Title of Regulation: 18VAC60-21. Regulations Governing the Practice of Dentistry (adding 18VAC60-21-107).

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

Public Hearing Information:

June 11, 2021 - 9:05 a.m. - Department of Health Professions, Perimeter Building, 9960 Mayland Drive, 2nd Floor, Board Room 4, Henrico, VA 23233 (Location subject to change - check the Virginia Regulatory Town Hall website at https://townhall.virginia.gov prior to meeting.)

Public Comment Deadline: July 9, 2021.

Agency Contact: Sandra Reen, Executive Director, Board of Dentistry, 9960 Mayland Drive, Suite 300, Richmond, VA 23233, telephone (804) 367-4437, FAX (804) 527-4428, or email sandra.reen@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 Dentistry 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 board may grant a one-year waiver from the requirement for e-prescribing of a controlled substance containing an opioid pursuant to Chapter 664 of the 2019 Acts of Assembly. Since the circumstances may vary from practitioner to practitioner, the board has used the conditions set forth in statute as the basis for the regulation and will take into consideration in making a case-by-case decision on a waiver the health, safety, and welfare of a practitioner's patients.

Substance: 18VAC60-21-107 is added to reiterate the requirement effective 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 provide for a one-year 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. Other matters of interest revolve around the implementation and application of statutory and regulatory provisions. Some prescribers are concerned about the requirement for electronic prescribing, which is required by statute by July 1, 2020.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. The Board of Dentistry (Board) proposes to amend 18VAC60-210 Regulations Governing the Practice of Dentistry 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; Schedules II through V prescriptions shall be transmitted in accordance with 21 CFR 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 10 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 acts enactment. Hence, the Board promulgated an emergency regulation that became effective on December 2, 2019.⁶

The proposed amendment adds a section to the regulation (specifically 18VAC60-21-107) containing the two sub-sections as quoted below:

18VAC60-21-107. Waiver for electronic prescribing.

A. 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.

B. Upon written request, the board may grant a one-time waiver of the

requirement of subsection A of this section, 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, and 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 Workgroups final report indicates that roughly 61 percent of prescribers and nearly 99% 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 dentists who had a proper application (approximately 1,430) 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. The Board currently regulates approximately 7,288 dentists. 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, and (iii) they do not already use e-prescription technology. According to DHP, approximately 1,430 dentists have been granted a waiver.

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

Localities⁹ Affected.¹⁰ 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=8755

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 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 amendment adds a section to (i) reiterate the requirement effective 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 from the requirement if the practitioner can demonstrate economic hardship technological limitations or other exceptional circumstances beyond the practitioner's control.

18VAC60-21-107. Waiver for electronic prescribing.

A. 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.

B. Upon written request, the board may grant a one-time waiver of the requirement of subsection A of this section 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.