The Florida Board of Medicine recently amended its office surgery rules to exclude numerous facilities, and providers who inadvertently may have been in violation of the previous rule requirements by not having registered their offices to perform office surgery. Rule 64B8-9.009, Fla. Admin. Code, sets forth the standard of care for office surgery. The rule previously defined office surgery, in part, as the type of surgical procedures that "do not result in blood loss of more than ten percent of estimated blood volume in a patient with normal hemoglobin; require major or prolonged intracranial, intrathoracic, abdominal, or major joint replacement procedures except for laparoscopic procures; directly involve major blood vessels; or are generally emergent or life threatening in nature."
The exclusion of surgical procedures that "directly involve major blood vessels" from the type of procedure that could be done in an office setting was confusing for many physicians. It was unclear whether procedures that require insertion of catheters, wires or other devices to advance through blood vessels, using imaging guidance, would be considered office surgery such that these physicians would be required to register their offices and comply with all office surgery rule requirements. The matter was brought to the attention of the Board of Medicine, input was solicited and gathered from the profession and other States, and the Board came up with a solution rather quickly. Rather than require these facilities and physicians to register and come under the regulatory scheme for office surgery providers, the Board opted to amend the rule to clarify that percutaneous endovascular intervention does not constitute office surgery.
The amended rule defines percutaneous intervention 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, artherectomy, covered or uncovered stenting, intentionally occluding vessels or organs (embolization), and delivering medications, radiation, or other energy such as laser, radiofrequency, or cryo."
This extensive definition covers a long list of procedures performed by a variety of specialties. Registration for all of the providers of these procedures could have overwhelmed regulatory inspectors and other staff. Moreover, given the other criteria for procedures eligible for office surgery—non emergent and not life threatening, no major blood loss, not overly invasive—percutaneous intervention fit nicely within the intended scope of the original rule.
However, despite the amendment, all physicians should remain mindful of the preamble to the office surgery rule:
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.
This remains good advice.