Findings Of Fact Background Petitioner was founded by Mr. Art Barker in 1970 and has been operated since that time as a private, non-profit entity. Petitioner receives no funds from any unit of government and is a valuable asset in the field of drug abuse treatment and prevention. Petitioner enjoys a good reputation in the community it serves and has demonstrated its ability to help people with substance abuse problems. Approximately 7,000 people have gone through Petitioner's drug abuse program with a success rate in excess of 90 percent. Petitioner was an innovator in the development of the type of drug abuse programs administered by it. The drug abuse program administered by Petitioner has been emulated by approximately 12 other programs in the state. There are not enough programs of this type to satisfy the needs of individuals in the state. Respondent first began licensing drug abuse programs in February, 1972. Petitioner has been continuously licensed by Respondent as a drug abuse program. Petitioner is authorized under License Number 10A-38 to provide "day care with host component." The licensed address for Petitioner is 919 East Broward Boulevard, Fort Lauderdale, Florida, 33301. Petitioner's license must be renewed annually. Applicable administrative rules require licensees to operate drug abuse programs under the supervision of a "qualified supervisor." Prior to September, 1986, a qualified supervisor was defined as an individual who, by "training or experience" was responsible for providing clinical guidance to counselors. 3/ In September, 1986, the ability of an individual to qualify as a qualified supervisor based solely upon his or her work experience was deleted. Since September, 1986, an individual who wished to satisfy the requirements of a qualified supervisor was required to either satisfy minimum educational requirements or become certified by the Certification Board of Addiction Professionals of Florida, or by a substantially equivalent certification process ("certified addiction professionals" or "CAP designation"). Petitioner demonstrated its good faith effort to comply with Respondent's rules. Respondent's licensing agent advised Petitioner in 1987 that Petitioner would be in compliance with the new requirements for qualified supervisors as long as staff personnel placed their full name and title next to the comments on the client's records. That procedure was followed by staff personnel during the license years for 1987-1988 and 1988-1989. Petitioner's license was renewed during those years with no question from Respondent concerning the credentials of Petitioner's qualified supervisors. During the same license years, Petitioner's personnel were led to believe by Respondent's licensing agent and reasonably did believe that they were in full compliance with Respondent's rules. Petitioner relocated in 1987 and purchased a building rather than leasing one. The decision to purchase the building at the new location was made, in part, in reliance upon Respondent's representation and Petitioner's belief that Petitioner was in compliance with applicable rules regarding qualified supervisors. Respondent refused to issue a regular annual license to Petitioner for the 1989-1990 license year for the sole reason that Petitioner did not have a qualified supervisor. 4/ Respondent specifically determined that neither Mr. Art Barker nor Ms. Lybbi Kienzle satisfy the educational or certification requirements for qualified supervisors. 5/ It is uncontroverted that Mr. Art Barker and Ms. Lybbi Kienzle are each competent to perform the duties of a qualified supervisor. Respondent determined that each individual is competent to perform the duties of a qualified supervisor and so stipulated in the joint prehearing stipulation filed in this proceeding. Respondent did not follow its own rule in rejecting Petitioner's request for a deviation. Respondent's current written policy was adopted as a rule after Petitioner's request for a deviation but prior to the formal hearing. Under Respondent's current rule, each district office must make a recommendation concerning each request for deviation made to the district office. The request for deviation and the district office recommendation is then considered by the licensure rules committee. The licensure rules committee then recommends action to appropriate department personnel who may either accept or reject the committee's recommendation. The approval of any request for deviation automatically ends at the time of the expiration date of the regular license. At the time of Petitioner's request for deviation, Respondent was in the process of developing its current written policy. Deviation requests and district office recommendations were considered at the time by an ad hoc committee of anywhere from three to seven people, depending upon who was available. The occurrence of such a meeting, the number of people, and the identity of the committee members was determined by "catch-as- you-can." A licensure rules committee was not officially formed until some time after Petitioner's request for deviation. Petitioner's request for deviation and the recommendation of the district office was not considered by any committee. The district office recommended that Petitioner's request for a deviation be granted. Approval of the request for deviation was recommended by the district office subject to the conditions that the deviation be limited to one year, that Petitioner submit a new request for deviation prior to its annual licensing date, and that the competency of Mr. Barker and Ms. Kienzle to perform the duties of qualified supervisors be documented by their respective resumes. Documentation in the form of resumes was not a significant concern to Respondent and was merely ministerial. The recommendation for approval of the request for deviation was made by employees of the Respondent who have personal knowledge of the experience and competency of Mr. Barker and Ms. Kienzle. It is uncontroverted that Mr. Barker and Ms. Kienzle are competent to perform the duties of a qualified supervisor. The district office, however, did recommend that either Mr. Barker or someone on his staff pursue CAP designation. The recommendation of the district office was overruled by Dr. Iver Groves, Ph.D., Assistant Secretary for Alcohol, Drug Abuse and Mental Health. The request for deviation was rejected on the grounds that Mr. Barker's honorary degree did not satisfy the educational requirements for a qualified supervisor. Dr. Groves determined that deviation from the educational requirements for a qualified supervisor cannot be granted under any circumstances. Dr. Groves suggested that Mr. Barker and Ms. Kienzle comply with the requirements for CAP designation or formal education. Dr. Groves has no personal knowledge of the experience and competency of either Mr. Barker or Ms. Kienzle to perform the duties of a qualified supervisor. Dr. Groves first became involved in this proceeding when a draft of a letter embodying the recommendation of the district office was presented to Dr. Groves for his signature. Dr. Groves spent an ". . . hour [or] maybe two hours . . ." considering Petitioner's request for deviation. Dr. Groves never saw the recommendation of the district office, was unaware that anyone in the district office recommended approval of the deviation, and did not consider the recommendation of the district office in making his determination to reject Petitioner's request for deviation. Dr. Groves never compared the requirements for a deviation in the applicable administrative rule to Petitioner's request for deviation. Dr. Groves rejected Petitioner's request for deviation based upon his concern over the establishment of a precedent for other programs in the state. Dr. Groves primary concern was whether it was appropriate to waive a ". . . fundamental standard in the rule that would have ramifications for the practice of the treatment of addiction across the State of Florida." It is uncontroverted, however, that there are no other programs in the state that are comparable to that administered by Petitioner. The experience and competency of Mr. Barker and Ms. Kienzle to perform the duties of a qualified supervisor satisfies the purposes of the educational requirements for qualified supervisors. As Dr. Groves stated during his testimony at the formal hearing, the purpose of imposing educational requirements on qualified supervisors is to give Respondent ". . . some assurance of the capability and competence of people within the program . . ." and to insure that ". . . somebody associated with that program . . . has been through a certain organized set of experiences and has been judged to be qualified." Transcript at 111. Grounds For Deviation Neither Mr. Barker nor Ms. Kienzle satisfy either the educational or certification requirements for qualified supervisors. Neither individual has the requisite education and neither has been certified by the Certification Board of Addiction Professionals of Florida, or by a substantially equivalent certification process. The honorary degree received by Mr. Barker from Fort Lauderdale University does not satisfy the educational requirements for a qualified supervisor. Mr. Barker was awarded "The Honorary Degree of Doctor of Social Science" in June, 1972, by Fort Lauderdale University. Fort Lauderdale University was accredited at the time the honorary degree was awarded. The citation attached to the honorary degree states in relevant part that the degree was awarded to: . . . the outstanding drug rehabilitation expert in the United States [who] saved 1,500 young men and women from a life in prison or mental hospital or a premature death from a drug overdose. . . . The ninety per cent success rate of The Seed is a tribute to your genius. Neither Mr. Barker nor Ms. Kienzle satisfy the educational requirements for becoming certified by the Certification Board of Addiction Professionals of Florida, or by a substantially equivalent certification process. Applicants for CAP designation must hold a minimum of an Associates Arts degree from a college or university. The degree requirement became effective on January 1, 1991, and it was impossible for either Mr. Barker or Ms. Kienzle to satisfy the educational requirements prior to the formal hearing. Requiring Mr. Barker and Ms. Kienzle to satisfy the educational requirements for a qualified supervisor would interfere with the efficient operation of Petitioner. The time and energy needed to obtain the academic credits would impose an unnecessary hardship on each of them and detract from the time and energy they could devote to the drug abuse program administered by Petitioner. Requiring Petitioner to hire a certified addiction professional would interfere with Petitioner's efficient operation. Petitioner has a positive net worth and can pay for such services. In recent years, however, Petitioner has experienced operating deficits. The amount of funds received as donations and pledges has been less than annual operating expenses. Expenses incurred by Petitioner to hire one or more additional personnel who have obtained the CAP designation would increase Petitioner's operating deficit and further erode Petitioner's remaining net worth. Supervision of either Mr. Barker or Ms. Kienzle by a certified addiction professional would be superfluous and would interfere with Petitioner's efficient operation. Neither Mr. Barker nor Ms. Kienzle need to be supervised by one or more individuals who have obtained the CAP designation in order to perform the duties of a qualified supervisor. It is uncontroverted that Mr. Barker and Ms. Kienzle are competent to perform such duties. Deviation from the educational requirements for qualified supervisors for Mr. Barker and Ms. Kienzle will not jeopardize the health and safety of clients in the program administered by Petitioner, will not abridge the rights of those clients, and will not diminish the level of quality of client care. Mr. Barker is competent to provide clinical guidance to counselors, approve and reassess treatment plans, supervise psychosocial assessment services, and supervise treatment services for Petitioner. Mr. Barker has focused his time continuously and exclusively on running the drug abuse program for Petitioner. Ms. Kienzle graduated from Petitioner's drug abuse program in 1971 and has been employed continuously and exclusively by Petitioner as a counselor and supervisor. A master's degree in a social or behavioral science does not assure competency to perform the duties of a qualified supervisor in a drug abuse program. Respondent's rule does not require the field of academic study to be related to the duties that must be performed by a qualified supervisor. As Dr. Groves stated in his testimony during the formal hearing, the requirement for a master's degree in a social or behavioral science is satisfied by a master's degree in history or English. For the same reason, the requirement of an Associate Arts degree for a CAP designation does not assure competency to perform the duties of a qualified supervisor for a drug abuse program.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that Petitioner should be granted a regular license for one year and the requested deviation. The deviation should automatically end at the time of the expiration date of the regular license or at such time as Petitioner's regular license is revoked, suspended, or otherwise terminated. DONE AND ORDERED in Tallahassee, Leon County, Florida, this 23rd day of October 1991. DANIEL MANRY Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 23rd day of October 1991.
The Issue The issue in this case is whether Florida Administrative Code Emergency Rule 65DER17-2 (the “Emergency Rule”) constitutes an invalid exercise of delegated legislative authority as defined in section 120.52(8), Florida Statutes. (Unless specifically stated otherwise herein, all references to Florida Statutes will be to the 2017 version.) More specifically, on September 19, 2017, the Florida Department of Children and Families (the “Department”), published the Emergency Rule, which dealt with the need for and licensing of new methadone medication-assisted treatment centers for persons dealing with opioid addiction. Pursuant to the Emergency Rule, the Department decided which providers would receive approval notices to submit licensure applications in certain counties based on the order in which complete and responsive applications were received by the Department. A number of parties are challenging the validity of the Emergency Rule.
Findings Of Fact Parties and Standing Respondent, the Department, is the state agency responsible for licensing providers of care in methadone medication-assisted treatment facilities. It is the agency, which promulgated the Emergency Rule. Petitioner, Dacco Behavioral Health, Inc. (“Dacco”), is a not-for-profit corporation and is currently licensed to operate methadone medication-assisted treatment clinics within the state of Florida. Dacco submitted three applications for licensure under the Emergency Rule. Its applications were not approved by the Department. Dacco timely filed an administrative challenge to its denied applications. Dacco has standing in this proceeding. Petitioner, OPI, is a not-for-profit corporation and is currently licensed to operate methadone medication-assisted treatment clinics within the state of Florida. OPI submitted six applications for licensure under the Emergency Rule. None of its applications were approved by the Department. OPI timely filed an administrative challenge to its denied applications. OPI has standing in this proceeding. Petitioner, Aspire Health Partners, Inc. (“Aspire”), is a not-for-profit corporation and is currently licensed to operate methadone medication-assisted treatment clinics within the state of Florida. Aspire submitted two applications for licensure under the Emergency Rule. Neither of its applications was approved by the Department. Aspire timely filed an administrative challenge to its denied applications. Aspire has standing in this proceeding. Intervenor, CRC, is a Delaware limited liability company registered to do business in Florida. CRC is currently licensed to operate a methadone medication-assisted treatment clinic in Florida. CRC submitted 16 applications for licensure under the Emergency Rule. Its applications were not approved by the Department. CRC timely filed an administrative challenge to its denied applications. CRC has standing to intervene in this proceeding. Intervenor, Riverwood Group, LLC (“Riverwood”), is a Delaware limited liability company authorized to do business in Florida. Riverwood is currently licensed to operate methadone medication-assisted treatment clinics within the state of Florida. Riverwood submitted six applications for licensure under the Emergency Rule. Its applications were not approved by the Department. Riverwood timely filed an administrative challenge to its denied applications. Riverwood has standing to intervene in this proceeding. Intervenor, Symetria, is a Florida limited liability company whose parent company is currently licensed to operate methadone medication-assisted treatment clinics within the state of Florida. Symetria submitted 11 applications for licensure under the Emergency Rule. One of its applications was approved; the other 10 were not approved by the Department. Symetria did not file an administrative challenge to the denial of its applications. Opposition to Symetria’s standing was raised by Intervenors appearing in support of Respondent. Symetria was allowed to participate at final hearing pending adequate proof of standing. Symetria did not prove its standing at final hearing. Symetria does not have standing in this proceeding on behalf of Petitioners as it does not satisfy the two-prong test announced in Agrico Chemical Company v. Department of Environmental Regulation, 406 So. 2d 478 (Fla. 1st DCA 1978). (After entry of this Final Order, Symetria will be stricken from the style of the case.) It should be noted that Symetria apparently never received notice as to its denied applications and may have challenged those denials, if notices had been issued, but that possibility is too speculative to award standing in this matter. It should also be noted that none of the parties hereto objected to Symetria’s involvement in the final hearing, including its introduction of evidence and examination of witnesses. Intervenor, CFSATC, d/b/a Central Florida Substance Abuse (“CFSATC”), is a Florida corporation and is currently licensed to operate methadone medication-assisted treatment clinics within the state of Florida. CFSATC submitted seven applications for licensure under the Emergency Rule. None of its applications were approved by the Department. CFSATC timely filed an administrative challenge to its denied applications. CFSATC has standing to intervene in this proceeding. Intervenor, Bay County Healthcare Services, LLC (“Bay County Healthcare”), is a Georgia limited liability company and is currently licensed to operate a methadone medication- assisted treatment clinic in Florida. Bay County Healthcare submitted eight applications for licensure under the Emergency Rule. None of its applications were approved by the Department. Bay County Healthcare timely filed an administrative challenge to its denied applications. Bay County Healthcare has standing to intervene in this proceeding. Intervenor, Palm Beach Drug Testing, LLC, d/b/a Relax Mental Health Care (“Relax”), submitted 14 applications for licensure under the Emergency Rule; eight of its applications were approved. Invalidation of the Emergency Rule would substantially affect the business interests of Relax. Relax has standing to intervene in this proceeding. Intervenor, Colonial Management Group, L.P. (“Colonial”), operates methadone medication-assisted treatment centers nationwide, including Florida. Colonial submitted 19 applications for licensure under the Emergency Rule; all 19 of its applications were approved. Invalidation of the Emergency Rule would substantially affect the business interests of Colonial. Colonial has standing to intervene in this proceeding. Intervenor, PAS, submitted 48 applications for licensure under the Emergency Rule; twenty of its applications were approved. Invalidation of the Emergency Rule would substantially affect the business interests of PAS. PAS has standing to intervene in this proceeding. Procedural History On May 3, 2017, Governor Scott signed Executive Order No. 17-146, alluding to the nearly 4,000 deaths in Florida caused by opioids during calendar year 2015. Florida had nearly 10 percent of all opioid-related deaths in the entire country that year. The Governor declared that an opioid epidemic threatens the State and has created an emergency situation. He directed the State Health Officer and Surgeon General to announce a statewide public health emergency. The Governor’s executive order noted that the United States Department of Health and Human Services had awarded a grant of $27,150,403 per year for two years to the Department to provide prevention, treatment, and recovery support services to address the opioid epidemic. The Governor said it was necessary to immediately draw down those federal grant funds in order to provide services to Florida communities, and that the State could not wait until the next fiscal year (which would start two months hence, on July 1, 2017) to begin that distribution. On June 29, 2017, the Governor signed Executive Order No. 17-177, extending for an additional 60 days the state of emergency declaration set forth in Executive Order 17-146. This action was precipitated by hurricanes threatening the State. The executive orders issued by the Governor appear to direct State agencies to utilize the federal grant monies to bolster existing providers of treatment. Nothing in the executive orders issued by the Governor directs the approval of additional opioid treatment centers. There is, however, an omnibus provision in the executive order directing the State Health Officer to “take any action necessary to protect the public health.” The Department’s response to the executive orders was to publish emergency rule 65DER17-1 in the FAR on August 25, 2017. That rule was superseded by the Emergency Rule, which revised the dates during which applications for licensure could be submitted. This change was deemed necessary in response to the devastation wrought by Hurricane Irma, making travel to Tallahassee (for delivery of applications) somewhat difficult during the timeframes set forth in emergency rule 65DER17-1. The Notice of Emergency Rule, as published in the Florida Administrative Register, states in full (with strikethrough/underline in original): Notice of Emergency Rule DEPARTMENT OF CHILDREN AND FAMILIESSubstance Abuse Program RULE NO.: RULE TITLE: 65DER17-2 Standards for Medication-Assisted Treatment for Opioid Addiction SPECIFIC REASONS FOR FINDING AN IMMEDIATE 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. Due to the impact of Hurricane Irma on providers and individuals in treatment, the department has determined that extending the submission dates for applicants is necessary. 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 65D-30.014 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@myflfamilies.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: 65DER17-2 (65D-30.014): Standards for Medication-Assisted Treatment for Opioid Addiction. 65DER17-2 supersedes 65DER17-1. In addition to Rule 65D-30.004, F.A.C., the following standards apply to Standards for Medication-Assisted Treatment for Opioid Addiction. State Authority. The state authority is the department’s Office of Substance Abuse and Mental Health. Federal Authority. The federal authority is the Center for Substance Abuse Treatment. Determination of Need. 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 of need 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: Population estimates by age and by county; Number of opioid-caused deaths; Estimated number of past-year nonmedical pain reliever users; and Estimated number of life-time heroin users; Procedure. By August 28, 2017, the department will conduct a needs assessment to determine whether additional methadone medication-assisted treatment providers are needed in Florida. The department will publish a determination of need in the Florida Administrative Register and on the department’s website at http://www.myfl families.com/service-programs/substance- abuse on August 30, 2017. If the department determines that additional providers are needed, the department will also publish instructions for submitting an appropriate application. Applicants interested in providing methadone medication-assisted treatment must complete and submit CF-MH 4036 titled, “Methadone Medication-Assisted Treatment Provider Application in Response to Emergency Rule”, June 2017, incorporated herein by reference. Form CF-MH 4036 is available from the department’s website at https://eds.myflfamilies.com/DCFForms Internet/Search/DCFFormSearch.aspx and at http://www.myflfamilies.com/service- programs/substance-abuse. Applications must be complete and responsive to all of the questions on this form. Applications will be accepted at department headquarters from October 2, 2017 September 22, 2017 at 8 a.m. Eastern Time until October 23, 2017 October 13, 2017, at 5 p.m. Eastern Time. Applications must be delivered to the following address: Florida Department of Children and Families, Office of Substance Abuse and Mental Health, 1317 Winewood Boulevard, Building 6, Tallahassee, Florida 32399-0700. For the application review period in response to this emergency rule, the department will use CF-MH 4037 titled, “Review Form for Methadone Medication- Assisted Treatment Provider Application in Response to Emergency Rule”, June 2017, incorporated herein by reference. Form CF- MH 4037 is available from the department’s website at https://eds.myflfamilies.com/ DCFFormsInternet/Search/DCFFormSearch.aspx and at http://www.myflfamilies.com/service- programs/substance-abuse. Should the number of applications for a new provider in a Florida county exceed the determined need, the selection of a provider shall be based on the order in which complete and responsive applications are received by the Office of Substance Abuse and Mental Health headquarters. Applicants who are approved to apply for licensure will receive notices from the department by November 17, 2017 November 10, 2017. Applicants who receive approval notices shall submit applications for licensure to the department’s regional Substance Abuse and Mental Health office(s) where the service will be provided. The regional Substance Abuse and Mental Health office will process applications for licensure in accordance with the standards and requirements in 65D-30, F.A.C. through (6) No change. Rulemaking Authority 397.321(5) F.S. Law Implemented 397.311(25)(a)7., 397.321(1), 397.419, FS. History–New 5-25-00, Amended 4-3-03, Amended 8-25-17, Amended 9-19-17. THIS RULE TAKES EFFECT UPON BEING FILED WITH THE DEPARTMENT OF STATE UNLESS A LATER TIME AND DATE IS SPECIFIED IN THE RULE. EFFECTIVE DATE: 9/19/2017 Petitioners filed challenges to the Emergency Rule at DOAH on December 11, 2017, 83 days after the effective date set forth in the FAR. Respondent asserts that the Emergency Rule is merely an amendment to Rule 65DER 17-1, which had an effective date of August 25, 2017. Thus, reasons Respondent, challenges to the Emergency Rule were due on or before November 23, 2017, i.e., 90 days after August 25, 2017. However, emergency rules are not renewable so as to expand their validity beyond 90 days. § 120.54(4), Fla. Stat. As set forth above, the clear language appearing in the FAR establishes September 19, 2017, as the effective date of the Emergency Rule. Had the Department wished to retain the effective date from the prior rule, it certainly could have done so. It did not. Petitioners’ challenge to the Emergency Rule was timely. Background Florida has had rules in effect for 18 years regarding the need for opioid treatment centers around the State. Florida Administrative Code Rule 65D-30.014 is entitled, “Standards for Medication and Methadone Maintenance Treatment.” This rule sets forth the process for providers to request licenses to establish new opioid treatment facilities, based on the Department’s annual determination of need. According to the rule, the Department is to conduct an annual assessment of need, publishing the results of that assessment by June 30 of each year, although, inexplicably, no assessment was done for calendar years 2016 or 2017. After the need assessment is published, the Department directs interested parties to submit applications for licensure to the Department’s district office in the area where the need exists. All such applications would have to be submitted no later than on a “closing date” to be provided by the Department. The Department’s district office would receive the application(s) and conduct a formal rating of the applicant(s). There were minimum requirements each applicant must meet in order to be considered for licensure. If the number of applicants exceeded the determined need, the selection of a provider would be done based on certain substantive criteria, e.g., number of years the applicant has been licensed; the organizational capability of the applicant; and the applicant’s history of noncompliance with Department rules. Pursuant to rule 65D-30.014, the Department had conducted assessments in calendar years 2012, 2013, 2014, and 2015. The award of licenses based on the 2012 and 2013 need assessment was delayed by litigation. A need for 31 additional treatment centers was found in 2014, but no applications were accepted by the Department due to the ongoing litigation relating to the previous years. The following year, 2015, the Department found a need for only five additional treatment centers, even though none of the 31 treatment centers identified as needed in 2014 had been awarded to anyone. The 2015 assessment was lower than the prior year due to some changes in the methodology used by the Department. The Department did not accept any applications to meet the established need in 2015. One rationale for not accepting applications, even though there was a need, was that the Department was drafting new rules. That process would give stakeholders an opportunity for input. The notices that the rules were being developed, however, were not filed until some 11 months after the 2015 need projections were published. The Department explained that it was busy with other rulemaking duties during that time, causing some delay. Developing the Emergency Rule After entry of the Governor’s executive orders, the Department began the process of distributing the federal grant money to existing treatment centers. The Department, though it never met with the Governor to discuss use of the grant funds, handed out the funds to various existing clinics in order to help them deal with the clinics’ backlogs and waiting lists. There was no discussion between the Governor and the Department concerning the necessity for new clinics. A needs assessment was apparently conducted by the Department. The Department based its assessment in part on data it had gathered when applying for the federal grant. Existing treatment centers had provided the Department waiting lists, indicative of a greater need than could be met by the existing clinics. That data, however, was only from public providers; private providers were not included. The public providers were essentially those contracting with the Department’s “managing entities,” who act as intermediaries between the provider and the Department. An emergency rule was proposed as the vehicle for addressing the need and acquiring applications for licensure. Though the Department’s Director of Substance Abuse and Mental Health thought it best to simply proceed with the rule currently under development, the Emergency Rule was pursued. The thinking at the Department was that the existing rule had created considerable litigation that the Emergency Rule might avoid. That did not happen. The emergent situation warranting an emergency rule was, according to the Department, the scenario described by the Governor in his executive orders. The Department of Health had declared a public health emergency, which was also used as a basis for creating the Emergency Rule. The federal grant funds, however, were not an impetus for creating the Emergency Rule. The Emergency Rule relied upon data from calendar year 2015, as it was the latest data available to the Department at that time. The Governor’s executive orders had also relied upon 2015 data. Some interim data had been available, but the only full year of information available at the time the rule was promulgated was for 2015. The interim data, however, indicated a sharp (approximately 30 percent) increase in need. The Department published a determination of need on its website on August 30, 2017. Apparently the need determination was not published in the FAR despite the directive to do so in subsection (3)(b) of the Emergency Rule. The Department found a need for one clinic each in 47 of Florida’s 67 counties, as well as for two in Hillsborough County, for a total of 49 new clinics. Pursuant to the Emergency Rule, interested applicants were to file an application on the Department’s approved form (CF-MH 4036, attached hereto as an Addendum) expressing an interest in becoming licensed in one or more of those counties. Such applications were to be “accepted at department headquarters from October 2, 2017, at 8 a.m., Eastern Time, until October 27, 2017 at 5 p.m., Eastern Time. Applications must be delivered to [the department].” In contrast to rule 65D- 30.014, applications under the Emergency Rule were to be filed at the Department’s headquarters in Tallahassee rather than in the various district offices around the State. The application form utilized by the Department is a one-page document. The form requests minimal identification information concerning the applicant and its business (questions 1 through 10). Question 11 asks if the applicant plans to accept Medicaid-eligible, indigent, and/or pregnant women as patients. The 12th question directs the applicant to submit documentation concerning its target population, proof of a physician on staff, the anticipated date of initiation of services, and proof of registration with the Department of Revenue or Division of Corporations. The Department also created a “review form,” used to check the completeness of applications. The review form mirrors the application, providing a space for the Department reviewer to state whether the applicant had completed each section of the application form. The Department maintains that the applicants’ responses to Question 11 were not considered in its review of the applications submitted under the Emergency Rule. This was because, according to the Department, a response to that question might favor one applicant over another. The Department did not elaborate as to how this “favoritism” might negatively affect the process. The question had been used under the prior rules and had been deemed important, presumably because--as reported by some of the parties herein--a large majority of their patients were either Medicaid-eligible, indigent persons, or pregnant women. It certainly was reasonable that the Department would ensure that those groups of citizens, who were undoubtedly accounted for in the need assessment, had access to approved treatment centers under the Emergency Rule. Nonetheless, the Department did not utilize the Question 11 responses in its review. This is contrary to the plain language of the Emergency Rule, which states: “Applications must be complete and responsive to all questions on this form.” (emphasis added). See 65DER17- 2(3)(b)1. The Emergency Rule as published contained the following language: “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.” Neither the Emergency Rule language nor the Department at final hearing provided a persuasive rationale for that statement and conclusion. In fact, the Department acknowledged that if the first person in line had filed applications for all 49 new clinics, all the other applicants would have been denied the right to seek licensure. How is that fair? What the Emergency Rule did was to set a window within which interested applicants could either mail, overnight-deliver, or hand-deliver a copy of the one-page application and attachments to the Department’s headquarters in Tallahassee. The Department felt that allowing applications to be submitted via email would potentially crash its email system, so email submission was not allowed. The applications received first by the Department were to be approved, notwithstanding any substantive shortcomings or comparative failings of those applications as compared to applications received later. No other criteria were considered; first was deemed best. What is fair about approving competing applications based on who filed first rather than on substantive differences in the services being proposed? What actually transpired vis-à-vis submission of the applications was not foreseen by the Department or by most of the applicants. That is, some applicants either lined up at Department headquarters days prior to the 8:00 a.m. acceptance time on October 2, 2017, or had someone wait in line for them. Then, when the doors opened at 8:00 a.m., the first person in line presented applications for 19 of the 49 sites identified by the Department as having a need. The second applicant in line submitted 17 applications, etc. By the time each of the Petitioners reached the front of the line, only minutes after the doors had opened, applications for their prospective counties of interest had already been filed. Under the Emergency Rule, the earlier filed applications were accepted without comparison to competing applications. As a result, Colonial was approved for 19 licenses; PAS was approved for 20; and Relax obtained eight; i.e., 47 of the 49 licenses were obtained by just three individual applicants. Again, the Department acknowledged that “[a]fter it, you know, happened the way it did, there were many considerations that we should have made.” Ute Gazioch, Jt. Exh. 6, page 81. Interestingly, the first application accepted by the Department was by an applicant who did not even appear at Department headquarters. That applicant, Lakeview Center, Inc., submitted its application via FedEx. The FedEx box containing Lakeview Center’s application was received and clocked in by an office at Department headquarters, other than the Substance Abuse and Mental Health office, at 7:40 a.m., i.e., prior to the window for filing. When the application made its way to the appropriate office, it was deemed received at 8:00 a.m. As a result, it was “first in line.” The incongruity of that situation was not persuasively justified by the Department. In fact, the Department testified that if all of the applications had been filed at the wrong office, it would likely have simply defaulted to an 8:00 a.m. arrival time for each one. Upon being approved, an applicant would then be allowed to submit an application for licensure. Under the licensure process, the applicant would be vetted in order to assure it met at least minimal requirements for obtaining a license. No comparison of the approved applicant to other applicants was made by the Department to ascertain whether another applicant might be superior as to services provided. Rather, if the approved applicant could satisfy, even minimally, the licensure requirements, it would be granted the right to seek a license. Once licensed, it could take considerable time and financial resources to effectuate the opening of a new opioid treatment clinic. There are many factors to be addressed and resolved, including but not limited to: acquisition of an appropriate site, whether by way of purchase of undeveloped property and new construction or lease/purchase of an existing building; construction or renovation, as needed; zoning concerns; permitting by state, county, and/or municipal bodies; staffing; coordination of state and federal licenses or certifications; etc. It is not uncommon for the process to take up to two years, sometimes more. In addition, the financial expenditures could be in the hundreds of thousands of dollars (and even as much as a million dollars) for each project. For this reason, the Department did not foresee that any entity might apply for so many applications as actually transpired. The likelihood that a single entity would have the time, money, or other resources to move forward on multiple products at one time is small. It is more likely that a single entity receiving approval for multiple new clinics might “bank” the approvals, expending time and money for only a few at a time, at best. If so, that could result in far fewer new clinics coming on line than the 49 projected by the Department under the Emergency Rule. As the applications contained no requirement to provide financial information, it is impossible for the Department to determine whether the approved entities, which received multiple approvals, could successfully–-and timely–-complete their projects. There is no specific time frame for which a granted applicant must commence operations once approved. However, as the approvals were done pursuant to an “emergency,” it follows that clinics should be opened as soon as practicable. Petitioners assert that the “first in line” scheme enunciated in the Emergency Rule is arbitrary, capricious, and patently contrary to a determination of the applicants’ ability to provide care to persons suffering opioid addiction. The facts bear that assertion out.
The Issue The issue is whether Billy H. Davis, on two occasions, sold to undercover detectives of the Miami Police Department the medicinal drug Ampicillin without prescriptions in contravention of Section 465.015(2)(c), Florida Statutes (1985), and is therefore subject to discipline pursuant to Section 465.016(1)(e), Florida Statutes (1985)?
Findings Of Fact Respondent, Billy H. Davis ("Mr. Davis"), at all times relevant herein, has been licensed as a pharmacist in the State of Florida, and has been issued license number 0010622. During the period at issue here, Mr. Davis was prescription manager for Service Drugs, Inc. located at 1304 N.W. 3rd Avenue, Miami, Florida 33136 (Exhibits 1 and 2). On March 27, 1985 Detective Carolyn Clarke of the Miami Police Department purchased thirteen red and gray capsules from Mr. Davis for $8.00 (T. 50, 54). She did not present a prescription during the transaction or represent that she had authorization from a physician to obtain any drugs for which a prescription is required (Tr. 52-3). In March of 1985 Officer Jesse J. Williams purchased twelve red and green capsules from Mr. Davis for $8.00 (Tr. 58- 61). He did not present a prescription or indicate that he had authorization from a physician to receive prescription medication during the transaction (Tr. 60). Upon analysis at the Metro Dade Police Department Crime Laboratory, the capsules purchased by Detectives Clarke and Williams proved to be Ampicillin (Tr. 63-77, Department Exhibits 7 and 8). Ampicillin is a prescription or medicinal drug in the United States (Tr. 96). Mr. Davis has sold or dispensed drugs as defined in Section 465.003(7), Florida Statutes (1985) without first being furnished with a prescription. When the drugs were sold, Mr. Davis had been told by the purchasers that they needed medication either for gonorrhea (Tr. 50) or for an unspecified venereal disease (Tr. 59). Oral antibiotics are not the appropriate treatment for drug-resistant strains of gonorrhea, such as penicillinase- producing neisseria gonorrhea ("PPNG") (Tr. 87). There has recently been a large outbreak of PPNG in Florida, and specifically Dade County and Miami (Tr. 89), with a large portion of the disease occurring in the black community in the Liberty City and Overtown areas (Tr. 90). Self-administration of antibiotics has played a role in the propagation of PPNG, because when there is a drug-resistant strain of venereal disease in a community and patients take antibiotics not appropriate to treat their condition, patients believe that they are getting better when they are still infectious (Tr. 93-94). This may cause those patients, if women, to develop pelvic inflammatory disease which can lead to infertility and occasionally users can develop an infection of the heart valves known as bacterial endocarditis (Tr. 94-95). It is not possible for patients to tell from symptoms or by mere physical examination whether they have been- infected with a drug-resistant strain of PPNG: a patient must have a culture done by a physician to make this determination (Tr. 96).
Recommendation Based on the foregoing, it is recommended that a final order be entered finding Mr. Davis guilty of violating Sections 465.015(2)(c) and 465.016(1)(e), Florida Statutes (1985). In view of the well-intentioned nature of Mr. Davis' actions, the apparent absence of any profit motive, but keeping in mind the potential public health hazard involved in dispensing of medicinal drugs for the relief of venereal disease without prescription, it is recommended that pursuant to Section 465.016(2)(b), Florida Statutes, his license to practice pharmacy be suspended for a period of thirty days; pursuant to Section 465.016(2)(c), Florida Statutes, that he be fined a total of $250.00; and pursuant to Section 465.016(2)(e), Florida Statutes, within one year he be required to attend continuing education courses pertaining or relating to the appropriate use of medicinal drugs in the treatment of venereal disease. DONE AND ORDERED this 17th day of June 1986 in Tallahassee, Leon County, Florida. WILLIAM R. DORSEY,JR., Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 17th day of June 1986. COPIES FURNISHED: Bruce D. Lamb, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Mr. Billy H. Davis 1304 N.W. Third Avenue Miami, Florida 33136 Mr. Rod Presnell Executive Director Board of Pharmacy Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Mr. Fred Roche Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Salvatore A. Carpino, Esquire General Counsel Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 ================================================================= AGENCY FINAL ORDER =================================================================
Findings Of Fact Richard Templeton is a registered nurse holding license #RN 137921-2 issued by the State Board through the Department of Professional Regulation. At all times pertinent to this case, Respondent was employed at Morton Plant Hospital, Clearwater, Florida. On the night of 19/20 July, 1983 Respondent was charge nurse on ward Bernard 5 at Morton Plant Hospital, and was responsible for the administering of medications to include controlled substances, to David Johnson. There were approximately 45 patients on the ward, and Respondent was responsible for at least one third of them. The narcotic sign out sheets reflect that Respondent signed out for 100 mg Demerol at 1:15 A.M. & 4:15 A.M. for David Johnson on said night. Johnson's nursing notes in his medical chart for 7:00 A.M. reflect that Johnson was given 2 pain medicines at 1:15 & 4:15. Johnson's charts reflect he got sleeping medicines at 11:50 P.M. and was sleeping at 2:00 A.M. & 6:00 A.M. 2/ Johnson testified as to the medicines he received while a patient at Morton Plant Hospital in July 1983. Johnson stated he did not receive any injections prior to his pre op medicines which were administered at approximately 1-2:00 P.M. on 20 July, 1983. Johnson's testimony is very concrete and reflects a good recollection of events. His testimony is borne out by the records and is credible. On April 2, 1984 the Respondent entered a plea of nolo contendere to criminal charges that he had violated Chapter 893.13(3)(a)1, Florida Statutes. See Petitioner's Exhibit 2. The court found the Respondent guilty of said charges. Registered nurses have a legal obligation to administer or waste properly controlled substances which they sign out, and to chart the administration of drugs they administer. Mepheridine is the generic name for Demerol, and is a controlled substance pursuant to Chapter 893, Florida Statutes.
Recommendation Having found the Respondent guilty of violating Sections 464.018(1)(c), Florida Statutes, it is recommended the Respondent's license be revoked; however, it is recommended that the revocation be suspended and the Respondent's license be suspended for one year and placed upon probation for two years thereafter during which time the Respondent would be required to submit regular drug screening tests and adhere to any other reasonable conditions imposed by the Board. Having found the Respondent guilty of violating Section 464.018(1)(f), Florida Statutes, it is recommended the Respondent's license be suspended for three years; however, it is recommended that the final two years of the suspension be abated and the Respondent be placed upon probation the final two years during which time the Respondent would be required to submit regular drug screening tests and adhere to any other reasonable conditions imposed by the Board. DONE and ORDERED this 28th day of June, 1985, in Tallahassee, Florida. STEPHEN F. DEAN Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 28th day of June, 1985.
The Issue The issues are whether Respondent violated Sections 458.331(1)(m), 458.331(1)(q), 458.331(1)(s), and 458.331(1)(t), Florida Statutes, and if so, what penalty should be imposed.
Findings Of Fact Petitioner is the state agency charged with regulating the practice of medicine pursuant to Section 20.42, Florida Statutes, and Chapters 455 and 458, Florida Statutes. Respondent is licensed to practice medicine in the state of Florida. She holds license number ME 0028693. 3 Respondent, a native of Manila, Philippines, attended medical school and received her M.D. degree in 1965 from Manila Central University. She completed an internship and residency in OB-GYN in Manila before immigrating to the United States in 1968. Respondent became a citizen of the United States in 1972. She obtained her license to practice medicine in the state of Florida in 1973. Thereafter, Respondent completed a residency in general practice in Portsmouth, Virginia, and a residency in pathology in Norfolk, Virginia. She is not board certified. Prior to October 23, 1996, Respondent was engaged in a solo practice of general and family medicine. Except for this proceeding, Respondent has never been the subject of disciplinary action in connection with her medical license. She has never had a medical malpractice claim asserted against her. Fiorinal No. 3 or Fiorinal with codeine is a legend drug as defined by Section 465.003(7), Florida Statutes. Fiorinal No. 3 is also a Schedule III controlled substance which is listed in Section 893.03, Florida Statutes. In March of 1991, Respondent began treating Patient G.C. for symptoms related to menopause and anxiety. Respondent's record of G.C.'s initial visit indicates that G.C. is allergic to penicillin and codeine. G.C. made 46 visits to Respondent's office from March 12, 1991 through February 21, 1995. On 37 of these visits, Respondent's records note G.C.'s allergy to codeine. On September 19, 1991, G.C. complained that her knee and calf on her right leg were hurting. Respondent ordered a venogram and prescribed Lorcet Plus for G.C. On December 13, 1991, G.C. complained that she had a cough, sore throat, and congestion. Respondent prescribed Lorcet Plus for G.C. in addition to other medication. G.C. made 15 visits to Respondent's office from June of 1995 through September of 1996. Respondent's records of these visits do not note G.C.'s allergy to codeine. Respondent did not charge G.C. for six of these visits. G.C. complained of pain and swelling in her left elbow on October 31, 1995. Respondent treated G.C. for bursitis and gave her a prescription for Fiorinal No. 3. Respondent did not charge G.C. for this visit. G.C. complained of pain in her elbow again on December 19, 1995. Respondent treated G.C. for bursitis and prescribed Fiorinal No. 3. Respondent did not charge G.C. for this visit. Respondent's records indicate that she saw G.C. for the last time on September 20, 1996. The records do not indicate the purpose of the visit. There is a notation which states, "Last time I'll give this Rx to her," followed by three prescriptions including Fiorinal No. 3. Respondent testified that she prescribed Fiorinal for G.C. because she had previously taken Lorcet with no problems or reactions. Lorcet, like Fiorinal, contains codeine. Allergic reactions to codeine can range from mere rashes to life-threatening problems. Accordingly, prescribing Fiorinal No. 3 for G.C. was contraindicated. Respondent concedes that G.C.'s medical chart was deficient in several ways. It failed to contain an adequate medical history, failed to reflect proper physical examinations, failed to reflect adequate tests and lab studies, and failed to fully document conditions/symptoms to warrant treatment rendered, including medications prescribed. Respondent and G.C. developed a social relationship in 1995. Respondent and G.C. were taking trips together, going out to eat together, and seeing each other quite often in a social setting. G.C. told Respondent that some investors in Sicily wanted to buy Respondent's medical practice. Respondent and the foreign investors could not agree on the terms of sale. Respondent lent G.C. a large sum of money in cash. G.C. would not re-pay the loan or acknowledge the debt. The friendship between G.C. and Respondent began to deteriorate. In March of 1996, G.C. contacted Lynn Flanders, a narcotics investigator from the Escambia County Sheriff's Department. G.C. informed Ms. Flanders that Respondent had written a prescription for Fiorinal No. 3 in G.C's name with the intention of diverting the medicine for her own consumption. The prescription was dated January 15, 1996. Respondent's records do not indicate that G.C. made a visit to Respondent's office in January of 1996. G.C. planned to meet Respondent at a restaurant on March 19, 1996. Before the meeting, Investigator Flanders had the prescription filled at a local drug store. She equipped G.C. with an audio listening device. Ms. Flanders also searched G.C.'s car and person. Finding no drugs or money in G.C.'s possession, the investigator gave the bottle of Fiorinal capsules to G.C. and sent her to meet Respondent at the restaurant. Investigator Flanders seated herself in the restaurant so that she could observe Respondent and G.C. during the meal. Respondent never left the table. Ms. Flanders was unable to observe G.C. when the confidential informant went to the ladies' room. The investigator did not see G.C. hand the prescription bottle to Respondent. After Respondent and G.C. ate lunch, they left the restaurant. Investigator Flanders subsequently discovered that the audio tape was inaudible. Ms. Flanders told G.C. to call the sheriff's office if the doctor gave her another prescription and asked her to get it filled. As referenced above, Respondent gave G.C. a prescription for Fiorinal No. 3 on September 20, 1996. Although the prescription was in G.C's name, Respondent intended to consume the medicine herself. G.C. contacted Investigator Flanders again. She told Ms. Flanders about the prescription. The investigator took the prescription and had it filled at a local drug store. G.C. planned to meet Respondent at another restaurant on September 15, 1996. Before the meeting, Investigator Flanders equipped G.C. with an audio listening device, searched her car and person, gave her the bottle of Fiorinal No. 3 capsules, and sent her to meet Respondent. Investigator Shelby and his partner arrived at the restaurant before G.C. or the Respondent. Investigator Shelby positioned himself in the restaurant so that he could observe G.C. and Respondent. Investigators located outside of the restaurant monitored the listening device. They recorded the conversation between Respondent and G.C. Investigator Shelby saw G.C. take the bottle containing 30 Fiorinal No. 3 capsules from her shirt pocket and pass it under the table to Respondent. Respondent leaned forward, accepted the bottle under the table, and placed it in her purse. Respondent left the restaurant and entered her vehicle. She was then placed under arrest. The bottle of medicine, containing 30 capsules, was recovered from her purse. Respondent's testimony that she did not intend to divert the narcotic for her own consumption is not persuasive. Criminal charges against Respondent are being processed through the Pretrial Intervention Program for nonviolent first offenders. Charges against Respondent will be dismissed if she does not commit any offense for ten months after March 27, 1997, and provided that she satisfactorily completes the program. As part of the ten-month probation, Respondent agreed to voluntary urinalysis and compliance with the mandates of her recovery program through the Physician's Recovery Network (PRN). Respondent has a history of chronic daily headaches and hypertension. She has been taking Fiorinal No. 3 which contains codeine and aspirin since 1972. Respondent was diagnosed with a bleeding ulcer just before her arrest in September of 1996. Her treating physician prescribed Fioricet which contains codeine but no aspirin. Respondent accepted this prescription without telling her treating physician about her codeine dependency. Respondent divorced her husband for the second time in August of 1996. Around the time of her arrest, Respondent experienced a lot of stress as a result of her relationship with her ex-husband. PRN is Florida's impaired practitioner program. Pursuant to contract with Petitioner, PRN offers educational intervention, treatment referral, and rehabilitation monitoring services for health care workers in Florida. The PRN's director, Dr. Roger Arthur Goetz, became aware of Respondent's arrest on October 3, 1996. On his recommendation, Respondent voluntarily agreed to undergo an evaluation by the following three doctors in Pensacola, Florida: (a) Dr. Rick Beach, an addiction specialist; (b) Dr. Doug H. Fraser, a board certified psychiatrist; and (c) Dr. Thomas Meyers, a psychologist. Dr. Beach and Dr. Meyers agreed that Respondent was impaired due to a substance abuse problem. All three doctors agreed that Respondent suffered from a depressive disorder and other psychological problems. Dr. Beach, the addictionologist, determined that Respondent had a dysfunctional relationship with her ex-husband, an unhealthy relationship with G.C., and a probable dependence on opiates. Dr. Fraser, Respondent's psychiatrist, diagnosed Respondent with generalized anxiety disorder and dysthymia. Generalized anxiety disorder is a life-long disorder from which the patient experiences a chronic sense of nervousness, tension, and worry. A patient suffering from this condition will have some physical symptoms such as gastrointestinal problems, headaches, muscle tension, or difficulty sleeping. Dysthymia is also a chronic life-long disorder which causes patients to suffer from chronic minor depression more days than not. On October 23, 1996, Respondent entered into a Voluntary Agreement to Withdraw from Practice with Petitioner. This agreement states that Respondent shall cease practicing medicine until Petitioner issues a Final Order in this case. On November 4, 1996, Respondent entered Jackson Recovery Center in Jackson, Mississippi. This facility was an in-patient substance abuse treatment center. Respondent's treating physician, Dr. Lloyd Gordon, admitted her for treatment with the following diagnosis: (a) Axis I, opioid dependence and dysthymia with anxiety; and (b) Axis II, avoidant and dependent traits. Respondent subsequently entered a residential treatment program, the Caduceus Outpatient Addictions Center (COPAC), in Hattiesburg, Mississippi. COPAC specializes in the treatment of physicians and other health care workers who abuse controlled substances. Respondent remained in this residential program for almost three months. She was discharged from COPAC on February 21, 1997. Respondent signed an Advocacy Contract with PRN the day that she was discharged from COPAC. The contract established a five-year monitoring period during which Respondent agreed to abide by certain terms and conditions, including but not limited to, the following: (a) to participate in a random urine drug and/or blood screen program; (b) to abstain from the use of controlled substances; (c) to attend group self-help meetings such as AA or NA; (d) to attend continuing care group therapy; and (e) to attend a twelve-step program for recovering professionals. In March of 1997, Respondent went to her office to see patients. She wrote prescriptions for some of these patients. She was under the impression that she could return to her practice because she had been therapeutically cleared to practice by COPAC. PRN learned that Respondent was practicing medicine in violation of her agreement to voluntarily withdraw from practice. PRN advised Respondent that she could not go into her office to see patients or write prescriptions until Petitioner gave her that right. Respondent immediately ceased her practice. Upon her discharge from COPAC, Respondent continued to see her psychiatrist, Dr. Fraser. In May of 1997, Respondent told Dr. Fraser that she was experiencing forgetfulness and panic attacks. She complained of having difficulty making decisions and sleeping. Respondent was feeling depressed and having suicidal thoughts. Dr. Fraser increased her antidepressant medication and referred her to a local counseling center. Respondent went to visit her family in California from May 25, 1997 through June 6, 1997. She did not tell Dr. Fraser that she was going out of town. However, she did tell one of the therapists from Dr. Fraser's office about the trip. Respondent saw Dr. Fraser again on June 18, 1997, when she returned to Pensacola. He made a tentative diagnosis of bipolar disorder and began appropriate treatment. Respondent was feeling better when she saw Dr. Fraser on June 25, 1997. Respondent moved to California to live with her sister on July 6, 1997. This move was necessary because Respondent had lost her home as well as her practice. While she was in California, Respondent saw a psychiatrist, Dr. Flanagan. She also attended AA meetings in California. Respondent returned to Pensacola a week before the hearing. She saw Dr. Fraser on August 21, 1997. Dr. Fraser was not aware that Respondent had been living in California and receiving treatment from Dr. Flanagan. During her visit with Dr. Fraser, Respondent admitted that she had a craving for codeine when she was tense. However, she denied use of any prescription drugs except those being currently ordered by her doctors. Respondent reported on-going mood swings even though Dr. Flanagan had increased her Depakote. She verbalized fantasies involving violent behavior toward G.C. Respondent revealed that she was experiencing grandiose delusions. She admitted that she was not ready to return to medical practice. Dr. Fraser concurs. Respondent needs intensive individual psychotherapy for at least six months on a weekly basis. At the time of the hearing, Respondent had not begun such therapy. The record indicates that Respondent was a caring and compassionate physician. Respondent's elderly patients testified that Respondent treated them with extraordinary concern when other doctors refused. Respondent's colleagues in nursing home settings attested to her skill and proficiency in the care of the elderly. None of these patients or associates were aware of Respondent's drug dependence or psychological problems before her arrest. Respondent is "in recovery" for her drug dependence. However, she is not mentally, emotionally, or psychologically ready to practice medicine with reasonable skill and safety for her patients.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is recommended that Petitioner enter a Final Order indefinitely suspending Respondent's license to practice medicine until she is able to demonstrate the ability to practice with reasonable skill and safety followed by five years of probation with appropriate terms, conditions, and restrictions, and imposing an administrative fine in the amount of $4,000. DONE AND ENTERED this 22nd day of October, 1997, in Tallahassee, Leon County, Florida. SUZANNE F. HOOD Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (904) 488-9675 SUNCOM 278-9675 Fax Filing (904) 921-6847 Filed with the Clerk of the Division of Administrative Hearings this 22nd day of October, 1997. COPIES FURNISHED: John E. Terrel, Esquire Agency for Health Care Administration Post Office Box 14229 Tallahassee, Florida 32317-4229 James M. Wilson, Esquire Wilson, Harrell and Smith, P.A. 307 South Palafox Street Pensacola, Florida 32501 Marm Harris, Executive Director Department of Health 1940 North Monroe Street Tallahassee, Florida 32399-0792 Angela T. Hall, Agency Clerk Department of Health 1317 Winewood Boulevard, Building 6 Tallahassee, Florida 32399-0700
The Issue The issues to be determined are whether Respondent possessed Dilaudid without a legitimate purpose, and whether Respondent is unable to practice nursing with reasonable skill and safety, in violation of section 464.018(1), Florida Statutes, as alleged in the Administrative Complaint and, if so, the appropriate penalty.
Findings Of Fact The Department of Health, Board of Nursing, is the state agency charged with regulating the practice of nursing in the state of Florida, pursuant to section 20.43, and chapters 456 and 464, Florida Statutes. At all times material to this proceeding, Lisa Michelle Jackson was a licensed registered nurse in the state of Florida, holding license number RN 9375240. Respondent’s current address of record is 2358 York Street, Jacksonville, Florida 32207. On Saturday, November 7, 2015, Respondent left work and picked up her minor son from her parents’ house. She drove home, parked at her front door, and lost consciousness. At some point, Respondent’s parents called her cell phone. The phone was answered by Respondent’s son, who advised them of the situation. Respondent’s parents went to her house, and apparently called emergency medical services. EMS personnel arrived on the scene and administered Narcan to Respondent. Narcan is a medication that blocks receptors for opioid-based drugs, and is used to reverse the effects of opioids. It is commonly used when medical personnel suspect a patient of an opioid overdose. Respondent was thereafter transported to St. Vincent’s Riverside Medical Center (Riverside), and admitted with encephalopathy and acute respiratory failure. Respondent had to be placed on a respirator. A urine drug screen was performed, which returned positive for benzodiazepines and opiates. Riverside related the encephalopathy and respiratory failure to a suspected drug overdose. Respondent denied having taken anything containing benzodiazepines. She did indicate that approximately a year earlier she had undergone a tooth extraction, for which her dentist had prescribed Percocet. She had some left over, and testified that she had taken some for back pain several days before November 7, 2015. Respondent was discharged from Riverside on November 9, 2015, at approximately 11:40 a.m. After her discharge from Riverside on November 9, 2015, but later that afternoon, Respondent was speaking with her mother on the telephone. Respondent’s mother did not like the way she sounded, and came to the house. Respondent’s mother believed that Respondent was lethargic, but Respondent admitted only to being tired from her earlier hospital stay. EMS was called, and Respondent was again transported to Riverside, where she was admitted at approximately 5:45 p.m. Her diagnosis on admission was hypertensive disorder. She self-discharged against medical advice, signing the discharge papers at 6:36 p.m. There was no evidence that Respondent’s admission to Riverside on November 9, 2015, was the result of the use or abuse of any substance. On November 20, 2015, Respondent and Carl Nesmith were at Respondent’s residence. Respondent testified that she was experiencing back pain. At some time during the evening, Respondent took three or more Dilaudid tablets. Respondent testified that the tablets belonged to Mr. Nesmith, though the evidence was not sufficient to support a finding to that effect. Nonetheless, by the time of the arrival of the EMS team and her subsequent admission to Riverside as described herein, the tablets were in her possession. Dilaudid is a brand name of hydromorphone, an opioid. Pursuant to section 893.03(2)(a)1.k., Florida Statutes, hydromorphone is a Schedule II controlled substance that “has a high potential for abuse and has a currently accepted but severely restricted medical use in treatment in the United States, and abuse of the substance may lead to severe psychological or physical dependence.” Respondent did not have a prescription for Dilaudid. At some point during the evening of November 20, 2015, Respondent passed out in her bathroom. EMS was called and dispatched to Respondent’s residence. The inference is that Mr. Nesmith called them, but since Respondent was unconscious, and Mr. Nesmith did not testify, the identity of the caller is not known. More to the point, the identity of the caller is not relevant. When EMS personnel arrived, they found Respondent unresponsive on the bathroom floor. Mr. Gorsuch recognized Respondent’s symptoms, including agonal breathing, as characteristic of an opioid overdose, and administered Narcan to counteract the effects of the suspected drug. The Narcan “worked,” and Respondent regained consciousness. EMS personnel discovered a plastic bag with loose pills in Respondent’s purse. The pills were taken with Respondent as she was transported by EMS to Riverside. Respondent was received at the Riverside emergency room shortly after midnight on November 21, 2015. Her condition was described as “drowsy but arousable with slurred speech.” Upon her arrival at Riverside, Ms. Quartano observed that Respondent was clutching a Ziplock-type bag of pills in her hand. How the pills came to be in her hand was not explained. Whether in her purse or in her hand, the pills were in Respondent’s possession. The pills were provided to Dr. McBride Johnson, who identified the pills as Dilaudid based on their shape, color, and markings. Respondent’s diagnosis upon admission was acute encephalopathy; poisoning by unspecified drugs, medicaments, and biological substances, accidental, initial encounter; and altered mental status. Respondent underwent a urine screening, which returned positive for benzodiazepines. Despite the fact that Respondent knew that she had taken “pills” during the evening in question, she denied to hospital personnel that she had taken any drugs or alcohol. As she had on November 9, 2015, Respondent self- discharged against medical advice, signing the discharge papers at 5:30 a.m. Upon her discharge from the hospital, Respondent was taken into custody by Sergeant Coleman from the Jacksonville Sheriff’s Office. Respondent told Sergeant Coleman that the Dilaudid had been given to her by a friend for back pain, and that she had them for several days. Despite her deposition testimony that she had taken pills allegedly provided to her by Mr. Nesmith, she told Sergeant Coleman that she had taken one of her previously prescribed Percocet tablets, and denied having taken any of the pills given to her by her “friend.” Respondent was then placed under arrest. Respondent’s mother had, for years, taken care of Respondent’s son while Respondent was working, often at night. Between November 2015 and January 2016, Respondent’s parents took over primary care of her son in order to provide him with a more stable environment. There is no evidence that Respondent ever diverted opioids, or any other drugs, from her employer. However, after having been visited by a Department of Health investigator, Respondent’s employer, University of Florida Health - Shands (Shands), first suspended and then, in January 2016, terminated Respondent’s employment as a registered nurse. On February 14, 2016, a Jacksonville Sheriff’s Deputy performed a traffic stop on Respondent after observing her fail to maintain her lane of traffic, stop past the stop bar at a stop light, drive up onto the curb nearly striking a pole, drive onto another curb and nearly onto the sidewalk, and while attempting to negotiate a turn, nearly strike another pole. The deputies called to the scene observed that Respondent had bloodshot eyes, slurred speech, lethargic movements, and that she was unsteady on her feet. She underwent Field Sobriety Exercises but failed to perform them to standard. Respondent testified that she had taken some over-the- counter sleeping medication at least 12 hours before being stopped. She could think of no reason why such medications would have had an effect on her by the time of the stop. Respondent stated that her erratic driving was caused by her vehicle pulling to the right and being difficult to control, which was consistent with her deposition testimony that it was because her car needed an alignment. That explanation was not believable. Respondent was arrested for driving while under the influence. The charges were ultimately reduced to reckless driving, but Respondent was required to attend DUI driving school, attend the DUI Victim Impact Panel, and perform community service. On March 15, 2016, Respondent was walking from her mother’s house to her car when she passed out in her mother’s yard. The Jacksonville Fire and Rescue Department responded, arriving at approximately 12:15 p.m. The EMS personnel administered Narcan to Respondent, and transported her to Baptist Medical Center (Baptist). By the time she arrived, she was able to communicate with medical personnel, and attributed the incident to a fight with her mother, and lightheadedness from not eating that day. Respondent testified that “they told me at the hospital that I had morphine in my system, and I had no morphine.” Respondent’s understanding of what she was told is not substantiated by the Baptist medical records. Thus, the evidence is not sufficient to support a finding that Respondent had morphine in her system on March 15, 2016. Respondent was discharged from Baptist at approximately 1:15 p.m., about an hour after her arrival. Beginning “towards the end of 2015,” and extending “maybe up until March or April [2016], maybe a little later,” Respondent went to the Jacksonville Metro Treatment Center where she received daily methadone treatments in an effort to wean herself off of controlled substances. She “somewhat” received counseling, but the substance of her testimony indicates that the methadone was the driving cause of her visits to the treatment center. She stopped attending the treatment center due to the cost. From April 2016, when she stopped receiving methadone treatment at the Jacksonville Metro Treatment Center, until June or July 2016, Respondent received outpatient Suboxone treatment at Merit Health River Region, which accepts Medicaid. Suboxone is like methadone, but it blocks opioid receptors. Respondent stopped going to River Region because it was hard for her to get there due to transportation issues. Respondent did not complete her treatment, and she was not advised that she was in remission or that she should discontinue her treatment. Respondent has received no substance abuse treatment since she stopped going to River Region. On or about March 17, 2016, Dr. Sanchez evaluated Respondent as allowed by section 464.018(1)(j). The evaluation included not only a face-to-face interview with Respondent, but included a review of records, including medical and law enforcement records, related to each of the incidents described herein. During the evaluation, Respondent advised Dr. Sanchez that she had used opioids “opportunistically” for about 10 years, with her usage being sporadic and impulsive. Respondent further advised Dr. Sanchez that she had used a Fentanyl patch three to four days prior to the evaluation. Pursuant to section 893.03(2)(b)9., Florida Statutes, Fentanyl is a Schedule II controlled substance with the same potential for abuse as Dilaudid. Respondent did not have a prescription for Fentanyl. Dr. Sanchez opined that Respondent’s use of Fentanyl that close to the evaluation, with the risk of detection in the toxicology screen, was an indication of the strength of her addiction. Respondent did not tell Dr. Sanchez about the March 15, 2016, incident during which she passed out in her mother’s yard, an incident that occurred only two days prior to the evaluation. She agreed that the incident would have been relevant to Dr. Sanchez’s evaluation. The failure to disclose the incident is indicative of an evasive attitude towards matters that would reasonably be expected to affect Respondent’s ability to practice nursing with reasonable skill and safety. Dr. Sanchez noted that Respondent had a history of emergency room visits over extended periods of time with different pain complaints, including back pain, abdominal pain related to gastric bypass surgery, and a broken tooth, all of which resulted in recommendations for short-term opiate therapy. Dr. Sanchez opined that Respondent’s actions suggested drug- seeking behavior. However, the maladies described, including a bulging disc from a car accident, and chronic tooth issues including, at the time of the evaluation, an abscess, were diagnosed by physicians, who prescribed pain management medications, and were not illusory. Regardless of whether Respondent’s use of opioids was initiated as a result of a medically-prudent prescription, the evidence is clear and convincing that Respondent’s use has passed to the stage of addiction. Dr. Sanchez opined that the incident on November 7, 2015, when Respondent took some form of opioid and picked up her child on the way home, ultimately losing consciousness at the wheel of her car, was evidence of a strong compulsion to use opioids. Dr. Sanchez’s opinion that this incident indicated a significant lack of judgment and control is credited. The incident on November 20, 2016, is further strong evidence of a growing and dangerous addition. In light of the other incidents described herein, and Respondent’s familiarity with opioids over the years, both as a patient and a nurse, Respondent’s testimony that she did not understand what she was taking that evening is simply not credible. Dr. Sanchez stated the circumstances surrounding Respondent’s February 14, 2016, arrest for driving under the influence is further evidence that Respondent was “losing control” of her addiction. The suggestion that the incident was the result of poor alignment is not credible, particularly in light of Respondent’s appearance and performance during the stop. Dr. Sanchez determined that Respondent refuses to accept responsibility for her behavior and remains in denial of her substance abuse issues, a conclusion that is supported and accepted. As a result of his evaluation, Dr. Sanchez diagnosed Respondent with severe opioid use disorder. He opined that Respondent has significantly impaired judgment due to her substance abuse, which precludes her from functioning as a registered nurse with the necessary skill and safety to patients. His testimony is credited. Dr. Sanchez further opined that Respondent requires an extended period of continuous supervision with monitoring, substance abuse treatment, random toxicology testing, and an extended period of time of documented abstinence from controlled substances before Respondent would be able to practice nursing with sufficient skill and safety to patients. He recommended that Respondent complete a full course of treatment geared to substance abuse and chemical dependency, initially as inpatient treatment, followed by an intensive outpatient program after a reasonable period of abstinence. Finally, Dr. Sanchez recommended that Respondent execute an Intervention Project for Nurses (IPN) monitoring agreement. IPN is the impaired practitioner program for the Board of Nursing, pursuant to section 456.076. IPN monitors the evaluation, care, and treatment of impaired nurses. IPN oversees random drug screens and provides for the exchange of information between treatment providers, evaluators, and the Department for the protection of the public. Respondent has not entered any form of inpatient treatment, though she indicated that she is currently on a wait- list for inpatient treatment, has discontinued outpatient treatment, and has not entered into an IPN agreement.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Department of Health, Board of Nursing, enter a final order: determining that Respondent violated sections 464.018(1)(i) and 464.018(1)(j); imposing a suspension of license number RN 9375240 for one year and thereafter until such time as Respondent personally appears before the Board and can demonstrate the present ability to engage in the safe practice of nursing, with such demonstration to include at least one IPN evaluation in which the evaluator finds Respondent to be able to engage in the safe practice of nursing or recommend the conditions under which safe practice could be attained; requiring compliance with IPN recommendations and contract conditions, as imposed; imposing an administrative fine in the amount of $250.00; and awarding costs incurred in the prosecution of this case to the Department. DONE AND ENTERED this 29th day of November, 2016, in Tallahassee, Leon County, Florida. S E. GARY EARLY Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 29th day of November, 2016. COPIES FURNISHED: Lisa Michelle Jackson 2356 York Street Jacksonville, Florida 32207-3541 (eServed) Rob F. Summers, Esquire Brynna J. Ross, Esquire Prosecution Services Unit Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 (eServed) Nichole C. Geary, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 (eServed) Joe Baker, Jr., Executive Director Department of Health 4052 Bald Cypress Way, Bin C02 Tallahassee, Florida 32399-1701 (eServed) Jody Bryant Newman, EdD, EdS Department of Health 4052 Bald Cypress Way, Bin C02 Tallahassee, Florida 32399-1701
