The Department’s intends to create Rule Chapter 65E-16, F.A.C., to adopt standards for the Indigent Psychiatric Medication Program.

 

DEPARTMENT OF CHILDREN AND FAMILIES

Mental Health Program

RULE NO.:RULE TITLE:

65E-16.001Definitions

65E-16.002Individual Eligibility Criteria

65E-16.003Provider Requirements

65E-16.004Sanctions

PURPOSE AND EFFECT: The Department’s intends to create Rule Chapter 65E-16, F.A.C., to adopt standards for the Indigent Psychiatric Medication Program.

SUMMARY: The rules prescribe the clinical and financial eligibility of clients who may receive services under the indigent psychiatric medication program, the requirements that community-based mental health providers must meet to participate in the program, and the sanctions to be applied for failure to meet those requirements.

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.

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 paragraph 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: 394.676(2), F.S.

LAW IMPLEMENTED: 394.676, 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: Jodi Abramowitz. Jodi can be reached at 850-717-4470 or [e-mail].

 

THE FULL TEXT OF THE PROPOSED RULE IS:

65E-16 Indigent Psychiatric Medication Program

65E-16.001 Definitions

(1) “IPMP” or “the Program” means the Indigent Psychiatric Medication Program.

(2) “IPMP/FSH Warehouse” means a physical space located on the campus of Florida State Hospital (FSH) at Chattahoochee, Florida.  This space is reserved for receiving, storing, and shipping IPMP psychiatric medications.

(3) “Managing Entity” means a corporation as defined in s. 394.9082(2)(e), F.S.

(4) “Provider” means an agency that contracts with a Managing Entity to provide substance abuse and mental health services in accordance with Chapters 394 and 397, F.S.

(5) “Psychiatric Medication” means any drug prescribed with the primary intent to stabilize or improve mood, mental status, symptoms of behavioral health disorders, mental health or substance use disorders. The medications include the following major categories:

(a) Antipsychotics;

(b) Antidepressants;

(c) Anxiolytics;

(d) Mood stabilizers;

(e) Cerebral or psychomotor stimulants;

(f) Beta blockers,

(g) Anticonvulsants,

(h) Cognition enhancers, and

(i) Opiate blockers. 

Rulemaking Authority 394.676(2), F.S.  Law Implemented 394.676, F.S.  History-New.

 

65E-16.002 Individual Eligibility Criteria

To be eligible for the Program, individuals must meet the following clinical and financial eligibility criteria.

(1) To meet the clinical criteria, individuals:

(a) Must be a member of at least one (1) of the Department’s priority populations, as defined in 394.674(1), F.S.; and

(b) Must not currently be admitted to a state mental health treatment facility, an inpatient psychiatric hospital, or a crisis stabilization unit.

(2) To meet the financial eligibility criteria, individuals:

(a) Must have a net family income at or below 150 percent of the Federal Poverty Income Guidelines, as published annually in the Federal Register; and

(b) Must lack third-party insurance, including Medicaid, or other funding sources for psychotropic medications.

If individuals have third party insurance for psychiatric medications but the prescribed medication is not covered or not authorized, they may receive IPMP psychiatric medications until the prescribed medication is covered or authorized by the third-party insurer.

Rulemaking Authority 394.676(2), F.S.  Law Implemented 394.676, F.S.  History-New.

 

65E-16.003 Provider Requirements

(1) To participate in the IPMP program, providers must be under contract with a Managing Entity.

(2) The provider must operate a licensed pharmacy or subcontract with a licensed pharmacy.

(3) Providers shall submit the following information to the IPMP/FSH Warehouse and Managing Entity to enroll in the IPMP program:

(a) The provider’s IPMP contact information, including name, e-mail, and phone number;

(b) The name of the person authorized by the provider to approve the Supply Requisition; and

(c) A copy of the pharmacy license(s) from the provider, or the provider’s subcontracted pharmacy.   Copies of the license(s) and the permit issued must be maintained in accordance with the Department of Health’s requirements specified in s. 499.012(1)(d), F.S.

(4) IPMP providers shall ensure that the information in subsection (3) is updated annually and provided to the IPMP/Warehouse and to the Managing Entity with the first medication order of the fiscal year.

Rulemaking Authority 394.676(2), F.S.  Law Implemented 394.676, F.S. History-New.

 

65E-16.004 Sanctions

(1) If an IPMP provider is not in compliance with the requirements in Chapter 65E-16 F.A.C. and Chapters 465 and 499, Part I, F.S., and the violation does not present a threat to the health, safety, or welfare of an individual or the public, the Department shall:

(a) Provide a notice of noncompliance to the provider as the first enforcement action taken; and

(b) Require a corrective action plan within 10 business days from receipt of the notice of noncompliance. The corrective action plan is subject to approval by the contracted Managing Entity. The severity of the noncompliance may affect the period of time allowed for correction, but in no event shall the corrective action period exceed 90 days. 

(2) When the violation does present a threat to the health, safety, or welfare of an individual or the public:

(a) The Department will require a corrective action plan from the Managing Entity and the IPMP provider within 10 business days from receipt of the notice of noncompliance. The corrective action plan must include a procedure to ensure that individuals who participate in IPMP continue to have access to psychiatric medications; and

(b) The Department will impose an immediate moratorium on IPMP prescriptions; and

(c) In no event shall the corrective action period exceed 90 days.

(3) Notice of the moratorium shall be posted and visible to the public at the location of the provider until the action is lifted.

(4) Each Managing Entity will terminate participation of an IPMP provider from this Program for:

(a) False representation or omission of information relevant to approving a provider to participate in the Program.

(b) An intentional or negligent act materially affecting the health or safety of an individual receiving IPMP services from the provider.

(c) A demonstrated pattern of deficient performance.

(5) If an IPMP provider’s contract is terminated for cause by the Managing Entity, or if the provider is terminated from participation in the Program, the IPMP provider is barred from submitting any request to participate in this Program to the Managing Entity for a period of one (1) year after the termination.

Rulemaking Authority 394.676(2), F.S.  Law Implemented 394.676, F.S.  History-New.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Heather Allman

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Chad Poppell

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: June 11, 2019

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: June 21, 2019