The Issue Whether Respondent's permit to operate a pharmacy should be suspended or revoked for alleged violations of Sections 465.22(1)(c), 465.18(1)(b), 465.18(2)(b) F.S., and Rule 21S-1.14 F.A.C. At the hearing, Petitioner withdrew Count-I of the Complaint. Respondent's Motion To Dismiss Counts II and III of the Complaint at the conclusion of Petitioner's case in chief was denied.
Findings Of Fact Respondent presently holds and did so hold at the time of the events alleged in the Complaint a permit to operate a pharmacy issued by Petitioner (Stipulation.) Prior to the events alleged in the Complaint, Petitioner's agent, Vernon K. Bell, an inspector, obtained an authentic prescription from another pharmacy that had not been picked up by a customer, for use in investigations of other pharmacies. The prescription was issued by Dr. George A. Fernandez, Miami, Florida, Number 012194, dated December 11, 1975, to Fela Rivias and was for twenty-one tablets of Erythrocin, 250 miligrams. Erythrocin is an antibiotic prescription drug used for various infections (Testimony of Bell, Petitioner's Exhibit 1.) On December 19, 1975, Bell visited Respondent's pharmacy and observed that the door to the prescription area was unlocked. On December 22, 1975, at approximately 3:30 P.M., Reynaldo Santiago, another agent of the Board of Pharmacy, entered Respondent's pharmacy with the prescription referred to in paragraph 2 above that had been given to him by Bell. Santiago gave it to the cashier to be filled. He observed her go to the prescription department, open a door, and place the prescription on a counter. He then observed Hildelisa Hernandez go to the prescription department and start filling the prescription. Thereafter, Ms. Hernandez, accompanied by Mr. Jose E. Valdez, came out of the prescription area and Hernandez gave a pill bottle to the cashier. The cashier in turn gave it to Santiago for the price of $3.95 or $4.00. The bottle contained 21 tablets and a label affixed thereon contained pertinent information as set forth in the prescription that Santiago had given to that cashier, including the name of the drug, doctor, prescription number and name of patient (Testimony of Santiago, Petitioner's Exhibit 2.) Santiago took the bottle of pills outside and then he and Bell re- entered the Pharmacy. Bell identified himself to Mr. Valdez and asked him who was his registered pharmacist and if he had a pharmacist on duty. Mr. Valdez stated that Hal Glass was his pharmacist, but that he had left the store at 2:00 P.M. Bell then asked Valdez if he had filled the prescription which Santiago had taken into the store and, after some hesitation, Bell asked Hernandez if she had filled it. She replied in the affirmative. She stated that she was not a licensed pharmacist in Florida, but had been a pharmacist in Cuba. Bell then wrote a violation and left the store. Neither he nor Santiago recalled seeing a sign indicating that the prescription department was closed on December 22 (Testimony of Bell, Santiago.) Jose E. Valdez testified that although he formerly had two pharmacists at his previous pharmacy, in August or September of 1975 he was forced to cut back to one part-time pharmacist because of the bad economic situation. He conceded that Ms. Hernandez was not a registered Florida pharmacist. He also stated that he was not aware of the rules requiring that the prescription department be locked when no pharmacist was present until this incident occurred and that, in fact, the door to the prescription area had not been locked although a sign indicating that the prescription department was closed had always been used. He further testified that on February 1, 1976, he hired a full-time pharmacist who is present at all times when the pharmacy is open and that the prescription department is now always locked when she is not present.
Recommendation That a civil penalty in the sum of $250.00 be imposed against Respondent in lieu of suspension or revocation of its permit, for violation of Section 465.18(1)(b), Florida Statutes, and Rule 21S-1.14, Florida Administrative Code DONE and ENTERED this 26th day of April, 1976, in Tallahassee, Florida. THOMAS C. OLDHAM Hearing Officer Division of Administrative Hearings Room 530, Carlton Building Tallahassee, Florida 32304 COPIES FURNISHED: Stanley Kaplan, Esquire 404 Biscayne Building Miami, Florida Seymour M. Litman, Esquire 10 Northwest 14 Avenue Miami, Florida 33125
The Issue Whether the Petitioner was overpaid for Medicaid prescriptions. The Agency for Health Care Administration (AHCA, Agency or Respondent) asserts the Petitioner, Compscript, Inc., d/b/a Compscript (Petitioner or Compscript) failed to maintain proper records to support and document the Medicaid prescription claims paid by the Agency for the audit period. According to the Agency, the audit findings must be extrapolated to the universe of all claims for the audit period. If so, the Agency maintains the Petitioner should reimburse AHCA for a Medicaid overpayment in the amount of $216,974.07 (this is the “recoupment” amount). The Petitioner denies it was overpaid any amount, asserts it kept records in accordance with applicable laws and regulations governing pharmacy records, and maintains that the Agency may not apply the extrapolation accounting procedure in this case.
Findings Of Fact At all times material to the allegations of this case, the Petitioner was a licensed pharmacy authorized to do business in the State of Florida; its pharmacy license number is PH0016271. At all times material to the allegations of this case, the Petitioner was authorized to provide Medicaid prescriptions pursuant to a provider agreement with the Respondent. The Petitioner’s Medicaid provider number is 106629300. The terms of the provider agreement govern the contractual relationship between this provider and the Agency. The parties do not dispute that the provider agreement together with the pertinent laws or regulations controls the relationship between the provider and the Agency. The provider agreement pertinent to this case is a voluntary agreement between AHCA and the Petitioner. Pursuant to the provider agreement, the Petitioner was to “keep, maintain, and make available in a systematic and orderly manner all medical and Medicaid-related records as AHCA requires for a period of at least five (5) years.” In addition to the foregoing, a Medicaid provider must maintain a patient record for each recipient for whom new or refill prescriptions are dispensed. Any Medicaid providers not in compliance with the Medicaid documentation and record retention policies may be subject to the recoupment of Medicaid payments. A Medicaid provider must retain all medical, fiscal, professional, and business records on all services provided to a Medicaid recipient. The records may be kept on paper, magnetic material, film, or other media. However, in order to qualify for reimbursement, the records must be signed and dated at the time of service, or otherwise attested to as appropriate to the media. Rubber stamp signatures must be initialed. The records must be accessible, legible and comprehensive. Specific to the issues of this case, a Medicaid provider must also retain prescription records for five years. The Respondent is the state agency charged with the responsibility and authority to administer the Medicaid program in Florida. Pursuant to this authority AHCA conducts audits to assure compliance with the Medicaid provisions and provider agreements. These “integrity” audits are routinely performed and Medicaid providers are aware that they may be audited. At all times material to the allegations of this case, the Medicaid program in Florida was governed by a “pay and chase” procedure. Under this procedure, the Agency paid Medicaid claims submitted by Medicaid providers and then, after-the-fact, audited such providers for accuracy and quality control. These “integrity” audits are to assure that the provider maintains records to support the paid claims. In this case, the audit period is May 28, 1999 through July 18, 2000. The pertinent audit has been designated AHCA audit no. 01-0514-000-3/H/KNH and was initiated on October 23, 2000. The Petitioner does not dispute the Agency’s authority to perform audits such as the one at issue. The Petitioner maintains its records are sufficient to support the paid claims and that the Agency has unreasonably imposed its interpretation of the requirements. The Medicaid provider agreement that governs this case required that the Petitioner comply with all Medicaid handbooks in effect during the audit period. Essentially, this standard dictates the records that must be kept for quality control so that the after-the-fact audit can verify the integrity of the Medicaid claims that were paid by the Agency. During the audit period the Petitioner sold or dispensed drugs to Medicaid recipients. Equally undisputed is the fact that Medicaid claims were paid by the Agency during the audit period. Each claim reviewed and at issue in this cause was a paid Medicaid claim subject to the Petitioner’s provider agreement and the pertinent regulations. The Agency required that each and every claim submitted by the Petitioner during the audit period under the Medicaid program be filed electronically. Each claim submitted was filed electronically. Nevertheless, the Agency also required the Petitioner to retain records supporting the claim. Additionally, the Petitioner was to make such supporting records available to the Agency upon request. The Agency asked the Petitioner to present its records to support the claims for the audit period. The disclosure of the records proved difficult for this Medicaid provider because it does not operate in a conventional pharmacy setting. More specifically, it operates solely to serve a nursing home population. All of the patients whose prescriptions were filled were nursing home residents. Compscript maintains its manner of doing business is slightly different from the conventional pharmacy. Rather than the walk-in patient who presents a written prescription to be filled, this Petitioner receives its pharmacy orders by telephone or facsimile transmission from nursing homes. Typically, the staff at Compscript takes the call, writes down the pertinent information, enters the data into the pharmacy’s computer system, and the item is dispensed and routed to the nursing home via the delivery driver. All drugs are dispensed in sealed containers and are delivered with a manifest listing all the medications by name and patient. Given the volume of prescriptions being prepared and delivered, for the audit period at issue in this case, the Petitioner made 2-3 trips to the nursing home per day. Once the information for the prescription was entered into the Petitioner’s computer system, Compscript had little interest in maintaining the written telephone message or the facsimile sheet that generated the request. In some instances the Compscript employee did not make a written record of the prescription request. In those instances the employee entered the request directly into the Petitioner’s computer system and bypassed the written step altogether. The Compscript computer system tracks the initials of the pharmacist who entered the prescription information and cannot be altered without such alteration being tracked and noted. Since the pharmacy fills “over the counter” items, as well as controlled and non-controlled pharmacy products, the computer record denotes that information along with the patient information. When the Respondent’s audit agents went into the Compscript facility to audit the Medicaid claims, the Petitioner could not readily produce the written documentation to support the dispensed drugs. In fact, many of the records that verified the prescriptions dispensed were found on the nursing home records. The nursing home patient’s physician order sheet specified the item or items requested for the patient. This “physician order sheet” (POS) should theoretically always support the dispensing of the product from the Petitioner. In this case there were instances when the POS did not corroborate the claim. When the auditors from the Agency presented at Compscript, the Petitioner did not have the POS records to produce. Obviously, those records were maintained within the nursing home. Additionally, Compscript did not have the telephone notes or the facsimile transmission sheets to support items dispensed during the audit period. When the hearing in this cause proceeded it was also discovered that records that were generated daily by the Petitioner’s computer system that would have corroborated the claims (and which were allegedly maintained in storage) were not produced or available to support Medicaid claims submitted during the audit period. During the audit the Agency’s auditors requested records from a random sample of the claims submitted during the audit period. The results from that sample where then applied to the universe of claims for the audit period. When this mathematical calculation was performed the audit produced a Medicaid overpayment in the amount of $1,341,466.27. Afterwards, when the Petitioner was able to locate additional records to correspond to and support the prescriptions dispensed, the amount of overpayment was reduced to $217,715.28 (the amount set forth in the parties’ Pre-hearing Stipulation). At hearing, the Agency maintained that the amount of overpayment was $216,974.07 for which the Petitioner could produce no adequate documentation. At hearing, the Petitioner continued to dispute the procedure of applying the audit sample overpayment to the population of claims to mathematically compute the overpayment for the audit period. This “extrapolation” process was admitted into evidence and has been fully considered in the findings reached in this case. The Petitioner was required to maintain Medicaid- related records for a period of 5 years. Thus, for the audit period in this case, any record supporting the claims should have been maintained and made available for the Agency. Such records would have been within the five-year period. The Agency designates Medicaid compliance to its office of Medicaid Program Integrity. In turn, that office contracted with Heritage Information Systems, Inc. (Heritage) to perform and report pharmacy audits of the numerous pharmacy providers within the state. Auditors from Heritage were assigned the Compscript audit. At the time of the audit the Heritage auditors were not privy to any of the POS documents later produced in the case. Ken Yon is the Agency’s administrator who was responsible for managing the instant case and who worked with the Heritage auditors to assure the policies and practices of the Agency were met. In this case, the Heritage auditors presented at Compscript unannounced on October 23, 2000, and sought 250 randomly selected claims for review. By limiting the number of claims, the auditors were not required to sift through the records of 46,000+ claims (the approximate number of claims that the Petitioner submitted during the audit period). For the universe of 46,000+ claims, 250 randomly selected claims is a reasonable sample to audit. The adequacy of the sample number as well as the manner in which it was generated is supported by the weight of credible evidence presented in this matter. Also, the results of a sample of 250 from the universe of 46,000+ would be statistically valid if randomly chosen as they were in this case. In this regard the testimony of Dr. Mark Johnson, an expert in statistical sampling and analysis, has been deemed credible and persuasive as to the issues of the appropriateness of the sample (as to size and how it was generated), the use of the sample overpayment to calculate an overall payment, and the statistical trustworthiness of the amounts claimed in this cause. If anything, as Dr. Johnson asserted, the actual overpayment would be greater than the recoupment amount sought by the Agency. The Agency has used a statistical extrapolation method to compute overpayments for years. The statistical concept and process of applying a sample to a universe to mathematically compute an overpayment is not novel to this case. After the auditors completed their review of the records at the Compscript pharmacy, Kathryn Holland, a licensed pharmacist (who is also a consulting pharmacist) prepared the Respondent’s Final Agency Audit Report. Prior to completing the report, Ms. Holland received and reviewed the information provided by the Petitioner through the auditors. As a result of the review, a number of “can’t find” conclusions were reached. By “can’t find” the auditors and Ms. Holland meant that the original prescription or refill documentation could not be located for the paid Medicaid claim. These “can’t find” claims were reported to the Petitioner, who was given additional time to locate and produce documents to support the claims. In fact, the Agency continued to accept documentation for claims up through the time of hearing. Consequently, the amount sought for overpayment has been substantially reduced. Whether the Agency had the authority to accept documents outside the prescription records maintained by the pharmacy is not an issue. In fact, the Agency did reduce the overpayment amount when subsequent supporting documents were located. A second error in the documentation for the Petitioner’s prescriptions was noted as “no doctor’s address on the prescription.” That expression meant that pursuant to state and federal law the physician’s address is required for a controlled substance and when it was not provided the auditor deemed the documentation incomplete. Although the Petitioner maintained doctor addresses in its computer system, the records did not correspond to the specific prescriptions that were filled for the audited claims. In order to stand as a sufficient prescription form, a writing must be created contemporaneous to the order (phone requests that are transcribed are acceptable), must contain specific information (type of drug, strength, dose, patient, doctor, DEA number, refill, etc.), and it must be kept for the requisite time. It would be acceptable for the prescription to be computer generated so long as it was written contemporaneous to the order and preserved as required by law. In this case, at the conclusion of the audit, the Agency identified 194 discrepant claims within the random sample of 250. The vast majority of those discrepancies were noted as “can’t find.” Had the Agency not accepted other documentation to support the dispensing of the drugs, the calculated overpayment would have been $1,575,707.44. Applying a lower confidence limit of 95 percent to that amount generated the calculated overpayment of $1,341,466.27. The audit findings set forth in the Agency’s Final Agency Audit Report (dated April 6, 2001) is supported by the weight of credible evidence in this case. Nevertheless, the Agency did allow the provider here to supplement the documentation disclosed during the audit. And, to that end, the calculated overpayment was reduced to $216,974.07 (this amount is 95% of the calculated overpayment). In reality, the amount owed by this Petitioner for failure to maintain proper documentation for this audit would be greater than the recoupment amount sought by the Agency. Had the Agency held the Petitioner to a standard of “no prescription, no payment” standard arguably 194 of the 250 audited claims could have been disallowed. That is not the standard applied by the Agency. A “patient record” may include information regarding the patient’s prescription history. The terms “patient record” and “prescription” are not synonymous. For example, while a prescription would contain information such as patient's name, doctor, DEA number, doctor's address, dosage, drug, and whether it may be refilled, it would be expected that the “patient record” would contain additional information not typically found on a prescription. For instance, a “patient record” might contain a historical track of past medications or known patient allergies. In this case, the computer records or “patient records” maintained by the Petitioner did not retain the prescriptions in the format dictated by rule. An electronic imaging recording system may be used when the system captures, stores, and can reproduce the exact image of the prescription, including the reverse side of the prescription if necessary. The Petitioner’s system did not do that. An electronic system must be able to produce a daily hard-copy printout of all original prescriptions dispensed and refilled. If the Petitioner’s system could do that, it did not. An acceptable electronic system must generate the prescription contemporaneous to the dispensing order. The Petitioner’s system did not do that. The Agency has not alleged, and there is no evidence to suggest, fraud in the Petitioner’s failure to maintain its records. The Agency’s interpretation of the requirement that a prescription be reduced to writing is consistent with the rules and regulations in effect at the time of this audit. The last category of discrepant items was “UR” which stood for “unauthorized refills.” These were claims for refills on drugs for which the original prescription could not be located or documentation from the nursing home could not be found. Again, the Petitioner the maintained that within the nursing home setting a physician’s reorder for medications for the patient could be found on the POS. These refill requests were handled orally among the physician, the nursing home staff, and the pharmacy. Nevertheless, because they were not documented in writing the Agency disallowed this claims and included them among the discrepant list. If the Petitioner was able to produce a physician order to support the UR claims, it was removed from the recoupment list. In most instances, the Petitioner did not have the requisite paperwork to support the refill. Instead, the Petitioner relied on its computer records (again not kept in accordance with the applicable standards) to support the UR claims. The Agency has not claimed that the refills were not dispensed, merely that the paperwork to support the claim cannot be produced.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Agency for Health Care Administration enter a Final Order that accepts an amended Final Agency Action Report to support an overpayment and recoupment against the Petitioner in the amount of $216,974.07. S DONE AND ENTERED this 6th day of October, 2005, in Tallahassee, Leon County, Florida. J. D. PARRISH 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 6th day of October, 2005. COPIES FURNISHED: Richard Shoop, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive, Mail Station 3 Tallahassee, Florida 32308 William Roberts, Acting General Counsel Agency for Health Care Administration Fort Knox Building, Suite 3431 2727 Mahan Drive Tallahassee, Florida 32308 L. William Porter, II, Esquire Agency for Health Care Administration Fort Knox Executive Center III 2727 Mahan Drive, Building 3, Mail Stop 3 Tallahassee, Florida 32308-5403 Kenneth W. Sukhia, Esquire Fowler, White, Boggs, Banker, P.A. 101 North Monroe Street, Suite 1090 Post Office Box 11240 Tallahassee, Florida 32302 Ralph E. Breitfeller, Esquire McGrath & Breitfeller, LLP 140 East Town Street, Suite 1070 Columbus, Ohio 43215
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 Based upon all of the evidence, the following findings of fact are determined: Petitioner, Stadtlander Drug Company, Inc. (SDC), is a provider of pharmacy services located at 600 Penn Center Boulevard, Pittsburgh, Pennsylvania. It is licensed by respondent, Agency for Health Care Administration (AHCA), as a special non-resident mail order pharmacy having been issued License No. PH 0013072. Petitioner is now enrolled as a Medicaid provider in twenty-three states around the country and provides mail-order drugs in all those states. In addition, it holds at least forty pharmacy licenses in various states, as well as thirty-five drug wholesale licenses. Petitioner's specialty is to target certain "disease states" and provide expensive, "high-tech" drugs to persons with serious, chronic illnesses such as cancer and AIDS. On November 7, 1995, petitioner submitted an application to respondent for enrollment as an out-of-state Medicaid provider. If the application is approved, petitioner would be assigned a Medicaid provider number and be able to provide prescription drugs by mail to Florida residents who reside within the State of Florida. It would then be reimbursed under the state's Medicaid program. After reviewing the application, including a supplemental submission by SDC, on February 28, 1996, AHCA denied the application on the following grounds: (Y)ou have failed to demonstrate that SDC meet the requirements for enrollment of out-of-state providers as outlined in Rule 59G-5.050, Florida Administrative Code (F.A.C.) Furthermore, SDC's locality would create an undo hardship on AHCA for meeting the requirments and oversight duties set forth in applicable federal laws, state statutes, administrative rules, regulations and manuals. For example, conducting on site audit reviews of your pharmacy operations, which requires (that) our field auditors take a physical inventory of the pharmacy department, and enforcing the oversight provisions cited in Section 409.913, Florida Statutes (F.S.), would be difficult and create an unwarranted expense. After receiving this advice, SDC filed a petition for hearing claiming that it had satisfied all pertinent requirements for enrollment. The parties have stipulated that there are no federal laws, administrative rules or manuals that would preclude SDC's enrollment as a Florida Medicaid provider and prevent it from providing prescribed drug services to qualified Medicaid beneficiaries who reside in the State of Florida. Under both federal and state law, AHCA is authorized to conduct audits of Medicaid pharmacy providers. The manner in which such audits are to be performed is set forth in the "Florida Medicaid/Unisys, Inc. Pharmacy Audit Program" manual. As a ground for denial, AHCA contends that, if the application is approved, an undue burden would be placed on the agency in auditing petitioner's records in Pittsburg. SDC acknowledges that there could be some hardship to AHCA in performing its audit responsibilities. SDC has, however, made accommodations to other states in attempting to address their concerns about the need to audit Medicaid pharmacy providers. For example, for the State of California, SDC maintains certified copies of all documents within that state to permit on-site inspection and comparison of records in California by the auditor. SDC has proposed to make the same kind of accommodation for AHCA. In addition to this accommodation, SDC is willing to answer by telephone any questions raised by Medicaid auditors and provide documentation for specific patients. Alternatively, if a Florida auditor found it necessary to make an audit of petitioner's offices in Pittsburg, SDC would willingly allow an on-site inspection. Other than the ground cited in its letter of denial, respondent offered no evidence to rebut SDT's showing that the accommodations are reasonable and adequate. Further, given these accommodations, there is no evidence that AHCA would suffer "an undue hardship" or that it would be unable to perform its auditing responsibilities under the Medicaid manual. Finally, since no Medicaid auditors from any of the twenty-three states in which SDC is certified as a Medicaid provider have found it necessary to make an audit in SDC's home office during the last four years, it is fair to draw an inference that the proffered accommodations would be satisfactory. AHCA has also denied the application on the ground petitioner does not meet any of the four criteria in Rule 59G-5.050(1), Florida Administrative Code. That rule specifies the circumstances under which an out-of-state provider may enroll in the Florida Medicaid program. Those criteria apply, however, when out-of-state providers intend to provide services to Florida recipients who purchase drugs while out of the State of Florida. In this case, petitioner intends to provide services by mail to recipients who reside within the State of Florida. Therefore, the rule does not apply. Because SDC has completed a provider agreement, is not under suspension in Florida or any other state, and has a current pharmacy license from AHCA, and its locality will not create an undue auditing hardship on AHCA, its application for enrollment as an out-of-state Medicaid provider should be approved.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Agency for Health Care Administration enter a final order granting petitioner's application for enrollment as an out-of-state Medicaid provider. DONE AND ENTERED this 16th day of August, 1996, in Tallahassee, Florida. DONALD R. ALEXANDER, Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 16th day of August, 1996. APPENDIX TO RECOMMENDED
Findings Of Fact The Respondent, Natalie Patton, is a licensed pharmacist and has been licensed since 1959. She is a graduate of Sanford University, Birmingham, Alabama, and was initially licensed in Alabama as a pharmacist. She has worked as a licensed pharmacist for twelve years in Highlands County in the vicinity of Sebring. She is licensed as a pharmacy consultant as well and has been employed at several hospitals and pharmacies in that geographical area. She opened her present pharmacy' business in November, 1978, in a rural area southwest of Sebring at the community of Spring Lake. Her's is the only pharmacy in seventeen miles and her business volume reflects the rural nature of her business location and clientele in that she fills an average of thirty-five to fifty prescriptions a day. On "Race Friday," the day prior to the Sports Car Race at Sebring, a man entered her pharmacy complaining of severe headache and allergy to fumes associated with the infield and pits at the racetrack. He asked for Darvon, explaining that this was the only medication successful in treating his headaches. He explained he was from another part of the State and had no way to contact his physician. She sold him a non-prescription drug. He came back the next day, the day in question, March 22, and explained that her suggestion that he go to the emergency room the day before was impractical because a newspaper ad he had seen described the emergency room as overloaded and turning patients away. He complained of a worsening headache. She testified that she felt sympathy for him and ultimately and reluctantly sold him, at her cost, four Darvon to be used that Saturday and four for that Sunday. The individual requesting the medication then revealed himself to be a Deputy Sheriff of Highlands County, who arrested her on the spot, charging her with dispensing the Darvon without a prescription in violation of the above authority. She ultimately was tried on the charges and convicted, but adjudication was withheld and she was placed on three years probation by the Circuit Judge. A second related criminal charge was ultimately dismissed. She has been under the direction of a probation officer since that time and must report all her activities and receive permission before traveling out of her county. She also has been required to pay fifty dollars a month to reimburse the public defender for his services on her behalf. She is still operating her business and her customers have professed loyalty to her and her business is still increasing in volume. She has never had any altercation with law enforcement authorities of any type in her past and has never been convicted of any felony or misdemeanor. With the agreement of counsel for the Petitioner, certain testimonial letters on her behalf from persons who were not in attendance at the hearing were admitted as composite exhibit 1. These letters attest to and establish the fact, in corroboration of her testimony, that she is a decent and useful citizen and that she was totally unaware that she was committing a felonious act. These letters corroborate her testimony and establish that she is a crucial asset to her rural community. She is depended upon by numerous citizens, many of whom are of advanced years and who require frequent medication and are unable to travel any great distance. She has obviously gone to great lengths to operate her business in a professional and compassionate manner even to the extent of delivering medications to senior citizens and others long after the closing hours of her pharmacy. These letters in support of her position also are replete with instances described where she adheres strictly to the dictates of the various physicians' prescriptions and refused on a number of occasions to prescribe medication without a prescription. There is no question that the evidence in this record establishes that the Respondent is clothed with the highest personal integrity and moral character and that the isolated incident when she dispensed medication in violation of the above authority is not characteristic of the regular and otherwise consistent manner in which she practices pharmacy and conducts her business. The Respondent's probation officer sent a letter which is incorporated in Respondent's Exhibit 1 attesting to her conscientious efforts to obey the law and her usefulness as a citizen. He expressed the belief that she was unaware that she was actually committing a crime when the subject violation occurred and that she was simply and compassionately attempting to help a customer in trouble. He is convinced that revoking her pharmacy license would serve no useful purpose and would indeed impose a hardship on the rural customers she serves. He firmly believes she would not consciously violate the law or purposefully commit an illegal act. The Respondent was authorized by the Circuit Judge in the Respondent's criminal proceeding to make the following statement on the record in this proceeding: In re Natalie Patton: In open Court, in disposing of this case, and putting Natalie Patton on probation without adjudication, I made note of the numerous letters I received from people in the community, urging the Court to be lenient. The Respondent then noted that there were a hundred and forty signatures on those testimonial letters. At the conclusion of the Respondent's case the Respondent requested that the penalty herein be limited to a letter of reprimand. The Petitioner introduced no evidence and otherwise took no position with regard to the question of an appropriate penalty.
Recommendation Having considered the foregoing findings of fact, conclusions of law, the candor and demeanor of the witness and the evidence in the record, it is RECOMMENDED: That Natalie N. Patton and Spring Lake Pharmacy remain licensed and that Natalie Patton be accorded a written reprimand by the Board regarding the subject violation and that she be placed on probation by the Board for a period of time coextensive with the probation imposed in the criminal proceeding related hereto during which time her conduct of the practice of pharmacy be subjected to periodic monitoring by the Board. DONE AND ENTERED this 2nd day of November, 1981, in Tallahassee, Florida. COPIES FURNISHED: William M. Furlow, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Michael J. Trombley, Esquire 329 South Commerce Avenue Sebring, Florida 33870 P. MICHAEL RUFF, 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 4th day of November, 1981.
The Issue At issue in this proceeding is whether Respondent committed the offenses set forth in the Administrative Complaint1 and, if so, what penalty should be imposed.
Findings Of Fact Respondent's licensure and employment Respondent, Nury D. Soler, is now, and was at all times material hereto, licensed as a pharmacist by the State of Florida, having been issued license number PS 0014628. Pertinent to this case, Respondent was the prescription department manager for Westchester Pharmacy for a two-month period extending from some time in October 1996 and at least through December 13, 1996. Westchester Pharmacy is a community pharmacy licensed by Petitioner, pursuant to Section 465.018, Florida Statutes, and located at 7253 Southwest 24th Street, Miami, Florida. The pharmacy owner or permittee was Noriel Batista. The pharmacy inspection On December 14, 1996, a Saturday, Richard Castillo, an investigator employed by the State of Florida, entered the Westchester Pharmacy to conduct a routine community pharmacy inspection. Upon entry, Mr. Castillo observed only one person in the pharmacy, a man later identified as the permittee (Mr. Batista). At the time, Mr. Batista was observed in the vicinity of the prescription area, at the rear of the store. Mr. Castillo proceeded to the counter at the rear of the store, and was approached by Mr. Batista. Thereupon, Mr. Castillo feigned a toothache, and the following events transpired: . . . I put my hands on my face and I said I have some tooth pain, is there anything you can do about it. At which time, he said you really need to go see a dentist. I said that dentists cost a lot of money and that I believed that it was an infection. At which time he came back with a bottle of twenty Amoxicillin, 500 milligram capsules. He sold me the bottle for $10.00 and I gave him the $10.00. He then gave me some preliminary instructions, and went back into the prescription department area. He returned and said that as a gift I'm going to give you these medications; which was four capsules of Motrin 800 milligrams. Amoxicillin is a prescription drug, which Mr. Batista, who was not licensed as a pharmacist, sold without benefit of a prescription. Following the sale, Mr. Castillo identified himself as an investigator, told Mr. Batista he was present to conduct a routine inspection, and asked to speak with the pharmacist. When told the pharmacist was not available, Mr. Castillo asked Mr. Batista to telephone her and ask her to come to the store. Mr. Batista did so, and about an hour later Respondent arrived. Mr. Castillo inspected the pharmacy and completed a community pharmacy inspection report on which he noted a number of perceived deficiencies. (Petitioner's Exhibit 2). First, with regard to Mr. Batista's sale of amoxicillin, Mr. Castillo noted three deficiencies or violations against the pharmacy business, to-wit: (1) there was no pharmacist on duty when the prescription department was open (a perceived violation of Rule 64B16-28.109, Florida Administrative Code); (2) there was no pharmacist present to provide patient counseling, if requested (a perceived violation of Rule 64B16-27.820, Florida Administrative Code); and, (3) since Mr. Batista did not document the sale, Mr. Castillo considered the pharmacy records of dispensing to be incomplete (a perceived violation of Rule 64B16-28.140(3)(b), Florida Administrative Code). Other deficiencies noted by Mr. Castillo against the pharmacy business were as follows: (1) there was no sign displayed that the pharmacy was closed (a perceived violation of Rule 64B16-28.109(1), Florida Administrative Code); (2) the pharmacist's (Ms. Soler's) license was not displayed (a perceived violation of Rule 64B16-27.100(1), Florida Administrative Code); and, (3) there was no sign displayed which stated the hours the prescription department was open each day (a perceived violation of Rule 64B16-28.404, Florida Administrative Code). No further deficiencies were observed and, apart from those noted deficiencies, the prescription department appeared appropriately maintained and operated. Following Respondent's arrival at the pharmacy, Mr. Castillo discussed with her the various deficiencies he had found and had noted on his report. Then, as the "Pharmacist," Respondent signed the report. By signing the report, she acknowledged that "I have read and have had this inspection report and the laws and regulations concerned herein explained, and do affirm that the information given herein is true and correct to the best of my knowledge." Among the information provided on the inspection report was the name of the prescription department manager, which was stated to be the Respondent. Respondent's employment status with Westchester Pharmacy on the date of the inspection Notwithstanding her appearance at Westchester Pharmacy on Saturday, December 14, 1996, and her signing of the inspection report as the Pharmacist for Westchester Pharmacy, Respondent averred, at hearing, that by December 14, 1996, she was no longer affiliated with the pharmacy or responsible for the deficiencies noted. According to Respondent, by December 12, 1996, she had agreed with another pharmacy, Coral Way Pharmacy, Inc., (Coral Way Pharmacy) to serve as its pharmacist effective December 16, 1996, at its pharmacy located at 6965 Southwest 24th Street, Miami, Florida, and that her last date of employment with Westchester Pharmacy was December 13, 1996. While perhaps not entirely free from doubt (given the facial inconsistency between Respondent's contention at hearing and the conclusion one could reasonably draw regarding her association with Westchester Pharmacy, as evidenced by her activities on the date of inspection), the proof demonstrates, more likely than not, that, as Respondent averred, she was no longer employed by Westchester Pharmacy on the day of inspection, her presence on the day of inspection was a matter of accommodation to Mr. Batista, and her signing of the report was a matter of misunderstanding. In so concluding, it is observed that, while the pharmacy was open Monday through Saturday, the prescription department was not open on Saturday, or, stated differently, under the terms of Respondent's employment with Weschester Pharmacy she did not work week-ends. Given that Respondent and Coral Way Pharmacy, reached an agreement on December 12, 1996, for her to begin work at Coral Way Pharmacy on December 16, 1996, it is reasonable to conclude, given the nature of her work-week at Westchester Pharmacy, that her last day of employment with Westchester Pharmacy was Friday, December 13, 1996. Moreover, consistent with the conclusion that Respondent's association with Weschester Pharmacy terminated on December 13, 1996, is the absence of Respondent's wall certificate and license on the date of inspection. Notably, Respondent had not suffered prior disciplinary action in 19 years of practice, and presumably knew that, if employed, she was required to display her wall certificate and license in or near the prescription department. Conversely, she also knew, presumably, that she could not lawfully display them, if she was no longer employed by Westchester Pharmacy. Rule 64B16-27.100, Florida Administrative Code. Since it is presumed that persons will observe the law, the absence of Respondent's wall certificate and license on the date of inspection is consistent with her assertion that, by that date, she was no longer employed by Westchester Pharmacy. Atlantic Coast Line R. Co. v. Mach, 57 So. 2d 447 (Fla. 1952). Finally, also consistent with the conclusion that Respondent's employment with Westchester Pharmacy terminated before the date of the inspection is a statement Respondent made to the inspector. According to the investigator, when asked about the infractions, Respondent stated the following: . . . She said that things needed to change. She asked if she were to leave the pharmacy whether that would change anything, and I said, no, it doesn't matter because you're the pharmacist of record at this point of time. Such statement, when considered in context with other proof of record, discussed supra, is consistent with Respondent having resolved, previously, to terminate her employment with Weschester Pharmacy and, since she did not specifically tell the investigator of her decision, his response evidenced a misunderstanding that resulted in Respondent's execution of the report.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a Final Order be entered dismissing the Administrative Complaint. DONE AND ENTERED this 25th day of August, 1998, in Tallahassee, Leon County, Florida. WILLIAM J. KENDRICK Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 Filed with the Clerk of the Division of Administrative Hearings this 25th day of August, 1998.
The Issue At issue is whether Respondent committed the offenses set forth in the Administrative Complaint and, if so, what penalty should be imposed.
Findings Of Fact Respondent's license and employment Respondent, Patrick O. Ojo, is now, and was at all times material hereto, licensed as a pharmacist by the State of Florida, having been issued license number PS 0032023. At all times pertinent hereto, Respondent was under contract with Healthcare Consultants of Central Florida, Inc., d/b/a Healthcare Consultants Pharmacy Staffing (Healthcare Consultants) , a corporation engaged in "the business of placing licensed pharmacists on a temporary and permanent basis" with businesses in need of their services. Pursuant to the agreement, Healthcare Consultants would "from time to time during the term of . . . [the] agreement offer [the] pharmacist the right to perform pharmaceutical services at the location of various clients, " which the pharmacist had the option to accept or reject. If accepted, for temporary services provided under the agreement, Healthcare Consultants would pay the pharmacist $25.50 per hour, except for legal holidays when the rate would be $41.25 per hour. Pursuant to a referral from Healthcare Consultants, Respondent accepted a position, on a temporary basis, as pharmacy manager for A & N Discount Pharmacy on June 2, 1997. A & N Discount Pharmacy is a community pharmacy licensed by Petitioner pursuant to Section 465.018, Florida Statutes, and located at 900 Alton Road, Miami Beach, Florida. The pharmacy inspection On June 24, 1997, Harold Gluck, a senior pharmacist employed by the Agency for Health Care Administration (AHCA), entered A & N Discount Pharmacy to conduct a routine community pharmacy inspection. Pertinent to this case, that inspection noted three deficiencies or violations against the pharmacy business, to wit: (1) there was a 2:1 technician to pharmacist ratio, without prior approval of the Board of Pharmacy (a perceived violation of Rule 64B16-27.410, Florida Administrative Code); (2) the two technicians were not wearing identification badges ( a perceived violation of Rule 64B16-27.410, Florida Administrative Code); and (3) the prescription department was only open 24 hours per week, as opposed to 40 hours per week (a perceived violation of Rule 64B16-28.404, Florida Administrative Code). Mr. Gluck's visual observations are supported by compelling proof, and are credited.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered which dismisses Counts I and IV of the Administrative Complaint; finds Respondent guilty of violating Section 465.016(1)(n), Florida Statutes, by failing to comply with Rule 64B16-27.410, Florida Administrative Code, as alleged in Counts II and III of the Administrative Complaint; and, which imposes, as a penalty for such violations, the issuance of a letter of guidance. DONE AND ENTERED this 15th day of September, 1998, in Tallahassee, Leon County, Florida. WILLIAM J. KENDRICK Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 Filed with the Clerk of the Division of Administrative Hearings this 15th day of September, 1998.
The Issue The issue is whether the pharmacy permit issued to the Respondent, North Florida Drug Corporation, d/b/a Scottie Discount Drugs, should be revoked or otherwise penalized based on the acts alleged in the Administrative Complaint.
Findings Of Fact North Florida Drug Corporation, d/b/a Scottie Discount Drugs, currently holds permit No. PH 0004096 as a Community Pharmacy. Respondent is located at 1448 Bakers Square, Macclenny, Florida. On December 24, 1987, Gustave Goldstein, who had been the designated prescription department manager for Respondent, resigned as a pharmacist at the Respondent's location. He notified Frankie Rosier, the owner and operator of the Respondent, that he was leaving and he notified the DPR that he would no longer be the designated prescription department manager. Carl Messina is the relief pharmacist for the Respondent. From the time of Goldstein's resignation, Messina has told Ms. Rosier many times that it is illegal to operate without a prescription department manager. DPR inspected the Respondent's pharmacy in December, 1987, and determined that there was no prescription department manager after Goldstein quit. DPR conducted an inspection of the Respondent's premises on February 16, 1988, and discovered that there still was no prescription department manager employed there. Frankie Rosier was made aware of this deficiency. On February 16, 1988, the official records of DPR showed that no new designation of a prescription department manager had been filed by Respondent and Goldstein was still listed as the prescription department manager by Respondent. On May 22, 1988, DPR again inspected the premises and determined that there was still no prescription department manager. It is important that each permittee have a designated prescription department manager to assure that all required records are kept and that the pharmacy complies with all legal requirements. This is especially important regarding control and accountability for controlled substances. Without a prescription department manager, a non-pharmacist owner, like Ms. Rosier, would and does have access to these controlled substances without any accountability. By Final Order entered and filed with the agency clerk on December 17, 1987, this same permittee was fined and placed on probation for operating a community pharmacy with an expired permit and for obtaining a permit by misrepresentation or fraud or through an error of the department or the board.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Department of Professional Regulation, Board of Pharmacy, enter a Final Order finding North Florida Drug Corporation, d/b/a Soottie Discount Drugs, guilty of the violations alleged and revoking the community pharmacy permit No. PH 0004096. DONE and ENTERED this 14th day of October, 1988, in Tallahassee, Florida. DIANE K. KIESLING Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 14th day of October, 1988. COPIES FURNISHED: Michael A. Mone' Staff Attorney Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 North Florida Drug Corporation Scottie Discount Drugs 1448 Bakers Square Macclenny, Florida 32063 Bruce Lamb General Counsel Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 Rod Presnell, Executive Director Board of Pharmacy Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750
