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ARIZONA STATE SENATE
Fifty-Fourth Legislature, First Regular Session
AMENDED
AHCCCS; opioid treatment programs; requirements
Purpose
Establishes reporting requirements for opioid treatment programs (OTP) who receive reimbursement from the Arizona Health Care Cost Containment System (AHCCCS) and AHCCCS contractors. Directs AHCCCS to suspend reimbursement for OTP providers who do not meet prescribed reporting requirements. Establishes the Opioid Use Disorder Review Council (Council).
Background
The federal Substance Abuse and Mental Health Services Administration’s (SAMHSA) Guidelines for OTPs (Guidelines) outline and describe how prescribed opioid treatment standards are to be satisfied by OTPs, and include standards for OTP facility management, administrative organization, provider responsibilities, quality improvement, community relations and diversion control. An OTP is a licensed and accredited program, also referred to as a medication-assisted treatment (MAT) program, that is authorized to dispense medications for the treatment of opioid use disorder through highly structured protocols as prescribed by federal and state law. AHCCCS serves as the State Opioid Treatment Authority (SOTA) and is the entity responsible for providing administrative and clinical oversight to certified OTPs, including planning, developing, educating and implementing policies and procedures to ensure that opioid dependency treatment is provided at an optimal level.
Federal law requires that OTPs have a current and valid accreditation status, SAMHSA certification and U.S. Drug Enforcement Administration registration before OTPs are permitted to administer or dispense opioid drugs for MAT. These requirements apply to opioid agonist treatment medications that are approved by the U.S. Food and Drug Administration (U.S. FDA), including methadone and other pharmaceutical products containing buprenorphine. Federal law allows MAT for other pharmacotherapies if they are provided in a manner consistent with the best medical practices for each drug. For example, the use of naltrexone is permitted in OTPs but is not subject to these regulations. The federal regulations and SAMHSA Guidelines describe a minimum-acceptable standard for the operation of OTPs. According to SAMHSA, the Guidelines are intended to assure the safety of both the patient and the public (42 C.F.R. § 8).
There is no anticipated fiscal impact to the state General Fund associated with this legislation.
Provisions
1. Permits AHCCCS and AHCCCS contractors to reimburse OTP providers for enrolled members only if the OTP provider demonstrates enforcement of each plan required in the annual report and the annual report is approved by AHCCCS as prescribed.
2. Directs OTP providers that receive reimbursement from AHCCCS or their contractors to submit an annual report, on a schedule prescribed by AHCCCS, that contains:
a) a detailed security plan that incorporates standards from SAMHSA and the U.S. Drug Enforcement Administration, and includes patient management strategies designed to reduce potential harm to patients and lower this risk of exposure to illicit transactions and other consequences of overcrowding and poor patient management;
b) a neighborhood engagement plan that outlines engagement with key stakeholders in the neighborhood where the OTP is located, and that includes information about ensuring consideration of and response to concerns of neighborhood stakeholders;
c) a comprehensive plan related to patient care that:
i. demonstrates how the OTP ensures appropriate standards of care are met for MAT, including dosing, and the provision of or referral to counseling, behavioral therapy services and peer support services, as required by SAMHSA;
ii. includes whether the OTP provides therapy services directly or refers patients for services through a separate provider; and
iii. includes strategies employed to ensure patients can access referred services in a timely manner, if patients are referred for services through a separate provider;
d) a community relations and education plan that includes:
i. policies and procedures to minimize the impact the OTP may have on the community, promote coexistence and plan for change and growth in the OTP; and
ii. a process for community contacts to notify AHCCCS's Clinical Resolution Unit of unresolved deficiencies, and if appropriate, coordination with the SOTA; and
e) a diversion control plan that contains specific measures to reduce the possibility of the diversion of controlled substance from legitimate treatment use.
3. Requires AHCCCS to post the reports on its public website.
4. Directs AHCCCS to:
a) notify each city or town where an OTP is located of the report;
b) allow 30 days for the city or town to provide comments on the report;
c) consider the city's or town's comments on the report; and
d) approve or reject the report within 30 days of the close of the comment period.
5. Requires AHCCCS to provide an OTP with 30 days to revise a report if AHCCCS identifies areas of concern regarding compliance with federal and state OTP regulations.
6. Requires AHCCCS to take any appropriate regulatory action based on deficiencies identified in a report.
7. Requires AHCCCS and AHCCCS contractors to suspend reimbursement to an OTP, with appropriate notification to the provider, if:
a) an OTP does not submit a report as required;
b) the OTP does not demonstrate enforcement of each plan contained in the report; or
c) AHCCCS does not approve the report initially or after revision.
8. Requires AHCCCS and the Department of Health Services (DHS), before December 31, 2019, to establish standards for designating centers of excellence (COE) for treating opioid use disorder in Arizona.
9. Establishes that minimum standards for COEs include:
a) information regarding OTP providers and facilities, including office-based OTP providers;
b) parameters to ensure coordination of care that includes behavioral health, physical health and MAT;
c) tracking and reporting requirements that identify treatment capacity and qualitative metrics related to quality of care, patient satisfaction and patient outcomes; and
d) an annual evaluation by a third-party auditor of the accuracy and completeness of data provided by COEs.
10. Requires that COEs:
a) increase capacity for treating opioid use disorder in OTPs and office-based opioid agonist treatment statewide;
b) demonstrate the effective delivery of MAT for opioid use disorder using evidence-based practices as defined by SAMHSA, AHCCCS and a federally-designated accreditation agency for rehabilitation facilities;
c) comply with all tracking, reporting and evaluation requirements; and
d) participate in the statewide learning collaborative.
11. Requires the Director of AHCCCS to publish draft and final COE standards on the AHCCCS website.
12. Establishes that the Director of AHCCCS must hold at least two public hearings to receive input before implementing CEO standards.
13. Directs AHCCCS to establish a statewide learning collaborative to share best practices and establish peer-to-peer support between COEs.
14. Requires AHCCCS to submit, by January 15th of each year, a report to the Governor, the President of the Senate and the Speaker of the House of Representatives that outlines:
a) the standards for designating COEs;
b) the statewide list of designated COEs; and
c) a summary of the performance of COEs.
15. Requires that a copy of the report be submitted to the Secretary of State.
16. Establishes the Council and prescribes Council membership.
17. Requires AHCCCS to provide periodic reports, on a schedule determined by the Council, that include the following information based on utilization data:
a) the number of patients provided MAT services for each provider submitting claims and encounters received by AHCCCS for services during the period covered by the report;
b) the treatment type, if available, including medications and other related services provided by each provider and the number of patients receiving those treatment types and services; and
c) the length of stay based on utilization data for each treatment type.
18. Requires the Council to review and make recommendations to AHCCCS regarding:
a) standards for designating COEs for MAT;
b) reporting requirements for care delivery activities in designated COEs;
c) the availability of and barriers to all U.S. FDA-approved medications for treating opioid use disorder and whether utilization controls are appropriate;
d) other state licensure and OTP models; and
e) patient outcomes that are reported to AHCCCS by providers who receive reimbursement for opioid use disorder MAT.
19. Directs the Council to recommend to the Legislature changes to laws related to MAT.
20. Requires the Council, before December 15th of each year, to submit a report regarding the Council's activities and recommendations to the Governor, the President of the Senate and the Speaker of the House of Representatives and requires that a copy be provided to the Secretary of State.
21. Directs AHCCCS and DHS to provide technical assistance to the Council.
22. Repeals the Council on January 1, 2024.
23. Defines relevant terms.
24. Becomes effective on the general effective date.
Amendments Adopted by Committee
1. Eliminates proposed language prohibiting AHCCCS from reimbursing OTP providers that exceed census and square footage limitations, and instead requires AHCCCS to reimburse OTP providers only if they demonstrate enforcement of each plan in the required annual report.
2. Expands OTP reporting requirements to include a diversion control plan and a community relations and education plan to the report and outlines policies that must be included in the plans.
3. Directs AHCCCS and DHS, by December 31, 2019, to establish standards for designating COEs for treating opioid use disorder.
4. Establishes minimum standards and additional requirements for COEs.
5. Establishes the Council.
Amendments Adopted by Committee of the Whole
1. Modifies Council membership and expands Council duties.
2. Establishes AHCCCS reporting requirements to the Council.
3. Requires the detailed security plan to include DEA and SAMHSA standards, rather than best practices.
4. Eliminates the requirement that an OTP submit information to AHCCCS regarding patient census, facility square footage and patient treatment types and lengths.
5. Requires that a process for community contacts to notify AHCCCS regarding unresolved deficiencies in OTP facilities be included in an OTP community relations plan.
6. Requires that AHCCCS provide notification to an OTP prior to suspending reimbursement.
7. Directs the Director of AHCCCS to publish and hold public hearings on COE standards.
8. Makes technical and conforming changes.
Senate Action
HHS 2/20/19 DPA 8-0-0
Prepared by Senate Research
March 7, 2019
CRS/kja