The Issue The issue posed for decision herein is whether or not the Respondent's license to practice nursing should be suspended, revoked, or otherwise disciplined based on conduct which will be set forth hereinafter in detail as outlined by the Administrative Complaint filed herein on or about March 5, 1979.
Findings Of Fact Karyn Elaine Houghton Ruen, Respondent, is a licensed Registered Nurse who holds license No. 0942442. On March 5, 1979, the Florida State Board of Nursing, Petitioner, filed a five-count Administrative Complaint against the Respondent alleging that during the period February 4, 1978, through April 6, 1978, the Respondent engaged in unprofessional conduct in violation of Subsection 464.21(1)(b), Florida Statutes, in that on approximately five occasions, Respondent signed out on the hospital's narcotic control records on various occasions for a controlled substance and failed to chart the same on patients' medication administration records. Additionally, it is alleged that the Respondent failed to follow effective doctors' orders in the administering of prescribed drugs and that the Respondent failed to follow establish "wastage" procedures as required by her employer, St. Luke's Hospital, Jacksonville, Florida. 2/ Elmer H. Schorer, R.Ph., is the Chief Pharmacist (Director of Pharmacy) for St. Luke's Hospital, Jacksonville, Florida, and has been registered to practice pharmacy in the State of Florida for approximately twenty years. Pharmacist Schorer is the custodian of controlled substances records for St. Luke's Hospital and tendered copies of those records during the course of the hearing. He testified that all written doctors' orders automatically terminate after forty-eight hours unless renewed by a written prescription. (Petitioner's Composite Exhibit 1.) Donald J. Smith, the Director of Medical Records for St. Luke's Hospital since January 18, 1978, appeared and testified that he is custodian of patients' medical treatment records and tendered such records during the course of the hearing. (Petitioner's Composite Exhibit 2.) Juanita B. Gold, a Registered Nurse licensed to practice in this state for approximately thirty-three years, is the Head Nurse for the Orthopedic Floor for St. Luke's Hospital. She has been so employed for the past eight years. Ms. Gold testified that she knew Respondent as a staff nurse on her floor during times material to the complaint allegations filed herein. Count 1 of the Administrative Complaint alleges that on or about February 4, 1978, while employed as a Registered Nurse at St. Luke's Hospital, Respondent signed out on the narcotic control record on three occasions for a controlled substance, to-wit: Demerol (Mepheridine), for a patient, Margery E. Murrhee, and charted same on the patient's medication administration record. It is alleged that on said date and time, there was no doctor's order for said drug for said patient. Respecting the Compliant allegations, the evidence showed that the last written doctor's orders for the administration of Demerol to Patient Murrhee was written on the physician's direction on February 1, 1978, and according to the testimony of Juanita Gold, R.N., there was an automatic termination of said doctor's orders forty-eight hours after it was given, unless renewed by a physician. An examination of the medication administration record revealed that the Respondent administered Demerol on three occasions on February 4, 1978, to said patient. As an aside, it was also noted that the same medication was also administered by nurses on other shifts on the same date also subsequent to and in violation of the doctor's orders which had terminated. In Count 2 of the Administrative Complaint, it is alleged that on February 5, 1978, at approximately 7:30 p.m., Respondent signed out on the narcotic control record for Demerol, a controlled substance, for Patient Murrhee when there was no doctor's order in force on said date and time and she (Respondent) charted the administration of same on the patient's administration record, but failed to chart same on the patient's nurses' notes. The same facts were offered to establish the allegations in Count 2 of the patient, Margery E. Murrhee, on the date and time alleged in Count 2. Much like the evidence offered in support of Count 1, evidence also showed that Demerol had been given to Patient Murrhee by other nurses on the prior shift contrary to doctor's orders and the automatic termination procedures in effect at the hospital. However, contrary to the Complaint allegations, the evidence revealed that the Respondent charted the administration of Demerol on the patient's nurses' notes which, according to the notes, revealed that the Demerol was administered to Patient Murrhee for pain. Count 3 of the Administrative Complaint alleges that on February 9, 1978, Respondent, while employed as a Registered Nurse at St. Luke's Hospital, signed out on the narcotic control record for Demerol 75 mg., a controlled substance, for Patient David Demick, at 7:30 p.m., 1:30 p.m. and 11:00 p.m. The patient's doctor's orders called for Demerol 75 mg. every three to four hours for severe pain. It is thus alleged that the time interval was incorrect and contrary to the doctor's orders called for Demerol 75 mg. every three to four hours for severe pain. It is thus alleged that the time interval was incorrect and contrary to the doctor's orders. Additionally, it is alleged that the Respondent indicated that the 11:00 p.m. dosage was "wasted", but (Respondent) failed to have the wastage witnessed and signed as required. The evidence revealed that the Respondent did not administer any medication to Patient David Demick contrary to the doctor's orders. What the evidence shows is that Demerol, as prescribed by the treating physician, was administered to Patient Demick at 7:30 p.m. and 10:30 p.m. on February 9, 1978, which administrations complied with the doctor's orders for the administration of Demerol every three to four hours. Respecting the allegations that the Respondent failed to follow the established wastage procedure at 11:00 p.m. on February 9, 1978, the evidence shows that the Respondent stated that the 11:00 p.m. dosage was taken from the narcotic cabinet in error and as such had to be wasted. The wastage policy of St. Luke's Hospital is that any wastage of drugs must be witnessed and signed by a nurse other than the nurse wasting the medication. In this regard, the evidence showed that this wastage in question was witnessed only by the Respondent, although Respondent testified that to her best recollection, she was unable to find another nurse to witness the wastage at that particular time, 11:00 p.m., which was the time when the nurses changed shifts. Respondent offered that she felt it improper to leave an open narcotic vial in the narcotics cabinet in order that she summon another nurse to witness the wastage. Additionally, she testified that she did not feel she could properly take an open narcotic vial with her in the hallway in order to find a person who could witness the wastage. Therefore, she considered the safest alternative was to waste the narcotic on her own since obtaining a witness was impractical under the circumstances. In this regard, the evidence does establish that during shift changes, the nurses stations are fairly busy and that it would not be unusual for an employee to encounter difficulty obtaining a witness to a wastage of a drug in conformance with established policy. Count 4 of the Administrative Complaint alleges that on or about April 6, 1978, Respondent signed out for Demerol 75 mg. at 7:15 p.m. and 10:20 p.m. for a patient, Mildred Blake, and charted it as having been administered at 7:45 p.m. and 10:45 p.m., a three-hour interval, contrary to the patient's doctor's orders which called for the administration of said drug every four hours. The evidence in this regard revealed that through the Respondent's own admission, Demerol was administered to Patient Blake at three-hour intervals contrary to the doctor's orders. An examination of the medication administration records revealed that there were no subsequent doses of Demerol administered to Patient Blake. Count 5 of the Administrative Complaint alleges that on or about April 6, 1978, Respondent signed out on the narcotic control record for Demerol 75 mg. for a patient, Bruce Hanks, at 5:15 p.m. and 10:00 p.m., and failed to chart the administration of the 5:15 p.m. dose on the patient's medication administration record. It is also alleged that Respondent incorrectly charted Percodan, a controlled substance, as having been administered at 10:30 p.m. instead of 8:15 p.m., the time Respondent signed out for it on the narcotic control record. It is alleged that Respondent charted Demerol as having been given at 8:15 p.m. when no Demerol was signed out at that hour by the Respondent on the narcotic control record. (The remaining allegations of Count 5 were withdrawn.) An examination of the narcotic control record and the medication administration chart reveals that the Respondent properly administered the dosage of Demerol to Patient Hanks at 5:15 p.m. and 10:30 p.m. on April 6, 1978, and such was properly noted on the narcotic control record and medication administration chart. Evidence also reveals, as reflected on the narcotic control record and the medication administration chart, that the Respondent properly administered the dosage of Percodan at 8:15 p.m. and properly charted same on the medication chart. Additionally, the testimony of Respondent's supervisor, Juanita Gold, establishes that the administration of the Demerol at 5:15 p.m., the Percodan at 8:15 p.m. and the Demerol at 10:30 p.m. was in compliance with the treating physician's orders. The Respondent's nurses' notes revealed that she failed to chart the 5:15 p.m. administration of Demerol on the nurses' notes. The evidence also reveals that the nurses' notes also reflect that the Respondent improperly noted the administration of Demerol at 8:15 p.m. instead of Percodan and that the Respondent further improperly noted the administration of Percodan at 10:30 p.m. instead of Demerol. However, the nurses' notes showed that the Respondent realized her mistake and made a notation on the nurses' notes in an attempt to correct the proper administration of Percodan at 8:15 p.m. and the administration of Demerol at 10:30 p.m. In this regard, the testimony of Respondent's immediate supervisor, Juanita Gold, revealed that nurses often find it necessary to return and complete their nurses' notes after medications have been administered and sometimes after the narcotic control record and medication administration charts have been properly noted. The situations, according to Ms. Gold, occur when nurses are extremely busy. Additionally, Ms. Gold testified that occasionally nurses are allowed discretion in determining at what time certain medications should be administered to particular patients without outstanding physicians' directions.
Conclusions The Respondent's conduct, as alleged in paragraphs 1 and 2 of the Administrative Complaint, evidences a departure from the minimal standards of acceptable and prevailing nursing standards since there were no doctor's orders in effect at the times alleged. It is thus found that the Respondent failed to properly review the physician's directions at said times. As a mitigating factor, it is found that as reflected on the administration records introduced, other nurses on the same dates, albeit different shifts, were also improperly administering the same medication to patients in questions as noted on the various medication charts. Contrary to the Complaint allegations, the Respondent in fact charted the February 5, 1978, administration on the patient's nurses' notes. As to the allegations of paragraph 3, it is found that the Respondent did not administer any medication contrary to the doctors' orders. Although it is found that the Respondent failed to summon a witness to the wastage dosage of Demerol at 11:00 p.m., as alleged in paragraph 3, it is found that the Respondent exercised her best judgment under the circumstances and thus did not depart from the minimal standards of acceptable and prevailing nursing practices as alleged. As to the Complaint allegations in paragraph 4, it is found that the Respondent administered the medication to Patient Mildred Blake contrary to the doctor's orders and thus Respondent departed from the minimal standards of acceptable and prevailing nursing practices. Respecting the Complaint allegations of paragraph 5, it is found that the acceptable prevailing nursing practice is for nurses on occasion to revert back and complete their nurses' notes as the circumstances dictate. Therefore, although Respondent initially made a mistake regarding the noting of the 8:15 p.m. administration of Percodan and the 10:30 p.m. administration on the nurses' notes, she (Respondent) attempted to rectify this mistake immediately on the nurses' notes by a proper notation thereon. Therefore, Respondent did not depart from the minimal standards of acceptable and prevailing nursing practices as alleged. However, in view of the Respondent's failure to note the 5:15 p.m. administration of Demerol on the nurses' notes, although noted on the other administration narcotic control records and the medication administration charts, Respondent departed from the minimal standard of acceptable and prevailing nursing practices in failing to note the 5:15 p.m. administration of Demerol on the nurses' notes, although noted on the other administration narcotic control records and the medication administration charts, Respondent departed from the minimal standard of acceptable and prevailing nursing practices in failing to note the 5:15 p.m. administration on the nurses' notes. It was also noted in mitigation, that although the Respondent was employed at St. Luke's Hospital for a period of more than ten months, the instances alleged occurred on only three days during that period, and further, that the Respondent has not been the subject of any other disciplinary proceedings.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is hereby, RECOMMENDED: That the Respondent be placed on probation for a period of two (2) years. The above recommendation is based on mitigating factors offered during the hearing, including the fact that Respondent's employment record does not reflect that the Respondent has been the subject of any other disciplinary actions either prior to or subsequent to the instant proceedings. DONE AND ORDERED in Tallahassee, Leon County, Florida, this 5th day of October, 1979. JAMES E. BRADWELL Hearing Officer Division of Administrative Hearings Room 101, Collins Building Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 5th day of October, 1979.
Findings Of Fact Respondent, Gregory Burgess Stone, is a licensed practical nurse holding license number 0463451. Respondent was so licensed at all times relevant to this proceeding. Respondent was employed at Orlando Lutheran Towers Health Care Center, 300 East Church Street, Orlando, Florida, as a practical nurse at all times material hereto. During April, 1982, Respondent acted as the full-time medicine nurse on the 7:00 a.m. through 3:00 p.m. nursing shift at Orlando Lutheran Towers. Orlando Lutheran Towers utilizes the Unidose system of medication administration. The individual who administers the medication is required only to remove the appropriate dosage from the Unidose card which may contain from thirty to sixty doses of medication and thereafter record the administration of the medication on a medication administration record by inserting his initials under the appropriate date on the medication administration record format. Each patient at Orlando Lutheran Towers is assigned a Unidose card for each medication he may require. The patient's name and other pertinent information appear on a label placed on the front of the Unidose card. Respondent was intermittently relieved from duty in April by Gloria Underhill, another nurse-employee of Orlando Lutheran Towers. Underhill worked in place of Respondent on April 8, and the Respondent thereafter worked the intervening period from April 9 through April 12. Underhill returned to work in place of Respondent again on April 13, and in the course of administering medications, she observed that certain prescribed medications had not been administered between April 9 and April 13. Underhill ascertained this information because of the procedure she had previously followed. It was Underhill's general practice to place her initials not only on the medication administration record but also on the Unidose card next to the particular unit of medication she intended to administer. By comparing her initials with the physical presence of the succeeding units of medication in the Unidose card, she determined that the Respondent had apparently failed to administer medication to the following patients: PATIENT MEDICATION UNITS NOT RECEIVED 1. Lowe DDS 100 milligrams 4 2. Doze Corgard 40 milligrams 4 3. Miller TAM/LL 3 The medication administration record, however, indicated by the placement of the Respondent's initials that the foregoing medications had been received. Respondent speculated that he may have administered the medication by utilizing doses not taken by other patients. This possibility was not supported by the evidence and is rejected. Underhill's findings were given to the Director of Nursing and the Administrator of Orlando Lutheran Towers, who thereafter confronted Respondent with the Unidose card discrepancies. Respondent did not offer any explanation for the discrepancies and was therefore discharged from employment at Orlando Lutheran Towers.
Recommendation Based on the foregoing, it is RECOMMENDED: That Petitioner enter a final order finding Respondent guilty of the violations of law charged in the Administrative Complaint and placing his license in a probationary status for two years. DONE and ORDERED this 18th day of March, 1983, in Tallahassee, Florida. R. T. CARPENTER, Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 18th day of March, 1983. COPIES FURNISHED: W. Douglas Moody, Esquire 119 North Monroe Street Tallahassee, Florida 32301 James M. Nicholas, Esquire 170 East Washington Street Orlando, Florida 32801 Helen P. Keefe, Executive Director Board of Nursing Department of Professional Regulation Room 504, 111 East Coastline Drive Jacksonville, Florida 32202 Fred Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301
Findings Of Fact The following findings of fact are based upon the stipulation of the parties: The Respondent pharmacy, Drug Mart, Inc., of Lake Wales, doing business as Drug Mart, is a corporation holding community pharmacy permit number 0007122. The Respondent Gerald W. Gettel is a pharmacist licensed under the laws of the State of Florida, license number 0015091, whose last known address is 168 Poe Drive, Winter Haven, Florida 33890. Pursuant to Section 465.081, Florida Statutes, Gettel was employed as the pharmacy department manager at Drug Mart, Inc., of Lake Wales, 608 Lake Wales Plaza, Lake Wales, Florida 33853. On or about March 30, 1982, when inspected, the Respondents did not have on file Schedule II controlled substance prescriptions for the period of June 1980 through and including August 1980. If a hearing had been held in this case, Respondent Gettel would have testified that the destruction of the Schedule II controlled substance prescriptions mentioned above was unintentional . Gettel's testimony would have been supported by two witnesses whose affidavits are attached to this Recommended Order as Exhibits A and B. At a hearing, Gettel would have testified he could reproduce from computer records all of the dispensing information contained on the original prescriptions but admits it is accepted practice of pharmacists to maintain the original Schedule II controlled substance prescriptions for a period of two years. It is specifically stipulated that Schedule II controlled substance prescriptions are not subject to the exceptions provided by Section 893.07(4)(b), Florida Statutes. The responsibility for maintaining Schedule II controlled substance records is imposed upon the pharmacy manager (per the stipulation of the parties; however, the law is contrary). The permit holder, Drug Mart, Inc., of Lake Wales, is not directly responsible for the maintenance of said records. The Respondent Gettel notified the Drug Enforcement Administration of the destruction of the subject prescriptions. (See Exhibits C and D attached hereto.) At a hearing, Gettel would have stated that he also notified the Board of Pharmacy and would have introduced a letter and certified mail receipt relating to this notice to the Board. (See Exhibit E attached hereto.) If called to testify, the custodian of records of the Board of Pharmacy would state that the Board does not have a copy of the above-referenced letter (Exhibit E) in Respondent Gettel's file or in the Board's records of correspondence relating to lost or destroyed drugs or records. At a hearing, the Petitioner would offer no testimony contrary to the tendered testimony of Respondent Gettel and the referenced exhibits regarding the destruction of the subject records.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, the Hearing Officer recommends that the Administrative Complaint filed against the Respondents be dismissed. DONE AND ENTERED this 3rd day of May, 1984, in Tallahassee, Leon County, Florida. STEPHEN F. DEAN, Hearing Officer Division of Administrative Hearings 2009 Apalachee Parkway Tallahassee, Florida 32301 904/488-9675 Filed with the Clerk of the Division of Administrative Hearings this 3rd day of April, 1984. COPIES FURNISHED: Bruce D. Lamb, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Mr. Gerald W. Gettel 168 Poe Drive Winter Haven, Florida 33880 Drug Mart, Inc., of Lake Wales 608 Lake Wales Plaza Lake Wales, Florida 33853 Frederick Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Wanda Willis, Executive Director Board of Pharmacy 130 North Monroe Street Tallahassee, Florida 32301
Findings Of Fact Based upon the entire record, the following findings of fact are determined: Background At all times relevant hereto, respondent, Obi E. Enemchukwu, was licensed as a pharmacist having been issued license number PS 0023082 by petitioner, Department of Professional Regulation, Board of Pharmacy (Board). He has been licensed as a pharmacist since 1981. There is no evidence that respondent has been the subject of disciplinary action prior to this occasion. When the events herein occurred, respondent was the designated prescription department manager and pharmacy permittee for Oviedo Drug World (ODW), a community pharmacy located at 83 Geneva Drive, Oviedo, Florida. A community pharmacy is not defined by statute or rule. However, a Board witness described such a pharmacy as being a drug store that serves customers in an outpatient or ambulatory setting. As the prescription manager for the pharmacy, respondent was responsible for maintaining all drug records, providing for the security of the prescription department, and following all other rules governing the practice of pharmacy. Count I This count alleges that respondent violated a Board rule by virtue of the ODW prescription department being "opened at 9:00 a.m. with a pharmacy technician only on duty with no pharmacist present until approximately 9:15 a.m.". In this regard, the evidence shows that on February 28, 1991, a DPR senior pharmacist, Charles C. Lewis, made a routine inspection of ODW. He entered the premises at approximately 9:00 a.m. and found the drug store open, the lights on in the pharmacy section, and only a pharmacist technician on duty. Respondent was not on the premises. Respondent eventually entered the premises around 9:10 a.m. Because the law requires that a registered pharmacist be on duty whenever a community pharmacy is open, respondent, as the designated manager, was in contravention of that requirement. Count II The second count alleges that "on one occasion in approximately August 1990, pharmacist technicians on duty were required to dispense medicinal drugs despite no pharmacist having been present". As to this charge, respondent admitted without further proof that the allegations were true. Thus, the charge in Count II has been sustained. Count III The third count alleges that "on at least two occasions refills for medicinal drugs were dispensed without authorization from the prescribing physician." As to this count, during the course of his inspection of ODW's prescription file, Lewis found copies of two original prescriptions dispensed by respondent on Saturday, February 9, 1991, and Saturday, February 16, 1991, respectively. Original prescriptions are those either handwritten by a doctor and brought in for filling by the patient or those that are telephoned in to the pharmacy by the doctor's office. If a prescription is telephoned in, it must be immediately reduced to writing by the pharmacist. Original prescriptions do not include refills. In this case, the two prescriptions were the type telephoned in by the doctor directly to the pharmacy. Because doctors are rarely in their offices on Saturday, Lewis turned the prescription records over to DPR for further investigation. The records of the prescriptions have been received in evidence as a part of petitioner's exhibits 1 and 2. The prescriptions indicate that Dr. James E. Quinn prescribed thirty Nalfon tablets (600 mg.) to patient L. C. on February 9, 1991, and Dr. Michael E. Meyer prescribed ten Tagamet tablets (300 mg.) to patient J. K. on February 16, 1991. The record does not disclose whether the drugs are scheduled legend drugs or non-scheduled legend drugs. Deposition testimony given by Drs. Quinn and Meyer established that neither doctor authorized by telephone or in writing that the two prescriptions in question be filled. Respondent concedes that he dispensed the drugs, and by doing so, he violated the law. Count IV The final count alleges that respondent, as a pharmacy permittee, violated former rule 21S-1.023 (now renumbered as rule 21S-28.112) by dispensing a medicinal drug in violation of state law. Because this charge is founded on the same set of facts set forth in findings of fact 4, 5 and 6, it is found that this charge has been sustained. Mitigation and Penalty At hearing, respondent generally offered mitigating testimony. As to Count I, he indicated he planned to arrive at the store at 9:00 a.m. but an automobile accident tied up traffic and caused him to be ten minutes late. He suspects that the store owner, who had the only other set of keys, opened up the store and pharmacy area and improperly let the technician into the pharmacy area even though respondent had not yet arrived. As to Count II, respondent acknowledged that two prescriptions were dispensed by pharmacy technicians without a pharmacist on duty but believes the store owner authorized the technician to dispense two prescriptions that he had filled the previous evening. He says appropriate instructions have been given to insure that this will not occur again. Finally, respondent gave the following explanation for dispensing the two prescriptions without authorization from a doctor. During the time period in question, respondent had a practice of partially filling prescriptions. In other words, even though a prescription might authorize a total of 100 tablets, respondent would dispense them piecemeal (e.g., 10 at a time) over the life of the prescription. Thus, at the end of the prescription period, if only 80 of 100 tablets had been previously dispensed, he would fill the remaining 20 tablets even though the prescription from a particular doctor had expired. In the case of the two prescriptions in issue, respondent believes that the customers either had a valid prescription from another doctor but he inadvertently refilled the prescription using the former doctor's name because the prescription had not been used up, or he noted that the patient had not been given the total number of tablets authorized under the original prescription. However, no documentation was submitted by respondent to support the claim that he was presented with a new valid prescription by one of the customers. Respondent apparently no longer engages in this practice. Finally, throughout the course of this proceeding, respondent has fully cooperated with the Board. Although the Board did not submit a proposed order containing a recommended penalty, at hearing counsel for the Board suggested that respondent's conduct warrants the imposition of a fine, probation and a reprimand.
Recommendation Based upon the foregoing findings of facts and conclusions of law, it is RECOMMENDED that respondent be found guilty of violating Sections 465.014, 465.015(2)(c), 465.016(1)(e)and (n), and 465.023(1)(c), Florida Statutes (1989), and that he be given a reprimand, fined $500 and his license placed on probation for one year. DONE and ENTERED this 12th day of March, 1992, in Tallahassee, Florida. DONALD R. ALEXANDER Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, FL 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 12th day of March, 1992. COPIES FURNISHED: Tracey S. Hartman, Esquire 1940 North Monroe Street, Suite 60 Tallahassee, FL 32399-0792 Obi E. Enemchukwu P. O. Box 32 Tavares, FL 32778-0032 Jack L. McRay, Esquire 1940 North Monroe Street, Suite 60 Tallahassee, FL 32399-0792 John Taylor, Executive Director Board of Pharmacy 1940 North Monroe Street Tallahassee, FL 32399-0792
The Issue Whether the permit held by the Respondents to operate a pharmacy in the State of Florida should be revoked.
Findings Of Fact A Complaint and Notice to Show Cause was filed against the Respondents, Ponce de Leon, Inc., doing business as Capel Drugstore, and Milagros Ferreras, Evina Valera and Julio C. Pascual, on December 27, 1978, alleging that the Respondents failed to maintain on a current basis a complete and accurate record of controlled substances controlled by Chapter 893, Florida Statutes, and that Respondents while holding a permit to operate a pharmacy in the State of Florida permitted the unlawful practice of pharmacy at Ponce de Leon, Inc., doing business as Capel Drugstore, located at 6661 SW 8th Street, Miami, Florida, by permitting a person not licensed or registered as a pharmacist or pharmacy intern in this state, to wit Milagros Ferreras, to fill and dispense a controlled substance with prescriptions and without prescriptions to various people on various dates. A hearing was requested by the Respondents on January 5, 1979. Notice of Hearing was sent to the parties on February 5, 1979. The first witness called on behalf of the Petitioner was V. K. Bell, Agent for the Florida Board of Pharmacy and a licensed pharmacist. Agent Bell testified that while at a local wholesaler in the Miami area he noticed that Ponce de Leon, Inc., doing business as Capel Drugstore, had been buying a large volume of Quaalude tablets, which is a Schedule II controlled substance that has been the subject of high abuse in the Dade County area. Thereupon, he proceeded to Capel Drugstore in order to review their records. He said that he found the prescription records did not account for proper disposition through lawful dispensing of a large volume of the Quaalude tablets that were purchased and documented by the invoices. He testified that he talked with the pharmacist, Francisco DeQueuedo, and Respondent, Milagros Ferreras, one of the owners of Ponce de Leon, Inc., doing business as Capel Drugstore, and the President of the corporation. Mr. Bell advised Ms. Ferreras and Mr. DeQueuedo of their right to remain silent and not answer questions, that anything they said could be used against them, and that they had the right to have an attorney present if they desired. He then questioned the Respondent, Ms. Ferreras, and Mr. DeQueuedo. Ms. Ferreras stated that she had bought a bad business and found that she was having financial difficulties with the business, and she started to sell Quaalude tablets for 50 cents each to some 15 or 20 different people without prescriptions. Mr. Bell testified that Ms. Ferreras then stated that she had made sales of the controlled substance without prescriptions. Agent Bell testified that the pharmacist, Mr. DeQueuedo, admitted to him that he knew that Respondent Ferreras was making these sales, and that she would from time to time bring him prescriptions which he would sign, indicating on the prescriptions that he did in fact fill them, although he had not, and then put them on file at the pharmacy in an attempt to cover up some of the shortages due to the unlawful sales of the Quaalude tablets. After this conversation Mr. Bell testified that he proceeded to do a drug accountability audit. Mr. Bell said that even with giving the pharmacy credit for those prescriptions which were signed by the pharmacist, he could not account for 27,440 Quaalude tablets. The drug accountability report was identified by Mr. Bell and was introduced into evidence as Petitioner's Exhibit number 1. Agent Bell identified a series of documents which constituted various invoices and prescriptions utilized in the drug accountability audit as well as a perpetual inventory, which the pharmacist had run. These documents were marked as Petitioner's Composite Exhibit number 2 and were introduced into evidence. Thereafter, Mr. Bell identified a document which he noted was a copy of a receipt which he gave to the pharmacist noting the various invoices contained in Composite Exhibit number 2, which were removed from the pharmacy. This receipt was marked as Petitioner's Exhibit number 3 and was introduced into evidence. Mr. Bell verified a document which was the receipt that he gave to the pharmacist, Mr. DeQueuedo, when he removed the original prescriptions from the pharmacy file, which prescriptions were also part of the Composite Exhibit number 2. This receipt was marked as Petitioner's Exhibit number 4 and was introduced into evidence. Mr. Bell then identified another document, which was marked for identification as Petitioner's Exhibit number 5, and Agent Bell testified that this was a statement made to him in his conversations with the Respondent, Ms. Ferreras, and the pharmacist, Mr. DeQueuedo, which he reduced to writing and which both the pharmacist and Respondent Ferreras signed. Exhibit number 5 substantiates the testimony which was given by Mr. Bell in respect to the unlawful dispensing of controlled substances by Ms. Ferreras, falsification of the prescription records by Mr. DeQueuedo, and the shortages found in the drug accountability audit. Robert S. Pacitti, a police officer with the Dade County Public Safety Department, was called as a witness for Petitioner. Officer Pacitti stated that he had received a telephone call from Agent Bell with reference to Ms. Ferreras and Mr. DeQueuedo. Officer Pacitti testified that he went to the Capel Drugstore and advised both the Respondent Ferreras and Mr. DeQueuedo, the pharmacist, of their Miranda rights. Officer Pacitti obtained a verbal statement from Mr. DeQueuedo that he was aware of the fact that Ms. Ferreras was dispensing Quaalude tablets. Officer Pacitti then took Respondent Ferreras down to the Dade County Public Safety Department, where she made a statement taken by a stenographer in Officer Pacitti's presence confirming the testimony of Agent Bell and Officer Pacitti. Respondent Ferreras stated that the individuals to whom she had sold Quaalude tablets promised to bring her prescriptions for them at a later date but did not do so. Officer Pacitti identified a document marked as Petitioner's Exhibit number 6 as a copy of the statement of Respondent Milagros Ferreras, and thereafter this statement was introduced into evidence as Petitioner's Exhibit number 6. Officer Pacitti testified that even though the large quantity of Quaalude tablets was being sold for 50 cents each, the street value of these tablets was between $3.00 and $5.00 per tablet. The secretary of Jack R. Blumenfeld, the attorney of record for Respondent Milagros Ferreras, presented photocopies of letters from two physicians indicating that Ms. Ferreras had been in the hospital and then had been advised to restrict her physical activity and avoid emotional strain. These letters were marked and filed by the Hearing Officer. After listening to the testimony of Agent Bell and Officer Pacitti, and after examining the exhibits introduced into evidence, it is the finding of this Hearing Officer that the Respondent, Milagros Ferreras, did permit the improper keeping of records at Ponce de Leon, Inc., doing business as Capel Drugstore, and that complete and accurate records of controlled substances were not maintained on a current basis. It is the further finding of this Hearing Officer that the Respondent, Milagros Ferreras, allowed the pharmacist, Francisco DeQueuedo, to file false information in the files of Ponce de Leon, Inc., doing business as Capel Drugstore, by placing prescriptions in the files which were not actually dispensed by the pharmacist to the individuals named thereon. The Hearing Officer finds that the Respondent, Milagros Ferreras, President of the corporation doing business as Capel Drugstore, improperly dispensed and sold Quaalude tablets to individuals with prescriptions and to individuals without prescriptions.
Recommendation Revoke the permit to operate a pharmacy in the State of Florida issued to Ponce de Leon, Inc., doing business as Capel Drugstore, and Milagros Ferreras, Evina Valera and Julio C. Pascual. DONE and ORDERED this 15th day of March, 1979, in Tallahassee, Leon County, Florida. DELPHENE C. STRICKLAND Hearing Officer Division of Administrative Hearings Room 530, Carlton Building Tallahassee, Florida 32304 (904) 488-9675 COPIES FURNISHED: Jack R. Blumenfeld, Esquire 619 NW 12th Avenue Miami, Florida 33136 Michael Schwartz, Esquire Suite 201, Ellis Building 1311 Executive Center Drive Tallahassee, Florida 32301 H. F. Bevis Executive Secretary Florida Board of Pharmacy Post Office Box 3355 Tallahassee, Florida 32302
The Issue Whether Petitioner is entitled to additional compensation under the Agreement with Respondent?
Findings Of Fact On August 1, 1986, Respondent issued ,Invitation to Bid Number 87-2, which was titled, "Invitation to Bid for Providing Financial Services Related to the Payment of State Employees' Group Health Self Insurance Claims: (Invitation to Bid). Under the terms of the Invitation to Bid, the winning bidder would agree to provide banking services for two interest bearing accounts. One account (Prescription Drug Account), was to be used to transfer funds from the Respondent to Paid Prescriptions, Inc., the administrator of the prescription drug component of the State Employee's Group Health Self Insurance Plan (Plan). The other account (Health Claims Account) was to be used to pay drafts issued by Blue Cross and Blue Shield of Florida, Inc., to participants and providers for payment of all health claims, except prescription drugs. Blue Cross and Blue Shield of Florida, Inc., was the administrator of the Plan, except for Prescription drugs. For both accounts, the Invitation to Bid required that all fees and charges of the winning bidder must be offset by "the required minimum daily balance." The required minimum daily balance was an amount of money which Respondent would have to maintain deposited in the account with Petitioner. Interest earned by the winning bidder on the required minimum daily balance amount would compensate the winning bidder for providing the services required by Respondent. In addition, funds deposited in the accounts in excess of the required minimum daily balance would earn interest credited to the account each month. Responses to the Invitation to Bid were to be evaluated based on the amount of required minimum daily balances and the amount of interest Respondent would earn on funds on deposit in excess of the required minimum daily balance. Appendix 1 to the Invitation to Bid, was titled "Prescription Drug Account Activity" and contained the following information: Estimated number of deposits per month 2 Estimated number of wire transfers per month 2 Average amount per transfer from February 1986 through May 1986 $480,000 Appendix 2 to the Invitation to Bid was Titled "Heath Claims Account Activity" and contained the following information: The following data was collected from the Period May 1, 1985 through April 30, 1986. Average number of drafts paid per month $40,568 Average daily amount of drafts paid $395,398 Average number of deposits per month 8 Average number of stop Payments per month 19 In preparing its response to the Invitation to Bid, Petitioner based its calculations on the number of transactions set forth in the Appendix. Petitioner determined that, to cover its costs plus a 20 percent profit margin, it would need to receive 13.7 cents per draft handled on the Health Claims Account. By using the 13.7 cents per draft, the average number of drafts per month listed in Appendix 2, and by assuming that it could earn 6.3 percent interest on the required minimum daily balance, Petitioner determined that it needed to ask for a required minimum daily balance of $1,059,000, if the funds were to be maintained in a Demand Deposit Account. Before petitioner submitted its response, Mr. Dale Thompson, an employee of Petitioner's, contacted Mr. Andrew Lewis, Respondent's contact for the invitation to bid, to ask a few questions, and make sure Petitioner understood what it was doing. During this conversation, Mr. Thompson asked Mr. Lewis if he had any reason to expect that the average number of drafts listed in Appendix 2 would increase. Mr. Lewis responded that the number reflected what it had been over the last period and that he had no expectation that it would increase. Petitioner submitted a response which asked for a required minimum daily balance of $0.00 for the Prescription Drug Account, contingent upon having the Health Claims Account of $961,216, if funds were to be maintained in a zero interest Certificate of Deposit, $1,059,522, if funds were to be maintained in a Demand Deposit Account. Also, the amounts on deposit in excess of the required minimum daily balance would earn interest based on the current month's auction average of the ninety-day U. S. Treasury Bill Discount Rate, but not less than 4 Percent. Based on Respondent's analysis of the bids submitted by five firms, Petitioner was selected as having submitted the best bid. Thereupon, Petitioner and Respondent entered into and Agreement whereby Petitioner agreed to provide the services set forth in the Invitation to Bid and pay the interest set forth in Finding of Fact 13, supra, in exchange for Respondent's maintaining a required minimum daily balance of $1,059,522 in a Demand Deposit account with Petitioner. Nowhere in the Agreement is there mention of the average number of drafts listed on Appendix 2. Page 6 of the Agreement contains the following language: SECTION VI - ADDITIONAL DOCUMENTS Invitation to Bid Number 87-2, mailed August 1, 1986 and Capital City's Response to Invitation to Bid Number 87-2 are incorporated herein by reference, except where there is a conflict between this Agreement and the Invitation to Bid shall take precedence over Capital City's Response to the Invitation to Bid. Petitioner began performing services under the Agreement on November 8, 1986, and continued to do so until December 31, 1987, when the agreement expired. Immediately after beginning to perform services, the number of drafts being processed in the Health Claims Account exceeded the number Petitioner had anticipated. This continued for the entire period of the Agreement, during which Petitioner processed the following number of drafts: Nov. 8 - Nov. 30, 1986 38,291 December 55,313 January, 1987 59,887 February 73,309 March 74,468 April 68,654 May 67,911 June 81,065 July 86,838 August 74,337 September 82,846 October 85,624 November 74,474 December 76,374 Monthly Average 72,217 On April 21, 1987, Petitioner, requested that Respondent pay additional compensation to Petitioner based on 13.7 cents per draft for the number of drafts which were being processed in excess of the number reflected on Appendix 2 of the Invitation to Bid. By letter dated May 25, 1987, Respondent denied Petitioner's request, stating that the "unpredictable fluctuations in the volume of drafts was a business risk agreement." Petitioner's Exhibit 4.. After further oral communications between the parties, Petitioner requested an administrative hearing regarding its request for additional compensation. The number of drafts paid from Respondent's, account during May, 1985 through April 1986, which formed the basis for the average number of drafts listed on Appendix 2 were: May 1985 32,783 June 28,045 July 32,697 August 32,822 September 34,923 October 41,430 November 41,491 December 39,136 January 1986 53,103 February 51,390 March 50,775 April 48,176 Total $486,811 Additionally, the number of drafts paid in May, June and July, 1986 were 44,020; 45,123; and 53,095; respectively. At the time Mr. Lewis was working on the Invitation to Bid and had the conversation with Mr. Thompson described in Finding of Fact 12, supra, he was not aware that the number of drafts paid per month had been increasing over the prior three months. In preparing the Invitation to Bid, Mr. Lewis had asked someone in his office to give him an average for the past 12 months and the number he received is the number reflected in Appendix 2.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED, that Respondent issue a final order denying Petitioner's request for additional compensation. Done and ENTERED this 17th day of May, 1988, in Tallahassee, Florida. JOSE A. DIEZ-ARGUELLES Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 Filed with the Clerk of the Division of Administrative Hearings this 17th day of May, 1988. APPENDIX The parties submitted proposed findings of fact which are addressed below. Paragraph numbers in the Recommended Order are referred to as "RO ." Petitioner's Proposed Findings of Fact Proposed Finding Ruling and Paragraph Number in of Fact Number Recommended Order Accepted. RO1, 2. Accepted, generally. RO3, 4 Accepted, generally. RO5 Accepted. RO9 Irrelevant Accepted. RO12 Accepted. RO11, 13 First sentence, accepted. RO14, 15. Second sentence, generally accepted, except to the extent it indicates that the number of items was limited by the Agreement. RO16, 17 and last paragraph of Conclusions of Law. Generally supported by the evidence, but irrelevant. The fact that Respondent had this information in its records does not mean that it had a duty to inform bidders when, at the time, it did not know its significance. Accepted. RO19 Accepted, except for parenthetical on incorporation by reference. RO19 Supported by competent evidence but not necessary for the decision reached 13-15. Rejected as argument Respondent's Proposed Finding's of Fact Proposed Finding Ruling and Paragraph Number in of Fact Number Recommended Order 1-3. Irrelevant 4,5. Accepted RO3, 4, 5, 13, 15 6. Accepted 7. Accepted generally. RO12 8. Accepted generally. RO12 9. Accepted 10. Accepted. RO5 11-13. Accepted. RO20 14. Supported by the evidence, but unnecessary to the decision. COPIES FURNISHED: James D. Beasley, Esquire Ausley, McMullen, McGehee, Carothers & Proctor 227 South Calhoun Street Post Office Box 391 Tallahassee, Florida 32302 Augustus D. Aikens, Jr., Esquire General Counsel Department of Administration 435 Carlton Building Tallahassee, Florida 32399-1550 Adis Vila, Secretary Department of Administration 435 Carlton Building Tallahassee, Florida 32399-1550
The Issue Whether Emergency Rule 10CER92-4 should be invalidated because it constitutes an invalid exercise of delegated legislative authority.
Findings Of Fact The Medicaid program is a program authorized under Title XIX of the federal Social Security Act that provides for payments for medical items or services for eligible recipients. Section 409.901(7), Florida Statutes. Prior to July 1, 1993, the Medicaid program was administered by the Department of Health and Rehabilitative Services (HRS). Effective July 1, 1993, Section 20.42, Florida Statutes, 1992 Supplement, was amended by Chapter 93-129, Section 58, Laws of Florida, to give the Agency for Health Care Administration (AHCA) the responsibility for the Medicaid program. The Medicaid program provides for mandatory and optional services to eligible recipients. Prescribed drug services are optional Medicaid services. Medicaid services may be provided only when medically necessary, must be provided in accordance with state and federal law, and are subject to any limitation established by the general appropriations act or Chapter 216, Florida Statutes. Sections 409.905 and 409.906, Florida Statutes. Medical providers participating in the Medicaid program receive reimbursement from Medicaid. Section 409.908, Florida Statutes. States are given the option to charge Medicaid recipients copayments for services. 42 CFR Section 447.50. Certain categories of services and recipients are exempt from copayments. 42 CFR Section 447.53. Forty-five percent of the Medicaid program is funded by state funds and fifty-five percent is funded with federal "matching funds." In order to receive federal matching funds for its Medicaid program, the state must submit a plan describing the nature and scope of its Medicaid program and giving assurances that the program will be administered in accordance with Title XIX and applicable federal regulations. This plan is known as the State plan. Effective February 14, 1992, the Legislature enacted Chapter 92-5, Laws of Florida, which amended the appropriations Act for fiscal year 1991-92. Proviso language in Chapter 92-5 relating to Specific Appropriation 1035 for Medicaid prescribed medicine/drug provides: The Department of Health and Rehabilitative Services is directed to implement, beginning April 1, 1992, a co-payment program for Prescribed Medicine in order to implement spending reductions of at least $770,213 from general revenue and $929,661 from the Medical Care Trust Fund in Specific Appropriation 1035. The State plan was amended effective April 10, 1992, to require a copayment of $1.00 per prescription for pharmacy services provided to Medicaid recipients. Certain categories of services and recipients were exempted from the copayment requirement. Providers were prohibited from denying services to recipients who were unable to pay the copayment. Prior to April 10, 1992, copayments had not been required for prescribed drug services. HRS adopted Emergency Rule 10CER92-4, effective April 10, 1992. HRS published notice of the emergency rule in the Florida Administrative Weekly, Vol. 18, No. 16, April 17, 1992. In this notice under the section entitled "SPECIFIC REASONS FOR FINDING AN IMMEDIATE DANGER TO THE PUBLIC HEALTH, SAFETY OR WELFARE," it states in pertinent part: The 1992 Legislature reduced the prescribed drug services program FY 1991-1992 budget in Senate Bill 2408 which was signed by the Governor on February 14, 1992. This law requires the Medicaid program to implement a copayment requirement for prescription drugs by April 1992. . . . The emergency rule amended Rule 10C-7.042, Florida Administrative Code and required recipients to pay the pharmacy provider a $1.00 co-payment for each prescription or other prescribed drug service reimbursed by Medicaid. Certain categories of recipients and services were exempted from the copayment requirement. The pharmacy provider was required to request a copayment from non-exempt recipients. The pharmacy must determine a recipient's ability to pay the copayment based on the recipient's reply to the request for copayment, the recipient's past purchase history with that provider, and the recipient's recent purchase of non-essential items. A provider could not deny prescribed drug services to eligible recipients because of inability to pay the copayment. Although a recipient may not be able to pay the copayment, the recipient remains liable for the copayment. HRS began the rulemaking process to adopt the same amendments to Rule 10C-7.042 as a regular rule. Emergency Rule 10CER92-4 was challenged via a lawsuit in state court and was later removed to federal court. The proposed amendments to Rule 10C-7.042 were challenged in an administrative rule challenge, which was withdrawn and added to the lawsuit in federal court dealing with the challenge to the emergency rule. Chapter 92-293, Laws of Florida, the Appropriations Act for fiscal year beginning July 1, 1992 and ending June 30, 1993 contains the following proviso language relating to Medicaid prescribed drug services: Funds in Specific Appropriation 1019 are reduced by $18,581,894 from the General Revenue Fund, $3,281,004 from the Grants and Donations Trust Fund, $22,647,089 from the Medical Care Trust Fund, $2,632,000 from the Public Medical Assistance Trust Fund, and $58,013 from the Special Grants Trust Fund for the Department to implement a Medicaid comprehensive cost containment program. This program shall, at a minimum, incorporate: a prior authorization component; a co-payment program; an on site education program for providers prescribing the drugs; enhancements to the Department's ability to identify fraud and abuse; utilization of specific nursing home pharmacy consultants; and, shall implement new electronic technology to speed payments and capture third party liability information. By notice in the Florida Administrative Weekly, Rule 10CER92-4 has been continued pursuant to Section 120.54(9)(c), Florida Statutes. Chapter 93-184, Laws of Florida, the Appropriations Act for the fiscal year beginning July 1, 1993 and ending June 30, 1994, contains no language concerning reductions in the appropriations for Medicaid prescription medicine services and contains no language concerning copayments for recipients receiving Medicaid prescription medicine services. The amounts appropriated for the Medicaid prescription medicine services was at or below the amounts appropriated in Chapter 92-293 Laws of Florida. Chapter 93-129, Section 48, Laws of Florida, created section 409.9081, Florida Statutes, which requires Medicaid recipients to pay nominal copayments for hospital outpatient services and physician services effective July 1, 1993. Prior to the enactment of section 409.9081, Florida Statutes, a one dollar copayment had been required for Medicaid outpatient hospital and physician service. Effective July 1, 1993, the copayments were raised to two dollars. Current revenues generated by the copayments for the Medicaid prescribed drug services is approximately $12 million. Thus, the discontinuance of the copayment would result in a $12 million shortfall for the provision of Medicaid prescribed drug services, and a restriction on services to the extent necessary to account for the shortfall. The Social Services Estimating Conference (SSEC) is a statutorily created body established to develop official information relating to the social service system of the state for use in the state planning and budgeting system. Section 216.136(6), Florida Statutes. Section 216.134(1), Florida Statutes, provides in pertinent part: Unless otherwise provided by law or decided by unanimous agreement of the principals of the conference, all official information developed by the conference shall be based on the assumption that current law and current administrative practices will remain in effect throughout the period for which the official information is to be used. . . . The social services estimating conference for 1993-94 took into consideration the revenues from the copayments for the Medicaid prescribed drug services. Petitioner, Mildred Henry, resides in Jacksonville, Florida, and is disabled. She has received Medicaid since December, 1991. Her only income is Supplemental Income ("SSI") benefits of $434 per month. Ms. Henry suffers from many disabilities including chronic obstructive pulmonary disease, asthma, hypertension, severe and chronic urinary tract infections, and depression. Her physicians have prescribed a number of medications to address these conditions including Cardizem (for high blood pressure), Zantac (for ulcers), Cipro (for chronic urinary tract infections), Phenazopyridine (for bladder problems), Imipramine (for depression), Premarin (hormone), Thes-dur (for asthma), Brethine (for asthma), Ventalin (for asthma), Furosemide (for excess fluid), K-Dur (potassium), Propoxy N (for pain), Nizoral (for skin irritations), Darvoset (for pain), Tylenol 3 (for pain), and Halcion (for anxiety). She needs to refill most of these prescriptions each month. Copayments for all of Ms. Henry's prescription medications amount to $16.00. Ms. Henry's income is below the federal poverty level. She cannot afford to pay a copayment for all her medications. Petitioner has informed her pharmacy that she does not have the money to pay copayments. However, the pharmacy has refused to provide the medications without payment of the co-payments. As a result, Petitioner runs out of medications and delays getting her prescriptions refilled until she can pay the copayment.
The Issue Whether Petitioner failed to maintain required records to support and document Medicaid prescription claims paid by the Medicaid program for the audit period (June 24, 1998, to June 1, 2000). If so, whether Petitioner received overpayments from the Medicaid program. If so, whether extrapolation was appropriately used to determine the amount of that overpayment (alleged by Respondent to be $1,053,137.49).
Findings Of Fact PETITIONER At all times relevant to the allegations of this case, the Petitioner was licensed pursuant to Chapter 465, Florida Statutes, to provide pharmacy services in Florida with pharmacy license number PH0012223. At all times relevant to this proceeding, Petitioner was an authorized Medicaid provider with provider number 102126500. At all times relevant to this proceeding, Petitioner had a valid Medicaid Provider Agreement with Respondent. During the audit period, Petitioner provided pharmacy services to Medicaid recipients and billed those services to the Medicaid program under its Medicaid provider number. Specifically Petitioner sold or dispensed drugs to Medicaid recipients who resided in nursing homes. Petitioner operated solely to serve nursing home populations. Petitioner usually received pharmacy orders by telephone or facsimile transmission from a nursing home. Typically, the staff at Petitioner’s facility would take the call or receive the facsimile transmission, write down the pertinent information, enter the data into the pharmacy’s computer system, dispense the item, and route the drugs to the nursing home via courier. All drugs are dispensed in sealed containers and are delivered with a manifest listing all the medications by name and patient. Jerry Kelly, a pharmacist employed by Petitioner’s parent corporation, described how nursing home orders or prescriptions were obtained and taken, beginning on line 11, page 716, of Volume VI of the hearing transcript: The vast majority, probably 90, 95 percent, are faxed over from the nursing home by nurses. A few may be called in with the nurse acting under the regulatory authority to act as the agent of the physician. These orders are then reviewed by the pharmacist. An order issue technician will enter that information into the computer, creating the original prescription.[2] The pharmacist then checks that data that was entered into the prescription to make sure all elements are there and the order entry is correct. Labels are then printed, which go to the floor to be filled by technicians. The pharmacist then checks the final product. That product is sent to a staging area where delivery manifests are printed. Those orders are then checked off the delivery manifest to make sure that no orders have been missed. The tote is sealed and then delivered to a nursing home by courier service. At the nursing home, the nurse and the driver check these orders off together, both sign that delivery manifest, and a copy of that delivery manifest comes back to the pharmacy. Q. Can you explain to the Court the typical process at [Petitioner’s parent corporation] by which refills, so to speak, are received and handled. A. Back then refills were handled by pulling a label off of the prescription container, apply it to a refill order sheet or a piece of paper of any kind that would fax . . . those are faxed to the pharmacy, those labels are pulled and faxed to the pharmacy by a nurse acting again under the regulatory authority of a -- to act as the agent of the physician. That’s also verifying to us that those orders are continued for another month. The prescription number is put in by an order entry tech. Those labels are printed and filled. From there on, the process is exactly the same. Prior to the audit period, Petitioner was purchased by another corporation. Subsequent to the audit, Petitioner ceased to operate as a pharmacy. RESPONDENT Respondent is the state agency charged with the responsibility and authority to administer the Medicaid program in Florida. Respondent’s OMPI is responsible for overseeing the integrity of the Medicaid program in Florida. Pursuant to this authority Respondent’s OMPI oversees 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, Respondent paid Medicaid claims submitted by Medicaid providers and then, after- the-fact, OMPI audited such providers for accuracy and quality control. These integrity audits are to assure that the provider maintains records to support the paid claims. HERITAGE In 1999 OMPI contracted with Heritage through Consultec, L.L.C. (Medicaid’s fiscal agent), to perform and report pharmacy audits of pharmacy providers within the state. Auditors from Heritage were assigned Petitioner’s audit. The Heritage employees in charge of the subject audit were experienced and appropriately trained. THE AUDIT Respondent’s audit no 01-1017-00-3/H/JDJ reviewed Petitioner’s Medicaid claims paid by Respondent for the period June 24, 1998, through June 1, 2000. Ken Yon is the OMPI administrator who was responsible for managing the instant case and who worked with the Heritage auditors to assure the policies and practices of Respondent were met. In this case, the Heritage auditors presented at Petitioner’s facility unannounced on July 31, 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 139,036 claims (the total number of claims that the Petitioner submitted during the audit period). For the universe of 139,036 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 extrapolating a sample of 250 claims to the universe of 139,036 claims would be statistically valid if the sampled claims were randomly chosen. The 250 sample claims selected for the subject audit were randomly chosen. Heritage asked the Petitioner to present prescription records it was required to retain to support the claims for the audit period. Petitioner offered the auditors its computerized records for many of the 250 samples in lieu of the hard copies the auditors requested. The auditors refused to accept the computerized records and, as reflected by the Audit Report, Petitioner was unable to produce acceptable evidence of prescriptions for a great many of the 250 samples.3 The auditors found that 171 of the 250 claims sampled were discrepant, in that they did not meet standards for payment. The auditors analyzed the number of discrepant claims and determined that the average overcharge per sampled claim was $36.3434 (sic). Multiplying the number of claims in the universe by that average yielded an initial estimate of the overcharge in the amount of $5,053,040.96. The 95% one-sided, lower-confidence limit4 for the initial estimate was determined to be $3,946.215.96, which is the amount of the overpayment alleged in the FAAR. THE FAAR AND SUBSEQUENT COMPUTATIONS After the auditors completed their review of the records at Petitioner’s facility, JoAnn Jackson, a licensed pharmacist with extensive experience in auditing pharmacies, was assigned by Respondent to review Heritage’s audit report and to prepare the Respondent’s FAAR. The vast majority of the discrepant claims (165 of the 171) were categorized as CF, which meant that the auditors could not find required documentation of the subject prescription or could not find required documentation for the refill of a prescription. These findings were reported to the Petitioner, who was given additional time to locate and produce documents to support the claims. Respondent was willing to accept documentation for claims up through the time of hearing.5 Based on additional documentation submitted by Petitioner after the auditors had completed their field work, Respondent’s staff recalculated the amount of the overpayment by the use of extrapolation (including the reduction of the initial estimate to the 95% one-sided, lower confidence limit) to be the amount of $1,053,137.49, which is the amount of the overpayment at issue at the formal hearing. Respondent established that each alleged discrepant claim that it used to recalculate the amount of the overpayment was, in fact, discrepant and did not meet Medicaid record-keeping standards. RECORD RETENTION REQUIREMENTS Although Petitioner’s manner of doing business was different from the conventional pharmacy (the so-called corner drugstore), it was subject to the same Medicaid records retention requirements as a conventional pharmacy that serves as a Medicaid provider. Pursuant to the applicable Medicaid Provider Agreement between Petitioner and Respondent, Petitioner was to comply with all Medicaid handbooks in effect during the audit period. Petitioner was also required to comply with all applicable state and federal Medicaid Program rules and laws in effect during the audit period. For each claim submitted during the audit period by Petitioner to Respondent for payment under the Medicaid Program, Petitioner was required to “keep, maintain, and make available in a systematic and orderly manner all medical and Medicaid- related records as Respondent requires for a period of at least five (5) years.” Petitioner was also required to make these supporting records available to Respondent upon Respondent’s request. A Medicaid provider must retain all medical, fiscal, professional, and business records on all services provided to a Medicaid recipient. In addition to the foregoing, a Medicaid provider must maintain a patient record for each recipient for whom new or refill prescriptions are dispensed. Specific to the issues of this case, a Medicaid provider must retain prescription records for five years from the date the prescription was last filled or refilled. For the audit period in this case, the prescription that authorized the dispensing of each drug for which Petitioner claimed payment under the Medicaid program should have been maintained and made available for the auditors since each prescription would have been within the five-year period. 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. Applicable records that must be kept for quality control so that an after-the-fact audit can verify the integrity of the Medicaid claims that were paid by Respondent. 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. 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. At the times relevant to this proceeding, Florida Administrative Code Rule 64B16-28.140(1)(d) and (e), provided, in part, as follows: Original prescriptions . . . shall be reduced to writing if not received in written form. All original prescriptions shall be retained for a period of not less than two years from date of last filling. To the extent authorized by 21 C.F.R. Section 1304.04, a pharmacy may, in lieu of retaining the actual original prescriptions, use an electronic imagining record keeping system, provided such system is capable of capturing, storing, and reproducing the exact image of the prescription, including the reverse side of the prescription if necessary, and that such image be retained for a period of no less than two years from the date of the last filling. Original prescriptions shall be maintained in a two or three file system as specified in 21 C.F.R. 1304.04(h). PETITIONER’S COMPUTERIZED RECORDS There was a dispute between the parties as to whether Petitioner’s computer records should have been accepted as evidence that valid prescriptions underlie each dispensed drug within the sample. That dispute is resolved by finding that the computer records maintained by the Petitioner did not retain 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 contemporaneous hard-copy printout of all original prescriptions dispensed and refilled. The original prescriptions must be maintained in a two or three file system as specified in 21 C.F.R. 1304.04(h). If the Petitioner’s system could do that, it did not. Fundamentally, a Medicaid claim for a drug that has been dispensed by a Medicaid provider must have as its basis a valid prescription. While Petitioner’s computer records established what drugs had been dispensed, those records did not meet the requirements for establishing that the drugs were dispensed pursuant to valid prescriptions. OVERPAYMENT Any Medicaid providers not in compliance with the Medicaid documentation and record retention policies may be subject to the recoupment of Medicaid payments. As set forth in the Conclusions of Law section of this Recommended Order, the term “overpayment” is defined by Section 409.913(1)(d), Florida Statutes (2000). EXTRAPOLATION At hearing, 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. Extensive testimony was taken as to the extrapolation process used in this proceeding. Respondent 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. All testimony, including the testimony of Dr. Intriligator, has been fully considered in the findings reached in this case. 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 case. The only way to determine the amount of the actual overpayment is to examine each of the 139,036 claims that were made during the audit period. Dr. Johnson’s testimony established that the probability is overwhelming that the amount of the alleged overpayment is substantially less than the actual overpayment. Respondent established that Petitioner received an overpayment during the audit period as alleged in the FAAR and it established that the amount of the overpayment is at least $1,053,137.49.
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 finds that Petitioner has received an overpayment from the Medicaid program in the amount of $1,053,137.49. It is further recommended that the final order require Petitioner to repay that overpayment. DONE AND ENTERED this 28th day of February, 2006, in Tallahassee, Leon County, Florida. S CLAUDE B. ARRINGTON 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 28th of February, 2006.
