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AGENCY FOR HEALTH CARE ADMINISTRATION vs BROWN PHARMACY, 05-003366MPI (2005)
Division of Administrative Hearings, Florida Filed:Tallahassee, Florida Sep. 16, 2005 Number: 05-003366MPI Latest Update: Oct. 08, 2015

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.

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RAMS PHARMACY, INC., D/B/A MORENO PHARMACY vs AGENCY FOR HEALTH CARE ADMINISTRATION, 02-000480MPI (2002)
Division of Administrative Hearings, Florida Filed:Tallahassee, Florida Feb. 05, 2002 Number: 02-000480MPI Latest Update: Sep. 13, 2005

The Issue Whether Respondent Agency for Health Care Administration (AHCA) preliminary determination of alleged Medicaid overpayment to Rams Pharmacy, Inc. d/b/a Moreno Pharmacy (Rams) which arose from a Medicaid pharmacy audit, should become final agency action.

Findings Of Fact The Medicaid program is a cooperative federal-state venture designed to provide health care to the needy. States participating in the program receive federal financial assistance for compensating enrolled providers for the good and/or services they provide to Medicaid recipients. Florida is a participant in the Medicaid program, AHCA is the state agency responsible for making payments to enrolled providers in Florida. AHCA contracts with pharmacies such as Rams to provide medicine to Medicaid patients. After medicine is dispensed by a pharmacy to a Medicaid patient, the pharmacy must submit a claim to AHCA for that dispensed medication. The amount a pharmacy bills AHCA for dispensed medication generally consists of the pharmacy's wholesale costs for the medicine, plus a small dispensing fee. For each claim submitted, pharmacy Medicaid providers must disclose the information that is described in detail in Section 6 of the Prescribed Drug Handbook. Section 6 contains 11 pages of instruction for filling out of a claim form for one prescription reimbursement. A pharmacy must provide the following information for each medication dispensed: pharmacy provider number; recipient's name; recipient's Medicaid I.D. number; the prescription number; the manufacturer item; the date the prescription was filled; the quantify dispensed; the number of days the prescription covers; whether the recipient has any other insurance; the pharmacy's internal number that was assigned to the prescription; whether the prescription is being filled for the first time or is a refill; the National Drug Code from the package for the drug dispensed; the pharmacy's Florida license number; the medical certification code; whether the drug is generic or a name brand; the unit dose; the amount billed; other payer amount; and the billing date. After submission of a claim, AHCA reimburses the pharmacy for the amount billed. From time to time, after Medicaid's reimbursement and payment to a pharmacy, AHCA through its agent reviews a pharmacy's records to validate the pharmacy's claims and to assist AHCA in determining whether Medicaid may have overpaid the pharmacy. These findings are included in a proposed audit report. AHCA sends the proposed audit report to pharmacies advising them that it intends to adopt the proposed audit report and its underlying documents as the final report unless the pharmacy timely contests the proposed audit report. The AHCA analyst involved in this case opened a file in this matter on or around March 17, 2000. The file was opened after her review of a routine audit of the pharmacy performed by the fiscal agent on or about January 19, 2000, which alleged some discrepancies. The analyst chose an audit period of August 5, 1998 through December 31, 1999. She next requested from AHCA's Information Technology Department a list of Rams' "paid claims" for that period for the "top twenty" drugs, in terms of money paid to the pharmacy. She received a print-out of what purported to be those claims, which was introduced into evidence as part of the Final Agency Audit Report. The analyst then asked Rams to provide invoices to prove that during the audit period it purchased or acquired the drugs for which it had been paid by Medicaid as shown in Exhibit numbered 5. Between the dates of March 1998 and March 1999, Rams' physical location underwent substantial renovations. During the course of those renovations, boxes containing purchase invoices were either destroyed by the elements, inadvertently discarded, or misplaced. Because those invoices were not available, Rams could not produce invoices for all of its purchases of drugs during the relevant time period. However, Rams did provide some invoices and Rams' owner testified that the pharmacy acquired sufficient inventory during the audit period to cover the billings to Medicaid. Rams was credited for the invoices provided by Rams during the audit and prior to the hearing, although they were not identified or offered into evidence by AHCA or Rams. The claims that were unsupported by invoices were documented in the AHCA audit. A substantial number of invoices were not produced by Rams and are presumed lost during the renovation. From the invoices Rams provided, the analyst determined that there was three wholesalers who provided drugs to Rams during the audit period. The analyst wrote to the three wholesalers and asked them to provide lists of Rams' purchases of the "top twenty" drugs from them during the audit period. The purchase information print-outs received from Rams' three suppliers were of some assistance in reconstructing Rams' purchases. The request for invoices and purchase information and the responses received by the analyst were admitted into evidence as part of the Final Agency Audit Report. In this case, the analyst had a shelf inventory taken by the fiscal agent during a visit to the pharmacy on August 5, 1998, the date which the analyst chose as the start date of the audit period. That inventory was admitted into evidence as part of the Final Agency Audit Report. To obtain the total quantity of the twenty audited drugs purchased by Rams during the audit period by, the analyst (1) took the quantity of drugs listed in the August 5, 1998, shelf inventory; (2) added the quantity purchased on invoice from Rams' three suppliers; and (3) the total on the invoices provided by Rams. The analyst testified that she did not double count any purchase information for the audit period. She then compared the total quantity of drugs purchased by Rams, as evidenced by the invoice records, to the "reimbursed claims" for the twenty audited drugs. The quantity of drugs for which Rams was reimbursed exceeded the quantity of drugs purchases on documented invoices. The dollar value of those undocumented drugs is what AHCA seeks to recoup. Based upon that analysis, Rams was sent a Preliminary Audit Report on January 10, 2001, which alleged an overpayment of $390,327.19. A Final Agency Audit Report was issued on May 18, 2001, claiming an overpayment of $390,327.19. During the course of preparing for the hearing the amount of "overpayment" was recalculated by the analyst several times based upon: (1) additional invoices subsequently provided by Rams; and (2) additional purchase information previously provided to AHCA by one of the three suppliers, which AHCA had inadvertently overlooked during the initial review of the data. The final overpayment alleged by AHCA continued to be adjusted over the course of the hearing, and was finally set at $299,758.61. AHCA asserts that Rams was overpaid this amount for the audited drugs based on Rams' inability to establish through invoices or other purchase documentation that it actually purchased those drugs from legitimate sources.

Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law set forth herein, it is RECOMMENDED: That a final order be issued to recoup $299,758.61. DONE AND ENTERED this 22nd day of June, 2005, in Tallahassee, Leon County, Florida. S __ STEPHEN F. DEAN 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 22nd day of June, 2005.

Florida Laws (3) 120.569120.57409.913
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BOARD OF MEDICAL EXAMINERS vs. JEFFREY A. CHANCE, 86-002968 (1986)
Division of Administrative Hearings, Florida Number: 86-002968 Latest Update: Feb. 05, 1987

Findings Of Fact Respondent, Jeffrey A. Chance, is and has been at all times material to both Administrative Complaints, a licensed physician in the State of Florida having been issued license number MEO14972. On October 13, 1983, an Administrative Complaint against Respondent was filed, which resulted in a Stipulation being entered into between Petitioner and Respondent on January 12, 1984. By its Order filed March 2, 1984, approving and adopting the Stipulation between Petitioner and Respondent, the Board of Medical Examiners directed Respondent to submit carbon copies of all Schedule II controlled substance prescriptions written by him to the Department of Professional Regulation and the Board of Medical Examiners, on a bi-monthly basis. During the period between May 1984 and December 1984, Respondent filed with Petitioner copies of 70 prescriptions that he wrote for Schedule II controlled substances. During that same period of time, however, he failed to submit copies of a total of twelve (12) prescriptions that he had written for Percocet-5 which is a Schedule II controlled substance, pursuant to Chapter 893, Florida Statutes. When Petitioner brought to Respondent's attention his failure to file all required prescriptions, Respondent readily admitted having written the 12 prescriptions and indicated to Petitioner's investigator that he was in error in neglecting to send copies of the prescriptions to Petitioner as required by the conditions of his probation. Respondent also admitted in deposition that his failure to submit the prescriptions was unintentional and that he did not think that he was violating his probation. He further stated that the persons for whom he had written the prescriptions were persons who were not only patients of his but personal friends as well for whom he personally had the prescriptions filled. Since the Petitioner's (and therefore the Respondent's) discovery of the uncopied prescriptions, Respondent has begun using carbonless prescription pads, and there have been no recurrences of this problem. The second Administrative Complaint herein charges Respondent with failure to properly document patient records. The parties in their pre-trial stipulation stipulated as to the testimony of two witnesses to be considered as expert witnesses. It was further stipulated that if called to testify as a witness, Petitioner's expert would testify that Respondent's admitting note in the hospital records of one patient was illegible and that Respondent's discharge summary was inadequate because it did not mention a myocardial infarction as the cause of death. It was further stipulated that Respondent's expert would testify that Respondent's admitting note was legible and that the discharge summary was adequate. Further, Respondent's expert witness disagrees that a myocardial infarction was the cause of death, indicating that one could not determine the cause of this patient's demise absent an autopsy. When asked to read his charts and records in deposition, Respondent was able to do so.

Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is, RECOMMENDED that a Final Order be entered dismissing the Administrative Complaint against Respondent in DOAH Case No. 86-3339 but finding Respondent guilty of the allegations contained in the Administrative Complaint filed in DOAH Case No. 86-2968 and reprimanding him therefor. DONE and RECOMMENDED this 5th day of February, 1987, at Tallahassee, Florida. LINDA M. RIGOT, 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 5th day of February, 1987. APPENDIX TO RECOMMENDED ORDER IN CASE NOS. 86-2968,86-3339 In its proposed recommended order, Petitioner submitted a single set of proposed findings of fact as to both DOAH Case Nos. 86-2968 and 86-3339. Each of Petitioner's proposed findings of fact has been adopted in this Recommended Order either verbatim or in substance. In his proposed recommended order, Respondent submitted one set of proposed findings of fact as to DOAH Case No. 86-2968 and a second set of proposed findings of fact as to DOAH Case No. 86-3339. Respondent, however, used the same numbers in numbering both sets of proposed findings of fact. As to DOAH Case No. 86-2968, Respondent's proposed findings of fact numbered 2, 3, 4, 5, 6, the first sentence of 7, and the first three sentences of 13 have been adopted either verbatim or in substance in this Recommended Order. The remainder of Respondent's proposed findings of fact have been rejected as follows: 1 as not constituting a finding of fact; 7 (other than the first sentence), 8, and 14 as being unnecessary; and 9, 10, 11, 12, and the last two sentences of 13 as being immaterial. As to DOAH Case No. 86-3339, Respondent's proposed findings of fact numbered 2, 5, and 6 have been adopted either verbatim or in substance in this Recommended Order. The remainder of Respondent's proposed findings of fact have been rejected as follows: 3 and 7 as being unnecessary; and 1, 4, and 8 as not constituting findings of fact. COPIES FURNISHED: Julie Gallagher, Esquire Department of Professional Regulation 130 N. Monroe Street Tallahassee, Florida 32301 Joel S. Fass, Esquire 626 N.E. 124 Street North Miami, Florida 33161 Deborah J. Miller, Esquire 2100 Ponce de Leon Boulevard Suite 1201 Coral Gables, Florida 33134 Dorothy Faircloth Executive Director Board of Medical Examiners Department of Professional Regulation 130 N. Monroe Street Tallahassee, Florida 32301 Fred Roche Secretary Department of Professional Regulation 130 N. Monroe Street Tallahassee, Florida 32301

Florida Laws (2) 120.57458.331
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BOARD OF PHARMACY vs. MARK S. GORSKY, 75-001314 (1975)
Division of Administrative Hearings, Florida Number: 75-001314 Latest Update: Dec. 24, 1975

The Issue Whether or not the Respondent's license to practice pharmacy should be suspended or revoked pursuant to Section 465.101(1)(e) and 893.13(3)(a) 1 , Florida Statutes. The Hearing Officer explained to the Respondent the nature of the hearing and his rights under the Administrative Procedure Act, including the right to be represented by counsel at his own expense, if he so desires. It was also explained to the Respondent that he could testify in his own behalf, but that he was not required to do so and that if he did so testify, he could be cross- examined by counsel for Petitioner. Respondent acknowledged understanding of these rights and elected not to testify in his own behalf during the course of the hearing; however, he did participate in the cross-examination of Petitioner's witnesses and made a closing statement in which he denied the allegations against him.

Findings Of Fact During the period in question, i.e., April, 1975, Mr. Stanley Margolis was the manager of Gray Drug Store, No. 365, located at 12852 Biscayne Boulevard, North Miami, Florida. He and the Respondent are the only licensed pharmacists employed at that store (testimony of Mr. Margolis). "Eskatrol" is a trade name for a drug which is bottled and sold in capsules called "spansules". It contains dextro- amphetaminesulfate and acts as a stimulant on the central nervous system. It is used primarily as an appetite suppressant, although it also is sometimes prescribed in an emergency situation for narcolepsy to keep a person awake. It is a Schedule II drug under the Florida Comprehensive Drug Abuse and Prevention Act, Chapter 893, F.S. because it is an amphetamine (Testimony of Mr. Bell, Dr. Danoff). The procedure employed by Gray Drug Store to order Schedule 11 drugs was for Mr. Margolis to write a narcotic order form which he sent to a wholesaler who would then fill the order and send back an invoice with the narcotics in a box that was signed for by one of the pharmacists. At that time, the drugs would be counted, checked off and written down. Either Margolis or Respondent was on duty at the drug store at all times when it was open for business and Respondent could sign for such deliveries if Margolis was not then present. On approximately April 10 or 11, the store had run out of narcotics order forms and had exhausted its supply of several drugs, including ones with the trade name of Eskatrol. However, on Saturday, April 12, a prior order for ten bottles of Eskatrol, each bottle containing 50 capsules or "spansules" as they were termed, were received at the store. Respondent was on duty at this time and signed for the shipment. It was his responsibility to check the numbers of bottles received, enter the amount in a narcotics journal and place the drugs in a locked cabinet. On Monday, April 14, Margolis came on duty, reviewed the receipt of Eskatrol and determined that the shipment was correct based upon his examination of the invoice. He did not check the drug cabinet at this time. About 6:00 or 7:00 p.m. he received a prescription for 50 sparsules of Eskatrol. At this time, he noticed that there were only eight bottles in the cabinet when there should have been ten. He thereupon checked his prescription files for narcotic and other drugs and found no prescription to cover the two missing bottles of Eskatrol ewhich would have contained a total of 100 spansules. The store maintained a daily prescription log which indicated the prescriptions filled and a "waiting" file which was used to hold prescriptions for emergency drugs which had been issued pursuant to a telephonic request of a physician while waiting for the written prescription from the physician to arrive at the store. Mr. Margolis, on the morning of April 16, asked Respondent about the discrepancy. The Respondent told him that the wholesaler had been" short two bottles." Margolis was disturbed about this alleged shortage and therefore called the district manager of Gray Drugs, a Mr. Krake. On the morning of April 17, Margolis found a telephoned prescription form for 50, spansules of Estatrol in the "waiting" file (Petitioner's Exhibit 1). The Respondent told him that it had been called in and that he was waiting for the prescription. He said that he had written the prescription. Margolis identified the handwriting as being that of the Respondent. The prescription was in the name of Ron Richards and showed an address of "2405 Northeast 135". It did not bear a street, avenue, or city designation. There was no date entered in the "Date" space on the form, but the figures "4/14" appeared on the "RX" portion of the form. This portion also bore the handwritten number 221030, and showed the figures "825". The doctor's name was Danoff and shown with address of 4100 South Hospital at Plantation. The number 5870448 also appeared on the prescription form and the words "will mail". Mr. Margolis then reviewed what had been entered on Sunday in the prescription log book and discovered that prescription number 221030 showed a patient named Kasen and a price of $1.95 for the prescription (Petitioner's Exhibit 2) . The practice of the pharmacy had been to use a numbering machine which would stamp the prescription and the patient's receipt with the prescription number. Although 99 percent of the prescriptions are marked with the numbered stamp, occasionally there can be some mistake if the machine jumps, and the same number can only be stamped two times by the machine. On April 14, while Mr. Margolis was checking the non-narcotic prescription files, he had seen a prescription numbered 221030 for 15 Actifed tablets, prescribed by a Dr. Wrench for a patient named Kasen. The retail price of 15 Actifed tablets is $1.95. His log book also reflected that the next number in sequence, prescription no. 221031, was also prescribed by Dr. Wrench for patient Kasen for Keflex (Petitioner's Exhibit 3). Both of these prescriptions were entered on the log for April 13th. Margolis does not know what happened to the other prescription bearing the number 221030; he saw it last on the night of April 15 (testimony of Mr. Margolis; Petitioner's Exhibits 1-3). Dr. Sherwood Danoff, a licensed physician who practices at Plantation, Florida, specializes in dermatology. He is not familiar with the name of Ron Richards and did not call the Gray Drug Store of North Miami, Florida, on April 13, 1975, to order Eskatrol for that individual. He had never written a prescription for Eskatrol, which is a combination of an amphetamine and a barbituate used in diet control as an appetite suppressant. He did not receive a phone call on April 13 from the Gray Drug Store and has never spoken on the phone to anyone representing himself to be the Respondent Mark Gorsky. The normal dosage of Eskatrol is one or two capsules a day and, although he has prescribed Schedule II drugs on an emergency basis over the phone, he would never issue a prescription for a dosage that would cover more than a 10-day period. An emergency prescription by telephone is usually given only for the period until the patient can get in to see the doctor. This is known as an oral prescription and the doctor must follow this up with a written prescription within 72 hours. Although Petitioner's Exhibit 1 reflects Dr. Danoff's phone number, he did not phone in the prescription (testimony of Dr. Danoff). On April 17, Mr. William W. Smith, the regional manager of Professional Services for Gray Drug Stores, Mr. Anthony Difulio, the Director of Loss Prevention for the drug Store chain for Florida, and Mr. Vernon K. Bell, an agent for the Florida Board of Pharmacy, met at the Gray Drug Store in North Miami to look into the discrepancy reported by Mr. Margolis. Mr. Smith made an inspection of the books and records of the store and discovered that certain narcotic drugs were missing, including two bottles of Eskatrol. He checked with Dr. Danoff's nurse and Gulf Company, the wholesaler of Eskatrol. He tried to find the address of Ron Richards, as shown on the prescription in an incomplete form, but any projection of the address by avenues or streets would place it in Biscayne Bay or the ocean. Mr. Smith, together with Mr. Difulio, Mr. Bell, and Mr. Krake, went into a back room of the drug store to discuss the situation and later asked the Respondent to join them. Neither Mr. Difulio nor Mr. Bell arc law enforcement officers and do not have the power to take a person into custody other than that effected under an ordinary citizen's powers. During this period, not all of the above-mentioned individuals remained in the room during the entire period of approximately an hour or an hour and a half. Mr. Gorsky left the room on two occasions. Prior to questioning the Respondent, Mr. Bell advised him that he did not have to answer any questions, that he had a right to remain silent and a right to counsel. He did not threaten him or offer him any inducements to answer questions. After this warning, Respondent decided not to take the polygraph or make a written statement, but he did make oral statements. At no time was Respondent told he was under arrest. Mr. Bell asked Respondent if he could explain or know anything about the shortage of Eskatrol. The Respondent stated that he had received a call from Dr. Danoff on Sunday, April 13, concerning the prescription and that he called the doctor back to make sure that it was authentic; that he had placed the `number at the right bottom of the prescription and in his mind it was legitimate. When asked about the existence of Ron Richards, Respondent told Bell that Richards had been in the store several times. Respondent admitted to Bell that he had written the prescription (Petitioner's Exhibit l) and that it was his handwriting. There is a certain conflict in what Respondent stated at this meeting in view of the fact that Mr. Difulio testified that Respondent had said a customer had come into the store on April 13 and said that a doctor wanted him to have Eskatrol; that he had called the doctor and verified the prescription. Difulio did not recall if Respondent had stated that he had first had a call from the doctor, although he testified that Respondent said that he had prepared the prescription and filled it for Richards. When shown by Difulio that the cash register tapes for April 13 did not reflect an entry of $8.25, and Respondent was asked for an explanation, he stated that he had probably "got taken" by believing the telephone number he called was that of the doctor. In addition, Respondent told Difulio that after filling the prescription, he became scared and put a number on it from another patient and, when asked by Difulio what had happened to it, Respondent stated that he had torn it up and destroyed it. Difulio did not recall Respondent telling Mr. Bell about Dr. Danoff calling Respondent concerning the prescription. However, Respondent made several different statements during the course of his interrogation while various of the parties to the meeting went in and out of the room (testimony of Mr. Smith, Mr. Difulio, Mr. Bell).

Florida Laws (3) 893.02893.03893.13
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BOARD OF PHARMACY vs. ROGER ALLEN BOWERS, 79-000682 (1979)
Division of Administrative Hearings, Florida Number: 79-000682 Latest Update: Dec. 03, 1979

The Issue Whether disciplinary action should be taken against the license of the Respondent, Roger Allen Bowers, to practice pharmacy in, the State of Florida.

Findings Of Fact The Respondent, Roger Allen Bowers, a registered pharmacist in the State of Florida, practiced pharmacy and was the manager of the prescription department at Scotty Discount Drugs at 3620 Blanding Boulevard in Jacksonville, Florida, during the period of time from May 1, 1978, to February 10, 1979. On February 28, 1979, a Complaint and Notice to Show Cause was issued by the Petitioner Board charging Respondent with violation of Sections 465.101(1)(e) and 893.07, Florida Statutes, for permitting improper maintenance of records in that he failed to keep "on a current basis a complete and accurate record of each controlled substance, controlled by Chapter 893, Florida Statutes," at said community pharmacy. Respondent Bowers requested an administrative hearing. Mary Haddad, a pharmacist licensed in the State of Florida and employed at Scotty Discount Drugs during January, February and March of 1979, noticed that large quantities of Percocet-5 were being ordered by Respondent Bowers. Ms. Haddad felt such an order was unusual, inasmuch as she did not fill any prescriptions for this medication during her first month of employment. She checked the pharmacy Schedule II files for a one-month period and found approximately three (3) prescriptions for Percocet-5 during that period. She noticed, however, that numerous narcotic forms were signed by Respondent reordering this medication. Ms. Haddad noted on February 9, 1979, that there was one 500 stock bottle of Percocet-5 on the shelf which was about three- quarters full. She reported her findings to Owen Scott, a supervisor for Scotty Discount Drugs. Mr. Scott considered the communication from Ms. Haddad and called David Hodge, an agent for Petitioner Board, and requested an immediate audit of the pharmacy. After Mr. Hodge's report was filed with Mr. Owen, Mr. Owen terminated Respondent from the employ of Scotty Discount Drugs. David L. Hodge, the inspector-investigator for the Petitioner Board, audited the pharmacy for a period of approximately nine (9) months previous to February, 1979. The audit showed that during the said nine (9) months' period there was a shortage of 17,628 Percocet-5 tablets, 4,097 Percodan tablets, 609 Dilaudid 4 mg. tablets, and 610 Dilaudid 2 mg. tablets. The audit was introduced into evidence without objection. Mr. Hodge made copies of all the order forms for the said nine (9) months' period at Lawrence Pharmaceuticals which had been sent to said firm and were signed by Respondent Bowers. These copies were introduced into evidence without objection. The Respondent properly filled out the forms, signed them, and properly filed the forms on which the narcotics were ordered. He properly filed the prescriptions that were filled. No explanation was given for the discrepancy between the large amount of narcotics ordered by Respondent as the manager of the pharmacy and the small number of prescriptions filled for these narcotics and the absence of these narcotics in the pharmacy at the time of the audit by Mr. Hodge. There were seven (7) licensed pharmacists employed by the pharmacy managed by Respondent. The store in which the pharmacy was located remained locked until unlocked by an employee, and the pharmacy remained locked. Several people had keys to the store, and the licensed pharmacists had keys to the pharmacy. There was a spare key to the pharmacy within the store in the store manager's office under a ledge by a small door next to the pharmacy. The assistant manager of the store, an unlicensed person, knew the location of this key, as perhaps did other people, inasmuch as it was left on the ledge when not in use. Petitioner submitted proposed findings of fact, memoranda of law and proposed recommended orders. These instruments were considered in the writing of this Order. To the extent the proposed findings of fact have not been adopted in, or are inconsistent with, factual findings in this Order they have been specifically rejected as being irrelevant or not having been supported by the evidence.

Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, the Hearing Officer recommends that the license of the Respondent, Roger Allen Bowers, be revoked. DONE and ORDERED this 12th day of October, 1979, in Tallahassee, Leon County, Florida. COPIES FURNISHED: Michael I. Schwartz, Esquire Suite 201, Ellis Building 1311 Executive Center Drive Tallahassee, Florida 32301 William J. Sheppard, Esquire 215 Washington Street Jacksonville, Florida 32202 DELPHENE C. STRICKLAND Hearing Officer Division of Administrative Hearings Room 101, Collins Building Tallahassee, Florida 32301 (904) 488-9675

Florida Laws (2) 120.57893.07
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MAYHUGH DRUGS, INC. vs AGENCY FOR HEALTH CARE ADMINISTRATION, 00-004065 (2000)
Division of Administrative Hearings, Florida Filed:Green Cove Springs, Florida Oct. 03, 2000 Number: 00-004065 Latest Update: May 02, 2001

The Issue The issues are whether Petitioner is liable to Respondent for Medicaid reimbursement overpayments, and if so, in what amount.

Findings Of Fact Respondent is the agency charged with administration of the Medicaid program in Florida pursuant to Section 409.907, Florida Statutes. Petitioner provides services to Medicaid beneficiaries under provider No. 1000098-00 pursuant to a contract with Respondent. Under the provider agreement dated March 31, 1997, Petitioner agreed to comply with all local, state and federal laws, rules, regulations, licensure laws, Medicaid bulletins, manuals, handbooks, and statements of policy. The contract also sets forth Petitioner's responsibilities to keep and maintain in a systematic and orderly manner all medical and Medicaid-related records, and to make them available for state and federal audits for five years. Heritage Information Systems, Inc. (Heritage) is and has been a pharmacy audit company since 1980. In 1999, Respondent contracted with Heritage to perform audits of pharmacies enrolled in the Florida Medicaid program. Respondent and Heritage subsequently created a list of violations to be investigated during an audit. The list is based upon provisions in the Florida Statutes and federal Medicaid policies and regulations. The purpose of the list is to guide Heritage in performing its duty during an audit. Heritage conducts its audits based on a standard methodology and protocol. During the course of an audit, Heritage examines a provider's records to determine whether a pharmacy is compliant with all rules and regulations that apply to the pharmacy. Heritage uses an established set of neutral criteria to select pharmacies for participation in an audit. Using these criteria, Heritage selected Petitioner as a candidate for audit. By letter dated January 17, 2000, Heritage advised Petitioner that it would be audited on January 26, 2000. The letter stated as follows in relevant part: The auditor(s) will require access to original hard-copy prescription records, third party signature logs, and, in some cases, pharmacy computer screens relating to a sample of prescription claims billed by your pharmacy between 12/25/1998 and 12/24/1999. Please note that the sample claim may actually be a refill of a prescription originally dispensed prior to the audit period. Because of this, we recommend that you also have the prior twelve months of prescription records available the day of the audit. For your reference, the audit terms are defined in your participating provider agreement and the prescribed drug services handbook. If you have any additional questions prior to the audit, please call Heritage Information Systems, Inc. . . . Between December 25, 1998, and December 24, 1999, Petitioner submitted claims and received payments from the Medicaid program for 7,065 claims. Using an industry standard software application, Heritage selected a random sample of 101 of Petitioner's claims to be analyzed during the audit. In performing the audit, Heritage utilized a methodology similar to that used by auditing agencies who examined Medicaid providers in previous years. During the audit, Heritage identified four areas of noncompliance for Petitioner. First, Heritage requested Petitioner's staff to produce hard-copy prescription records for the 101 sampled claims. Hard-copy prescriptions include those ordered and signed by a physician on a handwritten form and the records created by the pharmacists immediately after receiving verbal authorization from a physician by telephone. In this case, Petitioner could not produce hard-copy prescriptions for five claims. The second area of noncompliance involved unauthorized refills. In seven instances, Petitioner refilled prescriptions more times than the number authorized on the documented prescription. There were no notations on the hard-copy prescriptions or in the pharmacy computer to indicate that the doctors or someone from their office called to increase the number of authorized refills. The third area of noncompliance involved one instance in which Petitioner claimed payment for a "days supply value" that was inconsistent with the quantity and directions on the prescription. The prescription at issue was for sixty tablets with directions for the patient to take the drug once a day, constituting a sixty-day supply of medicine. Petitioner filled this prescription as a thirty-day supply and claimed Medicaid payment accordingly. Respondent did not include this violation in the calculation of overpayment. The fourth area of noncompliance involved a prescription that was refilled 30 days earlier than appropriate with respect to the quantity and directions for use that appeared on the prescription. This was the same prescription referenced above in paragraph twelve. After completing the audit, Heritage completed a final audit report. Said report documents the following: (a) 7,310 claims submitted by Petitioner; (b) $350,639.95 paid by Respondent for all claims; (c) 101 claims in total random sample; (d) $3,839.33 paid by Respondent for claims in total random sample; (e) 13 discrepant claims in random sample; $778.09 paid by Respondent for discrepant claims; 13 documented sanctions in random sample; (h) $724.91 paid by Respondent for documented sanctions in random sample; (i) $52,466.25 as the total calculated overpayment; and (j) $13,798.70 as the amount of the overpayment based on a 95 percent one-sided lower confidence limit. The final audit report also contained a listing of the violations discovered during the audit. The final audit report contained the following comments/notes in relevant part: Five prescriptions could not be found by auditors and could not be found by pharmacist Geiger and technician Daniels either. Many unauthorized refills were noticed. Pharmacy staff stated some information may be on the old computer system that was not functioning because of Y2K problems. Any authorization or documentation that was found on the computer system was accepted. Under cover of a letter dated March 2, 2000, Petitioner furnished Respondent with statements relative to the discrepant claims/documented sanctions signed by several physicians. All of the statements included the following: (a) statements that the doctors had prescribed the medication(s) for their patients; (b) the patient name; (c) the prescription number; (d) a print-out of a computer screen; and (e) opinions that Petitioner would not fill or refill prescriptions without authority and approval. None of these physicians testified at the hearing. By letter dated August 16, 2000, Respondent notified Petitioner of the determination of a Medicaid overpayment in the amount of $13,798.70. The greater weight of the evidence indicates that Petitioner received an overpayment in that amount or more.

Recommendation Based upon the findings of fact and conclusions of law, it is RECOMMENDED: That Respondent enter a final order finding that Petitioner must timely pay Respondent $13,798.70 for Medicaid reimbursement overpayments from December 25, 1998, through December 24, 1999. DONE AND ENTERED this 30th day of January, 2001, in Tallahassee, Leon County, Florida. SUZANNE F. HOOD Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 30th day of January, 2001. COPIES FURNISHED: Melvin H. Fletcher, R.Ph. Corporate Representative Mayhugh Drugs, Inc. 200 South Orange Avenue Green Cove Springs, Florida 32043 L. William Porter, II, Esquire Agency for Health Care Administration 2727 Mahan Drive Building 3, Suite 3431 Tallahassee, Florida 32308 Sam Power, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive Building 3, Suite 3431 Tallahassee, Florida 32308 Julie Gallagher, General Counsel Agency for Health Care Administration 2727 Mahan Drive Building 3, Suite 3431 Tallahassee, Florida 32308 Ruben J. King-Shaw, Jr., Director Agency for Health Care Administration 2727 Mahan Drive Building 3, Suite 3116 Tallahassee, Florida 32308

CFR (2) 21 CFR 1304.04(h)21 CFR 1304.4 Florida Laws (9) 120.569120.57409.907409.913465.003465.015465.016465.186812.035 Florida Administrative Code (4) 59G-4.25064B16-27.10364B16-27.81064B16-28.140
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DEPARTMENT OF HEALTH, BOARD OF PHARMACY vs MARLENE BASS, R.PH., 00-004310PL (2000)
Division of Administrative Hearings, Florida Filed:West Palm Beach, Florida Oct. 19, 2000 Number: 00-004310PL Latest Update: Jul. 06, 2004

The Issue Whether Respondent committed the violation alleged in the Administrative Complaint, and, if so, what disciplinary action should be taken against her.

Findings Of Fact Based upon the evidence adduced at the final hearing and the record as a whole, the following findings of fact are made: Respondent is now, and has been since 1976, a Florida-licensed pharmacist. At all times material to the instant case, Respondent was employed by Eckerd Corporation as one of two full-time pharmacists assigned to the Eckerd Drug Store (Store Number 3372) located at 312 North Lake Boulevard in North Palm Beach, Florida, which housed a community pharmacy that was open 14 hours a day. Respondent and the store's other full-time pharmacist worked separate, alternating shifts. At the beginning of each shift, Respondent "signed on" the pharmacy's computer system. She "logged off" the system at the end of the shift. Respondent was responsible for the supervision of all activities in the pharmacy during her shift. Among the activities it was her responsibility to supervise were those engaged in by the pharmacy technician on duty. The pharmacy technician assisted Respondent by, among other things, preparing computer-generated prescription labels and customer receipts for prescriptions that needed to be filled. The technician prepared these items by entering the required information, including the name and strength of the prescribed medication, into the pharmacy's computer system. 1/ All prescription labels and customer receipts prepared by the pharmacy technician on duty during Respondent's shift contained Respondent's initials ("MCB"). After they were prepared, the prescription labels and customer receipts were placed in bags, and the bags were put in baskets on the counter near Respondent, where they remained until the prescriptions were filled. When filling a prescription, it was Respondent's practice to examine the actual prescription written by the prescribing physician or, in the case of an oral prescription, the pharmacy's written record of such prescription, to confirm the accuracy of the prescription information on the prescription label and customer receipt and to make sure that she was dispensing what the physician had prescribed. 2/ The pharmacy was a "very busy" one. As a result, at the end of her shift, there were sometimes prescriptions for which labels and receipts (bearing her initials) had been prepared, but which Respondent had not had the opportunity to fill, and it was not until the following shift, when she was off duty, that these prescriptions were actually filled. Respondent was on duty on June 18, 1998, when a computer-generated prescription label and customer receipt for a prescription (Prescription Number 6071853) for Patient H. V. were prepared. The computer-generated prescription label and customer receipt, which had Respondent's initials on them, indicated, among other things, that the prescription was for 15 180 milligram tablets of Thyroid and that the prescribing physician was Dr. H. Pomeranz. It is unclear when, and by whom, Prescription Number 6071853 was filled. On or about October 9, 1998, Patient H. V.'s son, R. V., filed a complaint with Petitioner alleging that "the prescription [his mother] was suppose[d] to [have] be[en] taking was 15 mil[li]grams," but she instead "was given 180 mil[lli]grams per day by [the] Eckerd Drug Store [on North Lake Boulevard]." David Dimon, a Medical Malpractice Investigator with the Agency for Health Care Administration, investigated the complaint. As part of his investigation, Mr. Dimon contacted Respondent, who advised him that she did not want to make a statement regarding the complaint. Mr. Dimon also spoke with the prescribing physician, Dr. Pomeranz, who told him that she "prescribed Thyroid, 15 milligrams, for the patient, and not the 180 milligram dose given by Eckerd Pharmacy." 3/ Dr. Pomeranz further indicated to Mr. Dimon that H. V. 4/ suffered "side effects" as a result of taking the 180 milligram tablets.

Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is hereby RECOMMENDED that the Board enter a final order dismissing the Administrative Complaint issued against Respondent in its entirety. DONE AND ENTERED this 13th day of March, 2001, in Tallahassee, Leon County, Florida. ___________________________________ STUART M. LERNER 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 13th day of March, 2001.

Florida Laws (7) 120.569120.57120.60465.016465.019465.02590.801 Florida Administrative Code (2) 64B16-27.41064B16-28.140
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