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
Findings Of Fact On June 27, 1991, Petitioner applied for licensure in the State of Florida by endorsement as a physician. He is presently licensed in the states of Alabama, Louisiana and Wisconsin. He is board eligible in dermatology and is currently a house physician for New Orleans General Hospital in New Orleans, Louisiana. On January 5, 1993, Respondent denied Petitioner's Florida application because of Petitioner's previous history of psychiatric problems and psychotherapy which affected his ability to practice medicine with skill and safety; his current psychiatric and psychological evaluations indicating an obsessive-compulsive disorder which could affect his abilities to practice with skill and safety; and the prior denial of his licensure application in 1987 as the result of material misrepresentations in the application. On three separate occasions, Petitioner has applied for licensure in Florida. In addition to the current application, he applied on April 4, 1986 and on August 2, 1990. Following a formal hearing, the 1986 application was denied on December 22, 1987, as the result of misrepresentation in the application. An application for admission filed in 1990 was subsequently not timely completed and became void. All of Petitioner's applications and materials submitted with regard to those applications are maintained by Respondent in one file, a normal practice for Respondent. Documents in that application file have been generated by Respondent or supplied by Petitioner. Diagnosed in 1977 with an obsessive-compulsive disorder, obsessive- compulsive personality and dysthymia, Petitioner has been receiving treatment for his mental illness since 1979. He was hospitalized for a psychotic episode in 1987. From 1988 until the present, Petitioner has been taking Sinequan and Mellaril. The daily dosage of 50 milligrams of Mellaril has not varied during that time period. The daily dosage of Sinequan initially was 150 milligrams per day, tapered to 40 milligrams each night at present. About three months ago, Petitioner began taking about a gram of Valproic acid each night. These medications have a sedating or hangover effect on Petitioner in the morning. At one point in 1992, Petitioner temporarily switched to another drug, Anaframil, for a month to a month and a half. One of the reasons for the switch was that Petitioner was going to be reevaluated by a psychiatric expert, Dr. Dohn, at Respondent's request. Dr. Dohn's previous evaluation had expressed concerns about possible effects on Petitioner's clinical abilities as a result of medication side effects. After Dohn's second evaluation of Petitioner, Dohn was much more confident of Petitioner's abilities in view of the then change to Anaframil for treatment of Petitioner's obsessive-compulsive disorder. Mellaril and Valproic acid are psychotropic medications which have confusion as a side effect. Sinequan can have confusion and sedation as a side effect. Valproic acid also has a sedating effect. The dosage of these medications as taken by Petitioner are sufficient to produce these side effects. The effects of the medications carry over to the following day, although taken the evening before. Psychological evaluations of Petitioner dated October 7, 1991 and August 28, 1992, reflect that Petitioner's cognitive abilities have been affected by his mental condition, inclusive of the medications he takes. The 1991 evaluation documents Petitioner's difficulties with recall of verbal instructions and numbers presented verbally to him; completing eye-hand coordination tasks within the maximum time limit; distinguishing visual details; and a tendency to become stymied with anxiety. Further, the 1992 report indicates that certain symptoms of Petitioner's obsessive-compulsive disorder could conceivably interfere with his ability to perform surgery. The 1992 report was done following testing of Petitioner after his brief change to the drug, Anaframil. Following Petitioner's 1992 evaluation by Dr. Dohn, conducted in close proximity to the August 1992 psychological evaluations, Petitioner quit taking Anaframil and resumed his previous medications of Mellaril and Sinequan. At deposition following a recent psychiatric evaluation of Petitioner by Dr. Edward Foulks, Foulks opined that Petitioner's illness should not be a barrier to the practice of medicine. Foulks opinion is not credited in view of his lack of independent knowledge of Petitioner's medications or mental condition; his lack of knowledge of whether Petitioner's condition had stabilized; how the condition had been resolved; or how much further treatment Petitioner would likely require. Foulks' opinions were based in large part upon Petitioner's representations to him. Petitioner's evaluations from Lazarus S. Gerald of the University of Pennsylvania Department of Dermatology, dated August 21, 1990 and July 8, 1991; from the chief of the Dermatology Department of Lloyd Noland Hospital and Clinic in Fairfield, Alabama, dated August 21, 1990; and from Dr. Derek J. Cripps, Director of the Department of Dermatology of the University Station Clinics, University of Wisconsin, note Petitioner's psychiatric condition as a possible explanation for performance difficulties. In 1986, Petitioner made numerous misrepresentations in his application for licensure. He answered "no" to the application question of whether he had a mental or emotional illness, although he had been ill since 1977 and had been treated from 1979 until 1986 by several psychiatrists. He also answered "no" to whether he had received psychotherapy. He was suspended from seeing patients during the last three months of residency at the University of Wisconsin, but answered "no" to the question of whether he had ever ceased practice for more than a month. He also answered "no" to the question of whether he had ever been denied hospital privileges or had such privileges acted against. In his August 2, 1990 application, Petitioner again answered "no" to whether he had been denied hospital privileges or had his hospital privileges acted against. Later, recognizing that this was not an accurate representation, Petitioner forwarded an affidavit, dated May 16, 1991. In that affidavit, Petitioner changed his answer to "yes". While only receiving partial credit of three months for his residency at the University of Wisconsin, Petitioner listed the dates on the form so that it appeared that he had received one year's credit. In his current application, dated June 27, 1991, Petitioner again failed to show that he only received partial credit for his residency at the University of Wisconsin. An affidavit dated November 21, 1991, was submitted by him regarding the residency program at Tulane University in which he was then participating. The affidavit failed to indicate that his participation in the residency program was conditioned upon his being in the impaired residents program and that the residency lasted 18 months, although he needed only six months to complete residency requirements for the dermatology board examination. Petitioner also failed to tell his supervising physician at Tulane, Dr. Shrum, of Petitioner's previous application for licensure in Florida or denial of that application for licensure, until after Shrum had been deposed regarding Petitioner's reputation for truthfulness.
Recommendation Based on the foregoing, it is hereby RECOMMENDED that a Final Order be entered denying the application for licensure by endorsement. DONE AND ENTERED this 10th day of December, 1993, 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 10th day of December, 1993. APPENDIX TO RECOMMENDED ORDER, CASE NO. 93-1671 The following constitutes my specific rulings, in accordance with Section 120.59, Florida Statutes, on findings of fact submitted by the parties. Petitioner's Proposed Findings. 1.-2. Accepted. Rejected, weight of the evidence. Rejected, cumulative. Subordinate to HO findings. Accepted. Subordinate to HO findings. 8.-13. Accepted, but not verbatim. 14. Rejected, credibility. 15.-20. Rejected, unnecessary. 21.-25. Subordinate to HO findings. 26. Rejected, credibility. 27.-38. Rejected, credibility. 39.-45. Rejected, credibility. 46.-51. Rejected, subordinate to HO findings. 52. Rejected, relevancy. 53.-59. Rejected, credibility. Respondent's Proposed Findings. 1.-13. Accepted, but not verbatim. COPIES FURNISHED: Claire D. Dryfuss, Esquire Department of Legal Affairs The Capitol, PL-01 Tallahassee, Florida 32399-1050 Steven W. Huss, Esquire 1017-C Thomasville Road Tallahassee, Florida 32303 Jack McRay General Counsel Department of Business and Professional Regulation The Northwood Centre 1940 North Monroe Street Tallahassee, Florida 32399-0750 Dorothy Faircloth Board of Medicine Department of Business and Professional Regulation The Northwood Centre 1940 North Monroe Street Tallahassee, Florida 32399-0750
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.
The Issue Whether the Respondent committed the violations alleged in the Amended Administrative Complaint dated March 26, 2010, and, if so, the penalty that should be imposed.
Findings Of Fact Based on the oral and documentary evidence presented at the final hearing, the facts stipulated to by the parties in the Joint Prehearing Stipulation, and on the entire record of this proceeding, the following findings of fact are made: The Department is the state agency responsible for the investigation and prosecution of complaints involving physicians licensed to practice medicine in Florida. See § 456.072, Fla. Stat. The Board of Medicine ("Board") is the entity responsible for regulating the practice of medicine and for imposing penalties on physicians found to have violated the provisions of section 458.331(1). See § 458.331(2), Fla. Stat. At the times pertinent to this proceeding, Dr. Christensen was a physician licensed to practice in Florida, having been issued license number 92135, and he practiced with the A1A Health & Wellness Clinic ("Clinic"), specializing in pain management. In 1975, Dr. Christensen received a degree in chiropractic, and he specialized in chiropractic orthopedics. Dr. Christensen has been practicing chiropractic orthopedics in the Palm Beach, Florida, area since 1975, although he took time away from his practice to attend medical school and to obtain a master's degree in public health. Dr. Christensen received his medical degree in 1995, and he completed a one-year internship in internal medicine. Dr. Christensen was certified in preventive medicine by the American Board of Preventive Medicine on January 22, 2007, and, after passing an examination, he was credentialed in March 2007 by the American Academy of Pain Management. Between February 9, 1997, and February 1998, Dr. Christensen was certified as an addiction professional by the American Association of Acupuncture and Oriental Medicine and the American College of Addictionology and Compulsive Disorders after having taken a 120-hour program in addictionology. Dr. Christensen first saw A.L. at the Clinic on February 12, 2007. At the time, A.L. was 21 years old, having been born on September 17, 1985. At the February 12, 2007, office visit, A.L. completed a Personal History form in which he stated that he was self- employed and worked in construction; that his major complaint was knee and back pain; and that the condition of which he complained began when he was 13 years old, which would have been in or about 1998. A.L. also noted on the Personal History form that he had seen other doctors for "pain management," but he did not include the names of any of the doctors who had provided pain management treatment. Dr. Christensen completed the New Patient History Form at A.L.'s first office visit. He noted that A.L. complained of intense, sharp, incapacitating pain in his left knee, with associated pain in his lower back. A.L. reported that he had had multiple surgeries on his knee that had been unsuccessful. Dr. Christensen performed a general examination of A.L. to confirm that he was alert and oriented and that his organ systems functioned properly. Dr. Christensen noted that A.L. was thin, but he did not identify any abnormal finding. Dr. Christensen did note that A.L. complained of anxiety. Because of A.L.'s complaints, however, Dr. Christensen focused his examination on A.L.'s left knee and lower back. Dr. Christensen observed scars on A.L.'s left knee, which confirmed the multiple surgeries that A.L. reported, and he also noted muscle atrophy of A.L.'s left leg, a condition that Dr. Christensen attributed to lack of exercise of the left leg. Dr. Christensen performed several orthopedic tests targeted at A.L.'s left knee and lower back, and Dr. Christensen's objective physical examination confirmed A.L.'s subjective complaints of pain. The differential diagnosis noted by Dr. Christensen on the New Patient History Form was multiple failed knee surgeries with associated lower back pain and lumbar disc syndrome. Dr. Christensen concluded that A.L. most likely had a lumbar disc problem because of A.L.'s abnormal gait resulting from the knee injury and the resulting pressure on A.L.'s pelvis. Dr. Christensen also noted on the New Patient History Form that A.L. reported that, each month for years, he had taken 60 to 90 80-milligram tablets of Oxycontin; 400 to 600 30- milligram tablets of Roxicodone; 200+ 40-milligram tablets of Methadone; 60 to 90 2-milligram tablets of Xanax; and 3 bottles of Oxifast. Based on these medications, dosages, and quantities, Dr. Christensen considered A.L. overmedicated, and he intended, during his treatment of A.L., to gradually reduce the amount of medications prescribed for A.L. Oxycontin and Methadone are pain medications, and Oxycontin and Roxicodone are trade names for the generic drug Oxycodone. Oxifast is a liquid form of Oxycodone, and Xanax is a drug used to treat anxiety. Both Oxycodone and Methadone are classified as schedule II controlled substances in section 893.03(2), Florida Statutes, and have a high potential for abuse; Xanax, which is the trade name for the generic drug Alprazolam, is classified as a schedule IV controlled substance in section 893.03(4), with a low potential for abuse relative to schedule I, II, and III controlled substances. As part of his initial office visit with Dr. Christensen, A.L. signed a Pain Management Agreement, in which he agreed that, among other things, he would not take any pain medications not prescribed by Dr. Christensen or seek treatment from any other doctors in order to obtain pain medications; prescriptions would be filled at the same pharmacy, which A.L. identified as "Gordons Pharmacy"; he would take the medications prescribed in the manner indicated on the label; he agreed to random urine drug tests; and he understood he would be discharged by Dr. Christensen if he failed to abide by the Pain Management Agreement. Dr. Christensen went over this agreement with A.L. during this initial office visit, and he emphasized that the agreement was a legal document that, if breached, would result in A.L.'s being discharged as Dr. Christensen's patient. In his typed notes for A.L.'s February 12, 2007, office visit, Dr. Christensen stated: Subjective: Mr. [L] indicated on his first visit today that he is feel constant severe pain in his left knee causing him to limp which refers pain to the lower back. Mr. L additionally reports restricted movement pain localized in the right lumbar, left lumbar, right lower lumbar area, and left lower lumbar area. Mr. [L] stated that for years he is made fairly comfortably by taking pain pills but his low back pain is a lot more uncomfortable due to bending, driving, lifting, and standing. He also stated today that he is experiencing constant severe pain in the area of the left knee joint and related he has had 7 failed knee surgeries since he was 13 years old. Mr. [L] additionally made particular comment about stiffness, restricted movement, and inflexibility pain localized in the left kneecap. Mr. [L]'s knee joint pain feels worse due to bending, standing, and walking. He states that taking pain pills reduces the severity of the pain. Dr. Christensen also noted in his typed notes that A.L. rated the level of knee joint and low back pain at nine on a scale of one to ten; Dr. Christensen's handwritten notes indicate that A.L. rated the level of pain at "10+". Dr. Christensen's assessment, as reflected in his typed notes, was that A.L. showed a persistent chronic symptomatology; that is, Dr. Christensen considered A.L.'s knee and lower back pain to be a chronic and stable condition, with no hope of improvement given that A.L. rejected additional surgery on his left knee as an option. Dr. Christensen also requested at the February 12, 2007, office visit that A.L. provide him with any MRI reports or other radiologic studies as soon as possible, and A.L. provided several radiological consultation reports the day after his initial office visit. The reports included an MRI of A.L.'s left knee done on or about April 1998; an MRI of A.L.'s lumbosacral spine done on or about December 2000; an MRI of A.L.'s left knee done on February 9, 2001; an MRI of A.L.'s left knee done on August 23, 2002; and a radiological study of A.L.'s cervical spine and a CT scan of A.L.'s brain in April 2006. Dr. Christensen reviewed the reports and confirmed that A.L.'s diagnosis was an osteochondral defect of his left knee, most likely from a sports injury. Dr. Christensen did not order additional diagnostic studies of A.L.'s knee and lower back because he concluded, as a chiropractic orthopedist and based both on his objective findings from the physical examination of A.L. and on his review of the radiological reports, that A.L.'s injury would not get better on its own; that additional diagnostic tests would show only that A.L.'s condition had gotten worse; and that the results of additional diagnostic tests would not change his diagnosis or treatment of A.L. The treatment plan for A.L. that Dr. Christensen outlined in his typed notes is as follows: One month appointment is scheduled for the patient. Pain medication that he was taking was reviewed and a decreased amount of pain medicine was prescribed. He was given a book on Subutex/Suboxone. I covered our pain management agreement, cautioned of side effects, addiction, health concepts, physical therapy, patient is too young for knee replacement, etc. Our plan is to reduce the patients [sic] present intake of pain meds . . . to a lessor [sic] amount each month as we are able. Dr. Christensen believed that A.L. was taking too much pain medication. He wanted to help A.L. undo the damage that had been done by the excessive pain medications that Dr. Christensen believed had been prescribed for A.L., and Dr. Christensen planned to reduce the amount gradually to a more appropriate level of medication. Accordingly, on February 12, 2007, Dr. Christensen wrote A.L. prescriptions for 60 40-milligram tablets of Methadone, with instructions to take one tablet two times per day; 300 30-milligram tablets of Roxicodone, with instructions to take two tablets five times per day; and 60 2-milligram tablets of Xanax, with instructions to take one tablet two times per day. Based on the quantities and dosages of medications that A.L. reported he was taking as of February 12, 2007, Dr. Christensen eliminated the prescriptions for Oxycodone and Oxifast and significantly reduced the number of 30-milligram Roxicodone tablets and 40-milligram Methadone tablets A.L. could take each month. Dr. Christensen prescribed Xanax for A.L. because A.L. reported to Dr. Christensen that he had anxiety; because Dr. Christensen observed that he was anxious during the office visit and knew that pain could cause anxiety; and because A.L. reported to Dr. Christensen that he had been taking Xanax prior to February 12, 2007. Although Dr. Christensen prescribed less Xanax for A.L. than A.L. reported that he had been taking, Dr. Christensen did not want to A.L. to stop taking Xanax abruptly because A.L. could have seizures and die. The prescriptions written for A.L. by Dr. Christensen significantly decreased the amount of pain medication A.L. was reportedly taking prior to February 12, 2007, but Dr. Christensen was satisfied that the prescriptions would provide a sufficient amount of medication to control A.L.'s pain. Dr. Christensen felt that he could not refuse to prescribe pain medications for A.L. on February 12, 2007, because, once a patient has been on pain medications for years, as A.L. reportedly had, stopping the pain medications abruptly could result in very severe withdrawal symptoms. In addition, Dr. Christensen was concerned that, if he did not prescribe pain medications for A.L., A.L. would not continue his treatment with Dr. Christensen. As part of his treatment plan, Dr. Christensen also discussed with A.L. on February 12, 2007, health concepts such as improving his diet, getting exercise, considering physical therapy, setting goals, and increasing spiritual awareness. In addition, he gave A.L. information on Suboxone, a drug used primarily to prevent withdrawal symptoms when the amount of opioids such as Roxicodone is significantly reduced. Although A.L. was not interested in discussing Suboxone at the February 12, 2007, office visit, Dr. Christensen intended to continue discussing the drug with A.L. at subsequent office visits because Dr. Christensen's ultimate plan was to wean A.L. off of opioids completely. A.L. continued treatment with Dr. Christensen until June 29, 2007, seeing Dr. Christensen on March 12, 2007; April 10, 2007; May 7, 2007; June 2, 2007; and June 29, 2007. As recorded in Dr. Christensen's typed notes, A.L. complained at each office visit of "constant severe pain" in his lower back and his left knee area, with restricted movement in the lower back area and "stiffness, restricted movement, and inflexibility pain localized in the left kneecap." At each office visit, A.L. rated his knee and/or lower back pain at nine on a scale of one to ten, except that, at the office visit on May 7, 2007, A.L. rated his knee joint pain at eight on a scale of one to ten. Dr. Christensen reviewed A.L.'s systems at each office visit and conducted a physical examination focused on A.L.'s left knee and back. Dr. Christensen's assessment of A.L.'s status at each office visit was that his condition was chronic and/or stable. At A.L.'s March 12, 2007, Dr. Christensen prescribed 60 40-milligram tablets of Methadone, with instructions to take one tablet two times per day; 300 30-milligram tablets of Roxicodone, with instructions to take two tablets five times per day; and 60 2-milligram tablets of Xanax, with instructions to take one tablet two times per day. In his handwritten notes of the March 12, 2007, office visit, Dr. Christensen noted that A.L. was stable on the pain medications prescribed. On March 12, 2007, A.L. also completed a Pain Outcomes Profile, in which he rated his pain generally as five or six on a scale of one to ten; A.L. rated his level of anxiety as seven on a scale of one to ten. In his handwritten notes of the April 10, 2007, office visit, Dr. Christensen stated that he had a long discussion with A.L. about weaning him off of the pain medications and developing goals for doing so. Dr. Christensen drew a graph in his notes of the April 10, 2007, office visit to illustrate his discussion with A.L. about taking one 30-milligram Roxicodone ten times at a time instead of two. Dr. Christensen noted that A.L. wanted to take the Roxicodone tablets more often than ten times per day, and Dr. Christensen explained to A.L. that he needed to take enough pain medication to control his pain but not enough that he would go into a state of euphoria because that would lead to addiction. Dr. Christensen expanded on his point about weaning A.L. off of the large dose of Roxicodone in his typewritten notes of the April 10, 2007, office visit: I explained the concept of 2 roxicodone's [sic] (60 mg) verse [sic] 30 mg taken more often. 2 tabs can cause excess, waste, build tolerance and the patient will run out of meds. Taking the roxicone [sic] 30 mg tablets one at a time will allow the patient to dose himself better, decrease tolerance, reduce waste, laste [sic] longer. Less pain, and ultimately take less pain meds. I showed him how 240 roxies would provide more pain relief than 300 roxies if taken 1 at a time more often then [sic] taking 2 or more at a time which is how the patient was taking them. On April 10, 2007, Dr. Christensen prescribed 60 40-milligram tablets of Methadone, with instructions to take one tablet two times per day and 60 2-milligram tablets of Xanax, with instructions to take one tablet two times per day. Dr. Christensen also prescribed 300 30-milligram tablets of Roxicodone, but he instructed A.L. to take one tablet ten times per day rather than two tablets five times per day. A.L. completed a Pain Outcomes Profile at the April 10, 2007, office visit, and he rated his pain level generally at five on a scale of one to ten; A.L. rated his level of anxiety at seven on a scale of one to ten. A.L. also signed an A1A Health & Wellness Clinic Patient Informed Consent and Notice of Material Risks for Treatment of Intractable Pain with Controlled Substances on April 10, 2007, in which A.L. confirmed that Dr. Christensen had recommended and A.L. had requested treatment with opioid pain medication. By signing the form, A.L. also confirmed that he and Dr. Christensen had discussed alternative therapies, including drug cessation treatment using Suboxone and potential side effects and risks of controlled substances. At A.L.'s next office visit, on May 7, 2007, Dr. Christensen prescribed 60 40-milligram tablets of Methadone, with instructions to take one tablet two times per day and 60 2- milligram tablets of Xanax, with instructions to take one tablet two times per day. Dr. Christensen decreased A.L.'s prescription for Roxicodone from 300 30-milligram tablets to 240 30-milligram tablets, with instructions to take one tablet eight times per day. Dr. Christensen also noted in his typewritten notes that A.L. refused physical therapy and that Suboxone/Subutex was discussed with A.L. but that A.L. indicated that he was "not at all interested." At A.L.'s June 2, 2007, office visit, Dr. Christensen further reduced to 210 the number of 30-milligram Roxicodone tablets he prescribed for A.L., and he instructed A.L. to take one tablet seven times per day. Dr. Christensen noted in the Follow Up Visit form that he completed on June 2, 2007, that A.L. was not happy about the decrease in the number of Roxicodone tablets and complained that he would be in pain. Dr. Christensen noted that he explained again that the goal was to get A.L. drug-free. Dr. Christensen also discussed additional knee surgery as an option, but he noted that A.L. emphatically refused further surgery. Dr. Christensen included on the Follow Up Visit form for the June 2, 2007, office visit a notation that states in part that A.L. brought with him a "Drug Class II w/o Script (it was meds prescribed by in wrong bottle.)." There is no further explanation or mention of this in either Dr. Christensen's handwritten notes or typewritten notes for the June 2, 2007, office visit. A.L.'s final office visit to Dr. Christensen was on June 29, 2007. Dr. Christensen noted on the Follow Up Visit form that A.L. complained of knee pain that was "unbearable" at times. Dr. Christensen also noted that A.L. was experiencing increased lower back pain because he was walking with a limp. Dr. Christensen again decreased to 180 the number of 30-milligram Roxicodone tablets he prescribed for A.L., with one tablet to be taken every six hours. Dr. Christensen noted: "Patient will be underdosed but it was explain [sic] the importance of ? Roxi More H2O, reviewed [pain management] contract & goals of ? meds over time." According to the notes on the Follow Up Visit form, Dr. Christensen intended to let A.L. stabilize at 180 30-milligram Roxicodone tablets per month and to talk with A.L. again about beginning Suboxone. Dr. Christensen believed that the amount of medications that A.L. claimed to be taking at the first office visit on February 12, 2007, was clearly excessive, but he believed that A.L. was telling the truth. Although doubts about A.L.'s truthfulness regarding his medications crossed Dr. Christensen's mind, he chose to believe A.L. was telling the truth for several reasons. First, Dr. Christensen believed that a physician must assume that a patient is telling the truth, especially a complex patient like A.L., unless there is an objective reason for doubting the patient's veracity. Second, Dr. Christensen considered A.L. to be a model patient; he was clean, polite, fully alert, and competent. In addition, A.L. continued to keep his appointments with Dr. Christensen even though Dr. Christensen was decreasing the amount of Roxicodone he prescribed for A.L. each month. Third, Dr. Christensen was aware from his physical examinations of A.L. and from A.L.'s medical history that A.L. had long-standing problems with his knee that caused him pain. A.L. reported that he had been on pain medication for approximately ten years, and, even though Dr. Christensen thought the amount of medications A.L. reported he was taking at his first office visit with Dr. Christensen on February 12, 2007, was excessive, Dr. Christensen thought that A.L. could conceivably be taking the amount of pain medications he reported because, over time, A.L. probably had built up a tolerance for the pain medications and needed to take more of the medication. Dr. Christensen was concerned about the amount of pain medication A.L. reportedly was taking, however, and, therefore, one of Dr. Christensen's goals for A.L.'s treatment was to reduce the amount of pain medications A.L. was taking and, eventually, to wean him off of pain medications entirely. Fourth, an incident occurred early in his relationship with A.L. that made Dr. Christensen doubt A.L.'s veracity, but this assessment was proven wrong. Shortly after his first office visit on February 12, 2007, A.L. returned to Dr. Christensen's office and asked for a replacement prescription for Roxicodone, explaining that the prescription was in the pocket of his jeans and that the prescription had been damaged when his mother washed the jeans. Dr. Christensen thought that A.L. was simply seeking an additional amount of the pain medication. Dr. Christensen told A.L. he would have to bring in the damaged prescription, but Dr. Christensen doubted that he would do so. A.L. brought in the prescription, which had obviously been damaged, and Dr. Christensen felt badly because he had misjudged A.L. He taped the damaged prescription in A.L.'s medical file to remind himself that he should not prejudge his patients. Even though A.L. had consented to urine drug tests in the Pain Management Agreement he signed on February 12, 2007, Dr. Christensen did not order A.L. to submit to a urine toxicology screening test on his initial office visit, as a condition of Dr. Christensen's taking him on as a patient, nor did Dr. Christensen order A.L. to submit to a random urine toxicology screening test during the time A.L. was Dr. Christensen's patient. Given the extremely large amount of pain medications A.L. reported to Dr. Christensen that he had been taking prior to his first office visit on February 12, 2007, and Dr. Christensen's concern that A.L. was overmedicated, Dr. Christensen should have considered asking A.L. to submit to a urine toxicology screening test as provided in the Pain Management Agreement. Even if Dr. Christensen had administered one or more urine toxicology screening tests to A.L., however, the results of the test would have revealed only the types of drugs in A.L.'s system; that is, the urine toxicology screening test could have confirmed that A.L. was taking the medications that he reported to Dr. Christensen on February 12, 2007, and would have identified any illicit drugs he was taking at the time of the test; it would not, however, have provided any information on the quantities of drugs in A.L.'s system and, therefore, would not have confirmed the quantities of drugs A.L. reported to Dr. Christensen that he was taking at the time of his first office visit. Summary and findings of ultimate fact A few words of explanation are necessary before proceeding with the analysis of the evidence in this case. Given A.L.'s tragic death in July 2007, it is difficult for all concerned in this case to restrict their analysis of the evidence to those facts of which Dr. Christensen was aware during the time he treated A.L., yet it is essential that the evidence be viewed from this perspective. It became apparent during the course of this hearing that A.L. did not disclose certain matters to Dr. Christensen that might have changed the course of Dr. Christensen's treatment of A.L. These matters are irrelevant to the issues presented in the Department's Administrative Complaint; they are not part of the record in this case; and they have not, therefore, been considered in the preparation of this Recommended Order. Counts One and Three through Eight The evidence presented by the Department is not sufficient to establish with the requisite degree of certainty that Dr. Christensen prescribed Roxicodone, Methadone, or Xanax for A.L. inappropriately or in excessive amounts or that he breached the standard of care in prescribing these medications. The Department's expert witness testified that Dr. Christensen violated the standard of care because the combination, quantities, and dosages of the medications Dr. Christensen prescribed for A.L. were excessive. The Department's expert witness did not, however, identify the standard of care that would have governed Dr. Christensen's treatment of A.L., nor did he provide a clear explanation of the basis for his opinion that the combination, quantities, and dosages of medications Dr. Christensen prescribed for A.L. were excessive, especially considering the combination, quantities, and dosages of medications that A.L. reported to Dr. Christensen that he was taking at the time of his first office visit with Dr. Christensen. Rather, the Department's expert witness repeatedly stated his opinion, based on "his knowledge of pharmacology and more than 20 years['] experience,"5 that the prescriptions written by Dr. Christensen, if taken by A.L. as directed, would be "100 percent lethal, 100 percent of the time."6 The Department's expert witness gave no cogent explanation for his opinion that the combination, quantities, and dosages of the drugs would be 100 percent lethal, 100 percent of the time,7 which opinion, in any event, is refuted by the fact that A.L. was successfully treated by Dr. Christensen with the same combination of drugs, albeit with decreasing quantities of Roxicodone, for a period of four and one-half months.8 In addition, in formulating his opinion that the quantities and dosages of the medications Dr. Christensen prescribed for A.L. were excessive, the Department's expert witness apparently did not consider the possibility that A.L. had, over the years, developed a tolerance for these medications.9 In fact, the Department's expert witness did not give credence to A.L.'s complaints of pain; he did not believe that A.L. should have been treated with narcotics for pain; and it can reasonably be inferred from his testimony that the Department's expert witness would have refused to treat A.L. The Department's expert witness dismissed A.L.'s complaints of pain as not credible, stating that "[t]he patient is extremely young to have any pain complaints."10 The Department's expert witness testified that, if he had been consulted, he "would have recommended a trial of spinal cord stimulation"; that Dr. Christensen could have "prescribe[d] an appropriate brace for the knee"; or that Dr. Christensen might have chosen "to then make a referral to an orthopedic surgeon" for surgery on A.L.'s knee.11 The testimony of the Department's expert witness as to the treatment he would have provided to A.L. was repeatedly conditioned by the word "if"; if A.L.'s reported knee problem were confirmed, and if the Department's expert witness had agreed to treat A.L. In fact, on the basis of the written medical records alone, the Department's expert witness dismissed A.L. as "a liar and probably a substance abuser and certainly diverting his medication" and labeled as "outlandish" A.L.'s "self reported history of medication and prescription" and his "claims of being prescribed high dosages and lethal quantities" of controlled substances.12 In rendering his opinion that the combination, quantities, and dosages of the medications Dr. Christensen prescribed for A.L. were excessive and in violation of the standard of care, the Department's expert witness did not acknowledge in his testimony that Dr. Christensen considered the quantities, dosages, and number of different pain medications that A.L. reported on his first office visit to be excessive; that Dr. Christensen concluded that A.L. was overmedicated; that Dr. Christensen's treatment plan focused on decreasing the quantity of medications prescribed for A.L.; that Dr. Christensen did, in fact, refuse to write A.L. prescriptions for Oxycodone and Oxifast; that, at A.L.'s first office visit, Dr. Christensen wrote prescriptions for Roxicodone and Methadone for A.L. that were for quantities substantially smaller than those A.L. reportedly was taking; that Dr. Christensen assumed that A.L. was truthful when he reported that he was taking 60 to 90 two-milligram Xanax; that Dr. Christensen could not eliminate Xanax from the prescriptions he wrote for A.L. because abrupt withdrawal from Xanax could cause death; that Dr. Christensen reduced by one-third the number of two-milligram Xanax he prescribed for A.L.; that Dr. Christensen introduced at A.L.'s first office visit the possibility of A.L.'s using Suboxone to help in weaning him off of opioid analgesics such as Roxicodone and Methadone; that Dr. Christensen steadily decreased the quantity of Roxicodone he prescribed for A.L., until the amount was substantially less than the amount A.L. reportedly was taking at the time of his first office visit with Dr. Christensen. By failing to indicate that he considered these factors in rendering his opinions and by making the broad and unsupported assertion that the medications prescribed by Dr. Christensen for A.L. were 100 percent lethal, 100 percent of the time, the Department's expert witness substantially diminished the credibility of his opinions. Rather than taking an objective view of the treatment that Dr. Christensen provided A.L. from February 12, 2007, to June 29, 2007, the Department's expert witness demonstrated throughout his testimony a disdain for Dr. Christensen as a physician. This disdain for Dr. Christensen is made particularly clear when the Department's expert witness attributed to Dr. Christensen a purely economic motive in his treatment of A.L. The Department's expert witness testified that Dr. Christensen, in common with "most pill mills or physicians like the subject," had "a huge economic incentive" for his treatment of A.L.13 These statements demonstrated a bias against Dr. Christensen that substantially diminished the credibility of his testimony, in general, for the following reasons. First, there was no allegation in the Administrative Complaint and no evidence in this record to support the categorization of Dr. Christensen by the Department's expert witness as a physician associated with a "pill mill." Second, in reaching his conclusion that Dr. Christensen's motivation for treating A.L. was purely financial, the Department's expert witness assumed, in the absence of even a scintilla of evidence in this record, that Dr. Christensen required his patients to pay a substantial amount of cash for each office visit and that Dr. Christensen was a "dispensing physician," that is, a physician who sells drugs as well as prescribing them.14 Count Two In Count Two of the Administrative Complaint, the Department charged Dr. Christensen with violating the standard of care in four respects, which are discussed in detail below. Failure to diagnose a history of anxiety The evidence presented by the Department is not sufficient to establish with the requisite degree of certainty that Dr. Christensen's treatment of A.L. fell below the standard of care because he failed "to diagnose a history of anxiety to support prescribing Alprazolam."15 Dr. Christensen noted on the New Patient History Form completed during A.L.'s first office visit on February 12, 2007, that A.L. reported a history of anxiety as a psychiatric condition, and A.L. also reported that he was currently taking Alprazolam, or Xanax. On each of A.L.'s subsequent office visits to Dr. Christensen, A.L. reported on the Pain Outcomes Profile that he had significant feelings of anxiety, and Dr. Christensen observed that A.L. exhibited anxious behaviors during his office visits. The Department's expert witness apparently overlooked this information in Dr. Christensen's medical records because he testified that he could find no justification for prescribing Alprazolam for A.L.16 Failure to order urine toxicology screening test The evidence presented by the Department is not sufficient to establish with the requisite degree of certainty that Dr. Christensen's treatment of A.L. fell below the standard of care because he failed "to order screening urine toxicology to rule out usage of illicit substances or confirm usage of prescribed medications." The Department's expert witness identified the standard of care at the times pertinent to this proceeding as requiring patients to submit to intermittent urine toxicology screening studies so that the patient wouldn't know when such testing would take place. The Department's expert witness further explained that it was always a matter of clinical judgment as to when to require a patient to submit to a urine toxicology screening study, even to a patient such as A.L., who had reported taking a large quantity of pain medications at the time of his first office visit to Dr. Christensen. The Department's expert witness testified that, given the amount of pain medications A.L. reported to Dr. Christensen that he was taking at the time of A.L.'s first office visit, a urine toxicology screening study of A.L. at the first office visit would be "indicated," but the Department's expert witness did not testify that Dr. Christensen violated the standard of care by failing to require A.L. to submit to such a study at that first office visit or during the time he was treating A.L. In fact, according to Dr. Christensen's expert witness, at the times pertinent to this proceeding, it would not be within the standard of care to require a patient to submit to a urine toxicology screening study within the first four and one-half months of treatment.17 Finally, there is no indication in the record that Dr. Christensen had any reason to suspect that A.L. was taking illicit substances; the primary concern Dr. Christensen, and the Department's expert witness, had with respect to A.L. was the quantity of pain medications he was reportedly taking at the time of his first office visit. Because a urine toxicology screening study reveals only the types of substances in the urine and not the quantity of such substances, a urine toxicology screening study would not have revealed whether A.L. was lying about the quantities of pain medications he reported to Dr. Christensen on his first office visit, as was concluded by the Department's expert witness; such a study would have revealed only whether A.L. was, in fact, taking these substances, a concern that, based on the information available to him, Dr. Christensen did not have at A.L.'s first or subsequent office visits. According to the standard of care identified by the Department's expert witness, Dr. Christensen did not deviate from this standard of care by using his clinical judgment to decide not to require A.L. to submit to a urine toxicology screening study. Failing to refer A.L. for treatment for substance abuse The evidence presented by the Department is not sufficient to establish with the requisite degree of certainty that Dr. Christensen's treatment of A.L. fell below the standard of care because he failed "to refer Patient A.L. to a psychiatrist and/or addiction specialist and/or rehabilitation center for substance abuse." The only mention of Dr. Christensen's failure to refer A.L. to a psychiatrist, addiction specialist, or rehabilitation center in the testimony of the Department's expert witness was in answer to the question of the Department's counsel: "Would respondent's failure to do so in this case fall below the standard of care?" The Department's expert witness answered: "Given his [A.L.'s] claims of previous medication prescription and usage, yes."18 The Department's expert witness never defined the standard of care to which he was referring, and his opinion, therefore, is not persuasive on this issue.19 Failure to order diagnostic tests The evidence presented by the Department is not sufficient to establish with the requisite degree of certainty that Dr. Christensen's treatment of A.L. fell below the standard of care because he failed "to order diagnostic tests to justify the course of treatment for patient A.L." The Department's expert witness testified that he would "not be prepared to say that [Dr. Christensen's failure to order a diagnostic test to justify his course of treatment for A.L. fell below the standard of care] because there's no justification for the course of treatment regardless of any study or consultation that the subject could have initiated."20 There was no allegation in the Administrative Complaint that Dr. Christensen violated the standard of care because there was no justification for the treatment he provided A.L., and this testimony is irrelevant to a determination of whether Dr. Christensen should have ordered additional diagnostic tests for A.L. The Department's expert witness did, however, go on to state that, under the circumstances of this case, "a reasonable and prudent physician . . . should have, at the very least, ordered an MRI study of the knee, [and] performed a comprehensive physical examination of the effected [sic] joint" and that "many physicians would have ordered an MRI of the knee or at the very least, perform [sic] a very detailed and well documented physical examination and then written down his treatment plan and the justification for his treatment plan."21 To the extent that this testimony constitutes the articulation of the standard of care by the Department's expert witness, the opinion of the Department's expert witness that Dr. Christensen fell below this standard of care is unsupportable for two reasons. First, the Department's expert witness incorrectly identified the report of the MRI of A.L.'s knee done in 1998 as the only MRI report in Dr. Christensen's medical records. The Department's expert witness overlooked the report in Dr. Christensen's medical records of the post-surgical MRI done of A.L.'s left knee on August 23, 2002, four and one-half years before A.L.'s first office visit to Dr. Christensen in February 2007. Therefore, the opinion of the Department's expert witness that Dr. Christensen fell below the standard of care for failing to order an MRI is not persuasive because it is based on the incorrect assumption that the most recent MRI of A.L.'s knee was done nine years prior to his first office visit with Dr. Christensen. Second, Dr. Christensen did a comprehensive physical examination of A.L.'s left knee joint. Dr. Christensen, aided by his background in chiropractic orthopedics, performed several tests on A.L.'s left knee, which, together with the post- operative MRI done in August 2002, led him to the conclusion that, if anything, the condition of A.L.'s left knee would not have improved, and probably would have worsened, over the intervening years. Dr. Christensen documented the results of the examination in the typed notes he prepared on February 12. 2007, and set out his diagnosis and treatment plan for A.L. Therefore, the opinion of the Department's expert witness that Dr. Christensen fell below the standard of care for failing to conduct a comprehensive physical examination of A.L.'s left knee and to document the results of the examination and the treatment plan for A.L. is unpersuasive because the Department's expert witness apparently overlooked this information in A.L.'s medical records.22
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order dismissing the Administrative Complaint filed against John Christensen, M.D., by the Department of Health. DONE AND ENTERED this 28th day of June, 2011, in Tallahassee, Leon County, Florida. S Patricia M. Hart Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 28th day of June, 2011.
Findings Of Fact The Petitioner, Department of Professional Regulation, Board of Pharmacy, seeks to take disciplinary action against Respondent based on its complaint filed February 24, 1982. Respondent, Herbert Lazarus, is a licensed pharmacist in the State of Florida and is holder of license number 5426. During times material herein, Respondent was employed at Don's Discount Drugs, 6234 S. Dixie Highway, South Miami, Florida. Respondent was the managing pharmacist of Don's Discount Drug Pharmacy Department throughout his employment and particularly during the period October 23, 1981 through January 6, 1982. The Drug Enforcement Administration, Department of Justice, conducted two audits to determine the quantities of Methaqualone dispensed from Don's Discount Drugs. The initial audit covered the period August 4, 1981 through October 23, 1981. The second audit covered the period October 23, 1981 through January 6, 1982. The first audit revealed that during the period August 4, 1981 through October 23, 1981, Don's Discount Drugs dispensed 68,738 300 milligram tablets of Methaqualone on 1,114 prescriptions. The second audit revealed that during the period October 23, 1981 through January 6, 1982, Don's Discount Drugs dispenses 133,667 Methaqualone 300 milligram tablets on 3,081 prescriptions from 6 physicians writing 2,241 of those prescriptions. The dosage appearing on more than 90 percent of the prescriptions relating to both audit periods is 45 units per prescription. The audit further revealed that the Methaqualone prescriptions constituted over 95 percent of all Schedule II prescriptions and more than one half of all prescriptions filled at Don's Discount Drugs. During times relevant herein, Methaqualone was a Schedule II controlled substance by virtue of statutory categorization in Section 893.03(2)(a)(4)(c)(5), Florida Statutes (1981). As such, Methaqualone is a substance which has a high potential for abuse and has severely restricted medical use. Abuse of Methaqualone leads to severe psychological or physical dependence. Methaqualone was designed to induce sleep. The drug generally should not be utilized for more than a period of three (3) weeks. (Testimony of John B. Handwerker, M.D.) Louis Fisher, a trained pharmacist, received his Bachelor of Science degree in Pharmacy from Hamden College of Pharmacy in Massachusetts. During the past eleven years, he has been a Federal Drug Enforcement Administration agent whose primary responsibility is to investigate pharmacists who handle and dispense Schedule II substances. Additionally, Mr. Fisher participated in the drafting of regulations that are now part of the federal Controlled Substances Act. Mr. Fisher was tendered and received as an expert herein in pharmacy. Mr. Fisher was presented with a hypothetical question encompassing the facts as presented herein respecting the dispensation of Methaqualone by the Respondent as managing pharmacist for Don's Discount Drugs during the period October, 1981 through January, 1982. Utilizing those facts, Mr. Fisher opined that such a managing pharmacist who permits the dispensation of Methaqualone in the amounts as described herein above would amount to the dispensing of Methaqualone in a manner outside the course of the professional practice of pharmacy; in a manner not in the good faith practice of pharmacy; in a manner considered to be excessive and inappropriate in the practice of pharmacy and not in good faith in dispensing those amounts of Methaqualone. An examination of one of the medical doctors who was prescribing the drug Methaqualone, was one Camila Dwyer, a stress clinic doctor. A review of Dr. Dwyer's prescribing patterns reveals that on an average day during the period during late December, 1981, Dr. Dwyer prescribed an average of 20 prescriptions which were tendered to be filled by Respondent at Don's Discount Drugs. The average prescription was for a quantity of 40 tablets of 300 milligram Methaqualone tablets. Mr. Fisher reviewed the prescribing pattern of Dr. Dwyer and expressed his opinion that Respondent, as managing pharmacist for Don's Discount Drugs, should have become alerted and inquired into Dr. Dwyer's prescribing practices since, in his opinion, the prescriptions were of doubtful origin and should have been refused by the Respondent and/or the filling pharmacist. Dr. John B. Handwerker, M.D. is a doctor who has practiced as such in Florida in excess of 31 years. Dr. Handwerker attended the University of Tennessee School of Medicine and trained at Jackson Memorial Hospital, Miami, Florida. Dr. Handwerker is an Assistant Professor of Clinical Pharmacology at the University of Miami Medical School. Dr. Handwerker was tendered and received herein as an expert in the dispensing of Schedule II drugs and in pharmacology. The recommended dosage for Methaqualone is 300 milligrams at bedtime used to induce sleep for a period not to exceed two to three weeks. This time period is used inasmuch as the effectiveness of the drug ceases following an approximate period of two weeks due to the pharmacological makeup of Methaqualone. Dr. Handwerker was also requested to review the prescribing patterns of Dr. Camila Dwyer. (Petitioner's Composite Exhibit 2) Dr. Handwerker determined, after reviewing Dr. Dwyer's prescribing pattern, that Dr. Dwyer's prescriptions should not have been accepted by the managing pharmacist at Don's Discount Drugs due to her abnormal prescribing pattern which should have been reported to the appropriate regulatory authorities. Methaqualone, a known street drug, is highly abused in south Florida. It is incumbent upon a pharmacist to question a doctor's prescribing patterns for drugs which are known to be abused. Jacob Hodus, a registered pharmacist since June, 1951, is an equal partner in Sandy's Drug, Inc., North Miami Beach, Florida. Mr. Hodus has practiced at Sandy's Drugs in excess of 28 years. Mr. Hodus was tendered and received as an expert herein in the practice of pharmacy in Florida. Mr. Hodus reviewed the prescribing patterns of the doctors who had prescribed Methaqualone and presented to Don's Discount Drugs to be filled. Based on what Mr. Hodus considered to be a pharmacist's obligation to report questionable prescribing practices to the appropriate regulatory agencies, he expressed the opinion that the Respondent, as manager of Don's Discount Drugs, should not have continued to fill the prescriptions for Methaqualone and that for him to continue to do so would not be either acting in the normal course of the professional practice of pharmacy or in the good faith practice of pharmacy. The Respondent's Position Herbert Lazarus, Respondent herein, is a registered pharmacist who has practiced that profession since 1947. Respondent has worked for numerous hospitals and drug stores and is presently still employed at Don's Discount Drug Store. At one time, Respondent owned Shadowlawn Pharmacies, but sold it due to medical problems. Respondent has served as the Chief Pharmacist at several hospitals including Victoria Hospital. From the period August 25, 1981 through May 3, 1982, Respondent served as a pharmacist for Stuart Levine, the former owner of Don's Discount Drugs. Respondent gave conflicting testimony as to the time that he became the manager of Don's Discount Drugs. At one point in his testimony, Respondent states that he became manager during mid-December, 1981 while, on other occasions, he testified that he became manager during January, 1982. Respondent avers that he was only a pharmacist employee and that all policy decisions respecting whether or not Methaqualone prescriptions should be filled were made by Stuart Levine. 2/ Stuart Levine expired on May 3, 1982. Thereafter, Respondent changed the policy of filling prescriptions for Methaqualone. It was noted, however, in this regard, that as of July 1, 1982, Methaqualone became a Class I drug and, therefore, is no longer sold in retail pharmaceutical outlets. Respondent expressed his belief that a pharmacist, in general, has no obligation to question a physician's prescribing practices. Respondent considered his primary responsibility to be that of verifying whether or not the prescription was, in fact, completed by a duly licensed physician authorized to dispense Schedule II drugs and whether that person presenting the prescription is the one for whom it was written. Once satisfied that those conditions were met, Respondent would fill that prescription and "keep his nose out of it." Respondent never inquired by physicians, whether the drug Methaqualone was medically necessary for treatment. Respondent maintained a detailed patient profile system. That system was used to monitor the dispensing of Schedule II substances. That system insured that Respondent had, at minimum, constructive knowledge of all the dispensing activity at Don's Discount Drugs. Prescriptions of doubtful origin were not filled as were prescriptions where the physical condition of the patient could not be readily determined. Respondent also would not fill a prescription where a doctor's license was in jeopardy. Respondent feels that he took the usual necessary steps to insure that the prescriptions for Methaqualone were properly filled. Don's Discount Drugs received an unusually large number of prescriptions for Methaqualone due to the large number of pharmacists who would not fill the prescriptions and due to the reasonable rate that Respondent charged for each Methaqualone tablet, i.e. $.50 versus the charges of approximately $1.00 to $1.50 per 300 milligram tablet at other pharmacies. Finally, Respondent considered that he was not obligated to second-guess a doctor's medical opinion where Methaqualone was prescribed. Respondent acknowledged that Methaqualone is a dangerous drug and has a high potential for abuse.
Recommendation Based on the foregoing findings of fact and conclusions of law, it is hereby recommended that the license of Respondent Herbert Lazarus, number 5426, be REVOKED. RECOMMENDED this 9th day of May, 1984, at Tallahassee, Florida. JAMES E. BRADWELL, 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 9th day of May, 1984.
Findings Of Fact The parties stipulated that Monroe C. Schiffman is a pharmacist licensed by the Florida Board of Pharmacy. They further stipulated that Sharon Drugs, d/b/a Mercy Professional Building pharmacy is located at 3661 south Miami Avenue, Miami, Florida and that Sharon Drugs owns and operates Mercy Professional Building Pharmacy. The parties also stipulated that Monroe C. Schiffman was a corporate officer and share holder in Sharon Drugs, Inc., a Florida corporation, from February 1, 1975 until the dates of the audits in question and that Monroe C. Schiffman was a corporate officer and stockholder in Monroe Pharmacy, Inc. from March, 1974, until the audits in question. An inspection and audit of Sharon Drugs, Inc. d/b/a Mercy Professional Building Pharmacy, was begun on April 23, 1976 and lasted for several days. The audited period was from March 17, 1975 until April 26, 1976, during which dates Monroe C. Schiffman was the registered pharmacist for the operation of Sharon Drugs, Inc. The procedures for the audits were to assume a zero stockage as of March 17, 1975 and to account for the drugs received after that date. The drugs audited were controlled drugs as defined by Chapter 893, Florida Statutes. These drugs were chosen for audit because complete records of their order, receipt and dispensing must be kept pursuant to Chapter 893, Florida Statutes. Exhibit 1, a summary of the audit of Sharon Drugs, Inc., was identified by the Board's agent, Vernon K. Bell, as the summary of the discrepancies in controlled drugs revealed by the audit which he conducted. The audit conducted by Vernon K. Bell revealed a shortage of controlled drugs for which no records had been kept of 296,481 total units or pills. The drugs audited were Desoxyn (methamphetamine hydrochloride), Tuinal (sodium amobarbital and sodium secobarbital), Biphetamine (d- and dl-Amphetamine), Dilaudid (hydromorphone), Nembutal (sodium pentobarbital), Seconal (sodium secobarbital), Quaalude (methaqualone), Eskatrol Spansule (dextroamphetamine sulfate and prochlorperazine) , and Dexedrine (dextroamphetamine sulfate). Monroe C. Schiffman, while the registered pharmacist at Mercy Professional Building Pharmacy, did not keep the record required to be kept by law.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, the Hearing Officer recommends that the license and registration of Monroe Charles Schiffman be revoked. DONE and ENTERED this 5th day of January, 1977, in Tallahassee, Florida. STEPHEN F. DEAN, Hearing Officer Division of Administrative Hearings Room 530, Carlton Building Tallahassee, Florida 32304 (904) 488-9675 COPIES FURNISHED: Michael Schwartz, Esquire Suite 201, Ellis Building 1311 Executive Center Drive Tallahassee, Florida 32301 Gerald Kogan, Esquire Suite 500 Security Trust Building 700 Brickell Avenue Miami, Florida 33131 H. F. Bevis, Executive Secretary State Board of Pharmacy 252 East Sixth Avenue Box 3355 Tallahassee, Florida 32303
The Issue The issue 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
