The Issue The issues to be resolved in this proceeding concern whether the Respondent properly maintained and supplied required records to support and document prescription claims, which it billed to Medicaid and for which it received payment from the Medicaid program during the audit period of April 1, 2000 through December 31, 2001. If that is not the case, it must be determined whether the Agency is entitled to recoup from the Respondent the sum it seeks of $108,478.77, as the purported amount overpaid to the Respondent by the Agency. It must also be determined whether the applicable laws and regulations referenced herein were complied with by the Respondent, in terms of its accepting and filling prescriptions, dispensing relevant drugs, and recording and documenting such activities in its pharmacy records. Finally, it must be determined whether the statistical methodologies employed by the Agency, through its audit and investigation of the Respondent, were sufficiently representative and accurate so as to support the calculation of estimated overpayments.
Findings Of Fact The Petitioner is an Agency of the State of Florida charged by the statutes and rules referenced herein with ensuring that proper reimbursement is effected to providers, including pharmacies, by the Medicaid system. Because of its duty to enforce and regulate the Medicaid system, the Petitioner Agency has an audit and oversight function, as well as an enforcement function, to ensure that Medicaid payments and the general operations of the Medicaid system are carried out correctly. It is through this duty imposed by the cited Florida Statutes and rules, as well as the federal regulations it is charged with enforcing, that the Petitioner carried out an audit of the Respondent, Brown Pharmacy, concerning the audit period of April 1, 2000 through December 31, 2001. The Petitioner conducts audits of providers such as Brown in order to ensure compliance with the Medicaid provisions and Medicaid provider agreements. These are called "integrity audits" and are routinely performed by auditors contracted from private firms such as Heritage. Brown Pharmacy (Brown) is licensed in the State of Florida as a pharmacy (license Number PH562). Brown maintained a business location at 312 West 8th Street, Jacksonville, Florida 32206, at times pertinent to this case. During the audit period Brown was an enrolled Medicaid provider authorized to provide Medicaid prescriptions pursuant to a provider agreement with the Agency. The terms of the provider agreement governed the contractual relationship between Brown and the Agency. Pursuant to that provider agreement, Brown was to maintain the Medicaid-related records and documentation for at least five years. Any Medicaid provider, such as Brown, not in compliance with the Medicaid documentation and record retention policies may be subject to the recoupment of Medicaid payments. During the audit period, Brown dispensed prescription drugs to Medicaid recipients. Medicaid claims were filed and paid electronically as "point of sale" transactions during the audit period. Each claim reviewed and at issue in this case was a paid Medicaid claim subject to the provider agreement and pertinent regulations. As a condition of participating in the Medicaid program, a Medicaid provider must comply with all provisions of a provider agreement, which is a voluntarily agreement between the Agency and the provider. Those provisions include the provider's agreement to comply with all relevant local, state and federal laws, rules, regulations, licensure laws, bulletins, manuals, and handbooks, etc. The provider must agree to keep and maintain, in a systematic and orderly manner, all Medicaid- related records as may be required by the Agency and make them available for state and federal agencies and review. It must maintain complete and accurate medical, business, and fiscal records that will justify and disclose the extent of goods and services rendered to customers or patients and rendered as billings to the Medicaid system. Florida Administrative Code Rule 59G-4.250 promulgates, as part of the rule, the above-referenced handbook (handbook) which sets out Medicaid polices and rules. The polices and rules govern the rights and responsibilities of drug providers, such as Brown, including coverage and payment methodologies for services and goods rendered to Medicaid recipients and billed to the Medicaid program. The types of records that must be maintained are as follows: Medicaid claim forms, professional records such as patient treatment plans, prior and post authorization information, prescription records, business records, including accounting ledgers, financial statements, purchase and acquisition records etc., tax records, patient counseling information and provider enrollment documentation. Providers who are not in compliance with the Medicaid documentation and record retention policies described in the handbook are subject to administrative sanctions and/or recoupment of Medicaid payments. Medicaid payments for services that lack required documentation and/or appropriate signatures will be recouped. Chapter five of the handbook, in defining overpayment provides that any amount not authorized to be paid by the Medicaid program, whether paid as a result of inaccurate or improper cost reporting, improper claims, unacceptable practices, fraud, abuse or mistake, constitutes overpayment. Incomplete records are records that lack documentation that all requirements or conditions for the providing of services have been met. Medicaid may recoup payments for services or goods when the provider has incomplete records or cannot locate the records. The Agency contracted with Heritage to conduct an on- site audit at Brown. The audit was conducted March 18th through March 20, 2002. Heritage isolated a sample of 205 prescription claims, known as the "judgmental sample" out of a total universe of paid pharmacy claims from Brown totaling 16,727 for the audit period. Heritage also selected 250 random prescription claims out of the remaining total universe of paid pharmacy claims of 16,522, which remained after the 205 judgmental sample claims had been removed or isolated from the remainder of the total claims. With the acquiescence of the Agency, Heritage chose the 205 claims by weighing it in favor of the "high dollar" or more expensive drug prescriptions. Those prescriptions are primarily for HIV and Aids therapy drugs and psychotherapeutic drugs for various mental conditions, including schizophrenia. Weighing of the judgmental sample strongly in favor of the high dollar prescription claims would seem to render the judgmental sample fundamentally unfair against Brown if the judgmental sample had then been extrapolated to the entire universe of claims ($16,727). This was not done, however. The judgmental sample was audited and compiled by doing an actual count and totaling of claim amounts in dollars represented by all the discrepant prescriptions, including all those the Agency and Heritage maintained resulted in "overpayments" to Brown. Therefore, the judgmental sample is an actual number rather than an extrapolated calculation so that weighing the sample in favor of the high dollar prescriptions does not result in an unfair or biased sample, as to the judgmental sample. Because the judgmental sample was drawn from the total pool of audited claims and removed from that claim pool prior to the identification and drawing of the random sample, the two are mutually exclusive and the amounts calculated do not represent a duplication or overlap. Thus the findings from the judgmental sample and then the random sample may be properly added together. The randomly selected claims (random sample) were taken of the remaining 16,522 claims in the audit claim pool after the judgmental sample of 205 claims had been removed. According to the report rendered by Heritage, the 250 randomly selected claims totaled $10,632.59 in paid Medicaid dollars. The Heritage auditors determined that there were 56 discrepant claims out of these which totaled, according to their calculation, $2,450.13 in apparent overpayments. This resulted in an average overcharge per claim of $9.80 (determined by dividing the documented "sanction amount" by the total number of claims in the random sample (250), multiplied by the universe of claims from which the random sample was taken (16,522) which yielded an extrapolated overcharge of $161,924.19. Applying the statistically appropriate 95 percent "one-sided" lower confidence limit of this extrapolation resulted in a purported overpayment extrapolated from the randomly selected claims of $102,700.85. This means that the overpayment amount calculated by Heritage represents an amount statistically 95 percent certain to be the lowest amount overpayment based on the extrapolation of the overpayment represented in the 250 randomly selected claims. The non-extrapolated judgmental findings showed, according to Heritage, that there were 72 discrepant claims. Heritage then determined that, of these, there were $29,381.09 in apparent actual overcharges. The discrepancies determined by Heritage involved the failure to produce documentation of refill authorizations for 80 prescription claims; 31 prescription claims containing an incorrect Medicaid provider number; the failure to produce 12 "hard copy" prescriptions representing 25 claims; four claims that did not have the prescriber's DEA number on the prescription for controlled substances; three claims for prescriptions that did not contain the original date of service; two claims that were billed for quantities greater than that authorized by the physician; one claim that was billed for an incorrect day's supply; one claim that was billed in excess of the maximum allowable quantity of prescription of the drug, set by Medicaid policy; and one prescription claim that was billed for an incorrect prescriber's Medicaid provider number (although this should not be a discrepancy because the correct prescriber was documented in the pharmacy's computer, which the regulations allowed). Additionally, there was one claim billed for a drug different than that prescribed by the physician, according to Heritage in its report. Heritage also conducted an invoice review using utilization reports provided by the Respondent. This was apparently a review of 25 different drugs that purportedly showed that the prorated purchases of those drugs were insufficient to cover the number of units billed to Medicaid for all 25 drugs reviewed, and thus yielded a purported shortage of $87,942.13, representing the amount billed to Medicaid above the amount the records of purchases from suppliers proved that Brown had purchased of those drugs. Based upon the Heritage audit as well as documentation findings and overpayments calculations (see Exhibit 8), the Agency issued a PAAR dated September 27, 2002, determining that Brown had been overpaid $150,036.71 for Medicaid claims during the audit period. That report advised Brown that it was a provisional report only and encouraged Brown to submit any additional information or documentation which might serve to change the overpayment. The report listed examples of documentation that the Agency would consider for a possible reduction in the overpayment amount initially claimed. Thereafter, the Agency agreed to an extension of time for Brown to submit additional documentation and sent a letter to Brown dated October 31, 2003, advising that the audit had been placed in abeyance pending the outcome in a related case, but that the Agency expected to resume the audit and that therefore all Medicaid-related records and documentation regarding paid claims should be maintained and preserved until the audit was finalized. The FAAR was addressed in the testimony of Ms. Stewart for the Agency. Through her testimony it was revealed that certain corrections should be made to the FAAR updating it from the findings in the Heritage initial audit report. The Agency corrected the information in the FAAR for this reason and for the reason that it secured some additional information from the Respondent. Thus, for the audit period it was established that there were 16,727 total claims for prescriptions dispensed by Brown, for which it was paid $795,564.59 during the 21-month audit period, of those claims, 205 were pulled out from the total universe of claims as the judgmental sample. There were some 72 allegedly "discrepant claims" totaling $36,393.51 in dollars paid to Brown. The Agency's position is that $29,381.09 of those are so called "documented overcharges." The random sample of 250 claims was extrapolated to the remaining universe of 16,522 prescription claims. The Agency now takes the position that it found 49 "discrepant claims" in the random sample which totaled $2,154.40 in dollars paid to Brown's pharmacy and of that it maintains that $1,927.55 are "documented overcharges" for the 250 randomly selected claims (for which Brown had been paid $10,632.59). Thus the Agency found an average overcharge for the 250 randomly sampled claims of $7.71 per claim. The $7.71 average per claim overcharge was then multiplied by the remaining universe of 16,522 claims, yielding an extrapolated purported overcharge of $127,387.92. The Agency then applied the 95 percent "one-sided lower confidence limit" to this extrapolation, that is, that it or its statistician, Dr. Johnson, felt that there was a 95 percent chance that the lower confidence limit number it calculated was accurate. That number is $79,097.68. When that number is combined with the Agency's position as to overcharges from the judgmental sample results in a total postulated overcharge of $108,478.77. This is the final amount the Agency claims as an overpayment that must be recouped for Medicaid. The FAAR summarized the discrepant claims for the judgmental sample as follows: 61 claims involve refills which exceeded the authorized number of refills without documentation of reauthorization; 10 claims showed an incorrect prescriber license number but the correct prescriber license number was documented in the pharmacy's computer; and For two claims the hard copy description did not have an original date of service depicted on it and did not reference a DEA number. The discrepant claims shown in the FAAR as to the random sample were as follows: There were 19 claims for refills without documentation of refill authorization (refills had been previously authorized, but for the 19 claims at least one refill had been issued beyond the authorization limit); Fifteen claims showed an incorrect prescriber license number on the claim and the license number was not documented in the Respondent's computer; Seven claims showed an incorrect prescriber license number, but the correct license number was documented in the pharmacy's computer; There were seven claims for which the original hard copy prescriptions could not be found on file during the audit period; For one claim the hard copy prescription did not have an original date of service or DEA number; For one claim the quantity paid exceeded the quantity authorized by the prescriber or dispensed to the recipient; and For one claim the number of days supply submitted by the pharmacy was not consistent with the quantity and directions of the prescriber and the quantity exceeded the limit set by the plan. The most common discrepancies with regard to the judgmental sample and the random sample occurred when the Respondent billed refills in excess of the number authorized by the prescriber, without any written authorization for such being provided in the audit process or later. Concerning the random sample, the second most common discrepancy occurred when the claim depicted an incorrect precriber number on the claim and the license number of the prescriber was not documented in the computer. In the judgmental sample the second most common discrepancy occurred when the claim showed an incorrect prescriber number, but the correct prescriber number was documented in the pharmacy's computer. The discrepancies in the FAAR with the indication "UR", references "unauthorized refills." The records of the pharmacy showed that Brown issued refills of prescriptions to Medicaid recipients in excess of the presriber's limit depicted on the prescriptions but showed no written record of a telephonic or written authorization by the prescriber allowing the additional refill or refills. It is also true that as to some or even many of these the Respondent may have obtained verbal authorization, but failed to document that re- authorization. Medicaid policy, the statutory authority cited herein, and the PDSCLR Handbook provide that all verbal orders authorized by the prescriber of a prescription must be recorded either as a "hard copy" or noted in the pharmacy's computer in order to comply with the relevant law cited herein, for record- keeping and auditing purposes under Medicaid policy. The Agency's Statistical Methodology Mark E. Johnson, Ph.D., testified on behalf of the Petitioner. He was qualified as an expert witness in the area of statistical formulas, statistical methodology, and random sampling, including the random sample statistical methodology employed by the Agency in determining the overpayment amount. He is a professor of statistics at the University of Central Florida. Dr. Johnson reviewed the statistical methodology, numbers and calculations arrived at by the Agency and its extrapolation method of arriving at the overpayment amount. He also used his own independent analysis based upon a software package he commonly uses in the practice of his discipline in testing the methodology employed by the Agency and the random sample employed by the Agency and Heritage. The statistical formula employed by Dr. Johnson and the Agency is a standard one routinely used in Dr. Johnson's profession and statistical sampling. He established through his own testing of the methodology that the random sample was appropriate for Medicaid program integrity audits and determinations as employed in this case. The random sampling, according to Dr. Johnson, was employed because it would be time and cost prohibitive to examine individually each of 16,522 claims regarding overpayment issues. The random sampling methodology using 250 randomly chosen samples is a time and cost saving device and yet still presents a "plausible estimate" as established by Dr. Johnson. He established that for the universe of 16,522 claims which were subjected to the random sample and extrapolation statistical analysis and calculation, that such is a reasonable sample for purposes of this audit and that the 250 random samples employed by the Agency are indeed statistically appropriate random samples. His calculation of overpayment was at variance with the Agency's by 55 cents. He established that is not a significant difference since the 95 percent certainty limit of $79,097.68 for the random sample extrapolation analysis is so much lower than the estimate established at $108,478.22. Dr. Johnson established that the Agency had employed appropriate and valid statistical methods in its determination of the above-referenced overpayment amount based upon the random sample of paid claims. The expert testimony of Dr. Johnson, together with his written report in evidence, is credible and persuasive as to the validity of the random sampling of the claims during the audit period and as to the random sample portion of the analysis employed in arriving at the final overpayment calculation and numbers depicted in the FAAR. Dr. Johnson established the appropriateness of the statistical formula, including extrapolation, used to calculate the overpayment amount, the appropriateness of the sample size relative to the universe of claims, and the improbability that the overpayment amount is attributable to chance causes alone. Thus Dr. Johnson's testimony is accepted as credible and persuasive in establishing the validity of the Agency's method of overpayment calculation, and the overpayment calculation in conjunction with the statistical evidence in this record, except as modified by the findings below.1/ The Respondent's Position Gary Steinberg testified on behalf of the Respondent, Brown Pharmacy. He was accepted as an expert witness in the areas of Medicaid policy, audits and pharmacy practice, including Florida pharmacy practice. Mr. Steinberg acknowledged that Brown had not properly documented all claims that had been paid by the Medicaid program nor maintained all required records. He emphasized in his testimony, however, that Brown had not fraudulently billed the Medicaid program with claims for prescription medications that it had not actually dispensed to the patients or recipients. Rather, all medications involved in the subject prescription claims had actually been dispensed. There is no evidence or claim on the part of the Agency that Brown charged and collected more than the appropriate approved price for the prescriptions at issue. Through the explanation given in his testimony, Mr. Steinberg opined that although Brown was guilty of technical errors in record keeping and documentation as to the prescriptions involved in the subject claims, Brown had made substantial compliance with the Medicaid program requirements of the Medicaid provider agreement and the statutes and rules at issue and policies embodied in the subject handbook. He explained in his testimony that in the pharmacy practice setting in which Brown has operated, whereby it serves a large indigent population in an inner city environment, it is difficult to contact a prescriber at the time when a patient needs a critical prescription refilled in order to get a refill authorization. The prescriptions at issue mostly involve critical medications for HIV/Aids and psychotropic medications for severe mental conditions such as schizophrenia. The patients who need these critical medications (and there are very few patients, since most of the procedures involve filling and refilling for a small number of such recipients) are patients of clinics operated at the nearby university hospital (Shands). In these circumstances, where the patient literally needs the HIV/Aids medication refilled on an immediate basis, possibly even to prevent death, and the mental health patient critically needs a refill in order to prevent harm to the patient or harm to the members of the public if the patient goes without medication and "decompensates," the ethical thing for a pharmacist to do is to refill the prescription and seek authorization later. Mr. Steinberg established that it is often difficult to obtain authorization from the original prescriber since the medication were prescribed by residents practicing in the various clinics at the Shands Hospital and that the residents can not always be identified or contacted easily since they do not maintain a fixed medical practice in the area. Consequently, some of the prescriptions were not documented as to authorization, although in some cases the pharmacy actually obtained authorization and entered it in its computer. In some cases, being unable to obtain re-authorization from the resident who originally prescribed the medication the pharmacy used the DEA license or prescribing number of the hospital itself. He explained that although under the law a pharmacy can refill a prescription on an emergency basis for up to a 72-hour supply, that this is generally impracticable and unsafe for patients in this plight because such indigent, mental health and HIV/Aids patients tend to be non-compliant with their medication regimes quite often anyway, and it is often unreasonable to expect them to return to the pharmacy for another refill within two or three days. He thus opined that the ethical and safe thing for the pharmacist to do was to refill and re-dispense the medical approved medication for up to a 30 or 34-day supply (the normal refill supply duration). He further explained that the Shands Hospital license number was used in some of these circumstances because the resident doctor who originally issued the prescription could not be identified on the Shands Hospital prescription forms and because the resident doctors at the Shands clinics only have and can use Shands Hospital prescription forms in any event. Mr. Steinberg thus established that 35 percent of those prescription claims classified as "WMP," that is the prescription claims contained an incorrect prscriber license number were for these reasons and the pharmacist could only use the Shands Hospital license number because the resident could not be identified from the Shands Hospital prescription forms. He thus opined that 35 percent of the random sample extrapolation amount, the 95 percent statistical confidence limit amount of $79,097.00, should be deleted from that amount in determining the correct amount of overpayment predicated on the random sample. Likewise, with regard to the judgmental sample concerning the HIV/Aids and mental health patient prescriptions and related claims, he opined that, in effect, $19,500.00 of the total $29,381.09 overpayment amount claimed by the Agency pursuant to the judgmental sample portion of the claims, should be deleted from that portion of the overpayment claim by the Agency; this is a result of his explanation regarding "substantial compliance" in the critical refill situation he described concerning the HIV/Aids and mental health patients and their prescription drugs. The preponderant, persuasive evidence does establish (and indeed the Agency acknowledged in its Proposed Recommended Order) with regard to the judgmental sample, that 10 of the claims at issue listed an incorrect prescriber license number, but that the correct prescriber license number was actually documented in the pharmacy's computer record with the name of the prescriber. This circumstances comports with the law referenced below and in the Petitioner's Proposed Recommended Order. This results in a reduction in the overpayment claim with regard to the judgmental sample of 13.88 percent of the judgmental sample claims or a reduction of $4,078.09. Likewise, with regard to the random sample extrapolation calculation of overpaid claims, the preponderant, persuasive evidence, also as acknowledged by the Agency in its Proposed Recommended Order, disclosed that seven claims listed an incorrect prescriber license number on the claims, but had been correctly documented in the pharmacy's computer system and therefore were in compliance with the relevant statutes, rules, and the subject handbook. Thus the discrepant claims and the overpayment amount related to the random sample portion of the audit claims should be reduced by 14.28 percent of the total amount of $79,097.00 for a $11,295.05 reduction of that $79,097.00 random sample overpayment amount. Mr. Steinberg demonstrated that Brown was not overcharging on the drugs prescribed and dispensed and was charging the Medicaid-authorized amount for the drugs involved in the prescription claims at issue. The Agency is not claiming that there was any fraudulent practice or illegal overcharging for the prescriptions involved. In fact, Brown was earning only a very small profit on the drugs dispensed that are the subject of the prescription claims at issue. Mr. Steinberg thus opined that since Brown did indeed dispense all the drugs at issue and was only paid the legal authorized amounts for the drugs and prescriptions at issue that recoupment of the amounts sought by the Agency or, in effect, established in these findings of fact, would be fundamentally unfair. He and the Respondent contend, rather, that since Brown performed substantial compliance, but was guilty of technical non-compliance with the relevant rules, agreement, and Medicaid policy, that the Agency should impose a lesser fine instead of seeking recoupment. In summary, in view of the preponderant persuasive evidence establishing the above facts, it has been shown that the documentation and record-keeping, dispensing errors, and omissions in the manner found above, with regard to the prescription claims and types of claims addressed in the above findings of fact, occurred. If those deficiencies amount to violations of the authority cited and discussed below which justify recoupment, then the amount of overpayment established by the above findings of fact is $93,104.95.
Recommendation Having considered the foregoing findings of fact, conclusions of law, the evidence of record, the candor and demeanor of the witnesses, and the pleadings and arguments of the parties, it is, therefore, RECOMMENDED that a final order be entered by the Agency for Health Care Administration providing for recoupment of $93,104.95, and that the Respondent, Brown Pharmacy, must re-pay that amount to the Petitioner Agency, through a reasonable re- payment plan established between the parties. DONE AND ENTERED this 3rd day of November, 2006, in Tallahassee, Leon County, Florida. S P. MICHAEL RUFF Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with Clerk of the Division of Administrative Hearings this 3rd day of November, 2006.
Findings Of Fact The Board of Pharmacy is the state agency in Florida charged with the regulation of the practice of pharmacy in this state. By stipulation, at all times material to the allegations herein, Respondent was a pharmacist in Florida having been issued license Number TS 0017388. On or about December 13, 1985, Respondent dispensed 20 Empirin #3 tablets with codeine to Sandra Robinson, a dental assistant to Dr. J. T. Flannigan, pursuant to a prescription written by Dr. Flannigan that same day. On January 8, 1986, Respondent again dispensed 20 Empirin #3 with codeine to Ms. Robinson pursuant to another prescription written by Dr. Flannigan that same day. Empirin #3 with codeine is a brand name of a medicinal drug defined by Section 465.003(7), Florida Statutes, containing codeine, a controlled substance, in sufficient quantity to be listed in Schedule III, Chapter 893, Florida Statutes. On January 14, February 3 and 26, March 10, and November 11, 1986, Respondent again honored prescriptions written on those dates for Empirin #3 with codeine, in the amounts of 20, 20, 30, 30, and 20 tablets respectively, to Marsha Villani, Dr. Flannigan's office manager. At all times relevant to the allegations in the Complaint, Respondent was prescription department manager for Jake's Health Mart, a community pharmacy as described in Section 465.018, Florida Statutes, as well as sole shareholder and owner of the facility. Ms. Villani, Ms. Norris, and Ms. Laxen, all, at the time in issue, presented the prescriptions to Respondent and received the substance indicated from him under a scheme devised by Dr. Flannigan who suffered from a bad back. The prescriptions were written and given to the women by Flannigan with the understanding that they would have them filled and then deliver the drugs to him. Ms. Villani worked for Dr. Flannigan from July, 1984 to April, 1988. During that period, Flannigan also treated her as a patient and, at various times, prescribed medicine for her for relief of pain from a broken foot and a dislocated shoulder. Over the period of time she worked for him, he also gave her prescriptions for drugs containing controlled substances issued in her name which were really for him. Many of these prescriptions were taken by Ms. Villani to Respondent's store where some were filled by Respondent, personally. Others were filled by other pharmacists who worked for him. It is her recollection that during the time she was doing this, she discussed what she was doing with Respondent because she was nervous about it since she knew it to be improper. She claims to have told Respondent on many occasions that the prescriptions were not for her use and discussed the possible repercussions of her actions with him several times. When she mentioned her concerns about Dr. Flannigan's continued drug use and his use of her as a courier, Respondent allegedly was very supportive and indicated it was nothing to be concerned about. After a period of time, during which Respondent never failed to honor the invalid prescriptions, on one occasion he did refuse to honor a prescription and told Ms. Villani to tell Flannigan to call him. At the time, she felt this might be Respondent's way of handling the situation, but she found, thereafter, that it was because he had been contacted by a Department investigator who was looking into Flannigan's activities. On cross examination, Ms. Villani indicated she believed other pharmacists working for the Respondent also knew what was going on because she also told them of the scheme. In this, her testimony is inconsistent with that given on direct wherein she indicated she did not discuss what she was doing regarding Flannigan's prescriptions with any other pharmacist. She also indicates that Respondent's brother, Pete, who worked at the pharmacy, filled some of the prescriptions for her and that she told him what was going on as well. Ms. Norris worked for Dr. Flannigan from October, 1984 through February, 1986 and, in addition to working with him, was a patient in 1985. At that time, he prescribed Percodan and an antibiotic. During the period of time she worked for him, he gave her several prescriptions for Empirin #3 with codeine which she was to have filled and then transfer the drug to him. Ms. Norris took those prescriptions to the Respondent for filling, but usually did not tell him who the pills were actually for. However, on one instance in December, 1985, she took a prescription for Empirin #3 with codeine in and when the Respondent asked her if the prescription was for her throat, she indicated they were not for her even though her name was indicated as patient on the prescription form. Nonetheless, the Respondent filled the prescription. In January, 1986, when she took another prescription in, Respondent asked her if it was for her throat and she indicated it was. Ms. Laxen worked for Dr. Flannigan as a dental assistant over two different periods, from March, 1984 through July, 1985, and again from October, 1987 through January, 1988. During those periods, she was not treated by him as a patient, however, he gave her prescriptions for drugs which she was to have filled and return to him during the period before she left in July, 1985. These prescriptions, which were written in her name, were filled by Respondent and on at least one occasion, when Respondent asked her if the prescription was for her, she indicated it was not. He nonetheless filled it. Though she had received other prescriptions of that nature from Flannigan which she had filled by Respondent and his associates previously, she had not discussed any of the details with Respondent. In fact, she is not sure which prescription is the one she discussed with Respondent. The entire situation was not comfortable for her and she preferred not to do it. Under the circumstances shown here, since no substance is indicated and no actual date is shown, Ms. Laxen's testimony is relevant only to corroborate the allegation that Respondent would fill prescriptions knowing that the name appearing thereon was not the actual individual for whom the substance was destined. Respondent does not deny knowing Ms. Villani or Ms. Norris but does not recall having met Ms. Laxen. He cooperated fully with the Department's investigator, Ms. Gossett, and even suggested ways in which she could get additional information. Most of the prescriptions in question presented by Ms. Villani, Ms. Norris, and Ms. Laxen are what are known as "third party prescriptions" paid for by an insurance company with the presenter paying only a $2.00 co-payment. Under the terms of the agreements he has with the various insurance companies, Mr. Beckel receives only the wholesale cost of the drug he provides plus a service fee of $3.00. As a result, there is very little profit in this type of prescription and he claims he would not place his license in jeopardy for the small amount of profit that might be realized from supplying Dr. Flannigan's drug needs. Consistent with that thesis, Respondent claims not to have known that he was filling false prescriptions when the investigator first came in. In September, 1987, at the time of the investigation, Ms. Gossett told Respondent that the prescriptions given by Flannigan to his employees were bad and that he should fill no more of them. He agreed. About an hour later, Ms. Villani came in with one of them and he asked her about it. At that time she admitted that the prescription, though written to her, was not for her, and at that point, he refused to honor it and requested that she have Dr. Flannigan call him and he would take care of it. Respondent is adamant in insisting, however, that he found out what Flannigan was doing, and received the admission from Ms. Villani that the prescription she was offering was not for her, only once. This was after he was advised of the situation by the Department investigator. He denies Villani's claim that she told him on several occasions that the prescriptions she presented were not for her. When Dr. Flannigan came to see Respondent at his request, only then did he admit what he had done. After that, Respondent would not fill any prescriptions written by Flannigan to any of his employees. He continues to fill other Flannigan prescriptions to bona fide patients. Regarding the prescriptions presented by Ms. Norris, Respondent admits that he would have asked the question about her throat if he knew what her medical profile was. However, he strongly contends that if, as she states, she advised him that the prescription was not for her, he would have asked her more, including who it was for and for what purpose it was written. If, in that case, she did not have a satisfactory answer, he would not fill the prescription. He further contends that had he known the drugs were for Flannigan, he would not have filled the prescription Ms. Norris gave him. He repeatedly asserts he stood to gain nothing by providing Flannigan with controlled drugs through this scheme. When it was suggested by Petitioner's counsel that a valid reason would be to maintain Dr. Flannigan's good will because of the volume of prescriptions he writes, Respondent astutely responded that Dr. Flannigan does not write enough prescriptions totally, throughout his practice, for him to risk his license on the potential for future business and this is accepted. The last prescription Respondent filled for Ms. Villani which is alleged in the Complaint was presented on November 11, 1986. This was at least several months before the conversation he had with her in September, 1987, in which Ms. Villani admitted that the prescription was not for her but was for Dr. Flannigan. He is sure that prior to that prescription, and all during the time he honored the prescriptions which form the substance of the complaint against him, Ms. Villani never told him the prescriptions she had him fill were for Flannigan. He recalls seeing her in the store often and has had many conversations with her, but, characterizing her as somewhat "spacey and illogical in conversation", he denies ever having knowingly filled a prescription for her which was intended for Flannigan. In addition, he contests her assertion that his brother, Peter, filled a prescription for her since Peter is not a pharmacist and, though he works in the store and may have filled other orders for Villani for non-controlled medical supplies, he is not permitted to work in the pharmacy and fill prescriptions. Turning to the issue of an economic motive for filling the illegal prescriptions, and relating it to his prior comment about the volume of Flannigan's prescription business not justifying Respondent's risk of his license to get it, examination of his records indicated to Respondent that over the period of their relationship, Dr. Flannigan's prescriptions in the past year have amounted to approximately 3 to 4 thousand dollars valuation. In that same year, Respondent's gross sales in the pharmacy were 1.8 million dollars. Therefore, Flannigan accounts for a very small percentage of the overall business, and while he might have made some profit filling the bad prescriptions, the amount involved was not nearly big enough to justify risking his license. In addition, in February, 1987, Respondent opened a second store on South MacDill Avenue, in Tampa. From that point on, he spent a majority of his time at that store, remaining there at least five days a week during the normal business day. He admits he was in his main store approximately 30 minutes out of every day, performing administrative functions such as checking mail, signing checks, and the like. Rarely, during that time, did he work in the pharmacy there. Based on the above, the evidence appears to be in equipoise. On the one hand, three employees of Dr. Flannigan have indicated that at various times they presented false prescriptions to Respondent for controlled substances intended for Flannigan which Respondent filled knowing that the ultimate receiver was not the individual whose name appeared on the prescription. On the other hand, Respondent unequivocally and frankly denies knowledge of the situation at the time the prescriptions were presented and asserts that when he discovered the true situation, he immediately declined to fill any more prescriptions of this nature. This equipoilent situation must be evaluated in light of the surrounding evidence. On one side is the testimony of the three individuals which, while it is certain as to what Respondent may have been told, is uncertain as to exact times the conversations were held. This is not to state that these witnesses do not, at this point, truly believe what they say, and it is recognized that, as counsel for Petitioner points out, they jeopardize their position by admitting to what might be classified as criminal behavior. On the other side, Respondent was unequivocal in denying any knowledge of the true nature of the questioned prescriptions. He also presented the testimony of three individuals, all of whom are responsible, significant individuals in the community, who are familiar with his reputation for truth and veracity in the community. All three, Dr. Caspar, Mr. Quigley, and Mr. Brynjolffson, one a physician and the others financial leaders in the community, indicate his reputation in that regard is excellent. Two, Quigley and Brynjolffson, related Respondent has been asked to be a bank director in their organization and as a result thereof, has undergone a strenuous and comprehensive background investigation by the Federal Bureau of Investigation and been determined to be completely free of misconduct or disqualification. Dr. Caspar also indicated that in addition to Respondent's excellent reputation for truth and veracity, he has a reputation for being a tough pharmacist who calls and questions any odd prescription. Taken together, and considering the evidence as a whole, evaluating and measuring the relative probabilities and improbabilities of the testimony, it must be concluded that the evidence is insufficient to clearly and convincingly establish that at the time Respondent filled the prescriptions for controlled substances alleged in the Administrative Complaint, he knew the prescriptions were false.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is, therefore: RECOMMENDED that Petitioner enter a Final Order dismissing both Counts I and II of the Amended Administrative Complaint against the Respondent. RECOMMENDED this 31st day of July, 1989 at Tallahassee, Florida. ARNOLD H. POLLOCK, 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 31st day of July, 1989. APPENDIX TO RECOMMENDED ORDER IN CASE NO. 88-6270 The following constitutes my specific rulings pursuant to Section 120.59(2), Florida Statutes, on all of the Proposed Findings of Fact submitted by the parties to this case. FOR THE PETITIONER: Accepted and incorporated herein. Accepted. &. 4. Accepted and incorporated herein. Accepted and incorporated herein. Accepted. Accepted. Accepted and incorporated herein. & 10. Rejected as unproven. FOR THE RESPONDENT: Accepted and incorporated herein. & 3. Accepted and incorporated herein. 4. - 8. Accepted and incorporated herein. 9. & 10. Accepted and incorporated herein. Accepted. & 13. Accepted and incorporated herein. Accepted and incorporated herein. Accepted. & 17. Accepted and incorporated herein. 18. Accepted and incorporated herein. COPIES FURNISHED: Bruce D. Lamb, Esquire Department of Professional Regulation 730 South Sterling, Suite 201 Tampa, Florida 33609 Terrence Pyle, Esquire Post Office Box 3126 Apollo Beach, Florida 33570-3126 Kenneth E. Easley, Esquire General Counsel Department of Professional Regulation 1940 North Monroe Street Tallahassee, Florida 32399-0792 Rod Presnell Executive Director Board of Pharmacy 1940 North Monroe Street Tallahassee, Florida 32399-0792
The Issue The issues presented herein are whether or not Respondent's incense to practice medicine should be suspended, revoked or the licensee otherwise disciplined for alleged violation of Chapters 458 and 893, Florida Statutes, as set forth in the Administrative Complaint filed herein signed May 31, 1983.
Findings Of Fact Based upon my observation of the witnesses and their demeanor while testifying, documentary evidence received, stipulations of the parties and the entire record compiled herein, I hereby make the following relevant factual findings. Respondent is a medical doctor and has been issued license number ME 0017825. Respondent's last known address is 2361 N.W. 24 Terrace, Miami, Florida 33172. (Stipulation of the parties) Respondent has been licensed as a medical doctor in Florida since 1971. Respondent studied at Havana University School of Medicine and graduated in 1957. He practiced in Cuba from 1957 through 1966. During that period, he was engaged in a general practice and was also a psychiatrist at Clinica Dependiente. While at Clinica Dependiente, Respondent served as a medical director for the rehabilitation of minors and as medical director for Santa Clinica Psiquiatria. Respondent relocated from Cuba and came to Miami on or about February 15, 1967. Respondent sat for the Federation of State and Medical Boards of the United States during September of 1968, the standardized test for graduates of foreign medical schools. During 1968 and 1969, Respondent was engaged as a psychiatrist at Halifax District Hospital in Daytona Beach, Florida. During 1969, he served a rotating internship at Mount Sinai Hospital for one year. Thereafter, he served rotating internships at Doctors, Victoria, Parkway and one other hospital in the Dade County area until approximately 1974. During his tenure at Halifax Hospital, Respondent treated some parties who were drug addicts. Respondent admits to having treated the patients referred to in the Administrative Complaint filed herein. Additionally, pursuant to Petitioner's Request for Admissions filed herein, Respondent has admitted the allegations set forth in paragraphs 3, 10, 17, 24, 31, 38, 45, 52 and 59 of the Administrative Complaint, to wit: Between the dates of approximately January 5, 1981 and December 15, 1981, Respondent prescribed 360 Dilaudid 2/ (Hydromorphone), a controlled substance, pursuant to Chapter 893, Florida Statutes, for Patrick Golden. Between the dates of approximately March 26, 1981 and January 15, 1982, Respondent prescribed 1425 Dilaudid (Hydromorphone) for Ellen Henderson. Between the dates of approximately March 2, 1981 and November 11, 1982, Respondent prescribed 855 Dilaudid (Hydromorphone) for Ronald Chica. Between the dates of approximately May 12, 1981 and January 9, 1982, Respondent prescribed 132 Dilaudid (Hydromorphone) for James Brannigan. Between the dates of approximately February 19, 1981 and February 2, 1982, Respondent prescribed 965 Dilaudid (Hydromorphone) for Gilbert Fernandez. Between the dates of approximately November 21, 1981 and December 12, 1981, Respondent prescribed 180 Dilaudid (Hydromorphone) for Patsy Gamlin. Between the dates of approximately January 7, 1981 and January 14, 1982, Respondent prescribed 820 Dilaudid (Hydromorphone) for Rudolph Ferguson. Between the dates of approximately February 24, 1981 and February 15, 1982, Respondent prescribed 2220 Dilaudid (Hydromorphone) for Michael Salle. Between the dates of approximately February 24, 1981 and February 15, 1982, Respondent prescribed 2190 Dilaudid (Hydromorphone) for Ronald Weatherington. Dale K. Lindberg, M.D., was tendered and received as an expert in these proceedings in the area of Family Practice, Methadone and Drug Addiction. Dr. Lindberg has been instrumental in establishing a methadone detoxification program at Memorial Hospital in Hollywood, Florida. Methadone is the only legally recognized Schedule II controlled substance used in this country for the treatment of drug addiction. Private practitioners, pursuant to specific federal law, cannot legally administer methadone or any other Schedule II controlled substance for the treatment of drug addition. In order to qualify or be certified to treat drug addicts, application must be made simultaneously with the Federal Food and Drug Administration (to their Methadone Monitor Division), to the Federal Drug Enforcement Agency and to the Federal Department of Mental Health and Drug Abuse. Upon certification with these governmental departments, only then can a physician prescribe methadone to a drug addict to be ingested in oral form, once a day. (21 C.F.R. 291.505) Dr. Lindberg received and reviewed the nine (9) patients' records listed in the Administrative Complaint as well as the prescriptions written for those patients by Respondent. (Petitioner's Exhibit 2-19). Dr. Lindberg, after review, concluded that Respondent inappropriately and excessively prescribed Dilaudid to said patients. Dr. Lindberg opined that Respondent prescribed Dilaudid for those patients for "very little indication" and continued over long periods of time prescribing Dilaudid to those patients. He considered that Respondent was maintaining the patients on Dilaudid in violation of the law. (TR 148, 239). Dr. John Handwerker, M.D., testified as an expert herein on behalf of Petitioner. He has served as the first Chairman of the Department of Family Practice at the University of Florida Family and Community Medicine Programs. He is Chairman of the Family Practice Department of Mercy Hospital in Miami and is Assistant Professor of Pharmacology at the University of Miami. Dr. Handwerker is knowledgeable regarding generally prevailing and accepted standards of family practice in Dade County and was accepted, without challenge, as an expert in the field of Family Practice. Dr. Handwerker reviewed the nine (9) patients' records listed in the Administrative Complaint as well as the prescriptions written for each patient. Based upon Dr. Handwerker's review of those records and prescriptions, Respondent committed gross and repeated malpractice. This opinion stems from Respondent's "inappropriately and excessively prescribing Dilaudid to patient for chronic" while the Physicians Desk Reference clearly stated that Dilaudid should not be prescribed for patients with chronic pain. (Testimony of Dr. Handwerker) SPECIFIC PATIENTS A. Patrick Golden first visited Respondent's office on October 7, 1981. Golden complained of chronic pain arising from trauma suffered while he was involved in an industrial accident. His diagnosis was a compression of the fourth and fifth lumbar disk. He was treated for radiculitis. Respondent prescribed Dilaudid to relieve the pain that patient Golden was suffering from and based on the fact that Golden reportedly had been receiving Dilaudid from a former physician. Respondent conducted an examination of patient Golden and prescribed exercises for him. Respondent did not take x-rays although he states that he observed x-rays which had been taken by Golden's former physician. Respondent prescribed Dilaudid for Golden because it was the only drug which "killed the pain, unlike motrin and metrobromate." Nearing the end of Respondent's treatment of patient Golden, his wife began stealing Mr. Golden's drugs. Respondent referred her to a methadone program and obtained a notarized statement from Mrs. Golden to substantiate the fact that she was diverting drugs intended for her husband. Respondent observed that patient Golden was becoming addicted to Dilaudid nearing the end of his treatment although throughout the major portion of his treatment of patient Golden, he felt that while he was dependent on Dilaudid, he was not felt that while he was dependent on Dilaudid, he was not "addicted." Respondent tried to reduce the amount of Dilaudid that he was prescribing to patient Golden without success. Respondent believed that Dilaudid was medically necessary to treat patient Golden due to the suffering he was undergoing from the chronic pain. (Respondent's testimony and Petitioner's Exhibit 20). B. Ellen Henderson was treated by Respondent during the dates of approximately March, 1981 through January, 1982. Henderson suffered with her lumbar spine. Patient Henderson took motrin tablets since her preteen years. Patient Henderson has been treated at several methadone centers and is believed to have been taking approximately 25-40 Dilaudid four-milligram tablets per day. Upon Respondent's first treatment of patient Henderson, he advised her that she was "killing herself and that she needed to reduce that terrible dosage of Dilaudid." Patient Henderson was "treated for pain in the back and to reduce the amount of Dilaudid." In this regard, Respondent tried to reduce her intake of Dilaudid to approximately 8 Dilaudid four-milligram tablets per day. When Respondent stopped treating patient Henderson, he had reduced the amount of Dilaudid that he was prescribing for her to approximately 8 four- milligram tablets of Dilaudid per day. C. Respondent treated Ronald Chica from approximately March, 1981 through November, 1982. Chica was treated for spondylolysis--a degeneration of the vertebrae. Respondent prescribed Dilaudid for patient Chica because it relieved the pain. Respondent knew that patient Chica was addicted to the drug Dilaudid. D. James Brannigan was treated by Respondent from approximately May of 1981 through January of 1982. Respondent knew that Mr. Brannigan was dependent upon Dilaudid. Despite this knowledge, Respondent continued to prescribe Dilaudid for Mr. Brannigan in an effort to treat Brannigan's addiction with Dilaudid. Respondent was attempting to ease the withdrawal symptoms that patient Brannigan would suffer if he were immediately cut off from his supply of Dilaudid. E. Respondent treated patient Gilbert Fernandez during the dates of approximately February of 1981 through approximately February of 1982. During that period, Mr. Fernandez suffered from compression features of the ribs and the lumbar region. Mr. Fernandez had a physical and psychological dependence on the drug Dilaudid. Respondent treated patient Fernandez by prescribing Dilaudid tablets for him. Patient Fernandez had been treated at methadone centers in the past and presently was receiving methadone treatment while Respondent was treating him. Respondent prescribed Dilaudid to relieve the pain as well as to ease the withdrawal symptoms that patient Fernandez would undergo if he was immediately taken from the administration of Dilaudid. F. Between the dates of approximately February of 1981 through February of 1982, Respondent prescribed approximately 2,190 four-milligram Dilaudid tablets for patient Ronald Wetherington. Patient Wetherington was given approximately 60 tablets every 7 days. Patient Wetherington was addicted to the drug Dilaudid and Respondent ultimately referred him to a methadone center to deal with his withdrawal problems. G. During the period of February, 1981 through February, 1982, Respondent prescribed approximately 2,220 four-milligram Dilaudid tablets for patient Michael Sallee. Patient Sallee suffered from and was treated by Respondent for a compression fracture of the fifth lumbar. Mr. Sallee was a cabinetmaker and did considerable lifting in the performance of his work. Respondent knew that Mr. Sallee was dependent upon Dilaudid and continued to prescribe the narcotic during the term of his treatment. Respondent attempted to treat Mr. Sallee's addiction with Dilaudid. H. During the period of January of 1981 through January of 1982, Respondent treated patient Rudolph Ferguson and, during that period, prescribed approximately 820 four-milligram Dilaudid tablets for him. Patient Ferguson suffered from and was treated for back and rib problems from an auto accident. Respondent knew that patient Ferguson was dependent upon the drug Dilaudid and knew he was addicted to Dilaudid. Despite this knowledge, Respondent continued prescribing the drug Dilaudid to patient Ferguson to reduce the withdrawal symptoms and "to continue to treat the disease." Respondent referred patient Ferguson to a methadone clinic and, in fact, drove him to a nearby clinic for treatment. I. Respondent treated patient Patsy Gamlin during the period of November 21, 1981 through December 12, 1981. During that period, he prescribed 180 tablets or approximately 60 tablets every 10-14. Respondent administered a drug screen during December of 1981 and did not treat patient Gamlin after December. Dilaudid is a narcotic analgesic; its principal therapeutic effect is relief of pain. There is no intrinsic limit to the analgesic effect of Dilaudid; like morphine, adequate doses will relieve even the most severe pain. Clinically however, dosage limitations are imposed by the adverse effect, primarily respiratory, depression, nausea and vomiting which can result from high dosages. (Physicians Desk Reference, page 1038 [1984 Edition]) The Physicians Desk Reference has this to say about drug abuse and dependence: Dilaudid is a schedule II narcotic. Psychic dependence, physical dependence, and tolerance may develop upon repeated administration of narcotics; therefore dilaudid should be prescribed and administered with caution. However, psychic dependence is unlikely to develop when dilaudid is used for a short time for treatment of pain. Physical dependence, the condition in which continued administration of the drug is required to prevent the appearance of a withdrawal syndrome, usually assumes clinically significant proportions only after several weeks of continued narcotic use, although some mild degree of physical dependence may develop after a few days of narcotic therapy. Tolerance, in which increasingly large doses are required in order to produce the same degree of analgesia, is manifested initially by a shortened duration of analgesic effect, and subsequently by decreases in the intensity of analgesia. The rate of development of tolerance varies among patients. Prior to prescribing a drug such as Dilaudid, a physician should take a full history from a patient and perform a thorough physical examination. The history should include, inter alia, the patient's chief complaint, with questions from the physician to the patient involving areas of past problems with the nervous system, ears, eyes, lungs, chest, respiratory system, GI tract and urinary tract. The physical examination should involve all body systems, including blood pressure, examination of the head, neck, chest and back regions. If patient complains of low back pain, there should be a physical examination specifically involving the low back area before prescribing the scheduled controlled substance here at issue. The past history is important to determine the duration of the problem, any previous medical treatment, examinations or tests by other physicians regarding the lumbosacral or low back area. A physical examination should be performed designed to elicit indications of neurological evolvement, including straight-leg raise tests, impairment of sensation in the extremities tests and other neurological inquiries. Such a full history and a physical examination is prior to initiating a course of treatment involving treatment of chronic pain due to the existence of a wide assortment of other treatment modalities which might treat the root of the problem, rather than merely being pain symptoms. An examination of the Respondent's records and the prescribing patterns of Dilaudid for the patients involved indicates that Respondent simply made insufficient findings upon which to base the decision to prescribe the drug Dilaudid. By prescribing Dilaudid, without an adequate physical examination, or the gathering of detailed patient medical history, would constitute a failure to conform to the level of care, skill and treatment recognized by reasonably prudent similar physicians under these conditions and circumstances. By continuing to prescribe these drugs, without any involved discussion or consideration of the effect the previous course of treatment had had on the patient, other than simple inquiry by Respondent concerning, as example, how the patient was feeling, 3/ also constitutes inappropriate prescribing of scheduled controlled substances, and demonstrates a failure to conform to the generally accepted an prevailing standards of medical practice in the Dade County community. (Testimony of Dr. Handwerker) Respondent has never been subjected to disciplinary proceedings in the past. His past professional record reveals that he has a sincere concern for his patients. Throughout these investigative proceedings and the final hearing herein, the Respondent was candid, forthright and truthful. His prescribing of the controlled substance Dilaudid was based on his mistaken opinion that it was medically necessary to prescribe Dilaudid for his patients. Throughout these proceedings, it became clear that Respondent had not kept abreast of the proper course of treatment, detection and proper prescribing patterns for scheduled drugs for the patients be treated. To Respondent's credit, he has been studying the proper prescribing of controlled substances since the initiation of the investigation and the administrative proceedings involved herein. Respondent has never "faked" exams and every prescription that he wrote was based on an office visit and an exam, though a very cursory exam. Respondent did not receive any illegal profits from the sale of drugs nor did he divert, or attempt to divert, any drugs for illegal profit. His office fees, which range from $15 to $25 were not based on the amount of the drugs prescribed but, rather, on the patient's ability to pay. Respondent operates a small general practice with his wife serving as his receptionist. He personally completes all prescription forms with his wife/receptionist. Patients receiving treatment from Respondent are free to get their prescriptions filled at any pharmacy of their choice. Respondent was unaware and the evidence does not show that any of his patients had prior criminal records.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, and the entire evidence of record, it is therefore recommended that a Final Order be entered imposing a written reprimand and one year's probation upon the Respondent Carlos de la Fe, and requiring that during the probationary, he enroll and complete, to the satisfaction of the Board of Medical Examiners, a continuing medical education course concerned with the appropriate indications for and prescription of scheduled controlled substances. 4/ RECOMMENDED this 24th day of October, 1984 in Tallahassee, Florida. JAMES E. BRADWELL 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 25th day of October, 1984.
Findings Of Fact Respondent is a medical doctor, licensed to practice in Florida, and holds license number ME 0009310, issued by Petitioner. Respondent specializes in family practice and has been board certified by the American Academy of Family Physicians since 1974. Percodan is the manufacturer's brand name for oxycodone, which is a Schedule II controlled substance pursuant to Chapter 893, F.S. 2/ It is a drug used for the relief of pain, a synthetic analgesic, and is both a physically and psychologically dependent producing drug. It can cause drowsiness, urinary retention, nausea, vomiting, and interacts unfavorably with other sedative drugs, and is considered a depressant. On December 30, 1966, Evelyn Milstead, a 30 year old woman, came to Respondent's office complaining of nausea and a rash in her mouth. Respondent conducted a physical examination, took her medical history and thereafter prescribed tigan for the nausea. Ms. Milstead became a regular patient of Respondent's and he continued treating her for various ailments over a period of years. During the course of Respondent's treatment, Milstead developed a chronic urinary tract infection and kidney condition in which she passed kidney stones. On occasion Milstead was treated by Dr. Gillespie, a specialist in the field of urology for her kidney condition. In 1978, Respondent also referred instead to the Ochsner Clinic for evaluation of her urinary tract and kidney problems. She was evaluated at Ochsner Clinic and received prescriptions for darvocet, a pain medication, and keflex, an antibiotic, and was told that she would continue to have a chronic kidney problem. Over the years, Milstead was hospitalized several times by Dr. Gillespie for treatment of her kidney condition. The testimony of Dr. William H. Nass and Dr. Robert P. Johnson established that Respondent's initial prescriptions of percodan to Milstead were appropriate. However, Respondent's percodan prescriptions to Milstead eventually became inappropriate. Specifically, the prescriptions for 2,668 percodan tablets between August, 1980 and November, 1982, were established as excessive. On July 30, 1977, Bruce White, a 25 year old male, came to Respondent for medical treatment for headaches and thereafter returned to Respondent for treatment of various medical problems. Mr. White's wife, Vicki White, and their children were also seen by Respondent as their family doctor. On May 18, 1981, White came to Respondent complaining of neck and back pain from an automobile accident in which he also fractured his left lower leg. Respondent noted that White had been seen by a neurologist and an orthopedic surgeon for his head and leg. In addition to other medication, Respondent prescribed percodan to White for pain. White had also developed arthritis in his left leg, as a result of the car accident and fracture, and on one occasion was hospitalized for swelling of his left leg. Respondent referred White to Dr. Tippett, a neurosurgeon, concerning his headaches and to Dr. Graybiel, a rheumatologist, concerning his arthritis. However, White continued to see Respondent as his medical doctor because his work schedule on an offshore oil rig would only permit Saturday appointments with his doctor and Respondent's offices are open on Saturday mornings. White also found it difficult to pay the fees charged by specialists. Between May 8, 1981 and September 30, 1982, Respondent prescribed 780 percodan tablets for Bruce White. The testimony of Dr. Nass and Dr. Johnson established that Respondent's initial prescriptions of percodan to White were appropriate. However, the percodan prescriptions to White became inappropriate over time due to their excessiveness. The seriousness of this lapse is underscored by Respondent's failure to try other pain alleviating measures and failure to investigate abuse possibilities. On October 18, 1979, Vicki White, the wife of Bruce White, a 23 year old woman, came to Respondent's office seeking treatment. She complained of migraine headaches and stated that her father was in the hospital with cancer. She also stated that she had seen Dr. Eyser, a neurosurgeon, for her headaches. Respondent prescribed wygesic for her pain. She subsequently returned to Respondent for treatment of various complaints including chronic migraine headaches, colds, and a dislocated right shoulder. Initially, Respondent prescribed norcet for relief of this pain, and on July 31, 1981, first prescribed percodan for her migraine headaches. Respondent prescribed percodan on other occasions in response to her complaints of pain from migraine headaches and back strain. Respondent considered referring her to a neurologist for the headaches but White stated that she could not afford to see a specialist. Respondent prescribed 590 percodan tablets for Vicki White between July 31, 1981 and September 22, 1982. Percodan is an appropriate and acceptable medicine for the relief of migraine headaches, and Respondent's initial prescription of percodan to Ms. White was appropriate. However, his prescriptions became excessive over time since percodan is not to be used for long term treatment of migraine headaches. On September 7, 1982, M. D. Medlen, an Escambia County Deputy Sheriff, went to Respondent's office as an undercover police officer, under the assumed name of Donna Slay. She had been asked by Robert Powers, a narcotics officer with the Escambia County Sheriff's Department and Charles Deckard, an investigator with the Department of Professional Regulation, to go to Respondent's office in an undercover capacity and attempt to obtain a prescription for percodan. Medlen/Slay first gave general information to the receptionist, including identification, in the name of Donna Slay, chief complaint of a backache, previous illnesses, drug allergies, address, social security number, and insurance information. Medlen/Slay was shown to an examination room where her blood pressure and weight were taken by the nurse and a urinalysis was performed. Respondent then came in and asked Medlen/Slay what her problem was. She informed him that she had been pushed into a wall during a fight, and had injured her back. Respondent checked her pulse, did a range of motion test, and checked the alleged injured area by palpation. Each time Respondent pressed on the alleged injured area, Medlen/Slay told him it hurt. Respondent did not visually inspect the alleged injured area but asked Medlan/Slay if there was a bruise and she said no. In order to get the percodan, Medlen/Slay told Respondent that she had injured her back one other time and a doctor in Louisiana had prescribed percodan for that injury. Respondent asked how long ago Medlen/Slay had taken the percodan and she said one year ago. Respondent discussed the dangers of drug addiction with Medlan/Slay and then prescribed 20 tablets of percodan for pain and 30 tablets of indocin to reduce inflammation. Upon leaving Respondent's office, Medlen/Slay did not fill the prescriptions but turned them over to Deckard. Percodan is an acceptable medicine for back and shoulder pain. However, Respondent should have considered the possibility of fracture, visually examined the area to ascertain the presence of a hematoma (blood clot) and listened to the patient's chest to determine the presence of lung injury. Respondent did not perform an appropriate examination prior to prescribing percodan, and the prescription was therefore inappropriate. Respondent used poor judgment in his excessive prescriptions of percodan to the patients discussed herein. However, there is no evidence that Respondent prescribed the percodan for personal financial gain or that any patient was injured by Respondent's prescribing practices. The testimony of the expert witness established that the records maintained on these patients were inadequate. Frequently, the only notation for a given visit was the prescription for percodan, with no evaluation of the patient's condition. Further, Respondent's patient records did not even list all the percodan prescriptions issued. Thus, these records essentially reflect partial inventories of prescriptions issued, and do not justify the course of prescribing, which is important to the safe practice of medicine.
Recommendation Based on the foregoing, it is RECOMMENDED that Petitioner enter a final order placing Respondent on probation for a period of five years, require that Respondent practice under the supervision of another physician to be named by Petitioner during the initial year of his probation and that Petitioner restrict Respondent's license against prescribing Schedule II controlled substances while he is under such supervision. 4/ DONE and ENTERED this 24th day of April, 1984 in Tallahassee, Florida. R. T. CARPENTER, 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 24th day of April, 1984.
