In addition to Rule 65D-30.004, F.A.C., the following standards apply to Medication and Methadone Maintenance Treatment.
(1) State Authority. The state authority is the department’s Substance Abuse Program Office.
(2) Federal Authority. The federal authority is the Center for Substance Abuse Treatment.
(3) Determination of Need.
(a) 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 programs. 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.), and data on treatment accessibility.
(b) Procedure. The department shall publish the results of the assessment in the Florida Administrative Weekly by June 30. The publication shall direct interested parties to submit applications for licensure to the department’s district office where need has been demonstrated and shall provide a closing date for submission of applications. The district office shall conduct a formal rating of applicants on a form titled MEDICATION AND METHADONE 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 treatment in compliance with these rules; and
3. History of substantial noncompliance by the respondent with departmental rules.
(4) General Requirements.
(a) Medication or Methadone Maintenance Sponsor. The sponsor of a new provider shall be a licensed health professional and shall have worked in the field of substance abuse at least 5 years.
(b) Medical Director. The medical director of a provider shall have a minimum of 2 years experience in the field of substance abuse.
(c) Special Permit and Consultant Pharmacist.
1. Special Permit.
a. All 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 department.
b. Providers obtaining a special pharmacy permit shall hire a consultant pharmacist licensed by the state of Florida.
2. Consultant Pharmacist. The responsibilities of the consultant pharmacist include the following:
a. Develop operating procedures relative to the supervision of the compounding and dispensing of all drugs dispensed in the clinic;
b. Provide pharmaceutical consultation;
c. Develop operating procedures for maintaining all drug records and security in the area within the facility in which the compounding, storing, and dispensing of 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 to the medical director; and
f. Visit the facility at least every 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.
(d) Pregnancy and Medication and Methadone Maintenance.
1. Use of Methadone. Prior to the initial dose, each female client shall be fully informed of the possible risks from the use of methadone during pregnancy and shall be told that safe use in pregnancy has not been established in relation to possible adverse effects on fetal development. The client shall sign and date a statement acknowledging this information. Pregnant clients shall be informed of the opportunity for prenatal care either by the provider or by referral to other publicly or privately funded health care providers. In any event, the provider shall establish a system for referring clients to prenatal care. 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 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 client record. If the client is referred for prenatal services, the practitioner to whom she is referred shall be notified that she is undergoing methadone maintenance treatment. If a pregnant client refuses prenatal care or referral, the provider shall obtain a signed statement from the client acknowledging that she had the opportunity for the prenatal care but refused it. The physician shall sign or countersign and date all entries related to prenatal care.
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. The 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 client record before the 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, all changes in the frequency of take-home 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 client record for reducing the frequency of visits to the provider for observed drug ingesting, providing additional take-home methadone in 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.
5. To ensure that a face-to-face assessment is conducted with each client at least annually, including evaluation of the 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) Client Registry.
1. Providers shall participate in regional registry 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 may volunteer to coordinate the registry activities or, in the event that no provider volunteers, the state authority shall designate a provider.
3. 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 a client who is known to be currently participating in another provider.
5. The 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 at the facility of another provider shall be granted only in exceptional circumstances and shall be noted in the client record.
6. Individuals applying for 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 placed in maintenance treatment.
7. If an individual is found trying to secure or has succeeded in obtaining duplicate doses of methadone or other medication, the client shall be referred back to the original provider. A written statement documenting the incident shall be forwarded to the original provider. The physician of the original provider shall evaluate the client as soon as medically feasible for continuation of treatment. In addition, a record of violations by individual clients shall become part of the record maintained in an automated system and permit access by all participating providers.
(g) Operating Hours and Holidays. Providers shall post operating hours in a conspicuous place within the facility. This information shall include hours for counseling and medicating clients. All providers shall be open Monday through Saturday. Providers shall have medicating hours and counseling hours that accommodate clients, including 2 hours of medicating time accessible daily outside the hours of 9:00 a.m. to 5:00 p.m. Providers are required to medicate on Sundays according to client needs. This would include clients on Phase 1, clients on a 30 to 180-day detoxification regimen, and clients who need daily observation. The provider shall develop operating procedures for Sunday coverage. When holidays are observed, all clients shall be given a minimum of a 7-day notice. When applying for a license, providers shall inform the respective district offices of their intended holidays. In no case shall two or more holidays occur in immediate succession unless the provider is granted an exemption by the federal authority. Take-out privileges shall be available to all methadone clients during holidays, but only if clinically advisable. On those days during which the provider is closed, services shall be accessible to clients for whom take out methadone is not clinically advisable. Clients who fall into this category shall receive adequate notification regarding the exact hours of operation.
(5) Maintenance Treatment Standards.
(a) Standards for Placement.
1. A person aged 18 or over shall be placed in treatment as a client only if the physician determines that the person is currently physiologically addicted to opioid drugs and became physiologically addicted at least 1 year before placement in maintenance treatment. A 1-year history of addiction means that an applicant for placement in maintenance treatment was physiologically addicted to opioid drugs at least 1 year before placement and was addicted continuously or episodically for most of the year immediately prior to placement in a provider. In the event the exact date of physiological addiction cannot be determined, the physician may admit the person to maintenance treatment if, by the evidence presented and observed, it is reasonable to conclude that the person was physiologically addicted during the year prior to placement. Such observations shall be recorded in the client record by the physician. Participation in treatment must be voluntary.
2. A person under 18 is required to have had two documented unsuccessful attempts at short-term detoxification or drug-free treatment within the last year to be eligible for maintenance treatment. The physician shall document in the client’s record that the client continues to be or is again physiologically dependent on opioid drugs. No person under 18 years of age shall be placed in maintenance treatment unless a parent, legal guardian, or responsible adult provides written consent.
3. In determining the current physiological addiction of the client, the physician shall consider signs and symptoms of drug intoxication, evidence of use of drugs through a urine drug screen, and needle marks. Other evidence of current physiological dependence shall be considered by noting early signs of withdrawal such as lachrymation, rhinorrhea, pupilary dilation, pilo erection, body temperature, pulse rate, blood pressure, and respiratory rate.
(b) Exemption from Minimum Standards for Placement.
1. A person who has resided in a penal or chronic-care institution for 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 person would have been eligible for placement before incarceration or institutionalization, and in the reasonable clinical judgment of the physician, treatment is medically justified. Documented evidence 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 in the client record. The physician shall sign and date these recordings before the initial dose is administered.
2. Pregnant 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 with all its attendant dangers during pregnancy, may be placed in maintenance treatment. For such clients, evidence of current physiological addiction to opioid drugs is not needed if a physician certifies the pregnancy and, in utilizing reasonable clinical judgment, finds treatment to be medically justified. Pregnant clients may be placed on a maintenance regimen using a medication other than methadone only upon the written order of a physician who determines this to be the best choice of therapy for that client. Documented evidence of current or prior addiction and criteria used to determine such findings shall be recorded in the client record by the admitting physician. The physician shall sign and date these recordings prior to administering the initial dose.
3. Up to 2 years after discharge or detoxification, a client who has been previously involved in 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 6 months or more and the physician, utilizing reasonable clinical judgment, finds readmission to maintenance treatment to be medically justified. Evidence of prior treatment and the criteria used to determine such findings shall be recorded in the client record by the physician. The physician shall sign and date the information recorded in the 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.
(c) Denying a Client Treatment. If a client will not benefit from a treatment regimen that includes the use of methadone or other medication, or if treating the client would pose a danger to other clients, staff, or other individuals, the client may be refused treatment. This is permitted even if the client meets the standards for placement. The physician shall make this determination and shall document the basis for the decision to refuse treatment.
(d) Take-home Privileges.
1. Take-home doses are permitted only for clients participating on a methadone maintenance regimen.
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.
3. When considering 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 client.
4. The requirement of time in treatment is a minimum reference point after which a client may be eligible for take-home privileges. The time reference is not intended to mean that a client in treatment for a particular length of time has a right to take-home methadone. Thus, regardless of time in treatment, the physician, with cause, may deny or rescind the take-home methadone privileges of a client.
(e) Take-home Phases. To be considered for take-home privileges, clients shall be in compliance with subparagraph (d)2. No take-homes shall be permitted during the first 30 days following placement unless approved by the state authority.
1. Phase I. Following 30 consecutive days in treatment, the client may be eligible for 1 take-home per week from day 31 through day 90, provided that the client has had negative drug screens for the preceding 30 days.
2. Phase II. Following 90 consecutive days in treatment, the client may be eligible for 2 take-homes per week from day 91 through day 180, provided that the client has had negative drug screens for the preceding 60 days.
3. Phase III. Following 180 consecutive days in treatment, the client may be eligible for 3 take-homes per week with no more than a 2-day supply at any one time from day 181 through 1 year, provided that the client has had negative drug screens for the preceding 90 days.
4. Phase IV. Following 1 year in treatment, the client may be eligible for 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 client has had negative drug screens for the preceding 90 days.
5. Phase V. Following 2 years in treatment, the client may be eligible for 5 take-homes per week with no more than a 3-day supply at any one time, provided that the client has had negative drug screens for the preceding 90 days.
6. Phase VI. Following 3 years in treatment, the client may be eligible for 6 take-homes per week provided that the client has passed all negative drug screens for the past year.
(f) Medical Maintenance. Providers must receive prior approval in writing from the State Authority to use the medical maintenance protocol. The provider may place a client on medical maintenance in those cases where it can be demonstrated that the potential benefits of medical maintenance to the client far exceed the potential risks. Only a physician may authorize placement of a client on medical maintenance. The physician shall provide justification in the client record regarding the decision to place a client on medical maintenance. The following conditions shall apply to medical maintenance.
1. To qualify for partial medical maintenance a client may receive no more than 13 take homes and must have been in treatment with the same clinic for four years with at least two years of negative drug screens.
2. To qualify for full medical maintenance a client may receive no more than 27 take homes and must have been in treatment with the same clinic for five years with at least three years of negative drug screens.
3. All clients in medical maintenance will receive their medication in tablet form only.
4. All clients will participate in a “call back” program by reporting back to the provider upon notice.
5. All criteria for take homes as listed under paragraph (d) shall continue to be met.
The provider shall develop operating procedures for medical maintenance.
(g) Transfer Clients and Take Home Privileges. Any client who transfers from one provider to another within the state of Florida shall be eligible for placement on the same phase provided that verification of enrollment is received from the previous provider within two weeks of placement. The physician at the previous provider shall also document that the client met all criteria for their current phase and are at least on Phase I.
Any client who transfers from out-of-state is required to meet the requirements of subparagraph (d)2., and with verification of previous client records, the physician shall determine the phase level based on the client’s history.
(h) Transfer Information. When a client transfers from one provider to another, the referring provider shall release the following information:
1. Results of the latest physical examination;
2. Results of the latest laboratory tests on blood and urine;
3. Results of drug screens for the past 12 months;
4. Medical history;
5. Current dosage level and dosage regimen for the past 12 months;
6. Documentation of the conditions which precipitated the referral; and
7. A written summary of the client’s last 3 months of treatment.
This information shall be released prior to the client’s arrival at the provider to which he or she is transferred. Providers shall not withhold a client’s records when requested by the client for any reason, including client debt. The referring provider shall forward the records directly to the provider of the client’s choice.
(i) Exemptions from Take Home Privileges and Phasing Requirements for Methadone Maintained Clients.
1. If a client is found to have a physical disability which interferes with the client’s ability to conform to the applicable mandatory schedule, the client may be permitted a temporarily or permanently reduced schedule by the physician, provided the client is also found to be responsible in handling methadone. Providers shall obtain medical records and other relevant information as needed to verify the physical disability. Justification for the reduced schedule shall be documented in the client record by the physician who shall sign and date these entries.
2. 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 client to become unable to conform to the applicable mandatory schedule. This is permitted only if the client is also found to be responsible in handling methadone. The necessity for an exemption from a mandatory schedule is to be based on the reasonable clinical judgment of the physician and such determination of necessity shall be recorded in the client record by the physician 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. In those instances where client access to a provider is limited because of travel distance, the physician is authorized to reduce the frequency of a client’s attendance. This is permitted if the client is currently employed or attending a regionally approved educational or vocational program or the client has regular child-caring responsibilities that preclude daily trips to the provider.
The reason for reducing the frequency of attendance shall be documented in the client record by the physician who shall sign and date these entries.
4. Any exemption that is granted to a client regarding travel shall be documented in the client’s record. Such documentation shall include tickets prior to a trip, copies of boarding passes, copies of gas or lodging receipts, or other verification of the client’s arrival at the approved destination. Clients who receive exemptions for travel shall be required to submit to a drug test on the day of return to the facility.
(j) Random Drug Screening.
1. At least one drug screen, random and monitored, shall be performed on each client each month. 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. Clients who are on Phase VI shall be required to submit to one random drug screen at least every 90 days.
3. Each specimen shall be analyzed for methadone, benzodiazepines, opiates, cocaine, and marijuana.
4. The physician shall review all positive drug screens in accordance with the medical protocol established in subsection 65D-30.004(7), F.A.C.
(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 federal and state authorities. Any approved personnel on a maintenance regimen shall not be allowed access to or responsibility for handling methadone or other medication.
(l) Caseload. No full-time counselor shall have a caseload that exceeds the equivalent of 32 currently participating clients. Participating client equivalents are determined in the following manner. A client seen once per week would count as 1.0 client equivalent. A client seen bi-weekly would count as a .5 client equivalent. A client seen monthly or less would count as a .25 client equivalent. As an example, a counselor has 15 clients that are seen weekly (counts as 15 equivalent clients), 30 clients seen biweekly (counts as 15 equivalent clients), and 8 clients seen monthly (counts as 2 equivalent clients). The counselor would have a total caseload of 53 individual clients equaling 32 equivalent clients.
(m) Termination from Treatment.
1. There will be occasions when clients will need to be terminated from maintenance treatment. Clients who fall into this category are those who:
a. Attempt to sell or deliver their prescribed 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 drugs other than methadone; or
e. Do not effectively participate in treatment programs to which they are referred.
Such 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 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 clients shall be given a copy of these criteria upon placement and shall sign and date a statement that they have received the criteria.
(n) Withdrawal from Maintenance.
1. The physician shall ensure that all clients in 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 client’s progress in treatment and the justification for continued maintenance. The assessment and recommendations shall be recorded in the client record.
2. A client being withdrawn from maintenance treatment shall be closely supervised during withdrawal. A dosage reduction schedule shall be established by the physician.
1. Comprehensive Services. A comprehensive range of services shall be available to each client. The type of services to be provided shall be determined by client needs, the characteristics of clients served, and the available community resources.
a. Each client on maintenance shall receive regular counseling. A minimum of one counseling session per week shall be provided to new clients through the first 90 days. A minimum of two counseling sessions per month shall be provided to clients who have been in treatment for at least 91 days and up to one year. A minimum of one counseling session per month shall be provided to clients who have been in treatment for longer than one 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.
c. A counseling session shall be at least 30 minutes in duration and shall be documented in the client record.
(6) Satellite Maintenance.
(a) A 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) 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.