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
Findings Of Fact Upon consideration of the oral and documentary evidence adduced at the hearing, the following relevant facts are found: At all times material to this proceeding, the Respondent, Howard E. Staats, was licensed as a pharmacist with license number PS 0007704. On July 15, 1985, Dr. Ali A. Zomorodian treated James C. Jowers for thrombose hemorrhoids at the Memorial Medical Center in Jacksonville, Florida and prescribed Proctofoam HC, allowing three (3) refills of the medication. Proctofoam HC is a "medicinal" drug which is commonly known as a "legend" or "prescription" drug which can only be dispensed by prescription. On July 15, 1985, James Jowers presented the prescription for Proctofoam HC issued by Dr. Zomorodian to the Respondent for filling at Scottie's Discount Drug Store, 41 Arlington Road South, Jacksonville, Florida. During the course of filling the prescription on July 15, 1985, the Respondent discussed genital cancer with Jowers and showed Jowers pictures of the genital area. There was insufficient evidence to show that Respondent asked Jowers to come behind the prescription counter that day on the pretense of checking Jowers' hemorrhoids, and then pulling down Jowers' shorts and touching Jowers' penis and testicles. After Respondent had filled Jowers' prescription for Proctofoam HC on July 15, 1985, Jowers decided that the price was too high and asked that Respondent return his prescription. Respondent returned the prescription to Jowers and Jowers had it filled at the Mayport Naval Station pharmacy on July 16, 1985. While Respondent had the prescription in his possession on July 15, 1985, and before returning it to Jowers, Respondent copied certain information from the prescription and gave the prescription a number (83116) on Respondent's prescription log. This information was placed on file at Scottie's. Based on information furnished by Jowers concerning Respondent's behavior on July 15, 1985, John Danson, Investigator for Petitioner and detectives from the Duval County Sheriff's Office asked Jowers to return to Scottie's and make contact with the Respondent on the pretense of needing the prescription for Proctofoam HC filled. On July 29, 1985, Jowers returned to Scottie's where Respondent was on duty and told Respondent that he had lost the prescription for Proctofoam HC but that he needed it filled. Using the information that he had copied from the original prescription on July 15, 1985, Respondent filled the prescription for Proctofoam HC and gave the medication to Jowers. Jowers upon leaving Scottie's gave the medication to Danson and the detectives from the Duval County Sheriff's Office. There was insufficient evidence to show that Respondent knew on July 29, 1985 that the prescription had been filled at the Mayport Naval Station pharmacy or that the prescription was on file at the Mayport Naval Station pharmacy. The medication given to Danson and the detectives contained the same prescription number (83116) that Respondent had given the prescription when presented to him on July 15, 1985. There was insufficient evidence to show that Respondent asked Jowers into his office and pulled down Jowers' pants and touched Jowers' penis or testicles on July 29, 1985. At all times relevant to this proceeding, the original prescription for Proctofoam HC used by Dr. Zomorodian to Jowers on July 15, 1985 was on file at the Mayport Naval Station pharmacy. The Mayport Naval Station pharmacy did not transfer the prescription for Proctofoam HC issued by Dr. Zomorodian to Jowers on July 15, 1985. Neither Dr. Zomorodian nor his staff "called-in" the prescription for Proctofoam HC given to Jowers by Dr. Zomorodian on July 15, 1985 to Scottie's or the Respondent. The Respondent did not call Dr. Zomorodian or his staff for authorization to dispense Proctofoam HC to Jowers under the prescription issued by Dr. Zomorodian to Jowers on July 15, 1985. Respondent prepared and maintains in his files a written record of the information copied from the original prescription presented to him by Jowers issued by Dr. Zomorodian for Poctofoam HC on July 15, 1985. In addition to the number (83116) being listed in the Scottie's prescription log, it is also listed on the above-referenced record. Respondent's dispensing of the Proctofoam HC to Jowers on July 29, 1985 under the circumstances of this cause was done in good faith. Although there was conflicting expert testimony, Respondent's dispensing of the Proctofoam HC to Jowers on July 29, 1985 under the circumstances of this cause was done in the course of professional practice of pharmacy.
Recommendation Having considered the foregoing Findings of Fact, Conclusions of Law, the evidence of record and the candor and demeanor of the witnesses, it is, therefore RECOMMENDED that the Amended Administrative Complaint be DISMISSED. Respectfully submitted and entered this 12th day of November, 1987, in Tallahassee, Leon County, Florida. WILLIAM R. CAVE Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 12th day of November, 1987. APPENDIX TO RECOMMENDED ORDER, CASE NO. 86-0287 The following constitutes my specific rulings pursuant to Section 120.59(2), Florida Statutes, on all of the Proposed Findings of Fact submitted by the Petitioner in this case. Rulings on Proposed Findings of Fact Submitted by the Petitioner Adopted in Finding of Fact 1. Adopted in Finding of Fact 2. Adopted in Finding of Fact 3. Adopted in Findings of Fact 4 and 6. Adopted in Finding of Fact 6. Adopted in Finding of Fact 8. Adopted in Findings of Fact 8 and 15 but clarified. Adopted in Finding of Fact 8. Adopted in Findings of Fact 6 and 12 but clarified. Rejected as not supported by substantial competent evidence, as being hearsay and as not being material or relevant. 11-13. Adopted in Findings of Fact 13 and 14 but clarified. 14.-15. Although Dr. Zaenger's background and the fact that she testified as an expert witness on the standards of practice in pharmacy are important to determine the weight given her testimony, these findings are not necessary and add nothing to the finding of fact in this order. Rejected as being a conclusions of law rather than a Finding of Fact. Rejected as not being material or relevant since it is not a finding of fact but only a statement of a hypothetical situation. Rejected as not supported by substantial competent evidence. 19.-23. Rejected as not being material or relevant. Rulings on Proposed Findings of Fact Submitted by the Respondent 1. Adopted in Finding of Fact 1. 2-3. Adopted in Finding of Fact 4. 4. Adopted in Finding of Fact 13 but clarified. 5.-6. Adopted in Findings of Fact 13 and 14 but clarified. 7.-8. Paragraph 7 and the first sentence of paragraph 8 rejected as a restatement of the testimony and not a finding of fact. The balance of paragraph 8 is adopted in Findings of Fact 6, 7 and 8 but clarified. Adopted in Finding of Fact 6. Adopted in Finding of Fact 7. Adopted in Finding of Fact 5 but clarified. 12.-14. Adopted in Finding of Fact 8. Adopted in Finding of Fact 6. Rejected as not being material or relevant. 17.-19. Adopted in Finding of Fact 8. Adopted in Finding of Fact 12. Adopted in Finding of Fact 14 but clarified. Adopted in Finding of Fact 3. Adopted in Finding of Fact 8. 24.-27. The first two (2) sentences of paragraph 25 are adopted in Findings of Fact 3 and 10. The balance of paragraphs 24-27 are rejected as being a restatement of the testimony and not a finding of fact. COPIES FURNISHED: Robert D. Newell, Jr., Esquire Newell & Stahl, P.A. 102 S. Monroe St. Tallahassee, Florida 32301 Robert Palmer, Esquire Michael Ed wards, Esquire Suite 305, 24 N. Market St. Jacksonville, Florida 32202 Tom Gallagher, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 Rod Presnell, Executive Director Board of Pharmacy Department of Professional Regulation 130 N. Monroe St. Tallahassee, Florida 32399-0750
The Issue The issue is whether Petitioner is entitled to a permit as a prescription drug wholesale distributor.
Findings Of Fact On August 29, 2007, Petitioner filed with Respondent an application for a permit as a prescription drug wholesaler establishment (Application). Pursuant to a change in the law effective July 1, 2008, this permit is now for a prescription drug wholesale distributor. The Application lists Boris Rios as the sole owner of Petitioner and its president and manager. The Application lists Alexander Valdes as the next highest-ranking employee with a title of certified designated representative (CDR). The Application requires Petitioner to list all persons who meet the following descriptions of affiliates: a) "a director, officer, trustee, partner, or committee member of a permittee or applicant or a subsidiary or service corporation of the permittee or applicant"; b) "a person who, directly or indirectly, manages, controls, or oversees the operation of a permittee or applicant, regardless of whether such person is a partner, shareholder, manager, member, officer, director, independent contractor, or employee of the permittee or applicant"; c) "a person who has filed or is required to file a personal information statement pursuant to s. 499.012(4), F.S., or is required to be identified in an application for a permit or to renew a permit pursuant to s. 499.012(3), F.S."; d) "the five largest natural shareholders who own at least 5 percent of the permittee or applicant . . ."; and e) "shareholder[s] owning 5% or more of the applicant." In response to this item, the Application states that Mr. Rios meets the criteria set forth in paragraphs a) through e), and Mr. Valdes meets the criteria set forth in paragraph b). Attached to the Application are Personal Information Statements for Mr. Rios and Mr. Valdes. Mr. Rios's Personal Information Statement discloses his employment, from July 2003 to July 2007, as a "sales mgr" with Worldwide Medical Supplies and Pharmaceuticals, Inc. (Worldwide). His statement includes a resume that states he was a "sales executive" for Worldwide from July 2003 to February 2004, a "purchasing/deliver[ies] manager" for Worldwide from February 2004 to May 2005, and a "sales manager" for Worldwide from May 2005 to July 2007. As sales manager, Mr. Rios stated that he "[o]ver looked all sales transactions for all sales reps (7 man sales force). Buy establishing sales strategies and product promotions to help increase our sales and profit margins. And keeping sales force motivated and inspired by creating incentives to reach goals." Mr. Rios's attached resume shows that he had been a sales manager for another pharmaceutical manufacturer from January 2001 to July 2003. Mr. Rios's statement also answers in the negative a question asking whether he, "or a company for which you were an owner, officer, director, or manager, has been fined or disciplined by a regulatory agency in any state (including Florida) for any offense that would constitute a violation of Chapter 499, Florida Statutes?" However, his statement answers in the affirmative a question asking whether he, "or a company for which you were an owner, officer, director, or manager, ever held a permit issued under Chapter 499, Florida Statutes, in a different name than [Petitioner's name]?" However, on a mostly blank page entitled, Additional Information," Mr. Rios handwrote that he was employed by Worldwide from July 2003 to July 2007 as the sales manager of seven salespersons from May 2005 to July 2007, as the purchasing manager from February 2004 to May 2005, and as a sales representative from July 2003 to February 2004. Mr. Valdes's Personal Information Statement discloses his employment with Worldwide from 2003 to present as a "sales mgr" and "D Rep," meaning certified designated representative. Inserted in the Application is a letter dated May 30, 2008, from Mr. Valdes to Rebecca Burnett, an employee of Respondent, stating that he was "hereby submit[ting] my resignation from Worldwide . . . effective May 30, 2008 " Mr. Valdes's Personal Information Statement contains a long typewritten statement that says he was employed at Worldwide since 2003 in "various positions," starting as a sales person, then a sales manager, and finally a CDR, following his preparing for and passing the certification test. At about the same time, a newer Worldwide employee, Rick Nielsen, also took the CDR test, passed, and became a CDR for Worldwide, working a different shift from Mr. Valdes. Mr. Valdes stated that he often ordered Worldwide not to accept or to return a product due to product-safety issues, and he helped state inspectors in their investigations concerning these matters. However, on the Personal Information Statement itself, Mr. Valdes answered in the negative a question whether he or any company for which he had been a manager had been fined or disciplined by a regulatory agency. By letter dated September 8, 2008 (Denial Letter), Respondent advised Petitioner of its intent to deny the application. Among the reasons cited for denial are that Petitioner listed Mr. Valdes as its CDR. The Denial Letter states that, in Final Order Number 08-1216, Respondent found 37 violations of the Florida Drug and Cosmetic Act, Chapter 499, Florida Statutes, and revoked the permit of Worldwide Medical Supplies and Pharmaceuticals, Inc. (Worldwide), to operate as a prescription drug wholesale distributor. According to the Denial Letter, Mr. Valdes was Worldwide's CDR from August 2005 to May 2008 and sales manager from April 2003 to May 2008; he is also the son of the president and owner of Worldwide, Miriam Gonzalez. The Denial Letter states that Mr. Valdes was listed on the Application as a key employee of Worldwide and did not submit to Respondent his resignation as Worldwide's CDR until May 30, 2008. The Denial Letter asserts that, on four occasions from July 18 to November 8, 2005, Mr. Valdes received and authenticated a pedigree that was not authenticated, so that Worldwide failed to keep the required records of prescription drug transactions. The Denial Letter states that, on six occasions between October 17 and 31, 2005, Mr. Valdes or another Worldwide employee falsely represented under Mr. Valdes's signature that a pedigree had been presented to Worldwide and authenticated by Mr. Valdes, but Worldwide had not received the complete and accurate pedigrees and had not maintained them. The Denial Letter states that receipt of the drugs without a complete or accurate pedigree caused the drugs to be deemed adulterated. The Denial Letter states that, on August 16 and September 23, 2004; and September 25, October 16, and October 27, 2006, Worldwide purchased a prescription drug from an unlicensed manufacturer or wholesaler. The letter states that this activity constituted the purchase of contraband in commerce and was detrimental to the public health. The Denial Letter asserts that Mr. Rios was an affiliated party of Worldwide at all material times. The Denial Letter states that Mr. Rios owns Petitioner and provides financial support and assistance to Petitioner, so he is an affiliate of Petitioner. The Denial Letter states that Respondent found that Petitioner was not entitled to licensure under Section 499.012(4)(d)9, Florida Statutes. The Denial Letter states that, pursuant to Section 499.012(10)(b), Florida Statutes, Respondent may deny an application if it finds that the managers, officers, or directors of the applicant or an affiliate of the applicant are incompetent or untrustworthy. Based on the facts set forth above, Respondent finds Mr. Valdes, an affiliate, incompetent or untrustworthy. The Denial Letter states that, pursuant to Section 499.012(10)(g), Florida Statutes, Respondent may deny an application if it finds that the applicant is affiliated, directly or indirectly through ownership, control or other business relations, with any person or persons whose business operations are or have been detrimental to the public health. Based on the facts set forth above, Respondent finds Mr. Valdes is an affiliate whose prior business operations are or have been detrimental to the public health The Denial Letter states that, pursuant to Section 499.012(10)(r), Florida Statutes, Respondent may deny an application if it finds that the applicant or any affiliate has failed to comply with the requirements for manufacturing or distributing prescription drugs under Chapter 499, Florida Statutes. The Denial Letter asserts that Section 499.003(3), Florida Statutes, defines an affiliate to be a person who has filed or is required to file a personal information statement or a person who, directly or indirectly, manages, controls, or oversees the operation of a permittee or applicant, regardless whether such person is a partner, shareholder, manager, member, officer, director, independent contractor, or employee of the permittee or applicant. The Denial Letter states that Respondent finds that Mr. Valdes, while employed at Worldwide, failed to comply with the laws related to the distribution of prescription drugs while having a duty to be actively involved in and aware of the actual daily operation of the company. The Denial Letter states that Mr. Valdes had a duty to be actively involved in and aware of the actual daily operations of the company. The Denial Letter states that, while Mr. Valdes was CDR for Worldwide, the company purchased prescription drugs from an unauthorized source, in violation of Section 499.005(16), Florida Statutes; failed to maintain records of prescription drug distributions as required by Florida Administrative Code Rule 64F-12.012(6) and (10), in violation of Section 499.005(18), Florida Statutes; accepted or maintained incomplete or nonexistent pedigrees and sold drugs to unlicensed persons, thus violating the adulterated-drug provisions of Section 499.005(1), (2), and (4), Florida Statutes. The Denial Letter states that, pursuant to Section 499.012(10)(m), Florida Statutes, Respondent may deny an application if the applicant or affiliate receives, directly or indirectly, financial support and assistance from a person who was an affiliate of a permittee whose permit was subject to discipline or suspended or revoked. The Denial Letter states that Petitioner receives financial support and assistance from Mr. Rios, who was an affiliate of Worldwide and is an affiliate of Petitioner. The Denial Letter states that, at all material times, Worldwide engaged in business operations that were detrimental to the public health by purchasing adulterated prescription drugs and by adulterating prescription drugs. Worldwide filed a renewal application on May 17, 2007, for a renewal term from July 1, 2007, to June 30, 2008. The renewal application lists Ms. Gonzalez as the company's sole shareholder and manager. The only persons listed among the next four highest-ranking employees are Mr. Valdes, who is listed as the CDR and "Longistic [sic] Manager" and Mr. Rios, who is listed as "Purch/Sales Director." Each man is reported as "a person who, directly or indirectly, manages, controls, or oversees the operation of a permittee " Sometime in 2007, Respondent commenced a disciplinary proceeding against Worldwide. In its Second Amended Administrative Complaint dated August 24, 2007, Respondent alleged that Worldwide violated Sections 499.001 through 499.081, Florida Statutes, based on documents that it had prepared during 2004-06. A formal hearing took place on February 11 and 12, 2008, and Administrative Law Judge Patricia M. Hart entered a Recommended Order on May 1, 2008, which was adopted in its entirety by Final Order entered October 12, 2008 (FO). The Final Order finds Worldwide guilty of 37 violations of Chapter 499, Florida Statutes, imposes administrative fines of $185,000, and revokes Worldwide's permit as a Prescription Drug Wholesaler. The Final Order (FO) was never appealed. The FO finds multiple acts and omissions attributable to Worldwide in the handling of prescription drugs shipped to it or, in some cases, purchased by it. Concerning incomplete and thus fraudulent authentications of pedigree papers, these acts and omissions ranged from February to April, June to September, and December 2004; and April to November 2005. Only seven of these violations occurred in 2004; the rest were in 2005. Concerning purchases from unlawful persons, of which there were a dozen, these acts and omissions took place in August 2004, December 2004, June 2005 (two), April 2006, September 2006 (two purchases from Kuehne & Nagel) October 2006 (four purchases from Kuehne & Nagel), and March 2007. Mr. Valdes is named in connection with six of the unlawful transactions. For October 2005 (except for one transaction in November 2005, as indicated), the FO found a pedigree paper bearing a "stamp" showing receipt and authentication by Mr. Valdes of 35 6GM vials of Carimune was incomplete and thus "false," a pedigree paper bearing a "stamp" showing receipt and authentication by Mr. Valdes of seven 10ML units of Baygam as incomplete and thus "false," a pedigree paper bearing a "stamp" showing receipt and authentication by Mr. Valdes of 15 12GM vials of Carimune as incomplete and thus "false," a pedigree paper bearing a "stamp" showing receipt and authentication by Mr. Valdes of 100 2ML units of Baygam was incomplete and thus "false," a pedigree paper bearing a "stamp" showing receipt and authentication by Mr. Valdes of 100 units of Gammar P as incomplete and thus "false" (November 2005), and one pedigree paper bearing a "stamp" showing receipt and authentication by Mr. Valdes of one 2ML unit of Baygam SDV and three 10CP units of Tamiflu 75MG was incomplete and thus "fraudulent." In his responses to requests for admission in this case, Mr. Valdes admits that he received and authenticated the pedigree paper, on October 10, 2005, for Carimune; the pedigree paper, on October 18, 2005, for Baygam; the pedigree paper, on July 18, 2005, for Baygam; and the pedigree paper, on November 8, 2005, for Gammar P. Worldwide never employed many employees, perhaps never more than 8-10. Ms. Gonzalez owned the company, but reduced her interest to 51 percent from February 2004 to December 31, 2006, during which period Mr. Nielsen owned 49 percent. However, Mr. Nielsen terminated his employment with Worldwide on December 31, 2006, and evidently relinquished his interest in the company at that time. Upon initial employment, Mr. Nielsen occupied a position in which he supervised the purchasing manager, Mr. Rios, who, even though called a manager, supervised no one. At that time, Mr. Rios was lower-ranking than Ms. Gonzalez, Mr. Nielsen, Mr. Valdes, and possibly another employee. At some point, Mr. Nielsen was designated a CDR for Worldwide, and he remained a CDR for Worldwide until he left employment with the company. Prior to that, Mr. Gonzalez had served as the CDR for Worldwide. Mr. Valdes also served as a CDR for Worldwide. Based on his responses to requests for admission, Mr. Valdes started as CDR for Worldwide in August 2005, so he and Mr. Nielsen were both CDRs for Worldwide at the same time. Mr. Valdes served until the end of July or early August 2006, when, dissatisfied with his employment situation, he terminated his employment. Mr. Valdes did not return until early January 2007 when his mother needed him to serve as CDR again because Mr. Nielsen had left, and no one remaining with Worldwide could pass the test to become a CDR. Mr. Valdes produced testimonials from various persons, such as a former drug agent supervisor of Respondent and current investigators of Medicaid fraud, who commend him for assisting in combating fraud in the wholesale pharmaceutical industry. However, at the hearing, Mr. Valdes never explained how he was not at fault or responsible for the violations in which the paperwork bore his stamp or other violations taking place, particularly while he was CDR. Mr. Valdes was sales manager during the 2004 violations and a CDR during all of the bad-pedigree transactions from August to December 2005, as well as one bad-purchase transaction in April 2006. He had sizable responsibilities during a timeframe that many violations were taking place at Worldwide, and, despite the three commendations and candid demeanor at the hearing, does not appear to have done a good job discharging these important duties. As confirmed by Ms. Gonzalez, Mr. Rios was the sales manager from May 2005 to July 2007, and he had supervisory authority over a sales staff that, at most, numbered seven persons. Mr. Rios could hire and fire salespersons, but he had no contact with the prescription drugs. From February 2004 to May 2005, Mr. Rios was purchasing manager, but worked under the supervision of Mr. Nielsen and lacked any managerial duties.
Recommendation It is RECOMMENDED that the Department of Health enter a final order denying the application for a permit as a prescription drug wholesale distributor until Mr. Rios substitutes a qualified CDR for Mr. Valdes--a condition that the Department of Health should allow Mr. Valdes a reasonable time to satisfy. If Mr. Rios cannot submit the name of a qualified CDR within such time, the final order should provide for the denial of the application without prejudice to refiling at a later date with a qualified CDR. DONE AND ENTERED this 9th day of March, 2009, in Tallahassee, Leon County, Florida. ROBERT E. MEALE 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 9th day of March, 2009. COPIES FURNISHED: Alexander Valdes, Qualified Representative 14052 Southwest 80th Street Miami, Florida 33183 Gary L. Asbell, Esquire Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1703 Rebecca Poston, R.Ph., Executive Director Drugs, Devices, and Cosmetics Program Department of Health 4052 Bald Cypress Way, BIN C04 Tallahassee, Florida 32399-1701 R. S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way, BIN A02 Tallahassee, Florida 32399-1701 Josefina M. Tamayo, General Counsel Department of Health 4052 Bald Cypress Way, BIN A02 Tallahassee, Florida 32399-1701
Findings Of Fact Respondent Dora Villanueva, is a licensed pharmacist, having been issued license number PS 0014957, and whose last known address is 3017 Southwest 107the Avenue, Miami, Florida 33165. At all times material hereto, Respondent Villanueva was the prescription department manager and part-owner of Century Pharmacy, 3017 Southwest 107th Avenue, Miami, Florida 33165. Respondent Century is permitted to operate a community pharmacy under the laws of the State of Florida, having been issued permit number PH 0006839 and operating at 3017 Southwest 107th Avenue, Miami, Florida 33165. On or about August 5, 1983, a Department of Professional Regulation investigator purchased 20 Librax and 20 Donnatal from Century Pharmacy, without first presenting a prescription. The aforementioned Librax and Donnatal were dispensed by Jose Ceferino Calvera, not a licensed pharmacist in the State of Florida. Librax and Donnatal are medicinal drugs as defined in Subsection 465.003(7), Florida Statutes (1983)(F.S.), and require a prescription to be dispensed. Respondent Dora Villanueva was not present in the pharmacy when the Librax and Donnatal were dispensed on August 5, 1983, and the prescription department of the pharmacy had a sign stating that the prescription department was closed. On or about August 17, 1983, a Department of Professional Regulation investigator purchased ten Dalmane, 20 Librax and 20 Donnatal, from Respondent Villanueva at the Respondent Century Pharmacy, Inc. without first furnishing a prescription. Dalmane, Librax and Donnatal are medicinal drugs as defined in Section 465.003(7), F.S. and require a prescription to be dispensed. On or about August 22, 1983, a Department of Professional Regulation investigator purchased ten Tranxene 7.5 mg and ten Dalmane, 30 mg, from Respondent Villanueva at the Respondent Century Pharmacy, Inc., without a prescription. Tranxene and Dalame are medicinal drugs as defined in Section 465.003(7), F.S., and require a prescription to be dispensed. On or about September 8, 1983, an audit was conducted of the controlled substances at Respondent Century Pharmacy, Inc., for the time period of January 1, 1983 through September 8, 1983. Said audit revealed the following shortages in the drugs which were audited: DRUG SHORTAGE Dalmane 30 mg 1,590 Dalmane 15 mg 799 Ativan 1 mg 151 Ativan 2 mg 4,163 Talwin Injectable 22 Dalmane, Ativan and Talwin are controlled substances as defined in Chapter 893, F.S. and are medicinal drugs as defined in Subsection 465.003(7), F.S. Respondent Villanueva denied making the August 17, 1983 sale. However, she did remember Petitioner's investigator from the August 22, 1983, transaction. Since Petititoner's investigator kept a contemporaneous record of her purchases, Respondent's denial is rejected as not credible. Both Respondent Villanueva and Petitioners investigator are immigrants from Cuba. Respondents claim the investigator was allowed to make the August 22, 1983 purchase without a prescription because she stated she had recently arrived from Cuba and had no doctor or money to pay one. Even if this were an accurate account of the transaction (which Petitioner denies) it would not provide grounds for dispensing controlled drugs without a prescription.
Recommendation Based on the foregoing, it is RECOMMENDED: That Petitioner issue a final order suspending the license of Respondent Dora Villanueva and the permit of Century Pharmacy, Inc. for a period of 90 days. DONE and ENTERED this 31st day of July, 1984 in Tallahassee, Florida. R. T. CARPENTER, Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 31st day of July, 1984. COPIES FURNISHED: Bruce D. Lamb, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Blas E. Padrino, Esquire 2355 Salzedo Street, Suite 309 Coral Gables, Florida 33134 Wanda Willis, Executive Director Board of Pharmacy 130 North Monroe Street Tallahassee, Florida 32301 Fred M. Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 =================================================================
The Issue Whether Respondent Agency for Health Care Administration (AHCA) preliminary determination of alleged Medicaid overpayment to Rams Pharmacy, Inc. d/b/a Moreno Pharmacy (Rams) which arose from a Medicaid pharmacy audit, should become final agency action.
Findings Of Fact The Medicaid program is a cooperative federal-state venture designed to provide health care to the needy. States participating in the program receive federal financial assistance for compensating enrolled providers for the good and/or services they provide to Medicaid recipients. Florida is a participant in the Medicaid program, AHCA is the state agency responsible for making payments to enrolled providers in Florida. AHCA contracts with pharmacies such as Rams to provide medicine to Medicaid patients. After medicine is dispensed by a pharmacy to a Medicaid patient, the pharmacy must submit a claim to AHCA for that dispensed medication. The amount a pharmacy bills AHCA for dispensed medication generally consists of the pharmacy's wholesale costs for the medicine, plus a small dispensing fee. For each claim submitted, pharmacy Medicaid providers must disclose the information that is described in detail in Section 6 of the Prescribed Drug Handbook. Section 6 contains 11 pages of instruction for filling out of a claim form for one prescription reimbursement. A pharmacy must provide the following information for each medication dispensed: pharmacy provider number; recipient's name; recipient's Medicaid I.D. number; the prescription number; the manufacturer item; the date the prescription was filled; the quantify dispensed; the number of days the prescription covers; whether the recipient has any other insurance; the pharmacy's internal number that was assigned to the prescription; whether the prescription is being filled for the first time or is a refill; the National Drug Code from the package for the drug dispensed; the pharmacy's Florida license number; the medical certification code; whether the drug is generic or a name brand; the unit dose; the amount billed; other payer amount; and the billing date. After submission of a claim, AHCA reimburses the pharmacy for the amount billed. From time to time, after Medicaid's reimbursement and payment to a pharmacy, AHCA through its agent reviews a pharmacy's records to validate the pharmacy's claims and to assist AHCA in determining whether Medicaid may have overpaid the pharmacy. These findings are included in a proposed audit report. AHCA sends the proposed audit report to pharmacies advising them that it intends to adopt the proposed audit report and its underlying documents as the final report unless the pharmacy timely contests the proposed audit report. The AHCA analyst involved in this case opened a file in this matter on or around March 17, 2000. The file was opened after her review of a routine audit of the pharmacy performed by the fiscal agent on or about January 19, 2000, which alleged some discrepancies. The analyst chose an audit period of August 5, 1998 through December 31, 1999. She next requested from AHCA's Information Technology Department a list of Rams' "paid claims" for that period for the "top twenty" drugs, in terms of money paid to the pharmacy. She received a print-out of what purported to be those claims, which was introduced into evidence as part of the Final Agency Audit Report. The analyst then asked Rams to provide invoices to prove that during the audit period it purchased or acquired the drugs for which it had been paid by Medicaid as shown in Exhibit numbered 5. Between the dates of March 1998 and March 1999, Rams' physical location underwent substantial renovations. During the course of those renovations, boxes containing purchase invoices were either destroyed by the elements, inadvertently discarded, or misplaced. Because those invoices were not available, Rams could not produce invoices for all of its purchases of drugs during the relevant time period. However, Rams did provide some invoices and Rams' owner testified that the pharmacy acquired sufficient inventory during the audit period to cover the billings to Medicaid. Rams was credited for the invoices provided by Rams during the audit and prior to the hearing, although they were not identified or offered into evidence by AHCA or Rams. The claims that were unsupported by invoices were documented in the AHCA audit. A substantial number of invoices were not produced by Rams and are presumed lost during the renovation. From the invoices Rams provided, the analyst determined that there was three wholesalers who provided drugs to Rams during the audit period. The analyst wrote to the three wholesalers and asked them to provide lists of Rams' purchases of the "top twenty" drugs from them during the audit period. The purchase information print-outs received from Rams' three suppliers were of some assistance in reconstructing Rams' purchases. The request for invoices and purchase information and the responses received by the analyst were admitted into evidence as part of the Final Agency Audit Report. In this case, the analyst had a shelf inventory taken by the fiscal agent during a visit to the pharmacy on August 5, 1998, the date which the analyst chose as the start date of the audit period. That inventory was admitted into evidence as part of the Final Agency Audit Report. To obtain the total quantity of the twenty audited drugs purchased by Rams during the audit period by, the analyst (1) took the quantity of drugs listed in the August 5, 1998, shelf inventory; (2) added the quantity purchased on invoice from Rams' three suppliers; and (3) the total on the invoices provided by Rams. The analyst testified that she did not double count any purchase information for the audit period. She then compared the total quantity of drugs purchased by Rams, as evidenced by the invoice records, to the "reimbursed claims" for the twenty audited drugs. The quantity of drugs for which Rams was reimbursed exceeded the quantity of drugs purchases on documented invoices. The dollar value of those undocumented drugs is what AHCA seeks to recoup. Based upon that analysis, Rams was sent a Preliminary Audit Report on January 10, 2001, which alleged an overpayment of $390,327.19. A Final Agency Audit Report was issued on May 18, 2001, claiming an overpayment of $390,327.19. During the course of preparing for the hearing the amount of "overpayment" was recalculated by the analyst several times based upon: (1) additional invoices subsequently provided by Rams; and (2) additional purchase information previously provided to AHCA by one of the three suppliers, which AHCA had inadvertently overlooked during the initial review of the data. The final overpayment alleged by AHCA continued to be adjusted over the course of the hearing, and was finally set at $299,758.61. AHCA asserts that Rams was overpaid this amount for the audited drugs based on Rams' inability to establish through invoices or other purchase documentation that it actually purchased those drugs from legitimate sources.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law set forth herein, it is RECOMMENDED: That a final order be issued to recoup $299,758.61. DONE AND ENTERED this 22nd day of June, 2005, in Tallahassee, Leon County, Florida. S __ STEPHEN F. DEAN Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings This 22nd day of June, 2005.
Findings Of Fact Respondent, Jeffrey A. Chance, is and has been at all times material to both Administrative Complaints, a licensed physician in the State of Florida having been issued license number MEO14972. On October 13, 1983, an Administrative Complaint against Respondent was filed, which resulted in a Stipulation being entered into between Petitioner and Respondent on January 12, 1984. By its Order filed March 2, 1984, approving and adopting the Stipulation between Petitioner and Respondent, the Board of Medical Examiners directed Respondent to submit carbon copies of all Schedule II controlled substance prescriptions written by him to the Department of Professional Regulation and the Board of Medical Examiners, on a bi-monthly basis. During the period between May 1984 and December 1984, Respondent filed with Petitioner copies of 70 prescriptions that he wrote for Schedule II controlled substances. During that same period of time, however, he failed to submit copies of a total of twelve (12) prescriptions that he had written for Percocet-5 which is a Schedule II controlled substance, pursuant to Chapter 893, Florida Statutes. When Petitioner brought to Respondent's attention his failure to file all required prescriptions, Respondent readily admitted having written the 12 prescriptions and indicated to Petitioner's investigator that he was in error in neglecting to send copies of the prescriptions to Petitioner as required by the conditions of his probation. Respondent also admitted in deposition that his failure to submit the prescriptions was unintentional and that he did not think that he was violating his probation. He further stated that the persons for whom he had written the prescriptions were persons who were not only patients of his but personal friends as well for whom he personally had the prescriptions filled. Since the Petitioner's (and therefore the Respondent's) discovery of the uncopied prescriptions, Respondent has begun using carbonless prescription pads, and there have been no recurrences of this problem. The second Administrative Complaint herein charges Respondent with failure to properly document patient records. The parties in their pre-trial stipulation stipulated as to the testimony of two witnesses to be considered as expert witnesses. It was further stipulated that if called to testify as a witness, Petitioner's expert would testify that Respondent's admitting note in the hospital records of one patient was illegible and that Respondent's discharge summary was inadequate because it did not mention a myocardial infarction as the cause of death. It was further stipulated that Respondent's expert would testify that Respondent's admitting note was legible and that the discharge summary was adequate. Further, Respondent's expert witness disagrees that a myocardial infarction was the cause of death, indicating that one could not determine the cause of this patient's demise absent an autopsy. When asked to read his charts and records in deposition, Respondent was able to do so.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is, RECOMMENDED that a Final Order be entered dismissing the Administrative Complaint against Respondent in DOAH Case No. 86-3339 but finding Respondent guilty of the allegations contained in the Administrative Complaint filed in DOAH Case No. 86-2968 and reprimanding him therefor. DONE and RECOMMENDED this 5th day of February, 1987, at Tallahassee, Florida. LINDA M. RIGOT, Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 5th day of February, 1987. APPENDIX TO RECOMMENDED ORDER IN CASE NOS. 86-2968,86-3339 In its proposed recommended order, Petitioner submitted a single set of proposed findings of fact as to both DOAH Case Nos. 86-2968 and 86-3339. Each of Petitioner's proposed findings of fact has been adopted in this Recommended Order either verbatim or in substance. In his proposed recommended order, Respondent submitted one set of proposed findings of fact as to DOAH Case No. 86-2968 and a second set of proposed findings of fact as to DOAH Case No. 86-3339. Respondent, however, used the same numbers in numbering both sets of proposed findings of fact. As to DOAH Case No. 86-2968, Respondent's proposed findings of fact numbered 2, 3, 4, 5, 6, the first sentence of 7, and the first three sentences of 13 have been adopted either verbatim or in substance in this Recommended Order. The remainder of Respondent's proposed findings of fact have been rejected as follows: 1 as not constituting a finding of fact; 7 (other than the first sentence), 8, and 14 as being unnecessary; and 9, 10, 11, 12, and the last two sentences of 13 as being immaterial. As to DOAH Case No. 86-3339, Respondent's proposed findings of fact numbered 2, 5, and 6 have been adopted either verbatim or in substance in this Recommended Order. The remainder of Respondent's proposed findings of fact have been rejected as follows: 3 and 7 as being unnecessary; and 1, 4, and 8 as not constituting findings of fact. COPIES FURNISHED: Julie Gallagher, Esquire Department of Professional Regulation 130 N. Monroe Street Tallahassee, Florida 32301 Joel S. Fass, Esquire 626 N.E. 124 Street North Miami, Florida 33161 Deborah J. Miller, Esquire 2100 Ponce de Leon Boulevard Suite 1201 Coral Gables, Florida 33134 Dorothy Faircloth Executive Director Board of Medical Examiners Department of Professional Regulation 130 N. Monroe Street Tallahassee, Florida 32301 Fred Roche Secretary Department of Professional Regulation 130 N. Monroe Street Tallahassee, Florida 32301
The Issue Whether Petitioner is liable to Respondent for Medicaid overpayments, fines, interests, and costs, pursuant to the Agency’s Final Agency Audit Letter of May 2, 2001 (hereinafter FAAL), in the amount of $194,526.97.
Findings Of Fact The Parties Petitioner Petitioner, Lifeline Pharmacy, is a retail pharmacy formed in early 2000. Martin Calano is the owner and president of Lifeline. It is co-owned by his wife, Barbara Calano, who serves as the treasurer; Frank Hernandez, who oversees the pharmacy operations; and Imada Hernandez. None of the pharmacy's owners has an educational background in pharmacy or Medicaid regulations. Dr. William Bebell is the sole pharmacist employed by Lifeline Pharmacy. He is responsible for managing the prescriptions and has been involved with the practice of pharmacy for 25 years. Respondent Respondent, Agency for Health Care Administration (AHCA), is the state agency charged with administration of the Medicaid program in Florida under Section 409.907, Florida Statutes. As one of its duties, Respondent must recover overpayments paid to providers by the Medicaid program. The term "overpayment" is statutorily defined to mean "any amount that is not authorized to be paid by the Medicaid program whether paid as a result of inaccurate or improper cost reporting, improper claiming, unacceptable practices, fraud, abuse, or mistake." See Section 409.913(1)(d), Florida Statutes. Petitioner participated in the Medicaid program, under contract with Respondent, from December 17, 1999 through April 21, 2000, and was issued provider number 021780800. In 1999, Respondent hired Heritage Information Systems ("Heritage") to perform audits of various Medicaid providers. Louis Elie, an auditor employed with Heritage since 1999, is responsible for auditing retail home infusion pharmacies. He is a pharmacist with a degree from Howard University, registered in the State of Virginia, and has practiced for over ten years. He has worked in a retail pharmacy for five years coordinating home infusion therapies, and has worked at Medical College of Virginia, a teaching institution that has a community pharmacy embedded in a home infusion pharmacy that services the community. William Thomas is an investigator for Heritage and serves as the project manager for the Florida Medicaid audits. He has a B.A. in economics, a B.S. in pharmacy, and is a licensed pharmacist in Florida. Kelly Rubin is employed by AHCA within the Medicaid Program Integrity (MPI) office as a pharmacy investigator. The MPI office audits health care providers who participate in the Medicaid program and reviews the provider's compliance with applicable statutes, rules, and policies regarding billing Medicaid for services rendered. Ms. Rubin has been a licensed Florida pharmacist for approximately nine years, and was a pharmacy tech for approximately eight years. She has experience in hospital and retail pharmacy, and has served as the director of a home infusion pharmacy. As an investigator employed by Respondent, Ms. Rubin reviewed Petitioner's pharmacy records as well as the audit performed by Heritage. Upon review of the records and the Heritage audit, Ms. Rubin and the MPI office calculated the amount of Petitioner's overpayment and issued the FAAL with supporting documentation. The Audit During the four-month time period reviewed in the audit, Petitioner submitted 744 prescription claims to Medicaid totaling $445,713.19 and received payment for each of them. Respondent, acting as the state's enforcement arm of the Medicaid program, chose to audit 329 of Petitioner's 744 claims. Specifically, Respondent selected 128 of the 744 claims to be audited through a judgmental sample analysis and 201 claims from the remaining 616 claims to be audited through a random sample analysis. On May 15, 2000, Respondent, and its contract auditor Heritage, arrived unannounced at Petitioner's place of business to conduct the in-depth audit. The audit team was met by Petitioner's sole pharmacist, Dr. Bebell, who was responsible for managing the prescription records. Upon their arrival, Dr. Bebell was provided a list of 329 provider claim prescription numbers selected by Respondent for review. Although the audit team did not specify the precise records it needed, the auditors instructed Dr. Bebell to provide "all" records pertaining to the selected prescriptions, purportedly filled by the pharmacy during the December 17, 1999 through April 21, 2000, audit period. In response, Dr. Bebell provided the auditors with the prescription records, invoice records, and financial records of the specific prescriptions requested. It is apparent, however, that at some point during the first day of the audit, Petitioner retrieved some records back from the audit team prior to review. During the audit, the team reviewed each record provided by Dr. Bebell and occasionally requested Dr. Bebell to produce additional prescription records for a given claim. Any additional records provided by the pharmacist were considered by the auditors. Although the communication between the parties appeared to be strained, the auditors remained at Petitioner's place of business for four days and interacted with Dr. Bebell on a regular basis. At the conclusion of the audit on the fourth day, the auditors departed the pharmacy. A formal exit conference, involving Petitioner's counsel, was not held. Audit findings Judgmental sample As indicated, the auditors selected 128 of the 744 claims for review through a judgmental sample analysis. Using this technique, the auditors reviewed each claim and identified discrepancies with the rules, laws, and policies governing both the Medicaid Program and the practice of pharmacy, and assessed a monetary sanction for each discrepancy. In the judgmental sample, the auditors cited 81 alleged discrepancies that were predominately attributed to unauthorized refills ("UR"), original hard-copy prescriptions that could not be found ("CF"), and oral prescriptions that were not properly documented ("MISC"). The monetary sanctions totaled $172,410.84. Random sample The audit team also utilized a mutually exclusive random sample to review claims. The random sample consisted of 201 claims selected at random from the remaining population of 616 Medicaid provider claims. In the random sample, the auditors again looked at each claim and identified discrepancies with the rules, laws, and policies governing both the Medicaid Program and the practice of pharmacy. However, in this review, the auditors also calculated a claim discrepancy average and multiplied it by the remaining population of 616 claims. During the random sample review, Respondent discovered 58 discrepancies that averaged $51.546661 per claim. Thereafter, the random sample average was extended to the remaining population of claims in the judgmental sample and totaled $31,752.71. For added confidence in the extrapolated findings and to mitigate any "over penalizing," Respondent calculated the 95 percent one-sided lower confidence limit of the extrapolated random sample and reduced the applied discrepancy amount to $22,116.13. The random sample and judgmental sample discrepancy amount were aggregated and a monetary sanction in the amount of $194,526.97 was assessed against Petitioner for the overpayment. Respondent's case At the administrative hearing, during Respondent's case-in-chief, counsel for Respondent introduced an exhaustive list of 35 exhibits relating to the audit, presented the testimony of Mr. Thomas, Mr. Elie, and Ms. Rubin, and explained each discrepancy documented during the audit. Respondent presented evidence identifying the 152 discrepancies identified in the audit report. Specifically, the auditors cited: 23 "CF" discrepancies where the original hard-copy prescription could not be found on file during the audit; 50 "UR" discrepancies where the number of refills billed and paid to the pharmacy exceeded the number authorized by the prescribing physician; 4 "OBQ" discrepancies where the quantity paid exceeded the quantity authorized by the prescribing physician; 1 "EQL" discrepancy where the quantity paid exceeds the limit set by the Medicaid Plan; 6 "DS" discrepancies where the day's supply value submitted by the pharmacy was not consistent with the quantity and directions prescribed; 1 "WDB" discrepancy where the pharmacy submitted a claim for medication that was different from the medication dispensed; 1 "NDEA" discrepancy where the hard-copy prescription did not contain a DEA number as required; and 64 "MISC" discrepancies where the telephone prescription orders were not reduced to writing. Petitioner's Case Following Respondent's case-in-chief, counsel for Petitioner introduced seven exhibits; presented the testimony of four witnesses including Mr. and Mrs. Calano, Mr. Hernandez and Dr. Bebell; and strenuously attacked the actions, motivations and findings of Respondent. Specifically, Petitioner alleged that the 23 documented "CF" discrepancies, relating to missing prescriptions, actually existed and were available at the time of the audit. Petitioner argued that the missing prescriptions were subsequently "found," introduced into evidence at hearing, available to Respondent, and entitled them to relief. Petitioner's assertions and the newly found prescriptions are highly suspect and summarily rejected. Respondent proved the 23 "CF" discrepancies by a preponderance of the evidence. Petitioner also argued that the 50 "UR" discrepancies, representing unauthorized refills, identified in the audit report, were in fact authorized. Specifically, Petitioner claimed that the abbreviation "IV," written in Rx numbers 50619, 50622, 50623, 50631, 50638, and 50641, and cited for 20 discrepancies, stood for "4" refills and not the term "intravenous." Dr. Bebell testified under oath that he utilized the abbreviation in each of the 20 discrepancies to reflect the numeral "4" and not the term "intravenous." Petitioner's assertion regarding these 20 cited "UR" discrepancies are not accepted for several reasons. First, Respondent demonstrated that the excessive number of refills would have been inappropriate therapy. Second, Petitioner's position does not comport with standard pharmacy practice. Third, Petitioner's assertion and Dr. Bebell's testimony are directly inconsistent with Dr. Bebell's routine use of standard numerals within his written prescriptions. In fact, there appear to be no Roman numerals within any of his prescriptions. And finally, accepting the argument that "IV" actually meant "4" creates unreasonable inconsistencies and ambiguities within Dr. Bebell's written prescriptions. For these reasons, Petitioner's assertion is without credit. Respondent proved the 20 cited "UR" discrepancies by a preponderance of the evidence. With respect to the 30 remaining "UR" discrepancies relating to Rx numbers 50624, 50631, 50632, 50633, 50634, 50635, 50723, 50280, and 50330, Petitioner demonstrated that the prescriptions were valid, often included both the prescribing doctor and pharmacist's signature, occasionally were not billed for refill, and in fact were authorized. Respondent failed to prove the 30 above-cited "UR" discrepancies by a preponderance of the evidence. Petitioner also contested three of the four "OBQ" discrepancies relating to the quantity paid exceeding the quantity authorized, and specifically conceded to Rx number 50505. Petitioner presented credible evidence that Petitioner properly received Medicaid payment for the precise medicine prescribed by Dr. Contreras in Rx numbers 50331 and 50463, as well as the precise medication (30 tablets plus one refill) prescribed by Dr. Folkerth in Rx number 50548. Respondent proved, by a preponderance of the evidence, the single "OBQ" discrepancy conceded by Petitioner in Rx 50505. Petitioner argued that Rx number 50678, cited as a discrepancy due to the quantity paid exceeded the Medicaid Plan, was proper. Respondent proved the single "EQL" discrepancy by a preponderance of the evidence. Petitioner contested the six "DS" discrepancies identified in the audit report relating to Rx numbers 50505, 50331, 50451, 50463, 50548, and 50678, and argued that the day's supply value submitted by the pharmacy was consistent with the quantity and directions provided by the physician. Respondent failed to prove the discrepancies related to Rx numbers 50331, 50463, and 50548, and applied no penalty to Rx number 50451. Respondent proved the two "DS" discrepancies relating to Rx numbers 50505 and 50678 by a preponderance of the evidence. Respondent proved, by a preponderance of the evidence, the single "WDB" discrepancy relating to Rx number 50308. Respondent proved, by a preponderance of the evidence, the single "NDEA" discrepancy relating to Rx number 50740. And finally, counsel for Petitioner strongly contested the 64 "MISC" discrepancies identified in the audit report that allege Dr. Bebell failed to properly reduce telephone prescriptions to writing. Petitioner suggested that, at best, the "MISC" discrepancies were "technical" and should not be assessed. While the evidence proves that Petitioner often received its prescriptions via physician telephone orders, it is clear that these records were not received, recorded, managed and maintained in the method provided by law. In fact, at the time of the audit, Petitioner indicated that they were in the initial stages of setting up the pharmacy and had problems with paperwork. Dr. Bebell admitted that he was unfamiliar with the computer system, kept prescription records in patient charts rather than in the computer, and did not understand many of the regulations governing prescription records including telephone orders. He testified that "according to regulation either myself or one of my staff members reduce the verbal order . . . to writing immediately," notwithstanding the fact that Dr. Bebell is the only registered pharmacist on staff and the only individual legally permitted to accept and sign the prescription. While Petitioner further argues that the telephone orders relating to the 64 "MISC" discrepancies were properly reduced to writing and later signed by the pharmacist shortly after taking the order, the evidence demonstrates otherwise. Scanned images of Petitioner's prescription records, taken at the time of the audit, clearly demonstrate that telephone prescription orders were improperly received, signed and recorded. Furthermore, Dr. Bebell admitted that he occasionally did not sign each telephone order prescription as required by law. Petitioner further asserts that the scanned images were only draft documents and the newly provided, signed prescription documents are the actual prescriptions. Petitioner's new evidence relating to the 64 "MISC" discrepancies is suspect and not accepted. The 64 "MISC" discrepancies identified verbal orders allegedly taken by a registered pharmacist and not signed by that pharmacist. Standard pharmacy practice, as well as state and federal law, require pharmacists to reduce telephone prescription orders to writing immediately upon receipt. Respondent proved, by a preponderance of the evidence, all of the 64 "MISC" discrepancies including Rx numbers 563, 565, 602, 639, 723, 821, 829, 131, 133, 271, 275, 276, 278, 279, 280, 281, 282, 283, 284, 286, 287, 296, 306, 311, 330, 341, 344, 365, 389, 390, 411, 412, 475, 477, 478, 479, 529, 537, 538, 539, 552, 556, 557, 558, 564, 676, 704, 705, 706, 708, 709, 713, 714, 716, 740, 779, and 885. A total recovery for each of those claims to Medicaid is appropriate.
Recommendation Based upon the foregoing Findings of Facts and Conclusions of Law, it is recommended that: Respondent shall recalculate the monetary sanctions, excluding the 30 "UR," three "OBQ," and four "DS" discrepancies identified in the Findings of Fact, utilizing the same statistical formula. Petitioner shall repay Respondent the recalculated monetary sanction, plus interest derived from April 6, 2001 through December 1, 2002, at the statutory rate, within a reasonable period of time agreed to by both parties. Petitioner shall not be obligated to pay any other costs or fees related to this matter. DONE AND ENTERED this 8th day of March, 2002, in Tallahassee, Leon County, Florida. WILLIAM R. PFEIFFER 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 8th day of March, 2002. COPIES FURNISHED: Kelly A. Bennett, Esquire Agency for Health Care Administration 2727 Mahan Drive, Suite 3431 Fort Knox Building III Tallahassee, Florida 32308-5403 Craig A. Brand, Esquire Brand & Fernandez, P.A. 2 Northeast 40th Street Suite 403 Miami, Florida 33137 Julie Gallagher, General Counsel Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building, Suite 3431 Tallahassee, Florida 32308 Diane Grubbs, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building, Suite 3431 Tallahassee, Florida 32308
Findings Of Fact The Petitioner is the Department of Professional Regulation, Board of Pharmacy. Petitioner seeks to suspend, revoke or take other disciplinary action against the Respondents. Respondent BGJM, Inc. (hereinafter "Save-on Drugs") holds Permit No. 7171 located at 4282 North State Road 7, Lauderdale Lakes, Florida. Save on Drugs has held said permit at all times material hereto. Respondent Robert E. Levy holds Pharmacy License No. 0017283 and has held said license at all times material hereto. Respondent Levy operated Save on Drugs as the sole proprietor and is the only pharmacist employed at the aforementioned store. Respondent Levy, while working at Save on Drugs, between the dates October 16, 1981 and April 2, 1982, dispensed approximately 139,000 Methaqualone tablets on 3,136 prescriptions. Respondent Levy ceased dispensing Methaqualone tablets approximately three (3) weeks prior to the institution of Petitioner's investigation of Respondent Levy's dispensing of controlled substances. The Respondent dispensed, over a three-month period, some 57,250 units of Methaqualone on behalf of one practitioner, a Dr. Lena. A specific breakdown of Dr. Lena's prescribing activity for part of the relevant period is as follows: DATE PHARMACY DRUG AMOUNT SCRIPT 12/14/81 Save-On Quaa-300 mg. 630 14 12/15 Save-On 720 16 12/16 Save-On 495 11 12/17 Save-On 765 17 12/18 Save-On 1,440 32 12/21 Save-On 945 21 12/22 Save-On 1 x 30 mg. 675 15 12/23 Save-On incl. 1,080 24 12/24 Save-On 1,215 27 12/28 Save-On 1,035 23 12/29 Save-On 1,305 29 12/30 Save-On 1,575 35 12/31 Save-On 1,305 29 Totals 13,185 293 The numerous prescriptions introduced into evidence by the Petitioner reflect circumstances where Respondent Levy failed to properly initial and date Schedule II prescriptions as they were filed. As example, Petitioner offered the following: prescription Nos. 48854, 48052, 50189, 48068, 48856, 48912 and 48905. Louis Fisher 2/ , an employee of the Department of Justice, Drug Enforcement Administration, since approximately November, 1971, has been involved with the regulation of controlled substances. Mr. Fisher works with doctors as well as pharmacists at the retail level. Mr. Fisher is a registered pharmacist and has been charged with drafting regulations for controlled substances. Without question, Methaqualone is a Schedule II drug and is a sedative and hypnotic agent. The drug has a high abuse potential. During the summer of 1982, Methaqualone was changed from Schedule II to a Schedule I controlled substance. After being provided with a hypothetical situation giving the number of prescriptions that Respondent Levy had filled during the time period involved, Mr. Fisher concluded that a pharmacist filling the number of prescriptions within the time period as is here involved by Respondent Levy was, in Mr. Fisher's opinion, unprofessional, excessive, outside the course of good professional practices, and not conduct amounting to professional practice in the patients' best interest. 3/ Dr. Lena was employed by Northeast Medical Services, a stress clinic. In this regard, the parties stipulated that all the prescriptions involved herein were written by a licensed medical doctor. Daniel O'Connell, an investigator with the Department of Professional Regulation, visited the Respondent's store during approximately October 1981, and performed a routine change of ownership inspection. At that time, Respondent Levy engaged in a conversation with investigator O'Connell at which time Respondent Levy was apprised of the problem with respect to dispensing Methaqualone in the south Florida area. Jim R. Golden, an investigator with the Department of Professional Regulation since approximately September 1981, visited Respondent Levy's store during April 1982, to perform a routine inspection to determine the amount of Schedule II drug prescriptions that Respondent was filling. Investigator Golden reviewed a large number of prescriptions that were filled by Respondent for Dr. Lena and inquired of Respondent the reason for dispensing such a large number of prescriptions for Methaqualone tablets. Respondent Levy replied that it was the "money end of it" and that he (Respondent) could fill six (6) Methaqualone prescriptions and do better with those prescriptions from a profit viewpoint than he could with the remainder of his other prescribing activities in the store for the remainder of any given day. Further, Respondent related that he hand to do extensive repairs to make the store operational. (Testimony of Investigator Golden)
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is hereby RECOMMENDED: That Respondent BGJM, Inc.'s Permit No.7171 be REVOKED. That Respondent Robert E. Levy's Pharmacy License No. 0017283 be placed on probation for a period of two (2) years. RECOMMENDED this 12th day of May, 1983, in Tallahassee, Florida. JAMES E. BRADWELL, Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 12th day of May, 1983.
