The Issue The issue is whether Petitioner overpaid Respondent Medicaid funds, for which Section 409.913(10), Florida Statutes (2002), authorizes Petitioner to seek repayment from Respondent.
Findings Of Fact During 1998, Respondent was an authorized Medicaid provider, pursuant to Medicaid provider number 105425200, and was a party to a valid Medicaid Provider Agreement with Petitioner. Respondent filed claims with Petitioner for payment, under the Medicaid program, for the goods and services that are the subject of the audit described below, and Petitioner paid Respondent for these claims. The audit period in this case is 1998. During 1998, Respondent submitted to Petitioner 36,257 claims for nearly 5.5 million units of over one thousand types of drugs. These claims totaled $3,075,449.88, which Petitioner paid Respondent. On June 2, 1999, Petitioner sent a letter to Respondent informing it of a review of its pharmacy claims for 1998. The letter requests documentation of all purchases of 12 named drugs for 1998 and documentation of all credits for these drugs during the same period. The letter states that acceptable documentation includes itemized wholesaler sales history reports, itemized manufacturer sales history reports, itemized invoices, and credit return receipts. By letter dated June 5, 1999, Respondent provided the requested information. By letter dated June 23, 2000, Petitioner advised Respondent that it had examined the paid Medicaid claims for 1998 and the acquisition documentation that Respondent had provided in June 1999. The letter states: "You have failed to provide adequate documentation to the effect that the available quantity of certain drugs of given strength was as great as the quantity of those drugs billed to and reimbursed by Medicaid.” Thus, Petitioner made a "provisional" determination that it had overpaid Respondent $1,092,205.32. The letter invites Respondent to provide additional information to reduce the overpayment determination. The June 23 letter contains an Overpayment Attachment that lists ten of the twelve drugs for which Petitioner had sought documentation in its earlier letter. For each of these ten drugs, the Overpayment Attachment lists the generic code, number of units for which Medicaid paid, the total amount of Medicaid payments, the total units documented by Respondent to have been available during the relevant period, and the number of units for which Respondent provided no availability documentation. The Overpayment Attachment also calculates the amount of Medicaid payments attributable to the unavailable units and the total overpayment, which is $1,092,205.32. The overpayment calculations described in the preceding paragraph assume that all available units of the audited drugs were sold to Medicaid patients. The effect of this improbable scenario reduces the amount of the overpayment. The overpayment calculations attempt no extrapolation of overpayments on the over 10,000 other drugs for which Respondent received Medicaid payments during 1998. The effect of limiting the overpayment calculation to the ten listed drugs reduces the amount of the overpayment. However, the ten listed drugs are the drugs that generated the most Medicaid payments to Respondent and account for over one-third of the total Medicaid payments during the relevant period. Respondent provided additional information to Petitioner on August 30 and November 3, 2000. However, after examining the information, Petitioner advised Respondent, by letter dated April 8, 2002, that its final determination was that Respondent owed $1,096,489.77 due to its receipt of Medicaid overpayments. The overpayment increased by over $4000 due to the determination that Respondent's records documented 1000 fewer available units of two dosages of Risperdone than Petitioner had previously determined.
Recommendation It is RECOMMENDED that the Agency for Health Care Administration enter a final order directing Respondent to pay Petitioner $1,096,489.77, plus interest, to repay overpayments that it received from the Medicaid program for the sale of drugs in 1998. DONE AND ENTERED this 3rd day of November, 2003, in Tallahassee, Leon County, Florida. S 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 3rd day of November, 2003. COPIES FURNISHED: Rhonda M. Medows, M.D., Secretary Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building, Suite 3116 Tallahassee, Florida 32308 Valda Clark Christian, General Counsel Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building, Suite 3431 Tallahassee, Florida 32308 Grant P. Dearborn Assistant General Counsel Building 3, Mail Stop 3 2727 Mahan Drive Tallahassee, Florida 32308-5407 Jose M. Herrera Jose M. Herrera, P.A. 1401 Ponce de Leon Boulevard Suite 200 Coral Gables, Florida 33134
The Issue Whether the Department of Health and Rehabilitative Services improperly determined the Petitioners' rate of Medicaid reimbursement for the period January 1, 1990, through June 30, 1990?
Findings Of Fact The Emergency Rule and the Permanent Rule have been determined to be valid in a Final Order entered simultaneously with this Recommended Order. The Department's action in freezing the Medicaid reimbursement rate of the Petitioners in these cases was taken pursuant to the Emergency Rule and the Permanent Rule.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Department enter a Final Order in these cases dismissing the Petitioners' amended petitions. DONE and ENTERED this 26 day of May, 1992, in Tallahassee, Florida. LARRY J. SARTIN Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this day of May, 1992. APPENDIX Case Numbers 91-4893, 91-4894, 91-4895, 91-4914, 91-4929, 91-5837 and 91-6191 The parties have submitted proposed findings of fact. It has been noted below which proposed findings of fact have been generally accepted and the paragraph number(s) in the Recommended Order where they have been accepted, if any. Those proposed findings of fact which have been rejected and the reason for their rejection have also been noted. The Petitioners' Proposed Findings of Fact Proposed Finding Paragraph Number in Recommended Order of Fact Number of Acceptance or Reason for Rejection 1 1 and 4. 2 5-6. 3 13. 4 7. 5 3 and 13-14. 6 15. 7 17-19. 8 20. 9 21. 10 22. 11 23. 12 8. 13 12. 14 11. 15 24. 16 25-27. 17 28-29. 18 29. 19 30-32. 20 34-37. See 39. The last three sentences are not relevant. The determination of compliance with specific federal requirements for the Department's action was the responsibility of HCFA. HCFA presumably determined that the Department complied with all federal requirements since it approved the Department's plan amendment. 39. The last two sentences are not relevant. The determination of compliance with specific federal requirements for the Department's action was the responsibility of HCFA. HCFA presumably determined that the Department complied with all federal requirements since it approved the Department's plan amendment. 23 40-41. 24 43. 25 45. 26 46. 27 47. 28 48. The last two sentences are argument. 29 49. 30 42. 31 29 and 32. The weight of the evidence failed to prove the Department's motive for providing assurances to HCFA were anything other than to meet federal requirements. 32 28. 33 55. 34 34-35. See 59-60 and 63. The detailed findings of fact concerning the nature of the Department's inflationary analysis are not necessary. HCFA rejected this analysis and based its decision on other information provided by the Department. Additionally, the determination of compliance with specific federal requirements for the Department's action was the responsibility of HCFA. HCFA presumably determined that the Department complied with all federal requirements since it approved the Department's plan amendment. 35 See 60-63. 36 52-54. 37 54. 38 55 and hereby accepted. 39 59 and hereby accepted. 40 See 60-65. HCFA did not "reject" the Department's proposed plan amendment. 41 See 63. 42-43 See 60-66. 44-46, 50-54 Although the proposed findings of fact concerning what the Department told HCFA are generally correct, these proposed findings of fact are not relevant to this proceeding. As previously stated, the determination of compliance with specific federal requirements for the Department's action was the responsibility of HCFA. HCFA presumably determined that the Department complied with all federal requirements since it approved the Department's plan amendment. 47 Hereby accepted. 48-49 Hereby accepted except for the proposed findings that the Department "misled", "misrepresented" or provided "inaccurate and misleading information." The last sentence of proposed finding of fact 49 is not relevant. 55 67. 56 Hereby accepted. 57 Not relevant. 58 69. 59 70. 60 71. 61 50 and 73. The Department's Proposed Findings of Fact Proposed Finding Paragraph Number in Recommended Order of Fact Number of Acceptance or Reason for Rejection 1 1. 2 4. 3 5. 4 6. 5 3 and 13-14. 6 15. 7 17-19. 8 20. 9 21. 10 22. 11 23. 12 8. 13 11. 14 24. 15 25-26. 16 Hereby accepted. 17 27 and 29-32. 18 34-37. 19 39-41. 20 41. 21 43. 22 33. 23 42. 24 52-53 and 58. 25 54. 26 55. 27 56. 28 57. 29 60-65. 30 67. 31 68. 32 69. 33 70. 34 71. 35 50 and 73. 36 72. 37 73. 38 Hereby accepted. COPIES FURNISHED: Sam Power Agency Clerk Department of Health and Rehabilitative Services 1323 Winewood Boulevard Building One, Room 407 Tallahassee, Florida 32399-0700 John Slye General Counsel Department of Health and Rehabilitative Services 1323 Winewood Boulevard Building One, Room 407 Tallahassee, Florida 32399-0700 Thomas C. Fox, Esquire Michael D. Smith, Esquire 1200 18th Street, N.W. Washington, D.C. 20036 Alfred W. Clark, Esquire Post Office Box 623 Tallahassee, Florida 32302 W. David Watkins, Esquire Post Office Box 6507 Tallahassee, Florida 32314-6507 David Pius Medicaid Counsel Department of Health and Rehabilitative Services 1317 Winewood Boulevard Building 6, Room 230 Tallahassee, Florida 32399-0700
The Issue The issue for determination in this case is whether Respondent’s application of a fair rental value system of property cost reimbursement to Petitioner under the Florida Title XIX Long-Term Care Medicaid Reimbursement Plan is appropriate.
Findings Of Fact Petitioner, CONSULTING MANAGEMENT AND EDUCATION, INC., d/b/a GULF COAST NURSING AND REHABILITATION CENTER (CME), is the licensed operator of a 103-bed nursing home in Clearwater, Florida, which is presently known as GULF COAST NURSING AND REHABILITATION CENTER (GULF COAST). CME participates in the Florida Medicaid Program as an enrolled provider. Respondent, AGENCY FOR HEALTH CARE ADMINISTRATION (AHCA), is the agency of the State of Florida authorized to implement and administer the Florida Medicaid Program, and is the successor agency to the former Department of Health and Rehabilitative Services, pursuant to Chapter 93-129, Laws of Florida. Stipulated Facts Prior to 1993, the GULF COAST nursing home facility was known as COUNTRY PLACE OF CLEARWATER (COUNTRY PLACE), and was owned and operated by the Clearwater Limited Partnership, a limited partnership which is not related to CME. In 1993 CME agreed to purchase, and did in fact purchase, COUNTRY PLACE from the Clearwater Limited Partnership. Simultaneous with the purchase of COUNTRY PLACE, CME entered into a Sale/Leaseback Agreement with LTC Properties, Inc., a Maryland real estate investment trust which engages in the financing of nursing homes. The Purchase and Sale Agreement between Clearwater Limited Partnership and CME was contingent upon the Sale/Leaseback Agreement and the proposed Lease between CME and LTC Properties, Inc. On September 1, 1993, CME simultaneously as a part of the same transaction purchased COUNTRY PLACE, conveyed the facility to LTC Properties, Inc., and leased the facility back from LTC Properties, Inc. As required, CME had notified AHCA of the proposed transaction. AHCA determined that the transaction included a change of ownership and, by lease, a change of provider. CME complied with AHCA's requirements and became the licensed operator and Medicaid provider for COUNTRY PLACE. Thereafter, CME changed the name of the facility to GULF COAST. After CME acquired the facility and became the licensed operator and Medicaid provider, AHCA continued to reimburse CME the same per diem reimbursement which had been paid to the previous provider (plus certain inflation factors) until CME filed its initial cost report, as required for new rate setting. In the normal course of business, CME in 1995 filed its initial Medicaid cost report after an initial period of actual operation by CME. Upon review of the cost report, AHCA contended that the cost report was inaccurate and engaged in certain "cost settlement" adjustments. During this review, AHCA took the position that CME's property reimbursement should be based on FRVS methodologies rather than "cost" due to the lease. In November of 1995, CME received from AHCA various documents which recalculated all components of Petitioner's Medicaid reimbursement rates for all periods subsequent to CME's acquisition of the facility. In effect, AHCA placed CME on FRVS property reimbursement. The practical effect of AHCA's action was to reduce CME's property reimbursement both retroactively and prospectively. The retroactive application would result in a liability of CME to AHCA, due to a claimed overpayment by AHCA. The prospective application would (and has) resulted in a reduction of revenues. CME is substantially affected by AHCA's proposed action and by Sections I.B., III.G.2.d.(1), V.E.1.h., and V.E.4. of the Florida Medicaid Plan. Additional Findings of Fact The Florida Medicaid Plan establishes methodologies for reimbursement of a nursing home's operating costs and patient care costs, as well as property costs. The dispute in this matter relates only to reimbursement of property costs. CME as the operator of the GULF COAST nursing home facility is entitled to reimbursement of property costs in accordance with the Florida Medicaid Plan. CME as the operator of the GULF COAST facility entered into a Florida Medicaid Program Provider Agreement, agreeing to abide by the provisions of the Florida Medicaid Plan. The Sale/Leaseback Agreement entered into by CME and LTC Properties Inc. (LTC) specifically provides for a distinct sale of the nursing home facility to LTC. LTC holds record fee title to GULF COAST. LTC, a Maryland corporation, is not related to CME, a Colorado corporation. The Florida Medicaid Plan is intended to provide reimbursement for reasonable costs incurred by economically and efficiently operated facilities. The Florida Medicaid Plan pays a single per diem rate for all levels of nursing care. After a nursing home facility's first year of operation, a cost settling process is conducted with AHCA which results in a final cost report. The final cost report serves as a baseline for reimbursement over the following years. Subsequent to the first year of operation, a facility files its cost report annually. AHCA normally adjusts a facility's reimbursement rate twice a year based upon the factors provided for in the Florida Medicaid Plan. The rate-setting process takes a provider through Section II of the Plan relating to cost finding and audits resulting in cost adjustments. CME submitted the appropriate cost reports after its first year of operation of the GULF COAST facility. Section III of the Florida Medicaid Plan specifies the areas of allowable costs. Under the Allowable Costs Section III.G.2.d.(1) in the Florida Title XIX Plan, a facility with a lease executed on or after October 1, 1985, shall be reimbursed for lease costs and other property costs under the Fair Rental Value System (FRVS). AHCA has treated all leases the same under FRVS since that time. AHCA does not distinguish between types of leases under the FRVS method. The method for the FRVS calculation is provided in Section V.E.1.a-g of the Florida Medicaid Plan. A “hold harmless” exception to application of the FRVS method is provided for at Section V.E.1.h of the Florida Medicaid Plan, and Section V.E.4 of the Plan provides that new owners shall receive the prior owner’s cost-based method when the prior owner was not on FRVS under the hold harmless provision. As a lessee and not the holder of record fee title to the facility, neither of those provisions apply to CME. At the time CME acquired the facility, there was an indication that the Sale/Leaseback transaction with LTC was between related parties, so that until the 1995 cost settlement, CME was receiving the prior owner’s cost-based property method of reimbursement. When AHCA determined that the Sale/Leaseback transaction between CME and LTC was not between related parties, AHCA set CME’s property reimbursement component under FRVS as a lessee. Property reimbursement based on the FRVS methodology does not depend on actual period property costs. Under the FRVS methodology, all leases after October 1985 are treated the same. For purposes of reimbursement, AHCA does not recognize any distinction between various types of leases. For accounting reporting purposes, the Sale/Leaseback transaction between CME and LTD is treated as a capital lease, or “virtual purchase” of the facility. This accounting treatment, however, is limited to a reporting function, with the underlying theory being merely that of providing a financing mechanism. Record fee ownership remains with LTC. CME, as the lease holder, may not encumber title. The Florida Medicaid Plan does not distinguish between a sale/leaseback transaction and other types of lease arrangements. Sections IV.D., V.E.1.h., and V.E.4., the “hold harmless” and “change of ownership” provisions which allow a new owner to receive the prior owner’s method of reimbursement if FRVS would produce a loss for the new owner, are limited within the Plan’s organizational context, and within the context of the Plan, to owner/operators of facilities, and grandfathered lessee/operators. These provisions do not apply to leases executed after October 1, 1985. Capital leases are an accounting construct for reporting purposes, which is inapplicable when the Florida Medicaid Plan specifically addresses this issue. The Florida Medicaid Plan specifically addresses the treatment of leases entered into after October 1985 and provides that reimbursement will be made pursuant to the FRVS method.
The Issue The issues in this case are whether Petitioner received Medicaid overpayments, and, if so, what is the aggregate amount of the overpayments.
Findings Of Fact The Parties Respondent, the Agency for Health Care Administration, is the single state agency charged with administration of the Medicaid program in Florida under Section 409.907, Florida Statutes. Petitioner, The Doctor's Office, was a Florida corporation approved by the Agency to provide group Medicaid services. At all times relevant to this matter, Petitioner was owned entirely by non-physicians who employed salaried physicians to provide Medicaid services. Petitioner, at all times relevant to this matter, offered physician services to Medicaid beneficiaries pursuant to a contract with the Agency under provider number 371236P-00. Petitioner, pursuant to the specific terms in the contract with the Agency, agreed to abide by the Florida Administrative Code, Florida Statutes, policies, procedures, manuals of the Florida Medicaid Program, and Federal laws and regulations. Petitioner, pursuant to its contract with the Agency, agreed to only seek reimbursement from the Medicaid program for services that were "medically necessary" and "Medicaid compensable." The Audit In mid-1996, the Agency, pursuant to its statutory responsibility, advised Petitioner that it intended to audit Petitioner's paid Medicaid claims for the alleged medical services it provided between July 1, 1994 and June 30, 1996. In September 1996, the Agency conducted an initial audit site visit, and randomly selected 61 patient files for review. The complete patient files, provided by Petitioner, were reviewed by Sharon Dewey, a registered nurse consultant and Agency employee, as well as Dr. Solenberger, a physician consultant and Agency employee. In accordance with its procedure, the Agency determined that Petitioner had submitted a total of 580 claims for reimbursement relating to the 61 patient files and had received full payment from the Medicaid program for each claim. On March 3, 1997, the Agency issued a Preliminary Agency Audit Report (PAAR), and advised Petitioner that it had over-billed Medicaid and received an overpayment from the program. Shortly thereafter, the Agency auditors, Dr. Solenberger and Ms. Dewey, met with Frank Colavecchio, Petitioner's Corporate Representative, and discussed the Medicaid violations alleged in the review. During the meeting, the Agency requested Mr. Colavecchio to instruct Petitioner's staff physicians to review their records and provide a written rebuttal to the Agency's initial determinations. Within days, and prior to any further action, the Agency placed the audit on indefinite hold. The Agency decided to delay the audit until certain proposed legislation relating to peer review and the integrity of the Medicaid reimbursement program was enacted. Two years later, Section 409.9131, Florida Statutes, was enacted during the 1999 legislative session and became law. Shortly thereafter, in 1999, the Agency hired Dr. Larry Deeb, a board-certified, practicing pediatrician, to perform a peer review of Petitioner's practices and procedures. Dr. Deeb has performed similar medical records reviews for the Medicaid program since 1981 and possesses a thorough understanding of CPT coding and the EPSDT requirements. Dr. Deeb received the medical files provided by Petitioner, and reviewed each patient file in the random sample, including the medical services and Medicaid-related claim records. On November 11, 1999, Dr. Deeb completed his peer review of 564 of the 580 claims provided in the random sample and forwarded his findings to the Agency. Dr. Deeb advised the Agency that 16 reimbursement claims involved adult patients and he therefore did not review them. Utilizing Dr. Deebs findings, the Agency employed appropriate and valid auditing and statistical methods, and calculated the total Medicaid overpayment that Petitioner received during the two year audit period. On July 17, 2000, approximately four years after the original audit notification, the Agency issued its Final Agency Audit Report (FAAR). The Agency advised Petitioner that, based upon its review of the random sample of 61 patients for whom Petitioner submitted 580 claims for payment between 1994 and 1996, Petitioner received $875,261.03 in total overpayment from the Medicaid program during the audit period. Petitioner denied the overpayment and requested a formal administrative hearing. Following the initial commencement of the final hearing in this matter in December 2001, Dr. Deeb, again, reviewed the disputed claims and modified his opinion relating to 6 claims. Thereafter, the Agency recalculated the alleged overpayment and demanded Petitioner to pay $870,748.31. The Allegations The Agency alleges that specific claims submitted by Petitioner, which were paid by the Medicaid program, fail to comply with specific Medicaid requirements and therefore must be reimbursed. Since its inception, the Medicaid program has required providers to meet the Medicaid program's policies and procedures as set forth in federal, state, and local law. To qualify for payment, it is the provider's duty to ensure that all claims "[a]re provided in accord with applicable provisions of all Medicaid rules, regulations, handbooks, and policies and in accordance with . . . state . . . law." Section 409.913(5)(e), Florida Statutes (1993). Medicaid manuals are available to all Providers. Petitioner, as a condition of providing Medicaid services pursuant to the Medicaid program, is bound by the requirements and restrictions specified in the manuals, and under the contract, is required to reimburse the Medicaid program for any paid claims found to be in violation of Medicaid policies and procedures. The evidence presented at hearing established that Petitioner frequently violated various Medicaid policies and procedures. First, Petitioner repeatedly failed to comply with Section 10.9 of the Medicaid Physician's Provider Handbook, (MPPH), and Sections 409.905(9), 409.913(5)(e), 409.913(7)(e), and 409.913(7)(f), (1993, 1994 Supp. 1995, and 1996), Florida Statutes, which require all medical services to be rendered by, or supervised by a physician, and attested to by the physician's signature. Medical records reflecting services for paid claims must be physician signature certified and dated, or the services are not defined as physician's services. In addition, Petitioner routinely failed to correctly document the provision of certain physician's assistant (P.A.) Medicaid services that require the personal supervision of a physician or osteopath. See Chapter 1 of the Physician Assistant Coverage and Limitations Handbook, March 1995, and Appendix D (Glossary) in the Medicaid Provider Reimbursement Handbook, HCFA-1500 (HCFA-1500). In addition, Petitioner failed to comply with Medicaid regulations that require an approved physician to be present in the facility when certain P.A. services are delivered and to attest to it by signature within twenty-four hours of service. See Section 11.1 of the MPPH, effective July 1994, and Sections 409.905, and 409.913 (1993, 1994 Supp., 1995, and 1996 Supp.), Florida Statutes. The evidence presented at hearing also demonstrates that Petitioner repeatedly violated specific record keeping requirements located in Section 10.9 of the MPPH, Sections 10.6 and 11.5 of the Medicaid EPSDT Provider Handbook (EPSDT), and Sections 409.913(5)(e), 409.913(7)(e), and 409.913(7)(f), (1993, 1994 Supp., 1995, and 1996), Florida Statutes. In addition, the Agency demonstrated that Petitioner occasionally failed to document support for the necessity of certain services or simply billed for services that were not medically necessary. As indicated, Medicaid policy limits a physician to bill only for services that are medically necessary and defines the circumstances and varying levels of care authorized. In fact, Section 11.1 of the MPPH, effective July 1994, provides in part: The physician services program pays for services performed by a licensed physician or osteopath within the scope of the practice of medicine or osteopathy as defined by state law . . . . The services in this program must be performed for medical necessity for diagnosis and treatment of an illness on an eligible Medicaid recipient. Delivery of all services in this handbook must be done by or under the personal supervision of a physician or osteopath . . . at any place of service . . . . Each service type listed has special policy requirements that apply specifically to it. These must be adhered to for payment. The manual further provides clear guidelines defining authorized services for reimbursement which Petitioner apparently overlooked. For example, the manual defines the four types of medical history exams that Medicaid providers may conduct, the nature of the problems presented, and the appropriate and authorized tests. The manual also identifies the varying degrees of medical decision-making complexity related to Medicaid services and provides instructions relating to the method of selecting the correct evaluation and management code for billing. Petitioner consistently violated coding restrictions. Moreover, the Medicaid policy manual also outlines the specific procedures and billing requirements necessary for seeking payment for medical services including the early periodic screening for diagnosis and treatment (EPSDT) services. Chapter 10 and 11 of the MPPH specifically state that services that do not include all listed components of the EPSDT are not defined as an EPSDT, and upon audit, the Agency re-calculated Petitioner's medical services at the appropriate procedure code. Stipulation Prior to the commencement of the hearing, the parties stipulated that certain paid claims were correctly determined by the Agency to be overpayments. Specifically, the parties agreed that portions of samples 1, 3, 14, 21, 28, 41, 46, 47, 51, 53, and 56 could not be claimed for reimbursement since lab services which are part of an office visit reimbursement and/or lab service fees performed by an independent outside lab are not permitted. In addition, the parties agreed that specific portions of samples 1, 13, 14, 27, 28, 33, 35, 43, 46, 47, 52, 53, and 55 could not be claimed since Modifier 26 billing, the professional component, is only appropriate when the service is rendered in a hospital and Petitioner's services were rendered in an office. Pediatric Sample With regard to the random sample of pediatric files, upon careful review, the evidence presented at hearing sufficiently demonstrates that Petitioner was overpaid the following amounts on the following paid claims for the following reasons: The prolonged physician's services billed to Medicaid were not documented as having been provided or medically necessary. Cluster Number Date of Service Procedure Code Billed and Paid Overpayment 1 1/18/1996 99354 $ 36.64 1 5/14/1996 99354 $ 36.64 13 9/25/1995 99354 $ 36.64 19 9/28/1994 99354 $ 39.50 21 12/18/1995 99354 $ 36.64 28 3/06/1995 99354 $ 36.64 42 6/04/1996 99354 $ 36.64 43 12/19/1994 99354 $ 36.64 47 9/28/1994 99354 $ 39.50 47 10/17/1995 99354 $ 36.64 51 4/05/1995 99354 $ 36.64 53 11/02/1995 99354 $ 36.64 56 5/01/1996 99354 $ 36.64 The level of care billed to and reimbursed by Medicaid at the 99215 office visit procedure code level was improper since the level of care provided was at the 99213 office visit procedure code level. Cluster Number Date of Service Overpayment 1 9/14/1995 $ 34.14 1 1/18/1996 $ 34.14 1 5/14/1996 $ 34.14 33 9/28/1994 $ 20.00 47 10/17/1995 $ 34.14 The level of care billed and paid at the 99215 office visit procedure code level was improper since the level of care that was provided was at the 99214 office visit procedure code level. Cluster Number Date of Service Overpayment 53 5/31/1995 $ 21.69 The level of care billed and paid at the 99205 office visit procedure code level was improper since the level of care that was provided was at the 99204 office visit procedure code level. Cluster Number Date of Service Overpayment 25 7/27/1994 $ 2.00 The level of care that was billed and paid at the 99205 office visit procedure code level was improper since the level of care that was provided was at the 99203 office visit procedure code level. Cluster Number Date of Service Overpayment 35 5/11/1995 $ 37.96 51 12/08/1994 $ 15.00 55 11/21/1995 $ 37.96 58 9/22/1995 $ 37.96 The level of care that was billed and paid at the 99215 office visit procedure code level was improper since the level of care that was provided was at the 99204 office visit procedure code level. Cluster Number Date of Service Overpayment 43 12/11/1994 ($ 3.00) credit The level of care that was billed and paid at the 99205 office visit procedure code level was improper since the medical services provided and documentation supported an EPSDT visit. Cluster Number Date of Service Overpayment 53 2/06/1995 $ 16.53 The required components of the EPSDT were not documented as being performed at the office visit that had been claimed and paid as an EPSDT and therefore, the difference between the EPSDT payment received and the value of the procedure code for the documented level of office visit that occurred (i.e., 99214, 99213, 99212, 99211, or 99203), is deemed an overpayment. Cluster Number Date of Service Level of Visit Overpayment 1 7/28/1995 99213 $ 39.82 3 6/28/1995 99213 $ 39.82 5 3/03/1995 99203 $ 21.43 6 7/07/1994 99213 $ 5.00 10 8/17/1995 99212 $ 43.82 12 1/31/1996 99204 $ 0.00 14 5/31/1995 99213 $ 39.82 18 10/04/1994 99213 $ 5.00 18 1/29/1996 99214 $ 27.37 20 8/25/1994 99213 $ 5.00 21 12/11/1995 99214 $ 27.37 29 8/17/1994 99212 $ 9.00 Cluster Number Date of Service Level of Visit Overpayment 29 9/06/1995 99213 $ 39.82 40 7/25/1994 99203 $ 0.00 41 5/06/1996 99214 $ 27.37 46 9/19/1994 99213 $ 5.00 46 10/19/1995 99213 $ 39.82 47 11/02/1994 99213 $ 5.00 51 9/07/1995 99213 $ 39.82 53 7/10/1995 99213 $ 39.82 53 1/19/1995 99213 $ 39.82 59 5/02/1996 99203 $ 43.39 Adult Samples At hearing, Petitioner disputed all of the Agency's findings relating to patients over the age of 21 and objected to Dr. Deeb, a pediatrician, performing any review of their files. While Dr. Deeb is not the appropriate peer to review adult patient files, the following adult claims did not require substantive peer review and resulted in overpayment due to the stated reason: There were not any medical records in existence to indicate that any medical services were performed. Cluster Number Date of Service Procedure Code Billed and Paid Overpayment 2 2/20/1995 99215 $ 53.00 2 7/11/1995 99215 $ 59.14 2 8/09/1995 99215 $ 57.14 2 9/07/1995 99213 $ 23.00 2 10/11/1995 99213 $ 23.00 2 1/02/1996 99213 $ 23.00 2 3/22/1996 73560/Rad.Ex. $ 16.36 2 4/01/1996 99215 $ 57.14 2 4/05/1996 99213 $ 23.00 2 4/23/1996 99213 $ 23.00 15 2/16/1996 99213 $ 23.00 15 2/19/1996 99215 $ 57.14 16 5/14/1996 Blood Count $ 8.00 Cluster Number Date of Service Procedure Code Billed and Paid Overpayment 16 5/14/1996 UA $ 3.00 16 5/14/1996 99215 $ 57.14 23 7/28/1994 99213 $ 23.00 23 5/09/1995 72069/26 Rad.Ex. $ 6.98 23 5/09/1995 72069/Rad.Ex. $ 17.45 23 10/20/1995 99213 $ 23.00 34 4/24/1996 99214 $ 35.45 57 11/17/1995 99215 $ 59.14 60 4/10/1996 99215 $ 57.14 61 5/22/1995 99213 $ 23.00 The medical records failed to contain the required physician's signature and date authenticating the fact that the services billed were performed by either P.A. Olsen or P.A. Avidon under physician supervision. The services provided by the non-physician employee were reviewed and down-coded by the Agency to the appropriate level physician's office visit code. Cluster Number Date of Service Proc. Code Pd./ P. Code Allowed Overpayment 2 6/30/1995 99215/99212 $ 36.14 2 7/20/1995 99215/99213 $ 34.14 2 7/28/1995 99215/99213 $ 34.14 2 9/05/1995 99215/99212 $ 36.14 8 4/17/1995 99205/99203 $ 35.96 17 3/27/1995 99205/99203 $ 35.96 23 5/09/1995 99215/99213 $ 32.14 23 6/09/1995 99215/99213 $ 32.14 34 4/23/1996 99205/99203 $ 35.96 The medical records failed to contain the required physician signature authenticating the fact that the services were provided by a physician. The services provided were reviewed and down-coded by the Agency to the appropriate level physician's office visit code. Procedure Code Cluster Number Date of Service Billed and Paid Overpayment 2 6/14/1995 99215/99211 $ 45.14 16 5/15/1996 99215/99211 $ 45.14 61 5/05/1995 99205/99204 $ 14.53 The provider improperly sought payment for lab services that were part of the office visit reimbursement and/or lab services performed by an independent outside lab. Cluster Number Date of Service Procedure Billed and Paid Overpayment 2 3/08/1996 UA $ 3.00 2 4/03/1996 UA $ 3.00 15 2/08/1996 UA $ 3.00 16 5/15/1996 Blood Count $ 8.50 16 5/15/1996 Blood Count $ 8.00 The provider improperly sought payment for Modifier 26 billings (professional component) which are only appropriate when the service is rendered in a hospital. Cluster Number Date of Service Procedure Billed and Paid Overpayment 2 2/17/1995 Radiologic exam $ 6.98 2 6/14/1995 Radiologic exam $ 7.20 8 4/17/1995 Tympanometry $ 9.00 16 5/13/1996 Radiologic exam $ 5.45 16 5/15/1996 Radiologic exam $ 6.98 In addition to the policy and procedural violations, Petitioner, in egregious violation of the Medicaid program, admittedly submitted Medicaid claims for the services of specialist physicians (such as an allergist, OB/GYN, podiatrist, psychologists, and ophthalmologists) not within its Provider group, collected Medicaid funds based on those claims, and reimbursed the respective specialist. While Petitioner's corporate representative, Mr. Colavecchio, was admittedly responsible for the coding and billing of the Medicaid services submitted for reimbursement, he was minimally aware of the Medicaid policy requirements and possessed limited working knowledge of CPT coding and EPSDT billing. In addition, Petitioner's employees, Dr. Keith Wintermeyer and Dr. Marcia Malcolm, were only moderately familiar with the CPT coding and EPSDT component requirements. They provided little input to Petitioner regarding CPT coding and the sufficiency of certain physician's services relating to EPSDT billing.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Agency re-calculate the overpayment consistent with the Findings of Fact, and include only those identified violations in the cluster samples of the adult patient files, and issue a Final Order requiring Petitioner to reimburse, within 60 days, the Agency for the Medicaid overpayments plus any interest that may accrue after entry of the Final Order. DONE AND ENTERED this 14th day of February, 2003, in Tallahassee, Leon County, Florida. WILLIAM R. PFEIFFER Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 14th day of February, 2003. COPIES FURNISHED: Susan Felker-Little, Esquire Agency for Health Care Administration 2727 Mahan Drive, Suite 3431 Fort Knox Building III Tallahassee, Florida 32308 Charles D. Jamieson, Esquire Ward, Damon & Posner, P.A. 4420 Beacon Circle West Palm Beach, Florida 33407 Lealand McCharen, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive, Mail Stop 3 Tallahassee, Florida 32308 Valda Clark Christian, General Counsel Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building, Suite 3431 Tallahassee, Florida 32308 Rhonda M. Medows, M.D., Secretary Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building, Suite 3116 Tallahassee, Florida 32308
The Issue The issue in this case is whether the provider, Orietta Medical Equipment, Inc., d/b/a Pharmco Pharmacy (Respondent or Provider) should repay an alleged Medicaid overpayment and, if so, in what amount. The Petitioner’s Final Agency Audit Report (FAAR) claims the Provider must repay $486,879.06.
Findings Of Fact The Petitioner is the state agency charged with the responsibility of administering the Medicaid Program in Florida. As such, the Petitioner monitors payments to Medicaid providers and seeks to recover reimbursements when an overpayment is claimed. At all times material to the allegations of this case, the Respondent was a licensed pharmacy and was designated a “provider” of Medicaid pharmacy services pursuant to its provider agreement with the Petitioner. As a provider of Medicaid pharmacy services, the Respondent was authorized to dispense drugs to Medicaid recipients and to bill the Medicaid Program for the expenses associated with such pharmacy services. The Petitioner may, after-the-fact, seek to verify the claims paid for Medicaid recipients. This “pay and chase” methodology presumes that the Provider will maintain appropriate documentation to support the paid claims. When the Agency audits a provider, records supporting the claims paid must be produced. In this case, the Petitioner elected to perform an “invoice audit” for the audit period June 2, 2003 through May 28, 2004. The Agency sought to review the Provider’s drug acquisition records for the same drugs that were dispensed to Medicaid recipients. The paid claims should compare to the drugs acquired and held in inventory for the subject period of time. After performing a Provisional Agency Audit Report (PAAR) detailing an alleged overpayment, the Provider was notified of the audit results and was provided a spreadsheet of the work papers that detailed the overpayment claim. The Provider was given an opportunity to provide additional documentation to support the Medicaid claims and to establish the inventory to support its claims. After an additional review of the Provider's information, the Agency issued its FAAR dated February 2, 2005, which claimed a Medicaid overpayment in the amount of $486,879.06. This amount has not been repaid to the Petitioner. Instead, the Provider disputed the amount of the overpayment and requested an administrative proceeding. That request was timely submitted. All of the audit results were provided to the Provider at the time of the issuance of the FAAR and were, in fact, attached to the request for hearing submitted by the Provider on or about February 7, 2005. Florida Medicaid providers are required by their agreements with the state to comply with the Florida Medicaid Prescribed Drug Services Coverage, Limitations, and Reimbursement Handbook (the handbook). The handbook is furnished to providers and is also available on-line. The handbook outlines requirements for record keeping, as well as other pertinent information to assist providers. In this case, the Provider was obligated to maintain records to support the Medicaid claims paid by the State. The Agency contracted with Heritage Information Systems, Inc., to conduct the audit in this case. Auditors went to the Provider’s business location in Hialeah, Florida, to analyze the Respondent’s business records. More specifically, the auditors sought the records from the Provider to show that it had acquired sufficient inventory of the specific drugs for which claims had been paid during the audit period. It stands to reason that the drug inventory on hand for the Provider had to exceed the drugs dispensed during the audit period (presumably some of the Provider’s patients were not Medicaid recipients). In fact, in this case, the Provider could not produce inventory records to support the claims paid for the audit period. As the records did not support the claims, the Agency deemed the claims to be overpayments. As such, the Agency maintains the Provider was, under the terms of the guidelines set forth in the handbook, required to reimburse the Petitioner for the overpayment. To compute the overpayment the Agency used a methodology that established the use rate of the product for the audit period. For example, for the drug Acetylcysteine the Medicaid recipient use rate for the audit period was 97.27 percent. Applying this percentage to the units purchased for the audit period would establish the expected claims. Therefore, since the Respondent purchased 16,890 units of this drug, the number of units billed would be expected to be 97.27 percent (the Medicaid use rate) of that amount. Instead, the claims for this drug for the audit period totaled 96,120-- a difference of 79,691 units. The difference (79,691) must then be multiplied by the drug's $.56 cost to show an apparent overcharge in the amount of $44,626.96 for this drug. The Agency applied the same methodology described above for 20 different drugs that were billed during the audit period. The total overcharge for these drugs was $486,879.06. The Respondent presented no evidence to refute the audit findings. No acquisition records were produced to reduce the calculated overpayment. That is to say, no purchase records could demonstrate that the Provider had on hand the number of units of the drugs billed to Medicaid. The Respondent has not disputed that the pharmacy was a provider, was subject to the handbook and pertinent guidelines, was required to maintain records to support the claims, and was paid for claims submitted to the Agency. Moreover, the Respondent does not dispute that the audit, the audit work papers, and the spreadsheets describing the methodology used to compute the overpayment were provided to the Provider more than 14 days prior to the hearing. It claims the trial book of exhibits was not provided 14 days prior to the hearing date. The hearing in this cause was originally scheduled for two days, to commence on August 15, 2006. The Agency provided a trial book of its exhibits to the Respondent on or about 4:00 p.m., August 1, 2006. The Respondent maintains that all evidence presented by the Agency in this cause must be excluded pursuant to Section 409.913(22), Florida Statutes (2005).
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 sustaining the Medicaid overpayment in the amount of $486,879.06. DONE AND ENTERED this 1st day of December, 2006, in Tallahassee, Leon County, Florida. S J. D. PARRISH 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 1st day of December, 2006. COPIES FURNISHED: Richard J. Shoop, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive, Mail Stop 3 Tallahassee, Florida 32308 William Roberts, Acting General Counsel Agency for Health Care Administration Fort Knox Building, Suite 3431 2727 Mahan Drive, Mail Stop 3 Tallahassee, Florida 32308 Christa Calamas, Secretary Agency for Health Care Administration Fort Knox Building, Suite 3116 2727 Mahan Drive Tallahassee, Florida 32308 David W. Nam, Esquire Agency for Health Care Administration Fort Knox Building, Mail Station 3 2727 Mahan Drive, Suite 3431 Tallahassee, Florida 32308 William M. Furlow, III, Esquire Akerman Senterfitt Highpoint Center, Suite 1200 106 East College Avenue Tallahassee, Florida 32301
The Issue Whether Emergency Rule 10CER92-4 should be invalidated because it constitutes an invalid exercise of delegated legislative authority.
Findings Of Fact The Medicaid program is a program authorized under Title XIX of the federal Social Security Act that provides for payments for medical items or services for eligible recipients. Section 409.901(7), Florida Statutes. Prior to July 1, 1993, the Medicaid program was administered by the Department of Health and Rehabilitative Services (HRS). Effective July 1, 1993, Section 20.42, Florida Statutes, 1992 Supplement, was amended by Chapter 93-129, Section 58, Laws of Florida, to give the Agency for Health Care Administration (AHCA) the responsibility for the Medicaid program. The Medicaid program provides for mandatory and optional services to eligible recipients. Prescribed drug services are optional Medicaid services. Medicaid services may be provided only when medically necessary, must be provided in accordance with state and federal law, and are subject to any limitation established by the general appropriations act or Chapter 216, Florida Statutes. Sections 409.905 and 409.906, Florida Statutes. Medical providers participating in the Medicaid program receive reimbursement from Medicaid. Section 409.908, Florida Statutes. States are given the option to charge Medicaid recipients copayments for services. 42 CFR Section 447.50. Certain categories of services and recipients are exempt from copayments. 42 CFR Section 447.53. Forty-five percent of the Medicaid program is funded by state funds and fifty-five percent is funded with federal "matching funds." In order to receive federal matching funds for its Medicaid program, the state must submit a plan describing the nature and scope of its Medicaid program and giving assurances that the program will be administered in accordance with Title XIX and applicable federal regulations. This plan is known as the State plan. Effective February 14, 1992, the Legislature enacted Chapter 92-5, Laws of Florida, which amended the appropriations Act for fiscal year 1991-92. Proviso language in Chapter 92-5 relating to Specific Appropriation 1035 for Medicaid prescribed medicine/drug provides: The Department of Health and Rehabilitative Services is directed to implement, beginning April 1, 1992, a co-payment program for Prescribed Medicine in order to implement spending reductions of at least $770,213 from general revenue and $929,661 from the Medical Care Trust Fund in Specific Appropriation 1035. The State plan was amended effective April 10, 1992, to require a copayment of $1.00 per prescription for pharmacy services provided to Medicaid recipients. Certain categories of services and recipients were exempted from the copayment requirement. Providers were prohibited from denying services to recipients who were unable to pay the copayment. Prior to April 10, 1992, copayments had not been required for prescribed drug services. HRS adopted Emergency Rule 10CER92-4, effective April 10, 1992. HRS published notice of the emergency rule in the Florida Administrative Weekly, Vol. 18, No. 16, April 17, 1992. In this notice under the section entitled "SPECIFIC REASONS FOR FINDING AN IMMEDIATE DANGER TO THE PUBLIC HEALTH, SAFETY OR WELFARE," it states in pertinent part: The 1992 Legislature reduced the prescribed drug services program FY 1991-1992 budget in Senate Bill 2408 which was signed by the Governor on February 14, 1992. This law requires the Medicaid program to implement a copayment requirement for prescription drugs by April 1992. . . . The emergency rule amended Rule 10C-7.042, Florida Administrative Code and required recipients to pay the pharmacy provider a $1.00 co-payment for each prescription or other prescribed drug service reimbursed by Medicaid. Certain categories of recipients and services were exempted from the copayment requirement. The pharmacy provider was required to request a copayment from non-exempt recipients. The pharmacy must determine a recipient's ability to pay the copayment based on the recipient's reply to the request for copayment, the recipient's past purchase history with that provider, and the recipient's recent purchase of non-essential items. A provider could not deny prescribed drug services to eligible recipients because of inability to pay the copayment. Although a recipient may not be able to pay the copayment, the recipient remains liable for the copayment. HRS began the rulemaking process to adopt the same amendments to Rule 10C-7.042 as a regular rule. Emergency Rule 10CER92-4 was challenged via a lawsuit in state court and was later removed to federal court. The proposed amendments to Rule 10C-7.042 were challenged in an administrative rule challenge, which was withdrawn and added to the lawsuit in federal court dealing with the challenge to the emergency rule. Chapter 92-293, Laws of Florida, the Appropriations Act for fiscal year beginning July 1, 1992 and ending June 30, 1993 contains the following proviso language relating to Medicaid prescribed drug services: Funds in Specific Appropriation 1019 are reduced by $18,581,894 from the General Revenue Fund, $3,281,004 from the Grants and Donations Trust Fund, $22,647,089 from the Medical Care Trust Fund, $2,632,000 from the Public Medical Assistance Trust Fund, and $58,013 from the Special Grants Trust Fund for the Department to implement a Medicaid comprehensive cost containment program. This program shall, at a minimum, incorporate: a prior authorization component; a co-payment program; an on site education program for providers prescribing the drugs; enhancements to the Department's ability to identify fraud and abuse; utilization of specific nursing home pharmacy consultants; and, shall implement new electronic technology to speed payments and capture third party liability information. By notice in the Florida Administrative Weekly, Rule 10CER92-4 has been continued pursuant to Section 120.54(9)(c), Florida Statutes. Chapter 93-184, Laws of Florida, the Appropriations Act for the fiscal year beginning July 1, 1993 and ending June 30, 1994, contains no language concerning reductions in the appropriations for Medicaid prescription medicine services and contains no language concerning copayments for recipients receiving Medicaid prescription medicine services. The amounts appropriated for the Medicaid prescription medicine services was at or below the amounts appropriated in Chapter 92-293 Laws of Florida. Chapter 93-129, Section 48, Laws of Florida, created section 409.9081, Florida Statutes, which requires Medicaid recipients to pay nominal copayments for hospital outpatient services and physician services effective July 1, 1993. Prior to the enactment of section 409.9081, Florida Statutes, a one dollar copayment had been required for Medicaid outpatient hospital and physician service. Effective July 1, 1993, the copayments were raised to two dollars. Current revenues generated by the copayments for the Medicaid prescribed drug services is approximately $12 million. Thus, the discontinuance of the copayment would result in a $12 million shortfall for the provision of Medicaid prescribed drug services, and a restriction on services to the extent necessary to account for the shortfall. The Social Services Estimating Conference (SSEC) is a statutorily created body established to develop official information relating to the social service system of the state for use in the state planning and budgeting system. Section 216.136(6), Florida Statutes. Section 216.134(1), Florida Statutes, provides in pertinent part: Unless otherwise provided by law or decided by unanimous agreement of the principals of the conference, all official information developed by the conference shall be based on the assumption that current law and current administrative practices will remain in effect throughout the period for which the official information is to be used. . . . The social services estimating conference for 1993-94 took into consideration the revenues from the copayments for the Medicaid prescribed drug services. Petitioner, Mildred Henry, resides in Jacksonville, Florida, and is disabled. She has received Medicaid since December, 1991. Her only income is Supplemental Income ("SSI") benefits of $434 per month. Ms. Henry suffers from many disabilities including chronic obstructive pulmonary disease, asthma, hypertension, severe and chronic urinary tract infections, and depression. Her physicians have prescribed a number of medications to address these conditions including Cardizem (for high blood pressure), Zantac (for ulcers), Cipro (for chronic urinary tract infections), Phenazopyridine (for bladder problems), Imipramine (for depression), Premarin (hormone), Thes-dur (for asthma), Brethine (for asthma), Ventalin (for asthma), Furosemide (for excess fluid), K-Dur (potassium), Propoxy N (for pain), Nizoral (for skin irritations), Darvoset (for pain), Tylenol 3 (for pain), and Halcion (for anxiety). She needs to refill most of these prescriptions each month. Copayments for all of Ms. Henry's prescription medications amount to $16.00. Ms. Henry's income is below the federal poverty level. She cannot afford to pay a copayment for all her medications. Petitioner has informed her pharmacy that she does not have the money to pay copayments. However, the pharmacy has refused to provide the medications without payment of the co-payments. As a result, Petitioner runs out of medications and delays getting her prescriptions refilled until she can pay the copayment.
The Issue The issues are whether Petitioner is liable to Respondent for Medicaid reimbursement overpayments, and if so, in what amount.
Findings Of Fact Respondent is the agency charged with administration of the Medicaid program in Florida pursuant to Section 409.907, Florida Statutes. Petitioner provides services to Medicaid beneficiaries under provider No. 1000098-00 pursuant to a contract with Respondent. Under the provider agreement dated March 31, 1997, Petitioner agreed to comply with all local, state and federal laws, rules, regulations, licensure laws, Medicaid bulletins, manuals, handbooks, and statements of policy. The contract also sets forth Petitioner's responsibilities to keep and maintain in a systematic and orderly manner all medical and Medicaid-related records, and to make them available for state and federal audits for five years. Heritage Information Systems, Inc. (Heritage) is and has been a pharmacy audit company since 1980. In 1999, Respondent contracted with Heritage to perform audits of pharmacies enrolled in the Florida Medicaid program. Respondent and Heritage subsequently created a list of violations to be investigated during an audit. The list is based upon provisions in the Florida Statutes and federal Medicaid policies and regulations. The purpose of the list is to guide Heritage in performing its duty during an audit. Heritage conducts its audits based on a standard methodology and protocol. During the course of an audit, Heritage examines a provider's records to determine whether a pharmacy is compliant with all rules and regulations that apply to the pharmacy. Heritage uses an established set of neutral criteria to select pharmacies for participation in an audit. Using these criteria, Heritage selected Petitioner as a candidate for audit. By letter dated January 17, 2000, Heritage advised Petitioner that it would be audited on January 26, 2000. The letter stated as follows in relevant part: The auditor(s) will require access to original hard-copy prescription records, third party signature logs, and, in some cases, pharmacy computer screens relating to a sample of prescription claims billed by your pharmacy between 12/25/1998 and 12/24/1999. Please note that the sample claim may actually be a refill of a prescription originally dispensed prior to the audit period. Because of this, we recommend that you also have the prior twelve months of prescription records available the day of the audit. For your reference, the audit terms are defined in your participating provider agreement and the prescribed drug services handbook. If you have any additional questions prior to the audit, please call Heritage Information Systems, Inc. . . . Between December 25, 1998, and December 24, 1999, Petitioner submitted claims and received payments from the Medicaid program for 7,065 claims. Using an industry standard software application, Heritage selected a random sample of 101 of Petitioner's claims to be analyzed during the audit. In performing the audit, Heritage utilized a methodology similar to that used by auditing agencies who examined Medicaid providers in previous years. During the audit, Heritage identified four areas of noncompliance for Petitioner. First, Heritage requested Petitioner's staff to produce hard-copy prescription records for the 101 sampled claims. Hard-copy prescriptions include those ordered and signed by a physician on a handwritten form and the records created by the pharmacists immediately after receiving verbal authorization from a physician by telephone. In this case, Petitioner could not produce hard-copy prescriptions for five claims. The second area of noncompliance involved unauthorized refills. In seven instances, Petitioner refilled prescriptions more times than the number authorized on the documented prescription. There were no notations on the hard-copy prescriptions or in the pharmacy computer to indicate that the doctors or someone from their office called to increase the number of authorized refills. The third area of noncompliance involved one instance in which Petitioner claimed payment for a "days supply value" that was inconsistent with the quantity and directions on the prescription. The prescription at issue was for sixty tablets with directions for the patient to take the drug once a day, constituting a sixty-day supply of medicine. Petitioner filled this prescription as a thirty-day supply and claimed Medicaid payment accordingly. Respondent did not include this violation in the calculation of overpayment. The fourth area of noncompliance involved a prescription that was refilled 30 days earlier than appropriate with respect to the quantity and directions for use that appeared on the prescription. This was the same prescription referenced above in paragraph twelve. After completing the audit, Heritage completed a final audit report. Said report documents the following: (a) 7,310 claims submitted by Petitioner; (b) $350,639.95 paid by Respondent for all claims; (c) 101 claims in total random sample; (d) $3,839.33 paid by Respondent for claims in total random sample; (e) 13 discrepant claims in random sample; $778.09 paid by Respondent for discrepant claims; 13 documented sanctions in random sample; (h) $724.91 paid by Respondent for documented sanctions in random sample; (i) $52,466.25 as the total calculated overpayment; and (j) $13,798.70 as the amount of the overpayment based on a 95 percent one-sided lower confidence limit. The final audit report also contained a listing of the violations discovered during the audit. The final audit report contained the following comments/notes in relevant part: Five prescriptions could not be found by auditors and could not be found by pharmacist Geiger and technician Daniels either. Many unauthorized refills were noticed. Pharmacy staff stated some information may be on the old computer system that was not functioning because of Y2K problems. Any authorization or documentation that was found on the computer system was accepted. Under cover of a letter dated March 2, 2000, Petitioner furnished Respondent with statements relative to the discrepant claims/documented sanctions signed by several physicians. All of the statements included the following: (a) statements that the doctors had prescribed the medication(s) for their patients; (b) the patient name; (c) the prescription number; (d) a print-out of a computer screen; and (e) opinions that Petitioner would not fill or refill prescriptions without authority and approval. None of these physicians testified at the hearing. By letter dated August 16, 2000, Respondent notified Petitioner of the determination of a Medicaid overpayment in the amount of $13,798.70. The greater weight of the evidence indicates that Petitioner received an overpayment in that amount or more.
Recommendation Based upon the findings of fact and conclusions of law, it is RECOMMENDED: That Respondent enter a final order finding that Petitioner must timely pay Respondent $13,798.70 for Medicaid reimbursement overpayments from December 25, 1998, through December 24, 1999. DONE AND ENTERED this 30th day of January, 2001, in Tallahassee, Leon County, Florida. SUZANNE F. HOOD Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 30th day of January, 2001. COPIES FURNISHED: Melvin H. Fletcher, R.Ph. Corporate Representative Mayhugh Drugs, Inc. 200 South Orange Avenue Green Cove Springs, Florida 32043 L. William Porter, II, Esquire Agency for Health Care Administration 2727 Mahan Drive Building 3, Suite 3431 Tallahassee, Florida 32308 Sam Power, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive Building 3, Suite 3431 Tallahassee, Florida 32308 Julie Gallagher, General Counsel Agency for Health Care Administration 2727 Mahan Drive Building 3, Suite 3431 Tallahassee, Florida 32308 Ruben J. King-Shaw, Jr., Director Agency for Health Care Administration 2727 Mahan Drive Building 3, Suite 3116 Tallahassee, Florida 32308
The Issue Whether the Respondent committed the violations alleged in paragraphs 5 through 24 and 26 through 37 of the Corrected Second Amended Complaint, as modified, and, if so, the penalties that should be imposed.
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: The Department is the state agency charged with the administration and enforcement of Sections 499.001 through .081. § 499.004, Fla. Stat. Worldwide Medical Supply is a prescription drug wholesaler who has been issued a permit, numbered 22:01390, to operate at 1452 North Krome Avenue, Suite 102F, Florida City, Miami-Dade County, Florida. On December 7, 2005, an inspection of Worldwide Medical Supply was conducted after a complaint against Worldwide Medical Supply was filed with the Department. Additional inspections were conducted in or about March 2006 and on May 15, 2007. During all three inspections, the Department's inspectors did not review all of the documents in Worldwide Medical Supply's files but took a sampling of the documents maintained by Worldwide Medical Supply relating to prescription drug sales and purchases. All of the drugs at issue herein are prescription drugs, also known as legend drugs. Paragraph 5 of the Corrected Second Amended Administrative Complaint, as amended; sale of prescription drugs to an unauthorized person in violation of § 499.005(15), Fla. Stat.; Petitioner's Exhibit 1.3 Petitioner's Exhibit 1 contains, in pertinent part, a Worldwide Medical Supply invoice, a Uniform Complaint Form, and a written report of an investigation conducted by the complainant, who was a drug agent. The Worldwide Medical Supply invoice, which is dated September 20, 2005, shows that five "Caverject Imp 20MCGKIT 2"4 were billed and shipped to "Health Environment" at an address in Hialeah, Florida. The Invoice includes a physician's license number and indicates that the Caverject was sent to the attention of "Amneris & Angel." The charge relating to this transaction arose out of a complaint and investigative report filed by a drug agent regarding the subject transaction, in which he reported that the physician whose number was included on the invoice was not employed by Health Environment at the time of the shipment. The Department did not present the testimony of the complaining drug agent, and the Sharon Roberts, one of the Department's inspectors who testified at the final hearing, stated that she had not conducted an investigation into the matter and had no personal knowledge of the matter beyond that which appeared on the invoice and in the report. The evidence related to the violation charged in paragraph 5 of the Corrected Second Amended Administrative Complaint is hearsay and cannot support a finding that the Caverject was delivered to an unauthorized person. See § 120.57(1)(c), Fla. Stat.( Hearsay evidence may be used for the purpose of supplementing or explaining other evidence, but it shall not be sufficient in itself to support a finding unless it would be admissible over objection in civil actions.") The evidence presented by the Department is not, therefore, sufficient to establish that the Caverject was sold or transferred to a person who was not authorized to purchase or possess the prescription drug. Paragraph 6 of the Corrected Second Amended Administrative Complaint, as amended; fraudulent authentication of a pedigree in violation of §§ 499.005(14), (18), and (28) and 499.006(10), Fla. Stat.; Petitioner's Exhibit 2. Petitioner's Exhibit 2 consists of a Picking Ticket, a Sales Order, an Invoice, and a Prescription (Legend) Drug Pedigree Form DH2129 ("Pedigree Paper")5 relating to a transaction between CT International and Worldwide Medical Supply. The Invoice, which is dated October 13, 2005, indicates that CT International shipped and billed to Worldwide Medical Supply 15 12GM vials of Carimune and 35 6GM vials of Carimune. The Pedigree Paper was signed by a vice president of CT International, and the signature was dated October 10, 2005. The Pedigree Paper relates to the 35 6GM vials of Carimune sold to Worldwide Medical Supply, it identifies "ZLB" as the manufacturer, and lists "ZLB - CT International" as the "wholesaler's name." The Pedigree Paper does not identify the wholesaler that purchased the prescription drug from the manufacturer or the authorized distributor of record, nor does it contain any information on wholesale distributions subsequent to the purchase from the manufacturer or the authorized distributor of record. A stamp on the Pedigree Paper indicates that it was received and authenticated by Alex Valdes of Worldwide Medical Supply. None of the documents relating to this transaction contain the Florida license number of CT International or Worldwide Medical Supply. The evidence presented by the Department establishes that Worldwide Medical Supply failed to authenticate the Pedigree Paper provided by CT International and to review it for accuracy and completeness. The Pedigree Paper lacked much of the information that must be included in a pedigree paper, and it was, therefore, incomplete and could not be authenticated with the information provided. As a result, the attestation that the Pedigree Paper had been authenticated was false. The evidence presented by the Department was sufficient to establish that the omission of Worldwide Medical Supply's Florida license number constituted a failure to keep the required records of prescription drug transactions. The Department failed, however, to establish that CT International was not authorized to distribute prescription drugs in Florida. Although the records kept by prescription drug wholesalers of transactions involving prescription drugs must include the license number of the person distributing a prescription drug and the person purchasing the drug, the absence of the Florida license number of CT International constitutes an omission in the records. The omission is not, however, proof that CT International is not licensed in Florida, and the Department did not present any evidence to establish the Florida licensure status of CT International. Rather, Ms. Roberts, the Department's inspector, testified that she had no information regarding CT International's licensure status in Florida at the time of the sale of the Carimune because that "was not the issue."6 Paragraph 7 of the Corrected Second Amended Administrative Complaint, as amended; fraudulent authentication of a pedigree in violation of §§ 499.005(14), (18), and (28) and 499.006(10), Fla. Stat.; Petitioner's Exhibit 3. Petitioner's Exhibit 3 consists of a Picking Ticket, a Sales Order, an Invoice, a Credit Memo, and a Pedigree Paper relating to a transaction between CT International and Worldwide Medical Supply. The Invoice, which is dated October 17, 2005, indicates that CT International shipped and billed to Worldwide Medical Supply seven 10ML units of Baygam intramuscular immune globulin. The Pedigree Paper was signed by a vice president of CT International, and the signature was dated October 18, 2005. The Pedigree Paper relates to the seven 10ML units of Baygam sold to Worldwide Medical Supply; lists "CT International" as the wholesaler; identifies "Bayer/Talecris" as the manufacturer; and identifies "McKesson Drug" as the wholesaler that purchased the prescription drug from the manufacturer. The Pedigree Paper does not identify the wholesaler that purchased the prescription drug from McKesson, nor does it contain any information on wholesale distributions subsequent to the purchase from the manufacturer by McKesson. A stamp on the pedigree paper indicates that it was received and authenticated by Alex Valdes of Worldwide Medical Supply. None of the documents relating to this transaction contain the Florida license number of CT International or of Worldwide Medical Supply. The Baygam was returned by Worldwide Medical Supply to CT International, and a credit memo was issued to Worldwide Medical Supply refunding the cost of the drugs. The evidence presented by the Department establishes that Worldwide Medical Supply failed to authenticate the Pedigree Paper provided by CT International and to review it for accuracy and completeness. The Pedigree Paper lacked much of the information that must be included in a pedigree paper, and it was, therefore, incomplete and could not be authenticated with the information provided. As a result, the attestation that the Pedigree Paper had been authenticated was false. For the reasons stated in paragraph 12 above, the evidence presented by the Department failed to establish that CT International was not authorized to distribute prescription drugs in Florida. The evidence was, however, sufficient to establish that the omission of Worldwide Medical Supply's Florida license number constituted the failure to maintain the records required for prescription drug transactions. Paragraph 8 of the Corrected Second Amended Administrative Complaint, as amended; fraudulent authentication of a pedigree and purchase of contraband prescription drugs in violation of §§ 499.005(1)-(4), (14), (18), and (28); 499.006(10); and 499.0051(1)(b), Fla. Stat.; Petitioner's Exhibit 4. Petitioner's Exhibit 4 consists of a Picking Ticket, an Invoice, and two Pedigree Papers relating to a transaction between CT International and Worldwide Medical Supply. The Invoice, which is dated October 7, 2005, indicates that CT International shipped and billed to Worldwide Medical Supply 14 6GM vials of Carimune and 15 12GM vials of Carimune. The Pedigree Papers for both the 6GM and the 12GM vials of Carimune were signed by a vice president of CT International, and the signatures were dated October 10, 2005. The Pedigree Papers identify "ZLB" as the manufacturer, and lists "ZLB - CT International" as the "wholesaler's name." The Pedigree Papers do not identify the wholesaler that purchased the prescription drugs from the manufacturer or the authorized distributor of record, nor does it contain any information on wholesale distributions subsequent to the purchase from the manufacturer or the authorized distributor of record. A stamp on the Pedigree Paper for the 12GM vials of Carimune indicates that it was received and authenticated by Alex Valdes of Worldwide Medical Supply; there is no such stamp on the Pedigree Paper for the 6MG vials. None of the documents relating to this transaction contain the Florida license number of CT International or of Worldwide Medical Supply. The evidence presented by the Department establishes that Worldwide Medical Supply failed to authenticate the Pedigree Papers provided by CT International and to review them for accuracy and completeness. The Pedigree Papers lacked much of the information that must be included in a pedigree paper, and they were, therefore, incomplete and could not be authenticated with the information provided. There was no indication that the Pedigree Paper relating to the 6GM vials of Carimune was reviewed for completeness, and the attestation that the Pedigree Paper relating to the 12GM vials of Carimune had been authenticated was false. For the reasons stated in paragraph 12 above, the evidence presented by the Department failed to establish that CT International was not authorized to distribute prescription drugs in Florida. The evidence was, however, sufficient to establish that the omission of Worldwide Medical Supply's Florida license number constituted the failure to maintain the records required for prescription drug transactions. The evidence presented by the Department was sufficient to establish that the 6MG and 12MG vials of Carimune purchased by Worldwide Medical Supply from CT International were adulterated drugs in that the pedigree papers for the drugs were incomplete. Paragraph 9 of the Corrected Second Amended Administrative Complaint, as amended; fraudulent authentication of a pedigree and purchase of contraband prescription drugs in violation of §§ 499.005(1)-(4), (14), (18), and (28); 499.006(10); and 499.0051(1)(b), Fla. Stat.; Petitioner's Exhibit 33. Petitioner's Exhibit 33 consists of a Picking Ticket, an Invoice, and a Pedigree Paper relating to a transaction between CT International and Worldwide Medical Supply. The Invoice, which is dated October 3, 2005, indicates that CT International shipped and billed to Worldwide Medical Supply 100 2ML units of Baygam intramuscular immune globulin. The Pedigree Paper was originated by First Choice Pharmaceutical Wholesalers and signed by its sales manager, with the signature dated July 18, 2005. The Pedigree Paper does not identify the manufacturer of the Baygam and no quantity of Baygam is listed; First Choice Pharmaceutical is identified as the wholesaler that purchased an unspecified quantity of Baygam from the manufacturer; and the Pedigree Paper indicates that the first subsequent wholesale distribution of the Baygam was to CT International. It appears that all of the required information is included in reference to CT International's purchase of Baygam from First Choice Pharmaceuticals, and Drew Arnold signed the Petitioner as the authenticator from CT International. Finally, the Pedigree Paper shows that the second subsequent wholesale distribution was to Worldwide Medical Supply in the amount of "100 vls." A stamp on the Pedigree Paper indicates that it was received and authenticated by Alex Valdes of Worldwide Medical Supply. None of the documents relating to this transaction contain the Florida license number of CT International or of Worldwide Medical Supply. The evidence presented by the Department establishes that Worldwide Medical Supply failed to authenticate the Pedigree Paper provided by CT International and to review it for accuracy and completeness. The Pedigree Paper lacked the name of the manufacturer and the quantity of Baygam purchased by First Choice. The Pedigree Paper was, therefore, incomplete and could not be authenticated with the information provided. As a result, the attestation that the Pedigree Paper had been authenticated was false. For the reasons stated in paragraph 12 above, the evidence presented by the Department failed to establish that CT International was not authorized to distribute prescription drugs in Florida. The evidence was, however, sufficient to establish that the omission of Worldwide Medical Supply's Florida license number constituted the failure to maintain the records required for prescription drug transactions. The evidence presented by the Department was sufficient to establish that the 100 2ML units of Baygam purchased by Worldwide Medical Supply from CT International were adulterated drugs in that the Pedigree Paper for the drugs was incomplete. Paragraph 10 of the Corrected Second Amended Administrative Complaint, as amended; fraudulent authentication of a pedigree and purchase of contraband prescription drugs in violation of §§ 499.005(1)-(4), (14), (18), and (28); 499.006(10); and 499.0051(1)(b), Fla. Stat.; Petitioner's Exhibit 5. Petitioner's Exhibit 5 consists of a Sales Invoice and a document entitled "Pedigree" relating to a transaction between Medex BioPharm and Worldwide Medical Supply. The Invoice, which is dated August 31, 2005, indicates that Medex BioPharm shipped and billed to Worldwide Medical Supply 11 12gm units of Carimune NF. The pedigree paper is a form apparently generated by Medex BioPharm to conform to the requirements of "Section 503(e)(1) of the Federal Food Drug and Cosmetic Act," and it was signed by Medex BioPharm's compliance officer, with the signature dated September 6, 2005. The pedigree paper identifies the manufacturer of the Carimune as "ZLB" and indicates that Medex BioPharm purchased the Carimune as an "Authorized Distributor," but there is nothing in the pedigree paper regarding the source from which Medex BioPharm purchased the Carimune. The pedigree paper does not contain any information on wholesale distributions subsequent to the purchase by Medex BioPharm, and, in addition, the pedigree paper was not issued prior to or at the same time the prescription drug was shipped. A stamp on the Invoice attached to the pedigree paper indicates that it was received and authenticated by Daphne Csendes of Worldwide Medical Supply. None of the documents relating to this transaction contain the Florida license number of Medex BioPharm or of Worldwide Medical Supply. At the times relevant to the purchase of the Carimune by Worldwide Medical Supply, however, Medex BioPharm held two licenses in Florida, one as a pharmacy and one as a prescription drug wholesaler. The evidence presented by the Department establishes that Worldwide Medical Supply failed to authenticate the pedigree paper provided by Medex BioPharm and to review it for accuracy and completeness. The pedigree paper was incomplete and could not be authenticated with the information provided. As a result, the attestation that the pedigree paper had been authenticated was false. The evidence presented by the Department was sufficient to establish that the omission of Worldwide Medical Supply's Florida license number constituted the failure to maintain the records required for prescription drug transactions. The evidence presented by the Department was not sufficient to establish that Medex BioPharm was not authorized to distribute the Carimune identified in the Invoice and pedigree paper to Worldwide Medical Supply. Medex BioPharm had a wholesaler's license to sell prescription drugs in Florida at the time relevant to this transaction; the failure to include Medex BioPharm's license number in the documentation of the sale constitutes only a recordkeeping error. As further proof that Worldwide Medical Supply purchased the Carimune from an unauthorized source, the Department presented the testimony of Ms. Roberts, one of the Department's inspectors. Ms. Roberts testified that she attempted to authenticate the purchase of the Carimune by Medex BioPharm and learned that Medex BioPharm was "purchasing [the Carimune] using their pharmacy license, and then, selling [the Carimune], using their wholesale license."7 According to Ms. Roberts, this practice is not permitted and renders the Carimune contraband drugs. Ms. Roberts did not, however, provide any more specific information regarding the purchase of the Carimune by Medex BioPharm. Ms. Robert's testimony is hearsay and cannot support a finding of fact that Medex BioPharm was not authorized to distribute prescription drugs to Worldwide Medical Supply. See § 120.57(1)(c), Fla. Stat. ("Hearsay evidence may be used for the purpose of supplementing or explaining other evidence, but it shall not be sufficient in itself to support a finding unless it would be admissible over objection in civil actions.") The evidence presented by the Department was sufficient to establish that the 11 12gm units of Carimune NF purchased by Worldwide Medical Supply from Medex BioPharm were adulterated drugs in that the pedigree paper for the drugs was incomplete. Paragraph 11 of the Corrected Second Amended Administrative Complaint, as amended; fraudulent authentication of a pedigree and purchase of contraband prescription drugs in violation of §§ 499.005(1)-(4), (14), (18), and (28); 499.006(10); and 499.0051(1)(b), Fla. Stat.; Petitioner's Exhibit 6. Petitioner's Exhibit 6 consists of a Packing Slip dated September 6, 2005, a Sales Invoice dated September 7, 2005, and a document entitled "Pedigree" relating to a transaction between Medex BioPharm and Worldwide Medical Supply. The Invoice, which is dated September 7, 2005, indicates that Medex BioPharm shipped and billed to Worldwide Medical Supply 20 2ml units of Baygam. The pedigree paper is a form apparently generated by Medex BioPharm to conform to the requirements of "Section 503(e)(1) of the Federal Food Drug and Cosmetic Act," and it was signed by Medex BioPharm's compliance officer, with the signature dated September 8, 2005. The pedigree paper identifies the manufacturer of the Baygam as "Talecris" and indicates that Medex BioPharm purchased the Baygam as an "Authorized Distributor," but there is nothing in the pedigree paper regarding the source from which Medex BioPharm purchased the Baygam or the date on which it was purchased. The pedigree paper does not contain any information on wholesale distributions subsequent to the purchase by Medex BioPharm, and, in addition, the pedigree paper was not issued prior to or at the same time the prescription drug was shipped. A stamp on the pedigree paper indicates that it was received and authenticated by Daphne Csendes of Worldwide Medical Supply. None of the documents relating to this transaction contain the Florida license number of Medex BioPharm or of Worldwide Medical Supply. At the times relevant to the purchase of the Baygam by Worldwide Medical Supply, however, Medex BioPharm held two licenses in Florida, one as a pharmacy and one as a prescription drug wholesaler. The evidence presented by the Department establishes that Worldwide Medical Supply failed to authenticate the pedigree paper provided by Medex BioPharm and to review it for accuracy and completeness. The pedigree paper was incomplete and could not be authenticated with the information provided. As a result, the attestation that the pedigree paper had been authenticated was false. For the reasons stated in paragraph 33 above, the evidence presented by the Department failed to establish that Medex BioPharm was not authorized to distribute prescription drugs in Florida. The evidence was, however, sufficient to establish that the omission of Worldwide Medical Supply's Florida license number constituted the failure to maintain the records required for prescription drug transactions. The evidence presented by the Department was sufficient to establish that the 20 2ml units of Baygam purchased by Worldwide Medical Supply from Medex BioPharm were adulterated drugs in that the pedigree paper for the drugs was incomplete. Paragraph 12 of the Corrected Second Amended Administrative Complaint, as amended; fraudulent authentication of a pedigree and purchase of contraband prescription drugs in violation of §§ 499.005(1)-(4), (14), (18), and (28); 499.006(10); and 499.0051(1)(b), Fla. Stat.; Petitioner's Exhibit 7. Petitioner's Exhibit 7 consists of an Invoice and a document entitled "Pedigree Paper/Product History" relating to a transaction between Medical Infusion Technologies and Worldwide Medical Supply. The Invoice, which is dated June 10, 2005, indicates that Medical Infusion Technologies shipped and billed to Worldwide Medical Supply 33 10gm units of Gammunex and 14 5gm units of Gammunex. The pedigree paper is a form apparently generated by Medical Infusion Technologies to conform to the requirements of "section (e)(1) of the Federal Food Drug and Cosmetic Act." The pedigree paper was not signed or dated. The pedigree paper identifies the manufacturer of the Gammunex as "Bayer" and indicates that the distributor of record is "FFF" and that the Gammunex was purchased by FFF on June 8, 2005, but there is nothing in the pedigree paper regarding the source from which Medical Infusion Technologies purchased the Gammunex. The pedigree paper does not contain any information on wholesale distributions subsequent to the purchase by FFF. A stamp on the Invoice attached to the pedigree paper indicates that it was received and authenticated by Daphne Csendes of Worldwide Medical Supply. None of the documents relating to this transaction contain the Florida license number of Medical Infusion Technologies or of Worldwide Medical Supply. Medical Infusion Technologies was, however, authorized to distribute prescription drugs in Florida at the time relevant to the sale of the Gammunex.8 The evidence presented by the Department establishes that Worldwide Medical Supply failed to authenticate the pedigree paper provided by Medical Infusion Technologies and to review it for accuracy and completeness. The pedigree paper was incomplete and could not be authenticated with the information provided. As a result, the attestation that the pedigree paper had been authenticated was false. 48. The evidence presented by the Department was sufficient to establish that the omission of Worldwide Medical Supply's Florida license number constituted the failure to maintain the records required for prescription drug transactions. The evidence presented by the Department was not sufficient to establish that Medical Infusion Technologies was not authorized to distribute the Gammunex identified in the Invoice and pedigree paper to Worldwide Medical Supply. Medical Infusion Technologies had a wholesaler's license to sell prescription drugs in Florida at the time relevant to this transaction; the failure to include Medical Infusion Technologies' license number in the documentation of the sale constitutes a recordkeeping error. The evidence presented by the Department was sufficient to establish that the 33 10gm units of Gammunex and 14 5gm units of Gammunex purchased by Worldwide Medical Supply from Medical Infusion Technologies were adulterated drugs in that the pedigree paper for the drugs was incomplete. Paragraph 13 of the Corrected Second Amended Administrative Complaint, as amended; fraudulent authentication of a pedigree and purchase of contraband prescription drugs in violation of §§ 499.005(1)-(4), (14), (18), and (28); 499.006(10); and 499.0051(1)(b), Fla. Stat.; Petitioner's Exhibit 8. Petitioner's Exhibit 8 consists of an Invoice and a document entitled "Pedigree Paper/Product History" relating to a transaction between Medical Infusion Technologies and Worldwide Medical Supply. The Invoice, which is dated June 16, 2005, indicates that Medical Infusion Technologies shipped and billed to Worldwide Medical Supply 25 units of Flebogamma. The exhibit also contains a document from Cardinal Health showing that, on June 14, 2005, it sold 25 units of Flebogamma to Medical Infusion Technologies. The pedigree paper is a form apparently generated by Medical Infusion Technologies to conform to the requirements of "section (e)(1) of the Federal Food Drug and Cosmetic Act." The pedigree paper is not signed or dated. It identifies the manufacturer of the Flebogamma as "Grifols" and indicates that the distributor of record is "Cardinal Health." An Invoice attached to the pedigree paper shows that the Flebogamma was sold to Medical Infusion Technologies by Cardinal Health, but the pedigree paper does not indicate the lot number and quantity of Flebogamma that Cardinal Health purchased from Grifols, nor does it or the Invoice indicate the dosage form of the Flebogamma purchased by Cardinal Health from Grifols. A stamp on the Invoice attached to the pedigree paper indicates that it was received and authenticated by Daphne Csendes of Worldwide Medical Supply. None of the documents relating to this transaction contain the Florida license number of Medical Infusion Technologies or of Worldwide Medical Supply. Medical Infusion Technologies was, however, authorized to distribute prescription drugs in Florida at the time relevant to the sale of the Flebogamma.9 The evidence presented by the Department establishes that Worldwide Medical Supply failed to authenticate the pedigree paper provided by Medical Infusion Technologies and to review it for accuracy and completeness. The pedigree paper was incomplete and could not be authenticated with the information provided. As a result, the attestation that the pedigree paper had been authenticated was false. For the reasons stated in paragraph 47 above, the evidence presented by the Department failed to establish that Medical Infusion Technologies was not authorized to distribute prescription drugs in Florida.10 The evidence was, however, sufficient to establish that the omission of Worldwide Medical Supply's Florida license number constituted the failure to maintain the records required for prescription drug transactions. As further proof that Worldwide Medical Supply purchased the Flebogamma from an unauthorized source, the Department presented the testimony of Ms. Roberts that, when she attempted to authenticate the pedigree of the Flebogamma, she telephoned Cardinal Health and asked if they sold the Flebogamma to Medical Infusion Technologies: "They did confirm that they sold to Medical Infusion Technologies this product, but Cardinal explained to me that they sold to Medical Infusion Technologies as an end-user, like a pharmacy, which is not permitted for resale to a wholesaler."11 According to Ms. Robert's, an end- user may not sell a prescription drug to a wholesaler, and such a sale renders the Flebogamma contraband drugs. Ms. Roberts did not provide any more specific information regarding the purchase of the Flebogamma by Medical Infusion Technologies. Ms. Robert's testimony is hearsay and cannot support a finding of fact that Medical Infusion Technologies was not authorized to distribute prescription drugs to Worldwide Medical Supply. See § 120.57(1)(c), Fla. Stat. ("Hearsay evidence may be used for the purpose of supplementing or explaining other evidence, but it shall not be sufficient in itself to support a finding unless it would be admissible over objection in civil actions.") The evidence presented by the Department was sufficient to establish that the 25 units of Flebogamma purchased by Worldwide Medical Supply from Medical Infusion Technologies were adulterated drugs in that the pedigree paper for the drugs was incomplete. Paragraph 14 of the Corrected Second Amended Administrative Complaint, as amended; fraudulent authentication of a pedigree and purchase of contraband prescription drugs in violation of §§ 499.005(1)-(4), (14), (18), and (28); 499.006(10); and 499.0051(1)(b), Fla. Stat.; Petitioner's Exhibit 9. Petitioner's Exhibit 9 consists of an Invoice and a document entitled "Pedigree Paper/Product History" relating to a transaction between Medical Infusion Technologies and Worldwide Medical Supply. The Invoice, which is dated November 8, 2005, indicates that Medical Infusion Technologies shipped and billed to Worldwide Medical Supply 100 units of Gammar P. The pedigree paper is a form apparently generated by Medical Infusion Technologies to conform to the requirements of "section (e)(1) of the Federal Food Drug and Cosmetic Act." The pedigree paper is not signed or dated. It identifies the manufacturer of the Gammar P as "Aventis" and indicates that the distributor of record is "Cardinal Health." The pedigree paper does not include the lot number and quantity of Gammar P that Cardinal Health purchased from Aventis, nor does it indicate the dosage form of the Gammar P purchased by Cardinal Health from Aventis. A stamp on the Invoice attached to the pedigree paper indicates that it was received and authenticated by Alex Valdes of Worldwide Medical Supply. None of the documents relating to this transaction contain the Florida license number of Medical Infusion Technologies or of Worldwide Medical Supply. Medical Infusion Technologies was, however, authorized to distribute prescription drugs in Florida at the time relevant to the sale of the Flebogamma.12 The evidence presented by the Department establishes that Worldwide Medical Supply failed to authenticate the pedigree paper provided by Medical Infusion Technologies and to review it for accuracy and completeness. The pedigree paper was incomplete and could not be authenticated with the information provided. As a result, the attestation that the pedigree paper had been authenticated was false. For the reasons stated in paragraph 47 above, the evidence presented by the Department failed to establish that Medical Infusion Technologies was not authorized to distribute prescription drugs in Florida. The evidence was, however, sufficient to establish that the omission of Worldwide Medical Supply's Florida license number constituted the failure to maintain the records required for prescription drug transactions. The evidence presented by the Department was sufficient to establish that the 100 units of Gammar P purchased by Worldwide Medical Supply from Medical Infusion Technologies were adulterated drugs in that the pedigree paper for the drugs was incomplete. Paragraph 15 of the Corrected Second Amended Administrative Complaint, as amended; purchase of prescription drugs from an unauthorized person in violation of § 499.005(14); Petitioner's Exhibit 10. Petitioner's Exhibit 10 consists of an Order Acknowledgement, a Packing List, a Statement of Account, and an Invoice relating to a transaction between Lupin Pharmaceuticals, Inc., and Worldwide Medical Supply. The Invoice, which is dated August 16, 2004, indicates that Lupin Pharmaceuticals, Inc., shipped and billed to Worldwide Medical Supply two units of Octagam 5%. Lupin Pharmaceuticals, Inc., was not required to provide a pedigree paper to Worldwide Medical Supply for the sale of the Octagam because Lupin Pharmaceuticals, Inc., is the manufacturer of the drug. It did not, however, have a manufacturer's license to ship prescription drugs to Florida from the address in Kentucky from which it shipped the Octagam to Worldwide Medical Supply. The evidence presented by the Department was sufficient to establish that Worldwide Medical Supply purchased the Octagam from an unauthorized person. Paragraph 16 of the Corrected Second Amended Administrative Complaint, as amended; fraudulent authentication of a pedigree and purchase of contraband prescription drugs in violation of §§ 499.005(1)-(4), (14), (18), and (28); 499.006(10); and 499.0051(1)(b), Fla. Stat.; Petitioner's Exhibit 11. Petitioner's Exhibit 11 consists of an Invoice, a copy of the same Invoice stamped "Paid," and a document entitled "Pedigree Statement" relating to a transaction between Premium Health Services and Worldwide Medical Supply. The Invoice, which is dated September 23, 2004, indicates that Premium Health Services shipped and billed to Worldwide Medical Supply 16 12gm vials of Carimune. The pedigree paper is a form apparently generated by Premium Health Services to conform to the requirements of "section (e)(1) of the Federal Food Drug and Cosmetic Act." The pedigree paper is signed by a "corporate officer" and dated September 23, 2004. The pedigree paper identifies the manufacturer of the Carimune as "ZLB Bioplasma" and indicates that Premium Health Services is the authorized distributor of the Carimune. The pedigree paper does not include the address, telephone number, or purchase invoice number for the purchase of the Carimune by Premium Health Services from ZLB Bioplasma.13 A stamp on the Invoice attached to the pedigree paper indicates that it was received and authenticated by Luis Dilan of Worldwide Medical Supply. None of the documents relating to this transaction contain the Florida license number of Premium Health Services or of Worldwide Medical Supply. The state database shows that Premium Health Services' Florida prescription drug wholesaler license expired on June 30, 2004. The evidence presented by the Department establishes that Worldwide Medical Supply failed to authenticate the pedigree paper provided by Medical Infusion Technologies and to review it for accuracy and completeness. The pedigree paper was incomplete and could not be authenticated with the information provided. As a result, the attestation that the pedigree paper had been authenticated was false. The evidence presented by the Department also was sufficient to establish that Premium Health Services was not authorized to distribute prescription drugs in Florida at the time it sold the Carimune to Worldwide Medical Supply. The evidence was, additionally, sufficient to establish that the omission of Worldwide Medical Supply's Florida license number constituted the failure to maintain the records required for prescription drug transactions. The evidence presented by the Department was sufficient to establish that the 16 12gm vials of Carimune purchased by Worldwide Medical Supply from Premium Health Services were adulterated drugs in that the pedigree paper for the drugs was incomplete. Paragraph 17 of the Corrected Second Amended Administrative Complaint, as amended; purchase of contraband prescription drugs in violation of §§ 499.005(1)-(4) and (18); 499.006(10); and 499.0051(1)(b), Fla. Stat.; Petitioner's Exhibit 12. Petitioner's Exhibit 12 consists of a Packing Slip, an Invoice, a copy of the same Invoice stamped "Paid," and a Pedigree Paper relating to a transaction between Priority Pharmaceuticals and Worldwide Medical Supply. The Invoice, which is dated May 25, 2005, indicates that Priority Pharmaceuticals shipped and billed to Worldwide Medical Supply 10 10ml units of Baygam. The Pedigree Paper is signed by an individual who identifies himself as "Buyer"; the date of the signature is incomplete, giving the month but no day or year. The Pedigree Paper identifies the manufacturer of the Baygam as "Bayer" and also indicates that "Bayer" is the "authorized distributor of record" in addition to being the manufacturer. The Pedigree Paper shows a subsequent wholesale distribution to Worldwide Medical Supply, but the same individual that signed the Pedigree Paper also signed the subsequent distribution section as the "authenticator." A stamp on the Invoice marked "Paid" indicates that it was received and authenticated by Daphne Csendes of Worldwide Medical Supply. The evidence presented by the Department was sufficient to establish that the 10 10ml units of Baygam purchased by Worldwide Medical Supply from Priority Pharmaceuticals were adulterated drugs in that the pedigree paper for the drugs was incomplete. Paragraph 18 of the Corrected Second Amended Administrative Complaint, as amended; purchase of contraband prescription drugs in violation of §§ 499.005(1)-(4) and (18); 499.006(10); and 499.0051(1)(b), Fla. Stat.; Petitioner's Exhibit 13. Petitioner's Exhibit 13 consists of five sets of documents relating to transactions between Prodigy Health Supplier Corporation and Worldwide Medical Supply on or about April 27, 2005, and May 11, 18, and 20, 2005. The Department has charged Worldwide Medical Supply in its Corrected Second Amended Administrative Complaint with four violations of Sections 499.001 through .081, Florida Statutes, each corresponding to a specific date.14 The first set of documents consists of a Picking Slip and Invoice dated April 27, 2005, together with a copy of the Picking Slip showing that it was posted April 28, 2005, and a copy of the Invoice showing that it was paid on May 11, 2005. The Invoice, which is dated May 25, 2005, indicates that Prodigy Health Supplier Corporation 30 10g vials of Gammar. No pedigree paper was included with the Invoices and Picking Slips. The evidence presented by the Department was, therefore, sufficient to establish that the 30 10g vials of Gammar were adulterated because they were not accompanied by a pedigree paper. The second set of documents consists of a Pedigree Paper dated May 17, 2005, and Picking Slip and Invoice dated May 11, 2005. The Invoice indicates that 20 6g vials and 10 3g vials of Carimune NF was sold by Prodigy Health Supplier Corporation to Worldwide Medical Supply on May 11, 2005. The Pedigree Paper indicates that ZLB Bioplasma is the manufacturer of the drugs and includes the NDC number, the lot numbers, and the quantity of the drug, which correspond to the lot numbers and quantity of the Carimune sold by Prodigy Health Supplier Corporation to Worldwide Medical Supply. The Pedigree Paper further indicates that Prodigy Health Supplier Corporation was the authorized distributor of record for the Carimune, but the invoice number and date identified on the Pedigree Paper are the invoice number of the Invoice and date relating to the transaction between Prodigy Health Supplier Corporation and Worldwide Medical Supply, not between ZLB Bioplasma and Prodigy Health Supplier Corporation. The Pedigree Paper shows no subsequent wholesale distribution. The Pedigree Paper is signed by an individual who identifies himself as "VP"; the signature is dated May 17, 2005. The evidence presented by the Department with respect to this set of documents was sufficient to establish that the 20 6g vials and 10 3g vials of Carimune NF purchased by Worldwide Medical Supply from Prodigy Health Supplier Corporation were adulterated drugs in that the pedigree paper for the drugs was incomplete. The third set of documents consists of a Pedigree Paper dated May 17, 2005, and a Picking Slip and Invoice dated May 18, 2005. The Invoice indicates that 20 6g vials of Carimune NF were sold by Prodigy Health Supplier Corporation to Worldwide Medical Supply on May 18, 2005. The Pedigree Paper indicates that ZLB Bioplasma is the manufacturer of the drugs and includes the NDC number, the lot numbers, and the quantity of the drug, which correspond to the lot numbers and quantity of the Carimune sold by Prodigy Health Supplier Corporation to Worldwide Medical Supply. The Pedigree Paper further indicates that Prodigy Health Supplier Corporation was the authorized distributor of record for the Carimune, but the invoice number and date identified on the Pedigree Paper is the number of the Invoice and date relating to the transaction between Prodigy Health Supplier Corporation and Worldwide Medical Supply, not between ZLB Bioplasma and Prodigy Health Supplier Corporation. The Pedigree Paper shows no subsequent wholesale distribution history. The evidence presented by the Department with respect to this set of documents was sufficient to establish that the 20 6g vials of Carimune NF purchased by Worldwide Medical Supply from Prodigy Health Supplier Corporation were adulterated drugs in that the pedigree paper for the drugs was incomplete. The fourth set of documents consists of two Pedigree Papers dated May 20, 2005, and an Invoice dated May 20, 2005. The Invoice indicates that 20 10g vials of Gammar, five 10g units of Flebogamma, and 10 5g units of Flebogamma were sold by Prodigy Health Supplier Corporation to Worldwide Medical Supply on May 20, 2005. The Pedigree Papers indicate that ZLB Bioplasma is the manufacturer of the Gammar P and that Grifols Biologicals is the manufacturer of the Flebogamma; they include the NDC numbers, the lot numbers, and the quantities of the drugs, which correspond to the lot numbers and quantity of the Gammar P and Flebogamma sold by Prodigy Health Supplier Corporation to Worldwide Medical Supply. The Pedigree Paper for the Flebogamma further indicates that Prodigy Health Supplier Corporation was the authorized distributor of record for the Flebogamma, but the invoice number and date identified on the Pedigree Paper is the number of the Invoice and the date relating to the transaction between Prodigy Health Supplier Corporation and Worldwide Medical Supply, not between Grifols Biologicals and Prodigy Health Supplier Corporation. The Pedigree Paper shows no subsequent wholesale distribution history relating to the Flebogamma. The Pedigree Paper for the Gammar P indicates that Premium Health Services was the authorized distributor of record for the Gammar P and that Prodigy Health Supplier Corporation purchased the Gammar P from Premium Health Services, but the invoice number and date identified on the Pedigree Paper is the number of the Invoice and date relating to the transaction between Prodigy Health Supplier Corporation and Worldwide Medical Supply, not between Grifols Biologicals and Premium Health Services. In addition, there is nothing on the Pedigree Paper for the Gammar P to indicate that the pedigree from Premium Health Services was authenticated by Prodigy Health Supplier Corporation. The evidence presented by the Department with respect to this set of documents was sufficient to establish that the 20 10g vials of Gammar, five 10g units of Flebogamma, and 10 5g units of Flebogamma purchased by Worldwide Medical Supply from Prodigy Health Supplier Corporation were adulterated drugs in that the pedigree paper for the drugs was incomplete. Paragraph 19 of the Corrected Second Amended Administrative Complaint, as amended; fraudulent authentication of a pedigree and purchase of contraband prescription drugs in violation of §§ 499.005(1)-(4), (14), (18), and (28); 499.006(10); and 499.0051(1)(b), Fla. Stat.; Petitioner's Exhibit 14. Petitioner's Exhibit 14 consists of an Invoice, a Pedigree Paper, and a facsimile transmittal cover page relating to a transaction between PMP Health Services and Worldwide Medical Supply. The Invoice, which is dated April 26, 2004, indicates that PMP Health Services shipped and billed to Worldwide Medical Supply eight 10GM units of Gammagard S/D. The Pedigree Paper was apparently originated by PMP Health Services and was signed by an individual who identified himself as "Sec.," with the signature dated April 26, 2004. The Pedigree Paper identifies the manufacturer of the Gammagard as Baxter and includes the lot number and quantity of the drug.15 The invoice number and date below the information related to the manufacturer correspond to the Invoice and date relating to the transaction between PMP Health Services and Worldwide Medical Supply. Cardinal Health is identified on the Pedigree Paper as the authorized distributor of record of the Gammagard, and the subsequent wholesale distribution history shows that the Gammagard was purchased from Cardinal Health by a prescription drug wholesaler in Maryland whose name is illegible on the Pedigree Paper and that the Gammagard was purchased from this company by PMP Health Services. The Pedigree Paper does not contain the purchase date or invoice number for any of the transactions prior to the sale to Worldwide Medical Supply, nor is there any indication that the pedigree of the Gammagard was authenticated by the Maryland company or by PMP Health Services. A facsimile transmittal cover page includes a handwritten note that "This is the pedigree for the Gammagard" and appears to relate to the April 26, 2005, transaction. A stamp on the facsimile transmittal cover page indicates that it was received and authenticated by Luis Dilan of Worldwide Medical Supply. None of the documents relating to this transaction contain the Florida license number of PMP Health Services or of Worldwide Medical Supply. PMP Health Services was, however, authorized to distribute prescription drugs in Florida at the time relevant to the sale of the Gammagard. The evidence presented by the Department establishes that Worldwide Medical Supply failed to authenticate the Pedigree Paper provided by PMP Health Services and to review it for accuracy and completeness. The Pedigree Paper did not include much of the information required for a pedigree, and it was, therefore, incomplete and could not be authenticated with the information provided. As a result, the attestation that the Pedigree Paper had been authenticated was false. The evidence presented by the Department was not sufficient to establish that PMP Health Services was not authorized to distribute the Gammagard identified in the Invoice and Pedigree Paper to Worldwide Medical Supply. PMP Health Services had a wholesaler's license to sell prescription drugs in Florida at the time relevant to this transaction; the failure to include PMP Health Services' license number in the documentation of the sale constitutes only a recordkeeping error. The evidence was, additionally, sufficient to establish that the omission of Worldwide Medical Supply's Florida license number constituted the failure to maintain the records required for prescription drug transactions. The evidence presented by the Department was sufficient to establish that the eight 10GM units of Gammagard S/D purchased by Worldwide Medical Supply from PMP Health Services were adulterated drugs in that the Pedigree Paper for the drugs was incomplete. Paragraph 20 of the Corrected Second Amended Administrative Complaint, as amended; purchase of contraband prescription drugs in violation of §§ 499.005(1)-(4) and (18); 499.006(10); and 499.0051(1)(b), Fla. Stat.; Petitioner's Exhibit 15. Petitioner's Exhibit 15 consists of an Invoice and a "Statement Identifying Pharmaceutical Sale" relating to a transaction between PMP Health Services and Worldwide Medical Supply. The Invoice, which is dated June 3, 2004, indicates that PMP Health Services shipped and billed to Worldwide Medical Supply eight 10GM units of Gammagard S/D. The "Statement Identifying Pharmaceutical Sale" is a form apparently generated by PMP Health Services to conform to the requirements of "Section 503(e)(1) of the Federal Food Drug and Cosmetic Act," and was intended as a pedigree paper for the transaction. The pedigree paper is not signed or dated but includes under a paragraph entitled "Unauthorized Vendor Certification" the typewritten name of an individual who is otherwise unidentified. The pedigree paper identifies the manufacturer of the Gammagard as "Baxter" and also includes the NDC number, expiration date, and lot number of the drug. No quantity or dosage amount is included, however. The pedigree paper shows that PMP Health Services purchased the Gammagard from BioMed Plus, which is identified as an "Authorized Distributor"; there is no information regarding BioMed Plus's purchase of the drug or and no further information regarding PMP Health Services' purchase of the drug from BioMed Plus. A stamp on the Invoice indicates that it was received and authenticated by Luis Dilan of Worldwide Medical Supply. The evidence presented by the Department was sufficient to establish that the eight 10GM units of Gammagard S/D purchased by Worldwide Medical Supply from PMP Health Services were adulterated drugs in that the pedigree paper for the drugs was incomplete. Paragraph 21 of the Corrected Second Amended Administrative Complaint, as amended; fraudulent authentication of a pedigree and purchase of contraband prescription drugs in violation of §§ 499.005(1)-(4), (14), (18), and (28); 499.006(10); and 499.0051(1)(b), Fla. Stat.; Petitioner's Exhibit 16. Petitioner's Exhibit 16 consists of an Invoice and a Pedigree Paper dated June 21, 2004, and an Invoice and a Pedigree Paper dated July 19, 2004, relating to two transactions between PMP Health Services and Worldwide Medical Supply. The Invoice dated July 19, 2004, indicates that PMP Health Services shipped and billed to Worldwide Medical Supply 32 10GM units of Gammunex 10%.16 The Pedigree Paper related to the July 19, 2004, transaction was apparently originated by PMP Health Services and was signed by an individual who identified himself as "Sec.," with the signature dated July 19, 2004. The Pedigree Paper identifies Bayer as the manufacturer of the Gammunex and includes the lot number and quantity of the drug.17 The invoice number and date below the information related to the manufacturer correspond to the Invoice and date relating to the transaction between PMP Health Services and Worldwide Medical Supply. "PHC" is identified on the Pedigree Paper as the authorized distributor of record of the Gammunex, and the subsequent sales history shows that the Gammunex was purchased from PHC by PMP Health Services. The Pedigree Paper contains the purchase date, but it does not include the invoice number for the purchase by PMP Health Services from PHC, nor is there any indication that the pedigree of the Gammunex was authenticated by PMP Health Services. A stamp on the July 19, 2004, Invoice indicates that it was received and authenticated by Luis Dilan of Worldwide Medical Supply. None of the documents relating to this transaction contain the Florida license number of PMP Health Services or of Worldwide Medical Supply. PMP Health Services was, however, authorized to distribute prescription drugs in Florida at the time relevant to the sale of the Gammunex. The evidence presented by the Department establishes that Worldwide Medical Supply failed to authenticate the Pedigree Paper provided by PMP Health Services and to review them for accuracy and completeness. The Pedigree Paper did not include much of the information required for a pedigree, and it was, therefore, incomplete and could not be authenticated with the information provided. As a result, the attestation that the Pedigree Paper had been authenticated was false. The evidence presented by the Department was not sufficient to establish that PMP Health Services was not authorized to distribute the Gammunex identified in the Invoice and Pedigree Paper to Worldwide Medical Supply. PMP Health Services had a wholesaler's license to sell prescription drugs in Florida at the time relevant to this transaction; the failure to include PMP Health Services' license number in the documentation of the sale constitutes only a recordkeeping error. The evidence was, however, sufficient to establish that the omission of Worldwide Medical Supply's Florida license number constituted the failure to maintain the records required for prescription drug transactions. The evidence presented by the Department was sufficient to establish that the 32 10GM units of Gammunex 10% purchased by Worldwide Medical Supply from PMP Health Services were adulterated drugs in that the Pedigree Paper for the drugs was incomplete. Paragraph 22 of the Corrected Second Amended Administrative Complaint, as amended; purchase of prescription drugs from an unauthorized person in violation of § 499.005(14); Petitioner's Exhibit 17. Petitioner's Exhibit 17 consists of a Sales Order Pick Suggestion and Invoice dated June 7, 2005, and a Sales Order Pick Suggestion and Invoice dated June 22, 2005, relating to two transactions between Questcor Pharmaceuticals, Inc., and Worldwide Medical Supply. The Invoice dated June 7, 2005, indicates that Questcor Pharmaceuticals, Inc., shipped and billed to Worldwide Medical Supply five units of Acthar; the Invoice dated June 22, 2004, indicates that Questcor Pharmaceuticals, Inc., shipped and billed to Worldwide Medical Supply five units of Acthar. Questcor Pharmaceuticals, Inc., was not required to provide a pedigree paper to Worldwide Medical Supply for the sale of the Acthar because it is the manufacturer of the drug, but it did not have a manufacturer's license to distribute prescription drugs in Florida from the address in Kentucky from which it shipped the Acthar to Worldwide Medical Supply. It did, however, have a manufacturer's license to distribute prescription drugs in Florida from an address in California. The evidence presented by the Department was sufficient to establish that Worldwide Medical Supply purchased the Acthar from an unauthorized person on June 7 and 22, 1005. Paragraph 23 of the Corrected Second Amended Administrative Complaint, as amended; fraudulent authentication of a pedigree and purchase of contraband prescription drugs in violation of §§ 499.005(1)-(4), (14), (18), and (28); 499.006(10); and 499.0051(1)(b), Fla. Stat.; Petitioner's Exhibit 18. Petitioner's Exhibit 18 consists of an Invoice dated March 5, 2004, and an Invoice dated October 16, 2003, relating to two transactions between FPP Distribution, Inc., acting as "Logistic Service Providers for: RxBazaar.com," and Worldwide Medical Supply. The Invoice dated October 16, 2003, indicates that FPP Distribution, Inc. shipped and billed to Worldwide Medical Supply 60 10GM tabs of Zyprexa. A handwritten notation appears on this Invoice indicating that the Zyprexa was "Returned for no (1) Pedigree Papers (2) RxBazaar not license [sic] in State of Florida for wholesale distribution." The Invoice dated March 5, 2004, indicates that FPP Distribution, Inc., shipped and billed to Worldwide Medical Supply 3 5MG units of Aricept.18 No pedigree paper was included with the Invoice, and there is no indication that the Aricept was returned. As noted by Worldwide Medical Supply on the October 16, 2003, Invoice, RxBazaar.com was not licensed to distribute prescription drugs in Florida at the time relevant to the sale of the Zyprexa, and neither it nor FPP Distribution, Inc., was licensed to distribute prescription drugs in Florida at the time relevant to the sale of the Aricept. Because neither FPP Distribution, Inc., nor RxBazaar.com was licensed to distribute prescription drugs in Florida at the time relevant to the March 5, 2004, transaction, the evidence presented by the Department was sufficient to establish that Worldwide Medical Supply purchased the Aricept from an unauthorized person. However, even though Worldwide Medical Supply did purchase Zyprexa from FPP Distribution, Inc./RxBazaar.com, the evidence establishes that Worldwide Medical Supply returned the shipment and, therefore, for purposes of a separate violation of Sections 499.001 through .081, Florida Statutes, the evidence presented by the Department was not sufficient to establish that Worldwide Medical Supply completed the purchase of the Zyprexa from an unauthorized person. The evidence presented by the Department was sufficient to establish that the 3 5MG units of Aricept purchased by Worldwide Medical Supply from FPP Distribution, Inc./RxBazaar.com were adulterated drugs in that no pedigree paper was provided for the drugs. Finally, no pedigree papers are included in Petitioner's Exhibit 18, and there is no representation on either the October 16, 2003, or the March 5, 2004, Invoices that anyone at Worldwide Medical Supply authenticated the prescription drug pedigrees. Therefore, the evidence presented by the Department was not sufficient to establish that Worldwide Medical Supply fraudulently authenticated the pedigrees of these drugs. Paragraph 24 of the Corrected Second Amended Administrative Complaint, as amended; purchase of prescription drugs from an unauthorized person and purchase of contraband prescription drugs in violation of §§ 499.005(1)-(4) and (18); 499.006(10); and 499.0051(1)(b), Fla. Stat.; Petitioner's Exhibit 19.19 Petitioner's Exhibit 19 consists of an Invoice and four documents entitled "Statement Identifying Prior Sales of Prescription Drugs by Wholesalers Required by the Prescription Drug Marketing Act," which apparently are intended to be pedigree papers, relating to a transaction between Allscripts Healthcare Solutions and Worldwide Medical Supply. The Invoice, which is dated February 2, 2004, indicates that Allscripts Healthcare Solutions shipped and billed to Worldwide Medical Supply 30 200mg tabs of Diflucan; 60 2mg tablets of Risperdal; 60 10mg tabs of Zyprexa; and 60 20mg tabs of Zyprexa. Allscripts Healthcare Solutions provided a statement identifying prior sales to Worldwide Medical Supply for each of these four prescription drugs; these statements were apparently intended to be pedigree papers for each of the drugs. The statements identify the manufacturer and NDC number for each drug; include the bulk lot numbers and expiration dates for the drugs; indicate that Allscripts Healthcare Solutions sold the drugs to Worldwide Medical Supply; provide Allscripts Healthcare Solutions' Florida Out-Of-State Prescription Drug Wholesaler Permit number; identify Amerisource Bergen as the person from whom Allscripts Healthcare Solutions purchased the drugs; identify Amerisource Bergen as an authorized distributor for the drugs; and state that Amerisource Bergen did not provide pedigree documents to Allscripts Healthcare Solutions for the drugs. The statements did not include any information regarding the purchase of the drugs from the manufacturers. The evidence presented by the Department was not sufficient to establish that Worldwide Medical Supply purchased the four prescription drugs from an unauthorized person. Allscripts Healthcare Solutions was properly licensed to distribute prescription drugs in Florida at the times of the transactions at issue. The evidence presented by the Department was sufficient to establish that the 30 200mg tabs of Diflucan, 60 2mg tablets of Risperdal, 60 10mg tabs of Zyprexa, and 60 20mg tabs of Zyprexa purchased by Worldwide Medical Supply from Allscripts Healthcare Solutions were adulterated drugs in that the statements intended to provide the pedigrees for the drugs were incomplete. Paragraph 26 of the Corrected Second Amended Administrative Complaint, as amended; fraudulent authentication of a pedigree and purchase of contraband prescription drugs in violation of §§ 499.005(1)-(4), (14), (18), and (28); 499.006(10); and 499.0051(1)(b), Fla. Stat.; Petitioner's Exhibit 21. Petitioner's Exhibit 21 consists of an Invoice, a Packing Slip, and a "Pedigree" relating to a transaction between ActSys Medical, Inc., and Worldwide Medical Supply. The Invoice dated December 22, 2004, indicates that ActSys Medical, Inc., shipped and billed to Worldwide Medical Supply 10 10ml vials of Baygam. The pedigree paper provided by ActSys Medical, Inc., identified the manufacturer of the Baygam as Bayer, and included the NDC number, the quantity, the lot number, and the expiration date of the drugs. The pedigree paper further identified ActSys Medical, Inc., as the supplier of the drugs and identified ActSys Medical, Inc., as the "authorized distributor." There is no further wholesale distribution history for the drugs in the pedigree paper; there is no information in the pedigree paper regarding the purchase of the drugs by ActSys Medical, Inc.; and the pedigree paper is not signed. A stamp on the December 22, 2004, Invoice indicates that it was received and authenticated by Luis Dilan of Worldwide Medical Supply. None of the documents relating to this transaction contain the Florida license number of ActSys Medical, Inc., or of Worldwide Medical Supply. ActSys Medical, Inc., was not authorized to distribute prescription drugs in Florida at the time relevant to the sale of the Baygam. The evidence presented by the Department establishes that Worldwide Medical Supply failed to authenticate the pedigree paper provided by ActSys Medical, Inc., and to review it for accuracy and completeness. The pedigree paper did not include much of the information required for a pedigree, and it was, therefore, incomplete and could not be authenticated with the information provided. As a result, the attestation that the pedigree paper had been authenticated was false. The evidence presented by the Department was sufficient to establish that ActSys Medical, Inc., was not authorized to distribute the Baygam identified in the Invoice and "Pedigree" provided to Worldwide Medical Supply. The evidence was, additionally, sufficient to establish that the omission of Worldwide Medical Supply's Florida license number constituted the failure to maintain the records required for prescription drug transactions. The evidence presented by the Department was sufficient to establish that the 10 10ml vials of Baygam purchased by Worldwide Medical Supply from ActSys Medical, Inc., were adulterated drugs in that the pedigree paper for the drugs was incomplete. Paragraph 27 of the Corrected Second Amended Administrative Complaint, as amended; fraudulent authentication of a pedigree and purchase of contraband prescription drugs in violation of §§ 499.005(1)-(4), (14), (18), and (28); 499.006(10); and 499.0051(1)(b), Fla. Stat.; Petitioner's Exhibit 22. Petitioner's Exhibit 22 consists of an Invoice, a copy of the Invoice marked "Paid," a Work Order, and a Pedigree Paper relating to a transaction between Florida Infusion/Nations Drug and Worldwide Medical Supply. The Invoice dated September 15, 2005, indicates that Florida Infusion shipped and billed to Worldwide Medical Supply 14 2ML units of Baygam Immune Globulin I.M. The Pedigree Paper provided by Florida Infusion identified the manufacturer of the Baygam as "Talecris," and included the NDC number, the quantity, the lot number, and the expiration date of the drugs. The Pedigree Paper further identified Florida Infusion as the "authorized distributor of record." There is no further wholesale distribution history for the drugs in the Pedigree Paper and there is no information in the Pedigree Paper regarding the purchase of the drugs by Florida Infusion.20 The invoice number and date included on the Pedigree Paper corresponds to the invoice number and date of the transaction between Florida Infusion and Worldwide Medical Supply. The Pedigree Paper is signed and dated September 19, 2005. A stamp on the September 15, 2005, Work Order indicates that it was received and authenticated by Daphne Csendes of Worldwide Medical Supply. None of the documents relating to this transaction contain the Florida license number of Florida Infusion or of Worldwide Medical Supply. Florida Infusion was, however, authorized to distribute prescription drugs in Florida at the time relevant to the sale of the Baygam. The evidence presented by the Department was not sufficient to establish that Florida Infusion was not authorized to distribute the Baygam identified in the Invoice and Pedigree Paper to Worldwide Medical Supply. Florida Infusion had a wholesaler's license to sell prescription drugs in Florida at the time relevant to this transaction; the failure to include Florida Infusion's license number in the documentation of the sale constitutes only a recordkeeping error. The evidence was, additionally, sufficient to establish that the omission of Worldwide Medical Supply's Florida license number constituted the failure to maintain the records required for prescription drug transactions. The evidence presented by the Department establishes that Worldwide Medical Supply failed to authenticate the Pedigree Paper provided by Florida Infusion and to review it for accuracy and completeness. The Pedigree Paper did not include much of the information required for a pedigree, and it was, therefore, incomplete and could not be authenticated with the information provided. As a result, the attestation that the Pedigree Paper had been authenticated was false. The evidence presented by the Department was sufficient to establish that the 14 2ML units of Baygam Immune Globulin I.M. purchased by Worldwide Medical Supply from Florida Infusion were adulterated drugs in that the Pedigree Paper for the drugs was incomplete. Paragraph 28 of the Corrected Second Amended Administrative Complaint, as amended; purchase of contraband prescription drugs in violation of §§ 499.005(1)-(4), (18), and (29); 499.006(10); and 499.0051(1)(b), Fla. Stat.; Petitioner's Exhibit 23. Petitioner's Exhibit 23 consists of five Invoices and accompanying shipping documents and a sixth Invoice that is not accompanied by a shipping document; these documents relate to six transactions between Bellco Drug Corp and Worldwide Medical Supply. The first Invoice, dated October 17, 2005, indicates that Bellco Drug Corp shipped and billed to Worldwide Medical Supply eight 10ML units of Chorionic Gonad (N/RTN); the second Invoice, dated October 17, 2005, indicates that Bellco Drug Corp shipped and billed to Worldwide Medical Supply 10 10ML units of Chorionic Gonad (N/RTN); the third Invoice, dated October 17, 2005, indicates that Bellco Drug Corp shipped and billed to Worldwide Medical Supply 5 10ML units of Nubain Inj 10MG/ML N/f; the fourth Invoice, dated October 18, 2005, indicates that Bellco Drug Corp shipped and billed to Worldwide Medical Supply four 20ML units of Ceftriaxone DOD Inj 1GM and 4 2ML units of Thiamine HCL Inj 100MG/ML; the fifth Invoice, dated October 20, 2005, indicates that Bellco Drug Corp shipped and billed to Worldwide Medical Supply 24 10CP units of Tamiflu 75MG; and the sixth Invoice, dated October 31, 2005, indicates that Bellco Drug Corp shipped and billed to Worldwide Medical Supply one 2ML unit of Baygam SDV and three 10CP units of Tamiflu 75MG.21 A stamp on the October 31, 2005, Invoice indicates that it was received and authenticated by Alex Valdes of Worldwide Medical Supply. No pedigree papers were, however, provided for any of the six transactions. The evidence presented by the Department was sufficient to establish that the prescription drugs purchased by Worldwide Medical Supply from Bellco Drug Corp on October 17, 18, 20, and 31, 2005, were adulterated drugs in that no pedigree papers were provided for the drugs. In addition, the evidence presented by the Department was sufficient to establish that Worldwide Medical Supply's purported authentication of the pedigrees of the drugs purchased from Bellco Drug Corp on October 31, 2005, was fraudulent. No authentication was possible because no pedigree paper was provided for the drugs. Paragraph 29 of the Corrected Second Amended Administrative Complaint, as amended; purchase of contraband prescription drugs in violation of §§ 499.005(1)-(4), (18), and (29); 499.006(10); and 499.0051(1)(b), Fla. Stat.; Petitioner's Exhibit 24. Petitioner's Exhibit 24 consists of a Packing List and three statements entitled "Prescription Drug Pedigree" relating to a transaction between BioMed Plus Miami and Worldwide Medical Supply. The Packing List, which is dated December 9, 2004, indicates that BioMed Plus Miami shipped and billed to Worldwide Medical Supply 35 5-gram units of Gammunex 10%; 15 10-gram units of Gammunex 10%; and 5 20- gram units of Gammunex 10%. The "Prescription Drug Pedigree" statements included with the Invoices were apparently created by BioMed Plus Miami. The three "pedigree" statements are not signed or dated. The statements identify the manufacturer of the Gammunex 10% as Bayer, and the only information included on the documents is the name and dosage of the drugs, the NDC numbers, the lot numbers, the expiration dates, and the quantities of the drugs expressed in grams. The statements include no information regarding the purchase of the Gammunex by BioMed Plus Miami or the wholesale distribution history of the drugs. A stamp on the Packing List indicates that it was received and authenticated by Luis Dilan of Worldwide Medical Supply. The evidence presented by the Department was sufficient to establish that the 35 5-gram units of Gammunex 10%, the 15 10-gram units of Gammunex 10%, and the 5 20-gram units of Gammunex 10% purchased by Worldwide Medical Supply from BioMed Plus Miami were adulterated drugs in that the pedigree papers for the drugs were wholly inadequate and incomplete. Paragraph 30 of the Corrected Second Amended Administrative Complaint, as amended; receipt of a prescription drug by a non- permitted facility in violation of §§ 499.005(14) and 499.006(10), Fla. Stat.; Petitioner's Exhibit 25. Petitioner's Exhibit 25 consists of an Invoice and a Packing Slip relating to a transaction between Mercury Medical and Worldwide Medical Supply. The Invoice, which is dated October 13, 2006, indicates that Mercury Medical shipped 20 5ML units of flu vaccine to Rick Nielson at 7904 West Drive, Unit 1017, North Bay Village, Florida 33141 and billed the vaccine to Worldwide Medical Supply. At the time the vaccine was shipped, Rick Nielson was the certified designated representative of Worldwide Medical Supply, and the address to which it was shipped was Mr. Nielson's home address. Mr. Nielson's home was not a facility licensed to receive prescription drug in Florida. The evidence presented by the Department was sufficient to establish that the drug was adulterated because the drug was held by a person not authorized to do so, but the Department presented no evidence to establish that Worldwide Medical Supply was responsible for the shipment or that it committed a violation with respect to this transaction. Paragraph 31 of the Corrected Second Amended Administrative Complaint, as amended; purchase of prescription drugs from an unauthorized person in violation of §§ 499.005(14) and (15) and 499.0051(1)(b), (4),and (5), Fla. Stat.; Petitioner's Exhibit 26. Petitioner's Exhibit 26 consists of a Packing Slip, a Pedigree Paper, and copies of the Georgia and Florida licenses of Medical Infusion Technologies relating to a transaction between Medical Infusion Technologies and Worldwide Medical Supply. The Packing Slip, which is dated April 25, 2006, indicates that a number of 3 gram vials of Carimune NF were shipped to Medical Infusion Technologies at an address in Bossier City, Louisiana. The Pedigree Paper prepared by Worldwide Medical Supply and dated March 6, 2007, indicates that Worldwide Medical Supply purchased nine of the 3 gram vials of Carimune from Medical Infusion Technologies, whose address was noted on the Pedigree Paper as 1525 Doctors Drive, Bossier City, Louisiana. Medical Infusion Technologies did not have a Florida license to distribute prescription drugs from its Bossier City, Louisiana, address. Medical Infusion Technologies' Florida license was issued to Medical Infusion Technologies at 115 Echols Street, Savannah, Georgia. The evidence presented by the Department was, therefore, sufficient to establish that Worldwide Medical Supply purchased the Carimune from a person not authorized to sell the drug in Florida. Paragraph 32 of the Corrected Second Amended Administrative Complaint, as amended; purchase of prescription drugs from an unauthorized person in violation of §§ 499.005(14) and (15) and 499.0051(1)(b), (4),and (5), Fla. Stat.; Petitioner's Exhibit 27. Petitioner's Exhibit 27 consists of a two-page Invoice dated September 25, 2006, and an Order Pick Sheet dated October 10, 2006. These documents relate to transactions involving Broughton Pharmaceuticals, LLC, Worldwide Medical Supply, and an entity referred to as "Kuehne & Nagel - Dallas." The Invoice indicates that, on September 25, 2006, Broughton Pharmaceuticals, LLC, shipped and billed to Worldwide Medical Supply at an address in Dallas, Texas, "c/o Kuehne + Nagel, Inc. (Texas)," 702 6gm units of Carimune. The Order Pick Sheet indicates that, on October 10, 2006, Kuehne + Nagel consigned 46 6gm units of Carimune to Worldwide Medical Supply in Florida City, Florida, and a notation appears on the sheet that a particular Federal Express account was to be used. Kuehne + Nagel is a licensed wholesale distributor of prescription drugs in the State of Texas, as is Worldwide Medical Supply, but it is not licensed as a wholesale distributor of prescription drugs in the State of Florida. The evidence presented by the Department was sufficient to support an inference that the 46 6gm units of Carimune were shipped by Kuehne + Nagel to Worldwide Medical Supply in Florida. The evidence presented by the Department was, therefore, sufficient to establish that Worldwide Medical Supply purchased the Carimune from a person not authorized to sell the drug in Florida. Paragraph 33 of the Corrected Second Amended Administrative Complaint, as amended; purchase of prescription drugs from an unauthorized person in violation of §§ 499.005(14) and (15) and 499.0051(1)(b), (4),and (5), Fla. Stat.; Petitioner's Exhibit 28. Petitioner's Exhibit 28 consists of two Invoices and a two-page Pedigree Paper that relate to transactions involving Broughton Pharmaceuticals, LLC, Worldwide Medical Supply, and Kuehne + Nagel." The first Invoice indicates that, on September 25, 2006, Broughton Pharmaceuticals, LLC, shipped and billed to Worldwide Medical Supply at an address in Dallas, Texas, "c/o Kuehne + Nagel, Inc. (Texas)," 416 6gm units of Carimune. The second Invoice, dated September 29, 2006, indicates that Worldwide Medical Supply shipped and billed to Reliance Pharmaceuticals, LLC, 28 6gm units of Carimune from an address in Florida City, Florida. The Pedigree Paper indicates that Broughton Pharmaceuticals, LLC, sold 28 6gm vials of Carimune NF to Kuehne + Nagel on September 25, 2006, and that these prescription drugs were shipped to Worldwide Medical Supply in Texas. The Pedigree Paper further indicates that Kuehne + Nagel sold the Carimune to Worldwide Medical Supply in Florida on September 26, 2006.22 As previously noted, Kuehne + Nagel is a licensed wholesale distributor of drugs in the State of Texas, but it is not licensed as a wholesale distributor of drugs in the State of Florida. The evidence presented by the Department was, therefore, sufficient to establish that Worldwide Medical Supply purchased the Carimune from a person not authorized to sell the drug in Florida. Paragraph 34 of the Corrected Second Amended Administrative Complaint, as amended; purchase of prescription drugs from an unauthorized person in violation of §§ 499.005(14) and (15) and 499.0051(1)(b), (4),and (5), Fla. Stat.; Petitioner's Exhibit 29. Petitioner's Exhibit 29 consists of an Invoice and a two-page Pedigree Paper that relate to a transaction involving Kuehne + Nagel, Worldwide Medical Supply, and Reliance Pharmaceuticals, LLC. The Invoice indicates that, on October 27, 2006, Worldwide Medical Supply shipped and billed to Reliance Pharmaceuticals, LLC, 45 6gm vials of Carimune NF from an address in Florida City, Florida. The Pedigree Paper indicates that Broughton Pharmaceuticals, LLC, sold 33 6gm vials of Carimune NF to Kuehne + Nagel on September 25, 2006, and that these prescription drugs were shipped to Worldwide Medical Supply in Texas. The Pedigree Paper further indicates that Kuehne + Nagel sold the Carimune to Worldwide Medical Supply in Florida on September 26, 2006. As previously noted, Kuehne + Nagel is a licensed wholesale distributor of drugs in the State of Texas, but it is not licensed as a wholesale distributor of drugs in the State of Florida. The evidence presented by the Department was, therefore, sufficient to establish that Worldwide Medical Supply purchased the Carimune from a person not authorized to sell the drug in Florida. Paragraph 35 of the Corrected Second Amended Administrative Complaint, as amended; purchase of prescription drugs from an unauthorized person in violation of §§ 499.005(14) and (15) and 499.0051(1)(b), (4),and (5), Fla. Stat.; Petitioner's Exhibit 30. Petitioner's Exhibit 30 consists of an Invoice and a two-page Pedigree Paper that relate to a transaction involving Kuehne + Nagel, Worldwide Medical Supply, and Juan F. Lamas, Inc., M.D. The Invoice indicates that, on October 16, 2006, Worldwide Medical Supply shipped and billed to Dr. Lamas 7 6gm vials of Carimune NF from an address in Florida City, Florida. The Pedigree Paper indicates that Broughton Pharmaceuticals, LLC, sold the 7 6gm vials of the Carimune NF to Kuehne + Nagel on September 25, 2006, and that these prescription drugs were shipped to Worldwide Medical Supply in Texas. The Pedigree Paper further indicates that Kuehne + Nagel sold the Carimune to Worldwide Medical Supply in Florida on September 26, 2006. As previously noted, Kuehne + Nagel is a licensed wholesale distributor of drugs in the State of Texas, but it is not licensed as a wholesale distributor of drugs in the State of Florida. The evidence presented by the Department was, therefore, sufficient to establish that Worldwide Medical Supply purchased the Carimune from a person not authorized to sell the drug in Florida. Paragraph 36 of the Corrected Second Amended Administrative Complaint, as amended; purchase of prescription drugs from an unauthorized person in violation of §§ 499.005(14) and (15) and 499.0051(1)(b), (4),and (5), Fla. Stat.; Petitioner's Exhibit 31. Petitioner's Exhibit 31 consists of an Invoice and a two-page Pedigree Paper that relate to a transaction involving Kuehne + Nagel, Worldwide Medical Supply, and Integrated Health Center of America, Inc. The Invoice indicates that, on October 10, 2006, Worldwide Medical Supply shipped and billed to Integrated Health Center of America, Inc., 20 6gm vials of Carimune NF from an address in Florida City, Florida. The Pedigree Paper indicates that Broughton Pharmaceuticals, LLC, sold the 20 6gm vials of the Carimune NF to Kuehne + Nagel on September 25, 2006, and that these prescription drugs were shipped to Worldwide Medical Supply in Texas. The Pedigree Paper further indicates that Kuehne + Nagel sold the Carimune to Worldwide Medical Supply in Florida on September 26, 2006. As previously noted, Kuehne + Nagel is a licensed wholesale distributor of drugs in the State of Texas, but it is not licensed as a wholesale distributor of drugs in the State of Florida. The evidence presented by the Department was, therefore, sufficient to establish that Worldwide Medical Supply purchased the Carimune from a person not authorized to sell the drug in Florida. Paragraph 37 of the Corrected Second Amended Administrative Complaint, as amended; purchase of prescription drugs from an unauthorized person in violation of §§ 499.005(14) and (15) and 499.0051(1)(b), (4),and (5), Fla. Stat.; Petitioner's Exhibit 32. Petitioner's Exhibit 32 consists of an Invoice and a two-page Pedigree Paper that relate to a transaction involving Kuehne + Nagel, Worldwide Medical Supply, and Dr. Wohlfeiler Piperato & Associates. The Invoice indicates that, on September 28, 2006,, Worldwide Medical Supply shipped and billed to Dr. Wohlfeiler Piperato & Associates 12 6gm vials of Carimune NF from an address in Florida City, Florida. The Pedigree Paper indicates that Broughton Pharmaceuticals, LLC, sold the 12 6gm vials of the Carimune NF to Kuehne + Nagel on September 25, 2006, and that these prescription drugs were shipped to Worldwide Medical Supply in Texas. The Pedigree Paper further indicates that Kuehne + Nagel sold the Carimune to Worldwide Medical Supply in Florida on September 26, 2006. As previously noted, Kuehne + Nagel is a licensed wholesale distributor of drugs in the State of Texas, but it is not licensed as a wholesale distributor of drugs in the State of Florida. The evidence presented by the Department was, therefore, sufficient to establish that Worldwide Medical Supply purchased the Carimune from a person not authorized to sell the drug in Florida. The violations committed by Worldwide Medical Supply are substantial, are of long duration, and involve a significant number of transactions relating to the sale and purchase of prescription drugs.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Department of Health enter a final order finding that Worldwide Medical Supply and Pharmaceuticals, Inc., has committed 37 violations of Sections 499.001 through .081, Florida Statutes; imposing an administrative of $185,000.00; and revoking the license of Worldwide Medical Supply and Pharmaceuticals, Inc., to operate as a prescription drug wholesale distributor. DONE AND ENTERED this 1st day of May, 2008, 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 1st day of May, 2008.
