The Issue The issues are whether Petitioner is liable to Respondent for Medicaid reimbursement overpayments, and if so, in what amount.
Findings Of Fact Respondent is the agency charged with administration of the Medicaid program in Florida pursuant to Section 409.907, Florida Statutes. Petitioner provides services to Medicaid beneficiaries under provider No. 1000098-00 pursuant to a contract with Respondent. Under the provider agreement dated March 31, 1997, Petitioner agreed to comply with all local, state and federal laws, rules, regulations, licensure laws, Medicaid bulletins, manuals, handbooks, and statements of policy. The contract also sets forth Petitioner's responsibilities to keep and maintain in a systematic and orderly manner all medical and Medicaid-related records, and to make them available for state and federal audits for five years. Heritage Information Systems, Inc. (Heritage) is and has been a pharmacy audit company since 1980. In 1999, Respondent contracted with Heritage to perform audits of pharmacies enrolled in the Florida Medicaid program. Respondent and Heritage subsequently created a list of violations to be investigated during an audit. The list is based upon provisions in the Florida Statutes and federal Medicaid policies and regulations. The purpose of the list is to guide Heritage in performing its duty during an audit. Heritage conducts its audits based on a standard methodology and protocol. During the course of an audit, Heritage examines a provider's records to determine whether a pharmacy is compliant with all rules and regulations that apply to the pharmacy. Heritage uses an established set of neutral criteria to select pharmacies for participation in an audit. Using these criteria, Heritage selected Petitioner as a candidate for audit. By letter dated January 17, 2000, Heritage advised Petitioner that it would be audited on January 26, 2000. The letter stated as follows in relevant part: The auditor(s) will require access to original hard-copy prescription records, third party signature logs, and, in some cases, pharmacy computer screens relating to a sample of prescription claims billed by your pharmacy between 12/25/1998 and 12/24/1999. Please note that the sample claim may actually be a refill of a prescription originally dispensed prior to the audit period. Because of this, we recommend that you also have the prior twelve months of prescription records available the day of the audit. For your reference, the audit terms are defined in your participating provider agreement and the prescribed drug services handbook. If you have any additional questions prior to the audit, please call Heritage Information Systems, Inc. . . . Between December 25, 1998, and December 24, 1999, Petitioner submitted claims and received payments from the Medicaid program for 7,065 claims. Using an industry standard software application, Heritage selected a random sample of 101 of Petitioner's claims to be analyzed during the audit. In performing the audit, Heritage utilized a methodology similar to that used by auditing agencies who examined Medicaid providers in previous years. During the audit, Heritage identified four areas of noncompliance for Petitioner. First, Heritage requested Petitioner's staff to produce hard-copy prescription records for the 101 sampled claims. Hard-copy prescriptions include those ordered and signed by a physician on a handwritten form and the records created by the pharmacists immediately after receiving verbal authorization from a physician by telephone. In this case, Petitioner could not produce hard-copy prescriptions for five claims. The second area of noncompliance involved unauthorized refills. In seven instances, Petitioner refilled prescriptions more times than the number authorized on the documented prescription. There were no notations on the hard-copy prescriptions or in the pharmacy computer to indicate that the doctors or someone from their office called to increase the number of authorized refills. The third area of noncompliance involved one instance in which Petitioner claimed payment for a "days supply value" that was inconsistent with the quantity and directions on the prescription. The prescription at issue was for sixty tablets with directions for the patient to take the drug once a day, constituting a sixty-day supply of medicine. Petitioner filled this prescription as a thirty-day supply and claimed Medicaid payment accordingly. Respondent did not include this violation in the calculation of overpayment. The fourth area of noncompliance involved a prescription that was refilled 30 days earlier than appropriate with respect to the quantity and directions for use that appeared on the prescription. This was the same prescription referenced above in paragraph twelve. After completing the audit, Heritage completed a final audit report. Said report documents the following: (a) 7,310 claims submitted by Petitioner; (b) $350,639.95 paid by Respondent for all claims; (c) 101 claims in total random sample; (d) $3,839.33 paid by Respondent for claims in total random sample; (e) 13 discrepant claims in random sample; $778.09 paid by Respondent for discrepant claims; 13 documented sanctions in random sample; (h) $724.91 paid by Respondent for documented sanctions in random sample; (i) $52,466.25 as the total calculated overpayment; and (j) $13,798.70 as the amount of the overpayment based on a 95 percent one-sided lower confidence limit. The final audit report also contained a listing of the violations discovered during the audit. The final audit report contained the following comments/notes in relevant part: Five prescriptions could not be found by auditors and could not be found by pharmacist Geiger and technician Daniels either. Many unauthorized refills were noticed. Pharmacy staff stated some information may be on the old computer system that was not functioning because of Y2K problems. Any authorization or documentation that was found on the computer system was accepted. Under cover of a letter dated March 2, 2000, Petitioner furnished Respondent with statements relative to the discrepant claims/documented sanctions signed by several physicians. All of the statements included the following: (a) statements that the doctors had prescribed the medication(s) for their patients; (b) the patient name; (c) the prescription number; (d) a print-out of a computer screen; and (e) opinions that Petitioner would not fill or refill prescriptions without authority and approval. None of these physicians testified at the hearing. By letter dated August 16, 2000, Respondent notified Petitioner of the determination of a Medicaid overpayment in the amount of $13,798.70. The greater weight of the evidence indicates that Petitioner received an overpayment in that amount or more.
Recommendation Based upon the findings of fact and conclusions of law, it is RECOMMENDED: That Respondent enter a final order finding that Petitioner must timely pay Respondent $13,798.70 for Medicaid reimbursement overpayments from December 25, 1998, through December 24, 1999. DONE AND ENTERED this 30th day of January, 2001, 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 30th day of January, 2001. COPIES FURNISHED: Melvin H. Fletcher, R.Ph. Corporate Representative Mayhugh Drugs, Inc. 200 South Orange Avenue Green Cove Springs, Florida 32043 L. William Porter, II, Esquire Agency for Health Care Administration 2727 Mahan Drive Building 3, Suite 3431 Tallahassee, Florida 32308 Sam Power, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive Building 3, Suite 3431 Tallahassee, Florida 32308 Julie Gallagher, General Counsel Agency for Health Care Administration 2727 Mahan Drive Building 3, Suite 3431 Tallahassee, Florida 32308 Ruben J. King-Shaw, Jr., Director Agency for Health Care Administration 2727 Mahan Drive Building 3, Suite 3116 Tallahassee, Florida 32308
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
Findings Of Fact At all times relevant hereto, respondent, Edwardo A. Garcia, held physician license number ME 0021719 issued by petitioner, Department of Professional Regulation, Board of Medical Examiners (DPR). Garcia is a 1936 graduate of the medical school at the University of Colombia in Bogota, Colombia. He moved to New York City in 1959 where he completed a residency in neurology and psychiatry. He was then issued a temporary license to practice medicine in the State of New York. In 1973, Garcia relocated to Vero Beach. He received his Florida license the following year and practiced in the field of family medicine until May, 1986 when he sold his practice. He is now retired. Earl D. Tovatt, a sixty-two year male whose complaint against respondent precipitated this proceeding, has a long history of back ailments. He fell off of a bunk bed in 1943, was a passenger in an Army jeep that struck a land mine in 1944, and unsuccessfully attempted to lift a 350 pound woman in 1950. As a result of these unfortunate incidents, Tovatt has used various back braces and orthopedic shoes, and has had at least five myelograms since 1951. He has also been treated by a shopping list of physicians over the years, most of whom were in the Detroit area where he once lived. For back pain, Tovatt began using prescription drugs many years ago. By his own admission he became addicted to painkillers as early as 1979. He began with codeine and empirim, but later switched to pure codeine. He then used percodan, and finally began using demerol in 1977. Demerol is a Schedule II controlled substance and has a high potential for abuse. It can also cause addiction after a short period of use. Access to quantities of demerol was made easier by the fact that Tovatt's wife was a medical doctor at the Doctor's Clinic in Vero Beach. Tovatt received demerol injections from his wife until 1981 when they divorced. Thereafter, Dr. Tovatt continued to give her former husband prescriptions of demerol (one per month) for another year. Beginning in 1982, and continuing until at least December, 1984, Tovatt was treated without charge by Dr. Gold, one of his ex-wife's partners at the clinic. Initially Dr. Gold gave Tovatt one or two injections of demerol per day for pain. By December, 1984, however, Dr. Gold had reduced the injection to one-half of an ampule per day. Because he was still experiencing pain, Tovatt was advised by an unnamed clinic employee in December, 1984 to contact respondent to obtain more demerol. Just prior to Christmas, 1984 Tovatt telephoned Dr. Garcia's office and attempted to make an appointment. After learning that Garcia's office hours were filled, Tovatt requested that Dr. Garcia make a house call to his apartment after 5:00 p.m. That same day, Dr. Garcia visited Tovatt's apartment and was told by Tovatt that he had a lot of pain in his lumbar spine and down his right leg. Without making any tests, obtaining a history, or inquiring about prior medical treatment, Dr. Garcia gave Tovatt an injection of demerol and a shot of valium. For this he charged Tovatt $600, or $300 per shot. Tovatt paid Dr. Garcia in cash. Garcia acknowledged that he knew Tovatt was addicted to demerol at that time. After the first house visit, Tovatt went to respondent's office the next day, and received two more shots for $150 each. When Tovatt complained that the visits were expensive, Dr. Garcia agreed to write Tovatt demerol prescriptions for $1,000 each. Dr. Garcia also insisted that only cash be used, and accordingly no checks were ever given to respondent. In addition, Dr. Garcia asked for and was given $25,000 cash for "one year's privilege of having him write a prescription." Approximately six weeks after the first office visit, Dr. Garcia conducted his first complete physical examination of Tovatt. However, he obtained a patient history from Tovatt during the first office visit on December 19, 1984. Even so, it was inadequate since it failed to contain any interpretations of the patient's history. On each visit he took Tovatt's blood pressure and checked his heart. Also, he noted in his patient records that the patient had "severe back pain, history of slipped disc of 30 years duration with arthritis following a fall. Had been using demerol for long periods of time for the above. He takes biroca, which is vitamin B, for the heart condition. He has had two heart attacks." For the next fourteen months or so, Tovatt continued to obtain one or two prescriptions per week from Dr. Garcia at a cost of $1,000 per prescription. The prescriptions generally contained 25 ampules of demerol per box. They were filled at various pharmacies in the Vero Beach and Melbourne areas. Copies of the prescription have been received in evidence as petitioner's exhibits 3-17 and a compilation is set forth in petitioner's exhibit 18. In all, there were 137 prescriptions for demerol, 15 for valium and 9 for percodan. Valium is a Schedule IV controlled substance while percodan is a Schedule II controlled substance. Finally, ten of those prescriptions had orders for demerol and valium on the same prescription while one had an order for demerol, percodan and valium. This was inappropriate. In addition to the above prescriptions, several times Tovatt purchased bottles or boxes of demerol directly from Dr. Garcia. Each bottle was the equivalent of twenty shots while a box had twenty-five ampules, or the equivalent of twenty-five shots. On one occasion he was charged $7,000 for one or two bottles, on another $9,000 for one box of 25 ampules, and $8,000 on another occasion for four boxes. Becoming concerned that Dr. Garcia would stop writing prescriptions, Tovatt purchased an air dehumidifier at a cost of $312.70 for Garcia's birthday. On several occasions Garcia suggested to Tovatt that he include Garcia as a beneficiary in his will. In Garcia's presence, Tovatt directed his attorney to prepare a codicil to his will and bequeath $75,000 to Dr. Garcia. This was executed on November 20, 1985. The codicil is still in effect. At Dr. Garcia's request, Tovatt gave respondent a copy of the codicil. Each time that Tovatt requested a prescription, Garcia provided him with one. Tovatt's injections numbered from five to six a day when he first began seeing Dr. Garcia, and numbered around fifty per week towards the end. Tovatt suffered side effects from the massive amounts of painkillers, including passing out on one occasion and being unable to move on another. He also lost an undisclosed amount of weight. In all, Tovatt paid Dr. Garcia approximately $200,000 in cash over a fourteen month period, which represented his entire life savings. He is now in the process of filing a malpractice suit against respondent. In early 1986 Tovatt obtained four final prescriptions for demerol from Dr. Garcia. When he found no drug store would honor them, he refused to pay Dr. Garcia. Dr. Garcia came to his apartment at least six times demanding payment for the same. Tovatt then mailed the unfilled prescriptions to a DPR investigator. In February, 1986 a DPR investigator interviewed Dr. Garcia concerning the Tovatt prescriptions. At that time Dr. Garcia acknowledged he had treated Tovatt and had charged him $1,000 per prescription for demerol. He also admitted this to his office receptionist. During the same interview, the investigator observed that Dr. Garcia's Drug Enforcement Agency (DEA) registration had expired on September 30, 1985. This was necessary in order to write certain prescriptions. Finally, when the administrative complaint in this case was issued in April, 1986 respondent told Tovatt "we're in trouble" and that Tovatt was "going to pay for my lawyer." Tovatt also filed a complaint with the City of Vero Beach Police Department in April, 1986. While a police officer tape recorded the call, Tovatt telephoned respondent on April 29 and requested a prescription of demerol. Since Tovatt still owed Garcia $4,000 for the four unfilled prescriptions, Dr. Garcia demanded payment of that sum. Tovatt said it would take time to raise the money. Tovatt then told Garcia he knew of a pharmacy in Cocoa Beach that would fill a prescription. Garcia said he didn't want to use Tovatt's name on the prescription, but agreed to use a fictitious name. Garcia also said he would require the usual amount, or $1,000, up front before he would give Tovatt the prescription. According to the uncontradicted testimony of a board certified family practitioner, Dr. Garcia should have taken a complete patient history on the first visit to Tovatt's apartment and at least "a cursory examination" of the patient. Because the patient complained of persistent pain, it would have been prudent to take additional tests and refer Tovatt to a neurologist or orthopedist after several visits. Garcia also had insufficient records to justify the course of treatment rendered, that is, the dispensing of various pain killers and sedatives. It was further inappropriate to prescribe addictive drugs to a patient in that quantity, combination and duration of time "for anything except a terminal illness." In this case, Tovatt did not have a terminal illness. In short, Dr. Garcia did not practice medicine with that level of care, skill and treatment which a reasonably prudent similar physician would recognize as acceptable under similar conditions and circumstances. Finally, the fees charged by Dr. Garcia were clearly excessive and represented an exploitation of the patient for financial gain. Moreover, it is not customary in the medical community to charge a patient for writing a prescription. In December, 1985 a pharmacist in Vero Beach became concerned that Tovatt was filling an excessive number of prescriptions for demerol and percodan. He called Dr. Garcia who explained Tovatt had a back condition caused by a brain tumor and that Tovatt needed large amounts of painkillers until he received an operation in San Francisco. However, Tovatt's medical records contained no reference to a brain tumor or an operation/consultation in San Francisco. Until 1985 Dr. Garcia had no prior complaints filed against him by any person. Dr. Garcia portrayed Tovatt as a desperate man who he knew to be a drug addict. Although he contended he did not wish to treat Tovatt, he stated he did so only because Tovatt constantly approached him for drugs, and because he feared Tovatt might harm him. Dr. Garcia denied receiving excessive fees from Tovatt, and estimated he charged Tovatt only $20,000 while he was a patient. However, this version of events is not deemed to be credible and is accordingly discredited.
Recommendation Based on the foregoing findings of fact and conclusions of law, it is RECOMMENDED that respondent be found guilty of all violations charged in Counts I-VII of the administrative complaint and that his medical license be REVOKED. DONE and ORDERED this 17th day of December, 1986 in Tallahassee, Leon County, Florida. DONALD R. ALEXANDER 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 17th day of December, 1986. APPENDIX TO RECOMMENDED ORDER, CASE NO. 86-1490 Petitioner: Covered in finding of fact 1. Covered in finding of fact 2. Covered in finding of fact 3. Covered in finding of fact 4. Covered in findings of fact 3 and 4. Covered in finding of fact 5. Covered in finding of fact 3. Covered in finding of fact 5. Covered in finding of fact 5. Covered in finding of fact 15. Covered in finding of fact 7. Covered in finding of fact 15. Covered in finding of fact 15. Covered in finding of fact 15. Covered in finding of fact 6. Covered in finding of fact 6. Covered in finding of fact 8. Covered in finding of fact 8. Covered in finding of fact 8. Covered in finding of fact 9. Covered in finding of fact 11. Covered in finding of fact 13. Covered in finding of fact 16. Covered in finding of fact 16. Covered in finding of fact 15. Covered in finding of fact 15. Covered in finding of fact 8. Covered in finding of fact 8. Covered in finding of fact 13. Covered in findings of fact 8 and 15. Covered in finding of fact 15. COPIES FURNISHED: E. Raymond Shope, Jr., Esquire Stephanie A. Daniel, Esquire 130 North Monroe Street Tallahassee, Florida 32399-0750 Robert L. Pegg, Esquire P. O. Box 1000 Vero Beach, Florida 32961 Fred Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 Wings S. Benton, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 Dorothy J. Faircloth Executive Director Board of Medical Examiners 130 North Monroe Street Tallahassee, Florida 32301
The Issue The issues to be resolved in this proceeding concern whether the Respondent properly maintained and supplied required records to support and document prescription claims, which it billed to Medicaid and for which it received payment from the Medicaid program during the audit period of April 1, 2000 through December 31, 2001. If that is not the case, it must be determined whether the Agency is entitled to recoup from the Respondent the sum it seeks of $108,478.77, as the purported amount overpaid to the Respondent by the Agency. It must also be determined whether the applicable laws and regulations referenced herein were complied with by the Respondent, in terms of its accepting and filling prescriptions, dispensing relevant drugs, and recording and documenting such activities in its pharmacy records. Finally, it must be determined whether the statistical methodologies employed by the Agency, through its audit and investigation of the Respondent, were sufficiently representative and accurate so as to support the calculation of estimated overpayments.
Findings Of Fact The Petitioner is an Agency of the State of Florida charged by the statutes and rules referenced herein with ensuring that proper reimbursement is effected to providers, including pharmacies, by the Medicaid system. Because of its duty to enforce and regulate the Medicaid system, the Petitioner Agency has an audit and oversight function, as well as an enforcement function, to ensure that Medicaid payments and the general operations of the Medicaid system are carried out correctly. It is through this duty imposed by the cited Florida Statutes and rules, as well as the federal regulations it is charged with enforcing, that the Petitioner carried out an audit of the Respondent, Brown Pharmacy, concerning the audit period of April 1, 2000 through December 31, 2001. The Petitioner conducts audits of providers such as Brown in order to ensure compliance with the Medicaid provisions and Medicaid provider agreements. These are called "integrity audits" and are routinely performed by auditors contracted from private firms such as Heritage. Brown Pharmacy (Brown) is licensed in the State of Florida as a pharmacy (license Number PH562). Brown maintained a business location at 312 West 8th Street, Jacksonville, Florida 32206, at times pertinent to this case. During the audit period Brown was an enrolled Medicaid provider authorized to provide Medicaid prescriptions pursuant to a provider agreement with the Agency. The terms of the provider agreement governed the contractual relationship between Brown and the Agency. Pursuant to that provider agreement, Brown was to maintain the Medicaid-related records and documentation for at least five years. Any Medicaid provider, such as Brown, not in compliance with the Medicaid documentation and record retention policies may be subject to the recoupment of Medicaid payments. During the audit period, Brown dispensed prescription drugs to Medicaid recipients. Medicaid claims were filed and paid electronically as "point of sale" transactions during the audit period. Each claim reviewed and at issue in this case was a paid Medicaid claim subject to the provider agreement and pertinent regulations. As a condition of participating in the Medicaid program, a Medicaid provider must comply with all provisions of a provider agreement, which is a voluntarily agreement between the Agency and the provider. Those provisions include the provider's agreement to comply with all relevant local, state and federal laws, rules, regulations, licensure laws, bulletins, manuals, and handbooks, etc. The provider must agree to keep and maintain, in a systematic and orderly manner, all Medicaid- related records as may be required by the Agency and make them available for state and federal agencies and review. It must maintain complete and accurate medical, business, and fiscal records that will justify and disclose the extent of goods and services rendered to customers or patients and rendered as billings to the Medicaid system. Florida Administrative Code Rule 59G-4.250 promulgates, as part of the rule, the above-referenced handbook (handbook) which sets out Medicaid polices and rules. The polices and rules govern the rights and responsibilities of drug providers, such as Brown, including coverage and payment methodologies for services and goods rendered to Medicaid recipients and billed to the Medicaid program. The types of records that must be maintained are as follows: Medicaid claim forms, professional records such as patient treatment plans, prior and post authorization information, prescription records, business records, including accounting ledgers, financial statements, purchase and acquisition records etc., tax records, patient counseling information and provider enrollment documentation. Providers who are not in compliance with the Medicaid documentation and record retention policies described in the handbook are subject to administrative sanctions and/or recoupment of Medicaid payments. Medicaid payments for services that lack required documentation and/or appropriate signatures will be recouped. Chapter five of the handbook, in defining overpayment provides that any amount not authorized to be paid by the Medicaid program, whether paid as a result of inaccurate or improper cost reporting, improper claims, unacceptable practices, fraud, abuse or mistake, constitutes overpayment. Incomplete records are records that lack documentation that all requirements or conditions for the providing of services have been met. Medicaid may recoup payments for services or goods when the provider has incomplete records or cannot locate the records. The Agency contracted with Heritage to conduct an on- site audit at Brown. The audit was conducted March 18th through March 20, 2002. Heritage isolated a sample of 205 prescription claims, known as the "judgmental sample" out of a total universe of paid pharmacy claims from Brown totaling 16,727 for the audit period. Heritage also selected 250 random prescription claims out of the remaining total universe of paid pharmacy claims of 16,522, which remained after the 205 judgmental sample claims had been removed or isolated from the remainder of the total claims. With the acquiescence of the Agency, Heritage chose the 205 claims by weighing it in favor of the "high dollar" or more expensive drug prescriptions. Those prescriptions are primarily for HIV and Aids therapy drugs and psychotherapeutic drugs for various mental conditions, including schizophrenia. Weighing of the judgmental sample strongly in favor of the high dollar prescription claims would seem to render the judgmental sample fundamentally unfair against Brown if the judgmental sample had then been extrapolated to the entire universe of claims ($16,727). This was not done, however. The judgmental sample was audited and compiled by doing an actual count and totaling of claim amounts in dollars represented by all the discrepant prescriptions, including all those the Agency and Heritage maintained resulted in "overpayments" to Brown. Therefore, the judgmental sample is an actual number rather than an extrapolated calculation so that weighing the sample in favor of the high dollar prescriptions does not result in an unfair or biased sample, as to the judgmental sample. Because the judgmental sample was drawn from the total pool of audited claims and removed from that claim pool prior to the identification and drawing of the random sample, the two are mutually exclusive and the amounts calculated do not represent a duplication or overlap. Thus the findings from the judgmental sample and then the random sample may be properly added together. The randomly selected claims (random sample) were taken of the remaining 16,522 claims in the audit claim pool after the judgmental sample of 205 claims had been removed. According to the report rendered by Heritage, the 250 randomly selected claims totaled $10,632.59 in paid Medicaid dollars. The Heritage auditors determined that there were 56 discrepant claims out of these which totaled, according to their calculation, $2,450.13 in apparent overpayments. This resulted in an average overcharge per claim of $9.80 (determined by dividing the documented "sanction amount" by the total number of claims in the random sample (250), multiplied by the universe of claims from which the random sample was taken (16,522) which yielded an extrapolated overcharge of $161,924.19. Applying the statistically appropriate 95 percent "one-sided" lower confidence limit of this extrapolation resulted in a purported overpayment extrapolated from the randomly selected claims of $102,700.85. This means that the overpayment amount calculated by Heritage represents an amount statistically 95 percent certain to be the lowest amount overpayment based on the extrapolation of the overpayment represented in the 250 randomly selected claims. The non-extrapolated judgmental findings showed, according to Heritage, that there were 72 discrepant claims. Heritage then determined that, of these, there were $29,381.09 in apparent actual overcharges. The discrepancies determined by Heritage involved the failure to produce documentation of refill authorizations for 80 prescription claims; 31 prescription claims containing an incorrect Medicaid provider number; the failure to produce 12 "hard copy" prescriptions representing 25 claims; four claims that did not have the prescriber's DEA number on the prescription for controlled substances; three claims for prescriptions that did not contain the original date of service; two claims that were billed for quantities greater than that authorized by the physician; one claim that was billed for an incorrect day's supply; one claim that was billed in excess of the maximum allowable quantity of prescription of the drug, set by Medicaid policy; and one prescription claim that was billed for an incorrect prescriber's Medicaid provider number (although this should not be a discrepancy because the correct prescriber was documented in the pharmacy's computer, which the regulations allowed). Additionally, there was one claim billed for a drug different than that prescribed by the physician, according to Heritage in its report. Heritage also conducted an invoice review using utilization reports provided by the Respondent. This was apparently a review of 25 different drugs that purportedly showed that the prorated purchases of those drugs were insufficient to cover the number of units billed to Medicaid for all 25 drugs reviewed, and thus yielded a purported shortage of $87,942.13, representing the amount billed to Medicaid above the amount the records of purchases from suppliers proved that Brown had purchased of those drugs. Based upon the Heritage audit as well as documentation findings and overpayments calculations (see Exhibit 8), the Agency issued a PAAR dated September 27, 2002, determining that Brown had been overpaid $150,036.71 for Medicaid claims during the audit period. That report advised Brown that it was a provisional report only and encouraged Brown to submit any additional information or documentation which might serve to change the overpayment. The report listed examples of documentation that the Agency would consider for a possible reduction in the overpayment amount initially claimed. Thereafter, the Agency agreed to an extension of time for Brown to submit additional documentation and sent a letter to Brown dated October 31, 2003, advising that the audit had been placed in abeyance pending the outcome in a related case, but that the Agency expected to resume the audit and that therefore all Medicaid-related records and documentation regarding paid claims should be maintained and preserved until the audit was finalized. The FAAR was addressed in the testimony of Ms. Stewart for the Agency. Through her testimony it was revealed that certain corrections should be made to the FAAR updating it from the findings in the Heritage initial audit report. The Agency corrected the information in the FAAR for this reason and for the reason that it secured some additional information from the Respondent. Thus, for the audit period it was established that there were 16,727 total claims for prescriptions dispensed by Brown, for which it was paid $795,564.59 during the 21-month audit period, of those claims, 205 were pulled out from the total universe of claims as the judgmental sample. There were some 72 allegedly "discrepant claims" totaling $36,393.51 in dollars paid to Brown. The Agency's position is that $29,381.09 of those are so called "documented overcharges." The random sample of 250 claims was extrapolated to the remaining universe of 16,522 prescription claims. The Agency now takes the position that it found 49 "discrepant claims" in the random sample which totaled $2,154.40 in dollars paid to Brown's pharmacy and of that it maintains that $1,927.55 are "documented overcharges" for the 250 randomly selected claims (for which Brown had been paid $10,632.59). Thus the Agency found an average overcharge for the 250 randomly sampled claims of $7.71 per claim. The $7.71 average per claim overcharge was then multiplied by the remaining universe of 16,522 claims, yielding an extrapolated purported overcharge of $127,387.92. The Agency then applied the 95 percent "one-sided lower confidence limit" to this extrapolation, that is, that it or its statistician, Dr. Johnson, felt that there was a 95 percent chance that the lower confidence limit number it calculated was accurate. That number is $79,097.68. When that number is combined with the Agency's position as to overcharges from the judgmental sample results in a total postulated overcharge of $108,478.77. This is the final amount the Agency claims as an overpayment that must be recouped for Medicaid. The FAAR summarized the discrepant claims for the judgmental sample as follows: 61 claims involve refills which exceeded the authorized number of refills without documentation of reauthorization; 10 claims showed an incorrect prescriber license number but the correct prescriber license number was documented in the pharmacy's computer; and For two claims the hard copy description did not have an original date of service depicted on it and did not reference a DEA number. The discrepant claims shown in the FAAR as to the random sample were as follows: There were 19 claims for refills without documentation of refill authorization (refills had been previously authorized, but for the 19 claims at least one refill had been issued beyond the authorization limit); Fifteen claims showed an incorrect prescriber license number on the claim and the license number was not documented in the Respondent's computer; Seven claims showed an incorrect prescriber license number, but the correct license number was documented in the pharmacy's computer; There were seven claims for which the original hard copy prescriptions could not be found on file during the audit period; For one claim the hard copy prescription did not have an original date of service or DEA number; For one claim the quantity paid exceeded the quantity authorized by the prescriber or dispensed to the recipient; and For one claim the number of days supply submitted by the pharmacy was not consistent with the quantity and directions of the prescriber and the quantity exceeded the limit set by the plan. The most common discrepancies with regard to the judgmental sample and the random sample occurred when the Respondent billed refills in excess of the number authorized by the prescriber, without any written authorization for such being provided in the audit process or later. Concerning the random sample, the second most common discrepancy occurred when the claim depicted an incorrect precriber number on the claim and the license number of the prescriber was not documented in the computer. In the judgmental sample the second most common discrepancy occurred when the claim showed an incorrect prescriber number, but the correct prescriber number was documented in the pharmacy's computer. The discrepancies in the FAAR with the indication "UR", references "unauthorized refills." The records of the pharmacy showed that Brown issued refills of prescriptions to Medicaid recipients in excess of the presriber's limit depicted on the prescriptions but showed no written record of a telephonic or written authorization by the prescriber allowing the additional refill or refills. It is also true that as to some or even many of these the Respondent may have obtained verbal authorization, but failed to document that re- authorization. Medicaid policy, the statutory authority cited herein, and the PDSCLR Handbook provide that all verbal orders authorized by the prescriber of a prescription must be recorded either as a "hard copy" or noted in the pharmacy's computer in order to comply with the relevant law cited herein, for record- keeping and auditing purposes under Medicaid policy. The Agency's Statistical Methodology Mark E. Johnson, Ph.D., testified on behalf of the Petitioner. He was qualified as an expert witness in the area of statistical formulas, statistical methodology, and random sampling, including the random sample statistical methodology employed by the Agency in determining the overpayment amount. He is a professor of statistics at the University of Central Florida. Dr. Johnson reviewed the statistical methodology, numbers and calculations arrived at by the Agency and its extrapolation method of arriving at the overpayment amount. He also used his own independent analysis based upon a software package he commonly uses in the practice of his discipline in testing the methodology employed by the Agency and the random sample employed by the Agency and Heritage. The statistical formula employed by Dr. Johnson and the Agency is a standard one routinely used in Dr. Johnson's profession and statistical sampling. He established through his own testing of the methodology that the random sample was appropriate for Medicaid program integrity audits and determinations as employed in this case. The random sampling, according to Dr. Johnson, was employed because it would be time and cost prohibitive to examine individually each of 16,522 claims regarding overpayment issues. The random sampling methodology using 250 randomly chosen samples is a time and cost saving device and yet still presents a "plausible estimate" as established by Dr. Johnson. He established that for the universe of 16,522 claims which were subjected to the random sample and extrapolation statistical analysis and calculation, that such is a reasonable sample for purposes of this audit and that the 250 random samples employed by the Agency are indeed statistically appropriate random samples. His calculation of overpayment was at variance with the Agency's by 55 cents. He established that is not a significant difference since the 95 percent certainty limit of $79,097.68 for the random sample extrapolation analysis is so much lower than the estimate established at $108,478.22. Dr. Johnson established that the Agency had employed appropriate and valid statistical methods in its determination of the above-referenced overpayment amount based upon the random sample of paid claims. The expert testimony of Dr. Johnson, together with his written report in evidence, is credible and persuasive as to the validity of the random sampling of the claims during the audit period and as to the random sample portion of the analysis employed in arriving at the final overpayment calculation and numbers depicted in the FAAR. Dr. Johnson established the appropriateness of the statistical formula, including extrapolation, used to calculate the overpayment amount, the appropriateness of the sample size relative to the universe of claims, and the improbability that the overpayment amount is attributable to chance causes alone. Thus Dr. Johnson's testimony is accepted as credible and persuasive in establishing the validity of the Agency's method of overpayment calculation, and the overpayment calculation in conjunction with the statistical evidence in this record, except as modified by the findings below.1/ The Respondent's Position Gary Steinberg testified on behalf of the Respondent, Brown Pharmacy. He was accepted as an expert witness in the areas of Medicaid policy, audits and pharmacy practice, including Florida pharmacy practice. Mr. Steinberg acknowledged that Brown had not properly documented all claims that had been paid by the Medicaid program nor maintained all required records. He emphasized in his testimony, however, that Brown had not fraudulently billed the Medicaid program with claims for prescription medications that it had not actually dispensed to the patients or recipients. Rather, all medications involved in the subject prescription claims had actually been dispensed. There is no evidence or claim on the part of the Agency that Brown charged and collected more than the appropriate approved price for the prescriptions at issue. Through the explanation given in his testimony, Mr. Steinberg opined that although Brown was guilty of technical errors in record keeping and documentation as to the prescriptions involved in the subject claims, Brown had made substantial compliance with the Medicaid program requirements of the Medicaid provider agreement and the statutes and rules at issue and policies embodied in the subject handbook. He explained in his testimony that in the pharmacy practice setting in which Brown has operated, whereby it serves a large indigent population in an inner city environment, it is difficult to contact a prescriber at the time when a patient needs a critical prescription refilled in order to get a refill authorization. The prescriptions at issue mostly involve critical medications for HIV/Aids and psychotropic medications for severe mental conditions such as schizophrenia. The patients who need these critical medications (and there are very few patients, since most of the procedures involve filling and refilling for a small number of such recipients) are patients of clinics operated at the nearby university hospital (Shands). In these circumstances, where the patient literally needs the HIV/Aids medication refilled on an immediate basis, possibly even to prevent death, and the mental health patient critically needs a refill in order to prevent harm to the patient or harm to the members of the public if the patient goes without medication and "decompensates," the ethical thing for a pharmacist to do is to refill the prescription and seek authorization later. Mr. Steinberg established that it is often difficult to obtain authorization from the original prescriber since the medication were prescribed by residents practicing in the various clinics at the Shands Hospital and that the residents can not always be identified or contacted easily since they do not maintain a fixed medical practice in the area. Consequently, some of the prescriptions were not documented as to authorization, although in some cases the pharmacy actually obtained authorization and entered it in its computer. In some cases, being unable to obtain re-authorization from the resident who originally prescribed the medication the pharmacy used the DEA license or prescribing number of the hospital itself. He explained that although under the law a pharmacy can refill a prescription on an emergency basis for up to a 72-hour supply, that this is generally impracticable and unsafe for patients in this plight because such indigent, mental health and HIV/Aids patients tend to be non-compliant with their medication regimes quite often anyway, and it is often unreasonable to expect them to return to the pharmacy for another refill within two or three days. He thus opined that the ethical and safe thing for the pharmacist to do was to refill and re-dispense the medical approved medication for up to a 30 or 34-day supply (the normal refill supply duration). He further explained that the Shands Hospital license number was used in some of these circumstances because the resident doctor who originally issued the prescription could not be identified on the Shands Hospital prescription forms and because the resident doctors at the Shands clinics only have and can use Shands Hospital prescription forms in any event. Mr. Steinberg thus established that 35 percent of those prescription claims classified as "WMP," that is the prescription claims contained an incorrect prscriber license number were for these reasons and the pharmacist could only use the Shands Hospital license number because the resident could not be identified from the Shands Hospital prescription forms. He thus opined that 35 percent of the random sample extrapolation amount, the 95 percent statistical confidence limit amount of $79,097.00, should be deleted from that amount in determining the correct amount of overpayment predicated on the random sample. Likewise, with regard to the judgmental sample concerning the HIV/Aids and mental health patient prescriptions and related claims, he opined that, in effect, $19,500.00 of the total $29,381.09 overpayment amount claimed by the Agency pursuant to the judgmental sample portion of the claims, should be deleted from that portion of the overpayment claim by the Agency; this is a result of his explanation regarding "substantial compliance" in the critical refill situation he described concerning the HIV/Aids and mental health patients and their prescription drugs. The preponderant, persuasive evidence does establish (and indeed the Agency acknowledged in its Proposed Recommended Order) with regard to the judgmental sample, that 10 of the claims at issue listed an incorrect prescriber license number, but that the correct prescriber license number was actually documented in the pharmacy's computer record with the name of the prescriber. This circumstances comports with the law referenced below and in the Petitioner's Proposed Recommended Order. This results in a reduction in the overpayment claim with regard to the judgmental sample of 13.88 percent of the judgmental sample claims or a reduction of $4,078.09. Likewise, with regard to the random sample extrapolation calculation of overpaid claims, the preponderant, persuasive evidence, also as acknowledged by the Agency in its Proposed Recommended Order, disclosed that seven claims listed an incorrect prescriber license number on the claims, but had been correctly documented in the pharmacy's computer system and therefore were in compliance with the relevant statutes, rules, and the subject handbook. Thus the discrepant claims and the overpayment amount related to the random sample portion of the audit claims should be reduced by 14.28 percent of the total amount of $79,097.00 for a $11,295.05 reduction of that $79,097.00 random sample overpayment amount. Mr. Steinberg demonstrated that Brown was not overcharging on the drugs prescribed and dispensed and was charging the Medicaid-authorized amount for the drugs involved in the prescription claims at issue. The Agency is not claiming that there was any fraudulent practice or illegal overcharging for the prescriptions involved. In fact, Brown was earning only a very small profit on the drugs dispensed that are the subject of the prescription claims at issue. Mr. Steinberg thus opined that since Brown did indeed dispense all the drugs at issue and was only paid the legal authorized amounts for the drugs and prescriptions at issue that recoupment of the amounts sought by the Agency or, in effect, established in these findings of fact, would be fundamentally unfair. He and the Respondent contend, rather, that since Brown performed substantial compliance, but was guilty of technical non-compliance with the relevant rules, agreement, and Medicaid policy, that the Agency should impose a lesser fine instead of seeking recoupment. In summary, in view of the preponderant persuasive evidence establishing the above facts, it has been shown that the documentation and record-keeping, dispensing errors, and omissions in the manner found above, with regard to the prescription claims and types of claims addressed in the above findings of fact, occurred. If those deficiencies amount to violations of the authority cited and discussed below which justify recoupment, then the amount of overpayment established by the above findings of fact is $93,104.95.
Recommendation Having considered the foregoing findings of fact, conclusions of law, the evidence of record, the candor and demeanor of the witnesses, and the pleadings and arguments of the parties, it is, therefore, RECOMMENDED that a final order be entered by the Agency for Health Care Administration providing for recoupment of $93,104.95, and that the Respondent, Brown Pharmacy, must re-pay that amount to the Petitioner Agency, through a reasonable re- payment plan established between the parties. DONE AND ENTERED this 3rd day of November, 2006, in Tallahassee, Leon County, Florida. S P. MICHAEL RUFF 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 Clerk of the Division of Administrative Hearings this 3rd day of November, 2006.
Findings Of Fact Dora F. Villanueva is a licensed pharmacist in the State of Florida, holding license number PS 0014957. Ms. Villanueva is an elderly woman who owns the Century Pharmacy, a community pharmacy located at 3017 S.W. 107th Avenue in Dade County, which holds permit number PH 0006839. She depends on the pharmacy for her livelihood and is manager of its prescription department. An investigator for the Department of Professional Regulation, Thomas Daniels, entered the Century Pharmacy in the early afternoon on January 7, 1988. He was there to follow up on a previous inspection of the Century Pharmacy. When Mr. Daniels arrived at the pharmacy, Ms. Villanueva, the registered pharmacist, was not there. It is Ms. Villanueva's practice to open the prescription department from 9:00 a.m. to 1:00 p.m. and 3:00 p.m. to 8:00 p.m. She returns to her home for lunch from 1:00 p.m. to 3:00 p.m. While there, Mr. Daniels, observed a person in the pharmacy department, who was visible through a pass-through window which connects the prescription department with the over- the-counter drug section of the pharmacy. That person was Mary Washington, a pharmacy technician who works at the Century Pharmacy. Ms. Washington is not, and never has been a licensed pharmacist. No other licensed pharmacist was present and on duty at the pharmacy. Ms. Villanueva is the only pharmacist employed at the Century Pharmacy. While Ms. Villanueva was absent, there was no sign indicating the pharmacy prescription department was closed due to the absence of a pharmacist. The records of the Board of Pharmacy admitted into evidence indicate that Ms. Villanueva was placed on probation on November 5, 1984, for one year. The reason for the probation cannot be determined from the records offered in evidence.
Recommendation It is, therefore, RECOMMENDED that Dora F. Villanueva and Century Pharmacy receive a reprimand and a fine of $400 for violations of Rule 21S-1.014, Florida Administrative Code. DONE AND ENTERED in Tallahassee, Leon County, Florida, this 26th day of August, 1988. WILLIAM R. DORSEY, JR. Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1050 (904) 488-9765 Filed with the Clerk of the Division of Administrative Hearings this 26th day of August, 1988. APPENDIX Rulings on the proposed findings of fact and conclusions of law of the petitioner. Covered in finding of fact 1. Covered in finding of fact 2. Covered in finding of fact 2. Covered in finding of fact 4. Covered in finding of fact 4. Covered in finding of fact 4. Covered in finding of fact 5. Rulings on the proposed findings of fact and conclusions of law of the respondent. Covered in finding of fact 1. Covered in finding of fact 2. Covered in findings of fact 2 and 3. Generally covered in findings of fact 2 and 3. Rejected because I accepted the testimony of Mr. Daniels on this point, that there was no closed sign at all. Whether Dr. Villanueva places a sign in the dispensing window on most days cannot be determined from the evidence, but she did not do so on January 7, 1988. Rejected because I have accepted the testimony of Mr. Daniels that he saw Mary Washington in the pharmacy department. Rejected for the reasons stated in the preceding paragraph. COPIES FURNISHED: Michael A. Mone', Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 Regla M. Sibila-Zaidner, Esquire 2260 S.W. 8th Street Suite 204 Miami, Florida 33135 Rod Presnell, Executive Director Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 William O'Neil, Esquire General Counsel Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750
The Issue The issue posed for decision herein is whether or not the Respondent's license to practice nursing should be suspended, revoked, or otherwise disciplined based on conduct which will be set forth hereinafter in detail as outlined by the Administrative Complaint filed herein on or about March 5, 1979.
Findings Of Fact Karyn Elaine Houghton Ruen, Respondent, is a licensed Registered Nurse who holds license No. 0942442. On March 5, 1979, the Florida State Board of Nursing, Petitioner, filed a five-count Administrative Complaint against the Respondent alleging that during the period February 4, 1978, through April 6, 1978, the Respondent engaged in unprofessional conduct in violation of Subsection 464.21(1)(b), Florida Statutes, in that on approximately five occasions, Respondent signed out on the hospital's narcotic control records on various occasions for a controlled substance and failed to chart the same on patients' medication administration records. Additionally, it is alleged that the Respondent failed to follow effective doctors' orders in the administering of prescribed drugs and that the Respondent failed to follow establish "wastage" procedures as required by her employer, St. Luke's Hospital, Jacksonville, Florida. 2/ Elmer H. Schorer, R.Ph., is the Chief Pharmacist (Director of Pharmacy) for St. Luke's Hospital, Jacksonville, Florida, and has been registered to practice pharmacy in the State of Florida for approximately twenty years. Pharmacist Schorer is the custodian of controlled substances records for St. Luke's Hospital and tendered copies of those records during the course of the hearing. He testified that all written doctors' orders automatically terminate after forty-eight hours unless renewed by a written prescription. (Petitioner's Composite Exhibit 1.) Donald J. Smith, the Director of Medical Records for St. Luke's Hospital since January 18, 1978, appeared and testified that he is custodian of patients' medical treatment records and tendered such records during the course of the hearing. (Petitioner's Composite Exhibit 2.) Juanita B. Gold, a Registered Nurse licensed to practice in this state for approximately thirty-three years, is the Head Nurse for the Orthopedic Floor for St. Luke's Hospital. She has been so employed for the past eight years. Ms. Gold testified that she knew Respondent as a staff nurse on her floor during times material to the complaint allegations filed herein. Count 1 of the Administrative Complaint alleges that on or about February 4, 1978, while employed as a Registered Nurse at St. Luke's Hospital, Respondent signed out on the narcotic control record on three occasions for a controlled substance, to-wit: Demerol (Mepheridine), for a patient, Margery E. Murrhee, and charted same on the patient's medication administration record. It is alleged that on said date and time, there was no doctor's order for said drug for said patient. Respecting the Compliant allegations, the evidence showed that the last written doctor's orders for the administration of Demerol to Patient Murrhee was written on the physician's direction on February 1, 1978, and according to the testimony of Juanita Gold, R.N., there was an automatic termination of said doctor's orders forty-eight hours after it was given, unless renewed by a physician. An examination of the medication administration record revealed that the Respondent administered Demerol on three occasions on February 4, 1978, to said patient. As an aside, it was also noted that the same medication was also administered by nurses on other shifts on the same date also subsequent to and in violation of the doctor's orders which had terminated. In Count 2 of the Administrative Complaint, it is alleged that on February 5, 1978, at approximately 7:30 p.m., Respondent signed out on the narcotic control record for Demerol, a controlled substance, for Patient Murrhee when there was no doctor's order in force on said date and time and she (Respondent) charted the administration of same on the patient's administration record, but failed to chart same on the patient's nurses' notes. The same facts were offered to establish the allegations in Count 2 of the patient, Margery E. Murrhee, on the date and time alleged in Count 2. Much like the evidence offered in support of Count 1, evidence also showed that Demerol had been given to Patient Murrhee by other nurses on the prior shift contrary to doctor's orders and the automatic termination procedures in effect at the hospital. However, contrary to the Complaint allegations, the evidence revealed that the Respondent charted the administration of Demerol on the patient's nurses' notes which, according to the notes, revealed that the Demerol was administered to Patient Murrhee for pain. Count 3 of the Administrative Complaint alleges that on February 9, 1978, Respondent, while employed as a Registered Nurse at St. Luke's Hospital, signed out on the narcotic control record for Demerol 75 mg., a controlled substance, for Patient David Demick, at 7:30 p.m., 1:30 p.m. and 11:00 p.m. The patient's doctor's orders called for Demerol 75 mg. every three to four hours for severe pain. It is thus alleged that the time interval was incorrect and contrary to the doctor's orders called for Demerol 75 mg. every three to four hours for severe pain. It is thus alleged that the time interval was incorrect and contrary to the doctor's orders. Additionally, it is alleged that the Respondent indicated that the 11:00 p.m. dosage was "wasted", but (Respondent) failed to have the wastage witnessed and signed as required. The evidence revealed that the Respondent did not administer any medication to Patient David Demick contrary to the doctor's orders. What the evidence shows is that Demerol, as prescribed by the treating physician, was administered to Patient Demick at 7:30 p.m. and 10:30 p.m. on February 9, 1978, which administrations complied with the doctor's orders for the administration of Demerol every three to four hours. Respecting the allegations that the Respondent failed to follow the established wastage procedure at 11:00 p.m. on February 9, 1978, the evidence shows that the Respondent stated that the 11:00 p.m. dosage was taken from the narcotic cabinet in error and as such had to be wasted. The wastage policy of St. Luke's Hospital is that any wastage of drugs must be witnessed and signed by a nurse other than the nurse wasting the medication. In this regard, the evidence showed that this wastage in question was witnessed only by the Respondent, although Respondent testified that to her best recollection, she was unable to find another nurse to witness the wastage at that particular time, 11:00 p.m., which was the time when the nurses changed shifts. Respondent offered that she felt it improper to leave an open narcotic vial in the narcotics cabinet in order that she summon another nurse to witness the wastage. Additionally, she testified that she did not feel she could properly take an open narcotic vial with her in the hallway in order to find a person who could witness the wastage. Therefore, she considered the safest alternative was to waste the narcotic on her own since obtaining a witness was impractical under the circumstances. In this regard, the evidence does establish that during shift changes, the nurses stations are fairly busy and that it would not be unusual for an employee to encounter difficulty obtaining a witness to a wastage of a drug in conformance with established policy. Count 4 of the Administrative Complaint alleges that on or about April 6, 1978, Respondent signed out for Demerol 75 mg. at 7:15 p.m. and 10:20 p.m. for a patient, Mildred Blake, and charted it as having been administered at 7:45 p.m. and 10:45 p.m., a three-hour interval, contrary to the patient's doctor's orders which called for the administration of said drug every four hours. The evidence in this regard revealed that through the Respondent's own admission, Demerol was administered to Patient Blake at three-hour intervals contrary to the doctor's orders. An examination of the medication administration records revealed that there were no subsequent doses of Demerol administered to Patient Blake. Count 5 of the Administrative Complaint alleges that on or about April 6, 1978, Respondent signed out on the narcotic control record for Demerol 75 mg. for a patient, Bruce Hanks, at 5:15 p.m. and 10:00 p.m., and failed to chart the administration of the 5:15 p.m. dose on the patient's medication administration record. It is also alleged that Respondent incorrectly charted Percodan, a controlled substance, as having been administered at 10:30 p.m. instead of 8:15 p.m., the time Respondent signed out for it on the narcotic control record. It is alleged that Respondent charted Demerol as having been given at 8:15 p.m. when no Demerol was signed out at that hour by the Respondent on the narcotic control record. (The remaining allegations of Count 5 were withdrawn.) An examination of the narcotic control record and the medication administration chart reveals that the Respondent properly administered the dosage of Demerol to Patient Hanks at 5:15 p.m. and 10:30 p.m. on April 6, 1978, and such was properly noted on the narcotic control record and medication administration chart. Evidence also reveals, as reflected on the narcotic control record and the medication administration chart, that the Respondent properly administered the dosage of Percodan at 8:15 p.m. and properly charted same on the medication chart. Additionally, the testimony of Respondent's supervisor, Juanita Gold, establishes that the administration of the Demerol at 5:15 p.m., the Percodan at 8:15 p.m. and the Demerol at 10:30 p.m. was in compliance with the treating physician's orders. The Respondent's nurses' notes revealed that she failed to chart the 5:15 p.m. administration of Demerol on the nurses' notes. The evidence also reveals that the nurses' notes also reflect that the Respondent improperly noted the administration of Demerol at 8:15 p.m. instead of Percodan and that the Respondent further improperly noted the administration of Percodan at 10:30 p.m. instead of Demerol. However, the nurses' notes showed that the Respondent realized her mistake and made a notation on the nurses' notes in an attempt to correct the proper administration of Percodan at 8:15 p.m. and the administration of Demerol at 10:30 p.m. In this regard, the testimony of Respondent's immediate supervisor, Juanita Gold, revealed that nurses often find it necessary to return and complete their nurses' notes after medications have been administered and sometimes after the narcotic control record and medication administration charts have been properly noted. The situations, according to Ms. Gold, occur when nurses are extremely busy. Additionally, Ms. Gold testified that occasionally nurses are allowed discretion in determining at what time certain medications should be administered to particular patients without outstanding physicians' directions.
Conclusions The Respondent's conduct, as alleged in paragraphs 1 and 2 of the Administrative Complaint, evidences a departure from the minimal standards of acceptable and prevailing nursing standards since there were no doctor's orders in effect at the times alleged. It is thus found that the Respondent failed to properly review the physician's directions at said times. As a mitigating factor, it is found that as reflected on the administration records introduced, other nurses on the same dates, albeit different shifts, were also improperly administering the same medication to patients in questions as noted on the various medication charts. Contrary to the Complaint allegations, the Respondent in fact charted the February 5, 1978, administration on the patient's nurses' notes. As to the allegations of paragraph 3, it is found that the Respondent did not administer any medication contrary to the doctors' orders. Although it is found that the Respondent failed to summon a witness to the wastage dosage of Demerol at 11:00 p.m., as alleged in paragraph 3, it is found that the Respondent exercised her best judgment under the circumstances and thus did not depart from the minimal standards of acceptable and prevailing nursing practices as alleged. As to the Complaint allegations in paragraph 4, it is found that the Respondent administered the medication to Patient Mildred Blake contrary to the doctor's orders and thus Respondent departed from the minimal standards of acceptable and prevailing nursing practices. Respecting the Complaint allegations of paragraph 5, it is found that the acceptable prevailing nursing practice is for nurses on occasion to revert back and complete their nurses' notes as the circumstances dictate. Therefore, although Respondent initially made a mistake regarding the noting of the 8:15 p.m. administration of Percodan and the 10:30 p.m. administration on the nurses' notes, she (Respondent) attempted to rectify this mistake immediately on the nurses' notes by a proper notation thereon. Therefore, Respondent did not depart from the minimal standards of acceptable and prevailing nursing practices as alleged. However, in view of the Respondent's failure to note the 5:15 p.m. administration of Demerol on the nurses' notes, although noted on the other administration narcotic control records and the medication administration charts, Respondent departed from the minimal standard of acceptable and prevailing nursing practices in failing to note the 5:15 p.m. administration of Demerol on the nurses' notes, although noted on the other administration narcotic control records and the medication administration charts, Respondent departed from the minimal standard of acceptable and prevailing nursing practices in failing to note the 5:15 p.m. administration on the nurses' notes. It was also noted in mitigation, that although the Respondent was employed at St. Luke's Hospital for a period of more than ten months, the instances alleged occurred on only three days during that period, and further, that the Respondent has not been the subject of any other disciplinary proceedings.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is hereby, RECOMMENDED: That the Respondent be placed on probation for a period of two (2) years. The above recommendation is based on mitigating factors offered during the hearing, including the fact that Respondent's employment record does not reflect that the Respondent has been the subject of any other disciplinary actions either prior to or subsequent to the instant proceedings. DONE AND ORDERED in Tallahassee, Leon County, Florida, this 5th day of October, 1979. JAMES E. BRADWELL Hearing Officer Division of Administrative Hearings Room 101, Collins Building Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 5th day of October, 1979.
The Issue The issues to be determined here concern disciplinary action to be taken against Respondent for those administrative offenses pertaining to the controlled substances Talwin, Dilaudid and Paregoric dispensed by Scottie Drug Store in Duval County, Florida, during the period April 2, 1981, to March 23, 1982, in violation of various provisions of Chapter 465, Florida Statutes. These contentions made by the State of Florida, Department of Professional Regulation, are more particularly described in the Administrative Complaint, DPR Case No. 0022147.
Findings Of Fact Howard E. Staats is a pharmacist who has been issued a license by the State of Florida, Department of Professional Regulation, Board of Pharmacy. The license number is 0007704. At times relevant to this proceeding, Staats practiced pharmacy in Jacksonville, Florida. At all times pertinent to the Administrative Complaint, which is the focus of this action, Staats was the managing pharmacist at American Apothecaries, Inc., which does business as Scottie Drug Store at 41 Arlington Road South, Jacksonville, Florida. A copy of Respondent's most recent license may be found as Petitioner's Exhibit No. 1, admitted into evidence. Petitioner's Exhibit No. 2, admitted into evidence, is a copy of the permit for American Apothecaries. Sometime within the period March 23, 1982, through March 29, 1982, an audit was conducted at the Scottie Drug Store. The audit revealed that in the period April 2, 1981, through March 23, 1982, the drug store had purchased 66,900 tablets of Talwin, 50 mg., had sold 29,373 tablets of that drug, had lost by robbery or theft, 1,000 tablets of the drug, leaving 36,527 tablets of Talwin unaccounted for. During that same audit period, the pharmacy purchased 4,000 tablets of Dilaudid, 4 mg., selling 3,025 tablets of that drug, losing by robbery or theft, 200 tablets of the drug and failing to account for 775 tablets of the drug. Finally, during the audit period, 2,064 ounces of Paregoric had been purchased and 699 ounces sold, with the remaining amount of 1,285 ounces being unaccounted for. See Petitioner's Exhibit No. 4. Talwin is a Schedule IV controlled substance within the meaning of Chapter 893, Florida Statutes. Dilaudid is a Schedule II controlled substance within the meaning of Chapter 893, Florida Statutes. Paregoric is a Schedule III controlled substance within the meaning of Chapter 893, Florida Statutes. The audit which was conducted at the Scottie Drug Store revealed numerous prescriptions for the controlled substance Talwin, 50 mg., written on prescription blanks of Drs. W. W. Shell, Jr., and L. T. McCarthy, Jr., which had allegedly been signed by those physicians, when in fact the patients for whom the prescriptions were written were unknown to the physicians and the signatures of the physicians were forgeries. Those prescriptions are depicted in Petitioner's Exhibit No. 5, admitted into evidence. During the period covered by the audit, it was shown that Staats filled a number of prescriptions for various patients for the controlled substance Talwin, which had been written on prescription pads of Methodist Hospital and Baptist Medical Center in Jacksonville, Florida, and signed by individuals who are not physicians having hospital privileges at those medical centers nor practicing as physicians in the Duval County area. Copies of those prescriptions may be found as Petitioner's Exhibit No. 6, admitted into evidence. In the course of the time sequence related to the audit review process, it was discovered that Staats had refilled numerous prescriptions for controlled substances on more occasions than had been authorized by physicians, namely prescription No. 51632 was refilled twice although the physician indicated there were to be no refills; prescription No. 51579 was refilled once although the prescription indicated there should be no refills; prescription No. 51639 was refilled twice although the prescription indicated there should be no refills; prescription No. 51217 was refilled once although the prescription indicated there should be no refills; prescription No. 51238 was refilled once although the prescription indicated that there should be no refills; prescription No. 53010 was refilled once although the prescription indicated that there should be no refills; prescription No. 53597 was refilled four (4) times although the prescription indicated that it should only be refilled once; prescription No. 53537 was refilled once although the prescription indicated that it should not be refilled; and prescription No. 53592 was refilled twice although the prescription indicated that there should be no refills. Petitioner's Exhibit No. 7, admitted into evidence, is copies of prescriptions spoken to in this paragraph. Respondent Staats had operated the Scottie store under a lease arrangement during 1979 and 1980, and in January of 1981, took a position as an active pharmacist in that store. After becoming the principal operating pharmacist in the Scottie store, Staats began to receive prescriptions from doctors Shell and McCarthy for the substance Talwin and when a prescription purportedly written by those physicians was in question, Staats would call the office of the physicians for confirmation, which at times would be given over the phone and at other times an indication was made that a call back from the physician's office to Staats would be necessary. Some of the indications of physicians' prescription authority of the substances in question would be placed on a separate log and not on the back of the prescription and on other occasions, the note of the prescription information would be placed on the back of the prescription form and not in the log. Normally, this information would be reflected both in the log and on the back of the prescription. There were occasional circumstances in which the authority was not stated in either place. At approximately the same time as was covered by the audit, Staats began to ask for identification from customers who were seeking prescriptions for Talwin and noted that the demand for that substance declined with the advent of the request for identification. Staats posted a notice in the window of the pharmacy to the effect that state law imposed a fine of $5,000.00 or might cause incarceration for five (5) years for presenting forged prescriptions or conspiring or agreeing with another to have a forged prescription filled. On two (2) occasions Staats called law enforcement officials on a circumstance involving suspect prescriptions and those persons were apprehended. (Poor record keeping and mistakes in estimating the amount of losses due to a robbery and a larceny which occurred in the period covered by the audit contributed to the unaccounted for controlled substances, but those matters of record keeping and theft reports would cause only a slight differential in the disparity, as opposed to explaining the whereabouts of a substantial portion of the missing controlled substances.) Beginning on March 25, 1982, Staats began to keep a daily inventory log on the substance Talwin and a number of other controlled substances. A copy of that log may be found as Respondent's Exhibit No. 9, admitted into evidence. In addition, certain out-of-date and otherwise undesirable controlled substances, Schedules II, III and IV, have been removed from inventory and turned over to appropriate authorities for destruction.
The Issue The issues for determination are whether Respondent failed to make reasonable efforts to ensure that a prescription for a resident was refilled in a timely manner in violation of Florida Administrative Code Rule 58A-5.0185(7)(f); and, if so, whether Respondent should reclassify Respondent's license from standard to conditional, impose an administrative fine of $2,000, and impose a survey fee of $500 pursuant to Sections 400.419(1)(b) and 400.419(9), Florida Statutes (2001). (All references to chapters and statutes are to Florida Statutes (2001) unless otherwise stated. Unless otherwise stated, all references to rules are to rules promulgated in the Florida Administrative Code in effect on the date of this Recommended Order.)
Findings Of Fact Petitioner is the state agency responsible for regulating assisted living facilities (ALFs) and for investigating complaints received anonymously by a state hotline in accordance with Chapter 400, Part III, and Rule 58A-5. Respondent is an ALF located at 312 East 124th Avenue, Tampa, Florida 33612 (the facility). Petitioner conducted a complaint survey of the facility on August 10, 2001. Petitioner noted the results of the survey on a form entitled Form 3020-0001 "Statement of Deficiencies and Plan of Correction" (the 3020). The 3020 is the document used to charge ALFs with deficiencies that violate applicable law. The 3020 identifies each alleged deficiency by reference to a tag number. Each tag number on the 3020 includes a narrative description of the allegations against the ALF and cites a provision of the relevant rule or rules that the alleged deficiency violates. The 3020 in this case involves one allegation in Tag A630. Tag A630 alleges that Respondent violated Rule 58A- 5.0185(7)(f) by failing to make every reasonable effort to ensure that prescriptions for residents who receive assistance with self-administration or medication administration are "refilled" in a timely manner. Resident 2 receives assistance with the self- administration of medication. Resident 2 suffers from dementia and chronic obstructive pulmonary disease. Tag A630 alleges that Respondent failed to make reasonable efforts to ensure that a prescription for an antibiotic known as Tequin was refilled in a timely manner on or about August 2, 2001. University Community Hospital (the hospital) admitted Resident 2 on June 27, 2001, with relevant diagnoses of urinary tract infection and sepsis. The hospital administered Tequin to Resident 2 intravenously and discharged Resident 2 to the facility on August 2, 2001. On August 6, 2001, the hospital readmitted Resident 2 for treatment of the urinary tract infection. The discharge instructions from the hospital on August 2, 2001, included instructions for several medications. The instructions indicated that Resident 2 was to continue taking Tequin 200 mg one tab a day for 11 days; Prednisone 20 mg tab take as needed; Albuterol and Atrovent nebulizer every 6 hours as needed; and home O2 2 liters by nasal canula [sic] 24 hours. Resident 2 had prescriptions for all of the medications included in the discharge instructions except Tequin. The hospital discharged Resident 2 late in the evening on August 2, 2001. The next morning, the facility manager faxed the new prescriptions for Resident 2 to the pharmacy that the facility used in the ordinary course of its business. The pharmacy timely filled the new prescriptions. Facility staff never saw a written prescription for Tequin. Resident 2 was in good spirits and had no signs of a urinary tract infection or other signs of infection such as a change in mental status or a loss of appetite. Facility personnel reasonably believed that the hospital had successfully treated the urinary tract infection. Petitioner's surveyor testified that he saw a prescription for Tequin in the facility files for Resident 2 and wrote down the exact wording of the prescription. That testimony is neither credible nor persuasive. Even if the testimony of Petitioner's surveyor were credible and persuasive, other evidence in the case outweighs that testimony. Neither Petitioner's agents, the facility Manager, the facility administrator, the owner of the facility, the hospital, the discharging physician, nor the pharmacy, is able to produce a prescription for Tequin, a copy of the prescription, or a record that the physician ever wrote such a prescription. In addition, a discharge instruction is not a prescription. Finally, Petitioner admits in its PRO that a prescription for Tequin was "missing" when Resident 2 returned to the facility. Respondent could not have failed to refill a prescription for Tequin because there is no credible and persuasive evidence that a prescription for Tequin ever existed between August 2 and 6, 2001. The facility Manager did not compare the discharge instructions with the written prescriptions that accompanied Resident 2 on her discharge from the hospital. While that omission may constitute a violation of some law or rule, it is not the violation alleged in the Administrative Complaint and Tag A630. The omission alleged in the Administrative Complaint and Tag A630 is that Respondent failed to ensure that an existing prescription for Tequin was "refilled." That allegation, in the context of this case, requires Petitioner to show that Respondent failed to ensure that the pharmacist refilled an existing prescription previously issued by a physician and on file with the pharmacist. Petitioner failed to prove that factual allegation. The factual allegations that Petitioner sought to prove in the administrative hearing are substantially different from those contained in either the Administrative Complaint or Tag A630. The Administrative Complaint alleges at paragraph 8 that Respondent failed to make reasonable efforts to ensure that a prescription for Resident 2 was refilled. Tag A630 alleges in relevant part: Based on a review of resident records and on interview with the facility's Owner, Administrator and Manager, the facility failed to fill a prescription for one resident upon the resident's return from the hospital. Per interview with the three employees noted above, on 8/10/01 at 12:45pm, and based on a review of the Resident's files, Resident #2 was admitted to University Community Hospital on 7/27/01, and was there diagnosed with a urinary tract infection and sepsis . . . The Resident was discharged from UCH on 8/2/01, with the following medication instructions; Tequin 200mg one tab a day for 11 X days. . . . These discharge instructions were found in the Resident's file. Also observed in the Resident's file were the prescriptions for the above-noted medications. However, when asked, none of the three employees noted above were aware of the prescription for the wide-spectrum antibiotic; each stated the belief that the Resident's infections had been treated and resolved in the hospital and that an antibiotic wasn't needed. A review of the Resident's Medication Observation Record for 8/01 showed the entry of the other medications per the discharge instructions except for the Tequin. On 8/7/01 the Resident was readmitted to the hospital with symptoms of a urinary tract infection, per Owner, the Administrator and the Manager. (emphasis supplied) It can be reasonably assumed that the facility's failure to note either the Resident's discharge instructions or the prescription slip for the antibiotic (Tequin) resulted in the Resident's continued suffering of a urinary tract infection and the Resident's return to the hospital. Regardless of whether this failure to give the Resident his prescribed medication was primarily responsible for the Resident's continued UTI, the facility failed to properly note the physician's orders and to fill the prescription. Petitioner's Exhibit 4 at pages 2-3. Before the administrative hearing, Tag A630 expressly alleged that a prescription for Tequin existed in the file of Resident 2 at the facility and charged that Respondent failed to fill the existing prescription. The Administrative Complaint alleges that the failure to fill an existing prescription violates the requirement in Rule 58A-5.0185(7)(f) to ensure that prescriptions are refilled. At the hearing, Petitioner sought to prove factual allegations that are different from those in Tag A630 and the Administrative Complaint. Rather than proving that Respondent failed to fill a prescription that existed in the file of Resident 2, as alleged in Tag A630, Petitioner sought to prove that Respondent failed to compare the discharge instructions with the prescriptions issued by the treating physician, remind the physician that he or she failed to issue a prescription for Tequin, retrieve the pretermitted prescription, deliver it to the pharmacist, and then ensure that the pharmacist timely "filled" the new prescription. Petitioner cannot put Respondent on notice in the Administrative Complaint and Tag A630 that Respondent must be prepared to defend the factual allegation that Respondent failed to refill an existing prescription and then prove at the administrative hearing that Respondent committed acts or omissions not alleged in either the Administrative Complaint or Tag A630. To do so, is a violation of fundamental notions of due process and adequate notice of the charges against Respondent in a penal proceeding.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that Petitioner enter a Final Order finding Respondent not guilty of the acts and omissions alleged in the Administrative Complaint and Tag A630 and restoring Respondent's previous license rating nunc pro tunc. DONE AND ENTERED this 21st day of October, 2002, in Tallahassee, Leon County, Florida. DANIEL MANRY 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 21st day of October, 2002. COPIES FURNISHED: Colleen O'Rouke, Esquire Riley Law Firm, P.A. 4805 West Laurel Street, Suite 230 Tampa, Florida 33607 Michael P. Sasso, Esquire Agency for Health Care Administration 525 Mirror Lake Drive, North Suite 330K St. Petersburg, Florida 33701 Lealand McCharen, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive, Mail Stop 3 Tallahassee, Florida 32308 Valda Clark Christian, General Counsel Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building, Suite 3431 Tallahassee, Florida 32308 Rhonda M. Medows, M.D., Secretary Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building, Suite 3116 Tallahassee, Florida 32308
