Title of Regulation: 18VAC105-20. Regulations Governing the Practice of Optometry (amending 18VAC105-20-70).

Statutory Authority: § 54.1-2400 of the Code of Virginia.

Public Hearing Information:

July 22, 2009 - 9 a.m. - Department of Health Professions, 9960 Mayland Drive, 2nd Floor, Richmond, VA

Public Comments: Public comments may be submitted until 5 p.m. on August 7, 2009.

Agency Contact: Elizabeth A. Carter, Ph.D., Executive Director, Board of Optometry, 9960 Mayland Drive, Suite 300, Richmond, VA 23233, telephone (804) 367-4426, FAX (804) 527-4466, or email elizabeth.carter@dhp.virginia.gov.

Basis: Section 54.1-2400 of the Code of Virginia provides the Board of Optometry the authority to promulgate regulations to administer the regulatory system.

There is a statutory mandate for the Board of Optometry to require continuing education for renewal of licensure provided in § 54.1-3219 of the Code of Virginia.

Purpose: Issues relating to the validity and value of continuing education for the optometrist have been apparent to the board through audits of continuing education, disciplinary cases and personal observation by members. For example, the current regulation allows courses that are primarily a sales pitch for a manufacturer product, so long as the course offers a miniscule segment relating to patient care. The board has determined that such courses should not be counted toward a practitioner’s renewal requirement. Likewise, prescribing and treating with therapeutic pharmaceutical agents privileges has been expanded with many more classes of drugs available to optometrists, so the subject of required continuing education in treatment with pharmaceutical agents has been clarified. By adding value and substance to the continuing education requirements, the board intends to address the need to ensure continuing competency for the health and safety of consumers of optometric services.

Substance: The following substantive changes are proposed:

1. Affirmatively state in regulation that falsifying the attestation or failure to comply with continuing education requirements may subject a licensee to disciplinary action by the board, consistent with § 54.1-3215 of the Code of Virginia. Currently, falsifying an application is grounds for disciplinary action, so this change is a clarification that makes it clear that falsifying or failure to comply with requirements for a renewal application may provide grounds.

2. Specify that an approved continuing education sponsor must provide a certificate of attendance that shows the date, location, lecturer, content hours of the course, and contact information of the provider/sponsor. The certificate of attendance must be based on verification by the sponsor of the attendee’s presence throughout the course – either provided by a post-test or by an independent monitor. The proposal also adds a requirement for an approved continuing education provider/sponsor to maintain documentation about the course and attendance for at least three years following its completion. Specifying the provision and content of a certificate of attendance and the length of time that records must be maintained by a continuing education sponsor/provider is consistent with current expectations and practices and should not represent any change or increased burden.

Issues: The advantage to the public may be that optometrists will take continuing education more closely related to patient care and to the treatment of the eye with prescription drugs. Further specification of requirements for approved sponsors will necessitate closer monitoring of participation. Optometrists will benefit from assuring that sponsors are able to verify continuing education attendance during a board audit.

There are no disadvantages to the agency or the Commonwealth. Clarification of the board’s intent and policies relating to continuing education should alleviate some misunderstanding by licensee relating to approval of sponsors and filing for extensions.

The Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. The Board of Optometry (Board) proposes to make amendments to the regulations that include: (1) requiring that in order to maintain approval for continuing education courses, providers or sponsors provide a certificate of attendance that shows the date, location, presenter or lecturer, content hours of the course, and contact information of the provider/sponsor for verification, and maintain documentation about the course and attendance for at least three years following its completion, (2) requiring that requests for the extension or waiver for the fulfillment of continuing education hours must be received by the Continuing Education Committee prior to December 31 of each year, and 3) changing the requirement that optometrists who are certified in the use of therapeutic pharmaceutical agents have at least two hours of continuing education "directly related to the prescribing and administration of such drugs" to "directly related to the treatment of the human eye and its adnexa with pharmaceutical agents,"

Result of Analysis. The benefits likely exceed the costs for one or more proposed changes. There is insufficient data to accurately compare the magnitude of the benefits versus the costs for other changes.

Estimated Economic Impact. The proposed regulation includes language that requires providers or sponsors to do two things in order to maintain approval for continuing education courses. First, providers or sponsors must provide a certificate of attendance that shows the date, location, presenter or lecturer, content hours of the course, and contact information of the provider/sponsor for verification. This certificate of attendance must be based on verification by the sponsor of the attendee’s presence throughout the course, either provided by a post-test or by an independent monitor. Second, providers or sponsors must maintain documentation about the course and attendance for at least three years following its completion. This amendment is being proposed because by observation and experience with audits of continuing education, the Board is concerned that some sponsors do not provide a certificate of completion that gives sufficient information about the course, nor do they provide verification of attendance. These requirements will ensure that the certificate of attendance and all necessary information can be verified. The requirement that continuing education providers/sponsors maintain documentation about the course and attendance for at least three years following its completion came about because in conducting an audit of a licensee continuing education, it is often necessary to contact a sponsor or provider to request additional information about a course or about the licensee’s attendance.

The cost of these amendments will most likely be born by the continuing education provider. Since most providers offer a certificate of completion—the Board’s concern is that the certificates do not give sufficient information—this amendment should not impose prohibitively high costs. For those who do not currently provide certificates, it does not seem that the cost need exceed $0.50 per participant, which is a cost that will probably be born either by the provider, or passed on to the participant. For those course providers who do not provide a post-test, the proposed amendment would require them to verify the attendee’s presence in the course through an independent monitor. The cost of the monitor is difficult to ascertain since, according to the Department of Health Professions (Department), the cost of the monitor is likely to vary widely depending upon how different vendors work out staffing across the different kinds of venues. Some vendors might pay an independent monitor, while some may ask staff members to monitor as a part of their regular duties. The costs associated with the certificate and the three years of recordkeeping are likely to be outweighed by the benefits of being able to conduct an accurate audit of continuing education acquisition, especially since many providers and sponsors already provide certificates and maintain documentation. Many courses already provide post-tests and independent monitors and for those courses, the benefits of this amendment are likely to outweigh the costs. For those courses that, under this proposal, will have to provide an independent monitor for each course delivered, however, it is not clear if the benefits of this particular amendment will outweigh the costs.

The proposed regulation includes language that “A request for an extension or a waiver [for meeting continuing education requirements] shall be received prior to December 31 of each year.” This change is being proposed because the Board has had instances in which licensees realize that they are missing continuing education hours at the time of renewal and request an extension after the renewal date has passed. The license renewal period is January 1 to December 31, so this amendment ensures that the hours be completed, or an extension be granted, before the renewal deadline. This proposal should not impose any cost on licensees. Therefore, the benefit of this amendment outweighs the cost.

Under current regulation, for optometrists who are certified in the use of therapeutic pharmaceutical agents, at least two of the 16 required continuing education hours must be "directly related to the prescribing and administration of such drugs." The Board proposes to amend "prescribing and administration of such drugs" to "treatment of the human eye and its adnexa with pharmaceutical agents." The Board feels that the new language of "treatment of the human eye and its adnexa…" is more inclusive and descriptive of the types of courses related to patient care. The proposed language is more inclusive and remains directly relevant to patient care, this proposed amendment likely provides a net benefit.

Businesses and Entities Affected. There are 1444 optometrists¹ and 470 offices of optometrists² in Virginia who would be affected by these amendments. Of those optometrists, 1194 are TPA-certified (i.e., who are certified for treatment of diseases or abnormal conditions with therapeutic pharmaceutical agents) and therefore would be subject to all of the amendments. All 470 offices of optometrists qualify as small businesses.

Localities Particularly Affected. The proposals do not disproportionately affect specific localities.

Projected Impact on Employment. The proposed amendments are not anticipated to have any significant impact on employment.

Effects on the Use and Value of Private Property. The cost of providing an independent monitor could increase costs for certain course providers, thereby moderately decreasing the value of their business.

Small Businesses: Costs and Other Effects. The proposal to require continuing education course providers to provide either a post-test or an independent monitor will increase costs for those providers who do not already do so. The requirement is reasonable though, so as to ensure actual course attendance by the licensee claiming continuing education credits.

Small Businesses: Alternative Method that Minimizes Adverse Impact. No alternative methods would reduce cost while still achieving the desired policy goals.

Real Estate Development Costs. The proposed amendments do not create additional costs related to the development of real estate for commercial or residential purposes.

Legal Mandate. The Department of Planning and Budget (DPB) has analyzed the economic impact of this proposed regulation in accordance with § 2.2-4007.04 of the Administrative Process Act and Executive Order Number 36 (06). Section 2.2-4007.04 requires that such economic impact analyses include, but need not be limited to, the projected number of businesses or other entities to whom the regulation would apply, the identity of any localities and types of businesses or other entities particularly affected, the projected number of persons and employment positions to be affected, the projected costs to affected businesses or entities to implement or comply with the regulation, and the impact on the use and value of private property. Further, if the proposed regulation has adverse effect on small businesses, § 2.2-4007.04 requires that such economic impact analyses include (i) an identification and estimate of the number of small businesses subject to the regulation; (ii) the projected reporting, recordkeeping, and other administrative costs required for small businesses to comply with the regulation, including the type of professional skills necessary for preparing required reports and other documents; (iii) a statement of the probable effect of the regulation on affected small businesses; and (iv) a description of any less intrusive or less costly alternative methods of achieving the purpose of the regulation. The analysis presented above represents DPB’s best estimate of these economic impacts.

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¹ Source: Department of Health Professions

² Source: Virginia Employment Commission

Agency's Response to the Department of Planning and Budget's Economic Impact Analysis: The Board of Optometry concurs with the analysis of the Department of Planning and Budget on proposed regulations for 18VAC105-20, Regulations Governing the Practice of Optometry, relating to continuing education requirements.

Summary:

The proposed amendments (i) require that, in order to maintain approval for continuing education courses, providers or sponsors provide a certificate of attendance that shows the date, location, presenter or lecturer, content hours of the course, and contact information of the provider/sponsor for verification, and maintain documentation about the course and attendance for at least three years following its completion; (ii) require that requests for the extension or waiver for the fulfillment of continuing education hours must be received by the Continuing Education Committee prior to December 31 of each year; and (iii) require that optometrists who are certified in the use of therapeutic pharmaceutical agents have at least two hours of continuing education "directly related to the treatment of the human eye and its adnexa with pharmaceutical agents."

18VAC105-20-70. Requirements for continuing education.

A. Each license renewal shall be conditioned upon submission of evidence to the board of 16 hours of continuing education taken by the applicant during the previous license period.

1. Fourteen of the 16 hours shall pertain directly to the care of the patient. The 16 hours may include up to two hours of recordkeeping for patient care and up to two hours of training in cardiopulmonary resuscitation (CPR).

2. For optometrists who are certified in the use of therapeutic pharmaceutical agents, at least two of the required continuing education hours shall be directly related to the prescribing and administration of such drugs treatment of the human eye and its adnexa with pharmaceutical agents.

3. Courses that are solely designed for which the primary purpose is to promote the sale of specific instruments or products and courses offering instruction on augmenting income are excluded and will not receive credit by the board.

B. Each licensee shall attest to fulfillment of continuing education hours on the required annual renewal form. All continuing education shall be completed prior to December 31 unless an extension or waiver has been granted by the Continuing Education Committee. A request for an extension or waiver shall be received prior to December 31 of each year.

C. All continuing education courses shall be offered by an approved sponsor listed in subsection G or accredited as provided in subsection H of this section. Courses that are not approved by a board-recognized sponsor in advance shall not be accepted for continuing education credit. For those courses that have a post-test requirement, credit will only be given if the optometrist receives a passing grade as indicated on the certificate.

D. Licensees shall maintain continuing education documentation for a period of not less than three years. A random audit of licensees may be conducted by the board which will require that the licensee provide evidence substantiating participation in required continuing education courses within 14 days of the renewal date.

E. Documentation of hours shall clearly indicate the name of the continuing education provider and its affiliation with an approved sponsor as listed in subsection G or accredited as provided in subsection H of this section. Documents that do not have the required information shall not be accepted by the board for determining compliance. Correspondence courses shall be credited according to the date on which the post-test was graded as indicated on the continuing education certificate.

F. A licensee shall be exempt from the continuing competency requirements for the first renewal following the date of initial licensure by examination in Virginia.

G. An approved continuing education course or program, whether offered by correspondence, electronically or in person, shall be sponsored or approved by one of the following:

1. The American Optometric Association and its constituent organizations.

2. Regional optometric organizations.

3. State optometric associations and their affiliate local societies.

4. Accredited colleges and universities providing optometric or medical courses.

5. The American Academy of Optometry and its affiliate organizations.

6. The American Academy of Ophthalmology and its affiliate organizations.

7. The Virginia Academy of Optometry.

8. Council on Optometric Practitioner Education (C.O.P.E.).

9. 8. State or federal governmental agencies.

10. 9. College of Optometrists in Vision Development.

11. The Accreditation Council for Continuing Medical Education of the American Medical Association for Category 1 or Category 2 credit.

12. 10. Providers of training in cardiopulmonary resuscitation (CPR).

13. 11. Optometric Extension Program.

H. Courses accredited by the Council on Optometric Practitioner Education (COPE) or the Accreditation Council for Continuing Medical Education (ACCME) of the American Medical Association for Category 1 or Category 2 credit shall be approved.

I. In order to maintain approval for continuing education courses, providers or sponsors shall:

1. Provide a certificate of attendance that shows the date, location, presenter or lecturer, content hours of the course, and contact information of the provider/sponsor for verification. The certificate of attendance shall be based on verification by the sponsor of the attendee's presence throughout the course, either provided by a post-test or by an independent monitor.

2. Maintain documentation about the course and attendance for at least three years following its completion.

J. Falsifying the attestation of compliance with continuing education on a renewal form or failure to comply with continuing education requirements may subject a licensee to disciplinary action by the board, consistent with § 54.1-3215 of the Code of Virginia.