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 question presented in this case, is whether or not the Respondent, James R. Gibbons, has violated the conditions of Section 465.22(1)(c), Florida Statutes, by failing to maintain on a current basis a complete and accurate record of each controlled substance controlled by Chapter 893, Florida Statutes; in particular controlled by Section 893.07, Florida Statutes. This violation is alleged to have occurred at Washington Park Pharmacy, Inc., 750 Northwest 22 Road, Ft. Lauderdale, Florida. The alleged violation was noted by V. K. Bell, agent, Florida Board of Pharmacy, based upon a drug accountability audit which covered the period from September 1, 1976 to October 3, 1977.
Findings Of Fact This cause comes on for consideration based upon the complaint and notice to show cause brought by the Petitioner, Florida Board of Pharmacy, in an action against James R. Gibbons, who is licensed to practice pharmacy by the Petitioner and who is the owner/operator of Washington Park Pharmacy, Inc., located at 750 Northwest 22 Road, Ft. Lauderdale, Florida. The action charges that James R. Gibbons, while licensed to practice pharmacy in the State of Florida, violated the provisions of Section 465.22(1)(c), Florida Statutes. This claim of violation is premised upon the alleged failure of the Respondent, James R. Gibbons, to comply with the conditions of Section 893.07, Florida Statutes, in that the Respondent permitted the improper keeping of records, by failing to maintain on a current basis a complete and accurate record of each controlled substance controlled by Chapter 893, Florida Statutes. This failure of control was alleged to have occurred at the Washington Park Pharmacy, Inc., at 750 Northwest 22 Road, Ft. Lauderdale, Florida. The prosecution is grounded on the investigation performed by V. K. Bell, agent, of the Petitioner and specifically arises from a drug accountability audit which covered the period from September 1, 1976 to October 3, 1977. As a part of his duties, agent V. K. Bell, an employee with the Florida Board of Pharmacy, conducted an audit of the Washington Park Pharmacy, Inc., located at 750 Northwest 22 Road, Ft. Lauderdale, Florida. The period of the audit covered September 1, 1976 through October 3, 1977. An element of the audit concerned the class II drugs, Dilaudid, 4mg. tablets and Quaalude, 300 mg. tablets. A synopsis or summary of the audit process pertaining to the two drugs by weight, may be found as Petitioner's Exhibit #1, admitted into evidence. In that audit report, agent Bell has broken down the amounts of the questioned drugs into categories. These categories begin with a zero initial inventory on September 1, 1976 and report the total number of tablets purchased; the amount of ending inventory; the amount of sales by prescription, both legitimate and possible forgeries; the amount of losses by theft; and the amount short, for which there is allegedly no explanation. By the figures reported by agent Bell; 59,100 Dilaudid 4mg. tablets were purchased in the audit period; 200 tablets remained as ending inventory; 49,869 tablets were reported as sales or loss by theft; and 9,031 tablets were reported short. Looking at the report rendered by agent Bell on the substance Quaalude, 300 mg. tablets, it shows a total purchase within the inventory period of 32,200; an ending inventory of 50; sales of 25,421 by prescription; and 6,729 tablets short. The Respondent has taken issue with the statistical data offered by the Petitioner. In its argument against the case of the Petitioner, the Respondent has offered Respondent's Exhibits 5 & 6, admitted into evidence. These exhibits are respectively a compilation of the sales made to the Respondent by the Gulf Drug Company and Crandon Drugs, Inc. The tapes which are attached to those exhibits act as a take-off in adding the amounts of the two questioned substances, and show that 54,200 Dilaudid 4mg. tablets were purchased during the audit period and 29,700 Quaalude 300mg. tablets were purchased during the audit period, according to the computations of the Respondent, James R. Gibbons. Gibbons also takes issue with the allegation found in the audit summary, to the effect that certain prescriptions were forged by the doctors listed. The depositions of Drs. Collier, Cohen, Morris, and Walker were taken prior to the hearing. Those depositions have been admitted into the record in lieu of testimony at the hearing. The deposition of David Collier, D.O., shows that during the audit period, he wasn't treating the patients who needed the two drugs Dilaudid and Quaalude. He did indicate that at one time he had left prescription pads in the treatment rooms where someone may have picked those prescription pads up. However, he denies signing any prescriptions which were shown to him and alleged to have been under his signature. He thereby states that those prescriptions are forgeries. He also denied that any prescription forms with the name Washington Park Pharmacy had been provided to him. Dr. Collier's partner for a time, was Bernard Cohen, D.O. Dr. Cohen states that he wrote prescriptions for Quaalude and Dilaudid in November, 1975, but not on pads from Washington Park Pharmacy. He also admitted that employees within his office other than he and Dr. Collier had access to the prescription pads. He recalls that during the audit period one patient was on Dilaudid and one patient was receiving Quaalude. The writing exemplars that were shown to him which are prescriptions allegedly written by him were felt to be forgeries, with the exception of his patients which he identified as his. From his recollection the Washington Park Pharmacy never called about any alleged forgeries that may have been received bearing his name. The deposition of William A. Morris, III, M.D. establishes that he has prescribed Dilaudid and Quaalude, but not in the amounts attributed to him in the audit. He also stated that in February, 1976, there was a "break-in" and certain prescription pads were missing. The signature on the exemplars shown to him were felt to be similar to his signature; however, he did not recognize any of the names to be his patients and therefore felt that the substance of the prescription was a forgery. The deposition of Dr. Thomas J. Walker, M.D., establishes that he was not prescribing the drugs Dilaudid and Quaalude at the time of the audit. After looking at the exemplars of the prescriptions presented him he stated that those prescriptions had not been written by him. In his estimation, the prescription pads in his office were secure during the audit period and no "break-ins" or thefts had occurred. The explanation which the Respondent gave on the question of any possible forgeries was to the effect that he has a duty to fill the prescriptions which are tendered to him by a treating physician, and further that his practice is to notify the alleged treating physician when there is some question about the authenticity of the prescription given to him by a customer. The Respondent's explanation for any shortage of prescriptions during the audit period was to the effect that either the agent for the Petitioner or the representatives of the United States Drug Enforcement Authority had lost some of the records in transporting his books and records to their office for examination, or in the alternative those records still remained in his pharmacy and were undiscovered by the Petitioner's representative and representatives of the Drug Enforcement Authority. The positions of the parties should be examined in view of the requirements of the law under which the charge is brought. Section 465.22(1)(c), Florida Statutes, reads as follows: 465.22 Authority to revoke or suspend pharmacy permits.- (1) The Board of Pharmacy may revoke or suspend the permit of any pharmacy after giving reasonable notice and an opportunity to be heard to any permittee who shall have: * * * (c) Violated any of the requirements of this chap- ter or any of the rules and regulations of the Board of Pharmacy, of chapter 500, known as the Florida Food, Drug and Cosmetic Law, of Chapter 893, or who has been convicted of a felony or any other crime involving moral turpitude in any of the courts of this state, of any other state, or of the United States. By this charging document, the Petitioner is claiming that the Respondents have violated Section 893.07, Florida Statutes. A portion of that section is Section 893.07(3), Florida Statutes, which calls for the record of all controlled substances sold, administered, dispensed, or otherwise disposed of to be kept; to the extent of among other things, showing the kind and quantity of controlled substances sold, administered, or dispensed. Section 893.07 (4), Florida Statutes, also states that these records shall be kept and made available for a period of at least two years for inspection and copying by law enforcement officials. Section 893.07(5), Florida Statutes, calls for the maintenance of records of any substances lost, destroyed or stolen, as to the kind and quantity of such controlled substances and the date of discovery of the loss, destruction or theft. In reviewing the facts offered into evidence at the hearing, in the context of the position taken by the Petitioner at that hearing, it appears that the Petitioner is most concerned with the shortages, as opposed to the questioned prescriptions which they feel might be forgeries. Moreover, the facts establish that there was a "break-in" on August 30, 1977, in which the Respondent, James R. Gibbons' inventory showed that 128 Dilaudid 4mg. tablets were stolen or missing, for which the Petitioner gives credit in the audit process. Therefore, the analysis to be given this case will center on the "so- called" shortages of the two substances. The undersigned has reviewed the Exhibits 5 & 6 by the Respondent and finds the computations of the Respondent to be incorrect. An examination of those exhibits shows that 55,400 Dilaudid 4mg. tablets were purchased in the audit period and 30,200 Quaalude 300mg. tablets were purchased in the audit period. Using those figures, and subtracting the amount of tablets dispensed by prescriptions or lost through theft, to include questioned prescriptions, it shows 5,531 Dilaudid 4mg. tablets are short and 4,779 Quaalude 300mg. tablets are short. These shortages are shortages in which no meaningful explanation has been offered. The substances Dilaudid and Quaalude are class II drugs, for which records must be kept in a manner described above, in keeping with Section 893.07, Florida Statutes. The Respondent, James R. Gibbons, has failed to maintain the records in accordance with Section 893.07, Florida Statutes, and has thereby violated Section 465.22(1)(c), Florida Statutes.
Recommendation It is recommended that the permit to operate a pharmacy given to James R. Gibbons, owner/operator of Washington Park Pharmacy, Inc., be revoked. DONE AND ENTERED this 5th day of April, 1978, in Tallahassee, Florida. CHARLES C. ADAMS Hearing Officer Division of Administrative Hearings 530 Carlton Building Tallahassee, Florida 32304 (904) 488-9675 COPIES FURNISHED: Robert A. Pierce, Esquire Suite 201 Ellis Building 1311 Executive Center Drive Tallahassee, Florida 32301 W. George Allen, Esquire 116 Southeast Sixth Court Post Office Box 14738 Ft. Lauderdale, Florida 33302
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.
The Issue At issue is whether Respondent committed the offenses set forth in the Administrative Complaint dated March 3, 2000, and, if so, what penalty should be imposed.
Findings Of Fact Respondent, Robert Gibson McLester, III ("McLester") is a licensed pharmacist 2 with a heretofore unblemished record. McLester graduated from the University of Florida with a degree in pharmacy in August 1977. He was licensed by the State of Florida to practice pharmacy in February 1978. He currently holds an Alabama pharmacy license, and was previously licensed in Mississippi but at some point ceased to pay the state's licensing fee; the license thus lapsed by operation of law. McLester received a Master of Science degree in hospital pharmacy from the University of Mississippi in December 1987 and a Master of Health Care Administration from the same institution the following May. McLester entered the Navy as an aviator cadet in June 1965, and was commissioned as a naval aviator in February 1967. He flew 103 missions with Attack Squadron 147 and was honorably discharged as a lieutenant in December 1970. Following a brief stint in the insurance and investment business, McLester applied unsuccessfully to medical school. McLester entered the University of Florida's pharmacy school in September 1974 and following his graduation in August 1977, has been continuously employed as a pharmacist when not pursuing advanced degrees in pharmacy and related fields. Much of McLester's pharmacy employment has been in the Navy, which he reentered in February 1978 as an ensign in the Medical Service Corps. McLester served in a variety of posts before retiring as a lieutenant commander in August 1992, including at the National Naval Medical Center in Bethesda, Maryland, where he supervised in excess of 25 pharmacists and pharmacy technicians in the preparation of an average of 1600 outpatient prescriptions per day. McLester continued the practice of pharmacy as a civilian, working briefly as a relief pharmacist for the Eckerd Drug chain in the Vero Beach area before being hired full time by Winn-Dixie in August 1992. Under McLester's supervision, Store No. 2358 enjoyed high sales volume and was used as a training site for other Winn-Dixie pharmacies. At all times during McLester's employment at Winn- Dixie, reports of annual inspections of his pharmacy conducted by the Agency for Health Care Administration ("AHCA") pursuant to law showed no deficiencies of any kind. McLester worked at the Winn-Dixie Store No. 2358 until June 17, 1998. McLester's separation from Winn-Dixie was voluntary. McLester left Winn-Dixie because he considered the hours assigned to him by his new supervisor, Steve Howard ("Howard") to be "slave hours." Following McLester's departure, sales and customer satisfaction at Store No. 2358 deteriorated. For most of the time relevant to this case, McLester was responsible for filling in the neighborhood of 150 prescriptions per day. That number placed his store at the high end of Winn- Dixie pharmacy productivity. 3 During the course of his employment at Winn-Dixie, McLester had occasion to report approximately a dozen instances of prescription drug fraud to the authorities, including St.Lucie County Detective Scott Silverman (Silverman). Following his resignation from Winn-Dixie, McLester worked briefly with various services which would find him work as a relief pharmacist. On the instructions of Howard, McLester was not permitted to work at any of the Winn-Dixie stores in the area. In October 1998, McLester found full-time employment with Doctors' Clinic Pharmacy in Vero Beach, a "closed pharmacy" which serves only the patients of that multi-specialty practice. During his term of employment at Winn-Dixie, McLester was assisted by about a half dozen pharmacy technicians. Pharmacy technicians are licensed by the state and must work under the close supervision of a registered pharmacist. Tasks which the law permits to be delegated to pharmacy technicians and which, in fact, are typically delegated to a pharmacy technician include ordering drugs, including controlled substances; receiving drugs and other inventory; counting and transferring drugs from their original containers to packages for individual prescriptions; shelf maintenance; department maintenance; and stocking shelves. Other tasks which pharmacy technicians may legally perform, and which were in fact performed by technicians at Winn-Dixie stores, include logging invoices into the computer system for payment; verifying orders shipped into the store; answering telephones; taking refills from patients or doctors provided that there is no change in any element of the prescription (i.e. instructions to the patient, dosage, etc.); requests to doctors to issue new prescriptions on behalf of a patient; preparing labels and delivering filled prescriptions to the pharmacist for final verification. Because of the nature of the tasks delegated to pharmacy technicians, the relationship between pharmacist and technician must be one of, as several witnesses testified, implicit trust. McLester trusted all of the pharmacy technicians with whom he worked at Winn-Dixie. One of the Winn-Dixie pharmacy technicians, Tonya Tipton ("Tipton") betrayed McLester's trust, along with the trust of the State of Florida which licensed her, Winn-Dixie which employed her, and several other pharmacists under whose supervision she worked. Weeks after McLester left Winn-Dixie, Tipton's betrayal of trust was discovered. Soon after, she was fired from Winn-Dixie and subsequently arrested for crimes she allegedly committed in and against the Winn-Dixie pharmacy. Tipton's arrest set in motion a chain of events which led to this Administrative Complaint. Following a work-related injury suffered in the early 1990s, Tipton developed a dependence upon prescription painkilling medication, including the narcotic nasal spray Stadol.4 Unbeknownst to anyone, Tipton devised a scheme by which she could steal Stadol from Winn-Dixie, and also obtain Stadol under a forged prescription. At all times prior to Tipton's firing from Winn-Dixie, she was a trusted employee. Tipton fell under suspicion when she stated to a co- worker that a package would be arriving the following day and that it should not be opened. Store employees opened the package nevertheless and discovered it contained Stadol. Thereafter, a fellow pharmacy technician followed Tipton into the ladies' room and discovered empty bottles of Stadol in the wastebasket. Confronted by store employees about her inappropriate instruction to the co-worker not to open the package, as well as the empty Stadol containers in the ladies' room, Tipton admitted only to taking one bottle of Stadol from the Winn-Dixie pharmacy. Abundant circumstantial evidence suggests that Tipton's dependence upon Stadol led her to commit more than the one offense to which she admitted. McLester had been the primary pharmacist on duty at Store No. 2358 during many of the shifts when Tipton was alleged to have illegally obtained Stadol. Following a criminal investigation by Detective Silverman and the arrest of Tipton, McLester's former supervisor, Howard, lodged a complaint against McLester with the Board of Pharmacy. In his letter of complaint, Howard characterized his complaint as an effort to protect the interests of Winn-Dixie "in case this problem was found out." Howard claimed that Mostafa Macida ("Macida"), who had replaced McLester as the store's primary pharmacist,"discovered" that Stadol was being stolen from the pharmacy but this testimony is rejected as inconsistent with the testimony of numerous individuals who, unlike Howard, had personal knowledge of the events surrounding Tipton's arrest. Macida suspected nothing and discovered nothing. Tipton's employment at Winn-Dixie began in February 1995 when she was hired as a pharmacy technician by McLester.5 In that capacity, Tipton worked not only with McLester, but also with then-Head Technician Ava Forsythe (Forsythe). Forsythe trained Tipton in the technicians' duties, including the various methods by which prescription drugs, both controlled and non-controlled, may be ordered. At all times relevant to this case, there are three ways in which Winn-Dixie pharmacies may procure drugs and medical supplies requiring prescriptions for resale to the public. The primary system is a computer-generated daily order. The system was referred to by many witnesses as "the PDX system" ("PDX"). Technicians, working under the supervision of the pharmacist, would review the order to verify that the required types and quantities of supplies were being ordered. When the order was deemed complete, "the button was pushed" and the order electronically transmitted to Winn-Dixie's major drug supplier, Bindley-Western.6 In theory, the computer would accurately track stock in over 2,000 line items. The computer was supposed to automatically add to the inventory based upon what was ordered, and subtract based upon records of what was actually dispensed to customers. In reality, the computer-generated inventory was corrupt on a daily basis. Because of the PDX system's unreliability, technicians often had to make adjustments by hand so that the computerized records would match what was actually in stock. Orders could also be manually keypunched into a unit called a Telxon, which also transmitted orders to Bindley- Western. The Telxon unit is portable. The size of a telephone, the Telxon unit at Store No. 2358 was generally kept in a drawer when not being used. Finally, drugs can be ordered from Bindley-Western and/or from one of two secondary suppliers used by Winn-Dixie from any telephone, whether or not the telephone is located in a Winn-Dixie store. None of the systems used by Winn-Dixie, either singly or in combination, had the ability to flag the fact that hundreds of bottles of Stadol had been ordered and paid for by Winn-Dixie, yet not placed on the shelves as pharmacy inventory in Store No. 2358, during the period of Tipton's employment. Under Winn-Dixie's system, it is possible for a pharmacy technician to order medications unbeknownst to the pharmacist, to have them paid for by Winn-Dixie, and to physically divert them to his possession before the medications were logged in to pharmacy inventory. Once drugs are properly entered into inventory, it is reasonable to expect that the pharmacist could be aware of large amounts of a drug being stolen from the inventory. Any single incident of placing unauthorized drug orders could take place in the two or three minutes the duty pharmacist might be absent to go to the restroom, or have his attention diverted for any reason. Silverman is an experienced police officer, having served for over two decades in various law enforcement positions in Florida. For nearly five years Silverman has been exclusively assigned to work with pharmacies and other law enforcement agencies in St. Lucie County. Silverman's job is to assist in the prevention and prosecution of crimes involving the misuse of prescription drugs. Silverman's involvement in this case began when Tipton sought him out. Tipton knew Silverman because her husband is a fellow St. Lucie County detective, and Tipton herself was a sworn St. Lucie officer. Tipton approached Silverman to confess that she had taken a bottle of Stadol from the Winn-Dixie store where she worked. Tipton's confession was not provoked by an attack of conscience. Rather, after she was fired by Winn-Dixie, she began damage control. As Silverman's investigation progressed, substantial effort was made to determine how Tipton had diverted Stadol and what, if any, other crimes may have been committed. Documents collected in the course of the investigation revealed that Tipton had developed a dependency on prescription painkillers dating to a back injury in 1990 in which she suffered a herniated disc. Tipton developed a dependency on Stadol in 1996, after dealing with pain related to the 1990 injury. Tipton claimed to Winn-Dixie security supervisor Robert Blakely ("Blakely") that she had told McLester of the problem, and that he referred her to her doctor for help. Ultimately, Silverman arrested Tipton on 17 counts of insurance fraud and one count of felony possession of a controlled substance. No evidence was offered regarding the disposition of Tipton's case. No evidence was presented of what, if any, effort was made to determine from Tipton if McLester had any complicity in her crimes. It was clear to Silverman that while Tipton had figured out a way to illegally divert Stadol to her unauthorized use, as of the date of the final hearing, "nobody knows how it was done." 7 There was conflicting testimony as to precisely how much Stadol was diverted by Tipton over the relevant period of time but Tipton's ability to obtain the drug through the use of fraudulent prescriptions and outright theft was audacious in scale. Stadol was a legend drug until June 1997 when the Drug Enforcement Agency upgraded its status to a Schedule IV controlled substance. Prior to October 19, 1996, Tipton had a legitimate prescription for Stadol. On that date, Les Gessley ("Gessley"), a relief pharmacist at Store No. 2358, approved a new Stadol prescription for Tipton under a legend number. Tipton used this approved prescription number subsequently when she herself prepared numerous unauthorized refills under this same number. Each of these unauthorized refills was listed on daily pharmacy logs certified mostly by McLester, but also by other duty pharmacists as well. Because these unauthorized prescriptions were refills rather than original prescriptions, the duty pharmacist was not required to personally view the original written prescription. McLester was the pharmacist on duty a majority of the days on which Tipton is believed to have diverted Stadol illegally. Somewhere between ten and twenty percent of the Stadol believed to have been unlawfully diverted by Tipton from Store No. 2358 was diverted after McLester had ceased to be employed there. Some of the Stadol obtained by Tipton under fraudulent prescription at Store No. 2358 was obtained on days when McLester was not the pharmacist on duty. In addition to Les Gessley and Mostafa Macida, other pharmacists on duty while Tipton was believed to have engaged in the criminal diversion of Stadol are Ted Kline and Al Leota. McLester admitted knowing Tipton had a problem with Stadol but did not know the extent of her problem. Forsythe told McLester that she thought there might be some Stadol missing from the shelves. When she shared her concern with McLester, he instructed Forsythe not to leave Tipton alone in the pharmacy. No evidence placed McLester's conversation[s] with Tipton and other parties about her use of Stadol in the context of when Tipton's alleged diversions occurred. According to Forsythe's unrebutted testimony, If you were that desperate you could order any medication you wanted on the Telxon machine or verbally order without knowledge of the pharmacist knowing what you were doing. And then when the medication comes in, you pay the invoice. You throw the invoice away. You throw the copy that you received from the computer away. The invoice is paid. The only person that will know about it will be the person at the headquarters that pays the payment on the invoice without knowing what is on it and the person gets the medication. Take the medication home via however and no one is the wiser. Winn-Dixie has no security procedures in place, such as searching handbags or packages, to prevent employee theft in the pharmacy. Winn-Dixie's ordering system is tailor-made to be abused by individuals who are, in Forsythe's words, "that desperate." It is not illegal for pharmacy technicians to fill their own prescriptions. It is possible for a pharmacy technician to fill or refill a prescription without the pharmacist knowing that had been done if he was absent from the pharmacy or had his attention diverted in some fashion. It appears that Tipton refilled her own fraudulent prescription on a number of occasions, but that her preferred method of diverting Stadol was outright theft. The Winn-Dixie system by which the pharmacies are stocked is flawed in a manner which allowed Tipton to divert Stadol without being detected by the duty pharmacist. The Department failed to show that McLester knew or should have known that Tipton had diverted Stadol to her unauthorized use at Store No. 2358.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the charges in the Administrative Complaint be dismissed. DONE AND ENTERED this 17th day of November, 2000, in Tallahassee, Leon County, Florida. FLORENCE SNYDER RIVAS 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 17th day of November, 2000.
The Issue At issue in this proceeding is whether Respondent committed the offenses set forth in the Administrative Complaint1 and, if so, what penalty should be imposed.
Findings Of Fact Respondent's licensure and employment Respondent, Nury D. Soler, is now, and was at all times material hereto, licensed as a pharmacist by the State of Florida, having been issued license number PS 0014628. Pertinent to this case, Respondent was the prescription department manager for Westchester Pharmacy for a two-month period extending from some time in October 1996 and at least through December 13, 1996. Westchester Pharmacy is a community pharmacy licensed by Petitioner, pursuant to Section 465.018, Florida Statutes, and located at 7253 Southwest 24th Street, Miami, Florida. The pharmacy owner or permittee was Noriel Batista. The pharmacy inspection On December 14, 1996, a Saturday, Richard Castillo, an investigator employed by the State of Florida, entered the Westchester Pharmacy to conduct a routine community pharmacy inspection. Upon entry, Mr. Castillo observed only one person in the pharmacy, a man later identified as the permittee (Mr. Batista). At the time, Mr. Batista was observed in the vicinity of the prescription area, at the rear of the store. Mr. Castillo proceeded to the counter at the rear of the store, and was approached by Mr. Batista. Thereupon, Mr. Castillo feigned a toothache, and the following events transpired: . . . I put my hands on my face and I said I have some tooth pain, is there anything you can do about it. At which time, he said you really need to go see a dentist. I said that dentists cost a lot of money and that I believed that it was an infection. At which time he came back with a bottle of twenty Amoxicillin, 500 milligram capsules. He sold me the bottle for $10.00 and I gave him the $10.00. He then gave me some preliminary instructions, and went back into the prescription department area. He returned and said that as a gift I'm going to give you these medications; which was four capsules of Motrin 800 milligrams. Amoxicillin is a prescription drug, which Mr. Batista, who was not licensed as a pharmacist, sold without benefit of a prescription. Following the sale, Mr. Castillo identified himself as an investigator, told Mr. Batista he was present to conduct a routine inspection, and asked to speak with the pharmacist. When told the pharmacist was not available, Mr. Castillo asked Mr. Batista to telephone her and ask her to come to the store. Mr. Batista did so, and about an hour later Respondent arrived. Mr. Castillo inspected the pharmacy and completed a community pharmacy inspection report on which he noted a number of perceived deficiencies. (Petitioner's Exhibit 2). First, with regard to Mr. Batista's sale of amoxicillin, Mr. Castillo noted three deficiencies or violations against the pharmacy business, to-wit: (1) there was no pharmacist on duty when the prescription department was open (a perceived violation of Rule 64B16-28.109, Florida Administrative Code); (2) there was no pharmacist present to provide patient counseling, if requested (a perceived violation of Rule 64B16-27.820, Florida Administrative Code); and, (3) since Mr. Batista did not document the sale, Mr. Castillo considered the pharmacy records of dispensing to be incomplete (a perceived violation of Rule 64B16-28.140(3)(b), Florida Administrative Code). Other deficiencies noted by Mr. Castillo against the pharmacy business were as follows: (1) there was no sign displayed that the pharmacy was closed (a perceived violation of Rule 64B16-28.109(1), Florida Administrative Code); (2) the pharmacist's (Ms. Soler's) license was not displayed (a perceived violation of Rule 64B16-27.100(1), Florida Administrative Code); and, (3) there was no sign displayed which stated the hours the prescription department was open each day (a perceived violation of Rule 64B16-28.404, Florida Administrative Code). No further deficiencies were observed and, apart from those noted deficiencies, the prescription department appeared appropriately maintained and operated. Following Respondent's arrival at the pharmacy, Mr. Castillo discussed with her the various deficiencies he had found and had noted on his report. Then, as the "Pharmacist," Respondent signed the report. By signing the report, she acknowledged that "I have read and have had this inspection report and the laws and regulations concerned herein explained, and do affirm that the information given herein is true and correct to the best of my knowledge." Among the information provided on the inspection report was the name of the prescription department manager, which was stated to be the Respondent. Respondent's employment status with Westchester Pharmacy on the date of the inspection Notwithstanding her appearance at Westchester Pharmacy on Saturday, December 14, 1996, and her signing of the inspection report as the Pharmacist for Westchester Pharmacy, Respondent averred, at hearing, that by December 14, 1996, she was no longer affiliated with the pharmacy or responsible for the deficiencies noted. According to Respondent, by December 12, 1996, she had agreed with another pharmacy, Coral Way Pharmacy, Inc., (Coral Way Pharmacy) to serve as its pharmacist effective December 16, 1996, at its pharmacy located at 6965 Southwest 24th Street, Miami, Florida, and that her last date of employment with Westchester Pharmacy was December 13, 1996. While perhaps not entirely free from doubt (given the facial inconsistency between Respondent's contention at hearing and the conclusion one could reasonably draw regarding her association with Westchester Pharmacy, as evidenced by her activities on the date of inspection), the proof demonstrates, more likely than not, that, as Respondent averred, she was no longer employed by Westchester Pharmacy on the day of inspection, her presence on the day of inspection was a matter of accommodation to Mr. Batista, and her signing of the report was a matter of misunderstanding. In so concluding, it is observed that, while the pharmacy was open Monday through Saturday, the prescription department was not open on Saturday, or, stated differently, under the terms of Respondent's employment with Weschester Pharmacy she did not work week-ends. Given that Respondent and Coral Way Pharmacy, reached an agreement on December 12, 1996, for her to begin work at Coral Way Pharmacy on December 16, 1996, it is reasonable to conclude, given the nature of her work-week at Westchester Pharmacy, that her last day of employment with Westchester Pharmacy was Friday, December 13, 1996. Moreover, consistent with the conclusion that Respondent's association with Weschester Pharmacy terminated on December 13, 1996, is the absence of Respondent's wall certificate and license on the date of inspection. Notably, Respondent had not suffered prior disciplinary action in 19 years of practice, and presumably knew that, if employed, she was required to display her wall certificate and license in or near the prescription department. Conversely, she also knew, presumably, that she could not lawfully display them, if she was no longer employed by Westchester Pharmacy. Rule 64B16-27.100, Florida Administrative Code. Since it is presumed that persons will observe the law, the absence of Respondent's wall certificate and license on the date of inspection is consistent with her assertion that, by that date, she was no longer employed by Westchester Pharmacy. Atlantic Coast Line R. Co. v. Mach, 57 So. 2d 447 (Fla. 1952). Finally, also consistent with the conclusion that Respondent's employment with Westchester Pharmacy terminated before the date of the inspection is a statement Respondent made to the inspector. According to the investigator, when asked about the infractions, Respondent stated the following: . . . She said that things needed to change. She asked if she were to leave the pharmacy whether that would change anything, and I said, no, it doesn't matter because you're the pharmacist of record at this point of time. Such statement, when considered in context with other proof of record, discussed supra, is consistent with Respondent having resolved, previously, to terminate her employment with Weschester Pharmacy and, since she did not specifically tell the investigator of her decision, his response evidenced a misunderstanding that resulted in Respondent's execution of the report.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a Final Order be entered dismissing the Administrative Complaint. DONE AND ENTERED this 25th day of August, 1998, in Tallahassee, Leon County, Florida. WILLIAM J. KENDRICK 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 Filed with the Clerk of the Division of Administrative Hearings this 25th day of August, 1998.
