The Issue The issues to be determined here concern disciplinary action to be taken against Respondent for those administrative offenses pertaining to the controlled substances Talwin, Dilaudid and Paregoric dispensed by Scottie Drug Store in Duval County, Florida, during the period April 2, 1981, to March 23, 1982, in violation of various provisions of Chapter 465, Florida Statutes. These contentions made by the State of Florida, Department of Professional Regulation, are more particularly described in the Administrative Complaint, DPR Case No. 0022147.
Findings Of Fact Howard E. Staats is a pharmacist who has been issued a license by the State of Florida, Department of Professional Regulation, Board of Pharmacy. The license number is 0007704. At times relevant to this proceeding, Staats practiced pharmacy in Jacksonville, Florida. At all times pertinent to the Administrative Complaint, which is the focus of this action, Staats was the managing pharmacist at American Apothecaries, Inc., which does business as Scottie Drug Store at 41 Arlington Road South, Jacksonville, Florida. A copy of Respondent's most recent license may be found as Petitioner's Exhibit No. 1, admitted into evidence. Petitioner's Exhibit No. 2, admitted into evidence, is a copy of the permit for American Apothecaries. Sometime within the period March 23, 1982, through March 29, 1982, an audit was conducted at the Scottie Drug Store. The audit revealed that in the period April 2, 1981, through March 23, 1982, the drug store had purchased 66,900 tablets of Talwin, 50 mg., had sold 29,373 tablets of that drug, had lost by robbery or theft, 1,000 tablets of the drug, leaving 36,527 tablets of Talwin unaccounted for. During that same audit period, the pharmacy purchased 4,000 tablets of Dilaudid, 4 mg., selling 3,025 tablets of that drug, losing by robbery or theft, 200 tablets of the drug and failing to account for 775 tablets of the drug. Finally, during the audit period, 2,064 ounces of Paregoric had been purchased and 699 ounces sold, with the remaining amount of 1,285 ounces being unaccounted for. See Petitioner's Exhibit No. 4. Talwin is a Schedule IV controlled substance within the meaning of Chapter 893, Florida Statutes. Dilaudid is a Schedule II controlled substance within the meaning of Chapter 893, Florida Statutes. Paregoric is a Schedule III controlled substance within the meaning of Chapter 893, Florida Statutes. The audit which was conducted at the Scottie Drug Store revealed numerous prescriptions for the controlled substance Talwin, 50 mg., written on prescription blanks of Drs. W. W. Shell, Jr., and L. T. McCarthy, Jr., which had allegedly been signed by those physicians, when in fact the patients for whom the prescriptions were written were unknown to the physicians and the signatures of the physicians were forgeries. Those prescriptions are depicted in Petitioner's Exhibit No. 5, admitted into evidence. During the period covered by the audit, it was shown that Staats filled a number of prescriptions for various patients for the controlled substance Talwin, which had been written on prescription pads of Methodist Hospital and Baptist Medical Center in Jacksonville, Florida, and signed by individuals who are not physicians having hospital privileges at those medical centers nor practicing as physicians in the Duval County area. Copies of those prescriptions may be found as Petitioner's Exhibit No. 6, admitted into evidence. In the course of the time sequence related to the audit review process, it was discovered that Staats had refilled numerous prescriptions for controlled substances on more occasions than had been authorized by physicians, namely prescription No. 51632 was refilled twice although the physician indicated there were to be no refills; prescription No. 51579 was refilled once although the prescription indicated there should be no refills; prescription No. 51639 was refilled twice although the prescription indicated there should be no refills; prescription No. 51217 was refilled once although the prescription indicated there should be no refills; prescription No. 51238 was refilled once although the prescription indicated that there should be no refills; prescription No. 53010 was refilled once although the prescription indicated that there should be no refills; prescription No. 53597 was refilled four (4) times although the prescription indicated that it should only be refilled once; prescription No. 53537 was refilled once although the prescription indicated that it should not be refilled; and prescription No. 53592 was refilled twice although the prescription indicated that there should be no refills. Petitioner's Exhibit No. 7, admitted into evidence, is copies of prescriptions spoken to in this paragraph. Respondent Staats had operated the Scottie store under a lease arrangement during 1979 and 1980, and in January of 1981, took a position as an active pharmacist in that store. After becoming the principal operating pharmacist in the Scottie store, Staats began to receive prescriptions from doctors Shell and McCarthy for the substance Talwin and when a prescription purportedly written by those physicians was in question, Staats would call the office of the physicians for confirmation, which at times would be given over the phone and at other times an indication was made that a call back from the physician's office to Staats would be necessary. Some of the indications of physicians' prescription authority of the substances in question would be placed on a separate log and not on the back of the prescription and on other occasions, the note of the prescription information would be placed on the back of the prescription form and not in the log. Normally, this information would be reflected both in the log and on the back of the prescription. There were occasional circumstances in which the authority was not stated in either place. At approximately the same time as was covered by the audit, Staats began to ask for identification from customers who were seeking prescriptions for Talwin and noted that the demand for that substance declined with the advent of the request for identification. Staats posted a notice in the window of the pharmacy to the effect that state law imposed a fine of $5,000.00 or might cause incarceration for five (5) years for presenting forged prescriptions or conspiring or agreeing with another to have a forged prescription filled. On two (2) occasions Staats called law enforcement officials on a circumstance involving suspect prescriptions and those persons were apprehended. (Poor record keeping and mistakes in estimating the amount of losses due to a robbery and a larceny which occurred in the period covered by the audit contributed to the unaccounted for controlled substances, but those matters of record keeping and theft reports would cause only a slight differential in the disparity, as opposed to explaining the whereabouts of a substantial portion of the missing controlled substances.) Beginning on March 25, 1982, Staats began to keep a daily inventory log on the substance Talwin and a number of other controlled substances. A copy of that log may be found as Respondent's Exhibit No. 9, admitted into evidence. In addition, certain out-of-date and otherwise undesirable controlled substances, Schedules II, III and IV, have been removed from inventory and turned over to appropriate authorities for destruction.
The Issue The issues are whether Respondent failed to maintain an accurate medication record relating to narcotic medications in violation of Section 400.419(1)(b), Florida Statutes, and Rule 58A-5.0185(3)(b), Florida Administrative Code; and if so, what penalty should be imposed.
Findings Of Fact Petitioner has authority to license assisted living facilities (ALFs) and the duty to enforce all statutes and rules governing such facilities. Respondent is a licensed ALF with a total capacity for 35 residents. Respondent's License No. AL5888 is effective March 20, 2002, through March 19, 2004. On January 31, 2002, Petitioner completed a biennial survey of Respondent's facility. During the survey, Petitioner's staff observed Respondent's staff administering medication to six residents who needed medication assistance. Resident No. 6 received a narcotic medication, in tablet form, that she was supposed to take by mouth three times daily, as needed, for pain. The medication is addictive and may be obtained only by prescription. The prescription bottle at issue here indicated that it was filled on January 21, 2002, with 100 tablets. There is no other evidence regarding the number of tablets in the bottle when it arrived at Respondent's facility. Respondent did not count the tablets in the bottle upon receiving it from the pharmacy. Resident 6's MOR showed that she received the narcotic tablet three times daily, everyday, with no missed doses during the time period at issue here. According to the MOR, Resident 6 received a total of 32 doses of the medication beginning January 21, 2002, at 7:00 a.m. through January 31, 2002, at 12:25 p.m. However, the bottle contained only 54 tablets as of January 31, 2002, at 12.25 p.m. Respondent's staff could not explain or account for the 14 missing narcotic tablets. Under cover of a letter dated February 12, 2002, Petitioner advised Respondent that the biennial survey had identified a Class II deficiency relative to Resident 6's medication administration. The letter requested Respondent to file a plan of correction within ten days. Resident 6's narcotic medication was refilled on February 19, 2002, with 100 tablets. As of March 8, 2002, Resident 6 had 51 pills remaining in the new prescription bottle. On March 8, 2002, Petitioner's staff conducted a follow-up visit to Respondent's facility. The count of tablets in Resident 6's narcotic medication prescription bottle, when compared to the MOR, was correct at that time. Under cover of a letter dated March 15, 2002, Petitioner advised Respondent that the previously cited deficiency had been corrected.
Recommendation Based on the foregoing Findings of Facts and Conclusions of Law, it is RECOMMENDED: That Petitioner enter a final order dismissing the Administrative Complaint. DONE AND ENTERED this 10th day of October, 2002, 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 10th day of October, 2002. COPIES FURNISHED: Michael O. Mathis, Esquire Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building Three, Suite 3431 Tallahassee, Florida 32308-5403 Alvin L. Peters, Esquire 25 East Eighth Street Panama City, Florida 32401 Lealand McCharen, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive, Mail Stop 3 Tallahassee, Florida 32308 Valda Clark Christian, General Counsel Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building, Suite 3431 Tallahassee, Florida 32308
Findings Of Fact The Respondent Herman Ginsberg is a licensed pharmacist having been issued license number 0008019. The last known address of the Respondent is 775 Northeast 164th Street, North Miami Beach, Florida 33162. At all times material to this proceeding, the Respondent was the managing pharmacist at Jaffe Pharmacy, also known as Jaffe Discount Drugs, located at 737 Northeast 167th Street, North Miami Beach, Florida 33162. On or about November 26, 1980, the Respondent Ginsberg directed a clerk at the pharmacy, Lorraine Gronfine to remove nine (9) prescriptions from the class II prescription records and place them under a desk blotter. The scripts were pulled by Ms. Gronfine prior to a drug inspection by the authorities. According to the Respondent Ginsberg, he was ordered by the manager of the pharmacy, Ed Terry, to pull the prescriptions in order to inflate an insurance claim resulting from a burglary which occurred in September 1980. The Respondent complied with Mr. Terry's request and reported that drugs were stolen which were not in fact stolen in order to inflate an insurance claim to approximately $7,000. The prescriptions were discovered under the blotter by Irving Losee, another pharmacist employed by Jaffe, who turned them over to Graymark Security. Graymark personnel questioned both the Respondent and Ms. Gronfine about the prescriptions and both gave statements to Graymark concerning how the prescriptions came to be placed under the blotter. Many, although not all, of the prescriptions found by Losee were altered. No testimony expert or otherwise was introduced to prove that the Respondent altered the prescriptions in question. As noted by counsel for Respondent, no direct evidence was introduced to rebut the Respondent's sworn denial that he personally altered the prescriptions. In the normal course of business at Jaffee Pharmacy, a patient log was kept for all prescriptions filled on a daily basis. It is undisputed by the parties that the patient log, which was kept by the Respondent, was not altered and reflected the actual number of pills dispensed by the pharmacy. In order to divert classified drugs for personal profit, it is logical to assume that the Respondent would have altered the patient logs along with the prescriptions to consistently cover the amount of classified drugs ordered from pharmaceutical companies and placed on record with the Drug Enforcement Administration. Indeed, the failure to alter the daily patient logs to be consistent with the altered prescriptions was one of the ways that the problem with the altered prescriptions was uncovered. Although Mr. Terry examined the patient logs nightly to grade his employees on their sales of drugs, this would not have necessarily stopped the logs from being changed to conform to the altered prescriptions. The Respondent or anyone with access to the patient logs, could have altered the logs after the nightly review and conform the logs and prescriptions without arousing undue suspicion. No testimony was presented concerning this point other than that the logs did not go to accounting and were presented to Mr. Terry for his review. If Mr. Terry kept the logs and the Respondent had no further access to them, the Petitioner's theory concerning the alterations would be more plausible; however, the record failed to show that the Respondent lacked the ability to alter the logs subsequent to Mr. Terry's review. Each prescription placed into evidence and filled by the Respondent is marked as being "verified by the issuing physician." The Respondent has admitted that some of these prescriptions were not verified and that the certifications were erroneous. The Respondent admitted that a person named Fred Sessler, who was associated with a stress or obesity clinic, was permitted to pick up controlled drugs for the clinic without a prescription. Mr. Sessler was apparently permitted this privilege because the Respondent knew that one of the clinic physicians would eventually furnish a prescription. Additionally, the Respondent has admitted that in connection with the Sessler transactions, he failed to immediately record all the information required in order to dispense oral prescriptions and failed to notify the Drug Enforcement Administration that he was emergency dispensing via telephone. While acting as managing pharmacist at Jaffee, the Respondent ordered and distributed excessive quantities of a Schedule II drug. (See Petitioner's Exhibit 26 and Respondent's Exhibit 1.)
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED: That the license of the Respondent Herman Ginsberg be suspended for two (2) years and that he be placed on probation for three (3) years thereafter, subject to attending appropriate continuing education classes and working under the direct supervision of a pharmacist approved by the Board. DONE and ENTERED this 27th day of January, 1983, in Tallahassee, Florida. SHARYN L. SMITH Hearing Officer Division of Administrative Hearings Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 904/488-9675 Filed with the Clerk of the Division of Administrative Hearings this 27th day of January, 1983.
Findings Of Fact The Home is licensed as an assisted living facility. It is also licensed to provide extended congregate care, limited nursing services, and limited mental health services. The Home accepted Respondent as a resident. In July 1998, Petitioner had to transport Respondent to the hospital due to an overdose of medication. Upon his return from the hospital, Respondent told Petitioner's staff that he had taken the overdose intentionally. Thereafter, the Home required Respondent to sign a mental health contract dated September 9, 1998. This contract states as follows in relevant part: Qualifications for the Home requires [sic] that a member or applicant must not be mentally ill, habitually inebriated, or addicted to the use of a controlled substance. With these requirements, I understand that to be eligible and maintain my membership in the Home, I must agree to the terms of this contract. * * * If I use alcohol or any non-prescribed drugs I understand I may be dismissed from the Home. I understand that I will allow the Veterans' Domiciliary Home of Florida to supervise the self-administering of my medications. I will take my medication as it is prescribed by the primary physician. I will only be given my full prescription at the time of my discharge. I understand upon reasonable suspicion of being under the influence of alcohol or illegal drugs, I consent to testing. The Domiciliary Home staff may take a blood, saliva, or supervised urine sample to test for illegal drugs or alcohol. I authorize members of the Domiciliary staff to perform random searches of my person, vehicle, living quarters, or belongings to determine if I am using drugs or alcohol. If I refuse to allow a blood, saliva, or urine test, or search, or if I interfere in any way with the staff's performance of these duties, I may be dismissed. The Home also required Respondent to sign a Dual Diagnosis/Substance Abuse/Psychiatric (dual diagnosis) contract dated September 14, 1998. In addition to terms and conditions similar to the ones set forth above, the dual diagnosis contract provides as follows in relevant part: 10. In order to assist me in gaining freedom from alcohol and drugs, I will not use alcohol, tranquilizers, sleeping medication, over the counter medications, or any other chemical escapes which have not been prescribed by a physician. If I use alcohol or non-prescribed drugs, I understand I will be dismissed from the Home. In November 1998, one of Respondent's doctors wrote him a prescription for Ritalin. Respondent became very upset when a nurse would not administer the Ritalin to him without first checking with Petitioner's staff physician. Eventually, Respondent's primary care physician approved the administration of Ritalin together with Respondent's other medications. In January 1999, Respondent worked for Petitioner as a receptionist. After working overtime on one occasion, Respondent's speech was slurred, his eyes were dull, and his voice was horse. Petitioner's staff became suspicious that Respondent was taking medication in violation of his contracts. Respondent subsequently tested negatively for all substances except his prescribed medicines. In March 1999, Respondent violated his contracts by having a prescription for methadone filled at a drugstore and removing twenty-four of the pills from the bottle before turning the medicine over to Petitioner's staff as required by his contract. Petitioner's staff advised Respondent that he would be dismissed from the Home by letter dated March 23, 1999. Respondent subsequently requested Petitioner's Executive Director to review the decision to discharge him from the Home. By letter dated August 16, 1999, Petitioner rescinded its decision to dismiss Respondent from the Home but warned him that any further infraction would result in his immediate expulsion. On April 14, 2000, Petitioner conducted a routine facility-wide room inspection at the Home. During the course of the inspection, Petitioner found a bottle of Ephedra 250 in Respondent's room. According to the label on the bottle, Ephedra 250 is a dietary supplement that General Nutrition Corporation (GNC) markets. During the hearing, Respondent admitted that he heard about Ephedra 250 on a television show that discussed its benefits as a diet aid as well as its dangerous side effects. The label states as follows in pertinent part: WARNING: Seek advice from a health care practitioner prior to use if you are pregnant or nursing, or if you have high blood pressure, heart or thyroid disease, diabetes, difficulty in urination due to prostate enlargement, or if taking MAO inhibitor or any other prescription drug. Reduce or discontinue use if nervousness, tremor, sleeplessness, loss of appetite or nausea occur. Not intended for use by person under the age of 18. The maximum recommended dosage of Ephedrine for a healthy adult is no more than 100 mg in a 24 hour period for not more than 12 weeks. Improper use of this product may be hazardous to a person's health. Each capsule of Ephedra 250 contains 250 mg of MA Huang Extract (Ephedra sinica) or ( 15 mg of 6 percent Ephedrine). The greater weight of the evidence indicates that Ephedra 250 is an over-the-counter medication despite being labeled as a diet supplement. Ephedrine is a prescription drug in Florida unless an individual dose is less than a specified quantity. Petitioner's staff properly became concerned about Respondent's possession of Ephedra 250 because he takes numerous prescribed medications, which can have serious side effects, if taken with certain other medications. Ephedrine is one of those drugs. For instance, Respondent takes Cozaar for high blood pressure, Methadose to reduce his dependency on Percoset, and Ritalin. Persuasive evidence indicates that large doses of Ephedra can be used as a recreational drug. Respondent knew or should have known that Ephedra 250 was prohibited by his contracts with the Home.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED: That Petitioner enter a final order dismissing Respondent as a resident of the Robert H. Jenkins Veterans' Domiciliary Home of Florida. DONE AND ENTERED this 6th day of October, 2000, 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 6th day of October, 2000. COPIES FURNISHED: James W. Sloan, Esquire Department of Veterans' Affairs Post Office Box 21003 St. Petersburg, Florida 33731-8903 William T. Fisher 1300 Sycamore Lane, Suite 148 Lake City, Florida 32025 Lt. Col. Robin L. Higgins, Executive Director Department of Veterans' Affairs Post Office Box 31003 St. Petersburg, Florida 33731-8903
The Issue The issues to be resolved in this proceeding concern whether the Respondent properly maintained and supplied required records to support and document prescription claims, which it billed to Medicaid and for which it received payment from the Medicaid program during the audit period of April 1, 2000 through December 31, 2001. If that is not the case, it must be determined whether the Agency is entitled to recoup from the Respondent the sum it seeks of $108,478.77, as the purported amount overpaid to the Respondent by the Agency. It must also be determined whether the applicable laws and regulations referenced herein were complied with by the Respondent, in terms of its accepting and filling prescriptions, dispensing relevant drugs, and recording and documenting such activities in its pharmacy records. Finally, it must be determined whether the statistical methodologies employed by the Agency, through its audit and investigation of the Respondent, were sufficiently representative and accurate so as to support the calculation of estimated overpayments.
Findings Of Fact The Petitioner is an Agency of the State of Florida charged by the statutes and rules referenced herein with ensuring that proper reimbursement is effected to providers, including pharmacies, by the Medicaid system. Because of its duty to enforce and regulate the Medicaid system, the Petitioner Agency has an audit and oversight function, as well as an enforcement function, to ensure that Medicaid payments and the general operations of the Medicaid system are carried out correctly. It is through this duty imposed by the cited Florida Statutes and rules, as well as the federal regulations it is charged with enforcing, that the Petitioner carried out an audit of the Respondent, Brown Pharmacy, concerning the audit period of April 1, 2000 through December 31, 2001. The Petitioner conducts audits of providers such as Brown in order to ensure compliance with the Medicaid provisions and Medicaid provider agreements. These are called "integrity audits" and are routinely performed by auditors contracted from private firms such as Heritage. Brown Pharmacy (Brown) is licensed in the State of Florida as a pharmacy (license Number PH562). Brown maintained a business location at 312 West 8th Street, Jacksonville, Florida 32206, at times pertinent to this case. During the audit period Brown was an enrolled Medicaid provider authorized to provide Medicaid prescriptions pursuant to a provider agreement with the Agency. The terms of the provider agreement governed the contractual relationship between Brown and the Agency. Pursuant to that provider agreement, Brown was to maintain the Medicaid-related records and documentation for at least five years. Any Medicaid provider, such as Brown, not in compliance with the Medicaid documentation and record retention policies may be subject to the recoupment of Medicaid payments. During the audit period, Brown dispensed prescription drugs to Medicaid recipients. Medicaid claims were filed and paid electronically as "point of sale" transactions during the audit period. Each claim reviewed and at issue in this case was a paid Medicaid claim subject to the provider agreement and pertinent regulations. As a condition of participating in the Medicaid program, a Medicaid provider must comply with all provisions of a provider agreement, which is a voluntarily agreement between the Agency and the provider. Those provisions include the provider's agreement to comply with all relevant local, state and federal laws, rules, regulations, licensure laws, bulletins, manuals, and handbooks, etc. The provider must agree to keep and maintain, in a systematic and orderly manner, all Medicaid- related records as may be required by the Agency and make them available for state and federal agencies and review. It must maintain complete and accurate medical, business, and fiscal records that will justify and disclose the extent of goods and services rendered to customers or patients and rendered as billings to the Medicaid system. Florida Administrative Code Rule 59G-4.250 promulgates, as part of the rule, the above-referenced handbook (handbook) which sets out Medicaid polices and rules. The polices and rules govern the rights and responsibilities of drug providers, such as Brown, including coverage and payment methodologies for services and goods rendered to Medicaid recipients and billed to the Medicaid program. The types of records that must be maintained are as follows: Medicaid claim forms, professional records such as patient treatment plans, prior and post authorization information, prescription records, business records, including accounting ledgers, financial statements, purchase and acquisition records etc., tax records, patient counseling information and provider enrollment documentation. Providers who are not in compliance with the Medicaid documentation and record retention policies described in the handbook are subject to administrative sanctions and/or recoupment of Medicaid payments. Medicaid payments for services that lack required documentation and/or appropriate signatures will be recouped. Chapter five of the handbook, in defining overpayment provides that any amount not authorized to be paid by the Medicaid program, whether paid as a result of inaccurate or improper cost reporting, improper claims, unacceptable practices, fraud, abuse or mistake, constitutes overpayment. Incomplete records are records that lack documentation that all requirements or conditions for the providing of services have been met. Medicaid may recoup payments for services or goods when the provider has incomplete records or cannot locate the records. The Agency contracted with Heritage to conduct an on- site audit at Brown. The audit was conducted March 18th through March 20, 2002. Heritage isolated a sample of 205 prescription claims, known as the "judgmental sample" out of a total universe of paid pharmacy claims from Brown totaling 16,727 for the audit period. Heritage also selected 250 random prescription claims out of the remaining total universe of paid pharmacy claims of 16,522, which remained after the 205 judgmental sample claims had been removed or isolated from the remainder of the total claims. With the acquiescence of the Agency, Heritage chose the 205 claims by weighing it in favor of the "high dollar" or more expensive drug prescriptions. Those prescriptions are primarily for HIV and Aids therapy drugs and psychotherapeutic drugs for various mental conditions, including schizophrenia. Weighing of the judgmental sample strongly in favor of the high dollar prescription claims would seem to render the judgmental sample fundamentally unfair against Brown if the judgmental sample had then been extrapolated to the entire universe of claims ($16,727). This was not done, however. The judgmental sample was audited and compiled by doing an actual count and totaling of claim amounts in dollars represented by all the discrepant prescriptions, including all those the Agency and Heritage maintained resulted in "overpayments" to Brown. Therefore, the judgmental sample is an actual number rather than an extrapolated calculation so that weighing the sample in favor of the high dollar prescriptions does not result in an unfair or biased sample, as to the judgmental sample. Because the judgmental sample was drawn from the total pool of audited claims and removed from that claim pool prior to the identification and drawing of the random sample, the two are mutually exclusive and the amounts calculated do not represent a duplication or overlap. Thus the findings from the judgmental sample and then the random sample may be properly added together. The randomly selected claims (random sample) were taken of the remaining 16,522 claims in the audit claim pool after the judgmental sample of 205 claims had been removed. According to the report rendered by Heritage, the 250 randomly selected claims totaled $10,632.59 in paid Medicaid dollars. The Heritage auditors determined that there were 56 discrepant claims out of these which totaled, according to their calculation, $2,450.13 in apparent overpayments. This resulted in an average overcharge per claim of $9.80 (determined by dividing the documented "sanction amount" by the total number of claims in the random sample (250), multiplied by the universe of claims from which the random sample was taken (16,522) which yielded an extrapolated overcharge of $161,924.19. Applying the statistically appropriate 95 percent "one-sided" lower confidence limit of this extrapolation resulted in a purported overpayment extrapolated from the randomly selected claims of $102,700.85. This means that the overpayment amount calculated by Heritage represents an amount statistically 95 percent certain to be the lowest amount overpayment based on the extrapolation of the overpayment represented in the 250 randomly selected claims. The non-extrapolated judgmental findings showed, according to Heritage, that there were 72 discrepant claims. Heritage then determined that, of these, there were $29,381.09 in apparent actual overcharges. The discrepancies determined by Heritage involved the failure to produce documentation of refill authorizations for 80 prescription claims; 31 prescription claims containing an incorrect Medicaid provider number; the failure to produce 12 "hard copy" prescriptions representing 25 claims; four claims that did not have the prescriber's DEA number on the prescription for controlled substances; three claims for prescriptions that did not contain the original date of service; two claims that were billed for quantities greater than that authorized by the physician; one claim that was billed for an incorrect day's supply; one claim that was billed in excess of the maximum allowable quantity of prescription of the drug, set by Medicaid policy; and one prescription claim that was billed for an incorrect prescriber's Medicaid provider number (although this should not be a discrepancy because the correct prescriber was documented in the pharmacy's computer, which the regulations allowed). Additionally, there was one claim billed for a drug different than that prescribed by the physician, according to Heritage in its report. Heritage also conducted an invoice review using utilization reports provided by the Respondent. This was apparently a review of 25 different drugs that purportedly showed that the prorated purchases of those drugs were insufficient to cover the number of units billed to Medicaid for all 25 drugs reviewed, and thus yielded a purported shortage of $87,942.13, representing the amount billed to Medicaid above the amount the records of purchases from suppliers proved that Brown had purchased of those drugs. Based upon the Heritage audit as well as documentation findings and overpayments calculations (see Exhibit 8), the Agency issued a PAAR dated September 27, 2002, determining that Brown had been overpaid $150,036.71 for Medicaid claims during the audit period. That report advised Brown that it was a provisional report only and encouraged Brown to submit any additional information or documentation which might serve to change the overpayment. The report listed examples of documentation that the Agency would consider for a possible reduction in the overpayment amount initially claimed. Thereafter, the Agency agreed to an extension of time for Brown to submit additional documentation and sent a letter to Brown dated October 31, 2003, advising that the audit had been placed in abeyance pending the outcome in a related case, but that the Agency expected to resume the audit and that therefore all Medicaid-related records and documentation regarding paid claims should be maintained and preserved until the audit was finalized. The FAAR was addressed in the testimony of Ms. Stewart for the Agency. Through her testimony it was revealed that certain corrections should be made to the FAAR updating it from the findings in the Heritage initial audit report. The Agency corrected the information in the FAAR for this reason and for the reason that it secured some additional information from the Respondent. Thus, for the audit period it was established that there were 16,727 total claims for prescriptions dispensed by Brown, for which it was paid $795,564.59 during the 21-month audit period, of those claims, 205 were pulled out from the total universe of claims as the judgmental sample. There were some 72 allegedly "discrepant claims" totaling $36,393.51 in dollars paid to Brown. The Agency's position is that $29,381.09 of those are so called "documented overcharges." The random sample of 250 claims was extrapolated to the remaining universe of 16,522 prescription claims. The Agency now takes the position that it found 49 "discrepant claims" in the random sample which totaled $2,154.40 in dollars paid to Brown's pharmacy and of that it maintains that $1,927.55 are "documented overcharges" for the 250 randomly selected claims (for which Brown had been paid $10,632.59). Thus the Agency found an average overcharge for the 250 randomly sampled claims of $7.71 per claim. The $7.71 average per claim overcharge was then multiplied by the remaining universe of 16,522 claims, yielding an extrapolated purported overcharge of $127,387.92. The Agency then applied the 95 percent "one-sided lower confidence limit" to this extrapolation, that is, that it or its statistician, Dr. Johnson, felt that there was a 95 percent chance that the lower confidence limit number it calculated was accurate. That number is $79,097.68. When that number is combined with the Agency's position as to overcharges from the judgmental sample results in a total postulated overcharge of $108,478.77. This is the final amount the Agency claims as an overpayment that must be recouped for Medicaid. The FAAR summarized the discrepant claims for the judgmental sample as follows: 61 claims involve refills which exceeded the authorized number of refills without documentation of reauthorization; 10 claims showed an incorrect prescriber license number but the correct prescriber license number was documented in the pharmacy's computer; and For two claims the hard copy description did not have an original date of service depicted on it and did not reference a DEA number. The discrepant claims shown in the FAAR as to the random sample were as follows: There were 19 claims for refills without documentation of refill authorization (refills had been previously authorized, but for the 19 claims at least one refill had been issued beyond the authorization limit); Fifteen claims showed an incorrect prescriber license number on the claim and the license number was not documented in the Respondent's computer; Seven claims showed an incorrect prescriber license number, but the correct license number was documented in the pharmacy's computer; There were seven claims for which the original hard copy prescriptions could not be found on file during the audit period; For one claim the hard copy prescription did not have an original date of service or DEA number; For one claim the quantity paid exceeded the quantity authorized by the prescriber or dispensed to the recipient; and For one claim the number of days supply submitted by the pharmacy was not consistent with the quantity and directions of the prescriber and the quantity exceeded the limit set by the plan. The most common discrepancies with regard to the judgmental sample and the random sample occurred when the Respondent billed refills in excess of the number authorized by the prescriber, without any written authorization for such being provided in the audit process or later. Concerning the random sample, the second most common discrepancy occurred when the claim depicted an incorrect precriber number on the claim and the license number of the prescriber was not documented in the computer. In the judgmental sample the second most common discrepancy occurred when the claim showed an incorrect prescriber number, but the correct prescriber number was documented in the pharmacy's computer. The discrepancies in the FAAR with the indication "UR", references "unauthorized refills." The records of the pharmacy showed that Brown issued refills of prescriptions to Medicaid recipients in excess of the presriber's limit depicted on the prescriptions but showed no written record of a telephonic or written authorization by the prescriber allowing the additional refill or refills. It is also true that as to some or even many of these the Respondent may have obtained verbal authorization, but failed to document that re- authorization. Medicaid policy, the statutory authority cited herein, and the PDSCLR Handbook provide that all verbal orders authorized by the prescriber of a prescription must be recorded either as a "hard copy" or noted in the pharmacy's computer in order to comply with the relevant law cited herein, for record- keeping and auditing purposes under Medicaid policy. The Agency's Statistical Methodology Mark E. Johnson, Ph.D., testified on behalf of the Petitioner. He was qualified as an expert witness in the area of statistical formulas, statistical methodology, and random sampling, including the random sample statistical methodology employed by the Agency in determining the overpayment amount. He is a professor of statistics at the University of Central Florida. Dr. Johnson reviewed the statistical methodology, numbers and calculations arrived at by the Agency and its extrapolation method of arriving at the overpayment amount. He also used his own independent analysis based upon a software package he commonly uses in the practice of his discipline in testing the methodology employed by the Agency and the random sample employed by the Agency and Heritage. The statistical formula employed by Dr. Johnson and the Agency is a standard one routinely used in Dr. Johnson's profession and statistical sampling. He established through his own testing of the methodology that the random sample was appropriate for Medicaid program integrity audits and determinations as employed in this case. The random sampling, according to Dr. Johnson, was employed because it would be time and cost prohibitive to examine individually each of 16,522 claims regarding overpayment issues. The random sampling methodology using 250 randomly chosen samples is a time and cost saving device and yet still presents a "plausible estimate" as established by Dr. Johnson. He established that for the universe of 16,522 claims which were subjected to the random sample and extrapolation statistical analysis and calculation, that such is a reasonable sample for purposes of this audit and that the 250 random samples employed by the Agency are indeed statistically appropriate random samples. His calculation of overpayment was at variance with the Agency's by 55 cents. He established that is not a significant difference since the 95 percent certainty limit of $79,097.68 for the random sample extrapolation analysis is so much lower than the estimate established at $108,478.22. Dr. Johnson established that the Agency had employed appropriate and valid statistical methods in its determination of the above-referenced overpayment amount based upon the random sample of paid claims. The expert testimony of Dr. Johnson, together with his written report in evidence, is credible and persuasive as to the validity of the random sampling of the claims during the audit period and as to the random sample portion of the analysis employed in arriving at the final overpayment calculation and numbers depicted in the FAAR. Dr. Johnson established the appropriateness of the statistical formula, including extrapolation, used to calculate the overpayment amount, the appropriateness of the sample size relative to the universe of claims, and the improbability that the overpayment amount is attributable to chance causes alone. Thus Dr. Johnson's testimony is accepted as credible and persuasive in establishing the validity of the Agency's method of overpayment calculation, and the overpayment calculation in conjunction with the statistical evidence in this record, except as modified by the findings below.1/ The Respondent's Position Gary Steinberg testified on behalf of the Respondent, Brown Pharmacy. He was accepted as an expert witness in the areas of Medicaid policy, audits and pharmacy practice, including Florida pharmacy practice. Mr. Steinberg acknowledged that Brown had not properly documented all claims that had been paid by the Medicaid program nor maintained all required records. He emphasized in his testimony, however, that Brown had not fraudulently billed the Medicaid program with claims for prescription medications that it had not actually dispensed to the patients or recipients. Rather, all medications involved in the subject prescription claims had actually been dispensed. There is no evidence or claim on the part of the Agency that Brown charged and collected more than the appropriate approved price for the prescriptions at issue. Through the explanation given in his testimony, Mr. Steinberg opined that although Brown was guilty of technical errors in record keeping and documentation as to the prescriptions involved in the subject claims, Brown had made substantial compliance with the Medicaid program requirements of the Medicaid provider agreement and the statutes and rules at issue and policies embodied in the subject handbook. He explained in his testimony that in the pharmacy practice setting in which Brown has operated, whereby it serves a large indigent population in an inner city environment, it is difficult to contact a prescriber at the time when a patient needs a critical prescription refilled in order to get a refill authorization. The prescriptions at issue mostly involve critical medications for HIV/Aids and psychotropic medications for severe mental conditions such as schizophrenia. The patients who need these critical medications (and there are very few patients, since most of the procedures involve filling and refilling for a small number of such recipients) are patients of clinics operated at the nearby university hospital (Shands). In these circumstances, where the patient literally needs the HIV/Aids medication refilled on an immediate basis, possibly even to prevent death, and the mental health patient critically needs a refill in order to prevent harm to the patient or harm to the members of the public if the patient goes without medication and "decompensates," the ethical thing for a pharmacist to do is to refill the prescription and seek authorization later. Mr. Steinberg established that it is often difficult to obtain authorization from the original prescriber since the medication were prescribed by residents practicing in the various clinics at the Shands Hospital and that the residents can not always be identified or contacted easily since they do not maintain a fixed medical practice in the area. Consequently, some of the prescriptions were not documented as to authorization, although in some cases the pharmacy actually obtained authorization and entered it in its computer. In some cases, being unable to obtain re-authorization from the resident who originally prescribed the medication the pharmacy used the DEA license or prescribing number of the hospital itself. He explained that although under the law a pharmacy can refill a prescription on an emergency basis for up to a 72-hour supply, that this is generally impracticable and unsafe for patients in this plight because such indigent, mental health and HIV/Aids patients tend to be non-compliant with their medication regimes quite often anyway, and it is often unreasonable to expect them to return to the pharmacy for another refill within two or three days. He thus opined that the ethical and safe thing for the pharmacist to do was to refill and re-dispense the medical approved medication for up to a 30 or 34-day supply (the normal refill supply duration). He further explained that the Shands Hospital license number was used in some of these circumstances because the resident doctor who originally issued the prescription could not be identified on the Shands Hospital prescription forms and because the resident doctors at the Shands clinics only have and can use Shands Hospital prescription forms in any event. Mr. Steinberg thus established that 35 percent of those prescription claims classified as "WMP," that is the prescription claims contained an incorrect prscriber license number were for these reasons and the pharmacist could only use the Shands Hospital license number because the resident could not be identified from the Shands Hospital prescription forms. He thus opined that 35 percent of the random sample extrapolation amount, the 95 percent statistical confidence limit amount of $79,097.00, should be deleted from that amount in determining the correct amount of overpayment predicated on the random sample. Likewise, with regard to the judgmental sample concerning the HIV/Aids and mental health patient prescriptions and related claims, he opined that, in effect, $19,500.00 of the total $29,381.09 overpayment amount claimed by the Agency pursuant to the judgmental sample portion of the claims, should be deleted from that portion of the overpayment claim by the Agency; this is a result of his explanation regarding "substantial compliance" in the critical refill situation he described concerning the HIV/Aids and mental health patients and their prescription drugs. The preponderant, persuasive evidence does establish (and indeed the Agency acknowledged in its Proposed Recommended Order) with regard to the judgmental sample, that 10 of the claims at issue listed an incorrect prescriber license number, but that the correct prescriber license number was actually documented in the pharmacy's computer record with the name of the prescriber. This circumstances comports with the law referenced below and in the Petitioner's Proposed Recommended Order. This results in a reduction in the overpayment claim with regard to the judgmental sample of 13.88 percent of the judgmental sample claims or a reduction of $4,078.09. Likewise, with regard to the random sample extrapolation calculation of overpaid claims, the preponderant, persuasive evidence, also as acknowledged by the Agency in its Proposed Recommended Order, disclosed that seven claims listed an incorrect prescriber license number on the claims, but had been correctly documented in the pharmacy's computer system and therefore were in compliance with the relevant statutes, rules, and the subject handbook. Thus the discrepant claims and the overpayment amount related to the random sample portion of the audit claims should be reduced by 14.28 percent of the total amount of $79,097.00 for a $11,295.05 reduction of that $79,097.00 random sample overpayment amount. Mr. Steinberg demonstrated that Brown was not overcharging on the drugs prescribed and dispensed and was charging the Medicaid-authorized amount for the drugs involved in the prescription claims at issue. The Agency is not claiming that there was any fraudulent practice or illegal overcharging for the prescriptions involved. In fact, Brown was earning only a very small profit on the drugs dispensed that are the subject of the prescription claims at issue. Mr. Steinberg thus opined that since Brown did indeed dispense all the drugs at issue and was only paid the legal authorized amounts for the drugs and prescriptions at issue that recoupment of the amounts sought by the Agency or, in effect, established in these findings of fact, would be fundamentally unfair. He and the Respondent contend, rather, that since Brown performed substantial compliance, but was guilty of technical non-compliance with the relevant rules, agreement, and Medicaid policy, that the Agency should impose a lesser fine instead of seeking recoupment. In summary, in view of the preponderant persuasive evidence establishing the above facts, it has been shown that the documentation and record-keeping, dispensing errors, and omissions in the manner found above, with regard to the prescription claims and types of claims addressed in the above findings of fact, occurred. If those deficiencies amount to violations of the authority cited and discussed below which justify recoupment, then the amount of overpayment established by the above findings of fact is $93,104.95.
Recommendation Having considered the foregoing findings of fact, conclusions of law, the evidence of record, the candor and demeanor of the witnesses, and the pleadings and arguments of the parties, it is, therefore, RECOMMENDED that a final order be entered by the Agency for Health Care Administration providing for recoupment of $93,104.95, and that the Respondent, Brown Pharmacy, must re-pay that amount to the Petitioner Agency, through a reasonable re- payment plan established between the parties. DONE AND ENTERED this 3rd day of November, 2006, in Tallahassee, Leon County, Florida. S P. MICHAEL RUFF Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with Clerk of the Division of Administrative Hearings this 3rd day of November, 2006.
The Issue 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
