Florida Administrative Code › 65 - DEPARTMENT OF CHILDREN AND FAMILIES › 65D - Substance Abuse Program › Chapter 65DER22 - EMERGENCY RULE FOR YEAR 2021 › Section 65DER22-2 - Clinical and Operational Standards for Medication-Assisted Treatment for Opioid Use Disorders

Current through Reg. 50, No. 138; July 16, 2024
(1) General
				Requirements.
(a) Methadone
				Medication-Assisted Treatment Program Sponsor. The methadone
				medication-assisted treatment 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 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.
(c) Special Permit and Consultant Pharmacist.
1. Special Permit.
a. All providers 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 policies and
				procedures relative to the supervision of the compounding and dispensing of all
				medications dispensed in the facility;
b. Provide ongoing pharmaceutical
				consultation;
c. Develop operating
				procedures for maintaining all medication records and security in the area
				within the facility in which the compounding, storing, and dispensing of
				medications 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
				visit the provider 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, 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 SOTA.
(d) Providers shall develop
				policies and procedures for the treatment of pregnant women.
1. Prior to the initial dose, each female
				shall be fully informed of the risks of taking and not taking methadone during
				pregnancy, including possible adverse effects on the mother or fetus. If the
				medication is not taken, risk includes withdrawal syndrome which has been
				associated with fetal demise. The individual 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 shall be informed of
				the opportunity and need for prenatal care by referral to publicly or privately
				funded health care providers. The provider shall establish a documented system
				for referring individuals to prenatal care.
3. In the event there are no publicly funded
				prenatal referral resources to serve those who are indigent, or if the
				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
				record.
4. When the individual is
				referred for prenatal services, the practitioner to whom she is referred shall
				be notified that she is undergoing methadone 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 refuses referral and prenatal instruction and counseling, the
				provider shall obtain a signed statement from the individual acknowledging that
				she had the opportunity for the prenatal care but declined.
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.
(e)
				Minimum Responsibilities of the Physician. Physicians must adhere to best
				practice standards for an individual receiving methadone medication-assisted
				treatment. Best practices are evidence-based practices which are subject to
				scientific evaluation for effectiveness and efficacy. Best practice standards
				may be established by entities such as the Substance Abuse and Mental Health
				Services Administration, national trade associations, accrediting organizations
				recognized by the Department, or comparable authorities in substance use
				treatment. In addition, 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 clinical record before the
				individual receives the initial dose of 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;
3. To ensure that justification is recorded
				in the clinical record for any change to the frequency of visits to the
				provider for observed medication ingesting, including cases involving the need
				for exemptions, or when prescribing medication for physical or emotional
				problems;
4. To review, sign or
				countersign, and date treatment plans at least annually; and
5. To ensure that an assessment is conducted,
				either face-to-face or via telehealth, with each individual at least annually,
				including evaluation of the individual's physical/medical status, progress in
				treatment, and justification for continued maintenance or medical clearance for
				voluntary withdrawal or a dosage reduction protocol. The initial assessment for
				methadone medication-assisted treatment shall be conducted face-to-face. The
				assessment shall be conducted by a physician or a P.A. or A.P.R.N. under the
				supervision of a physician. The protocol shall include criteria and the
				conditions under which the assessment would be conducted more
				frequently.
(f) Central
				Registry.
1. Providers shall register and
				participate in the Department-approved electronic 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, §2.13. The provider must submit to
				information gathering activities by the SOTA for state planning
				purposes.
2. Methadone shall not be
				administered or dispensed to an individual who is known to be currently
				enrolled with another provider. Providers shall develop policies and procedures
				to ensure compliance with
				42 C.F.R.
				8.12(g) 2. If an individual
				changes providers, the current provider shall assist with coordinating the
				transfer to another provider. The evidence of linkage to care shall be noted in
				the clinical 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.
3. Individuals applying for methadone
				medication-assisted 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.
4. If an individual is
				found trying to secure or has succeeded in obtaining duplicate doses of
				methadone or other medication, the individual 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 or their qualified
				designee shall evaluate the individual as soon as medically feasible for
				continuation of treatment. In addition, a record of violations by individuals
				must become part of the clinical record maintained by all participating
				providers and shall be made available to Department staff upon
				request.
5. With the application
				for licensure, providers shall submit with the application for licensure
				written plans for participating in registry activities.
(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) Operating Hours and Holidays.
1. Providers shall post operating hours in
				full view of the public. This information shall include hours for counseling
				and administering medication.
2.
				All providers shall be open Monday through Saturday. Providers shall have
				medicating hours and counseling hours that accommodate individuals, 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. This
				includes individuals on Phase 1, individuals on a 30 to 180-day detoxification
				regimen, and individuals who need daily observation. Providers shall develop
				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 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 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 during holidays, if clinically advisable. Services shall be
				accessible to individuals for whom take-home medication is not clinically
				advisable. Individuals who fall into this category shall receive a minimum of
				seven (7) days notification regarding arrangements and exact hours of
				operation.