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:

The Ohio Board of Pharmacy is responsible for

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:

http://www.registerofohio.state.oh.us/pdfs/4731/0/29/4731-29-01_PH_FF_N_RU_20110819_1130.pdf

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:

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: 

  1. Prescriber identification; 
  2. Patient identification; 
  3. Date drug was personally furnished by the prescriber;
  4. Indication of whether the drug is new or a refill; 
  5. Name, strength, and national drug code of drug furnished; 
  6. Quantity of drug furnished;
  7. 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:

  1. All schedule II controlled substances
  2. All Schedule III controlled substances
  3. All Schedule IV controlled substances
  4. All schedule V controlled substances dispense pursuant to a prescription;
  5. All schedule V controlled substances sold to a prescriber at wholesale;
  6. All dangerous drug products containing carisoprodol
  7. 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:

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:

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.  

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