PROPOSED RULEMAKING
[49 PA. CODE CH. 23]
General Revisions
[33 Pa.B. 1120] The State Board of Optometry (Board) proposes to amend §§ 23.1, 23.33--23.35, 23.42, 23.64 and 23.71 and to add § 23.72 to read as set forth in Annex A. The proposed rulemaking would generally update the Board's regulations to reflect current practices in the profession and to simplify the formation of professional corporations.
Effective Date
The proposed rulemaking would be effective upon publication of the final-form rulemaking in the Pennsylvania Bulletin.
Statutory Authority
Section 3(a)(2.1) of the Optometric Practice and Licensure Act (act) (63 P. S. § 244.3(a)(2.1)) added by the act of October 30, 1996 (P. L. 721, No. 130) (Act 130) provides that the Board shall have the duty ''[t]o determine, in accordance with optometric education, training, professional competence and skill, the means and methods for examination, diagnosis and treatment of conditions of the visual system.'' Section 3(a)(3) of the act requires the Board ''[t]o record all licenses in its office.'' Section 3(b)(9) of the act authorizes the Board ''[t]o establish and administer a records system which records shall be open to public inspection during the regular business hours of the Board.'' Finally, section 3(b)(14) of the act authorizes the Board ''[t]o promulgate all rules and regulations necessary to carry out the purposes of this act.''
Background and Need for the Proposed Amendments
The Board's current regulations were promulgated prior to the amendments made by Act 130 and do not address the means and methods for the examination, diagnosis and treatment of conditions of the visual system. Act 130 placed additional duties on the Board. In addition, the Board routinely receives numerous requests for information regarding whether optometrists are permitted to perform specific procedures. Act 130 defines the practice of optometry very broadly. Act 130 specifies that the Board has the duty to address the more specific means and methods that optometrists may employ. This proposed rulemaking addresses both public inquiry and the amendments made by Act 130.
The Board's current regulations are outdated in that they do not set minimum requirements that optometrists shall follow in writing prescriptions and do not require optometrists to record the pharmaceutical agents used in a patient's medical record (optometrists were granted use of limited pharmaceutical agents by Act 130). In addition, the Board's regulations do not reflect the Board's current recordkeeping system. These proposed amendments are necessary to bring the Board's regulations into compliance with the amendments made in Act 130.
Following numerous meetings of the Board's regulations committee and consideration by the entire Board, an exposure draft was sent to the Pennsylvania Optometric Association (Association), the Pennsylvania College of Optometry (College) and the Pennsylvania Academy of Ophthalmology (Academy). Following this solicitation of input from stakeholders, the Board placed notices of a public hearing in major newspapers of this Commonwealth inviting the general public to a public hearing on July 12, 2001. The Association, College and Academy sent representatives to the public hearing. No members of the general public attended the meeting. After considering the input received, the Board now proposes the amendments as set forth in Annex A.
Description of the Proposed Amendments
§ 23.1 (relating to definitions)
In accordance with the mandate of Act 130, the Board proposes to amend § 23.1 to define ''means and methods for the examination, diagnosis and treatment of condifitions of the visual system.'' In formulating the provisions of the proposal, the Board considered extensive comments from the College, Academy and Association at its public hearing held on July 12, 2001. The Board's proposal includes diagnostic and treatment procedures that have been performed by optometrists for up to 25 years as well as newer technologies that have only become a standard part of optometric practice in the past few years.
The proposed amendment provides that optometrists may employ the following diagnostic techniques: the use of any computerized or automatic refracting device, visual field testing, ophthalmoscopy, anterior and posterior segment photography, provocative tests, electrodiagnostic tests, the use of lasers for diagnostic purposes, ultrasound examination of the eye and orbit and diagnostic tests to determine the patency of the lacrimal system. In addition, the proposed amendments provide that optometrists may order radiographs, computer assisted tomography scans, magnetic resonance imaging scans and laboratory work. Finally, the proposed amendments provide that optometrists may order, interpret and report on angiographic studies. The proposed amendments also address means and methods of treatment. The amendments provide that optometrists may employ vision therapy or orthoptics, low vision rehabilitation, epilation of lashes and may treat the lacrimal system including using punctal plugs. The specific procedures are authorized by Act 130 and are consistent with the practice of optometry in all states surrounding this Commonwealth.
§ 23.33 (relating to practice)
The Board proposes to amend § 23.33 to conform to current practice in the field of optometry. Subsection (a) of the current regulation restricts an optometrist to practice in a room used exclusively for the practice of optometry. The Board proposes to amend subsection (a) to clarify that this restriction applies only when the optometrist is practicing in his own office. The reality of today's practice is that optometrists practice in health care facilities as well as their offices and cannot, therefore, always practice in a room used exclusively for the practice of optometry.
The Board also proposes to amend subsection (b) to further define the practice of an optometrist in a licensed health care facility. The proposed amendment merely reflects the current state of practice of the profession, defining ''licensed health care facility'' to include ''in-patient or out-patient hospitals and emergency rooms, nursing homes and long term care facilities, or any facility with the need for optometric services.''
Finally, the Board proposes to amend § 23.33 by adding a subsection (e) to permit optometrists to provide visual screenings at any location, public or private, within this Commonwealth. Optometrists are frequently asked to perform simple visual screenings, which do not require the facilities of the optometric office or health care facility, at various events and locations. The amendment would permit optometrists to perform these screenings. The provision of vision screening services is a great benefit to the citizens of this Commonwealth.
§§ 23.34 and 23.35 (relating to professional corporations; and fictitious names)
The Board proposes to amend §§ 23.34 and 23.35 to reflect current optometric practice and to reflect the current recordkeeping procedures of the Board administrative office and the Department of State Corporation Bureau (Bureau). The Board proposes to amend § 23.34(a) to permit optometrists to incorporate with other health care professionals if authorized by the Commonwealth's laws pertaining to incorporation. The Board proposes to amend §§ 23.34 and 23.35 by deleting the requirements that optometrists file articles of incorporation or fictitious name registrations with the Board for approval prior to filing with the Bureau. Departmental practice is for the Bureau to send copies of all optometric filings to the Board for review. Because the Bureau is essentially a filing office and is not staffed to ensure compliance with the current §§ 23.34 and 23.35, there is no way to enforce the current provisions. In addition, the Board has found no public benefit to the current requirements of these sections.
§ 23.42 (relating to equipment)
The Board proposes to amend § 23.42 first by clarifying that the equipment listed in the section is the minimum required for performing a basic, rather than ''complete'' optometric examination. In addition, the Board proposes to replace the equipment ophthalmometer with the equipment keratometer. This change reflects current practice.
§ 23.64 (relating to professional conduct)
The Board proposes to add subsection (c) to § 23.64. Subsection (c) would allow an optometrist to terminate his care of a patient who is not adhering to appropriate regimens of care and follow-up. The proposed subsection would require the optometrist to notify the patient in writing and explain why the optometrist was terminating his care of the patient. Finally, the proposed subsection would require the optometrist to copy the patient's record and give the record either to the patient or to the subsequent treating optometrist.
§ 23.71 (relating to patient records)
The Board proposes to amend § 23.71 to reflect current practice. The changes reflect the current terms used (''uncorrected'' vision instead of ''naked'' vision) and refer to the use of perimtery, which is the standard in visual field testing. In addition, the Board proposes to amend § 23.71 by adding subsection (a)(19) which requires the optometrist to record in the patient's medical record any pharmaceutical agents used or prescribed, including strength, dosage, number of refills and adverse reaction, if applicable. The information updates the regulations in compliance with Act 130's grant of authority to use pharmaceutical agents and reflects proper medical practice in recordkeeping.
Finally, the Board proposes to amend § 23.71(c) by setting forth requirements for optometrists who provide a patient with a contact lens prescription. The current section provides that the optometrist has the discretion to determine whether to provide a patient with a contact lens prescription rather than dispensing the lens to the patient. Some optometrists have been reluctant to provide patients with a contact lens prescription, even when the patient requested the prescription, for fear of liability if the dispenser provides the patient with incorrect lenses. The proposed subsection (c)(1) requires the optometrist to determine all requirements for a satisfactory fit prior to providing a contact lens prescription. This provision protects the optometrist by clarifying the optometrist's responsibility in determining fit requirements for contact lenses. The proposed subsection (c)(2) provides that an optometrist shall consider all contact lenses used in determining the contact lens prescription to be diagnostic lenses. This provision protects the optometrist by clarifying that the optometrist has not determined the final prescription until the optometrist writes the prescription, because any trial lenses used are merely diagnostic.
§ 23.72 (relating to prescriptions)
The Board proposes to amend its regulations by adding requirements for prescriptions in § 23.72. Act 130 expanded the scope of practice of optometry to include ''[t]he administration and prescription of legend and nonlegend drugs as approved by the Secretary of Health. . .'' 63 P. S. § 244.2. Prior to 1996, optometrists only wrote prescriptions for contact lenses and spectacles, and the Board's regulations did not set requirements for these prescriptions. To standardize practice in this Commonwealth and ensure that all optometrists in this Commonwealth include information important to the patient on any prescription written, the Board proposes requirements on optometric prescriptions generally and proposes to set specific requirements for contact lens, spectacle and pharmaceutical prescriptions.
Proposed § 23.72 would require that all optometric prescriptions bear the name, address and license number of the optometrist, the name of the patient, date the prescription is issued and expiration date. Contact lens prescriptions would have to specify the lens type, all specifications necessary for the ordering and fabrication of the lenses, number of refills and expiration date consistent with the type and modality of use of the contact lens being prescribed, but in no case greater than 1 year. These requirements are consistent with the generally accepted standard of optometric practice and ensure that the contact lens dispenser will dispense the proper lenses for the patient as determined by the optometrist. In addition, the maximum of 1 year expiration date ensures that contact lens wearing patients will be rechecked by the optometrist at least yearly, the maximum time period recommended by medical professionals. For spectacles, the maximum time period recommended for reexamination is 2 years. This time period is reflected in § 23.71(b).
Fiscal Impact and Paperwork Requirements
The proposed amendments should have no fiscal impact on licensees, the Board, the private sector, the general public or any political subdivisions. The proposed amendments should not create additional paperwork for the Board or the private sector.
Sunset Date
The Board continuously monitors its regulations. Therefore, no sunset date has been assigned.
Regulatory Review
Under section 5(a) of the Regulatory Review Act (71 P. S. § 745.5(a)), on February 12, 2003, the Board submitted a copy of this proposed rulemaking to the Independent Regulatory Review Commission (IRRC), the Senate Consumer Protection and Professional Licensure Committee (SCP/PLC) and the House Professional Licensure Committee (HPLC). In addition to submitting the proposed rulemaking, the Board has provided IRRC, SCP/PLC and HPLC with a copy of a detailed Regulatory Analysis Form prepared by the Board. A copy of this material is available to the public upon request.
Under section 5(g) of the Regulatory Review Act (71 P. S. § 745.5(g)), if IRRC has objections to any portion of the proposed rulemaking, it will notify the Board within 30 days of the close of the public comment period. The notification shall specify the regulatory review criteria which have not been met. The Regulatory Review Act specifies detailed procedures for review of objections by the Board, the General Assembly and the Governor prior to publication of the regulations.
Public Comment
Interested persons are invited to submit written comments, suggestions or objections regarding this proposed rulemaking to Deborah Smith, Board Administrator, P. O. Box 2649, Harrisburg, PA 17105-2649, www.dos.state.pa.us, within 30 days following publication of this proposed rulemaking in the Pennsylvania Bulletin.
STEVEN J. RETO, O.D.,
ChairpersonFiscal Note: 16A-528. No fiscal impact; (8) recommends adoption.
Annex A
TITLE 49. PROFESSIONAL AND VOCATIONAL STANDARDS
PART I. DEPARTMENT OF STATE
Subpart A. PROFESSIONAL AND OCCUPATIONAL AFFAIRS
CHAPTER 23. STATE BOARD OF OPTOMETRY
GENERAL PROVISIONS § 23.1. Definitions.
The following words and terms, when used in this chapter, have the following meanings, unless the context clearly indicates otherwise:
* * * * * Means and methods for the examination, diagnosis and treatment of conditions of the visual system--
(i) The means and methods for the examination, diagnosis and treatment of conditions of the visual system that may be employed by licensed optometrists include:
(A) The use of any computerized or automatic refracting device.
(B) Visual field testing such as manual or automated perimetry.
(C) Ophthalmoscopy, including ophthalmoscopy of a patient who has been anesthetized by a practitioner authorized to provide anesthesia services and in accordance with applicable law and regulation governing the anesthesia provider and facility, and with or without the use of diagnostic lenses including, any condensing lenses, gonioscopy lenses and fundus contact lenses.
(D) Anterior and posterior segment photography.
(E) Provocative tests for glaucoma and electrodiagnostic testing.
(F) The use of lasers for diagnostic purposes.
(G) The employment of vision therapy or orthoptics.
(H) Low vision rehabilitation.
(I) Treatment of the lacrimal system including the use of punctal plugs and diagnostic procedures to determine the patency of the lacrimal system.
(J) Epilation of lashes.
(K) Ultrasound examination of the eye and orbit, including A-scans with or without Intraocular Lens calculations and B-scans.
(L) Ordering of radiographs, computer assisted tomography scans (''CAT'' scans), magnetic resonance imaging scans (''MRI'' scans) and laboratory work.
(M) Ordering, interpretation and reporting of angiographic studies of ocular vasculature and blood flow.
(ii) The practice of optometry includes all levels of evaluation and management services and also includes, for those optometrists who are therapeutically certified, the administration and prescription of approved legend and nonlegend drugs.
* * * * *
BUSINESS PRACTICES § 23.33. Practice.
(a) An optometrist engaged in the active practice of optometry shall practice in a room used exclusively for the practice of optometry when practicing in his office. A change in this address, or the addition of places of practice, shall comply with §§ 23.43 and 23.44 (relating to offices; and additional practice locations).
(b) In compliance with § 23.36 (relating to consultant, advisor, staff or employe optometry), an optometrist may arrange the professional practice to include service to a licensed health care service facility, including in-patient or out-patient hospitals and emergency rooms, nursing homes and long-term care facilities, or any facility with the need for optometric services.
* * * * * (e) An optometrist may provide visual screenings at any location, public or private, within this Commonwealth.
(f) * * *
§ 23.34. Professional corporations.
(a) An optometrist licensed by the Board may professionally incorporate with other optometrists, medical doctors, doctors of osteopathy, dentists, psychologists, podiatrists [and], chiropractors[,] and other health care professionals if this incorporation is authorized by Chapter 5, 17, 25, 29, 33 or 41.
(b) [The articles of incorporation and registry statement of the proposed corporation shall be filed with the Board for review and approval, prior to submission to the Corporation Bureau.
(c) The name of a professional corporation will be approved by the Board.] If a name is chosen for the professional corporation which does not contain the names of all the licensed professionals with an ownership interest in the practice, the Board shall be supplied with a list of these persons. [The Board will notify the optometrist of its approval, or disapproval, and this notice shall be submitted to the Corporation Bureau, together with the documents and fees required by that agency for filing articles of incorporation.
(d)] An optometrist [incorporating] practicing under the terms of this section shall notify the Board of a change in the name or ownership of the [corporation, and shall seek Board approval of these changes prior to practicing under a new name or ownership structure] business.
§ 23.35. Fictitious names.
* * * * * (b) [A fictitious name registration shall be filed with the Board for approval, prior to submission to the Corporation Bureau.
(c) A fictitious name will be approved by the Board.] A list of the optometrists with an ownership interest in the practice shall be submitted to the Board concurrently with the fictitious name registration. [The Board will notify the optometrist of its approval, or disapproval, and this notice shall be submitted to the Corporation Bureau, together with the documents and fees required by that agency for filing a fictitious name registration.
(d)] An optometrist practicing under the terms of this section shall notify the Board of changes in the name or ownership of the business[, and shall seek Board approval of these changes prior to practicing under a new name or ownership structure].
OFFICE OF OPTOMETRIST § 23.42. Equipment
An office maintained for the practice of optometry shall be fully equipped for the making of a [complete] basic optometrical examination including[, but not limited to,] the following:
(1) [Ophthalmometer] Keratometer.
* * * * *
UNLAWFUL PRACTICES § 23.64. Professional conduct.
* * * * * (c) An optometrist may terminate his or her optometric care of a patient who, in the professional opinion of the optometrist, is not adhering to appropriate regimens of care and follow-up.
(1) The optometrist shall notify the patient, in writing, that the optometrist is terminating the professional relationship and the reasons for the termination.
(2) In addition, the optometrist shall make a copy of the patient's medical record available to the patient or successor eye care provider designated by the patient, and may charge a reasonable fee for copying the record.
[RECORDS] PROFESSIONAL PRACTICE § 23.71. Patient records.
(a) An optometrist shall use professional judgment to determine what services are to be provided to his patients. Records of the actual services rendered shall be maintained for a minimum of 5 years after the last consultation with a patient. Records shall indicate when a referral has been made to a physician. An examination may include[, but is not limited to,] the following:
* * * * * (2) [Naked] Uncorrected visual acuity.
* * * * * (14) Visual fields [, central (after age 40)] including manual or automated perimetry.
* * * * * (19) Pharmaceutical agents used or prescribed, including strength, dosage, number of refills and adverse reaction, if applicable.
(b) An optometrist shall comply with a patient request for a copy of the patient's spectacle prescription, within 2 years of the patient's last eye examination. Requests for spectacle prescriptions from examinations over 2 years prior to the request[, or for contact lens prescriptions,] may be complied with at the discretion of the optometrist. Requests for contact lens prescriptions may be complied with at the discretion of the optometrist.
(c) [An optometrist's license number shall appear on each prescription written by that optometrist.] An optometrist who, in his discretion, provides a contact lens prescription, shall comply with the following:
(1) The optometrist shall determine the requirements for a satisfactory fit of a contact lens prior to providing a contact lens prescription.
(2) The optometrist shall consider the contact lenses used in determining the contact lens prescription to be diagnostic lenses.
§ 23.72. Prescriptions.
(a) Optometric prescriptions shall bear:
(1) The name, address and license number of the optometrist.
(2) The name of the patient.
(3) The date the prescription is issued by the licensed practitioner.
(4) The expiration date.
(b) Contact lens prescriptions shall specify the lens type, the specifications necessary for the ordering and fabrication of the lenses, number of refills and expiration date consistent with the type and modality of use of the contact lens being prescribed, but in no case shall the expiration date be greater than 1 year. The prescription may include a statement of caution or a disclaimer if the statement or disclaimer is supported by appropriate findings and documented in the patient's medical record.
(c) Pharmaceutical prescriptions shall specify the name of the drug prescribed, quantity and potency prescribed, expiration date, number of refills allowed, instructions for use and any indicated precautionary statements.
(d) Spectacle prescriptions shall specify any information that would be relevant to manufacturing glasses including the dioptic value of the sphere, astigmatism, prism, slab off, add power and axis or orientation of the astigmatism correction.
[Pa.B. Doc. No. 03-351. Filed for public inspection February 28, 2003, 9:00 a.m.]
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