65D-30.0036. Licensure Application and Renewal

(1) Application for Licensing. Applications for any license described in this rule chapter shall be submitted initially and annually thereafter to the Department along with the required licensing fee. A renewal application is subject to the provisions of s. 397.407(8). Applications for renewal submitted less than 60, but more than 30 calendar days, prior to the expiration of the regular license, will be processed. Late fees will be applied to all renewal applications submitted after 60 days. If the application for renewal is not received by the Department prior to the expiration of the regular license, the application will be returned to the applicant, including any fees. In addition to requirements pursuant to Section 397.403, F.S., and unless otherwise specified, all applications for licensure shall include the following:

(a) A standard application for licensing, using CF-MH Form 4024, (December 2023), titled “Application for Licensing to Provide Substance Abuse Treatment Services,” which is incorporated by reference and available at https://www.flrules.org/Gateway/reference.asp?No=Ref-16219. In lieu of a standard application, the applicant may complete an online process through the Department’s statewide electronic system specific to licensure, which can be accessed at https://www.myflfamilies.com/services/licensing/samh.

(b) Written proof of compliance for all licensed facilities, including community housing, with local health, fire and safety inspections;

(c) Information on the competency and ability of the applicant, chief executive officer, chief financial officers, and clinical supervisors to carry out the requirements of these rules, including education, previous employment history, and list of references.

(d) A financial audit or review conducted by a certified accountant must be completed within the last 12 months of the calendar year showing proof of the applicant’s financial ability and organizational capability to operate. Providers that are accredited according to the provisions of s. 394.741, F.S. by a Department recognized accrediting organizations and Inmate Substance Abuse Programs operated by or under contract with the Department of Corrections, the Department of Management Services, or the Department of Juvenile Justice are exempt from this requirement;

(e) Proof of professional liability and general liability coverage. (Inmate Substance Abuse Programs operated by or under contract with the Department of Corrections, or the Department of Management Services, or the Department of Juvenile Justice are exempt from this requirement) Professional liability insurance coverage shall be in an amount not less than $250,000 per claim, with a minimum annual aggregate of not less than $750,000;

(f) Confirmation of completion of basic HIV/AIDS education requirements pursuant to Section 381.0035, F.S., for renewal applications;

(g) If delivering services through telehealth, detailed procedures outlining the equipment and implementation plan for services shall be included. Providers utilizing telehealth must implement technical written policies and procedures for telehealth systems that comply with the Health Insurance Portability and Accountability Act privacy regulations, and applicable state and federal laws that pertain to patient privacy. Policies and procedures must also address the technical safeguards required by Title 45, Code of Federal Regulations, Section 164.312, where applicable. All staff shall have a working knowledge of the substance use operating procedures; and

(h) The Drug Enforcement Administration registration for all physicians.

(2) Items listed in paragraphs (1)(a)-(h) must accompany the application for a license and shall be maintained.

(a) Renewal applicants shall submit item (1)(a)-(h) along with the licensure application. However, regarding items in paragraph (1)(c), only new applicants or where there is a change in chief executive officer, chief financial officers, or clinical supervisors shall submit this information with the application. All documents attached to the application, including items listed in paragraphs (1)(a)-(h) for renewal applicants, shall be made available for review at the provider facility. Documents attached to the application, including items listed in paragraphs (1)(a)-(h) that expire during the licensure period shall be renewed by the provider prior to the expiration date.

(b) The provider shall notify the Department prior to the expiration date if the provider will cease operation and not renew the license. Providers must be accredited by a Department-approved accrediting entity.

(c) Applications for licensure must include proof of application for accreditation pursuant to s. 397.403, F.S.

(3) Once the application is determined to meet licensure requirements, a methadone medication assisted treatment for opioid use disorder addiction provider shall be issued a probationary license while awaiting verification of certification from the Substance Abuse and Mental Health Services Administration (SAMHSA) and registration with the Drug Enforcement Agency (DEA). Upon receipt of the SAMHSA certification, DEA registration, and an approved probationary Department inspection, the Department will issue the provider a regular license to provide methadone medication assisted treatment for opioid use disorder treatment.

(4) Upon notification of a change in ownership of a methadone medication assisted treatment for opioid use disorder addiction provider,  the provider shall submit the DEA Form 223 Certificate of Registration, which shall be kept with the original DEA Certificate of Registration until the expiration date. The provider must submit proof of notification from SAMHSA based upon all other compliance actions.

(5) Nonresponsive applicant. If certified mail sent to the provider’s address of record, mailing address if applicable, is returned as unclaimed or undeliverable, the Department will send a copy of the letter by regular mail to the provider’s address of record, or mailing address if applicable, with a copy to the applicant’s address if different from the provider. The applicant must respond to the request within 21 days of the date of the letter sent by regular mail. If timely response is not received, the application will be denied.

(6) Inspections of Accredited Providers. In addition to conducting licensing inspections every three (3) years, the Department has the right to conduct inspections of accredited providers in accordance with Section 394.741(6) and 397.411, F.S., in cases where any of the following conditions exist:

(a) The accredited provider or component of the provider fails to submit the accreditation report and any corrective action plan related to its accreditation upon request by the Department;

(b) The provider or component of the provider has not received or has not maintained accreditation as provided for in subsection (7) of this rule;

(c) The Department’s investigation of complaints results in findings of one (1) or more violations of the licensing standards of any accredited component; or

(d) The Department has concerns regarding the health, safety or welfare of individuals served.

(7) Determination of Accreditation. Providers shall submit a copy of the accreditation survey report to the Department annually. The Department shall review the report and confirm that accreditation has been awarded for the applicable components. If the survey report indicates that the provider or any components of the provider have been issued provisional or conditional accreditation, the Department shall conduct a licensing inspection as permitted in subsection (6) of this rule.

Rulemaking Authority 397.321(5), 397.4014 FS. Law Implemented 397.321(6), 397.4014, 397.403, 397.407, 397.410, 397.4014, 397.411 FS. History–New 8-29-19, Amended 11-22-22, 1-1-24.