The Board proposes the rule amendment to 64B13-3.002, F.A.C. to delete language that is a restatement of subsection 456.057(2), F.S., and to renumber the rule accordingly; the proposed amendment to 64B13-3.006, F.A.C. is to delete language that is ...

 

DEPARTMENT OF HEALTH

Board of Optometry

RULE NOS.:RULE TITLES:

64B13-3.002Responsibility to Patient

64B13-3.006Licenses and Signs in Office

64B13-3.008Corporate, Lay, and Unlicensed Practice of Optometry Prohibited

64B13-3.009False, Fraudulent, Deceptive and Misleading Advertising Prohibited; Policy; Definitions; Affirmative Disclosure

64B13-3.010Standards of Practice

64B13-3.012Prescriptions

64B13-3.015Performance of Delegated Tasks by Non-Licensed Personnel

PURPOSE AND EFFECT: The Board proposes the rule amendment to 64B13-3.002, F.A.C. to delete language that is a restatement of subsection 456.057(2), F.S., and to renumber the rule accordingly; the proposed amendment to Rule 64B13-3.006, F.A.C. is to delete language that is a restatement of subsection 463.011, F.S. from the rule and to renumber the rule accordingly; the proposed amendment to Rule 64B13-3.008, F.A.C., is to delete language from the rule that is a restatement of subsections 463.001, 463.002, 463.014, and 483.002, F.S., and to renumber the rule accordingly; The proposed amendment to Rule 64B13-3.009, F.A.C. is to delete language that is a policy statement and does not constitute a rule, restates subsection 463.016, F.S., and delete language that contradicts Florida Statutes and to renumber the rule accordingly; the proposed amendment to Rule 64B13-3.010, F.A.C. is to delete language that restates subsections 463.016, 463.0135, and 463.072, F.S. and to add language to clarify administration and prescription of ocular pharmaceutical agents, and to renumber the rule accordingly; the proposed amendment to Rule 64B13-3.012, F.A.C. is to delete unnecessary language from the rule and renumber the rule accordingly; the proposed amendment to Rule 64B13-3.015, F.A.C. is to delete language from the rule that is a restatement of subsection 463.009, F.S. and renumber the rule accordingly.

SUMMARY: The rule amendment to Rule 64B13-3.002, F.A.C. will delete language that is a restatement of section 456.057(2), F.S., and renumber the rule accordingly; the proposed amendment to Rule 64B13-3.006, F.A.C. will delete language that is a restatement of subsection 463.011, F.S. from the rule and renumber the rule accordingly; the proposed amendment to Rule 64B13-3.008, F.A.C., will delete language from the rule that is a restatement of subsections 463.001, 463.002, and 463.014, F.S., and renumber the rule accordingly; The proposed amendment to Rule 64B13-3.009, F.A.C. will delete language that is a policy statement and does not constitute a rule, restates subsection 463.016, F.S., and delete language that contradicts Florida Statutes and renumber the rule accordingly; the proposed amendment to Rule 64B13-3.010, F.A.C. will delete language that restates subsections 463.016, 463.0135, and 463.072, F.S., add language to clarify administration and prescription of ocular pharmaceutical agents, and renumber the rule accordingly; the proposed amendment to Rule 64B13-3.012, F.A.C. will delete unnecessary language from the rule and renumber the rule accordingly; the proposed amendment to Rule 64B13-3.015, F.A.C. will delete language from the rule that is a restatement of section 463.009, F.S. and renumber the rule accordingly.

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, based upon the expertise and experience of its members, 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: 456.058, 463.005(1) FS.

LAW IMPLEMENTED: 456.058, 456.062, 456.072(1)(a), (j), (m), (p), 463.005(1), 463.002(3), 463.009, 463.011, 463.012, 463.014, 463.016(1)(f), (g), (k) 463.0135(1) 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: Anthony Spivey, D.B.A., Executive Director, Board of Optometry/MQA, 4052 Bald Cypress Way, Bin # C07, Tallahassee, Florida 32399-3257

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

64B13-3.002 Responsibility to Patient

(1) No change

(2) A licensed practitioner shall give notice to the patient when he or she relocates his or her practice or withdraws his or her services so that the patient may make arrangements for his or her eye care. Notice to the patient shall specifically identify the new location of the licensed practitioner’s practice or the location at which the patient may obtain his or her patient record, and shall be in compliance with Rule 64B13-3.003, F.A.C.

(2)(3) No change

Rulemaking Specific Authority 456.058, 463.005(1) FS. Law Implemented 456.058, 463.005(1), 463.0135 FS. History–New 11-13-79, Formerly 21Q-3.02, Amended 12-16-86, Formerly 21Q-3.002, Amended 3-16-94, Formerly 61F8-3.002, Amended 12-31-95, Formerly 59V-3.002, Amended                           .

 

64B13-3.006 Licenses and Signs in Office

(1) Every licensed practitioner shall keep the Board office advised of each office from which he or she practices optometry. If a licensed practitioner or certified optometrist engages in the practice of optometry at more than one location, he or she shall keep his or her current license conspicuously displayed at any locations where he or she practices at all times and shall, whenever required, exhibit the license to any authorized representative of the Department.

(2) A licensed practitioner who is not a certified optometrist shall display at every location at which he or she practices optometry a sign in at least Times New Roman 40 point font size or Courier New 44 point font size which states:

“I am a Licensed Practitioner, not a Certified Optometrist, and I am not able to prescribe topical ocular pharmaceutical agents.”

Rulemaking Authority 463.005(1) FS. Law Implemented 463.002(3), 463.011 FS. History–New 11-13-79, Amended 3-13-81, 6-29-82, Formerly 21Q-3.06, Amended 12-16-86, 2-13-90, Formerly 21Q-3.006, 61F8-3.006, 59V-3.006, Amended 11-13-06, 4-17-13,                             .

 

64B13-3.008 Corporate, Lay, and Unlicensed Practice of Optometry Prohibited

(1) By its enactment of Chapter 463, Florida Statutes, the legislature has determined that the public health and welfare is best protected when only those individuals who have graduated from an accredited school or college of optometry approved by the Board, and who have been tested and licensed as meeting the minimum requirements for safe practice, are permitted to engage in the practice of optometry.

(2) No corporation, lay body, organization, or individual other than a licensed practitioner shall engage in the practice of optometry through the means of engaging the services, upon a salary, commission, or other means or inducement, of any person licensed to practice optometry in this state.

(3) No licensed practitioner shall engage in the practice of optometry with any corporation, organization, group or lay individual.

(4) Notwithstanding subsections (2) and (3) above, a licensed practitioner may associate with a multidisciplinary group of licensed health care professionals, the primary objective of which is the diagnosis and treatment of the human body. A licensed practitioner may also employ, or form a partnership or professional association with, other Florida licensed practitioners, or with other licensed health care professionals, the primary objective of whom is the diagnosis and treatment of the human body. A licensed practitioner may also be a contract provider for health maintenance organizations.

(1)(5) No change

(6) For the purposes of this rule, “licensed practitioner” shall mean a person who is a primary health care provider licensed to engage in the practice of optometry under the authority of Chapter 463, Florida Statutes.

(2)(7) For the purposes of this rule, “Oother means or inducement” shall include the provision of equipment or leased space to a licensed practitioner, if the provision of such equipment or leased space is dependent upon the licensed practitioner’s agreement to or forbearance of any term or condition relative to his/her practice of optometry.

(3)(8) No change

(4)(9) No change

(5)(10) No change

(a) through (i) No change

(6)(11) No change

(12) For the purposes of this rule, “optometric services” shall mean any professional service included within the meaning of “optometry” as defined in Section 463.002(5), Florida Statutes.

(13) Provided he/she is otherwise in compliance with Section 463.014, Florida Statutes, and the Board rules promulgated thereunder, a licensed practitioner may, pursuant to Section 463.014(1)(c), Florida Statutes, physically locate his/her professional practice in or on the premises of a commercial or mercantile establishment.

(7)(14) No change

(15) The following shall constitute evidence that the licensed practitioner has violated Section 463.014, Florida Statutes:

(a) Holding him/herself out to the public, or allowing him/herself to be held out to the public, as available to render professional services in any manner which states, implies, or suggests that the licensed practitioner is professionally associated or affiliated with, or employed by, an entity which itself is not a licensed practitioner;

(b) Entering into any agreement (whether written or oral) which allows, permits, or facilitates any entity which itself is not a licensed practitioner to practice optometry, to offer optometric services to the public, or to control through any means whatever any aspect of the practice of optometry;

(c) Failing to maintain full and independent responsibility and control over all files and records relating to patients and the optometric practice as prescribed by Rule 64B13-3.003, F.A.C.;

(d) Agreeing not to compete in the provision of optometric services with any entity which is not itself a licensed practitioner, or which is not licensed or otherwise permitted by law to provide the services which are the subject of the agreement not to compete;

(e) Failing to maintain full and independent responsibility and control over information disseminated to the public regarding optometric services provided by the licensed practitioner, except in the case of an association, partnership, or employment relationship permitted pursuant to Sections 463.014(1)(a) and (b), Florida Statutes;

(f) Allowing, permitting, encouraging, forbearing, or condoning any advertisement, including those placed in a newspaper, magazine, brochure, flier, telephone directory, or on television or radio, which implies or suggests that the licensed practitioner is professionally associated or affiliated with an entity which itself is not a licensed practitioner;

(g) Occupying or otherwise using professional office space in any manner which does not clearly and sufficiently indicate to the public that his/her practice of optometry is independent of and not associated or affiliated with an entity which itself is not a licensed practitioner;

(h) Using or employing office staff in any manner that implies or suggests that the licensed practitioner is professionally associated or affiliated with an entity which itself is not a licensed practitioner;

(i) Occupying or otherwise using professional office space where the entrance to the commercial or mercantile area in which the licensed practitioner’s practice is located fails to sufficiently identify that the licensed practitioner is practicing his or her profession independent of, and not associated or affiliated with, an entity which itself is not a licensed practitioner;

(j) Failing to have a telephone listing and number that is separate and distinct from that of an entity which itself is not a licensed practitioner;

(k) Answering the telephone, or allowing the telephone to be answered, in a manner that does not clearly and distinctly identify his/her independent optometric practice, or in a manner that implies or suggests that the licensed practitioner is professionally associated or affiliated with an entity which itself is not a licensed practitioner;

(l) Agreeing to any provision of a lease or space agreement (whether oral or written) that in any way impairs, limits, or restricts the licensed practitioner’s full and independent professional judgment and responsibility;

(m) Accepting reduced rent or lease payments based upon the number of patients examined or treated or based upon the number of prescriptions written;

(n) Agreeing to any arrangement for the furnishing of equipment, supplies, or office staff that in any way impairs, limits, or restricts the licensed practitioner’s full and independent professional judgment and responsibility;

(o) Failing to maintain full and independent control and discretion over fees charged to patients for optometric services and materials, including billing methods, except in the case of an association, partnership, or employment relationship permitted pursuant to Sections 463.014(1)(a) and (b); Florida Statutes, or

(p) Accepting a commission for the writing or filling of any optometric prescription.

(8)(16) No change

Rulemaking Specific Authority 463.005(1) FS. Law Implemented 456.072(1)(a), (j), (m), (p), 463.014, 463.016(1)(f), (g), 463.0135 FS. History–New 11-13-79, Amended 4-24-80, 12-19-84, Formerly 21Q-3.08, Amended 12-16-86, 3-25-91, 1-27-92, Formerly 21Q-3.008, 61F8-3.008, Amended 2-14-96, Formerly 59V-3.008Amended                   .

 

64B13-3.009 False, Fraudulent, Deceptive and Misleading Advertising Prohibited; Policy; Definitions; Affirmative Disclosure

(1) It is the policy of the Board of Optometry that advertising by licensed practitioners in this state shall be regulated so as to effectuate the duty of the State of Florida to protect the health, safety, and welfare of its residents, while not abridging any rights guaranteed to practitioners or to the public by the constitutions of the United States and the State of Florida, as construed by the United States Supreme Court and the Florida courts. To that end, the dissemination to the public of information regarding the practice of optometry and where and for whom optometric services may be obtained is authorized so long as such information is in no way fraudulent, false, deceptive or misleading.

(2) A licensed practitioner shall not disseminate or cause the dissemination of any advertisement or advertising which is in any way fraudulent, false, deceptive or misleading. Any advertisement or advertising shall be deemed by the Board to be fraudulent, false, deceptive, or misleading, if it:

(a) Contains a misrepresentation of facts; or

(b) Has the capacity or tendency to mislead or deceive because in its content or in the context which it is presented makes only a partial disclosure of relevant facts; or

(c) Has the capacity of tendency to create false, or unjustified expectations or beneficial treatment or successful cures; or

(d) Contains false, fraudulent, deceptive, or misleading representations relating to the quality or quantity of the optometric services offered; or

(e) Contains any representations or claims which the licensed practitioner referred to in the advertising fails to perform; or

(f) Contains any other representation, statement, or claim which has the capacity or tendency to mislead or deceive.

(3) When determining what constitutes fraudulent, false, deceptive, or misleading advertisement, the Board shall be guided by applicable federal and state status, rules and court decisions.

(1)(4) No change

(5) A licensed practitioner may practice under practice identification names, trade names, or service names, so long as any dissemination of information, including signs, by the practitioner, to consumers contains the name under which the practitioner is licensed or that of the professional association in which the practitioner practices and so long as the information identifies the practitioner of the professional association as being engaged in the practice of optometry. However, a licensed practitioner may not adopt and publish or cause to be published any practice identification name, trade name, or service name which is, contains, or is intended to serve as an affirmation of the quality or competitive value of the optometric services provided at the identified practice. Any licensed practitioner who is practicing or intends to practice under a practice identification name, trade name or service name must register with the Board of Optometry identifying the specific name as registered under applicable Florida law.

(6) All advertisements which advertise services available at branch office locations shall state the hours that a licensed practitioner is practicing at each location mentioned in the advertisement, or shall advise the reader to secure information as to the availability of the licensed practitioner. Excepted from this requirement are:

(a) White page telephone book listings;

(b) Yellow page telephone book advertising which lists only the name, address(es) and phone number(s) of the licensed practitioner;

(c) Advertising such as business cards, which are distributed by the licensed practitioner personally or at her or his premises; and

(d) Advertising posted at or in the immediate vicinity of the office advertised.

(2)(7) No change

(3)(8) No change

(4) When determining what constitutes fraudulent, false, deceptive, or misleading advertisement, the Board shall be guided by applicable federal and state statutes, rules and court decisions.

Rulemaking Authority 463.005 FS. Law Implemented 456.062, 456.072(1)(a), (m), 463.014, 463.016(1)(f), (g) FS. History–New 11-13-79, Amended 4-17-80, 8-20-81, Formerly 21Q-3.09, Amended 1-8-86, 12-16-86, Formerly 21Q-3.009, 61F8-3.009, 59V-3.009, Amended 1-2-02, 11-13-06, 11-5-07, 4-21-10, 10-13-10,                   .

 

64B13-3.010 Standards of Practice

(1) Section 463.016(1)(g), F.S., authorizes the Board to take disciplinary action against an optometrist who is found guilty of “fraud, deceit, negligence, incompetence, or misconduct in the practice of optometry.” Conduct which deceives, or defrauds the public and which is thereby prohibited by Section 463.016(1)(g), F.S., shall include, but not be limited to, accepting and performing an optometric practice or procedure which the optometrist knows or has reason to know that he or she is not competent to undertake.

(1)(2) No change

(2)(3) No change

(3)(4) Certified optometrists employing the topical ocular pharmaceuticals listed in subsection 64B13-18.002(8)(9), F.A.C., Anti-Glaucoma Agents, shall comply with the following:

(a) No change

1.No change

2. In the event the certified optometrist cannot otherwise comply with the requirements of subsections 463.016(1)(s), 463.0135(1), F.S. and 64B13-3.010(1)-(3), F.A.C., a co-management plan shall be established with a physician skilled in the diseases of the human eye and licensed under Chapter 458 or 459, F.S.

(b) through (c) No change

(4)(5) No change

(5)(6) No change

(6)(7) No change

(7)(8) No change

(8) Only a certified optometrist may administer and prescribe ocular pharmaceutical agents. A licensed Practitioner who is not certified may use topically applied anesthetics soley for the purpose of glaucoma examinations, but is otherwise prohibited from administering or prescribing ocular pharmaceutical agents. Certified optometrists may administer and prescribe only those ocular pharmaceutical agents identified by the rule of the Board and oral ocular pharmaceutical agents listed in the statutory formulary.

(9) Only certified optometrists who have successfully completed the Board approved pharmaceutical course and examination specified in paragraph 463.0055(1)(b), F.S. provided proof of such to the Department are authorized to administer and prescribe the oral ocular pharmaceutical agents or their therapeutic equivalents specified in subsectin 463.0055(3), F.S.

(10) Controlled substances listed on the statutory formulary of oral pharmaceutical agents may only be administered or prescribed by a certified optometrist who has successfully completed the board approved oral drug course and examination specified in paragraph 463.0055(1)(b), F.S., provided proof of such to the Department, and after the certified optometrist has acquired a United States Drug Enforcement Administration registration number

(9) Engaging or attempting to engage in the possession, sale, or distribution of controlled substances as set forth in Chapter 893, F.S., for any other than legitimate purposes, constitutes grounds for disciplinary action by the Board.

       (11)(a) Any prescription for an ocular pharmaceutical agent written by a certified optometrist shall contain the following information:

1. Name of the person for whom the pharmaceutical agent is prescribed;

2. Full name and address of the prescribing certified optometrist;

3. Name of the ocular pharmaceutical agent prescribed and the strength, quantity, and directions for use thereof; and

4. Prescriber number and signature of the prescribing certified optometrist.

(b) All written prescriptions must comply with the requirements  of Sections 456.42 and 893.04, F.S.

(12) When an ocular pharmaceutical agent is either administered or prescribed to a patient by a certified optometrist, such shall be documented in the patients record.

Rulemaking Specific Authority 463.005(1) FS. Law Implemented 463.005(1), 463.0135(1), 463.016(1) FS. History–New 9-16-80, Amended 12-20-82, Formerly 21Q-3.10, Amended 7-11-88, 6-18-92, 1-28-93, Formerly 21Q-3.010, Amended 3-16-94, Formerly 61F8-3.010, Amended 8-24-94, 9-21-94, 2-13-95, 12-31-95, Formerly 59V-3.010, Amended 6-15-00, 2-7-01, 11-16-05, 11-5-07, 11-4-08.

 

64B13-3.012 Prescriptions

(1) No change

(2) A spectacle prescription shall be considered valid for a period of five (5) years, and a licensed practitioner shall make available to the patient or his or her agent any spectacle prescription or duplicate copy determined for that patient.

(3) A prescription for daily wear soft contact lens shall be considered valid for a period of two (2) years and a licensed practitioner shall make available to the patient or his or her agent any daily wear soft contact lens prescription or duplicate copy determined for that patient. This subsection applies only to contact lenses determined by the Food and Drug Administration Federal Drug Administration to be daily wear lenses.

(4) through (5) No change

Rulemaking Specific Authority 463.005 FS. Law Implemented 463.005, 463.012, 463.0135, 463.016(1)(k) FS. History–New 4-10-84, Formerly 21Q-3.12, Amended 3-4-86, 8-30-87, Formerly 21Q-3.012, 61F8-3.012, Amended 2-5-96, Formerly 59V-3.012, Amended 1-2-02, 6-5-06, 3-11-09,                       .

 

64B13-3.015 Performance of Delegated Tasks by Non-Licensed Personnel

(1) Non-licensed supportive personnel may not be delegated diagnosis or treatment duties under any circumstances.

(1)(2) Non-licensed personnel, who need not be employees of the licensed practitioner, may perform ministerial duties, tasks and functions assigned to them by and performed under the general supervision of a licensed practitioner, including obtaining information from patients for the purpose of making appointments for the licensed practitioner. Tasks and functions that may be performed shall include, but not be limited to, delivery of eyeglasses, selection of frames, adjustment of frames, and instruction for the insertion, removal and care of contact lenses. However, to ensure patient confidentiality of examination records in accordance with Section 456.057(5), Florida Statutes, a non-employee shall not be allowed to perform any task or function which would require or give them access to patient records or examination reports of any person without prior written authorization of that patient.

(3) The licensed practitioner shall be responsible for all delegated acts performed by persons under his or her direct and general supervision.

(2)(4) Direct supervision means supervision to an extent that the licensee remains on the premises while all procedures are being done and gives final approval to any procedures by non-licensed supportive personnel. Such non-licensed supportive personnel may perform data gathering, preliminary testing, prescribed visual therapy and related duties under the direct supervision of the licensed practitioner.

Rulemaking Specific Authority 463.005(1) FS. Law Implemented 463.009 FS. History–New 10-23-88, Formerly 21Q-3.015, 61F8-3.015, 59V-3.015, Amended 11-16-05,                             .

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Board of Optometry

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

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

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: April 5, 2016