The proposed rule amendments are intended to address the requirement for transfer agreements and to clarify when transfer agreements are necessary.

 

DEPARTMENT OF HEALTH
Board of Medicine

RULE NOS.:RULE TITLES:
64B8-9.009Standard of Care for Office Surgery
64B8-9.0091Requirement for Physician Office Registration; Inspection or Accreditation
PURPOSE AND EFFECT: The proposed rule amendments are intended to address the requirement for transfer agreements and to clarify when transfer agreements are necessary.
SUMMARY: The proposed rule amendments to Rule 64B8-9.009, F.A.C., require that in certain office settings, either the physician or the facility must have a transfer agreement with a licensed hospital. The proposed rule amendments to Rule 64B8-9.0091, F.A.C., specify that when the physician is performing the procedures outlined in the rule, and in instances where the facility is already registered, the physician must document compliance with the transfer agreement and training requirements. Additionally, another form of authorization is not necessary in an office which is registered with the Department.
SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION:
The Agency has determined that this will not have an adverse impact on small business or likely increase directly or indirectly regulatory costs in excess of $200,000 in the aggregate within one year after the implementation of the rule. A SERC has not been prepared by the agency.
The Agency has determined that the proposed rule is not expected to require legislative ratification based on the statement of estimated regulatory costs or if no SERC is required, the information expressly relied upon and described herein: During discussion of the economic impact of this rule at its Board meeting, the Board, based upon the expertise and experience of its members, determined that a Statement of Estimated Regulatory Costs (SERC) was not necessary and that the rule will not require ratification by the Legislature. No person or interested party submitted additional information regarding the economic impact at that time.
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.
RULEMAKING AUTHORITY: 458.309(1),(3), 458.331(1)(v) FS.
LAW IMPLEMENTED: 456.069, 458.309(3), 458.331(1)(v), 458.351 FS.
IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN THE FAR.
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Allison M. Dudley, Executive Director, Board of Medicine/MQA, 4052 Bald Cypress Way, Bin # C03, Tallahassee, Florida 32399-3253

THE FULL TEXT OF THE PROPOSED RULE IS:

64B8-9.009 Standard of Care for Office Surgery.

NOTHING IN THIS RULE RELIEVES THE SURGEON OF THE RESPONSIBILITY FOR MAKING THE MEDICAL DETERMINATION THAT THE OFFICE IS AN APPROPRIATE FORUM FOR THE PARTICULAR PROCEDURE(S) TO BE PERFORMED ON THE PARTICULAR PATIENT.

(1) through (3) No change.

(4) Level II Office Surgery.

(a) No change.

(b) Standards for Level II Office Surgery.

1. Transfer Agreement Required. The physician, or the facility where the procedure is being performed, must have a transfer agreement with a licensed hospital within reasonable proximity if the physician performing the procedure does not have staff privileges to perform the same procedure as that being performed in the out-patient setting at a licensed hospital within reasonable proximity. “Reasonable proximity” is defined as not to exceed thirty (30) minutes transport time to the hospital.

2.  through 4.  No change.

(5)  through (6) No change.

Rulemaking Authority 458.309(1), 458.331(1)(v) FS. Law Implemented 458.331(1)(v), 458.351 FS. History–New 2-1-94, Amended 5-17-94, Formerly 61F6-27.009, Amended 9-8-94, 11-15-94, Formerly 59R-9.009, Amended 2-17-00, 12-7-00, 2-27-01, 9-01-01, 8-12-01, 3-25-02, 3-22-05, 4-19-05, 10-23-05, 10-10-06, 4-18-07, 9-03-07, 3-25-12, 8-6-12, 11-22-12,               .

64B8-9.0091 Requirement for Physician Office Registration; Inspection or Accreditation.

(1) Registration.

(a) through (d)  No change. 

(e)  If a physician intends to perform liposuction procedures where more than 1,000 cubic centimeters of supernatant fat is removed, Level II surgical procedures with a maximum planned duration of more than five (5) minutes, or any Level III office surgery in an office that is already registered puruant to this rule, the physician must document compliance with the transfer agreement requirements set forth in Rule 64B8-9.009(4)(b)1. and the training requirements set forth in Rule 64B8-9.009(4)(b)2.a. prior to performing such procedures.

(f)  This rule shall not be interpreted as requiring a physician to register with the Department of Health or to obtain any other form of authorization from the Department of Health to perform office surgery in an office that has been registered in accordance with this rule.

(2) through (3)  No change.

Rulemaking Authority 458.309(1),(3) FS. Law Implemented 456.069,458.309(3) FS. History–New 5-15-00, Amended 9-18-01, 8-5-03, 9-1-03, 2-9-05, 8-22-06, 10-30-07,                  .

NAME OF PERSON ORIGINATING PROPOSED RULE: Surgical Care Committee, Board of Medicine
NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Board of Medicine
DATE PROPOSED RULE APPROVED BY AGENCY HEAD: November 30, 2012
DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: December 14, 2012