The Issue The issue is whether Dr. Namen is entitled to a re-grading of the score which he received on the written clinical portion of the podiatry examination given in Orlando in July 1990.
Findings Of Fact Dr. Namen is a candidate for licensure as a podiatrist and sat for the clinical portion of the podiatry examination administered in Orlando in July 1990. At the time of the final hearing, Dr. Namen challenged the Department's grading of his answers to questions 3, 47, 118, and 145. At the final hearing, the expert for the Department, Dr. Warren Simmonds, agreed with Dr. Namen that the challenges to the grading of questions 3 and 118 had merit. Dr. Namen's score was increased so that Dr. Namen would be entitled to a passing score if the answers he gave to either of the two remaining questions under challenge, questions 47 and 145, were correct. Question 145 is based on case history #50, concerning a patient with a painful left ankle. Although the case history does not state directly that the joint is inflamed, it does state that "the joint is slightly warm" which is an indication of the presence of inflammation, which is confirmed by the patient's report of pain in the joint. Question 145 asked which of a number of possible treatments was the "least indicated (emphasis in original)." Dr. Simmonds testified that the answer chosen by the Board, "systemic adrenal corticosteroid therapy," was the least indicated treatment because of the side effects of steroids. Dr. Simmonds believes that steroids should not be used unless there is some acute inflammatory reaction which needs to be controlled. The best treatment, or the treatment of choice, is a non-steroidal anti-inflammatory drug. Dr. Namen contends Tylanol is the least indicated treatment because all available choices other than Tylanol were anti-inflammatory drugs, and the case history provides an indication of inflammation. Tylanol relives pain but has no anti-inflammatory effect, and is therefore the least appropriate treatment. The question stem is somewhat unusual because it asks the candidate for the "least indicated" treatment. Since Tylanol has no anti-inflammatory effect at all, Dr. Namen's testimony was persuasive that the "least indicated" treatment was Tylanol. Among the remaining choices, systemic adrenal corticosteroid therapy is the least appropriate among that group, but all answers within that group are better answers than administration of Tylanol. Question 47 is based on case history 19 concerning the appropriate dose of anesthetics to be used in a procedure for the removal of toe nails on a 58- year-old, Caucasian male weighing 150 pounds. The case history states that a certain combination of two anesthetics was used, bupivicaine and lidocaine. The question asks "how close to toxic dose would use of the entire amount bring the patient." The Department's answer was that the stated dose would be within 96 percent of a toxic dose; Dr. Namen believed that the use of the anesthetics in the amounts stated would bring the patient only within 66 percent of a toxic dose. The crux of the question is whether the toxicities for the two anesthetics interact in such a way that their toxicities must be added, or whether the correct answer involves only the calculation of the toxicity of the drug with the higher level of toxicity. On balance, the Department's answer is the most persuasive. The article in the Journal of Anesthesiology written by deJong and Bonin concludes, based upon their research which is described in the article, that local anesthetic toxicity for lidocaine and bupivicaine are essentially additive. The letter from Dr. Orta only states that the administration of both the lidocaine and bupivicaine at the doses described in the question are "well below toxic level." This observation does not answer the question posed, which is just how far below the toxic level use of the mixture stated would bring the patient. The letter from Dr. Padron, also a board certified anesthesiologist offered by Dr. Namen, says that "studies on compounding local anesthetics were done in animals and it was found that the toxicity was synergistic rather than additive," but no study was offered in evidence. The study in the Journal of Anesthesiology the Department offered into evidence is to the contrary. The evidence based on actual research is more persuasive. Dr. David's letter only reports in a hearsay fashion the opinion of an unidentified pharmacologist, and is entitled to little weight.
Recommendation It is therefore, RECOMMENDED that a final order be entered by the Department of Professional Regulation raising Dr. Namen's score, and designating him as having successfully completed the examination in clinical podiatry. DONE AND ENTERED in Tallahassee, Leon County, Florida, this 1st day of April 1992. WILLIAM R. DORSEY, JR. 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 1st day of April 1992.
Findings Of Fact The parties stipulated that Monroe C. Schiffman is a pharmacist licensed by the Florida Board of Pharmacy. They further stipulated that Sharon Drugs, d/b/a Mercy Professional Building pharmacy is located at 3661 south Miami Avenue, Miami, Florida and that Sharon Drugs owns and operates Mercy Professional Building Pharmacy. The parties also stipulated that Monroe C. Schiffman was a corporate officer and share holder in Sharon Drugs, Inc., a Florida corporation, from February 1, 1975 until the dates of the audits in question and that Monroe C. Schiffman was a corporate officer and stockholder in Monroe Pharmacy, Inc. from March, 1974, until the audits in question. An inspection and audit of Sharon Drugs, Inc. d/b/a Mercy Professional Building Pharmacy, was begun on April 23, 1976 and lasted for several days. The audited period was from March 17, 1975 until April 26, 1976, during which dates Monroe C. Schiffman was the registered pharmacist for the operation of Sharon Drugs, Inc. The procedures for the audits were to assume a zero stockage as of March 17, 1975 and to account for the drugs received after that date. The drugs audited were controlled drugs as defined by Chapter 893, Florida Statutes. These drugs were chosen for audit because complete records of their order, receipt and dispensing must be kept pursuant to Chapter 893, Florida Statutes. Exhibit 1, a summary of the audit of Sharon Drugs, Inc., was identified by the Board's agent, Vernon K. Bell, as the summary of the discrepancies in controlled drugs revealed by the audit which he conducted. The audit conducted by Vernon K. Bell revealed a shortage of controlled drugs for which no records had been kept of 296,481 total units or pills. The drugs audited were Desoxyn (methamphetamine hydrochloride), Tuinal (sodium amobarbital and sodium secobarbital), Biphetamine (d- and dl-Amphetamine), Dilaudid (hydromorphone), Nembutal (sodium pentobarbital), Seconal (sodium secobarbital), Quaalude (methaqualone), Eskatrol Spansule (dextroamphetamine sulfate and prochlorperazine) , and Dexedrine (dextroamphetamine sulfate). Monroe C. Schiffman, while the registered pharmacist at Mercy Professional Building Pharmacy, did not keep the record required to be kept by law.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, the Hearing Officer recommends that the license and registration of Monroe Charles Schiffman be revoked. DONE and ENTERED this 5th day of January, 1977, in Tallahassee, Florida. STEPHEN F. DEAN, Hearing Officer Division of Administrative Hearings Room 530, Carlton Building Tallahassee, Florida 32304 (904) 488-9675 COPIES FURNISHED: Michael Schwartz, Esquire Suite 201, Ellis Building 1311 Executive Center Drive Tallahassee, Florida 32301 Gerald Kogan, Esquire Suite 500 Security Trust Building 700 Brickell Avenue Miami, Florida 33131 H. F. Bevis, Executive Secretary State Board of Pharmacy 252 East Sixth Avenue Box 3355 Tallahassee, Florida 32303
The Issue The issue in this case is whether Florida Administrative Code Rule 64B16-27.500(6) regarding the negative drug formulary is an invalid exercise of delegated legislative authority within the meaning of Subsection 120.52(8), Florida Statutes (2007).1
Findings Of Fact Levothyroxine Sodium is a drug used to treat Hypothyroidism and Pituitary TSH Suppression. Mylan develops, manufactures, and sells generic pharmaceuticals and is licensed as a non-resident prescription drug manufacturer and an out-of-state prescription drug wholesaler in Florida pursuant to Section 499.01, Florida Statutes. Mylan has received approval from the United States Food and Drug Administration (FDA) to market 12 strengths of generic Levothyroxine Sodium tablets, which the FDA has determined to be bioequivalent and therefore therapeutically equivalent to corresponding strengths of four reference listed drugs2: Unithorid® tablets, Synthroid® tablets, Levoxyl® tablets, and Levothroid® tablets. Abbott is the manufacturer of Synthroid®, a Levothyroxine Sodium product marketed in Florida and other places. The Board of Pharmacy “has authority to adopt rules pursuant to ss. 120.536(1) and 120.54 to implement the provisions of [Chapter 465] conferring duties upon it.” § 465.005, Fla. Stat. Subsection 465.025(6), Florida Statutes, provides: The Board of Pharmacy and the Board of Medicine shall establish by rule a formulary or generic drug type and brand name drug products which are determined by the boards to demonstrate clinically significant biological or therapeutic inequivalence and which, if substituted, would pose a threat to the health and safety of patients receiving prescription medication. Subsection 465.025(1)(a), Florida Statutes, defines “brand name” as “the registered trademark name given to a drug product by its manufacturer, labeler, or distributor.” “Generically equivalent drug product” is defined in Subsection 465.025(1)(b), Florida Statutes, as “a drug product with the same active ingredient, finished dosage form, and strength.” Subsection 465.025(2), Florida Statutes, provides: A pharmacist who receives a prescription for a brand name drug shall, unless requested otherwise by the purchaser, substitute a less expensive, generically equivalent drug product that is: Distributed by a business entity doing business, and subject to suit and service of legal process, in the United States; and Listed in the formulary of generic and brand name products as provided in subsection (5) for the brand name drug prescribed unless the prescriber writes the words “MEDICALLY NECESSARY,” in her or his own handwriting, on the face of a written prescription; unless, in the case of an oral prescription, the prescriber expressly indicates to the pharmacist that the brand name drug prescribed is medically necessary; or unless, in the case of a prescription that is electronically generated and transmitted, the prescriber makes an overt act when transmitting the prescription to indicate that the brand name drug prescribed is medically necessary. When done in conjunction with the electronic transmission of the prescription, the prescriber’s overt act indicates to the pharmacist that the brand name drug prescribed is medically necessary. Subsection 465.025(5), Florida Statutes, provides: Each community pharmacy shall establish a formulary of generic and brand name drug products which, if selected as the drug product of choice, would not pose a threat to the health and safety of patients receiving prescription medication. In compiling the list of generic and brand name drug products for inclusion in the formulary, the pharmacist shall rely on drug product research, testing, information, and formularies compiled by other pharmacies, by states, by the United States Department of Health, Education, and Welfare, by the United States Department of Health and Human Services, or by any other source which the pharmacist deems reliable. Each community pharmacy shall make such formulary available to the public, the Board of Pharmacy, or any physician requesting same. The formulary shall be revised following each addition, deletion, or modification of said formulary. If a brand name drug or a generic drug type drug product is listed on the negative drug formulary established by the Board of Pharmacy and Board of Medicine, a pharmacist is prohibited from substituting a generically equivalent drug product for a prescribed brand name drug product. § 465.025(6)(b), Fla. Stat. The Board of Pharmacy has adopted a negative drug formulary which is contained in Florida Administrative Code Rule 64B16-27.500, and Levothyroxine Sodium is listed on the negative drug formulary. Thus, Mylan’s generic products currently cannot be substituted where a prescription is written for a brand name Levothyroxine Sodium product. Mylan has challenged Florida Administrative Code Rule 64B16-27.500(6), which provides: The negative drug formulary is composed of medicinal drugs which have been specifically determined by the Board of Pharmacy and the Board of Medicine to demonstrate clinically significant biological or therapeutic inequivalence and which, if substituted, could produce adverse clinical effects, or could otherwise pose a threat to the health and safety of patients receiving such prescription medications. Except where certain dosage forms are included on the negative drug formulary as a class, all medicinal drugs are listed by their official United States Pharmacopoeia Non-Proprietary (generic) name. The generic name of a drug shall be applicable to and include all brand-name equivalents of such drug for which a prescriber may write a prescription. Substitution by a dispensing pharmacist on a prescription written for any brand name equivalent of a generic named drug product listed on the negative drug formulary or for a drug within the class of certain dosage forms as listed, is strictly prohibited. In cases where the prescription is written for a drug listed on the negative drug formulary but a name brand equivalent is not specified by the prescriber, the drug dispensed must be one obtained from a manufacturer or distributor holding an approved new drug application or abbreviated new drug application issued by the Food and Drug Administration, United States Department of Health and Welfare permitting that manufacturer or distributor to market those medicinal drugs or when the former is not applicable, those manufacturers or distributors supplying such medicinal drugs must show compliance with other applicable Federal Food and Drug Administration marketing requirements. The following are included on the negative drug formulary: * * * (6) Levothyroxine Sodium. Subsection 465.0251(1), Florida Statutes, provides: The Board of Pharmacy and the Board of Medicine shall remove any generic named drug product from the formulary established by s. 465.025(6), if every commercially marketed equivalent of that drug is “A” rated as therapeutically equivalent to a reference listed drug or is a reference listed drug as referred to in “Approved Drug Products with Therapeutic Equivalence Evaluations” (Orange Book) published by the United States Food and Drug Administration. The Orange Book identifies drug products approved on the basis of safety and effectiveness by the FDA under the Federal Food, Drug, and Cosmetic Act. It also includes therapeutic equivalence evaluations for approved multisource prescription drug products. The Orange Book is updated annually and is supplemented with monthly cumulative updates. Additionally, the FDA has a website containing an electronic version of the Orange Book, which is also updated. The Orange Book used in 2007 is the 27th Edition. The Orange Book in effect at the date of the enactment of Section 465.0251, Florida Statutes,3 was the 21st Edition. Generally, approval by the FDA is required before a prescription drug product may be marketed, distributed, or sold in the United States. See 21 U.S.C. § 355(a). When a product contains a new active ingredient or otherwise differs significantly from previously approved products, the sponsor must provide the FDA with data demonstrating the product’s safety and effectiveness for the intended use. See, e.g., 21 U.S.C. § 355(b). When a product is a copy of a previously approved product—-what is commonly called a “generic” version of the original drug—-proof of safety and effectiveness is not required. Instead, the FDA requires a showing that, with regard to certain characteristics, the proposed generic product is essentially the same as the approved product it purports to copy, which is called the “reference listed drug.” See 21 U.S.C. § 355(j). The FDA’s previous finding that the reference listed drug is safe and effective is then imputed to the generic product. In general, the generic product must contain the same active ingredient in the same strength, and it must be in the same dosage form (e.g., tablet, capsule, solution) as the reference listed drug. See 21 U.S.C. § 355(j). Products that share these characteristics are considered “pharmaceutical equivalents” by the FDA. Orange Book, 27th Ed., at v-vi (Jan. 2007). Subsection 465.025(1)(b), Florida Statutes, uses the term “generically equivalent drug products” to describe such products. “Drug products are considered to be therapeutic equivalents only if they are pharmaceutical equivalents and if they can be expected to have the same clinical effect and safety profile when administered to patients under the conditions specified in the labeling.” Orange Book, 27th Ed. at vi. The FDA classifies as therapeutically equivalent those products that meet the following criteria: they are approved as safe and effective; they are pharmaceutical equivalents in that they (a) contain identical amounts of the same active drug ingredient in the same dosage form and same route of administration, and (b) meet compendial or other applicable standards of strength, quality, purity, and identity; (3) they are bioequivalent in that (a) they do not present a known or potential bioequivalence problem, and they meet an acceptable in vitro standard, or (b) if they do present such a known or potential problem, they are shown to meet an appropriate bioequivalence standard; (4) they are adequately labeled; (5) they are manufactured in compliance with Current Good Practice Manufacturing Practice regulations. Id. These criteria are essentially the same criteria that existed in 2001 as shown in the final staff analysis of HB69, which was passed and became Chapter 2001-146, Laws of Florida, now codified as Section 465.0251, Florida Statutes. Drug products that have been relied on as reference listed drugs are so identified in the Orange Book, and products that are therapeutically equivalent to each other are identified by a shared therapeutic equivalence evaluation code (TE code). These are primarily, but not exclusively, reference listed drugs and the generic drugs approved on the grounds of pharmaceutical equivalence and bioequivalence to those reference listed drugs. Generally, the FDA uses a two-letter TE code, with a code of “AB” given to solid oral dosage form products that have demonstrated therapeutic equivalence. Orange Book, 27th Ed. at xii-xiii. For the vast majority of most multi-source drugs, there is one product that is the reference listed drug and one or more generic versions of that product, and all the products share a TE code of AB. However, there are situations in which there is more than one reference listed drug. These situations are discussed in the Orange Book, 27th Ed. at xiv. In certain instance, a number is added to the end of the AB code to make a three character code ( i.e., AB1, AB2, AB3, etc.). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against. . . . Drugs coded as AB under a heading are considered therapeutically equivalent only to other drugs coded as AB under that heading. Drugs coded with a three-character code under a heading are considered therapeutically equivalent only to other drugs coded with the same three- character code under that heading. The FDA first officially described the three-character code rating system in the 16th edition of the Orange Book in 1996. Levothyroxine Sodium tablets are a drug product for which there are multiple reference listed drugs. Currently the Orange Book identifies seven Levothyroxine Sodium products approved for sale in the United States: Synthroid®, Levo-T®, Levoxyl®, Levothroid®, Unithroid®, a generic-named product manufactured by Genpharm, and a generic manufactured by Mylan. The current Orange Book also contains the following levothyroxine sodium products in a section identifying “Discontinued” products that, although approved for distribution in the United States, are not being marketed: Novothyrox, Levolet, and Tirosint. The following drug products are currently identified in the Orange Book as reference listed drugs: Synthroid®, Levo-T®, Levoxyl®, Levothroid®, and Unithroid®. In the case of Levothyroxine Sodium products, not all the reference listed drugs are considered therapeutically equivalent to one another. The Orange Book discusses this situation and explains the therapeutic evaluations for Levothyroxine Sodium products as follows: Because there are multiple reference listed drugs of levothyroxine sodium tablets and some reference listed drugs’ sponsors have conducted studies to establish their drugs’ therapeutic equivalence to other reference listed drugs, FDA has determined that its usual practice of assigning two or three character TE codes may be potentially confusing and inadequate for these drug products. Accordingly, FDA provides the following explanation and chart of therapeutic equivalence evaluations for levothyroxine sodium products. Levothyroxine Sodium (Mylan ANDA 76187) tablets have been determined to be therapeutically equivalent to corresponding strengths of Unithroid (Jerome Stevens NDA 021210) tablets. Levo-T (Alara NDA 021342), Levothyroxine Sodium (Mylan ANDA 76187), Unithroid (Jerome Stevens NDA 021210) and Levothyroxine Sodium (Genpharm ANDA 76752) tablets have been determined to be therapeutically equivalent to corresponding strengths of Synthroid (Abbott NDA 021402) tablets. Levo-T (Alara NDA 021342), Unithroid (Jerome Stevens NDA 021210), Levothyroxine Sodium (Mylan ANDA 076187) and Levothyroxine Sodium (Genpharm ANDA 76752) tablets have been determined to be therapeutically equivalent to corresponding strengths of Levoxyl (King/Jones Pharma NDA 021301) tablets. Levothyroxine Sodium (Mylan ANDA 76187) tablets have been determined to be therapeutically equivalent to corresponding strengths of Levothroid (Lloyd NDA 021116) tablets. Novothyrox (Genpharm NDA 021292) requires further investigation and review to establish therapeutic equivalence to corresponding strengths of any other Levothyroxine Sodium drug products and is rated BX. Levolet (Vintage NDA 021137) requires further investigation and review to establish therapeutic equivalence to corresponding strengths of any other Levothyroxine Sodium drug products and is rated BX. The chart outlines TE codes for all 0.025mg products with other products being similar. Therapeutic equivalence has been established between products that have the same AB+number TE code. More than one TE code may apply to some products. One common TE code indicates therapeutic equivalence between products. Trade Name Applicant Potency TE CODE Appl No Product No UNITHROID STEVENS J 0.025mg AB1 21210 001 LEVOTHYROXINE SODIUM MYLAN 0.025mg AB1 76187 001 LEVOXYL JONES PHARMA 0.025mg AB1 21301 001 SYNTHROID ABBOTT 0.025mg AB1 21402 001 SYNTHROID ABBOTT 0.025mg AB2 21402 001 LEVOTHYROXINE SODIUM MYLAN 0.025mg AB2 76187 001 LEVO-T ALARA PHARM 0.025mg AB2 21342 001 UNITHROID STEVENS J 0.025mg AB2 21210 001 LEVOTHYROXINE SODIUM GENPHARM 0.025mg AB2 76752 001 LEVOXYL JONES PHARMA 0.025mg AB3 21301 001 LEVO-T ALARA PHARM 0.025mg AB3 21342 001 UNITHROID STEVENS J 0.025mg AB3 21210 001 LEVOTHYROXINE SODIUM MYLAN 0.025mg AB3 76187 001 LEVOTHYROXINE SODIUM GENPHARM 0.025mg AB3 76752 001 LEVOTHROID LLOYD 0.025mg AB4 21116 001 LEVOTHYROXINE SODIUM MYLAN 0.025mg AB4 76187 001 NOVOTHYROX GENPHARM 0.025mg BX 21292 001 LEVOLET VINTAGE PHARMS 0.025mg BX 21137 001 Orange Book, 27th Ed. at xix-xx. In the Orange Book, 21st Ed. (Cumulative Supplement 6, June 2001), only two Levothyroxine Sodium tablet products were listed, Levoxyl® and Unithroid®, and both were rated as BX, meaning that the data that had been reviewed by FDA was insufficient to determine therapeutic equivalence. There were also 12 additional Levothryroxine Sodium products that were being commercially marketed in the United States and were not listed in the Orange Book.
The Issue The issue is whether the Department’s intended award allowing Metro to proceed to licensure for a methadone Medication-Assisted Treatment (“MAT”) facility in Lake County violated Florida Administrative Code Rule 65D- 30.0141, was arbitrary or capricious, or was otherwise unlawful as alleged in LifeStream’s Petition for Administrative Hearing (“Petition”).
Findings Of Fact Based on the evidence adduced at hearing, and the record as a whole, the following Findings of Fact are made: PARTIES Petitioner LifeStream is a Florida not-for-profit corporation and provider of substance abuse treatment. LifeStream applied for the ability to proceed to licensure to provide methadone MAT services in Lake County. The Department is the agency with regulatory authority over the provision of substance abuse services. § 397.321(1), Fla. Stat. The Department’s duties include, but are not limited to, the licensing and regulation of the delivery of substance abuse services, including clinical treatment and clinical treatment services such as “medication-assisted treatment for opiate disorder.” §§ 397.321(1) and (6); and 397.311(26)(a)7., Fla. Stat. The Department also promulgates rules governing substance abuse providers. § 397.321(5), Fla. Stat. Metro is a provider of care for opioid use disorder treatment and operates methadone medication treatment centers nationwide, including in the state of Florida. Metro applied for the ability to proceed to licensure to provide methadone MAT services in Lake County. STATUTORY AND REGULATORY FRAMEWORK AND NEEDS ASSESSMENTS The substance abuse regulatory scheme in Florida is designed to provide a statewide system of care for the prevention, treatment, and recovery of children and adults with serious substance abuse disorders. Substance abuse providers, which include methadone MAT clinics, are subject to a strict statutory, regulatory, and licensing scheme, which provides direction for a continuum of community-based services including prevention, treatment, and detoxification services. See chs. 394 and 397, Fla. Stat. MAT is “the use of medications approved by the United States Food and Drug Administration, in combination with counseling and behavioral therapies, to provide a holistic approach to the treatment of substance abuse.” § 397.311(27), Fla. Stat. The Department is responsible for the licensure and oversight of all MAT providers in the state. See § 397.321, Fla. Stat. Further, the Department is required to “determine the need for establishing providers of [MAT]” on an annual basis. New MAT providers may only be established in the state in response to a determination and publication of such need by the Department. § 397.427(2), Fla. Stat. Rule 65D-30.0141 provides the process for determining the need for MAT providers, as follows, in relevant part: Determination of Need. The Department shall annually perform the assessment detailed in the “Methodology of Determination of Need Methadone Medication- Assisted Treatment,” CF-MH 4038, May 2019, incorporated by reference and available at http://www.flrules.org/Gateway/reference.asp?No= Ref-11993. The Department shall publish the results of the assessment in the Florida Administrative Register by June 30. Facilities owned and operated by the Florida Department of Corrections are exempt from the needs assessment process. However, these facilities must apply for a license to deliver this service. The publication shall direct interested parties to submit a letter of intent to apply for licensure to provide medication-assisted treatment for opioid use disorders to the Regional Office of Substance Abuse and Mental Health where need has been demonstrated. The publication shall provide a closing date for submission of letters of intent. Interested parties must identify the fiscal year of the needs assessment to which they are responding and the number of awards they are applying for per county identified in the assessment in their letter of intent. Within seven (7) business days of the closing date, the Regional Office shall notify parties who submitted a letter of intent on how to proceed. If the number of letters of intent equals or is less than the determined need, parties shall be awarded the opportunity to proceed to licensure by completing an “Application for Licensure to Provide Substance Abuse Services” form, C&F-SA Form 4024, May 2019, incorporated by reference and available at http://www.flrules.org/Gateway/reference.asp?No= Ref-11996. If the number of letters of intent exceeds the determined need, parties shall be invited to submit a “Methadone Medication-Assisted Treatment (MAT) Application to Proceed to Licensure Application” form, CF-MH 4041, May 2019, incorporated by reference and available at http://www.flrules.org/Gateway/reference.asp?No= Ref-11995. Applications may not be rolled over for consideration in response to a needs assessment published in a different year and may only be submitted for a current fiscal year needs assessment. The Department shall utilize an evaluation team made up of industry experts to conduct a formal rating of applications as stipulated in the “Methadone Medication-Assisted Treatment (MAT) Application Evaluation” form, CF-MH 4040, May 2019, incorporated by reference and available at http://www.flrules.org/Gateway/reference.asp?No= Ref-11994. The evaluation team members shall not be affiliated with the Department, current methadone medication-assisted treatment providers operating in Florida, or the applicants. The selection of a provider shall be based on the following criteria: Capability to Serve Selected Area(s) of Need and Priority Populations. Area(s) of Need are the counties identified as having a need for additional clinics. Priority Populations are pregnant women, women with young children, and individuals with financial hardships; Patient Safety and Quality Assurance/Improvement; Scope of Methadone Medication-Assisted Treatment Services; Capability and Experience; and Revenue Sources. Applicants with the highest-scored applications in each county shall be awarded the opportunity to apply for licensure for the number of programs specified in their letter of intent to meet the need of that county. If there is unmet need, the next highest scored applicant(s) will receive an award(s) based on the remaining need and the number of programs specified in their letter of intent. This process will continue until the stated need is met. Regional offices shall inform the highest-scoring applicant(s) in writing of the award. All awarded applicants must submit a letter of intent to apply for licensure to the appropriate regional office within 30 calendar days after the award. If an applicant declines an award or fails to submit the letter of intent within the specified time, the Department shall rescind the award. After the Department rescinds the original award for that selected area of need, the applicant with the next highest score shall receive the award. Awarded applicants must receive at least a probationary license within two (2) years of receipt of an award letter connected to their “Methadone Medication-Assisted Treatment (MAT) Application to Proceed to Licensure Application” form, CF-MH 4041. If an applicant fails to obtain a probationary license within the specified time, the Department shall rescind the award. See Rule 65D-30.0036, F.A.C. for licensure application requirements. Applicants may submit a request to the State Authority and Substance Abuse and Mental Health Program Office for an exception if unable to meet timeframes due to a natural disaster that causes physical damage to the applicant’s building(s). Proof of natural disaster and impact on physical property must accompany the request. Upon receipt of the request for exception and accompanying proof, a one-time extension shall be granted for six (6) months. Providers who are delayed for a reason other than a natural disaster may petition the Department for a rule waiver pursuant to Section 120.542, F.S…. In brief, potential applicants are directed to submit letters of intent to apply for a methadone MAT services license for any county in which the Department’s process demonstrates a need. Should the number of letters of intent received for a certain county be less than or equal to the need found in that county, the potential applicants may proceed directly to licensure. In the event the number of letters of intent is greater than the need found in a particular county, then potential applicants must submit an application form to the Department. The application form is adopted by reference in the rule as Form CF-MH 4041. The rule requires the Department to “utilize an evaluation team made up of industry experts to conduct a formal rating of applications” to determine which applicant, or applicants, may proceed to licensure in a particular county. Such evaluators “shall not be affiliated with the Department, current methadone [MAT] providers operating in Florida, or the applicants.” The scoring form that the evaluators must use is incorporated by reference in the rule as Form CF-MH 4040 (“Scoring Form”). The Scoring Form requires that each application be “independently scored by each member of the evaluation team.” It also mandates that the “same scoring principles must be applied to every application received.” The Scoring Form expressly states that “no attempt by Department personnel, or other evaluators or other persons to influence an evaluator’s scoring shall be tolerated.” There are five general “Criteria” in the Scoring Form upon which applicants are scored, with a number of subsections within each criterion. An application could be awarded a maximum of 220 points. The evaluators were to assign a score ranging from zero to five for each subsection, with some subsections receiving an additional “weighted value” (in which the score given would be multiplied by two). The Department gave the weighted values to provisions upon which it placed a “premium.” The “General Instructions” section of the Scoring Form provides what an applicant must demonstrate to earn a particular score: Superior (5 points): the application demonstrates or describes extensive competency, proven capabilities, an outstanding approach to the subject area, innovative, practical and effective solutions, full responsiveness to the question, a clear and comprehensive understanding of the requirements and planning for the unforeseen. Good (4 points): the application demonstrates or describes clear competency, consistent capability, a reasoned approach to the subject area, feasible solutions, extensive but incomplete responsiveness to the question, and a sound understanding of the requirements. Adequate (3 points): the application demonstrates or describes fundamental competency, adequate capability, a basic approach to the subject area, apparently feasible but somewhat unclear solutions, partial responsiveness to the question, a fair understanding of the requirements and a lack of staff experience and skills in some areas. Poor (2 points): the application demonstrates or describes little competency, minimal capability, an inadequate approach to the subject area, infeasible or ineffective solutions, somewhat unclear, incomplete or non-responsive to the question, a lack of understanding of the requirements and a lack of demonstrated experience and skills. Insufficient (1 point): the application demonstrates or describes a significant or complete lack of understanding, an incomprehensible approach, a significant or complete lack of skill and experience and extensive non-responsiveness to the question. Not Addressed (0 points): the application demonstrates or describes [that the] criteria is not addressed, approach is not described, complete non- responsiveness to the question. Criterion Five of the Scoring Form concerns “Revenue Sources.” It contains two subsections, each worth zero to five points and each given “weighted value,” meaning that a perfect score for each subsection would earn 10 points, or a total of 20 points for Criterion Five. Subsection one asked the following question: 1. How well did the organization detail its accepted forms of payment for treatment services? At a minimum, the response should describe the procedure for each payment method offered: Assess a point for each accepted form of payment (5 maximum points) Self-Pay (1 point) One form of Private Insurance (1 point) Multiple forms of Private Insurance (1 point) Medicaid (1 point) Scholarship or Sliding Fee Scale (1 point) While other sections of the Scoring Form permit the evaluator to subjectively evaluate the responsiveness of the answer, subsection one of Criterion Five is manifestly objective. It directs the evaluator to award one point for each of the five accepted forms of payment addressed by the applicant, up to the maximum of five points. Subsection two of Criterion Five asks, “How well does the application detail how the organization will determine if its pricing is competitive?” This subsection was also worth five points and allowed the evaluator to subjectively address the quality of the applicant’s response. Christopher Weller, Manager of the Licensure and Designation Unit within the Department’s Office of Substance Abuse and Mental Health, testified that Florida MAT providers historically have accepted only out-of- pocket payments for their services, meaning that those who could not afford to pay cash or credit were often left untreated. The Department wanted to ensure that the need for MAT services would be met and that no one needing such services would be priced out of treatment. Therefore, the Department included Criterion Five in the application and gave it weighted value to encourage providers to accept multiple forms of payment. The Department completed a needs assessment and published it in the June 20, 2020, edition of the Florida Administrative Register. The Department then announced that it would begin accepting applications to proceed to licensure. The needs assessment indicated a need for one new MAT clinic in Lake County. Pursuant to rule 65D-30.041(1)(c)2.a., the Department contracted with an outside provider to evaluate the applications received for counties throughout the state, including Lake County. That provider, iSF, established four teams of three evaluators to score the applications and divided the counties with need among the teams. Each evaluation team consisted of a medical professional, a public health policy professional, and an academic professional. Applicant names were redacted so evaluators would not know the identity of the applicant they were scoring. Each iSF evaluator independently evaluated the various applications. THE LAKE COUNTY APPLICATIONS LifeStream and Metro both timely submitted letters of intent and applications for the new methadone MAT clinic needed in Lake County. Four other entities also applied for the one available license in Lake County. LifeStream’s response to subsection one of Criterion Five provided as follows: Our organization has developed a detailed Financial Assistance Policy (FAP) that provides assistance to all individuals served, including insured, uninsured and underinsured individuals whose family income is less than or equal to 240% of the Federal Poverty Level without discrimination on grounds of race, sex, national origin, disability, sexual orientation, immigration status, religious preference, or any other grounds unrelated to an individual’s need for the service or the availability of the service needed for emergency and medically necessary care. Furthermore, all individuals served receive a financial screening by staff knowledgeable of the various funding mechanisms in an effort to identify the best form of payment. No one is turned away for services due to their inability to pay. As a comprehensive provider with a sound financial infrastructure, our organization is able to accept several forms of payment for any of the services provided. This includes self-pay, private insurance (both one form and multiple forms), Medicaid and scholarship or sliding scale fee. All the individuals served are charged based upon a board of directors approved charge master which ensures that all individuals are charged the same fees for the same services. Discounts are available for individuals who qualify for financial assistance using a sliding fee discount. Our organization provides payment flexibility, including payment plans/options. In addition, our staff are trained to assist individuals in obtaining benefits and coverage as appropriate to meet any ongoing needs for treatment. Self-Pay: The proposed clinic will conduct a financial screening in order to determine if an individual qualifies for any of the organization’s accepted forms of payment for treatment services. Individuals will be offered two payment options, by the day or by the week. The fee will include dosing, treatment services and ancillary services. Individuals will be offered the ability to pay using cash or credit card. The organization also has a mechanism to bill the individual if that is his/her preference. This allows the individual to pay for services in a manner that meets his/her current ability and timeframe. Private Insurance (One or Multiple Forms): Our organization has numerous contracts with private insurance providers. This includes major providers such as Aetna, Blue Cross/Blue Shiled, Cigna, Magellan, Tricare, PsycCare, United Health Care and Value Options to name a few. In order to ensure that our organization has the ability to bill private insurance for these services, staff will possess the appropriate credentials, training and experience to allow them to be paneled by the insurance providers. In addition, our organization has staff that conduct financial assessments in order to determine the best funding source for the services provided. They are experienced and knowledgeable about the various private insurance plans and have the ability to determine if one or multiple forms of insurance will be utilized. Medicaid: Our organization is an established Medicaid provider and has the ability to bill Multiple Medicaid Associations (MMAs) as a result of having contracts with several of the organizations such as Prestige, Wellcare, United Healthcare and Sunshine. All of our sites and appropriate staff have the proper credentials to bill for Medicaid services. In addition, the treatment services and ancillary services we propose to offer will be Medicaid credentialed in order to bill for those services as well. Scholarship or Sliding Fee Scale: As stated earlier, our organization has extensive experience working with indigent individuals. As a result of a financial assessment, the level of discount for which an individual is eligible is determined based upon the individual’s family income and family size as a percentage of the FPL. Our developed policies and procedures define the meaning of “uninsured,” “underinsured,” “family income,” and “Federal Poverty Level.” All of our financial policies are listed on our website that address payment for treatment services and are provided in detail for the people we serve. Metro’s response to subsection one of Criterion Five provided as follows: To facilitate the ease of payment by individuals in need of treatment and to minimize financial barriers to treatment, we offer a wide array of payment options that include: Self-Pay—Patients with the financial capacity to pay for their own treatment may pay using cash, credit card, Apple Pay, and/or debit card. Upon receiving the medication portion of their treatment, self-pay patients either tender cash to clinic staff for the cost of treatment or, alternatively, provide a credit card, Apple Pay, or debit card that is entered into a card processing terminal for verification and transaction authorization. Private Insurance—We accept multiple forms of private insurance as we are in network with many private insurers (including, but not limited to, Beacon Health, Triwest, United/Optum, and Aetna). Also, we have established single case agreements with private insurers with whom we are not yet in-network so that the cost to each patient is minimized and keeps the patient in treatment. Procedurally, patients present their private insurance information to clinic staff who verify eligibility, benefits, and individual financial responsibility (e.g., deductibles, co-pays, co- insurance). A patient’s financial responsibility, if any, is collected from the patient pursuant to their insurer’s benefit design, and the treatment services are billed to their health insurer. An assignment of benefits is signed by the patient to permit us to bill and collect directly from their health insurer. Medicaid—Opioid Use Disorder treatment is a covered benefit under Florida Medicaid. As a result, all of our existing clinics are enrolled in the Florida Medicaid network. If our organization is awarded the clinic for this county, we would immediately enroll this clinic in the Florida Medicaid program. Patients covered by Florida Medicaid simply present their Medicaid card to clinic personnel who are able to immediately verify active coverage. Upon verification of coverage, the patient completes an assignment of benefits and is treated without any financial outlay. Treatment services received by the patient are then billed to Florida Medicaid directly for as long as the individual remains Medicaid eligible. Sliding Fee Scale—Patients without the financial capacity to pay for their own treatment, or are without Florida Medicaid or private health insurance coverage, may qualify for our Sliding Fee Scale. The Sliding Fee Scale offers discounted fees to patients in need of treatment. Eligibility is determined based on Federal poverty guidelines, household income, and the number of people in the patient’s household. Patients who are eligible for the Sliding Fee Scale must simply provide the following financial data as a part of their application: Pay stubs for at least the last six months; A copy of their most recent federal income tax return; Proof of current living situation (such as lease documents, or utility bills in the patient’s name); A financial attestation signed by the patient, which our clinic will provide. Upon the establishment of a patient’s eligibility, the patient’s cost of treatment is reduced to the discounted fee per the Sliding Fee Scale. In the event that a patient’s financial status changes, the patient must inform clinic staff of the changes. At a minimum, the clinic staff will review financial status with the patient every six (6) months. Financial status may be reviewed at the request of the patient or clinic at any time. Grants—Our organization routinely pursues, and has secured, grant funding to cover the cost of treatment for patient who are [sic] unable to pay for their treatment and who do not have insurance. Grant finds are awarded through regional Managing Entities. Available grant funds are sought to cover [the] cost of care for eligible patients receiving treatment at our clinics. As mentioned, our organization is currently the recipient of grant funds from multiple Managing Entities in the State of Florida. Eligible patients must simply provide the following financial data as a part of their application: Pay stubs for at least the last six months; A copy of their most recent federal income tax return; Proof of current living situation (such as lease documents, or utility bills in the patient’s name); A financial attestation signed by the patient, which our clinic will provide. Upon the establishment of a patient’s eligibility, the patient’s cost of treatment is reduced in accordance with the grant guidelines. In the event that a patient’s financial status changes, the patient must inform clinic staff of the changes. At a minimum, the clinic staff will review financial status with the patient every six (6) months. Financial status may be reviewed at the request of the patient or clinic at any time. Credit—Patients with the financial capacity to pay for their own treatment via cash, credit card, and/or debit card occasionally find themselves in need of treatment but, for a variety of reasons, are unable to pay. Our organization empowers its clinic Program Directors (i.e., the on-site clinic managers) to extend credit to patients in such situations for a short period (typically one day) with the understanding that the patient will repay the credit amount extended in short order. Upon receiving credit authorization, the patient receives all medically necessary treatment as may be required. Both the LifeStream and Metro proposals appear to have described the procedure for each of the five payment methods listed and appear to be entitled to the maximum score of five points according to the objective standards set forth in subsection one of Criterion Five. At the very least, it would be impossible to justify giving either proposal a score of zero, which is reserved for “complete nonresponsiveness” to the question. LifeStream’s response to subsection two of Criterion Five provided as follows: In order to ensure that pricing is competitive, our organization will review the current environment using several data sources on a regular basis. This will include the Department of Children and Families, our state trade association, Florida Behavioral Health association and discussions with other providers. We also propose to conduct focus groups with the individuals that we serve and our stakeholders to collect input that will be part of this review. On an annual basis, our organization will conduct a pricing study to ensure that the pricing is competitive. As a safety net provider and an organization committed to serving individuals regardless of their ability to pay, we feel that the input from those we serve and our stakeholders is a critical piece in determining if pricing is competitive. Our organization will identify and provide solutions to ensure that those that need care are able to receive the care. We are dedicated to ensuring that the pricing will be reasonable and that options are identified and offered for low income/indigent individuals. More importantly, our organization will commit to supporting the people we serve through a continuum of services that not only addresses their opioid disorders, but also the social determinants that may affect their successful recovery. Our organization is a Medicaid provider and also has access to other funds to ensure that individuals who need this service will receive it regardless of their ability to pay. Metro’s response to subsection two of Criterion Five provided as follows: As a longstanding provider of Opioid Use Disorder treatment services in the State of Florida, our organization is keenly aware of the need to properly price our services given the circumstances typically facing patients battling opioid addiction which include, but are not limited to, financial hardship. Consequently, we recognize that appropriate pricing of our services is critical so as to ensure that individuals in need of care do not perceive that treatment for their disease is unattainable. While a material and increasing number of patients have their treatment paid by Medicaid, private health insurance, and grants (as fully discussed in question 1 of Criteria 5), those patients who pay for treatment out of their own pockets routinely encounter financial barriers which, unfortunately, result in them not seeking treatment, or leaving treatment prematurely. Given our experience operating outpatient clinics in Florida, our organization has developed a substantial amount of year-by-year internal pricing data, which includes specific market economic data, that guides us in pricing our services within a particular Florida region. This data, which is updated annually, is measured against other payer rates (such as Medicaid and private health insurance), and compared to the rates we are paid for opioid addiction treatment services provided by our clinics in other states. Taken together, this data allows us to develop regional benchmarks that we use to price our services fairly and competitively, bearing in mind the financial challenges typically encountered by opioid addicted patients. To be clear, this is a fluid process that takes into account changing market conditions, both inside and outside of Florida, regarding the pricing of opioid addiction treatment. This allows our organization to maintain a current view of what patients can realistically afford to pay and, when necessary, immediately adjust our pricing expectations when the market data indicates that such adjustments are needed to ensure continuity of patient care. In addition to our routine pricing analysis using our historical internal data, we will, prior to opening a new clinic in a particular area, conduct a survey of other opioid treatment clinics within the region (if any). This survey process not only allows us to gain a better understanding of what the pricing for services is in that region, but helps us identify any additional services that should be offered to patients as part of our pricing structure. Once these surveys are completed, we then use this information, along with our internal analysis of historical data, to price our treatment services according to our planned treatment protocol (e.g., timely delivery of service, having the clinic open seven (7) days per week, maintaining a Call Center that is open and available to assist existing and prospective patients 24 hours per day, 7 days a week, etc.) and our analysis of specific market dynamics (e.g., quality of care indicators, availability of qualified clinical professionals, attendant costs of support services in the particular market, etc.). Finally, to ensure our pricing remains competitive, we repeat our outpatient treatment clinic surveys at least annually for each and every market in which our clinics operate, and use this information, along with routine feedback voluntarily provided by our existing patients, to determine if our pricing remains appropriate given the market where the clinic is located. To be clear, we believe that our practice of conducting outpatient clinic surveys relieve patients of having to make pricing and service comparisons while trying to manage their disease. Stated differently, patients can take comfort in knowing that when they inquire as to our treatment pricing, they will receive the identical type and number of services that would typically be offered by all similarly-situated outpatient treatment programs within their geographic region at comparable prices. While this particular process can be burdensome, we have found time and again that the effort is worthwhile given the positive patient feedback we routinely receive regarding the value of services offered at our clinics. If awarded the clinic license for this particular county, we will deploy each of the aforementioned pricing techniques (i.e., internal analysis of historical pricing data, benchmarking using public and private payer rates from within and outside of Florida, and regional pricing surveys) to develop pricing for our services that will not only be competitive, but affordable for the people within the community in need of treatment. These processes have proved tremendously effective for us thus far, and we fully expect them to be successful within this particular county. As noted above, subsection two allowed for a more subjective evaluation of the applications. LifeStream’s response was shorter and more general than Metro’s, but both responses addressed similar themes and procedures for ensuring competitive pricing at their clinics. Both proposals showed the applicants’ understanding of the need for competitive pricing and outlined their plans for setting their prices accordingly. Even allowing for the subjectivity permitted by subsection two, it would be impossible to justify giving either proposal a score of zero, which is reserved for “complete nonresponsiveness” to the question. SCORING OF THE LAKE COUNTY APPLICATIONS As explained above, the applications were given to the four teams of iSF evaluators for scoring. After the evaluators completed their review, iSF provided the Department with a final report that explained the evaluation process and provided a series of tables for each county that identified each applicant’s scores. The Lake County applications were scored by “Team Two” of the iSF evaluators. Team Two also reviewed applications for five other counties. Team Two gave LifeStream a total score of 633.5 for Lake County and gave Metro a total score of 619 for Lake County. Mr. Weller testified that one of his employees found a typographical error in a spreadsheet that iSF produced for the Department. This error prompted Mr. Weller to take a look at the scoring of the proposals by the iSF evaluators. Mr. Weller noted what appeared to be an anomaly. He found a series of scores in Lake County that went “5, 5, 5, zero, 5, 5, which caught my eye as unusual, and we discovered that the answers for both [subsections one and two of Criterion Five] were different in Lake County compared to all of the other ones that the particular evaluator scored for the other counties.” A closer review of the scores revealed that each of the three Team Two evaluators gave LifeStream scores of five in both subsections of Criterion Five in its Lake County application. Two of the three evaluators gave Metro scores of five for both subsections of Criterion Five. However, the medical professional on Team Two gave Metro zeros in both subsections of Criterion Five of its Lake County application. The Criterion Five responses of LifeStream and Metro were essentially identical in all of the six county applications reviewed by Team Two. In the five counties other than Lake County, all of the evaluators, including the medical professional, gave both LifeStream and Metro scores of five for both subsections of Criterion Five. It was only in Lake County that the medical professional decided that Metro’s identical response was completely nonresponsive and deserving of zero points. As found above, it is impossible to justify scores of zero for Metro’s responses to Criterion Five. It was also extremely unusual for the same evaluator to give such radically different scores to the same response made in different applications. Mr. Weller wanted an explanation. He asked iSF to ask the medical evaluator to explain her reasoning for the inconsistency in her scoring of Metro’s Lake County application and to ask whether she wished to amend her score for Metro’s application. On April 27, 2020, iSF’s contract manager, Roger Balettie, sent an email to the Team Two medical evaluator, Linda Saucier. The email requested Ms. Saucier’s response as to four scoring questions raised by the Department’s review, including the following: You have two applicant response questions (Criteria 5 Questions 1 and 2) where an applicant (DCF 12) has two different scores for the same answer across six counties (one with 0s for each question and five with 5s for each question, and your notes are identical). DCF would like for you to review the applicant’s C5Q1 and C5Q2 response (I will provide that section for you) and confirm either that you intended the 6 counties to be different, or that you intended the 6 counties to have consistent scores for those two questions (and provide those scores). On May 1, 2020, Ms. Saucier responded as follows: I just saw your email. It went to my spam folder. I am extremely busy with work. But, I can tell you that the scores are different because of the county or vicinity in which the clinic would be housed and clinicians/service availability. It’s not a cookie cutter process. Later on May 1, 2020, Mr. Balettie sent an email asking Ms. Saucier to confirm that she did not wish to consider changing her scores for any of the four questions raised in his initial email, including Criterion Five in Lake County. Ms. Saucier responded: Correct. Roger, there are so many variables when looking at the submissions. I have written and reviewed grants and similar documents in my position. I realized the proposals were the same for each county, unfortunately not all of the counties share the same similarities. Read in the context of Criterion Five, it is clear that Ms. Saucier did not bother even to look again at her work on these applications before responding to Mr. Balettie. Her response is vague and defensive nonsense. Lake County possesses no unique quality that would render Metro’s pricing strategy and accepted forms of payment completely nonresponsive to Criterion Five, particularly when Ms. Saucier herself found the same responses “superior” in five other counties. Moreover, subsection one of Criterion Five did not give Ms. Saucier the discretion to award zero points to an application that addressed the five listed forms of payment as Metro’s application manifestly did. She violated the instructions of the Scoring Form and offered no real justification for doing so. The Department reasonably believed that it was not possible to rationalize the zeros that were given to Metro’s Lake County response. The Department reasonably believed there were no differences between counties that would have any impact on pricing or payment methods. William Sutton, General Counsel for Metro’s parent entity, Colonial Management Group, LP, testified that he personally worked on the applications Metro filed for the 2018-2019 licensure process. Mr. Sutton testified that the “forms of payment and the process [that Metro uses] to determine whether our pricing is competitive is consistent throughout the state of Florida.” He noted that Metro currently has 80 clinics operating throughout the country and that it is “critical” for the company “to have processes in place to deal with those [payment and pricing] issues consistently.” After digesting the response from iSF, the Department concluded that Ms. Saucier’s scores of zero for Criterion Five of Metro’s Lake County application “could not be justified.” Department personnel met to discuss what action to take regarding the scoring discrepancy. Eventually, the Department decided to override Ms. Saucier’s scores and to assign a score of five to both Criterion Five subsections in Metro’s Lake County application. The score of five was chosen because it was the same score that Ms. Saucier assigned to all of Metro’s other substantively identical Criterion Five responses in the other five counties she reviewed. The Department took this action “in the interests of fairness.” The Department also believed that Metro would challenge any intended award if the scores of zero were left unchanged and that Metro would likely prevail in such a challenge.2 The Department’s adjustment of the score gave Metro a total score of 639 points, reflecting two double-weighted scores of five instead of two scores 2 Mr. Sutton testified that Metro indeed would have raised such a challenge. of zero in the Criterion Five subsections. LifeStream’s total score in Lake County remained 633.5 points.3 On July 10, 2020, the Department published the Notice, which declared its intention to award the new MAT license in Lake County to Metro. The Notice explained the adjustment as follows: During the review of the evaluators scoring process by the Department, it was discovered that the medical evaluator for Team Two provided scores of zero for both responses in Criteria Five for [Metro’s] Lake County application. The two questions responded to pertained to types of payments accepted and competitive pricing. The responses to these questions were identical to Metro’s responses in the other six applications reviewed by the same medical evaluator. Each of the responses in the other six applications were awarded the full point values (5 points each) by the medical evaluator. In addition, the same responses were awarded either 4 or 5 points by both the other Team Two evaluators and by all the evaluators in the other teams. The scoring inconsistency resulted in Metro’s Lake County application losing 20 points (5 points for 2 questions, which were weighted by a factor of 2). Correction of the inconsistency results in Metro having the highest scoring application. Upon the Department learning of the scoring discrepancy, the medical evaluator declined to amend the scores and participate in the public meeting of the evaluators. The responses provided by Metro’s Lake County application were identical to its six non-Lake County applications assigned to Team Two, which were awarded five points each, and identical to all other responses provided by Metro. Thus, the 3 Metro could have received five fewer points through this correction and still received the intended award. Based on the scores possible and the double-weighting of this criterion, any combination of (a) two scores of five, (b) one score of five and one score of four, (c) one score of five and one score of three, or (d) two scores of four would have caused Metro to jump past LifeStream as the successful applicant. recommendation is to override the scores and award the licensure opportunity to Metro. The Department’s actions in reviewing the scores awarded and making the changes to Metro’s Criterion Five scores were reasonable under the facts and circumstances presented. LifeStream was unable to mount a serious defense of Ms. Saucier’s scoring or to offer any tangible evidence that the Department was biased either against LifeStream or in favor of Metro.4 LifeStream’s chief argument is that the Department deviated from its own rule by reviewing the scores submitted by iSF, by asking iSF to inquire as to aspects of the scores and suggesting the evaluator change them, and most egregiously by changing Metro’s score after the iSF evaluator declined to amend her evaluation. This legal argument is discussed below.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, the undersigned hereby RECOMMENDS that the Department of Children and Families enter a final order awarding the right to proceed to licensure for a methadone MAT facility in Lake County to Metro Treatment of Florida, L.P., and dismissing the Petition for Administrative Hearing filed by LifeStream Behavioral Center, Inc. DONE AND ENTERED this 1st day of February, 2021, in Tallahassee, Leon County, Florida. S LAWRENCE P. STEVENSON Administrative Law Judge 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 1st day of February, 2021. COPIES FURNISHED: Daniel Ryan Russell, Esquire Dean Mead and Hall Suite 1200 106 East College Avenue Tallahassee, Florida 32301 Mia L. McKown, Esquire Holland & Knight, LLP Suite 600 315 South Calhoun Street Tallahassee, Florida 32301 William D. Hall, Esquire Dean Mead and Dunbar Suite 1200 106 East College Avenue Tallahassee, Florida 32301 Chad Poppell, Secretary Department of Children and Families Building 1, Room 202 1317 Winewood Boulevard Tallahassee, Florida 32399-0700 Javier Enriquez, General Counsel Department of Children and Families Building 2, Room 204F 1317 Winewood Boulevard Tallahassee, Florida 32399-0700 Brittany Adams Long, Esquire Radey Law Firm, P.A. Suite 200 301 South Bronough Street Tallahassee, Florida 32301 John L. Wharton, Esquire Dean Mead and Dunbar Suite 1200 106 East College Avenue Tallahassee, Florida 32301 Eddie Williams, III, Esquire Holland & Knight, LLP Suite 600 315 South Calhoun Street Tallahassee, Florida 32301 Lacey Kantor, Agency Clerk Department of Children and Families Building 2, Room 204Z 1317 Winewood Boulevard Tallahassee, Florida 32399-0700
Findings Of Fact Respondent is a medical doctor, licensed to practice in Florida, and holds license number ME 0009310, issued by Petitioner. Respondent specializes in family practice and has been board certified by the American Academy of Family Physicians since 1974. Percodan is the manufacturer's brand name for oxycodone, which is a Schedule II controlled substance pursuant to Chapter 893, F.S. 2/ It is a drug used for the relief of pain, a synthetic analgesic, and is both a physically and psychologically dependent producing drug. It can cause drowsiness, urinary retention, nausea, vomiting, and interacts unfavorably with other sedative drugs, and is considered a depressant. On December 30, 1966, Evelyn Milstead, a 30 year old woman, came to Respondent's office complaining of nausea and a rash in her mouth. Respondent conducted a physical examination, took her medical history and thereafter prescribed tigan for the nausea. Ms. Milstead became a regular patient of Respondent's and he continued treating her for various ailments over a period of years. During the course of Respondent's treatment, Milstead developed a chronic urinary tract infection and kidney condition in which she passed kidney stones. On occasion Milstead was treated by Dr. Gillespie, a specialist in the field of urology for her kidney condition. In 1978, Respondent also referred instead to the Ochsner Clinic for evaluation of her urinary tract and kidney problems. She was evaluated at Ochsner Clinic and received prescriptions for darvocet, a pain medication, and keflex, an antibiotic, and was told that she would continue to have a chronic kidney problem. Over the years, Milstead was hospitalized several times by Dr. Gillespie for treatment of her kidney condition. The testimony of Dr. William H. Nass and Dr. Robert P. Johnson established that Respondent's initial prescriptions of percodan to Milstead were appropriate. However, Respondent's percodan prescriptions to Milstead eventually became inappropriate. Specifically, the prescriptions for 2,668 percodan tablets between August, 1980 and November, 1982, were established as excessive. On July 30, 1977, Bruce White, a 25 year old male, came to Respondent for medical treatment for headaches and thereafter returned to Respondent for treatment of various medical problems. Mr. White's wife, Vicki White, and their children were also seen by Respondent as their family doctor. On May 18, 1981, White came to Respondent complaining of neck and back pain from an automobile accident in which he also fractured his left lower leg. Respondent noted that White had been seen by a neurologist and an orthopedic surgeon for his head and leg. In addition to other medication, Respondent prescribed percodan to White for pain. White had also developed arthritis in his left leg, as a result of the car accident and fracture, and on one occasion was hospitalized for swelling of his left leg. Respondent referred White to Dr. Tippett, a neurosurgeon, concerning his headaches and to Dr. Graybiel, a rheumatologist, concerning his arthritis. However, White continued to see Respondent as his medical doctor because his work schedule on an offshore oil rig would only permit Saturday appointments with his doctor and Respondent's offices are open on Saturday mornings. White also found it difficult to pay the fees charged by specialists. Between May 8, 1981 and September 30, 1982, Respondent prescribed 780 percodan tablets for Bruce White. The testimony of Dr. Nass and Dr. Johnson established that Respondent's initial prescriptions of percodan to White were appropriate. However, the percodan prescriptions to White became inappropriate over time due to their excessiveness. The seriousness of this lapse is underscored by Respondent's failure to try other pain alleviating measures and failure to investigate abuse possibilities. On October 18, 1979, Vicki White, the wife of Bruce White, a 23 year old woman, came to Respondent's office seeking treatment. She complained of migraine headaches and stated that her father was in the hospital with cancer. She also stated that she had seen Dr. Eyser, a neurosurgeon, for her headaches. Respondent prescribed wygesic for her pain. She subsequently returned to Respondent for treatment of various complaints including chronic migraine headaches, colds, and a dislocated right shoulder. Initially, Respondent prescribed norcet for relief of this pain, and on July 31, 1981, first prescribed percodan for her migraine headaches. Respondent prescribed percodan on other occasions in response to her complaints of pain from migraine headaches and back strain. Respondent considered referring her to a neurologist for the headaches but White stated that she could not afford to see a specialist. Respondent prescribed 590 percodan tablets for Vicki White between July 31, 1981 and September 22, 1982. Percodan is an appropriate and acceptable medicine for the relief of migraine headaches, and Respondent's initial prescription of percodan to Ms. White was appropriate. However, his prescriptions became excessive over time since percodan is not to be used for long term treatment of migraine headaches. On September 7, 1982, M. D. Medlen, an Escambia County Deputy Sheriff, went to Respondent's office as an undercover police officer, under the assumed name of Donna Slay. She had been asked by Robert Powers, a narcotics officer with the Escambia County Sheriff's Department and Charles Deckard, an investigator with the Department of Professional Regulation, to go to Respondent's office in an undercover capacity and attempt to obtain a prescription for percodan. Medlen/Slay first gave general information to the receptionist, including identification, in the name of Donna Slay, chief complaint of a backache, previous illnesses, drug allergies, address, social security number, and insurance information. Medlen/Slay was shown to an examination room where her blood pressure and weight were taken by the nurse and a urinalysis was performed. Respondent then came in and asked Medlen/Slay what her problem was. She informed him that she had been pushed into a wall during a fight, and had injured her back. Respondent checked her pulse, did a range of motion test, and checked the alleged injured area by palpation. Each time Respondent pressed on the alleged injured area, Medlen/Slay told him it hurt. Respondent did not visually inspect the alleged injured area but asked Medlan/Slay if there was a bruise and she said no. In order to get the percodan, Medlen/Slay told Respondent that she had injured her back one other time and a doctor in Louisiana had prescribed percodan for that injury. Respondent asked how long ago Medlen/Slay had taken the percodan and she said one year ago. Respondent discussed the dangers of drug addiction with Medlan/Slay and then prescribed 20 tablets of percodan for pain and 30 tablets of indocin to reduce inflammation. Upon leaving Respondent's office, Medlen/Slay did not fill the prescriptions but turned them over to Deckard. Percodan is an acceptable medicine for back and shoulder pain. However, Respondent should have considered the possibility of fracture, visually examined the area to ascertain the presence of a hematoma (blood clot) and listened to the patient's chest to determine the presence of lung injury. Respondent did not perform an appropriate examination prior to prescribing percodan, and the prescription was therefore inappropriate. Respondent used poor judgment in his excessive prescriptions of percodan to the patients discussed herein. However, there is no evidence that Respondent prescribed the percodan for personal financial gain or that any patient was injured by Respondent's prescribing practices. The testimony of the expert witness established that the records maintained on these patients were inadequate. Frequently, the only notation for a given visit was the prescription for percodan, with no evaluation of the patient's condition. Further, Respondent's patient records did not even list all the percodan prescriptions issued. Thus, these records essentially reflect partial inventories of prescriptions issued, and do not justify the course of prescribing, which is important to the safe practice of medicine.
Recommendation Based on the foregoing, it is RECOMMENDED that Petitioner enter a final order placing Respondent on probation for a period of five years, require that Respondent practice under the supervision of another physician to be named by Petitioner during the initial year of his probation and that Petitioner restrict Respondent's license against prescribing Schedule II controlled substances while he is under such supervision. 4/ DONE and ENTERED this 24th day of April, 1984 in Tallahassee, Florida. R. T. CARPENTER, 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 24th day of April, 1984.
Findings Of Fact Respondent Alden Craig Schewe is a 50-year-old, board certified surgeon who practiced in Pittsfield, Illinois, before relocating to Plantation Key, Florida, in 1973, where he joined the staff of what is now Mariners Hospital. He was originally licensed to practice in Florida in 1970, and the parties stipulated that he was licensed to practice medicine in Florida at all pertinent times. MISFORTUNES Respondent had a series of accidents, beginning in 1976, that left him able to perform surgery, but which nevertheless caused painful injuries. At hearing Dr. Schewe recounted a "number of misfortunes." The first was an electrical shock from an auxiliary generator at his home which knocked him unconscious. He hurt his back as he fell. Later the same year, a 23-foot boat fell on him when a davit cable parted, injuring his left shoulder and his back. He was not hospitalized on either occasion, but he began taking pain killers. Some time later Dr. Schewe was at the controls of a helicopter which plunged into the water shortly after taking off. He swam to shore unassisted. Still later he broke his foot when an engine was dropped on it. Finally, in 1978, he stepped through a rotten dock and injured his right shoulder. PILLS PRESCRIBED Demerol or meperidine, T: Vol. I, p. 28, Vol II, p. 145, is a synthetic narcotic, an analgesic for relief of pain. Vol. I, p. 11. Percodan and Tylox are trade names for compounds that include a Class II narcotic. T: Vol. I, p. 33. Vol II, p. 173. They are very similar. The only difference between them may be that Tylox contains Tylenol, while Percodan contains aspirin. They are both "morphine derivatives. They contain an isomer of codeine called Oxycodone and will create a positive finding in the urine in the morphine or codeine screen." Vol. I, p. 12. These drugs are prescribed as pain relievers, and are occasionally used in weaning a heroin addict from heroin. T: Vol. I, p. 35. On January 29, 1976, Dr. Schewe wrote a prescription for 100 Percodan tablets for himself for use "as directed." He wrote other prescriptions for 100 Percodan tablets for himself for use "as directed" on February 16, 1976, and March 16, 1976. On April 1, 1976, he wrote himself another prescription for 100 Percodan tablets. Dr. Schewe wrote additional prescriptions for 100 Percodan Tablets for himself for use "as directed" on April 22, 1976, on May 20, 1976, on June 10, 1976, on June 25, 1976, on July 19, 1976, on August 3, 1976, on August 30, 1976, on September 17, 1976, on October 7, 1976, on October 30, 1976, on November 15, 1976, on November 29, 1976, and on December 17, 1976. In all, Dr. Schewe prescribed 1700 Percodan tablets for himself in 1976. At various times throughout 1976, respondent also wrote 15 prescriptions for himself for Demerol or meperidine. Three of these were marked "as directed," and three were marked "office use" or had the word "office" on the prescription form elsewhere than in the address blank. The following year saw Dr. Schewe prescribe an additional 1700 Percodan tablets for himself. He wrote 100- tablet Percodan prescriptions for himself for use "as directed" on January 3, 1977, on January 14, 1977, on February 16, 1977, on March 17, 1977, on May 16, 1977, on June 30, 1977, on July 12, 1977, on July 28, 1977, on October 31, 1977, and on November 14, 1977. He also wrote 50- tablet Percodan prescriptions for himself for use "as directed" on April 27, 1977, on May 26, 1977, and on October 13, 1977. He wrote a prescription for himself for 50 Percodan tablets on May 11, 1977, on which he made the notation "office stock." "Office stock" was also written on prescriptions respondent wrote for himself on June 4, 1977, on June 13, 1977, on August 9, 1977, on August 26, 1977, and on September 1, 1977, each for 100 tablets. At various times during 1977, respondent also wrote 10 prescriptions for himself for Demerol or meperidine. Three of these prescriptions had the notation "as directed", four had the notation "office stock" and one read "for med bag." In 1977, DEA agents came to Mariners' Hospital to investigate, and the medical staff of the hospital met with respondent in or about December of 1977. He was asked why he had prescribed so many controlled substances for himself, and was advised that it was against the law to write such prescriptions for himself. On March 7, 1978, on April 24, 1978, in May of 1978, in June of 1978 and on two other occasions in 1978, Dr. Halvor Leopoldo Franco wrote prescriptions for respondent for a total of 550 Percodan pills, after respondent told him that "he needed them for his chronic pain in his back or in his right shoulder, for his bursitis." Vol. II, p. 40. Dr. Franco is the anesthesiologist who regularly worked with respondent in surgery. He kept no medical records on Dr. Schewe because Dr. Schewe was not "an official patient of [his]." (Vol. II, p. 35) During 1979, Dr. Schewe wrote Percodan prescriptions for himself and for his second wife, Judy. For himself he prescribed 100 tablets of Percodan on August 12, 1979, 100 tablets of Percodan on September 24, 1979, and 50 tablets of Percodan on October 24, 1979, all for use "as directed." Respondent prescribed 50 Percodan tablets for Mrs. Schewe on April 16, 1979, another 50 on June 16, 1979, and another 50 on July 18, 1979. Dr. Halvor Franco prescribed Percodan tablets for respondent in 1979. On June 26, 1979, and again on July 21, 1979, Dr. Franco prescribed 100 Percodan tablets for respondent as needed for bursitis of the right shoulder. During the following year, Dr. Franco again prescribed Percodan tablets for respondent. On April 24, 1980, Dr. Franco wrote a 100-tablet prescription for Dr. Schewe for "acute pain in rt shoulder." On February 12, 1980, on August 6, 1980, and on November 21, 1980, Dr. Franco prescribed Tylox tablets for respondent Each prescription was for 100 tablets. The April and August prescriptions were ostensibly for "lumbar pain." On December 1, 1980, Dr. Ross prescribed 100 Tylox tablets for respondent. At various times during 1980, Dr. Schewe wrote Percodan and Tylox prescriptions for his wife. PILLS INGESTED All of the foregoing prescriptions were filled by the Mariners Hospital pharmacy. Respondent took almost all of these pills. He may have given some away to indigent patients, as he testified, but the nurse who began working for him on June 24, 1974, and worked in the office he shared with three other physicians for three and a half years testified that she could not remember respondent ever dispensing Percodan. The Percodan and Demerol in the office were not obtained pursuant to Dr. Schewe's prescriptions, in any event. When the Percodan supply was replenished, moreover, it was in batches of "perhaps twenty-four..." He might have given some Demerol to the son of a business associate who was addicted to cocaine or heroin. There was some testimony to that effect. But, by and large, respondent himself took the pills prescribed for him by himself and others, including the Percodan he prescribed for himself after July 1, 1979. The evidence was circumstantial but it was overwhelming. Mrs. Schewe took some of the pills respondent prescribed for her. She was ill and in pain for some time. But she did not like the side effects of Tylox and told her physician so, at the time. Respondent took some of the Tylox pills he prescribed for his wife. She saw him do it. In fact, even though she saw him take these pills several times, she never saw him take Percodan or Tylox that he prescribed for himself. Vol. II, pp. 137 and 140. Respondent never told Dr. Franco that he was getting Percodan or Tylox elsewhere when he made his repeated requests for prescriptions. Once, when he asked Dr. Ross for Tylox and Dr. Ross prescribed ten tablets, Dr. Schewe "refused because of the numbers, and [Dr. Ross] increased that number to 100 at his request." T: Vol. I, p. 17. PATIENTS' SAFETY Dolores A. Morgan, a board-certified family practitioner with considerable experience and expertise in treating physicians with chemical dependency problems, testified that a functional addict is one who seems to function normally so long as he maintains a certain blood level of an addictive substance, such as oxycodone. When respondent voluntarily submitted to an evaluation by her, no oxycodone was detected in his system, but Dr. Morgan was nevertheless persuaded, principally because of what she took to be his evasiveness, that Dr. Schewe was an "impaired physician." Sanford Jacobson, a psychiatrist, disagreed. More than one witness recalled Dr. Franco's expressing concern because Dr. Schewe's hands shook while he was operating. At hearing, however, Dr. Franco denied that he had ever seen respondent's hands shake or that he had ever told anybody that he had. Because the only testimony of shaking hands was hearsay to which timely objection was made, respondent's motion to strike was granted and there is no evidence to support a finding that Dr. Schewe's hands shook in surgery. All the competent evidence was the other way. Fellow physicians and operating room nurses all said that they had never seen any indication that Dr. Schewe's abilities as a surgeon were in any way diminished. He performed surgery at something like the rate of 250 operations a year during the period in question, and at all hours of the day and night. There was no showing that respondent has ever made any error in the practice of medicine for any reason, on any patient other than himself.
Recommendation Upon consideration of the foregoing, it is RECOMMENDED: That petitioner suspend respondent's license for six (6) months and place him on probation thereafter for five (5) years. DONE and ENTERED this 14th day of September, 1983, in Tallahassee, Florida. ROBERT T. BENTON, II 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 14th day of September, 1983. COPIES FURNISHED: Joel S. Fass, Esquire 626 N.E. 124th Street North Miami, Florida 33161 Alfred K. Frigola, Esquire Post Office Box 177 Marathon, Florida 33050 Ellis S. Rubin, Esquire and S. Richard Kaplan, Esquire 265 N.E. 26th Terrace Miami, Florida 33137 Fred M. Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Deborah J. Miller, Esquire Department of Professional Regulation Board of Medical Examiners 130 North Monroe Street Tallahassee, Florida 32301 Dorothy Faircloth, Executive Director Department of Professional Regulation Board of Medical Examiners 130 North Monroe Street Tallahassee, Florida 32301 ================================================================= AGENCY FINAL ORDER ================================================================= BEFORE THE BOARD OF MEDICAL EXAMINERS DEPARTMENT OF PROFESSIONAL REGULATION, Petitioner, vs. CASE NO. 81-2362 ALDEN CRAIG SCHEWE, M.D. License No. 18477 Respondent. /
Findings Of Fact The Respondent Walter L. Hurt is a licensed medical doctor having been issued license number ME 0007892. The last known address of the Respondent Hurt is 9871 Indigo Street, Perrine, Florida 33157. The Respondent's medical practice during the period set forth in the Administrative Complaint dealt primarily with weight control. Between approximately February 22, 1980 and August 11, 1981, the Respondent Hurt prescribed to Ms. Gloria Litton the following schedule II controlled substances as defined by Chapter 893, Florida Statutes: DATE DRUG AMOUNT 2/22/80 Sodium Amytal, 50 mg. 30 tablets 2/7/81 Sodium Amytal, 50 mg. 30 tablets 4/6/81 Sodium Amytal, 50 mg. 30 tablets 5/7/81 Sodium Amytal, 50 mg. 30 tablets 6/11/81 Sodium Amytal, 50 mg. 30 tablets 7/12/81 Sodium Amytal, 50 mg. 30 tablets 8/11/81 Sodium Amytal, 50 mg. 30 tablets 12/22/80 Dexedrine Sulfate, 5 mg. 30 tablets 2/26/81 Dexedrine Sulfate, 5 mg. 30 tablets 4/6/81 Dexedrine Sulfate, 5 mg. 30 tablets 5/7/81 Dexedrine Sulfate, 5 mg. 30 tablets 6/11/81 Dexedrine Sulfate, 5 mg. 30 tablets 7/12/81 Dexedrine Sulfate, 5 mg. 30 tablets 8/11/81 Dexedrine Sulfate, 5 mg. 30 tablets 1/14/80 Eskatrol Spans, 15 mg. 30 tablets No Date Tenuate Tabs, 25 mg. 60 tablets These drugs prescribed to Ms. Litton were excessive and inappropriate drugs for the purpose of weight loss. Between October 1, 1980 and December 1, 1980, the Respondent Hurt prescribed 90 tablets of Dexedrine, an amphetamine or sympathomimetic amine drug or compound designated as a schedule II controlled substance pursuant to Chapter 893, Florida Statutes to Ms. Litton for obesity. The drugs prescribed by the Respondent Hurt for Ms. Litton were ineffectual in treating her weight problem. In prescribing the type and quantity of controlled drugs for Ms. Litton, the Respondent failed to practice medicine with that level of care, skill and treatment required by a reasonably prudent similar physician confronted with the same conditions and circumstances. Moreover, the drugs were prescribed for a purpose outside the scope of Section 458.331(1)(cc), Florida Statutes, which prohibits prescribing an amphetamine or sympathomimetic amine drug except for certain enumerated purposes which do not include weight control. On January 29, 1981, the Respondent Hurt issued to Ms. Madeline Lyons a prescription for 30 tablets of Eskatrol Spansules, 15 mg. Further, on July 23, 1981, the Respondent Hurt issued a prescription to Ms. Lyons for 100 tablets of Fastin. These medications are amphetamines or sympathomimetic amine drugs or compounds designated as schedule II controlled substances pursuant to Chapter 893, Florida Statutes, and were given to Ms. Lyons by the Respondent for weight control. In prescribing these schedule II drugs for purposes of weight control, the Respondent failed to practice medicine with the degree of care, skill and treatment which is recognized as acceptable by a reasonably prudent similar physician confronted with similar conditions and circumstances. Moreover, these drugs were prescribed to Ms. Lyons for a purpose outside the scope of Section 458.331(1)(cc), Florida Statutes, which prohibits prescribing amphetamines or sympathomimetic amine drugs except for certain enumerated purposes which do not include weight control. Between approximately June 16, 1980 and October 1, 1981, the Respondent Hurt issued to Mr. Stephen Noel prescriptions for the following controlled substances as defined by Chapter 893, Florida Statutes. DATE DRUG AMOUNT 6/16/80 Preludin Endurets, 75 mg. 100 tablets 8/2/80 Preludin Endurets, 75 mg. 50 tablets 8/19/80 Preludin Endurets, 75 mg. 100 tablets 8/23/80 Preludin Endurets, 75 mg. 45 tablets 9/5/80 Preludin Endurets, 75 mg. 50 tablets 9/11/80 Preludin Endurets, 75 mg. 60 tablets 9/22/80 Preludin Endurets, 75 mg. 60 tablets 10/10/80 Preludin Endurets, 75 mg. 75 tablets 9/3/81 Didrex 100 tablets 9/17/81 Didrex 100 tablets 9/25/81 Didrex 100 tablets 10/1/81 Didrex 100 tablets The prescribing of these controlled substances by the Respondent Hurt to Mr. Noel was excessive and inappropriate for purposes of weight control. In prescribing excessive and inappropriate drugs, the Respondent engaged in gross or repeated malpractice or failed to practice medicine with the level of care, skill and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. Between approximately July 5, 1980 and October 1, 1981, the Respondent Hurt issued to Mrs. Edna Noel prescriptions for the following controlled substances as defined by Chapter 893, Florida Statutes: DATE DRUG AMOUNT 7/5/80 Preludin Endurets, 75 mg. 15 tablets 7/7/80 Preludin Endurets, 75 mg. 60 tablets 7/10/80 Preludin Endurets, 75 mg. 60 tablets 7/29/80 Preludin Endurets, 75 mg. 100 tablets 8/19/80 Preludin Endurets, 75 mg. 60 tablets 8/29/80 Preludin Endurets, 75 mg. 60 tablets 9/8/80 Preludin Endurets, 75 mg. 60 tablets 9/25/80 Preludin Endurets, 75 mg. 60 tablets 10/4/80 Preludin Endurets, 75 mg. 60 tablets 10/14/80 Preludin Endurets, 75 mg. 60 tablets 9/8/81 Didrex 100 tablets 9/12/81 Didrex 100 tablets 9/21/81 Didrex 100 tablets 9/28/81 Didrex 100 tablets 10/5/81 Didrex 100 tablets The prescribing of these controlled substances to Mrs. Edna Noel for purposes of weight control was excessive and inappropriate. In prescribing excessive and inappropriate controlled medications, the Respondent Hurt failed to practice medicine with the degree of care, skill and treatment which is recognized as acceptable by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. The prescriptions issued by the Respondent to Mrs. Edna Noel on October 4 and 14, 1980, for 120 tablets of Preludin Endurets, 75 mg. were for weight control. Preludins are amphetamines or sympathomimetic amine drug or compounds designated as a schedule II controlled substance pursuant to Chapter 893, Florida Statutes. These schedule II controlled substances were prescribed for Mrs. Noel for a purpose outside the scope of Section 458.331(1)(cc), Florida Statutes which prohibits prescribing such drugs except for certain statutorily enumerated purposes.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED: That the Board of Medical Examiners issue a Final Order finding the Respondent guilty of violating Sections 458.331(1)(q), (t) and (cc), Florida Statutes (1981), and revoking his license. DONE and ORDERED this 28th day of December, 1982, in Tallahassee, Florida. SHARYN L. SMITH, 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 December, 1982.
