Developments of new drugs and medical technology have enabled physicians to perform treatments and procedures in the comfort of medical offices that were once only able to be performed in hospital settings. To confirm whether obtaining an Office Surgery License is required for your office to perform these surgeries you must carefully examine the rules on office surgeries because they have changed recently.
The Office Surgery Rule
On June 25, 2019, Governor Ron DeSantis signed Senate Bill 732 into law. This rule provides guidance on how office procedures can be performed. It also delivers certain standards for these offices and requires that any office performing office surgery procedures be registered with the Department of State. As of January 2020, all offices performing liposuctions over 1000ccs, or Level 2 or Level 3 surgeries must register and comply with statute requirements. According to the Florida Board of Medicine, any office performing “Level 2 procedures lasting more than 5 minutes, and all level 3 surgical procedures in an office setting must register the office with the department unless that office is licensed as a facility under chapter 395, 458.309(3) F.A.C.)”. In any case, office surgical procedures should not result in blood loss of more than 10 percent of estimated blood volume in a patient or directly engage any main blood vessels, or be considered life threatening in nature.
What are the levels of Office Surgery?
Level 1 Surgeries are procedures that require none to minimal pre-operative medications or tranquilizations. Any anesthesia used must be local and conscious altering medication is not administered. This includes but is not limited to excision of moles, warts, lesions, cysts; liposuction, removing less than 4000cc of fat, skin biopsies, drainage of superficial abscesses, etc.
Level 2 Surgeries can use sedation or peri-operative medicines that alter levels of consciousness which, in turn, require some post-operative monitoring. These procedures include, but are not limited to breast biopsies, colonoscopies, hernia repair, etc.
Level 3 Surgeries are procedures that absolutely should utilize general anesthesia or pre-operative sedation. This can include intravenous sedation, major conductive anesthesia, and general anesthesia.
For each level, there are specific outlines for medication, equipment, and registration requirements which can be found by visiting: http://www.doh.state.fl.us/mqa/medical/osr_home.html.
Pain Management Facilities
While anesthesia blocks are considered ‘surgical procedures’ by the Florida Board of Medicine, the level of sedation would determine the surgery procedure level.
How to Register for an Office Surgery License
The registering Surgeon should submit an Office Surgery Registration form with an original signature. The office must also provide proof of completion of necessary training (i.e. certificates/diplomas) by all physicians. If any physicians that will also be performing Level 2 or Level 3 surgeries are hired to the office after the approval, the Department must be notified immediately to update records.
If an office plans to engage in surgeries that require a license and recognition with the Department of Health, there are ethics standards to be upheld and requirements that must be complied with. The requesting medical offices are subject to be inspected by the Department of Health and each office should have a designated physician responsible for ensuring compliance. Medical offices also need to exhibit the required minimal financial responsibility as outlined by the State.
It should be noted that I am not your lawyer (unless you have presently retained my services through a retainer agreement). This post is not intended as legal advice, it is purely educational and informational, and no attorney-client relationship shall result after reading it. Please consult your own attorney for legal advice. If you do not have one and would like to retain my legal services, please contact me using the contact information listed above.
All information and references made to laws, rules, regulations, and advisory opinions were accurate based on the law as it existed at this time, but laws are constantly evolving. Please contact me to be sure that the law which will govern your business is current. Thank you.