The proposed rule amendment is intended to clarify the rule including 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 amendment is intended to clarify the rule including the definition of office surgery.

SUMMARY: Clarification of the rule including 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 concluded that this rule change will not have any impact on licensees and their businesses or the businesses that employ them. The rule will not increase any fees, business costs, personnel costs, will not decrease profit opportunities, and will not require any specialized knowledge to comply. This change will not increase any direct or indirect regulatory costs. Hence, 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. 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), 458.328(2), 458.331(1)(v) FS.

LAW IMPLEMENTED: 458.328, 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: Paul Vazquez, J.D., Executive Director, Board of Medicine/MQA, 4052 Bald Cypress Way, Bin #C03, Tallahassee, Florida 32399-3253, [e-mail]

 

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.

1.  For the purpose of this rule, office surgery is defined as surgery which is performed in an office maintained by a physician for the practice of medicine where a surgeon performs procedures as permitted by this rule and is governed pursuant to Rule 64B8-9.0091, F.A.C., and Section 458.328, F.S.  The Physician’s office must be an office at which the the surgeon regularly performs consultations with surgical patients, pre-surgical examinations, and post-surgical care related to the surgeries performed at the physician’s office, and where patient records are readily maintained and available. 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; 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.

2.  A facility that meets the definition of an ambulatory surgical center as defined in Section 395.002(3), F.S., a hospital as defined in Section 395.002(12), F.S., or an abortion clinic as defined in Section 390.011(2), F.S., may not be registered as an office surgery facility under Rule 64B8-9.0091, F.A.C.

(e) through (g)  No change.

(2)  through (6) No change.  

(7)  This rule shall be reviewed, and if necessary, repealed, modified, or renewed through the rulemaking process five years from the effective date.

Rulemaking Authority 458.309(1), 458.328(2), 458.331(1)(v) FS. Law Implemented 458.328, 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, 7-22-14, 4-6-15, 9-4-16, 5-22-17, 6-23-17, 9-4-17, 5-7-18, 7-2-18, 9-3-19, 3-2-20, 3-10-22,                   .

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Joint Surgical Care/Quality Assurance Committee, Board of Medicine and Board of Osteopathic Medicine

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

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: December 1, 2023

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: April 12, 2024