FLORIDA DEPARTMENT OF CHILDREN AND FAMILIES DACCO BEHAVIORAL HEALTH, INC., RECEIVED Petitioner, OEC O7 2017 vs. STATE OF FLORIDA DEPARTMENT OF CHILDREN AND FAMILIES, OCF Department Clerk Respondent. - - - - - - - - - - - - - - - - -I PETITION FOR FORMAL ADMINISTRATIVE HEARING Petitioner, DACCO Behavioral Health, Inc., by and through undersigned counsel and pursuant to Section 120.57(1 ), Fla. Stat., and R. 28-106.201, Fla. Admin. Code, petitions for a formal administrative proceeding and states: The parties 1. The affected agency is: Florida Department of Children and Families 1317 Winewood Blvd. Tallahassee, Florida, 32399-0700 2. The petitioner is represented by: J. Carter Andersen, Esq. Bryan D. Hull, Esq. BUSH ROSS , P.A P.O. Box 3913 Tampa, Florida 33601-3913 Tel: (813) 224-9255 Fax: (813) 223-9620 candersen@bushross.com bhull@bushross.com 3. Donna E. Blanton, Esq. Brittany Adams Long Ratley Law Firm 301 South Bronaugh Street, Suite 200 Tallahassee, FL 32301 Tel.: 850-425-6654 Fax: 850-425-6694 dblanton@radeylaw.com balong@radeylaw.com Petitioner DACCO Behavioral Health, Inc. (DACCO) is a Florida not-for-profit corporation working for a Drug Free Community, one person, one family at a time and setting a 65N649 I-DACCO - Petition for DOAl-1 hearing.DOCX Filed December 21, 2017 4:37 PM Division of Administrative Hearings standard for excellence in Behavioral Health. DACCO operates methadone medication-assisted treatment clinics within the State of Florida. 4. Entities that operate methadone medication-assisted clinics are subject to a strict statutory and regulatory scheme and rigorous licensing requirements to ensure the highest quality care for patients. In addition to obtaining the necessary licenses for their clinics, the Petitioner has successfully completed the rigorous vetting and approval process conducted by the Drug Enforcement Agency and the Substance Abuse and Mental Health Services Administration for the operation of such clinics. Petitioner is accredited by the Commission on Accreditation of Rehabilitation Facilities. Petitioner's substantial interests are affected 5. The Petitioner filed applications under Emergency Rule 65DER 17-2, F.A.C. for selection to apply for licenses to operate new methadone medication-assisted treatment programs in several different counties. The Petitioner' s substantial interests are being affected because the Florida Depa11ment of Children and Families (Department) did not approve any of its applications. In addition to losing the ability to service new patients in one new county, Petitioner is already servicing patients in methadone medication-assisted treatment clinics in some of the same counties for which it was denied the right to apply for add itional licenses. Petitioner will lose the ability to service additional patients in the counties where it is now operating, and Petitioner may also lose current patients to other providers. Notification of the Department's decision 6. The Depai1ment notified Petitioner that its respective applications were not approved by a letter dated November 16, 2017. See Exhibit A. 2 65N649 l -DACCO - Petition fo r DOA H hearing.DOCX Factual allegations 7. On May 3, 2017, the Governor of the State of Florida signed an executive order, No. 17-146, declaring that the opioid epidemic threatens the State with an emergency, and directing the State Health Officer and Surgeon General to declare a statewide public health emergency. The order explained that the United States Department of Health and Human Services awarded a grant to the Department to provide prevention, treatment, and recovery support services to address the epidemic and that it was necessary to draw down those federal grant funds to provide services to Florida communities instead of waiting until the stai1 of the next fiscal year, July 1, 2017. 8. On June 29, 2017, the Governor signed another executive order, No. 17-177, extending the state of emergency declaration. 9. The Department determined to expand methadone medication-assisted treatment services in the State of Florida to address the opioid epidemic and amended its existing permanent rule by issuing an emergency rule. 10. Under the permanent Depai1ment rule before amended by the emergency rule, the Department was required to determine whether there was a need for additional providers of medication-assisted treatment for opioid addiction on an annual basis. Fla. Admin. Code R. 65D30.014(3)(a). The rule required that the Department publish the results of the needs assessment in the Florida Administrative Weekly (now the Florida Administrative Register) each year by June 30th. Fla. Admin. Code R . 65D-30.014(3)(b). Providers could then apply for licenses based on the published need. Id. 3 65N649 1-DACCO - Petition for DOA!-! hearing. DOCX 11. Under the permanent rule, if the number of applicants for selection to serve as methadone medication-assisted treatment providers for a paiticular area exceeded the determined need, the Department was to select the appropriate provider based on several factors, including: 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 m compliance with these rules, and 3. History of substantial noncompliance by the respondent with departmental rules. 650-30.014, F.A.C. See Exhibit B. 12. Although the Governor's May 2017 executive order explained that it was necessary to provide services to communities prior to the July 1, 2017 fiscal year, the Department did not adhere to its rule and publish its needs assessment in June of 2017. Instead, the Depaitment promulgated an emergency rule, 65DER17-1 , which amended Rule 650-30.014, F.A.C. on August 25, 2017. See Exhibit C. 13. The emergency rule eschewed the above-quoted factors and any other critical selection criteria. In their place, the Department determined to award the right to apply for a total of 49 new methadone medication-assisted treatment provider licenses solely on a first-come firstserved basis-regardless of the applicant's experience, capability, prior compliance with the Department's rules, or any other factors or qualifications. 14. As a result of the emergency rule change, the Department was unable to consider any other critical decisional factors, such as whether the applicant could effectively serve the entire patient population, regardless of the patient's income level. 4 65N6491-DACCO - Petition for DOAH hearing.DOCX 15. One of the laws implemented by the emergency rule is section 397.311 (25)(a)7, Fla. Stat. (2016), 1 which defines "Medication-assisted treatment for opiate addiction" as "a service that uses methadone or other medication as authorized by state or federal law, in combination with medical, rehabilitative, and counseling services in the treatment of individuals who are dependent on opioid drugs." This service is a licensed service component, which the statute explains includes "a comprehensive continuum of accessible and quality" services. § 397 .311 (25), Fla. Stat. (2016). But under the emergency rule, the order in which the applications were received formed the sole selection criterion, and those applicants alone would be permitted to apply for the limited number of additional provider licenses, without any assessment of the accessibility or quality of the services provided or even that all combined services would be offered. 16. To support the use of an emergency rule, the Department found: "Revising the licensure requirements through an emergency rule is necessary to accommodate the critical need for more methadone medication-assisted treatment providers." 65DER17-1. 17. The Department further found : REASON FOR CONCLUDING THAT THE PROCEDURE IS FAIR UNDER THE CIRCUMSTANCES: The procedure is fair under the circumstances because it ensures equitable treatment of methadone medication-assisted treatment providers. 65DER17-1. 18. According to the emergency rule, the window to apply for the limited additional provider licenses would be open from September 22, 2017 at 8 :00 a.m. to October 13, 2017 at 5 :00 p.m. 1 In 2017, the section was renumbered and is now section 397.311 (26)(a)7., Florida Statutes. 5 6SN649 1-DACCO - Petition for DOAH hearing.DOCX 19. On September 19, 2017, the Department adopted emergency rule 65DER17-2, which superseded 65DER17-1 , and was substantively identical except for certain date changes, including revising the application window to run from October 2, 2017 at 8:00 a.m. to October 23, 2017, at 5:00 p.m. 2 See Exhibit D. 20. DACCO sent a representative to Tallahassee to hand-deliver applications to the Department on October 2 at 8:00 a.m., to ensure that the applications would be received as early as possible within the submission window. 21. After arriving in Tallahassee on Sunday, October 1, DACCO's representative drove by the Department' s offices to confirm the address. 22. She discovered that a line had already formed. Some individuals had arrived days earlier and were camping outside the Department offices in tents, with portable chairs, sleeping bags, and coolers stocked with provisions. Pictures are attached hereto as Exhibit E. The applicants remained in line, and male applicants would leave only to urinate behind the building, but female applicants had no options for restroom facilities. 23. At least one of the applicants was armed, ostensibly to protect their spot in line. 24. DACCO' s representative joined the line on Sunday, October 1 and remained there overnight. 25. Many persons in line did not have applications with them. Shortly before 8:00 a.m., deliveries of boxes containing applications to be submitted to the Department arrived, and clean, well-rested persons took their place in line. 26. At 8:00 a.m. on October 2, the Department opened its doors to receive applications. Rather than identifying and logging all applicants who were present at 8:00 a.m. , the Department 2 According to the Department, the original dates in the rule were revised due to Hurricane Irma. 6 65N649 I-DACCO - Petition for DOAH hearing.DOCX only allowed the first person in line- who had been camping out for several days- to submit a package of applications at 8:00 a.m. The Department accepted 19 applications from the first person in line, who submitted applications on behalf of Metro Treatment of Florida, L.P., later changed to Colonial Management Group, L.P. 27. The other persons in line were logged in, one at a time, after the Department received applications from each person in front of them. 28. The Department' s log shows the first application was delivered by Fed Ex, but DACCO' s representative never saw a Fed Ex delivery at 8:00 a.m. , and the log shows later applications were delivered by Fed Ex between 9:39 and 9:43. 29. On the morning of October 2, DACCO submitted applications for selection to apply for one additional provider license in Pasco County and two in Hillsborough County. Although DACCO had arrived the night before and was present at the Department at 8:00 a.m. on October 2, the Department's log indicated the Department received DACCO' s applications at 8:13 a.m. DACCO also hand-delivered an application for Monroe County on October 5. 30. Of the 49 new provider licenses, a for-profit entity, Colonial Management Group, L.P., was selected to apply for 19, including licenses in Hillsborough and Pasco Counties instead ofDACCO. 31. Another for-profit entity, Relax Mental Health, was selected to apply for 8 of the 49 licenses, including a license in Monroe County instead of DACCO. 32. A third for-profit entity, Psychological Addiction Services, LLC, was selected to apply for 20 of the 49 licenses. 33. The three for-profit entities selected to apply for 47 of the 49 licenses do not accept Medicaid funds and do not accept third-party payments, such as health insurance. Petitioner, by 7 65N6491-DACCO - Petition for DOAH hearing.DOCX contrast, accepts Medicaid funds and third-party payments, and thus, is able to serve the general and indigent populations. 34. By granting a full 96% of the new license slots to companies that are unable to accept Medicaid or third-party payments, the Department has alienated indigent patients and failed to expand methadone medication-assisted treatment services effectively, despite the stated purpose of the rule. 35. In short, the process was not fair and equitable in its treatment of providers (as full consideration of the applications would have allowed, or even as a lottery or draft process would have been) and failed to ensure that methadone medication-assisted treatment services would be expanded in a way that was capable of treating patients in need of critical services, no matter where they fall on the economic spectrum. Disputed issues of material fact 36. Whether there was an immediate danger to the public health, safety or welfare to support the emergency rule under section 120.54(4), Florida Statutes. 37. Whether the emergency rule was necessary to protect the public interest under section 120.54(4), Florida Statutes. 38. Whether the process provided by the emergency rule was fair under the circumstances under section 120.54(4 ), Florida Statutes. 39. Whether the emergency rule "ensure[d] equitable treatment of methadone medication-assisted treatment providers." 40. Whether the Department relied on sufficient facts to support its decision to select providers solely on a first-come first-served basis, and what those facts were. 8 65N649 I-DACCO - Petition for DOAH hearing.DOCX 41. Whether the Depmtment relied on sufficient facts to support its decision not to consider merit, qualifications, or any other factors when selecting providers, and what those facts were. 42. Whether applicants had to camp-out in order to apply for methadone medication- assisted treatment provider licenses. 43. Whether a camp-out for methadone medication-assisted treatment provider licenses was envisioned or intended by the emergency rule. 44. Whether Petitioner was present to submit its applications in person at 8:00 a.m. on October 2. 45. Whether Petitioner was logged in at the correct dates and times. 46. Whether the emergency rule constitutes an invalid exercise of delegated legislative authority under section 120.52(8)(a), Florida Statutes, because the Department fai led to follow the applicable emergency rulemaking procedures and requirements. 4 7. Whether the emergency rule constitutes an invalid exercise of delegated legislative authority under section 120.52(8)(c ), Florida Statutes, because it enlarges, modifies, or contravenes the specific provisions of law implemented. 48. Whether the emergency rule constitutes an invalid exercise of delegated legislative authority under section 120.52(8)(d), Florida Statutes, because it fails to establish adequate standards for agency decisions. 49. Whether the emergency rule constitutes an invalid exercise of delegated legislative authority under section 120.52(8)(e), Florida Statutes, because it is arbitrary and capricious. 9 65N649 1-DACCO- Petition for DOAl-1 hearing.DOCX 50. Whether the Department accurately determined the order in which complete and responsive applications were received by the Office of Substance Abuse and Mental Health headquarters. 51. Whether the Department acted contrary to its rules in determining who was approved to apply for licensure for methadone medication assisted treatment providers. Rules and statutes requiring reversal 52. The specific rules and statutes that support the relief requested in this proceeding are: sections 120.52, 120.54, 120.57(1), and 397.311, Florida Statutes, and rule chapters 65D30.014, 65DERI 7-2, and 28-106, Florida Administrative Code. The application of the relevant facts to these statutes and rules has been discussed in previous sections of this Petition. Relief requested WHEREFORE, Petitioner requests that this Petition be sent to the Division of Administrative Hearings for a formal administrative hearing under § 120.57(1 ), Fla. Stat. Petitioner further requests a Recommended Order by an Administrative Law Judge and Final Order from the Department that (1) invalidates the procedure directed in Emergency Rule 65DER17-2, F.A.C., (2) reverses the proposed Department action denying Petitioner' s applications for selection to apply for Ii censure, and (3) requires the Department to follow the requirements of Rule 65D30.014 in selecting the new methadone medication-assisted treatment provider licenses. Dated: December 7, 2017 /s/ Brittany Adams Long Donna E. Blanton, (FBN 948500) Brittany Adams Long, (FBN 504556) Radey Law Firm 301 South Bronough Street, Suite 200 Tallahassee, FL 32301 Tel.: 850-425-6654 /s/ Bryan D. Hull J. Carter Andersen, Esq. (FBN 0143626) Bryan D. Hull , Esq. (FBN 20969) BUSH ROSS, P.A P.O. Box 3913 Tampa, Florida 33601-3913 Tel: (813) 224-9255 10 65N649 1-DACCO - Petition for DOAl-1hearing.DOCX Fax: (81 3) 223-9620 candersen(a),bushross.com bhull@bushross.com Fax: 850-425-6694 dblanton(a),radeylaw.com balong@radeylaw.com CERTIFICATE OF SERVICE I ce1tify that a true copy of the foregoing was hand delivered to the Agency Clerk, Depattment of Ch ildren and Families, 1317 Winewood Boulevard, Building 2, Room 204, Tallahassee, Florida 32399-0700. Isl Brittany Adams Long Brittany Adams Long 11 65N6491-DACCO- Petition for DOAH hearing.DOCX State of Florida Department of Children and Families Rick Scott Governor Mike Carroll Secretary November 16, 2017 Dear Applicant, Thank you for your recent application in response to the emergency rule, 65DER 17-1, F.A.C., to establish a methadone medication-assisted treatment program. The number of applications for new providers in the county/ies you applied for exceeded the determined need. Pursuant to the emergency rule, the selection of a provider was based on the order in which complete and responsive applications were received. Your application was not approved to apply for licensure. Please note if one of the approved applicants elects to forfeit a county then the unclaimed county will go to the next applicant in the order in which complete and responsive applications were received. Please be advised that you have the right to appeal this decision. Any party whose substantial interests are affected by this determination has a right to request an administrative proceeding pursuant to s. 120.57, Florida Statutes, and rules promulgated pursuant thereto, within 21 days of this notice. Failure to timely request a hearing shall be deemed a waiver of any right to a proceeding pursuant to s. 120.57, Florida Statutes, and this decision shall become final agency action. NOTIFICATION OF RIGHTS UNDER CHAPTER 120, FLORIDA STATUTES IF YOU BELIEVE THE DEPARTMENT'S DECISION IS IN ERROR, YOU MAY REQUEST AN ADMINISTRATIVE HEARING TO CONTEST THE DECISION, IN ACCORDANCE WITH THE ENCLOSED "NOTIFICATION OF RIGHTS UNDER CHAPTER 120, FLORIDA STATUTES." Sincerely, 14.£~, ~e,l) Ute Gazioch Director of Substance Abuse and Mental Health cc: Lacey Kantor, Assistant General Counsel Corine Stancil, State Opioid Treatment Authority Teresa Berdoll, Licensure and Designations Manager EXHIBIT I A 131 7 Winewood Boulevard, Tallahassee, Florida 32399-0700'-------r Mission: Work in Partnership with Local Communities to Protect the Vulnerable, Promote Strong and Economically Self-Sufficient Families, and Advance Personal and Family Recovery and Resiliency 65D-30.014 Standards for Medication and Methadone Maintenance Treatment. In addition to Rule 65D-30.004, F.A.C., the following standards apply to Medication and Methadone Maintenance Treatment. ( I) 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, 200 I, 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: I. 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. I . 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. T he responsibilities of the consultant pharmac ist include the following: a. Develop operating procedures relative to the supervision of the compounding and dispens ing of all drugs dispensed in the clinic, b. Provide pharmace utical 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 sha ll be prepared at least semi-annually and submitted, s igned a nd 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 IO days of any change of consultant pharmacists. (d) Pregnancy and Medication and Methadone Ma intenance. I . Use of Methadone. Prior to the initial dose, each female client shall be full y informed of the possible risks from the use of EXHIBIT 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: I. 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, a ll 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. (t) Client Registry. I. Providers shall participate in regional registry activities for the purpose of sharing client identifying information with other providers located within a I 00-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 a nd 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 I, 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 advisab le. 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. I. 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 add icted to opioid drugs and became physiologically addicted at least I year before placement in maintenance treatment. A I-year history of addiction means that an applicant for placement in maintenance treatment was physiologically addicted to opioid drugs at least I 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 phys ician may admit the person to maintenance treatment if, by the evidence presented and observed, it is reasonable to conclude that the person was physiologically add icted 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. I. A person who has resided in a penal or chronic-care institution for I 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 e ligible 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 a ll other findings, and the criteria used to determine the findings shall be recorded by the phys ician 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 c lients, 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 c lient. Documented evidence of current or prior addiction and criteria used to determine such findings shall be recorded in the client record by the admitting phys ician. 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. lfa 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. I. 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 e ligible 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 takehome 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. I . Phase I. Following 30 consecutive days in treatment, the client may be eligible for I 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 I year, provided that the client has had negative drug screens for the preceding 90 days. 4. Phase IV. Following I 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. (t) Medical Maintenance. Providers must rece ive prior approval in writing from the State Authority to use the medical maintenance protocol. T he 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 sha ll apply to medical maintenance. I. 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: I. Results of the latest physical examination, 2. Results of the latest laboratory tests on blood and urine, 3. Resu Its 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. I. 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 reg ionally 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 sha ll 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. U) Random Drug Screening. I. 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 65030.004(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. (I) 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. I. 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. I. 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. (o) Services. I. 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. 2. Counseling. 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-30.0 14(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 term ination criteria. Rulemaking Authority 397.2 I (5) FS. Law Implemented 397.311 (f 8)(g), 397.321 (I), 397.419, 397.427, 465 FS. History-New 5-25-00, Amended 43-03. Florida Administrative Register Section IV Emergency Rules DEPARTMENT OF CHILDREN AND FAMILIES Substance Abuse Program RULE NO.: 65 DER 17- I RULE TITLE: Standard for Medication-Assisted Treatment for Opioid Addiction SPECIFIC REASONS FOR FINDING AN IM MEDIATE DANGER TO THE PUBLIC HEALTH, SAFETY OR WELFARE: On May 3, 2017, the Governor of the State of Florida signed Executive Order Number 17-146 declaring that the opioid epidemic threatens the State with an emergency and that, as a consequence of this danger, a state of emergency exists. Also, in the executive order, the Governor directed the State Health Officer and Surgeon General to declare a statewide public health emergency, pursuant to its authority in section 381.00315, F.S. On June 29, 2017, the Governor signed Executive Order Number 17-177 to extend the state of emergency declaration. The department was recently awarded a two-year grant to address this opioid epidemic. The department will use these funds in part to expand methadone medication-assisted treatment services in needed areas of the state as part of a comprehensive plan to address the opioid crisis. Revising the licensure requirements through an emergency rule is necessary to accommodate the critical need for more methadone medication-assisted treatment providers. REASON FOR CONCLUDING THAT THE PROCEDURE IS FAIR UNDER THE CIRCUMSTANCES: The procedure is fair under the circumstances because it ensures equitable treatment of methadone medication-assisted treatment providers. SUMMARY: This rule makes changes to permanent Rule 65030.014 F.A.C., relating to licensure requirements for methadone medication-assisted treatment programs. THE PERSON TO BE CONTACTED REGARDING THE EMERGENCY RULE IS: Bill Hardin. He can be reached at William.Hardin@mytlfamilies.com or Office of Substance Abuse and Mental Health, 1317 Winewood Boulevard, Building 6, Tallahassee, Florida 32399-0700. THE FULL TEXT OF THE EMERGENCY RULE IS: 65DER 17-1 (65D-30.014): Standards for MedicationAssisted Treatment for Opioid Addiction. 8taAdards for MedieatioA aAd MethadoAe MaiAteAaAee TreatmeAt In addition to Rule 65D-30.004, F.A.C., the following standards apply to Standards for Medication-Assisted Treatment for Opioid Addiction MedieatioA aAd Methad0Ae MaiAteAaAce TreatmeAt. Volume 43, Number 166, August 25, 2017 (I) State Authority. The state authority is the department's Office of Substance Abuse and Mental Health 8ubstaAee Abuse Program Office. (2) Federal Authority. The federal authority is the Center for Substance Abuse Treatment. (3) Determination ofNeed. (a) Criteria. In accordance with s. 397.427, F.S., the department shall not license any new medication-assisted treatment programs for opioid addiction until the department conducts a needs assessment to determine whether additional providers are needed in Florida. The determination ofneed shall only apply to methadone medication-assisted treatment programs for opioid addiction. Department of Correction facilities are excluded from this process. The department shall use a methodology based on a formula that identifies the number of people who meet the criteria for dependence or abuse of heroin or pain relievers who did not receive any treatment. and the number of opioid-caused deaths. This formula will be weighted, with 70 percent driven by the number of people with an unmet need for treatment and 30 percent driven by the number of deaths. In its effort to determine need. the department shall examine the following data: I. Population estimates by age and by county; 2. Number of opioid-caused deaths; 3. Estimated number of past-year nonmedical pain reliever users; and 4. Estimated number of life-time heroin users; l'Jew pro\JE MAll>ffEl>IAl>ICE TREATMEl>ff NEEDS ASSES SM HIT, September e, 200 I, incoff)ornted hereiR by reference. The ferm ma)' be obtaiRed from the DepartmeRt of Children aRd l