The department determined the need to update the clinic registration requirements in accordance with Chapter 2010-211, Laws of Florida.

DEPARTMENT OF HEALTH
Division of Medical Quality Assurance

Rule No.: RULE TITLE
64B-7.001: Pain Management Clinic Registration Requirements
PURPOSE AND EFFECT: The department determined the need to update the clinic registration requirements in accordance with Chapter 2010-211, Laws of Florida.
SUMMARY: This rule describes the ownership and other requirements for registering as a pain-management clinic and for maintaining that registration. It defines what constitutes practice at the clinic location and incorporates by reference the form required for registration.
SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS: The agency has determined that this rule will have an impact on small business. A SERC has been prepared by the agency. The SERC indicates the number of pain-management clinics that will be affected by the rule.
Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.
SPECIFIC AUTHORITY: 456.004, 458.3265(4), 459.0137(4) FS.
LAW IMPLEMENTED: 456.037, 456.0635, 458.3265, 459.0137 FS.
IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN FAW.
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Larry McPherson, Executive Director, 4052 Bald Cypress Way, Bin #C03, Tallahassee, Florida 32399-3253

THE FULL TEXT OF THE PROPOSED RULE IS:

64B-7.001 Pain Management Clinic Registration Requirements.

(1) Every practice location or clinic that is advertising pain-management services or employing a physician who is primarily treating pain by administering, prescribing or dispensing controlled substance medications, unless exempt under Sections 458.3265(1) or 459.0137(1), F.S., must register and maintain a valid registration with the Department. Every registered practice clinic location upon change of ownership must register and maintain a valid registration with the Department. To be eligible to register with the Department, the clinic must meet the statutory requirements, which include the requirement that the clinic be fully owned by a physician or group of physicians who are currently licensed pursuant to Chapter 458 or 459, F.A.C., or licensed as a health care clinic with the Agency for Health Care Administration pursuant to Part X of Chapter 400, F.S.

(2) The clinic’s designated physician must have a full, active, and unencumbered license, which includes:

(a) Having a clear, active license as a medical doctor or osteopathic physician under Chapter 458 or 459, F.S., that permits the physician to perform all duties authorized by holding a license without restriction.

(b) Having a license that is not designated as limited, restricted, retired, temporary, training, or that includes other limitations.

(c) Having a license with no restrictions on practice and no current disciplinary or other unsatisfied obligations imposed by the Board of Medicine, Board of Osteopathic Medicine, or the Department that limits or restricts the practice of medicine or osteopathic medicine, which includes suspension, probation, or any other restrictions on practice.

(3) The designated physician “shall practice at the clinic location,” which means retaining documentation of being physically present and practicing medicine or osteopathic medicine at that location for no less than at least 33% of the hours per week that the clinic is open for business. For clinic locations with 3 or more physicians administering, prescribing, or dispensing controlled substance medications, including the designated physician, or for those clinic locations administering, prescribing or dispensing more than half the maximum number of controlled substance prescriptions that the boards allow a clinic to issue over a 24-hour period, the designated physician must be present at least 67% of the hours per week that the clinic is open for business. When the designated physician is unable to be present to meet these requirements, any administering, prescribing or dispensing of controlled substance medications at the clinic must cease unless and until another designated physician is approved by the board.

(4) To register with the Department, the designated physician must submit Application for Pain Management Clinic Registration, Form #DH-MQA 1219, 10/10, incorporated herein by reference. This form can be obtained from the Department of Health, Division of Medical Quality Assurance, at: 4052 Bald Cypress Way, Bin C-01, Tallahassee, FL 32399 or on the Board of Medicine or Board of Osteopathic Medicine website, which can be accessed at: www.flhealthsource.com or at [e-mail]. At this mail or electronic address, the clinic owner is responsible to provide notice of the departure of the designated physician and, within 10 days after termination, the identity of another designated physician for the clinic. At this mail or electronic address, the designated physician at a registered clinic also within 10 days of departure shall notify the board of the date of termination from employment.

Rulemaking Authority 456.004, 458.3265(4), 459.0137(4) FS. Law Implemented 456.037, 456.0635, 458.3265, 459.0137 FS. History– New_______.

NAME OF PERSON ORIGINATING PROPOSED RULE: Larry McPherson
NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Ana M. Viamonte Ros, M.D. M.P.H.
DATE PROPOSED RULE APPROVED BY AGENCY HEAD: September 14, 2010
DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAW: August 6, 2010