Administrative Code

Virginia Administrative Code
4/25/2024

Article 1. Medication Assisted Treatment (Opioid Treatment Services)

12VAC35-105-925. Standards for the evaluation of new licenses for providers of services to individuals with opioid addiction.

A. Applicants requesting an initial license to provide a service for the treatment of opioid addiction through the use of methadone or any other opioid treatment medication or controlled substance shall supply information to the department that demonstrates the appropriateness of the proposed service in accordance with this section.

B. The proposed site of the service shall comply with § 37.2-406 of the Code of Virginia.

C. In jurisdictions without zoning ordinances, the department shall request that the local governing body advise it as to whether the proposed site is suitable for and compatible with use as an office and the delivery of health care services. The department shall make this request when it notifies the local governing body of a pending application.

D. Applicants shall demonstrate that the building or space to be used to provide the proposed service is suitable for the treatment of opioid addiction by submitting documentation of the following:

1. The proposed site complies with the requirements of the local building regulatory entity;

2. The proposed site complies with local zoning laws or ordinances, including any required business licenses;

3. In the absence of local zoning ordinances, the proposed site is suitable for and compatible with use as offices and the delivery of health care services;

4. In jurisdictions where there are no parking ordinances, the proposed site has sufficient off-street parking to accommodate the needs of the individuals being served and prevent the disruption of traffic flow;

5. The proposed site can accommodate individuals during periods of inclement weather;

6. The proposed site complies with the Virginia Statewide Fire Prevention Code; and

7. The applicant has a written plan to ensure security for storage of methadone at the site, which complies with regulations of the Drug Enforcement Agency (DEA), and the Virginia Board of Pharmacy.

E. Applicants shall submit information to demonstrate that there are sufficient personnel available to meet the following staffing requirements and qualifications:

1. The program sponsor means the person responsible for the operation of the opioid treatment program and who assumes responsibility for all its employees, including any practitioners, agents, or other persons providing medical, rehabilitative, or counseling at the program at any of its medication units. The program sponsor is responsible for ensuring the program is in continuous compliance with all federal, state, and local laws and regulations.

2. The program director shall be licensed or certified by the applicable Virginia health regulatory board or registered as eligible for this license or certification with relevant training, experience, or both, in the treatment of individuals with opioid addiction. The program director is responsible for the day-to-day management of the program.

3. The medical director shall be a board-certified addictionologist or have successfully completed or will complete within one year a course of study in opiate addiction that is approved by the department; and:

a. Is responsible for ensuring all medical, psychiatric, nursing, pharmacy, toxicology, and other services offered by the medication assisted opioid treatment provider are conducted in compliance with federal regulations at all times; and

b. Shall be physically present at the program for a sufficient number of hours to ensure regulatory compliance and carry out those duties specifically assigned to the medical director by regulation.

4. A minimum of one pharmacist.

5. Nurses.

6. Counselors shall be licensed or certified by the applicable Virginia health regulatory board or eligible for this license or certification.

7. Personnel to provide support services.

8. Have linkage with or access to psychological, medical, and psychiatric consultation.

9. Have access to emergency medical and psychiatric care through affiliations with more intensive levels of care.

10. Have the ability to conduct or arrange for appropriate laboratory and toxicology tests.

11. Ensure all clinical staff, whether employed by the provider or available through consultation, contract, or other means, are qualified by training and experience and appropriately licensed, certified, or registered by the appropriate health regulatory board to serve individuals admitted to the service.

F. The applicant may provide peer recovery specialists (PRS). Peer recovery specialists shall be professionally qualified by education and experience in accordance with 12VAC35-250. A registered peer recovery specialist shall be a PRS registered with the Board of Counseling in accordance with 18VAC115-70 and provide such services as an employee or independent contractor of DBHDS, a provider licensed by the DBHDS, a practitioner licensed by or holding a permit issued from the Department of Health Professions, or a facility licensed by the Virginia Department of Health.

G. If there is a change in or loss of any staff in the positions listed or any change in the provider's ability to comply with the requirements in subsection E of this section, the provider shall formally notify the Substance Abuse and Mental Health Services Administration (SAMHSA) and DBHDS. The provider shall also submit a plan to SAMHSA and DBHDS for immediate coverage within three weeks.

H. Applicants shall submit a description for the proposed service that includes:

1. Proposed mission, philosophy, and goals of the provider;

2. Care, treatment, and services to be provided, including a comprehensive discussion of levels of care provided and alternative treatment strategies offered;

3. Proposed hours and days of operation;

4. Plans for onsite security and services adequate to ensure the safety of patients, staff, and property; and

5. A diversion control plan for dispensed medications, including policies for use of drug screens.

I. Applicants shall, in addition to the requirements of 12VAC35-105-580 C 2, provide documentation of their capability to provide the following services and support directly or by arrangement with other specified providers when such services and supports are (i) requested by an individual being served or (ii) identified as an individual need, based on the assessment conducted in accordance with 12VAC35-105-60 B and included in the individualized services plan:

1. General.

a. Psychological services;

b. Social services;

c. Vocational services;

d. Educational services, including HIV/AIDS education and other health education services; and

e. Employment services.

2. Initial medical examination services.

3. Special services for pregnant patients.

4. Initial and periodic, individualized, patient-centered assessment and treatment services.

5. Counseling services.

6. Drug abuse testing services.

7. Case management services, including medical monitoring and coordination, with onsite and offsite treatment services provided as needed.

J. Applicants shall submit documentation of contact with community services boards or behavioral health authorities in their service areas to discuss their plans for operating in the area and to develop joint agreements, as appropriate.

K. Applicants shall provide policies and procedures that shall address assessment, administration, and regulation of medication and dose levels appropriate to the individual. The policies and procedures shall at a minimum require that each individual served be assessed every six months by the treatment team to determine if that individual is appropriate for safe and voluntary medically supervised withdrawal from opioid analgesics, including methadone or buprenorphine, alternative therapies including other medication assisted treatments, or continued federally approved pharmacotherapy treatment for opioid addiction.

L. Applicants shall submit policies and procedures describing services they will provide to individuals who wish to discontinue medication assisted opioid treatment services.

M. Applicants shall provide assurances that the service will have a community liaison responsible for developing and maintaining cooperative relationships with community organizations, other service providers, local law enforcement, local government officials, and the community at large.

N. The department shall conduct announced and unannounced reviews and complaint investigations in collaboration with the Virginia Board of Pharmacy and DEA to determine compliance with the regulations.

Statutory Authority

§§ 37.2-302 and 37.2-400 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 23, Issue 20, eff. July 11, 2007; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011; Volume 33, Issue 26, eff. October 6, 2017; Volume 39, Issue 11, eff. February 17, 2023.

12VAC35-105-930. Registration, certification, or accreditation.

A. The medication assisted opioid treatment service shall maintain current registration or certification with:

1. The federal Drug Enforcement Administration;

2. The federal Department of Health and Human Services; and

3. The Virginia Board of Pharmacy.

B. A provider of medication assisted opioid treatment services shall maintain accreditation with an entity approved under federal regulations.

Statutory Authority

§§ 37.2-302 and 37.2-400 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011; Volume 39, Issue 11, eff. February 17, 2023.

12VAC35-105-935. Criteria for patient admission.

A. Before a medication assisted opioid treatment program may admit an individual, the individual shall meet the criteria for admission as defined by the provider's policies. The provider's policy regarding admission shall at a minimum require the individual to (i) meet diagnostic criteria for opioid use disorder as defined within the DSM; and (ii) meet the admission criteria of Level 1.0 of ASAM. The policies shall be consistent with subsections B through E of this section.

B. A medication assisted opioid treatment program shall maintain current procedures that are designed to ensure that individuals are admitted to short-term or long-term detoxification treatment by qualified personnel, such as a program physician who determines that such treatment is appropriate for the specific individual by applying established diagnostic criteria. An individual with two or more unsuccessful detoxification episodes within a 12-month period must be assessed by the medication assisted opioid treatment program physician for other forms of treatment. A program shall not admit an individual for more than two detoxification treatment episodes in one year.

C. A medication assisted opioid treatment program shall maintain current procedures designed to ensure that individuals are admitted to maintenance treatment by qualified personnel who have determined, using accepted medical criteria, that the person is currently addicted to an opioid drug, and that the individual became addicted at least one year before admission for treatment. In addition, a program physician shall ensure that each individual voluntarily chooses maintenance treatment, that all relevant facts concerning the use of the opioid drug are clearly and adequately explained to the individual, and that each individual provides informed written consent to treatment.

D. A person younger than 18 years of age is required to have had two documented unsuccessful attempts at short-term detoxification or drug-free treatment within a 12-month period to be eligible for maintenance treatment. No individual younger than 18 years of age may be admitted to maintenance treatment unless parent, legal guardian, or responsible adult designated by the relevant state authority consents in writing to such treatment.

E. If clinically appropriate, the program physician may waive the requirement of a one-year history of addiction under subsection C of this section, for individuals released from penal institutions (within six months after release), for pregnant patients (program physician must certify pregnancy), and for previously treated individuals (up to two years after discharge).

Statutory Authority

§§ 37.2-302 and 37.2-400 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 39, Issue 11, eff. February 17, 2023.

12VAC35-105-940. Criteria for involuntary termination from treatment.

A. The provider shall establish criteria for involuntary termination from treatment that describe the rights of the individual receiving services and the responsibilities and rights of the provider.

B. The provider shall establish a grievance procedure as part of the rights of the individual.

C. On admission, the individual shall be given a copy of the criteria and grievance procedure and shall sign a statement acknowledging receipt of same. The signed acknowledgment shall be maintained in the individual's service record.

D. Upon admission and annually thereafter all individuals shall sign an authorization for disclosure of information to allow the provider access to the Virginia Prescription Monitoring System. Individuals who fail to sign this authorization shall be denied admission to the program.

Statutory Authority

§§ 37.2-302 and 37.2-400 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011; Volume 39, Issue 11, eff. February 17, 2023.

12VAC35-105-945. Criteria for patient discharge.

Before a medication assisted opioid treatment program may discharge or transfer an individual, the individual shall meet the criteria for discharge or transfer as defined by the provider's policies, which shall include provisions for the discharge or transfer of individuals who have:

1. Achieved the goals of the treatment services and no longer require medication assisted opioid treatment level of care;

2. Been unable to achieve the goals of the individual's treatment but could achieve the individual's goals with a different type of treatment; or

3. Achieved the individual's original treatment goals but have developed new treatment challenges that can only be adequately addressed in a different type of treatment.

Statutory Authority

§§ 37.2-302 and 37.2-400 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 39, Issue 11, eff. February 17, 2023.

12VAC35-105-950. Service operation schedule.

A. The service's days of operation shall meet the needs of the individuals served. If the service dispenses or administers a medication requiring daily dosing, the service shall operate seven days a week, 12 months a year, except for official state holidays. Prior approval from the state methadone authority shall be required for additional closed days.

B. The service may close on Sundays if all the following criteria are met:

1. The provider develops and implements policies and procedures that address recently admitted individuals receiving services, individuals not currently on a stable dose of medication, patients that present noncompliance treatment behaviors, and individuals who previously picked up take-home medications on Sundays, security of take-home medication doses, and health and safety of individuals receiving services.

2. The provider receives prior approval from the state opioid treatment authority (SOTA) for Sunday closings. Each program must have a policy that addresses medication for the newly inducted patients and those who are deemed at risk, for example, are still actively using illicit substances or medical issues that may warrant closer monitoring of medication.

3. Once approved, by the SOTA to close on Sundays, the provider shall notify individuals receiving services in writing at least 30 days in advance of their intent to close on Sundays. The notice shall address the risks to the individuals and the security of take-home medications. All individuals shall receive an orientation addressing take-home policies and procedures, and this orientation shall be documented in the individual's service record prior to receiving take-home medications.

4. The provider shall establish procedures for emergency access to dosing information 24 hours a day, seven days a week. This information may be provided via an answering service, pager, or other electronic measures. Information needed includes the individual's last dosing time and date, and dose.

C. Medication dispensing hours shall include at least two hours each day of operation outside normal working hours, that is, before 9 a.m. and after 5 p.m. The SOTA may approve an alternative schedule if the SOTA determines that schedule meets the needs of the population served by the provider.

Statutory Authority

§§ 37.2-302 and 37.2-400 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011; Volume 39, Issue 11, eff. February 17, 2023.

12VAC35-105-960. Initial and periodic assessment services.

A. The individual shall have a complete physical examination prior to admission to the service unless the individual is transferring from another licensed medication assisted opioid treatment service in Virginia. The provider shall maintain the report of the individual's physical examination in the individual's service record. The results of serology and other tests shall be available within 14 days of admission.

B. The program physician shall review a consent to treatment form with the patient and sign the form prior to the individual receiving the first dose of medication.

C. The provider shall maintain the report of the individual's physical examination in the individual's service record.

D. The program shall have a policy to ensure that coordination of care is in place with any prescribing physician.

E. The provider shall coordinate treatment services for individuals who are prescribed benzodiazepines and prescription narcotics with the treating physician. The coordination shall be the responsibility of the provider's physician and shall be documented.

Statutory Authority

§§ 37.2-302 and 37.2-400 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011; Volume 39, Issue 11, eff. February 17, 2023.

12VAC35-105-965. Special services for pregnant individuals.

The program shall ensure that every pregnant woman has the opportunity for prenatal care, prenatal education, and postpartum follow-up, either onsite or by referral to an appropriate health care provider.

Statutory Authority

§§ 37.2-302 and 37.2-400 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 39, Issue 11, eff. February 17, 2023.

12VAC35-105-970. Counseling sessions.

The provider shall conduct face-to-face counseling sessions (either individual or group) at least every two weeks for the first year of an individual's treatment and every month in the second year of the individual's treatment. After two years, the number of face-to-face counseling sessions that an individual receives shall be based on the individual's progress in treatment. The failure of an individual to participate in counseling sessions shall be addressed as part of the overall treatment process.

Statutory Authority

§ 37.2-203 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011.

12VAC35-105-980. Drug screens.

A. The provider shall perform at least one random drug screen per month unless the conditions in subsection B of this section apply.

B. Whenever an individual's drug screen indicates continued illicit drug use or when clinically and environmentally indicated, random drug screens shall be performed weekly.

C. Drug screens shall be analyzed for opiates, methadone (if ordered), benzodiazepines, cocaine, and buprenorphine. In addition, drug screens for other drugs that have the potential for addiction shall be performed when clinically and environmentally indicated.

D. The provider shall implement a written policy on how the results of drug screens shall be used to direct treatment.

Statutory Authority

§§ 37.2-302 and 37.2-400 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011; Volume 39, Issue 11, eff. February 17, 2023.

12VAC35-105-990. Take-home medication.

A. Prior to dispensing regularly scheduled take-home medication, the provider shall ensure the individual demonstrates a level of current lifestyle stability as evidenced by the following:

1. Regular clinic attendance, including dosing and participation in counseling or group sessions;

2. Absence of recent alcohol abuse and illicit drug use;

3. Absence of significant behavior problems;

4. Absence of recent criminal activities, charges, or convictions;

5. Stability of the individual's home environment and social relationships;

6. Length of time in treatment;

7. Ability to ensure take-home medications are safely stored; and

8. Demonstrated rehabilitative benefits of take-home medications outweigh the risks of possible diversion.

B. Determinations for the take-home approval shall be based on the clinical judgment of the physician in consultation with the treatment team and shall be documented in the individual's service record.

C. If it is determined that an individual in comprehensive maintenance treatment is appropriate for handling take-home medication, the amount of take-home medication shall not exceed:

1. A single take-home dose for one day when the clinic is closed for business, including Sundays and state or federal holidays.

2. A single dose each week during the first 90 days of treatment (beyond that in subdivision 1 of this subsection). The individual shall ingest all other doses under the supervision of a medication administration trained employee.

3. Two doses per week in the second 90 days of treatment (beyond that in subdivision 1 of this subsection).

4. Three doses per week in the third 90 days of treatment (beyond that in subdivision 1 of this subsection).

5. A maximum six-day supply of take-home doses in the remaining months of the first year of treatment.

6. A maximum two-week supply of take-home medication after one year of continuous treatment.

7. One month's supply of take-home medication after two years of continuous treatment with monthly visits made by the individual served.

D. No medication shall be dispensed to individuals in short-term detoxification treatment or interim maintenance treatment for unsupervised take-home use.

E. Medication assisted opioid treatment providers shall maintain current procedures adequate to identify the theft or diversion of take-home medications. These procedures shall require the labeling of containers with the medication assisted opioid treatment providers name, address, and telephone number. Programs shall ensure that the take-home supplies are packaged in a manner that is designed to reduce the risk of accidental ingestion, including child proof containers.

F. The provider shall educate the individual on the safe transportation and storage of take-home medication.

Statutory Authority

§§ 37.2-302 and 37.2-400 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011; Volume 39, Issue 11, eff. February 17, 2023.

12VAC35-105-1000. Preventing duplication of medication services.

To prevent duplication of medication assisted opioid treatment services to an individual, prior to admission of the individual, the provider shall implement written policy and procedures for contacting every medication assisted opioid treatment service within a 50-mile radius before admitting an individual.

Statutory Authority

§§ 37.2-302 and 37.2-400 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011; Volume 39, Issue 11, eff. February 17, 2023.

12VAC35-105-1010. Guests.

A. For the purpose of this section a guest is a patient of a medication assisted opioid treatment service in another state or another area of Virginia, who is traveling and is not yet eligible for take-home medication. Guest dosing shall be approved by the individual's home clinic.

B. The provider shall not dispense medication to any guest unless the guest has been receiving such medication services from another provider and documentation from that provider has been received prior to dispensing medication.

C. Guests may receive medication for up to 28 days. To continue receiving medication after 28 days, the guest must be admitted to the service. Individuals receiving guest medications as part of a residential treatment service may exceed the 28-day maximum time limit at the medication assisted opioid treatment service.

Statutory Authority

§§ 37.2-302 and 37.2-400 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011; Volume 39, Issue 11, eff. February 17, 2023.

12VAC35-105-1020. Detoxification prior to involuntary discharge.

The provider shall give an individual who is being involuntarily discharged an opportunity to detoxify from opioid agonist medication not less than 10 days or not more than 30 days prior to his discharge from the service, unless the state methadone authority has granted an exception.

Statutory Authority

§ 37.2-203 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011.

12VAC35-105-1030. Opioid agonist medication renewal.

Physician orders for opioid agonist medication shall be reevaluated and renewed at least every six months.

Statutory Authority

§ 37.2-203 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002.

12VAC35-105-1040. Emergency preparedness plan.

The provider's emergency preparedness plan shall include provision for the continuation of opioid treatment in the event of an emergency or natural disaster.

Statutory Authority

§ 37.2-203 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011.

12VAC35-105-1050. Security of opioid agonist medication supplies.

A. At a minimum, the provider shall secure opioid agonist medication supplies by restricting access to medication areas to medical or pharmacy personnel.

B. The provider shall reconcile the medication inventory monthly.

C. The provider shall keep inventory records, including the monthly reconciliation, for three years.

D. The provider shall maintain a current plan to control the diversion of medication to unprescribed or illegal uses.

Statutory Authority

§ 37.2-203 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 5, eff. December 7, 2011.

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