Due to the growth of office-based surgery in the state of Florida, members of the Board of Medicine have proposed changes to the office surgery rule. These changes are intended to clarify the definition of office surgery.
During the board meeting on February 6, 2014, the Office Surgery Procedures Subcommittee proposed the rule language which was ratified at the Board of Medicine meeting on April 4, 2014. The approved draft language was filed for adoption on July 2, 2014, and will go into effect on July 22, 2014.
Below is the approved draft language for Rule 64B8-9.009, F.A.C.:
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.
(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,_________.