To promulgate new rules related to the registration and inspection of pain management clinics.  


  • RULE NO: RULE TITLE
    64B-4.005: Pain Management Clinic Inspection Fee
    64B-4.006: Pain Management Clinic Registration Requirements, Fees
    PURPOSE AND EFFECT: To promulgate new rules related to the registration and inspection of pain management clinics.
    SUMMARY: Rule 64B-4.005, F.A.C., sets an inspection fee of $1,500 regardless of the number of physicians located in the clinic and Rule 64B-4.006, F.A.C., specifies who must register a clinic. The medical director must ensure that participating physicians have read a pain standards rule and the registration fee is $145 plus a $5 unlicensed activity fee.
    SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS: The agency has determined that these rules will have an impact on small business. It is estimated that approximately 320 pain clinics will register and require an annual inspection. The basis for the department’s charge of $1,500 per inspection is based on a 2 person inspection team including payment of about $125 per hour to a licensed physician and a lower hourly rate to a department employee trained with regard to pharmacy dispensing laws and rules. The purpose of the fees is to collect no more than the actual costs incurred by the department for registering and inspecting the facilities. A Statement of Estimated Regulatory Cost was prepared.
    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, 458.309, 459.005 FS.
    LAW IMPLEMENTED: 458.309(4), 459.005(3) 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-4.005 Pain Management Clinic Inspection Fee.

    An inspection fee of $1,500 shall be paid annually for each location required to be inspected, pursuant to Rule 64B8-9.0132 or 64B15-14.0052, F.A.C. Each location will be assessed the above referenced fee at the time of inspection regardless of the number of physicians who share this location.

    Rulemaking Authority 456.004, 458.309, 459.005 FS. Law Implemented 458.309(4), 459.005(3) FS. History–New________.

     

    64B-4.006 Pain Management Clinic Registration Requirements, Fees.

    (1) Registration Requirements.

    (a) Every practice location prescribing or dispensing Schedule II-IV controlled substances as defined in Sections 458.309(4) and (5) and 459.005(3) and (4), F.S., must register and maintain a valid registration with the Department. To register with the Department, the medical director of a health care clinic licensed pursuant to Chapter 400, F.S., or if the clinic is not licensed pursuant to Chapter 395 or 400, F.S., the clinic’s responsible physician who has an active, full, and unencumbered license issued pursuant to Chapter 458 or 459, F.S., must submit Application for Pain Management Clinic Registration, Form #DH-MQA 1219, effective 10/09, 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 C01, Tallahassee, FL 32399 or on the Board of Medicine or Board of Osteopathic Medicine website, which can be accessed at: www.doh.state.fl.us/mqa.

    (b) The medical director or the designated physician registering the clinic is required to agree to having read Rule 64B8-9.013, F.A.C., Standards for the Use of Controlled Substances for the Treatment of Pain, or Rule 64B15-14.009, F.A.C., Standards for Office Based Opioid Addiction Treatment, and that all physicians practicing in the clinic have been or will be provided with a copy of the rule prior to prescribing or dispensing controlled substance pain medications in the clinic.

    (2) Fees.

    (a) The registration fee shall be $145.00.

    (b) An additional five dollar ($5.00) fee shall be added to the cost of registration to cover unlicensed activity, as required by Section 456.065(3), F.S.

    Rulemaking Authority 456.004, 458.309, 459.005 FS. Law Implemented 458.309(4), 459.005(3) 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: October 28, 2009
    DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAW: September 11, 2009

Document Information

Comments Open:
11/6/2009
Summary:
Rule 64B-4.005, F.A.C., sets an inspection fee of $1,500 regardless of the number of physicians located in the clinic and Rule 64B-4.006, F.A.C., specifies who must register a clinic. The medical director must ensure that participating physicians have read a pain standards rule and the registration fee is $145 plus a $5 unlicensed activity fee.
Purpose:
To promulgate new rules related to the registration and inspection of pain management clinics.
Rulemaking Authority:
456.004, 458.309, 459.005 FS.
Law:
458.309(4), 459.005(3) FS.
Contact:
Larry McPherson, Executive Director, 4052 Bald Cypress Way, Bin C03, Tallahassee, Florida 32399-3253.
Related Rules: (2)
64B-4.005. Pain Management Clinic Inspection Fee
64B-4.006. Pain Management Clinic Fees