65D-30.0141. Needs Assessment for Medication-Assisted Treatment for Opioid Use Disorders

(1) Determination of Need.

(a) The Department shall annually perform the assessment detailed in the “Methodology of Determination of Need Methadone Medication-Assisted Treatment,” CF-MH 4038, May 2019, incorporated by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-11993. The Department shall publish the results of the assessment in the Florida Administrative Register by June 30. Facilities owned and operated by the Florida Department of Corrections are exempt from the needs assessment process. However, these facilities must apply for a license to deliver this service.

(b) The publication shall direct interested parties to submit a letter of intent to apply for licensure to provide medication-assisted treatment for opioid use disorders to the Regional Office of Substance Abuse and Mental Health where need has been demonstrated.

1. The publication shall provide a closing date for submission of letters of intent.

2. Interested parties must identify the fiscal year of the needs assessment to which they are responding and the number of awards they are applying for per county identified in the assessment in their letter of intent.

(c) Within seven (7) business days of the closing date, the Regional Office shall notify parties who submitted a letter of intent on how to proceed.

1. If the number of letters of intent equals or is less than the determined need, parties shall be awarded the opportunity to proceed to licensure by completing an “Application for Licensure to Provide Substance Abuse Services” form, C&F-SA Form 4024, May 2019, incorporated by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-11996.

2. If the number of letters of intent exceeds the determined need, parties shall be invited to submit a “Methadone Medication-Assisted Treatment (MAT) Application to Proceed to Licensure Application” form, CF-MH 4041, May 2019, incorporated by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-11995. Applications may not be rolled over for consideration in response to a needs assessment published in a different year and may only be submitted for a current fiscal year needs assessment.

a. The Department shall utilize an evaluation team made up of industry experts to conduct a formal rating of applications as stipulated in the “Methadone Medication-Assisted Treatment (MAT) Application Evaluation” form, CF-MH 4040, May 2019, incorporated by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-11994. The evaluation team members shall not be affiliated with the Department, current methadone medication-assisted treatment providers operating in Florida, or the applicants.

b. The selection of a provider shall be based on the following criteria:

(I) Capability to Serve Selected Area(s) of Need and Priority Populations. Area(s) of Need are the counties identified as having a need for additional clinics. Priority Populations are pregnant women, women with young children, and individuals with financial hardships;

(II) Patient Safety and Quality Assurance/Improvement;

(III) Scope of Methadone Medication-Assisted Treatment Services;

(IV) Capability and Experience; and

(V) Revenue Sources.

c. Applicants with the highest-scored applications in each county shall be awarded the opportunity to apply for licensure for the number of programs specified in their letter of intent to meet the need of that county. If there is unmet need, the next highest scored applicant(s) will receive an award(s) based on the remaining need and the number of programs specified in their letter of intent. This process will continue until the stated need is met. Regional offices shall inform the highest-scoring applicant(s) in writing of the award.

d. All awarded applicants must submit a letter of intent to apply for licensure to the appropriate regional office within 30 calendar days after the award. If an applicant declines an award or fails to submit the letter of intent within the specified time, the Department shall rescind the award. After the Department rescinds the original award for that selected area of need, the applicant with the next highest score shall receive the award.

(2) Awarded applicants must receive at least a probationary license within two (2) years of receipt of an award letter connected to their “Methadone Medication-Assisted Treatment (MAT) Application to Proceed to Licensure Application” form, CF-MH 4041. If an applicant fails to obtain a probationary license within the specified time, the Department shall rescind the award. See Rule 65D-30.0036, F.A.C. for licensure application requirements. Applicants may submit a request to the State Authority and Substance Abuse and Mental Health Program Office for an exception if unable to meet timeframes due to a natural disaster that causes physical damage to the applicant’s building(s). Proof of natural disaster and impact on physical property must accompany the request. Upon receipt of the request for exception and accompanying proof, a one-time extension shall be granted for six (6) months. Providers who are delayed for a reason other than a natural disaster may petition the Department for a rule waiver pursuant to Section 120.542, F.S.

This rule shall remain in effect for a period of five years after its effective date and shall be reviewed by the Department for its continued necessity at least 90 days before its expiration.

Rulemaking Authority 397.321(5) FS. Law Implemented 397.311(26), 397.321, 397.407, 397.410, 397.427 FS. History–New 8-10-20.