The proposed rule amendment updates the overall standards of practice for the prescribing of medication for the treatment of obesity in children and adults and allows for the use of telemedicine for such prescribing.

 

DEPARTMENT OF HEALTH

Board of Medicine

RULE NO.:RULE TITLE:

64B8-9.012Standards for the Prescription of Obesity Drugs

PURPOSE AND EFFECT: The proposed rule amendment updates the overall standards of practice for the prescribing of medication for the treatment of obesity in children and adults and allows for the use of telemedicine for such prescribing.

SUMMARY: To update the text with the prescribing of medication for the treatment of obesity in children and adults and the use of telemedicine for such prescribing.

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: 458.336 FS.

LAW IMPLEMENTED: 458.336 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:

 

64B8-9.012 Standards for the Prescription of Drugs to Treat Obesity Drugs. 

The prescribing prescription of anti-obesity  drugs medication for the purpose of enhancing weight loss should only be performed by physicians qualified by training and experience to treat obesity. All licensees are expected to abide by the following guidelines and standards in the utilization of any drug, any synthetic compound, any nutritional supplement, or herbal treatment, for the purpose of providing medically assisted weight loss. For purposes of this rule, “anti-obesity drugs” means any drug, synthetic compound, nutritional supplement, or herbal treatment used for the purpose of providing medically assisted weight loss. 

(1) To justify the use of anti-obesity drugs weight loss enhancers as set forth above, the patient must have an initial Body Mass Index (BMI) of 30 or above, or an initial BMI of greater than 27 with at least one comorbidity factor, or an initial measurable body fat content equal to or greater than 25% of total body weight for male patients or 30% of total body weight for women. The treating physician may also take into account other factors such as ethnicity-specific values and markers such as waist circumference when justifying the use of anti-obesity drugs. The prescription of such weight loss enhancers is not generally appropriate for children. Any time such prescriptions are made for children, the prescribing physician must obtain a written informed consent from the parent or legal guardian of the minor patient in addition to complying with the other guidelines and standards set forth in this rule. BMI is calculated by use of the formula BMI = weight(kg)/height(m2)BMI = kg/m2.

(2) Physicians in Florida are prohibited from prescribing, ordering, dispensing, or administering any anti-obesity drug weight loss enhancer that is both a serotonergic and anorexic agent unless the drug has been approved by the Food and Drug Administration (FDA) specifically for use in weight loss management. Selective serotonin re-uptake inhibitors (SSRIs) that have not been approved by the FDA for weight loss may not be prescribed, ordered, dispensed, or administered for such purposes.

(3) Physicians may only prescribe anti-obesity drugs to children with an initial BMI greater than 120th percent of the 95th percentile with significant comorbidity or an initial BMI greater than 140th percent of the 95th percentile.

(4)(3) An initial evaluation of the patient shall be conducted prior to the prescribing, ordering, dispensing, or administering of any drug, synthetic compound, nutritional supplement or herbal treatment and such evaluation shall include an appropriate physical and complete history; appropriate tests related to medical treatment for weight loss; and appropriate medical referrals as indicated by the physical examination, history, and testing; all in accordance with general medical standards of care. The initial evaluation may be delegated to an appropriately educated and trained physician’s assistant licensed pursuant to Chapter 458 or 459, F.S., or an appropriately educated and trained advanced practice registered nurse licensed pursuant to Chapter 464, F.S.

(a) The initial evaluation may be delegated to an appropriately educated and trained physician’s assistant licensed pursuant to Chapter 458, F.S., or an appropriately educated and trained advanced registered nurse practitioner licensed pursuant to Chapter 464, F.S.

(b) If the initial evaluation required above is delegated to a physician’s assistant or to an advanced registered nurse practitioner, then the delegating physician must personally review the resulting medical records prior to the issuance of an initial prescription, order, or dosage.

(4) Prescriptions or orders for any drug, synthetic compound, nutritional supplement or herbal treatment for the purpose of assisting in weight loss must be in writing and signed by the prescribing physician. Initial prescriptions or orders of this type shall not be called into a pharmacy by the physician or by an agent of the physician. Even if the physician is registered as a dispensing physician, a hard copy of the written prescription must be maintained in the patient’s medical records for each time such weight loss enhancers are prescribed, ordered, dispensed, or administered.

(5) Prior to prescribing, ordering, dispensing, or administering anti-obesity drugs At the time of delivering the initial prescription or providing the initial supply of such drugs to a patient, the prescribing physician must personally meet with the patient and personally obtain an appropriate written informed consent from the patient. Such consent must state that there is a lack of scientific data regarding the potential danger of long term use of combination weight loss treatments, and shall discuss potential benefits versus potential risks of weight loss treatments. The written consent must also clearly state the need for dietary intervention and physical exercise as a part of any weight loss regimen. A copy of the signed informed consent shall be included in the patient’s permanent medical record.

(6) Each physician who is prescribing, ordering, or providing anti-obesity drugs weight loss enhancers to patients must assure that such patients undergo an in-person re-evaluation at least once every 3 months. within 2 to 4 weeks of receiving a prescription, order, or dosage. The re-evaluation shall include the elements of the initial evaluation and an assessment of the medical effects of the treatment being provided. Any patient that continues on a drug, synthetic compound, nutritional supplement or herbal treatment assisted weight loss program shall be re-evaluated at least once every 3 months.

(7) Each physician who prescribes, orders, dispenses, or administers any drug, synthetic compound, nutritional supplement or herbal treatment for the purpose of assisting a patient in weight loss shall maintain medical records in compliance with Rule 64B8-9.003, F.A.C., and must also reflect compliance with all requirements of this rule.

(7)(8) Each physician who prescribes, orders, dispenses, or administers anti-obesity drugs weight loss enhancers for the purpose of providing medically assisted weight loss shall provide to each patient a legible copy of the Weight-Loss Consumer Bill of Rights as set forth in Sections 501.0575(1)(a) through (e)3., F.S. The physician shall also conspicuously post said document in those rooms wherein patients are evaluated for weight loss treatment.

(8)(9) Any physician who advertises practice relating to weight loss that includes the prescribing of anti-obesity drugs or whose services are advertised by another person or entity shall be responsible for assuring that such advertising meets the requirements of Rule 64B8-11.001, F.A.C. In addition Aadvertising of weight loss treatment shall be considered false, deceptive, or misleading if it contains representations that:

(a) through (e)  No change.  

Rulemaking Authority 458.336 FS. Law Implemented 458.336 FS. History–New 12-4-97, Amended 2-17-98,                          .

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Rules/Legislative Committee, Board of Medicine

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

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: April 8, 2022

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: July 9, 2021