ER physician who runs an integrated pain management clinic near Doctors Hospital here in Columbus.
Other medical organizations presenting testimony included: the American Board of Pain Management, the Ohio State Medical Association, the Ohio Society of the American Academy of Pediatricians, the Ohio Psychiatric Physicians Association, the Ohio Society of Anesthesiologists, the Ohio Hospice Organization, the Ohio Medical Directors Associations (Nursing Homes) and the Ohio Pain Initiative.
Several MDs also testified, as well a chiropractor and the former wife of an MD, who inherited a pain clinic from her husband. Both have own pain clinics where prescribing physicians practice. The new law restricts pain management clinic ownership to physicians only.
- For a copy of the AOA's testimony, which focused on laws in other states and AOA certificates of added qualification, click here: AOA Pain Testimony
- For a copy of the OOA's testimony, which recommends deletion of BWC patients from the definition of a pain management clinic patient, click here: OOA Testimony
- For a copy of a "House of Medicine" letter, recommending that the OARRS rule be issued as recommendations only, click here: House of Medicine Testimony