The Issue The issue for determination is whether Petitioner must reimburse Respondent an amount up to $1,676,390.45, which sum Petitioner received from the Florida Medicaid Program in payment of claims arising from Petitioner's dispensing of pharmaceuticals between July 3, 2000 and March 28, 2002. Respondent alleges that the amount in controversy represents an overpayment related to Petitioner's failure to demonstrate the availability of sufficient quantities of drugs to support its billings to the Medicaid program.
Findings Of Fact Respondent Agency for Health Care Administration ("AHCA" or the "Agency") is the state agency responsible for administering the Florida Medicaid Program ("Medicaid"). Petitioner Disney Medical Equipment, Inc., d/b/a Disney Pharmacy Discount ("Disney Pharmacy"), was, at all relevant times, a Medicaid provider authorized, pursuant to contracts it had entered into with the Agency known as Provider Agreements, to receive reimbursement for covered services rendered to Medicaid beneficiaries. Exercising its statutory authority to oversee the integrity of Medicaid, the Agency directed its agent, Heritage Information Systems, Inc. ("Heritage"), to conduct an audit of Disney Pharmacy's records to verify that claims paid by Medicaid during the period from July 3, 2000 to March 28, 2002 (the "Audit Period") had not exceeded authorized amounts. Over the course of four days in May 2002, three of Heritage's auditors reviewed records on-site at Disney Pharmacy's drugstore in Hialeah, Florida; they also interviewed some of the store's personnel. Thereafter, Heritage analyzed the data it had collected using several different approaches. Each approach pointed to the conclusion that Medicaid had paid too much on claims submitted by Disney Pharmacy during the Audit Period. The total amount of the alleged overpayment differed substantially, however, depending on the analytical approach taken. The approach that yielded the largest apparent overpayment was the "prorated purchase invoice" analysis. Generally speaking, under this approach, the volume of pharmaceuticals that the provider maintained in its inventory during the Audit Period is compared to the provider's contemporaneous Medicaid claims to determine whether the provider possessed enough of the relevant pharmaceuticals to support the Medicaid claims presented. If the total amount purportedly dispensed, according to the claims made in connection with a particular drug, exceeds the amount of that drug available at the time for dispensing, then an inference of impropriety arises with regard to those claims for which product was apparently unavailable; the Agency considers amounts paid on such claims to be overpayments. To determine the quantities of certain drugs that Disney Pharmacy had kept on hand during the Audit Period, Heritage tallied up the total number of "units" of selected drugs that Disney Pharmacy had acquired, using as a database the invoices reflecting Disney Pharmacy's purchases of the drugs under review. Heritage then ascertained——again using Disney Pharmacy's records——the utilization rate of Medicaid beneficiaries for each of the pharmaceuticals under consideration. In other words, Heritage determined, for each drug at issue, the relative demand——expressed as a percentage of the total number of units of that drug dispensed to all customers during the Audit Period——attributable to Medicaid beneficiaries. Heritage found, for example, that Medicaid recipients accounted for 55.13% of Disney Pharmacy's total sales of the drug Acetylcysteine-10% solution ("Acetylcysteine") during the Audit Period. Having calculated the total amount of each drug at issue that Disney Pharmacy had acquired during the Audit Period, and having further determined for each such drug the Medicaid utilization rate, Heritage multiplied the total number of available units of each drug by the applicable utilization rate, prorating the entire supply of each drug to reflect the approximate number of units available for dispensing to Medicaid recipients specifically. For example, Disney Pharmacy's records showed that it had purchased a total of 121,440 units of Acetylcysteine during the Audit Period. Disney Pharmacy's records showed, additionally, that this drug was dispensed to Medicaid beneficiaries 55.13% of the time. Thus, the prorated quantity of Acetylcysteine available for Medicaid recipients was approximately 66,950 units (121,440 x 0.5513). The prorated number of available units of each subject drug was compared to the total number of units for which Medicaid had reimbursed Disney Pharmacy during the Audit Period. For Acetylcysteine, these figures were 66,950 and 1,076,070, respectively. If the total number of units for which Medicaid had paid on claims for a particular drug were found to exceed the amount of that drug which Disney Pharmacy apparently had on hand——as it did for Acetylcysteine——then the inventory shortfall——1,009,120 units in the case of Acetylcysteine——was multiplied by the drug's average per-unit cost to Medicaid, producing a drug-specific apparent overcharge. Thus, for example, because the average cost of Acetylcysteine was $0.65 per unit, the apparent overcharge with respect to this drug was $655,928.00. Using the foregoing approach, Heritage identified apparent overcharges in connection with 13 drugs. The sum of these drug-specific overcharges is $1,676,390.45. Two drugs—— Acetylcysteine and Ipratropium Solution ("Ipratropium")——account for nearly 93% of this grand total. Two other drugs——Albuterol- 0.83% ("Albuterol") and Metaproterenol-0.4% ("Metaproterenol")—— account for another 7.0% of the total alleged overcharge. These four drugs——whose individual overcharges, taken together, comprise approximately 99.8% of the total alleged overcharge of $1,676,390.45——are used for treating breathing disorders and typically are inhaled by the patients who use them.i There is no genuine dispute regarding the reason why Disney Pharmacy was unable to document its acquisition of Acetylcysteine, Ipratropium, Albuterol, and Metaproterenol (collectively the "Inhalation Therapy Drugs") in quantities sufficient to support its claims to Medicaid for these pharmaceuticals. During the Audit Period, Disney Pharmacy generally filled prescriptions for the Inhalation Therapy Drugs by "compounding" the prescribed medications. (Compounding is a process whereby the pharmacist mixes or combines ingredients to fashion a tailor-made medication for the patient.) Thus, Disney Pharmacy (for the most part) did not purchase the commercially available versions of the Inhalation Therapy Drugs; rather, it created its own "generic copies" of these medications, purchasing only the raw materials needed to make finished products. Medicaid reimburses for compound drugs under certain conditions, which will be spelled out below. But first: it is undisputed that Disney Pharmacy did not submit claims for compound drugs. Instead, in presenting claims to Medicaid for the Inhalation Therapy Drugs, Disney Pharmacy billed the medications under their respective National Drug Code ("NDC") numbers, as though commercially manufactured drug products had been dispensed. (An NDC is an 11-digit number, unique to each commercially available pharmaceutical, which identifies the manufacturer, product, and package size.) As a result, Medicaid paid Disney Pharmacy for mass produced products when, in fact, the pharmacy actually had dispensed its own homemade copies thereof. According to the Prescribed Drug Coverage, Limitations and Reimbursement Handbook ("Medicaid Handbook"), which authoritatively sets forth the terms and conditions under which Medicaid reimburses providers for dispensing pharmaceuticals, Medicaid may pay for a compound drug if the following criteria are met: At least one pharmaceutical is a reimbursable legend drug; The finished product is not otherwise commercially available; and The finished product is being prepared to treat a specific recipient's condition. Medicaid Handbook at 9-16.ii To present a claim for a compound drug, the provider must adhere to the following instructions: Compound drug codes must be submitted on paper Pharmacy 061 claim forms, because they are reviewed and manually priced by Medicaid. When billing for a compound drug, enter one of the following compound drug codes. More than one code is available so that more than one compound can be dispensed to a recipient on the same day without using the same number. Id. 55555-5555-55 66666-6666-66 77777-7777-77 88888-8888-88 Disney Pharmacy attempts to defend its failure to follow the unambiguous instructions for billing compound drugs by explaining that, before commencing the practice of compounding, the provider's owner, Sara Padron, made a telephone call to AHCA to ask for guidance on submitting claims for drugs created on-site. Ms. Padron testified at hearing that the AHCA employee with whom she spoke had told her to present claims for compound drugs by billing for the manufactured products that they most resembled, using the manufactured products' NDC numbers. Ms. Padron could not identify the person who purportedly gave her this plainly incorrect advice. Ms. Padron's testimony in this regard was not contradicted——although in fairness to the Agency hers was the kind of testimony that resists direct evidential challenge, forcing an opponent to stress the implausibility of the claim as a means of discrediting it. Ms. Padron's account cannot simply be dismissed as incredible, for an AHCA employee undoubtedly could give an incorrect answer to a provider's question. But even assuming that Ms. Padron reached a person whom one reasonably could suppose to be knowledgeable about Medicaid billing procedures, and further assuming Ms. Padron asked a clear question which fairly and accurately described the situation, neither of which was proved or should be taken for granted, the undersigned remains skeptical that Ms. Padron was instructed to bill for compound drugs as if billing for their commercially available counterparts: the advice is just too obviously wrong. It is not necessary, however, to accept or reject Ms. Padron's testimony concerning the "official" answer she says she received because even if Ms. Padron were told to bill for compound drugs as though manufactured products had been dispensed, no reasonable provider could have relied upon such a dubious oral representation. The statement, for starters, is an invitation to commit fraud. Common sense should inform any reasonable provider that a claim for something other than what was actually delivered will, if discovered, almost certainly be viewed as deceptive (or worse) by the payor. Additionally, the alleged statement attributed to AHCA's employee contradicts the plain instructions in the Medicaid Handbook on that very subject. No provider can reasonably rely upon verbal advice, given anonymously (or functionally so, since the advisor's name, if given, was evidently easily forgotten) over the telephone, which contravenes the clear language of the Medicaid Handbook. Disney Pharmacy's other defenses are likewise unpersuasive. Disney Pharmacy maintains that compounding the drugs in question substantially benefited the patients who received them, which is probably true——but certainly beside the point. The problem here is not with the practice of compounding per se; the problem is that Disney Pharmacy sought and received reimbursement from Medicaid for mass produced, commercially available drugs that had not actually been dispensed. For the same reason, it is irrelevant, even if likely true, that the Board of Pharmacy, which periodically inspects Disney Pharmacy, never objected to the compounding that was occurring at the premises. Again, to be clear, the problem is not that the compounding was improper, but that the Medicaid billing was improper.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Agency enter a final order requiring Disney Pharmacy to repay the Agency the principal amount of $1,676,390.45. DONE AND ENTERED this 11th day of April, 2006, in Tallahassee, Leon County, Florida. S JOHN G. VAN LANINGHAM Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 11th day of April, 2006.
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 issues to be decided are whether Respondent violated portions of chapter 458, Florida Statutes, as alleged in the Administrative Complaints; and, if so, what penalty should be imposed.
Findings Of Fact Petitioner is the state agency charged with regulating the practice of medicine pursuant to section 20.43 and chapters 456 and 458, Florida Statutes. At all times material to this matter, Dr. Mubang was a licensed physician within the State of Florida, having been issued license number ME55171. Respondent’s address of record is 741 Martin Luther King Boulevard West, Seffner, Florida 33584. Since at least March 17, 2010, Dr. Mubang’s practice at 741 Martin Luther King Boulevard has been registered as a pain management clinic with Petitioner. Dr. Mubang is board-certified in geriatric medicine and ambulatory medicine. Dr. Mubang immigrated to the United States from Cameroon, West Africa, to obtain his college education at State University of New York-Buffalo (“SUNY-Buffalo”). Dr. Mubang received a bachelor of arts degree in biology from SUNY-Buffalo. Dr. Mubang attended medical school at Southwestern University School of Medicine in the Philippines. Upon completion of his medical education, Dr. Mubang attended the Medical College of Pennsylvania for clinical rotations. He performed his residency at State University of New York-Brooklyn and Hahnemann University. Dr. Mubang’s license was first issued June 14, 1989, and is valid through January 31, 2020. His license has not been the subject of prior discipline. Dr. Mubang has maintained his Drug Enforcement Agency (“DEA”) Certificate of Registration without revocation, suspension, or other sanction. He has additionally qualified for, and obtained, a separate DEA Certificate of Registration to dispense Suboxone and buprenorphine. This secondary DEA Certificate of Registration requires training in addiction medicine. Dr. Mubang has continuously practiced as the primary care physician for many of his patients. He began his practice in Florida with CIGNA Health Group in one of its managed care clinics at University Mall in Tampa. When CIGNA closed its clinics, Dr. Mubang became employed by Correctional Medical Services (“CMS”), initially at Lake Correctional Facility, and then as the medical director for the Hillsborough County Sheriff’s Office. During his tenure with the Hillsborough County Sheriff’s Office, Dr. Mubang was recognized as the “Medical Director of the Year” for CMS in 1998. After leaving the Hillsborough County Sheriff’s Office, Dr. Mubang joined a practice with Dr. Encarnacion in Seffner, Florida. When Dr. Encarnacion retired, Dr. Mubang acquired the practice. In May 2009, Dr. Mubang received from the Board of Medicine and the Department of Health a publication entitled, “responsible opioid prescribing.” Dr. Mubang learned through his participation in various continuing medical education seminars about certain forms recommended for the treatment of patients suffering from chronic pain. He did not use electronic medical records prior to the dates of treatment charged in these consolidated Administrative Complaints. While in private practice, Dr. Mubang continued to treat patients committed to the State of Florida Juvenile Assessment Centers in Pasco, Pinellas, Sarasota, and Manatee counties. Dr. Mubang’s practice was licensed as a pain management clinic in 2010, despite his having limited formal training or education in pain management. Since initial licensure, his pain management clinic has remained continuously in operation, and has consistently passed all inspections. Pain Management Clinics are subject to annual inspections by DOH pursuant to section 458.3265(4)(a). Dr. Mubang’s Pain Management Clinic has never failed an inspection. DOH Investigator Victor Troupe of the Investigative Services Unit performed inspections of Dr. Mubang’s clinic. The clinic passed inspection. Dr. Mubang’s charged treatment of Patients A.M., B.B., C.C., W.B., and M.H., as alleged in the Administrative Complaint, occurred prior to October 17, 2010, the effective date of revised rule 64B8-9.013. Both parties presented expert witnesses board-certified in pain management to testify as to the standard of care required in this matter. Dr. Robert Guskiewicz testified as a medical expert for Petitioner. Dr. Guskiewicz is board-certified by the American Board of Anesthesiology in anesthesiology with a subspecialty in pain medicine. Dr. Guskiewicz practices as part of a large multispecialty practice in Gainesville, Florida, called Southeast Integrated Medical (“SIMED”). SIMED’s practice areas include neurology, neurosurgery, rheumatology, gynecology, psychology, urology, physiatry, allergy, family practice, and internal medicine. Dr. Guskiewicz is not now, and never has been, a primary care physician. About 40 percent of Dr. Guskiewicz’s practice is performing injections or interventions on patients. Most of the balance is patients on medication management seeking to achieve better functionality. Dr. Guskiewicz defines the standard of care as “what a prudent physician would do with a particular patient in a particular situation at that particular time.” In his practice, Dr. Guskiewicz prescribes 30 mg of oxycodone. Oxycodone is an effective pain medication. According to him, there is no maximum recommended dose for 30 mg of oxycodone. For the purposes of his expert testimony, Dr. Guskiewicz has no knowledge or information regarding Dr. Mubang or his practice. He does not know how big the clinic is where Dr. Mubang practices, who owns it, how many patients are seen each day, how many employees work there, or the types of patients treated there. Dr. Guskiewicz was paid an hourly fee for his expert testimony and preparation for deposition in this matter. Dr. Guskiewicz testified that he did a page-by-page review of the medical records he initially reviewed and those provided for his deposition in lieu of live testimony. Dr. Guskiewicz testified that the records were identical for Patients A.M., B.B., W.B., and M.H., but that the Bates numbers for the records for Patients C.C. and B.D. were not in sync. For Patient B.B., it was apparent at the hearing that Dr. Guskiewicz was in possession of the requisite records, which Respondent argued, had not been reviewed. For Patient M.H., Dr. Mubang argued that Joint Exhibit 6, covering records of treatment from 2010-2012, was not reviewed by Dr. Guskiewicz. Dr. Guskiewicz testified that the records for Patient M.H. were identical. In any event, the records subject to Respondent’s objection concern treatment after the treatment dates at issue in the Administrative Complaint. Only the records concerning the allegations contained in the Administrative Complaints will be considered for purposes of this Recommended Order. Dr. Mubang also raised the issue that Dr. Guskiewicz was not a similarly situated practitioner to Respondent. Dr. Mubang self-identified as practicing in pain management, and he owned and operated a clinic that was registered as a pain management clinic with DOH. Each patient treated by Dr. Mubang signed an Attestation for Pain Management, along with an Agreement for Treatment with Controlled Substances Therapy for Pain. Dr. Mubang acknowledged that if he gave a patient a pain management agreement, he was providing pain management to that patient. If a health care provider is providing evaluation, treatment, or diagnosis for a condition that is not within his or her specialty, a specialist trained in the evaluation, treatment, or diagnosis for that condition shall be considered a similar health care provider, pursuant to section 766.102(8), Florida Statutes. Because Respondent’s care at issue in this case is pain management, which is not specifically within his specialty, Dr. Guskiewicz is considered a similarly situated practitioner to Respondent. Petitioner did not provide Dr. Guskiewicz with any deposition testimony in this action until after his deposition in lieu of live testimony on October 9, 2018. Consequently, the depositions were not considered at the time Dr. Guskiewicz prepared his reports in this action. Dr. Guskiewicz never interviewed any of the patients at issue in this matter; never conducted any physical examination of the patients; and does not know where any of these patients are today. Further, he does not know what their current condition is; whether any of the patients are still receiving treatment for chronic pain; and whether any of the patients are still receiving opioid pain medications for the treatment of chronic pain. During the time periods relevant to these consolidated actions, Florida did not have a prescription drug monitoring database or E-FORCSE. At the time Dr. Guskiewicz authored his November 29, 2011, report, there was not a prescription drug monitoring database in Florida to permit practitioners to verify a patient’s representations about the medications they were taking and who had prescribed them. Dr. Guskiewicz is not a primary care physician, and has never been called upon to cover for a primary care physician who is treating a patient and has an ongoing relationship with that patient. Dr. Guskiewicz agrees that physicians in Florida have an obligation to consider their patients’ subjective complaints of pain and to treat them. Dr. Guskiewicz defines pain management as “treating patients who have chronic pain and provide different modalities of care to increase the functionality and well-being within that patient.” The goal of pain management is to optimize the patient’s functionality, lifestyle, and well-being within his or her family and community. Dr. Guskiewicz acknowledged that a patient coming to him for medical management of his or her pain is looking for an increase in function so he or she can get back to work and participate in normal activities of daily living. Dr. Guskiewicz defines intractable pain as “pain that perpetuates itself no matter what modalities are tried and will always be there. It’s now thought of being a more centralized pain that is basically within the brain itself.” Dr. Thomas Simopoulos testified as a medical expert for Respondent. Dr. Simopoulos is board-certified by the American Board of Anesthesiology in anesthesiology with a subspecialty in pain medicine. Dr. Simopoulos testifies as an expert for the defense more than 90 percent of the time. In the last five years, Respondent’s counsel has paid Dr. Simopoulos $30,000 to $50,000 in expert witness fees. Dr. Simopoulos lives in and practices medicine in Massachusetts. Dr. Simopoulos is not licensed to practice medicine in any other state; and he has never practiced medicine in the State of Florida. Dr. Simopoulos testified that the standard of care at the time material to this case was more regional than national. Dr. Simopoulos educated himself about the regional standard of care in Florida through conversations with his students and through hearing from people at national meetings. Dr. Simopoulos testified that patients have the right to reject a surgical recommendation: “Patients who are younger, in their more productive years, may not want to seek out surgery as a solution, particularly of the spine because it usually means that they’re at risk for having multiple surgeries. So and that even continues today, we try to manage younger folks with more conservative measure [sic], including medications to try to avoid surgery, because we know where that trajectory is going to go.” Dr. Simopoulos admitted that there were no studies at the time material to this case that revealed the exact nature and course of practice in the State of Florida. While Dr. Simopoulos is credited as an expert in anesthesiology and pain management, his reliance on the second- hand accounts from students and conferences he attended to form his opinions about the regional standard of care in Florida, are not as persuasive as the accounts of Dr. Guskiewicz, a physician practicing in the area of anesthesiology and pain management in Florida. Accordingly, Dr. Guskiewicz’s testimony is entitled to greater weight in this proceeding. Dr. Simopoulos also opined that the standard of care can only be violated when a patient is harmed. DOH argued that his definition is inconsistent with the definition in Florida law as contained in section 766.102(1). DOH Investigator Victor Troupe served a subpoena on September 2, 2010, for patient records to include: A.M., B.B., C.C., M.H., and W.B. Investigator Troupe took possession of the original files on that date. He has no reason to believe those patient files had been altered in any way. Investigator Troupe had performed numerous annual inspections of Dr. Mubang’s clinic, and neither found any violations or issued any citations. Investigator Troupe never interviewed Patients A.M., B.B., C.C., M.H., W.B., or B.D. Further, Investigator Troupe has no knowledge or information regarding the present whereabouts of any of those individuals. Finally, he has no information about whether those patients are still receiving opioid analgesic pain medication, even though DOH has access to E-FORCSE for investigative purposes. Drug Definitions Oxycodone is commonly prescribed to treat pain. Roxicodone is a brand name for oxycodone. Oxycodone is a Schedule II controlled substance. Oxycodone will be used throughout this Order, even if the brand name Roxicodone was prescribed. All Schedule II controlled substances have a high potential for abuse and have currently accepted, but severely restricted, medical use in treatment in the United States. Abuse of Schedule II controlled substances may lead to severe psychological or physical dependence. § 893.03(2), Fla. Stat. Fentanyl is a very strong opioid that is prescribed to treat pain and is listed as a Schedule II controlled substance. § 893.03(2)(b), Fla. Stat. Hydromorphone is a Schedule II controlled substance that is commonly prescribed to treat pain. Hydromorphone is commonly prescribed under the brand name Dilaudid. § 893.03(2)(a), Fla. Stat. Methadone is a synthetic opioid prescribed to treat pain. Methadone is a Schedule II controlled substance. § 893.03(2)(b), Fla. Stat. Vicodin and Lortab are brand names for hydrocodone/APAP. Hydrocodone/APAP contains hydrocodone and acetaminophen and is prescribed to treat pain. Hydrocodone in the dosages found in Vicodin is a Schedule III controlled substance. § 893.03(3)(c)4., Fla. Stat. All Schedule III controlled substances have a potential for abuse less than the substances in Schedules I and II. Abuse of Schedule III controlled substances may lead to moderate or low physical dependence or high psychological dependence. § 893.03(3), Fla. Stat. Fiorinal with codeine is the brand name for a drug that contains butalbital and codeine and is commonly prescribed to treat migraine headaches. Butalbital is a Schedule III controlled substance. Codeine is commonly prescribed to treat pain. Codeine is a Schedule II controlled substance. § 893.03(3)(a) and (2)(a), Fla. Stat. Ultram is a brand name for tramadol, an opioid-class narcotic medication prescribed to treat pain. At the time of the events of this case, tramadol was not a controlled substance. Tramadol is currently a Schedule IV controlled substance. § 893.03(4)(b), Fla. Stat. (2018). All Schedule IV controlled substances have a low potential for abuse relative to the substances in Schedule III. Abuse of Schedule IV controlled substances may lead to limited physical or psychological dependence relative to the substances in Schedule III. § 893.03(4), Fla. Stat. Soma is the brand name for carisoprodol. Carisoprodol is a muscle relaxant commonly prescribed to treat muscular pain. Carisoprodol is a Schedule IV controlled substance. § 893.03(4), Fla. Stat. Adderall is the brand name for a drug that contains amphetamine. Adderall is commonly prescribed to treat attention deficit disorder (“ADD”). Adderall is a Schedule II controlled substance. § 893.03(2)(c), Fla. Stat. Xanax is the brand name for alprazolam. Klonopin is the brand name for clonazepam. Valium is the brand name for diazepam. All three drugs are benzodiazepine-class drugs prescribed to treat anxiety, and all three drugs are Schedule IV controlled substances. During the time Respondent treated the five patients, who are the subject of the DOH Case No. 2010-12384, Florida did not have a prescription drug monitoring database. Before E-FORCSE, practitioners had to rely upon a patient’s representation regarding his or her medication history and verify the information by calling identified pharmacies. This “trust but verify” policy was in place at Dr. Mubang’s practice. During the time of Dr. Mubang’s treatment of these patients, he received a letter from Ana M. Viamonte Ros, M.D., the surgeon general for the State of Florida, and Fred Bearison, M.D., the chairman of the Florida Board of Medicine, dated May 13, 2009. That letter enclosed a copy of Responsible Opioid Prescribing, A Physician’s Guide, written by Scott M. Fishman, M.D. The letter advised Dr. Mubang, and others similarly situated, that Dr. Fishman’s book “is a practical guide to Florida’s current standards for the use of controlled substances for the treatment of pain,” based upon the Federation of State Medical Board’s Model Rule, “so it is right on point for Florida practicing doctors.” The book also stated, at page 25: Although Medicare and other institutions have defined what constitutes a physical examination for purposes of coding and reimbursement, exactly what comprises an appropriate or acceptable physical examination for pain is not well-defined, largely because it will differ from case to case. Regulators who expect to see a physical examination as part of the evaluation that leads to appropriate pain care involving controlled substances assume that a basic, if not focused, examination is warranted. The exact components of the examination are left to the judgment of the clinician who is expected to have performed an examination proportionate to the diagnosis that justifies a treatment. Dr. Mubang testified at the hearing, “many point-of- care screens for ‘opiates’ do not reliably detect any opioid other than codeine and morphine, or may not report if levels are below a certain threshold. Therefore, they may give false negative results for semisynthetic and synthetic oil opioid analgesics.” Dr. Mubang received feedback from pharmacists and patients regarding limitations on prescribing imposed on distributors and pharmacies by the DEA, including during the fall of 2010. During the time Dr. Mubang treated the six patients subject to these consolidated administrative actions, there was no upper limit recommended or identified regarding the maximum dosage for opioid analgesics. New patients to Dr. Mubang’s practice have to fill out paperwork, including a patient history. Patients were also required to sign an opioid contract, which mandated patients to use only one pharmacy and required that the patient only obtain medication from Dr. Mubang. Dr. Mubang obtained authorizations for release of medical information to acquire records of prior treating physicians. His office consistently obtained prior records, including MRIs and other diagnostic studies. Dr. Mubang testified that he performed a physical examination of each patient on each office visit. The initial exam was broad, while follow-up examinations were focal. His physical examinations included a review of systems, from head to toe. He stated that each physical examination included a review of the patient’s neurological status and notes whether the patient is oriented to person, time, and place. Dr. Mubang’s practice was to observe patients in his waiting room, and watch each patient as they come to the exam room. This observation is intended to identify things like gait abnormalities, guarding, and posture. Pain patients in Dr. Mubang’s practice are required to complete a Brief Pain Inventory, which he reviews with each patient. Dr. Mubang also reviews past medications with each patient to determine whether the medication has been effective in relieving pain and increasing activities of daily living. He reviews with each patient potential side effects of medication and the risks and benefits of using those medications. Dr. Mubang prepares a progress note for each office visit with a patient. Additionally, he maintains copies of each prescription issued to a patient. The identified treatment plan for each of these six patients was to improve the patient’s functional abilities, to allow them to return to work, and to participate in relationships. Dr. Mubang periodically required patients to submit to a urine immunoassay. This is a presumptive screening test for illicit substances and some other controlled substances. As Dr. Fishman points out on page 61 in his book Responsible Opioid Prescribing, Dr. Mubang was aware that “point-of-care screens for opioids do not reliably detect any opiate other than codeine and morphine.” During the 2010 timeframe, a physician who ordered a urine drug screen was not required to do anything with the results. Further, the requirements of rule 64B8-9.013(3)(d) to monitor patient compliance were not mandatory until after October 17, 2010. Dr. Mubang is aware of the sedative effects of opioids taken with muscle relaxants like Soma. This combination of medication should be dispensed with caution, but if a patient has been taking it for a period of time with no problems, he believes the prescription is appropriate. Dr. Mubang’s approach to changing pain medication, as explored more fully in the following discussion of the six patients subject to this proceeding is consistent, but deserves close scrutiny. He testified that: If the vital signs are stable, you can do what you want, so long as it doesn't have consequences. If you see the visit after this, this patient did not come in with hypertension or they did not end up in the hospital or I was not called at 2:00 in the morning. So it tells you what you're doing is right. See? That's why we do these vital signs. The Patients Each of the patients in this cause completed a two-page questionnaire about his or her pain, titled “brief pain inventory,” during each visit after the initial visit. The pain inventory contained: an anatomical figure for the patient to mark painful areas, 12 questions with a one-to-ten scale for pain level and for activities of daily living, and spaces for the patient to describe the pain in writing. Dr. Mubang’s progress notes for each of the patients consisted of a printed form, containing a similar anatomical figure at the top of the page with most of the rest of the page containing a checklist for “assessment.” Patient A.M. From December 22, 2009, to October 20, 2010, Dr. Mubang provided pain management treatment to Patient A.M., a then 23-year-old female, for lower back pain related to a car accident that occurred several years earlier. Dr. Mubang had first begun treating Patient A.M. while covering for Dr. Luis Azan at Plant City Polyclinic, where he prescribed her 240 30 mg tablets of oxycodone and 120 10 mg tablets of methadone. Dr. Mubang noted that Patient A.M. had been a passenger in the back of the car and was wearing a seatbelt. He noted that Patient A.M. did not lose consciousness, and while she went to the emergency room, she did not have an in-patient stay. On her initial evaluation questionnaire, Patient A.M. reported trying four alternative treatment methods for her pain out of 18 possible treatment options on Dr. Mubang’s checklist form: chiropractic treatment (no relief); muscle injections (no relief); massage (no relief); and pain relievers (some relief). By her own report, Patient A.M. had not tried physical therapy, nerve blocks, or surgery. Patient A.M. had sequential MRI findings from November 7, 2007 (ordered by Dr. Murthy Ravipati), and March 23, 2010 (ordered by Dr. Mubang), which demonstrated a central focal disc protrusion (herniated nucleus pulposus) at L5-S1. On her first visit at his office, Dr. Mubang increased Patient A.M.’s oxycodone from 240 to 270 30 mg tablets per month. He failed to document a rationale for the 30-pill increase. Dr. Mubang’s medical records included Patient A.M.’s medical history and physical examination; diagnostic, therapeutic, and laboratory results; evaluations and consultations; objectives identified; risks and benefits of the treatment ordered; treatments and medications ordered and documented; and instructions and agreements regarding pain management. Dr. Mubang made referrals to consulting physicians, including Dr. Goldsmith (orthopedic) and physical therapy (Select Physical Therapy). From December 22, 2009, to August 27, 2010, Dr. Mubang prescribed 270 30 mg tablets of oxycodone in combination with 120 10 mg tablets of methadone to Patient A.M. monthly. In ten months, Patient A.M. received 3,870 pain pills from Dr. Mubang. In order to take the pain medication as prescribed, Patient A.M. would have to take 13 pain pills per day. By comparison, Dr. Mubang’s expert, Dr. Simopoulos, testified that in his practice the most 30 mg of oxycodone that he ever prescribed was six tablets per day, or 180-200 tablets per month. Petitioner’s expert, Dr. Guskiewicz, testified that in his practice the most 30 mg of oxycodone that he ever prescribed was five per day, or 150 tablets. In addition to the pain medication, Dr. Mubang prescribed 90 350 mg tablets of Soma to Patient A.M. per month. On August 2, 2010, Dr. Mubang ordered a urine drug screen for Patient A.M. The drug screen was positive for benzodiazepines and negative for methadone. If a patient tests negative for a prescribed medication, the physician should consider the possibility that the patient is not taking the drug and, instead, is diverting it. Given Patient A.M.’s negative test for methadone, Dr. Mubang should not have continued to prescribe methadone to her, or at least should have questioned her about her usage of the prescribed drug. Despite the aberrant test result, Dr. Mubang continued to prescribe potentially lethal doses of oxycodone, methadone, and Soma to Patient A.M. Further, from December 22, 2009, through August 27, 2010, Dr. Mubang did not perform nor did he document performing a complete and adequate physical examination or medical history to justify his prescribing of potentially lethal doses of methadone, oxycodone, and Soma to Patient A.M. From December 22, 2009, through August 27, 2010, Dr. Mubang did not diagnose Patient A.M. with intractable pain prior to prescribing potentially lethal doses of methadone, oxycodone, and Soma to Patient A.M. To meet the standard of care, Dr. Mubang should have immediately reduced the amount of medication that he prescribed to Patient A.M. Additionally, he should have tried to determine the root cause of Patient A.M.’s pain. Dr. Mubang should have followed up on his ordering of alternative treatment modalities, such as physical therapy, and if Patient A.M. refused to follow his instructions, he should have discharged Patient A.M. While Dr. Mubang’s records are at times difficult to read, some were legible enough for review by the two experts who offered opinions in this matter. On the whole, however, the medical records for Patient A.M. were inadequate (and some of them were actually illegible) to provide complete information to either Dr. Mubang or another reviewing physician or investigator. Patient B.B. From March 25, 2010, to August 23, 2010, Respondent provided pain management treatment to Patient B.B., a then 25- year-old female. Patient B.B. initially visited Dr. Mubang on March 25, 2010, with a history of cervical spinal fusion in 2003 following a motor vehicle accident. Dr. Mubang’s Initial Evaluation documented a thorough review of systems, including skin; HEENT (head, eyes, ears, nose, and throat); neurological; and musculoskeletal. Simultaneously, Dr. Mubang and the patient completed a Pain Questionnaire documenting the location and severity of Patient B.B.’s pain and other treatment modalities, which had been tried, but failed (surgery, braces, chiropractic, physical therapy, TENS, and massage). On her initial visit with Dr. Mubang, Patient B.B. reported having neck, shoulder, and upper back pain. Dr. Mubang noted on his initial range of motion assessment that Patient B.B. had no thoraco-lumbar spine pain. Patient B.B. never indicated on her brief pain inventories that she had pain radiating down the leg. Instead, she consistently marked pain in the neck, radiating down the right arm, and pain in the middle back. After the initial visit, Dr. Mubang recorded that Patient B.B. had lower back pain by noting “LBP & radiculopathy” with a line drawn down the leg of the anatomical figure. Dr. Mubang’s explanation for the discrepancy between his notation on the anatomical figure and Patient B.B.’s notation was that the patient was noting pain, but that he was noting tenderness. He did not explain the difference. As discussed below, this same inconsistency appears frequently in many of the patients’ records. Dr. Mubang’s offered explanation for the discrepancy between his records and the patient-generated records is not credible. From March 25, 2010, to August 23, 2010, Dr. Mubang prescribed 240 30 mg tablets of oxycodone in combination with 60 2 mg tablets of Xanax to Patient B.B. monthly. From March 25, 2010, to May 20, 2010, Dr. Mubang also prescribed 120 350 mg tablets of Soma to Patient B.B., in addition to the oxycodone and Xanax each month. To justify the amount of Xanax he prescribed to Patient B.B., Dr. Mubang relied on an anxiety checklist questionnaire completed by Patient B.B. In his practice, if a patient marked five to six of the criteria on his anxiety checklist, Dr. Mubang would prescribe the patient Xanax. For Patient B.B., on three of his five progress notes, Dr. Mubang checked the box for anxiety. Other than that, there is no annotation or documentation by Dr. Mubang concerning Patient B.B.’s anxiety. From March 25, 2010, through August 23, 2010, based on Patient B.B.’s history and physical findings, Dr. Mubang prescribed potentially lethal doses of oxycodone, Xanax, and Soma to Patient B.B. in excessive quantities and without sufficient justification. From March 25, 2010, through August 23, 2010, Dr. Mubang neither performed nor documented performing a complete and adequate physical examination or medical history to justify his prescribing of potentially lethal doses of oxycodone, Xanax, and Soma to Patient B.B. From March 25, 2010, through August 23, 2010, Dr. Mubang failed to diagnose Patient B.B. with an anxiety disorder, which would have supported his prescribing of Xanax to Patient B.B. From March 25, 2010, through August 23, 2010, Dr. Mubang did not diagnose Patient B.B. with intractable pain prior to prescribing potentially lethal doses of oxycodone, Xanax, and Soma to Patient B.B. To meet the standard of care, Dr. Mubang should have done more to treat Patient B.B.’s underlying source of pain through referrals for physical therapy or orthopedics. Depending on the particular findings, he should have tried intervention care to relieve Patient B.B.’s pain instead of relying solely on medication management, particularly, excessive amounts of oxycodone. Patient B.B., as a relatively young patient, would have benefited from more aggressive physical therapy, massage therapy, and other treatment modalities to keep her off of addictive pain medication as much as possible. Dr. Mubang attempted, in part, to justify his excessive amounts of medications, based upon The Super Saver pharmacy profile for Patient B.B., which confirms that this patient was receiving the same quantities and combination of medications from the prior physician, Ibem R. Borges, M.D. He also cites rule 64B8-9.013 (2003) to support the heavy prescribing of medications, which indicates the Board of Medicine will not judge the validity of prescribing, “based upon the quantity and chronicity,” and that a “physician’s conduct will be evaluated to a great extent by treatment outcome.” He argues that Petitioner failed to introduce any evidence to establish Patient B.B. suffered any adverse effect from Dr. Mubang’s treatment. Patient C.C. From April 29, 2010, to May 28, 2012, Dr. Mubang provided pain management treatment to Patient C.C., a then 32-year-old female. At her initial evaluation, Patient C.C. reported having lower back pain and left knee pain. On her subsequent brief pain inventories, Patient C.C. consistently marked pain at the middle of the lower back and pain at the left knee. Almost identical to Patient B.B., Dr. Mubang’s progress notes for Patient C.C. note “LBP & radiculopathy” with a line drawn down the leg of an anatomical figure indicating pain radiating down the leg. Contained in Respondent’s records were notes from two prior treating providers, Drs. David Herson and Marc Weinstein. On a note dated February 27, 2007, Dr. Herson noted that Patient C.C.’s cervical and lumbar range of motion was within normal limits, and he noted no tenderness to palpation of the lumbar spine. Dr. Herson recommended epidural injections to Patient C.C. for the left knee pain. Dr. Herson prescribed Patient C.C. 30 tablets of Ultram for her pain. On a note dated March 1, 2007, Dr. Weinstein noted that “MRI scans of her cervical and lumbar spine and left knee were performed and show no significant abnormalities that would require surgery.” From April 29, 2010, to August 19, 2010, Dr. Mubang prescribed 290 30 mg tablets of oxycodone in combination with 180 10 mg tablets of methadone to Patient C.C. monthly. In a period of four months, Patient C.C. received 2,350 pain pills from Dr. Mubang, which equates to a daily prescription of 15.5 pills. In addition to addictive pain medication, Dr. Mubang also prescribed 60 2 mg tablets of Xanax to Patient C.C. per month. Opioids and benzodiazepines in combination increase the risk of respiratory depression, which can be fatal. On April 29, 2010, and May 27, 2010, Dr. Mubang added 90 350 mg tablets of Soma to the potentially lethal cocktail of medications he prescribed to Patient C.C. Dr. Mubang failed to document his rationale for starting and stopping Soma. On April 29, 2010, as part of her initial evaluation with Dr. Mubang, Patient C.C. reported to him that her current medications were oxycodone, methadone, Xanax, and Soma. On April 29, 2010, Dr. Mubang ordered a urine drug screen for Patient C.C. The drug screen was positive for opiates, oxycodone, and benzodiazepines, but was negative for methadone. Opiates and opioids are discernibly different categories of drugs. Opiates are morphine derivatives. Opioids are synthetic opiates. No medications Patient C.C. reported taking were opiates. The standard of care required Dr. Mubang to inquire as to the reasons behind the aberrant drug test result and adjust Patient C.C.’s medications accordingly. In his 2012 deposition, Dr. Mubang speculated that he may have consulted Patient C.C. about the drug test and that maybe she ran out of medication. He could not tell from his records if he discussed the results with Patient C.C. or the reason for the aberrant test result because his records lacked any such information. At the final hearing in this matter, Dr. Mubang raised for the first time the defense that the urine drug screen he used at that time was incapable of testing for methadone. He also argued that if a patient is taking oxycodone and methadone together, then either one, both, or neither may show up positive on a urine drug screen due to “tolerance” and methadone’s interaction with oxycodone and with the NMDA (the amino acid neuro receptor that increases the tolerance of oxycodone by interacting with methadone). This was a clear misunderstanding by Dr. Mubang of his expert’s testimony regarding the use of methadone in pain management. Dr. Mubang testified many times at hearing that methadone has a tolerance effect on oxycodone, which causes a physician to increase the dose of oxycodone. Respondent’s testimony was incongruent with the description given by his expert witness. Dr. Simopoulos explained that methadone can antagonize NMDA receptors, which can help some patients who have a tolerance to oxycodone. However, Dr. Simopoulos’s testimony regarding NMDA did not relate to the ability to detect methadone in a urine drug screen. Despite the negative test result for methadone, during the same visit, Dr. Mubang prescribed 180 10 mg tablets of methadone to Patient C.C. No questions of whether Patient C.C. may have diverted her methadone or notations of such were in the doctor’s notes. Dr. Mubang failed to order a second urine drug screen for Patient C.C. until ten months later on February 2, 2011. The second test was also negative for the prescribed medication methadone. From April 29, 2010, through August 19, 2010, based on Patient C.C.’s presentation, Dr. Mubang prescribed potentially lethal doses of oxycodone, methadone, Xanax, and Soma to Patient C.C. inappropriately, in excessive quantities, and without justification. From April 29, 2010, through August 19, 2010, Dr. Mubang neither performed nor documented performing a complete and adequate physical examination or medical history to justify his prescribing potentially lethal doses of oxycodone, methadone, Xanax, and Soma to Patient C.C. Dr. Mubang did not diagnose Patient C.C. with intractable pain prior to prescribing to the patient the potentially lethal doses of oxycodone, methadone, Xanax, and Soma. To meet the standard of care, Dr. Mubang should not have prescribed such large amounts of pain medication to Patient C.C., a patient who did not have a significant pathology for pain. Instead, he should have pursued other treatment modalities, such as injections and physical therapy. Patient W.B. From December 13, 2008, to February 18, 2011, Dr. Mubang provided pain management treatment to Patient W.B., a then 52-year-old male. On or about April 20, 2008, prior to visiting Dr. Mubang, Patient W.B. presented to the emergency room at Sarasota Memorial Hospital after being hit by a “slow moving vehicle,” while riding his bicycle. The emergency room physician diagnosed Patient W.B. with a bruise of the left knee and left hip and prescribed an unknown quantity of 7.5 mg Lortab to Patient W.B. Patient W.B. then visited Physician’s Group, LLC, in Sarasota for follow-up care on April 20, May 28, November 11, and December 2, 2008. On May 28, 2008, Patient W.B. reported to a provider at Physician’s Group, LLC, that he had taken Dilaudid from a friend. On November 11, 2008, Patient W.B. saw Dr. Frederic Sonstein. Dr. Sonstein noted that Patient W.B. missed a scheduled appointment because he was incarcerated. While incarcerated, Patient W.B. was treated with Flexeril and Ultram. Dr. Sonstein recommended referral to a pain management specialist and prescribed Vicodin for pain control. A November 24, 2008, MRI report of Patient W.B.’s lumbar spine was unremarkable. On December 13, 2008, Patient W.B. came to Dr. Mubang and reported having pain in his neck and shoulders, with pain radiating down both arms. In contrast to Patient W.B.’s report, on his initial range of motion evaluation, Dr. Mubang did not document any findings under cervical spine. Instead, he noted lumbar spine pain with radiculopathy. On his initial evaluation questionnaire, Patient W.B. reported only having tried one alternative treatment method for his pain, “braces or cast.” By his own report, Patient W.B. had not tried any of the other alternative treatment options on Dr. Mubang’s checklist form, such as physical therapy, chiropractic, muscle injections, or surgery. Despite the minimal objective findings in Patient W.B.’s history, Dr. Mubang began to prescribe escalating amounts of oxycodone to Patient W.B. On December 13, 2008, Dr. Mubang prescribed 120 30 mg tablets of oxycodone to Patient W.B. Then, he increased the amount of oxycodone he prescribed to Patient W.B. over the following monthly visits as follows: 150, 180, 210, 210, 240, 240, and ultimately settling at 270 30 mg tablets of oxycodone per month. From December 13, 2008, to August 24, 2010, Dr. Mubang prescribed Patient W.B. 4,050 30 mg tablets of oxycodone. On July 11, 2009, in addition to oxycodone and Soma, Dr. Mubang added Xanax and Fiorinal with codeine to Patient W.B.’s monthly prescription regimen. Like with Patient B.B., Dr. Mubang prescribed Xanax to Patient W.B. based on Patient W.B.’s answers to his checklist anxiety questionnaire. On July 11, 2009, Dr. Mubang saw Patient W.B. and renewed his medication. He scheduled Patient W.B. to return on August 9, 2009; however, Patient W.B. missed the appointment. Patient W.B. next visited Dr. Mubang two months later, on October 13, 2009. Dr. Mubang failed to document the reason for Patient W.B.’s three-month absence. He failed to document if Patient W.B. continued to receive pain medication from another source. He did not note whether Patient W.B. experienced withdrawal symptoms without his oxycodone for two months or how Patient W.B. managed his pain without oxycodone for two months. Dr. Mubang admitted during the hearing that, “[i]t is important to me to know why he misses visits. And you're right. Your point is well-taken.” Dr. Mubang’s own controlled substance agreement, which was executed by Patient W.B., explicitly stated that renewals are contingent on keeping scheduled appointments. Despite the unexplained absence, on October 13, 2009, he renewed Patient W.B.’s prescriptions for 270 tablets oxycodone, 30 tablets Soma, 60 tablets Xanax, and 90 tablets of Fiorinal with codeine. Dr. Mubang should not have restarted Patient W.B. at the same high dosage of oxycodone that he had previously prescribed, as it was potentially fatal. On November 10, 2009, Dr. Mubang ordered a urine drug screen for Patient W.B. The drug screen was positive for cocaine and hydromorphone. The drug screen was negative for the prescribed medications Soma (carisoprodol) and Xanax (alprazolam). Based upon the November 10, 2009, drug screen result, the standard of care required Dr. Mubang to refer Patient W.B. to a drug treatment center. When questioned about the positive cocaine result, Dr. Mubang’s expert, Dr. Simopoulos, testified, “That’s the part where this patient has a substance abuse disorder, obviously.” Dr. Simopoulos opined that, “if you are going to continue prescribing in this case, because the patient has duel diagnoses, you would want the input of a psychiatrist for this case.” Patient W.B. next visited Dr. Mubang approximately three months later on February 9, 2010. Again, Dr. Mubang failed to document the reason for the absence. At the February 9, 2010, visit, Dr. Mubang ordered a urine drug screen for Patient W.B., which returned completely negative results. After a multi-month absence and with a completely negative urine drug screen, Patient W.B. would have been opioid negative. In his 2012 deposition, Dr. Mubang theorized that the completely negative result may have been because Patient W.B. drove himself to his appointment and Dr. Mubang instructed his patients not to drive while on medication. This made little sense. Despite the completely negative result and unexplained absence, Respondent prescribed Patient W.B. 270 tablets of oxycodone, 30 tablets of Soma, 60 tablets of Xanax, and 90 tablets of Fiorinal with codeine. Again, Dr. Mubang should not have restarted Patient W.B. at the same high dosage of oxycodone that he had previously prescribed, as it was potentially fatal. Despite prescribing 270 tablets of oxycodone per month to Patient W.B., or nine pills per day, Dr. Mubang testified at hearing that, “[i]f I give them what they call ‘breakthrough medications,’ like oxycodone, all these, they'll tell you some days they take it, some days they don't take it.” Dr. Mubang was aware that Patient W.B. did not require nine oxycodone tablets per day and that the amount of oxycodone he prescribed to Patient W.B. was not justified. The foregoing pattern of unexplained absence and completely negative urine drug screen result, followed by Dr. Mubang renewing prescriptions, was repeated in November 2010. From December 13, 2008, through November 10, 2010, Dr. Mubang prescribed potentially lethal doses of oxycodone, Soma, Xanax, and Fiorinal with codeine to Patient W.B. inappropriately, in excessive quantities, and without justification. From December 13, 2008, through November 10, 2010, Dr. Mubang neither performed nor did he document performing a complete and adequate physical examination or medical history to justify his prescribing of the potentially lethal doses of oxycodone, Soma, Xanax, and Fiorinal with codeine to Patient W.B. From December 13, 2008, through August 24, 2010, Respondent did not diagnose Patient W.B. with intractable pain prior to prescribing potentially lethal doses of oxycodone, Soma, Xanax, and Fiorinal with codeine to Patient W.B. To meet the standard of care, Dr. Mubang should have discontinued prescribing the amount of medication that he prescribed to Patient W.B. based on the minimal findings in Patient W.B.’s history and the minimal changes on examination. In addition, Dr. Mubang should have referred Patient W.B. to a drug treatment center. Patient M.H. From January 10, 2005, to May 29, 2012, Dr. Mubang provided pain management treatment to Patient M.H., who first visited him as a 29-year-old female, suffering lower back pain. Prior to seeing Dr. Mubang, on March 24, 2004, Patient M.H. visited Dr. Edward Jacobson. Dr. Jacobson noted that Patient M.H. had been in a car accident on February 21, 2004, and that Patient M.H. was complaining of headaches. He prescribed 15 tablets of Vicodin to her. On January 10, 2005, Patient M.H.’s first visit with Dr. Mubang, he prescribed her 60 tablets of Vicodin. On January 21, 2005, Dr. Mubang added clonazepam and Adderall to Patient M.H.’s medication regimen. Dr. Mubang’s note for the January 21, 2005, visit does not make any mention of Patient M.H. suffering from an anxiety disorder or ADD that would justify his use of clonazepam or Adderall, save for a simple “ADD” noted in the assessment/plan portion of the form. Dr. Mubang should have referred Patient M.H. to a psychiatrist for diagnostic confirmation of ADD before automatically prescribing (or refilling) the Adderall prescription. From June 15, 2005, to March 7, 2007, Dr. Mubang prescribed Valium in combination with clonazepam to Patient M.H. monthly. Then on March 23, 2009, he discontinued clonazepam and started Patient M.H. on 90 2 mg tablets of Xanax. Dr. Mubang neglected to document a justification for prescribing Patient M.H. benzodiazepine-class drugs, or for prescribing her a combination of two different benzodiazepine- class drugs, or for the changes he made to the benzodiazepines he prescribed. On January 6, 2009, Patient M.H. reported having lower back pain from a car accident in 2003. Dr. Mubang noted that Patient M.H. was the driver of a car that was rear-ended. He also noted that Patient M.H. did not lose consciousness during the accident and did not go to the emergency room. At the January 6, 2009, visit, Patient M.H. reported trying three alternative treatment methods for her pain. By her own report, Patient M.H. had not tried any of the other 18 alternative treatment options on Dr. Mubang’s checklist form, such as physical therapy, muscle injections, or surgery. In 2009, for unexplained reasons, Dr. Mubang began significantly increasing Patient M.H.’s opioid pain medication. In January 2009, he increased Patient M.H.’s Vicodin from 60 to 90 tablets per month, then in July 2009 from 90 to 120 tablets per month. On October 19, 2009, Dr. Mubang prescribed Patient M.H. ten 50 mcg patches of fentanyl in combination with 120 tablets of Vicodin. A 50 mcg fentanyl patch is intended to last for 72 hours; so, a prescription of ten patches is intended to last one month. Fentanyl is a very strong opioid. Based on Patient M.H.’s experience with opioids, Dr. Mubang’s prescribing fentanyl to Patient M.H. was potentially lethal. On November 16, 2009, Dr. Mubang discontinued fentanyl and started Patient M.H. on 90 15 mg tablets of oxycodone, which he increased to 120 tablets the next month. Dr. Mubang prescribed the oxycodone in combination with 120 tablets of Vicodin. At hearing, Dr. Mubang could not tell from his notes and was, therefore, unable to explain his rationale as to why he prescribed fentanyl to Patient M.H., or why he discontinued the fentanyl and started Patient M.H. on oxycodone. The limited documentation that was included in Dr. Mubang’s records contradicted his course of treatment, as he routinely documented that Patient M.H.’s pain was a two out of ten with medication. From March 8, 2010, to June 28, 2010, Dr. Mubang added and then discontinued prescribing Soma to Patient M.H. His records do not contain any justification for starting Patient M.H. on Soma or for stopping Soma. On May 3, 2010, Dr. Mubang ordered a urine drug screen for Patient M.H. The urine drug screen result was negative for the prescribed medication oxycodone. The standard of care required Dr. Mubang to ask about the reason for the aberrant result to determine whether she was taking the medications or diverting them. Depending upon Patient M.H.’s answer, he should have ordered a repeat urine drug screen at the following visit. Despite the negative test, Dr. Mubang continued to prescribe potentially lethal doses of oxycodone and Vicodin to Patient M.H. From January 10, 2005, through August 23, 2010, Dr. Mubang prescribed potentially lethal doses of Vicodin, Xanax, Adderall, Soma, Valium, clonazepam, fentanyl, or oxycodone to Patient M.H. inappropriately, in excessive quantities, and without justification. From January 10, 2005, through August 23, 2010, Dr. Mubang did not diagnose Patient M.H. with ADD or any other clinical indication to support his prescribing Adderall to Patient M.H. From January 10, 2005, through August 23, 2010, Dr. Mubang neither performed nor documented performing a complete and adequate physical examination or medical history to justify his prescribing of the potentially lethal doses of Vicodin, Xanax, Adderall, Soma, Valium, clonazepam, fentanyl, or oxycodone to Patient M.H. Dr. Mubang did not diagnose Patient M.H. with intractable pain prior to prescribing to the patient the potentially lethal doses of Vicodin, Xanax, Adderall, Soma, Valium, clonazepam, fentanyl, or oxycodone. To meet the standard of care in his treatment of Patient M.H., Dr. Mubang should not have prescribed fentanyl to Patient M.H. without sufficient medical justification, as doing so was life threatening. Respondent should have referred Patient M.H. to specialists, such as orthopedics, physical therapy, and psychiatry. To the extent Dr. Mubang documented referrals to specialists, he should have followed up on his ordering of referrals to minimize the amount of medications he provided to Patient M.H., instead of escalating the amounts of pain medicine he prescribed. Patient B.D. From November 11, 2010, to November 8, 2012, Dr. Mubang provided pain management treatment to Patient B.D., a then 24- to 26-year-old female. In addition to lower back pain, Patient B.D. was also diagnosed with fibromyalgia. Dr. Mubang’s medical records for Patient B.D. contain a note from Dr. Indira Koshy, a prior treating provider, for a visit on August 24, 2010, in New York. Dr. Koshy noted that Patient B.D. was “entering rehab” and that Patient B.D. has seizures when she does not take her medications. Dr. Koshy’s note indicates potential for doctor shopping. At no point during his treatment of Patient B.D. did Dr. Mubang address the note from Dr. Koshy, specifically; Patient B.D.’s entry into rehabilitation; Patient B.D.’s seizures when she did not take her medications; or Patient B.D.’s potential for doctor shopping. Dr. Mubang previously treated Patient B.D. at Care Point Medical Center as a covering physician. He testified that when covering as a physician he provided “continuation of care” and that his practice was not to change a patient’s medication. Despite his testimony, when covering at Care Point Medical Center, Dr. Mubang increased Patient B.D.’s oxycodone from 210 tablets per month to 240 tablets per month. Then, on November 11, 2010, when Patient B.D. visited his practice, Dr. Mubang decreased her oxycodone from 240 to 180 tablets. As discussed below, this decrease came after he received notice of Petitioner’s investigation. From November 11, 2010, until May 24, 2012, Dr. Mubang prescribed Patient B.D. 180 30 mg tablets of oxycodone, 30 or 60 10 mg tablets of methadone, 60 350 mg tablets of Soma, and 30 0.5 mg to 2 mg tablets of Xanax monthly. On June 21, 2012, Dr. Mubang changed Patient B.D.’s prescribed muscle relaxant from Soma to baclofen; and on July 19, 2012, he changed Patient B.D.’s prescribed anxiolytic medication from 60 0.5 mg tablets of Xanax to 60 2 mg tablets of clonazepam. Dr. Mubang did not document any justification for the foregoing medication changes. From September 13, 2012, until November 8, 2012, Dr. Mubang prescribed 112 8 mg tablets of Dilaudid, 28 10 mg tablets of methadone, and 60 tablets of clonazepam to Patient B.D. monthly. On June 23, 2011, Dr. Mubang performed a urine drug screen on Patient B.D. The drug screen was negative for benzodiazepines, even though he prescribed Xanax to Patient B.D. The urine drug screen was positive for methadone, despite Dr. Mubang’s testimony that his urine drug screen could not detect methadone. On December 8, 2011, and June 21, 2012, Dr. Mubang performed urine drug screens on Patient B.D. Both drug screens were negative for the prescribed medication methadone. The standard of care required a reasonably prudent physician to question the patient about the aberrant urine drug screens results and cease prescribing methadone to a patient whose urine drug screen was negative for the drug. Despite the negative test results, Dr. Mubang continued to prescribe methadone to Patient B.D. From November 11, 2010, through November 8, 2012, Dr. Mubang neither performed nor documented performing an adequate history or physical examination to justify his prescribing of the potentially lethal controlled substances to Patient B.D. From November 11, 2010, through November 8, 2012, based on Patient B.D.’s history and physical findings, Dr. Mubang’s prescribing of the controlled substances to Patient B.D. was excessive and without justification. From June 23, 2011, through November 8, 2012, Dr. Mubang failed to address Patient B.D.’s aberrant urine drug screen results. To meet the standard of care in his treatment of Patient B.D., Dr. Mubang should not have prescribed the quantity and combination of drugs he prescribed to Patient B.D. He should have referred Patient B.D. for a rheumatology consult to confirm or rule out fibromyalgia and other diseases. He should have offered more physical therapy, and other, non-opioid modalities of care, and he should have routinely followed up with Patient B.D. to ensure that she was complying with his orders. Dr. Mubang testified that Soma was part of the “holy trinity,” which is a slang drug term used to refer to the prescription combination of oxycodone, a benzodiazepine, and Soma. He prescribed the “holy trinity” to five of the six patients in this cause. Dr. Mubang’s Medical Records Dr. Mubang’s medical records for the six patients, who are the subjects of the Administrative Complaints, were generally lacking in specificity to justify the level of his prescribing. Some examples common to the patients at issue illustrate these shortcomings. For each visit for each of the patients, Dr. Mubang noted that the patient had straight leg raise pain at 30 degrees, even though he testified that a patient can have straight leg raise pain at 15, 20, 30, or 45 degrees. Maybe this was a coincidence, but more credibly it is a pattern of sloppiness or autofill by the doctor. Also, for each patient, Dr. Mubang routinely drew a line down one leg of the anatomical figure on his progress notes indicating radiculopathy, regardless of where the patient reported pain. At hearing, on multiple occasions, Dr. Mubang could not determine his rationale for changing a patient’s medication regimen, based on his progress notes. His own expert, Dr. Simopoulos, testified that, “there's not much rationale on the plans in--in Dr. Mubang's notes in general.” Dr. Mubang tried to justify the lack of documented rationale by explaining that if a subsequent treating physician needed to know why he made medication changes, the physician would just call him and ask. While this should be true in an ideal world, his attempted justification is contrary to the purpose of medical records, which is continuity of care. No doctor, regardless of his education and experience, can be expected to remember every detail about every patient when he only sees the patient periodically. The medical record and doctor’s notes comprise his guide to ensuring the patient receives continuous, appropriate care. In addition to lacking in rationale, both experts were unable to read some of Dr. Mubang’s handwritten notes due to legibility. His own expert testified that, “The hardest part about these records is, obviously, how legible they are. I wish they were more legible.” Dr. Mubang’s medical records were inadequate for all six of the patients at issue here. Dr. Mubang’s Defenses Dr. Mubang passionately testified at hearing that he practices addiction medicine, that he prescribes Suboxone, and that his goal is to titrate patients’ medication. However, Dr. Mubang’s interest in addiction medicine and Suboxone is a recent phenomenon. In his 2012 deposition, he did not mention practicing addiction medicine, and the word Suboxone does not even appear in that deposition. Dr. Mubang titrated the medication he prescribed for four of the six patients in this cause. His reasoning for titrating the patients’ medication changed from his deposition testimony to his hearing testimony. In his 2018 deposition, he testified that he reduced the patients’ pain medication because the patients’ conditions were improving, and his goal was to titrate the medication. At hearing, he asserted the theory that he changed his prescribing practices because pharmacies contacted him and told him that they would no longer fill prescriptions written for such large quantities. The first of these is based upon a consideration of quality of care, while the second is based upon the practical reality of changing pharmacy practices as the dangers of over-prescribing opiates started to become more prevalent in the eyes of health professionals and regulators. On September 2, 2010, Investigator Victor Troupe personally served Dr. Mubang with a notice of investigation and a subpoena for medical records for Patients A.M., B.B., C.C., W.B., and M.H., among others. Following receipt of the notice of investigation, the doctor radically changed his prescribing practice for the patients in this cause. For ten months, Dr. Mubang prescribed Patient A.M. 270 tablets of oxycodone. Then on September 24, 2010, three weeks after being served by Petitioner, Respondent reduced Patient A.M.’s prescription of oxycodone from 270 tablets to 210, and then from 210 tablets to 180. For five months, Dr. Mubang prescribed Patient C.C. 290 tablets oxycodone. Then on September 9, 2010, Respondent reduced Patient C.C.’s prescription of oxycodone from 290 tablets to 210. At the patient’s next visit on January 5, 2011, Dr. Mubang reduced the patient’s prescription of oxycodone from 210 tablets to 180. Dr. Mubang also reduced Patient C.C.’s methadone. For five months, he prescribed 180 10 mg tablets of methadone to Patient C.C., but he reduced that number first to 60 tablets, then to 30, then discontinued the prescription. Further, in a matter of three visits, the doctor went from prescribing Patient C.C. 470 pain pills per month to 180 tablets. For ten months, Dr. Mubang prescribed Patient W.B. 270 tablets of oxycodone. Then on November 6, 2010, Patient W.B.’s first visit after the doctor received notice of the investigation, he reduced Patient W.B.’s prescription of oxycodone to 240 tablets, then to 210 on the next visit. For five months, Dr. Mubang prescribed Patient B.D. 240 tablets of oxycodone. Then on November 11, 2010, Patient B.D.’s first visit with the doctor after he had received notice of the investigation, he reduced Patient B.D.’s prescription of oxycodone to 180 tablets. The logical explanation for Dr. Mubang’s sudden reduction in amounts of pain medication prescribed is that the Petitioner’s notice of investigation triggered him to change his prescribing practice. The notice of investigation might have been his “eureka” moment or it might have served as a wake-up call to him concerning his prior over-prescribing practices. The evidence clearly and convincingly demonstrates that Dr. Mubang used little critical medical judgment when prescribing dangerous controlled substances to the patients in this matter. His diagnoses were based solely on patient report, and his primary tool for treating these patients was the prescription of controlled substances without first exhausting less harmful treatment modalities or combining lower doses of controlled substances with his patients seeking other treatment modalities.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order: finding that Respondent, John Nkolo Mubang, M.D., violated sections 458.331(1)(nn), 458.331(1)(q), 458.331(1)(t), 458.331(1)(m), and 458.331(1)(cc), Florida Statutes, as charged in Petitioner’s Administrative Complaints; and revoking Dr. Mubang’s Florida medical license. DONE AND ENTERED this 25th day of June, 2019, in Tallahassee, Leon County, Florida. S ROBERT S. COHEN Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 25th day of June, 2019. COPIES FURNISHED: Chad Wayne Dunn, Esquire Prosecution Services Unit Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 (eServed) Dale R. Sisco, Esquire Sisco-Law 1110 North Florida Avenue Tampa, Florida 33602 (eServed) Zachary Bell, Esquire Prosecution Services Unit Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 (eServed) Claudia Kemp, JD, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way, Bin C-03 Tallahassee, Florida 32399-3253 (eServed) Louise Wilhite-St Laurent, General Counsel Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 (eServed)
Findings Of Fact Alexander G. Toth graduated from medical school in 1943 and migrated to Miami in 1948. He took his three-year residency in general surgery at the V. A. Hospital in Miami starting in 1951 and thereafter practiced general surgery until 1976 when he had a serious accident. This accident plus additional health problems caused him to give up surgery and he has practiced family medicine since 1976. His office hours have been limited from 9 until 12 each week day since 1976. Approximately 10 patients per day were seen by Respondent during the period involved in these charges. At all times here relevant Respondent was licensed by Petitioner as a physician. Richard Hatcher was a patient of Respondent in 1975 at which time he complained of headaches and low back pain. Respondent prescribed Percodan, Doriden, Dilaudid and Placidyl during a one-year period Hatcher was a regular patient. At this time Hatcher had a suit pending to recover damages for injuries received in an automobile collision. Hatcher did not see Respondent with any regularity again until 1978. Respondent's patient records of Hatcher (Exhibit 5) show he treated Hatcher on 11-20-78 on complaint of can't sleep, low back pain and spasm of lower back, by prescribing 100 Valium and 100 Percodan. Exhibit 6, which is a copy of prescriptions written by Respondent for Hatcher, shows the following prescriptions were written for Hatcher on dates indicated: 6/2/78 - 30 Valium 10 mg; 8/8/78 - 50 Seconal and 30 Fastin 30 mg; 10/11/78 60 Tuinal 3 grs, 60 Fastin 30 mg, 50 Valium 10 mg and 100 Percodan; and 11/20/78 - Valium 10 mg, 30 Fastin 30 mg and 100 Percodan. Exhibit 5 shows in 1975 Hatcher was 6 feet and 180 pounds. The entry dated 12/18/78 opposite Fastin is (Wt 205). During the period 12/18/78 to 2/27/79 Respondent prescribed for Hatcher on numerous prescriptions the following: 300 Percodan, 250 Valium, 230 Tuinal 3 gr, 60 Fastin, 60 Demerol 100 mg, one 30 cc vial Demerol 100 mg per cc, and 30 syringes (Exhibit 6) . Exhibit 5 contains an entry dated 3/2/79 "(Wants Demerol) Refused - refer to JMH", and a final entry (3-19) Deceased." Hatcher voiced the same or similar complaints of pain on each visit to Respondent. Richard Hatcher was found dead in his apartment on or about 21 March 1979 some 24 to 36 hours after he died. Cause of death was acute intravenous narcotism. The syringe with which the fatal narcotic was injected was still in his arm when his body was found. Due to the rapid clearing of many drugs from the blood the autopsy failed to reveal which of the opiate drugs caused Hatcher's death. About one week later Mrs. Hatcher, the mother of Richard, received from her ex-husband and father of Richard a page from a notebook found in Richard's apartment after his death signed by Richard which indicates some concern by Hatcher that he might overdose on drugs given him by Dr. Toth, the Respondent (Exhibit 12). Richard Hatcher became seriously involved with drugs in 1967 when he was 21 years old. By 1975 his mother noted a personality change where he would quickly go from normal to extremely agitated. In the fall of 1978 Hatcher committed himself to Village South, a drug rehabilitation program in Dade County, for some 4 or 5 months. After release from Village South Hatcher continued to take drugs. To his mother's knowledge he overdosed several times before his death. Three times she found him unconscious on the floor of her apartment and on numerous other occasions he was "spaced out". Respondent testified that Hatcher showed no indication he had abused or misused the medications Respondent prescribed. If so, it is evident that Respondent did not closely observe Hatcher or do more than hear his litany of pain. On the other hand, Exhibit 5 shows that some 2-1/2 weeks before Hatcher's death Respondent refused to prescribe the Demerol wanted by Hatcher. Unless Respondent recognized the seriousness of Hatcher's addiction it is not conceivable that he would suddenly refuse drugs so freely prescribed in the past. Michael Kavney was a patient of Respondent from June 1979 until his death from an overdose of Placidyl on 14 or 15 January 1980. On June 11 1979 Kavney complained of pain in his shoulder and Respondent prescribed 50 Tylenol. Kavney was 6 feet tall, weighed 189 pounds, and told Respondent he wanted to lose weight. Respondent on June 11, 1979 also prescribed 50 Fastin. On 8-16-79 Respondent, at Kavney's request, called in a prescription for 50 Valium. On 9/7/79 he called in a prescription for 50 Tylenol. Both of these prescriptions resulted from a phone call to Respondent. On October 29, 1979 Kavney visited Respondent, told him the shoulder pain persists and he would like some more weight reducers. By this time Kavney's weight was down to 185 pounds from 189 four months earlier. Respondent prescribed 50 Tylenol, 50 Valium (Exhibit 4) and 30 Fastin (Exhibit 3). By script dated 11/21/79 Respondent prescribed 50 Fastin for Kavney and by script dated 11/26/79 he prescribed 50 Tylenol (Exhibit 4). No record of these is contained in Exhibit 3. By entry on Exhibit 3 dated December 17, 1979 Respondent recorded "pain left shoulder, using heat at home, can't take codeine, Percodan 50". The Tylenol, which had been prescribed on four previous occasions, contains 1 grain of codeine per tablet. On January 14, 1980 Kavney visited Respondent, told him of disturbed sleep patterns, that he had taken Placidyl on prior occasions with good results and Respondent prescribed 60 Placidyl (750). Kavney was found dead in his automobile with an empty bottle with Placidyl label on the floor. An autopsy done on January 15, 1980 shows Kavney died from an overdose of Placidyl. Terry McGarey grew up in Miami and played in bands with Kavney as early as high school days. He had also known Hatcher since 1963. McGarey first visited Respondent in 1970 with an arm injury. He next saw Respondent near the end of 1976 and he complained of headache and leg pains from an earlier motorcycle accident. McGarey received a prescription for Percodan. McGarey, who appeared as a witness, testified that he had visited Respondent every three or four weeks in 1976 complaining of headache and during these visits he also received Placidyl, Demerol, Parest and Valium. These visits continued in 1977 with the same frequency and results. Respondent's patient records for Terrance McGarey (Exhibit 1) commence 3/28/78. The first entry is not dated but states "cc severe headaches - nausea - at JMH March `78. Neuological dept. - treated for organic brain syndrome - at JMH 1976 migraine - no allergies - only relief Demerol. Rx demerol 100 mg #5 fiorinal tabs." Thereafter Exhibit 1 shows entries 7-31-78, 8-7-78, 8-28, 9-1, 9-6, 9-11, 9-27, 10-9, 10-20, 10-29, 10-31, 11-16, 11-22, 12-18, 12-22, 12-29, 1-3, 1-8, 3-21 and 4-19-79. Most of these entries resulted from office visits but some entries recorded prescriptions as a result of phone calls. During this period prescriptions were issued to McGarey for Percodan, Emperin, Doriden Parest, Tuinal, Demerol, Placidyl, Dalmane, Darvon, Seconal and Valium (Exhibit 2) On May 7, 1979 McGarey called the Cardella Pharmacy saying he was Dr. Toth, gave the correct DEA number and authorized the delivery of 18 Placidyl 50 mg to patient Jerry McGaret. The pharmacist called the doctor's office, which was closed, and then issued the drugs to McGarey. A subsequent try was unsuccessful when the pharmacist was told by Respondent's office that this man was no longer a patient of Respondent. Respondent testified that he treated McGarey for migraine headaches, insomnia, nervousness, and low back pain. He found no evidence of abnormal conditions in his examination of McGarey. Through mid-October Respondent had no indication McGarey was in a methadone program or addicted and the drugs were continued with each visit or phone call. On December 29 Respondent learned from McGarey that he had been admitted to JMH for seizures and the resident recommended Seconal. On this basis Respondent prescribed Seconal but did not learn the cause of the seizures. On January 8, 1979 McGarey's mother called Respondent to advise that her son was a drug abuser and had been on a methadone program for 18 months. Following this entry is the notation "No more Rx's - back to JMH". Respondent's next entry on Exhibit 1 is "Called records at JMH patient admitted 2-9-79 - overdosed - discharged 2-14 Signed out - mother took him home." Although Respondent testified it never entered his mind that McGarey might be a drug abuser he also testified that the symptoms of narcotic addiction are agitation, nervousness, slurred speech and poor equilibrium. On the witness stand McGarey exhibited traits of nervousness and agitation. He appeared hyperactive rather than calm and sedate. His movements were jerky rather than fluid and he did not give the impression of a normally relaxed person under tension because he was testifying. On 11 January 1980 Kirk Kratz, a 29-year-old male, visited Respondent's office as a patient. He had a cast on his right upper arm and stated it was fractured some two weeks earlier. Also he had received a gunshot wound in the abdomen before Christmas and a laparotomy had been performed. He complained of pain in the right arm. He was given a prescription for 100 Percodan for pain and 60 Tuinal 3 gr for sleep. Kratz returned 12 February with same complaints and was given prescriptions for 100 Percodan, 60 Tuinal and 30 Valium. On 2/29 Kraft appeared without the cast, told Respondent the police had broken the cast, held him in jail for 3 days and confiscated his medication. He was given prescriptions for 100 Percodan and 60 Tuinal. On 4/8/80 Kratz still complained of "pain in the shoulder and arm and can't sleep." Prescriptions for 100 Percodan, 60 Tuinal and 100 Valium were given him. Finally on 6/13, with complaint of pain in hand and shoulder, Kratz was given prescriptions for 100 Percodan and 30 Doriden (Exhibit 9). Hatcher and McGarey were drug addicts before and during the time they were being treated by Respondent. At one time or another both of them had been enrolled in the methadone program at Jackson Memorial Hospital and/or other withdrawal programs for addicts. In addition to getting drugs from Respondent, they were also obtaining drug prescriptions from other doctors. Also from the quantity of drugs prescribed for Kavney and Kratz it is evident that both of these individuals were also addicts. During the period between 1 January 1980 and 14 June 1980 Respondent, with an active practice of some 700 patients prescribed approximately 28,000 Percodan and 2,000 Percocet tablets to various patients. Exhibit 16 shows a breakdown of the 130 patients treated by Respondent during this period. While Exhibit 16 shows Kirk Kratz received 100 Percodan only on 2/29/80, Exhibit 8 indicates he received 500 Percodan between 1 January and 14 June 1980. Assuming all other entries on Exhibit 16 to be accurate, a spot check shows the following patients were given Percodan or Percocet during the period 1 January - 14 June in the following quantities: Steven Arnold - 300; Cathy Blauk - 450; Bill Davis - 500; Kirk Decker - 300; George Fernandez - 300; Sidney Ford - 600; Ron Jangie - 300; Jerome Johnson - 300; Patty La Fortuna - 310; Vincent La Fortuna - 200; William Leonard - 350; Mary Leslie - 300; Gus Melquezo - 400; Michael Pravioski - 225; Debbie Saey - 250; Robert Sandifer - 400; James Setters - 300; Alvin Terrell - 300; Mike Thill - 300; Mark Wolfson - 200; Joe Worth - 300; and Harvey Zemaster - 200. Exhibit 16 also shows that most of these prescriptions were written for quantities of 100. It also lists almost 18,000 Percodan issued to 130 patients during this period, or an average of 140 per patient. Percodan, Tuinal, Parest, Demerol and Seconal are Class II drugs. One hundred Percodan taken in a one-month period will cause addiction in the taker. After 48 hours taking Percodan every 4 to 6 hours the patient will have withdrawal symptoms. Although Placidyl, Valium, Doriden, Empirin and Dalmane are not Class II drugs, they are dangerous and therefore controlled. Fifteen Placidyls taken at one time can be fatal. Many of the drugs prescribed by Respondent, when taken in combination, create a synergistic effect which makes the combination greater than the sum of its parts. Similarly a synergistic effect is created when some of these drugs are taken in conjunction with alcohol. Fastin is used for weight control. Neither Hatcher nor Kavney at 6 feet and 180 - 185 pounds should have been a candidate for weight loss. Further, prescriptions for Fastin and Seconal (for sleep) at the same time are incompatible as one is an upper, the other a downer. Tuinal in combination with Valium will increase depression. When Fastin is added, a pharmacological jungle can result. Respondent acknowledged that he relied more on the statements of his patients than upon an examination to determine when to prescribe medications. If the patient said he hurt, Respondent would prescribe a pain killer. A two- week-old fracture properly set and in a cast should cause little pain. If pain persists two weeks after casting something is wrong that will not likely heal itself. Therefore, painkillers to mask the symptoms are contraindicated. Similarly, a persistent pain in the shoulder is likely to be caused by inflammation and an anti-flammatory agent is indicated. Neither Tylenol nor Percodan are anti-inflammatory agents. Dr. John V. Handwerker, M.D. was accepted as an expert in family practice medicine. After reviewing Respondent's records of Hatcher, Kavney, Kratz and McGarey he expressed the strong opinion that the complaints of the patients did not justify the narcotics prescribed; that much larger quantities of each drug were prescribed at one time than was medically indicated or prudent; that drugs were prescribed in dangerous combinations due to the synergistic effect if taken together, plus some of these drugs such as Fastin and Valium are mutually exclusive; that issuing a prescription to take these drugs "as needed" was improper and dangerous; and that narcotics were frequently prescribed for alleged ailments for which more effective non-narcotic drugs were available. This witness was particularly critical of the prescription for liquid Demerol, as this should be prescribed only when the patient can't take the drug orally. After reviewing Exhibit 7 Dr. Handwerker expressed the opinion that prescribing 28,000 Percodan tablets during a 5-1/2 month period could only be justified with a large practice limited to trauma patients and that the records and prescription schedules show a practice harmful to the public. This opinion was based partially on Dr. Handwerker's practice in which, during the same period, he saw 2,081 patients and wrote 73 prescriptions for 1,996 Percodan tablets. Exhibit 7 contains 291 prescriptions issued by Respondent during this period, and recovered by Petitioner's investigator from pharmacies in the vicinity of Respondent's office. These coupled with Respondent's patient records show some 28,000 Percodan and 2000 Percocet tablets were prescribed. Valium is the most commonly prescribed drug in the United States and one of the most abused drugs. If a patient is emotionally stable 60 Valium is too many to prescribe for a patient at one time. If a patient is emotionally disturbed there is even greater reason for not prescribing 60 Valium. Dr. Roderick Palmer, M.D., testified as an expert in clinical pharmacology. He opined that prescribing 100 Percodan for a patient at one time was not appropriate because if the pain results from a traumatic injury, such injury will normally cease being painful in 4 or 5 days, and 100 Percodan is enough to commit suicide or become addicted. Dr. Palmer described Percodan and Placidyl as widely abused drugs. Sixty Placidyl in one prescription is too many because of suicide potential. Further, if one Placidyl is taken every day for 60 days the patient would probably become addicted. Taking more than one Placidyl per day could impair coordination enough to result in an industrial or automobile accident or other injury. With respect to Exhibit 7, Dr. Palmer cited instructions for Percodan or Percocet that the physician should not prescribe enough to result in addiction (not more than 30) nor prescribe enough for patient to commit suicide. It is necessary for patients to return to the physician before the patient can become addicted to the drugs prescribed. In this way the doctor will not lose control over the patient which could result in the patient becoming addicted. With respect to the 28,000 Percodan prescribed in a 5-1/2 months period Dr. Palmer viewed that quantity as more than he would prescribe in a lifetime. Dr. Murray Sims, M.D., is a Board certified surgeon who testified on behalf of Respondent. He found the prescriptions issued to Hatcher, Kavney, McGarey and Kratz to be proper for the complaints of the patients. Sims has known Respondent for many years, and has worked, studied, and taken examinations with Respondent. Dr. Sims prescribes Percodan in quantities of 100 and even 200. He does not believe 100 Percodan taken in a 30-day period is addictive. He has one 93-year old patient to whom he mails prescriptions for 100 Percodan per month (40 to 60 days) because, as she told him, "It makes my day start off right." (Tr. Vol. II, p. 102). When asked if Percodan and Tuinal taken together would have a synergistic effect Dr. Sims said no (Tr. Vol. II, p. 67) but on p. 119 he testified "I guess it would, you get a relief of both, yes. Don't hold me too much about pharmacy." Dr. Sims practice is 99 percent devoted to surgery patients and if he has a patient with a non-surgical related disorder he usually refers the patient to another doctor. This witness's testimony regarding the various drugs prescribed by Respondent and the appropriateness thereof was not deemed as credible as was the testimony of Drs. Hardwerker and Palmer. This was so because the latter had more expertise in this area of medicine and demonstrated greater credibility on the witness stand.
The Issue Whether the Respondent committed the violations alleged in the Amended Administrative Complaint dated March 26, 2010, and, if so, the penalty that should be imposed.
Findings Of Fact Based on the oral and documentary evidence presented at the final hearing, the facts stipulated to by the parties in the Joint Prehearing Stipulation, and on the entire record of this proceeding, the following findings of fact are made: The Department is the state agency responsible for the investigation and prosecution of complaints involving physicians licensed to practice medicine in Florida. See § 456.072, Fla. Stat. The Board of Medicine ("Board") is the entity responsible for regulating the practice of medicine and for imposing penalties on physicians found to have violated the provisions of section 458.331(1). See § 458.331(2), Fla. Stat. At the times pertinent to this proceeding, Dr. Christensen was a physician licensed to practice in Florida, having been issued license number 92135, and he practiced with the A1A Health & Wellness Clinic ("Clinic"), specializing in pain management. In 1975, Dr. Christensen received a degree in chiropractic, and he specialized in chiropractic orthopedics. Dr. Christensen has been practicing chiropractic orthopedics in the Palm Beach, Florida, area since 1975, although he took time away from his practice to attend medical school and to obtain a master's degree in public health. Dr. Christensen received his medical degree in 1995, and he completed a one-year internship in internal medicine. Dr. Christensen was certified in preventive medicine by the American Board of Preventive Medicine on January 22, 2007, and, after passing an examination, he was credentialed in March 2007 by the American Academy of Pain Management. Between February 9, 1997, and February 1998, Dr. Christensen was certified as an addiction professional by the American Association of Acupuncture and Oriental Medicine and the American College of Addictionology and Compulsive Disorders after having taken a 120-hour program in addictionology. Dr. Christensen first saw A.L. at the Clinic on February 12, 2007. At the time, A.L. was 21 years old, having been born on September 17, 1985. At the February 12, 2007, office visit, A.L. completed a Personal History form in which he stated that he was self- employed and worked in construction; that his major complaint was knee and back pain; and that the condition of which he complained began when he was 13 years old, which would have been in or about 1998. A.L. also noted on the Personal History form that he had seen other doctors for "pain management," but he did not include the names of any of the doctors who had provided pain management treatment. Dr. Christensen completed the New Patient History Form at A.L.'s first office visit. He noted that A.L. complained of intense, sharp, incapacitating pain in his left knee, with associated pain in his lower back. A.L. reported that he had had multiple surgeries on his knee that had been unsuccessful. Dr. Christensen performed a general examination of A.L. to confirm that he was alert and oriented and that his organ systems functioned properly. Dr. Christensen noted that A.L. was thin, but he did not identify any abnormal finding. Dr. Christensen did note that A.L. complained of anxiety. Because of A.L.'s complaints, however, Dr. Christensen focused his examination on A.L.'s left knee and lower back. Dr. Christensen observed scars on A.L.'s left knee, which confirmed the multiple surgeries that A.L. reported, and he also noted muscle atrophy of A.L.'s left leg, a condition that Dr. Christensen attributed to lack of exercise of the left leg. Dr. Christensen performed several orthopedic tests targeted at A.L.'s left knee and lower back, and Dr. Christensen's objective physical examination confirmed A.L.'s subjective complaints of pain. The differential diagnosis noted by Dr. Christensen on the New Patient History Form was multiple failed knee surgeries with associated lower back pain and lumbar disc syndrome. Dr. Christensen concluded that A.L. most likely had a lumbar disc problem because of A.L.'s abnormal gait resulting from the knee injury and the resulting pressure on A.L.'s pelvis. Dr. Christensen also noted on the New Patient History Form that A.L. reported that, each month for years, he had taken 60 to 90 80-milligram tablets of Oxycontin; 400 to 600 30- milligram tablets of Roxicodone; 200+ 40-milligram tablets of Methadone; 60 to 90 2-milligram tablets of Xanax; and 3 bottles of Oxifast. Based on these medications, dosages, and quantities, Dr. Christensen considered A.L. overmedicated, and he intended, during his treatment of A.L., to gradually reduce the amount of medications prescribed for A.L. Oxycontin and Methadone are pain medications, and Oxycontin and Roxicodone are trade names for the generic drug Oxycodone. Oxifast is a liquid form of Oxycodone, and Xanax is a drug used to treat anxiety. Both Oxycodone and Methadone are classified as schedule II controlled substances in section 893.03(2), Florida Statutes, and have a high potential for abuse; Xanax, which is the trade name for the generic drug Alprazolam, is classified as a schedule IV controlled substance in section 893.03(4), with a low potential for abuse relative to schedule I, II, and III controlled substances. As part of his initial office visit with Dr. Christensen, A.L. signed a Pain Management Agreement, in which he agreed that, among other things, he would not take any pain medications not prescribed by Dr. Christensen or seek treatment from any other doctors in order to obtain pain medications; prescriptions would be filled at the same pharmacy, which A.L. identified as "Gordons Pharmacy"; he would take the medications prescribed in the manner indicated on the label; he agreed to random urine drug tests; and he understood he would be discharged by Dr. Christensen if he failed to abide by the Pain Management Agreement. Dr. Christensen went over this agreement with A.L. during this initial office visit, and he emphasized that the agreement was a legal document that, if breached, would result in A.L.'s being discharged as Dr. Christensen's patient. In his typed notes for A.L.'s February 12, 2007, office visit, Dr. Christensen stated: Subjective: Mr. [L] indicated on his first visit today that he is feel constant severe pain in his left knee causing him to limp which refers pain to the lower back. Mr. L additionally reports restricted movement pain localized in the right lumbar, left lumbar, right lower lumbar area, and left lower lumbar area. Mr. [L] stated that for years he is made fairly comfortably by taking pain pills but his low back pain is a lot more uncomfortable due to bending, driving, lifting, and standing. He also stated today that he is experiencing constant severe pain in the area of the left knee joint and related he has had 7 failed knee surgeries since he was 13 years old. Mr. [L] additionally made particular comment about stiffness, restricted movement, and inflexibility pain localized in the left kneecap. Mr. [L]'s knee joint pain feels worse due to bending, standing, and walking. He states that taking pain pills reduces the severity of the pain. Dr. Christensen also noted in his typed notes that A.L. rated the level of knee joint and low back pain at nine on a scale of one to ten; Dr. Christensen's handwritten notes indicate that A.L. rated the level of pain at "10+". Dr. Christensen's assessment, as reflected in his typed notes, was that A.L. showed a persistent chronic symptomatology; that is, Dr. Christensen considered A.L.'s knee and lower back pain to be a chronic and stable condition, with no hope of improvement given that A.L. rejected additional surgery on his left knee as an option. Dr. Christensen also requested at the February 12, 2007, office visit that A.L. provide him with any MRI reports or other radiologic studies as soon as possible, and A.L. provided several radiological consultation reports the day after his initial office visit. The reports included an MRI of A.L.'s left knee done on or about April 1998; an MRI of A.L.'s lumbosacral spine done on or about December 2000; an MRI of A.L.'s left knee done on February 9, 2001; an MRI of A.L.'s left knee done on August 23, 2002; and a radiological study of A.L.'s cervical spine and a CT scan of A.L.'s brain in April 2006. Dr. Christensen reviewed the reports and confirmed that A.L.'s diagnosis was an osteochondral defect of his left knee, most likely from a sports injury. Dr. Christensen did not order additional diagnostic studies of A.L.'s knee and lower back because he concluded, as a chiropractic orthopedist and based both on his objective findings from the physical examination of A.L. and on his review of the radiological reports, that A.L.'s injury would not get better on its own; that additional diagnostic tests would show only that A.L.'s condition had gotten worse; and that the results of additional diagnostic tests would not change his diagnosis or treatment of A.L. The treatment plan for A.L. that Dr. Christensen outlined in his typed notes is as follows: One month appointment is scheduled for the patient. Pain medication that he was taking was reviewed and a decreased amount of pain medicine was prescribed. He was given a book on Subutex/Suboxone. I covered our pain management agreement, cautioned of side effects, addiction, health concepts, physical therapy, patient is too young for knee replacement, etc. Our plan is to reduce the patients [sic] present intake of pain meds . . . to a lessor [sic] amount each month as we are able. Dr. Christensen believed that A.L. was taking too much pain medication. He wanted to help A.L. undo the damage that had been done by the excessive pain medications that Dr. Christensen believed had been prescribed for A.L., and Dr. Christensen planned to reduce the amount gradually to a more appropriate level of medication. Accordingly, on February 12, 2007, Dr. Christensen wrote A.L. prescriptions for 60 40-milligram tablets of Methadone, with instructions to take one tablet two times per day; 300 30-milligram tablets of Roxicodone, with instructions to take two tablets five times per day; and 60 2-milligram tablets of Xanax, with instructions to take one tablet two times per day. Based on the quantities and dosages of medications that A.L. reported he was taking as of February 12, 2007, Dr. Christensen eliminated the prescriptions for Oxycodone and Oxifast and significantly reduced the number of 30-milligram Roxicodone tablets and 40-milligram Methadone tablets A.L. could take each month. Dr. Christensen prescribed Xanax for A.L. because A.L. reported to Dr. Christensen that he had anxiety; because Dr. Christensen observed that he was anxious during the office visit and knew that pain could cause anxiety; and because A.L. reported to Dr. Christensen that he had been taking Xanax prior to February 12, 2007. Although Dr. Christensen prescribed less Xanax for A.L. than A.L. reported that he had been taking, Dr. Christensen did not want to A.L. to stop taking Xanax abruptly because A.L. could have seizures and die. The prescriptions written for A.L. by Dr. Christensen significantly decreased the amount of pain medication A.L. was reportedly taking prior to February 12, 2007, but Dr. Christensen was satisfied that the prescriptions would provide a sufficient amount of medication to control A.L.'s pain. Dr. Christensen felt that he could not refuse to prescribe pain medications for A.L. on February 12, 2007, because, once a patient has been on pain medications for years, as A.L. reportedly had, stopping the pain medications abruptly could result in very severe withdrawal symptoms. In addition, Dr. Christensen was concerned that, if he did not prescribe pain medications for A.L., A.L. would not continue his treatment with Dr. Christensen. As part of his treatment plan, Dr. Christensen also discussed with A.L. on February 12, 2007, health concepts such as improving his diet, getting exercise, considering physical therapy, setting goals, and increasing spiritual awareness. In addition, he gave A.L. information on Suboxone, a drug used primarily to prevent withdrawal symptoms when the amount of opioids such as Roxicodone is significantly reduced. Although A.L. was not interested in discussing Suboxone at the February 12, 2007, office visit, Dr. Christensen intended to continue discussing the drug with A.L. at subsequent office visits because Dr. Christensen's ultimate plan was to wean A.L. off of opioids completely. A.L. continued treatment with Dr. Christensen until June 29, 2007, seeing Dr. Christensen on March 12, 2007; April 10, 2007; May 7, 2007; June 2, 2007; and June 29, 2007. As recorded in Dr. Christensen's typed notes, A.L. complained at each office visit of "constant severe pain" in his lower back and his left knee area, with restricted movement in the lower back area and "stiffness, restricted movement, and inflexibility pain localized in the left kneecap." At each office visit, A.L. rated his knee and/or lower back pain at nine on a scale of one to ten, except that, at the office visit on May 7, 2007, A.L. rated his knee joint pain at eight on a scale of one to ten. Dr. Christensen reviewed A.L.'s systems at each office visit and conducted a physical examination focused on A.L.'s left knee and back. Dr. Christensen's assessment of A.L.'s status at each office visit was that his condition was chronic and/or stable. At A.L.'s March 12, 2007, Dr. Christensen prescribed 60 40-milligram tablets of Methadone, with instructions to take one tablet two times per day; 300 30-milligram tablets of Roxicodone, with instructions to take two tablets five times per day; and 60 2-milligram tablets of Xanax, with instructions to take one tablet two times per day. In his handwritten notes of the March 12, 2007, office visit, Dr. Christensen noted that A.L. was stable on the pain medications prescribed. On March 12, 2007, A.L. also completed a Pain Outcomes Profile, in which he rated his pain generally as five or six on a scale of one to ten; A.L. rated his level of anxiety as seven on a scale of one to ten. In his handwritten notes of the April 10, 2007, office visit, Dr. Christensen stated that he had a long discussion with A.L. about weaning him off of the pain medications and developing goals for doing so. Dr. Christensen drew a graph in his notes of the April 10, 2007, office visit to illustrate his discussion with A.L. about taking one 30-milligram Roxicodone ten times at a time instead of two. Dr. Christensen noted that A.L. wanted to take the Roxicodone tablets more often than ten times per day, and Dr. Christensen explained to A.L. that he needed to take enough pain medication to control his pain but not enough that he would go into a state of euphoria because that would lead to addiction. Dr. Christensen expanded on his point about weaning A.L. off of the large dose of Roxicodone in his typewritten notes of the April 10, 2007, office visit: I explained the concept of 2 roxicodone's [sic] (60 mg) verse [sic] 30 mg taken more often. 2 tabs can cause excess, waste, build tolerance and the patient will run out of meds. Taking the roxicone [sic] 30 mg tablets one at a time will allow the patient to dose himself better, decrease tolerance, reduce waste, laste [sic] longer. Less pain, and ultimately take less pain meds. I showed him how 240 roxies would provide more pain relief than 300 roxies if taken 1 at a time more often then [sic] taking 2 or more at a time which is how the patient was taking them. On April 10, 2007, Dr. Christensen prescribed 60 40-milligram tablets of Methadone, with instructions to take one tablet two times per day and 60 2-milligram tablets of Xanax, with instructions to take one tablet two times per day. Dr. Christensen also prescribed 300 30-milligram tablets of Roxicodone, but he instructed A.L. to take one tablet ten times per day rather than two tablets five times per day. A.L. completed a Pain Outcomes Profile at the April 10, 2007, office visit, and he rated his pain level generally at five on a scale of one to ten; A.L. rated his level of anxiety at seven on a scale of one to ten. A.L. also signed an A1A Health & Wellness Clinic Patient Informed Consent and Notice of Material Risks for Treatment of Intractable Pain with Controlled Substances on April 10, 2007, in which A.L. confirmed that Dr. Christensen had recommended and A.L. had requested treatment with opioid pain medication. By signing the form, A.L. also confirmed that he and Dr. Christensen had discussed alternative therapies, including drug cessation treatment using Suboxone and potential side effects and risks of controlled substances. At A.L.'s next office visit, on May 7, 2007, Dr. Christensen prescribed 60 40-milligram tablets of Methadone, with instructions to take one tablet two times per day and 60 2- milligram tablets of Xanax, with instructions to take one tablet two times per day. Dr. Christensen decreased A.L.'s prescription for Roxicodone from 300 30-milligram tablets to 240 30-milligram tablets, with instructions to take one tablet eight times per day. Dr. Christensen also noted in his typewritten notes that A.L. refused physical therapy and that Suboxone/Subutex was discussed with A.L. but that A.L. indicated that he was "not at all interested." At A.L.'s June 2, 2007, office visit, Dr. Christensen further reduced to 210 the number of 30-milligram Roxicodone tablets he prescribed for A.L., and he instructed A.L. to take one tablet seven times per day. Dr. Christensen noted in the Follow Up Visit form that he completed on June 2, 2007, that A.L. was not happy about the decrease in the number of Roxicodone tablets and complained that he would be in pain. Dr. Christensen noted that he explained again that the goal was to get A.L. drug-free. Dr. Christensen also discussed additional knee surgery as an option, but he noted that A.L. emphatically refused further surgery. Dr. Christensen included on the Follow Up Visit form for the June 2, 2007, office visit a notation that states in part that A.L. brought with him a "Drug Class II w/o Script (it was meds prescribed by in wrong bottle.)." There is no further explanation or mention of this in either Dr. Christensen's handwritten notes or typewritten notes for the June 2, 2007, office visit. A.L.'s final office visit to Dr. Christensen was on June 29, 2007. Dr. Christensen noted on the Follow Up Visit form that A.L. complained of knee pain that was "unbearable" at times. Dr. Christensen also noted that A.L. was experiencing increased lower back pain because he was walking with a limp. Dr. Christensen again decreased to 180 the number of 30-milligram Roxicodone tablets he prescribed for A.L., with one tablet to be taken every six hours. Dr. Christensen noted: "Patient will be underdosed but it was explain [sic] the importance of ? Roxi More H2O, reviewed [pain management] contract & goals of ? meds over time." According to the notes on the Follow Up Visit form, Dr. Christensen intended to let A.L. stabilize at 180 30-milligram Roxicodone tablets per month and to talk with A.L. again about beginning Suboxone. Dr. Christensen believed that the amount of medications that A.L. claimed to be taking at the first office visit on February 12, 2007, was clearly excessive, but he believed that A.L. was telling the truth. Although doubts about A.L.'s truthfulness regarding his medications crossed Dr. Christensen's mind, he chose to believe A.L. was telling the truth for several reasons. First, Dr. Christensen believed that a physician must assume that a patient is telling the truth, especially a complex patient like A.L., unless there is an objective reason for doubting the patient's veracity. Second, Dr. Christensen considered A.L. to be a model patient; he was clean, polite, fully alert, and competent. In addition, A.L. continued to keep his appointments with Dr. Christensen even though Dr. Christensen was decreasing the amount of Roxicodone he prescribed for A.L. each month. Third, Dr. Christensen was aware from his physical examinations of A.L. and from A.L.'s medical history that A.L. had long-standing problems with his knee that caused him pain. A.L. reported that he had been on pain medication for approximately ten years, and, even though Dr. Christensen thought the amount of medications A.L. reported he was taking at his first office visit with Dr. Christensen on February 12, 2007, was excessive, Dr. Christensen thought that A.L. could conceivably be taking the amount of pain medications he reported because, over time, A.L. probably had built up a tolerance for the pain medications and needed to take more of the medication. Dr. Christensen was concerned about the amount of pain medication A.L. reportedly was taking, however, and, therefore, one of Dr. Christensen's goals for A.L.'s treatment was to reduce the amount of pain medications A.L. was taking and, eventually, to wean him off of pain medications entirely. Fourth, an incident occurred early in his relationship with A.L. that made Dr. Christensen doubt A.L.'s veracity, but this assessment was proven wrong. Shortly after his first office visit on February 12, 2007, A.L. returned to Dr. Christensen's office and asked for a replacement prescription for Roxicodone, explaining that the prescription was in the pocket of his jeans and that the prescription had been damaged when his mother washed the jeans. Dr. Christensen thought that A.L. was simply seeking an additional amount of the pain medication. Dr. Christensen told A.L. he would have to bring in the damaged prescription, but Dr. Christensen doubted that he would do so. A.L. brought in the prescription, which had obviously been damaged, and Dr. Christensen felt badly because he had misjudged A.L. He taped the damaged prescription in A.L.'s medical file to remind himself that he should not prejudge his patients. Even though A.L. had consented to urine drug tests in the Pain Management Agreement he signed on February 12, 2007, Dr. Christensen did not order A.L. to submit to a urine toxicology screening test on his initial office visit, as a condition of Dr. Christensen's taking him on as a patient, nor did Dr. Christensen order A.L. to submit to a random urine toxicology screening test during the time A.L. was Dr. Christensen's patient. Given the extremely large amount of pain medications A.L. reported to Dr. Christensen that he had been taking prior to his first office visit on February 12, 2007, and Dr. Christensen's concern that A.L. was overmedicated, Dr. Christensen should have considered asking A.L. to submit to a urine toxicology screening test as provided in the Pain Management Agreement. Even if Dr. Christensen had administered one or more urine toxicology screening tests to A.L., however, the results of the test would have revealed only the types of drugs in A.L.'s system; that is, the urine toxicology screening test could have confirmed that A.L. was taking the medications that he reported to Dr. Christensen on February 12, 2007, and would have identified any illicit drugs he was taking at the time of the test; it would not, however, have provided any information on the quantities of drugs in A.L.'s system and, therefore, would not have confirmed the quantities of drugs A.L. reported to Dr. Christensen that he was taking at the time of his first office visit. Summary and findings of ultimate fact A few words of explanation are necessary before proceeding with the analysis of the evidence in this case. Given A.L.'s tragic death in July 2007, it is difficult for all concerned in this case to restrict their analysis of the evidence to those facts of which Dr. Christensen was aware during the time he treated A.L., yet it is essential that the evidence be viewed from this perspective. It became apparent during the course of this hearing that A.L. did not disclose certain matters to Dr. Christensen that might have changed the course of Dr. Christensen's treatment of A.L. These matters are irrelevant to the issues presented in the Department's Administrative Complaint; they are not part of the record in this case; and they have not, therefore, been considered in the preparation of this Recommended Order. Counts One and Three through Eight The evidence presented by the Department is not sufficient to establish with the requisite degree of certainty that Dr. Christensen prescribed Roxicodone, Methadone, or Xanax for A.L. inappropriately or in excessive amounts or that he breached the standard of care in prescribing these medications. The Department's expert witness testified that Dr. Christensen violated the standard of care because the combination, quantities, and dosages of the medications Dr. Christensen prescribed for A.L. were excessive. The Department's expert witness did not, however, identify the standard of care that would have governed Dr. Christensen's treatment of A.L., nor did he provide a clear explanation of the basis for his opinion that the combination, quantities, and dosages of medications Dr. Christensen prescribed for A.L. were excessive, especially considering the combination, quantities, and dosages of medications that A.L. reported to Dr. Christensen that he was taking at the time of his first office visit with Dr. Christensen. Rather, the Department's expert witness repeatedly stated his opinion, based on "his knowledge of pharmacology and more than 20 years['] experience,"5 that the prescriptions written by Dr. Christensen, if taken by A.L. as directed, would be "100 percent lethal, 100 percent of the time."6 The Department's expert witness gave no cogent explanation for his opinion that the combination, quantities, and dosages of the drugs would be 100 percent lethal, 100 percent of the time,7 which opinion, in any event, is refuted by the fact that A.L. was successfully treated by Dr. Christensen with the same combination of drugs, albeit with decreasing quantities of Roxicodone, for a period of four and one-half months.8 In addition, in formulating his opinion that the quantities and dosages of the medications Dr. Christensen prescribed for A.L. were excessive, the Department's expert witness apparently did not consider the possibility that A.L. had, over the years, developed a tolerance for these medications.9 In fact, the Department's expert witness did not give credence to A.L.'s complaints of pain; he did not believe that A.L. should have been treated with narcotics for pain; and it can reasonably be inferred from his testimony that the Department's expert witness would have refused to treat A.L. The Department's expert witness dismissed A.L.'s complaints of pain as not credible, stating that "[t]he patient is extremely young to have any pain complaints."10 The Department's expert witness testified that, if he had been consulted, he "would have recommended a trial of spinal cord stimulation"; that Dr. Christensen could have "prescribe[d] an appropriate brace for the knee"; or that Dr. Christensen might have chosen "to then make a referral to an orthopedic surgeon" for surgery on A.L.'s knee.11 The testimony of the Department's expert witness as to the treatment he would have provided to A.L. was repeatedly conditioned by the word "if"; if A.L.'s reported knee problem were confirmed, and if the Department's expert witness had agreed to treat A.L. In fact, on the basis of the written medical records alone, the Department's expert witness dismissed A.L. as "a liar and probably a substance abuser and certainly diverting his medication" and labeled as "outlandish" A.L.'s "self reported history of medication and prescription" and his "claims of being prescribed high dosages and lethal quantities" of controlled substances.12 In rendering his opinion that the combination, quantities, and dosages of the medications Dr. Christensen prescribed for A.L. were excessive and in violation of the standard of care, the Department's expert witness did not acknowledge in his testimony that Dr. Christensen considered the quantities, dosages, and number of different pain medications that A.L. reported on his first office visit to be excessive; that Dr. Christensen concluded that A.L. was overmedicated; that Dr. Christensen's treatment plan focused on decreasing the quantity of medications prescribed for A.L.; that Dr. Christensen did, in fact, refuse to write A.L. prescriptions for Oxycodone and Oxifast; that, at A.L.'s first office visit, Dr. Christensen wrote prescriptions for Roxicodone and Methadone for A.L. that were for quantities substantially smaller than those A.L. reportedly was taking; that Dr. Christensen assumed that A.L. was truthful when he reported that he was taking 60 to 90 two-milligram Xanax; that Dr. Christensen could not eliminate Xanax from the prescriptions he wrote for A.L. because abrupt withdrawal from Xanax could cause death; that Dr. Christensen reduced by one-third the number of two-milligram Xanax he prescribed for A.L.; that Dr. Christensen introduced at A.L.'s first office visit the possibility of A.L.'s using Suboxone to help in weaning him off of opioid analgesics such as Roxicodone and Methadone; that Dr. Christensen steadily decreased the quantity of Roxicodone he prescribed for A.L., until the amount was substantially less than the amount A.L. reportedly was taking at the time of his first office visit with Dr. Christensen. By failing to indicate that he considered these factors in rendering his opinions and by making the broad and unsupported assertion that the medications prescribed by Dr. Christensen for A.L. were 100 percent lethal, 100 percent of the time, the Department's expert witness substantially diminished the credibility of his opinions. Rather than taking an objective view of the treatment that Dr. Christensen provided A.L. from February 12, 2007, to June 29, 2007, the Department's expert witness demonstrated throughout his testimony a disdain for Dr. Christensen as a physician. This disdain for Dr. Christensen is made particularly clear when the Department's expert witness attributed to Dr. Christensen a purely economic motive in his treatment of A.L. The Department's expert witness testified that Dr. Christensen, in common with "most pill mills or physicians like the subject," had "a huge economic incentive" for his treatment of A.L.13 These statements demonstrated a bias against Dr. Christensen that substantially diminished the credibility of his testimony, in general, for the following reasons. First, there was no allegation in the Administrative Complaint and no evidence in this record to support the categorization of Dr. Christensen by the Department's expert witness as a physician associated with a "pill mill." Second, in reaching his conclusion that Dr. Christensen's motivation for treating A.L. was purely financial, the Department's expert witness assumed, in the absence of even a scintilla of evidence in this record, that Dr. Christensen required his patients to pay a substantial amount of cash for each office visit and that Dr. Christensen was a "dispensing physician," that is, a physician who sells drugs as well as prescribing them.14 Count Two In Count Two of the Administrative Complaint, the Department charged Dr. Christensen with violating the standard of care in four respects, which are discussed in detail below. Failure to diagnose a history of anxiety The evidence presented by the Department is not sufficient to establish with the requisite degree of certainty that Dr. Christensen's treatment of A.L. fell below the standard of care because he failed "to diagnose a history of anxiety to support prescribing Alprazolam."15 Dr. Christensen noted on the New Patient History Form completed during A.L.'s first office visit on February 12, 2007, that A.L. reported a history of anxiety as a psychiatric condition, and A.L. also reported that he was currently taking Alprazolam, or Xanax. On each of A.L.'s subsequent office visits to Dr. Christensen, A.L. reported on the Pain Outcomes Profile that he had significant feelings of anxiety, and Dr. Christensen observed that A.L. exhibited anxious behaviors during his office visits. The Department's expert witness apparently overlooked this information in Dr. Christensen's medical records because he testified that he could find no justification for prescribing Alprazolam for A.L.16 Failure to order urine toxicology screening test The evidence presented by the Department is not sufficient to establish with the requisite degree of certainty that Dr. Christensen's treatment of A.L. fell below the standard of care because he failed "to order screening urine toxicology to rule out usage of illicit substances or confirm usage of prescribed medications." The Department's expert witness identified the standard of care at the times pertinent to this proceeding as requiring patients to submit to intermittent urine toxicology screening studies so that the patient wouldn't know when such testing would take place. The Department's expert witness further explained that it was always a matter of clinical judgment as to when to require a patient to submit to a urine toxicology screening study, even to a patient such as A.L., who had reported taking a large quantity of pain medications at the time of his first office visit to Dr. Christensen. The Department's expert witness testified that, given the amount of pain medications A.L. reported to Dr. Christensen that he was taking at the time of A.L.'s first office visit, a urine toxicology screening study of A.L. at the first office visit would be "indicated," but the Department's expert witness did not testify that Dr. Christensen violated the standard of care by failing to require A.L. to submit to such a study at that first office visit or during the time he was treating A.L. In fact, according to Dr. Christensen's expert witness, at the times pertinent to this proceeding, it would not be within the standard of care to require a patient to submit to a urine toxicology screening study within the first four and one-half months of treatment.17 Finally, there is no indication in the record that Dr. Christensen had any reason to suspect that A.L. was taking illicit substances; the primary concern Dr. Christensen, and the Department's expert witness, had with respect to A.L. was the quantity of pain medications he was reportedly taking at the time of his first office visit. Because a urine toxicology screening study reveals only the types of substances in the urine and not the quantity of such substances, a urine toxicology screening study would not have revealed whether A.L. was lying about the quantities of pain medications he reported to Dr. Christensen on his first office visit, as was concluded by the Department's expert witness; such a study would have revealed only whether A.L. was, in fact, taking these substances, a concern that, based on the information available to him, Dr. Christensen did not have at A.L.'s first or subsequent office visits. According to the standard of care identified by the Department's expert witness, Dr. Christensen did not deviate from this standard of care by using his clinical judgment to decide not to require A.L. to submit to a urine toxicology screening study. Failing to refer A.L. for treatment for substance abuse The evidence presented by the Department is not sufficient to establish with the requisite degree of certainty that Dr. Christensen's treatment of A.L. fell below the standard of care because he failed "to refer Patient A.L. to a psychiatrist and/or addiction specialist and/or rehabilitation center for substance abuse." The only mention of Dr. Christensen's failure to refer A.L. to a psychiatrist, addiction specialist, or rehabilitation center in the testimony of the Department's expert witness was in answer to the question of the Department's counsel: "Would respondent's failure to do so in this case fall below the standard of care?" The Department's expert witness answered: "Given his [A.L.'s] claims of previous medication prescription and usage, yes."18 The Department's expert witness never defined the standard of care to which he was referring, and his opinion, therefore, is not persuasive on this issue.19 Failure to order diagnostic tests The evidence presented by the Department is not sufficient to establish with the requisite degree of certainty that Dr. Christensen's treatment of A.L. fell below the standard of care because he failed "to order diagnostic tests to justify the course of treatment for patient A.L." The Department's expert witness testified that he would "not be prepared to say that [Dr. Christensen's failure to order a diagnostic test to justify his course of treatment for A.L. fell below the standard of care] because there's no justification for the course of treatment regardless of any study or consultation that the subject could have initiated."20 There was no allegation in the Administrative Complaint that Dr. Christensen violated the standard of care because there was no justification for the treatment he provided A.L., and this testimony is irrelevant to a determination of whether Dr. Christensen should have ordered additional diagnostic tests for A.L. The Department's expert witness did, however, go on to state that, under the circumstances of this case, "a reasonable and prudent physician . . . should have, at the very least, ordered an MRI study of the knee, [and] performed a comprehensive physical examination of the effected [sic] joint" and that "many physicians would have ordered an MRI of the knee or at the very least, perform [sic] a very detailed and well documented physical examination and then written down his treatment plan and the justification for his treatment plan."21 To the extent that this testimony constitutes the articulation of the standard of care by the Department's expert witness, the opinion of the Department's expert witness that Dr. Christensen fell below this standard of care is unsupportable for two reasons. First, the Department's expert witness incorrectly identified the report of the MRI of A.L.'s knee done in 1998 as the only MRI report in Dr. Christensen's medical records. The Department's expert witness overlooked the report in Dr. Christensen's medical records of the post-surgical MRI done of A.L.'s left knee on August 23, 2002, four and one-half years before A.L.'s first office visit to Dr. Christensen in February 2007. Therefore, the opinion of the Department's expert witness that Dr. Christensen fell below the standard of care for failing to order an MRI is not persuasive because it is based on the incorrect assumption that the most recent MRI of A.L.'s knee was done nine years prior to his first office visit with Dr. Christensen. Second, Dr. Christensen did a comprehensive physical examination of A.L.'s left knee joint. Dr. Christensen, aided by his background in chiropractic orthopedics, performed several tests on A.L.'s left knee, which, together with the post- operative MRI done in August 2002, led him to the conclusion that, if anything, the condition of A.L.'s left knee would not have improved, and probably would have worsened, over the intervening years. Dr. Christensen documented the results of the examination in the typed notes he prepared on February 12. 2007, and set out his diagnosis and treatment plan for A.L. Therefore, the opinion of the Department's expert witness that Dr. Christensen fell below the standard of care for failing to conduct a comprehensive physical examination of A.L.'s left knee and to document the results of the examination and the treatment plan for A.L. is unpersuasive because the Department's expert witness apparently overlooked this information in A.L.'s medical records.22
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order dismissing the Administrative Complaint filed against John Christensen, M.D., by the Department of Health. DONE AND ENTERED this 28th day of June, 2011, in Tallahassee, Leon County, Florida. S Patricia M. Hart Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 28th day of June, 2011.
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
The Issue The issue to be determined in this proceeding is whether Petitioner is entitled to a refund of the costs paid for prescriptions for compound Midrin.
Findings Of Fact The Division of State Group Insurance (Division) is the executive agency within the Department of Management Services (Department) that is responsible for the administration of the State Group Insurance Program (Program). Petitioner is retired and receives medical benefits through the State Employees’ HMO Standard Medical Plan (the Plan), which is administered by Capital Health Plan (CHP). The State Employees’ Prescription Drug Program is administered by CVS Caremark. Respondent is the state agency responsible for resolving appeals of medical claims denied by Caremark. Background Mr. Abele was employed with the State of Florida until he retired. He was covered by the Plan and his coverage has remained since his retirement. For the past three years, Mr. Abele has filled a prescription for generic Midrin to treat migraine headaches. The medication was prescribed by his primary care physician, John Ness, M.D. The evidence offered at hearing includes a total of 18 claims2 for prescriptions for compound Midrin that Mr. Abele submitted to Caremark for reimbursement. Mr. Abele submitted claims for prescriptions filled in 2018 dated: July 12 and 25, 2018; August 2, 2018; September 7, 2018; October 5 and 22, 2018; November 6 and 26, 2018; December 12, 2018. Mr. Abele also submitted claims for prescriptions filled in 2019 dated: January 9 and 30, 2019; February 12, 2019; March 6, 18, and 29, 2019; April 10 and 25, 2019; and May 10, 2019. Each of the 18 claims was for reimbursement of $105 for a total of $1,890. Relevant Definitions The Plan Booklet and Benefit Document (“Plan”) includes definitions, relevant in part here, as follows: "Covered Services and Supplies" means those health care services and supplies, including pharmaceuticals as described in Section VIII, for which reimbursement is covered under this Plan. "Exclusions" is defined as any provision of the Plan whereby coverage for a specific hazard or condition is entirely eliminated. “Medically Necessary” is defined as any appropriate medical treatment ... as provided by a physician ... which is necessary for the diagnosis, care and/or treatment of a Health Plan Member’s illness or injury, and which is: Consistent with the symptom, diagnosis, and treatment of the Health Member’s condition; The most appropriate level of supply and/or service for the diagnosis and treatment of the Health Plan Member’s condition; In accordance with standards of acceptable community practice; Not primarily intended for the personal comfort or convenience of the Health Plan Member, the Health Plan Member’s family, the physician or other health care providers; Approved by the appropriate medical body or health care specialty involved as effective, 2 The claims at issue are those claims submitted by Mr. Abele in support of his request for reimbursement. appropriate and essential for the care and treatment of the Health Plan Member’s condition; and Not Experimental or investigational. Medical Necessity Dr. Ness, a family practice physician with 30 years of experience, prescribed generic Midrin for Mr. Abele to treat migraine headaches. Dr. Ness prescribed generic Midrin to treat Mr. Abele based on his assessment that other medications were contraindicated for Mr. Abele due to Mr. Abele’s risk for cardiovascular adverse effects if he uses other medications. Dr. Ness credibly testified that Midrin is medically necessary to treat Mr. Abele’s migraine headaches. Anthony Arnett, M.D., the physician for Caremark responsible for reviewing claims for coverage, determined that Midrin was not medically necessary to treat Mr. Abele’s migraine headaches. However, Dr. Arnett conceded that his decision was based on his general determination that there are other options available for migraine headaches. The undersigned finds Dr. Ness’ testimony more persuasive concerning the determination that Midrin was medically necessary to treat Mr. Abele for migraines. Midrin History At the time Dr. Ness prescribed generic Midrin to Mr. Abele, it was an FDA-approved drug. In fact, Midrin was approved for use in 1948 based on safety and effectiveness. However, in 2017, the United States Food and Drug Administration (the “FDA”) determined that Midrin was no longer safe and effective. On October 12, 2017, the FDA notified manufacturers of prescription drugs containing isometheptene mucate that they should immediately cease distribution of the product. On June 13, 2018, the FDA issued a subsequent notice listing the drugs that were no longer approved by the FDA and that manufacturing companies were required to stop producing. The drug combination for Mr. Abele’s prescription for compound Midrin (acetaminophen, dichloralphenazone, and isometheptene mucate) is on the FDA non-approved list. Midrin Prescription/Coverage Denial In January 2018, Mr. Abele presented his prescription for generic Midrin to his local CVS Pharmacy to be filled but the prescription was refused. Mr. Abele indicated that the pharmacist told him that the manufacturer had stopped producing the drug and suggested that he could have the drug compounded. Since generic Midrin was no longer available, Dr. Ness issued a prescription for the compound Midrin, in capsule form, with a 10-day supply for each prescription. The medication name was listed as “Midrin (ALTERNATE) 325MG/100MG/65MG Capsule,” and the ingredients were listed as acetaminophen, dichloralphenazone, isometheptene mucate, and microcrystalline cellulose3. Mr. Abele filled the prescriptions at a local in- network compounding pharmacy. On January 14, 2018, Mr. Abele contacted Caremark about his compound Midrin prescription and Mr. Abele was told that he would need to submit a claim to determine whether the compound drug ingredients would be covered. There is no evidence that the Caremark representative made any false or misleading representation that Mr. Abele’s compound prescription would be approved. On December 14, 2018, Mr. Abele submitted claims to Caremark for reimbursement for compound Midrin. On December 17, 2018, Caremark notified Mr. Abele by letter that the claims he submitted were not allowed. The reason provided for disallowance was because the drug was not on the plan’s formulary. The letter also notified Mr. Abele that his request for exception did not include the information necessary to approve the request. On February 1, 2019, Dr. Ness, on behalf of Mr. Abele, submitted a non-covered drug formulary exception request seeking approval for compound Midrin. He requested the drug in capsule form for the treatment of Mr. Abele’s migraines. However, the request form did not include a copy of the prescription for the compound formula for Midrin. The form also did not describe the drug as the compound alternative. Dr. Ness testified that it is a common medical practice to use “cap” to refer to the capsule form, even for the compound formula. The Caremark appeals department faxed a response to Dr. Ness as follows: “In researching your fax request, the member’s prescription benefit coverage indicates a [p]rior [a]uthorization is NOT required. For additional questions regarding the medication’s coverage under the member’s plan, please contact Customer Service using the number on the back of the member’s prescription benefit card.” Dr. Anthony Arnett testified that he interpreted the exception request as being for Midrin capsules, rather than the compound form. Based on that interpretation, the response to the exception request was that prior authorization was not necessary. The undersigned finds that even if prior authorization was not required for the prescription, it does not amount to an approval for coverage of the claims. Appeal of Coverage Denial On February 5, 2019, Mr. Abele appealed the denial of reimbursement for compound Midrin. On February 13, 2019, Caremark responded to Mr. Abele instructing him to submit additional information for his claims to be processed. On February 18, 2019, he submitted the requested information and materials. On March 30, 2019, Caremark notified Mr. Abele by letter that his drug coverage request was denied. The basis for the denial was that the 3 Microcrystalline cellulose may be used as a bulking agent in pharmaceutical products. prescription was for a compound drug containing, as relevant here, bulk powder. Mr. Abele then submitted a Level I appeal, also referred to as a clinical appeal4, on April 18, 2019. Dr. Arnett reviewed Mr. Abele’s claims for the Level I appeal. While Dr. Arnett acknowledged that compounding could be approved if no other drug is available for treatment of migraines, he concluded that Mr. Abele’s exception request could not be approved because the compound formula included bulk powder. Caremark denied Mr. Abele’s Level I appeal and notified Mr. Abele by letter of their decision on April 22, 2019. In the letter, Caremark stated that “petitioner’s appeal for Dichloralphenazone Powder Compound has been determined as not medically necessary; and, ‘the plan criteria does not allow coverage of dichloralphenazone Powder Compound’ if the compound contained ‘bulk powder’ as an ingredient.” On May 8, 2019, dissatisfied with the outcome of the Level I appeal, Mr. Abele requested a Level II appeal. The Department denied the Level II appeal on the basis that the compound Midrin “did not meet the medical necessity criteria and non-FDA approved compounds are excluded from the plan.” Limitations and Exclusions The Department's concurrence of Caremark’s decision that coverage for the compound Midrin prescription should be denied was based on the Plan’s general Limitations and Exclusions section, which applies to the Prescription Drug Program. The Prescription Drug Program also outlines specific exclusions related to medications. The Prescription Drug Program, described in Part VIII, provides that covered drugs shall include, but are not limited to, any drug, medicine, medication, or communication that is consumed, administered, or provided at 4 Level I appeals are handled by Caremark by a specific group that focuses on prescriptions appeals. the place where the prescription is given at the medical provider’s office or healthcare facility. The Plan’s limitations and exclusions section provides, “the following services and supplies are excluded from coverage under this Plan unless a specific exception is noted. Exceptions may be subject to certain coverage Limitations.” Under the Plan, the exclusions include “any non-prescription medicine, remedy, biological product, pharmaceutical or chemical compound, vitamins, mineral supplements, fluoride products, health foods, or blood pressure kits, except as specifically provided for in the covered benefits section under prescription drugs.” The Additional Exclusions section provides that bulk powders, bulk chemicals, and proprietary bases used in compound medications and over-the- counter (“OTC”) products used in compound medications are excluded from coverage. Further, the plan excludes services or supplies not medically necessary as determined by the Plan and/or the Prescription Drug Program clinical staff and the state. The Prescription Drug Program provides that the Prescription Drug Program does not cover non-federal legend or OTC products, and bulk powders, bulk chemicals, and proprietary bases used in compounded medications.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Division of State Group Insurance, Department of Management Services, enter a final order denying Lawrence Abele’s request for reimbursement for the claims submitted for his compound Midrin prescription. DONE AND ENTERED this 14th day of May, 2020, in Tallahassee, Leon County, Florida. S YOLONDA Y. GREEN Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 14th day of May, 2020. COPIES FURNISHED: Lawrence Abele 841 Maderia Circle Tallahassee, Florida 32312 (eServed) Erica D. Moore, Esquire Office of the General Counsel Department of Management Services 4050 Esplanade Way, Suite 160 Tallahassee, Florida 32399-0950 (eServed) Jacob Koffsky, Esquire Foley & Lardner LLP 2 South Biscayne Boulevard, Suite 1900 Miami, Florida 33131 (eServed) Gayla Grant, Esquire Office of the General Counsel Department of Management Services 4050 Esplanade Way, Suite 160 Tallahassee, Florida 32399-0950 (eServed) William Chorba, General Counsel Office of the General Counsel Department of Management Services 4050 Esplanade Way, Suite 160 Tallahassee, Florida 32399 (eServed)
