Title of Regulation: 18VAC105-20. Regulations Governing the Practice of Optometry (amending 18VAC105-20-47).

Statutory Authority: §§ 54.1-2400 and 54.1-3408.02 of the Code of Virginia.

Public Hearing Information:

June 7, 2021 - 10:00 a.m. - Electronic meeting. Instructions will be posted at http://www.dhp.virginia.gov prior to the meeting.

Public Comment Deadline: July 23, 2021.

Agency Contact: Leslie L. Knachel, Executive Director, Board of Optometry, 9960 Mayland Drive, Suite 300, Richmond, 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, which provides the Board of Optometry the authority to promulgate regulations to administer the regulatory system. The specific statutory provisions for electronic prescribing and the authority for granting a waiver are found in § 54.1-3408.02 of the Code of Virginia.

Purpose: The purpose of this regulatory action is compliance with a statutory requirement to promulgate regulations setting out the conditions upon which the boards may grant a one-year waiver from the requirement for e-prescribing of a controlled substance containing an opioid. Since the circumstances may vary from practitioner to practitioner, the boards have used the conditions set forth in the Code of Virginia as the basis for the regulation and take into consideration in making a case-by-case decision on a waiver the health, safety, and welfare of a practitioner's patients.

Substance: Subsection D is added to 18VAC105-20-47 to (i) reiterate the requirement that takes effect on July 1, 2020, that a prescription for a controlled substance that contains an opioid must be issued as an electronic prescription unless the prescriber qualifies for an exemption provided in the law; and (ii) provide for a one-year waiver from the requirement if the practitioner can demonstrate economic hardship technological limitations or other exceptional circumstances beyond the practitioner's control.

Issues: There are no advantages or disadvantages to the public apart from those in the statutory language. Submitting opioid prescriptions electronically has been shown to reduce prescription fraud and thereby reduce the volume of opioids available for abuse or misuse. The waiver provision (in addition to the specific exemptions to electronic prescribing) will allow for continued prescribing for practitioners who are not able to comply for exceptional circumstances beyond their control. There are no particular advantages or disadvantages to the agency; there may be an advantage to the Commonwealth by a reduction in fraudulent prescriptions.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. The Board of Optometry (Board) proposes to amend 18VAC105-20 Regulations of the Virginia Board of Optometry in order to require that prescriptions of medications containing opioids be transmitted electronically from the prescribing authority to the pharmacist and to grant one-time waivers up to one year if a prescriber cannot transmit prescriptions electronically as of July 1, 2020. The proposed amendment would make permanent the existing emergency text and is intended to prevent the abuse of prescription drugs containing opioids.

Background. Section 54.1-3408.02 of the Code of Virginia states that prescriptions may be transmitted electronically or by facsimile machine and shall be treated as valid original prescriptions.¹ The 2017 Acts of Assembly (Chapters 115 and 429) amended and reenacted this section of the Code to require that "any prescription for a controlled substance that contains an opiate shall be issued as an electronic prescription." The reenacted section containing this requirement took effect on July 1, 2020.² The same legislation also updated the definition of "electronic prescriptions" to be "a written prescription that is generated on an electronic application and is transmitted to a pharmacy as an electronic data file; Schedule II through V prescriptions shall be transmitted in accordance with 21 C.F.R. Part 1300."³

Subsequently, pursuant to a statutory change requested by the Board,⁴ Chapter 664 of the 2019 Acts of Assembly further amended this section to insert ten exemptions to this requirement and to authorize the licensing health regulatory board to grant a hardship waiver for one year.⁵ Chapter 664 also required that the Board of Medicine, the Board of Nursing, the Board of Dentistry, and the Board of Optometry promulgate regulations to implement the waivers within 280 days of the act's enactment. Hence, the Board promulgated an emergency regulation that became effective on August 12, 2020.⁶

The proposed amendment adds a section to the regulation (specifically 18VAC105-20-47) containing a subsection as quoted below.

18VAC105-20-47. Therapeutic pharmaceutical agents.

D. Beginning July 1, 2020, a prescription for a controlled substance that contains an opioid shall be issued as an electronic prescription consistent with § 54.1-3408.02 of the Code of Virginia, unless the prescription qualifies for an exemption as set forth in subsection C of that section. Upon written request, the board may grant a one-time waiver of the requirement for electronic prescribing, for a period not to exceed one year, due to demonstrated economic hardship, technological limitations that are not reasonably within the control of the prescriber, or other exceptional circumstances demonstrated by the prescriber.

Thus, the proposed amendment would inform readers as to the electronic transmission requirement and the waiver that may be obtained, but readers would need to refer to § 54.1-3408.02 of the Code to find the exemptions that were added by Chapter 664 of the 2019 Acts of Assembly.

The exemptions provided in the Code would directly affect the potential cost of transmitting electronic prescriptions in a variety of settings. Thus, although they are not explicitly mentioned in the text of the regulation, the exemptions are listed here for the reader's reference, with parenthetical notes inserted for clarity of context.

§ 54.1-3408.02 C. The requirements of subsection B (electronic transmission) shall not apply if:

1. The prescriber dispenses the controlled substance that contains an opioid directly to the patient or the patient's agent;

2. The prescription is for an individual who is residing in a hospital, assisted living facility, nursing home, or residential health care facility or is receiving services from a hospice provider or outpatient dialysis facility;

3. The prescriber experiences temporary technological or electrical failure or other temporary extenuating circumstance that prevents the prescription from being transmitted electronically, provided that the prescriber documents the reason for this exception in the patient's medical record;

4. The prescriber issues a prescription to be dispensed by a pharmacy located on federal property, provided that the prescriber documents the reason for this exception in the patient's medical record;

5. The prescription is issued by a licensed veterinarian for the treatment of an animal;

6. The FDA requires the prescription to contain elements that are not able to be included in an electronic prescription;

7. The prescription is for an opioid under a research protocol;

8. The prescription is issued in accordance with an executive order of the Governor of a declared emergency;

9. The prescription cannot be issued electronically in a timely manner and the patient's condition is at risk, provided that the prescriber documents the reason for this exception in the patient's medical record; or

10. The prescriber has been issued a waiver pursuant to subsection D (hardship waiver).

Further, Chapter 664 also amended § 54.1-3410 of the Code, effective July 1, 2020, which addresses when pharmacists may sell and dispense drugs. It adds a subsection to clarify that, "A dispenser who receives a non-electronic prescription for a controlled substance containing an opioid is not required to verify that one of the exceptions set forth in § 54.1-3408.02 applies and may dispense such controlled substance pursuant to such prescription and applicable law."

Estimated Benefits and Costs. The 2017 Acts of Assembly (Chapters 115 and 429) also directed the Secretary of Health and Human Resources to convene a work group of interested stakeholders to review actions necessary for the implementation of electronic prescriptions for controlled substances and evaluate the burden on prescribers, including the inability of prescribers to comply with the deadline. The E-Prescribing Workgroup's final report indicates that roughly 61 percent of prescribers and nearly 99 percent of pharmacies in Virginia had already adopted electronic prescriptions by 2018 and faced no additional costs.⁷ The Department of Health Professions (DHP) states that all optometrists who had a proper application (five optometrists) have been granted a waiver thus far.

It appears those who needed a waiver have already been granted an extension and those with a waiver who need to implement e-prescribing before their waiver expires would face additional costs such as acquisition and integration of software and possibly internet connectivity. The public would benefit to the extent that increasing electronic prescriptions of controlled substances decreases diversion and instances of substance abuse.

Businesses and Other Entities Affected. There are approximately 1,623 Therapeutic Pharmaceutical Agent (TPA) certified optometrists. Licensees would only be affected by the new requirements if (i) they prescribe medications containing opioids, (ii) they do not work in a type of facility that is included in the exemptions listed above, and (iii) they do not already use e-prescription technology. The only Schedule II drug containing an opioid that optometrists can prescribe is hydrocodone in combination with acetaminophen, so not all optometrists are affected by the requirement for electronic prescribing. According to DHP, five optometrists have been granted a waiver thus far.

Small Businesses⁸ Affected. It is not known exactly how many optometrists are small businesses or employees of a small business, but most optometrists do work in small businesses. However, there does not appear to be disproportionately higher costs for small businesses.

Localities⁹ Affected¹⁰. The proposed amendments potentially affect prescribers and patients in all localities. The proposed amendments are unlikely to introduce new costs for local governments.

Projected Impact on Employment. The proposed amendments are unlikely to affect total employment in the industry.

Effects on the Use and Value of Private Property. The proposed amendments are unlikely to substantively affect the use or value of private property. Real estate development costs are unlikely to be affected.

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¹See https://law.lis.virginia.gov/vacode/title54.1/chapter34/section54.1-3408.02/

²See http://lis.virginia.gov/cgi-bin/legp604.exe?171+ful+CHAP0429

³See Definitions effective July 1, 2020: https://law.lis.virginia.gov/vacode/title54.1/chapter34/section54.1-3401/

⁴See https://townhall.virginia.gov/L/GetFile.cfm?File=Meeting\30\26790\Agenda_DHP_26790_v1.pdf (page 172)

⁵See http://lis.virginia.gov/cgi-bin/legp604.exe?191+ful+CHAP0664

⁶See https://townhall.virginia.gov/l/ViewStage.cfm?stageid=8834

⁷https://rga.lis.virginia.gov/Published/2018/RD416

⁸Pursuant to § 2.2-4007.04 of the Code of Virginia, 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."

⁹"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.

¹⁰§ 2.2-4007.04 defines "particularly affected" as bearing disproportionate material impact.

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:

Pursuant to Chapter 664 of the 2019 Acts of Assembly, the proposed amendments (i) reiterate the requirement that takes effect on July 1, 2020, that a prescription for a controlled substance that contains an opioid must be issued as an electronic prescription unless the prescriber qualifies for an exemption set out in the law; and (ii) provide for a one-year waiver from the requirement if the practitioner can demonstrate economic hardship technological limitations or other exceptional circumstances beyond the practitioner's control.

18VAC105-20-47. Therapeutic pharmaceutical agents.

A. A TPA-certified optometrist, acting within the scope of his practice, may procure, administer, and prescribe medically appropriate therapeutic pharmaceutical agents (or any therapeutically appropriate combination thereof) to treat diseases and abnormal conditions of the human eye and its adnexa within the following categories:

1. Oral analgesics - Schedule II controlled substances consisting of hydrocodone in combination with acetaminophen and Schedules III, IV, and VI narcotic and nonnarcotic agents.

2. Topically administered Schedule VI agents:

a. Alpha-adrenergic blocking agents;

b. Alpha-adrenergic agonists;

c. Anesthetic (including esters and amides);

d. Anti-allergy (including antihistamines and mast cell stabilizers);

e. Anti-fungal;

f. Anti-glaucoma (including carbonic anhydrase inhibitors and hyperosmotics);

g. Anti-infective (including antibiotics and antivirals);

h. Anti-inflammatory;

i Cycloplegics and mydriatics;

j. Decongestants; and

k. Immunosuppressive agents.

3. Orally administered Schedule VI agents:

a. Aminocaproic acids (including antifibrinolytic agents);

b. Anti-allergy (including antihistamines and leukotriene inhibitors);

c. Anti-fungal;

d. Anti-glaucoma (including carbonic anhydrase inhibitors and hyperosmotics);

e. Anti-infective (including antibiotics and antivirals);

f. Anti-inflammatory (including steroidal and nonsteroidal);

g. Decongestants; and

h. Immunosuppressive agents.

B. Schedules I, II, and V drugs are excluded from the list of therapeutic pharmaceutical agents with the exception of controlled substances in Schedule II consisting of hydrocodone in combination with acetaminophen and gabapentin in Schedule V.

C. Over-the-counter topical and oral medications for the treatment of the eye and its adnexa may be procured for administration, administered, prescribed, or dispensed.

D. Beginning July 1, 2020, a prescription for a controlled substance that contains an opioid shall be issued as an electronic prescription consistent with § 54.1-3408.02 of the Code of Virginia, unless the prescription qualifies for an exemption as set forth in subsection C of § 54.1-3408.02. Upon written request, the board may grant a one-time waiver of the requirement for electronic prescribing, for a period not to exceed one year, due to demonstrated economic hardship, technological limitations that are not reasonably within the control of the prescriber, or other exceptional circumstances demonstrated by the prescriber.