The Department intends to amend 65D-30.0033 and 65D-30.0036 to align with statutory changes from the 2022 legislative session, clarify the rule language, and correct a conflict with Florida Statute and federal regulations.....

 

DEPARTMENT OF CHILDREN AND FAMILIES

Substance Abuse Program

RULE NOS.:RULE TITLES:

65D-30.0033License Types

65D-30.0036Licensure Application and Renewal

PURPOSE AND EFFECT: The Department intends to amend 65D-30.0033 and 65D-30.0036 to align with statutory changes from the 2022 legislative session, clarify the rule language, and correct a conflict with Florida Statute and federal regulations.

SUMMARY: The amendments to 65D-30.0033 clarifies that a methadone medication assisted treatment for opioid use disorder for addiction provider cannot provide services with the probationary license until the required SAMHSA certification and DEA registration has been issued. The amendments to 65D-30.0036 include the following: (1) clarifies that the rule applies to all substance abuse treatment providers, (2) converts business days to calendar days, (3) updates the application to include recovery residence referral section to align with 2022 legislative session as effective July 1, 2022, (4) removes the requirement that the application for licensure must include a copy of the provider’s business tax receipt as this conflicts with F.S., (5) deletes requirements in the rule as they are outlined on the application, and (6) clarifies that methadone medication assisted treatment for opioid use disorder addiction providers must submit verification or certification from SAMHSA and verification of registration from the DEA.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION:

The Agency has determined that this will not have an adverse impact on small business or likely increase directly or indirectly regulatory costs in excess of $200,000 in the aggregate within one year after the implementation of the rule. A SERC has not been prepared by the Agency.

A SERC has not been prepared.

The Agency has determined that the proposed rule is not expected to require legislative ratification based on the statement of estimated regulatory costs or if no SERC is required, the information expressly relied upon and described herein: The Department used a checklist to conduct an economic analysis and determine if there is an adverse impact or regulatory costs associated with this rule that exceeds the criteria in section 120.541(2)(a), F.S. Based upon this analysis, the Department has determined that the proposed rule is not expected to require legislative ratification.

Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.

RULEMAKING AUTHORITY: 394.46715, 394.879, 397.321(5), F.S.

LAW IMPLEMENTED: 397.321(6), 397.4014, 397.403, 397.407, 397.410, 397.4104, 397.411, F.S.

IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN THE FAR.

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Elizabeth Floyd. Elizabeth can be reached at [e-mail].

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

65D-30.0033 License Types.

(1) Probationary License.

(a) through (d) No change.

(e) Methadone Medication Assisted Treatment for Opioid Use Disorder Addiction Provider Licenses. A methadone medication assisted treatment for opioid use disorder for addiction provider shall not initiate methadone medication assisted treatment during the probationary period, until SAMHSA certification and DEA registration has been issued.

(2) Regular License.

(a) through (d) No change.

(3) Interim License.

(a) through (b) No change.

Rulemaking Authority 397.321(5) FS. Law Implemented 397.321(6), 397.407, 397.410 FS. History–New 8-29-19. Amended__________

 

65D-30.0036 Licensure Application and Renewal.

(1) Application for Licensing. Applications for any license described in this rule chapter licensing shall be submitted initially and annually thereafter to the Department along with the required licensing fee. An application for renewal of a regular license must be submitted to the Department at least 90 calendar 60 business days prior to the expiration of the regular license. Applications for renewal submitted less than 90 calendar 60 business days, but at least 45 calendar 30 business days before the license expires, will be processed and late fees will be applied. If the application for renewal is not received by the Department 30 business days prior to the expiration of the regular license, the application will be denied and 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, (insert date) Feb 2018, titled “Application for Licensing to Provide Substance Abuse Treatment Services,” which is incorporated herein by reference and available at https://www.flrules.org/Gateway/reference.asp?No=Ref-XXX in rule 65D-30.0034, F.A.C. In lieu of a standard application, the applicant may complete an online on-line process through the Department’s statewide electronic system specific to licensure, which can be accessed at http://www.myflfamilies.com/service-programs/substance-abuse/licensure-regulation;

(b) No change.

(c) A copy of the provider’s valid occupational license/business tax receipt, and zoning. (Inmate Substance Abuse Programs operated by or under contract with the Department of Corrections or the Department of Management Services are exempt from this requirement);

(d) A copy of the individual service fee schedule and policy regarding an individual’s financial responsibility. (Inmate Substance Abuse Programs operated by or under contract with the Department of Corrections or the Department of Management Services are exempt from this requirement);

(e) A comprehensive outline of the services to be provided, including the licensed bed capacity for addictions receiving facilities, inpatient detoxification, intensive inpatient treatment, residential treatment, and day or night treatment with community housing. The outline must be submitted with the initial application, with the addition of each new service component, or when there is a change of ownership, and it must provide sufficient detail to ensure consistency with clinical best practices;

(f) Information that establishes the name and address of the applicant, its chief executive officer, the chief financial officer, clinical supervisor and, if a corporation or legal entity, the name of each member of the applicant’s board, the name of the owner, the names of any officers of the corporation, and the names of any shareholders or persons who hold an equitable interest;

(c)(g) 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. (Inmate Substance Abuse Programs operated by or under contract with the Department of Corrections, or the Department of Management Services are exempt from this requirement);

(d)(h) Proof of the applicant’s financial ability and organizational capability to operate in accordance with these rules, such as a financial audit or review conducted by a certified accountant within the last 12 months of the calendar year. The fiscal infrastructure should demonstrate an understanding of generally accepted accounting principles to ensure program stability. (Providers that are accredited by a Department recognized accrediting organizations and 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);

(e)(i) 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)(j) Confirmation of completion of basic HIV/AIDS education requirements pursuant to section 381.0035, F.S., for renewal applications;

(k) A current organizational chart;

(g)(l) Demonstration of organizational capability through a written, indexed system of policies and procedures that are descriptive of services and the population served. 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 as well as 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;

(m) Verification that a qualified professional(s) is included on staff;

(n) Proof of a valid medical license for the medical director. The medical license must be free of administrative action(s), and be accompanied by the following documentation:

1. A copy of photo identification matching that of the physician named on the medical license; and

2. A letter from the physician attesting that he or she is:

a. Employed or contracted by the provider as a medical director, and specifying in which component he or she is acting (addictions receiving facility, detoxification, intensive inpatient treatment, residential treatment, or methadone medication-assisted treatment); and

b. Knowledgeable of the limitations to acting as medical director;

(h)(o) The Drug Enforcement Administration registration for all physicians;

(p) A state of Florida pharmacy permit for methadone medication-assisted treatment for opioid addiction and detoxification and any applicant with a pharmacy;

(q) Verification of the services of a consultant pharmacist for addictions receiving facility, detoxification, intensive inpatient, residential and methadone medication-assisted treatment for opioid addiction;

(r) Verification of professional licenses issued by the Department of Health;

(s) Verification that fingerprinting and background checks, including local law enforcement checks, have been completed as required by chapters 397 and 435, F.S.;

(t) Proof of the availability and provision of meals for addictions receiving facilities, inpatient detoxification, intensive inpatient treatment, residential treatment, day or night treatment with community housing, and day or night treatment, if applicable in the case of the two (2) latter components. (Inmate Substance Abuse Programs operated by or under contract with the Department of Corrections or the Department of Management Services are exempt from this requirement);

(u) Proof of accreditation or application for accreditation by a Department recognized accreditating organization for each location and clinical service component offered.

(2) Items listed in paragraphs (1)(a)-(h)(n) must accompany the application for a license and shall be maintained. Renewal applicants shall submit item (1)(a)-(h)(u) along with the licensure application. However, regarding items in paragraph (1)(c)(g), 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) Items listed in paragraphs (1)(o)-(t), including items in paragraph (1)(l) 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) In addition, documents listed in paragraphs (1)(a)-(u) that expire during the licensure period the license is in effect shall be renewed by the provider prior to the expiration date. The provider shall notify the Department prior to the expiration date if the provider will cease operation and not renew the license. shall be notified by the provider in writing within 24 hours upon renewal or in the event renewal does not occur. Accreditation is required for all clinical treatment components. Providers must be accredited by a Department-approved accrediting entity. Applications for initial licensure renewal must include shall submit proof of application for accreditation accreditiation. by a Department approved accrediting entity and proof of obtained accreditiation for any subsequent renewals. Applications for license renewal must demonstrate that accreditation is maintained.

(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). The provider must also submit verification of certification from SAMHSA to the Department when there is a change in the owner of record, sponsor, or physician. Upon receipt of the SAMHSA certification and DEA registration, the Department will issue the provider a license to provide methadone medication assisted treatment for opioid use disorder treatment.

In addition to the requirements outlined in paragraphs (1)(a)-(u) of this rule, methadone medication-assisted treatment for opioid addiction providers must submit the following:

(a) Verification of certification from the Substance Abuse and Mental Health Administration relating to methadone medication-assisted treatment for opioid addiction, submitted with the initial application and documented approval from the Substance Abuse and Mental Health Administration, and where there is a change in the owner of record, sponsor, or physician; and

(b) The Drug Enforcement Administration registration for methadone medication-assisted maintenance treatment for opioid addiction.

(4) In addition to the requirements outlined in paragraphs (1)(a)-(v) of this rule, day or night treatment with community housing providers shall submit information regarding location and the number of beds available in community housing with the application for licensure.

(5) An applicant, provider, or legal entity is required to register or file with the Florida Secretary of State, Division of Corporations. The principal name and mailing addresses submitted with the licensure application for the applicant, provider or controlling interests must be the same as the information registered with the Division of Corporations. (Inmate Substance Abuse Programs operated by or under contract with the Department of Corrections, or the Department of Management Services are exempt from this requirement).

(4)(6) 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

(7) Accredited Providers. This subsection implements sections 397.403, and 394.741(4), F.S. and applies to licensing inspections of providers or components of providers that are accredited by Department approved accrediting organizations. A list of Department approved accrediting agencies may be obtained from the Department of Children and Families, Office of Substance Abuse and Mental Health: http://www.myflfamilies.com/service-programs/substance-abuse/licensure-regulation. For accredited providers or components of providers, the Department shall conduct a licensing inspection once every three (3) years.

(5)(a) 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 subsection 394.741(6), and section 397.411, F.S., in cases where any of the following conditions exist:

(a)1. 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)2. The provider or component of the provider has not received or has not maintained accreditation as provided for in paragraph (6) (7)(b) of this rule;

(c)3. 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)4. The Department has concerns regarding the health, safety or welfare of individuals served.

(6)(b) 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 paragraph (5) (7)(a) of this rule.

Rulemaking Authority 394.46715, 394.879, 397.321(5) FS. Law Implemented 397.321(6), 397.4014, 397.403, 397.407, 397.410, 397.4104, 397.411 FS. History–New 8-29-19. Amended ___________

 

NAME OF PERSON ORIGINATING PROPOSED RULE: William Hardin and Courtney Smith

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Shevaun Harris

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: June 2, 2022

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: July 8, 2022