The proposed rule amendments are intended to clarify language with regard Level I office surgery procedures and to require the addition of certain drugs to be maintained when performing such procedures.

 

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 language with regard Level I office surgery procedures and to require the addition of certain drugs to be maintained when performing such procedures.

SUMMARY: The proposed rule amendments clarify language with regard Level I office surgery procedures and require the addition of certain drugs to be maintained when performing such procedures.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION: The Agency has determined that this will 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 been prepared by the Agency.

The Agency has determined that the proposed rule is 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: The SERC concludes that approximately 20,468 physicians’ offices would perform minor procedures as defined in the proposed rule, and would therefore require the inclusion of Flumazenil and Naloxone to be kept on hand when performing these procedures. The cost of these additional medications for each office which does not currently utilize these drugs would be approximately $94.66. The total amount calculated in the SERC is expected to be $1,937,500.88. The shelf life for these drugs is at, or exceeds 5 years, so no replacement costs are included in the SERC. Hence, the rule will 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), 458.331(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: Claudia Kemp, J.D., 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) through (2) No change.

(3) Level I Office Surgery.

(a) Scope. Level I office surgery includes the following:

1. Minor procedures such as excision of skin lesions, moles, warts, cysts, lipomas and repair of lacerations or surgery limited to the skin and subcutaneous tissue performed under topical or local anesthesia not involving drug-induced alteration of consciousness other than minimal pre-operative tranquilization of the patient. The patient’s level of sedation is that of minimal sedation and anxiolysis. Minimal sedation and anxiolysis is a drug-induced state during which patients respond normally to verbal commands. Although cognitive function and physical coordination may be impaired, airway reflexes, and ventilatory and cardiovascular functions are unaffected.

2. through 3. No change.

4. Anesthesia is limited to minimal sedation. The patient's level of sedation is that of minimal sedation and anxiolysis and the chances of complications requiring hospitalization are remote.  Minimal sedation and anxiolysis is a drug-induced state during which patients respond normally to verbal commands.  Although cognitive function and physical coordination may be impaired, airway reflexes, and ventilatory and cardiovascular functions are unaffected.  Controlled substances, as defined in Sections 893.02 and 893.03, Florida Statutes, are limited to oral administration in doses appropriate for the unsupervised treatment of insomnia, anxiety or pain. Pre-operative medications not required or used other than minimal pre-operative tranquilization of the patient; anesthesia is local, topical, or none. No drug-induced alteration of consciousness other than minimal pre-operative tranquilization of the patient is permitted in level I Office Surgery.

5. No change.

(b) Standards for Level I Office Surgery.

1. No change.

2. Equipment and Supplies Required. Intravenous access supplies, oxygen, oral airways, and a positive pressure ventilation device shall be available in the office, along with the following medications, stored per manufacturer’s recommendation:

a. through d. No change.

e. Hydrocortisone Hydrocortison 100 mg.

f. If a benzodiazepine is administered, Flumazenil 0.5 mg in 5 ml vial, 2 vials total; and

g. If an opiate is administered, Nalaxone 0.4 mg in 1 ml vial, 2 vials total.

3. through 4. No change.

(4) 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, 7-22-14, 4-6-15,_________.                 

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Board of Medicine and Board of Osteopathic Medicine Joint Office Surgery Subcommittee

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

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: December 4, 2015

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: April 21, 2016