Findings Of Fact Respondent holds community pharmacy license No. PH0007711, renewed January 13, 1983. On May 21, 1981, Lester J. Henderson signed a new establishment permit application as owner, officer, manager and registered pharmacist. On June 9, 1981, petitioner conducted a new establishment inspection of Tampa Park Plaza Pharmacy. On June 19, 1981, Mr. Henderson wrote that "Andrew Mobley is no longer the Pharmacy Manager of Tampa Park Plaza Pharmacy, but I am . . . ." Petitioner's Exhibit No. 1. Petitioner received this notification on June 24, 1981, and, on the following day, wrote Mr. Henderson "to advise that effective as of June 19, 1981, our records were amended to reflect that you are the pharmacist manager." MBHS Corp., Inc. (MBHS), owns Tampa Park Plaza Pharmacy, (the pharmacy) and MBHS is owned in turn by its three officers. MBHS' president, Andrew Mobley, and Lester Henderson, an MBHS vice-president, are registered pharmacists. Samuel Snowden, also an MBHS vice-president and the third stockholder, is not a pharmacist. After the pharmacy opened for business, Andrew Mobley left Florida, and left the every day operation of the pharmacy to Lester Henderson, whom he knew to have had no retail experience as a pharmacist. In December of 1981, Mr. Mobley returned from Oklahoma to find a complete dearth of pharmaceutical records. Mr. Henderson explained that he did not like paperwork. Mr. Mobley returned to Oklahoma, again leaving the every day operation of the pharmacy to Mr. Henderson, but returned to Tampa when a bank that had made the pharmacy a loan threatened to call it in. He found scheduled drugs mixed in together, with unscheduled drugs, and a continued lack of records. Mr. Mobley then set up an inventory control book, something that had been neglected to that point. It developed that some Dilaudid was missing, which seemed to be news to Mr. Henderson. Mr. Mobley told Mr. Henderson the fact that the drugs were missing would have to be reported to the Department of Professional Regulation and Mr. Mobley got forms from the Department of Professional Regulation's office on Henderson Boulevard, which he gave to Mr. Henderson to fill out. Mr. Henderson never did fill them out and reportedly said "Andrew . . . must be crazy if he thinks I'm going to fill out those papers and send them in to those people." (T. 35) Mr. Mobley worked with Mr. Henderson in an effort to straighten out record keeping at the pharmacy, but also took a job at Walgreen's beginning in February of 1983. He left this job in June to take over from Mr. Henderson as pharmacy manager at the pharmacy. Mr. Henderson has not been employed at the pharmacy since. Edward G. Bludworth and Merry L. Paige, investigators in petitioner's employ, visited the pharmacy about ten o'clock on February 16, 1983. The prescription department was open; it was unlocked and there was no "closed" sign, but there was no pharmacist on duty. When the investigators asked to speak to the pharmacist, the store clerk made several telephone calls. She was only able to locate Mr. Henderson at about two o'clock, after the investigators had left. Mr. Bludworth and Ms. Paige conducted an audit of scheduled drugs at the pharmacy on February 16, 1983. Because of the lack of an inventory report as of the spring of 1981, they assumed no drugs on hand as of June 9, 1981. On this assumption they concluded that 296 tablets of Dilaudid 2 mg. were missing and unaccounted for. Dilaudid contains dihy dromorphinone [sic]. On the same assumption, they found a shortage of 41 Percodan tablets, which contain oxycodone, and an overage of 97 Demerol tablets 50 mg. Petitioner's Exhibit No. During the audit period, the pharmacy purchased 400 tablets of Dilaudid 2 mg. and 500 Percodan tablets. Id. The discrepancies uncovered by the audit exceeded significantly the five percent error rate that the investigators commonly see. Mr. Bludworth and Ms. Paige returned for a second visit on April 19, 1983, at about ten o'clock in the morning. Once again, the prescription department was unlocked and open. There was no "closed" sign and no pharmacist to be seen. This time Mr. Henderson's presence was procured by noon. On one of their visits, Mr. Henderson told the investigators that there had been a break-in at the pharmacy more than a year earlier. He said he had reported the incident at the time to the authorities but was unable to produce documentation of any such report. The investigators requested such documentation at the time of the visit, and Ms. Paige later telephoned him to ask again for documentation.
Recommendation Upon consideration of the foregoing, it is RECOMMENDED: That petitioner suspend respondent's license for one (1) year. DONE and ENTERED this 20th day of October, 1983, in Tallahassee, Florida. ROBERT T. BENTON II 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 20th day of October, 1983. COPIES FURNISHED: Bruce D. Lamb, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Andrew Mobley Tampa Park Plaza Pharmacy 1497 Nebraska Avenue Tampa, Florida 33602 Fred M. Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Wanda Willis, Executive Director Department of Professional Regulation Board of Pharmacy 130 North Monroe Street Tallahassee, Florida 32301 =================================================================
The Issue Whether Petitioner’s application for a license as a Registered Pharmacy Technician should be approved.
Findings Of Fact On May 22, 2008, based on a plea of nolo contendere, Petitioner was adjudged guilty of the offense of Unlawful Sexual Activity with a Minor, a second-degree felony. She was placed on five years of Sexual Offender Probation. The special conditions of Petitioner’s probation included the following: a. Restitution to the victim in the amount of $425.00; b. No contact with the victim; and c. Attend parenting classes. The standard conditions of Sex Offender Probation were imposed upon Petitioner, including: (a) A mandatory curfew from 10 p.m. to 6 a.m.; (b) A prohibition on living within 1,000 feet of a school, day care center, park, playground, or other place where children regularly congregate; (c) Participation in a sex offender treatment program; (d) No contact with any children under the age of 18, unless court approved; and (e) A prohibition on working for pay or as a volunteer at any place that children regularly congregate, including but not limited to any school, day care center, park, playground, pet store, library, zoo, theme park or mall. On October 5, 2009, Petitioner submitted an application for licensure as a Registered Pharmacy Technician. On December 9, 2009, the Board voted to deny Petitioner’s application. A Notice of Intent to Deny reflecting the vote was filed on December 31, 2009. Petitioner testified that she has been a pharmacy technician since 1981. There was no evidence presented, however, indicating that Petitioner has been licensed in Florida as a Registered Pharmacy Technician. Petitioner is currently employed by Randolph Margrave, preparing intravenous medications (IVs) and supplies for administering to patients in their homes. She works in a clean room under a hood in an isolated barrier. She has no contact with the public, and she has no contacts with the patients. Although her position does not require Petitioner to review patient records, she has access to patient records. According to her current employer, Petitioner does an excellent job. Prior to her current position, Petitioner worked in a retail pharmacy from 1981 to 1989. From 1989 to 1999 she worked in the pharmacy department of a hospital. Petitioner’s current employment does not require her to have contact with the public. Petitioner described the circumstances that led to her arrest and subsequent conviction. She testified that she performed oral sex on her daughter’s seventeen-year-old boyfriend. In her testimony, Petitioner stated: My daughter’s boyfriend was very abusive. We got a restraining order against him, and they only granted it for two weeks, temporary. And he threatened me through her. And as it turned out, I made a bad decision. And it was an oral sex one time and . . . [h]e was 17 years old at the time. Petitioner testified that her daughter’s boyfriend was a very mature 17-year-old. Petitioner further testified: And I thought my daughter’s life was being threatened, and it was like making a deal with the devil. And it was a one-time thing and a very bad thing. In a typical retail pharmacy setting, a pharmacy technician is the first point of contact for patients that drop off or pick-up a prescription. A pharmacy technician in a retail setting gathers the patient’s information, enters it into the computer, prepares the label and counts and pours the medication. Pharmacy technicians have access to personal information of the patients that patronize the pharmacy. This information includes but is not limited to the patient’s name, gender, phone number (including cell number), address, allergy information and prescription medication history. Minors may purchase and pick-up medications from a pharmacy. A licensed Registered Pharmacy Technician may practice at any location without restriction.
Recommendation Based on the forgoing Findings of Fact and Conclusions of Law, it is RECOMMENDED: That the Board of Pharmacy enter a final order denying Celeste Donald’s application for licensure as a Registered Pharmacy Technician. DONE AND ENTERED this 30th day of June, 2010, in Tallahassee, Leon County, Florida. S JAMES H. PETERSON, III Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 30th day of June, 2010.
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 The Respondent, Natalie Patton, is a licensed pharmacist and has been licensed since 1959. She is a graduate of Sanford University, Birmingham, Alabama, and was initially licensed in Alabama as a pharmacist. She has worked as a licensed pharmacist for twelve years in Highlands County in the vicinity of Sebring. She is licensed as a pharmacy consultant as well and has been employed at several hospitals and pharmacies in that geographical area. She opened her present pharmacy' business in November, 1978, in a rural area southwest of Sebring at the community of Spring Lake. Her's is the only pharmacy in seventeen miles and her business volume reflects the rural nature of her business location and clientele in that she fills an average of thirty-five to fifty prescriptions a day. On "Race Friday," the day prior to the Sports Car Race at Sebring, a man entered her pharmacy complaining of severe headache and allergy to fumes associated with the infield and pits at the racetrack. He asked for Darvon, explaining that this was the only medication successful in treating his headaches. He explained he was from another part of the State and had no way to contact his physician. She sold him a non-prescription drug. He came back the next day, the day in question, March 22, and explained that her suggestion that he go to the emergency room the day before was impractical because a newspaper ad he had seen described the emergency room as overloaded and turning patients away. He complained of a worsening headache. She testified that she felt sympathy for him and ultimately and reluctantly sold him, at her cost, four Darvon to be used that Saturday and four for that Sunday. The individual requesting the medication then revealed himself to be a Deputy Sheriff of Highlands County, who arrested her on the spot, charging her with dispensing the Darvon without a prescription in violation of the above authority. She ultimately was tried on the charges and convicted, but adjudication was withheld and she was placed on three years probation by the Circuit Judge. A second related criminal charge was ultimately dismissed. She has been under the direction of a probation officer since that time and must report all her activities and receive permission before traveling out of her county. She also has been required to pay fifty dollars a month to reimburse the public defender for his services on her behalf. She is still operating her business and her customers have professed loyalty to her and her business is still increasing in volume. She has never had any altercation with law enforcement authorities of any type in her past and has never been convicted of any felony or misdemeanor. With the agreement of counsel for the Petitioner, certain testimonial letters on her behalf from persons who were not in attendance at the hearing were admitted as composite exhibit 1. These letters attest to and establish the fact, in corroboration of her testimony, that she is a decent and useful citizen and that she was totally unaware that she was committing a felonious act. These letters corroborate her testimony and establish that she is a crucial asset to her rural community. She is depended upon by numerous citizens, many of whom are of advanced years and who require frequent medication and are unable to travel any great distance. She has obviously gone to great lengths to operate her business in a professional and compassionate manner even to the extent of delivering medications to senior citizens and others long after the closing hours of her pharmacy. These letters in support of her position also are replete with instances described where she adheres strictly to the dictates of the various physicians' prescriptions and refused on a number of occasions to prescribe medication without a prescription. There is no question that the evidence in this record establishes that the Respondent is clothed with the highest personal integrity and moral character and that the isolated incident when she dispensed medication in violation of the above authority is not characteristic of the regular and otherwise consistent manner in which she practices pharmacy and conducts her business. The Respondent's probation officer sent a letter which is incorporated in Respondent's Exhibit 1 attesting to her conscientious efforts to obey the law and her usefulness as a citizen. He expressed the belief that she was unaware that she was actually committing a crime when the subject violation occurred and that she was simply and compassionately attempting to help a customer in trouble. He is convinced that revoking her pharmacy license would serve no useful purpose and would indeed impose a hardship on the rural customers she serves. He firmly believes she would not consciously violate the law or purposefully commit an illegal act. The Respondent was authorized by the Circuit Judge in the Respondent's criminal proceeding to make the following statement on the record in this proceeding: In re Natalie Patton: In open Court, in disposing of this case, and putting Natalie Patton on probation without adjudication, I made note of the numerous letters I received from people in the community, urging the Court to be lenient. The Respondent then noted that there were a hundred and forty signatures on those testimonial letters. At the conclusion of the Respondent's case the Respondent requested that the penalty herein be limited to a letter of reprimand. The Petitioner introduced no evidence and otherwise took no position with regard to the question of an appropriate penalty.
Recommendation Having considered the foregoing findings of fact, conclusions of law, the candor and demeanor of the witness and the evidence in the record, it is RECOMMENDED: That Natalie N. Patton and Spring Lake Pharmacy remain licensed and that Natalie Patton be accorded a written reprimand by the Board regarding the subject violation and that she be placed on probation by the Board for a period of time coextensive with the probation imposed in the criminal proceeding related hereto during which time her conduct of the practice of pharmacy be subjected to periodic monitoring by the Board. DONE AND ENTERED this 2nd day of November, 1981, in Tallahassee, Florida. COPIES FURNISHED: William M. Furlow, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Michael J. Trombley, Esquire 329 South Commerce Avenue Sebring, Florida 33870 P. MICHAEL RUFF, Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 904/488-9675 Filed with the Clerk of the Division of Administrative Hearings this 4th day of November, 1981.
The Issue 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.
