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 At all times material hereto, Respondent Alberto Calil was the owner of Farmacia La Familia, the holder of a permit to operate a pharmacy under the laws of the State of Florida, having been issued permit number 0007056. At all times material hereto, Respondent Hildelisa M. Hernandez has been licensed as a pharmacist under the laws of the State of Florida, having been issued license number 0016352. At all times material hereto, Hernandez has been the managing pharmacist at Farmacia La Familia and, specifically, has been the only pharmacist employed there. Prior to the events alleged in the Administrative Complaints filed herein, Respondent Nelson Torres had an ownership interest in Farmacia La Familia. In February 1982, he transferred his interest in the business, and his shares of stock in the corporation owning the business, to Respondent Calil. At the time of the formal hearing in this cause, Torres did not own or operate a pharmacy. The Miami office of the Department of Professional Regulation received an anonymous letter advising, essentially, that a number of pharmacies were being operated other than in compliance with the law. Georgina Auspitz, an investigator with the Department of Professional Regulation, was instructed by her supervisor to visit each of the pharmacies named in that letter to investigate the allegation. On Friday, March 26, 1982, Auspitz entered the Farmacia La Familia. After a brief conversation with Respondent Hernandez and a customer of the pharmacy, Auspitz asked Hernandez for three dollars' worth of Tranxene 3.75 mg. Hernandez went into the dispensary part of the pharmacy and returned with a manila envelope containing 15 capsules. At no time during this transaction did Auspitz present Hernandez with a prescription. On Monday, March 29, 1982, Auspitz took the envelope and its contents to the Dade County Public Safety Department. A subsequent chemical analysis of the capsules revealed the presence of the controlled substance known as clorazepate, the active ingredient in Tranxene. On April 6, 1982, Auspitz returned to the Farmacia La Familia. She asked Manuel J. Diaz Garcia1 an employee of the pharmacy, for three dollars' worth of Tranxene 7.5 mg. Diaz went into the dispensary part of the pharmacy, had a discussion with an unidentified female, and returned to the main part of the pharmacy to wait on customers. After being advised that the order was ready, Diaz gave Auspitz a manila envelope containing 11 capsules. Auspitz paid Diaz, Diaz placed the money in the cash register, and Auspitz left the pharmacy. At no time during this transaction did Auspitz present to Diaz a prescription. Auspitz took the manila envelope and its contents to the Dade County Public Safety Department. A subsequent chemical analysis of the capsules revealed the presence of the controlled substance known as clorazepate, the active ingredient in Tranxene. After she had made her second "buy" at Farmacia La Familia, Auspitz contacted the City of Miami Police Department to ascertain if one of its narcotics detectives would accompany her on subsequent "buys." As a result of her request, Detective Noel Rojas was assigned to accompany her. On April 8, 1982, Auspitz and Rojas went to the Farmacia La Familia. Crus Caballero, an employee of the pharmacy, approached them. Auspitz told Caballero she wanted three dollars' worth of Ativan, and Rojas told Caballero he wanted five dollars' worth of Valium 5 mg. Caballero wrote something on a scrap piece of paper and went into the dispensary portion of the pharmacy, left the piece of paper, and returned to wait on other customers. Respondent Hernandez came to the door of the dispensary area, "looked over" Auspitz and Rojas, and returned to the dispensary. A few moments later, Caballero brought two manila envelopes to where Auspitz and Rojas were waiting. Although Auspitz had ordered three dollars' worth of Ativan, Caballero only brought her two dollars' worth. After Auspitz agreed to take the smaller quantity, Caballero placed both manila envelopes into one bag, and Auspitz and Rojas paid for their purchases and left the pharmacy. At no time during this transaction did Auspitz or Rojas present Caballero with a prescription. Upon leaving the pharmacy, Auspitz and Rojas separated their purchases. Auspitz took hers to the Dade County Public Safety Department, and Rojas took his to the City of Miami Police Department. The chemical analysis performed on the six tablets purchased by Auspitz revealed the presence of the controlled substance lorazepam, the active ingredient in Ativan. The chemical analysis performed on the 23 tablets purchased by Rojas revealed the presence of the controlled substance diazepam, the active ingredient in Valium. Neither Manuel J. Diaz Garcia nor Crus Caballero is licensed as a pharmacist or registered as a pharmacy intern in the State of Florida.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a Final Order be entered dismissing the Administrative Complaint filed against Respondent Nelson Torres with prejudice; finding Respondents Farmacia La Familia, Alberto Calil and Hildelisa M. Hernandez guilty of each and every count in the Administrative Complaints filed against them; and revoking pharmacy permit number 0007056 issued to Respondents Farmacia La Familia and Alberto Calil, and further revoking pharmacist license number 0016352 issued to Respondent Hildelisa M. Hernandez DONE and RECOMMENDED this 5th day of April, 1983, in Tallahassee, Leon County, 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 April, 1983. COPIES FURNISHED: W. Douglas Moody, Esquire 119 North Monroe Street Tallahassee, Florida 32301 Raul A. Cossio, Esquire 1900 Coral Way, Suite 404 Miami, Florida 33145 Frederick Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Hinton F. Bevis, Executive Director Board of Pharmacy 130 North Monroe Street Tallahassee, Florida 3230123
The Issue Whether the Petitioner must reimburse the Respondent for Medicaid overpayments as set out in the Final Agency Audit Report dated January 24, 2008, and pay an administrative fine, and, if so, the amount of the fine and the amount to be repaid.
Findings Of Fact Based on the oral and documentary evidence presented at the final hearing and on the entire record of this proceeding, the following findings of fact are made: AHCA is the state agency charged with responsibility for overseeing the Florida Medicaid system, including the recovery of overpayments to Medicaid providers. § 409.913, Fla. Stat. Grand Pharmacy Discount was first issued a pharmacy license by the Department of Health on June 3, 2004; the license number was PH20078, and the owner of Grand Pharmacy Discount was Ana M. Grajales. On or about May 19, 2005, Mr. Mohebbi purchased Grand Pharmacy Discount from Ms. Grajales. At that time and at all times material to this proceeding, Mr. Mohebbi was a licensed pharmacist, license number PS33552. On July 6, 2005, Mr. Mohebbi applied to the Department of Health, Board of Pharmacy, for a new pharmacy license for Grand Pharmacy Discount, based on a change of ownership. A new pharmacy license, number PH21403, was issued. On July 10, 2005, Grand Pharmacy Discount, through Mr. Mohebbi, submitted a Florida Medicaid Provider Enrollment Application to AHCA, together with a signed Non-Institutional Medicaid Provider Agreement ("Provider Agreement"). The Florida Medicaid Provider Enrollment Application was submitted by Mr. Mohebbi because of a change in ownership, and the Grand Pharmacy Discount pharmacy license referenced in the application was numbered PH21403. Among the provisions of the Provider Agreement were the following: (5) Provider Responsibilities. The Medicaid provider shall Possess at the time of the signing of the provider agreement, and maintain in good standing throughout the period of the agreement's effectiveness, a valid professional, occupational, facility or other license appropriate to the services or goods being provided, as required by law. * * * (8) Ownership. The provider agrees to give AHCA sixty (60) days written notice before making any change in ownership of the entity named in the provider agreement as the provider. Grand Pharmacy Discount was assigned Medicaid provider numbers 0309401-00 and 0309401-01. At the times material to this proceeding, Mr. Mohebbi was the pharmacy manager for Grand Pharmacy Discount and dispensed all medications.2 On March 30, 2007, David Santiago filed papers with the Florida Department of State incorporating Grand Pharmacy Discount as a limited liability company. Mr. Santiago and Mr. Mohebbi entered into negotiations for Mr. Santiago to purchase Grand Pharmacy Discount, and Mr. Santiago and Mr. Mohebbi had a verbal agreement that Mr. Santiago would pay Mr. Mohebbi a deposit on the business, with the balance due at the time of the sale. In furtherance of his intention to purchase Grand Pharmacy Discount, Mr. Santiago, with the assistance of Mr. Mohebbi, prepared and signed an Application for Pharmacy requesting a new pharmacy license for Grand Pharmacy Discount. It was indicated on the Application for Pharmacy that the application was based on a change of ownership from Mr. Mohebbi to Mr. Santiago, and Mr. Santiago filed the application with the Department of Health on April 2, 2007. A new pharmacy license, license number PH22661, was issued to Grand Pharmacy Discount on April 19, 2007. Mr. Santiago did not fulfill his promise to pay Mr. Mohebbi a deposit on the purchase of Grand Pharmacy Discount, and the negotiations for the purchase and sale terminated. Mr. Santiago and Mr. Mohebbi did not enter into a purchase and sale agreement, and Mr. Mohebbi at no time relinquished ownership or control of Grand Pharmacy Discount, its assets or liabilities, to Mr. Santiago. On June 5, 2007, Mr. Mohebbi submitted an Application for Pharmacy to the Department of Health, Board of Pharmacy, requesting that a new permit be issued to Grand Pharmacy Discount based on a change of ownership; Mr. Mohebbi was listed as the owner. On August 2, 2007, Grand Pharmacy Discount was issued a new pharmacy license, number PH22843. In a letter dated June 13, 2007, AHCA notified Grand Pharmacy Discount that its Medicaid provider numbers had been terminated effective April 19, 2007, because it had been notified that Grand Pharmacy Discount's license number PH21403 had been "closed." AHCA conducted a review of the claims for Medicaid reimbursement submitted by Grand Pharmacy Discount from April 19, 2007, through September 30, 2007. In a Preliminary Audit Report dated October 30, 2007, AHCA notified Grand Pharmacy Discount that it found that Grand Pharmacy Discount was overpaid $10,655.44. On January 24, 2008, AHCA issued the FAR, in which it notified Grand Pharmacy Discount that it owed AHCA a total of $11,655.44, which included the previously-identified overpayment of $10,655.44 and a penalty in the amount of $1,000.00. The reasoning for finding an overpayment was stated as follows: The audit period for this review was from April 19, 2007, through June 5, 2007. Grand Pharmacy Discount, Florida Pharmacy license number PH0021403, located at 2140 N.W. 36th Street, Miami, Florida 33142 was issued Medicaid provider number 030940100 effective July 25, 2005. The Department of Health, due to a change of owners, issued Florida Pharmacy license number PH0022661 for Grand Pharmacy Discount at the same address effective April 19, 2007, which closed the previous license number, PH0021403. Medicaid requires an active pharmacy license for your Medicaid provider number to be valid. Additionally, Medicaid requires providers to notify the Agency of any proposed change of ownership 60 days prior to the date on which that ownership change will occur, per Section 409.907(6), F.S. Paid claims to your provider number were found with dates of service after April 19, 2007, when your pharmacy license was closed. The paid claims identified for the period when your provider number was invalid due to the closed pharmacy license number and ownership change resulted in an overpayment of $10,655.44. The termination date of the Audit Period was changed in the FAR from September 30, 2007, to June 5, 2007. The Audit Period was changed to June 5, 2007, because no Medicaid claims were submitted by Grand Pharmacy Discount after that date. According to AHCA's Documentation Worksheet for Imposing Administrative Sanctions, the $1,000.00 sanction was imposed because of Grand Pharmacy Discount's alleged failure "to report CHOW [Change of Ownership] & allowed unauthorized use of provider # to submit Rx claims." Grand Pharmacy Discount has never been disciplined by AHCA, and AHCA has never sought to recoup any Medicaid overpayments from Grand Pharmacy Discount.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Agency for Health Care Administration enter a final order withdrawing the Final Audit Report issued January 24, 2008, with respect to both the $10,655.44 overpayment and the $1,000.00 administrative fine. DONE AND ENTERED this 21st day of December, 2009, in Tallahassee, Leon County, Florida. PATRICIA M. HART 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 21st day of December, 2009.
Findings Of Fact Respondent, William van der Velden, was at all times material hereto a licensed pharmacist in the State of Florida, having been issued license number 0017023. During the month of October, 1985, while employed as a relief pharmacist at Lakeside Pharmacy, Pompano Beach, Florida, Respondent personally placed a flyer on the door of approximately 100 neighborhood residents which read as follows: We make house calls! I can cut your medical costs and save you hundreds to thousands of dollars each year! Now, you may not have to see your physician in order to be issued a prescription and then make a second stop at a pharmacy to have the prescription filled. According to a new Florida Law, I can issue you a prescription and fill that prescription in the nearby Lakeside Pharmacy. And if your [sic] can't get out of the house, I even make house calls. And I can bring you your medicine when I make my next visit. I am Dr. William van der Velden, Doctor of Pharmacy and Certified Consultant Pharmacist. I am an expert in the knowledge and usage of all Prescription Medicines, Patent Medicines, Vitamins and Nutrition. I can answer all of your medicine questions. Questions like: Are there any serious side effects to my medicines? What interactions should I watch out for? Are there newer or better medicines for my condition? Are there less expensive medicines that will work just as well for my condition? What about generics? How long should I expect to take this medicine? Get the most out of your prescriptions, vitamins and nutrition. Make sure they all work well together. By having your medication regimen tailor-made to individual requirements you will ... Gain better health Save money by taking only the medicines best suited for you. Don't buy inappropriate remedies in a supermarket. Some Patent Medicines may do more harm than good. First call me -- The Medicine Expert. I can either treat you or, if necessary, refer you to an equally well qualified physician. At Home Consultations allow me to look at the whole patient and then prescribe the best medicines for your condition. Call for an appointment today and start feeling healthier, wealthier and wiser about your medicines. I do make house calls! Call 782-0580 or 946-1717 The impetus for Respondent's action was, in his words: The store was not doing well in filling prescriptions, so the idea of prescribing was thought a means to possibly increase the volume of prescriptions . . . Respondent's efforts apparently engendered no interest except that of the Broward County Sheriff's Office, Organized Crime Division. On December 16, 1985, Detective Debra Slocum placed a telephone call to the number advertised on the flyer, 946-1717, 1/ and spoke with the Respondent at his residence. She informed Respondent that she had one of his flyers, that she was suffering from anxiety and insomnia because of a bad divorce, and requested an appointment. Respondent advised Detective Slocum that he worked through Lakeside Pharmacy and that she should call there to make an appointment with him or his associate, Bob Rideman. 2/ Later that day, Detective Slocum called the pharmacy and spoke with Mr. Rideman, who had been alerted by Respondent to expect her call. Following that conversation, Detective Slocum met Mr. Rideman at the pharmacy and, without benefit of a prescription, was given two tablets of Ergoloid. Ergoloid is a medicinal drug which requires a prescription to be dispensed. Respondent avers that his actions were authorized by Section 465.186, Florida Statutes, since they occurred subsequent to October 1, 1985. Respondent's assertion demonstrates an appalling lack of comprehension of the English language or a blatant fabrication. Section 465.186, Florida Statutes, effective October 1, 1985, provided: Pharmacist's order for medicinal drugs; dispensing procedure: development of formulary.- There is hereby created a committee composed of two members of the Board of Medical Examiners licensed under chapter 458 chosen by said board, one member of the Board of Osteopathic Medical Examiners licensed under chapter 459 chosen by said board, three members of the Board of Pharmacy licensed under this chapter and chosen by said board, and one additional person with a background in health care or pharmacology chosen by the committee. The committee shall establish a formulary of medicinal drugs which may be made available to the public upon the order of a pharmacist which is issued pursuant to a dispensing procedure established by the committee for each drug contained in such formulary. . . * * * The Board of Pharmacy, the Board of Medical Examiners, and the Board of Osteonathic Medical Examiners shall adopt by rule a formulary of medicinal drugs and dispensing procedures as established by the committee. A pharmacist may order and dispense a product from the formulary pursuant to the established dispensing procedure, as adopted by the boards, for each drug in conjunction with its inclusion in the formulary. Any drug product ordered by a pharmacist shall be selected and dispensed only by the pharmacist so ordering, and said order shall not be refilled, nor shall another medicinal drug be ordered for the same condition unless such act is consistent with dispensing procedures established by the committee. (Emphasis added) Not until May 1, 1986, was a formulary of medicinal drugs and dispensing procedures established. Rule 21S-18.001-18.004, Florida Administrative Code. Accordingly, pharmacists had no authority in 1985 to issue prescriptions, treat patients, or prescribe medicinal drugs, and Respondent could not have reasonably believed otherwise.
The Issue At issue is whether Respondent committed the offenses set forth in the Administrative Complaint dated March 3, 2000, and, if so, what penalty should be imposed.
Findings Of Fact Respondent, Robert Gibson McLester, III ("McLester") is a licensed pharmacist 2 with a heretofore unblemished record. McLester graduated from the University of Florida with a degree in pharmacy in August 1977. He was licensed by the State of Florida to practice pharmacy in February 1978. He currently holds an Alabama pharmacy license, and was previously licensed in Mississippi but at some point ceased to pay the state's licensing fee; the license thus lapsed by operation of law. McLester received a Master of Science degree in hospital pharmacy from the University of Mississippi in December 1987 and a Master of Health Care Administration from the same institution the following May. McLester entered the Navy as an aviator cadet in June 1965, and was commissioned as a naval aviator in February 1967. He flew 103 missions with Attack Squadron 147 and was honorably discharged as a lieutenant in December 1970. Following a brief stint in the insurance and investment business, McLester applied unsuccessfully to medical school. McLester entered the University of Florida's pharmacy school in September 1974 and following his graduation in August 1977, has been continuously employed as a pharmacist when not pursuing advanced degrees in pharmacy and related fields. Much of McLester's pharmacy employment has been in the Navy, which he reentered in February 1978 as an ensign in the Medical Service Corps. McLester served in a variety of posts before retiring as a lieutenant commander in August 1992, including at the National Naval Medical Center in Bethesda, Maryland, where he supervised in excess of 25 pharmacists and pharmacy technicians in the preparation of an average of 1600 outpatient prescriptions per day. McLester continued the practice of pharmacy as a civilian, working briefly as a relief pharmacist for the Eckerd Drug chain in the Vero Beach area before being hired full time by Winn-Dixie in August 1992. Under McLester's supervision, Store No. 2358 enjoyed high sales volume and was used as a training site for other Winn-Dixie pharmacies. At all times during McLester's employment at Winn- Dixie, reports of annual inspections of his pharmacy conducted by the Agency for Health Care Administration ("AHCA") pursuant to law showed no deficiencies of any kind. McLester worked at the Winn-Dixie Store No. 2358 until June 17, 1998. McLester's separation from Winn-Dixie was voluntary. McLester left Winn-Dixie because he considered the hours assigned to him by his new supervisor, Steve Howard ("Howard") to be "slave hours." Following McLester's departure, sales and customer satisfaction at Store No. 2358 deteriorated. For most of the time relevant to this case, McLester was responsible for filling in the neighborhood of 150 prescriptions per day. That number placed his store at the high end of Winn- Dixie pharmacy productivity. 3 During the course of his employment at Winn-Dixie, McLester had occasion to report approximately a dozen instances of prescription drug fraud to the authorities, including St.Lucie County Detective Scott Silverman (Silverman). Following his resignation from Winn-Dixie, McLester worked briefly with various services which would find him work as a relief pharmacist. On the instructions of Howard, McLester was not permitted to work at any of the Winn-Dixie stores in the area. In October 1998, McLester found full-time employment with Doctors' Clinic Pharmacy in Vero Beach, a "closed pharmacy" which serves only the patients of that multi-specialty practice. During his term of employment at Winn-Dixie, McLester was assisted by about a half dozen pharmacy technicians. Pharmacy technicians are licensed by the state and must work under the close supervision of a registered pharmacist. Tasks which the law permits to be delegated to pharmacy technicians and which, in fact, are typically delegated to a pharmacy technician include ordering drugs, including controlled substances; receiving drugs and other inventory; counting and transferring drugs from their original containers to packages for individual prescriptions; shelf maintenance; department maintenance; and stocking shelves. Other tasks which pharmacy technicians may legally perform, and which were in fact performed by technicians at Winn-Dixie stores, include logging invoices into the computer system for payment; verifying orders shipped into the store; answering telephones; taking refills from patients or doctors provided that there is no change in any element of the prescription (i.e. instructions to the patient, dosage, etc.); requests to doctors to issue new prescriptions on behalf of a patient; preparing labels and delivering filled prescriptions to the pharmacist for final verification. Because of the nature of the tasks delegated to pharmacy technicians, the relationship between pharmacist and technician must be one of, as several witnesses testified, implicit trust. McLester trusted all of the pharmacy technicians with whom he worked at Winn-Dixie. One of the Winn-Dixie pharmacy technicians, Tonya Tipton ("Tipton") betrayed McLester's trust, along with the trust of the State of Florida which licensed her, Winn-Dixie which employed her, and several other pharmacists under whose supervision she worked. Weeks after McLester left Winn-Dixie, Tipton's betrayal of trust was discovered. Soon after, she was fired from Winn-Dixie and subsequently arrested for crimes she allegedly committed in and against the Winn-Dixie pharmacy. Tipton's arrest set in motion a chain of events which led to this Administrative Complaint. Following a work-related injury suffered in the early 1990s, Tipton developed a dependence upon prescription painkilling medication, including the narcotic nasal spray Stadol.4 Unbeknownst to anyone, Tipton devised a scheme by which she could steal Stadol from Winn-Dixie, and also obtain Stadol under a forged prescription. At all times prior to Tipton's firing from Winn-Dixie, she was a trusted employee. Tipton fell under suspicion when she stated to a co- worker that a package would be arriving the following day and that it should not be opened. Store employees opened the package nevertheless and discovered it contained Stadol. Thereafter, a fellow pharmacy technician followed Tipton into the ladies' room and discovered empty bottles of Stadol in the wastebasket. Confronted by store employees about her inappropriate instruction to the co-worker not to open the package, as well as the empty Stadol containers in the ladies' room, Tipton admitted only to taking one bottle of Stadol from the Winn-Dixie pharmacy. Abundant circumstantial evidence suggests that Tipton's dependence upon Stadol led her to commit more than the one offense to which she admitted. McLester had been the primary pharmacist on duty at Store No. 2358 during many of the shifts when Tipton was alleged to have illegally obtained Stadol. Following a criminal investigation by Detective Silverman and the arrest of Tipton, McLester's former supervisor, Howard, lodged a complaint against McLester with the Board of Pharmacy. In his letter of complaint, Howard characterized his complaint as an effort to protect the interests of Winn-Dixie "in case this problem was found out." Howard claimed that Mostafa Macida ("Macida"), who had replaced McLester as the store's primary pharmacist,"discovered" that Stadol was being stolen from the pharmacy but this testimony is rejected as inconsistent with the testimony of numerous individuals who, unlike Howard, had personal knowledge of the events surrounding Tipton's arrest. Macida suspected nothing and discovered nothing. Tipton's employment at Winn-Dixie began in February 1995 when she was hired as a pharmacy technician by McLester.5 In that capacity, Tipton worked not only with McLester, but also with then-Head Technician Ava Forsythe (Forsythe). Forsythe trained Tipton in the technicians' duties, including the various methods by which prescription drugs, both controlled and non-controlled, may be ordered. At all times relevant to this case, there are three ways in which Winn-Dixie pharmacies may procure drugs and medical supplies requiring prescriptions for resale to the public. The primary system is a computer-generated daily order. The system was referred to by many witnesses as "the PDX system" ("PDX"). Technicians, working under the supervision of the pharmacist, would review the order to verify that the required types and quantities of supplies were being ordered. When the order was deemed complete, "the button was pushed" and the order electronically transmitted to Winn-Dixie's major drug supplier, Bindley-Western.6 In theory, the computer would accurately track stock in over 2,000 line items. The computer was supposed to automatically add to the inventory based upon what was ordered, and subtract based upon records of what was actually dispensed to customers. In reality, the computer-generated inventory was corrupt on a daily basis. Because of the PDX system's unreliability, technicians often had to make adjustments by hand so that the computerized records would match what was actually in stock. Orders could also be manually keypunched into a unit called a Telxon, which also transmitted orders to Bindley- Western. The Telxon unit is portable. The size of a telephone, the Telxon unit at Store No. 2358 was generally kept in a drawer when not being used. Finally, drugs can be ordered from Bindley-Western and/or from one of two secondary suppliers used by Winn-Dixie from any telephone, whether or not the telephone is located in a Winn-Dixie store. None of the systems used by Winn-Dixie, either singly or in combination, had the ability to flag the fact that hundreds of bottles of Stadol had been ordered and paid for by Winn-Dixie, yet not placed on the shelves as pharmacy inventory in Store No. 2358, during the period of Tipton's employment. Under Winn-Dixie's system, it is possible for a pharmacy technician to order medications unbeknownst to the pharmacist, to have them paid for by Winn-Dixie, and to physically divert them to his possession before the medications were logged in to pharmacy inventory. Once drugs are properly entered into inventory, it is reasonable to expect that the pharmacist could be aware of large amounts of a drug being stolen from the inventory. Any single incident of placing unauthorized drug orders could take place in the two or three minutes the duty pharmacist might be absent to go to the restroom, or have his attention diverted for any reason. Silverman is an experienced police officer, having served for over two decades in various law enforcement positions in Florida. For nearly five years Silverman has been exclusively assigned to work with pharmacies and other law enforcement agencies in St. Lucie County. Silverman's job is to assist in the prevention and prosecution of crimes involving the misuse of prescription drugs. Silverman's involvement in this case began when Tipton sought him out. Tipton knew Silverman because her husband is a fellow St. Lucie County detective, and Tipton herself was a sworn St. Lucie officer. Tipton approached Silverman to confess that she had taken a bottle of Stadol from the Winn-Dixie store where she worked. Tipton's confession was not provoked by an attack of conscience. Rather, after she was fired by Winn-Dixie, she began damage control. As Silverman's investigation progressed, substantial effort was made to determine how Tipton had diverted Stadol and what, if any, other crimes may have been committed. Documents collected in the course of the investigation revealed that Tipton had developed a dependency on prescription painkillers dating to a back injury in 1990 in which she suffered a herniated disc. Tipton developed a dependency on Stadol in 1996, after dealing with pain related to the 1990 injury. Tipton claimed to Winn-Dixie security supervisor Robert Blakely ("Blakely") that she had told McLester of the problem, and that he referred her to her doctor for help. Ultimately, Silverman arrested Tipton on 17 counts of insurance fraud and one count of felony possession of a controlled substance. No evidence was offered regarding the disposition of Tipton's case. No evidence was presented of what, if any, effort was made to determine from Tipton if McLester had any complicity in her crimes. It was clear to Silverman that while Tipton had figured out a way to illegally divert Stadol to her unauthorized use, as of the date of the final hearing, "nobody knows how it was done." 7 There was conflicting testimony as to precisely how much Stadol was diverted by Tipton over the relevant period of time but Tipton's ability to obtain the drug through the use of fraudulent prescriptions and outright theft was audacious in scale. Stadol was a legend drug until June 1997 when the Drug Enforcement Agency upgraded its status to a Schedule IV controlled substance. Prior to October 19, 1996, Tipton had a legitimate prescription for Stadol. On that date, Les Gessley ("Gessley"), a relief pharmacist at Store No. 2358, approved a new Stadol prescription for Tipton under a legend number. Tipton used this approved prescription number subsequently when she herself prepared numerous unauthorized refills under this same number. Each of these unauthorized refills was listed on daily pharmacy logs certified mostly by McLester, but also by other duty pharmacists as well. Because these unauthorized prescriptions were refills rather than original prescriptions, the duty pharmacist was not required to personally view the original written prescription. McLester was the pharmacist on duty a majority of the days on which Tipton is believed to have diverted Stadol illegally. Somewhere between ten and twenty percent of the Stadol believed to have been unlawfully diverted by Tipton from Store No. 2358 was diverted after McLester had ceased to be employed there. Some of the Stadol obtained by Tipton under fraudulent prescription at Store No. 2358 was obtained on days when McLester was not the pharmacist on duty. In addition to Les Gessley and Mostafa Macida, other pharmacists on duty while Tipton was believed to have engaged in the criminal diversion of Stadol are Ted Kline and Al Leota. McLester admitted knowing Tipton had a problem with Stadol but did not know the extent of her problem. Forsythe told McLester that she thought there might be some Stadol missing from the shelves. When she shared her concern with McLester, he instructed Forsythe not to leave Tipton alone in the pharmacy. No evidence placed McLester's conversation[s] with Tipton and other parties about her use of Stadol in the context of when Tipton's alleged diversions occurred. According to Forsythe's unrebutted testimony, If you were that desperate you could order any medication you wanted on the Telxon machine or verbally order without knowledge of the pharmacist knowing what you were doing. And then when the medication comes in, you pay the invoice. You throw the invoice away. You throw the copy that you received from the computer away. The invoice is paid. The only person that will know about it will be the person at the headquarters that pays the payment on the invoice without knowing what is on it and the person gets the medication. Take the medication home via however and no one is the wiser. Winn-Dixie has no security procedures in place, such as searching handbags or packages, to prevent employee theft in the pharmacy. Winn-Dixie's ordering system is tailor-made to be abused by individuals who are, in Forsythe's words, "that desperate." It is not illegal for pharmacy technicians to fill their own prescriptions. It is possible for a pharmacy technician to fill or refill a prescription without the pharmacist knowing that had been done if he was absent from the pharmacy or had his attention diverted in some fashion. It appears that Tipton refilled her own fraudulent prescription on a number of occasions, but that her preferred method of diverting Stadol was outright theft. The Winn-Dixie system by which the pharmacies are stocked is flawed in a manner which allowed Tipton to divert Stadol without being detected by the duty pharmacist. The Department failed to show that McLester knew or should have known that Tipton had diverted Stadol to her unauthorized use at Store No. 2358.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the charges in the Administrative Complaint be dismissed. DONE AND ENTERED this 17th day of November, 2000, in Tallahassee, Leon County, Florida. FLORENCE SNYDER RIVAS 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 17th day of November, 2000.
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 The issues to be resolved in this proceeding concern whether the Respondent properly maintained and supplied required records to support and document prescription claims, which it billed to Medicaid and for which it received payment from the Medicaid program during the audit period of April 1, 2000 through December 31, 2001. If that is not the case, it must be determined whether the Agency is entitled to recoup from the Respondent the sum it seeks of $108,478.77, as the purported amount overpaid to the Respondent by the Agency. It must also be determined whether the applicable laws and regulations referenced herein were complied with by the Respondent, in terms of its accepting and filling prescriptions, dispensing relevant drugs, and recording and documenting such activities in its pharmacy records. Finally, it must be determined whether the statistical methodologies employed by the Agency, through its audit and investigation of the Respondent, were sufficiently representative and accurate so as to support the calculation of estimated overpayments.
Findings Of Fact The Petitioner is an Agency of the State of Florida charged by the statutes and rules referenced herein with ensuring that proper reimbursement is effected to providers, including pharmacies, by the Medicaid system. Because of its duty to enforce and regulate the Medicaid system, the Petitioner Agency has an audit and oversight function, as well as an enforcement function, to ensure that Medicaid payments and the general operations of the Medicaid system are carried out correctly. It is through this duty imposed by the cited Florida Statutes and rules, as well as the federal regulations it is charged with enforcing, that the Petitioner carried out an audit of the Respondent, Brown Pharmacy, concerning the audit period of April 1, 2000 through December 31, 2001. The Petitioner conducts audits of providers such as Brown in order to ensure compliance with the Medicaid provisions and Medicaid provider agreements. These are called "integrity audits" and are routinely performed by auditors contracted from private firms such as Heritage. Brown Pharmacy (Brown) is licensed in the State of Florida as a pharmacy (license Number PH562). Brown maintained a business location at 312 West 8th Street, Jacksonville, Florida 32206, at times pertinent to this case. During the audit period Brown was an enrolled Medicaid provider authorized to provide Medicaid prescriptions pursuant to a provider agreement with the Agency. The terms of the provider agreement governed the contractual relationship between Brown and the Agency. Pursuant to that provider agreement, Brown was to maintain the Medicaid-related records and documentation for at least five years. Any Medicaid provider, such as Brown, not in compliance with the Medicaid documentation and record retention policies may be subject to the recoupment of Medicaid payments. During the audit period, Brown dispensed prescription drugs to Medicaid recipients. Medicaid claims were filed and paid electronically as "point of sale" transactions during the audit period. Each claim reviewed and at issue in this case was a paid Medicaid claim subject to the provider agreement and pertinent regulations. As a condition of participating in the Medicaid program, a Medicaid provider must comply with all provisions of a provider agreement, which is a voluntarily agreement between the Agency and the provider. Those provisions include the provider's agreement to comply with all relevant local, state and federal laws, rules, regulations, licensure laws, bulletins, manuals, and handbooks, etc. The provider must agree to keep and maintain, in a systematic and orderly manner, all Medicaid- related records as may be required by the Agency and make them available for state and federal agencies and review. It must maintain complete and accurate medical, business, and fiscal records that will justify and disclose the extent of goods and services rendered to customers or patients and rendered as billings to the Medicaid system. Florida Administrative Code Rule 59G-4.250 promulgates, as part of the rule, the above-referenced handbook (handbook) which sets out Medicaid polices and rules. The polices and rules govern the rights and responsibilities of drug providers, such as Brown, including coverage and payment methodologies for services and goods rendered to Medicaid recipients and billed to the Medicaid program. The types of records that must be maintained are as follows: Medicaid claim forms, professional records such as patient treatment plans, prior and post authorization information, prescription records, business records, including accounting ledgers, financial statements, purchase and acquisition records etc., tax records, patient counseling information and provider enrollment documentation. Providers who are not in compliance with the Medicaid documentation and record retention policies described in the handbook are subject to administrative sanctions and/or recoupment of Medicaid payments. Medicaid payments for services that lack required documentation and/or appropriate signatures will be recouped. Chapter five of the handbook, in defining overpayment provides that any amount not authorized to be paid by the Medicaid program, whether paid as a result of inaccurate or improper cost reporting, improper claims, unacceptable practices, fraud, abuse or mistake, constitutes overpayment. Incomplete records are records that lack documentation that all requirements or conditions for the providing of services have been met. Medicaid may recoup payments for services or goods when the provider has incomplete records or cannot locate the records. The Agency contracted with Heritage to conduct an on- site audit at Brown. The audit was conducted March 18th through March 20, 2002. Heritage isolated a sample of 205 prescription claims, known as the "judgmental sample" out of a total universe of paid pharmacy claims from Brown totaling 16,727 for the audit period. Heritage also selected 250 random prescription claims out of the remaining total universe of paid pharmacy claims of 16,522, which remained after the 205 judgmental sample claims had been removed or isolated from the remainder of the total claims. With the acquiescence of the Agency, Heritage chose the 205 claims by weighing it in favor of the "high dollar" or more expensive drug prescriptions. Those prescriptions are primarily for HIV and Aids therapy drugs and psychotherapeutic drugs for various mental conditions, including schizophrenia. Weighing of the judgmental sample strongly in favor of the high dollar prescription claims would seem to render the judgmental sample fundamentally unfair against Brown if the judgmental sample had then been extrapolated to the entire universe of claims ($16,727). This was not done, however. The judgmental sample was audited and compiled by doing an actual count and totaling of claim amounts in dollars represented by all the discrepant prescriptions, including all those the Agency and Heritage maintained resulted in "overpayments" to Brown. Therefore, the judgmental sample is an actual number rather than an extrapolated calculation so that weighing the sample in favor of the high dollar prescriptions does not result in an unfair or biased sample, as to the judgmental sample. Because the judgmental sample was drawn from the total pool of audited claims and removed from that claim pool prior to the identification and drawing of the random sample, the two are mutually exclusive and the amounts calculated do not represent a duplication or overlap. Thus the findings from the judgmental sample and then the random sample may be properly added together. The randomly selected claims (random sample) were taken of the remaining 16,522 claims in the audit claim pool after the judgmental sample of 205 claims had been removed. According to the report rendered by Heritage, the 250 randomly selected claims totaled $10,632.59 in paid Medicaid dollars. The Heritage auditors determined that there were 56 discrepant claims out of these which totaled, according to their calculation, $2,450.13 in apparent overpayments. This resulted in an average overcharge per claim of $9.80 (determined by dividing the documented "sanction amount" by the total number of claims in the random sample (250), multiplied by the universe of claims from which the random sample was taken (16,522) which yielded an extrapolated overcharge of $161,924.19. Applying the statistically appropriate 95 percent "one-sided" lower confidence limit of this extrapolation resulted in a purported overpayment extrapolated from the randomly selected claims of $102,700.85. This means that the overpayment amount calculated by Heritage represents an amount statistically 95 percent certain to be the lowest amount overpayment based on the extrapolation of the overpayment represented in the 250 randomly selected claims. The non-extrapolated judgmental findings showed, according to Heritage, that there were 72 discrepant claims. Heritage then determined that, of these, there were $29,381.09 in apparent actual overcharges. The discrepancies determined by Heritage involved the failure to produce documentation of refill authorizations for 80 prescription claims; 31 prescription claims containing an incorrect Medicaid provider number; the failure to produce 12 "hard copy" prescriptions representing 25 claims; four claims that did not have the prescriber's DEA number on the prescription for controlled substances; three claims for prescriptions that did not contain the original date of service; two claims that were billed for quantities greater than that authorized by the physician; one claim that was billed for an incorrect day's supply; one claim that was billed in excess of the maximum allowable quantity of prescription of the drug, set by Medicaid policy; and one prescription claim that was billed for an incorrect prescriber's Medicaid provider number (although this should not be a discrepancy because the correct prescriber was documented in the pharmacy's computer, which the regulations allowed). Additionally, there was one claim billed for a drug different than that prescribed by the physician, according to Heritage in its report. Heritage also conducted an invoice review using utilization reports provided by the Respondent. This was apparently a review of 25 different drugs that purportedly showed that the prorated purchases of those drugs were insufficient to cover the number of units billed to Medicaid for all 25 drugs reviewed, and thus yielded a purported shortage of $87,942.13, representing the amount billed to Medicaid above the amount the records of purchases from suppliers proved that Brown had purchased of those drugs. Based upon the Heritage audit as well as documentation findings and overpayments calculations (see Exhibit 8), the Agency issued a PAAR dated September 27, 2002, determining that Brown had been overpaid $150,036.71 for Medicaid claims during the audit period. That report advised Brown that it was a provisional report only and encouraged Brown to submit any additional information or documentation which might serve to change the overpayment. The report listed examples of documentation that the Agency would consider for a possible reduction in the overpayment amount initially claimed. Thereafter, the Agency agreed to an extension of time for Brown to submit additional documentation and sent a letter to Brown dated October 31, 2003, advising that the audit had been placed in abeyance pending the outcome in a related case, but that the Agency expected to resume the audit and that therefore all Medicaid-related records and documentation regarding paid claims should be maintained and preserved until the audit was finalized. The FAAR was addressed in the testimony of Ms. Stewart for the Agency. Through her testimony it was revealed that certain corrections should be made to the FAAR updating it from the findings in the Heritage initial audit report. The Agency corrected the information in the FAAR for this reason and for the reason that it secured some additional information from the Respondent. Thus, for the audit period it was established that there were 16,727 total claims for prescriptions dispensed by Brown, for which it was paid $795,564.59 during the 21-month audit period, of those claims, 205 were pulled out from the total universe of claims as the judgmental sample. There were some 72 allegedly "discrepant claims" totaling $36,393.51 in dollars paid to Brown. The Agency's position is that $29,381.09 of those are so called "documented overcharges." The random sample of 250 claims was extrapolated to the remaining universe of 16,522 prescription claims. The Agency now takes the position that it found 49 "discrepant claims" in the random sample which totaled $2,154.40 in dollars paid to Brown's pharmacy and of that it maintains that $1,927.55 are "documented overcharges" for the 250 randomly selected claims (for which Brown had been paid $10,632.59). Thus the Agency found an average overcharge for the 250 randomly sampled claims of $7.71 per claim. The $7.71 average per claim overcharge was then multiplied by the remaining universe of 16,522 claims, yielding an extrapolated purported overcharge of $127,387.92. The Agency then applied the 95 percent "one-sided lower confidence limit" to this extrapolation, that is, that it or its statistician, Dr. Johnson, felt that there was a 95 percent chance that the lower confidence limit number it calculated was accurate. That number is $79,097.68. When that number is combined with the Agency's position as to overcharges from the judgmental sample results in a total postulated overcharge of $108,478.77. This is the final amount the Agency claims as an overpayment that must be recouped for Medicaid. The FAAR summarized the discrepant claims for the judgmental sample as follows: 61 claims involve refills which exceeded the authorized number of refills without documentation of reauthorization; 10 claims showed an incorrect prescriber license number but the correct prescriber license number was documented in the pharmacy's computer; and For two claims the hard copy description did not have an original date of service depicted on it and did not reference a DEA number. The discrepant claims shown in the FAAR as to the random sample were as follows: There were 19 claims for refills without documentation of refill authorization (refills had been previously authorized, but for the 19 claims at least one refill had been issued beyond the authorization limit); Fifteen claims showed an incorrect prescriber license number on the claim and the license number was not documented in the Respondent's computer; Seven claims showed an incorrect prescriber license number, but the correct license number was documented in the pharmacy's computer; There were seven claims for which the original hard copy prescriptions could not be found on file during the audit period; For one claim the hard copy prescription did not have an original date of service or DEA number; For one claim the quantity paid exceeded the quantity authorized by the prescriber or dispensed to the recipient; and For one claim the number of days supply submitted by the pharmacy was not consistent with the quantity and directions of the prescriber and the quantity exceeded the limit set by the plan. The most common discrepancies with regard to the judgmental sample and the random sample occurred when the Respondent billed refills in excess of the number authorized by the prescriber, without any written authorization for such being provided in the audit process or later. Concerning the random sample, the second most common discrepancy occurred when the claim depicted an incorrect precriber number on the claim and the license number of the prescriber was not documented in the computer. In the judgmental sample the second most common discrepancy occurred when the claim showed an incorrect prescriber number, but the correct prescriber number was documented in the pharmacy's computer. The discrepancies in the FAAR with the indication "UR", references "unauthorized refills." The records of the pharmacy showed that Brown issued refills of prescriptions to Medicaid recipients in excess of the presriber's limit depicted on the prescriptions but showed no written record of a telephonic or written authorization by the prescriber allowing the additional refill or refills. It is also true that as to some or even many of these the Respondent may have obtained verbal authorization, but failed to document that re- authorization. Medicaid policy, the statutory authority cited herein, and the PDSCLR Handbook provide that all verbal orders authorized by the prescriber of a prescription must be recorded either as a "hard copy" or noted in the pharmacy's computer in order to comply with the relevant law cited herein, for record- keeping and auditing purposes under Medicaid policy. The Agency's Statistical Methodology Mark E. Johnson, Ph.D., testified on behalf of the Petitioner. He was qualified as an expert witness in the area of statistical formulas, statistical methodology, and random sampling, including the random sample statistical methodology employed by the Agency in determining the overpayment amount. He is a professor of statistics at the University of Central Florida. Dr. Johnson reviewed the statistical methodology, numbers and calculations arrived at by the Agency and its extrapolation method of arriving at the overpayment amount. He also used his own independent analysis based upon a software package he commonly uses in the practice of his discipline in testing the methodology employed by the Agency and the random sample employed by the Agency and Heritage. The statistical formula employed by Dr. Johnson and the Agency is a standard one routinely used in Dr. Johnson's profession and statistical sampling. He established through his own testing of the methodology that the random sample was appropriate for Medicaid program integrity audits and determinations as employed in this case. The random sampling, according to Dr. Johnson, was employed because it would be time and cost prohibitive to examine individually each of 16,522 claims regarding overpayment issues. The random sampling methodology using 250 randomly chosen samples is a time and cost saving device and yet still presents a "plausible estimate" as established by Dr. Johnson. He established that for the universe of 16,522 claims which were subjected to the random sample and extrapolation statistical analysis and calculation, that such is a reasonable sample for purposes of this audit and that the 250 random samples employed by the Agency are indeed statistically appropriate random samples. His calculation of overpayment was at variance with the Agency's by 55 cents. He established that is not a significant difference since the 95 percent certainty limit of $79,097.68 for the random sample extrapolation analysis is so much lower than the estimate established at $108,478.22. Dr. Johnson established that the Agency had employed appropriate and valid statistical methods in its determination of the above-referenced overpayment amount based upon the random sample of paid claims. The expert testimony of Dr. Johnson, together with his written report in evidence, is credible and persuasive as to the validity of the random sampling of the claims during the audit period and as to the random sample portion of the analysis employed in arriving at the final overpayment calculation and numbers depicted in the FAAR. Dr. Johnson established the appropriateness of the statistical formula, including extrapolation, used to calculate the overpayment amount, the appropriateness of the sample size relative to the universe of claims, and the improbability that the overpayment amount is attributable to chance causes alone. Thus Dr. Johnson's testimony is accepted as credible and persuasive in establishing the validity of the Agency's method of overpayment calculation, and the overpayment calculation in conjunction with the statistical evidence in this record, except as modified by the findings below.1/ The Respondent's Position Gary Steinberg testified on behalf of the Respondent, Brown Pharmacy. He was accepted as an expert witness in the areas of Medicaid policy, audits and pharmacy practice, including Florida pharmacy practice. Mr. Steinberg acknowledged that Brown had not properly documented all claims that had been paid by the Medicaid program nor maintained all required records. He emphasized in his testimony, however, that Brown had not fraudulently billed the Medicaid program with claims for prescription medications that it had not actually dispensed to the patients or recipients. Rather, all medications involved in the subject prescription claims had actually been dispensed. There is no evidence or claim on the part of the Agency that Brown charged and collected more than the appropriate approved price for the prescriptions at issue. Through the explanation given in his testimony, Mr. Steinberg opined that although Brown was guilty of technical errors in record keeping and documentation as to the prescriptions involved in the subject claims, Brown had made substantial compliance with the Medicaid program requirements of the Medicaid provider agreement and the statutes and rules at issue and policies embodied in the subject handbook. He explained in his testimony that in the pharmacy practice setting in which Brown has operated, whereby it serves a large indigent population in an inner city environment, it is difficult to contact a prescriber at the time when a patient needs a critical prescription refilled in order to get a refill authorization. The prescriptions at issue mostly involve critical medications for HIV/Aids and psychotropic medications for severe mental conditions such as schizophrenia. The patients who need these critical medications (and there are very few patients, since most of the procedures involve filling and refilling for a small number of such recipients) are patients of clinics operated at the nearby university hospital (Shands). In these circumstances, where the patient literally needs the HIV/Aids medication refilled on an immediate basis, possibly even to prevent death, and the mental health patient critically needs a refill in order to prevent harm to the patient or harm to the members of the public if the patient goes without medication and "decompensates," the ethical thing for a pharmacist to do is to refill the prescription and seek authorization later. Mr. Steinberg established that it is often difficult to obtain authorization from the original prescriber since the medication were prescribed by residents practicing in the various clinics at the Shands Hospital and that the residents can not always be identified or contacted easily since they do not maintain a fixed medical practice in the area. Consequently, some of the prescriptions were not documented as to authorization, although in some cases the pharmacy actually obtained authorization and entered it in its computer. In some cases, being unable to obtain re-authorization from the resident who originally prescribed the medication the pharmacy used the DEA license or prescribing number of the hospital itself. He explained that although under the law a pharmacy can refill a prescription on an emergency basis for up to a 72-hour supply, that this is generally impracticable and unsafe for patients in this plight because such indigent, mental health and HIV/Aids patients tend to be non-compliant with their medication regimes quite often anyway, and it is often unreasonable to expect them to return to the pharmacy for another refill within two or three days. He thus opined that the ethical and safe thing for the pharmacist to do was to refill and re-dispense the medical approved medication for up to a 30 or 34-day supply (the normal refill supply duration). He further explained that the Shands Hospital license number was used in some of these circumstances because the resident doctor who originally issued the prescription could not be identified on the Shands Hospital prescription forms and because the resident doctors at the Shands clinics only have and can use Shands Hospital prescription forms in any event. Mr. Steinberg thus established that 35 percent of those prescription claims classified as "WMP," that is the prescription claims contained an incorrect prscriber license number were for these reasons and the pharmacist could only use the Shands Hospital license number because the resident could not be identified from the Shands Hospital prescription forms. He thus opined that 35 percent of the random sample extrapolation amount, the 95 percent statistical confidence limit amount of $79,097.00, should be deleted from that amount in determining the correct amount of overpayment predicated on the random sample. Likewise, with regard to the judgmental sample concerning the HIV/Aids and mental health patient prescriptions and related claims, he opined that, in effect, $19,500.00 of the total $29,381.09 overpayment amount claimed by the Agency pursuant to the judgmental sample portion of the claims, should be deleted from that portion of the overpayment claim by the Agency; this is a result of his explanation regarding "substantial compliance" in the critical refill situation he described concerning the HIV/Aids and mental health patients and their prescription drugs. The preponderant, persuasive evidence does establish (and indeed the Agency acknowledged in its Proposed Recommended Order) with regard to the judgmental sample, that 10 of the claims at issue listed an incorrect prescriber license number, but that the correct prescriber license number was actually documented in the pharmacy's computer record with the name of the prescriber. This circumstances comports with the law referenced below and in the Petitioner's Proposed Recommended Order. This results in a reduction in the overpayment claim with regard to the judgmental sample of 13.88 percent of the judgmental sample claims or a reduction of $4,078.09. Likewise, with regard to the random sample extrapolation calculation of overpaid claims, the preponderant, persuasive evidence, also as acknowledged by the Agency in its Proposed Recommended Order, disclosed that seven claims listed an incorrect prescriber license number on the claims, but had been correctly documented in the pharmacy's computer system and therefore were in compliance with the relevant statutes, rules, and the subject handbook. Thus the discrepant claims and the overpayment amount related to the random sample portion of the audit claims should be reduced by 14.28 percent of the total amount of $79,097.00 for a $11,295.05 reduction of that $79,097.00 random sample overpayment amount. Mr. Steinberg demonstrated that Brown was not overcharging on the drugs prescribed and dispensed and was charging the Medicaid-authorized amount for the drugs involved in the prescription claims at issue. The Agency is not claiming that there was any fraudulent practice or illegal overcharging for the prescriptions involved. In fact, Brown was earning only a very small profit on the drugs dispensed that are the subject of the prescription claims at issue. Mr. Steinberg thus opined that since Brown did indeed dispense all the drugs at issue and was only paid the legal authorized amounts for the drugs and prescriptions at issue that recoupment of the amounts sought by the Agency or, in effect, established in these findings of fact, would be fundamentally unfair. He and the Respondent contend, rather, that since Brown performed substantial compliance, but was guilty of technical non-compliance with the relevant rules, agreement, and Medicaid policy, that the Agency should impose a lesser fine instead of seeking recoupment. In summary, in view of the preponderant persuasive evidence establishing the above facts, it has been shown that the documentation and record-keeping, dispensing errors, and omissions in the manner found above, with regard to the prescription claims and types of claims addressed in the above findings of fact, occurred. If those deficiencies amount to violations of the authority cited and discussed below which justify recoupment, then the amount of overpayment established by the above findings of fact is $93,104.95.
Recommendation Having considered the foregoing findings of fact, conclusions of law, the evidence of record, the candor and demeanor of the witnesses, and the pleadings and arguments of the parties, it is, therefore, RECOMMENDED that a final order be entered by the Agency for Health Care Administration providing for recoupment of $93,104.95, and that the Respondent, Brown Pharmacy, must re-pay that amount to the Petitioner Agency, through a reasonable re- payment plan established between the parties. DONE AND ENTERED this 3rd day of November, 2006, in Tallahassee, Leon County, Florida. S P. MICHAEL RUFF Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with Clerk of the Division of Administrative Hearings this 3rd day of November, 2006.
Findings Of Fact Based upon the entire record, the following findings of fact are determined: Background At all times relevant hereto, respondent, Obi E. Enemchukwu, was licensed as a pharmacist having been issued license number PS 0023082 by petitioner, Department of Professional Regulation, Board of Pharmacy (Board). He has been licensed as a pharmacist since 1981. There is no evidence that respondent has been the subject of disciplinary action prior to this occasion. When the events herein occurred, respondent was the designated prescription department manager and pharmacy permittee for Oviedo Drug World (ODW), a community pharmacy located at 83 Geneva Drive, Oviedo, Florida. A community pharmacy is not defined by statute or rule. However, a Board witness described such a pharmacy as being a drug store that serves customers in an outpatient or ambulatory setting. As the prescription manager for the pharmacy, respondent was responsible for maintaining all drug records, providing for the security of the prescription department, and following all other rules governing the practice of pharmacy. Count I This count alleges that respondent violated a Board rule by virtue of the ODW prescription department being "opened at 9:00 a.m. with a pharmacy technician only on duty with no pharmacist present until approximately 9:15 a.m.". In this regard, the evidence shows that on February 28, 1991, a DPR senior pharmacist, Charles C. Lewis, made a routine inspection of ODW. He entered the premises at approximately 9:00 a.m. and found the drug store open, the lights on in the pharmacy section, and only a pharmacist technician on duty. Respondent was not on the premises. Respondent eventually entered the premises around 9:10 a.m. Because the law requires that a registered pharmacist be on duty whenever a community pharmacy is open, respondent, as the designated manager, was in contravention of that requirement. Count II The second count alleges that "on one occasion in approximately August 1990, pharmacist technicians on duty were required to dispense medicinal drugs despite no pharmacist having been present". As to this charge, respondent admitted without further proof that the allegations were true. Thus, the charge in Count II has been sustained. Count III The third count alleges that "on at least two occasions refills for medicinal drugs were dispensed without authorization from the prescribing physician." As to this count, during the course of his inspection of ODW's prescription file, Lewis found copies of two original prescriptions dispensed by respondent on Saturday, February 9, 1991, and Saturday, February 16, 1991, respectively. Original prescriptions are those either handwritten by a doctor and brought in for filling by the patient or those that are telephoned in to the pharmacy by the doctor's office. If a prescription is telephoned in, it must be immediately reduced to writing by the pharmacist. Original prescriptions do not include refills. In this case, the two prescriptions were the type telephoned in by the doctor directly to the pharmacy. Because doctors are rarely in their offices on Saturday, Lewis turned the prescription records over to DPR for further investigation. The records of the prescriptions have been received in evidence as a part of petitioner's exhibits 1 and 2. The prescriptions indicate that Dr. James E. Quinn prescribed thirty Nalfon tablets (600 mg.) to patient L. C. on February 9, 1991, and Dr. Michael E. Meyer prescribed ten Tagamet tablets (300 mg.) to patient J. K. on February 16, 1991. The record does not disclose whether the drugs are scheduled legend drugs or non-scheduled legend drugs. Deposition testimony given by Drs. Quinn and Meyer established that neither doctor authorized by telephone or in writing that the two prescriptions in question be filled. Respondent concedes that he dispensed the drugs, and by doing so, he violated the law. Count IV The final count alleges that respondent, as a pharmacy permittee, violated former rule 21S-1.023 (now renumbered as rule 21S-28.112) by dispensing a medicinal drug in violation of state law. Because this charge is founded on the same set of facts set forth in findings of fact 4, 5 and 6, it is found that this charge has been sustained. Mitigation and Penalty At hearing, respondent generally offered mitigating testimony. As to Count I, he indicated he planned to arrive at the store at 9:00 a.m. but an automobile accident tied up traffic and caused him to be ten minutes late. He suspects that the store owner, who had the only other set of keys, opened up the store and pharmacy area and improperly let the technician into the pharmacy area even though respondent had not yet arrived. As to Count II, respondent acknowledged that two prescriptions were dispensed by pharmacy technicians without a pharmacist on duty but believes the store owner authorized the technician to dispense two prescriptions that he had filled the previous evening. He says appropriate instructions have been given to insure that this will not occur again. Finally, respondent gave the following explanation for dispensing the two prescriptions without authorization from a doctor. During the time period in question, respondent had a practice of partially filling prescriptions. In other words, even though a prescription might authorize a total of 100 tablets, respondent would dispense them piecemeal (e.g., 10 at a time) over the life of the prescription. Thus, at the end of the prescription period, if only 80 of 100 tablets had been previously dispensed, he would fill the remaining 20 tablets even though the prescription from a particular doctor had expired. In the case of the two prescriptions in issue, respondent believes that the customers either had a valid prescription from another doctor but he inadvertently refilled the prescription using the former doctor's name because the prescription had not been used up, or he noted that the patient had not been given the total number of tablets authorized under the original prescription. However, no documentation was submitted by respondent to support the claim that he was presented with a new valid prescription by one of the customers. Respondent apparently no longer engages in this practice. Finally, throughout the course of this proceeding, respondent has fully cooperated with the Board. Although the Board did not submit a proposed order containing a recommended penalty, at hearing counsel for the Board suggested that respondent's conduct warrants the imposition of a fine, probation and a reprimand.
Recommendation Based upon the foregoing findings of facts and conclusions of law, it is RECOMMENDED that respondent be found guilty of violating Sections 465.014, 465.015(2)(c), 465.016(1)(e)and (n), and 465.023(1)(c), Florida Statutes (1989), and that he be given a reprimand, fined $500 and his license placed on probation for one year. DONE and ENTERED this 12th day of March, 1992, in Tallahassee, Florida. DONALD R. ALEXANDER Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, FL 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 12th day of March, 1992. COPIES FURNISHED: Tracey S. Hartman, Esquire 1940 North Monroe Street, Suite 60 Tallahassee, FL 32399-0792 Obi E. Enemchukwu P. O. Box 32 Tavares, FL 32778-0032 Jack L. McRay, Esquire 1940 North Monroe Street, Suite 60 Tallahassee, FL 32399-0792 John Taylor, Executive Director Board of Pharmacy 1940 North Monroe Street Tallahassee, FL 32399-0792
The Issue Whether 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.
