TITLE 18. PROFESSIONAL AND OCCUPATIONAL LICENSING

BOARD OF MEDICINE

Fast-Track Regulation

Title of Regulation: 18VAC85-21. Regulations Governing Prescribing of Opioids and Buprenorphine (amending 18VAC85-21-20, 18VAC85-21-21, 18VAC85-21-30, 18VAC85-21-40, 18VAC85-21-60, 18VAC85-21-70, 18VAC85-21-80, 18VAC85-21-100, 18VAC85-21-130 through 18VAC85-21-160; adding 18VAC85-21-23).

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

Public Hearing Information: No public hearing is currently scheduled.

Public Comment Deadline: December 18, 2024.

Effective Date: January 2, 2025.

Agency Contact: Erin Barrett, Director of Legislative and Regulatory Affairs, Department of Health Professions, Perimeter Center, 9960 Mayland Drive, Suite 300, Henrico, VA 23233, telephone (804) 750-3912, FAX (804) 915-0382, or email erin.barrett@dhp.virginia.gov.

Basis: Regulations of the board are promulgated under the general authority of § 54.1-2400 of the Code of Virginia, which specifically states that the general powers and duties of health regulatory boards shall be to promulgate regulations. Section 54.1-2928.2 directs the Board of Medicine to promulgate regulations governing the prescribing of opioids and buprenorphine.

Purpose: The regulation is necessary to protect the health, safety, and welfare of patients because the regulation guides practitioners in the use of opioids and buprenorphine, which are addictive and often abused drugs. Similarly, the failure to appropriately prescribe these medications to the pain management or opioid use disorder populations can harm the public.

Rationale for Using Fast-Track Rulemaking Process: This rulemaking is expected to be noncontroversial because the board has received comments for several years of the need for these changes. Additionally, the board convened a regulatory advisory panel of 12 stakeholders from a variety of backgrounds to provide assistance in drafting these changes. These amendments have been the subject of substantial public participation.

Substance: These amendments (i) add other FDA-approved opioid reversal agents where "naloxone" is currently used; (ii) change references to addiction treatment to opioid use disorder; (iii) update prescribing guidelines based on patient population or type of pain treated; (iv) clarify tapering; (v) include subacute pain as a pain management category along with acute and chronic; (vi) remove references to the Substance Abuse and Mental Health Services Administration (SAMHSA) waiver to prescribe buprenorphine, as that is no longer issued by SAMHSA or required for buprenorphine prescribing; (vii) clarify the use of telemedicine for prescription of opioids; and (viii) increase the recommended quantity for initial prescription of opioids.

Issues: The primary advantage to the public is updated guidelines for practitioners regarding prescription of opioids and buprenorphine. There are no disadvantages to the public. There are no primary advantages or disadvantages to the agency or the Commonwealth.

Department of Planning and Budget 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 and Executive Order 19. The analysis presented represents DPB's best estimate of the potential economic impacts as of the date of this analysis.¹

Summary of the Proposed Amendments to Regulation. The Board of Medicine (board) proposes to update these regulations to incorporate the latest Clinical Practice Guideline for Prescribing Opioids for Pain issued by the Centers for Disease Control and Prevention (CDC); several other discretionary changes based on the feedback and information received by the board; and editorial changes to improve clarity and remove obsolete references.

Background. These regulations govern prescribing of opioids and buprenorphine for pain by practitioners. Prescribing of these controlled substances was significantly amended in 2018 pursuant to a mandate by the General Assembly.² According to the Department of Health Professions (DHP), medical research and CDC guidelines surrounding opioid and buprenorphine prescribing have changed since that time, and the CDC issued new guidelines in late 2022.³ The proposed action would mainly incorporate the revised guidelines but also make other discretionary changes based on the feedback and information received by the board, as well as editorial changes to improve clarity and remove obsolete references.

Estimated Benefits and Costs. The descriptions, rationales, and anticipated effects of the proposed changes are provided below. Changes that are prompted by the new CDC guidelines are indicated as "CDC," while other changes (those not prompted by the CDC guidelines) are indicated as "non-CDC."

Allow the use of other opioid reversal agents in addition to Naloxone if they are approved by the Federal Drug Administration (FDA) (non-CDC). According to the board, this change is in response to the expected approval by FDA of opioid reversal agents (also known as antagonists) other than naloxone, which should soon be available to practitioners and the public. This change would still allow naloxone to be used but would also allow use of new opioid reversal agents as they become available. This change would benefit the makers of the new opioid reversal agents as they would have immediate access to the Virginia market under this change. Conversely, however, the incumbent maker of naloxone, currently a de facto monopoly in Virginia, would no longer be sheltered from competition by this regulation. This would benefit consumers because a monopoly can command higher prices at the expense of consumers by controlling supply. Additionally, the practitioner ability to prescribe other opioid reversal agents if indicated would be possible and patients would have immediate access to any such new drugs. In essence, this change would remove a barrier to entry into the Virginia's market for opioid reversal agents. Several changes would remove or revise the limits on opioid-related drugs and expand the use of buprenorphine. One change in this category would increase the seven-day opioid prescription supply limit to 14 days for acute and subacute pain (CDC) and remove the limitation that practitioners must follow the manufacturer's directions for use (non-CDC). The board reports that the seven-day limitation is too restrictive in practice, and that the use of opioids for off-label uses may not need to be, and sometimes should not be, in accordance with manufacturer directions. Practitioners and patients would likely benefit from this change in terms of a decrease in the need to write prescriptions and the associated trips to the pharmacy, and perhaps fewer doctor visits as well. Practitioners and patients would likely also benefit from the ability to diverge from manufacturer directions when needed. Another change would remove the daily limits on buprenorphine, which are currently eight milligrams when starting therapy and 24 milligrams after the initial stages of therapy (CDC). This change is intended to allow practitioners to make clinical decisions based on the patient that presents before them rather than be limited to a set dosage amount for initial and ongoing therapy. Like the previous change, this would provide more flexibility to the practitioners when needed, and patients who need a higher dosage of buprenorphine would also be accommodated. A third set of changes would also allow buprenorphine treatment of a patient who has psychiatric comorbidities and is not stable (non-CDC). The board determined that excluding these patients from buprenorphine treatment was unnecessarily limiting. Many patients who need treatment for opioid use disorder may present with psychiatric comorbidities, but those comorbidities are resolved with successful treatment for opioid use disorder. In addition, according to the board, psychiatric comorbidities can be exacerbated by opioid use disorder, in which case it is proper to initiate treatment for both conditions simultaneously. With this change, practitioners would have buprenorphine treatment as an option for patients with psychiatric comorbidities. Thus, both practitioners and affected patients are likely to benefit from this change.

Several changes would provide some administrative relief to practitioners. The changes in this group would reduce the administrative burden on practitioners as the documentation requirements would be lessened and specific action would no longer be required in certain instances. One of these changes would remove the requirement that providers document the rationale for prescribing doses between 16 and 24 milligrams of buprenorphine per day (CDC). Currently, a practitioner may prescribe up to 24 milligrams per day, but when the dosage is over 16 milligrams certain documentation of the rationale is required. This change is a direct result of removing the daily limits on buprenorphine, as discussed. Another change would no longer require a practitioner to document absence of any indicators for medication misuse or diversion and subsequently take appropriate action when misuse or diversion is indicated (non-CDC). Currently, practitioners are required to record and take appropriate action not only when indicators of misuse or diversion are present, but also when they are absent. Under this change, practitioners would be required to document and take appropriate action only when indicators are present and take appropriate action as part of the standard of care. The board rationale is that in other disciplines of medicine, practitioners are not required to document the absence of symptoms, and it is viewed as unnecessarily burdensome and stigmatizing to include the requirement in these regulations. The regulation would also be amended to remove the requirement that a prescriber "take appropriate action" upon documenting the presence of indicators of medication misuse or diversion. This requirement placed practitioners in a difficult position when working with vulnerable populations, and the board states that it is additionally difficult to enforce. The proposal would also change the requirement that a practitioner "assure that [relapse prevention strategies] are addressed by" a mental health service provider to "document referral to" a mental health services provider (CDC). The board believes that practitioners have no way to "assure" strategies are addressed by another health professional. Documentation of a referral to a mental health service provider is a reasonable requirement that is attainable for prescribers. Additionally, the regulatory advisory panel and the board felt that the limitation of a referral to only certain mental health providers was unnecessarily limiting. This is particularly true in the current environment, in which it is difficult to obtain appointments with any mental health practitioner. Several proposed changes would add new requirements or limit existing options. One such change would newly require the practitioner to taper an opioid if the treatment plan includes opioid tapering (non-CDC). This change requires that no opioid patient should have their treatment stopped without the use of a tapering plan and documentation of extenuating circumstances. The board states that this is a direct result of complaints and communications it has received regarding practitioners who stop opioid treatment without tapering, which results in severe consequences for patients. The board does, however, recognize that extenuating circumstances may exist, such as if the practitioner receives evidence in the form of drug tests that indicate the patient is not taking the drugs as prescribed. In that example, the patient may be providing drugs to third parties or selling the medication, and continuing to provide prescription medication under such conditions would be inadvisable. Accordingly, tapering would not be required if extenuating circumstances exist and are documented. This change would help spare patients from severe withdrawal symptoms when appropriate, while balancing the need to address drug diversion. Practitioners would also be required to take specific steps to address potential misuse (i.e., using the lowest effective dose, scheduling frequent office visits, performing pill counts, and checking the Prescription Monitoring Program) to reduce chances of buprenorphine misuse, in addition to diversion (non-CDC). Currently, practitioners are required to take certain steps to reduce the chances of diversion, and the proposal would also require that those steps be taken in order to reduce the chances of misuse. According to the board, this change is intended to utilize the tools used to prevent diversion to also prevent misuse. This change is expected to help prevent misuse and benefit patients. Another change in this group would require practitioners to include liver function tests if clinically indicated when performing and documenting an assessment of the patient (non-CDC). The board proposes this change because it feels that liver function tests are an important component of assessing the risk of medication assisted treatment for any practitioner. Under this change, patients will be screened for liver function, thereby increasing the ability to diagnose liver problems and address patient safety and health when clinically indicated. However, any such additional tests would also add to the cost of treatment, which some patients may be responsible for, depending on the extent and nature of their insurance coverage. An additional change would remove the allowance that pregnant women may be treated with the buprenorphine mono product (CDC). According to the board, the latest CDC guidelines state that buprenorphine or methadone is the preferred treatment for pregnant women, not the buprenorphine mono-product. Therefore, this limitation and reference would be deleted. The board also notes that if a mother needs an exemption to take the mono-product, it can still be prescribed under the existing 3.0% rule, and that this change would improve patient safety.

Significant clarifying changes (non-CDC). The board also proposes to make several clarifying changes. First, to be consistent with CDC guidelines, the definition of "acute pain" would be revised and a definition for "subacute pain" would be added. Also, certain changes in descriptions of categories would be made for consistency with CDC guidelines and current terminology. The board states that changes in descriptions of type of pain, such as acute or subacute, do not affect practitioners since they can already prescribe for these categories. So, for example, the changes do not newly "allow" opioid prescriptions for subacute pain, because practitioners can already prescribe for any pain by virtue of having a license. Additionally, patients can already receive opioids for any type of pain. Thus, there would be no change in practice. Other clarifying changes would remove obsolete references to the SAMHSA (federal Substance Abuse and Mental Health Services Administration) waiver, known as "X-waivers," to prescribe buprenorphine, as that waiver is no longer issued by SAMHSA. Lastly, the board would add language stating that DMAS (Department of Medical Assistance Services) members should not pay for services involving prescription of an opioid for pain management related to opioid use disorder. This change incorporates the 2018 DMAS rule⁴ addressing cases where some members have been asked by providers for cash or other items of monetary value in exchange for Medicaid-covered substance use disorder services.

Businesses and Other Entities Affected. The proposed amendments mainly affect individual practitioners that prescribe opioids and buprenorphine as part of pain management, opioid use disorder treatment, or surgery, as well as their patients. DHP has no data regarding the number of practitioners that prescribe opioids for these purposes. As of March 31, 2023, DHP reported a total of 53,127 prescribers under the board (42,132 medical doctors, 4,941 doctors of osteopathy, and 6,054 physician assistants). The board believes practitioners affected by the regulatory amendments would likely be a minority of those numbers. No practitioners or patients appear to be disproportionately affected.

The Code of Virginia requires the DPB to assess whether an adverse impact may result from the proposed regulation.⁵ 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, all but one of the changes (i.e., the cost of newly required liver function screening) are expected to benefit patients based on the rationales provided or explained by the board. The cost of liver screening does not appear to outweigh the benefits to patients. Similarly, the new administrative requirements to prescribers do not appear to outweigh the benefits to them from many other changes. Thus, an adverse impact on patients or prescribers is not indicated.

However, the proposed changes would replace a reference to naloxone by name and would instead use generic "FDA-approved opioid reversal agents." This change would expose the maker of naloxone to competition from new and upcoming substitute drugs. Thus, an adverse impact on the incumbent maker of naloxone is indicated.

Small Businesses⁶ Affected.⁷ The proposed changes do not appear to adversely affect small businesses.

Localities⁸ Affected.⁹ The proposed amendments neither introduce costs for localities nor disproportionately affect them.

Projected Impact on Employment. The proposed amendments do not appear to directly affect total employment.

Effects on the Use and Value of Private Property. As mentioned, one of the proposed amendments would eliminate language protecting the maker of naloxone from competition when and if other substitute drugs are approved by the FDA. Thus, the asset value of that incumbent company may be negatively affected when that occurs. No other significant effect on the use and value of private property nor on real estate development costs is expected.

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¹ Section 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.

² https://townhall.virginia.gov/l/ViewStage.cfm?stageid=8216.

³ https://www.cdc.gov/mmwr/volumes/71/rr/rr7103a1.htm.

⁴ https://www.dmas.virginia.gov/media/1332/virginia-medicaid-providers-cannot-charge-cash-to-medicaid-enrolled-members-for-covered-substance-use-disorder-treatment.pdf.

⁵ Pursuant 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.

⁶ Pursuant 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."

⁷ If 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.

⁸ "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.

⁹ Section 2.2-4007.04 defines "particularly affected" as bearing disproportionate material impact.

Agency Response to Economic Impact Analysis: The Board of Medicine concurs with the economic impact analysis prepared by the Department of Planning and Budget.

Summary:

The amendments reflect changes in medical research and Centers for Disease Control and Prevention guidelines surrounding opioid and buprenorphine prescribing, including (i) replacing "naloxone" with "other federal Food and Drug Administration-approved opioid reversal agents"; (ii) replacing "addiction" with "opioid use disorder"; (iii) updating prescribing guidelines based on patient population or type of pain treated; (iv) clarifying tapering; (v) adding subacute pain as a pain management category along with acute and chronic; (vi) removing references to the "SAMHSA waiver" to prescribe buprenorphine, as that is no longer issued by the federal Substance Abuse and Mental Health Services Administration or required for buprenorphine prescribing; (vii) clarifying use of telemedicine for prescription of opioids; and (viii) increasing the recommended quantity for initial prescription of opioids.

18VAC85-21-20. Definitions.

The following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise:

"Acute pain" means pain that occurs within the normal course of a disease or condition or as the result of surgery for which controlled substances may be prescribed for no more than three months of any origin that has existed less than one month.

"Board" means the Virginia Board of Medicine.

"Chronic pain" means nonmalignant pain that goes beyond the normal course of a disease or condition for which controlled substances may be prescribed for a period greater than three months.

"Controlled substance" means drugs listed in The Drug Control Act (§ 54.1-3400 et seq. of the Code of Virginia) in Schedules II through IV.

"DMAS" means the Virginia Department of Medical Assistance Services.

"FDA" means the U.S. Food and Drug Administration.

"Induction phase" means the initial seven to 14 days of treatment with buprenorphine.

"MME" means morphine milligram equivalent.

"Prescription Monitoring Program" means the electronic system within the Department of Health Professions that monitors the dispensing of certain controlled substances.

"SAMHSA" means the federal Substance Abuse and Mental Health Services Administration.

"Subacute pain" means pain that has existed for one to three months.

18VAC85-21-21. Electronic prescribing.

A. Beginning July 1, 2020, a 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.

18VAC85-21-23. Prohibition on payment from DMAS members.

A. No practitioner shall request payment from a DMAS member for services involving the prescription of an opioid for pain management of opioid use disorder. The prohibition on payment shall not apply to the member's cost-sharing amounts set by DMAS.

B. All practitioners shall provide written notice to DMAS members that the services described in subsection A of this section will be covered by DMAS if medical necessity criteria are met.

Part II

Management of Acute Pain and Subacute Pain

18VAC85-21-30. Evaluation of the acute pain or subacute pain patient.

A. Nonpharmacologic and non-opioid treatment for pain shall be given consideration prior to treatment with opioids. If an opioid is considered necessary for the treatment of acute pain or subacute pain, the practitioner shall give a short-acting opioid in the lowest effective dose for the fewest possible days.

B. Prior to initiating treatment with a controlled substance containing an opioid for a complaint of acute pain or subacute pain, the prescriber shall perform a history and physical examination appropriate to the complaint, query the Prescription Monitoring Program as set forth in § 54.1-2522.1 of the Code of Virginia, and conduct an assessment of the patient's history and risk of substance misuse.

18VAC85-21-40. Treatment of acute pain and subacute pain with opioids.

A. Initiation of opioid treatment for patients with acute pain and subacute pain shall be with short-acting opioids.

1. A prescriber providing treatment for acute or subacute pain shall not prescribe a controlled substance containing an opioid in a quantity that exceeds a seven-day 14-day supply as determined by the manufacturer's directions for use, unless extenuating circumstances are clearly documented in the medical record. This shall also apply to prescriptions of a controlled substance containing an opioid upon discharge from an emergency department.

2. An opioid prescribed as part of treatment for a surgical procedure shall be for no more than 14 consecutive days in accordance with manufacturer's direction and within the immediate perioperative period, unless extenuating circumstances are clearly documented in the medical record.

B. Initiation of opioid treatment for all patients shall include the following:

1. The practitioner shall carefully consider and document in the medical record the reasons to exceed 50 MME/day.

2. Prior to exceeding 120 MME/day, the practitioner shall document in the medical record the reasonable justification for such doses or refer to or consult with a pain management specialist.

3. Naloxone An FDA-approved opioid reversal agent shall be prescribed for any patient when risk factors of prior overdose, substance misuse, doses in excess of 120 MME/day, or concomitant benzodiazepine are present.

C. Due to a higher risk of fatal overdose when opioids are prescribed with benzodiazepines, sedative hypnotics, carisoprodol, and tramadol (an atypical opioid), the prescriber shall only co-prescribe these substances when there are extenuating circumstances and shall document in the medical record a tapering plan to achieve the lowest possible effective doses if these medications are prescribed.

D. Buprenorphine is not indicated for acute pain in the outpatient setting, except when a prescriber who has obtained a SAMHSA waiver is treating pain in a patient whose primary diagnosis is the disease of addiction.

18VAC85-21-60. Evaluation of the chronic pain patient.

A. Prior to initiating management or continuing management of chronic pain with a controlled substance containing an opioid, a medical history and physical examination, to include a mental status examination, shall be performed and documented in the medical record, including:

1. The nature and intensity of the pain;

2. Current and past treatments for pain;

3. Underlying or coexisting diseases or conditions;

4. The effect of the pain on physical and psychological function, quality of life, and activities of daily living;

5. Psychiatric, addiction, and substance use disorder or misuse history of the patient and any family history of addiction or substance use disorder or misuse;

6. A urine drug screen or serum medication level;

7. A query of the Prescription Monitoring Program as set forth in § 54.1-2522.1 of the Code of Virginia;

8. An assessment of the patient's history and risk of substance misuse; and

9. A request for prior applicable records.

B. Prior to initiating opioid treatment for chronic pain, the practitioner shall discuss with the patient the known risks and benefits of opioid therapy and the responsibilities of the patient during treatment to include securely storing the drug and properly disposing of any unwanted or unused drugs. The practitioner shall also discuss with the patient an exit strategy for the discontinuation of opioids in the event they are not effective.

18VAC85-21-70. Treatment of chronic pain with opioids.

A. Nonpharmacologic and non-opioid treatment for pain shall be given consideration prior to treatment with opioids.

B. In initiating and treating with an opioid, the practitioner shall:

1. Carefully consider and document in the medical record the reasons to exceed 50 MME per day;

2. Prior to exceeding 120 MME per day, the practitioner shall document in the medical record the reasonable justification for such doses or refer to or consult with a pain management specialist;

3. Prescribe naloxone an FDA-approved opioid reversal agent for any patient when risk factors of prior overdose, substance misuse, doses in excess of 120 MME per day, or concomitant benzodiazepine are present; and

4. Document the rationale to continue opioid therapy every three months.

C. Buprenorphine mono-product in tablet form shall not be prescribed for chronic pain.

D. Due to a higher risk of fatal overdose when opioids, including buprenorphine, are given with other opioids, benzodiazepines, sedative hypnotics, carisoprodol, and tramadol (an atypical opioid), the prescriber shall only co-prescribe these substances when there are extenuating circumstances and shall document in the medical record a tapering plan to achieve the lowest possible effective doses of these medications if prescribed.

E. The practitioner (i) shall regularly evaluate the patient for opioid use disorder and (ii) shall initiate specific treatment for opioid use disorder, consult with an appropriate health care provider, or refer the patient for evaluation and treatment if indicated.

18VAC85-21-80. Treatment plan for chronic pain.

A. The medical record shall include a treatment plan that states measures to be used to determine progress in treatment, including pain relief and improved physical and psychosocial function, quality of life, and daily activities.

B. The treatment plan shall include further diagnostic evaluations and other treatment modalities or rehabilitation that may be necessary depending on the etiology of the pain and the extent to which the pain is associated with physical and psychosocial impairment.

C. The prescriber shall document in the medical record the presence or absence of any indicators for medication misuse or diversion and shall take appropriate action.

18VAC85-21-100. Opioid therapy for chronic pain.

A. The practitioner shall review the course of pain treatment and any new information about the etiology of the pain and the patient's state of health at least every three months.

B. Continuation of treatment with opioids shall be supported by documentation of continued benefit from such prescribing. If the patient's progress is unsatisfactory, the practitioner shall assess the appropriateness of continued use of the current treatment plan and consider the use of other therapeutic modalities.

C. If the treatment plan includes opioid tapering, the taper rate shall be individualized based on the patient's clinical situation. A practitioner should not abruptly stop opioid treatment without tapering unless the prescriber documents extenuating circumstances.

D. The practitioner shall check the Prescription Monitoring Program at least every three months after the initiation of treatment.

D. E. The practitioner shall order and review a urine drug screen or serum medication levels at the initiation of chronic pain management and thereafter randomly at the discretion of the practitioner but at least once a year.

E. F. The practitioner (i) shall (i) regularly evaluate the patient for opioid use disorder and (ii) shall initiate specific treatment for opioid use disorder, consult with an appropriate health care provider, or refer the patient for evaluation for treatment if indicated.

Part IV

Prescribing of Buprenorphine for Addiction Treatment Opioid Use Disorder

18VAC85-21-130. General provisions pertaining to prescribing of buprenorphine for addiction treatment opioid use disorder.

A. Practitioners engaged in office-based opioid addiction treatment with buprenorphine shall have obtained a SAMHSA waiver and the appropriate U.S. Drug Enforcement Administration registration.

B. A. Practitioners shall abide by all federal and state laws and regulations governing the prescribing of buprenorphine for the treatment of opioid use disorder.

C. B. Physician assistants and nurse practitioners who have obtained a SAMHSA waiver shall only prescribe buprenorphine for opioid addiction use disorder pursuant to a practice agreement with a waivered patient care team doctor of medicine or doctor of osteopathic medicine.

D. C. Practitioners engaged in medication-assisted treatment shall either provide counseling in their practice or refer the patient to a mental health service provider, as defined in § 54.1-2400.1 of the Code of Virginia, who has the education and experience to provide substance misuse counseling. The practitioner shall document provision of counseling or referral in the medical record.

18VAC85-21-140. Patient assessment and treatment planning for addiction treatment opioid use disorder.

A. A practitioner shall perform and document an assessment that includes a comprehensive medical and psychiatric history, substance misuse history, family history and psychosocial supports, appropriate physical examination, urine drug screen, pregnancy test for women of childbearing age and ability, a check of the Prescription Monitoring Program, and, when clinically indicated, infectious disease testing for human immunodeficiency virus, hepatitis B, hepatitis C, and tuberculosis, and liver function tests.

B. The treatment plan shall include the practitioner's rationale for selecting medication-assisted treatment medications for opioid use disorder, patient education, written informed consent, how counseling will be accomplished referral for counseling, and a signed treatment agreement that outlines the responsibilities of the patient and the prescriber.

18VAC85-21-150. Treatment with buprenorphine for addiction opioid use disorder.

A. Buprenorphine without naloxone (buprenorphine mono-product) shall not be prescribed except:

1. When a patient is pregnant;

2. When converting a patient from methadone or buprenorphine mono-product to buprenorphine containing naloxone for a period not to exceed seven days;

3. In formulations other than tablet form for indications approved by the FDA; or

4. For patients who have a demonstrated intolerance to naloxone; such prescriptions for the mono-product shall not exceed 3.0% of the total prescriptions for buprenorphine written by the prescriber, and the exception shall be clearly documented in the patient's medical record.

B. Buprenorphine mono-product tablets may be administered directly to patients in federally licensed opioid treatment programs. With the exception of those conditions listed in subsection A of this section, only the buprenorphine product containing naloxone shall be prescribed or dispensed for use off site from the program.

C. The evidence for the decision to use buprenorphine mono-product shall be fully documented in the medical record.

D. Due to a higher risk of fatal overdose when buprenorphine is prescribed with other opioids, benzodiazepines, sedative hypnotics, carisoprodol, and tramadol (an atypical opioid), the prescriber shall only co-prescribe these substances when there are extenuating circumstances and shall document in the medical record a tapering plan to achieve the lowest possible effective doses if these medications are prescribed.

E. Prior to starting medication-assisted treatment medications for opioid use disorder, the practitioner shall perform a check of the Prescription Monitoring Program.

F. During the induction phase, except for medically indicated circumstances as documented in the medical record, patients should be started on no more than eight milligrams of buprenorphine per day dosage shall be based on the patient's history and current usage, including exposure to high-potency opioids. The patient shall be seen evaluated by the prescriber at least once a week.

G. During the stabilization phase, the prescriber shall increase the daily dosage of buprenorphine in safe and effective increments to achieve the lowest dose that avoids intoxication, withdrawal, or significant drug craving.

H. Practitioners shall take steps to reduce the chances of buprenorphine diversion and misuse by using the lowest effective dose, appropriate frequency of office visits, pill counts, and checks of the Prescription Monitoring Program. The practitioner shall also require urine drug screens or serum medication levels at least every three months for the first year of treatment and at least every six months thereafter.

I. Documentation of the rationale for prescribed doses exceeding 16 24 milligrams of buprenorphine per day shall be placed in the medical record. Dosages exceeding 24 milligrams of buprenorphine per day shall not be prescribed.

J. The practitioner shall incorporate relapse prevention strategies into counseling or assure that they are addressed by document referral to a mental health service provider, as defined in § 54.1-2400.1 of the Code of Virginia, who has the education and experience to provide substance misuse counseling.

18VAC85-21-160. Special populations in addiction treatment for opioid use disorder.

A. Pregnant women may be treated with the buprenorphine mono-product, usually 16 milligrams per day or less.

B. A. Patients younger than the age of 16 years of age shall not be prescribed buprenorphine for addiction treatment unless such treatment is approved by the FDA.

C. B. The progress of patients with chronic pain shall be assessed by reduction of pain and functional objectives that can be identified, quantified, and independently verified.

D. C. Practitioners shall (i) evaluate patients with medical comorbidities by history, physical exam, and appropriate laboratory studies and (ii) be aware of interactions of buprenorphine with other prescribed medications.

E. Practitioners shall not undertake buprenorphine treatment with a patient who has psychiatric comorbidities and is not stable. A patient who is determined by the prescriber to be psychiatrically unstable shall be referred for psychiatric evaluation and treatment prior to initiating medication-assisted treatment.