Findings Of Fact At all times pertinent to the allegations involved in this hearing, Respondent, Robert A. Lieberman, was licensed to practice medicine in the State of Florida. John P. Spanogle, an investigator with the Department of Professional Regulation since 1980 and with the Board of Medical Examiners prior to that back to 1975, in November, 1979, was requested by representatives of the Orlando Florida Police Department to work with their detectives in several ongoing drug investigations. Respondent was not the subject of any of those particular Orlando Police Department investigations. However, during the course of these investigations, Mr. Spanogle secured certain prescriptions for Class II controlled substances that were written by the Respondent. As a result of these prescriptions, Mr. Spanogle interviewed the Respondent on July 7, 1982, at Respondent's office. At the outset of the interview, Mr. Spanogle advised Respondent of the nature of the allegations and of his rights regarding being questioned. He found Respondent to be extremely cooperative and received full answers to the questions asked, as well as patient release forms and patient records as to the patients listed in the various counts of the Administrative Complaint. During the course of the interview, Mr. Spanogle and Dr. Lieberman discussed several of the doctor's patients and the prescriptions he had written for them over the period in question. Dr. Lieberman seemed surprised he had prescribed so many Percodan and other drugs and could not readily explain why he had written so many prescriptions. Only one of the doctor's former patients testified for the Petitioner at the hearing. This was Linda Gorsuch Creed, a/k/a Linda Clary Morgan, the individual described in Count I of the Administrative Complaint. Ms. Creed is a former drug abuser who started abusing drugs when she was 18 years of age. She is now 26. During the course of her drug abuse, she used such substances as heroin, Dilaudid, Demerol, and others, injecting them into her arms and hands. She first saw Respondent in early 1979 for the purpose of securing drugs. Dr. Lieberman did not know this, however, because her stated complaint was of not being able to have sex without pain. This, however, was false. During the first visit, she was examined by the Respondent and was nude except for the examination gown. She cannot state whether she had drug injection track marks on her arms, but imagines she did since she was using drugs at the time. She does not know whether Respondent saw them, if in fact she had them. Respondent denies noticing any track marks on the witness; and on the basis of the evidence as presented, it can be concluded, reasonably, that Dr. Lieberman was not aware that this patient was in fact a drug abuser. During the first visit, she asked for Dilaudid and Valium and was given a prescription for both. Several months later, she again visited Dr. Lieberman for the purpose of securing drugs. On this visit, she complained of cramps, which again was not true, but at the conclusion of the visit was issued a prescription for Dilaudid. Approximately four years later, she again visited Respondent for the purpose of procuring drugs. At this time, she was mainlining and presumes that she had tracks which she feels may have been seen by the doctor. However, she asked for and received drugs based upon her represented "illness" and the Respondent's examination of her. Just about this time, she was arrested for drug abuse. At the time of her arrest, she had a prescription bottle for Dilaudid and one with Valium in it, both of which she had received from the Respondent. While she was out on bond, she again went to see the Respondent and asked for drugs. He refused, however, to give her any at this time because he had finally become aware that she was abusing drugs. She saw him several times thereafter and, on each occasion, he gave her only legitimate prescriptions; and she has not taken any illegal drug since 1980. The testimony of Dr. Lieberman on this same patient is consistent with that of the patient herself, though from a different perspective. The doctor's records reflect that the first visit from this patient on January 10, 1979, concerned her claim that she had had no period for three months and was in great pain. Examination revealed that her stomach was distended. He did a pelvic examination and found that her vagina was inflamed and she had a vaginal discharge. He gave her antibiotics for the infection and suggested that she have a laparoscopy examination in which a light device is passed through the navel into the fallopian tubes. The conditions described by the patient, if true, are in fact painful. The lack of period can be extremely painful because as a result the organs are swollen with fluid. The vaginal discharge and the history associated therewith indicated a possibility of pelvic disease and an inflammation of the fallopian tubes. It was for this reason that the laparoscopy was suggested. Because it was obvious that the patient was suffering great discomfort and because of her representation that Dilaudid was all that helped her (she was allergic to codeine and aspirin), he prescribed that drug for her. It is significant to note here that her allergy to codeine and aspirin limited the painkillers she could take and, as a result, which he could prescribe. He states that at the time of the examination, he saw no drug tracks on her body and did not know that she was an addict. He cautioned her on Dilaudid's addictive propensity and wanted her to have the laparoscopy so as to get her off Dilaudid as soon as possible. Dr. Lieberman was again visited by Ms. Creed in March 1979, approximately two months after the first visit. During this second visit, in which she stated she again had no period in the intervening two months since the first visit, the examination reflected that her stomach was tender, as were her organs, as well. The doctor gave her a hormone to start and regulate her periods and Dilaudid for the pain. On each prescription, Dr. Lieberman prescribed 20 capsules of Dilaudid. This drug is for severe pain, and he prescribed it only because, in his professional judgment, he felt she was in pain severe enough to justify it. Wilda Sue Boudreaux, another of Respondent's former patients, went to see him in May 1979, for the treatment of female problems. Dr. Lieberman recommended she have a hysterectomy, to which she agreed. She went into the hospital on May 23, 1979, for that operation and a bladder tac with removal of preexisting adhesions. Both operations were successful, and she was released after seven days' hospitalization. Dr. Lieberman saw her several times during her postoperative course of treatment. The surgery was done during the second or third day she was in the hospital. After the surgery, she was having severe pain and complications with a nerve in her leg that had been nicked during the hysterectomy surgery. After she was released from the hospital, because of these conditions, she was in constant, severe pain to the point she could not walk. Pain radiated through her leg and her lower body. She communicated these complaints to the doctor and received from him a prescription for Percodan. The Administrative Complaint alleges she received prescriptions on June 4, 5 and 19 and September 4 and 12. Ms. Boudreaux admits having received all prescriptions except the one on June 5 and denies emphatically that she received prescriptions for Percodan two days in a row. At the time the doctor prescribed Percodan for her, he told her it was a strong drug and should be taken carefully. She requested it, however, because it was the only drug that helped her. A couple of months after this surgery, she developed a urinary infection which resulted in severe pain during urination. She also continued to have severe pain in her left side where the leg nerve damage was and repeated pain from the prior surgery. She went back to the Respondent for a follow-up visit, and he hospitalized her for further tests. As a result of the tests, it was determined that the pain was due to severe nerve damage and that the pain would continue for some extended time until the nerve damage healed. Ms. Boudreaux considers Dr. Lieberman to be a good doctor who was concerned about her as a patient and who, at the time he gave her a prescription, explained to her why she was having the problems, what drugs he was giving her and what the drugs were for. It is her opinion that, throughout the entire period of time she was in contact with him, he appeared to be concerned about her as a person, not only as a patient. Respondent's testimony regarding his treatment of this patient was consistent with hers. He first saw her in March 1979, when she had a complaint regarding constant vaginal bleeding, painful periods and, as a result, he determined that she needed a complete hysterectomy, including complete removal of the tubes and ovaries, and surgery for preexisting bladder problems. During that operation, she sustained damage to a nerve which resulted in constant pain in her leg and abdomen. Nerve damage is one of the slowest types of damage to heal. As a result, this patient experienced constant pain over a long period after the surgery. On top of that, she developed a urinary tract infection as a result of the bladder surgery. As a result, she was maintained on Percodan until the infection cleared up and the nerve damage repaired itself. In the doctor's opinion, all the prescriptions for Percodan were appropriate. It is important to note here and with regard to the other allegations not the date of the prescriptions, but when and how they were to be used. Ms. Boudreaux is a school bus driver and a very responsible person; and Dr. Lieberman felt it was appropriate to prescribe Percodan as he did for her to stockpile them so that she would not have to come back into his office so often. In fact, she did not come back after June 19 until September 4, almost three months later. At that point, she still had the nerve damage and the bladder infection was first discovered. Petitioner made much of the fact that there may have been a less addictive drug that could have been used, both for this patient and for Linda Creed. Respondent claimed, however, that, based on his knowledge of the case of the individuals, he had no reason to disbelieve them; and in the case of Linda Creed, when she said Dilaudid had worked previously, he prescribed that in good faith. There is no evidence to show he did other than that in any case. Regarding the allegations pertaining to patient Patricia Rousseau, the patient information reflects that when first seen by Dr. Lieberman, Ms. Rousseau was a 30-year-old waitress with one child. She appeared well kept and was the sole support of herself and her child and needed to continue to work. At the first visit on July 9, 1979, Ms. Rousseau came in for an abortion, which was accomplished. At the time of her release, Dr. Lieberman prescribed 20 Percodan tablets to be taken one every six hours because, in this case, he thought it was medically indicated. Ms. Rousseau indicated she was in severe pain; and, based on the doctor's experience, he was convinced that, as a result of the procedure followed surgically, the pain could last for at least five days, which was the time it would take to use 20 tablets, taking one every six hours. Dr. Lieberman saw Ms. Rousseau again in January 1980. By this time, she had gotten pregnant again and wanted another abortion. She advised him that she had been to a clinic for that procedure and had developed an ovarian cyst. When Dr. Lieberman examined her, he felt that she could have a cyst, which, in his opinion, is a painful condition, and gave her medication for it. Here, he feels Percodan was indicated because of the fact that the condition arose from a second abortion and the additional pain that went along with it. Along with this condition, she also had dismenhorreah, a condition manifesting itself in painful periods, which, according to the Respondent, can be extremely painful and, in some women, totally disabling. Considering the fact that the patient needed to continue to work, as she was the sole support of herself and her child and could not be bedridden because of her period for three to five days each month, he felt Percodan was indicated, which he prescribed 15 or 20 at a time once a month for use during her period. The quantities prescribed were not, in his opinion, excessive. An additional patient who visited Respondent and whose course of treatment was considered to be improper by Petitioner was Martha Star Curtis, whose first visit to Respondent was on July 27, 1978. She was complaining of lower abdominal pain which, upon examination, turned out to result from a pregnancy. On August 2, 1978, this pregnancy was aborted. Her medical history, taken by Dr. Lieberman, revealed a prior ectopic pregnancy in the right tube and a lost tube and ovary. The following year, she had a cyst removed from her left ovary. At her first postoperative checkup, three weeks after surgery, Dr. Lieberman noticed a small ovarian cyst. When she came back a month later, the cyst was larger and was very painful. This pain related to the cyst was magnified because of chronic pelvic inflammatory disease, and Dr. Lieberman proposed to do a laparoscopy. Ms. Curtis had previously agreed that if this procedure had shown anything irregular, the doctor could go in, check it out and take care of whatever problem existed on the condition that her reproductive capability not be removed. As it turned out, upon accomplishment of the procedure, the doctor discovered that Ms. Curtis had substantial internal scar tissue in her pelvic area which had attached itself to her bladder, tubes, ovaries, intestines, interior of the "belly" and other internal and pelvic areas. This creates almost debilitating, constant pain as scar tissue develops, which increases as the scarring advances. Movement makes it worse--even the simple movements of walking, turning, etc. Even when the scar tissue is removed, it comes back unless there is a hysterectomy. Contra to this theory is the testimony of the Petitioner's expert, Dr. Lewis, who opined that movement not of the individual, but of the organ, would create pain. This difference in opinion is not particularly significant, however, as it is hard to conceive how movement by an individual, unless undertaken with an extremely delicate step, would not result in movement of the organs. In any case, since Dr. Lewis did not examine the patient, was not familiar with her nature, her makeup, or her disposition, it is more logical to assume that the physician who treated her over an extended period of time would be more acquainted with her condition and with the results of her activities than would one who sits in his office examining merely records. In this case, therefore, the observations and opinions of Respondent, who treated the patient, who performed the surgery and who was familiar with the individual, prevail. It is also pertinent to note here that Ms. Curtis, at the time this situation was going on, had met a man she intended to marry and bear children for. As a result, she did not agree to have the needed hysterectomy that was the only procedure that would cure the problem and remove the pain, at least until such time as she conceived and bore this man a child. Therefore, under those circumstances, in the opinion of the Respondent, Percodan was appropriate. Even though they are frequent and repeated, in his opinion, in light of her circumstances, her mental, physical, emotional and situational needs, this regimen was called for. While the Physician's Desk Reference indicates the standard dosage of Percodan as one every six hours, it also provides that this dosage can legitimately and should be exceeded when the situation calls for it. It is pertinent, also, to note here that Ms. Curtis at this time was traveling with her intended husband, a truck driver, in his truck, a situation which created more pain than would normally be experienced, and because of that could not come into the doctor's office as often as necessary. Therefore, in light of the fact that she would not agree to the only procedure that would alleviate her pain, the hysterectomy, and insisted on traveling with her putative husband, it was imperative that she receive relief from the pain, and Percodan was the only thing that would do it. Dr. Lieberman also treated a Julie Londy, first on August 18, 1980, when she came to see him, complaining of chronic pelvic pain, chronic bleeding from the vagina and painful periods. This lady was married, wanted no children and desired a hysterectomy. She entered the hospital for that procedure on April 22, 1980, and had a total abdominal hysterectomy plus an appendectomy on April 24, 1980. She was discharged on May 3, 1980. The conjunction of two major surgical procedures may have increased her pain, and her pain may have carried over from the previous condition she was experiencing, thereby reducing her tolerance for pain. Dr. Lieberman prescribed Tylox on three separate days within a six-day period, May 3, 7 and 9, 1980. Tylox is a Class II drug which is indicated for the reduction of pain. The generally accepted dosage is one every six hours, except in extreme discomfort, when the dosage can be increased. In this case, Ms. Londy was experiencing great pain because, coincident with her recuperation from the hysterectomy and appendectomy, she was experiencing a bladder infection; and, since she is allergic to codeine, Demerol, Dilaudid and aspirin and had told Respondent that Tylox was the only medication that would relieve her pain to which she was not allergic, he prescribed that substance. The first prescription was given on May 3, 1980, the day of her discharge from the hospital, and consisted of 40 pills. That should have lasted for ten days at the normal rate. The second prescription, for 30 pills, was given four days later because she was experiencing great discomfort. The third prescription, for 40 more, was administered on May 9, 1980, at her regular follow-up visit, after which the doctor was not to see her again for at least a month. It was his intention, by prescribing so many pills at one time, to give her a restful postoperative recovery; and the large number of pills was an advance. As a matter of fact, after May 9, the doctor did not see her again until late June 1980, some six weeks after the date of the last prescription. At that time, she was experiencing no pain, and neither asked for nor received additional narcotics. Respondent first saw Marilyn Quantrill on February 1, 1977. At that time, the patient, a 21-year-old female, was in early stages of pregnancy and wanted an abortion. This procedure was accomplished on February 7, 1977. Shortly thereafter, she got pregnant again and, despite the fact that she was being beaten by her husband, she decided to have the baby and did. Her husband continued to beat and emotionally abuse her (threats to take the child) to the point that she was a "nervous wreck." When she came to see Dr. Lieberman for the Seconal on July 17, 1978, her condition was such that she could not sleep because of her relationship with her husband, and Respondent gave her the Seconal to help her sleep. She was experiencing difficulty in coping with stress, and this condition is made worse by lack of sleep. She needed to sleep, and he gave her the pills in question to help her sleep. He thought his prescription for one pill per day at night for sleep was appropriate. The total number of Quaaludes prescribed over the five-month period was 210 pills. The period in question accounted for approximately 163 days. This is slightly over one pill per day, not notably excessive. It is also noted that Dr. Lieberman initially prescribed Seconal, thereafter switching to Quaaludes. He discontinued the Seconal because it was not strong enough to provide the necessary effect in light of her situation. It is also noted that Ms. Quantrill's husband was reported to be a drug dealer. When Dr. Lieberman found out this was the case, he not only stopped providing drugs for Ms. Quantrill, he declined to take her as a patient any longer. In the case of patient Stormy Druga (Smith) who received a drug called Eskatrol on three different occasions for weight loss, the allegation is not that the doctor prescribed improper amounts of the drug, but that the drug was prescribed for a purpose not permitted under Florida Statutes. Dr. Lieberman admits prescribing the drug on the date set out and the amount. He had used this drug for this patient before because she was overweight. She had just had a hysterectomy, was getting a divorce and desperately wanted to lose weight to improve her appearance. The prior use was successful in that she lost 30 pounds. Though Dr. Lieberman subscribed to numerous publications, he did not know that Florida had changed the law, prohibiting the use of Eskatrol for diet purposes. During the period in question, from August through November 1980, Ms. Druga came in every month for a weight control regimen, and he prescribed 30 pills each visit for a total of three visits. Unknown to him, the Florida Legislature had recently changed the law, prohibiting the use of any amphetamines or sympathomimetic amine drug or a compound designated as a Schedule II controlled substance, except for certain conditions of which weight control is not one. The first notice that Dr. Lieberman had that the law was changed was a bulletin issued by the Department of Professional Regulation in February 1981, three months after he stopped the prescription. In that regard, Dr. Lewis, the Petitioner's witness, stated that according to his experience, a doctor becomes aware of a change in one of several ways: (1) drug company flier, (2) a pharmacist's comment, and (3) national subscription-type letters. However, the State does not normally send out any bulletins regarding changes at the time the change is considered or initially made. Under these circumstances, it is quite likely that Respondent was not aware of the fact that the law had changed, prohibiting the use of Eskatrol for weight control purposes, during the time he prescribed it for Ms. Druga, as alleged. Each allegation against Respondent was evaluated by an expert in the field of obstetrics/gynecology for both Petitioner and Respondent. Petitioner's expert, Dr. Lewis, concluded, with regard to Ms. Rousseau, at least, that Respondent's charting is weak; he did not indicate on the record if the patient was seen on any of the visits which resulted in the issuance of a prescription and that Percodan, in this case, was prescribed without any clinical entry of observations on the records. On the other hand, Respondent's expert, Dr. Harry J. Stone, concluded that Percodan was appropriate in both the substance and the amount prescribed for Ms. Rousseau, a total of approximately 320 capsules over a two-plus-year period. If, as was claimed by Dr. Lewis, none of the prescriptions are charted, even that does not constitute malpractice because, according to Dr. Stone, in the practice of obstetrics end gynecology, quite often medications are not charted when the doctor is called out on an emergency situation before he can put it on the chart. As to Ms. Druga, Dr. Lewis indicated that Eskatrol was withdrawn from market use for weight control in 1980 because so much got into the Black Market and because of the undesirable side effects of amphetamines. The records examined by the doctor, which cover a period of time not alleged in the Administrative Complaint, show that over a period consisting of one year, five months and 21 days, Ms. Druga received 480 capsules and diuretics with a total weight loss of 10 pounds. While this is not successful weight loss maintenance, it is nonetheless not unusual depending upon the individual. Dr. Stone, himself, did not know of the change in the law regarding Eskatrol when it went into effect on July 1, 1980, and in his opinion, knowledge of this change within the medical community was poor. Both experts are in agreement that the State does not notify doctors of the changes, as the federal government does. The notices generally go to the pharmacists and, as a courtesy, the pharmacist should have called the Respondent, especially since the prescription here clearly stated it was for diet control. There is no question that prescriptions were issued for Eskatrol by Dr. Lieberman at a time when the law had been changed to prohibit the use of that drug for weight control purposes. It is equally clear, however, that Dr. Lieberman was unaware of the change and that insufficient effort was made by the State at the time to provide knowledge of the change to the various physicians. Turning to Ms. Quantrill, Dr. Lewis feels that because the patient came in and requested Valium and thereafter, as indicated in her letter to the Respondent, took 30 milligrams at one time, which is an excessive dose, Respondent should have suspected that she was likely to abuse drugs. She received prescriptions for 210 Quaalude capsules within a 163-day period. Dr. Stone, on the other hand, opined that the amounts in question were justified based on the emotional strain the patient was undergoing, as well as the pain from her condition. As to Ms. Creed, Dr. Lewis feels that when a patient asks for a particular Class II drug, that is characteristic of an addict, and he does not believe that Dilaudid was called for when Respondent administered it. On the other hand, Dr. Stone, based on the medical records he reviewed, including patient's case history, feels that under the circumstances of the first visit, the prescription of Dilaudid was appropriate in both substance and amount because of the acute pain associated with chronic pelvic disease. The antibiotics that were prescribed by Dr. Lieberman to cure this condition take a long time to work, and the patient needs help to stand the pain. If Dilaudid had worked in the past, it was not inappropriate to use it again. As to the second visit when Ms. Creed got Dilaudid, Dr. Stone feels that again the drug and the amounts prescribed were appropriate for much the same reasons. As to Ms. Boudreaux, Dr. Lewis feels that Respondent's records do not show any complications, and he feels that the drugs prescribed were too much in quantity for an uncomplicated postoperative course. It should be noted here, as elsewhere, that Dr. Lewis, in examining Dr. Lieberman's records, is at times very critical of them as being not complete enough, but at other times relies on them to support his viewpoint. For example, the witness uses the number of pills listed in the record to support the conclusion of over prescription without knowing the patient or having seen her, but when asked if the records say that Respondent stopped prescribing the drugs, this same witness states, "But we don't know what transpired because it's not in the record of what he saw the patient about, whether a medical problem or a drug problem." Dr. Stone, on the other hand, is of the opinion that the prescription of Percodan for Ms. Boudreaux was appropriate because of the combination of the two operations., the insertion of a painful catheter for a long period (six days) , the infection (which was painful) and the nerve injury (very painful). Because of the second hospitalization for the infection in September, Dr. Stone feels that the Percodan prescribed in September and October was appropriate. There does not appear to be an opinion from Dr. Lewis on the treatment given to Ms. Curtis. Dr. Stone, however, opines that the Percodan prescribed by Respondent for this patient from March to July 1979, was justified because of the repeated surgery. A second operation in the same area as former surgery is very painful. This drug can be given and was given at a prescribed rate of one every four hours as necessary for pain. In the opinion of Dr. Stone, this is reasonable, even though the Physician's Desk Reference calls for administration of one every six hours. In addition, continued use, which admittedly this patient had done, develops a tolerance which can result in raised usage. Therefore, even though Dr. Lieberman prescribed 830 pills over 121 days, a rate of almost seven a day, while higher than normal, this is not so aberrant a prescription rate under these circumstances as to be considered necessarily inappropriate or constitute substandard practice. Dr. Lewis also did not give an opinion as to Ms. Londy, for whom Tylox was prescribed. Dr. Stone, on the other hand, felt that the use of Tylox in the amounts prescribed was justified. Here, the patient had undergone major surgery, including an appendectomy, had had implanted a drain and had developed a fever, which indicates infection, with swelling and pain. All of these conditions justify the use of the drug in the amounts. Though the total quantity may seem high, it should be noted, however, this was only for a short period, and the pain of all the surgery and the patient's condition under these circumstances rendered this prescription in this amount not necessarily inappropriate. Based on his overall evaluation of the various patient records and his knowledge of Dr. Lieberman gained from observing him on staff at Florida Hospital and Respondent's excellent reputation as a gynecological and obstetrical surgeon in his community, he is satisfied there has been no gross or repeated malpractice in what Dr. Lieberman has done. Further, his review of the records reveals no indication of fraud, trickery, or any of the other alleged deceptive representations or any indication of bad faith on the part of the Respondent. Petitioner offered no evidence of these latter characteristics. Turning to the issue of medical stockpiling, however, Dr. Stone is quick to admit and recognize that the stockpiling of medicines as was done here in some cases by this Respondent is not a good idea. However, in the world as it exists, it may in some cases, and he is of the opinion that it was in the cases here, be acceptable practice, and not malpractice. Respondent, who has treated approximately 10,000 patients since he entered medical practice in 1976, routinely prescribes controlled substances in his practice. When he does so, he uses a high degree of care because of the addictive nature of Class II drugs. Before prescribing, he considers the individual and their medical problem needs. Modern OB/GYN practice allows physicians in these specialties to serve as "full" physicians to women, and they can treat their patients for illnesses other than those related to the OB/GYN practice. Under this situation, the doctor is required to also consider the emotional, physical, psychological and socioeconomic needs of his patients. It is wrong to merely consider records. A doctor treats people.
Recommendation On the basis of the above, it is, therefore, RECOMMENDED: That the Administrative Complaint against Respondent, Robert A. Lieberman, M.D., be dismissed and no disciplinary action be taken against him on the basis of the activity alleged in this Administrative Complaint. RECOMMENDED this 31st day of January 1984, in Tallahassee, Florida. ARNOLD H . POLLOCK 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 31st day of January 1984. COPIES FURNISHED: Barbara K. Hobbs, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Herbert M. Hill, Esquire Thomas Michael Burke, Esquire Post Office Box 1873 Orlando, Florida 32802 Mr. Fred Roche Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Ms. Dorothy Faircloth Executive Director Board of Medical Examiners Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301
The Issue The issue for determination is whether Petitioner must reimburse Respondent an amount up to $1,676,390.45, which sum Petitioner received from the Florida Medicaid Program in payment of claims arising from Petitioner's dispensing of pharmaceuticals between July 3, 2000 and March 28, 2002. Respondent alleges that the amount in controversy represents an overpayment related to Petitioner's failure to demonstrate the availability of sufficient quantities of drugs to support its billings to the Medicaid program.
Findings Of Fact Respondent Agency for Health Care Administration ("AHCA" or the "Agency") is the state agency responsible for administering the Florida Medicaid Program ("Medicaid"). Petitioner Disney Medical Equipment, Inc., d/b/a Disney Pharmacy Discount ("Disney Pharmacy"), was, at all relevant times, a Medicaid provider authorized, pursuant to contracts it had entered into with the Agency known as Provider Agreements, to receive reimbursement for covered services rendered to Medicaid beneficiaries. Exercising its statutory authority to oversee the integrity of Medicaid, the Agency directed its agent, Heritage Information Systems, Inc. ("Heritage"), to conduct an audit of Disney Pharmacy's records to verify that claims paid by Medicaid during the period from July 3, 2000 to March 28, 2002 (the "Audit Period") had not exceeded authorized amounts. Over the course of four days in May 2002, three of Heritage's auditors reviewed records on-site at Disney Pharmacy's drugstore in Hialeah, Florida; they also interviewed some of the store's personnel. Thereafter, Heritage analyzed the data it had collected using several different approaches. Each approach pointed to the conclusion that Medicaid had paid too much on claims submitted by Disney Pharmacy during the Audit Period. The total amount of the alleged overpayment differed substantially, however, depending on the analytical approach taken. The approach that yielded the largest apparent overpayment was the "prorated purchase invoice" analysis. Generally speaking, under this approach, the volume of pharmaceuticals that the provider maintained in its inventory during the Audit Period is compared to the provider's contemporaneous Medicaid claims to determine whether the provider possessed enough of the relevant pharmaceuticals to support the Medicaid claims presented. If the total amount purportedly dispensed, according to the claims made in connection with a particular drug, exceeds the amount of that drug available at the time for dispensing, then an inference of impropriety arises with regard to those claims for which product was apparently unavailable; the Agency considers amounts paid on such claims to be overpayments. To determine the quantities of certain drugs that Disney Pharmacy had kept on hand during the Audit Period, Heritage tallied up the total number of "units" of selected drugs that Disney Pharmacy had acquired, using as a database the invoices reflecting Disney Pharmacy's purchases of the drugs under review. Heritage then ascertained——again using Disney Pharmacy's records——the utilization rate of Medicaid beneficiaries for each of the pharmaceuticals under consideration. In other words, Heritage determined, for each drug at issue, the relative demand——expressed as a percentage of the total number of units of that drug dispensed to all customers during the Audit Period——attributable to Medicaid beneficiaries. Heritage found, for example, that Medicaid recipients accounted for 55.13% of Disney Pharmacy's total sales of the drug Acetylcysteine-10% solution ("Acetylcysteine") during the Audit Period. Having calculated the total amount of each drug at issue that Disney Pharmacy had acquired during the Audit Period, and having further determined for each such drug the Medicaid utilization rate, Heritage multiplied the total number of available units of each drug by the applicable utilization rate, prorating the entire supply of each drug to reflect the approximate number of units available for dispensing to Medicaid recipients specifically. For example, Disney Pharmacy's records showed that it had purchased a total of 121,440 units of Acetylcysteine during the Audit Period. Disney Pharmacy's records showed, additionally, that this drug was dispensed to Medicaid beneficiaries 55.13% of the time. Thus, the prorated quantity of Acetylcysteine available for Medicaid recipients was approximately 66,950 units (121,440 x 0.5513). The prorated number of available units of each subject drug was compared to the total number of units for which Medicaid had reimbursed Disney Pharmacy during the Audit Period. For Acetylcysteine, these figures were 66,950 and 1,076,070, respectively. If the total number of units for which Medicaid had paid on claims for a particular drug were found to exceed the amount of that drug which Disney Pharmacy apparently had on hand——as it did for Acetylcysteine——then the inventory shortfall——1,009,120 units in the case of Acetylcysteine——was multiplied by the drug's average per-unit cost to Medicaid, producing a drug-specific apparent overcharge. Thus, for example, because the average cost of Acetylcysteine was $0.65 per unit, the apparent overcharge with respect to this drug was $655,928.00. Using the foregoing approach, Heritage identified apparent overcharges in connection with 13 drugs. The sum of these drug-specific overcharges is $1,676,390.45. Two drugs—— Acetylcysteine and Ipratropium Solution ("Ipratropium")——account for nearly 93% of this grand total. Two other drugs——Albuterol- 0.83% ("Albuterol") and Metaproterenol-0.4% ("Metaproterenol")—— account for another 7.0% of the total alleged overcharge. These four drugs——whose individual overcharges, taken together, comprise approximately 99.8% of the total alleged overcharge of $1,676,390.45——are used for treating breathing disorders and typically are inhaled by the patients who use them.i There is no genuine dispute regarding the reason why Disney Pharmacy was unable to document its acquisition of Acetylcysteine, Ipratropium, Albuterol, and Metaproterenol (collectively the "Inhalation Therapy Drugs") in quantities sufficient to support its claims to Medicaid for these pharmaceuticals. During the Audit Period, Disney Pharmacy generally filled prescriptions for the Inhalation Therapy Drugs by "compounding" the prescribed medications. (Compounding is a process whereby the pharmacist mixes or combines ingredients to fashion a tailor-made medication for the patient.) Thus, Disney Pharmacy (for the most part) did not purchase the commercially available versions of the Inhalation Therapy Drugs; rather, it created its own "generic copies" of these medications, purchasing only the raw materials needed to make finished products. Medicaid reimburses for compound drugs under certain conditions, which will be spelled out below. But first: it is undisputed that Disney Pharmacy did not submit claims for compound drugs. Instead, in presenting claims to Medicaid for the Inhalation Therapy Drugs, Disney Pharmacy billed the medications under their respective National Drug Code ("NDC") numbers, as though commercially manufactured drug products had been dispensed. (An NDC is an 11-digit number, unique to each commercially available pharmaceutical, which identifies the manufacturer, product, and package size.) As a result, Medicaid paid Disney Pharmacy for mass produced products when, in fact, the pharmacy actually had dispensed its own homemade copies thereof. According to the Prescribed Drug Coverage, Limitations and Reimbursement Handbook ("Medicaid Handbook"), which authoritatively sets forth the terms and conditions under which Medicaid reimburses providers for dispensing pharmaceuticals, Medicaid may pay for a compound drug if the following criteria are met: At least one pharmaceutical is a reimbursable legend drug; The finished product is not otherwise commercially available; and The finished product is being prepared to treat a specific recipient's condition. Medicaid Handbook at 9-16.ii To present a claim for a compound drug, the provider must adhere to the following instructions: Compound drug codes must be submitted on paper Pharmacy 061 claim forms, because they are reviewed and manually priced by Medicaid. When billing for a compound drug, enter one of the following compound drug codes. More than one code is available so that more than one compound can be dispensed to a recipient on the same day without using the same number. Id. 55555-5555-55 66666-6666-66 77777-7777-77 88888-8888-88 Disney Pharmacy attempts to defend its failure to follow the unambiguous instructions for billing compound drugs by explaining that, before commencing the practice of compounding, the provider's owner, Sara Padron, made a telephone call to AHCA to ask for guidance on submitting claims for drugs created on-site. Ms. Padron testified at hearing that the AHCA employee with whom she spoke had told her to present claims for compound drugs by billing for the manufactured products that they most resembled, using the manufactured products' NDC numbers. Ms. Padron could not identify the person who purportedly gave her this plainly incorrect advice. Ms. Padron's testimony in this regard was not contradicted——although in fairness to the Agency hers was the kind of testimony that resists direct evidential challenge, forcing an opponent to stress the implausibility of the claim as a means of discrediting it. Ms. Padron's account cannot simply be dismissed as incredible, for an AHCA employee undoubtedly could give an incorrect answer to a provider's question. But even assuming that Ms. Padron reached a person whom one reasonably could suppose to be knowledgeable about Medicaid billing procedures, and further assuming Ms. Padron asked a clear question which fairly and accurately described the situation, neither of which was proved or should be taken for granted, the undersigned remains skeptical that Ms. Padron was instructed to bill for compound drugs as if billing for their commercially available counterparts: the advice is just too obviously wrong. It is not necessary, however, to accept or reject Ms. Padron's testimony concerning the "official" answer she says she received because even if Ms. Padron were told to bill for compound drugs as though manufactured products had been dispensed, no reasonable provider could have relied upon such a dubious oral representation. The statement, for starters, is an invitation to commit fraud. Common sense should inform any reasonable provider that a claim for something other than what was actually delivered will, if discovered, almost certainly be viewed as deceptive (or worse) by the payor. Additionally, the alleged statement attributed to AHCA's employee contradicts the plain instructions in the Medicaid Handbook on that very subject. No provider can reasonably rely upon verbal advice, given anonymously (or functionally so, since the advisor's name, if given, was evidently easily forgotten) over the telephone, which contravenes the clear language of the Medicaid Handbook. Disney Pharmacy's other defenses are likewise unpersuasive. Disney Pharmacy maintains that compounding the drugs in question substantially benefited the patients who received them, which is probably true——but certainly beside the point. The problem here is not with the practice of compounding per se; the problem is that Disney Pharmacy sought and received reimbursement from Medicaid for mass produced, commercially available drugs that had not actually been dispensed. For the same reason, it is irrelevant, even if likely true, that the Board of Pharmacy, which periodically inspects Disney Pharmacy, never objected to the compounding that was occurring at the premises. Again, to be clear, the problem is not that the compounding was improper, but that the Medicaid billing was improper.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Agency enter a final order requiring Disney Pharmacy to repay the Agency the principal amount of $1,676,390.45. DONE AND ENTERED this 11th day of April, 2006, in Tallahassee, Leon County, Florida. S JOHN G. VAN LANINGHAM Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 11th day of April, 2006.
Findings Of Fact The Home is licensed as an assisted living facility. It is also licensed to provide extended congregate care, limited nursing services, and limited mental health services. The Home accepted Respondent as a resident. In July 1998, Petitioner had to transport Respondent to the hospital due to an overdose of medication. Upon his return from the hospital, Respondent told Petitioner's staff that he had taken the overdose intentionally. Thereafter, the Home required Respondent to sign a mental health contract dated September 9, 1998. This contract states as follows in relevant part: Qualifications for the Home requires [sic] that a member or applicant must not be mentally ill, habitually inebriated, or addicted to the use of a controlled substance. With these requirements, I understand that to be eligible and maintain my membership in the Home, I must agree to the terms of this contract. * * * If I use alcohol or any non-prescribed drugs I understand I may be dismissed from the Home. I understand that I will allow the Veterans' Domiciliary Home of Florida to supervise the self-administering of my medications. I will take my medication as it is prescribed by the primary physician. I will only be given my full prescription at the time of my discharge. I understand upon reasonable suspicion of being under the influence of alcohol or illegal drugs, I consent to testing. The Domiciliary Home staff may take a blood, saliva, or supervised urine sample to test for illegal drugs or alcohol. I authorize members of the Domiciliary staff to perform random searches of my person, vehicle, living quarters, or belongings to determine if I am using drugs or alcohol. If I refuse to allow a blood, saliva, or urine test, or search, or if I interfere in any way with the staff's performance of these duties, I may be dismissed. The Home also required Respondent to sign a Dual Diagnosis/Substance Abuse/Psychiatric (dual diagnosis) contract dated September 14, 1998. In addition to terms and conditions similar to the ones set forth above, the dual diagnosis contract provides as follows in relevant part: 10. In order to assist me in gaining freedom from alcohol and drugs, I will not use alcohol, tranquilizers, sleeping medication, over the counter medications, or any other chemical escapes which have not been prescribed by a physician. If I use alcohol or non-prescribed drugs, I understand I will be dismissed from the Home. In November 1998, one of Respondent's doctors wrote him a prescription for Ritalin. Respondent became very upset when a nurse would not administer the Ritalin to him without first checking with Petitioner's staff physician. Eventually, Respondent's primary care physician approved the administration of Ritalin together with Respondent's other medications. In January 1999, Respondent worked for Petitioner as a receptionist. After working overtime on one occasion, Respondent's speech was slurred, his eyes were dull, and his voice was horse. Petitioner's staff became suspicious that Respondent was taking medication in violation of his contracts. Respondent subsequently tested negatively for all substances except his prescribed medicines. In March 1999, Respondent violated his contracts by having a prescription for methadone filled at a drugstore and removing twenty-four of the pills from the bottle before turning the medicine over to Petitioner's staff as required by his contract. Petitioner's staff advised Respondent that he would be dismissed from the Home by letter dated March 23, 1999. Respondent subsequently requested Petitioner's Executive Director to review the decision to discharge him from the Home. By letter dated August 16, 1999, Petitioner rescinded its decision to dismiss Respondent from the Home but warned him that any further infraction would result in his immediate expulsion. On April 14, 2000, Petitioner conducted a routine facility-wide room inspection at the Home. During the course of the inspection, Petitioner found a bottle of Ephedra 250 in Respondent's room. According to the label on the bottle, Ephedra 250 is a dietary supplement that General Nutrition Corporation (GNC) markets. During the hearing, Respondent admitted that he heard about Ephedra 250 on a television show that discussed its benefits as a diet aid as well as its dangerous side effects. The label states as follows in pertinent part: WARNING: Seek advice from a health care practitioner prior to use if you are pregnant or nursing, or if you have high blood pressure, heart or thyroid disease, diabetes, difficulty in urination due to prostate enlargement, or if taking MAO inhibitor or any other prescription drug. Reduce or discontinue use if nervousness, tremor, sleeplessness, loss of appetite or nausea occur. Not intended for use by person under the age of 18. The maximum recommended dosage of Ephedrine for a healthy adult is no more than 100 mg in a 24 hour period for not more than 12 weeks. Improper use of this product may be hazardous to a person's health. Each capsule of Ephedra 250 contains 250 mg of MA Huang Extract (Ephedra sinica) or ( 15 mg of 6 percent Ephedrine). The greater weight of the evidence indicates that Ephedra 250 is an over-the-counter medication despite being labeled as a diet supplement. Ephedrine is a prescription drug in Florida unless an individual dose is less than a specified quantity. Petitioner's staff properly became concerned about Respondent's possession of Ephedra 250 because he takes numerous prescribed medications, which can have serious side effects, if taken with certain other medications. Ephedrine is one of those drugs. For instance, Respondent takes Cozaar for high blood pressure, Methadose to reduce his dependency on Percoset, and Ritalin. Persuasive evidence indicates that large doses of Ephedra can be used as a recreational drug. Respondent knew or should have known that Ephedra 250 was prohibited by his contracts with the Home.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED: That Petitioner enter a final order dismissing Respondent as a resident of the Robert H. Jenkins Veterans' Domiciliary Home of Florida. DONE AND ENTERED this 6th day of October, 2000, in Tallahassee, Leon County, Florida. SUZANNE F. HOOD Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 6th day of October, 2000. COPIES FURNISHED: James W. Sloan, Esquire Department of Veterans' Affairs Post Office Box 21003 St. Petersburg, Florida 33731-8903 William T. Fisher 1300 Sycamore Lane, Suite 148 Lake City, Florida 32025 Lt. Col. Robin L. Higgins, Executive Director Department of Veterans' Affairs Post Office Box 31003 St. Petersburg, Florida 33731-8903
Findings Of Fact The Parties The Petitioner is the state agency that administers the Florida Medicaid program, which includes pharmacies that participate in the program. The Petitioner's Office of Program Integrity is responsible for insuring that the goods and services billed to the Medicaid program are those that are actually provided to Medicaid recipients. Medicaid is a joint program, funded by the federal government and by the State of Florida, and is administered pursuant to both state and federal statutes and rules. All services or goods billed to the program must be necessary, Medicaid compensable, and must also have actually been provided to eligible recipients by providers prior to submitting claims. Any payment made by the Medicaid program for goods or services not actually provided to an eligible recipient is subject to recoupment by the Petitioner, and the provider is also subject to the imposition of administrative fines and exclusion from the program for a specified period of time. The Respondent is a community pharmacy located in a hispanic section of Miami, Florida, which has been owned and operated for the past six years by Frances Larin, a licensed pharmacist, who makes all drug purchases and does all Medicaid billings at the pharmacy herself. Most of Respondent's customers have limited financial resources and are Medicaid recipients. The Respondent has participated in the Medicaid program for approximately eight years, and has not previously been charged with overbilling the Medicaid program. The Respondent has cooperated fully with the Petitioner throughout these proceedings. Prior Review From February to April 1988, the Petitioner's Office of Program Integrity had a review performed of the Respondent's billings to Medicaid from March 1, 1987 to December 31, 1987. This review was conducted for the Petitioner by the Foundation for Health Care, Inc. (Foundation), contract auditors, and resulted in the determination that the Respondent had overbilled the Medicaid program for prescription drugs dispensed to program recipients during the review period. In performing this review, the Foundation used an across-the-board Medicaid percentage of 54% in determining the available units of the various drugs on hand for dispensing to Medicaid recipients. Based upon the Foundation's review, the Petitioner sought recoupment for overpayments in the amount of $28,649.99 by letter to the Respondent dated July 20, 1988, as well as an administrative fine of $7,162.49, and a three month suspension from the program. The Respondent timely sought a formal administrative hearing in which it disputed the results of the Foundation review. However, after the matter was referred to the Division of Administrative Hearings, the Petitioner withdrew its notice of overpayment and imposition of administrative sanctions, and thus, without a determination on the merits, the Division of Administrative Hearings file was closed and jurisdiction was relinquished to the Petitioner. Subsequently, the Petitioner entered a Final Order which provided that the Respondent would be re-audited. The Respondent timely sought judicial review of this Final Order in which it challenged that Petitioner's right to conduct a further review of the period March 1, 1987 to December 31, 1987. However, the District Court of Appeal of Florida, Third District, dismissed the Respondent's appeal, and the Petitioner proceeded with a further review. The KPMG Review (a) For purposes of its further review, the Petitioner employed the public accounting and management consulting firm of KPMG Peat Marwick which designed a statistically valid sampling methodology to determine the Respondent's Medicaid percentage for each drug, and also to perform a management review of the Respondent. It was established by competent substantial evidence in the record, and in particular by the expert testimony in statistics from Dr. Robert Ladner and Robert Peirce, that the KPMG methodology was statistically valid. The KPMG review was conducted during the latter half of 1989, and included developing a Medicaid percentage for individual drugs based upon an analysis of prescriptions for all drugs in question to determine the portion of each drug's total sales that went to Medicaid recipients, calculating the total units claimed for each drug for which the Respondent sought reimbursement during the audit period, and calculating the total units purchased by the Respondent for each drug claimed for reimbursement during the audit period. The Medicaid percentage of each drug was then applied to total purchases for each specific drug to determine the amount of each drug that was on hand at the Respondent's pharmacy for dispensing to Medicaid recipients. This number of available units was then compared with the total units claimed for reimbursement. Where the units claimed exceeded the units available for dispensing, a positive variance was noted, and this number of excess units claimed was then multiplied by the per unit reimbursement amount for that particular drug in order to obtain the amount of the apparent overbilling for that particular drug. Where the total units available for dispensing exceeded the total units claimed for a particular drug, a negative variance was noted. It was stipulated by the parties that negative variances did not indicate underpayments, and the evidence, including specifically the testimony and report of Dr. Victor Pestien, an expert in statistics, does not establish that such negative variances should be offset against the positive variances or that they in any way reduce the positive variances. This is the first instance in which this methodology has been utilized by the Petitioner in seeking a recoupment of an alleged Medicaid overpayment from a pharmacy, and this methodology was not set forth in any rule or regulation of the Petitioner that had been adopted at any time material hereto. Previous audits used an overall Medicaid percentage to calculate the portion of a pharmacy's business that was comprised of Medicaid recipients, and the quantity of drugs that were available to them. Using a drug specific Medicaid percentage, however, is a more accurate and conservative approach to determining overpayments than using a fixed percentage. Based upon the consideration of all evidence in the record, it is specifically found that the greater weight of evidence establishes that the methodology used by KPMG in this review for calculating Medicaid percentages was sound and reasonable, and in no way precluded the Respondent from presenting additional competent substantial evidence to the Petitioner, or at hearing, which would have established different Medicaid percentages for particular drugs. (a) The type of review conducted by KPMG is known as an aggregate analysis, a generally accepted type of statistical analysis, in which drugs that have been billed to and paid for by the Medicaid program are reviewed to determine whether the pharmacy under review purchased or otherwise acquired a sufficient quantity of drugs to justify its billings to Medicaid. Interchangeable brand-name drugs and generic equivalents were grouped together so that in conducting this review, whole equivalent groups of drugs were considered as one type of drug, regardless of differences in individual product names. To obtain a statistically random sample, prescriptions were put in numerical order and every fourth prescription for the review period was examined, and since prescriptions may be refilled for up to a year after they are originally filled, reviewers also examined every prescription for the year prior to the review period. Competent substantial evidence establishes that KPMG performed an appropriate and valid statistical analysis, and that they used an acceptable sampling methodology which produced a truly random result. The underlying assumption of this analysis is that before a drug can be claimed to have been dispensed and billed to Medicaid, the pharmacy under review must have that drug in its possession. (b) The approach taken by KPMG and the Petitioner was to be as conservative as possible in resolving all uncertainties and questions which arose during the course of this review in favor of the Respondent. KPMG did not conduct a financial audit of the Respondent, but did prepare a management report based upon its review of Respondent's operations during the audit period. Data used by KPMG in its methodology in calculating the amount paid by Medicaid to the Respondent, the unit price of drugs dispensed, and the quantity claimed by Respondent for payment by Medicaid, was derived from computer based information provided by the Petitioner's fiscal agent. During the period of time being reviewed in this case, Electronic Data Systems (EDS) was the Petitioner's fiscal agent, while Consultec was the Petitioner's fiscal agent during the period when the KPMG review was actually being performed. When Consultec was selected as the Petitioner's fiscal agent and replaced EDS on January 1, 1989, EDS turned over its computer records to the new agent by copying all of its magnetic, computer files, along with supporting microfiche documentation, which it then provided to Consultec under the supervision of the Petitioner. Upon receipt of these magnetic tapes, Consultec placed them in a controlled environment vault, and then later converted the information on these tapes to a new format used by Consultec. It was established by competent substantial evidence that in this process, no data was added, deleted or changed in any manner. The "units claimed" data was subsequently provided by computer download from the Consultec claims data base directly to the Petitioner's Office of Program Integrity. It was established by competent substantial evidence that data regarding claims which originated with EDS passed through Consultec to the Petitioner's Office of Program Integrity unchanged. Specific information regarding Respondent, including the claimed quantity of drugs dispensed and amounts paid, was accessed by staff in the Office of Program Integrity, randomly verified, and then made available to KPMG. Both Consultec and EDS are nationally recognized data processing and management companies. Competent substantial evidence established that the claims processing function utilized by the Petitioner in the Medicaid program during the period at issue was subject to several quality control checks to insure that claims were properly processed and appropriate payments were made. On occasion claim adjustments were made, but these were reasonable and for good cause, such as a substantiated underpayment. The computer hardware utilized in this process was reliable and properly maintained. In order to verify the data used by KPMG concerning the dollar amount of claims paid and the quantity of units of medication claimed, an "audit trail" was performed using 140 randomly selected sample claims by tracing each claim from its claim reference number to its associated remittance voucher and cancelled checks, where available. This audit trail verified that the data used as the basis for quantity claimed and total dollars paid was valid and reliable. The KPMG review was not limited to the top 100 drugs, by volume claimed, during the audit period, but included each drug dispensed by the Respondent to Medicaid recipients during the audit period. In its report dated November 20, 1989, KPMG calculated a total Medicaid overpayment to Respondent of $30,452.59, and based thereon, the Petitioner notified the Respondent that it was seeking recoupment of this amount, as well as an administrative fine of $2,000 and termination from the Medicaid program for at least two years. Subsequently, however, the Petitioner and KPMG reviewed and considered additional invoices documenting additional purchases of drugs in question by the Respondent during the audit period, and prepared a revised report dated August 30, 1990. Based upon this revised report, the Petitioner sought recoupment of a revised, reduced overpayment calculated to be $21,939.93, as well as a $2,000 administrative fine and a minimum two year termination from the program, and it was on this basis that this matter proceeded to final hearing. The Top 100 Drugs Subsequent to the final hearing, the Petitioner issued an amended recoupment letter dated October 17, 1990, which limited the recoupment it is seeking in this matter to the top 100 drugs, by dollar volume of claims, plus their generic equivalents. This resulted in the elimination of many individual drugs with relatively small overpayments from the list of overpayments, and left only five instances among these top 100 drugs where the difference between the quantity available, adjusted for standard error, and the quantity claimed is less than 100 units. In many instances the difference is well in excess of 1,000 units. The sanctions being sought in this amended recoupment letter further reduced the recoupment being sought to $12,643.11, reduced the administrative fine to $1,400, and reduced the period of exclusion from the program that is being sought to 16 months. However, due to an error in calculating the top 100 drugs and equivalents, the Petitioner issued a second amended recoupment letter dated October 26, 1990, further reducing the administrative fine sought to $1,200 and reducing the period of exclusion to 14 months. Inventory Analysis In performing its review, KPMG obtained information concerning the quantities of drugs purchased during the review period by the Respondent directly from the pharmacy's wholesalers and from a review of invoices retained by the Respondent for a period that included one month prior to the review period through one month after the review period (February 1, 1987, to January 31, 1988). The effect of seasonal variations in pharmacy sales and ordering patterns was also taken into account, and balanced, by extending this period to a full twelve months. All documentation concerning drug acquisitions was requested from Respondent, and the information received and considered by KPMG and the Petitioner was checked for reasonableness by a consultant pharmacist and cross validated by two reviewers. It was stipulated by the parties that the Respondent's main wholesaler, Gulf Distribution, Inc., had and maintained accurate information and records regarding its sales to the Respondent, and that it properly transferred that information to computer disks which were provided to KPMG. Subsequent thereto, additional invoices were discovered and were also made available to KPMG. The Petitioner stipulated that these additional invoices from Gulf did not reduce the number of drug units purchased by, and invoiced to, Respondent. Pharmacies in Florida which choose to participate in the Medicaid program are required to maintain complete and accurate patient and fiscal records which fully substantiate the extent of services rendered and billings made for a period of five years from the date of billing or service, and are also required to retain all invoices from wholesalers, or from the transfer or receipt of drugs through barter or exchange, for a period of five years. (a) Actual beginning and ending inventories of the top 100 drugs reviewed by KPMG for which the Petitioner now seeks recoupment in the amount of $12,643.11 were not determined. Rather, an estimate of inventory on hand was derived by counting invoices of all drug acquisitions through purchase, transfer or exchange made by the Respondent during the review period, as well as invoices of acquisitions made one month prior to and one month after the review period. Additionally, all documentation provided by the Respondent of bulk, or large, acquisitions made during or prior to the review period was also considered and included in the Petitioner's estimate of inventory. It was established by competent substantial evidence that pharmacies generally keep a drug inventory consisting of a two to two-and-a-half week supply on hand, and acquire drugs in anticipation of future sales rather than as a replacement of inventory depletion from past sales. Therefore, a basic assumption of the KPMG methodology, relied upon and accepted by the Petitioner, that Respondent had only those drugs available for dispensing which were obtained by invoiced purchase from wholesalers, or through transfer or exchange, between February 1, 1987 and January 31, 1988, as well as documented invoiced bulk purchases prior to this time period, is reasonable. At hearing, the Respondent established that a significant quantity of nine specific drugs were purchased during the review period from suppliers other than Gulf that were not considered by KPMG. These drugs include Xanax (.5 mg.), Inderal (10 mg.), Tagamet (300 mg.), Nitrostat (.4 mg.), Trental (400 mg.), Motrin (400 mg.), Motrin (600 mg.), Quinamm (260 mg.), and Quinidine Sulfate (200 mg.). It is, therefore, found that the overpayment of $2,902.19 calculated by KPMG and relied upon by the Petitioner for these particular drugs has not been supported by competent substantial evidence. Frances Larin, Respondent's owner and operator, testified that she did not follow the generally accepted practice of retaining only a two to two-and-a- half week supply of drugs on hand. Rather, she testified that for a significant number of the top 100 drugs at issue in this proceeding, she would purchase large quantites in bulk, and was thus able to draw down on these inventories without making additional purchases of particular drugs for over a year. The Respondent sought to establish that due to very large beginning inventories of particular drugs at issue, it was able to legitimately dispense more units during the review period than it purchased during the same time. However, the Respondent did not produce evidence in support of its position, such as invoices for bulk purchases which KPMG or the Petitioner did not consider, or complete records of bartering or transfers which had not been considered, and which would have supported its claim of a significantly larger beginning inventory for these particular drugs than would be the generally accepted practice. To the contrary, competent substantial evidence in the record, as well as the demeanor of Larin while testifying, establishes that Respondent's claim is unreasonable and lacks credibility. The deposition testimony of JoAnn Padell is outweighed by the testimony of Deborah Launer, Susan McCleod, and Robert Peirce. A review of the Respondent's purchasing patterns clearly shows that Respondent generally and routinely kept low inventories of drugs on hand, placing daily orders with Gulf to obtain drugs on an as-needed basis. Recoupment Based upon the foregoing, it is found that competent substantial evidence establishes that the Respondent overbilled the Medicaid program during the review period at issue in this case in the amount of $9,740.92 ($12,643.11 claimed in the second amended recoupment letter minus the $2,902.19 claim associated with the nine specific drugs for which significant purchases were omitted from the KPMG review, as found above at Finding 13). Petitioner is authorized to recoup the established overpayment of $9,740.92 from the Respondent. Sanctions (a) In determining the sanctions stated in the second amended recoupment letter which Petitioner seeks to impose upon the Respondent, the Petitioner considered the provisions of Section 409.266(13), Florida Statutes, as well as the impact which sanctioning this Medicaid provider would have upon Medicaid recipients. Competent substantial evidence establishes that there are eight pharmacies which accept Medicaid within a one mile radius from the Respondent's location, and twenty-six such pharmacies within a two mile radius. Medicaid recipients are issued new cards each month and may transfer pharmacies at the beginning of each month. Therefore, it is found that Medicaid recipients would not be substantially affected by the imposition of sanctions upon the Respondent. The parties stipulated that the sanction matrix set forth in Rule10C- 7.063, Florida Administrative Code, was not applied by the Petitioner against the Respondent in this case because it was not in effect at the time of this review. The sanctions which the Petitioner seeks to impose against the Respondent, therefore, are based upon non-rule policy which must be explicated in this proceeding. In seeking to explicate its non-rule policy upon which the sanctions set forth in the second amended recoupment letter are based, the Petitioner established that it was concerned that sanctions imposed in prior cases, as well as in the original recoupment letter which had been sent to the Respondent in this case, had been too lenient in view of the seriousness of Medicaid violations. The Petitioner developed its non-rule sanctions policy after the KPMG review had been completed, and based its proposal upon the maximum sanctions set forth in state and federal statutes and rules. Specifically, Section 409.266(12), Florida Statutes, provides for a maximum fine of $10,000; the maximum exclusion period applied in previous cases by the Office of Program Integrity is ten years, and the minimum exclusionary period imposed by the federal government has been five years for the failure to supply payment information. At hearing, the Petitioner explained that it first determined the percent of Respondent's total Medicaid payments that the overpayment represented, and then applied that percentage to these maximum sanctions allowed under law and existing policy. The overpayment of $12,643.11 claimed by the Petitioner in its second amended letter of recoupment is 12% of the total payment of $100,397.88 made by the Petitioner to Respondent for the review period, and 12% of the maximum fine and exclusion period is $1,200 and 14 months, respectively. While the Petitioner explained the manner by which this exclusionary period and fine were calculated, it did not explicate its non-rule policy by establishing a reasonable, rational basis for applying the percentage of Medicaid overbillings to the maximum fine and exclusionary period. Certainly, the arithmetic calculation used to arrive at these proposed sanctions is clear, but there was no explication through competent substantial evidence which would establish that there is a basis in fact or logic for this calculation. Therefore, it is found that the Petitioner's non-rule policy used to propose these sanctions is arbitrary and capricious. Due to the lack of any evidentiary basis in the record which would support the imposition of the sanctions of an administrative fine or a period of exclusion from the Medicaid program, the Petitioner is not authorized to impose sanctions on the Respondent.
Recommendation Based upon the foregoing, it is recommended that Petitioner enter a Final Order which requires that Respondent to repay the Petitioner for Medicaid overbillings in the amount of $9,704.92, but which does not impose sanctions consisting of either an administrative fine or period of exclusion. DONE AND ENTERED this 18th day of January, 1991 in Tallahassee, Florida. DONALD D. CONN Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 Filed with the Clerk of the Division of Administrative Hearings this 18th day of January, 1991. APPENDIX TO RECOMMENDED ORDER Rulings on the Petitioner's Proposed Findings of Fact: Adopted in Finding 1. Adopted in Finding 2. Adopted in Finding 3. Adopted in Finding 1. Adopted in Finding 4. Adopted in Findings 4 and 5. 7-10. Adopted in Findings 6 and 7, but otherwise Rejected as unnecessary. 11-17. Rejected as unnecessary. 18-20. Adopted in Findings 6 and 7. 21-24. Adopted in Finding 12. 25. Adopted in Finding 2. 26-28. This is a conclusion of law and not a proposed finding. 29-30. Adopted in Finding 8. 31-32. Adopted in Findings 7 and 10. Adopted in Finding 6. Rejected as unnecessary. 35-39. Adopted in Finding 7. 40-47. Adopted in Finding 7, but otherwise Rejected as unnecessary. 48. Rejected as unnecessary and immaterial 49-51. Adopted in Finding 7, but otherwise Rejected as unnecessary. 52-53. Rejected as unnecessary. 54-63. Adopted in Finding 12, but otherwise Rejected as unnecessary. Adopted in Finding 8. Adopted in Finding 9. 66-67. Adopted in Finding 8, but otherwise Rejected as unnecessary. 68-69. Adopted in Finding 9. 70-78. Adopted in Finding 8, but otherwise Rejected as unnecessary. 79-82. Adopted in Finding 8. 83-85. Rejected as unnecessary. 86-93. Adopted in Finding 13, but otherwise Rejected as unnecessary. 94-97. Adopted in Finding 14, but otherwise Rejected as unnecessary. 98-103. Adopted in Finding 14. 104-105 Rejected as unnecessary and immaterial. 106-107 Adopted in Finding 12. 108. Adopted in Findings 12 and 13. 109-112 Rejected as unnecessary and immaterial. 113-115 Adopted in Finding 13, but otherwise Rejected as immaterial. This is a conclusion of law and not a proposed finding. Adopted in Finding 11. 118-119 Rejected as unnecessary and immaterial 120-122 Adopted in Finding 11. Rejected as unnecessary. Adopted in Finding 6. 125-128 Rejected as unnecessary. 129. Adopted in Finding 6. 130-132 Adopted in Finding 9. Adopted in Finding 11. This is a conclusion of law and not a proposed finding. 135-147 Adopted in Finding 16, but otherwise Rejected as unnecessary and immaterial. 148. Adopted in Finding 11. 149-150 Adopted in Finding 16, but otherwise Rejected as unnecessary. 151-152 Rejected as unnecessary. 153. Rejected as unnecessary and cumulative. Rulings on the Respondent's Proposed Findings of Fact: 1. Adopted in Finding 4. 2-3. Adopted in Finding 5, but otherwise Rejected as unnecessary and not based on competent substantial evidence. 4-5. Adopted in Findings 3, 6 and 7. 6-7. Adopted in Finding 10, but otherwise Rejected as unnecessary. 8-9. Adopted in Finding 11. 10-11. Adopted in Finding 3, but otherwise Rejected as unnecessary. Adopted in Finding 6. Rejected as immaterial and unnecessary. 14-15. Rejected as argument on the evidence rather than a proposed finding, and otherwise as not based on competent substantial evidence. Adopted in Finding 7, but otherwise Rejected as argument on the evidence rather than a proposed finding. Rejected as repetitive and otherwise as immaterial. Adopted in Finding 13, but Rejected in Finding 14 and otherwise as argument on the evidence rather than a proposed finding and as not based on competent substantial evidence. Rejected in Finding 14, as immaterial, speculative, and as not based on competent substantial evidence. 20-21. Rejected in Finding 6, as immaterial, and as not based on competent substantial evidence. 22-23. Rejected in Findings 13 and 14, and otherwise as immaterial and not based on competent substantial evidence. Rejected as repetitive and otherwise as argument on the evidence rather than a proposed finding. Rejected in Findings 13 and 14. 26-30. Rejected as a statement of the Respondent's position and not a proposed finding, as speculative and contrary to competent substantial evidence, and as totally without citation to authority in the record as required by Rule 22I-6.031(3), Florida Administrative Code. 31-35. Rejected in Finding 6, and as not based on competent substantial evidence and as unnecessary. 36-38. Adopted in Findings 12 and 13. 39-41. Adopted in Finding 8. 42. Rejected as immaterial. 43-44. Rejected in Finding 9. 45. Rejected as simply a summation of testimony and not a proposed finding. 46-48. Rejected in Finding 9, and otherwise as immaterial and not based on competent substantial evidence. 49-50. Rejected as unnecessary and immaterial. 51. Adopted in Finding 16, but otherwise Rejected as immaterial. 52-53. Rejected as unnecessary and immaterial. Rejected as not based on competent substantial evidence. Adopted and Rejected in part in Finding 16. 56-57. Adopted in Finding 16. 58-61. Rejected as immaterial and irrelevant. 62. Adopted and Rejected in part in Finding 15. COPIES FURNISHED: David G. Pius, Esquire Building Six, Room 233 1317 Winewood Boulevard Tallahassee, FL 32399-0700 James J. Breen, Esquire Michael P. Scian, Esquire 900 Sun Bank Building 777 Brickell Avenue Miami, FL 33131 R. S. Power, Agency Clerk 1323 Winewood Boulevard Tallahassee, FL 32399-0700 Linda Harris, Acting General Counsel 1323 Winewood Boulevard Tallahassee, FL 32399-0700 Robert B. Williams, Acting Secretary 1323 Winewood Boulevard Tallahassee, FL 32399-0700
Findings Of Fact At all times relevant hereto, petitioner, Maurice C. Guest, held license number ME0005036 issued by Petitioner, Department of Professional Regulation, Board of Medical Examiners. Said license authorized Guest to practice medicine and surgery in the State of Florida. He has held the license since August 13, 1952. Dr. Guest presently practices medicine at 825 West Linebaugh Avenue, Tampa, Florida. Dorothea Lankford was a patient of Respondent for almost ten years. Among other things, she had suffered from headaches and stomach pains during that period of time. For these ailments, Guest prescribed Nubain and Vistaril, which are used to relieve moderate pain and nausea. A detailed listing of the prescription dates, script, quantity and type of drug, and pharmacy dispensing the drugs is found in Petitioner's Exhibit 17 received into evidence. In 1979 and 1980, Lankford provided midwife services in the Lutz, Florida area. However, she held no licenses from the State to provide any type of medical care. Most of Lankford's clients were members of a local Jehovah's Witness Church. Although the services were to be provided without charge, at least one client paid Lankford a small fee. The prenatal care consisted of weekly meetings at Lankford's mobile home where Lankford discussed all aspects of having a home delivery. The clients were given physical examinations, breathing exercises, suggested diets, and were administered B-12 shots from time to time. On an unknown number of occasions, Lankford administered other drugs, including Nubain and Vistaril, to treat clients suspected of having miscarriages. No doctors were in attendance at these meetings or to supervise the administering of drugs. In May, 1980, Brenda Crall, one of Lankford's clients, visited Dr. Guest for a physical examination. The appointment had been prearranged, although it was not disclosed by whom. There was no discussion between Crall and Guest that Lankford was going to provide a home delivery for Crall, although Guest recommended she not have one. He also made clear that he would provide no care other than the physical examination given that day. In October, 1980, Kathleen Streeter, also a client of Lankford, visited the office of Dr. Guest to have a physical examination. Lankford was in the examination room when the examination was given. However, there was no discussion between them to indicate that Guest was providing oversight care to Lankford's clients to sanction the activities of Lankford. Although the clients were under the impression that medical records of each client had been prepared by Dr. Guest, and that either Guest or some other physician was overseeing the activities of Lankford, there was no competent testimony or documentation to support their belief. Neither was there any evidence to show that Lankford and Guest had entered into some type of agreement whereby she referred patients to Guest on a one-time basis to sanction her unlicensed activities or that Guest delegated professional responsibilities to Lankford. On April 23, 1980, Brenda Crall and Kathleen Montane, another of Lankford's clients, were attending a meeting at Lankford's home when two other women began experiencing premature labor pains. Lankford injected one with Nubain and Vistaril but had nothing to give the other. Crall, Montane and Lankford's son then went to Respondent's office to pick up a prescription for Lankford. They carried an empty vial of Vistaril so that Guest would know the type of drug needed. Guest gave them a new vial of Vistaril which he had in his office and wrote a prescription for Nubain in Lankford's name. The evidence is conflicting as to whether it was explained to Guest that the prescriptions were for two of Lankford's clients. The actual visit took no more than one or two minutes, and both women admitted they were quite excited and in a hurry at the time. They acknowledged that before Guest dispensed the drug and wrote a prescription he asked whether Lankford was suffering from a headache. Accordingly, it is found that Guest believed the drugs were to be used by Lankford, and not to be administered by Lankford to unknown third persons. Crall and Montane then filled the prescription for Nubain and gave both drugs to Lankford. Lankford later used the drugs to treat her client. Mary Ellen Odom was a patient of Dr. Guest between September, 1978 and October, 1980. Among her various ailments were an incarcerated incisional hernia, a previous head injury to the brain which caused recurring pain, hypertensive cardiovascular disease, arthritis and herpes of the vagina. Because Guest wished to alleviate the considerable pain caused by the various ailments, and to keep her in an ambulatory condition, he prescribed a number of drugs while treating her as a patient, including Talwin in an injectable form. An injectable form was used in lieu of a tablet since she had an intolerance to certain oral medications. However, Odom received the drug as an out- patient and was therefore able to inject herself. Between September 27, 1978 and November 21, 1980 Odom obtained approximately 168 prescriptions written or telephoned in by Guest to Boulevard Drugs, located at 227 East Davis Boulevard, Tampa, Florida. A detailed list of the dates, script, drug, quantity and quantity filled is found in Petitioner's Exhibit 16 received into evidence. The druggist at Boulevard Drugs became concerned with Odom's use of Talwin, particularly after Odom administered herself an injection at the drug counter. The druggist talked by telephone with Guest on a number of occasions and told him that he believed Odom was abusing the drug. On May 17, 1980, he made the following notation on the bottom of one of Odom's prescriptions: "Dr. aware of abuse". Despite these warnings Guest continued to give Odom prescriptions for injectable Talwin for at least six more months. He was also aware that Odom had been previously addicted to Demerol, a pain-killing narcotic drug. Dr. Guest "regrets" giving Odom the amount of drugs that he did, but did so because he believed the woman was in constant pain, and because he did not initially believe Talwin to be an addictive drug. He has subsequently changed his opinion on the addictive nature of Talwin based on literature that warns of the addictive characteristics of the drug. A physician-member of the Hillsborough County Utilization Review Committee examined the medical records of Odom, together with the amount of drugs prescribed, and concluded that the amount of injectable Talwin prescribed by Guest to Odom was "excessive", given her medical condition. He also concluded that while her ailments may have justified the use of Talwin in an oral form, there was no basis to prescribe Talwin in an injectable form, particularly on an outpatient basis. In reaching that conclusion, the physician was unaware of any impediment to Odom using Talwin in a tablet form. He acknowledged that Talwin tablets could cause nausea and vomiting while the injectable form does not, and that under certain circumstances the latter form might be preferable, although not in the magnitude prescribed by Guest. Based upon his review of the records, he concluded Guest did not practice medicine with the level of care, skill and treatment recognized by reasonably prudent similar physicians as being acceptable under similar conditions and circumstances acceptable, nor did he conform with generally prevailing standards of the medical community in his care and treatment of Odom. Respondent also treated Bernetha Cunningham as a patient for approximately twenty-two years. In 1976, Cunningham developed symptoms which were consistent with rheumatoid arthritis. After trying several medications which were unsuccessful, he began prescribing Talwin compound to ease her pain. He instructed her to take two tablets every four hours, or a total of twelve per day, which resulted in a daily dosage of 180 milligrams. At that time, he did not consider Talwin compound to be an addictive drug. He also prescribed Valium to relieve Cunningham's anxiety and to relax her muscles. Petitioner's Exhibit 15 received in evidence reflects that during the period between January 13, 1976, and February 5, 1979, Guest wrote prescriptions for 3,460 Valium tablets with authorization for 2500 tablets on refill, and 2,800 Talwin compound tablets with authorization for 2,200 tablets on refill. However, the last time he treated her as a patient was in December, 1977, at which time he advised her that he would not prescribe any more medicine. The evidence is conflicting as to whether Guest continued to telephone in prescriptions after that date, but it is found that Cunningham continued to refill her prescriptions in Dr. Guest's name after December, 1977, without his knowledge and consent. On February 1, 1979, Cunningham was examined by another Tampa physician (now deceased) whose specialty was psychiatry. In a deposition given prior to his death, he diagnosed her as having reactive depression and arthritis. He also concluded she displayed symptoms of being addicted to Talwin vis a vis Talwin compound, and that the drugs had been prescribed in dosages that would tend to addict the patient. In reaching these conclusions, the physician made no distinction between Talwin and Talwin compound, although the latter is a much less profound form of the drug. His examination was also conducted some fourteen months after Mrs. Cunningham had last been treated by Dr. Guest, and been given a prescription for drugs. In December, 1978, the Cunninghams filed a civil action against Respondent alleging that Respondent had been negligent in his treatment of Cunningham by prescribing an excessive level of central nervous system depressants. After being initially dismissed, the suit was refiled in April, 1979, and was ultimately settled out-of-court when Guest paid the Cunninghams $6,200. Guest represented himself in the initial stages of the suit, and only after a default summary final judgment as to the issue of liability was entered did he obtain counsel. Guest settled the case on advice of counsel since he had no malpractice insurance and would have incurred substantial legal fees had the case gone to trial on damages alone and then been appealed on the issues of liability and damages. A physician-member of the Hillsborough County Utilization Review Committee examined the medical records of Cunningham and concluded that Guest prescribed too great an amount of analgesics, sedatives and tranquilizers, and too little medication to counteract Cunningham's arthritic condition. He also concluded Guest failed to conform to generally prevailing standards of the medical community in his care and treatment of Cunningham, and failed to practice medicine with the level of care, skill and treatment recognized by reasonably prudent similar physicians as being acceptable under similar conditions and circumstances. Talwin is a controlled substance under Chapter 893, Florida Statutes. It is prescribed for relief of moderate to severe pain and is commonly referred to as an analgesic. The drug comes in various forms, including tablet, injectable and compound form. The latter form contains the least amount of Talwin in terms of milligrams. Its addictive characteristics were not recognized until approximately 1978 when reference to this was made in the Physicians' Desk Reference (PDR). The PDR provides that the maximum daily dosage should not exceed 600 milligrams, although the tolerance level will differ from individual to individual. Valium is also currently classified as a controlled substance pursuant to Chapter 893, Florida Statutes. It is used primarily as a tranquilizer although it has some muscle relaxant qualities. If given in sufficient quantity over time, a user may become addicted to the drug. Respondent was subjected to disciplinary action by the Board of Medical Examiners in 1978. In that action he was placed on probation for three years. Among the conditions of probation was the following: The licensee shall, during this probation period, demonstrate the type of exemplary conduct expected and required of a duly licensed physician in this State. If the licensee fails to meet the moral and professional standards expected of a duly licensed physician, said probationary order will be vacated and the licensee will be subject to further disciplinary action by the Board. In 1981, the probationary period was extended until August, 1982, presumably because of the case at bar. Respondent did not intentionally violate the law. While he wrote or telephoned an unusually large number of prescriptions for Odom and Cunningham, he believed that both patients were experiencing pain, and that the drugs were needed to aid them. However, because the patients were poor, could afford only one Medicaid trip per month to his office, and could not drive, Dr. Guest attempted to authorize a sufficient number of refills between office visits. In this respect, he was lax in failing to control the actual number of drugs obtained by the patients. Nonetheless, there were no monetary rewards or motivation in writing the prescriptions. Dr. Guest was portrayed by character witnesses as a sincere and dedicated practitioner. He has practiced medicine in Tampa, Florida, for almost thirty years. Although he suffered a heart attack in early 1980, he continues to work long hours. He is not motivated by the financial rewards of practicing medicine, for he has frequently accepted patients requiring medical care but who were too poor to pay the bill. There was no evidence that Respondent has any drinking or drug problems.
Recommendation Based on the foregoing findings of fact, and conclusions of law, it is RECOMMENDED that Respondent be found guilty as charged in Counts XIV, XV, XVII, XIX, XX and XXII. All other counts should be dismissed. It is further RECOMMENDED that Respondent's probation be extended for an additional seven years during which time he not be allowed to write prescriptions for scheduled controlled substances without such supervision and approval as the Board may require. DONE and ENTERED this 23rd day of June, 1982, in Tallahassee, Florida. DONALD R. ALEXANDER 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 23rd day of June, 1982.
The Issue Whether Petitioner should be granted a Retail Pharmacy Drug Wholesale Distribution Permit, pursuant to Subsection 499.01(2)(f), Florida Statutes (2009).1
Findings Of Fact Background Petitioner holds Florida Community Pharmacy License No. PH23699 (the “pharmacy license”), pursuant to Chapter 499, Florida Statutes. The establishment is located at 1507 Park Center Drive, Suite 1L, Orlando, Florida 32835 (“establishment”), where Petitioner’s records are stored. On or about July 29, 2009, Petitioner submitted the first portions an application to Respondent for a Retail Pharmacy Wholesaler Distributor Permit, pursuant to Subsection 499.01(2)(f), Florida Statutes (“application”). On September 16, 2009, Respondent's drug agents conducted an onsite inspection of the establishment (“inspection”) for purposes of assisting in Respondent’s determination of whether to issue the permit to Petitioner. On or about November 13, 2009, Respondent notified Petitioner that Respondent intended to deny the application (“notice”), and Petitioner filed a petition for administrative review, raising disputes of material fact (“petition”). Prescription Drug Inventory and Petition as a “Retail Pharmacy” To qualify as a retail pharmacy, Petitioner must have adequate inventory on hand that would be required by the general public for a variety of medical conditions. On the date of inspection, there was inadequate inventory on hand. There were only 18 commercially-available prescription drugs. Many of the drugs were injectables, which would only fill the needs of a very specific and limited patient population. At the time of inspection, Petitioner’s on-hand inventory of prescription drugs lacked any opiate painkillers and any drugs indicated for treatment or maintenance of (i) high blood cholesterol levels, (ii) systemic bacterial infections (oral antibiotics), (iii) osteoporosis, (iv) cough (syrups), (v) viral infections, (vi) depression, and (vii) asthma. These are some of the most commonly-required drugs in the pharmacological arsenal. Petitioner’s specialization in the area of compounded prescription drugs is evidenced by Petitioner’s prescription drug inventory and the nature of the prescriptions Petitioner filled in the months leading up to inspection. Most of Petitioner’s on-hand prescription drug inventory was composed of compounded prescription drugs or ingredients to be used in compounding prescription drugs. Less than eight percent of Petitioner's prescription drugs, or about 18 items, consisted of commercially-available prescription drugs in finished dosage forms. In the two-month period before September 29, 2009, Petitioner did not dispense a single dose of commercially- available, finished-form prescription drugs. All were specially-prepared or “compounded” products tailored to the specific needs of individual patients. Petitioner, as a result of an inability to meet the most basic and commonplace prescription drug needs of the general public, lacked adequate inventory required by the general public. Petitioner served a specific and limited patient population: i.e., those patients requiring specially-compounded prescription drugs and those rare patients whose needs could not be met by commercially-available products. Petitioner's explanation as to the reason for having only 18 commercially-available prescription drugs available at the time of inspection is not persuasive; Petitioner, therefore, was not a retail pharmacy. Life Specialty Pharmacy Medical Equipment and Supplies, Inc.: Petitioner’s Unauthorized Source for Prescription Drugs Life Specialty Pharmacy Medical Equipment and Supplies, Inc. (“Life Specialty”), a separate entity from Petitioner, is under common control with Petitioner. It has the same owners, principals, and pharmacy department manager. Life Specialty holds Community and Special Parenteral/Enteral Pharmacy License No. PH22346 for an establishment located at 1507 Park Center Drive, Suite 1L, Orlando, Florida 32835. It is not authorized under Florida law to purchase, receive, own, or distribute prescription drugs. Petitioner’s prescription drug inventory at the time of inspection included certain quantities of Sarapin, a prescription drug. Life Specialty acquired and received Sarapin from a Kmart pharmacy that is no longer in business. At the time Life Specialty acquired and received the Sarapin from Kmart pharmacy, that drug was readily available from Life Specialty’s prescription drug wholesale suppliers. Life Specialty later transferred the Sarapin to Petitioner. Life Specialty lacks any permit or authorization under Part I of the Florida Drug and Cosmetic Act, Chapter 499, Florida Statutes (Act), to engage in the wholesale distribution of prescription drugs. Petitioner, nevertheless, received prescription drugs from Life Specialty, and many of these drugs were in Petitioner’s prescription drug inventory at the time of inspection, including prescription drugs compounded by Life Specialty. Those drugs included: Sarapin Ketamine Hydrochorlide USP Progesterone Micro USP Chloral Hydrate (CIV), Crystal USP 100% 125gm Testosterone Propionate Micro USP Ketamine Hydrochloride USP 100% Powder 25mg Amphotericin B USP 100% Powder 1gm Cyclobenzaprine HCl USP Recordkeeping and Pedigree Papers During the course of the inspection, Respondent requested the opportunity to review pedigree papers and other source-related records for the prescription drugs Petitioner received from Life Specialty. Specifically, Petitioner could not produce any pedigree papers for prescription drugs received from Life Specialty. Petitioner received from Life Specialty, without a valid pedigree paper, the following: Sarapin Ketamine Hydrochorlide USP Progesterone Micro USP Testosterone Propionate Micro USP Cyclobenzaprine HCl USP Recordkeeping Petitioner did not acquire all of its pedigree papers contemporaneously with the underlying transactions. Petitioner acquired many of the pedigree papers for the prescription drugs in its inventory after the Respondent's inspection. Petitioner's explanation for these failures was not credible.
Recommendation Based on the Findings of Facts and the Conclusion of Law cited above, it is RECOMMENDED that the Department of Health enter a final order, denying Petitioner's application for a permit to act as a retail pharmacy drug wholesale distributor. DONE AND ENTERED this 1st day of September, 2010, in Tallahassee, Leon County, Florida. S DANIEL M. KILBRIDE 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 1st day of September, 2010.
The Issue The issue to be resolved in this proceeding is whether the Board's termination of Respondent's employment should be upheld.
Findings Of Fact The Respondent, Patricia Gadson, age 51, was employed as a department secretary by Petitioner, the Escambia County School Board. She worked for the School Board of Escambia County from April 12, 1968, through January 27, 1998.1 She was employed by the Board for twenty-nine years and nine months. Throughout this period of time, Ms. Gadson worked as a school or administrative secretary at various locations throughout the school system. Prior to 1994, Ms. Gadson was a successful employee who received good evaluations of her work. However, sometime prior to January, 1994, several departments were consolidated as a result of downsizing. Ms. Gadson was assigned as the sole administrative secretary for six departments working for four different supervisors. Ms. Gadson found her new job very stressful. The stress resulted in her missing work frequently due to illness and medical treatment. After being examined by her own and the School Board's psychiatrists, Ms. Gadson was diagnosed with depression and took a six-week leave of absence to recuperate. She was not involved with drugs at this time. However, sometime in 1996, approximately two years before her discharge in 1998, Ms. Gadson was introduced to crack cocaine by her sister. She did not refuse the drug and eventually became addicted. She used the drug with full knowledge of the Board's drug-free workplace policy and its policy of zero tolerance for such use. As a result of her addiction, Ms. Gadson's life spiraled downward. She had increased absences from work and deteriorating job performance. In fact, her supervisors had already decided to terminate her for her poor performance. However, her supervisors recognized that she was exhibiting the symptoms of someone suffering from substance abuse and instructed her to take a drug test on November 3, 1997. Ms. Gadson fully cooperated in taking the test. On the way home, Ms. Gadson volunteered to Dr. Larry Reed, one of her supervisors, that the test would be positive. The test came back positive for crack cocaine since Ms. Gadson had last smoked crack on November 2, 1997, the day before her drug test. As a result she was terminated on January 27, 1998, retroactive to December 5, 1997, for violation of the School Board's drug-free workplace policy and for having tested positive for an illegal drug. Ms. Gadson has not smoked crack since November 2, 1997. With the assistance of Dr. Reed, her supervisor, Ms. Gadson was admitted to an out-patient rehabilitation program at the Pavilion Chemical Dependency Hospitalization Program on November 12, 1997. She was discharged from that program on November 26, 1997. She continued the recommended program of treatment in the Aftercare Program until approximately February 1998. She stopped attending the aftercare program in order to care for her grandmother who is an invalid. Ms. Gadson is willing to voluntarily undergo regular drug testing in order to demonstrate her continued abstinence should she be reinstated. The School Board maintains and strictly follows a "zero tolerance" policy for use of illegal drugs. When an employee or student is found to have used illegal drugs, they are automatically terminated or expelled after exhaustion of any due process procedures available irrespective of any mitigating factors. The discipline which would be imposed on an employee for violation of the Board's drug policy was set forth in a memo from the superintendent. The memo was given to all employees, including Ms. Gadson. Additionally, the drug policy was made part of an employee's contract. This policy was applied to Ms. Gadson in this case. The School Board has not adopted the disciplinary part of the drug policy as a rule pursuant to Section 120.54, Florida Statutes (1997). However, the Board has adopted a disciplinary rule and has incorporated that rule in the contract it has with the union. The zero tolerance policy is generally applicable to all employees and, as stated in the School Board's answer, it implements the School Board's drug-free workplace policy, authorized under Chapter 440, Florida Statutes, and School Board Rule 6Gx17-2-62. The severity of the discipline is meant to emphasize the serious nature of drug use in relation to education, the students and the school, and its employees must set an example. Indeed, the very intent of the zero tolerance rule is to announce to all concerned that the sole penalty for illegal drug use is termination. Illegal drug use in a school setting is a serious misconduct warranting termination. The Board's "policy" of termination for illegal drug use by an employer falls within the disciplinary rule of the Board. Therefore the School Board's zero tolerance drug use policy is already implemented by Board rule. The rule adequately defines the discipline imposed for employee misconduct and need not define specific instances which warrant termination of any other type of discipline. Respondent's use of cocaine violated the Board's policy and her employment contract. The District has consistently terminated employees found in possession of or using controlled substances with or without evidence of prior disciplinary problems. No exceptions have ever been allowed with one exception related to arbitration. Violation of the Board's drug-free workplace program constitutes cause for termination. Additionally, even without the Board's zero tolerance policy, the use of crack cocaine over an extended period of time by a school employee which causes the employee's performance to fall below acceptable levels constitutes cause for termination. Therefore, superintendent's recommendation for termination of Respondent should be upheld.
Recommendation Based upon the foregoing findings of fact and conclusions of law, it is RECOMMENDED that a Final Order be entered by the Respondent, Escambia County School Board, terminating the employment of Patricia Gadson. DONE AND ENTERED this 2nd day of March, 1999, in Tallahassee, Leon County, Florida. DIANE CLEAVINGER Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 2nd day of March, 1999.
The Issue Whether petitioner should take disciplinary action against respondent for the reasons alleged in the administrative complaint?
Findings Of Fact At all pertinent times, respondent Manuel P. Villaflor, M.D., held a Florida license as a physician, No. ME 0020072. He practices in Daytona Beach, where he has an office on Ridgewood Avenue. UNTIMELY DEATH K.D., a white male, was pronounced dead at 3:59 P.M. on October 19, 1985, a few days shy of his 34th birthday. The autopsy disclosed superficial abrasions, acute blunt trauma to K.D.'s face, scalp and right hand, and acute, diffuse subdural hemorrhage. A paper bag full of prescriptidn medicine containers accompanied the body to the autopsy. Apparently because the labels indicated that Dr. Villaflor had written pain killing prescriptions for K.D., the medical examiner's office notified DPR. Some four months later, analysis of samples of K.D.'s blood and urine revealed that codeine, oxycodone, amitriptyline, also known as Elavil, nortriptyline, also known as Pamelor, and chlordiazepoxide, also known as Librium, had been present in the corpse in quantities "beyond the reference range for therapeutic use." Botting deposition, p. 6. The pathologist amended his initial conclusion that head injuries resulting from "multi-focal blunt trauma," id., p. 7, had caused R.D.'s death, by adding "multiple drug intoxication," id., as another cause of death. As far as the record shows, Dr. Villaflor never prescribed Elavil, Pamelor, Librium or their chemical equivalents for K.D. An osteopath whom K.D. saw toward the end of his life prescribed at least two of these medications, as well as medicine containing oxycodone. CONTROLLED SUBSTANCES UNCONTROLLED On November 15, 1985, Diane Rabideau, an investigator for DPR, called on Dr. Villaflor at his office. He was polite and cooperative. Ms. Rabideau had some difficulty understanding him; he is not a native English speaker, and he had recently suffered a stroke. But she understood well enough Dr. Villaflor's assertions that he did not believe K.D. to have been addicted to any drugs, and that he had not over-prescribed any medicine. Ms. Rabideau inspected the controlled substances kept in Dr. Villaflor's office. She found Tenuate Dospan, Restoril, Darvocet, Valium, Tylenol No. 4, Fiorinal No. 3, Xanax, Vicodin, Tylenol with codeine elixir, Dalmane, Anexsia, Centrax, "Tussend Ex. 1/2 oz.," Limbitrol, Equagesic, Phrenilin with codeine, Novahistine, Naldecon, Ativan, Nucofed, and "P.V. Tussin." When she saw them, they were not under lock and key. No inventory records reflected what was on hand and what had been dispensed. The parties stipulated that Dr. Villaflor "failed to maintain records of the[se] schedule controlled substances . . . as required by Section 893.07, Florida Statutes"; and that he "failed to keep the[se] drugs . . . under lock and key as required by 21 C.F.R. Section 1301.72." When Ms. Rabideau pointed out these omissions, Dr. Villaflor and his wife, who works with him in the office, said they would comply in the future. Mrs. Villaflor said she had not known of these requirements. A subsequent inspection by a DPR investigation found Dr. Villaflor in full compliance with reporting requirements governing controlled substances. K.D.'s PAIN On July 8, 1981, Dr. Villaflor saw K.D., apparently for the first time, at the Halifax Hospital Medical Center emergency room, and admitted him to the hospital. K.D. had sustained an electrical shock when he struck a high voltage power line with an aluminum ladder, as he was hurrying for shelter from a sudden rain. He lost consciousness "surrounded by a bluish flame." Petitioner's Exhibit No. 12. The elecricity burned his feet and made his lower legs tender, as well. Discharged from the hospital, he visited Dr. Villaflor's office on July 15, 1981. In these proceedings, DPR does not question Dr. Villaflor's prescription of Percocet, a combination of Tylenol and oxycodone, for pain on that visit. As a teenager, K.D. had broken his collar bone in falls from motorcycles on two separate occasions. One accident involved a ride over a waterfall. When he was 2l years old, he "was smashed between a construction vehicle and a bulldozer," Petitioner's Exhibit No. 12, suffering "a severe crushing injury to his chest." Some ten years later he "still ha[d] very mobile ribs secondary to this injury," and persistent pain in his back and legs. In November of 1981, Dr. Kolin, a psychiatrist in Orlando, admitted K.D. to Orlando Regional Medical Center. A myelogram "revealed a mild L5 radicular lesion on the left, consistent with chronic myofascial pain and left L5 radiculitis." Petitioner's Exhibit No. 11. During this hospital stay, K.D.'s "narcotic medications were tapered and discontinued." Id. Dr. Villaflor sent copies of his records to Dr. Kolin, to whom Dr. Gillespie in Nashua, New Hampshire, had referred K.D. Apparently Dr. Villaflor never asked and Dr. Kolin never volunteered to forward Dr. Kolin's records to Dr. Villaflor. Gary G. Parsons, a vocation rehabilitation counselor, met K.D. on February 8, 1982. After K.D. made a perfect score on an aptitude test, a state agency subsidized his vocational training at the American Computer Institute. When K.D.'s training there concluded on January 4, 1983, Mr. Parsons tried to assist him in obtaining employment, but eventually concluded that K.D. could not hold a job because "his pain, and his limitation was greater than" (T. 283) Mr. Parsons had originally realized. K.D.'s pain or his physical condition "was primary in his conversation almost every time" (T. 283-4) he and Mr. Parsons spoke. Even after the vocational rehabilitation file was closed on June 26, 1984, he came by Mr. Parsons' office twice. Both times K.D. seemed depressed to Mr. Parsons, who had recommended he go for counseling to the Human Resources Center, a community mental health center. Mr. Parsons saw K.D. for the last time on March 22, 1985. At least as early as August of 1984, K.D. mentioned suicide to Mr. Parsons as a possibility. In March of 1985, K.D. began weekly counselling sessions with Dr. Rafael Parlade, a clinical psychologist at the Human Resources Center. In these sessions "the two issues . . . were his suicidal ideation combination with the depression, and the departure of his live-in girlfriend." (T. 273) He "still had a lot of pain." (T. 274) Dr. Parlade hoped K.D. would "increase his activities," (T. 276) so that with . . . activity in his life more, he would focus away from his pain. Because for a period of time that was all he was living with. (T. 276) Dr. Parlade viewed decreasing the amount of pain medication as a secondary goal (T. 275), a result he hoped would flow from K.D.'s being less preoccupied with the pain he experienced continually. PAIN REMEDIES On January 31, 1983, K.D. visited Dr. Villaflor's office. Dr. Villaflor's notes for that day mentioned K.D.'s "Electrocution High Voltage in 7/81" and reflect a prescription for 50 tablets of Talwin. K.D.'s blood pressure, 120 over 70, is noted, and reference is made to a TENS unit, or transcutaneous nerve stimulator. Somebody at the Orlando Pain Clinic K.D. had visited had recommended one of these electrical devices to K.D., but it had proved ineffective against his pain. At one time or other, K.D. resorted to acupuncture and resumed wearing a corset of the kind originally prescribed for the back pain he experienced in the wake of the cascading motorcycle accident. Dr. Villaflor's office notes of April 15, 1983, record "Back Pain," a second prescription for 50 tablets of Talwin and another prescription for Xanax. On May 11, 1983, Dr. Villaflor's records again note K.D.'s "Back Pain" and indicate prescriptions for Xanax and Percocet. Nothing suggests Dr. Villaflor knew that Talwin had been dispensed to K.D. five days earlier, when K.D. appeared at his office on May 26, 1983. Essentially illegible, Dr. Villaflor's office notes for May 26, 1983, reflect prescriptions for Percocet and Xanax tablets, with which K.D. obtained 30 quarter milligram Xanax tablets on June 6, 1983, and 35 Percocet tablets on June 8, 1983. Xanax, a tranquilizer, is taken three or four times daily. Since Percocet may be taken every four to six hours, it was "very much within reason" (T. 239) for Dr. Villaflor to prescribe more on June 9, 1983. When this prescription was filled on June 22, 1983, K.D. received 45 tablets. On July 7, 1983, Dr. Villaflor saw K.D. at his office for the first time in almost a month, and prescribed 35 more tablets of Percocet, also known as oxycodone with acetaminophen. The same day K.D. had the prescription filled, obtaining 35 tablets. Some three weeks later, on July 29, 1983, Dr. Villaflor again prescribed and K.D. again obtained 35 Percocet tablets. On the same day two other prescriptions Dr. Villaflor wrote for K.D. were filled, one for Atarax, an antihistamine sometimes prescribed in lieu of a tranquilizer, and one for Tylenol with codeine. This 35-tablet Tylenol prescription was refilled on September 7, 1983. With more and less potent pain medications, K.D. could take one or the other, as appropriate, depending upon the intensity of the pain. Since no other prescription for pain killing medication was written or filled until October 4, 1983, these prescriptions were, according to one of the Department's witnesses, "[w]ithin reason." (T. 243) On the October 4 visit, Dr. Villaflor noted "Back Pain from Electrocution" and recorded K.D.'s blood pressure as 138 over 70 or 80, before prescribing 45 Percocet tablets. That day, K.D. obtained the Percocet. He returned to Dr. Villaflor's office on October 13, 1983, complaining not only of back pain, but also of nausea and vomiting. Dr. Villaflor prescribed an additional 30 Percocet tablets. On October 15, 1983, K.D. acquired 50 tablets of the antihistamine Dr. Villaflor had been prescribing for him, "hydroxizine pam." On November 3, 1983, he obtained 60 Percocet tablets and 50 Tylenol No. 3 tablets. On November 12, 1983, the antihistamine prescripton was refilled as was, on November 16, the Tylenol No. 3 prescription. Perhaps Dr. Villaflor wrote the antihistamine prescription two days before it was first filled. The office notes are difficult to decipher. He wrote the Percocet and Tylenol prescriptions when he saw K.D. on November 3, 1983, at which time he recorded his blood pressure (132 over 70) and noted "back injury." On December 2, 1983, Dr. Villaflor's office notes reflect a visit and prescriptions for Tylenol No. 3, Percocet and the antihistamine. With respect to prescriptions filled on and after November 3, 1983, but before December 2, 1983, DPR's witness testified that the amount of medication was "a little high, but it's still, you know, again, acceptable for a person in pain." (T. 246) On December 2, 1983, K.D. obtained 60 Percocet tablets and 50 Tylenol No. 3 tablets, the latter by virtue of a prescription that was refilled on December 14, 1983. On January 3, 1984, K.D. returned to Dr. Villaflor's office where he obtained prescriptions for Percocet and Tylenol No. 3. In March, Dr. Villaflor began prescribing a tranquilizer, Dalmane, instead of the antihistamine, but the new year progressed much as the old year had, in terms of Dr. Villaflor's prescriptions and documentation, and, apparently, of K.D.'s pain, as well, until early August. On August 3, 1984, Dr. Villaflor prescribed for K.D., 200 "Sk- Oxycodone w/Apap" tablets, 200 Tylenol No. 4 tablets and 180 Dalmane capsules. K.D. had asked for them to take along to New England, where he travelled for an extended visit with his parents and others. This represented more than a two months' supply, and the prescriptions inspired a pharmacist, Paul Douglas, to telephone Dr. Villaflor's office before filling them. Mr. Douglas had called once before in the spring of the year, when he noticed that a total of 100 Tylenol (acetaminophen with codeine) No. 3 tablets and 60 tablets of Percocet (or the generic equivalent) had been dispensed to K.D. for use over a 24-day (April 2 to April 26, 1984) period. The pharmacist was concerned on that occasion because K.D. would have needed only 144, not 160, tablets during that period, if he had been taking no more than one every four hours. Back in Daytona Beach, K.D. presented himself at Dr. Villaflor's office on November 5, 1984, and received prescriptions for 45 tablets of Percocet, 55 tablets of Tylenol No. 3 and a quantity of Dalmane. All three prescriptions were filled the same day, and the prescription for Tylenol No. 3 was refilled on November 19, 1984. After his last telephone call to Dr. Villaflor's office, the pharmacist talked to K.D., telling him he would "not fill these medications again . . . until the prescribed number of days." (T. 222). On December 5, 1984, K.D. appeared a second time after his return from up north, and Dr. Villaflor again prescribed all three drugs, this time specifying 50 tablets of Percocet and 50 tablets of Tylenol No. 3. K.D. caused these prescriptions to be filled the day he got them. The office notes for both these visits mention only electrical shock by way of explanation for the prescriptions. On December 19, 1984, Dr. Villaflor suffered a stroke and was hospitalized. Two days later prescriptions he had purportedly written for K.D. were filled, but their authenticity, like that of the prescriptions filled on November 21, 1984, is not certain. While Dr. Villaflor was indisposed on account of the stroke, Dr. Wagid F. Guirgis filled in for him. The day he began, K.D. came in complaining of severe pain in his lower back and legs. Dr. Guirgis prescribed Dalmane, 50 Percocet tablets and 50 Tylenol No. 3 tablets, the latter prescription being twice refillable. Dr. Guirgis suggested to R.D. that he see an orthopedist or a neurologist, and, on January 21, 1985, refused K.D.'s request to prescribe more Percocet. At no time did Dr. Guirgis and Dr. Villaflor discuss K.D. or his treatment. Later the same day K.D. went to Dr. M.H. Ledbetter's office. This osteopath prescribed 30 Percocet tablets to be taken twice daily, as well as Elavil and Tranxene. On February 4, 1985, Dr. Ledbetter prescribed the same medicines. On February 28, 1985, Dr. Ledbetter prescribed Elavil, Librium and 50 tablets of Percocet. On March 22, 1985, he prescribed the same things. On April 19, 1985, K.D. again visited Dr. Ledbetter. The same day he purchased Librium and 60 Percocet tablets at Walgreen's. Dr. Ledbetter prescribed Librium, Elavil and 60 tablets of Percocet, to be taken twice daily, when he saw K.D. on May 16, 1985. In May Dr. Villaflor returned to his office, and K.D. appeared on May 21, 1985, five days after he had seen Dr. Ledbetter. Dr. Villaflor prescribed 60 Percocet and 50 Tylenol No. 3 tablets for K.D., along with Dalmane and a vitamin (Bl2) injection. K.D. weighed 142 pounds that day and his blood pressure was also noted. The office notes report "same complaints." On June 18, 1985, Dr. Villaflor prescribed 60 Percocet tablets, ten fewer than he prescribed on K.D.'s next visit, on July 17, 1985 , when K.D. limped "on left foot." In July, Dr. Villaflor also prescribed Dalmane and 50 Tylenol No. 3 tablets. On both visits K.D.'s weight (142 then 138) and blood pressure (122 then 120 over 80) were noted. On August 19, 1985, K.D.'s weight had fallen to 132 pounds but his blood pressure remained 120 over 80. Sixty Percocet tablets - one every four hours - were prescribed, as were 50 Tylenol No. 3 tablets. The diagnosis indicated in Dr. Villaflor's office notes was "electrocution." On September 16, 1985, Dr. Villaflor again prescribed Dalmane, Tylenol and 60 Percocet tablets. On October 17, 1985, K.D. limped to his last visit to Dr. Villaflor's office. His face bruised, K.D. complained that both feet were swollen, and reported that he had lost his balance and fallen down four stairs and over a concrete wall. For the last time, Dr. Villaflor prescribed Tylenol No. 3 and Percocet for K.D., 30 and 60 tablets respectively. Unbeknownst to Dr. Villaflor, K.D. had continued to visit Dr. Ledbetter, himself unaware of Dr. Villaflor's renewed involvement with K.D. On June 7, July 5, July 26, August 27, September 16 and October 10, 1985, Dr. Ledbetter prescribed Librium, Elavil and Percocet. Dr. Ledbetter's office notes also reflect K.D.'s fall. REQUIRED PRACTICE Keeping complete medical records is important not only as a mnemonic aid for the treating physician, but also to make the patient's history available to other physicians who may succeed or assist the recordkeeper. Although each is "a moderate type of analgesic," (T. 324), both codeine and oxycodone are "narcotic derivatives . . . [and] addictive in nature." Id. Dalmane "can be" (T. 221) "potentially addictive." Id. Because of his depression, K.D. "was not a good candidate" to entrust with several hundred pills at once. A physician who suspects addiction should limit prescriptions to "around ten to fifteen" (T.326) tablets and "start checking with other pharmacies to make sure if a patient is getting drugs from any other source . . . ." Id. He should perform "very close and repeated physical exams" (T. 327) and be alert for "overdose side effects," id., such as dizziness, slurred speech, or staggering. The evidence here fell short of a clear and convincing showing that Dr. Villaflor was remiss in failing to suspect addiction, however, Dr. Ledbetter, who had similar, albeit similarly incomplete, information apparently did not suspect. The evidence did not prove the existence of side effects from the drugs Dr. Villaflor prescribed. Although, on his last visit to Dr. Villaflor's office, K.D. reported dizziness, the cause is unknown. On the other hand, his office records do not suggest that Dr. Villaflor took any steps to determine the cause of K.D.'s dizziness or of his swollen feet. Dr. Villaflor's treatment of K.D. fell below acceptable levels, if he failed to refer K.D. for periodic reevaluations of the underlying orthopedic or neurological problem, which his records suggest he did not do. His treatment was also inadequate for failure periodically to "get the medicine . . . out of the system . . . for a limited time" (T. 337) in an effort to learn what side effects, if any, the drugs he prescribed caused, either singly or in combination. This is so, even though the effort might have been frustrated, if K.D. had acquired the same medicines from other sources.
