TITLE 12. HEALTH

DEPARTMENT OF MEDICAL ASSISTANCE SERVICES

Final Regulation

Title of Regulation: 12VAC30-130. Amount, Duration and Scope of Selected Services (amending 12VAC30-130-5020, 12VAC30-130-5050, 12VAC30-130-5060, 12VAC30-130-5090, 12VAC30-130-5100, 12VAC30-130-5120 through 12VAC30-130-5150).

Statutory Authority: § 32.1-325 of the Code of Virginia; 42 USC 1396 et seq.

Effective Date: October 23, 2024.

Agency Contact: Meredith Lee, Policy, Regulations, and Manuals Supervisor, Department of Medical Assistance Services, 600 East Broad Street, Suite 1300, Richmond, VA 23219, telephone (804) 371-0552, FAX (804) 786-1680, TDD (800) 343-0634, or email meredith.lee@dmas.virginia.gov.

Background: Section 1262 of the federal Consolidated Appropriations Act of 2023 made substantial regulatory changes to remove barriers and promote access to evidence-based treatment of substance use disorders, including removing a requirement that practitioners obtain a special federal waiver, the DATA-Waiver or X-Waiver, to prescribe buprenorphine for the treatment of opioid use disorder. To conform to this federal rule change, the Department of Medical Assistance Services submitted a state plan amendment (SPA) to the Centers for Medicare and Medicaid Services that removed the X-Waiver requirement. The SPA was approved on September 21, 2023.

Summary:

The amendments allow providers who have a current license to practice and prescribe and a Drug Enforcement Administration registration authorizing the prescribing of Schedule III drugs to prescribe buprenorphine for the treatment of opioid use disorder without the federal X-Waiver.

12VAC30-130-5020. Definitions.

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

"Abstinence" means the intentional and consistent restraint from the pathological pursuit of reward or relief, or both, that involves the use of substances.

"Addiction" means a primary, chronic disease of brain reward, motivation, memory, and related circuitry. Addiction is defined as the inability to consistently abstain, impairment in behavioral control, persistence of cravings, diminished recognition of significant problems with one's behaviors and interpersonal relationships, and a dysfunctional emotional response. Like other chronic diseases, addiction often involves cycles of relapse and remission. Without treatment or engagement in recovery activities, addiction is progressive and can result in disability or premature death.

"Addiction-credentialed physician" means a physician who holds a board certification in addiction medicine from the American Board of Addiction Medicine, a subspecialty board certification in addition to certification in psychiatry from the American Board of Psychiatry and Neurology, or subspecialty board certification in addiction medicine from the American Osteopathic Association. DMAS also recognizes physicians with the DATA 2000 buprenorphine waiver and physicians treating addiction who have specialty training or experience in addiction medicine or addiction psychiatry. If treating adolescents, "addiction-credentialed physician" means an addiction-credentialed physician who also has experience and specialty training with adolescent medicine.

"Adherence" means the individual receiving treatment has demonstrated his ability to cooperate with, follow, and take personal responsibility for the implementation of his treatment plans.

"Adolescent" means an individual from 12 years of age to 20 years of age.

"Allied health professional" means counselor aides or group living workers who meet the DBHDS licensing requirements for unlicensed staff in residential settings.

"ARTS" means addiction and recovery treatment services.

"ARTS care coordinator" means an employee of DMAS, its contractor, or an MCO who is a licensed practitioner of the healing arts, including a physician or medical director, licensed clinical psychologist, licensed clinical social worker, licensed professional counselor, licensed substance abuse treatment practitioner, licensed marriage and family therapist, nurse practitioner, or registered nurse with two years of clinical experience in the treatment of substance use disorders. The ARTS care coordinator performs independent assessments of requests for all ARTS intensive outpatient programs (ASAM Level 2.1); partial hospitalization programs (ASAM Level 2.5); residential treatment services (ASAM Levels 3.1, 3.3, 3.5, and 3.7); and inpatient services (ASAM Levels 3.7 and 4.0).

"ASAM" means the American Society of Addiction Medicine.

"ASAM criteria" means the six different life areas used by the ASAM Patient Placement Criteria to develop a holistic biopsychosocial assessment of an individual that is used for service planning, level of care, and length of stay treatment decisions.

"BHA" means behavioral health authority.

"Biomedical" means biological or physical aspects of a member's condition that require assessment and services that are delivered by appropriately credentialed medical staff, who are available to assess and treat co-occurring biomedical disorders that may be the result of, or independent of, a substance use disorder.

"Buprenorphine-waivered practitioner" means a health care provider licensed under Virginia law and registered with the Drug Enforcement Administration (DEA) to prescribe Schedule III, IV, or V medications for treatment of pain. More specifically, a buprenorphine-waivered physician has obtained the buprenorphine waiver through the Drug Addiction Treatment Act of 2000 (DATA 2000), while a buprenorphine-waivered nurse practitioner or physician assistant has obtained the buprenorphine waiver through DATA 2000. A buprenorphine-waivered practitioner meets all federal and state requirements and is supervised by or works in collaboration with a qualifying physician in accordance with the applicable regulatory board. In accordance with § 54.1-2957 of the Code of Virginia, a nurse practitioner may practice without a written or electronic practice agreement with a qualifying physician. All buprenorphine-waivered practitioners have a DEA-X number to prescribe buprenorphine for the treatment of opioid use disorder.

"Care coordination" means collaboration and sharing of information among health care providers who are involved with an individual's health care to assist in improving the care of the individual. This includes e-consultations from primary care providers to specialists.

"Certified substance abuse counselor" or "CSAC" means the same as that term is defined in § 54.1-3507.1 of the Code of Virginia.

"Certified substance abuse counseling assistant" or "CSAC-A" means the same as that term is defined in § 54.1-3507.2 of the Code of Virginia.

"Certified substance abuse counselor-supervisee" means an individual who has completed the educational requirements described in clause (i) of § 54.1-3507.1 C of the Code of Virginia, but who has not completed the practice hours described in clause (ii) of § 54.1-3507.1 C of the Code of Virginia.

"Child" means an individual from birth up to 12 years of age.

"Clinical experience" means, for the purpose of these ARTS requirements, practical experience in providing direct services to individuals with diagnoses of substance use disorder. Clinical experience shall include supervised internships, supervised practicums, or supervised field experience. Clinical experience shall not include unsupervised internships, unsupervised practicums, and unsupervised field experience.

"Counseling" means the same as that term is defined in § 54.1-3500 of the Code of Virginia.

"Credentialed addiction treatment professional" or "CATP" means an individual licensed or registered with the appropriate board in the following roles: (i) an addiction-credentialed physician or physician with experience or training in addiction medicine; (ii) physician extenders with experience or training in addiction medicine; (iii) a licensed psychiatrist; (iv) a licensed clinical psychologist; (v) a licensed clinical social worker; (vi) a licensed professional counselor; (vii) a certified psychiatric clinical nurse specialist; (viii) a licensed psychiatric nurse practitioner; (ix) a licensed marriage and family therapist; (x) a licensed substance abuse treatment practitioner; (xi) a resident who is under the supervision of a licensed professional counselor (18VAC115-20-10), licensed marriage and family therapist (18VAC115-50-10), or licensed substance abuse treatment practitioner (18VAC115-60-10) and is registered with the Virginia Board of Counseling; (xii) a resident in psychology who is under supervision of a licensed clinical psychologist and is registered with the Virginia Board of Psychology (18VAC125-20-10); or (xiii) a supervisee in social work who is under the supervision of a licensed clinical social worker and is registered with the Virginia Board of Social Work (18VAC140-20-10).

"CSB" means community services board.

"DBHDS" means the Department of Behavioral Health and Developmental Services consistent with Chapter 3 (§ 37.2-300 et seq.) of Title 37.2 of the Code of Virginia.

"DEA" means Drug Enforcement Administration.

"DMAS" means the Department of Medical Assistance Services and its contractors consistent with Chapter 10 (§ 32.1-323 et seq.) of Title 32.1 of the Code of Virginia.

"DSM-5" means the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, copyright 2013, American Psychiatric Association.

"Evidence-based" means an empirically-supported empirically supported clinical practice or intervention with a proven ability to produce positive outcomes.

"Face-to-face" means encounters that occur in person or through telemedicine.

"FQHC" means federally qualified health center.

"Individual" means the patient, client, beneficiary, or member who receives services set out in 12VAC30-130-5000 et seq. These terms are used interchangeably.

"Individual service plan" or "ISP" means an initial and comprehensive treatment plan that is regularly updated and specific to an individual's unique treatment needs as identified in the assessment. An ISP contains an individual's treatment or training needs, the individual's goals and measureable measurable objectives to meet the identified needs, services to be provided with the recommended frequency to accomplish the measurable goals and objectives, and an individualized discharge plan that describes transition to other appropriate services. An individual is included in the development of the ISP, and the ISP is signed by the individual. If the individual is a minor, the ISP is also signed by the individual's parent or legal guardian. An ISP includes documentation if the individual is a minor child or an adult who lacks legal capacity and is unable or unwilling to sign the ISP.

"Induction phase" means the medically monitored initiation of buprenorphine, buprenorphine and naloxone, naltrexone, or methadone treatment performed in a qualified practitioner's office or licensed OTP. The goal of the induction phase is to find the individual's ideal dose of buprenorphine, buprenorphine and naloxone, naltrexone, or methadone. The ideal dose minimizes both side effects and drug craving.

"Licensed practical nurse" means a professional who is licensed by the Commonwealth as a practical nurse or holds a multistate licensure privilege to practice practical nursing according to 18VAC90-19-80.

"Managed care organization" or "MCO" means an organization that offers managed care health insurance plans (MCHIP), as defined by § 38.2-5800 of the Code of Virginia, which means an arrangement for the delivery of health care in which a health carrier undertakes to provide, arrange for, pay for, or reimburse any of the costs of health care services for a covered person on a prepaid or insured basis that (i) contains one or more incentive arrangements, including any credentialing requirements intended to influence the cost or level of health care services between the health carrier and one or more providers with respect to the delivery of health care services and (ii) requires or creates benefit payment differential incentives for covered persons to use providers that are directly or indirectly managed, owned, under contract with, or employed by the health carrier.

"Medication assisted treatment" or "MAT" means the same as that term is defined in 42 CFR 8.2.

"Multidimensional assessment" or "assessment" means the individualized, person-centered biopsychosocial assessment performed face-to-face, in which the provider obtains comprehensive information from the individual, and family members and significant others as needed, including history of the present illness; family history; developmental history; alcohol, tobacco, and other drug use or addictive behavior history; personal or social history; legal history; psychiatric history; medical history; spiritual history as appropriate; review of systems; mental status exam; physical examination; formulation and diagnoses; survey of assets, vulnerabilities, and supports; and treatment recommendations. The ASAM multidimensional assessment is a theoretical framework for this individualized, person-centered assessment that includes the following dimensions: (i) acute intoxication or likelihood of withdrawal, or both; (ii) medical conditions and complications, both historical and current; (iii) emotional, behavioral, or cognitive status and any identified issues; (iv) an individual's readiness to change; (v) risks for relapse or continued use; and (vi) home environment. The level of care determination, ISP, and recovery strategies development may be based upon this multidimensional assessment.

"Opioid" means any psychoactive chemical that resembles morphine in pharmacological effects, including opiates and synthetic or semisynthetic agents that exert their effects by binding to highly selective receptors in the brain where morphine and endogenous opioids affect their actions.

"Opioid treatment program" or "OTP" means the same as that term is defined in 42 CFR 8.2.

"Opioid treatment services" or "OTS" means preferred office-based opioid treatment (OBOT) and OTPs that encompass a variety of pharmacological and nonpharmacological treatment modalities, including substance use disorder counseling and psychotherapy.

"Overdose" means the inadvertent or deliberate consumption of a dose of a chemical substance much larger than either habitually used by the individual or ordinarily used for treatment of an illness that is likely to result in a serious toxic reaction or death.

"Physician extenders" means licensed nurse practitioners as defined in § 54.1-3000 of the Code of Virginia and licensed physician assistants as defined in § 54.1-2900 of the Code of Virginia.

"Preferred office-based opioid treatment" or "preferred OBOT" means addiction treatment services for individuals with a primary opioid use disorder provided by buprenorphine-waivered practitioners physicians and physician extenders who have a current DEA registration authorizing the prescribing of scheduled drugs, including Schedule III drugs, working in collaboration with CATPs providing psychotherapy and substance use disorder counseling in public and private practice settings.

"Program of assertive community treatment" or "PACT" means the same as that term is defined in 12VAC35-105-20.

"Psychoeducation" means (i) a specific form of education aimed at helping individuals who have a substance use disorder or mental illness and their family members or caregivers to access clear and concise information about substance use disorders or mental illness and (ii) a way of accessing and learning strategies to deal with substance use disorders or mental illness and its effects in order to design effective treatment plans and strategies.

"Psychotherapy" or "therapy" means the use of psychological methods in a professional relationship to assist a person to acquire great human effectiveness or to modify feelings, conditions, attitudes, and behaviors that are emotionally, intellectually, or socially ineffectual or maladaptive.

"Recovery" means a process of sustained effort that addresses the biological, psychological, social, and spiritual disturbances inherent in addiction and consistently pursues abstinence, behavior control, dealing with cravings, recognizing problems in one's behaviors and interpersonal relationships, and more effective coping with emotional responses leading to reversal of negative, self-defeating internal processes and behaviors and allowing healing of relationships with self and others. The concepts of humility, acceptance, and surrender are useful in this process.

"Registered nurse" or "RN" means the same as "professional nurse" is defined in § 54.1-3000 of the Code of Virginia.

"Relapse" means a process in which an individual who has established abstinence or sobriety experiences recurrence of signs and symptoms of active addiction, often including resumption of the pathological pursuit of reward or relief through the use of substances and other behaviors often leading to disengagement from recovery activities. Relapse can be triggered by exposure to (i) rewarding substances and behaviors, (ii) environmental cues to use, and (iii) emotional stressors that trigger heightened activity in brain stress circuits. The event of using or acting out is the latter part of the process, which can be prevented by early intervention.

"RHC" means rural health clinic.

"SBIRT" means screening, brief intervention, and referral to treatment. SBIRT services are an evidence-based and community-based practice designed to identify, reduce, and prevent problematic substance use disorders.

"Service authorization" means the process to approve specific services for an enrolled Medicaid, FAMIS Plus, or FAMIS individual by DMAS or its contractor, or an MCO prior to service delivery and reimbursement in order to validate that the service requested is medically necessary and meets DMAS and DMAS contractor criteria for reimbursement. Service authorization does not guarantee payment for the service.

"Substance use care coordinator" means staff in an OTP or preferred OBOT setting who have:

1. At least a bachelor's degree in one of the following fields: social work, psychology, psychiatric rehabilitation, sociology, counseling, vocational rehabilitation, or human services counseling, and at least either (i) one year of substance use disorder related direct experience or training or a combination of experience or training in providing services to individuals with a diagnosis of substance use disorder or (ii) a minimum of one year of clinical experience or training in working with individuals with co-occurring diagnoses of substance use disorder and mental illness; or

2. Licensure by the Commonwealth as a registered nurse with at least either (i) one year of direct experience or training or a combination of experience and training in providing services to individuals with a diagnosis of substance use disorder or (ii) a minimum of one year of clinical experience or training or a combination of experience and training in working with individuals with co-occurring diagnoses of substance use disorder and mental illness; or

3. Certification as a CSAC or a CSAC-A.

"Substance use case management" means the same as set out in 12VAC30-50-491.

"Substance use disorder" or "SUD" means a substance-related addictive disorder, as defined in the DSM-5 with the exception of tobacco-related disorders and non-substance-related disorders, marked by a cluster of cognitive, behavioral, and physiological symptoms indicating that the individual continues to use, is seeking treatment for the use of, or is in active recovery from the use of alcohol or other drugs despite significant related problems.

"Substance use disorder counseling" means the same as "substance abuse counseling" is defined in 18VAC115-30-10.

"Telemedicine" means the real-time, two-way transfer of medical data and information using an interactive audio-video connection for the purposes of medical diagnosis and treatment. The member is located at the originating site, while the provider renders services from a remote location via the audio-video connection. Equipment utilized for telemedicine shall be of sufficient audio quality and visual clarity as to be functionally equivalent to a face-to-face encounter for professional medical services.

"Tolerance" or "tolerate" means a state of adaptation in which exposure to a drug induces changes that result in diminution of one or more of the drug's effects over time.

"Withdrawal management" means services to assist an individual's withdrawal from the use of substances.

12VAC30-130-5050. Covered services: clinic services - opioid treatment program services.

A. Settings for opioid treatment program (OTP) services. The agency-based OTP provider shall be licensed by DBHDS and contracted by DMAS or its contractor or an MCO. The staffing requirements for OTP providers shall follow the DBHDS licensing requirements set forth in 12VAC35-105-925 and in the DBHDS guidance document entitled "Opioid Medication Assisted Treatment License and Oversight" (March, 2017). The interdisciplinary team shall include CATPs acting within the scope of practice in accordance to their professional regulatory board and state and federal requirements, including an addiction-credentialed physician as defined in 12VAC30-130-5020. OTP services are allowed simultaneously for members in other ASAM Levels, including 1.0 through 3.7 (excluding inpatient services). OTPs shall meet the service components, staff requirements, and risk management requirements.

B. OTP service components.

1. Linking the individual to psychological, medical, and psychiatric consultation as necessary to meet the individual's needs.

2. Access to emergency medical and psychiatric care through connections with more intensive levels of care.

3. Access to evaluation and ongoing primary care.

4. Ability to conduct or arrange for appropriate laboratory and toxicology tests including drug screenings, using either urine or blood serums.

5. Physicians who are available to evaluate and monitor (i) use of methadone, buprenorphine products, or naltrexone products and (ii) pharmacists and nurses to dispense and administer these medications and who follow the Board of Medicine guidance for treatment of individuals with buprenorphine for addiction.

6. Individualized, patient-centered assessment and treatment.

7. Ability to assess, order, administer, reassess, and regulate medication and dose levels appropriate to the individual; supervise withdrawal management from opioid analgesics, including methadone, buprenorphine products, or naltrexone products; and oversee and facilitate access to appropriate treatment for opioid use disorder.

8. Medication for other physical and mental health illness is provided as needed either onsite on site or through collaboration with other providers.

9. Cognitive, behavioral, and other substance use disorder-focused psychotherapies and substance use disorder counseling by a CATP reflecting a variety of treatment approaches, provided to the individual on an individual, group, or family basis. CSACs and CSAC-supervisees are recognized to provide substance use disorder counseling in these settings as allowed within scopes of practice as defined in § 54.1-3507.1 of the Code of Virginia.

10. Optional substance use care coordination that includes integrating behavioral health into primary care and specialty medical settings through interdisciplinary care planning and monitoring individual progress and tracking individual outcomes; supporting conversations between buprenorphine-waivered practitioners physicians and physician extenders who have a current DEA registration authorizing the prescribing of scheduled drugs, including Schedule III drugs, and behavioral health professionals to develop and monitor individualized treatment plans; linking individuals with community resources to facilitate referrals and respond to social service needs; and tracking and supporting individuals when they obtain medical, behavioral health, or social services outside the practice.

11. Provision of onsite screening or the ability to refer for screening for infectious diseases such as human immunodeficiency virus, hepatitis B and C, and tuberculosis at treatment initiation and then at least annually or more often based on risk factors and the ability to provide or refer for treatment of infectious diseases as necessary.

12. Onsite medication administration treatment during the induction phase, which must be provided by a physician, nurse practitioner, physician assistant, or registered nurse. Medication administration during the maintenance phase may be provided either by a registered nurse or licensed practical nurse.

13. Prescription of naloxone for each member receiving methadone, buprenorphine products, or naltrexone products.

14. Ability to provide pregnancy testing for women of childbearing age.

15. For individuals of childbearing age, the ability to provide family planning services or to refer the individual for family planning services.

C. OTP staff requirements.

1. Staff requirements shall meet the licensing requirements of 12VAC35-105-925. The interdisciplinary team shall include CATPs trained in the treatment of opioid use disorder, including an addiction credentialed physician or physician extender and CATPs as defined in 12VAC30-130-5020. OTPs may utilize CSACs and CSAC-supervisees to provide substance use disorder counseling and psychoeducational services within their scopes of practice as defined in § 54.1-3507.1 of the Code of Virginia. OTPs may also utilize CSAC-As pursuant to § 54.1-3507.2 of the Code of Virginia as well as registered peer recovery specialists within their scopes of practice. A registered peer recovery specialist shall meet the definition in § 54.1-3500 of the Code of Virginia.

2. Staff shall be knowledgeable in the assessment, interpretation, and treatment of the biopsychosocial dimensions of alcohol or other substance use disorders.

3. A physician or physician extender as defined in 12VAC30-130-5020 shall be available during medication dispensing and clinical operating hours in person or by telephone.

D. OTP risk management shall be clearly and adequately documented in each individual's record and shall include:

1. Random drug screening, using either urine or blood serums, for all individuals, conducted at least eight times during a 12-month period as described in 12VAC35-105-980. Definitive screenings shall only be utilized when clinically indicated. Outcomes of the drug screening shall be used to support positive patient outcomes and recovery.

2. A check of the Virginia Prescription Monitoring Program prior to initiation of buprenorphine products or naltrexone products and at least quarterly for all individuals.

3. Prescription of naloxone.

4. Opioid overdose prevention education, including the purpose of and the administration of naloxone and the impact of polysubstance use. Education shall include discussion of the role of medication assisted treatment and the opportunity to reduce harm associated with polysubstance use. The goal is to help individuals remain in treatment to reduce the risk for harm.

5. Clinically indicated infectious disease testing for diseases such as HIV; hepatitis A, B, and C; syphilis; and tuberculosis at treatment initiation and then annually or more frequently, depending on the clinical scenario and the patient's risk. Those who test positive shall be treated either onsite on site or through referral.

6. For individuals without immunity to the hepatitis B virus, vaccination, either onsite on site or through referral, shall be offered.

7. For individuals without HIV infection, pre-exposure prophylaxis to prevent HIV infection, either onsite on site or through referral, shall be offered.

8. Pregnancy testing for women of childbearing age, and contraceptive services, either onsite on site or through referral, shall be offered.

12VAC30-130-5060. Covered services: clinic services - preferred office-based addiction treatment.

A. Preferred office-based addiction treatment (OBAT) shall be provided by a buprenorphine-waivered practitioner physician or physician extender who has a current DEA registration authorizing the prescribing of scheduled drugs, including Schedule III drugs, and may be provided in a variety of practice settings, including primary care clinics, outpatient health system clinics, psychiatry clinics, FQHCs, CSBs, BHAs, local health department clinics, and physician offices. The practitioner shall be contracted by DMAS or its contractor or an MCO to perform OBAT services. OBAT services shall meet the criteria established in this section.

B. OBAT service components.

1. Access to emergency medical and psychiatric care.

2. Affiliations with more intensive levels of care such as intensive outpatient programs and partial hospitalization programs to which individuals can be referred when clinically indicated.

3. Individualized, patient-centered multidimensional assessment and treatment.

4. Assessing, ordering, administering, reassessing, and regulating medication and dose levels appropriate to the individual; supervising withdrawal management from opioid analgesics and other substances; and overseeing and facilitating access to appropriate treatment for substance use disorder.

5. Medication for other physical and mental health disorders shall be provided as needed either onsite on site or through collaboration with other providers.

6. Assurance that medications for opioid use disorder and alcohol use disorder are only dispensed onsite on site during the induction phase. After the induction phase, medications shall be prescribed to the member.

7. Assurance that buprenorphine monoproduct is only prescribed in accordance with Board of Medicine rules related to the prescribing of buprenorphine for addiction.

8. Cognitive, behavioral, and other substance use disorder-focused counseling and psychotherapies, reflecting a variety of treatment approaches, shall be provided to the individual on an individual, group, or family basis and shall be provided by CATPs working in collaboration with the buprenorphine-waivered practitioner a physician or physician extender who has a current DEA registration authorizing the prescribing of scheduled drugs, including Schedule III drugs. These therapies can be provided via telemedicine as long as they meet DMAS requirements for an OBAT and for the use of telemedicine. Preferred OBATs may utilize CSACs and CSAC-supervisees to provide substance use disorder counseling and psychoeducational services within their scope of practice as defined in § 54.1-3507.1 of the Code of Virginia.

9. Substance use care coordination provided, including interdisciplinary care planning between the buprenorphine-waivered practitioner physicians or physician extenders who have a current DEA registration authorizing the prescribing of scheduled drugs, including Schedule III drugs, and the treatment team to develop and monitor individualized and personalized treatment plans focused on the best outcomes for the individual. This care coordination includes monitoring individual progress, tracking individual outcomes, linking the individual with community resources to facilitate referrals and respond to social service needs, and tracking and supporting the individual's medical, behavioral health, or social services received outside the practice.

10. Provision of onsite screening or referral for screening for clinically indicated infectious disease testing for diseases such as HIV; hepatitis A, B, and C; syphilis; and tuberculosis at treatment initiation and then at least annually or more often based on risk factors and the ability to provide or refer for treatment of infectious diseases as necessary.

11. Onsite medication administration treatment during the induction phase, which shall be provided by a physician, nurse practitioner, physician assistant, registered nurse, or licensed practical nurse.

12. Ability to provide pregnancy testing for women of childbearing age.

13. For individuals of childbearing age, the ability to provide family planning services or to refer the individual for family planning services.

C. OBAT staff requirements.

1. Buprenorphine-waivered practitioners Physicians or physician extenders who have a current DEA registration authorizing the prescribing of scheduled drugs, including Schedule III drugs, are required.

2. CATPs are required and shall work in collaboration with the buprenorphine-waivered practitioner a physician or physician extender who has a current DEA registration authorizing the prescribing of scheduled drugs, including Schedule III drugs. This collaboration can be in person or via telemedicine as long as it meets the department's requirements for the OBAT setting and for telemedicine. CSACs, CSAC-supervisees, and CSAC-As are also recognized in the preferred OBAT setting as well as registered peer recovery specialists. A registered peer recovery specialist shall meet the definition in § 54.1-3500 of the Code of Virginia.

D. OBAT risk management shall be documented in each individual's record and shall include:

1. Random drug screening, using either urine or blood serums, for all individuals, conducted at a minimum of eight times per year. Drug screenings include presumptive and definitive screenings and shall be accurately interpreted. Definitive screenings shall only be utilized when clinically indicated. Outcomes of the drug screening shall be used to support positive patient outcomes and recovery.

2. A check of the Virginia Prescription Monitoring Program prior to initiation of buprenorphine products or naltrexone products and at least quarterly for all individuals thereafter.

3. Prescription of naloxone.

4. Overdose prevention education, including the purpose of and the administration of naloxone and the impact of polysubstance use. Education shall include discussion of the role of medication assisted treatment and the opportunity to reduce harm associated with polysubstance use. The goal is to help individuals remain in treatment to reduce the risk for harm.

5. Periodic monitoring of unused medication and opened medication wrapper counts when clinically indicated.

6. Clinically indicated infectious disease testing for diseases such as HIV; hepatitis A, B, and C; syphilis; and tuberculosis at treatment initiation and then annually or more frequently, depending on the clinical scenario and the patient's risk. Those individuals who test positive shall be treated either onsite on site or through referral.

7. For individuals without immunity to the hepatitis B virus, vaccination either onsite on site or through referral.

8. For patients without HIV infection, pre-exposure prophylaxis to prevent HIV infection shall be offered either onsite on site or through referral.

9. Women of child-bearing age shall be tested for pregnancy and shall be offered contraceptive services either onsite on site or through referral.

12VAC30-130-5090. Covered services: community based services - intensive outpatient services (ASAM Level 2.1).

A. Intensive outpatient services (ASAM Level 2.1) shall be a structured program of skilled treatment services for adults, children, and adolescents delivering a minimum of three service hours per service day for adults to achieve an average of nine to 19 hours of services per week and a minimum of two service hours per service day for children and adolescents to achieve an average of six to 19 hours of services per week. Withdrawal management services may be provided as necessary. The following service components shall be provided weekly as directed by the ISP for reimbursement:

1. Medical, psychological, psychiatric, laboratory, and toxicology services, which are available through consultation or referral.

2. Psychiatric and other individualized treatment planning.

3. Individual, family, and group psychotherapy, substance use disorder counseling, medication management, and psychoeducation.

4. Medication assisted treatment that is provided onsite on site or through referral.

5. Occupational and recreational therapies, motivational interviewing, enhancement, and engagement strategies to inspire an individual's motivation to change behaviors.

6. Psychiatric and medical consultation, which shall be available within 24 hours of the requested consult by telephone and preferably within 72 hours of the requested consult in person or via telemedicine.

7. Psychopharmacological consultation.

8. Addiction medication management and 24-hour crisis services.

9. Medical, psychological, psychiatric, laboratory, and toxicology services.

B. Intensive outpatient services (ASAM Level 2.1) shall be provided by agency-based providers that shall be licensed by DBHDS as a substance abuse intensive outpatient service for adults, children, and adolescents and contracted with DMAS or its contractor or an MCO to provide this service. Intensive outpatient service providers shall meet the ASAM Level 2.1 service components and staff requirements as follows:

1. Interdisciplinary team of CATPs shall be required. ASAM Level 2.1 may utilize CSACs or CSAC-supervisees to provide substance use disorder counseling and psychoeducational services within their scopes of practice as defined in § 54.1-3507.1 of the Code of Virginia.

2. Generalist physicians or physicians with experience in addiction medicine are permitted to provide general medical evaluations and concurrent or integrated general medical care.

3. Physicians and physician extenders who have a current DEA registration authorizing the prescribing of scheduled drugs, including Schedule III drugs, who are either employed by or contracted with the agency or through referral arrangements with the agency and who shall have a DEA-X number to prescribe buprenorphine.

4. Staff who shall be cross-trained to understand signs and symptoms of psychiatric disorders and be able to understand and explain the uses of psychotropic medications and understand interactions with substance use and other addictive disorders.

5. Emergency services, which shall be available, when necessary, by telephone 24 hours per day and seven days per week when the treatment program is not in session.

6. Direct affiliation with, or close coordination through referrals to, higher and lower levels of care and supportive housing services.

C. Intensive outpatient services (ASAM Level 2.1) co-occurring enhanced programs.

1. Co-occurring capable programs offer these therapies and support systems in intensive outpatient services described in this section to individuals with co-occurring addictive and psychiatric disorders who are able to tolerate and benefit from a planned program of therapies.

2. Individuals who are not able to benefit from a full program of therapies will be offered enhanced program services to match the intensity of hours in ASAM Level 2.1, including substance use case management, program of assertive community treatment (PACT), medication management, and psychotherapy.

12VAC30-130-5100. Covered services: community based care - partial hospitalization services (ASAM Level 2.5).

A. Partial hospitalization services (ASAM Level 2.5) components. Partial hospitalization services components shall include the following, as defined in the ISP and provided on a weekly basis:

1. Individualized treatment planning.

2. A minimum of 20 hours per week and at least five service hours per service day of skilled treatment services with a planned format, including individual and group psychotherapy, substance use disorder counseling, medication management, education groups, occupational and recreational therapy, and other therapies. Withdrawal management services may be provided as necessary. Time not spent in skilled, clinically intensive treatment is not billable.

3. Family psychotherapy and substance use disorder counseling involving family members, guardians, or significant others in the assessment, treatment, and continuing care of the individual.

4. Motivational interviewing, enhancement, and engagement strategies.

5. Medication assisted treatment that is provided onsite on site or through referral.

B. Partial hospitalization services (ASAM Level 2.5). The substance use partial hospitalization service provider shall be licensed by DBHDS as a substance abuse partial hospitalization program or substance abuse or mental health partial hospitalization program and contracted with DMAS or its contractor or an MCO. Partial hospitalization service providers shall meet the ASAM Level 2.5 support systems and staff requirements as follows:

1. Interdisciplinary team comprised of CATPs, which shall include an addiction-credentialed physician or physician with experience in addiction medicine, or physician extenders as defined in 12VAC30-130-5020. ASAM Level 2.5 may utilize CSACs or CSAC-supervisees to provide substance use disorder counseling and psychoeducational services within their scopes of practice as defined in § 54.1-3507.1 of the Code of Virginia.

2. Physicians shall have specialty training or experience, or both, in addiction medicine or addiction psychiatry. Physicians who treat adolescents shall have experience with adolescent medicine.

3. Physicians and physician extenders who have a current DEA registration authorizing the prescribing of scheduled drugs, including Schedule III drugs, who are either employed by or contracted with the agency and who shall have a DEA-X number to prescribe buprenorphine.

4. Program staff shall be cross-trained to understand signs and symptoms of mental illness and be able to understand and explain the uses of psychotropic medications and understand interactions with substance use and other addictive disorders.

5. Medical, psychological, psychiatric, laboratory, and toxicology services that are available by consult or referral.

6. Psychiatric and medical formal agreements to provide medical consult within eight hours of the requested consult by telephone or within 48 hours in person or via telemedicine.

7. Emergency services are available 24-hours 24 hours a day and seven days a week.

8. Direct affiliation with or close coordination through referrals to higher and lower levels of care and supportive housing services.

C. Partial hospitalization services (ASAM Level 2.5) co-occurring enhanced programs shall offer:

1. Therapies and support systems as described in this section to individuals with co-occurring addictive and psychiatric disorders who are able to tolerate and benefit from a full program of therapies. Other individuals who are not able to benefit from a full program of therapies (who are severely or chronically mentally ill) will be offered enhanced program services to constitute intensity of hours in ASAM Level 2.5, including substance use case management, PACT, medication management, and psychotherapy.

2. Psychiatric services as appropriate to meet the individual's mental health condition. Services may be available by telephone and onsite on site, or closely coordinated offsite off site, or via telemedicine within a shorter time than in a co-occurring capable program.

3. Clinical leadership and oversight and, at a minimum, capacity to consult with an addiction psychiatrist via telephone, via telemedicine, or in person.

4. CATPs with experience assessing and treating co-occurring mental illness.

12VAC30-130-5120. Covered services: clinically managed population - specific high intensity residential service (ASAM Level 3.3).

A. Clinically managed population-specific high intensity residential service (ASAM Level 3.3). The facility-based provider shall be licensed by DBHDS as (i) a supervised residential treatment service for adults; (ii) a substance abuse residential treatment service for adults; (iii) a substance abuse residential treatment service for women with children; (iv) a substance abuse and mental health residential treatment service for adults that has substance abuse listed on its license or within the "licensed as" statement or be a Level C (psychiatric residential treatment facility) service provider; or (v) a "mental health residential-children" provider that has substance abuse listed on its license or within the "licensed as" statements. All providers shall be contracted by DMAS or its contractor or an MCO. ASAM Level 3.3 settings do not include sober houses, boarding houses, or group homes where treatment services are not provided. Residential treatment service providers for clinically managed population-specific high intensity residential service (ASAM Level 3.3) shall meet the service components and staff requirements in this section.

B. Clinically managed population-specific high intensity residential service (ASAM Level 3.3) service components.

1. Clinically managed population-specific high intensity residential service components shall include:

a. Access to a consulting physician or physician extender who is either employed by or contracted with the agency or through referral arrangements with the agency and who has a DEA-X number to prescribe buprenorphine and who has a current DEA registration authorizing the prescribing of scheduled drugs, including Schedule III drugs, and emergency services 24 hours a day and seven days a week;

b. Arrangements for higher and lower levels of care;

c. Arrangements for laboratory and toxicology services appropriate to the severity of need; and

d. Arrangements for addiction pharmacotherapy, including medication assisted treatment that is provided onsite on site or through referral.

2. The following therapies shall be provided as directed by the ISP for reimbursement:

a. Clinically-directed Clinically directed treatment to facilitate recovery skills, relapse prevention, and emotional coping strategies. Services shall promote personal responsibility and reintegration of the individual into the network systems of work, education, and family life;

b. Addiction pharmacotherapy, including medication assisted treatment that is provided onsite on site or through referral;

c. Drug screening, using either urine or blood serums;

d. A range of cognitive and behavioral psychotherapies administered individually and in family and group settings as appropriate to the individual's needs to assist the individual in initial involvement or re-engagement in regular productive daily activity;

e. Substance use disorder counseling and psychoeducation activities provided individually or in family and group settings to promote recovery;

f. Recreational therapy, art, music, physical therapy, and vocational rehabilitation;

g. Motivational enhancement and engagement strategies;

h. Regular monitoring of the individual's medication adherence;

i. Recovery support services;

j. Services for the individual's family and significant others, as appropriate to advance the individual's treatment goals and objectives identified in the ISP;

k. Education on benefits of medication assisted treatment and referral to treatment as necessary; and

l. Withdrawal management services may be provided as necessary.

C. Clinically managed population-specific high intensity residential service (ASAM Level 3.3) staff requirements.

1. The interdisciplinary team shall include CATPs and allied health professionals in an interdisciplinary team. ASAM Level 3.3 may utilize CSACs or CSAC-supervisees to provide substance use disorder counseling and psychoeducational services within their scopes of practice as defined in § 54.1-3507.1 of the Code of Virginia.

2. Staff shall provide awake 24-hour onsite supervision. The provider's staffing plan must be in compliance with DBHDS licensing regulations for staffing plans set forth in 12VAC35-46-870 and 12VAC35-105-590.

3. Clinical or credentialed staff shall be experienced and knowledgeable about the biopsychosocial dimensions and treatment of substance use disorders and who are available onsite on site or by telephone 24 hours per day. Licensed clinical staff shall be able to identify acute psychiatric conditions and decompensation.

4. Substance use case management is included in this level of care.

5. Appropriately credentialed medical staff shall be available to assess and treat co-occurring biomedical disorders and to monitor the individual's administration of prescribed medications.

D. Clinically managed population-specific high intensity residential service co-occurring enhanced programs, as required by ASAM.

1. Appropriate psychiatric services, including medication evaluation and laboratory services, shall be provided onsite on site or through a closely coordinated offsite provider, as appropriate to the severity and urgency of the individual's mental condition.

2. CATPs shall be available to assess and treat co-occurring substance use and mental illness using specialized training in behavior management techniques.

3. Credentialed addiction treatment professionals shall be cross-trained in addiction and mental health to understand the signs and symptoms of mental illness and be able to provide education to the individual on the interactions with substance use and psychotropic medications.

12VAC30-130-5130. Covered services: clinically managed high intensity residential services (adult) and clinically managed medium intensity residential services (adolescent) (ASAM Level 3.5).

A. Clinically managed high intensity residential services (adult) and clinically managed medium intensity residential services (adolescent) (ASAM Level 3.5) settings for services. The facility based residential treatment service provider (ASAM Level 3.5) shall be licensed as (i) a substance abuse residential treatment service for adults or children, (ii) a psychiatric unit that has substance abuse listed on its license or within the "licensed as" statements, (iii) a substance abuse residential treatment service for women with children, (iv) a substance abuse and mental health residential treatment service for adults and children that has substance abuse listed on its license or within the "licensed as" statements, (v) a Level C (psychiatric residential treatment facility) provider, or (vi) a "mental health residential-children" provider that has substance abuse on its license or within the "licensed as" statements and shall be contracted by DMAS or its contractor or an MCO. Residential treatment providers (ASAM Level 3.5) shall meet the service components and staff requirements in this section.

B. Clinically managed high intensity residential services (adult) and clinically managed medium intensity residential services (adolescent) (ASAM Level 3.5) service components.

1. These residential treatment services, as required by ASAM, include:

a. Telephone or in-person consultation with a physician or physician extender who shall be available to perform required physician services. Emergency services shall be available 24 hours per day and seven days per week;

b. Arrangements for more and less intensive levels of care and other services such as sheltered workshops, literacy training, and adult education;

c. Arrangements for needed procedures, including medical, psychiatric, psychological, laboratory, and toxicology services appropriate to the severity of need; and

d. Arrangements for addiction pharmacotherapy, including medication assisted treatment that is provided onsite on site or through referral.

2. The following therapies shall be provided as directed by the ISP for reimbursement:

a. Clinically directed treatment to facilitate recovery skills, relapse prevention, and emotional coping strategies. Services shall promote personal responsibility and reintegration of the individual into the network systems of work, education, and family life. Activities shall be designed to stabilize and maintain substance use disorder symptoms and apply recovery skills and may include relapse prevention, interpersonal choice exploration, and development of social networks in support of recovery.

b. Range of cognitive, behavioral psychotherapies, and substance use disorder counseling administered individually and in family and group settings to assist the individual in initial involvement or re-engagement in regular productive daily activities, including education on medication management, addiction pharmacotherapy, and education skill building groups to enhance the individual's understanding of substance use and mental illness.

c. Psychoeducational activities.

d. Addiction pharmacotherapy and drug screening.

e. Recreational therapy, art, music, physical therapy, and vocational rehabilitation.

f. Motivational enhancements and engagement strategies.

g. Monitoring of the adherence to prescribed medications and over-the-counter medications and supplements.

h. Daily scheduled professional services and interdisciplinary assessments and treatment designed to develop and apply recovery skills.

i. Services for family and significant others, as appropriate, to advance the individual's treatment goals and objectives identified in the ISP.

j. Withdrawal management services may be provided as necessary.

C. Clinically managed high intensity residential services (adult) and clinically managed medium intensity residential services (adolescent) (ASAM Level 3.5) staff requirements.

1. The interdisciplinary team shall include CATPs, physicians, or physician extenders and allied health professionals. Physicians and physician extenders who have a current DEA registration authorizing the prescribing of scheduled drugs, including Schedule III drugs, and who are either employed by or contracted with the agency or through referral arrangements with the agency and who shall have a DEA-X number to prescribe buprenorphine. ASAM Level 3.5 may utilize CSACs or CSAC-supervisees to provide substance use disorder counseling and psychoeducational services within their scopes of practice as defined in § 54.1-3507.1 of the Code of Virginia.

2. Staff shall provide awake 24-hour onsite supervision. The provider's staffing plan must be in compliance with DBHDS licensing regulations for staffing plans set forth in 12VAC35-46-870 and 12VAC35-105-590.

3. Clinical staff who are experienced in and knowledgeable about the biopsychosocial dimensions and treatment of substance use disorders. Clinical staff shall be able to identify acute psychiatric conditions and decompensations.

4. Substance use case management shall be provided in this level of care.

5. Appropriately credentialed medical staff shall be available onsite on site or by telephone 24 hours per day, seven days per week to assess and treat co-occurring biological and physiological disorders and to monitor the individual's administration of medications in accordance with a physician's prescription.

D. Clinically managed high intensity residential services (adult) and clinically managed medium intensity residential services (adolescent) (ASAM Level 3.5) co-occurring enhanced programs as required by ASAM.

1. Psychiatric services, medication evaluation, and laboratory services shall be provided. Such services shall be available by telephone within eight hours of requested service and onsite on site or via telemedicine, or closely coordinated with an offsite provider within 24 hours of requested service, as appropriate to the severity and urgency of the individual's mental and physical condition.

2. Staff shall be CATPs who are able to assess and treat co-occurring substance use and psychiatric disorders.

3. Planned clinical activities shall be required and shall be designed to stabilize and maintain the individual's mental health problems and psychiatric symptoms.

4. Medication education and management shall be provided.

12VAC30-130-5140. Covered services: medically monitored intensive inpatient services (adult) and medically monitored high intensity inpatient services (adolescent) (ASAM Level 3.7).

A. Medically monitored intensive inpatient services (adult) and medically monitored high intensity inpatient services (adolescent) (ASAM Level 3.7) settings for services. The facility-based provider of ASAM Level 3.7 services shall be licensed by DBHDS as (i) a freestanding psychiatric hospital or inpatient psychiatric unit with a DBHDS medical detoxification license or managed withdrawal license; (ii) a residential crisis stabilization unit with a DBHDS medical detoxification license or managed withdrawal license; (iii) a substance abuse residential treatment service for women with children with a DBHDS managed withdrawal license; (iv) a Level C (psychiatric residential treatment facility) provider; (v) a "mental health residential-children" provider with a substance abuse residential license and a DBHDS managed withdrawal license; (vi) a "managed withdrawal-medical detox adult residential treatment" provider; or (vii) a "medical detox-chemical dependency unit" for adults and shall be contracted by DMAS or its contractor or the MCO. ASAM Level 3.7 providers shall meet the service components and staff requirements in this section.

B. Medically monitored intensive inpatient services (adult) and medically monitored high intensity inpatient services (adolescent) (ASAM Level 3.7) service components. The following therapies shall be provided as directed by the ISP for reimbursement:

1. Daily clinical services provided by an interdisciplinary team to involve appropriate medical and nursing services, as well as individual, group, and family activity services. Activities may include pharmacological, including medication assisted treatment that is provided onsite on site or through referral; withdrawal management; cognitive-behavioral; and other psychotherapies and substance use disorder counseling administered on an individual or group basis and modified to meet the individual's level of understanding and assist in the individual's recovery.

2. Counseling and clinical monitoring to facilitate re-involvement in regular productive daily activities and successful re-integration into family living if applicable.

3. Psychoeducational activities.

4. Random drug screens to monitor use and strengthen recovery and treatment gains.

5. Regular medication monitoring.

6. Planned clinical activities to enhance understanding of substance use disorders.

7. Health education associated with the course of addiction and other potential health related risk factors, including tuberculosis, human immunodeficiency virus, hepatitis B and C, and other sexually transmitted infections.

8. Evidence based practices, such as motivational interviewing to address an individual's readiness to change, designed to facilitate understanding of the relationship of the substance use disorder and life impacts.

9. Daily treatments to manage acute symptoms of biomedical substance use or mental illness.

10. Services to family and significant others as appropriate to advance the individual's treatment goals and objectives identified in the ISP.

11. Physician monitoring, nursing care, and observation shall be available. A physician shall be available to assess the individual in person or via telemedicine within 24 hours of admission and thereafter as medically necessary.

12. A licensed and registered nurse who shall conduct an alcohol or other drug-focused nursing assessment upon admission. A licensed registered nurse or licensed practical nurse shall be responsible for monitoring the individual's progress and for medication administration duties.

13. Additional medical specialty consultation; psychological, laboratory, and toxicology services shall be available onsite on site, either through consultation or referral.

14. Coordination of necessary services shall be available onsite on site or through referral to a closely coordinated offsite provider to transition the individual to lower levels of care.

15. Psychiatric services shall be available onsite on site or through consultation or referral to a closely coordinated offsite provider when a presenting problem could be attended to at a later time. Such services shall be available within eight hours of requested service by telephone or within 24 hours of requested service in person or via telemedicine.

C. Medically monitored intensive inpatient services (adult) and medically monitored high intensity inpatient services (adolescent) (ASAM Level 3.7) staff requirements.

1. The interdisciplinary team shall include CATPs and addiction-credentialed physicians or physicians with experience in addiction medicine to assess, treat, and obtain and interpret information regarding the individual's psychiatric and substance use disorders. Physicians and physician extenders who have a current DEA registration authorizing the prescribing of scheduled drugs, including Schedule III drugs, and who are either employed by or contracted with the agency or through referral arrangements with the agency and who shall have a DEA-X number for prescribing buprenorphine. ASAM Level 3.7 may utilize CSACs or CSAC-supervisees to provide substance use disorder counseling and psychoeducational services within their scopes of practice as defined in § 54.1-3507.1 of the Code of Virginia.

2. Clinical staff shall be knowledgeable about the biological and psychosocial dimensions of substance use disorders and mental illnesses and their treatment. Clinical staff shall be able to identify acute psychiatric conditions, symptom increase or escalation, and decompensation.

3. Clinical staff shall be able to provide a planned regimen of 24-hour professionally directed evaluation, care, and treatment, including the administration of prescribed medications.

4. An addiction-credentialed physician or physician with experience in addiction medicine shall oversee the treatment process and assure ensure quality of care. Licensed physicians shall perform physical examinations for all individuals who are admitted. Staff shall supervise addiction pharmacotherapy integrated with psychosocial therapies. The professional may be a physician or a psychiatrist, or a physician extender as defined in 12VAC30-130-5020 if knowledgeable about addiction treatment.

D. Medically monitored intensive inpatient services (adult) and medically monitored high intensity inpatient services (adolescent) (ASAM Level 3.7) co-occurring enhanced programs as required by ASAM.

1. Appropriate psychiatric services, medication evaluation, and laboratory services shall be available.

2. A psychiatrist assessment of the individual shall occur within four hours of admission by telephone and within 24 hours following admission in person or via telemedicine, or sooner, as appropriate to the individual's behavioral health condition, and thereafter as medically necessary.

3. A behavioral health-focused assessment at the time of admission shall be performed by a registered nurse or licensed mental health clinician. A licensed registered nurse or licensed practical nurse supervised by a registered nurse shall be responsible for monitoring the individual's progress and administering or monitoring the individual's self-administration of medications.

4. Psychiatrists and CATPs who are able to assess and treat co-occurring psychiatric disorders and who have specialized training in the behavior management techniques and evidenced-based practices shall be available.

5. Access to an addiction-credentialed physician shall be available along with access to either a psychiatrist, a certified addiction psychiatrist, or a psychiatrist with experience in addiction medicine.

6. CATPs shall have experience and training in addiction and mental health to understand the signs and symptoms of mental illness and be able to provide education to the individual on the interaction of substance use and psychotropic medications.

7. Planned clinical activities shall be offered and designed to promote stabilization and maintenance of the individual's behavioral health needs, recovery, and psychiatric symptoms.

8. Medication education and management shall be offered.

12VAC30-130-5150. Covered services: medically managed intensive inpatient services (ASAM Level 4.0).

A. Medically managed intensive inpatient services (ASAM Level 4.0) settings for services. Acute care hospitals licensed by the Virginia Department of Health shall be the designated setting for medically managed intensive inpatient treatment and shall offer medically directed acute withdrawal management and related treatment designed to alleviate acute emotional, behavioral, cognitive, or biomedical distress resulting from, or occurring with, an individual's use of alcohol and other drugs. Such service settings shall offer medically directed acute withdrawal management and related treatment designed to alleviate acute emotional, behavioral, cognitive, or biomedical distress, or all of these, resulting from, or co-occurring with, an individual's use of alcohol or other drugs, with the exception of tobacco-related disorders, caffeine-related disorders or dependence or non-substance-related disorders.

B. Medically managed intensive inpatient services (ASAM Level 4.0) service components.

1. The service components of medically managed intensive inpatient services shall be:

a. An evaluation or analysis of substance use disorders shall be provided, including the diagnosis of substance use disorders and the assessment of treatment needs for medically necessary services.

b. Observation and monitoring the individual's course of withdrawal shall be provided. This shall be conducted as frequently as deemed appropriate for the individual and the level of care the individual is receiving. This may include, for example, observation of the individual's health status.

c. Medication services, including the prescription or administration related to substance use disorder treatment services or the assessment of the side effects or results of that medication, conducted by appropriate licensed staff who provide such services within their scope of practice or license.

2. The following therapies shall be provided for reimbursement:

a. Daily clinical services provided by an interdisciplinary team to stabilize acute addictive or psychiatric symptoms. Activities shall include pharmacological, cognitive-behavioral, and other psychotherapies or substance use disorder counseling administered on an individual or group basis and modified to meet the individual's level of understanding. For individuals with a severe biomedical disorder, physical health interventions are available to supplement addiction treatment. For the individual who has less stable psychiatric symptoms, ASAM Level 4.0 co-occurring capable programs offer individualized treatment activities designed to monitor the individual's mental health and to address the interaction of the mental health programs and substance use disorders.

b. Health education services.

c. Planned clinical interventions that are designed to enhance the individual's understanding and acceptance of illness of addiction and the recovery process.

d. Services for the individual's family, guardian, or significant other, as appropriate, to advance the individual's treatment and recovery goals and objectives identified in the ISP.

e. This level of care offers 24-hour nursing care and daily physician care for severe, unstable problems in any of the following ASAM dimensions: (i) acute intoxication or withdrawal potential; (ii) biomedical conditions and complications; and (iii) emotional, behavioral, or cognitive conditions and complications.

f. Discharge services shall be the process to prepare the individual for referral into another level of care, post treatment return or reentry into the community, or the linkage of the individual to essential community treatment, housing, recovery, and human services.

C. Medically managed intensive inpatient services (ASAM Level 4.0) staff requirements.

1. An interdisciplinary staff of appropriately credentialed clinical staff including, for example, addiction-credentialed physicians or physicians with experience in addiction medicine, licensed nurse practitioners, licensed physician assistants, registered nurses, licensed professional counselors, licensed clinical psychologists, or licensed clinical social workers who assess and treat individuals with severe substance use disorders or addicted individuals with concomitant acute biomedical, emotional, or behavioral disorders. Physicians and physician extenders who have a current DEA registration authorizing the prescribing of scheduled drugs, including Schedule III drugs, and who are either employed by or contracted through the agency or through referral arrangements with the agency and who shall have a DEA-X number to prescribe buprenorphine.

2. Medical management by physicians and primary nursing care shall be available 24 hours per day and counseling services shall be available 16 hours per day.

D. Medically managed intensive inpatient services (ASAM Level 4.0) co-occurring enhanced programs. These programs shall be provided by appropriately licensed or registered credentialed mental health professionals who assess and treat the individual's co-occurring mental illness and are knowledgeable about the biological and psychosocial dimensions of psychiatric disorders and his treatment.