Findings Of Fact Respondent, Norman G. Becker, Jr., is a licensed dentist having been issued license number DN 0002281 by Petitioner, Department of Professional Regulation, Board of Dentistry. He has practiced dentistry in the State since 1958. On or about September 8, 1980, Respondent furnished one William R. Northlick, 101 North Grandview, Mount Dora, Florida, a written prescription for four-ounces of dimethvl sulfoxide (DMSO). Northlick had been a patient of Respondent for approximately ten years, had complained of severe elbow pain, and inquired as to the status of DMSO and where it could be obtained. Respondent told him it was available at a local drug store and advised he could try a small amount. At an undisclosed date in 1980, Respondent was approached by a professional golfer named Gary Weintz who commlained of golfers elbow and who asked about the availability of DMSO. Respondent is active in arranging golf functions on the Professional Golf Association-(PGA) tour and presumably met Weintz, uho is a member of the PGA, in that capacity. Respondent telephoned William Kennedy, a pharmacist at Thayer's Colonial Pharmacy in Orlando, Florida, and asked whether DMSO could be legally prescribed. Kennedy replied that he believed it permissible for Becker to assist Weintz in obtaining the drug and thereafter took a prescription for the same over the telephone. Before filling the prescription, Kennedy required Weintz to sign a patient release form acknowledging that DMSO was a veterinary product and releasing anyone from liability due to its use. Other than the two occasions referred to above, Becker has not prescribed DMSO at any time. He did not charge Northlick or Weintz for his assistance nor did he provide any follow-up care or treatment to either individual. Respondent has never personally used DMSO or applied it to any other patient or friend. Respondent has been a practicing dentist in Florida since 1958, and has lived in Winter Park, Florida, for the last eighteen years. His specialty is periodontics and he was the founder and first president of the Florida Society of Periodontics. He enjoys an excellent personal and professional reputation in the community. This was attested to by Dr. Neil G. Powell, immediate past president of the Florida Dental Association. Other than the present incident, Respondent's record has been exemplary, and he has never been subject to prior disciplinary action. Although Becker wrote the prescription for Northlick on a prescription pad, he did not consider it to be a prescription item". Rather, he considered it the same as when giving customers written instructions for obtaining water piks, electric toothbrushes and other non-prescription items. For this reason, he wrote the words "use as directed" on the prescription pad in lieu of the detailed instructions typically given when writing a normal prescription.
Recommendation Based on the foregoing findings of fact and conclusions of law, it is RECOMMENDED that Respondent be found guilty of violating Subsection 466.028(1)(z), Florida Statutes, as charged in the Administrative Complaint and that the remaining charge in paragraph 11a be dismissed. It is further RECOMMENDED that Respondent be issued a private reprimand. DONE and ENTERED this 22nd day of February, 1982, in Tallahassee, Florida. DONALD R. ALEXANDER Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 22nd day of February, 1982. COPIES FURNISHED: Theodore R. Gay, Esquire 130 North Monroe Street Tallahassee, Florida 32301 James F. Page, Jr., Esquire P.O. Box 3068 Orlando, Florida 32802 Salvatore A. Carpino, Esquire 130 North Monroe Street Tallahassee, Florida 32301
Findings Of Fact Based upon the entire record, the following findings of fact are determined: Background At all times relevant hereto, respondent, Obi E. Enemchukwu, was licensed as a pharmacist having been issued license number PS 0023082 by petitioner, Department of Professional Regulation, Board of Pharmacy (Board). He has been licensed as a pharmacist since 1981. There is no evidence that respondent has been the subject of disciplinary action prior to this occasion. When the events herein occurred, respondent was the designated prescription department manager and pharmacy permittee for Oviedo Drug World (ODW), a community pharmacy located at 83 Geneva Drive, Oviedo, Florida. A community pharmacy is not defined by statute or rule. However, a Board witness described such a pharmacy as being a drug store that serves customers in an outpatient or ambulatory setting. As the prescription manager for the pharmacy, respondent was responsible for maintaining all drug records, providing for the security of the prescription department, and following all other rules governing the practice of pharmacy. Count I This count alleges that respondent violated a Board rule by virtue of the ODW prescription department being "opened at 9:00 a.m. with a pharmacy technician only on duty with no pharmacist present until approximately 9:15 a.m.". In this regard, the evidence shows that on February 28, 1991, a DPR senior pharmacist, Charles C. Lewis, made a routine inspection of ODW. He entered the premises at approximately 9:00 a.m. and found the drug store open, the lights on in the pharmacy section, and only a pharmacist technician on duty. Respondent was not on the premises. Respondent eventually entered the premises around 9:10 a.m. Because the law requires that a registered pharmacist be on duty whenever a community pharmacy is open, respondent, as the designated manager, was in contravention of that requirement. Count II The second count alleges that "on one occasion in approximately August 1990, pharmacist technicians on duty were required to dispense medicinal drugs despite no pharmacist having been present". As to this charge, respondent admitted without further proof that the allegations were true. Thus, the charge in Count II has been sustained. Count III The third count alleges that "on at least two occasions refills for medicinal drugs were dispensed without authorization from the prescribing physician." As to this count, during the course of his inspection of ODW's prescription file, Lewis found copies of two original prescriptions dispensed by respondent on Saturday, February 9, 1991, and Saturday, February 16, 1991, respectively. Original prescriptions are those either handwritten by a doctor and brought in for filling by the patient or those that are telephoned in to the pharmacy by the doctor's office. If a prescription is telephoned in, it must be immediately reduced to writing by the pharmacist. Original prescriptions do not include refills. In this case, the two prescriptions were the type telephoned in by the doctor directly to the pharmacy. Because doctors are rarely in their offices on Saturday, Lewis turned the prescription records over to DPR for further investigation. The records of the prescriptions have been received in evidence as a part of petitioner's exhibits 1 and 2. The prescriptions indicate that Dr. James E. Quinn prescribed thirty Nalfon tablets (600 mg.) to patient L. C. on February 9, 1991, and Dr. Michael E. Meyer prescribed ten Tagamet tablets (300 mg.) to patient J. K. on February 16, 1991. The record does not disclose whether the drugs are scheduled legend drugs or non-scheduled legend drugs. Deposition testimony given by Drs. Quinn and Meyer established that neither doctor authorized by telephone or in writing that the two prescriptions in question be filled. Respondent concedes that he dispensed the drugs, and by doing so, he violated the law. Count IV The final count alleges that respondent, as a pharmacy permittee, violated former rule 21S-1.023 (now renumbered as rule 21S-28.112) by dispensing a medicinal drug in violation of state law. Because this charge is founded on the same set of facts set forth in findings of fact 4, 5 and 6, it is found that this charge has been sustained. Mitigation and Penalty At hearing, respondent generally offered mitigating testimony. As to Count I, he indicated he planned to arrive at the store at 9:00 a.m. but an automobile accident tied up traffic and caused him to be ten minutes late. He suspects that the store owner, who had the only other set of keys, opened up the store and pharmacy area and improperly let the technician into the pharmacy area even though respondent had not yet arrived. As to Count II, respondent acknowledged that two prescriptions were dispensed by pharmacy technicians without a pharmacist on duty but believes the store owner authorized the technician to dispense two prescriptions that he had filled the previous evening. He says appropriate instructions have been given to insure that this will not occur again. Finally, respondent gave the following explanation for dispensing the two prescriptions without authorization from a doctor. During the time period in question, respondent had a practice of partially filling prescriptions. In other words, even though a prescription might authorize a total of 100 tablets, respondent would dispense them piecemeal (e.g., 10 at a time) over the life of the prescription. Thus, at the end of the prescription period, if only 80 of 100 tablets had been previously dispensed, he would fill the remaining 20 tablets even though the prescription from a particular doctor had expired. In the case of the two prescriptions in issue, respondent believes that the customers either had a valid prescription from another doctor but he inadvertently refilled the prescription using the former doctor's name because the prescription had not been used up, or he noted that the patient had not been given the total number of tablets authorized under the original prescription. However, no documentation was submitted by respondent to support the claim that he was presented with a new valid prescription by one of the customers. Respondent apparently no longer engages in this practice. Finally, throughout the course of this proceeding, respondent has fully cooperated with the Board. Although the Board did not submit a proposed order containing a recommended penalty, at hearing counsel for the Board suggested that respondent's conduct warrants the imposition of a fine, probation and a reprimand.
Recommendation Based upon the foregoing findings of facts and conclusions of law, it is RECOMMENDED that respondent be found guilty of violating Sections 465.014, 465.015(2)(c), 465.016(1)(e)and (n), and 465.023(1)(c), Florida Statutes (1989), and that he be given a reprimand, fined $500 and his license placed on probation for one year. DONE and ENTERED this 12th day of March, 1992, in Tallahassee, Florida. DONALD R. ALEXANDER Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, FL 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 12th day of March, 1992. COPIES FURNISHED: Tracey S. Hartman, Esquire 1940 North Monroe Street, Suite 60 Tallahassee, FL 32399-0792 Obi E. Enemchukwu P. O. Box 32 Tavares, FL 32778-0032 Jack L. McRay, Esquire 1940 North Monroe Street, Suite 60 Tallahassee, FL 32399-0792 John Taylor, Executive Director Board of Pharmacy 1940 North Monroe Street Tallahassee, FL 32399-0792
Findings Of Fact Based on the record evidence and the admissions made by Sandbank at hearing, the Hearing Officer makes the following findings of fact: Stanley Sandbank has been a licensed pharmacist in the State of Florida since 1975 and has actively engaged in the practice of pharmacy in this state since 1982. During the Fall of 1987, Sandbank was employed as a pharmacist at Rite- Aid Discount Pharmacy 2165 in Miami Beach, Florida. Toward the latter part of November of that year, Rite-Aid management received a telephone call from a Drug Enforcement Administration (DEA) agent, who stated that she had obtained a tip from a reliable informant that Sandbank "was selling drugs on the street." The DEA agent suggested that a controlled audit be conducted to ascertain whether these drugs were being misappropriated from the pharmacy at which Sandbank worked. Rite-Aid management followed the DEA agent's suggestion and performed such a controlled audit. The audit was completed on November 25, 1987. It revealed that 154 dosage units of Percocet and 201 dosage units of Percodan were unaccounted for and missing from the pharmacy's inventory of controlled substances. Percocet is a brand name of a "medicinal drug," as defined in Section 456.003(7), Florida Statutes, which contains Oxycodone, a controlled substance listed in Schedule II of Chapter 893, Florida Statutes. Percodan is a brand name of a "medicinal drug," as defined in Section 465.003(7), Florida Statutes, which also contains Oxycodone. Because Sandbank was the only pharmacist on duty during the time the audit was conducted, Rite Aid management believed that he was responsible for the shortages that had been discovered. Sandbank initially denied knowing anything about the matter, but later admitted his transgression. As Sandbank freely admitted, he had removed from the pharmacy and delivered to relatives and neighbors the following approximate quantities of controlled substances without first having been presented with a valid prescription and without Rite-Aid having received payment in full for these controlled substances: CONTROLLED SUBSTANCE QUANTITY Valium 10 mg. 300 Diazepam 10 mg. 400 Percodan 375 Percocet 360 Dilaudid 100 Hycodan Syrup 240 Placidyl 750 mg. 30 Valium, Dilaudid, Hycodan Syrup, and Placidyl are brand names of "medicinal drugs," within the meaning of Section 465.003(7). Valium contains Diazepam, which is a controlled substance listed in Schedule IV of Chapter 893, Florida Statutes. Dialudid contains Hydromorphone, which is a controlled substance listed in Schedule II of Chapter 893, Florida Statutes. Hycodan Syrup contains Hydrocodone, which is a controlled substance listed in Schedule III of Chapter 893, Florida Statutes. Placidyl contains Ethchlorvynol, which is a controlled substance listed in Schecdule IV of Chapter 893, Florida Statutes. Sandbank kept at least a portion of the money he had been given by this neighbors and relatives for having delivered to them the above-described controlled substances. He therefore reaped a financial gain as a result of his unauthorized and surreptitious diversion of these controlled substances from Rite-Aid Discount Pharmacy #2165.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Pharmacy enter a Final Order finding that Stanley Sandbank violated Section 465.016(1)(e), Florida Statutes, as alleged in the Administrative Complaint, and imposing the above-described disciplinary action which the Department of Professional Regulation has proposed. DONE and ENTERED this 25th day of April, 1989, in Tallahassee, Florida. STUART M. LERNER Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, FL 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 25th day of November, 1989. COPIES FURNISHED: Michael A. Mone', Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 Stanley Sandbank 4300 Sheridan Street Hollywood, Florida 32399-0750 Rod Presnell, Executive Director Board of Pharmacy Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 Kenneth D. Easley, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750
Findings Of Fact Respondent graduated from the University of Havana Medical School in 1951 and practiced medicine in Cuba from that time until he immigrated to the United States in 1960. In Cuba his practice was primarily in the fields of obstetrics and gynecology. In his application dated 9 February 1975 to take the Florida Medical Examination, Respondent listed work at Hudson County Hospital for Mental Diseases (New Jersey) in 1960, work for the American Plasma Company (Miami) from 1965 to 1968, work at the Opa Locka General Hospital from 1967 to 1970, and that he was presently working as assistant doctor at 620 Southwest 1st Street, Miami. Prior to commencing this work at the Southwest Medical Clinic he contacted Physicians's Association of Clinics, Hospitals and Annex (PACHA), an organization which helps Cuban doctors obtain Florida licenses, and was told he could work at the clinic under Dr. Tomas and should register with the Board of Medical Examiners. Respondent registered with the Florida State Board of Medical Examiners as an unlicensed physician in two undated registrations, copies of which were admitted into evidence as Exhibit 5. In the earlier registration he states he is not a naturalized citizen and in the later application he states he is a naturalized citizen, although the year of naturalization is not shown. Anne West, who was apparently running an abortion referral service, called the State's Attorneys office in Miami on behalf of Respondent and was told Respondent could work at the clinic under a licensed doctor. She subsequently became Mrs. Bulas. Respondent testified he commenced doing medical work in the Miami area in 1975 when he became associated with and worked under the supervision of Kamel Tomas, M.D. in a clinic located at 620 Southwest 1st Street, Miami. He subsequently worked at this clinic under the supervision of two other licensed doctors whose names are Hernandez and Martin. In 1976 Respondent successfully passed the Florida Medical Examination and was licensed in July 1976. While working at the clinic on Southwest 1st Street Respondent performed several abortions. In an 18-count Information filed 23 March 1978 (Exhibit 1) for the period 1 May 1975 through 5 March 1976 Respondent was charged with 11 counts of unlawful practice of medicine, 6 counts of larceny and one count of unlawful termination of pregnancy. At his trial and upon the advice of counsel he pleaded nolo contendere, was found guilty of 10 counts of unlawful practice of medicine, six counts of grand larceny and one count of unlawful termination of pregnancy, and Adjudication of Guilt was withheld (Exhibit 2). Most of these charges alleged felonies. In Exhibit 3 the court stayed imposition of sentence and placed Respondent on probation for 5 years with a condition of probation that he be confined in the Dade County Jail for a term of one year. From reading the counts of the Information, as well as from the testimony of Respondent, it is clear that the larcenies alleged resulted from the fees charged by the clinic to those patients treated by Respondent, which formed the bases for the unlawful practice of medicine counts. The information alleging unlawful termination of pregnancy was based upon the performance of an abortion by Respondent while not licensed in Florida. The testimony was unrebutted that numerous clinics in Miami employ Cuban doctors who are unlicensed in Florida. In a class conducted at Jackson Memorial Hospital to prepare former Cuban doctors for the Florida examination there were about 460 in the class attended by Respondent, most of whom worked in clinics in Miami. At the time Respondent worked at the clinic he believed that so long as he was under a licensed doctor the medical work he performed was lawful. However, Respondent was not under the direct supervision of the licensed doctor as each was working on a different patient in separate examining rooms at the same time. No evidence was presented to indicate Respondent was not fully qualified by training and experience to perform the medical practices that he performed prior to receipt of his Florida license.
Findings Of Fact The Respondent is a licensed dentist authorized to practice dentistry under the laws of the State of Florida. At all times pertinent to this proceeding, the Respondent was engaged in the practice of dentistry, specifically oral and maxillofacial surgery, in his office located in Hialeah, Florida. [This finding is determined from stipulation of the parties.] On or about October 2, 1979, Vernon K. Bell, an investigative supervisor employed by the Department of Professional Regulation, was conducting a routine pharmacy audit of the prescriptions of two drugstores in Miami, Florida. The audit was not based upon any complaint regarding the Respondent or any of the Respondent's patients, but was rather conducted in the routine course of the Department's business. During the course of such audits, Mr. Bess pays particular attention to prescriptions for "Schedule II" substances because the substances are regarded as having a high abuse potential. He located approximately thirty-seven prescriptions for "Quaalude," a Schedule II substance, which were issued by the Respondent to three persons: Wade Laremore, Patti Laremore, and Linda McKenzie. Bell considered the number of Quaalude prescriptions to be unusual for issuance by a dentist, and he confronted the Respondent with them on that same day. [This finding is determined from the testimony of the witness Bell.] The testimony of the witness Bell and the Respondent regarding their initial confrontation differs in material respects. Bell testified that the Respondent admitted issuing the prescriptions. Bell testified that the Respondent admitted issuing the prescriptions. Bell testified that the Respondent admitted issuing the prescriptions. Bell related that the Respondent told him he issued the prescriptions to the Laremores to aid them in sleeping, and not for dental work. He testified that the Respondent showed him the Laremores' records and that the records reflected no dental work since 1973. As to the prescriptions for Linda McKenzie, Bell testified that the Respondent admitted issuing the prescriptions, and that they were to assist her in overcoming nervousness and lack of sleep resulting from marital problems. Bell testified that the Respondent said he had no medical records for Linda McKenzie and that he had no treated her in his capacity as a dentist. The Respondent agreed that he admitted issuing the prescriptions. He testified, however, that he did not tell Bell that the prescriptions for the Laremores and McKenzie were issued for problems other than dental work. He testified that he did not show Bell the Laremores' complete records, but only their charts. He testified that he did not discuss his treatment of any of the patients with Bell. In resolving this conflict, the testimony of the Respondent has been found more credible as to his statements regarding the Laremores, but the testimony of the witness Bell has been found more credible regarding Linda McKenzie. As to the Laremores, Bell did not testify how long he was able to examine the records. The Respondent indicated that he waved the charts at Bell, and this testimony is consistent with what both witnesses agreed was the Respondent's angry reaction to the confrontation. Bell's notes regarding what the Respondent told him are considerably less definite than was his testimony at the hearing. Given the number of investigations that Bell conducts, it is likely that his memory regarding specific details of any particular confrontation would be unclear. The very sketchy notes that he kept would do little to refresh his memory, especially when he is trying to recall precise words that were uttered. As to McKenzie, however, Bell's testimony is directly corroborated by her testimony. This resolution of the conflicting testimony is reflected in the findings of fact which follow. [This finding is determined from the testimony of the Respondent, and the witnesses Bell and McKenzie, and from Petitioner's Exhibits 3 and 4, and Respondent's Exhibit 2.] Quaalude is classified as a Schedule II controlled substance. Such substances possess a significant risk of abuse and physical or psychological dependency. Quaalude works as a central nervous system depressant, and is classified as a hypnotic. The prescribing of Quaalude is not beyond the scope of the practice of oral and maxillofacial surgeons such as the Respondent. Oral and maxillofacial surgeons are fully trained in uses and potential for abuse of such substances. Numerous oral and maxillofacial surgeons testified at the hearing. Their opinions respecting the prescribing of Quaalude varied. Some of them do not prescribe the drug at all because of its reputation as a "street drug," and because of its potential for abuse. Others testified that Quaalude is among the most effective of the hypnotic drugs, that it has no more potential for abuse than other drugs which serve the same or similar beneficent purposes, and that its side effects are less profound then with similar drugs. Witnesses who testified to this effect expressed dismay at the bad reputation the drug has received due to its nontherapeutic abuse. Synthesizing the testimony of the various oral and maxillofacial surgeons, it becomes apparent that Quaalude is properly utilized in the practice for at least two purposes: First, it is used as a sedative or anesthetic prior to surgery. A onetime dosage of approximately three hundred milligrams would be appropriate in this context. Several of the oral and maxillofacial surgeons who testified have used Quaalude in this manner in the past. Several have discontinued its use due to the drug's bad reputation. One of the surgeons called as a witness by the Department of Professional Regulation continues to use the drug in this manner. The Respondent does not, however, because he feels, as do several of his peers, that patients might choose a surgeon who utilizes Quaalude in that manner because of the Quaalude rather than the competency of the surgeon. The second appropriate usage is for relieving anxiety associated with pain subsequent to surgery or pain and anxiety that result from very dramatic conditions. Temporomandibular joint problems are an example. Pain and anxiety of long duration can result from such conditions, and in some circumstances long-term usage of a hypnotic drug such as Quaalude can serve as a more conservative, less drastic approach to treatment than surgery. If such long-term use of the drug were prescribed, close observation of the patient would be important to assure that psychological and/or physical addiction was not occurring. Prescriptions in such instances should be given for a relatively short period of time to assure that proper supervision would occur. [This finding is determined from the testimony of the witnesses Farmer, Davis, Treadwell, Wruble, Laboda, Richman, Goodhart, and the Respondent; and from Petitioner's Exhibit 5 and Respondent's Exhibits 1 and 3.] Between August 9, 1978, and September 22, 1979, the Respondent issued forty-eight separate Quaalude prescriptions for Wade Laremore. The prescriptions were for three-hundred milligram tablets with the number of tablets prescribed each time varying from five to fifteen. Between October 2, 1978, and August 31, 1979, the Respondent issued twenty-three separate Quaalude prescriptions for Patti Laremore. These prescriptions were also for three- hundred milligram tablets. No testimony was presented to establish the purpose for these prescriptions. The testimony of the witness Bell to the effect that the Respondent told him the prescriptions were not for a proper dental purpose has not been credited. In order to conclude that the prescriptions were inappropriate, therefore, it would be necessary to find that prescriptions in these amounts would be in appropriate under any circumstances. No such conclusion can be made without knowing the medical history of the patient. Prescriptions in these quantities would be an appropriate manner for treating pain and anxiety resulting from severe temporomandibular joint problems, in order to obviate the need for drastic and potentially damaging surgery. The sequence of prescriptions issued for the Laremores is consistent with this sort of treatment. [This finding is determined from the testimony of the witnesses and the exhibits listed at the conclusion of paragraphs 4 of these Findings of Fact, and from Petitioner's Exhibits 1 and 2.] The Respondent prescribed Quaalude to Linda McKenzie on two occasions. The first of these was for five three-hundred milligram tablets issued on April 27, 1979; and the second was for four three-hundred milligram tablets issued on May 7, 1979. The purpose of these prescriptions was to assist Linda McKenzie in overcoming nervousness and sleeplessness connected with the breakup of her marriage, and not for any proper dental or oral and maxillofacial surgical purpose. The Respondent is not qualified by reason of his training as an oral and maxillofacial surgeon to treat anxiety resulting from marital discord. [This finding is determined from the testimony of the witnesses Bell and McKenzie, and from Petitioner's Exhibits 1, 2, 3, and 4.] The Respondent is an able oral and maxillofacial surgeon. He enjoys a high regard among his peers. Numerous general practice dentists refer cases to him on a continuing basis with confidence. [This finding is determined from the testimony of the witnesses Mas, Wruble, Sootin, Wolf, Cornbluth, Danziger, and Hoffner.]
Recommendation Based upon the foregoing findings of fact and conclusions of law, it is, hereby, RECOMMENDED: That the Department of Professional Regulation enter a final order finding the Respondent guilty of the allegations set out in Count III of the Administrative Complaint, suspending the Respondent's license to practice as a dentist in the State of Florida for a period of thirty days, and imposing an administrative fine against the Respondent in the amount of one thousand dollars. That the Administrative Complaint be dismissed in all other respects. DONE AND ENTERED this 11th day of February 1981 in Tallahassee, Florida. G. STEVEN PFEIFFER Hearing Officer Division of Administrative Hearings Department of Administration 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 11th day of February 1981. COPIES FURNISHED: Deborah J. Miller, Esquire Assistant General Counsel Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Richard G. Cushing, Esquire One Rockefeller Plaza New York, New York 10020 Ms. Nancy Kelley Wittenberg, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301
The Issue The issue for determination is whether Petitioner must reimburse Respondent an amount up to $1,676,390.45, which sum Petitioner received from the Florida Medicaid Program in payment of claims arising from Petitioner's dispensing of pharmaceuticals between July 3, 2000 and March 28, 2002. Respondent alleges that the amount in controversy represents an overpayment related to Petitioner's failure to demonstrate the availability of sufficient quantities of drugs to support its billings to the Medicaid program.
Findings Of Fact Respondent Agency for Health Care Administration ("AHCA" or the "Agency") is the state agency responsible for administering the Florida Medicaid Program ("Medicaid"). Petitioner Disney Medical Equipment, Inc., d/b/a Disney Pharmacy Discount ("Disney Pharmacy"), was, at all relevant times, a Medicaid provider authorized, pursuant to contracts it had entered into with the Agency known as Provider Agreements, to receive reimbursement for covered services rendered to Medicaid beneficiaries. Exercising its statutory authority to oversee the integrity of Medicaid, the Agency directed its agent, Heritage Information Systems, Inc. ("Heritage"), to conduct an audit of Disney Pharmacy's records to verify that claims paid by Medicaid during the period from July 3, 2000 to March 28, 2002 (the "Audit Period") had not exceeded authorized amounts. Over the course of four days in May 2002, three of Heritage's auditors reviewed records on-site at Disney Pharmacy's drugstore in Hialeah, Florida; they also interviewed some of the store's personnel. Thereafter, Heritage analyzed the data it had collected using several different approaches. Each approach pointed to the conclusion that Medicaid had paid too much on claims submitted by Disney Pharmacy during the Audit Period. The total amount of the alleged overpayment differed substantially, however, depending on the analytical approach taken. The approach that yielded the largest apparent overpayment was the "prorated purchase invoice" analysis. Generally speaking, under this approach, the volume of pharmaceuticals that the provider maintained in its inventory during the Audit Period is compared to the provider's contemporaneous Medicaid claims to determine whether the provider possessed enough of the relevant pharmaceuticals to support the Medicaid claims presented. If the total amount purportedly dispensed, according to the claims made in connection with a particular drug, exceeds the amount of that drug available at the time for dispensing, then an inference of impropriety arises with regard to those claims for which product was apparently unavailable; the Agency considers amounts paid on such claims to be overpayments. To determine the quantities of certain drugs that Disney Pharmacy had kept on hand during the Audit Period, Heritage tallied up the total number of "units" of selected drugs that Disney Pharmacy had acquired, using as a database the invoices reflecting Disney Pharmacy's purchases of the drugs under review. Heritage then ascertained——again using Disney Pharmacy's records——the utilization rate of Medicaid beneficiaries for each of the pharmaceuticals under consideration. In other words, Heritage determined, for each drug at issue, the relative demand——expressed as a percentage of the total number of units of that drug dispensed to all customers during the Audit Period——attributable to Medicaid beneficiaries. Heritage found, for example, that Medicaid recipients accounted for 55.13% of Disney Pharmacy's total sales of the drug Acetylcysteine-10% solution ("Acetylcysteine") during the Audit Period. Having calculated the total amount of each drug at issue that Disney Pharmacy had acquired during the Audit Period, and having further determined for each such drug the Medicaid utilization rate, Heritage multiplied the total number of available units of each drug by the applicable utilization rate, prorating the entire supply of each drug to reflect the approximate number of units available for dispensing to Medicaid recipients specifically. For example, Disney Pharmacy's records showed that it had purchased a total of 121,440 units of Acetylcysteine during the Audit Period. Disney Pharmacy's records showed, additionally, that this drug was dispensed to Medicaid beneficiaries 55.13% of the time. Thus, the prorated quantity of Acetylcysteine available for Medicaid recipients was approximately 66,950 units (121,440 x 0.5513). The prorated number of available units of each subject drug was compared to the total number of units for which Medicaid had reimbursed Disney Pharmacy during the Audit Period. For Acetylcysteine, these figures were 66,950 and 1,076,070, respectively. If the total number of units for which Medicaid had paid on claims for a particular drug were found to exceed the amount of that drug which Disney Pharmacy apparently had on hand——as it did for Acetylcysteine——then the inventory shortfall——1,009,120 units in the case of Acetylcysteine——was multiplied by the drug's average per-unit cost to Medicaid, producing a drug-specific apparent overcharge. Thus, for example, because the average cost of Acetylcysteine was $0.65 per unit, the apparent overcharge with respect to this drug was $655,928.00. Using the foregoing approach, Heritage identified apparent overcharges in connection with 13 drugs. The sum of these drug-specific overcharges is $1,676,390.45. Two drugs—— Acetylcysteine and Ipratropium Solution ("Ipratropium")——account for nearly 93% of this grand total. Two other drugs——Albuterol- 0.83% ("Albuterol") and Metaproterenol-0.4% ("Metaproterenol")—— account for another 7.0% of the total alleged overcharge. These four drugs——whose individual overcharges, taken together, comprise approximately 99.8% of the total alleged overcharge of $1,676,390.45——are used for treating breathing disorders and typically are inhaled by the patients who use them.i There is no genuine dispute regarding the reason why Disney Pharmacy was unable to document its acquisition of Acetylcysteine, Ipratropium, Albuterol, and Metaproterenol (collectively the "Inhalation Therapy Drugs") in quantities sufficient to support its claims to Medicaid for these pharmaceuticals. During the Audit Period, Disney Pharmacy generally filled prescriptions for the Inhalation Therapy Drugs by "compounding" the prescribed medications. (Compounding is a process whereby the pharmacist mixes or combines ingredients to fashion a tailor-made medication for the patient.) Thus, Disney Pharmacy (for the most part) did not purchase the commercially available versions of the Inhalation Therapy Drugs; rather, it created its own "generic copies" of these medications, purchasing only the raw materials needed to make finished products. Medicaid reimburses for compound drugs under certain conditions, which will be spelled out below. But first: it is undisputed that Disney Pharmacy did not submit claims for compound drugs. Instead, in presenting claims to Medicaid for the Inhalation Therapy Drugs, Disney Pharmacy billed the medications under their respective National Drug Code ("NDC") numbers, as though commercially manufactured drug products had been dispensed. (An NDC is an 11-digit number, unique to each commercially available pharmaceutical, which identifies the manufacturer, product, and package size.) As a result, Medicaid paid Disney Pharmacy for mass produced products when, in fact, the pharmacy actually had dispensed its own homemade copies thereof. According to the Prescribed Drug Coverage, Limitations and Reimbursement Handbook ("Medicaid Handbook"), which authoritatively sets forth the terms and conditions under which Medicaid reimburses providers for dispensing pharmaceuticals, Medicaid may pay for a compound drug if the following criteria are met: At least one pharmaceutical is a reimbursable legend drug; The finished product is not otherwise commercially available; and The finished product is being prepared to treat a specific recipient's condition. Medicaid Handbook at 9-16.ii To present a claim for a compound drug, the provider must adhere to the following instructions: Compound drug codes must be submitted on paper Pharmacy 061 claim forms, because they are reviewed and manually priced by Medicaid. When billing for a compound drug, enter one of the following compound drug codes. More than one code is available so that more than one compound can be dispensed to a recipient on the same day without using the same number. Id. 55555-5555-55 66666-6666-66 77777-7777-77 88888-8888-88 Disney Pharmacy attempts to defend its failure to follow the unambiguous instructions for billing compound drugs by explaining that, before commencing the practice of compounding, the provider's owner, Sara Padron, made a telephone call to AHCA to ask for guidance on submitting claims for drugs created on-site. Ms. Padron testified at hearing that the AHCA employee with whom she spoke had told her to present claims for compound drugs by billing for the manufactured products that they most resembled, using the manufactured products' NDC numbers. Ms. Padron could not identify the person who purportedly gave her this plainly incorrect advice. Ms. Padron's testimony in this regard was not contradicted——although in fairness to the Agency hers was the kind of testimony that resists direct evidential challenge, forcing an opponent to stress the implausibility of the claim as a means of discrediting it. Ms. Padron's account cannot simply be dismissed as incredible, for an AHCA employee undoubtedly could give an incorrect answer to a provider's question. But even assuming that Ms. Padron reached a person whom one reasonably could suppose to be knowledgeable about Medicaid billing procedures, and further assuming Ms. Padron asked a clear question which fairly and accurately described the situation, neither of which was proved or should be taken for granted, the undersigned remains skeptical that Ms. Padron was instructed to bill for compound drugs as if billing for their commercially available counterparts: the advice is just too obviously wrong. It is not necessary, however, to accept or reject Ms. Padron's testimony concerning the "official" answer she says she received because even if Ms. Padron were told to bill for compound drugs as though manufactured products had been dispensed, no reasonable provider could have relied upon such a dubious oral representation. The statement, for starters, is an invitation to commit fraud. Common sense should inform any reasonable provider that a claim for something other than what was actually delivered will, if discovered, almost certainly be viewed as deceptive (or worse) by the payor. Additionally, the alleged statement attributed to AHCA's employee contradicts the plain instructions in the Medicaid Handbook on that very subject. No provider can reasonably rely upon verbal advice, given anonymously (or functionally so, since the advisor's name, if given, was evidently easily forgotten) over the telephone, which contravenes the clear language of the Medicaid Handbook. Disney Pharmacy's other defenses are likewise unpersuasive. Disney Pharmacy maintains that compounding the drugs in question substantially benefited the patients who received them, which is probably true——but certainly beside the point. The problem here is not with the practice of compounding per se; the problem is that Disney Pharmacy sought and received reimbursement from Medicaid for mass produced, commercially available drugs that had not actually been dispensed. For the same reason, it is irrelevant, even if likely true, that the Board of Pharmacy, which periodically inspects Disney Pharmacy, never objected to the compounding that was occurring at the premises. Again, to be clear, the problem is not that the compounding was improper, but that the Medicaid billing was improper.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Agency enter a final order requiring Disney Pharmacy to repay the Agency the principal amount of $1,676,390.45. DONE AND ENTERED this 11th day of April, 2006, in Tallahassee, Leon County, Florida. S JOHN G. VAN LANINGHAM Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 11th day of April, 2006.
Findings Of Fact Background. Petitioner, George T. Lloyd, Jr., has been employed by the State of Florida, Department of Revenue, for over 14 years, and was, at all times material hereto, a participant in the State of Florida Employees Group Health Self Insurance Plan (Plan), with family coverage. On March 25, 1986, petitioner's son, George T. Lloyd, III (George), then 17 years of age and an eligible dependent under the Plan, was admitted through the emergency room to Broward General Medical Center (Hospital), Fort Lauderdale, Florida. George was placed in the Hospital's Intensive Care Unit, and remained there until his recovery and transfer to the Hospital's psychiatric floor on April 4, 1986. Upon admission, George was comatose and diagnosed as having suffered a severe barbiturate drug overdose. Blood tests performed at the time demonstrated a serum barbiturate level of 145.6 UG (milligrams per milliliter) and a serum Dilantin level of 23.3 UG. At such levels, or even one-half such levels, George would have died of respiratory depression absent medical intervention. On or about August 9, 1986, Blue Cross and Blue Shield of Florida, Inc., the State's administrator of the Plan, notified petitioner that the Hospital's statement for services and supplies rendered during the course of his son's admission of March 25, 1986 to April 4, 1986, totalling $17,402.95, was ineligible for payment based upon the Plan's exclusion of benefits for intentional self-inflicted injuries, to wit: attempted suicide. Pertinent to this case, the Plan provides: VII. EXCLUSIONS The following exclusions shall apply under the Plan: * * * E. Any services and supplies received due to the following circumstances: * * * 2. Resulting from an intentional self- inflicted injury. Over the course of the next two years petitioner's claim for such expenses was reevaluated by the Plan administrator, as well as respondent, Department of Administration (Department). At the conclusion of that review, the Plan administrator concluded that the documentation available to it demonstrated that such expenses were incurred as a consequence of George's attempt to take his own life and were therefore excluded from coverage. By letter of August 19, 1988, the Department notified petitioner that his claim for benefits arising from his son's hospital admission of March 25, 1986 to April 4, 1986, was denied because such expenses resulted from his son's attempt at suicide. Petitioner filed a timely protest of the Department's decision, and the matter was referred to the Division of Administrative Hearings to conduct a formal hearing. An Intentional Self-Inflicted Injury? Petitioner's son has a history of alcohol and drug (marijuana and cocaine) abuse and emotional problems accompanied by periods of depression that predate the incident in question by a number of years. His mother and father (petitioner) were divorced in 1971 when George was approximately three years of age. Thereafter, George resided in Florida with his mother until his fifth birthday, at which time he was sent out-of-state to reside with his father. George resided with his father until he was eleven years old, and then returned to live with his mother in Florida. In the summer of 1984, George was abusing alcohol and drugs, and experiencing difficulties in school. At that time, his mother again sent George to live with his father in the apparent hope that he could assist George in addressing these problems. The petitioner secured group counseling for George in an attempt to assist him. George continued, however, to use alcohol and drugs, and within four months, dropped out of school and ran away. Approximately four or five months later, George reappeared and returned to Fort Lauderdale to live with his mother and stepfather. Following his return, George did little of a constructive nature, and what jobs he was able to secure as a tenth grade dropout were menial in nature and of a minimal wage. Variously he worked as a bag boy, mowed lawns, and washed cars. On March 25, 1986, George was unemployed, and had just concluded an argument with his stepfather concerning his unemployment and failure to follow any constructive pursuit. Depressed at his circumstances, George ingested phenobarbital and Dilantin, drugs that had been prescribed for his stepfather, with the intention of taking his own life. But for the medical intervention previously discussed, George's attempt would have proven successful. At the time he ingested the drugs, George was not under the influence of alcohol or any other drug, and was of sufficient age and maturity to appreciate the consequences of his actions. Both the nature of the drugs he took and the vast quantity he ingested indicate an intentional attempt to take his own life rather than an accidental overdose during "recreational" use. Here, the drugs he took were not "recreational" drugs, they produce no "high," and the dosage, as heretofore noted, was massive. Considering these factors, George's admission that he attempted suicide, and the totality of the circumstances, compels the conclusion that he did consciously attempt to take his own life, and that what depression he suffered did not deprive him of the ability to appreciate the consequences of his actions.
Recommendation Based on the foregoing findings of fact and conclusions of law, it is RECOMMENDED that a final order be entered dismissing, with prejudice, the petition for administrative review. DONE and ENTERED this 16th day of May 1989, in Tallahassee, Leon County, Florida. WILLIAM J. KENDRICK Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 16th day of May, 1989.
