Notice of Comments Issued

[49 Pa.B. 2443]
[Saturday, May 11, 2019]

 Section 5(g) of the Regulatory Review Act (71 P.S. § 745.5(g)) provides that the Independent Regulatory Review Commission (Commission) may issue comments within 30 days of the close of the public comment period. The Commission comments are based upon the criteria contained in section 5.2 of the Regulatory Review Act (71 P.S. § 745.5b).

 The Commission has issued comments on the following proposed regulation. The agency must consider these comments in preparing the final-form regulation. The final-form regulation must be submitted within 2 years of the close of the public comment period or it will be deemed withdrawn.

Reg. No. Agency/TitleClose of the Public
Comment Period
16A-5213 State Board of Optometry
General Revisions
49 Pa.B. 922 (March 2, 2019)
4/1/19 5/1/19

State Board of Optometry Regulation # 16A-5213 (IRRC # 3223)

General Revisions

May 1, 2019

 We submit for your consideration the following comments on the proposed rulemaking published in the March 2, 2019 Pennsylvania Bulletin. Our comments are based on criteria in Section 5.2 of the Regulatory Review Act (71 P.S. § 745.5b). Section 5.1(a) of the Regulatory Review Act (71 P.S. § 745.5a(a)) directs the State Board of Optometry (Board) to respond to all comments received from us or any other source.

1. Section 23.82. Continuing education hour requirements; continuing education reporting; audit and enforcement.—Statutory authority; Whether the regulation is consistent with the intent of the General Assembly; Implementation procedures.

 The proposed amendment to Subsection (b) and the new language of Subsections (c)—(f) address reporting, audits and making up deficiencies of continuing education requirements. Subsection (b) will require licensees to certify completion of the required continuing education on the biennial renewal application. False certifications will be grounds for discipline under the Optometric Practice and Licensure Act (Act), 63 P.S. §§ 244.1—244.12. Subsection (c) states that the Board will randomly audit licensees to ensure compliance with continuing education requirements. Subsection (d) provides that a licensee found to be deficient as a result of a continuing education audit will be subject to formal disciplinary action under the Act or will be subject to the issuance of a citation. Subsection (e) requires a licensee found to be deficient in continuing education hours to make up the hours within six months from the issuance of a citation or the imposition of formal discipline. Finally, Subsection (f) states that failure to make up all deficiencies set forth in Subsection (e) will subject the licensee to further discipline. In the Preamble, the Board explains that the amendments will ''. . . provide notice to licensees of the audit requirements and of the affirmative requirement, notwithstanding any disciplinary action that might be taken by the Board, to make up all deficiencies that are identified through the audit process.''

 Section 5 of the Act, 63 P.S. § 244.5, relates to the renewal of a license of optometry. Section 5(b) states, in part, the following:

Beginning with the year 1998, a license shall not be renewed by the board unless the optometrist applying for renewal submits proof to the board that during the two calendar years immediately preceding his application he has satisfactorily completed a minimum of 30 hours of continuing professional optometric education approved by the board . . . .

 Based on the statutory provision cited above, we have several questions and concerns related to the Board's statutory authority and how it will implement the new continuing education requirements for optometrists. First, we are concerned that the regulatory language being added to this section is not consistent with the Board's statutory authority or with the intent of the General Assembly. Specifically, Section 5(b) of the Act does not allow the Board to renew a license when a licensee has not completed the required amount of continuing education. We acknowledge that discipline or citations may be imposed by the Board, but the regulatory language does not reflect the statutory mandate of nonrenewal of license. If the Board becomes aware of a continuing education deficiency, will it automatically suspend the license of the optometrist? Is there a provision in the Act that would allow the Board to renew a license or not suspend a license when it becomes aware that continuing education requirements have not been met? In the Preamble to the final-form regulation, we ask the Board to explain how the new language of this section of the rulemaking is consistent Section 5(b) of the Act and with the intent of the General Assembly.

 In addition, we have two concerns related to implementation procedures. First, if a biennial renewal application submitted by a licensee indicates that continuing education requirements have not been completed, what are the consequences? Specifically, will the license be renewed? Second, if the Board becomes aware of a continuing education deficiency as the result of an audit, will the Board automatically suspend the license of the optometrist and subject the licensee to discipline or a citation? We ask the Board to clarify how it will implement the new continuing education requirements.

2. Section 23.86. Sources of continuing education hours.—Clarity; Feasibility; Implementation procedures; Need.

 Subsections (b) and (d) address the application processes for approval as continuing education providers and individual courses offered by non-approved providers, respectively. These subsections do not reference the course requirements in § 23.83 (relating to continuing education subject matter). Subsections (a) and (e) require continuing education to meet the course requirements in § 23.83. Are providers who apply under Subsections (b) and (d) also obligated to meet the requirements in § 23.83? If so, we suggest that the Board add cross-references to § 23.83 in Subsections (b) and (d) for clarity.

 Subsection (e) allows a licensed optometrist to seek retroactive approval for attending an unapproved program. This subsection does not include the rate of awarded continuing education hours per minutes of a program, which is specifically stated in Subsections (f) and (g) as ''1 continuing education hour for every 50 minutes.'' To improve clarity, we ask the Board to add this rate in the final-form regulation.

 Subsection (h) credits continuing education hours to a licensed optometrist for service as an instructor or author. We have three concerns. First, under the existing regulation, an optometrist should apply for approval ''prior to the service to assure that approval will be given by the Board to the program.'' This pre-approval provision is proposed to be deleted. What is the rationale for deleting this provision? Second, under the new language, a licensee will be required to provide documentation at the Board's request, ''[o]therwise, the licensee will be required to secure retroactive approval as set forth in subsection (e).'' Under Subsection (e), an optometrist is required to apply for retroactive approval ''within 60 days of attending the program.'' Does this timeframe apply to Subsection (h) and, if so, when would the Board request documentation of instructor or author service? Third, is it feasible for an optometrist seeking credit under this subsection to meet the cross-referenced timeframe? How will the Board implement the proposed procedure for approval of credit hours for this type of service? We ask the Board to respond to these questions in the Preamble to the final-form regulation and clarify this subsection in the final-form regulation.

 Existing Subsection (f) prescribes the allocation of continuing education hours among the course and program options in subsections (a)—(e). The Board proposes to delete existing subsection (f) and add varying allocation requirements in subsections (e)—(i). Although the percentages appear to maintain the existing standard, the statements in subsections (e)—(i) are unclear. We ask the Board to explain how the existing and proposed allocations differ and the need for the restructuring of the percentages. A clear statement regarding the allotment of hours for proposed subsections (a) and (b) is not included in the proposed language. We ask the Board to explain in the Preamble to the final-form regulation why it proposed to delete the existing language. Further, we ask the Board to provide the allocation percentage for subsections (a) and (b) in the final-form regulation.

3. Section 23.87. Reporting of continuing education credit hours.—Implementation procedures.

 Subsection (b) provides for an optional service so that an optometrist may ''have the continuing education course entered into an electronic database for compliance purposes.'' (Emphasis added.) The Board explains in the Preamble that these databases allow ''licensing boards to review and audit the continuing education credits earned by their licensees electronically.'' Does the Board currently have access to these databases and use the information contained therein for compliance purposes? We ask the Board to explain in the Preamble to the final-form regulation how this provision will be implemented.

 In addition, we believe the use of a database to track continuing education credits would alleviate some of the concerns raised in our first comment. Has the Board considered the mandatory use of such a system for licensees?

4. Section 23.90. Standards for commercial support.—Clarity and lack of ambiguity; Implementation procedures.

 This section addresses conflicts of interest and benefits optometrists may receive from continuing education providers. Under Subsection (a), ''all continuing education must be free from the control of a commercial interest.'' How will the Board determine that this standard is met in continuing education programs and courses? We ask the Board to explain its implementation procedure in the Preamble to the final-form regulation.

 Subsection (c) allows continuing education providers to offer optometrists ''food and refreshment of modest value according to local standards for attending'' a program. (Emphasis added.) This is non-regulatory language that does not set a binding norm. A regulation has the full force and effect of law, and these terms do not establish a standard that could be predicted by the regulated community. The Department should revise this subsection in the final-form regulation to address the ambiguity of these terms and provide clarity for compliance.


[Pa.B. Doc. No. 19-728. Filed for public inspection May 10, 2019, 9:00 a.m.]

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