TITLE 18. PROFESSIONAL AND OCCUPATIONAL LICENSING
Title of Regulation: 18VAC85-21. Regulations
Governing Prescribing of Opioids and Buprenorphine (adding 18VAC85-21-10 through 18VAC85-21-170).
Statutory Authority: §§ 54.1-2400 and 54.1-2928.2
of the Code of Virginia.
Effective Dates: March 15, 2017, through September 14,
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
Regulations Governing Prescribing of Opioids and
Buprenorphine are being promulgated as emergency regulations to address the
opioid abuse crisis in Virginia. On November 16, 2016, State Health
Commissioner Marissa Levine declared the opioid addiction crisis to be a public
health emergency in Virginia. In a news conference about the opioid crisis,
Governor McAuliffe noted that the declaration would "provide a framework
for further actions to fight it, and to save Virginians' lives." One of
those "further actions" is adoption of emergency regulations by the
Board of Medicine setting out rules for prescribing opioids and buprenorphine.
Section 2.2-4011 of the Code of Virginia authorizes an agency to adopt
emergency regulations when they "are necessitated by an emergency
situation." The declaration by Commissioner Levine is indeed evidence that
such an emergency situation exists in the Commonwealth. In addition, the board
is required to adopt regulations by Chapter 291 of the 2017 Acts of Assembly,
effective March 3, 2017.
The regulations establish the practitioners to whom the
rules apply and the exceptions or nonapplicability. Regulations for the
management of acute pain include requirements for the evaluation of the
patient, limitations on quantity and dosage, and medical recordkeeping.
Regulations for management of chronic pain include requirements for evaluation
and treatment, including a treatment plan, informed consent and agreement,
consultation with other providers, and medical recordkeeping. Regulations for
prescribing of buprenorphine include requirements for patient assessment and
treatment planning, limitations on prescribing the buprenorphine mono-product
(without naloxone), dosages, co-prescribing of other drugs, consultation, and
medical records for opioid addiction treatment.
REGULATIONS GOVERNING PRESCRIBING OF OPIOIDS AND BUPRENORPHINE
A. This chapter shall apply to doctors of medicine,
osteopathic medicine, and podiatry and to physician assistants.
B. This chapter shall not apply to:
1. The treatment of acute or chronic pain related to (i)
cancer, (ii) a patient in hospice care, or (iii) a patient in palliative care;
2. The treatment of acute or chronic pain during an
inpatient hospital admission or in a nursing home or an assisted living
facility that uses a sole source pharmacy; or
3. A patient enrolled in a clinical trial as authorized by
state or federal law.
The following words and terms when used in this chapter
shall have the following meanings unless the context clearly indicates
"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.
"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
"FDA" means the U.S. Food and Drug
"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.
Management of Acute Pain
18VAC85-21-30. Evaluation of the acute 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, the practitioner shall
give a short-acting opioid in the lowest effective dose for the fewest possible
B. Prior to initiating treatment with a controlled
substance containing an opioid for a complaint of acute pain, the prescriber
shall perform a history and physical examination appropriate to the complaint,
query the Prescription Monitoring Program as set forth in § 54.1-2522.1of the
Code of Virginia, and conduct an assessment of the patient's history and risk
of substance abuse.
18VAC85-21-40. Treatment of acute pain with opioids.
A. Initiation of opioid treatment for patients with acute
pain shall be with short-acting opioids.
1. A prescriber providing treatment for acute pain shall
not prescribe a controlled substance containing an opioid in a quantity that
exceeds a seven-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 shall be prescribed for any patient when risk
factors of prior overdose, substance abuse, doses in excess of 120 MME/day, or
concomitant benzodiazepine is present.
C. Due to a higher risk of fatal overdose when opioids are
prescribed with benzodiazepines, sedative hypnotics, carisoprodol, and
tramadol, 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
18VAC85-21-50. Medical records for acute pain.
The medical record shall include a description of the
pain, a presumptive diagnosis for the origin of the pain, an examination
appropriate to the complaint, a treatment plan, and the medication prescribed
or administered to include the date, type, dosage, and quantity prescribed or
Management of Chronic Pain
18VAC85-21-60. Evaluation of the chronic pain patient.
A. Prior to initiating 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 abuse history of
the patient and any family history of addiction or substance abuse;
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 abuse; 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
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
1. 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. Prescribe naloxone for any patient when risk factors of
prior overdose, substance abuse, doses in excess of 120 MME/day, or concomitant
benzodiazepine is present; and
4. Document the rationale to continue opioid therapy every
C. Buprenorphine may be prescribed or administered for
chronic pain in formulation and dosages that are FDA-approved for that purpose.
D. Due to a higher risk of fatal overdose when opioids,
including buprenorphine, are given with other opioids, benzodiazepines,
sedative hypnotics, carisoprodol, and tramadol, 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 shall regularly evaluate for opioid use
disorder and 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
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, abuse, or
diversion and shall take appropriate action.
18VAC85-21-90. Informed consent and agreement for treatment
for chronic pain.
A. The practitioner shall document in the medical record
informed consent, to include risks, benefits, and alternative approaches, prior
to the initiation of opioids for chronic pain.
B. There shall be a written treatment agreement signed by
the patient in the medical record that addresses the parameters of treatment,
including those behaviors that will result in referral to a higher level of
care, cessation of treatment, or dismissal from care.
C. The treatment agreement shall include notice that the
practitioner will query and receive reports from the Prescription Monitoring
Program and permission for the practitioner to:
1. Obtain urine drug screens or serum medication levels
when requested; and
2. Consult with other prescribers or dispensing pharmacists
for the patient.
D. Expected outcomes shall be documented in the medical
record including improvement in pain relief and function or simply in pain
relief. Limitations and side effects of chronic opioid therapy shall be
documented in the medical record.
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. The practitioner shall check the Prescription
Monitoring Program at least every three months after the initiation of
D. The practitioner shall order and review a urine drug
screen or serum medication levels at the initiation of chronic pain management
and at least every three months for the first year of treatment and at least
every six months thereafter.
E. The practitioner shall regularly evaluate for opioid
use disorder and 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.
18VAC85-21-110. Additional consultations.
A. When necessary to achieve treatment goals, the
prescriber shall refer the patient for additional evaluation and treatment.
B. When a prescriber makes the diagnosis of opioid use
disorder, treatment for opioid use disorder shall be initiated or the patient
shall be referred for evaluation and treatment.
18VAC85-21-120. Medical records for chronic pain.
The prescriber shall keep current, accurate, and complete
records in an accessible manner readily available for review to include:
1. The medical history and physical examination;
2. Past medical history;
3. Applicable records from prior treatment providers or any
documentation of attempts to obtain those records;
4. Diagnostic, therapeutic, and laboratory results;
5. Evaluations and consultations;
6. Treatment goals;
7. Discussion of risks and benefits;
8. Informed consent and agreement for treatment;
10. Medications (including date, type, dosage, and quantity
prescribed and refills);
11. Patient instructions; and
12. Periodic reviews.
Prescribing of Buprenorphine for Addiction Treatment
18VAC85-21-130. General provisions pertaining to prescribing
of buprenorphine for addiction treatment.
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. Practitioners shall abide by all federal and state laws
and regulations governing the prescribing of buprenorphine for the treatment of
opioid use disorder.
C. Physician assistants and nurse practitioners who have
obtained a SAMHSA waiver shall only prescribe buprenorphine for opioid
addiction pursuant to a practice agreement with a waivered doctor of medicine
or doctor of osteopathic medicine.
D. 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 abuse
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.
A. A practitioner shall perform and document an assessment
that includes a comprehensive medical and psychiatric history, substance abuse
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.
B. The treatment plan shall include the practitioner's
rationale for selecting medication-assisted treatment, patient education,
written informed consent, how counseling will be accomplished, and a signed
treatment agreement that outlines the responsibilities of the patient and the
18VAC85-21-150. Treatment with buprenorphine for addiction.
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; or
3. In formulations other than tablet form for indications
approved by the FDA.
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, 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, 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. The patient
shall be seen 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
H. Practitioners shall take steps to reduce the chances of
buprenorphine diversion 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 milligrams of buprenorphine per day shall be placed in the medical
record. Dosages exceeding 24 milligrams of buprenorphine per day shall not be
J. The practitioner shall incorporate relapse prevention
strategies into counseling or assure that they are addressed by 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 abuse counseling.
18VAC85-21-160. Special populations in addiction treatment.
A. Pregnant women shall be treated with the buprenorphine
mono-product, usually 16 milligrams per day or less.
B. Patients younger than the age of 16 years shall not be
prescribed buprenorphine for addiction treatment unless such treatment is
approved by the FDA.
C. 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. Practitioners shall (i) evaluate patients with medical
comorbidities by history, physical exam, appropriate laboratory studies and
(ii) be aware of interactions of buprenorphine with other prescribed
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
18VAC85-21-170. Medical records for opioid addiction
A. Records shall be timely, accurate, legible, complete,
and readily accessible for review.
B. The treatment agreement and informed consent shall be
maintained in the medical record.
C. Confidentiality requirements of 42 CFR, Part 2 shall be
D. Compliance with 18VAC85-20-27, which prohibits willful
or negligent breach of confidentiality or unauthorized disclosure of
confidential Prescription Monitoring Program information, shall be maintained.
VA.R. Doc. No. R17-5033; Filed March 14, 2017, 3:12 p.m.