The Issue The issues to be determined are whether Respondent possessed Dilaudid without a legitimate purpose, and whether Respondent is unable to practice nursing with reasonable skill and safety, in violation of section 464.018(1), Florida Statutes, as alleged in the Administrative Complaint and, if so, the appropriate penalty.
Findings Of Fact The Department of Health, Board of Nursing, is the state agency charged with regulating the practice of nursing in the state of Florida, pursuant to section 20.43, and chapters 456 and 464, Florida Statutes. At all times material to this proceeding, Lisa Michelle Jackson was a licensed registered nurse in the state of Florida, holding license number RN 9375240. Respondent’s current address of record is 2358 York Street, Jacksonville, Florida 32207. On Saturday, November 7, 2015, Respondent left work and picked up her minor son from her parents’ house. She drove home, parked at her front door, and lost consciousness. At some point, Respondent’s parents called her cell phone. The phone was answered by Respondent’s son, who advised them of the situation. Respondent’s parents went to her house, and apparently called emergency medical services. EMS personnel arrived on the scene and administered Narcan to Respondent. Narcan is a medication that blocks receptors for opioid-based drugs, and is used to reverse the effects of opioids. It is commonly used when medical personnel suspect a patient of an opioid overdose. Respondent was thereafter transported to St. Vincent’s Riverside Medical Center (Riverside), and admitted with encephalopathy and acute respiratory failure. Respondent had to be placed on a respirator. A urine drug screen was performed, which returned positive for benzodiazepines and opiates. Riverside related the encephalopathy and respiratory failure to a suspected drug overdose. Respondent denied having taken anything containing benzodiazepines. She did indicate that approximately a year earlier she had undergone a tooth extraction, for which her dentist had prescribed Percocet. She had some left over, and testified that she had taken some for back pain several days before November 7, 2015. Respondent was discharged from Riverside on November 9, 2015, at approximately 11:40 a.m. After her discharge from Riverside on November 9, 2015, but later that afternoon, Respondent was speaking with her mother on the telephone. Respondent’s mother did not like the way she sounded, and came to the house. Respondent’s mother believed that Respondent was lethargic, but Respondent admitted only to being tired from her earlier hospital stay. EMS was called, and Respondent was again transported to Riverside, where she was admitted at approximately 5:45 p.m. Her diagnosis on admission was hypertensive disorder. She self-discharged against medical advice, signing the discharge papers at 6:36 p.m. There was no evidence that Respondent’s admission to Riverside on November 9, 2015, was the result of the use or abuse of any substance. On November 20, 2015, Respondent and Carl Nesmith were at Respondent’s residence. Respondent testified that she was experiencing back pain. At some time during the evening, Respondent took three or more Dilaudid tablets. Respondent testified that the tablets belonged to Mr. Nesmith, though the evidence was not sufficient to support a finding to that effect. Nonetheless, by the time of the arrival of the EMS team and her subsequent admission to Riverside as described herein, the tablets were in her possession. Dilaudid is a brand name of hydromorphone, an opioid. Pursuant to section 893.03(2)(a)1.k., Florida Statutes, hydromorphone is a Schedule II controlled substance that “has a high potential for abuse and has a currently accepted but severely restricted medical use in treatment in the United States, and abuse of the substance may lead to severe psychological or physical dependence.” Respondent did not have a prescription for Dilaudid. At some point during the evening of November 20, 2015, Respondent passed out in her bathroom. EMS was called and dispatched to Respondent’s residence. The inference is that Mr. Nesmith called them, but since Respondent was unconscious, and Mr. Nesmith did not testify, the identity of the caller is not known. More to the point, the identity of the caller is not relevant. When EMS personnel arrived, they found Respondent unresponsive on the bathroom floor. Mr. Gorsuch recognized Respondent’s symptoms, including agonal breathing, as characteristic of an opioid overdose, and administered Narcan to counteract the effects of the suspected drug. The Narcan “worked,” and Respondent regained consciousness. EMS personnel discovered a plastic bag with loose pills in Respondent’s purse. The pills were taken with Respondent as she was transported by EMS to Riverside. Respondent was received at the Riverside emergency room shortly after midnight on November 21, 2015. Her condition was described as “drowsy but arousable with slurred speech.” Upon her arrival at Riverside, Ms. Quartano observed that Respondent was clutching a Ziplock-type bag of pills in her hand. How the pills came to be in her hand was not explained. Whether in her purse or in her hand, the pills were in Respondent’s possession. The pills were provided to Dr. McBride Johnson, who identified the pills as Dilaudid based on their shape, color, and markings. Respondent’s diagnosis upon admission was acute encephalopathy; poisoning by unspecified drugs, medicaments, and biological substances, accidental, initial encounter; and altered mental status. Respondent underwent a urine screening, which returned positive for benzodiazepines. Despite the fact that Respondent knew that she had taken “pills” during the evening in question, she denied to hospital personnel that she had taken any drugs or alcohol. As she had on November 9, 2015, Respondent self- discharged against medical advice, signing the discharge papers at 5:30 a.m. Upon her discharge from the hospital, Respondent was taken into custody by Sergeant Coleman from the Jacksonville Sheriff’s Office. Respondent told Sergeant Coleman that the Dilaudid had been given to her by a friend for back pain, and that she had them for several days. Despite her deposition testimony that she had taken pills allegedly provided to her by Mr. Nesmith, she told Sergeant Coleman that she had taken one of her previously prescribed Percocet tablets, and denied having taken any of the pills given to her by her “friend.” Respondent was then placed under arrest. Respondent’s mother had, for years, taken care of Respondent’s son while Respondent was working, often at night. Between November 2015 and January 2016, Respondent’s parents took over primary care of her son in order to provide him with a more stable environment. There is no evidence that Respondent ever diverted opioids, or any other drugs, from her employer. However, after having been visited by a Department of Health investigator, Respondent’s employer, University of Florida Health - Shands (Shands), first suspended and then, in January 2016, terminated Respondent’s employment as a registered nurse. On February 14, 2016, a Jacksonville Sheriff’s Deputy performed a traffic stop on Respondent after observing her fail to maintain her lane of traffic, stop past the stop bar at a stop light, drive up onto the curb nearly striking a pole, drive onto another curb and nearly onto the sidewalk, and while attempting to negotiate a turn, nearly strike another pole. The deputies called to the scene observed that Respondent had bloodshot eyes, slurred speech, lethargic movements, and that she was unsteady on her feet. She underwent Field Sobriety Exercises but failed to perform them to standard. Respondent testified that she had taken some over-the- counter sleeping medication at least 12 hours before being stopped. She could think of no reason why such medications would have had an effect on her by the time of the stop. Respondent stated that her erratic driving was caused by her vehicle pulling to the right and being difficult to control, which was consistent with her deposition testimony that it was because her car needed an alignment. That explanation was not believable. Respondent was arrested for driving while under the influence. The charges were ultimately reduced to reckless driving, but Respondent was required to attend DUI driving school, attend the DUI Victim Impact Panel, and perform community service. On March 15, 2016, Respondent was walking from her mother’s house to her car when she passed out in her mother’s yard. The Jacksonville Fire and Rescue Department responded, arriving at approximately 12:15 p.m. The EMS personnel administered Narcan to Respondent, and transported her to Baptist Medical Center (Baptist). By the time she arrived, she was able to communicate with medical personnel, and attributed the incident to a fight with her mother, and lightheadedness from not eating that day. Respondent testified that “they told me at the hospital that I had morphine in my system, and I had no morphine.” Respondent’s understanding of what she was told is not substantiated by the Baptist medical records. Thus, the evidence is not sufficient to support a finding that Respondent had morphine in her system on March 15, 2016. Respondent was discharged from Baptist at approximately 1:15 p.m., about an hour after her arrival. Beginning “towards the end of 2015,” and extending “maybe up until March or April [2016], maybe a little later,” Respondent went to the Jacksonville Metro Treatment Center where she received daily methadone treatments in an effort to wean herself off of controlled substances. She “somewhat” received counseling, but the substance of her testimony indicates that the methadone was the driving cause of her visits to the treatment center. She stopped attending the treatment center due to the cost. From April 2016, when she stopped receiving methadone treatment at the Jacksonville Metro Treatment Center, until June or July 2016, Respondent received outpatient Suboxone treatment at Merit Health River Region, which accepts Medicaid. Suboxone is like methadone, but it blocks opioid receptors. Respondent stopped going to River Region because it was hard for her to get there due to transportation issues. Respondent did not complete her treatment, and she was not advised that she was in remission or that she should discontinue her treatment. Respondent has received no substance abuse treatment since she stopped going to River Region. On or about March 17, 2016, Dr. Sanchez evaluated Respondent as allowed by section 464.018(1)(j). The evaluation included not only a face-to-face interview with Respondent, but included a review of records, including medical and law enforcement records, related to each of the incidents described herein. During the evaluation, Respondent advised Dr. Sanchez that she had used opioids “opportunistically” for about 10 years, with her usage being sporadic and impulsive. Respondent further advised Dr. Sanchez that she had used a Fentanyl patch three to four days prior to the evaluation. Pursuant to section 893.03(2)(b)9., Florida Statutes, Fentanyl is a Schedule II controlled substance with the same potential for abuse as Dilaudid. Respondent did not have a prescription for Fentanyl. Dr. Sanchez opined that Respondent’s use of Fentanyl that close to the evaluation, with the risk of detection in the toxicology screen, was an indication of the strength of her addiction. Respondent did not tell Dr. Sanchez about the March 15, 2016, incident during which she passed out in her mother’s yard, an incident that occurred only two days prior to the evaluation. She agreed that the incident would have been relevant to Dr. Sanchez’s evaluation. The failure to disclose the incident is indicative of an evasive attitude towards matters that would reasonably be expected to affect Respondent’s ability to practice nursing with reasonable skill and safety. Dr. Sanchez noted that Respondent had a history of emergency room visits over extended periods of time with different pain complaints, including back pain, abdominal pain related to gastric bypass surgery, and a broken tooth, all of which resulted in recommendations for short-term opiate therapy. Dr. Sanchez opined that Respondent’s actions suggested drug- seeking behavior. However, the maladies described, including a bulging disc from a car accident, and chronic tooth issues including, at the time of the evaluation, an abscess, were diagnosed by physicians, who prescribed pain management medications, and were not illusory. Regardless of whether Respondent’s use of opioids was initiated as a result of a medically-prudent prescription, the evidence is clear and convincing that Respondent’s use has passed to the stage of addiction. Dr. Sanchez opined that the incident on November 7, 2015, when Respondent took some form of opioid and picked up her child on the way home, ultimately losing consciousness at the wheel of her car, was evidence of a strong compulsion to use opioids. Dr. Sanchez’s opinion that this incident indicated a significant lack of judgment and control is credited. The incident on November 20, 2016, is further strong evidence of a growing and dangerous addition. In light of the other incidents described herein, and Respondent’s familiarity with opioids over the years, both as a patient and a nurse, Respondent’s testimony that she did not understand what she was taking that evening is simply not credible. Dr. Sanchez stated the circumstances surrounding Respondent’s February 14, 2016, arrest for driving under the influence is further evidence that Respondent was “losing control” of her addiction. The suggestion that the incident was the result of poor alignment is not credible, particularly in light of Respondent’s appearance and performance during the stop. Dr. Sanchez determined that Respondent refuses to accept responsibility for her behavior and remains in denial of her substance abuse issues, a conclusion that is supported and accepted. As a result of his evaluation, Dr. Sanchez diagnosed Respondent with severe opioid use disorder. He opined that Respondent has significantly impaired judgment due to her substance abuse, which precludes her from functioning as a registered nurse with the necessary skill and safety to patients. His testimony is credited. Dr. Sanchez further opined that Respondent requires an extended period of continuous supervision with monitoring, substance abuse treatment, random toxicology testing, and an extended period of time of documented abstinence from controlled substances before Respondent would be able to practice nursing with sufficient skill and safety to patients. He recommended that Respondent complete a full course of treatment geared to substance abuse and chemical dependency, initially as inpatient treatment, followed by an intensive outpatient program after a reasonable period of abstinence. Finally, Dr. Sanchez recommended that Respondent execute an Intervention Project for Nurses (IPN) monitoring agreement. IPN is the impaired practitioner program for the Board of Nursing, pursuant to section 456.076. IPN monitors the evaluation, care, and treatment of impaired nurses. IPN oversees random drug screens and provides for the exchange of information between treatment providers, evaluators, and the Department for the protection of the public. Respondent has not entered any form of inpatient treatment, though she indicated that she is currently on a wait- list for inpatient treatment, has discontinued outpatient treatment, and has not entered into an IPN agreement.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Department of Health, Board of Nursing, enter a final order: determining that Respondent violated sections 464.018(1)(i) and 464.018(1)(j); imposing a suspension of license number RN 9375240 for one year and thereafter until such time as Respondent personally appears before the Board and can demonstrate the present ability to engage in the safe practice of nursing, with such demonstration to include at least one IPN evaluation in which the evaluator finds Respondent to be able to engage in the safe practice of nursing or recommend the conditions under which safe practice could be attained; requiring compliance with IPN recommendations and contract conditions, as imposed; imposing an administrative fine in the amount of $250.00; and awarding costs incurred in the prosecution of this case to the Department. DONE AND ENTERED this 29th day of November, 2016, in Tallahassee, Leon County, Florida. S E. GARY EARLY Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 29th day of November, 2016. COPIES FURNISHED: Lisa Michelle Jackson 2356 York Street Jacksonville, Florida 32207-3541 (eServed) Rob F. Summers, Esquire Brynna J. Ross, Esquire Prosecution Services Unit Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 (eServed) Nichole C. Geary, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 (eServed) Joe Baker, Jr., Executive Director Department of Health 4052 Bald Cypress Way, Bin C02 Tallahassee, Florida 32399-1701 (eServed) Jody Bryant Newman, EdD, EdS Department of Health 4052 Bald Cypress Way, Bin C02 Tallahassee, Florida 32399-1701
The Issue The issue is whether Dr. Namen is entitled to a re-grading of the score which he received on the written clinical portion of the podiatry examination given in Orlando in July 1990.
Findings Of Fact Dr. Namen is a candidate for licensure as a podiatrist and sat for the clinical portion of the podiatry examination administered in Orlando in July 1990. At the time of the final hearing, Dr. Namen challenged the Department's grading of his answers to questions 3, 47, 118, and 145. At the final hearing, the expert for the Department, Dr. Warren Simmonds, agreed with Dr. Namen that the challenges to the grading of questions 3 and 118 had merit. Dr. Namen's score was increased so that Dr. Namen would be entitled to a passing score if the answers he gave to either of the two remaining questions under challenge, questions 47 and 145, were correct. Question 145 is based on case history #50, concerning a patient with a painful left ankle. Although the case history does not state directly that the joint is inflamed, it does state that "the joint is slightly warm" which is an indication of the presence of inflammation, which is confirmed by the patient's report of pain in the joint. Question 145 asked which of a number of possible treatments was the "least indicated (emphasis in original)." Dr. Simmonds testified that the answer chosen by the Board, "systemic adrenal corticosteroid therapy," was the least indicated treatment because of the side effects of steroids. Dr. Simmonds believes that steroids should not be used unless there is some acute inflammatory reaction which needs to be controlled. The best treatment, or the treatment of choice, is a non-steroidal anti-inflammatory drug. Dr. Namen contends Tylanol is the least indicated treatment because all available choices other than Tylanol were anti-inflammatory drugs, and the case history provides an indication of inflammation. Tylanol relives pain but has no anti-inflammatory effect, and is therefore the least appropriate treatment. The question stem is somewhat unusual because it asks the candidate for the "least indicated" treatment. Since Tylanol has no anti-inflammatory effect at all, Dr. Namen's testimony was persuasive that the "least indicated" treatment was Tylanol. Among the remaining choices, systemic adrenal corticosteroid therapy is the least appropriate among that group, but all answers within that group are better answers than administration of Tylanol. Question 47 is based on case history 19 concerning the appropriate dose of anesthetics to be used in a procedure for the removal of toe nails on a 58- year-old, Caucasian male weighing 150 pounds. The case history states that a certain combination of two anesthetics was used, bupivicaine and lidocaine. The question asks "how close to toxic dose would use of the entire amount bring the patient." The Department's answer was that the stated dose would be within 96 percent of a toxic dose; Dr. Namen believed that the use of the anesthetics in the amounts stated would bring the patient only within 66 percent of a toxic dose. The crux of the question is whether the toxicities for the two anesthetics interact in such a way that their toxicities must be added, or whether the correct answer involves only the calculation of the toxicity of the drug with the higher level of toxicity. On balance, the Department's answer is the most persuasive. The article in the Journal of Anesthesiology written by deJong and Bonin concludes, based upon their research which is described in the article, that local anesthetic toxicity for lidocaine and bupivicaine are essentially additive. The letter from Dr. Orta only states that the administration of both the lidocaine and bupivicaine at the doses described in the question are "well below toxic level." This observation does not answer the question posed, which is just how far below the toxic level use of the mixture stated would bring the patient. The letter from Dr. Padron, also a board certified anesthesiologist offered by Dr. Namen, says that "studies on compounding local anesthetics were done in animals and it was found that the toxicity was synergistic rather than additive," but no study was offered in evidence. The study in the Journal of Anesthesiology the Department offered into evidence is to the contrary. The evidence based on actual research is more persuasive. Dr. David's letter only reports in a hearsay fashion the opinion of an unidentified pharmacologist, and is entitled to little weight.
Recommendation It is therefore, RECOMMENDED that a final order be entered by the Department of Professional Regulation raising Dr. Namen's score, and designating him as having successfully completed the examination in clinical podiatry. DONE AND ENTERED in Tallahassee, Leon County, Florida, this 1st day of April 1992. WILLIAM R. DORSEY, JR. Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 1st day of April 1992.
The Issue Whether petitioner should take disciplinary action against respondent for the reasons alleged in the administrative complaint?
Findings Of Fact At all pertinent times, respondent Manuel P. Villaflor, M.D., held a Florida license as a physician, No. ME 0020072. He practices in Daytona Beach, where he has an office on Ridgewood Avenue. UNTIMELY DEATH K.D., a white male, was pronounced dead at 3:59 P.M. on October 19, 1985, a few days shy of his 34th birthday. The autopsy disclosed superficial abrasions, acute blunt trauma to K.D.'s face, scalp and right hand, and acute, diffuse subdural hemorrhage. A paper bag full of prescriptidn medicine containers accompanied the body to the autopsy. Apparently because the labels indicated that Dr. Villaflor had written pain killing prescriptions for K.D., the medical examiner's office notified DPR. Some four months later, analysis of samples of K.D.'s blood and urine revealed that codeine, oxycodone, amitriptyline, also known as Elavil, nortriptyline, also known as Pamelor, and chlordiazepoxide, also known as Librium, had been present in the corpse in quantities "beyond the reference range for therapeutic use." Botting deposition, p. 6. The pathologist amended his initial conclusion that head injuries resulting from "multi-focal blunt trauma," id., p. 7, had caused R.D.'s death, by adding "multiple drug intoxication," id., as another cause of death. As far as the record shows, Dr. Villaflor never prescribed Elavil, Pamelor, Librium or their chemical equivalents for K.D. An osteopath whom K.D. saw toward the end of his life prescribed at least two of these medications, as well as medicine containing oxycodone. CONTROLLED SUBSTANCES UNCONTROLLED On November 15, 1985, Diane Rabideau, an investigator for DPR, called on Dr. Villaflor at his office. He was polite and cooperative. Ms. Rabideau had some difficulty understanding him; he is not a native English speaker, and he had recently suffered a stroke. But she understood well enough Dr. Villaflor's assertions that he did not believe K.D. to have been addicted to any drugs, and that he had not over-prescribed any medicine. Ms. Rabideau inspected the controlled substances kept in Dr. Villaflor's office. She found Tenuate Dospan, Restoril, Darvocet, Valium, Tylenol No. 4, Fiorinal No. 3, Xanax, Vicodin, Tylenol with codeine elixir, Dalmane, Anexsia, Centrax, "Tussend Ex. 1/2 oz.," Limbitrol, Equagesic, Phrenilin with codeine, Novahistine, Naldecon, Ativan, Nucofed, and "P.V. Tussin." When she saw them, they were not under lock and key. No inventory records reflected what was on hand and what had been dispensed. The parties stipulated that Dr. Villaflor "failed to maintain records of the[se] schedule controlled substances . . . as required by Section 893.07, Florida Statutes"; and that he "failed to keep the[se] drugs . . . under lock and key as required by 21 C.F.R. Section 1301.72." When Ms. Rabideau pointed out these omissions, Dr. Villaflor and his wife, who works with him in the office, said they would comply in the future. Mrs. Villaflor said she had not known of these requirements. A subsequent inspection by a DPR investigation found Dr. Villaflor in full compliance with reporting requirements governing controlled substances. K.D.'s PAIN On July 8, 1981, Dr. Villaflor saw K.D., apparently for the first time, at the Halifax Hospital Medical Center emergency room, and admitted him to the hospital. K.D. had sustained an electrical shock when he struck a high voltage power line with an aluminum ladder, as he was hurrying for shelter from a sudden rain. He lost consciousness "surrounded by a bluish flame." Petitioner's Exhibit No. 12. The elecricity burned his feet and made his lower legs tender, as well. Discharged from the hospital, he visited Dr. Villaflor's office on July 15, 1981. In these proceedings, DPR does not question Dr. Villaflor's prescription of Percocet, a combination of Tylenol and oxycodone, for pain on that visit. As a teenager, K.D. had broken his collar bone in falls from motorcycles on two separate occasions. One accident involved a ride over a waterfall. When he was 2l years old, he "was smashed between a construction vehicle and a bulldozer," Petitioner's Exhibit No. 12, suffering "a severe crushing injury to his chest." Some ten years later he "still ha[d] very mobile ribs secondary to this injury," and persistent pain in his back and legs. In November of 1981, Dr. Kolin, a psychiatrist in Orlando, admitted K.D. to Orlando Regional Medical Center. A myelogram "revealed a mild L5 radicular lesion on the left, consistent with chronic myofascial pain and left L5 radiculitis." Petitioner's Exhibit No. 11. During this hospital stay, K.D.'s "narcotic medications were tapered and discontinued." Id. Dr. Villaflor sent copies of his records to Dr. Kolin, to whom Dr. Gillespie in Nashua, New Hampshire, had referred K.D. Apparently Dr. Villaflor never asked and Dr. Kolin never volunteered to forward Dr. Kolin's records to Dr. Villaflor. Gary G. Parsons, a vocation rehabilitation counselor, met K.D. on February 8, 1982. After K.D. made a perfect score on an aptitude test, a state agency subsidized his vocational training at the American Computer Institute. When K.D.'s training there concluded on January 4, 1983, Mr. Parsons tried to assist him in obtaining employment, but eventually concluded that K.D. could not hold a job because "his pain, and his limitation was greater than" (T. 283) Mr. Parsons had originally realized. K.D.'s pain or his physical condition "was primary in his conversation almost every time" (T. 283-4) he and Mr. Parsons spoke. Even after the vocational rehabilitation file was closed on June 26, 1984, he came by Mr. Parsons' office twice. Both times K.D. seemed depressed to Mr. Parsons, who had recommended he go for counseling to the Human Resources Center, a community mental health center. Mr. Parsons saw K.D. for the last time on March 22, 1985. At least as early as August of 1984, K.D. mentioned suicide to Mr. Parsons as a possibility. In March of 1985, K.D. began weekly counselling sessions with Dr. Rafael Parlade, a clinical psychologist at the Human Resources Center. In these sessions "the two issues . . . were his suicidal ideation combination with the depression, and the departure of his live-in girlfriend." (T. 273) He "still had a lot of pain." (T. 274) Dr. Parlade hoped K.D. would "increase his activities," (T. 276) so that with . . . activity in his life more, he would focus away from his pain. Because for a period of time that was all he was living with. (T. 276) Dr. Parlade viewed decreasing the amount of pain medication as a secondary goal (T. 275), a result he hoped would flow from K.D.'s being less preoccupied with the pain he experienced continually. PAIN REMEDIES On January 31, 1983, K.D. visited Dr. Villaflor's office. Dr. Villaflor's notes for that day mentioned K.D.'s "Electrocution High Voltage in 7/81" and reflect a prescription for 50 tablets of Talwin. K.D.'s blood pressure, 120 over 70, is noted, and reference is made to a TENS unit, or transcutaneous nerve stimulator. Somebody at the Orlando Pain Clinic K.D. had visited had recommended one of these electrical devices to K.D., but it had proved ineffective against his pain. At one time or other, K.D. resorted to acupuncture and resumed wearing a corset of the kind originally prescribed for the back pain he experienced in the wake of the cascading motorcycle accident. Dr. Villaflor's office notes of April 15, 1983, record "Back Pain," a second prescription for 50 tablets of Talwin and another prescription for Xanax. On May 11, 1983, Dr. Villaflor's records again note K.D.'s "Back Pain" and indicate prescriptions for Xanax and Percocet. Nothing suggests Dr. Villaflor knew that Talwin had been dispensed to K.D. five days earlier, when K.D. appeared at his office on May 26, 1983. Essentially illegible, Dr. Villaflor's office notes for May 26, 1983, reflect prescriptions for Percocet and Xanax tablets, with which K.D. obtained 30 quarter milligram Xanax tablets on June 6, 1983, and 35 Percocet tablets on June 8, 1983. Xanax, a tranquilizer, is taken three or four times daily. Since Percocet may be taken every four to six hours, it was "very much within reason" (T. 239) for Dr. Villaflor to prescribe more on June 9, 1983. When this prescription was filled on June 22, 1983, K.D. received 45 tablets. On July 7, 1983, Dr. Villaflor saw K.D. at his office for the first time in almost a month, and prescribed 35 more tablets of Percocet, also known as oxycodone with acetaminophen. The same day K.D. had the prescription filled, obtaining 35 tablets. Some three weeks later, on July 29, 1983, Dr. Villaflor again prescribed and K.D. again obtained 35 Percocet tablets. On the same day two other prescriptions Dr. Villaflor wrote for K.D. were filled, one for Atarax, an antihistamine sometimes prescribed in lieu of a tranquilizer, and one for Tylenol with codeine. This 35-tablet Tylenol prescription was refilled on September 7, 1983. With more and less potent pain medications, K.D. could take one or the other, as appropriate, depending upon the intensity of the pain. Since no other prescription for pain killing medication was written or filled until October 4, 1983, these prescriptions were, according to one of the Department's witnesses, "[w]ithin reason." (T. 243) On the October 4 visit, Dr. Villaflor noted "Back Pain from Electrocution" and recorded K.D.'s blood pressure as 138 over 70 or 80, before prescribing 45 Percocet tablets. That day, K.D. obtained the Percocet. He returned to Dr. Villaflor's office on October 13, 1983, complaining not only of back pain, but also of nausea and vomiting. Dr. Villaflor prescribed an additional 30 Percocet tablets. On October 15, 1983, K.D. acquired 50 tablets of the antihistamine Dr. Villaflor had been prescribing for him, "hydroxizine pam." On November 3, 1983, he obtained 60 Percocet tablets and 50 Tylenol No. 3 tablets. On November 12, 1983, the antihistamine prescripton was refilled as was, on November 16, the Tylenol No. 3 prescription. Perhaps Dr. Villaflor wrote the antihistamine prescription two days before it was first filled. The office notes are difficult to decipher. He wrote the Percocet and Tylenol prescriptions when he saw K.D. on November 3, 1983, at which time he recorded his blood pressure (132 over 70) and noted "back injury." On December 2, 1983, Dr. Villaflor's office notes reflect a visit and prescriptions for Tylenol No. 3, Percocet and the antihistamine. With respect to prescriptions filled on and after November 3, 1983, but before December 2, 1983, DPR's witness testified that the amount of medication was "a little high, but it's still, you know, again, acceptable for a person in pain." (T. 246) On December 2, 1983, K.D. obtained 60 Percocet tablets and 50 Tylenol No. 3 tablets, the latter by virtue of a prescription that was refilled on December 14, 1983. On January 3, 1984, K.D. returned to Dr. Villaflor's office where he obtained prescriptions for Percocet and Tylenol No. 3. In March, Dr. Villaflor began prescribing a tranquilizer, Dalmane, instead of the antihistamine, but the new year progressed much as the old year had, in terms of Dr. Villaflor's prescriptions and documentation, and, apparently, of K.D.'s pain, as well, until early August. On August 3, 1984, Dr. Villaflor prescribed for K.D., 200 "Sk- Oxycodone w/Apap" tablets, 200 Tylenol No. 4 tablets and 180 Dalmane capsules. K.D. had asked for them to take along to New England, where he travelled for an extended visit with his parents and others. This represented more than a two months' supply, and the prescriptions inspired a pharmacist, Paul Douglas, to telephone Dr. Villaflor's office before filling them. Mr. Douglas had called once before in the spring of the year, when he noticed that a total of 100 Tylenol (acetaminophen with codeine) No. 3 tablets and 60 tablets of Percocet (or the generic equivalent) had been dispensed to K.D. for use over a 24-day (April 2 to April 26, 1984) period. The pharmacist was concerned on that occasion because K.D. would have needed only 144, not 160, tablets during that period, if he had been taking no more than one every four hours. Back in Daytona Beach, K.D. presented himself at Dr. Villaflor's office on November 5, 1984, and received prescriptions for 45 tablets of Percocet, 55 tablets of Tylenol No. 3 and a quantity of Dalmane. All three prescriptions were filled the same day, and the prescription for Tylenol No. 3 was refilled on November 19, 1984. After his last telephone call to Dr. Villaflor's office, the pharmacist talked to K.D., telling him he would "not fill these medications again . . . until the prescribed number of days." (T. 222). On December 5, 1984, K.D. appeared a second time after his return from up north, and Dr. Villaflor again prescribed all three drugs, this time specifying 50 tablets of Percocet and 50 tablets of Tylenol No. 3. K.D. caused these prescriptions to be filled the day he got them. The office notes for both these visits mention only electrical shock by way of explanation for the prescriptions. On December 19, 1984, Dr. Villaflor suffered a stroke and was hospitalized. Two days later prescriptions he had purportedly written for K.D. were filled, but their authenticity, like that of the prescriptions filled on November 21, 1984, is not certain. While Dr. Villaflor was indisposed on account of the stroke, Dr. Wagid F. Guirgis filled in for him. The day he began, K.D. came in complaining of severe pain in his lower back and legs. Dr. Guirgis prescribed Dalmane, 50 Percocet tablets and 50 Tylenol No. 3 tablets, the latter prescription being twice refillable. Dr. Guirgis suggested to R.D. that he see an orthopedist or a neurologist, and, on January 21, 1985, refused K.D.'s request to prescribe more Percocet. At no time did Dr. Guirgis and Dr. Villaflor discuss K.D. or his treatment. Later the same day K.D. went to Dr. M.H. Ledbetter's office. This osteopath prescribed 30 Percocet tablets to be taken twice daily, as well as Elavil and Tranxene. On February 4, 1985, Dr. Ledbetter prescribed the same medicines. On February 28, 1985, Dr. Ledbetter prescribed Elavil, Librium and 50 tablets of Percocet. On March 22, 1985, he prescribed the same things. On April 19, 1985, K.D. again visited Dr. Ledbetter. The same day he purchased Librium and 60 Percocet tablets at Walgreen's. Dr. Ledbetter prescribed Librium, Elavil and 60 tablets of Percocet, to be taken twice daily, when he saw K.D. on May 16, 1985. In May Dr. Villaflor returned to his office, and K.D. appeared on May 21, 1985, five days after he had seen Dr. Ledbetter. Dr. Villaflor prescribed 60 Percocet and 50 Tylenol No. 3 tablets for K.D., along with Dalmane and a vitamin (Bl2) injection. K.D. weighed 142 pounds that day and his blood pressure was also noted. The office notes report "same complaints." On June 18, 1985, Dr. Villaflor prescribed 60 Percocet tablets, ten fewer than he prescribed on K.D.'s next visit, on July 17, 1985 , when K.D. limped "on left foot." In July, Dr. Villaflor also prescribed Dalmane and 50 Tylenol No. 3 tablets. On both visits K.D.'s weight (142 then 138) and blood pressure (122 then 120 over 80) were noted. On August 19, 1985, K.D.'s weight had fallen to 132 pounds but his blood pressure remained 120 over 80. Sixty Percocet tablets - one every four hours - were prescribed, as were 50 Tylenol No. 3 tablets. The diagnosis indicated in Dr. Villaflor's office notes was "electrocution." On September 16, 1985, Dr. Villaflor again prescribed Dalmane, Tylenol and 60 Percocet tablets. On October 17, 1985, K.D. limped to his last visit to Dr. Villaflor's office. His face bruised, K.D. complained that both feet were swollen, and reported that he had lost his balance and fallen down four stairs and over a concrete wall. For the last time, Dr. Villaflor prescribed Tylenol No. 3 and Percocet for K.D., 30 and 60 tablets respectively. Unbeknownst to Dr. Villaflor, K.D. had continued to visit Dr. Ledbetter, himself unaware of Dr. Villaflor's renewed involvement with K.D. On June 7, July 5, July 26, August 27, September 16 and October 10, 1985, Dr. Ledbetter prescribed Librium, Elavil and Percocet. Dr. Ledbetter's office notes also reflect K.D.'s fall. REQUIRED PRACTICE Keeping complete medical records is important not only as a mnemonic aid for the treating physician, but also to make the patient's history available to other physicians who may succeed or assist the recordkeeper. Although each is "a moderate type of analgesic," (T. 324), both codeine and oxycodone are "narcotic derivatives . . . [and] addictive in nature." Id. Dalmane "can be" (T. 221) "potentially addictive." Id. Because of his depression, K.D. "was not a good candidate" to entrust with several hundred pills at once. A physician who suspects addiction should limit prescriptions to "around ten to fifteen" (T.326) tablets and "start checking with other pharmacies to make sure if a patient is getting drugs from any other source . . . ." Id. He should perform "very close and repeated physical exams" (T. 327) and be alert for "overdose side effects," id., such as dizziness, slurred speech, or staggering. The evidence here fell short of a clear and convincing showing that Dr. Villaflor was remiss in failing to suspect addiction, however, Dr. Ledbetter, who had similar, albeit similarly incomplete, information apparently did not suspect. The evidence did not prove the existence of side effects from the drugs Dr. Villaflor prescribed. Although, on his last visit to Dr. Villaflor's office, K.D. reported dizziness, the cause is unknown. On the other hand, his office records do not suggest that Dr. Villaflor took any steps to determine the cause of K.D.'s dizziness or of his swollen feet. Dr. Villaflor's treatment of K.D. fell below acceptable levels, if he failed to refer K.D. for periodic reevaluations of the underlying orthopedic or neurological problem, which his records suggest he did not do. His treatment was also inadequate for failure periodically to "get the medicine . . . out of the system . . . for a limited time" (T. 337) in an effort to learn what side effects, if any, the drugs he prescribed caused, either singly or in combination. This is so, even though the effort might have been frustrated, if K.D. had acquired the same medicines from other sources.
Findings Of Fact The Respondent is a licensed physician in the state of Florida, and holds license number ME 0034710. Respondent's last known address is 1430 Mason Avenue, Daytona Beach, Florida, 32117-4551. At all times material to these proceedings, Respondent, who is both a neurologist and a psychiatrist, specialized in the diagnosis and treatment of headaches in his medical practice with Daytona Neurological Associates in Daytona Beach, Florida. At various times from approximately May 18, 1984, through December 23, 1988, Respondent rendered neurological care to Patient C.R., a female born on November 14, 1963. On May 18, 1984, when C.R. initially came to Respondent's office complaining of severe headaches, Respondent noted in his medical records that the patient had been on birth control pills for three years and had ceased taking them two months prior to this visit. C.R. was also a cigarette smoker. From approximately May 18, 1984, until September 12, 1986, C.R. was prescribed a variety of medications at various times by Respondent for the patient's headaches. The medications included Asendin, Phrenilin Forte, Norpramin, and Tylenol #3. Medrol, Prednisone, and Decadron are legend drugs as defined in Section 465.003, Florida Statutes, and contain both natural and synthetic adrenocortical steroids (glucocorticoids). On September l2, 1986, Respondent prescribed a Medrol Dosepak unit to C.R. A Medrol Dosepak is a corticosteroid specific package that is tapered over six days from the first dose down to the last dose and contains a total of 84 mg of methylprednisolone (105 mg Prednisone equivalent). The medication was concluded on or about September 17, 1986. On October 30, 1986, Respondent prescribed another Medrol Dosepak unit to C.R. The patient took the Medrol tablets beginning on this date, in decreasing dosages, starting at 24 mg and ending at 4 mg six days later, for a total of another 84 mg of methylprednisolone (105 mg Prednisone equivalent). Both prescriptions of Medrol (September 12, 1986 and October 30, 1986) were short courses and treatment was not inappropriate. On November 7, 1986, C.R. went to a hospital emergency room where she was prescribed Prednisone 40 mg for three days and 20 mg for four days and referred back to the Respondent for follow-up care. During this hospitalization, C.R. received approximately 200 mg of Prednisone. On November 14, 1986, Respondent saw C.R. in his office and indicated in his records that the patient seemed to be doing better on Prednisone and "[w]e will keep her on this medication and re-evaluate her in one month. She is to . . . decrease the Prednisone and come off this in about a week or two." On November 25, 1986, Respondent saw C.R. in his office. Respondent indicated in his records that he would keep C.R. on Prednisone l0 mg daily for "another week or so." From November 7, 1986 until November 30, 1986, C.R. received a total of 465 mg of Prednisone. Appropriateness of corticosteroid use varies with both amount and duration. The amount initiated in the Emergency Room on November 7, 1986, was not excessive, but Respondent's rationale for continuation of the drug, or whether the November 14, 1986 dosage was tapered or less than that previously prescribed for C.R. in the emergency room, is not documented in Respondent's patient records. On January 20, 1987, Respondent saw C.R. in his office and documented that he was going to give the patient another "short course" of Prednisone. Respondent saw C.R. again in his office on January 30, 1987, and documented further prescription of Prednisone. The documentation for the above two visits does not indicate the dosage details nor suggest what circumstances of the patient's condition justify again prescribing prednisone other than the remark dated January 20, 1987, that "[p]atient is having some headaches again." For the period of January 20, 1987 through February 9, 1987, C.R. was prescribed a total of 510 mg of Prednisone. Petitioner's Exhibit 5 is a calendar prepared by C.R. which allegedly documents the patient's receipts for prescriptions which she purchased upon Respondent's authorization. C.R. has no independent recollection of amounts or times when she took the medications. On the basis of information reflected on the calendar, Petitioner seeks to establish that Respondent prescribed corticosteroids for C.R. in excess of that otherwise established by the evidence in this case. In view of the lack of C.R.'s independent recollection of when she took the medications, the lack of corroborating original receipts, C.R.'s lack of detail recall concerning her treatment by Respondent, her inability to remember when she prepared the calendar other than in preparation for civil litigation against Respondent following her treatment, and lack of other direct evidence corroborating the document's veracity, the calendar standing alone is not credited for the purpose of establishing amounts and times of medication prescribed for C.R. by Respondent. C.R. had an office visit on March 18, 1988 but there is no reference to any Prednisone prescription in the medical record. A handwritten note for the date of April 6, 1988 in the Respondent's medical record states that the patient was "told to stay on Prednisone." Respondent conceded in testimony that he apparently failed to document prescribing 60 mg Prednisone in April of 1988. From April 27, 1988 through May 8, 1988, Respondent had C.R. admitted to Halifax Medical Center in Daytona Beach, Florida. During that period, she received 909 mg. Prednisone equivalent (Decadron). Respondent discharged the patient with a diagnosis of severe vascular migraine headaches under control with a combination of Mellaril and Procardia. At the time of the April, 1988 admission, C.R. was suffering from crescendo migraine with numbness, blurring, and an episode of loss of consciousness. As established by testimony of Thomas M. Zizic, M.D., Respondent's expert in avascular necrosis, corticosteroid use, and treatment of headache, patients with the symptoms displayed by C.R., when she was hospitalized in April of 1988, are at risk for transient ischemic attacks and strokes. As opined by Dr. Zizic, and corroborated by testimony of Victor B. Robert, M.D., the short course of less than two weeks of high dose steroids in the course of the April, 1988 hospitalization was not inappropriate. Zizic also opined that the other courses of steroids prescribed previously for C.R. were not inappropriate. As established by Zizic, steroid medications in the amounts and duration prescribed for C.R. are not causative of avascular or aseptic necrosis. Dosage amounts of these drugs have to be much greater and for longer periods of time to occasion such side effects. Even assuming C.R.'s calendar of medications and the resultant supposition that she ingested more steroid medication than is established by the credible evidence, Zizic opined that the likelihood that such medication amounts and duration resulted in C.R.'s development of aseptic necrosis is less than five percent. Zizic also testified that he would not have felt it necessary to warn C.R. of the potential for avascular or aseptic necrosis in view of the remoteness of such a possibility at dosages prescribed for her. Dr. Jacob Green, an expert witness presented by Respondent, is a neurologist who provided insight into the clinical management of the difficult headache patient, noting that there is no standard treatment for such patients, "[y]ou just have to use what works . . . Its a matter of trial and error in a lot of cases." Green also noted that once a patient is treated with corticosteroids, the dosages must be tapered gradually, not stopped suddenly. Green concluded C.R.`s dosages were decreased appropriately, that duration of Medrol and Prednisone prescribed for the patient was appropriate, and that use and duration of Decadron during C.R.`s hospitalization in April, 1988, was also appropriate. While Green acknowledged that avascular necrosis of the hips is a known complication of steroid use, he testified that in 1986 or 1987 he would not have felt that failure to warn a patient about the potential for such a remote side effect constituted a breach of the standard of care and would not have warned the patient. In Green's opinion, Respondent did not prescribe Medrol, Prednisone or Decadron contrary to the best interests of C.R. In 1989, C.R. was diagnosed with aseptic necrosis of the femoral head of both her hips and underwent surgery in 1989 and 1990 resulting in total hip replacements. She has undergone surgery for "a revision on the left side" and continues to have problems. While differing expert testimony presented in this proceeding fails to clearly and convincingly establish a causal connection between the steroid medications given to C.R. and her resultant physical problems, the common consensus of those experts is that avascular necrosis is a complication that can arise from the use of steroids, given sufficient dosages and duration of such medication. Although Respondent did not inform C.R. of the potential of avascular necrosis from corticosteroid dosing by the prescribed medications and did not at any time during the course of his treatment discuss with CR the potential for such harmful side effects, the evidence fails to establish that the patient should have been informed in 1986 regarding the remote potential for harmful side effects of such medications. However, Respondent's medical records on the patient C.R. were inadequate. The records did not serve as an effective basis for planning patient care and providing for continuity in the evaluation of the patient's condition and treatment. The records did not furnish documentary evidence of the course of the patient's medical evaluation, treatment, and change in condition. Detail of the records was not sufficient to clearly demonstrate why one course of treatment was undertaken in preference to another course and would not have communicated sufficient information for any other practitioner who would have assumed the patient's care.
Recommendation ACCORDINGLY, it is recommended that a final order be entered finding the Respondent guilty of count two of the Administrative Complaint, violation of Section 458.331(l)(m), Florida Statutes; requiring as a penalty that Respondent's license to practice as a physician in the State of Florida be placed on probation for a period of one year upon conditions prescribed by the Board of Medicine; and further requiring that Respondent pay a fine in the amount of $5,000. DONE and ENTERED this 26th day of February, 1996, in Tallahassee, Leon County, Florida. DON W. DAVIS, Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 26th day of February, 1996. APPENDIX CASE NO. 94-2116 In accordance with requirements of Section 120.59, Florida Statutes, the following constitute my rulings with regard to proposed findings of fact submitted by the parties. Respondent's Proposed Findings. 1.-2. Accepted. Rejected, unnecessary. Rejected, subordinate to HO findings. Accepted, but not verbatim. While the calendar was admitted, it may only be used to corroborate direct testimony. C.R. had no independent recollections which could be corroborated by the calendar. Respondent took issue with the calendar, consequently the calendar is not credited as a basis for fact finding with the exception of Dr. Zizic's opinion regarding dosage levels. Incorporated by reference. 7.-10. Rejected, subordinate to HO findings. 11. Accepted, not verbatim. 12.-15. Incorporated by reference. 16.-18. Accepted. 19.-22. Rejected, subordinate to HO findings. Petitioner's Proposed Findings. 1-4. Accepted. 5. Rejected, unnecessary. 6.-9. Accepted, not verbatim. 10. Accepted in part, remainder rejected as subordinate. 11.-12. Accepted. 13.-19. Rejected, subordinate to HO findings. 20.-22. Accepted. 23.-25. Rejected, subordinate to HO findings. COPIES FURNISHED: Albert Peacock, Esquire Department of Business and Professional Regulation 1940 North Monroe Street Suite 60 Tallahassee, Florida 32399-0792 Donna J. Torsney, Esquire Donald W. Weidner, P.A. 10161 Centurion Parkway North Suite 190 Jacksonville, Florida 32256 Jerome W. Hoffman, General Counsel Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32308-5403 Dr. Marm Harris, Executive Director Agency for Health Care Administration Division of Medical Quality Assurance 1940 North Monroe Street Tallahassee, Florida 32399-0792
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 Whether respondent, a licensed physician, violated provisions of Chapter 458, Florida Statutes, by allegedly (1) failing to keep medical records justifying her course of treatment; (2) prescribing controlled substances (Methaqualone) other than in the scope of her professional practice; (3) prescribing a Scheduled II controlled substance (Methaqualone) for a purpose not allowed by statutes; (4) engaging in gross or repeated malpractice or failing to practice medicine in accordance with medical standards recognized as acceptable by reasonably prudent similar physicians under similar conditions; (5) failing to perform a statutory obligation; (6) making untrue or fraudulent representations or employing a trick or scheme in the practice of medicine, and exploiting patients for financial gain.
Findings Of Fact Respondent, 54, is a female medical doctor licensed to practice medicine in the State of Florida. From August through December 1981, she was the sole physician employed by Northeast Medical Services, Inc. ("the clinic"), a clinic located at 4600 North Federal Highway, Ft. Lauderdale, Florida. The clinic also employed a nurse, a psychologist, and a receptionist. Clinic patients were processed under a standardized office procedure. First, they would fill out personal information and medical history forms, then answer a written "Stress Questioanaire," and sign a "drug potency warning." Next, they would be screened by a psychologist and physically examined by a nurse and respondent. Most patients came to the clinic complaining of stress or stress related symptoms. 1/ Most patients were diagnosed as suffering from stress. The treatment usually consisted of prescribing stress (vitamin) tablets and 45 tablets of 300 mg. Methaqualone, for which patients paid $75 to $100 in cash. During the several months she was employed by the clinic, respondent saw 15 to 20 patients a day, sometimes many more. From August 13, 1981, through October 30, 1981, she wrote at least 378 separate prescriptions for Methaualone (45 tablets, 300 mg.) totaling 17,010 tablets. (Petitioner's Exhibit No. 2) II. Barbara Bennett: Counts 1-24 On September 9, 1981, Barbara Ann Bennett visited respondent at the clinic. She completed the personal information and medical history forms, was screened by the psychologist, and physically examined by respondent. The physical examination included taking her weight, height, pulse, respiration, and blood pressure. Respondent checked her general appearance, skin, head, eyes, ears, nose, throat, heart, lymph nodes and neurological responses. Respondent spoke with her and noted in her progress report that the patient did not like her job as a bartender and did not sleep well. The Stress Questionnaire completed by Ms. Bennett indicated that she came to the clinic for the sole purpose of reducing stress. She checked-off items reflected that, among other symptoms, she had experienced poor sleep, was under a great deal of stress, and was unable to relax. Respondent rendered an initial impression or diagnosis of stress and prescribed stress (vitamin) tablets, 600, No. 30, 30 tablets and Methaqualone, 300 mg., 45 tablets, with directions to take one tablet at bedtime and one-quarter tablet twice a day, as needed. At that time, Chapter 893, Florida Statutes, identified Methaqualone as a Schedule II controlled substance, a substance with a high potential for abuse but which had an accepted but severely restricted medical use and treatment in the United States. This statute recognized that it could be abused and result in severe psychological and physical dependency. In 1981, Methaqualone--a non-barbiturate--was known as a highly potent hypnotic drug which was subject to widespread and growing abuse. It was gaining a reputation as a street drug, and was referred to as quaaludes. For patients diagnosed as suffering from stress, prevailing medical standards (in the area where respondent practiced) dictated the prescription of a mild tranquilizer for daytime use, not a potent hypnotic such as Methaqualone. Generalized complaints of stress, including checked-off items such as contained on the Stress Questionnaire used by respondent, were insufficient to justify prescribing a powerful drug such as Methaqualone, for either night or daytime use. As Dr. Warren Zundell, a qualified physician, testified at hearing: If 100 people were taken off the street and asked if they had stress--100 would say "yes." Prescribing Methaqualone for such patients was, in Dr. Zundell's opinion "like hunting ants with an elephant gun." (TR.-250) For sleeping problems, a milder hypnotic--of which there were several--was the appropriate treatment. Although respondent's initial diagnosis of stress was justified, her prescription of Methaqualone for night and daytime use (though with a lesser dosage) was inappropriate, medically unjustified, and constituted a failure to practice medicine with that level of care which is recognized by reasonably prudent similar physicians as acceptable under similar conditions. Under prevailing medical standards of practice then in effect, the diagnosis of stress did not justify more than the prescription of a mild tranquilizer or sedative. Ms. Bennett's alluded to sleeping problem did not justify the prescribing of Methaqualone when there were many other hypnotics available which were less potent and less subject to abuse. The medical records kept by respondent did not justify her prescribing Methaqualone to Ms. Bennett. The Methaqualone was thus prescribed other than in the course of respondent's professional practice and for other than a legitimate medical purpose. On September 11, 1981, Ms. Bennett was hospitalized at Hollywood Memorial Hospital for a drug overdose. The hospital staff contacted respondent who confirmed that she had issued the September 9, 1981 prescription for Methaqualone. Notation of this call was made in Ms. Bennett's patient records. On or about November 17, 1981, respondent issued Ms. Bennett another prescription for stress tablets and Methaqualone, identical in amount to the September 9, 1981, prescription. Presumably, this prescription was for the purpose of treating the same symptom--stress. It was not medically justified, inappropriate, and outside the scope of her professional practice. The patient's medical records did not justify this prescription. In fact, there are no records of Ms. Bennett's having visited the clinic on November 17, 1981. The prescribing of Methaqualone to Ms. Bennett, especially in light of her prior hospitalization for a drug overdose, constituted a gross failure to practice medicine with that level of care recognized by reasonably prudent similar physicians as accepted under similar conditions. Adrienne Gampel: Counts 25-48 On August 28, 1981, Ms. Adrienne Gampel visited respondent at the clinic. Personal and medical history were taken and the Stress Questionnaire was completed. She acknowledged that she came to the clinic for the sole purpose of reducing stress, and checked off descriptors on the questionnaire indicating that she was under a great deal of pressure at home and had experienced poor sleep. After seeing the psychologist she was given a complete physical examination, similar to that given Ms. Bennett. Respondent rendered a diagnosis of stress and prescribed stress tablets and Methaqualone, 300 mg., 45 tablets. For the reasons stated in paragraphs 6 and 7 above, the prescription of Methaqualone to Ms. Gampel was inappropriate, not medically justified, and not justified by respondent's medical records. It was outside the scope of her professional practice and constituted a failure to practice medicine with that level of care recognized by reasonably prudent similar physicians as acceptable under similar conditions. In October and November 1981, Ms. Gample revisited respondent at the clinic. It has not been shown, however, that a new Methaqualone prescription was issued on either occasion. Robert Distillator: Counts 49-81 On September 3, 1981, Robert Distillator visited the respondent at the clinic. His personal and medical history were taken, and the Stress Questionnaire was completed. He acknowledged that he came for the sole purpose of reducing stress and checked-off descriptors on the questionnaire indicating that he had experienced loss of appetite, poor sleep, boredom on weekends, difficulty in making decisions, inability to have a good time, and a great deal of pressure. He also indicated he felt tense, depressed, unable to relax, and had more problems than he could handle. A complete physical examination was given him and his blood was analyzed. Respondent rendered an initial diagnosis of stress and prescribed stress tablets and Methaqualone, 300 mg. 45 tablets, with directions identical to those given Ms. Bennett. For the reasons provided in paragraphs 6 and 7 above, respondent's prescribing of Methaqualone for night and daytime use was medically unjustified, inappropriate, not justified by the records, and outside the scope of her professional practice. It constituted a failure to practice medicine with that level of care recognized by reasonably prudent similar physicians as acceptable under similar circumstances. Furthermore, it was inappropriate to prescribe Methaqualone to a patient, such as Mr. Distillator, who indicated depression, since such a symptom would increase the likelihood of self-abuse. On or about October 7, 1981, Mr. Distillator revisited respondent at the clinic. However, it has not been shown that he was issued another Methaqualone prescription on that occasion. On or about November 5, 1981, he revisited respondent at the clinic. His blood was analyzed and he was then issued another prescription for stress tablets and Methaqualone--identical in all respects to his first prescription. This prescription was not even noted by respondent in the patient's medical records. For the reasons stated in paragraphs 6 and 7 above, her prescription of Methaqualone was inappropriate, not medically justified, outside the scope of her professional practice, and constituted a failure to practice medicine with that level of care recognized as acceptable by reasonably prudent similar physicians under similar conditions. On December 14, 1981, respondent issued Mr. Distillator another prescription of stress tablets and Methaqualone, in like amount. The prescription was not noted in his patient records. Presumably, it was given for the continued treatment of stress. For the reasons specified in paragraphs 6 and 7 above, this prescription was inappropriate, medically unjustified, not justified--or even noted--in the patient's medical records, and was outside the scope of professional practice. It constituted a failure to practice medicine with that level of care recognized as acceptable by reasonably prudent similar physicians under similar conditions. Joe Morreale: Counts 81-96 On October 12, 1981, Joe Morreale visited respondent at the clinic. His personal and medical history were taken, the Stress Questionnaire was completed, and a physical was given. He acknowledged on the questionnaire that his sole purpose for coming was to reduce stress, and checked-off descriptors indicating that he had experienced pressure at home and at work, headaches, nightmares, and poor sleep. Respondent rendered an initial diagnosis of stress and prescribed stress tablets and Methaqualone 300 mg., 45 tablets, with her standard instructions--one daily at bedtime and one-quarter tablet, twice a day, as needed. For the reasons specified in paragraphs 6 and 7 above, the prescribing of Methaqualone to Mr. Morreale was inappropriate, medically unjustified, not justified by the records, outside the scope of professional practice, and constituted a failure to practice medicine with that level of care recognized as acceptable by reasonably prudent similar physicians under similar circumstances. On December 11, 1981, Mr. Morreale revisited respondent at the clinic. However, it has not been shown that she issued him another prescription for Methaqualone at that time. Joani Levi: Counts 97-104 On September 30, 1981, Ms. Joani Levi visited respondent at the clinic. A personal medical history was taken, the questionnaire was completed, and a physical was given. On the questionnaire, she indicated that the sole purpose of her visit was to reduce stress, and checked-off descriptors indicating she had experienced poor sleep, marital problems, and pressure at work. Respondent noted in her records that the patient was confused, nervous, and suffering extreme anxiety. Respondent rendered an initial diagnosis of stress and prescribed stress tablets and Methaqualone, 300 mg., 45 tablets, with her standard instructions for night and daytime use. For the reasons provided in paragraphs 6 and 7 above, this prescription was inappropriate, not medically justified, not justified by the patient's medical records, and outside the scope of professional practice. It constituted a failure to practice medicine with that level of care which is recognized by reasonably similar prudent physicians as acceptable under similar conditions. Rachel Mack: Counts 105-112 On September 28, 1981, Ms. Rachel Mack visited Respondent at the clinic. Her medical history was taken and the Stress Questionnaire was completed; then she was given a physical. On the questionnaire, she indicated her sole reason for coming was to reduce stress. She checked-off descriptors indicating that she had experienced poor sleep, difficulty in making decisions, disturbing thoughts or fears, pressure at work and at home, and inability to have a good time. Respondent rendered an initial diagnosis of stress and prescribed stress tablets and Methaqualone, 300 mg., 45 tablets, with her usual instructions. For the reasons stated in paragraphs 6 and 7 above, the prescribing of Methaqualone to Ms. Mack was inappropriate, medically unjustified, not justified by her patient records, and beyond the scope of professional practice. It constituted a failure to practice medicine with that level of care recognized as acceptable by reasonably prudent similar physicians under similar conditions. Robin Millman: Counts 113-128 On September 14 and 23, 1981, respondent issued Ms. Robin Millman, an employee at the clinic, a prescription for Methaqualone, 300 mg., 45 tablets. The purpose of this prescription was to relieve stress. There are no medical records justifying this treatment. Indeed, there were no patient records for Ms. Millman. For the reasons stated in paragraphs 6 and 7 above, this prescription was medically unjustified, inappropriate, outside the scope of professional practice, and constituted a failure to practice medicine with that level of care recognized as acceptable by reasonably prudent similar physicians under similar circumstances. Brenda Villa: Counts 127-161 On September 5, 9, 14, October 22, and November 12, 1981, respondent issued Ms. Brenda Villa, another employee of the clinic, a prescription for Methaqualone, 300 mg., 45 tablets, for the purpose of treating stress. There were no patient records for Miss Villa, and there were no medical records justifying this prescription. For the reasons stated in paragraphs 6 and 7 above, the prescription was inappropriate, medically unjustified, outside the scope of professional practice, and constituted a failure to practice medicine with that level of care recognized as acceptable by reasonably similar prudent physicians under similar conditions. Michael Bransfield: Counts 162-169 On September 24, 1981, Michael Bransfield visited respondent at the clinic. A personal and medical history was taken, the Stress Questionnaire was completed, and a physical was given. On the questionnaire, he indicated that the sole purpose of his visit was to reduce stress. He checked off descriptors indicating he had experienced poor sleep, pressure at home and at work, and inability to relax. Respondent rendered a diagnosis of stress and prescribed stress tablets and Methaqualone, 300 mg., 45 tablets, with her usual instructions for night and daytime use. For the reasons provided in paragraphs 6 and 7 above, this prescription was inappropriate, not medically justified, not justified by the patient's medical records, and outside the scope of professional practice. It also constituted a failure to practice medicine with that level of care recognized as acceptable by reasonably prudent similar physicians under similar conditions.
Recommendation Based on the foregoing, it is RECOMMENDED: That respondent's license to practice medicine be revoked for multiple violations of the Medical Practice Act. DONE and ENTERED this 5th day of April 1984, in Tallahassee, Florida. R. L. CALEEN, JR. Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 FILED with the Clerk of the Division of Administrative Hearings this 5th day of April 1984.
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)
