The proposed rule amendments are intended to clarify the definition of office surgery.

 

DEPARTMENT OF HEALTH

Board of Medicine

RULE NO.:RULE TITLE:

64B8-9.009Standard of Care for Office Surgery

PURPOSE AND EFFECT: The proposed rule amendments are intended to clarify the definition of office surgery.

SUMMARY: The proposed rule amendments clarify the definition of office surgery.

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 determined that a Statement of Estimated Regulatory Costs (SERC) was not necessary and that the rule will not require ratification by the Legislature because the rule amendment in question actually excludes certain surgical procedures involving major blood vessels from those that would require an office facility to register with DOH pursuant to Section 458.309(3). Prior to this action, some facilities had registered as office surgery facilities because they were performing the procedures outlined in the amendment. Upon the effective date of this amendment, these facilities will no longer require registration and this will result in less regulation and less regulatory costs. Representatives from the Florida Society of Thoracic Surgeons, Florida Vascular Society and Lifeline Vascular Access appeared and provided testimony to the Board as to the procedures that could be excluded from the scope of this rule and submitted additional information regarding the economic impact.

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), 458.331(1)(v) FS.

LAW IMPLEMENTED: 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) Definitions.

(a) through (c) No change.

(d) Office surgery. For the purpose of this rule office surgery is defined as surgery which is performed outside of any facility licensed under Chapter 390 or 395, F.S. Office surgical procedures shall not be of a type that generally result in blood loss of more than ten percent of estimated blood volume in a patient with a normal hemoglobin; require major or prolonged intracranial, intrathoracic, abdominal, or major joint replacement procedures, except for laparoscopic procedures; directly involve major blood vessels performed with direct visualization by open exposure of the major vessel, except for percutaneous endovascular intervention; or are generally emergent or life threatening in nature.

(e) Percutaneous endovascular intervention. For the purpose of this rule percutaneous endovascular intervention is defined as a procedure performed without open direct visualization of the target vessel, requires only needle puncture of an artery or vein followed by insertion of catheters, wires, or similar devices which are then advanced through the blood vessels using imaging guidance. Once the catheter reaches the intended location various maneuvers to address the diseased area may be performed which include,  but are not limited to, injection of contrast for imaging, treatment of vessels with angioplasty, atherectomy, covered or uncovered stenting, intentionally occluding vessels or organs (embolization), and delivering medications, radiation, or other energy such as laser, radiofrequency, or cryo.

(f) Major Blood Vessels. For the purpose of this rule major blood vessels are defined as group of critical arteries and veins including the aorta, coronary arteries, pulmonary arteries, superior and inferior vena cava, pulmonary veins, and any intra-cerebral artery or vein.

(g)(e) Pediatric patients are defined as those patients who are 13 years of age or under.

(2) 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, 8-1-01, 8-12-01, 3-25-02, 3-22-05, 4-19-05, 10-23-05, 10-10-06, 4-18-07, 9-3-07, 3-25-10, 8-6-12, 11-22-12, 1-9-13, 3-3-13,_________.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Office Surgery Procedures Subcommittee, Board of Medicine

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Board of Medicine

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: April 4, 2014

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: May 14, 2014