TITLE 12. HEALTH

DEPARTMENT OF MEDICAL ASSISTANCE SERVICES

Fast-Track Regulation

Titles of Regulations: 12VAC30-60. Standards Established and Methods Used to Assure High Quality Care (amending 12VAC30-60-181).

12VAC30-130. Amount, Duration and Scope of Selected Services (amending 12VAC30-130-5060).

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

Public Hearing Information: No public hearing is currently scheduled.

Public Comment Deadline: November 4, 2022.

Effective Date: December 8, 2022.

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

Basis: Section 32.1 325 of the Code of Virginia grants to the Board of Medical Assistance Services the authority to administer and amend the Plan for Medical Assistance and to promulgate regulations, and § 32.1-324 of the Code of Virginia grants the Director of the Department of Medical Assistance Services (DMAS) the authority of the board when it is not in session.

Item 313 PPPPP of the 2021 Appropriations Act states that DMAS shall seek federal authority through waiver and State Plan amendments under Titles XIX and XXI of the Social Security Act to expand the preferred office-based opioid treatment (OBOT) model to include individuals with substance use disorders that are covered in the addiction and recovery treatment services (ARTS) benefit.

Purpose: The purpose of this action is to expand the substance use disorder service called preferred office-based opioid treatment in accordance with a General Assembly mandate and incorporate ARTS utilization review changes. These regulatory changes are essential to protect the health, safety, and welfare of Medicaid members.

Previously OBOT was available only to individuals with a primary diagnosis of opioid use disorder. The action expands the program as preferred office-based addiction treatment (OBAT) to individuals with a substance-related or addictive disorder. In 2016, DMAS transformed the Medicaid substance use disorder benefit to address the opioid epidemic. According to data from the Virginia Department of Health, the number of fatal non-opioid illicit drug overdoses is increasing. This mandate allows DMAS to increase member access to preferred office-based addiction treatment to address other forms of substance-related or addictive disorders.

The purpose of the ARTS utilization review change to extend the time for credentialed addiction treatment professionals to sign and date multidimensional assessments and individualized services plans (ISPs) from one to three days was requested by the provider community. The intent is to reduce the administrative burden on providers and provide more realistic timeframes for completion. The updates to the ARTS utilization review regulations that include: prohibiting health care entities with provisional licenses by the Department of Behavioral Health and Developmental Services to be reimbursed as Medicaid providers; changing OBOT to OBAT; and stating that prescriptions for naloxone must be included in providers' documentation do not reflect changes in practice but rather align DMAS regulations with the department's existing practices. Lastly, the ARTS utilization regulations are being revised to allow certified substance abuse counselors-supervisees (CSAC-supervisees) to complete multidimensional assessments and ISPs in accordance with the Board of Counseling's scope of practice.

Rationale for Using Fast-Track Rulemaking Process: These regulatory changes are expected to be noncontroversial. A state plan amendment has been approved by Centers for Medicare and Medicaid Services, and these changes will generally replicate the state plan text in the Virginia Administrative Code.

The ARTS utilization review regulation changes are expected to be noncontroversial because they incorporate changes requested by the provider community, make changes that document existing DMAS practices, and make changes to align with the Board of Counseling's scope of practice for CSAC-supervisees.

Substance: Item 313 PPPPP of the 2021 Appropriations Act requires DMAS to revise the state plan to expand the substance use disorder service called preferred office-based opioid treatment.

The ARTS utilization review regulation changes incorporate modifications that (i) were requested by the provider community; (ii) document existing DMAS practices rather than changes in practice; and (iii) align with the Board of Counseling's scope of practice for CSAC-supervisees.

Issues: The advantages of this regulatory action include expanding preferred office-based opioid treatment, which has been available only to individuals with a primary diagnosis of opioid use disorder, to individuals with a substance-related or addictive disorders, reduced administrative burden for providers, alignment of DMAS regulations with the department’s existing practices and alignment with the Board of Counseling's scope of practice for certified substance abuse counseling supervisees. These changes create no disadvantages to the public, the agency, the Commonwealth, or the regulated community.

Department of Planning and Budget's Economic Impact Analysis: The Department of Planning and Budget (DPB) has analyzed the economic impact of this proposed regulation in accordance with § 2.2-4007.04 of the Code of Virginia (Code) and Executive Order 14 (as amended, July 16, 2018). The analysis presented below represents DPB's best estimate of these economic impacts.¹

Summary of the Proposed Amendments to Regulation. Pursuant to the 2021 Appropriations Act, Item 313.PPPPP, the Board of Medical Assistance Services (Board) proposes to expand the Medicaid treatment services previously offered only to individuals with opioid use disorder to now include individuals with other substance-related or addictive disorders. The Board also proposes to update the regulatory text to reflect certain current practices.

Background. The 2021 Appropriations Act, Item 313.PPPPP² states that the Department of Medical Assistance Services (DMAS) "shall seek federal authority through waiver and State Plan amendments under Titles XIX and XXI of the Social Security Act to expand the Preferred Office-Based Opioid Treatment (OBOT) model to include individuals with substance use disorders (SUD) that are covered in the Addiction and Recovery Treatment Services (ARTS) benefit." Consequently, DMAS obtained approval from the Centers for Medicare and Medicaid Services with an effective date of October 1, 2021. Consequently, this action would incorporate the legislatively mandated expanded eligibility for treatment services to cover individuals with other substance use disorders.

Additionally, this action would update the regulatory text to reflect certain current practices including: 1) aligning the regulatory text with the Board of Counseling's scope of practice for certified substance abuse counselor supervisees, and 2) allowing three days rather than one day to sign and date multidimensional assessments and individual service plans in response to requests by the provider community.

Estimated Benefits and Costs. Preferred Office-Based Opioid Treatment is a type of outpatient addiction treatment designed for people with opioid use disorder. In 2016, DMAS transformed the Medicaid substance use disorder benefit to address the opioid epidemic. However, DMAS reports that data from the Virginia Department of Health indicate the number of fatal non-opioid illicit drug overdoses is increasing. The purpose of the General Assembly mandate appears to be to offer similar treatment options to individuals with a substance-related or addictive disorder in addition to opioid use disorder. Prior to the legislative mandate, this type of treatment was available only to individuals with a primary diagnosis of opioid use disorder. The mandate expanded this treatment to cover individuals with other substance (e.g. alcohol, cannabis, hallucinogens, inhalants, sedatives/hypnotics, stimulants, polysubstance, etc.) use disorders.

The 2021 General Assembly appropriated $881,306 in general funds and $1,296,254 in federal funds to expand this treatment. DMAS estimates that approximately 1,400 members would be using the newly eligible services. The main benefit of this change is the treatment of approximately 1,400 individuals with additional types of substance use disorders. Additionally, the use of federal funds for this expanded coverage represents an injection of new resources into Virginia's economy with an expected expansionary effect.

The Board also proposes to update the regulatory text to reflect certain current practices in ARTS utilization review. One of these changes would allow certified substance abuse counselor supervisees to complete multidimensional assessments and individual service plans, to be consistent with the Board of Counseling's scope of practice. This assessment is not reimbursable and no thus fiscal impact is expected. Another change would extend the time for credentialed addiction treatment professionals to sign and date multidimensional assessments and individual service plans; this would be extended from one to three days in response to requests by the provider community. Providers stated to DMAS that the additional time would allow edits if needed to the assessment and the individual service plan based on the clinical judgment of the supervisor. The intent of this change was to reduce the administrative burden on providers and provide more realistic timeframes for completion. Since these changes have already been incorporated in to current practices, no significant economic effect is expected upon finalizing these proposed changes.

Businesses and Other Entities Affected. According to DMAS there are currently 178 providers offering treatment services for opioid use disorder. Fifty-two of these providers are Community Services Boards, eight are Federally Qualified Health Centers, and the remaining are private providers/clinics. DMAS projects that approximately 1,400 individuals are covered by the proposed expansion.

The Code of Virginia requires DPB to assess whether an adverse impact may result from the proposed regulation.³ An adverse impact is indicated if there is any increase in net cost or reduction in net revenue for any entity, even if the benefits exceed the costs for all entities combined. The proposed action updates regulatory text to expand treatment services to a broader population pursuant to a legislative mandate. No adverse impact is indicated.

Small Businesses⁴ Affected.⁵ The proposed action does not appear to adversely affect small businesses.

Localities⁶ Affected.⁷ The proposed changes do not disproportionately affect particular localities or introduce costs for local governments.

Projected Impact on Employment. The proposed expansion of treatment services to substance abuse disorders other than opioid would add to the demand for such services. Consequently, employment may increase.

Effects on the Use and Value of Private Property. The additional coverage of other substance use disorder treatment services would add to demand for such services and have a positive impact on such providers' revenues and their asset values. Other than that, no effect on the use and value of private property or real estate development costs is expected.

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¹Section 2.2-4007.04 requires that such economic impact analyses determine the public benefits and costs of the proposed amendments. Further the analysis should include but not be limited to: (1) the projected number of businesses or other entities to whom the proposed regulatory action would apply, (2) the identity of any localities and types of businesses or other entities particularly affected, (3) the projected number of persons and employment positions to be affected, (4) the projected costs to affected businesses or entities to implement or comply with the regulation, and (5) the impact on the use and value of private property.

²https://budget.lis.virginia.gov/item/2021/2/HB1800/Chapter/1/313/

³Pursuant to § 2.2-4007.04 D of the Code of Virginia: In the event this economic impact analysis reveals that the proposed regulation would have an adverse economic impact on businesses or would impose a significant adverse economic impact on a locality, business, or entity particularly affected, the Department of Planning and Budget shall advise the Joint Commission on Administrative Rules, the House Committee on Appropriations, and the Senate Committee on Finance. Statute does not define "adverse impact," state whether only Virginia entities should be considered, nor indicate whether an adverse impact results from regulatory requirements mandated by legislation.

⁴Pursuant to § 2.2-4007.04 of the Code of Virginia, small business is defined as "a business entity, including its affiliates, that (i) is independently owned and operated and (ii) employs fewer than 500 full-time employees or has gross annual sales of less than $6 million."

⁵If the proposed regulatory action may have an adverse effect on small businesses, § 2.2-4007.04 of the Code of Virginia requires that such economic impact analyses include: (1) an identification and estimate of the number of small businesses subject to the proposed regulation, (2) the projected reporting, recordkeeping, and other administrative costs required for small businesses to comply with the proposed regulation, including the type of professional skills necessary for preparing required reports and other documents, (3) a statement of the probable effect of the proposed regulation on affected small businesses, and (4) a description of any less intrusive or less costly alternative methods of achieving the purpose of the proposed regulation. Additionally, pursuant to § 2.2-4007.1 of the Code of Virginia, if there is a finding that a proposed regulation may have an adverse impact on small business, the Joint Commission on Administrative Rules shall be notified.

⁶"Locality" can refer to either local governments or the locations in the Commonwealth where the activities relevant to the regulatory change are most likely to occur.

⁷Section 2.2-4007.04 defines "particularly affected" as bearing disproportionate material impact.

Agency's Response to Economic Impact Analysis: The agency has reviewed the economic impact analysis prepared by the Department of Planning and Budget and raises no issues with this analysis.

Summary:

The amendments (i) in accordance with Item 313 PPPPP of the 2021 Appropriation Act, expand substance use disorder service preferred office-based treatment to individuals with a substance-related or addictive disorder other than opioid use disorder; and (ii) incorporate Addiction and Recovery Treatment Services benefits utilization review modifications that allow substance abuse counselor-supervisees to complete a multidimensional assessment under supervision if a credentialed addiction treatment professional signs the assessment within three business days.

12VAC30-60-181. Utilization review of addiction and recovery treatment services.

A. Providers shall be required to maintain documentation detailing all relevant information about the Medicaid individuals who are in the provider's care. Such documentation shall fully disclose the extent of services provided in order to support provider's claims for reimbursement for services rendered. This documentation shall be written and dated at the time the services are rendered. Claims that are not adequately supported by appropriate up-to-date documentation may be subject to recovery of expenditures.

B. Utilization reviews shall be conducted by the Department of Medical Assistance Services or its designated contractor.

C. Service authorizations shall be required for American Society of Addiction Medicine (ASAM) Levels 2.1, 2.5, 3.1, 3.3, 3.5, 3.7, and 4.0.

D. A multidimensional assessment by a credentialed addiction treatment professional (CATP), as defined in 12VAC30-130-5020, shall be required for ASAM Levels 1.0 through 4.0. Certified substance abuse counselors (CSACs) and CSAC-supervisees are able to complete a multidimensional assessment under supervision to make recommendations for an ASAM level of care, which shall be signed and dated by a CATP within one three business day days. The multidimensional assessment shall be maintained in the individual's record by the provider. Medical necessity for all ASAM levels of care shall be based on the outcome of the individual's multidimensional assessment.

E. Individual service plans (ISPs) and treatment plans shall be developed upon admission to medically managed intensive inpatient services (ASAM Level 4.0), substance use residential and inpatient services (ASAM Levels 3.1, 3.3, 3.5, and 3.7), and substance use intensive outpatient and partial hospitalization programs (ASAM Levels 2.1 and 2.5). ISPs or treatment plans shall be developed upon initiation of opioid treatment services (OTP), office-based opioid addiction treatment (OBOT) (OBAT), and substance use outpatient services (ASAM Level 1.0).

1. The provider shall include the individual and the family or caregiver, as may be appropriate, in the development of the ISP or treatment plan. To the extent that the individual's condition requires assistance for participation, assistance shall be provided. The ISP shall be updated at least annually and as the individual's needs and progress change. An ISP that is not updated either annually or as the individual's needs and progress change shall be considered outdated.

2. All ISPs shall be completed and contemporaneously signed and dated by the CATP preparing the ISP. For ASAM Levels 3.1, 3.3, and 3.5, the The ISP may be completed by a CSAC or CSAC-supervisee under supervision if the CATP signs and dates the ISP within one three business day days.

3. The child's or adolescent's ISP shall also be signed by the parent or legal guardian, and the adult individual shall sign his own ISP. If the individual, whether a child, adolescent, or adult, is unwilling or unable to sign the ISP, then the service provider shall document the reasons why the individual was not able or willing to sign the ISP.

F. A comprehensive ISP, as defined in 12VAC30-130-5020, shall be fully developed within 30 calendar days of the initiation of services. The comprehensive ISP shall be developed with the individual, in consultation with the individual's family, as appropriate, and shall address (i) a summary or reference to the individual's identified needs; (ii) short-term and long-term goals and measurable objectives for addressing each identified individually specific need; (iii) services and supports and frequency of services to accomplish the goals and objectives; (iv) target dates for accomplishment of goals and objectives; (v) estimated duration of service; (vi) medication assisted treatment assessment, which shall be provided onsite or through referral; and (vii) the role of other agencies if the plan is a shared responsibility and the staff designated as responsible for the coordination and integration of services. The ISP shall be reviewed at least every 90 calendar days and shall be modified as the needs and progress of the individual change. Documentation of the ISP review shall include the dated signatures of the CATP and the individual. CSACs and CSAC-supervisees may perform the ISP reviews in ASAM Levels 3.1, 3.3, and 3.5 if a CATP signs and dates the ISP review within one three business day days.

G. Progress notes, as defined in 12VAC30-60-185, shall disclose the extent of services provided and corroborate the units billed. Each progress note shall be individualized to the member to demonstrate the individual member's particular circumstances, treatment, and progress. Claim payments shall be retracted for services that are not supported by documentation that is individualized to the member.

H. Documentation shall include assessment and referral for medication assisted treatment as medically indicated. This shall include prescriptions for naloxone.

I. Health care entities with provisional licenses issued by the Department of Behavioral Health and Developmental Services shall not be reimbursed as Medicaid providers.

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

A. Preferred office-based opioid addiction treatment (OBOT) (OBAT) shall be provided by a buprenorphine-waivered practitioner 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 OBOT OBAT services. OBOT OBAT services shall meet the criteria established in this section.

B. OBOT 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 opioid substance use disorder and alcohol use disorder.

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

6. Assurance that buprenorphine products medications for opioid use disorder and alcohol use disorder are only dispensed onsite during the induction phase. After the induction phase, buprenorphine products 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 who is prescribing buprenorphine products or naltrexone products to individuals with a primary opioid use disorder. These therapies can be provided via telemedicine as long as they meet DMAS requirements for an OBOT OBAT and for the use of telemedicine. (See the Medicaid Memo entitled "Updates to Telemedicine Coverage" dated May 13, 2014.) Preferred OBOTs 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 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, or 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. OBOT OBAT staff requirements.

1. Buprenorphine-waivered practitioners are required.

2. CATPs are required and shall work in collaboration with the buprenorphine-waivered practitioner who is prescribing buprenorphine products or naltrexone products to individuals with a primary opioid use disorder. This collaboration can be in person or via telemedicine as long as it meets the department's requirements for the OBOT OBAT setting and for telemedicine. CSACs, CSAC-supervisees, and CSAC-As are also recognized in the preferred OBOT 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. OBOT 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. Opioid overdose 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 or through referral.

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

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

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