Administrative Code

Virginia Administrative Code
4/14/2021

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.

Article 1
Medication Assisted Treatment (Opioid Treatment Services)

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 director shall be licensed or certified by the applicable Virginia health regulatory board or by a nationally recognized certification board or eligible for this license or certification with relevant training, experience, or both, in the treatment of individuals with opioid addiction;

2. 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;

3. A minimum of one pharmacist;

4. Nurses;

5. Counselors shall be licensed or certified by the applicable Virginia health regulatory board or by a nationally recognized certification board or eligible for this license or certification; and

6. Personnel to provide support services.

F. 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 on-site security; and

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

G. 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. Psychological services;

2. Social services;

3. Vocational services;

4. Educational services; and

5. Employment services.

H. 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.

I. Applicants shall provide policies and procedures that each individual served to be assessed every six months by the treatment team to determine if that individual is appropriate for safe and voluntary medically supervised withdrawal, alternative therapies including other medication assisted treatments, or continued federally approved pharmacotherapy treatment for opioid addiction.

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

K. 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.

L. 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

§ 37.2-203 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.

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

A. The 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 opioid treatment services shall maintain accreditation with an entity approved under federal regulations.

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.

12VAC35-105-940. 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 shall sign a statement acknowledging receipt of same. The signed acknowledgement shall be maintained in the individual's record.

D. Upon admission and annually all individuals shall sign an authorization for disclosure of information to allow programs access to the Virginia Prescription Monitoring System. Failure to comply shall be grounds for nonadmission to the program.

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.

12VAC35-105-950. 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 the following criteria are met:

1. The provider develops and implements policies and procedures that address recently inducted 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 methadone authority for Sunday closings.

3. Once approved, 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 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, i.e., before 9 a.m. and after 5 p.m. The state methadone authority may approve an alternative schedule if that schedule meets the needs of the population served.

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.

12VAC35-105-960. Physical examinations.

A. The individual shall have a complete physical examination prior to admission to the service unless the individual is transferring from another licensed opioid agonist service. The results of serology and other tests shall be available within 14 days of admission.

B. Physical exams of each individual shall be completed annually or more frequently if there is a change in the individual's physical or mental condition.

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

D. On admission, all individuals shall be offered testing for AIDS/HIV. The individual may sign a notice of refusal without prejudice.

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

Statutory Authority

§ 37.2-203 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.

12VAC35-105-970. 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 eight random drug screens during a 12-month period unless the conditions in subdivision B of this subsection 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, and cocaine. 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

§ 37.2-203 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.

12VAC35-105-990. 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 assure take-home medications are safely stored; and

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

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

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.

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

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

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.

12VAC35-105-1010. Guests.

A. 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.

B. 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.

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.

12VAC35-105-1020. 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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