Title of Regulation: 18VAC105-20. Regulations Governing the Practice of Optometry (amending 18VAC105-20-45).

Statutory Authority: §§ 54.1-2400 and 54.1-3223 of the Code of Virginia.

Public Hearing Information: No public hearing is currently scheduled.

Public Comment Deadline: January 18, 2023.

Effective Date: February 2, 2023.

Agency Contact: Leslie L. Knachel, Executive Director, Board of Optometry, 9960 Mayland Drive, Suite 300, Henrico, VA 23233, telephone (804) 597-4130, FAX (804) 527-4471, or email leslie.knachel@dhp.virginia.gov.

Basis: Regulations are promulgated under the general authority of § 54.1-2400 of the Code of Virginia, which provides the Board of Optometry the authority to promulgate regulations to administer the regulatory system.

Purpose: The purpose of the regulatory change is greater assurance that patients will be given their contact lens prescriptions by an optometrist after the fitting is complete. By requiring some acknowledgment of receipt in the patient record, the optometrist is more likely to provide the prescription, and patient health and safety is better protected by having a prescription that may be filled from a variety of sources.

Rationale for Using the Fast-Track Rulemaking Process: There was no mandate for this action, but the impetus was a recent amendment to the Federal Trade Commission (FTC) Contact Lens Rule. The board has determined that a state version of that rule could be adopted via fast-track rulemaking process because state regulations currently follow the federal rule, and this amendment will continue that consistency. Optometrists pay more attention to their state regulations, so compliance with this chapter will assist practitioners with compliance with FTC rules.

Substance: The board is amending 18VAC105-20-45 to require an optometrist to maintain some documentation that a patient has received a contact lens prescription at the end of the final fitting, as required by state and federal rule.

Issues: The primary advantage to the public is greater protection as a patient and a consumer. The optometrist is also better protected by being able to show that the prescription was provided if a question were to arise at a later time. There are no disadvantages for the public. There are no advantages or disadvantages to the Commonwealth.

Department of Planning and Budget's Economic Impact Analysis:

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 Code of Virginia (Code) and Executive Order 14 (as amended, July 16, 2018). The analysis presented represents DPB's best estimate of these economic impacts.¹ Summary of the Proposed Amendments to Regulation. The Board of Optometry (Board) proposes to update the regulation to reflect changes made in 2020 to the Federal Trade Commission's (FTC) Contact Lens Rule. Optometrists prescribing contact lenses would be required to obtain a confirmation that patients received their prescription.

Background. The 2003 Fairness to Contact Lens Consumers Act established consumers' rights to shop around when buying contact lenses and prescribers' and sellers' duties to prevent anticompetitive behavior.² In 2004, the FTC issued the Contact Lens Rule to implement requirements for prescribers and sellers, specifically with regards to providing prescriptions to consumers and verifying prescriptions in a timely manner.³ In 2020, the FTC amended the Contact Lens Rule to add a requirement that prescribers obtain a confirmation from patients that the patient has received a copy of their prescription and retain the confirmation for three years.⁴ Accordingly, the Board proposes to add a sentence to 18VAC105-20-45 C 2 to state that "Patient confirmation of receipt of the prescription at the end of the contact lens fitting shall be maintained in the patient record." The regulation currently requires that all patient records be maintained for a period of six years; thus, the patient confirmation would also be retained for six years.

The FTC Rule provides greater detail as to how prescribers can obtain confirmation, either on paper or electronically. Specifically, prescribing providers may add language to an existing receipt for a contact lens fitting or to the prescription itself saying, "My eye care professional provided me with a copy of my contact lens prescription at the completion of my contact lens fitting." Patients may then sign under that text on the receipt or prescription, which would not require additional paperwork. If a digital copy of the prescription is provided to the patient, providers could retain evidence that the prescription was sent, received, or made accessible through an online patient portal. Rather than incorporating these details in the text of the regulation, the Board has indicated that they will issue guidance for optometrists that would contain this information.

Estimated Benefits and Costs. The proposed change is intended to enhance consumer freedom of choice among contact lens sellers. Although contact lens prescribers were already required to provide patients with a copy of their prescription, the additional requirement that prescribers obtain a confirmation would encourage compliance by prescribers and make it easier to verify compliance if the Board receives a complaint. The recordkeeping costs associated with this change are unlikely to be significant since the confirmation can be easily added to existing paperwork, such as the receipt for the contact lens fitting or to the prescription itself. Optometrists that currently provide digital copies of prescriptions through an online patient portal or encrypted email would likely be in compliance with the new requirement without having to make additional changes.

Businesses and Other Entities Affected. The proposed amendments affect the 1,680 optometrists in the Commonwealth.⁵ No optometrists appear to be disproportionately affected.

The Code of Virginia requires DPB to assess whether an adverse impact may result from the proposed regulation.⁶ An adverse impact is indicated if there is any increase in net cost or reduction in net revenue for any entity, even if the benefits exceed the costs for all entities combined. As noted, the proposed change would increase recordkeeping requirements but are unlikely to require additional paperwork or staff time. Thus, an adverse impact is not indicated.

Small Businesses⁷ Affected.⁸ The Department of Health Professions does not collect information regarding whether license holders run or are employed by a small business. However, the agency reports that the majority of licensed optometrists are likely to run small businesses. However, the proposed change would not create new costs for optometrists. Thus, an adverse economic impact⁹ is not indicated for small businesses.

Localities¹⁰ Affected.¹¹ The proposed amendment would not impact any local government or disproportionally affect the practice of optometry in any particular locality. Consequently, an adverse economic impact¹² is not indicated for localities.

Projected Impact on Employment. The proposed amendments would not affect employment by optometrist practices.

Effects on the Use and Value of Private Property. The proposed change would not create substantive new or ongoing costs. Consequently, the value of optometrist businesses would not be affected. The proposed amendments do not affect real estate development costs.

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¹Section 2.2-4007.04 of the Code of Virginia requires that such economic impact analyses determine the public benefits and costs of the proposed amendments. Further the analysis should include but not be limited to: (1) the projected number of businesses or other entities to whom the proposed regulatory action would apply, (2) the identity of any localities and types of businesses or other entities particularly affected, (3) the projected number of persons and employment positions to be affected, (4) the projected costs to affected businesses or entities to implement or comply with the regulation, and (5) the impact on the use and value of private property.

²See http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-chapter102&edition=prelim.

³See https://www.ftc.gov/tips-advice/business-center/guidance/contact-lens-rule-guide-prescribers-sellers.

⁴See section 315.3 (c) in https://www.ecfr.gov/current/title-16/chapter-I/subchapter-C/part-315.

⁵Agency Background Document, page 5: https://townhall.virginia.gov/L/GetFile.cfm?File=29\5862\9454\AgencyStatement_DHP_9454_v1.pdf

⁶Pursuant to § 2.2-4007.04 D: In the event this economic impact analysis reveals that the proposed regulation would have an adverse economic impact on businesses or would impose a significant adverse economic impact on a locality, business, or entity particularly affected, the Department of Planning and Budget shall advise the Joint Commission on Administrative Rules, the House Committee on Appropriations, and the Senate Committee on Finance. Statute does not define "adverse impact," state whether only Virginia entities should be considered, nor indicate whether an adverse impact results from regulatory requirements mandated by legislation.

⁷Pursuant to § 2.2-4007.04, small business is defined as "a business entity, including its affiliates, that (i) is independently owned and operated and (ii) employs fewer than 500 full-time employees or has gross annual sales of less than $6 million."

⁸If the proposed regulatory action may have an adverse effect on small businesses, § 2.2-4007.04 requires that such economic impact analyses include: (1) an identification and estimate of the number of small businesses subject to the proposed regulation, (2) the projected reporting, recordkeeping, and other administrative costs required for small businesses to comply with the proposed regulation, including the type of professional skills necessary for preparing required reports and other documents, (3) a statement of the probable effect of the proposed regulation on affected small businesses, and (4) a description of any less intrusive or less costly alternative methods of achieving the purpose of the proposed regulation. Additionally, pursuant to § 2.2-4007.1 of the Code of Virginia, if there is a finding that a proposed regulation may have an adverse impact on small business, the Joint Commission on Administrative Rules shall be notified.

⁹Adverse impact is indicated if there is any increase in net cost or reduction in net revenue for any entity, even if the benefits exceed the costs for all entities combined.

¹⁰"Locality" can refer to either local governments or the locations in the Commonwealth where the activities relevant to the regulatory change are most likely to occur.

¹¹Section 2.2-4007.04 defines "particularly affected" as bearing disproportionate material impact.

¹²Adverse impact is indicated if there is any increase in net cost or reduction in net revenue for any entity, even if the benefits exceed the costs for all entities combined.

Agency's Response to Economic Impact Analysis: The Board of Optometry concurs with the economic impact analysis of the Department of Planning and Budget.

Summary:

The amendment requires an optometrist to maintain some documentation that a patient has received the patient's contact lens prescription at the end of the final fitting, as required by state and federal rule.

18VAC105-20-45. Standards of practice.

A. An optometrist shall legibly document in a patient record the following:

1. During a routine or medical eye examination:

a. An adequate case history, including the patient's chief complaint;

b. The performance of appropriate testing;

c. The establishment of an assessment or diagnosis; and

d. A recommendation for an appropriate treatment or management plan, including any necessary follow-up.

2. During an initial contact lens examination:

a. The requirements of a routine or medical eye examination as prescribed in subdivision 1 of this subsection;

b. Assessment of corneal curvature;

c. Evaluation of contact lens fitting;

d. Acuity through the lens; and

e. Directions for the wear, care, and handling of lenses.

3. During a follow-up contact lens examination:

a. Evaluation of contact lens fitting and anterior segment health;

b. Acuity through the lens; and

c. Such further instructions as necessary for the individual patient.

4. In addition, the record of any examination shall include the signature of the attending optometrist and, if indicated, refraction of the patient.

B. The following information shall appear on a prescription for ophthalmic goods:

1. The printed name of the prescribing optometrist;

2. The address and telephone number at which the patient's records are maintained and the optometrist can be reached for consultation;

3. The name of the patient;

4. The signature of the optometrist;

5. The date of the examination;

6. If an expiration date is placed on a prescription for ophthalmic goods, the date shall not be less than one year unless the medical reason for a shorter expiration date is documented in the patient record; and

7. Any special instructions.

C. Contact lens.

1. Sufficient information for complete and accurate filling of an established contact lens prescription shall include (i) the power, (ii) the material or manufacturer or both, (iii) the base curve or appropriate designation, (iv) the diameter when appropriate, and (v) medically appropriate expiration date.

2. An optometrist shall provide a patient with a copy of the patient's contact lens prescription at the end of the contact lens fitting, even if the patient does not ask for it. An optometrist may first require all fees to be paid, but only if he the optometrist requires immediate payment from patients whose eye examinations reveal no need for corrective eye products. Patient confirmation of receipt of the prescription at the end of the contact lens fitting shall be maintained in the patient record.

3. An optometrist shall provide or verify the prescription to anyone who is designated to act on behalf of the patient, including contact lens sellers.

4. An optometrist shall not require patients to buy contact lenses, pay additional fees, or sign a waiver or release in exchange for a copy of the contact lens prescription.

5. An optometrist shall not disclaim liability or responsibility for the accuracy of an eye examination.

D. Spectacle lens.

1. A licensed optometrist shall provide a written prescription for spectacle lenses immediately after the eye examination is completed. He may first require all fees to be paid, but only if he requires immediate payment from patients whose eye examinations reveal no need for corrective eye products.

2. An optometrist shall not require patients to buy ophthalmic goods, pay additional fees, or sign a waiver or release in exchange for a copy of the spectacle prescription.

3. An optometrist shall not disclaim liability or responsibility for the accuracy of an eye examination.

E. Practitioners shall maintain a patient record for a minimum of six years following the last patient encounter with the following exceptions:

1. Records that have previously been transferred to another practitioner or health care provider or provided to the patient or his personal representative; or

2. Records that are required by contractual obligation or federal law to be maintained for a longer period of time.

F. Practitioners shall post information or in some manner inform all patients concerning the time frame for record retention and destruction. Patient records shall only be destroyed in a manner that protects patient confidentiality.

G. For the purpose of prescribing spectacles, eyeglasses, lenses, or contact lenses to a patient, a licensee shall establish a bona fide provider-patient relationship in accordance with requirements of § 54.1-2400.01:2 of the Code of Virginia.