Findings Of Fact At all pertinent times, respondent Koa-Shun Wu has been licensed to practice medicine and surgery in Florida. He holds license No. 32315. Dr. Wu trained in Taiwan as a thoracic surgeon. He taught in medical school there and published in his field. When Dr. Wu emigrated to the United States, he hoped to obtain a surgical residency here. Not finding such a position, he took a job at Polk General Hospital in Lakeland as a house physician, then worked as a staff physician in Polk General Hospital's ambulatory care center. In the spring of 1981, Dr. Wu began a general practice near Winter Haven, about 40 miles from Tampa. This lasted some fifteen months. His wife worked with him in the office but it was hard making a go of it financially and, in August of 1982, he closed the practice in order to take his present job at the Florida State Hospital in Chattahoochee. His professional reputation there is good. On April 13, 1982, a 29-year-old woman giving her name as Jennifer Gail Jones presented herself at Dr. Wu's office saying she needed a Pap smear because she was going to join a methadone program in Tampa. She returned on April 28, 1982, complaining of the frequency of her micturition and of discomfort when she urinated. Dr. Wu performed a physical examination and diagnosed a urinary tract infection. On that visit, according to his office records, in addition to dispensing medicine for this infection, Dr. Wu prescribed 50 milligrams of methadone "daily P.R.N,," a total of 30 ten milligram tablets. Joint Exhibit B. Other testimony established that five milligram methadone tablets, but not ten milligram methadone tablets, were available at local pharmacies. Depositions of Fox, Garrett. Perhaps this was communicated to Dr. Wu who wrote a revised prescription. In any event, the prescription that was filled for Jennifer G. Jones on April 28, 1982, was for 60 five milligram methadone tablets and the dosage prescribed was "fifty mg. p. o. daily in A.M." Joint Exhibit R. Dr. Wu wrote this prescription for methadone, his first, after the patient told him she had enrolled in a methadone maintenance program in Tampa on April 12, 1982. (This did not gibe precisely with her statement on her initial visit on April 13 that she was "going to join" at that time.) She said she was receiving 50 milligram doses daily at the Tampa clinic but that some days she could not go to Tampa because she had to work in Winter Haven. Dr. Wu took her at her word and acted to make the same dose available to her on days she did not get to the clinic as she received when she made the trip there. With this straightforward and arguably reasonable step, the die was cast. For this same patient, respondent prescribed an additional 30 five milligram tablets on May 5, 1982, with a prescribed dosage of 20 milligrams every other day and, on May 17, 1982, 40 five milligram tablets at the same dosage. On May 28, 1982, respondent prescribed 24 five milligram tablets to be taken twice daily "on days not going to Tampa clinic." On June 8 and 17, and July 21, 1982, respondent wrote prescriptions for Jennifer Jones, each for 24 five milligram methadone tablets, and each at the dosage of 30 milligrams every other day. (Counts Sixteen, Seventeen and Eighteen) Word spread among other clients of the Tampa methadone program and reached a heroin addict who had not enrolled in a methadone maintenance program, as well. The latter, Mary Joyce Strouse, lied to Dr. Wu on this point. On May 3, 1982, she told him that she had enrolled in the Tampa program a year earlier and that she was receiving 35 milligrams of methadone daily at the clinic. On May 29, June 9 and 25, July 9, 16 and 29 and August 5, 1982, Dr. Wu wrote methadone prescriptions for her. Each was for 24 five milligram tablets and the prescribed dosage was 30 milligrams every other day, except for the first prescription which was 15 milligrams every other day, "P.R.N." or "if not go to Tampa clinic." Joint Exhibit R. Ms. Strouse took the methadone so she "wouldn't have to buy street dope." Deposition of Ms. Strouse, p.10. (Counts Twenty-two, Twenty-three and Twenty-four) Respondent wrote all eleven of the methadone prescriptions for Ralph B. Strouse alleged in Count One. On Mr. Strouse's initial visit, respondent performed a physical examination and took his history, and, on another visit, he removed a bullet lodged in his thigh. He treated various other ailments as well. (Count One, Two and Three) Respondent wrote the seven methadone prescriptions for Voncil Frank Woodrow Snider alleged in Count Four. On the initial visit, he performed a physical examination, and concluded that Mr. Snider was mildly hypertensive and mildly obese. Respondent wrote the four methadone prescriptions for Frankie A. Bailey a/k/a Frankie Smith alleged in Count Seven, the methadone prescription for Angel Reel alleged in Count Ten, the nine methadone prescriptions for Wayne Hoskins alleged in Count Thirteen, the four methadone prescriptions for Henry M. Cain a/k/a Michael Cain alleged in Count Nineteen, the four methadone prescriptions for Deborah Asbel alleged in Count Twenty-five and the latter six of the seven methadone prescriptions for William Asbel alleged in Count Twenty-Eight. Except for Mary Joyce Strouse and Voncil Frank Woodrow Snider, the patients for whom Dr. Wu prescribed methadone participated in a Tampa methadone maintenance program. (Mr. Snider participated in such a program in Orlando.) The Tampa participants were not told what their methadone dosages were. The levels they reported to Dr. Wu were speculation at best. On several occasions Dr. Wu asked for and received receipts from the methadone maintenance clinics indicating current participation, but he did not always do this, and he never telephoned or otherwise contacted either clinic. In all, he wrote some 60 prescriptions for ten people. He charged $20 for an initial office visit and $15 per office visit thereafter. There was no surcharge for methadone prescriptions. (He charged $125 to remove the bullet from Mr. Strouse's thigh.) More than once, Mr. Fox, the pharmacist, telephoned and questioned respondent about the propriety of the methadone prescriptions. At least one patient recalled Dr. Wu's consulting a copy of the Physicians' Desk Reference. Every prescription he wrote after May 20, 1982, (and all but three of the total) was for 24 five milligram tablets. The 1983 Physicians' Desk Reference has this to say about methadone, which is sold under the trade name Dolophine Hydrochloride: CONDITIONS FOR DISTRIBUTION AND USE OF METHADONE PRODUCTS: Code of Federal Regulations. Title 21. Sec. 291.505 METHADONE PRODUCTS. WHEN USED FOR THE TREATMENT OF NARCOTIC ADDICTION IN DETOXIFICATION OR MAINTENANCE PROGRAMS, SHALL BE DISPENSED ONLY BY APPROVED HOSPITAL PHARMACIES, APPROVED COMMUNITY PHARMACIES, AND MAINTENANCE PROGRAMS APPROVED BY THE FOOD AND DRUG ADMINISTRATION AND THE DESIGNATED STATE AUTHORITY. APPROVED MAINTENANCE PROGRAMS SHALL DISPENSE AND USE METHADONE IN ORAL FORM ONLY AND ACCORDING TO THE TREATMENT REQUIREMENTS STIPULATED IN THE FEDERAL METHADONE REGULATIONS (21 CFR 291.505). FAILURE TO ABIDE BY THE REQUIREMENTS IN THESE REGULATIONS MAY RESULT IN CRIMINAL PROSECUTION, SEIZURE OF THE DRUG SUPPLY, REVOCATION OF THE PROGRAM APPROVAL, AND INJUNCTION PRECLUDING OPERATION OF THE PROGRAM. A METHADONE PRODUCT, WHEN USED AS AN ANALGESIC, MAY BE DISPENSED IN ANY LICENSED PHARMACY. Indications: (See Note below.) For relief of severe pain. For detoxification treatment of narcotic addiction. For temporary maintenance treatment of narcotic addiction. NOTE If methadone is administered for treatment of heroin dependence for more than three weeks, the procedure passes from treatment of the acute withdrawal syndrome (detoxification) to maintenance therapy. Maintenance treatment is permitted to be undertaken only by approved methadone programs. This does not preclude the maintenance treatment of an addict who is hospitalized for medical conditions other than addiction and who requires temporary maintenance during the critical period of his stay or whose enrollment has been verified in a program which has approval maintenance treatment with methadone. Contraindication: Hypersensitivity to methadone. Warnings: Methadone hydrochloride, a narcotic, is a Schedule II controlled substance under the Federal Controlled Substances Act. Appropriate security measures should be taken to safeguard stocks of methadone against diversion. DRUG DEPENDENCE--METHADONE CAN PRODUCE DRUG DEPENDENCE OF THE MORPHINE TYPE AND, THEREFORE, HAS THE POTENTIAL FOR BEING ABUSED. PSYCHIC DEPENDENCE, PHYSICAL DEPENDENCE, AND TOLERANCE MAY DEVELOP UPON REPEATED ADMINISTRATION OF METHADONE, AND IT SHOULD BE PRESCRIBED AND ADMINISTERED WITH THE SAME DEGREE OF CAUTION APPROPRIATE TO THE USE OF MORPHINE. Adverse Reactions: THE MAJOR HAZARDS OF METHADONE. AS OF OTHER NARCOTIC ANALGESICS, ARE RESPIRATORY DEPRESSION AND, TO A LESSER DEGREE, CIRCULATORY DEPRESSION. RESPIRATORY ARREST, SHOCK, AND CARDIAC ARREST HAVE OCCURRED. Dosage and Administration: For Relief of Pain--Dosage should be adjusted according to the severity of the pain and the response of the patient. Occasionally it may be necessary to exceed the usual dosage recommended in cases of exceptionally severe pain or in those patients who have become tolerant to the analgesic effect of narcotics. For Detoxification Treatment--THE DRUG SHALL BE ADMINISTERED DAILY UNDER CLOSE SUPERVISION AS FOLLOWS: A detoxification treatment course shall not exceed 21 days and may not be repeated earlier than four weeks after completion of the preceding course. In detoxification, the patient may receive methadone when there are significant symptoms of withdrawal. The dosage schedules indicated below are recommended but could be varied in accordance with clinical judgment. Initially, a single dose of 15 to 20 mg. of methadone will often be sufficient to suppress withdrawal symptoms. Additional methadone may be provided if withdrawal symptoms are not suppressed or if symptoms reappear. When patients are physically dependent on high doses, it may be necessary to exceed these levels. Forty mg./day in single or divided doses will usually constitute an adequate stabilizing dosage level. Stabilization can be continued for two to three days, and then the amount of methadone normally will be gradually decreased. The rate at which methadone is decreased will be determined separately for each patient. The dose of methadone can be decreased on a daily basis of at two-day intervals. But the amount of intake shall always be sufficient to keep withdrawal symptoms at a tolerable level. In hospitalized patients, a daily reduction of 20 percent of the total daily dose may be tolerated and may cause little discomfort. In ambulatory patients, a somewhat slower schedule may be needed. If methadone is administered for more than three weeks, the procedure is considered to have progressed from detoxification or treatment of the acute withdrawal syndrome to maintenance treatment, even though the goal and intent may be eventual total withdrawal. Overdosage: Symptoms--Serious overdosage of methadone is characterized by respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis), extreme somnolence progressing to stupor or coma, maximally constricted pupils, skeletal-muscle flaccidity, cold and clammy skin, and, sometimes, bradycardia and hypotension. In severe overdosage, particularly by the intravenous route, apnea, circulatory collapse, cardiac arrest, and death may occur. The foregoing appears under the heading "AMPOULES AND VIALS" to which a reader consulting the "Tablets" Section is referred. In each instance, Dr. Wu undertook maintenance and/or detoxification treatment of narcotic addicts, as opposed to prescribing methadone as an analgesic. Prescriptions for analgesic purposes by an oncologist in the Winter Haven area were for greater quantities (100 tablets) than Dr. Wu prescribed. As a matter of policy, maintenance doses at the Tampa clinic do not exceed 50 milligrams daily but there was testimony that 80 milligrams a day at another clinic in the area was not uncommon and that maintenance doses of 100 or even 120 milligrams, are not unheard of. Dr. Wu referred to Goodman's Textbook of Pharmacology (1980) which states: "Subjects who are maintained on daily oral doses of 100 mg. of methadone for more than 8 weeks still seem sedated and apathetic . . . [but] sedation and apathy are easily managed by reductions in dosage." At 547. Elsewhere the same text states, in reference to methadone maintenance: "Most commonly the procedure consists in the daily administration of 40 to 100 mg. of methadone . . ." At 574. Physicians who treat heroin addiction do not prescribe methadone even when urinalysis reveals the presence of an opiate, unless they observe objective signs (goose bumps, rhinorrhea, elevated blood pressure, body temperature, and pulse rate, etc.) corroborating reported symptoms of withdrawal. They want objective proof of addiction, not just use, before prescribing a maintenance dose of methadone, although they rely on the addict's subjective symptoms to some extent in calibrating the dosage. When the initial dose of methadone is administered, the addict is observed for a half hour, against the possibility of some adverse reaction. After the magnitude of the maintenance dose is determined, it may remain unchanged for months or years. Only when an addict and his counselor agree that there is hope for turning over a new leaf does therapeutic detoxification, the gradual diminution of the methadone dose, occur. Administrative or punitive detoxification, a relatively rapid decrease in dosage, may occur if an addict fails to abide by the rules of the maintenance program by, for example, ingesting or injecting addictive substances other than methadone. Urine samples are regularly taken from persons in methadone maintenance programs and analyzed for evidence of extracurricular drug use. Such analysis can detect the use of heroin but does not ordinarily reveal extra doses of methadone. From the standpoint of an addict who seeks some analgesic or euphoric effect, additional methadone is the ideal way to augment what the clinic prescribes. Partly for this reason, methadone maintenance programs require, at least initially, that their clientele appear personally for each dose, which is administered on the premises. This practice also makes continuity in counseling and urine screening more likely, and minimizes the danger of methadone reaching somebody for whom it was not intended. As time goes on, the program client may be entrusted with one or more "take homes," doses he is to administer to himself off the premises. It is not acceptable practice to give somebody on another maintenance program a dose of methadone without communicating with the people operating the other program. Paragraph 291, Title 21 of the Code of Federal Regulations spells out in detail the legal restrictions that federal law places on methadone maintenance programs. Neither a private medical practitioner nor any other person or organization can lawfully prescribe methadone for a patient for more than three days without being approved as a methadone treatment program by the health authorities. Dr. Wu never sought nor obtained such approval. Methadone is a Schedule II narcotic, a synthetic central nervous system depressant with effects like that of morphine. Dr. Wu testified without contradiction that be believed that the DEA license which he held at all pertinent times authorized him to prescribe all Schedule II narcotics, and that the legal restrictions on dispensing methadone that appeared in the Physicians' Desk Reference did not apply to DEA license holders like himself. These beliefs, were and are erroneous. Goodwin's Textbook of Pharmacology (1980) states: "In the United States, special controls on methadone have been enacted. . . " At 519. When Dr. Wu closed his office, the only notice he gave his patients was posted on the door at the office at the time he left.
Recommendation Upon consideration of the foregoing, it is RECOMMENDED: That petitioner suspend respondent's license for three months, but stay the suspension, on condition that respondent successfully complete two years' probation during which probation he be forbidden to prescribe controlled substances and be required to take at least fifty (50) hours of continuing professional education pertaining to controlled substances. DONE and ENTERED this 19th day of January, 1984, in Tallahassee, Florida. ROBERT T. BENTON II Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 19th day of January, 1984. COPIES FURNISHED: Joseph W. Lawrence, II, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Melissa Fletcher Allaman, Esquire and Wilfred C. Varn, Esquire Ervin, Varn, Jacobs, Odom & Kitchen Post Office Box 1170 Tallahassee, Florida 32302-1170 Fred M. Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Dorothy Faircloth, Executive Director Board of Medical Examiners Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 =================================================================
Findings Of Fact Respondent is a chiropractic physician licensed in the State of Florida, having been issued license No. 0001050. Respondent's office is located at 920 North Federal Highway, Hollywood, Florida. On July 31, 1980, Evelyn Yaxley, an elderly resident of Hollywood, was initially seen as a patient by Respondent. During that first visit, Respondent took a patient history, performed an examination, and administered a complete blood count and a urine test. He also dispensed to Mrs. Yaxley a bottle of Baldrian, a natural muscle relaxant, together with some vitamins. Respondent also performed an adjustment to Mrs. Yaxley's coccyx. At the end of the visit, Mrs. Yaxley was given a bill for $102.00 for Respondent's services, which she and her husband paid before leaving the office. On August 5, 1980, Mrs. Yaxley returned to Respondent for her next scheduled appointment, and was again accompanied by her husband. During the visit, Respondent informed Mrs. Yaxley that she had a urinary tract infection, which Respondent diagnosed partially from the laboratory test results obtained from the urine test taken on her previous visit. During the second visit, Mrs. Yaxley was taken into a treatment room where Respondent administered another adjustment. Dr. Kahn then left the treatment room and, in the presence of the patient's husband, instructed a receptionist who worked in his office to give Mrs. Yaxley four Azo Gantrisin tablets. The receptionist then entered the treatment room and gave four Azo Gantrisin tablets to Mrs. Yaxley, which Mrs. Yaxley took. At some point attendant to the administration of the Azo Gantrisin tablets, the Yaxleys questioned the Respondent about the advisability of administering Azo Gantrisin inasmuch as Mrs. Yaxley was sensitive to "sulfa drugs." The Yaxleys were assured, however, by Dr. Kahn that though the tablets were a sulfa drug derivative, they would be safe for her to take. The Yaxleys were then given, at Respondent's direction, a bottle of Azo Gantrisin tablets and instructed to have Mrs. Yaxley take two tablets every four hours. The Yaxleys paid Respondent $40.00 for his services rendered during the second visit. Azo Gantrisin is a product of two chemical entities, Phenaxopyridine and Sulfisoxazole, and is commonly referred to as a "sulfa drug." The drug is prescribed for treatment of urinary tract infections. Azo Gantrisin can cause adverse drug reactions, which are defined as any unintended or unexpected noxious effects that alter the structure or function of the body. Adverse drug reactions include allergic reactions, such as scratching, itching, swelling, and rashes. Other adverse drug reactions include swelling of the skin, difficulty in breathing, nausea, and vomiting. After the Yaxleys' visit to Respondent's office on August 5, 1980, they returned home, and later that same day Mrs. Yaxley took an additional dosage of Azo Gantrisin tablets in accordance with Respondent's instructions. Shortly thereafter, she became ill, experiencing severe nausea and vomiting. These symptoms continued throughout the night and into the next day. On the morning of August 6, 1980, Mrs. Yaxley was treated by her family physician for these symptoms, and was ultimately admitted to the hospital, where she remained for a period of approximately eight days. Mrs. Yaxley reported to both her family physician and hospital physicians that she had been given Azo Gantrisin tablets by a chiropractic physician and had taken them in the dosages reflected hereinabove. She also reported to hospital physicians, as she had indicated to Respondent earlier, that she was allergic to sulfa drugs. However, despite the similarities of the symptoms reported by Mrs. Yaxley to those which indicate an adverse reaction to sulfa drugs, tests run while she was hospitalized are inconclusive on the question of whether she in fact suffered such a reaction. These tests neither confirm nor rule out such an adverse reaction. Azo Gantrisin is a legend drug required to be dispensed or administered only by a physician. A chiropractic physician is expressly prohibited from administering or dispensing any legend medicine or drug. Respondent has never had an administrative complaint filed against him by the Department of Professional Regulation or the Board of Chiropractic prior to the instant Administrative Complaint.
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 Whether Dr. Henson inappropriately administered repeated injections of vitamin B-12 to his patient, Gertrude Ashton, without documenting their necessity in the patient's medical records? Whether Dr. Henson inappropriately administered repeated injections of steroids to his patient, Gertrude Ashton, without documenting their necessity in the patient's medical records? Whether Dr. Henson inappropriately administered repeated injections of Mandol to his patient, Gertrude Ashton, which were not considered to be therapeutically effective?
Findings Of Fact The parties stipulated to the following findings of fact: The Respondent, D. Ross Henson, D.O., is currently, and at all times relevant to this proceeding was, licensed as an osteopathic physician in the State of Florida; Dr. Henson's license number is OS 0001793; Between December 1979, and September 1983, Dr. Henson treated a patient by the name of Gertrude Ashton. Ms. Ashton's husband died in 1981. Ms. Ashton witnessed Mr. Ashton's death in the back yard of their residence. Mr. Ashton's death caused Ms. Ashton anxiety and depression. Ms. Ashton's business had some financial problems during the period at issue in this case. During the approximately forty-six months at issue in this proceeding, Dr. Henson treated Ms. Ashton on sixty occasions. During this period of time Dr. Henson prescribed 2,000 micrograms of vitamin B-12, to be administered intramuscularly, for Ms. Ashton. Ms. Ashton received injections of vitamin B-12 on sixteen separate occasions from Dr. Henson. When Dr. Henson prescribed vitamin B-12 injections for Ms. Ashton, he documented the various problems which she was having at the time in her medical records. Dr. Henson indicated that the reasons for the injections were that Ms. Ashton was under stress, she had long-standing, ongoing disease processes which produced further stress, she was on antibiotics and she was receiving diuretic therapy. Additionally, on occasion, Ms. Ashton requested vitamin B-12 injections. Generally, vitamin B-12 should be administered intramuscularly only if a patient is suffering from vitamin B-12 deficiency. A vitamin B-12 deficiency may be caused by pernicious anemia or malabsorption of vitamin B-12. If a physician suspects that a patient is suffering from vitamin B-12 deficiency, a simple blood test should be administered to determine if the patient's vitamin B-12 level is low. If it is, the physician should then attempt to determine the cause of the deficiency. Dr. Henson did not determine whether Ms. Ashton was suffering from a vitamin B-12 deficiency. Occasionally vitamin B-12 may be administered to a patient who believes that the vitamin will help him or her feel better. Although vitamin B-12 is included as part of nutritional supplements, it is not taken intramuscularly as a nutritional supplement. If a patient is in need of vitamin B-12, 1,000 micrograms is a sufficient dosage. An injection of 2,000 micrograms of vitamin B-12 is excessive. It would be difficult to harm a patient by injecting the patient with vitamin B-12. The reasons for administering vitamin B-12 injections to Ms. Ashton advanced by Dr. Henson and Dr. Henson's medical records fail to justify all of the vitamin B-12 shots administered to Ms. Ashton. Nowhere in Dr. Henson's records concerning Ms. Ashton is it indicated that Ms. Ashton suffered from a vitamin B-12 deficiency. Nor is any other adequate reason for administering the shots she received indicated. It is true that a few of the vitamin B-12 shots prescribed by Dr. Henson for Ms. Ashton may have been requested by Ms. Ashton because she believed they would help her. Not all of the sixteen shots were requested by Ms. Ashton, however. Nor would all sixteen shots be justified by such a request had it been made. Prescribing 2,000 micrograms of vitamin B-12 for Ms. Ashton was also not justified. The repeated injections of 2,000 micrograms of vitamin B-12 administered to Ms. Ashton were a deviation from the accepted standard of care. Dr. Henson also prescribed 34 intramuscular injections of steroids for Ms. Ashton over the 46 months at issue in this proceeding. Dr. Henson injected Ms. Ashton with methylprednisolone acetate, a form of injectable steroid. The brand name of the methylprednisolone acetate used by Dr. Henson was Depo-Medrol. The 34 injections of methylprednisolone acetate were given in doses of fifty milligrams. Methylprednisolone acetate should be given in doses of twenty to eighty milligrams per injection. Prednisolone tebutate, another form of injectable steroid, should be given in doses of four to forty milligrams. Dr. Henson did not, however, give Ms. Ashton prednisolone tebutate. Dr. Henson noted in his medical records concerning Ms. Ashton that he had given her an injection of "Pred." Identifying the injections as "Pred" was insufficient to inform others of how Ms. Ashton was treated with steroids. Dr. Henson indicated that he gave Ms. Ashton steroid injections for the following problems: Acute synovitis and osteoarthritis of the lumbar and cervical spine, acute contact dermatitis, acute allergic rhinitis and acute polyposis. Steroids can be used to treat bursitis and tendinitis. Usually, an injection of steroids for this type of treatment is administered locally. Ms. Ashton's acute contact dermatitis was attributable to her repeated contact with poison ivy and the use of undiluted bleach which Ms. Ashton bathed in as a treatment of her poison ivy. Ms. Ashton also inhaled the fumes from the bleach. Occasional injections of steroids for the treatment of poison ivy, especially when the area affected has been bathed in undiluted bleach, is appropriate. The weight of the evidence concerning Dr. Henson's treatment of Ms. Ashton with steroids proved that generally, most physicians would have administered the injections locally or orally. The evidence did not prove that Dr. Henson's treatment of Ms. Ashton with steroids was not within acceptable standards of care. Dr. Henson also prescribed three injections of Mandol for Ms. Ashton over the 46 months at issue in this proceeding. Injections of Mandol were administered on March 13, 1980 and November 13 and 16, 1981. The injections of Mandol administered to Ms. Ashton were in doses of 250 milligrams. The recommended dose of Mandol is from 500 milligrams to one gram. A dose of 250 milligrams is sub-therapeutic. Mandol is a cephalosporin, which is a form of antibiotic. The March 13, 1980, injection of Mandol was given for acute bronchitis, acute pyelonephritis and acute cystitis. Ms. Ashton was also taking Ceclor, another cephalosporin, orally at the time the injection of Mandol was given. The November 13 and 16, 1981, injections of Mandol were given for acute bronchitis and acute generalized dermatitis due to poison ivy and exposure to bleach. Ms. Ashton was taking another cephalosporin orally at the time the injections of Mandol were given. If a lower dose of Mandol would be effective, it would be listed by the drug manufacturer as a recommended dose. Although there are possible side effects from treatments with Mandol, Dr. Henson did not establish that those side effects were present in Ms. Ashton's case. Dr. Henson's treatment of Ms. Ashton with Mandol during the period of time at issue in this proceeding deviated from the standard of medical care reasonably acceptable under similar conditions and circumstances. Ms. Ashton subsequently filed a complaint concerning Dr. Henson with the Department. The Department investigated the complaint and found probable cause to formally charge Dr. Henson.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that Dr. Henson be found guilty of failing to keep written medical records justifying his treatment of Ms. Ashton with injections of vitamin B-12, steroids and Mandol between December 1979, and September 1983. A fine of $500.00 should be imposed on Dr. Henson for his treatment of Ms. Ashton with excessive doses of vitamin B-12; a fine of $500.00 should be imposed on Dr. Henson for his failure to adequately document the type of steroid administered to Ms. Ashton; and a fine of $500.00 should be imposed on Dr. Henson for his treatment of Ms. Ashton with sub-therapeutic doses of Mandol. Dr. Henson should also receive a reprimand for these three violations of Section 459.015(1)(p), Florida Statutes (1987) It is further RECOMMENDED that Dr. Henson be found guilty of failing to practice osteopathic medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar osteopathic physician as being acceptable under similar conditions and circumstances with regard to his treatment of Ms. Ashton with injections of vitamin B-12 and Mandol between December 1979, and September 1983. Dr. Henson should be fined $1,000.00 for his violations of Section 459.015(1)(y), Florida Statutes (1987), placed on probation for ninety (90) days and required to successfully complete ten (10) hours of Category I continuing medical education in prescribing controlled substances during the twelve months following the issuance of a final order in this case. It is further RECOMMENDED that the charge that Dr. Henson's treatment of Ms. Ashton with steroids between December 1979, and September 1983, constitutes a violation of Section 459.015(1)(y), Florida Statutes (1987), be dismissed. It is further RECOMMENDED that the charge that Dr. Henson's treatment of Ms. Ashton with vitamin B-12, steroids and Mandol between December, 1979, and September, 1983, constitutes a violation of Section 459.015(1)(u), Florida Statutes (1987), be dismissed. DONE and ENTERED this 24th day of June, 1988, in Tallahassee, Florida. LARRY J. SARTIN Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this day of June, 1988. APPENDIX Case Number 86-3336 The parties have submitted proposed findings of fact. It has been noted below which proposed findings of fact have been generally accepted and the paragraph number(s) in the Recommended Order where they have been accepted, if any. Those proposed findings of fact which have been rejected and the reason for their rejection have also been noted. The Department's Proposed Findings of Fact Proposed Finding Paragraph Number in Recommended Order of Fact Number of Acceptance or Reason for Rejection 1-2 1. 3-6 Hereby accepted. 7 4. 8 15-16. 9 19. 10 25-26. 11-13 Not relevant to the charges contained in the Administrative Complaint against Dr. Henson in this case. 14 2. 15-25 & 27 Not relevant to the charges contained in the Administrative Complaint against Dr. Henson in this case. 26 33. Dr. Henson's Proposed Findings of Fact Proposed Finding Paragraph Number Recommended Order of Fact Number of Acceptance or Reason for Rejection 1-2 1. 3 Not relevant to this case. 4 2-3. 5 Not relevant to this case or not supported by the weight of the evidence. 6 4-5. 7 5. 8 4-5. 9 Summary of testimony and events which took place during the formal hearing. The facts this testimony supports were not supported by the weight of the evidence. 10 15-19. 11 20. 12-13 22. Not relevant to this case. Summary of testimony. The facts this testimony supports were not supported by the weight of the evidence. 16 25 and 28. 17 26 and 28. The last three sentences are not supported by the weight of the evidence. 18 29. 19 Summary of testimony. The facts this testimony supports were not supported by the weight of the evidence. COPIES FURNISHED: Theodore Doran, Esquire James J. Kearn, Esquire DOPAN & DANIELS, P.A. P. O. Drawer 1231 Daytona Beach, Florida 32015 James W. Smith, Esquire Kim D. Bouck, Esquire SMITH, SCHODER & ROUSE, P.A. 605 S. Ridgewood Avenue Daytona, Florida 32014 Rod Presnell Executive Director Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 William O'Neil General Counsel Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 Lee Sims Staff Attorney Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 =================================================================
The Issue The issue to be determined in this proceeding is whether Petitioner is entitled to a refund of the costs paid for prescriptions for compound Midrin.
Findings Of Fact The Division of State Group Insurance (Division) is the executive agency within the Department of Management Services (Department) that is responsible for the administration of the State Group Insurance Program (Program). Petitioner is retired and receives medical benefits through the State Employees’ HMO Standard Medical Plan (the Plan), which is administered by Capital Health Plan (CHP). The State Employees’ Prescription Drug Program is administered by CVS Caremark. Respondent is the state agency responsible for resolving appeals of medical claims denied by Caremark. Background Mr. Abele was employed with the State of Florida until he retired. He was covered by the Plan and his coverage has remained since his retirement. For the past three years, Mr. Abele has filled a prescription for generic Midrin to treat migraine headaches. The medication was prescribed by his primary care physician, John Ness, M.D. The evidence offered at hearing includes a total of 18 claims2 for prescriptions for compound Midrin that Mr. Abele submitted to Caremark for reimbursement. Mr. Abele submitted claims for prescriptions filled in 2018 dated: July 12 and 25, 2018; August 2, 2018; September 7, 2018; October 5 and 22, 2018; November 6 and 26, 2018; December 12, 2018. Mr. Abele also submitted claims for prescriptions filled in 2019 dated: January 9 and 30, 2019; February 12, 2019; March 6, 18, and 29, 2019; April 10 and 25, 2019; and May 10, 2019. Each of the 18 claims was for reimbursement of $105 for a total of $1,890. Relevant Definitions The Plan Booklet and Benefit Document (“Plan”) includes definitions, relevant in part here, as follows: "Covered Services and Supplies" means those health care services and supplies, including pharmaceuticals as described in Section VIII, for which reimbursement is covered under this Plan. "Exclusions" is defined as any provision of the Plan whereby coverage for a specific hazard or condition is entirely eliminated. “Medically Necessary” is defined as any appropriate medical treatment ... as provided by a physician ... which is necessary for the diagnosis, care and/or treatment of a Health Plan Member’s illness or injury, and which is: Consistent with the symptom, diagnosis, and treatment of the Health Member’s condition; The most appropriate level of supply and/or service for the diagnosis and treatment of the Health Plan Member’s condition; In accordance with standards of acceptable community practice; Not primarily intended for the personal comfort or convenience of the Health Plan Member, the Health Plan Member’s family, the physician or other health care providers; Approved by the appropriate medical body or health care specialty involved as effective, 2 The claims at issue are those claims submitted by Mr. Abele in support of his request for reimbursement. appropriate and essential for the care and treatment of the Health Plan Member’s condition; and Not Experimental or investigational. Medical Necessity Dr. Ness, a family practice physician with 30 years of experience, prescribed generic Midrin for Mr. Abele to treat migraine headaches. Dr. Ness prescribed generic Midrin to treat Mr. Abele based on his assessment that other medications were contraindicated for Mr. Abele due to Mr. Abele’s risk for cardiovascular adverse effects if he uses other medications. Dr. Ness credibly testified that Midrin is medically necessary to treat Mr. Abele’s migraine headaches. Anthony Arnett, M.D., the physician for Caremark responsible for reviewing claims for coverage, determined that Midrin was not medically necessary to treat Mr. Abele’s migraine headaches. However, Dr. Arnett conceded that his decision was based on his general determination that there are other options available for migraine headaches. The undersigned finds Dr. Ness’ testimony more persuasive concerning the determination that Midrin was medically necessary to treat Mr. Abele for migraines. Midrin History At the time Dr. Ness prescribed generic Midrin to Mr. Abele, it was an FDA-approved drug. In fact, Midrin was approved for use in 1948 based on safety and effectiveness. However, in 2017, the United States Food and Drug Administration (the “FDA”) determined that Midrin was no longer safe and effective. On October 12, 2017, the FDA notified manufacturers of prescription drugs containing isometheptene mucate that they should immediately cease distribution of the product. On June 13, 2018, the FDA issued a subsequent notice listing the drugs that were no longer approved by the FDA and that manufacturing companies were required to stop producing. The drug combination for Mr. Abele’s prescription for compound Midrin (acetaminophen, dichloralphenazone, and isometheptene mucate) is on the FDA non-approved list. Midrin Prescription/Coverage Denial In January 2018, Mr. Abele presented his prescription for generic Midrin to his local CVS Pharmacy to be filled but the prescription was refused. Mr. Abele indicated that the pharmacist told him that the manufacturer had stopped producing the drug and suggested that he could have the drug compounded. Since generic Midrin was no longer available, Dr. Ness issued a prescription for the compound Midrin, in capsule form, with a 10-day supply for each prescription. The medication name was listed as “Midrin (ALTERNATE) 325MG/100MG/65MG Capsule,” and the ingredients were listed as acetaminophen, dichloralphenazone, isometheptene mucate, and microcrystalline cellulose3. Mr. Abele filled the prescriptions at a local in- network compounding pharmacy. On January 14, 2018, Mr. Abele contacted Caremark about his compound Midrin prescription and Mr. Abele was told that he would need to submit a claim to determine whether the compound drug ingredients would be covered. There is no evidence that the Caremark representative made any false or misleading representation that Mr. Abele’s compound prescription would be approved. On December 14, 2018, Mr. Abele submitted claims to Caremark for reimbursement for compound Midrin. On December 17, 2018, Caremark notified Mr. Abele by letter that the claims he submitted were not allowed. The reason provided for disallowance was because the drug was not on the plan’s formulary. The letter also notified Mr. Abele that his request for exception did not include the information necessary to approve the request. On February 1, 2019, Dr. Ness, on behalf of Mr. Abele, submitted a non-covered drug formulary exception request seeking approval for compound Midrin. He requested the drug in capsule form for the treatment of Mr. Abele’s migraines. However, the request form did not include a copy of the prescription for the compound formula for Midrin. The form also did not describe the drug as the compound alternative. Dr. Ness testified that it is a common medical practice to use “cap” to refer to the capsule form, even for the compound formula. The Caremark appeals department faxed a response to Dr. Ness as follows: “In researching your fax request, the member’s prescription benefit coverage indicates a [p]rior [a]uthorization is NOT required. For additional questions regarding the medication’s coverage under the member’s plan, please contact Customer Service using the number on the back of the member’s prescription benefit card.” Dr. Anthony Arnett testified that he interpreted the exception request as being for Midrin capsules, rather than the compound form. Based on that interpretation, the response to the exception request was that prior authorization was not necessary. The undersigned finds that even if prior authorization was not required for the prescription, it does not amount to an approval for coverage of the claims. Appeal of Coverage Denial On February 5, 2019, Mr. Abele appealed the denial of reimbursement for compound Midrin. On February 13, 2019, Caremark responded to Mr. Abele instructing him to submit additional information for his claims to be processed. On February 18, 2019, he submitted the requested information and materials. On March 30, 2019, Caremark notified Mr. Abele by letter that his drug coverage request was denied. The basis for the denial was that the 3 Microcrystalline cellulose may be used as a bulking agent in pharmaceutical products. prescription was for a compound drug containing, as relevant here, bulk powder. Mr. Abele then submitted a Level I appeal, also referred to as a clinical appeal4, on April 18, 2019. Dr. Arnett reviewed Mr. Abele’s claims for the Level I appeal. While Dr. Arnett acknowledged that compounding could be approved if no other drug is available for treatment of migraines, he concluded that Mr. Abele’s exception request could not be approved because the compound formula included bulk powder. Caremark denied Mr. Abele’s Level I appeal and notified Mr. Abele by letter of their decision on April 22, 2019. In the letter, Caremark stated that “petitioner’s appeal for Dichloralphenazone Powder Compound has been determined as not medically necessary; and, ‘the plan criteria does not allow coverage of dichloralphenazone Powder Compound’ if the compound contained ‘bulk powder’ as an ingredient.” On May 8, 2019, dissatisfied with the outcome of the Level I appeal, Mr. Abele requested a Level II appeal. The Department denied the Level II appeal on the basis that the compound Midrin “did not meet the medical necessity criteria and non-FDA approved compounds are excluded from the plan.” Limitations and Exclusions The Department's concurrence of Caremark’s decision that coverage for the compound Midrin prescription should be denied was based on the Plan’s general Limitations and Exclusions section, which applies to the Prescription Drug Program. The Prescription Drug Program also outlines specific exclusions related to medications. The Prescription Drug Program, described in Part VIII, provides that covered drugs shall include, but are not limited to, any drug, medicine, medication, or communication that is consumed, administered, or provided at 4 Level I appeals are handled by Caremark by a specific group that focuses on prescriptions appeals. the place where the prescription is given at the medical provider’s office or healthcare facility. The Plan’s limitations and exclusions section provides, “the following services and supplies are excluded from coverage under this Plan unless a specific exception is noted. Exceptions may be subject to certain coverage Limitations.” Under the Plan, the exclusions include “any non-prescription medicine, remedy, biological product, pharmaceutical or chemical compound, vitamins, mineral supplements, fluoride products, health foods, or blood pressure kits, except as specifically provided for in the covered benefits section under prescription drugs.” The Additional Exclusions section provides that bulk powders, bulk chemicals, and proprietary bases used in compound medications and over-the- counter (“OTC”) products used in compound medications are excluded from coverage. Further, the plan excludes services or supplies not medically necessary as determined by the Plan and/or the Prescription Drug Program clinical staff and the state. The Prescription Drug Program provides that the Prescription Drug Program does not cover non-federal legend or OTC products, and bulk powders, bulk chemicals, and proprietary bases used in compounded medications.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Division of State Group Insurance, Department of Management Services, enter a final order denying Lawrence Abele’s request for reimbursement for the claims submitted for his compound Midrin prescription. DONE AND ENTERED this 14th day of May, 2020, in Tallahassee, Leon County, Florida. S YOLONDA Y. GREEN Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 14th day of May, 2020. COPIES FURNISHED: Lawrence Abele 841 Maderia Circle Tallahassee, Florida 32312 (eServed) Erica D. Moore, Esquire Office of the General Counsel Department of Management Services 4050 Esplanade Way, Suite 160 Tallahassee, Florida 32399-0950 (eServed) Jacob Koffsky, Esquire Foley & Lardner LLP 2 South Biscayne Boulevard, Suite 1900 Miami, Florida 33131 (eServed) Gayla Grant, Esquire Office of the General Counsel Department of Management Services 4050 Esplanade Way, Suite 160 Tallahassee, Florida 32399-0950 (eServed) William Chorba, General Counsel Office of the General Counsel Department of Management Services 4050 Esplanade Way, Suite 160 Tallahassee, Florida 32399 (eServed)
The Issue The issue is whether the Department’s intended award allowing Metro to proceed to licensure for a methadone Medication-Assisted Treatment (“MAT”) facility in Lake County violated Florida Administrative Code Rule 65D- 30.0141, was arbitrary or capricious, or was otherwise unlawful as alleged in LifeStream’s Petition for Administrative Hearing (“Petition”).
Findings Of Fact Based on the evidence adduced at hearing, and the record as a whole, the following Findings of Fact are made: PARTIES Petitioner LifeStream is a Florida not-for-profit corporation and provider of substance abuse treatment. LifeStream applied for the ability to proceed to licensure to provide methadone MAT services in Lake County. The Department is the agency with regulatory authority over the provision of substance abuse services. § 397.321(1), Fla. Stat. The Department’s duties include, but are not limited to, the licensing and regulation of the delivery of substance abuse services, including clinical treatment and clinical treatment services such as “medication-assisted treatment for opiate disorder.” §§ 397.321(1) and (6); and 397.311(26)(a)7., Fla. Stat. The Department also promulgates rules governing substance abuse providers. § 397.321(5), Fla. Stat. Metro is a provider of care for opioid use disorder treatment and operates methadone medication treatment centers nationwide, including in the state of Florida. Metro applied for the ability to proceed to licensure to provide methadone MAT services in Lake County. STATUTORY AND REGULATORY FRAMEWORK AND NEEDS ASSESSMENTS The substance abuse regulatory scheme in Florida is designed to provide a statewide system of care for the prevention, treatment, and recovery of children and adults with serious substance abuse disorders. Substance abuse providers, which include methadone MAT clinics, are subject to a strict statutory, regulatory, and licensing scheme, which provides direction for a continuum of community-based services including prevention, treatment, and detoxification services. See chs. 394 and 397, Fla. Stat. MAT is “the use of medications approved by the United States Food and Drug Administration, in combination with counseling and behavioral therapies, to provide a holistic approach to the treatment of substance abuse.” § 397.311(27), Fla. Stat. The Department is responsible for the licensure and oversight of all MAT providers in the state. See § 397.321, Fla. Stat. Further, the Department is required to “determine the need for establishing providers of [MAT]” on an annual basis. New MAT providers may only be established in the state in response to a determination and publication of such need by the Department. § 397.427(2), Fla. Stat. Rule 65D-30.0141 provides the process for determining the need for MAT providers, as follows, in relevant part: Determination of Need. The Department shall annually perform the assessment detailed in the “Methodology of Determination of Need Methadone Medication- Assisted Treatment,” CF-MH 4038, May 2019, incorporated by reference and available at http://www.flrules.org/Gateway/reference.asp?No= Ref-11993. The Department shall publish the results of the assessment in the Florida Administrative Register by June 30. Facilities owned and operated by the Florida Department of Corrections are exempt from the needs assessment process. However, these facilities must apply for a license to deliver this service. The publication shall direct interested parties to submit a letter of intent to apply for licensure to provide medication-assisted treatment for opioid use disorders to the Regional Office of Substance Abuse and Mental Health where need has been demonstrated. The publication shall provide a closing date for submission of letters of intent. Interested parties must identify the fiscal year of the needs assessment to which they are responding and the number of awards they are applying for per county identified in the assessment in their letter of intent. Within seven (7) business days of the closing date, the Regional Office shall notify parties who submitted a letter of intent on how to proceed. If the number of letters of intent equals or is less than the determined need, parties shall be awarded the opportunity to proceed to licensure by completing an “Application for Licensure to Provide Substance Abuse Services” form, C&F-SA Form 4024, May 2019, incorporated by reference and available at http://www.flrules.org/Gateway/reference.asp?No= Ref-11996. If the number of letters of intent exceeds the determined need, parties shall be invited to submit a “Methadone Medication-Assisted Treatment (MAT) Application to Proceed to Licensure Application” form, CF-MH 4041, May 2019, incorporated by reference and available at http://www.flrules.org/Gateway/reference.asp?No= Ref-11995. Applications may not be rolled over for consideration in response to a needs assessment published in a different year and may only be submitted for a current fiscal year needs assessment. The Department shall utilize an evaluation team made up of industry experts to conduct a formal rating of applications as stipulated in the “Methadone Medication-Assisted Treatment (MAT) Application Evaluation” form, CF-MH 4040, May 2019, incorporated by reference and available at http://www.flrules.org/Gateway/reference.asp?No= Ref-11994. The evaluation team members shall not be affiliated with the Department, current methadone medication-assisted treatment providers operating in Florida, or the applicants. The selection of a provider shall be based on the following criteria: Capability to Serve Selected Area(s) of Need and Priority Populations. Area(s) of Need are the counties identified as having a need for additional clinics. Priority Populations are pregnant women, women with young children, and individuals with financial hardships; Patient Safety and Quality Assurance/Improvement; Scope of Methadone Medication-Assisted Treatment Services; Capability and Experience; and Revenue Sources. Applicants with the highest-scored applications in each county shall be awarded the opportunity to apply for licensure for the number of programs specified in their letter of intent to meet the need of that county. If there is unmet need, the next highest scored applicant(s) will receive an award(s) based on the remaining need and the number of programs specified in their letter of intent. This process will continue until the stated need is met. Regional offices shall inform the highest-scoring applicant(s) in writing of the award. All awarded applicants must submit a letter of intent to apply for licensure to the appropriate regional office within 30 calendar days after the award. If an applicant declines an award or fails to submit the letter of intent within the specified time, the Department shall rescind the award. After the Department rescinds the original award for that selected area of need, the applicant with the next highest score shall receive the award. Awarded applicants must receive at least a probationary license within two (2) years of receipt of an award letter connected to their “Methadone Medication-Assisted Treatment (MAT) Application to Proceed to Licensure Application” form, CF-MH 4041. If an applicant fails to obtain a probationary license within the specified time, the Department shall rescind the award. See Rule 65D-30.0036, F.A.C. for licensure application requirements. Applicants may submit a request to the State Authority and Substance Abuse and Mental Health Program Office for an exception if unable to meet timeframes due to a natural disaster that causes physical damage to the applicant’s building(s). Proof of natural disaster and impact on physical property must accompany the request. Upon receipt of the request for exception and accompanying proof, a one-time extension shall be granted for six (6) months. Providers who are delayed for a reason other than a natural disaster may petition the Department for a rule waiver pursuant to Section 120.542, F.S…. In brief, potential applicants are directed to submit letters of intent to apply for a methadone MAT services license for any county in which the Department’s process demonstrates a need. Should the number of letters of intent received for a certain county be less than or equal to the need found in that county, the potential applicants may proceed directly to licensure. In the event the number of letters of intent is greater than the need found in a particular county, then potential applicants must submit an application form to the Department. The application form is adopted by reference in the rule as Form CF-MH 4041. The rule requires the Department to “utilize an evaluation team made up of industry experts to conduct a formal rating of applications” to determine which applicant, or applicants, may proceed to licensure in a particular county. Such evaluators “shall not be affiliated with the Department, current methadone [MAT] providers operating in Florida, or the applicants.” The scoring form that the evaluators must use is incorporated by reference in the rule as Form CF-MH 4040 (“Scoring Form”). The Scoring Form requires that each application be “independently scored by each member of the evaluation team.” It also mandates that the “same scoring principles must be applied to every application received.” The Scoring Form expressly states that “no attempt by Department personnel, or other evaluators or other persons to influence an evaluator’s scoring shall be tolerated.” There are five general “Criteria” in the Scoring Form upon which applicants are scored, with a number of subsections within each criterion. An application could be awarded a maximum of 220 points. The evaluators were to assign a score ranging from zero to five for each subsection, with some subsections receiving an additional “weighted value” (in which the score given would be multiplied by two). The Department gave the weighted values to provisions upon which it placed a “premium.” The “General Instructions” section of the Scoring Form provides what an applicant must demonstrate to earn a particular score: Superior (5 points): the application demonstrates or describes extensive competency, proven capabilities, an outstanding approach to the subject area, innovative, practical and effective solutions, full responsiveness to the question, a clear and comprehensive understanding of the requirements and planning for the unforeseen. Good (4 points): the application demonstrates or describes clear competency, consistent capability, a reasoned approach to the subject area, feasible solutions, extensive but incomplete responsiveness to the question, and a sound understanding of the requirements. Adequate (3 points): the application demonstrates or describes fundamental competency, adequate capability, a basic approach to the subject area, apparently feasible but somewhat unclear solutions, partial responsiveness to the question, a fair understanding of the requirements and a lack of staff experience and skills in some areas. Poor (2 points): the application demonstrates or describes little competency, minimal capability, an inadequate approach to the subject area, infeasible or ineffective solutions, somewhat unclear, incomplete or non-responsive to the question, a lack of understanding of the requirements and a lack of demonstrated experience and skills. Insufficient (1 point): the application demonstrates or describes a significant or complete lack of understanding, an incomprehensible approach, a significant or complete lack of skill and experience and extensive non-responsiveness to the question. Not Addressed (0 points): the application demonstrates or describes [that the] criteria is not addressed, approach is not described, complete non- responsiveness to the question. Criterion Five of the Scoring Form concerns “Revenue Sources.” It contains two subsections, each worth zero to five points and each given “weighted value,” meaning that a perfect score for each subsection would earn 10 points, or a total of 20 points for Criterion Five. Subsection one asked the following question: 1. How well did the organization detail its accepted forms of payment for treatment services? At a minimum, the response should describe the procedure for each payment method offered: Assess a point for each accepted form of payment (5 maximum points) Self-Pay (1 point) One form of Private Insurance (1 point) Multiple forms of Private Insurance (1 point) Medicaid (1 point) Scholarship or Sliding Fee Scale (1 point) While other sections of the Scoring Form permit the evaluator to subjectively evaluate the responsiveness of the answer, subsection one of Criterion Five is manifestly objective. It directs the evaluator to award one point for each of the five accepted forms of payment addressed by the applicant, up to the maximum of five points. Subsection two of Criterion Five asks, “How well does the application detail how the organization will determine if its pricing is competitive?” This subsection was also worth five points and allowed the evaluator to subjectively address the quality of the applicant’s response. Christopher Weller, Manager of the Licensure and Designation Unit within the Department’s Office of Substance Abuse and Mental Health, testified that Florida MAT providers historically have accepted only out-of- pocket payments for their services, meaning that those who could not afford to pay cash or credit were often left untreated. The Department wanted to ensure that the need for MAT services would be met and that no one needing such services would be priced out of treatment. Therefore, the Department included Criterion Five in the application and gave it weighted value to encourage providers to accept multiple forms of payment. The Department completed a needs assessment and published it in the June 20, 2020, edition of the Florida Administrative Register. The Department then announced that it would begin accepting applications to proceed to licensure. The needs assessment indicated a need for one new MAT clinic in Lake County. Pursuant to rule 65D-30.041(1)(c)2.a., the Department contracted with an outside provider to evaluate the applications received for counties throughout the state, including Lake County. That provider, iSF, established four teams of three evaluators to score the applications and divided the counties with need among the teams. Each evaluation team consisted of a medical professional, a public health policy professional, and an academic professional. Applicant names were redacted so evaluators would not know the identity of the applicant they were scoring. Each iSF evaluator independently evaluated the various applications. THE LAKE COUNTY APPLICATIONS LifeStream and Metro both timely submitted letters of intent and applications for the new methadone MAT clinic needed in Lake County. Four other entities also applied for the one available license in Lake County. LifeStream’s response to subsection one of Criterion Five provided as follows: Our organization has developed a detailed Financial Assistance Policy (FAP) that provides assistance to all individuals served, including insured, uninsured and underinsured individuals whose family income is less than or equal to 240% of the Federal Poverty Level without discrimination on grounds of race, sex, national origin, disability, sexual orientation, immigration status, religious preference, or any other grounds unrelated to an individual’s need for the service or the availability of the service needed for emergency and medically necessary care. Furthermore, all individuals served receive a financial screening by staff knowledgeable of the various funding mechanisms in an effort to identify the best form of payment. No one is turned away for services due to their inability to pay. As a comprehensive provider with a sound financial infrastructure, our organization is able to accept several forms of payment for any of the services provided. This includes self-pay, private insurance (both one form and multiple forms), Medicaid and scholarship or sliding scale fee. All the individuals served are charged based upon a board of directors approved charge master which ensures that all individuals are charged the same fees for the same services. Discounts are available for individuals who qualify for financial assistance using a sliding fee discount. Our organization provides payment flexibility, including payment plans/options. In addition, our staff are trained to assist individuals in obtaining benefits and coverage as appropriate to meet any ongoing needs for treatment. Self-Pay: The proposed clinic will conduct a financial screening in order to determine if an individual qualifies for any of the organization’s accepted forms of payment for treatment services. Individuals will be offered two payment options, by the day or by the week. The fee will include dosing, treatment services and ancillary services. Individuals will be offered the ability to pay using cash or credit card. The organization also has a mechanism to bill the individual if that is his/her preference. This allows the individual to pay for services in a manner that meets his/her current ability and timeframe. Private Insurance (One or Multiple Forms): Our organization has numerous contracts with private insurance providers. This includes major providers such as Aetna, Blue Cross/Blue Shiled, Cigna, Magellan, Tricare, PsycCare, United Health Care and Value Options to name a few. In order to ensure that our organization has the ability to bill private insurance for these services, staff will possess the appropriate credentials, training and experience to allow them to be paneled by the insurance providers. In addition, our organization has staff that conduct financial assessments in order to determine the best funding source for the services provided. They are experienced and knowledgeable about the various private insurance plans and have the ability to determine if one or multiple forms of insurance will be utilized. Medicaid: Our organization is an established Medicaid provider and has the ability to bill Multiple Medicaid Associations (MMAs) as a result of having contracts with several of the organizations such as Prestige, Wellcare, United Healthcare and Sunshine. All of our sites and appropriate staff have the proper credentials to bill for Medicaid services. In addition, the treatment services and ancillary services we propose to offer will be Medicaid credentialed in order to bill for those services as well. Scholarship or Sliding Fee Scale: As stated earlier, our organization has extensive experience working with indigent individuals. As a result of a financial assessment, the level of discount for which an individual is eligible is determined based upon the individual’s family income and family size as a percentage of the FPL. Our developed policies and procedures define the meaning of “uninsured,” “underinsured,” “family income,” and “Federal Poverty Level.” All of our financial policies are listed on our website that address payment for treatment services and are provided in detail for the people we serve. Metro’s response to subsection one of Criterion Five provided as follows: To facilitate the ease of payment by individuals in need of treatment and to minimize financial barriers to treatment, we offer a wide array of payment options that include: Self-Pay—Patients with the financial capacity to pay for their own treatment may pay using cash, credit card, Apple Pay, and/or debit card. Upon receiving the medication portion of their treatment, self-pay patients either tender cash to clinic staff for the cost of treatment or, alternatively, provide a credit card, Apple Pay, or debit card that is entered into a card processing terminal for verification and transaction authorization. Private Insurance—We accept multiple forms of private insurance as we are in network with many private insurers (including, but not limited to, Beacon Health, Triwest, United/Optum, and Aetna). Also, we have established single case agreements with private insurers with whom we are not yet in-network so that the cost to each patient is minimized and keeps the patient in treatment. Procedurally, patients present their private insurance information to clinic staff who verify eligibility, benefits, and individual financial responsibility (e.g., deductibles, co-pays, co- insurance). A patient’s financial responsibility, if any, is collected from the patient pursuant to their insurer’s benefit design, and the treatment services are billed to their health insurer. An assignment of benefits is signed by the patient to permit us to bill and collect directly from their health insurer. Medicaid—Opioid Use Disorder treatment is a covered benefit under Florida Medicaid. As a result, all of our existing clinics are enrolled in the Florida Medicaid network. If our organization is awarded the clinic for this county, we would immediately enroll this clinic in the Florida Medicaid program. Patients covered by Florida Medicaid simply present their Medicaid card to clinic personnel who are able to immediately verify active coverage. Upon verification of coverage, the patient completes an assignment of benefits and is treated without any financial outlay. Treatment services received by the patient are then billed to Florida Medicaid directly for as long as the individual remains Medicaid eligible. Sliding Fee Scale—Patients without the financial capacity to pay for their own treatment, or are without Florida Medicaid or private health insurance coverage, may qualify for our Sliding Fee Scale. The Sliding Fee Scale offers discounted fees to patients in need of treatment. Eligibility is determined based on Federal poverty guidelines, household income, and the number of people in the patient’s household. Patients who are eligible for the Sliding Fee Scale must simply provide the following financial data as a part of their application: Pay stubs for at least the last six months; A copy of their most recent federal income tax return; Proof of current living situation (such as lease documents, or utility bills in the patient’s name); A financial attestation signed by the patient, which our clinic will provide. Upon the establishment of a patient’s eligibility, the patient’s cost of treatment is reduced to the discounted fee per the Sliding Fee Scale. In the event that a patient’s financial status changes, the patient must inform clinic staff of the changes. At a minimum, the clinic staff will review financial status with the patient every six (6) months. Financial status may be reviewed at the request of the patient or clinic at any time. Grants—Our organization routinely pursues, and has secured, grant funding to cover the cost of treatment for patient who are [sic] unable to pay for their treatment and who do not have insurance. Grant finds are awarded through regional Managing Entities. Available grant funds are sought to cover [the] cost of care for eligible patients receiving treatment at our clinics. As mentioned, our organization is currently the recipient of grant funds from multiple Managing Entities in the State of Florida. Eligible patients must simply provide the following financial data as a part of their application: Pay stubs for at least the last six months; A copy of their most recent federal income tax return; Proof of current living situation (such as lease documents, or utility bills in the patient’s name); A financial attestation signed by the patient, which our clinic will provide. Upon the establishment of a patient’s eligibility, the patient’s cost of treatment is reduced in accordance with the grant guidelines. In the event that a patient’s financial status changes, the patient must inform clinic staff of the changes. At a minimum, the clinic staff will review financial status with the patient every six (6) months. Financial status may be reviewed at the request of the patient or clinic at any time. Credit—Patients with the financial capacity to pay for their own treatment via cash, credit card, and/or debit card occasionally find themselves in need of treatment but, for a variety of reasons, are unable to pay. Our organization empowers its clinic Program Directors (i.e., the on-site clinic managers) to extend credit to patients in such situations for a short period (typically one day) with the understanding that the patient will repay the credit amount extended in short order. Upon receiving credit authorization, the patient receives all medically necessary treatment as may be required. Both the LifeStream and Metro proposals appear to have described the procedure for each of the five payment methods listed and appear to be entitled to the maximum score of five points according to the objective standards set forth in subsection one of Criterion Five. At the very least, it would be impossible to justify giving either proposal a score of zero, which is reserved for “complete nonresponsiveness” to the question. LifeStream’s response to subsection two of Criterion Five provided as follows: In order to ensure that pricing is competitive, our organization will review the current environment using several data sources on a regular basis. This will include the Department of Children and Families, our state trade association, Florida Behavioral Health association and discussions with other providers. We also propose to conduct focus groups with the individuals that we serve and our stakeholders to collect input that will be part of this review. On an annual basis, our organization will conduct a pricing study to ensure that the pricing is competitive. As a safety net provider and an organization committed to serving individuals regardless of their ability to pay, we feel that the input from those we serve and our stakeholders is a critical piece in determining if pricing is competitive. Our organization will identify and provide solutions to ensure that those that need care are able to receive the care. We are dedicated to ensuring that the pricing will be reasonable and that options are identified and offered for low income/indigent individuals. More importantly, our organization will commit to supporting the people we serve through a continuum of services that not only addresses their opioid disorders, but also the social determinants that may affect their successful recovery. Our organization is a Medicaid provider and also has access to other funds to ensure that individuals who need this service will receive it regardless of their ability to pay. Metro’s response to subsection two of Criterion Five provided as follows: As a longstanding provider of Opioid Use Disorder treatment services in the State of Florida, our organization is keenly aware of the need to properly price our services given the circumstances typically facing patients battling opioid addiction which include, but are not limited to, financial hardship. Consequently, we recognize that appropriate pricing of our services is critical so as to ensure that individuals in need of care do not perceive that treatment for their disease is unattainable. While a material and increasing number of patients have their treatment paid by Medicaid, private health insurance, and grants (as fully discussed in question 1 of Criteria 5), those patients who pay for treatment out of their own pockets routinely encounter financial barriers which, unfortunately, result in them not seeking treatment, or leaving treatment prematurely. Given our experience operating outpatient clinics in Florida, our organization has developed a substantial amount of year-by-year internal pricing data, which includes specific market economic data, that guides us in pricing our services within a particular Florida region. This data, which is updated annually, is measured against other payer rates (such as Medicaid and private health insurance), and compared to the rates we are paid for opioid addiction treatment services provided by our clinics in other states. Taken together, this data allows us to develop regional benchmarks that we use to price our services fairly and competitively, bearing in mind the financial challenges typically encountered by opioid addicted patients. To be clear, this is a fluid process that takes into account changing market conditions, both inside and outside of Florida, regarding the pricing of opioid addiction treatment. This allows our organization to maintain a current view of what patients can realistically afford to pay and, when necessary, immediately adjust our pricing expectations when the market data indicates that such adjustments are needed to ensure continuity of patient care. In addition to our routine pricing analysis using our historical internal data, we will, prior to opening a new clinic in a particular area, conduct a survey of other opioid treatment clinics within the region (if any). This survey process not only allows us to gain a better understanding of what the pricing for services is in that region, but helps us identify any additional services that should be offered to patients as part of our pricing structure. Once these surveys are completed, we then use this information, along with our internal analysis of historical data, to price our treatment services according to our planned treatment protocol (e.g., timely delivery of service, having the clinic open seven (7) days per week, maintaining a Call Center that is open and available to assist existing and prospective patients 24 hours per day, 7 days a week, etc.) and our analysis of specific market dynamics (e.g., quality of care indicators, availability of qualified clinical professionals, attendant costs of support services in the particular market, etc.). Finally, to ensure our pricing remains competitive, we repeat our outpatient treatment clinic surveys at least annually for each and every market in which our clinics operate, and use this information, along with routine feedback voluntarily provided by our existing patients, to determine if our pricing remains appropriate given the market where the clinic is located. To be clear, we believe that our practice of conducting outpatient clinic surveys relieve patients of having to make pricing and service comparisons while trying to manage their disease. Stated differently, patients can take comfort in knowing that when they inquire as to our treatment pricing, they will receive the identical type and number of services that would typically be offered by all similarly-situated outpatient treatment programs within their geographic region at comparable prices. While this particular process can be burdensome, we have found time and again that the effort is worthwhile given the positive patient feedback we routinely receive regarding the value of services offered at our clinics. If awarded the clinic license for this particular county, we will deploy each of the aforementioned pricing techniques (i.e., internal analysis of historical pricing data, benchmarking using public and private payer rates from within and outside of Florida, and regional pricing surveys) to develop pricing for our services that will not only be competitive, but affordable for the people within the community in need of treatment. These processes have proved tremendously effective for us thus far, and we fully expect them to be successful within this particular county. As noted above, subsection two allowed for a more subjective evaluation of the applications. LifeStream’s response was shorter and more general than Metro’s, but both responses addressed similar themes and procedures for ensuring competitive pricing at their clinics. Both proposals showed the applicants’ understanding of the need for competitive pricing and outlined their plans for setting their prices accordingly. Even allowing for the subjectivity permitted by subsection two, it would be impossible to justify giving either proposal a score of zero, which is reserved for “complete nonresponsiveness” to the question. SCORING OF THE LAKE COUNTY APPLICATIONS As explained above, the applications were given to the four teams of iSF evaluators for scoring. After the evaluators completed their review, iSF provided the Department with a final report that explained the evaluation process and provided a series of tables for each county that identified each applicant’s scores. The Lake County applications were scored by “Team Two” of the iSF evaluators. Team Two also reviewed applications for five other counties. Team Two gave LifeStream a total score of 633.5 for Lake County and gave Metro a total score of 619 for Lake County. Mr. Weller testified that one of his employees found a typographical error in a spreadsheet that iSF produced for the Department. This error prompted Mr. Weller to take a look at the scoring of the proposals by the iSF evaluators. Mr. Weller noted what appeared to be an anomaly. He found a series of scores in Lake County that went “5, 5, 5, zero, 5, 5, which caught my eye as unusual, and we discovered that the answers for both [subsections one and two of Criterion Five] were different in Lake County compared to all of the other ones that the particular evaluator scored for the other counties.” A closer review of the scores revealed that each of the three Team Two evaluators gave LifeStream scores of five in both subsections of Criterion Five in its Lake County application. Two of the three evaluators gave Metro scores of five for both subsections of Criterion Five. However, the medical professional on Team Two gave Metro zeros in both subsections of Criterion Five of its Lake County application. The Criterion Five responses of LifeStream and Metro were essentially identical in all of the six county applications reviewed by Team Two. In the five counties other than Lake County, all of the evaluators, including the medical professional, gave both LifeStream and Metro scores of five for both subsections of Criterion Five. It was only in Lake County that the medical professional decided that Metro’s identical response was completely nonresponsive and deserving of zero points. As found above, it is impossible to justify scores of zero for Metro’s responses to Criterion Five. It was also extremely unusual for the same evaluator to give such radically different scores to the same response made in different applications. Mr. Weller wanted an explanation. He asked iSF to ask the medical evaluator to explain her reasoning for the inconsistency in her scoring of Metro’s Lake County application and to ask whether she wished to amend her score for Metro’s application. On April 27, 2020, iSF’s contract manager, Roger Balettie, sent an email to the Team Two medical evaluator, Linda Saucier. The email requested Ms. Saucier’s response as to four scoring questions raised by the Department’s review, including the following: You have two applicant response questions (Criteria 5 Questions 1 and 2) where an applicant (DCF 12) has two different scores for the same answer across six counties (one with 0s for each question and five with 5s for each question, and your notes are identical). DCF would like for you to review the applicant’s C5Q1 and C5Q2 response (I will provide that section for you) and confirm either that you intended the 6 counties to be different, or that you intended the 6 counties to have consistent scores for those two questions (and provide those scores). On May 1, 2020, Ms. Saucier responded as follows: I just saw your email. It went to my spam folder. I am extremely busy with work. But, I can tell you that the scores are different because of the county or vicinity in which the clinic would be housed and clinicians/service availability. It’s not a cookie cutter process. Later on May 1, 2020, Mr. Balettie sent an email asking Ms. Saucier to confirm that she did not wish to consider changing her scores for any of the four questions raised in his initial email, including Criterion Five in Lake County. Ms. Saucier responded: Correct. Roger, there are so many variables when looking at the submissions. I have written and reviewed grants and similar documents in my position. I realized the proposals were the same for each county, unfortunately not all of the counties share the same similarities. Read in the context of Criterion Five, it is clear that Ms. Saucier did not bother even to look again at her work on these applications before responding to Mr. Balettie. Her response is vague and defensive nonsense. Lake County possesses no unique quality that would render Metro’s pricing strategy and accepted forms of payment completely nonresponsive to Criterion Five, particularly when Ms. Saucier herself found the same responses “superior” in five other counties. Moreover, subsection one of Criterion Five did not give Ms. Saucier the discretion to award zero points to an application that addressed the five listed forms of payment as Metro’s application manifestly did. She violated the instructions of the Scoring Form and offered no real justification for doing so. The Department reasonably believed that it was not possible to rationalize the zeros that were given to Metro’s Lake County response. The Department reasonably believed there were no differences between counties that would have any impact on pricing or payment methods. William Sutton, General Counsel for Metro’s parent entity, Colonial Management Group, LP, testified that he personally worked on the applications Metro filed for the 2018-2019 licensure process. Mr. Sutton testified that the “forms of payment and the process [that Metro uses] to determine whether our pricing is competitive is consistent throughout the state of Florida.” He noted that Metro currently has 80 clinics operating throughout the country and that it is “critical” for the company “to have processes in place to deal with those [payment and pricing] issues consistently.” After digesting the response from iSF, the Department concluded that Ms. Saucier’s scores of zero for Criterion Five of Metro’s Lake County application “could not be justified.” Department personnel met to discuss what action to take regarding the scoring discrepancy. Eventually, the Department decided to override Ms. Saucier’s scores and to assign a score of five to both Criterion Five subsections in Metro’s Lake County application. The score of five was chosen because it was the same score that Ms. Saucier assigned to all of Metro’s other substantively identical Criterion Five responses in the other five counties she reviewed. The Department took this action “in the interests of fairness.” The Department also believed that Metro would challenge any intended award if the scores of zero were left unchanged and that Metro would likely prevail in such a challenge.2 The Department’s adjustment of the score gave Metro a total score of 639 points, reflecting two double-weighted scores of five instead of two scores 2 Mr. Sutton testified that Metro indeed would have raised such a challenge. of zero in the Criterion Five subsections. LifeStream’s total score in Lake County remained 633.5 points.3 On July 10, 2020, the Department published the Notice, which declared its intention to award the new MAT license in Lake County to Metro. The Notice explained the adjustment as follows: During the review of the evaluators scoring process by the Department, it was discovered that the medical evaluator for Team Two provided scores of zero for both responses in Criteria Five for [Metro’s] Lake County application. The two questions responded to pertained to types of payments accepted and competitive pricing. The responses to these questions were identical to Metro’s responses in the other six applications reviewed by the same medical evaluator. Each of the responses in the other six applications were awarded the full point values (5 points each) by the medical evaluator. In addition, the same responses were awarded either 4 or 5 points by both the other Team Two evaluators and by all the evaluators in the other teams. The scoring inconsistency resulted in Metro’s Lake County application losing 20 points (5 points for 2 questions, which were weighted by a factor of 2). Correction of the inconsistency results in Metro having the highest scoring application. Upon the Department learning of the scoring discrepancy, the medical evaluator declined to amend the scores and participate in the public meeting of the evaluators. The responses provided by Metro’s Lake County application were identical to its six non-Lake County applications assigned to Team Two, which were awarded five points each, and identical to all other responses provided by Metro. Thus, the 3 Metro could have received five fewer points through this correction and still received the intended award. Based on the scores possible and the double-weighting of this criterion, any combination of (a) two scores of five, (b) one score of five and one score of four, (c) one score of five and one score of three, or (d) two scores of four would have caused Metro to jump past LifeStream as the successful applicant. recommendation is to override the scores and award the licensure opportunity to Metro. The Department’s actions in reviewing the scores awarded and making the changes to Metro’s Criterion Five scores were reasonable under the facts and circumstances presented. LifeStream was unable to mount a serious defense of Ms. Saucier’s scoring or to offer any tangible evidence that the Department was biased either against LifeStream or in favor of Metro.4 LifeStream’s chief argument is that the Department deviated from its own rule by reviewing the scores submitted by iSF, by asking iSF to inquire as to aspects of the scores and suggesting the evaluator change them, and most egregiously by changing Metro’s score after the iSF evaluator declined to amend her evaluation. This legal argument is discussed below.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, the undersigned hereby RECOMMENDS that the Department of Children and Families enter a final order awarding the right to proceed to licensure for a methadone MAT facility in Lake County to Metro Treatment of Florida, L.P., and dismissing the Petition for Administrative Hearing filed by LifeStream Behavioral Center, Inc. DONE AND ENTERED this 1st day of February, 2021, in Tallahassee, Leon County, Florida. S LAWRENCE P. STEVENSON Administrative Law Judge 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 1st day of February, 2021. COPIES FURNISHED: Daniel Ryan Russell, Esquire Dean Mead and Hall Suite 1200 106 East College Avenue Tallahassee, Florida 32301 Mia L. McKown, Esquire Holland & Knight, LLP Suite 600 315 South Calhoun Street Tallahassee, Florida 32301 William D. Hall, Esquire Dean Mead and Dunbar Suite 1200 106 East College Avenue Tallahassee, Florida 32301 Chad Poppell, Secretary Department of Children and Families Building 1, Room 202 1317 Winewood Boulevard Tallahassee, Florida 32399-0700 Javier Enriquez, General Counsel Department of Children and Families Building 2, Room 204F 1317 Winewood Boulevard Tallahassee, Florida 32399-0700 Brittany Adams Long, Esquire Radey Law Firm, P.A. Suite 200 301 South Bronough Street Tallahassee, Florida 32301 John L. Wharton, Esquire Dean Mead and Dunbar Suite 1200 106 East College Avenue Tallahassee, Florida 32301 Eddie Williams, III, Esquire Holland & Knight, LLP Suite 600 315 South Calhoun Street Tallahassee, Florida 32301 Lacey Kantor, Agency Clerk Department of Children and Families Building 2, Room 204Z 1317 Winewood Boulevard Tallahassee, Florida 32399-0700
The Issue Whether Respondent, Lawrie B. Glickman, D.D.S., violated Section 466.028(1)(q), Florida Statutes, by prescribing for himself, once, Promethazine/Phenyleph/Cod, and twice, Testosterone 200 mg/mcl 10 cc?
Findings Of Fact The Parties The Agency for Health Care Administration is in the Department of Business and Professional Regulation. Section 20.42, Florida Statutes. The Agency's Division of Health Quality Assurance contains the Board of Dentistry, Section 20.42(2)(a)2., Florida Statutes, which is responsible for "carry[ing] out the provisions of [Chapter 466, Florida Statutes,]" Section 466.004(1), Florida Statutes, the chapter through which the State of Florida regulates the practice of dentistry, dental hygiene, and dental laboratories. Lawrie B. Glickman, D.D.S., licensed by the State of Florida to practice dentistry under license number DN 0001383, has practiced dentistry in Tampa since 1957. Currently a sole practitioner, Dr. Glickman's practice includes all phases of general dentistry, among them, periodontal surgery, periodontal treatment, orthodontics, and orthopedic orthodontic treatment. Approximately ten percent of his practice is pediatric dentistry. Promethazine/Phenyleph/Codeine Phenergan VC or Promethazine VC with Codeine Cough Syrup ("promethazine cough syrup,") is an oral medication used by Dr. Glickman in his practice. Each 5 ml teaspoonful of promethazine cough syrup contains 6.25 mg of Promethazine Hydrochloride, 10 mg of codeine phosphate and 5 mg of phenylephrine hydrochloride. "Promethazine is a phenozathine derivative that is frequently used in dentistry, primarily in pediatric dentistry, as a sedative-hypnotic administered either orally or intramuscularly." Respondent's Ex. No. 2, Sedation, A Guide to Patient Management, Stanley F. Malamed, D.D.S., Professor and Chair, Section of Anesthesia and Medicine , University of Southern California, Mosby, 3rd Ed., p. 375. It also has antihistaminic action. Respondent's Ex. No. 2, Physician's Desk Reference, p. 2585. Phenylephrine, in therapeutic doses, "mainly causes vasoconstriction." Respondent's Ex. No. 2, Physician's Desk Reference, p. 2585. "Following oral administration . . ., constriction of blood vessels in the nasal mucosa relieves nasal congestion associated with allergy or head colds. [N]asal decongestion may occur within 15 or 20 minutes and may persist for up to 4 hours." Id. Codeine is a controlled substance listed in Schedule II of the Florida Comprehensive Drug Abuse Prevention and Control Act. As such, it "has a currently accepted but severely restricted medical use," Section 893.03(2), Florida Statutes, because it has "a high potential for abuse . . . [which] may lead to severe psychological or physical dependence." Id. Dr. Glickman provides promethazine cough syrup to congested patients to whom he wants to administer nitrous oxide. Consistent with the Physician's Desk Reference's description of its clinical pharmocology, he finds that within "fifteen or twenty minutes after [the syrup's] usage congestion is reduced to the point of the airway being opened." (Tr. 55). Reduction of congestion in the congested patient expected to receive nitrous oxide is necessary because nitrous, a legend drug commonly used in the practice of dentistry as a mild sedative, is administered in the form of gas via inhalation. For nitrous to be optimally effective, the patient must be able to breathe freely; hence, the use of the syrup with its decongestant capability. The syrup has additional uses of value during dental procedures. It depresses coughing, nausea, and vomiting. Testosterone Cypionate Injection Dr. Glickman uses testosterone cypionate in a preliminary stage of oral tissue graft surgical procedures. Prior to the actual grafting of the tissue onto the oral cavity where needed, tissue taken from the palate of the patient is soaked in testosterone cypionate in order to promote epithelization (a growth process of covering the surface of the oral cavity with epithelium, cellular tissues that normally cover the lining of body cavities), and ultimately healing and bonding of the graft tissue inside the mouth. Testosterone cypionate comes in a liquid form in an injectable vial. As an anabolic steroid, testosterone cypionate falls into the category of "any drug or hormonal substance, chemically and pharmacologically related to testosterone, other than estrogens, progestins and corticosteroids, that promotes muscle growth . . .". Section 893.03(3)(d)1., Florida Statutes. Furthermore, it is a named anabolic steroid in the Schedule III list of controlled substances. As a Schedule III controlled substance, use of testosterone cypionate may lead to physical damage, but it has a potential for abuse less than the substances contained in Schedules I and II. Section 893.03(3), Florida Statutes, states that "it has a currently accepted medical use in treatment in the United States . . .", although the statute does not describe the use. Testosterone has been accepted for use in Europe in the healing of gangrenous tissues of diabetic patients or patients with cardiovascular disease. Although its use in dentistry is not widespread, as evidenced by Dr. Glickman's lack of awareness of any publication proclaiming its use in periodontics and Dr. Gumm's lack of awareness of its use in dentistry, testosterone has been commended by at least one authority in the field of dentistry as useful for the healing of oral wounds. Dr. Glickman first learned of its potential for promoting healing and epithelization in dentistry at a Boston University muco-gingival surgery course presented by Dr. Gerald Kramer, at that time, head of the university's periodontal department. Dr. Kramer recommended the use of testosterone in dentistry because of healing powers due to its anabolic effects. Dr. Glickman, moreover, has personal knowledge of testosterone's effects because it was prescribed for him by a urologist, Lawrence F. Grey, M.D. of the Grey Clinic in Urology following a surgical procedure. Liquid Injectable Testosterone Dr. Glickman obtained testosterone cypionate for his practice in an injectable, liquid form because it is not available in any other form. At hearing, Dr. Glickman described his handling of it in the following way: . . . [A]n injectable bottle has a metal ring with a rubber stopper. We would cut off the metal ring and then you could use it as any other bottle that would have a top. We would take off the rubber stopper, pour a little bit in this little tray we would use, and the graft material would be saturated in that. And again, as I stated a minute ago, it aids in wound healing, epithelization, and that's what you need when you do a tissue graft. (Tr. 56). Three Prescriptions Dr. Glickman wrote and signed a prescription dated October 21, 1993. The actual prescription was introduced into evidence. Handwritten on the prescription is "TESTOSTERONE CYPIONATE INJECTION 200mg.ml 10cc," in the name of "LAWRIE B. GLICKMAN," age "61," address, "8027 INTERBAY BLVD." Petitioner's Ex. No. 2. Dr. Glickman's office address is printed on the head of the prescription form as 4221 El Prado Boulevard in Tampa. According to DEA Drug Usage Report No. RX0415, dated August 4, 1994, a record kept by Walgreen's Pharmacy, another prescription was submitted to its "Store No. 01000" at "225 W.Shore Plaza" in Tampa, four months earlier. This second prescription submitted on June 20, 1993, was for "promethazine/phenlyeph/cod" in the patient name of "Lawrie Glickman," with a patient address of "4221 El Prado, Tampa, Florida, 33629," written by "L.B. Glickman," and a doctor's address of "4221 El Prado." Petitioner's Ex. No. 1. According to the same DEA Drug Usage Report, a third prescription was submitted to Walgreen "Store No. 01000" at "225 W.Shore Plaza" in Tampa on January 17, 1994, for "testosterone 200mg/ml" in the patient name of "Lawrie Glickman," with a patient address of "4221 El Prado, Tampa, Florida, 33629," written by "L.B. Glickman," and a doctor's address of "4221 El Prado." Id. Oddly, the same DEA Drug Usage Report also reflects that the first prescription referred to above, the October 21, 1993 prescription for testosterone, had a patient's address the same as Dr. Glickman's office address, 4221 El Prado, rather than the address reflected for the patient on the actual prescription: "8027 INTERBAY BLVD." In any event, Dr. Glickman wrote three prescriptions in the name of Lawrie B. Glickman or Lawrie Glickman. One was for "promethazine/phenyleph/cod" on June 20, 1993. The other two were for tesotosterone cypionate injection 200 mg/ml 10 cc, referred to in short on the Walgreen's records as "testosterone 200 mg/ml." The two testosterone prescriptions were submitted to Walgreen's on October 21, 1993 and January 17, 1994. Not for Personal Use The three prescriptions were not written for Dr. Glickman in the sense that they were for his own personal use in the way of the testosterone prescription Dr. Glickman's urologist, Dr. Grey, had written following Dr. Glickman's surgery. Rather, Dr. Glickman wrote the three prescriptions for general office use and solely for such use. In the case of the promethazine/phenyleph/cod, the use to which the substance was to be put was decongestion of patients in conjunction with the administration of nitrous oxide. This finding is borne out not only by Dr. Glickman's unrebutted testimony as to the purpose of the prescription but by a sticker dated "06/20/93," attached to Respondent's Ex. No. 1, a bottle of Promethazine VC with Codeine Cough Syrup given to Dr. Glickman in the name of "Lawrie Glickman," id., with the typed notation, "office use." Id. In the case of the testosterone, the office use was a solution in which tissue taken from the palate of a patient was soaked in anticipation of a tissue graft. Not only were the prescriptions written by Dr. Glickman for use in his dental office and office use alone, but there is no evidence that they were later put to any other use. Dr. Glickman did not, in fact, use them at any time for or on himself personally. Improper Means When Dr. Glickman wrote the three prescriptions for general office use in his own name as if he were the patient, he did not follow proper procedure. If a practitioner wishes to obtain controlled substances for use in an office, the practitioner should order the substances by invoice from a wholesaler licensed to provide the substances. There is never an occasion when a practitioner is allowed to obtain controlled substances for use in an office by means of a prescription in his own name or the name of his office. The prohibition is codified in 21 Code of Federal Regulations, part 1300, s. 1306.04(b), of which official recognition has been taken: A prescription may not be issued in order for an individual practitioner to obtain controlled substances for supplying the individual practitioner for the purposes of general dispensing to patients.
Recommendation Accordingly, based on the foregoing findings of fact and conclusions of law, it is recommended that a final order be entered by the Board of Dentistry finding Lawrie B. Glickman, D.D.S., to have committed technical violations three times, on the dates charged in the Amended Administrative Complaint, of Section 428.066(1)(q), Florida Statutes, placing him on probation for three months during which time he should take and complete a continuing dental education course, if one is available, related to proper procedures for prescribing controlled substances, and fining him $250 per violation, for a total of $750. DONE AND ENTERED this 24th day of June, 1997, in Tallahassee, Leon County, Florida. DAVID M. MALONEY Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (904) 488-9675 SUNCOM 278-9675 Fax Filing (904) 921-6847 Filed with the Clerk of the Division of Administrative Hearings this 24th day of June, 1997. COPIES FURNISHED: Natalie Duguid, Esquire Agency for Health Care Administration Post Office Box 14229 Tallahassee, Florida 32308-14229 Michael L. Kinney, Esquire Post Office Box 18055 Tampa, Florida 33679-8055 Jerome W. Hoffman, General Counsel Agency for Health Care Administration Fort Knox Building 3 2727 Mahan Drive Tallahassee, Florida 32308-5403 William Buckhalt, Executive Director Board of Dentistry Division of Medical Quality Assurance Boards Agency for Health Care Administration Fort Knox Building 3 2727 Mahan Drive Tallahassee, Florida 32308-5403
Findings Of Fact At all times pertinent to the issues contained herein, Respondent, Lois E. Anderson Bailey, was a licensed practical nurse in the State of Florida under license number 12519-1. During the period between July, 1982 and January, 1983, and for an unknown period both before and after that time, Dr. Allan R. Varraux was a pulmonary specialist who, as a part of his practice, performed bronchoscopies at ORMC. As a routine part of this practice, Dr. Varraux utilized a cocaine solution to spray the back of the throat of his patients as an anesthetic prior to inserting the bronchoscope. Cocaine is also used as an anesthetic after the bronchoscope is inserted because it lasts between one-half an hour to forty-five minutes as opposed to xylocaine which lasts only fifteen minutes or so. Dr. Varraux also prefers to use cocaine over xylocaine because the latter often causes spasms in the patient. During this period, Dr. Varraux knew the Respondent, who was nursing supervisor of the Endoscopy section at the time, and discussed with her the controls for the use of cocaine for this purpose because cocaine is a controlled substance. At no time did Dr. Varraux ever discuss with Respondent the potential for the substitution of xylocaine for cocaine in this procedure nor did he ever approve its substitution. On or about January 18, 1983, Dr. Varraux wrote a letter to Mr. Holton, Director of the hospital pharmacy, asking for a survey of cocaine use at ORMC. He did this because of a survey done at another hospital at which he also practiced with which he was familiar to be sure that the amount of cocaine he was using was reasonable. The audit revealed that at the time in issue here, no cocaine was dispensed by the pharmacy for the Endoscopy section. Dr. Varraux considered this odd because he was ordering cocaine solution for the bronchoscopies he was performing and as a result, some cocaine should have been issued. He subsequently found out that xylocaine was being substituted for cocaine. He had not authorized the substitution and was greatly concerned because of the potentially serious impact the substitution might have on a patient if the patient were allergic to xylocaine and the physician did not know that the substitution had been made. In his opinion, it is not good medical practice to substitute xylocaine for cocaine without the doctor's orders and without informing the physician of the change. In practice, the cocaine is injected with a syringe into the apparatus being utilized during the bronchoscopy. At that point, the order for the use of cocaine is a verbal order which is, thereafter recorded in the nurse's notes and in the doctor's dictated report concerning the procedure. Since there is no standard procedure for this operation, Dr. Varraux established, in discussions with the Respondent, his general procedures which in all cases included the use of cocaine as an anesthetic. Respondent actually assisted in very few of Dr. Varraux procedures. Eighty-five percent of his procedures were done with Ken Rosenau assisting and Mary Ann Hinds assisted in others. However, Respondent was the supervisor of the endoscopy section and if there was a problem, Dr. Varraux would go to her first. Lynn W. Capraun, an instructor of respiratory therapy at Valencia Community College, and an advisor in that area to ORMC, was asked by Mr. Rogers to audit the endoscopy section records for bronchoscopies performed from July, 1982 through January, 1983. His audit was limited to only those on a list of procedures given him by Mr. Rogers and he is not aware of what percentage of the total bronchoscopy load this list consisted of. However, as a part of this audit, he reviewed for each specific case the doctor's clinical resume' and the nurse's notes to see what the doctor called for and what was in fact done. Based on his audit, it appeared that during the period in question, more than 203 ml of cocaine had been ordered by physicians but there was no supporting documentation in the nurse's notes to indicate that the cocaine had been administered even though there was documentation for the use of other drugs. Here, it should be noted that Mr. Capraun is also the partner of Mr. Rogers in a private respiratory therapy business. The records of the pharmacy at ORMC revealed that the last issue of cocaine too the endoscopy section prior to the audit was made in July, 1982. Prior to that time, as far back as 1981, records indicated that the pharmacy had issued 60 ml of cocaine solution every three or four weeks. All issues are reflected as such issues are logged and the name of the individual to whom the drug is issued, who must be licensed, is retained. In addition, pharmacy records reflected no issue of any controlled drug, not only cocaine, to the endoscopy section between late October, 1982 and January 3, 1983. After Respondent was suspended on January 19, 1983, Mr. Holton examined the drug sheets kept in the endoscopy section and the drugs kept on the floor. He found three bottles of cocaine solution, one of which contained 60 ml and the other two contained 40 ml. Analysis of the contents of one bottle reflected the solution at 3.9 percent cocaine which is acceptable. The other two bottles, however, were at a lower strength - one at .5 percent and the other at 1.4 percent cocaine. Though there were three bottles of solution, only two records to support these bottles were found. One was dated May 21, 1982 and the other, June 23, 1982. Cocaine is issued by the pharmacy only upon the presentment of a proof of use sheet which reflects the fact that the previous issue has been used up and it is the practice of the pharmacy, according to Mr. Holton, not to issue new supplies of a controlled substance without a proof of use sheet to show the use of the previous issue. The records of the hospital reflect that the Endoscopy section is a small user of any controlled drug. From the above, an inference can be drawn that cocaine was improperly removed from the Endoscopy section. However, from review of the evidence as a whole, not only that already discussed but that to be discussed as well, it is impossible to determine for certain that there was a loss and if so, who was responsible for it. It certainly cannot be said with any degree of certainty that the Respondent either took it or knew who did. When Mr. Rogers received the letter from Dr. Varraux regarding the use of cocaine in the Endoscopy section of his department, he went to look for the Respondent to discuss the problem with her. He found that she had gone for the day and so he discussed the situation with Mrs. Williams, one of Respondent's assistants, who advised that Respondent had, at times, asked her to substitute xylocaine for cocaine. The following day, he looked into the situation further and after talking with his supervisor, called in Respondent and showed her Dr. Varraux's letter. He says Respondent first indicated she was aware of the situation - then changed her position. She again changed her position, indicating that she was aware of only one incident and that she had discussed with the employees of the section the illegality of the practice advising them not to do it. Mr. Rogers was told by his employers that he could suspend the Respondent if he felt it to be necessary. As a part of his inquiry, he discussed the matter with Mr. Holton and other employees of the department whom he asked to make statements regarding the alleged substitution. His requests were for specifics of the incidents - if they knew of the practice, who had asked them to do it, and things of that nature. When he got the employees' statements back, he reviewed them and took them to the personnel office for advice. Thereafter, he notified Respondent by mail of her termination. Mary Ann Hinds worked at the Endoscopy section as an LPN during the period July, 1982 through September, 1983 assisting physicians, including Dr. Varraux, in bronchoscopy procedures. She contends that at some time during October or November, 1982, Respondent called her into the office and advised that cocaine would no longer be used in bronchoscopy procedures and xylocaine would be substituted. She says she was told to chart the initial 4 percent xylocaine solution but not the 10 percent xylocaine solution she would give to the doctor without telling him of the substitution even though the doctor might ask for cocaine. She says that Ms. Bailey told her this would be done because during a prior procedure when the assistant used xylocaine instead of cocaine, Dr. Varraux did not know the difference and Bailey concluded that they would use the xylocaine instead of cocaine thereafter. Ms. Hinds did not question this because Respondent was the head of the department. Ms. Bailey was, in her opinion, difficult to talk to and as a result of these instructions, she followed this new procedure from the time of the instruction on through January, 1983. During this period, she saw Mr. Rosenau and Mr. Hooper also do the same thing. Although Ms. Hinds was quite definite in her testimony regarding the conversation with Ms. Bailey, she is significantly less sure of her testimony regarding control of drugs on the ward. For example, she cannot recall ever signing any proof of use forms. She contends that the LPNs and technicians did not sign off on the drug book. They would tell the Respondent what was used and she made the entries. When cocaine was to be used, she got it from a bottle in the Respondent's office. Helen Williams also worked under Respondent in the endoscopy section until January, 1983 assisting doctors with bronchoscopy procedures. When she first came to work in this section, she did not know that cocaine was being used. She recalls that in a conversation shortly after she came to work, Respondent told her they were using 4 percent xylocaine solution in place of a cocaine solution because they had done it one time with Dr. Varraux and he did not notice and as a result, they continued to follow this procedure. However, Ms. Williams, though she subsequently heard from Rosenau that substitutions were being made, never saw it done nor did she ever substitute. Though she says she advised Respondent she didn't think this substitution was a good idea, Respondent is supposed to have replied that this is the way it was done. Ms. Williams accepted Ms. Bailey's word when told that there was no cocaine on the unit and that cocaine was not being used even though the drug book at the time showed 27 cc of cocaine solution unused and on the unit. She discussed this with Ms. Bailey and concluded that if her supervisor knew about it, that was sufficient, and she did not report this to anyone else. She also did not report her knowledge of the substitutions being made to anyone else because she did not feel it was her place to do so since Respondent was the section head and knew about it. Ted Hooper, also an endoscopy technician, did bronchoscopies with Dr. Varraux for several years and toward the end, substituted xylocaine for cocaine in these procedures without telling the doctor what he was doing. He had seen Rosenau substitute xylocaine while he was watching procedures to learn how to do them before becoming a technician. When he asked Bailey about this, he says, she responded that it was done, for one reason, because it was cheaper for the patient. She also told him it was all right to do this as it had already been taken care of. She did not tell him, outright, to make the substitution but because she had said it was taken care of, he thought it was permissible. However, he also contends that he observed cocaine being used by Hinds and others in Dr. Varraux' cases after he became a technician in July, 1982. James E. Hardy, in October, 1982, employed as a transporter in the Endoscopy section of ORMC, also assisted in bronchoscopies, working at times with Dr. Varraux and he was aware of the practice of substituting xylocaine for cocaine in these procedures. When he first went to work in the section, he says, he was asked to substitute by Respondent who told him it was being done because it was cheaper for the patient but refused to do so. To his knowledge, however, he does not recall seeing the substitution actually performed. On one bronchoscopy he recalls, which he set up, cocaine was used which he got from Respondent. Mr. Rosenau testified at the March, 1985 hearing. He clearly indicated that xylocaine was substituted for cocaine in the procedures performed by Dr. Varraux and the cocaine they had on hand was rarely taken from the drug locker. He absolutely denies that during all the period of time he was working with Respondent, he ever discussed with her or admitted to her that he had substituted xylocaine for cocaine nor did Respondent ever tell him to do this. In fact, he cannot recall how this practice got started. Here it should be noted that Rosenau, Hardy, and Hooper were all friends of Mr. Rogers and at least Rosenau and Hardy owed their employment at the time to him. Respondent was recognized by Dr. Bone as partially responsible for the growth of the Endoscopy section at ORMC. He recalls her as being an exceptional nurse: reliable, dependable, and proficient - a perfectionist who did an excellent job. He had complete confidence in her ability and in her honesty and integrity. If he asked her to do something, she did it more reliably than others. Because of her perfectionist nature, however, she may have alienated people and turned them away, but he never had any doubts about her nor did he ever have any reports from other doctors that she did not do her job well. He worked with her until she left the hospital. She was a "take charge" person but never exceeded her authority or deviated from prescribed procedures or doctors' orders. This opinion of Respondent is shared by Christina Stephens who worked under Respondent for a period of time. She found the Respondent to be stern, regimented as to order of procedures, and very organized, but she never saw any irregularities by the Respondent in carrying out doctor's orders. As to Mr. Rosenau, however, of whom she also had some knowledge, she found him to be somewhat unprofessional in his patient care and actions and brought this to the attention of the supervisor by written report on several occasions. This was, however, several years prior to the time in issue here and she has not worked with him since 1976 nor does she have any knowledge of his performance since that time. Respondent began work at ORMC after she was a student in the respiratory therapy program there at the request of Mr. Rogers. She started as a pulmonary rehabilitation technician part time. At that time, there were only two employees in the section. When, after a few months, the supervisor left, Respondent took over. Over a period of time, new procedures were introduced including gastroenterology and Respondent was trained in them as she went. She began doing more of the latter than pulmonary rehabilitation even though she remained head of that section. She was then asked to help set up an Endoscopy section and started doing those procedures as well. Rosenau was working on the floor in the respiratory therapy section and was having trouble with his supervisor. As a result he wanted to come to work in the Endoscopy section and Respondent arranged a transfer for him even though he had little experience in endoscopy and none in gastroenterology. When she first started working with gastroenterology, the patient and his medication were brought into the section. When the procedure was finished, the unused medication was sent back with the patient. As the section got bigger however, and more procedures were accomplished, this practice began to hold things up. The physicians requested that medications be kept in the section for their use. Respondent resisted this because she did not feel there were sufficient safeguards available to maintain proper control. Nonetheless, the physicians pushed for it but the change did not happen until Dr. Varraux became insistent that the medications be kept there. He worked through Rogers and Holton to get a narcotics box installed on the section. When this was done Mr. Holton gave two sets of keys to the box to Mr. Rogers who immediately turned one set over to the Respondent and gave one set to Rosenau. When Dr. Varraux decided to use cocaine for anesthesia he discussed it with Rogers and Holton since Respondent did not have the authority to request it. As a result, the pharmacy began dispensing 60 ml bottles of cocaine solution for use in bronchoscopies with a control sheet accompanying it to be kept in the locked portion of the bronchoscopy cart. Again, Respondent and Rosenau both had access to this cart. In fact, Rosenau had access to every key that Respondent had except the one to her desk. According to the Respondent, she had difficulty with Rosenau regarding drugs on several occasions when he would draw narcotics into syringes, a procedure he was neither trained nor authorized to do. In the Spring of 1982, bronchoscopies were done by nurses who would give valium but cocaine was administered by Rosenau only. However, when cocaine was used, Respondent would sign off on the sheets along with others whose names appeared on the form as administers of the drug. In mid-1982 bronchoscopies were transferred to the respiratory therapy section, by then headed by Rosenau, but this did not seem to work out and after a short period, the procedure was returned back to the endoscopy section, with Rosenau still doing them under the overall supervision of Respondent. Respondent contends that she did not train people to do the bronchoscopy procedures. Rosenau had been doing this for months before all of this took place. Ms. Hinds came to work in late July, 1982, and Respondent had no control over bronchoscopies at that point as they were in Rosenau's section. As to Hardy, she characterized him as an errand boy who was never trained to do bronchoscopies and with whom she never discussed them. She did, however, have a discussion with Rosenau on one occasion about cocaine. She relates that on this particular instance, Rosenau advised her in confidence that he had substituted Xylocaine for cocaine by mistake on a bronchoscopy performed by Dr. Varraux and wanted to get it off his chest. He assured her that if she would give him another chance, he would never let it happen again. Here, even though Rosenau had a previous disciplinary record which she had discussed with Rogers, she decided to take no action because she felt it would be fruitless. Rogers had taken no corrective action against Rosenau in the past and she had no reason to believe he would do so now. Rosenau, as was seen above, denies this conversation but no doubt it did occur. Respondent does not know why she was terminated and was shocked by the action. Rogers had mentioned something about cocaine and had given her an opportunity to resign but she refused. She claims to know nothing about the dilution of the cocaine solution. She claims to know nothing of the substitutions of xylocaine for cocaine other than that reported to her by Rosenau. She categorically denies ever telling Hinds, Williams, or anyone else to substitute xylocaine for cocaine. Counsel for Respondent spent considerable time attempting to establish that the charges against her are the result of a plot by Rogers, Rosenau and others at the hospital to remove her from her position. At best, the evidence shows a lack of control within the respiratory therapy section. There does appear to be a decided relationship between Mr. Rogers and Mr. Rosenau but Respondent has failed to establish that this relationship manifested itself in a plan to bring about her unjustified separation. The evidence establishes that xylocaine was substituted for cocaine and there is some substantial evidence to indicate the Respondent had some knowledge or information indicating that this was being done. There is no credible evidence, however, to establish that Respondent herself substituted xylocaine for cocaine or instructed or directed anyone else to do so. At worst hers is a sin of omission rather than commission.
