Title of Regulation: 18VAC85-21. Regulations Governing Prescribing of Opioids and Buprenorphine (adding 18VAC85-21-21).

Statutory Authority: §§ 54.1-2400 and 54.1-2928.2 of the Code of Virginia.

Public Hearing Information:

October 22, 2020 - 8:35 p.m. - Department of Health Professions, Perimeter Center, 9960 Mayland Drive, Suite 201, Richmond, VA 23233-1463

Public Comment Deadline: November 13, 2020.

Agency Contact: William L. Harp, M.D., Executive Director, Board of Medicine, 9960 Mayland Drive, Suite 300, Richmond, VA 23233, telephone (804) 367-4558, FAX (804) 527-4429, or email william.harp@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 Medicine the authority to promulgate regulations to administer the regulatory system. The specific statutory authority 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 electronic prescribing of a controlled substance containing an opioid. Since the circumstances may vary from practitioner to practitioner, the board has used the conditions set forth in the Code of Virginia as the basis for the regulation and will take into consideration the health, safety, and welfare of a practitioner's patients in making a case-by-case decision on a waiver.

Substance: The proposed amendments to 18VAC85-21 add 18VAC85-21-21 to (i) reiterate the requirement that took effect on July 1, 2020, that a prescription for a controlled substance that contains an opioid must be issued as an electronic prescription; 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, allows for continued prescribing for practitioners who are not able to comply for exceptional circumstances beyond their control.

Department of Planning and Budget's Planning and Budget:

Summary of the Proposed Amendments to Regulation. The Board of Medicine (Board) proposes to amend 18VAC85-21 Regulations Governing Prescribing of Opioids and Buprenorphine in order to require that prescriptions of medications containing opioids be transmitted electronically from the prescribing authority to the pharmacist. 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, as effective until July 1, 2020, 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 takes effect on July 1, 2020.² The same acts 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 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 of Medicine promulgated an emergency regulation that became effective on September 18, 2019.⁶

The proposed amendment, which is identical to the emergency text currently in effect, adds a section to the regulation (specifically 18VAC85-21-21) containing two sub-sections as quoted below.

18VAC85-21-21. 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.

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, 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 amends § 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 workgroup 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 75% of providers and nearly 99% of pharmacies in Virginia had already adopted electronic prescriptions by 2018 and face no additional costs.⁷

The remaining providers who need to implement e-prescription by July 1, 2020, would face additional costs, particularly those in remote areas without reliable internet connectivity. If this imposes a significant economic burden, these providers could mitigate these costs in the short run by obtaining a waiver from the Board by July 1, 2020, for a period of up to a year.⁸ The remaining one percent of pharmacies would likely find it beneficial to adopt e-prescriptions if they dispense opiates and intend to continue to do so. Finally, the public would stand to benefit to the extent that increasing electronic prescriptions of controlled substances decreases instances of substance abuse.

Businesses and Other Entities Affected. The Board currently has 38,947 licensed doctors of medicine and surgery, 3,834 licensed doctors of osteopathic medicine, 553 licensed doctors of podiatry, and 4,224 licensed physician assistants. 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.

Small Businesses⁹ Affected. The Department of Health Professions could not provide information on the number of licensees who may be proprietors or employees of a small business. However, there do not appear to be disproportionately higher costs for small businesses.

Localities¹⁰ Affected.¹¹ 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 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=8714

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

⁸In communications with the Department of Health Professions, they stated that providers would need to have their waiver in place by July 1st or they would be in violation of the regulation and the law if they did not e-prescribe opioids after the deadline.

⁹Pursuant 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."

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.

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

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

Summary:

The proposed amendments (i) require a prescription for a controlled substance that contains an opioid to be issued as an electronic prescription and (ii) provide a one-time waiver of this requirement for a maximum of one year if a practitioner can demonstrate economic hardship, technological limitations, or other exceptional circumstances beyond the practitioner's control. The proposed amendments would replace emergency regulations currently in effect.

18VAC85-21-21. 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.

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.