The Department is filing a Notice of Proposed Rule for 65D-30.014, F.A.C. Section 397.321(5), F.S., requires the Department to adopt rules necessary to comply with Chapter 397, Substance Abuse Services. Section 397.410, F.S., requires the Department ...

 

DEPARTMENT OF CHILDREN AND FAMILIES

Substance Abuse Program

RULE NO.:RULE TITLE:

65D-30.014Standards for Medication and Methadone Maintenance Treatment

PURPOSE AND EFFECT: The Department is filing a Notice of Proposed Rule for Rule 65D-30.014, F.A.C. subsection 397.321(5), F.S., requires the Department to adopt rules necessary to comply with Chapter 397, Substance Abuse Services. Section 397.410, F.S., requires the Department to amend rules in this Chapter to ensure that minimum licensure and best practice standards are met.

SUMMARY: The amendments will accomplish the following: (1) Repeal unnecessary rule language; (2) Revise methodology for determination of need for additional providers; (3) Ensure adequate minimum requirements for licensure of this service; (4) Amend procedures for new provider applicants; and (5) Update general requirements for provider and practitioner standards consistent with clinical and treatment best practices that ensure the provision of quality treatment for individuals receiving substance abuse treatment services.

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.

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: 397.321(5), 397.410(2), FS.

LAW IMPLEMENTED: 397.311(26), 397.321, 397.410, 397.427, FS.

A HEARING WILL BE HELD AT THE DATE, TIME AND PLACE SHOWN BELOW:

DATE AND TIME: April 5, 2019, 10:00 a.m. – 12:00 Noon

PLACE: (1) Attending in person at: Florida Department of Children and Families, 1317 Winewood Boulevard

Building 4, Tallahassee, FL 32399-0700; (2) Via Conference Call Dial: 1(888)585-9008; Code: 946-122-361

Pursuant to the provisions of the Americans with Disabilities Act, any person requiring special accommodations to participate in this workshop/meeting is asked to advise the agency at least 2 days before the workshop/meeting by contacting: Jodi Abramowitz. Jodi can be reached at [phone] or [e-mail]. If you are hearing or speech impaired, please contact the agency using the Florida Relay Service, 1(800)955-8771 (TDD) or 1(800)955-8770 (Voice).

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Jodi Abramowitz. Jodi can be reached at [phone] or [e-mail].

 

THE FULL TEXT OF THE PROPOSED RULE IS:

65D-30.014 Standards for Medication-Assisted and Methadone Maintenance Treatment for Opioid Use Disorders.

In addition to Rule 65D-30.004, F.A.C., subsections (1) through (7) of this rule the following standards apply to methadone mMedication-assisted and Methadone Maintenance tTreatment. Subsection (8) of this rule applies to all other medication-assisted treatments.

(1) State Authority. The state authority is the Ddepartment’s Office of Substance Abuse and Mental Health Program Office.

(2) No change.

(3) 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, (insert date), incorporated by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-XXX. The Ddepartment shall publish the results of the assessment in the Florida Administrative Weekly Register by June 30.

Criteria. New providers shall be established only in response to the department’s determination of need, which shall occur annually. The determination of need shall only apply to medication and methadone maintenance treatment.  In its effort to determine need, the department shall examine information on treatment, the consequences of the use of opioids (e.g., arrests, deaths, emergency room mentions, other incidence and prevalence data that may have relevance at the time, etc.), population and data on treatment accessibility.

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

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

2. Applicants must identify the fiscal year of the needs assessment to which they are responding 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, (insert date,), incorporated by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-XXX.

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, (insert date), incorporated by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-XXX. 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, (insert date), incorporated by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-XXX. 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 to meet the need of that county.  Regional offices shall inform the highest-scoring applicants 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.

(d) Awarded applicants must receive at least a probationary license within two (2) years of the published needs assessment connected to their application.  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.  

The district office shall conduct a formal rating of applicants on a form titled MEDICATION AND MAINTENANCE TREATMENT NEEDS ASSESSMENT, September 6, 2001, incorporated herein by reference. The form may be obtained from the Department of Children and Family Services, Substance Abuse Program Office, 1317 Winewood Boulevard, Tallahassee, Florida 32399-0700.

Should the number of responses to the publication for a new provider exceed the determined need, the selection of a provider shall be based on the following criteria: 

1. The number of years the respondent has been licensed to provide substance abuse services;

2. The organizational capability of the respondent to provide medication and methadone maintenance medication-assisted treatment in compliance with these rules; and

3. History of substantial noncompliance by the respondent with departmental rules;

(4) General Requirements.

(a) Methadone Medication-Assisted Treatment Program or Methadone Maintenance Sponsor. The sponsor, as defined in subsection 65D-30.002(42), F.A.C., of a new provider shall be a licensed health professional and shall have worked in the field of substance use abuse treatment at least five (5) years. The sponsor is responsible for the program operation and assumes responsibility for all its employees, including any practitioners, agents, or other persons providing medical, rehabilitative, or counseling services at the program or any of its medication units. The program sponsor need not be a licensed physician but shall employ a licensed physician for the position of medical director.

(b) Medical Director. The medical director of a provider shall have a minimum of two (2) years’ experience treating substance use disorders. in the field of substance abuse.

(c) Special Permit and Consultant Pharmacist.

1. Special Permit.

a. All providers facilities that distribute methadone or other medication shall obtain a special pharmacy permit from the State of Florida Board of Pharmacy. New applicants shall be required to obtain a special pharmacy permit prior to licensure by the Ddepartment.

b. No change.

2. Consultant Pharmacist. The responsibilities of the consultant pharmacist include the following:

a. Develop policies and operating procedures relative to the supervision of the compounding and dispensing of all medications drugs dispensed in the facility; clinic,

b. Provide ongoing pharmaceutical consultation;

c. Develop operating procedures for maintaining all medication drug records and security in the area within the facility in which the compounding, storing, and dispensing of medications medicinal drugs will occur;

d. Meet face-to-face, at least quarterly, with the medical director to review the provider’s pharmacy practices. Meetings shall be documented in writing and signed and dated by both the consultant pharmacist and the medical director;

e. Prepare written reports regarding the provider’s level of compliance with established pharmaceutical procedures. Reports shall be prepared at least semi-annually and submitted, signed, and dated by the consultant pharmacist and submitted to the medical director; and;

f. Physically vVisit the provider facility at least every two (2) weeks to ensure that established procedures are being followed, unless otherwise stipulated by the state Board of Pharmacy. A log of such visits shall be maintained, and signed, and dated by the consultant pharmacist at each visit.

3. Change of Consultant Pharmacist. The provider’s medical director shall notify the Board of Pharmacy within 10 days of any change of consultant pharmacists, and provide a copy of such notification to the Substance Abuse and Mental Health Program Office and the State Opioid Treatment Authority (SOTA).

(d) Providers shall develop policies and procedures for the treatment of pregnant women. Pregnancy and Medication and Methadone Maintenance.

1. Use of Methadone.

1. Prior to the initial dose, each female client shall be fully informed of the possible risks of taking and not taking from the use of methadone during pregnancy, including possible adverse effects on the mother or fetus. and shall be told that safe use in pregnancy has not been established in relation to possible adverse effects on fetal development. If the medication is not taken, risk includes withdrawal syndrome which has been associated with fetal demise. The individual client shall sign and date a statement acknowledging this information. Pregnant women shall be seen by the physician or their qualified designee as clinically advisable. The physician or qualified medical designee must document in the clinical record that the pregnant individual was informed of the risks in this paragraph.

2. Pregnant individuals clients shall be informed of the opportunity and need for prenatal care either by the provider or by referral to other publicly or privately funded health care providers. In any event, tThe provider shall establish a documented system for referring individuals clients to prenatal care.

3. In the event If there are no publicly funded prenatal referral resources to serve those who are indigent, or if the provider cannot provide such services, or if the client individual refuses the services, the provider shall offer her basic prenatal instruction on maternal, physical, and dietary care as part of its counseling service. The nature of prenatal support shall be documented in the clinical client record.

4. When the individual If the client is referred for prenatal services, the practitioner to whom she is referred shall be notified that she is undergoing methadone maintenance medication-assisted treatment and provided treatment plans addressing pregnancy and post-partum care. Documentation of referral shall be kept in the clinical record. If a pregnant individual client refuses prenatal care or referral and prenatal instruction and counseling, the provider shall obtain a signed statement from the individual client acknowledging that she had the opportunity for the prenatal care but declined refused it.

5. The physician shall sign or countersign and date all entries related to prenatal care.

6. Treating physicians or their qualified designee shall consult with other treating medical staff providing care and medications to ensure that prescribed medication protocols are not contraindicated.

2. Use of Other Medication. Providers shall adhere to the prevailing federal and state requirements regarding the use of medication other than methadone in the maintenance treatment of clients who are or become pregnant.

(e) Minimum Responsibilities of the Physician. Physicians must adhere to best practice standards for an individual receiving methadone medication-assisted treatment. Best practices mean practices that meet or exceed the standards established by nationally-recognized, research-validated substance use disorder-specific program standards regarding the types of services, hours of clinical care, and credentials of staff for levels of care.  In addition, tThe responsibilities of the physician include the following:

1. To ensure that evidence of current physiological addiction, history of addiction, and exemptions from criteria for admission are documented in the clinical client record before the individual client receives the initial dose of methadone or other medication;,

2. To sign or countersign and date all medical orders, including the initial prescription, all subsequent prescription changes, and all changes in the frequency of take-home medication; methadone, and the prescription of additional take-home doses of methadone in cases involving the need for exemptions,

3. To ensure that justification is recorded in the clinical client record for any change to the reducing the frequency of visits to the provider for observed medication drug ingesting, providing additional take-home methadone in cases involving the need for exemptions, including cases involving the need for exemptions, or when prescribing medication for physical or emotional problems; and

4. To review, sign or countersign, and date treatment plans at least annually; and.

5. To ensure that a face-to-face assessment is conducted with each individual client at least annually, including evaluation of the   individual’s physical/medical status, client’s progress in treatment, and justification for continued maintenance or medical clearance for voluntary withdrawal or a dosage reduction protocol. The assessment shall be conducted by a physician or a P.A. or A.R.N.P. under the supervision of a physician. If conducted by other than a physician, the assessment shall be reviewed and signed by a physician in accordance with the medical protocol established in subsection 65D-30.004(7), F.A.C. The protocol shall include criteria and the conditions under which the assessment would be conducted more frequently.

(f) Central Client Registry.

1. Providers shall register and participate in the Department-approved electronic regional registry system for individuals receiving methadone medication-assisted treatment services. The registry is used to prevent the enrollment of individuals at more than one (1) provider and to facilitate continuity of care in the event of program closure and guest dosing verification. The registry shall be implemented in compliance with 42 Code of Federal Regulations, Part 2. The provider must submit to information gathering activities by the SOTA for state planning purposes. activities for the purpose of sharing client identifying information with other providers located within a 100-mile radius, to prevent the multiple enrollment of clients in more than one provider. Each regional registry shall be conducted through an automated system where this capability exists. In those instances where the development and implementation of an automated system would require additional technology, an alternative method shall be used on an interim basis, as long as the alternative is implemented in compliance with 42 Code of Federal Regulations, Part 2, and approved by the state authority shall designate a provider.

2. Providers must maintain the registry by recording and updating identifying, demographic, emergency contact, dosing, and relevant medical information for all individuals receiving methadone medication-assisted treatment. 

a. Each business day, providers shall monitor individuals enrolled in more than one (1) site and discharge any individuals attempting to enroll in another location. Individuals shall not be dual enrolled in any two (2) locations for longer than three (3) days.  Providers shall monitor the following reports quarterly to ensure compliance with no higher than a five (5) percent rate for missing data for the following data reports:

(I) Missing Photos;

(II) Missing Zip Codes;

(III) Missing Dosing Summary;

(IV) Missing Mileage Information;

(V) Missing County Information;

(VI) Missing Emergency Medication Information;

b. Providers shall monitor the following reports quarterly and ensure data is accurate:

(I) Pregnancy Status. Providers must maintain accurate data on pregnancy status. 

(II) Emergency Consent. Providers must make monthly attempts to add emergency contact for individuals who have not provided consent to be contacted during an emergency facility closure. Refusals must be documented. Providers shall ensure accuracy of emergency contact information quarterly.

(III) Emergency Dosing Projected Inventory Requirements. Providers must ensure they maintain an inventory of methadone onsite to dispense in the event of a natural or manmade disaster.

Providers may volunteer to coordinate the registry activities or, in the event that no provider volunteers, the state authority shall designate a provider.

3. Program directors must certify monthly, via the Central Registry, the accuracy of census data.    Providers shall submit, with the application for licensure, written plans for participating in registry activities.

4. Methadone or other medication shall not be administered or dispensed to an individual a client who is known to be currently enrolled with participating in another provider. 5. The individual client shall always report to the same provider unless prior approval is obtained from the original provider for treatment at another provider. Permission to report for treatment with at the facility of another provider shall be granted only when the multi-disciplinary treatment team, in their professional judgement, determine it is in the best interest of the individual. The permission, supporting clinical documentation, and evidence of linkage to care in exceptional circumstances and shall be noted in the clinical client’s record. Upon notification that an individual is being admitted to a new provider, it is the responsibility of the original admission site to discharge an individual from the Central Registry.

56. Individuals applying for methadone medication-assisted maintenance treatment shall be informed of the registry procedures and shall be required to sign a consent form before receiving services. Individuals who apply for services and do not consent to the procedures will not be enrolled placed in medication-assisted treatment maintenance.

67. If an individual is found trying to secure or has succeeded in obtaining duplicate doses of methadone or other medication, the individual client shall be referred back to the original provider. A written statement documenting the incident shall be forwarded to the original provider and, if the individual succeeded in obtaining the duplicate dose, the incident must be reported in the Department-approved incident reporting system by the provider who dispensed the duplicate dose. The physician of the original provider shall evaluate the individual client as soon as medically feasible for continuation of treatment. In addition, a record of violations by individuals individual clients shall must become part of the clinical record maintained by all participating providers and shall be made available to Department staff upon request in an automated system and permit access by all participating providers.

7. Providers shall submit with the application for licensure written plans for participating in registry activities, maintaining accurate data on staff and individuals in treatment, and ensuring annual training for all staff on reporting and disaster preparedness procedures. 

8. It is the responsibility of the SOTA to run quarterly reports to identify providers with missing data related to patient identification, dosage information, dual enrollment, pregnancy outcomes, and demographic information. Providers with a higher than five (5) percent non-compliance rate (missing or inaccurate data) will be contacted by the SOTA and/or licensure staff. Pursuant to s. 397.415, F.S., a Class IV fine will be imposed on those providers who do not correct non-compliance issues within five (5) days.

9. Prior to conducting an inspection or program review, an authorized agent of the Department shall contact the SOTA to obtain a compliance report. Non-compliance shall be incorporated into inspection reports and included in corrective action plans.

(g) Wait lists.

1. Providers must maintain wait list data for individuals seeking care but unable to enroll within 24 hours of first

contact requesting initiation of treatment.

2. When an opening is available, providers must make at least one (1) attempt to contact the next prospective individual on the waiting list and maintain a system of documenting attempts. Documentation shall include at a minimum: date of attempted contact, individual’s name, date of birth, address, and contact information. 

3. Priority must be given to pregnant woman and HIV-positive individuals.

(h)(g) Operating Hours and Holidays

1. Providers shall post operating hours in full view of the public a conspicuous place within the facility. This information shall include hours for counseling and administering medication medicating clients.

2. All providers shall be open Monday through Saturday. Providers shall have medicating hours and counseling hours that accommodate individuals clients, including two (2) hours of medicating time accessible daily outside the hours of 9:00 a.m. to 5:00 p.m.

3. Providers are required to medicate on Sundays according to the needs of the individual client’s needs. This includes individuals would include clients on Phase 1, individuals clients on a 30 to 180-day detoxification regimen, and individuals clients who need daily observation. Providers The provider shall develop operating policies and procedures for Sunday coverage.

4. In case of impending disaster, providers shall implement disaster preparedness policies and procedures as necessary regarding operating hours and dosing.

5. When holidays are observed, all individuals clients shall be given a minimum of a seven (7)-day notice of any changes to the hours of operation.

6. When applying for a license, providers shall inform the respective program district offices of their intended holidays. In no case shall two (2) or more holidays occur in immediate succession unless the provider is granted an exemption by the state and federal authority. Take-out privileges shall be available to all eligible individuals methadone clients during holidays, but only if clinically advisable. On those days during which the provider is closed, Sservices shall be accessible to individuals clients for whom take-home medication out methadone is not clinically advisable. Individuals Clients who fall into this category shall receive a minimum of seven (7) days adequate notification regarding arrangements and the exact hours of operation.

(5) Maintenance Treatment Standards.

(a) Standards for Placement.

1. Determining Addiction and Placement.

a. An individual A person aged 18 or over shall be placed in treatment as a client only if the physician, or their qualified designee identified in accordance with the medical protocol established in subsection 65D-30.004(7), F.A.C., determines that the individual person is currently physiologically addicted to opioid drugs and became physiologically addicted at least one (1) year before placement in methadone medication-assisted maintenance treatment.

b. A one (1)-year history of addiction means that individuals seeking an applicant for placement in methadone medication-assisted maintenance treatment were was physiologically addicted to opioid drugs at least one (1) year before placement and were was addicted continuously or episodically for most of the year immediately prior to placement with in a provider.

c. In the event the exact date of physiological addiction cannot be determined, the physician or their qualified designee may admit the individual person to maintenance treatment if, by the evidence presented and observed, and utilizing reasonable clinical judgment, the physician or their qualified designee concludes it is reasonable to conclude that the individual person was physiologically addicted during the year prior to placement. Such observations shall be recorded in the clinical client record by the physician or their qualified designee. Participation in treatment must be voluntary.

d. Individuals with a chronic immune deficiency or who are pregnant must be screened and admitted on a priority basis.

e. Individuals seeking admission with only a primary medical diagnosis of a chronic pain condition must be referred to specialists qualified to treat chronic pain conditions and are not eligible for admission.

2. Placement of Individuals Under 18 Years of Age 

a. An individual A person under 18 is required to have had two (2) documented unsuccessful attempts at short-term detoxification or substance use drug-free treatment within the last year to be eligible for maintenance treatment.

b. The physician or their qualified designee shall document in the clinical client’s record that the individual client continues to be or is again physiologically dependent on opioid drugs and is appropriate for placement. No person under 18 years of age shall be placed in maintenance treatment unless a parent, legal guardian, or responsible adult provides written consent.

c. Treatment standards in this rule are not intended to limit current best practice protocols for this population.

3. Evidence of Addiction.

a. In determining the current physiological addiction of the individual client, the physician or their qualified designee shall consider signs and symptoms of drug intoxication, evidence of use of drugs through a urine drug screen, and needle marks.

b. Other evidence of current physiological dependence shall be considered by noting early signs of withdrawal, such as cramping, lachrymation, rhinorrhea, pupillary dilation, pilo erection, body temperature, pulse rate, elevated blood pressure, and increased respiratory rate.

(b) Individual Consent.

1. Individuals shall be advised of the benefits of therapeutic and supportive rehabilitative services, and that the goal of methadone medication-assisted treatment is stabilization of functioning. The individual shall be fully informed of the risks and consequences of methadone medication-assisted treatment.

2. Each provider shall provide a thorough explanation of all program services, as well as state and federal policies and regulations, and obtain a voluntary, written, and signed program-specific statement of fully informed consent from the individual at admission.

3. In full consultation with the individual, the counselor shall discuss present level of functioning, course of treatment, and future goals. Consultations shall occur, at a minimum, quarterly for individuals in year one of treatment, and, at a minimum, bi-annually for individuals in treatment longer than one (1) year. These discussions should not place pressure on the individual to withdraw from or to remain in methadone medication-assisted treatment, unless medically or clinically indicated. Acknowledgement of these discussions shall be documented in the clinical record.

4. No individual under 18 years of age shall be placed in methadone medication-assisted treatment unless a parent or legal guardian provides written consent.

(c)(b) Exemption from Minimum Standards for Placement.

1. An individual A person who has resided in a penal or chronic-care institution for one (1) month or longer may be placed in maintenance treatment within 14 days before release or within 6 months after release from such institution. This can occur without documented evidence to support findings of physiological addiction, providing the individual person would have been eligible for placement before incarceration or institutionalization, and in the reasonable clinical judgment of the physician or their qualified designee, methadone medication-assisted treatment is medically justified.

2. Documented Eevidence of prior residence in a penal or chronic-care institution, evidence of all other findings, and the criteria used to determine the findings shall be recorded by the physician or their qualified designee in the clinical client record.  

3. The physician or their qualified designee shall sign and date these entries recordings before the initial dose is administered.

(d) Pregnant individuals.

12. Pregnant individuals clients, regardless of age, who have had a documented addiction to opioid drugs in the past and who may be in direct jeopardy of returning to opioid drugs, may be placed in methadone medication-assisted treatment. with all its attendant dangers during pregnancy, may be placed in maintenance treatment. For such individuals clients, evidence of current physiological addiction to opioid drugs is not needed if a physician or their qualified designee certifies the pregnancy and, in utilizing reasonable clinical judgment, finds treatment to be medically justified.

2. Pregnant individuals clients may be placed on a medication-assisted maintenance treatment regimen using a medication other than methadone only upon the written order of the physician who determines this to be the best choice of therapy for that individual client. 

3. Documented Eevidence of current or prior addiction and criteria used to determine such findings shall be recorded in the clinical client record by the admitting physician or their qualified designee. The physician or their qualified designee shall sign and date these recordings prior to administering the initial dose.

(e)  Readmission to Treatment.

13. Up to 2 years after discharge or detoxification for opioid use disorders, an individual a client who has been previously involved in methadone medication-assisted maintenance treatment may be readmitted without evidence to support findings of current physiological addiction. This can occur if the provider is able to document prior maintenance treatment of six (6) months or more and the physician or their qualified designee, utilizing reasonable clinical judgment, finds readmission to maintenance treatment to be medically justified.

2. Evidence of prior treatment and the criteria used to determine such findings shall be recorded in the clinical client record by the physician or their qualified designee. The physician or their qualified designee shall sign and date the information recorded in the clinical client record. The provider shall not place a client on a maintenance schedule unless the physician has determined that the client is unable to be admitted for services other than maintenance treatment.

(f)(c) Denying an Individual a Client Treatment.

1. If an individual a client will not benefit from a treatment regimen that includes the use of methadone or other opioid treatment medications medication, or if treating the individual client would pose a danger to others other clients staff, or other individuals, the individual client may be refused treatment. This is permitted even if the individual client meets the standards for placement. The physician or their qualified designee shall make this determination and shall document the basis for the decision to refuse treatment.

(g)(d) Methadone Take-home Privileges.

1. Take-home doses of methadone are permitted only for individuals clients participating in a methadone medication-assisted treatment program on a methadone maintenance regimen.  Requests for take-home doses greater than the amount allowed, as stipulated in subparagraph (5)(h) of this rule, must be entered into the SAMHSA/CSAT Opioid Treatment Program Extranet for federal and state approval. The following must be indicated on the exception request:

a. Dates of Exception:  not to exceed a six (6) month period of time per request;

b. Justification;

c. Dates and results of last three (3) drug screens, for individuals in treatment longer than 90 days;

d. Indicate compliance with securing methadone in a lockable secure container;

e. Statement of supporting documentation on file; and

f. Any other information the provider deems necessary in support of the request.

2. Take-home doses of methadone may be granted if the client meets the following conditions:

a. Absence of recent abuse of drugs as evidenced by drug screening;

b. Regularity of attendance at the provider;

c. Absence of serious behavioral problems at the provider;

d. Absence of recent criminal activity of which the program is aware, including illicit drug sales or possession;

e. Client’s home environment and social relationships are stable;

f. Length of time in methadone maintenance treatment meets the requirements of paragraph (e);

g. Assurance that take-home medication can be safely stored within the client’s home or will be maintained in a locked box if traveling away from home;

h. The client has demonstrated satisfactory progress in treatment to warrant decreasing the frequency of attendance; and

i. The client has a verifiable source of legitimate income.

2. The medical director shall make determinations based on take-home criteria as stated in 42 CFR 8.12(i)(2).

3. When considering an individual’s client responsibility in handling methadone, the physician shall consider the recommendations of other staff members who are most familiar with the relevant facts regarding the individual client.

4. The requirement of time in treatment and participation is a minimum reference point after which an individual a client may be eligible for take-home privileges. The time in treatment reference is not intended to mean that an individual client in treatment for a particular length of time has a right to take-home methadone. Thus Rregardless of time in treatment, the physician, state or federal authorities with cause, may deny or rescind the take-home methadone privileges of an individual a client.

5. In the event of a disaster that prompts a program-wide exemption authorized by SAMHSA and the SOTA in advance, providers must make appropriate arrangements for unstable individuals. In the event there are medically unstable individuals, providers are responsible for contacting guest dosing centers (i.e. hospitals) in advance to ensure continuity of care. Providers shall make an effort to identify and provide individuals a list of nearby emergency shelters that will allow individuals to bring medication in a lockable secure container.

(h)(e) Take-home Phases. To be considered for take-home privileges, all individuals clients shall be in compliance with criteria as stated in 42 CFR 8.12(i)(2) subparagraph (d)2.

1. Differences in the nature of abuse potential in opioid treatment medications determine the course of treatment and subsequent take-home privileges available to the individual based on progress, participation, and circumstances.  The assessment and decision approving all take-homes shall be documented in the individual’s clinical record, signed and dated by the physician.

2. No take-homes shall be permitted during the first 30 days following placement unless approved by both the state and federal authorities authority.

a1. Phase I. Following 30 consecutive days in treatment, the individual client may be eligible for one (1) take-home per week from day 31 through day 90, provided that the individual client has had negative drug screens and is following program requirements for the preceding 30 days.

b2. Phase II. Following 90 consecutive days in treatment, the individual client may be eligible for two (2) take-homes per week from day 91 through day 180, provided that the individual client has had negative drug screens for the preceding 60 days.

c3. Phase III. Following 180 consecutive days in treatment, the individual client may be eligible for three (3) take-homes per week with no more than a two (2)-day supply at any one time from day 181 through one (1) year, provided that the individual client has had negative drug screens for the preceding 90 days.

d4. Phase IV. Following one (1) year in continuous treatment, the individual client may be eligible for four (4) take-homes per week with no more than a 2-day supply at any one time through the second year of treatment, provided that the individual client has had negative drug screens for the preceding 90 days.

e5. Phase V. Following two (2) years in continuous treatment, the individual client may be eligible for five (5) take-homes per week with no more than a 3-day supply at any one time, provided that the individual client has had negative drug screens for the preceding 90 days.

f6. Phase VI. Following three (3) years in treatment, the individual client may be eligible for six (6) take-homes per week provided that the individual had client has passed all negative drug screens for the past year.

3.(f) Methadone Medical Maintenance. Providers must receive prior approval in writing from the State Authority to use the medical maintenance protocol. The provider Providers may place an individual a client on methadone medical maintenance in those cases where it can be demonstrated that the potential benefits of medical maintenance to the individual exceed the potential risks, in the professional judgment of the physician. client far exceed the potential risks. Only a physician may authorize placement of an individual a client on medical maintenance. The physician shall provide justification in the clinical client record regarding the decision to place an individual a client on medical maintenance.

The following conditions shall apply to medical maintenance.

a1. To qualify for partial medical maintenance, an individual a client may receive no more than 13 take-homes and must have been in continuous treatment with the same clinic for four years (4) with negative drug screens for the previous two (2) years. all  with at  two previous years (2) of negative drug screens.

b2. To qualify for full medical maintenance an individual a client may receive no more than 27 take-homes and must have been in continuous treatment with the same clinic for five years (5) with negative drug screens for the previous two (2) years. at least three (3) years of negative drug screens.

c3. All individuals clients in medical maintenance will receive their medication orally in the form of liquid, diskette or tablet. tablet form only. Diskettes and tablets are allowed if formulated to reduce potential parenteral abuse.

d4. All individuals clients will participate in a “call back” program by reporting back to the provider upon notice for a medication count.

e5. All criteria for take-homes as listed under paragraph (5)(g)(d) shall continue to be met.

The provider shall develop operating procedures for medical maintenance.

(i)(g) Transferred Individuals Transfer Clients and Take-Home Privileges.

1. Any individual client who transfers from one (1) provider to another within the state of Florida shall be eligible for placement on the same phase provided that verification of enrollment and compliance with program requirements is received from the previous provider prior to implementing transfer within two weeks of placement. The physician at the previous provider shall also document that the individual client met all criteria for their current phase and are at least on Phase I.

2. Any individual client who transfers from out-of-state is required to comply with the criteria stated in 42 CFR 8.12(i)(2) meet the requirements of subparagraph (d)2., and with verification of previous clinical client records, the physician shall determine the phase level based on the individual’s client’s history.

(j)(h) Transfer Information. When an individual a client transfers from one (1) provider to another, the referring provider shall release the following information:

1. through 5. No change.

6. Documentation of the conditions which precipitated the referral; and

7. A written summary of the individual’s client’s last three (3) months of treatment;

8. Any history of behavioral non-compliance, emotional, or legal problems; and

9. A copy of the clinical records to ensure coordination of care, to include: discharge summary, medical assessments, and current medications and dosage. Additional records may be sent based on their appropriateness to ensure coordination of care.  This information shall be released prior to the individual’s client’s arrival at the provider to which he or she is transferred. Providers shall not withhold an individual’s a client’s records when requested by the individual client for any reason, including failure to pay bills owed to the provider client debt. The referring provider shall forward the records directly to the provider of the individual’s choosing with signed records releases from the individual client’s choice.

(k)(i) Exemptions from Take-Home Privileges and Phasing Requirements for Methadone Maintained Clients.

1. Exemptions for Disability or Illness

a. If an individual a client is found to have a physical disability which interferes with the individual’s client’s ability to conform to the applicable mandatory schedule, the individual client may be permitted a temporary or permanently reduced schedule by the physician, and, at the discretion of the SOTA and federal authorities, provided the individual client is also found to be responsible in handling opioid  treatment medication, is making progress in treatment, and is providing drug screens free of illicit  substances methadone.

b. Providers shall obtain medical records and other relevant information as needed to verify the medical condition physical disability. Justification for the reduced attendance schedule shall be documented in the clinical client record by the physician or their qualified designee who shall sign and date these entries.

2. Temporary Reduced Schedule of Attendance

a. An individual A client may be permitted a temporarily reduced schedule of attendance because of exceptional circumstances such as illness, personal or family crises, and travel, or other hardship which causes the individual client to become unable to conform to the applicable mandatory schedule. This is permitted only if the individual client is also found to be responsible in handling opioid treatment medication, has consistently provided drug screens free of illicit substances, and has made acceptable progress toward treatment goals methadone.

b. Any individual using prescription opioid medications or sedative medication not used in the medication-assisted treatment protocols shall provide a legitimate prescription from the prescribing physician. The physician, or medical designee, shall consult with the prescribing physician to coordinate care as outlined in medical protocols.

c. The necessity for an exemption from a mandatory schedule is to be based on the reasonable clinical judgment of the physician. and Ssuch determination of necessity shall be recorded in the clinical client record by the physician or their qualified designee who shall sign and date these entries. A client shall not be given more than a 14-day supply of methadone at any one time unless an exemption is granted by the state methadone authority and by the federal government.

3. Travel Distance.

a. In those instances where client access to a provider is limited because of travel distance, the physician is authorized to reduce the frequency of an individual’s a client’s attendance. This is permitted if the individual client is currently employed or attending a regionally approved educational or vocational program or the individual client has regular child-caring responsibilities that preclude daily trips to the provider. This does not extend to individuals who choose to travel further than the closest affordable program to dose.

b. The reason for reducing the frequency of attendance shall be documented in the clinical client record by the physician who shall sign and date these entries. These requests shall be reviewed and a decision rendered by state and federal authorities.

4. Other Travel.

a. Any exemption that is granted to an individual a client regarding travel shall be documented in the clinical client’s record. Such documentation shall include tickets prior to a trip, copies of boarding passes, copies of fuel receipts, gas or lodging receipts, or other verification of the individual’s client’s arrival at the approved destination. If travel is due to medical treatment, documentation shall include a physician’s note or related documentation.  Generally, special take-homes shall not exceed 27 doses at one (1) time.  Request for take-homes in excess of 27 doses must be submitted for approval through SAMHSA/CSAT Opioid Treatment Program Extranet for federal and state approval.

b. Individuals Clients who receive exemptions for travel shall be required to submit to a drug screening test on the day of return to the provider facility.

(l)(j) Random Drug Screening.

1. Individuals in the first six (6) months of treatment shall be required to submit to aAt least one (1) monthly random drug screen, random and monitored, shall be performed on each. The drug screen shall be conducted so as to reduce the risk of falsification of results. This shall be accomplished by direct observation or by another accurate method of monitoring.

2. Individuals Clients who are on Phase III or higher VI shall be required to submit to a minimum of eight (8) one random drug screens per year of an individual’s treatment plan. screen at least every 90 days.

3. All drug screens shall be conducted by direct observation, or by another accurate method of monitoring in order to reduce the risk of falsification of results. Each specimen shall be analyzed for opioids, methadone, buprenorphine, amphetamines, benzodiazepines, and opiates, cocaine, and marijuana. If there is a history of prescription opioid analgesic abuse, an expanded toxicology panel that includes these opioids shall administered. Additional testing is based on individual patient need and local drug use patterns and trends.

4. The physician shall review all positive drug screens from illicit substances in accordance with the medical protocol established in subsection 65D-30.004(7), F.A.C.

(m)(k) Employment of Persons on a Maintenance Protocol. No staff member, either full-time, part-time or volunteer, shall be on a maintenance protocol unless a request to maintain or hire staff undergoing treatment is submitted with justification to and approved by the state and federal authorities. Any approved personnel on a maintenance regimen shall not be allowed access to or responsibility for handling methadone or other opioid treatment medication.

(n)(1) Caseload. No full-time counselor shall have a caseload that exceeds the equivalent of 32 currently participating clients. Participating individual client equivalents are determined in the following manner.

1. An individual A client seen once per week would count as 1.0 client equivalent.

2. An individual A client seen bi-weekly would count as a .5 client equivalent.

3. An individual A client seen monthly or less would count as a .25 client equivalent.

4. As an example, a counselor has a caseload of 15 individuals clients that are seen weekly (counts as 15 an equivalent of 15 clients), 30 individuals clients seen biweekly (counts as an 15 equivalent of 15 clients), and 8 individuals clients seen monthly (counts as an 2 equivalent of 2 clients). The counselor would have a total caseload of 53 individuals individual clients equaling 32 equivalent individuals clients.

(o)(m) Termination from Treatment.

1. There will be occasions when individuals clients will need to be terminated from maintenance treatment. Individuals Clients who fall into this category are those who:

a. Attempt to sell or deliver their prescribed medication or any other drugs;,

b. Become or continue to be actively involved in criminal behavior;,

c. Consistently fail to adhere to the requirements of the provider;,

d. Persistently use illicit substances; drugs other than methadone, or

e. No change.

Such individuals clients shall be withdrawn in accordance with a dosage reduction schedule prescribed by the physician and referred to other treatment, as clinically indicated. This action shall be documented in the clinical client record by the physician.

2. Providers shall establish criteria for involuntary termination from treatment that describe the rights of clients as well as the responsibilities and rights of the provider. All individuals clients shall be given a copy of these criteria upon placement and shall sign and date a statement that they have received the criteria.

(p)(n) Withdrawal from Maintenance.

1. The physician shall ensure that all individuals clients in methadone medication-assisted maintenance treatment receive an annual assessment. This assessment may coincide with the annual assessment of the treatment plan and shall include an evaluation of the individual’s client’s progress in treatment and the justification for continued maintenance. The assessment and recommendations shall be recorded in the clinical client record.

2. All providers shall develop policies and procedures that allow for systemic withdrawal of individuals as part of on-going services of the program.  At least annually, the provider shall provide the individual with documentation that explains the titration of medication to maintain therapeutic levels or to withdraw from the medication with the least necessary discomfort. The provider shall discuss the advantages and potential problems associated with withdrawal. The provider shall document the request for titration in the clinical record with course of action and shall be signed by individual and consulting staff.

3. An individual A client being withdrawn from maintenance treatment shall be closely supervised during withdrawal. A dosage reduction schedule shall be established by the physician and documented in the clinical record. In the event withdrawal is clinically inadvisable, justification must be kept in the clinical record, signed and dated by the physician and individual.

(q)(o) Services.

1. Comprehensive Services. A comprehensive range of services shall be available to each individual as required in subsection 397.427(1), F.S. client. The type of services to be provided shall be determined by individual client needs, the characteristics of individuals clients served, and the availability of community resources.

2. Counseling.

a. Each individual receiving methadone medication-assisted treatment client on maintenance shall receive regular counseling. A minimum of one (1) counseling session per week shall be provided to individuals new clients through the first 90 days. A minimum of two (2) counseling sessions per month shall be provided to individuals clients who have been in treatment for at least 91 days and up to one (1) year. A minimum of one (1) counseling session per month shall be provided to clients who have been in treatment for longer than one (1) year.

b. If fewer sessions are clinically indicated for a client, this shall be justified and documented in the client record. In no case shall sessions be scheduled less frequently than every 90 days. This would apply to those clients who have been with the program longer than three years and have demonstrated the need for less frequent counseling in accordance with documentation in the treatment plan.

bc. A counseling session shall be at least 30 minutes in duration, conducted in a private room, and shall be documented in the clinical client record.

c. Any entity or qualified professional who has entered into a written agreement with a licensed provider is bound by these regulations.

(r) Overdose Prevention

1. All licensed providers must develop overdose prevention plans. Overdose prevention plans must be shared with individuals upon admission and discharge from medication-assisted treatment, regardless of the reason for discharge. Plans must also be shared with individuals placed on a waitlist to receive treatment services. Overdose prevention plans shall include, at a minimum:

a, Education about the risks of overdose, including having a lower tolerance for opioids once the individual is no longer on medication-assisted treatment;

b. Information about Naloxone, the medication that reverses opioid overdose, including where and how to access Naloxone in the county of residence;

c.  For providers who maintain an emergency overdose prevention kit, a developed and implemented plan to have staff trained in the prescribed use and the availability of the kit for use during all program hours of operation.

(6) Medication Units Satellite Maintenance.

(a) A provider that currently holds a state license and who has either exceeded site capacity or has a significant proportion of individuals in treatment with a travel burden, may apply to the SOTA to establish a medication unit. The provider must be in compliance with the Department and applicable regulating agencies. The licensed provider and medication unit must be owned by the same provider. satellite maintenance dosing station must be operated by a primary, licensed comprehensive maintenance provider and must meet all applicable regulations in Rule 65D-30.004 and subsection 65D-30.014(4), F.A.C.

(b) A medication unit’s services are limited to medication dosing and drug screening as defined in 42 CFR 8.2 and 42 CFR 8.11(i). In addition to the application for licensure for satellite maintenance, the comprehensive maintenance provider must submit a written protocol containing, at a minimum, a detailed service plan, a staffing pattern, a written agreement with any other organization providing facility or staff, operating procedures, and client eligibility and termination criteria.

(c) Providers interested in establishing a medication unit must submit a written proposal to the state authority for review and approval. Proposals must include the following for consideration of approval:

1. Description of proposed medication unit. Include description of target population, geographical catchment area, physical location/address, proposed capacity, and hours of operation;

2. Justification of need for medication unit. Provide explanation on why currently licensed facilities are insufficient and how the proposed medication unit addresses unmet need;

3. Copy of state license and federal certifications;

4. Required qualifications and job description for Medical Director, clinical on-site Director or Manager, and proposed staffing for the medication unit;

5. Implementation plan, including timeframes for securing federal approvals for a medication unit and anticipated start date of services;

6. Plans to secure proper zoning before medication unit opening; and

7. Plans on how medication unit will ensure individuals receive comprehensive support services such as counseling.

8. An affirmative statement that the primary full-service program agrees to retain responsibility for care;

9. An affirmative statement that the medication unit is limited to administering and dispensing the narcotic treatment medications and collecting samples for drug screening or analysis.

(d) Medication units must open within two (2) years of receiving approval.

(7) Best Practices. All licensed providers shall comply with best practices as defined in subsection (4)(e) of this rule.

(8) Other Medications

(a) Buprenorphine Products. Qualified medical personnel licensed to practice in the state of Florida and meeting all federal requirements can prescribe buprenorphine to individuals under their license. Medical personnel shall comply with federal regulations related to buprenorphine products.

(b) Naltrexone Products. Naltrexone can be prescribed by any healthcare provider who is licensed to prescribe medications. Healthcare providers must meet all federal requirements and shall conform to federal regulations related to naltrexone products.

(c) Providers shall adhere to the prevailing federal and state requirements regarding the use of opioid treatment medications in the maintenance treatment of individuals who are or become pregnant during the course of treatment.

Rulemaking Authority 397.321(5), 397.21(5) FS. Law Implemented 397.311(26), 397.321, 397.410, 397.427, 397.311(18)(g), 397.321(1), 397.419, 465 FS. History–New 5-25-00, Amended 4-3-03, Amended____.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Ute Gazioch

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

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: March 13, 2019

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: August 24, 2018