Findings Of Fact The Home is licensed as an assisted living facility. It is also licensed to provide extended congregate care, limited nursing services, and limited mental health services. The Home accepted Respondent as a resident. In July 1998, Petitioner had to transport Respondent to the hospital due to an overdose of medication. Upon his return from the hospital, Respondent told Petitioner's staff that he had taken the overdose intentionally. Thereafter, the Home required Respondent to sign a mental health contract dated September 9, 1998. This contract states as follows in relevant part: Qualifications for the Home requires [sic] that a member or applicant must not be mentally ill, habitually inebriated, or addicted to the use of a controlled substance. With these requirements, I understand that to be eligible and maintain my membership in the Home, I must agree to the terms of this contract. * * * If I use alcohol or any non-prescribed drugs I understand I may be dismissed from the Home. I understand that I will allow the Veterans' Domiciliary Home of Florida to supervise the self-administering of my medications. I will take my medication as it is prescribed by the primary physician. I will only be given my full prescription at the time of my discharge. I understand upon reasonable suspicion of being under the influence of alcohol or illegal drugs, I consent to testing. The Domiciliary Home staff may take a blood, saliva, or supervised urine sample to test for illegal drugs or alcohol. I authorize members of the Domiciliary staff to perform random searches of my person, vehicle, living quarters, or belongings to determine if I am using drugs or alcohol. If I refuse to allow a blood, saliva, or urine test, or search, or if I interfere in any way with the staff's performance of these duties, I may be dismissed. The Home also required Respondent to sign a Dual Diagnosis/Substance Abuse/Psychiatric (dual diagnosis) contract dated September 14, 1998. In addition to terms and conditions similar to the ones set forth above, the dual diagnosis contract provides as follows in relevant part: 10. In order to assist me in gaining freedom from alcohol and drugs, I will not use alcohol, tranquilizers, sleeping medication, over the counter medications, or any other chemical escapes which have not been prescribed by a physician. If I use alcohol or non-prescribed drugs, I understand I will be dismissed from the Home. In November 1998, one of Respondent's doctors wrote him a prescription for Ritalin. Respondent became very upset when a nurse would not administer the Ritalin to him without first checking with Petitioner's staff physician. Eventually, Respondent's primary care physician approved the administration of Ritalin together with Respondent's other medications. In January 1999, Respondent worked for Petitioner as a receptionist. After working overtime on one occasion, Respondent's speech was slurred, his eyes were dull, and his voice was horse. Petitioner's staff became suspicious that Respondent was taking medication in violation of his contracts. Respondent subsequently tested negatively for all substances except his prescribed medicines. In March 1999, Respondent violated his contracts by having a prescription for methadone filled at a drugstore and removing twenty-four of the pills from the bottle before turning the medicine over to Petitioner's staff as required by his contract. Petitioner's staff advised Respondent that he would be dismissed from the Home by letter dated March 23, 1999. Respondent subsequently requested Petitioner's Executive Director to review the decision to discharge him from the Home. By letter dated August 16, 1999, Petitioner rescinded its decision to dismiss Respondent from the Home but warned him that any further infraction would result in his immediate expulsion. On April 14, 2000, Petitioner conducted a routine facility-wide room inspection at the Home. During the course of the inspection, Petitioner found a bottle of Ephedra 250 in Respondent's room. According to the label on the bottle, Ephedra 250 is a dietary supplement that General Nutrition Corporation (GNC) markets. During the hearing, Respondent admitted that he heard about Ephedra 250 on a television show that discussed its benefits as a diet aid as well as its dangerous side effects. The label states as follows in pertinent part: WARNING: Seek advice from a health care practitioner prior to use if you are pregnant or nursing, or if you have high blood pressure, heart or thyroid disease, diabetes, difficulty in urination due to prostate enlargement, or if taking MAO inhibitor or any other prescription drug. Reduce or discontinue use if nervousness, tremor, sleeplessness, loss of appetite or nausea occur. Not intended for use by person under the age of 18. The maximum recommended dosage of Ephedrine for a healthy adult is no more than 100 mg in a 24 hour period for not more than 12 weeks. Improper use of this product may be hazardous to a person's health. Each capsule of Ephedra 250 contains 250 mg of MA Huang Extract (Ephedra sinica) or ( 15 mg of 6 percent Ephedrine). The greater weight of the evidence indicates that Ephedra 250 is an over-the-counter medication despite being labeled as a diet supplement. Ephedrine is a prescription drug in Florida unless an individual dose is less than a specified quantity. Petitioner's staff properly became concerned about Respondent's possession of Ephedra 250 because he takes numerous prescribed medications, which can have serious side effects, if taken with certain other medications. Ephedrine is one of those drugs. For instance, Respondent takes Cozaar for high blood pressure, Methadose to reduce his dependency on Percoset, and Ritalin. Persuasive evidence indicates that large doses of Ephedra can be used as a recreational drug. Respondent knew or should have known that Ephedra 250 was prohibited by his contracts with the Home.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED: That Petitioner enter a final order dismissing Respondent as a resident of the Robert H. Jenkins Veterans' Domiciliary Home of Florida. DONE AND ENTERED this 6th day of October, 2000, 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 6th day of October, 2000. COPIES FURNISHED: James W. Sloan, Esquire Department of Veterans' Affairs Post Office Box 21003 St. Petersburg, Florida 33731-8903 William T. Fisher 1300 Sycamore Lane, Suite 148 Lake City, Florida 32025 Lt. Col. Robin L. Higgins, Executive Director Department of Veterans' Affairs Post Office Box 31003 St. Petersburg, Florida 33731-8903
The Issue The issue for consideration in this hearing was whether the Agency for Health Care Administration should cancel Petitioner's Medicaid provider number for the reasons set out in its letter of October 1, 1995, as amended.
Findings Of Fact Petitioner, Alpha House of Tampa, Inc., is a provider of community mental health services. Its programs deal with all pregnant women and include several which pertain to drugs, alcohol and mental health. These services provided to pregnant woman at Alpha are unique to Hillsborough County because of Alpha's ability to provide residential programs as opposed to merely the day treatment programs offered at other facilities. In March, 1993, Alpha started billing Medicaid for the services it provided to Medicaid qualified patients. At the time, Francis C. Powers, Alpha's Executive Director, telephonically contacted the Medicaid fiscal agent's office and asked what she needed to do in order for Alpha to be declared eligible for Medicaid reimbursements. She was never told it was necessary for Alpha to have a written contract with the ADM, (alcohol, drug and mental health), office. Because of that, Ms. Powers concluded the routine provider agreement Alpha had with Medicaid, entered into on March 13, 1993, was enough. In that regard, Alpha received two letters, both dated March 13, 1993, from the Department of Health and Rehabilitative Services. One was from Gary Clarke, Assistant Secretary for Medicaid, and the other was from Consultec, Inc., the Medicaid fiscal agent for the Department. Both letters welcomed Alpha House to the Florida Medicaid program and neither indicated any need for additional contracts with ADM in order to bill Medicaid for services rendered. As a result of the income derived from Medicaid services Alpha has provided and for which it has been reimbursed, Alpha was able to employ additional staff to provide more comprehensive programs. In 1995 Alpha received $133,918 in reimbursement funds, which equals approximately 18 percent of its annual budget. As a result of the loss of Medicaid funds proposed as a result of the termination of the instant reimbursement, Alpha will have to eliminate the drug and alcohol residential treatment program for 33 residents who will now have to get their drug and alcohol treatment at day treatment centers. Alpha personnel anticipate that because this treatment may not be sought and received, these residents will have low weight babies with potential medical problems, all at an added dollar cost to the community. Paragraphs 8 and 9 of the Medicaid Provider Agreement Alpha signed on March 13, 1993 provide: The provider and the Department agree to abide by the Florida Administrative Code, Florida Statutes, policies, procedures, manuals of the Florida Medicaid Program and Federal laws and regulations. The agreement may be terminated upon thirty days written notice by either party. The Department may terminate this agreement in accordance with Chapter 120, Florida Statutes. Petitioner has, in the past, billed Medicaid for mental health services provided and has been paid in response to those billings. It does not now have, nor has it had in the past, a contract with the Department of Health and Rehabilitative Services' Alcohol, Drug Abuse and Mental Health office to provide ADM services to its residents.
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 in this case cancelling Alpha House of Tampa, Inc.'s Medicaid provider number 0299588-00. DONE and ENTERED this 26th day of April, 1996, in Tallahassee, Florida. ARNOLD H. POLLOCK, 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 26th day of April, 1996. COPIES FURNISHED: Lynette M. Wenner, Esquire Gillick & Wenner 100 North Tampa Street, Suite 2675 Tampa, Florida 33602 Gordon B. Scott, Esquire Agency for Health Care Administration 2727 Mahan Drive Ft. Knox Building Number 3 Tallahassee, Florida 32308-5403 Sam Power Agency Clerk Agency for Health Care Administration Ft. Knox Building Number 3, Suite 3431 2727 Mahan Drive Tallahassee, Florida 32308 Jerome W. Hoffman General Counsel Agency for Health Care Administration Ft. Knox Building Number 3 Tallahassee, Florida 32308
Findings Of Fact Petitioner, South Beach Pharmacy, Inc., d/b/a Southpointe Pharmacy (Southpointe), was at all times material hereto, a pharmacy located in Dade County, Florida, and a provider under the Medicaid program. Respondent, Department of Health and Rehabilitative Services (DHRS), was and is the state agency responsible for regulating the Medicaid program in Florida. Pharmacies participating in the Medicaid program are subject to routine audits, which are coordinated by the DHRS Office of Program Integrity. In early 1989 a routine audit of Southpointe was conducted by the Professional Foundation for Health Care (PFHC) at the request of DHRS. Following that audit, DHRS reasonably determined that further investigation was warranted and asked PFHC to perform an audit referred to as an "aggregate analysis." PFHC performed the aggregate analysis audit as instructed and determined that an overpayment had been made to Southpointe. The PFHC audit was submitted to and reviewed for accuracy and correctness by the Office of Program Integrity. In August 1989, DHRS took proposed final agency action against Southpointe in the form of a letter which, among other things, demanded repayment of funds alleged to have been overpaid under the Medicaid program, assessed an administrative fine against Southpointe, and terminated Southpointe from the Medicaid program for two years. That letter was revised in September 1989 to change the amount of the alleged overpayment. The alleged overpayment was challenged by Southpointe. The matter was submitted to the Division of Administrative Hearings and assigned DOAH Case No. 89-6057. At the times pertinent to this proceeding DHRS had not adopted the "aggregate analysis" methodology by rule. Instead, DHRS relied on incipient, non-rule policy and attempted, without success, to explicate its reasons for relying on this methodology. The first time the "aggregate analysis" methodology was used in an effort to determine the overpayment by Medicaid to a pharmacy was in the case of David's Pharmacy v. Department of Health and Rehabilitative Services, DOAH Case No. 88-1668 (Final Order entered September 15, 1988). The Final Order entered in the David's Pharmacy case specifically recognized that DHRS was not entitled to rely on non-rule policy in imposing sanctions against a provider because of the wording of Section 409.266(11)(g), Florida Statutes (1989), which limits the imposition of sanctions against a Medicaid provider to situations where the provider is not in compliance with the Florida Administrative Code. Further, the Final Order in the David's Pharmacy case concluded that the aggregate analysis methodology was flawed and, consequently, could not be relied upon by DHRS in determining that an overpayment had been made. Although DHRS again attempted to rely on the aggregate analysis methodology in the audit of Southpointe, DHRS had not adopted the aggregate analysis methodology as a rule (even though there were no changes in the governing statute) and it did not cure all the defects in the methodology that were specifically raised by the Final Order in David's Pharmacy. The only material change in the aggregate analysis procedure between the time of the David's Pharmacy final order and the time it was used to audit Southpointe was the elimination of the use of a Medicaid percentage applied to the quantities of audited drugs. The Recommended Order submitted by the undersigned following the formal hearing in the underlying proceeding (DOAH Case No. 89-6057) found that DHRS had not adopted the "aggregate analysis" methodology as a rule and that DHRS had not explicated its policy in attempting to rely on this non-rule policy. The Recommended Order concluded that DHRS had failed to prove any overpayment to Southpointe. The Recommended Order also found that certain data relied on by PFHC in performing the aggregate analysis was unreliable, which resulted in the amount of claimed overpayment being overstated. While DHRS was not aware that this data was unreliable, this data merely affected the amount of the overpayment. It was DHRS's continued reliance on the aggregate analysis that led DHRS to the assertion that there had been an overpayment. DHRS, by its Final Order in DOAH Case No. 89-6057, rejected many of the facts and the conclusion contained in the Recommended Order. Instead, DHRS determined that there had been an overpayment to Southpointe, demanded repayment of the alleged overpayment, imposed an administrative fine in the amount of $250.00, and suspended Southpointe as a Medicaid provider for three months. Thereafter, Southpointe appealed DHRS's Final Order to the First District Court of Appeal. The First District Court of Appeal reversed DHRS and concluded, in pertinent part, as follows: . . . Therefore, as found by the hearing officer, the Department was proceeding not under any existing rule but rather under incipient policy. That finding was based upon competent and substantial evidence, and we hold it was a gross abuse of discretion for the Department to reject that finding of fact. * * * . . . [W]e agree with the hearing officer that HRS failed in its mission to support and defend the aggregate analysis with competent and substantial evidence. In an earlier final order issued by the Department, David's Pharmacy v. Department of Health and Rehabilitative Services, 11 FALR 2935 (HRS 1988), wherein aggregate analysis was utilized for the first time, the Department found HRS had not appropriately explicated this non-rule policy by its failing to produce evidence that would establish a rational, reasonable basis for the procedure. In the instant case, despite rather pat testimony to the effect that the aggregate analysis is indeed contemplated by the rule, it was shown that HRS had not checked a single Medicaid patient to determine if the medication had been dispensed, or a single physician to see if the medication had been prescribed. Robert Peirce testified that the only thing HRS had done since David's Pharmacy, was to delete the requirement of utilizing a "percentage of Medicaid sales" from the formula. As pointed out by Southpointe, none of the other shortcomings of aggregate analysis which were identified in the David's final order were remedied by HRS at the hearing below. For example, neither a beginning nor ending inventory had been taken into consideration, and no consideration was given to whether Southpointe had acquired additional drugs to augment its inventory by means other than direct purchase from its manufacturers 1/ DHRS has failed to establish that it was substantially justified in taking action against Southpointe based on the aggregate analysis methodology. There was no evidence to show that an award of fees and costs to Southpointe would be unjust in this case. Southpointe has become obligated to pay costs and attorney's fees in excess of $15,000.00, the maximum allowable recovery under the Equal Access to Justice Act. The parties stipulated that these costs and fees are reasonable. Petitioner is a prevailing small business within the meaning of Section 57.111, Florida Statutes, and has met all conditions precedent for such an award.
The Issue The issue to be determined in this proceeding is whether Petitioner is entitled to a refund of the costs paid for prescriptions for compound Midrin.
Findings Of Fact The Division of State Group Insurance (Division) is the executive agency within the Department of Management Services (Department) that is responsible for the administration of the State Group Insurance Program (Program). Petitioner is retired and receives medical benefits through the State Employees’ HMO Standard Medical Plan (the Plan), which is administered by Capital Health Plan (CHP). The State Employees’ Prescription Drug Program is administered by CVS Caremark. Respondent is the state agency responsible for resolving appeals of medical claims denied by Caremark. Background Mr. Abele was employed with the State of Florida until he retired. He was covered by the Plan and his coverage has remained since his retirement. For the past three years, Mr. Abele has filled a prescription for generic Midrin to treat migraine headaches. The medication was prescribed by his primary care physician, John Ness, M.D. The evidence offered at hearing includes a total of 18 claims2 for prescriptions for compound Midrin that Mr. Abele submitted to Caremark for reimbursement. Mr. Abele submitted claims for prescriptions filled in 2018 dated: July 12 and 25, 2018; August 2, 2018; September 7, 2018; October 5 and 22, 2018; November 6 and 26, 2018; December 12, 2018. Mr. Abele also submitted claims for prescriptions filled in 2019 dated: January 9 and 30, 2019; February 12, 2019; March 6, 18, and 29, 2019; April 10 and 25, 2019; and May 10, 2019. Each of the 18 claims was for reimbursement of $105 for a total of $1,890. Relevant Definitions The Plan Booklet and Benefit Document (“Plan”) includes definitions, relevant in part here, as follows: "Covered Services and Supplies" means those health care services and supplies, including pharmaceuticals as described in Section VIII, for which reimbursement is covered under this Plan. "Exclusions" is defined as any provision of the Plan whereby coverage for a specific hazard or condition is entirely eliminated. “Medically Necessary” is defined as any appropriate medical treatment ... as provided by a physician ... which is necessary for the diagnosis, care and/or treatment of a Health Plan Member’s illness or injury, and which is: Consistent with the symptom, diagnosis, and treatment of the Health Member’s condition; The most appropriate level of supply and/or service for the diagnosis and treatment of the Health Plan Member’s condition; In accordance with standards of acceptable community practice; Not primarily intended for the personal comfort or convenience of the Health Plan Member, the Health Plan Member’s family, the physician or other health care providers; Approved by the appropriate medical body or health care specialty involved as effective, 2 The claims at issue are those claims submitted by Mr. Abele in support of his request for reimbursement. appropriate and essential for the care and treatment of the Health Plan Member’s condition; and Not Experimental or investigational. Medical Necessity Dr. Ness, a family practice physician with 30 years of experience, prescribed generic Midrin for Mr. Abele to treat migraine headaches. Dr. Ness prescribed generic Midrin to treat Mr. Abele based on his assessment that other medications were contraindicated for Mr. Abele due to Mr. Abele’s risk for cardiovascular adverse effects if he uses other medications. Dr. Ness credibly testified that Midrin is medically necessary to treat Mr. Abele’s migraine headaches. Anthony Arnett, M.D., the physician for Caremark responsible for reviewing claims for coverage, determined that Midrin was not medically necessary to treat Mr. Abele’s migraine headaches. However, Dr. Arnett conceded that his decision was based on his general determination that there are other options available for migraine headaches. The undersigned finds Dr. Ness’ testimony more persuasive concerning the determination that Midrin was medically necessary to treat Mr. Abele for migraines. Midrin History At the time Dr. Ness prescribed generic Midrin to Mr. Abele, it was an FDA-approved drug. In fact, Midrin was approved for use in 1948 based on safety and effectiveness. However, in 2017, the United States Food and Drug Administration (the “FDA”) determined that Midrin was no longer safe and effective. On October 12, 2017, the FDA notified manufacturers of prescription drugs containing isometheptene mucate that they should immediately cease distribution of the product. On June 13, 2018, the FDA issued a subsequent notice listing the drugs that were no longer approved by the FDA and that manufacturing companies were required to stop producing. The drug combination for Mr. Abele’s prescription for compound Midrin (acetaminophen, dichloralphenazone, and isometheptene mucate) is on the FDA non-approved list. Midrin Prescription/Coverage Denial In January 2018, Mr. Abele presented his prescription for generic Midrin to his local CVS Pharmacy to be filled but the prescription was refused. Mr. Abele indicated that the pharmacist told him that the manufacturer had stopped producing the drug and suggested that he could have the drug compounded. Since generic Midrin was no longer available, Dr. Ness issued a prescription for the compound Midrin, in capsule form, with a 10-day supply for each prescription. The medication name was listed as “Midrin (ALTERNATE) 325MG/100MG/65MG Capsule,” and the ingredients were listed as acetaminophen, dichloralphenazone, isometheptene mucate, and microcrystalline cellulose3. Mr. Abele filled the prescriptions at a local in- network compounding pharmacy. On January 14, 2018, Mr. Abele contacted Caremark about his compound Midrin prescription and Mr. Abele was told that he would need to submit a claim to determine whether the compound drug ingredients would be covered. There is no evidence that the Caremark representative made any false or misleading representation that Mr. Abele’s compound prescription would be approved. On December 14, 2018, Mr. Abele submitted claims to Caremark for reimbursement for compound Midrin. On December 17, 2018, Caremark notified Mr. Abele by letter that the claims he submitted were not allowed. The reason provided for disallowance was because the drug was not on the plan’s formulary. The letter also notified Mr. Abele that his request for exception did not include the information necessary to approve the request. On February 1, 2019, Dr. Ness, on behalf of Mr. Abele, submitted a non-covered drug formulary exception request seeking approval for compound Midrin. He requested the drug in capsule form for the treatment of Mr. Abele’s migraines. However, the request form did not include a copy of the prescription for the compound formula for Midrin. The form also did not describe the drug as the compound alternative. Dr. Ness testified that it is a common medical practice to use “cap” to refer to the capsule form, even for the compound formula. The Caremark appeals department faxed a response to Dr. Ness as follows: “In researching your fax request, the member’s prescription benefit coverage indicates a [p]rior [a]uthorization is NOT required. For additional questions regarding the medication’s coverage under the member’s plan, please contact Customer Service using the number on the back of the member’s prescription benefit card.” Dr. Anthony Arnett testified that he interpreted the exception request as being for Midrin capsules, rather than the compound form. Based on that interpretation, the response to the exception request was that prior authorization was not necessary. The undersigned finds that even if prior authorization was not required for the prescription, it does not amount to an approval for coverage of the claims. Appeal of Coverage Denial On February 5, 2019, Mr. Abele appealed the denial of reimbursement for compound Midrin. On February 13, 2019, Caremark responded to Mr. Abele instructing him to submit additional information for his claims to be processed. On February 18, 2019, he submitted the requested information and materials. On March 30, 2019, Caremark notified Mr. Abele by letter that his drug coverage request was denied. The basis for the denial was that the 3 Microcrystalline cellulose may be used as a bulking agent in pharmaceutical products. prescription was for a compound drug containing, as relevant here, bulk powder. Mr. Abele then submitted a Level I appeal, also referred to as a clinical appeal4, on April 18, 2019. Dr. Arnett reviewed Mr. Abele’s claims for the Level I appeal. While Dr. Arnett acknowledged that compounding could be approved if no other drug is available for treatment of migraines, he concluded that Mr. Abele’s exception request could not be approved because the compound formula included bulk powder. Caremark denied Mr. Abele’s Level I appeal and notified Mr. Abele by letter of their decision on April 22, 2019. In the letter, Caremark stated that “petitioner’s appeal for Dichloralphenazone Powder Compound has been determined as not medically necessary; and, ‘the plan criteria does not allow coverage of dichloralphenazone Powder Compound’ if the compound contained ‘bulk powder’ as an ingredient.” On May 8, 2019, dissatisfied with the outcome of the Level I appeal, Mr. Abele requested a Level II appeal. The Department denied the Level II appeal on the basis that the compound Midrin “did not meet the medical necessity criteria and non-FDA approved compounds are excluded from the plan.” Limitations and Exclusions The Department's concurrence of Caremark’s decision that coverage for the compound Midrin prescription should be denied was based on the Plan’s general Limitations and Exclusions section, which applies to the Prescription Drug Program. The Prescription Drug Program also outlines specific exclusions related to medications. The Prescription Drug Program, described in Part VIII, provides that covered drugs shall include, but are not limited to, any drug, medicine, medication, or communication that is consumed, administered, or provided at 4 Level I appeals are handled by Caremark by a specific group that focuses on prescriptions appeals. the place where the prescription is given at the medical provider’s office or healthcare facility. The Plan’s limitations and exclusions section provides, “the following services and supplies are excluded from coverage under this Plan unless a specific exception is noted. Exceptions may be subject to certain coverage Limitations.” Under the Plan, the exclusions include “any non-prescription medicine, remedy, biological product, pharmaceutical or chemical compound, vitamins, mineral supplements, fluoride products, health foods, or blood pressure kits, except as specifically provided for in the covered benefits section under prescription drugs.” The Additional Exclusions section provides that bulk powders, bulk chemicals, and proprietary bases used in compound medications and over-the- counter (“OTC”) products used in compound medications are excluded from coverage. Further, the plan excludes services or supplies not medically necessary as determined by the Plan and/or the Prescription Drug Program clinical staff and the state. The Prescription Drug Program provides that the Prescription Drug Program does not cover non-federal legend or OTC products, and bulk powders, bulk chemicals, and proprietary bases used in compounded medications.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Division of State Group Insurance, Department of Management Services, enter a final order denying Lawrence Abele’s request for reimbursement for the claims submitted for his compound Midrin prescription. DONE AND ENTERED this 14th day of May, 2020, in Tallahassee, Leon County, Florida. S YOLONDA Y. GREEN Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 14th day of May, 2020. COPIES FURNISHED: Lawrence Abele 841 Maderia Circle Tallahassee, Florida 32312 (eServed) Erica D. Moore, Esquire Office of the General Counsel Department of Management Services 4050 Esplanade Way, Suite 160 Tallahassee, Florida 32399-0950 (eServed) Jacob Koffsky, Esquire Foley & Lardner LLP 2 South Biscayne Boulevard, Suite 1900 Miami, Florida 33131 (eServed) Gayla Grant, Esquire Office of the General Counsel Department of Management Services 4050 Esplanade Way, Suite 160 Tallahassee, Florida 32399-0950 (eServed) William Chorba, General Counsel Office of the General Counsel Department of Management Services 4050 Esplanade Way, Suite 160 Tallahassee, Florida 32399 (eServed)
Findings Of Fact Background. Petitioner, George T. Lloyd, Jr., has been employed by the State of Florida, Department of Revenue, for over 14 years, and was, at all times material hereto, a participant in the State of Florida Employees Group Health Self Insurance Plan (Plan), with family coverage. On March 25, 1986, petitioner's son, George T. Lloyd, III (George), then 17 years of age and an eligible dependent under the Plan, was admitted through the emergency room to Broward General Medical Center (Hospital), Fort Lauderdale, Florida. George was placed in the Hospital's Intensive Care Unit, and remained there until his recovery and transfer to the Hospital's psychiatric floor on April 4, 1986. Upon admission, George was comatose and diagnosed as having suffered a severe barbiturate drug overdose. Blood tests performed at the time demonstrated a serum barbiturate level of 145.6 UG (milligrams per milliliter) and a serum Dilantin level of 23.3 UG. At such levels, or even one-half such levels, George would have died of respiratory depression absent medical intervention. On or about August 9, 1986, Blue Cross and Blue Shield of Florida, Inc., the State's administrator of the Plan, notified petitioner that the Hospital's statement for services and supplies rendered during the course of his son's admission of March 25, 1986 to April 4, 1986, totalling $17,402.95, was ineligible for payment based upon the Plan's exclusion of benefits for intentional self-inflicted injuries, to wit: attempted suicide. Pertinent to this case, the Plan provides: VII. EXCLUSIONS The following exclusions shall apply under the Plan: * * * E. Any services and supplies received due to the following circumstances: * * * 2. Resulting from an intentional self- inflicted injury. Over the course of the next two years petitioner's claim for such expenses was reevaluated by the Plan administrator, as well as respondent, Department of Administration (Department). At the conclusion of that review, the Plan administrator concluded that the documentation available to it demonstrated that such expenses were incurred as a consequence of George's attempt to take his own life and were therefore excluded from coverage. By letter of August 19, 1988, the Department notified petitioner that his claim for benefits arising from his son's hospital admission of March 25, 1986 to April 4, 1986, was denied because such expenses resulted from his son's attempt at suicide. Petitioner filed a timely protest of the Department's decision, and the matter was referred to the Division of Administrative Hearings to conduct a formal hearing. An Intentional Self-Inflicted Injury? Petitioner's son has a history of alcohol and drug (marijuana and cocaine) abuse and emotional problems accompanied by periods of depression that predate the incident in question by a number of years. His mother and father (petitioner) were divorced in 1971 when George was approximately three years of age. Thereafter, George resided in Florida with his mother until his fifth birthday, at which time he was sent out-of-state to reside with his father. George resided with his father until he was eleven years old, and then returned to live with his mother in Florida. In the summer of 1984, George was abusing alcohol and drugs, and experiencing difficulties in school. At that time, his mother again sent George to live with his father in the apparent hope that he could assist George in addressing these problems. The petitioner secured group counseling for George in an attempt to assist him. George continued, however, to use alcohol and drugs, and within four months, dropped out of school and ran away. Approximately four or five months later, George reappeared and returned to Fort Lauderdale to live with his mother and stepfather. Following his return, George did little of a constructive nature, and what jobs he was able to secure as a tenth grade dropout were menial in nature and of a minimal wage. Variously he worked as a bag boy, mowed lawns, and washed cars. On March 25, 1986, George was unemployed, and had just concluded an argument with his stepfather concerning his unemployment and failure to follow any constructive pursuit. Depressed at his circumstances, George ingested phenobarbital and Dilantin, drugs that had been prescribed for his stepfather, with the intention of taking his own life. But for the medical intervention previously discussed, George's attempt would have proven successful. At the time he ingested the drugs, George was not under the influence of alcohol or any other drug, and was of sufficient age and maturity to appreciate the consequences of his actions. Both the nature of the drugs he took and the vast quantity he ingested indicate an intentional attempt to take his own life rather than an accidental overdose during "recreational" use. Here, the drugs he took were not "recreational" drugs, they produce no "high," and the dosage, as heretofore noted, was massive. Considering these factors, George's admission that he attempted suicide, and the totality of the circumstances, compels the conclusion that he did consciously attempt to take his own life, and that what depression he suffered did not deprive him of the ability to appreciate the consequences of his actions.
Recommendation Based on the foregoing findings of fact and conclusions of law, it is RECOMMENDED that a final order be entered dismissing, with prejudice, the petition for administrative review. DONE and ENTERED this 16th day of May 1989, in Tallahassee, Leon County, Florida. WILLIAM J. KENDRICK 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 16th day of May, 1989.
Findings Of Fact At all times relevant hereto, petitioner, Maurice C. Guest, held license number ME0005036 issued by Petitioner, Department of Professional Regulation, Board of Medical Examiners. Said license authorized Guest to practice medicine and surgery in the State of Florida. He has held the license since August 13, 1952. Dr. Guest presently practices medicine at 825 West Linebaugh Avenue, Tampa, Florida. Dorothea Lankford was a patient of Respondent for almost ten years. Among other things, she had suffered from headaches and stomach pains during that period of time. For these ailments, Guest prescribed Nubain and Vistaril, which are used to relieve moderate pain and nausea. A detailed listing of the prescription dates, script, quantity and type of drug, and pharmacy dispensing the drugs is found in Petitioner's Exhibit 17 received into evidence. In 1979 and 1980, Lankford provided midwife services in the Lutz, Florida area. However, she held no licenses from the State to provide any type of medical care. Most of Lankford's clients were members of a local Jehovah's Witness Church. Although the services were to be provided without charge, at least one client paid Lankford a small fee. The prenatal care consisted of weekly meetings at Lankford's mobile home where Lankford discussed all aspects of having a home delivery. The clients were given physical examinations, breathing exercises, suggested diets, and were administered B-12 shots from time to time. On an unknown number of occasions, Lankford administered other drugs, including Nubain and Vistaril, to treat clients suspected of having miscarriages. No doctors were in attendance at these meetings or to supervise the administering of drugs. In May, 1980, Brenda Crall, one of Lankford's clients, visited Dr. Guest for a physical examination. The appointment had been prearranged, although it was not disclosed by whom. There was no discussion between Crall and Guest that Lankford was going to provide a home delivery for Crall, although Guest recommended she not have one. He also made clear that he would provide no care other than the physical examination given that day. In October, 1980, Kathleen Streeter, also a client of Lankford, visited the office of Dr. Guest to have a physical examination. Lankford was in the examination room when the examination was given. However, there was no discussion between them to indicate that Guest was providing oversight care to Lankford's clients to sanction the activities of Lankford. Although the clients were under the impression that medical records of each client had been prepared by Dr. Guest, and that either Guest or some other physician was overseeing the activities of Lankford, there was no competent testimony or documentation to support their belief. Neither was there any evidence to show that Lankford and Guest had entered into some type of agreement whereby she referred patients to Guest on a one-time basis to sanction her unlicensed activities or that Guest delegated professional responsibilities to Lankford. On April 23, 1980, Brenda Crall and Kathleen Montane, another of Lankford's clients, were attending a meeting at Lankford's home when two other women began experiencing premature labor pains. Lankford injected one with Nubain and Vistaril but had nothing to give the other. Crall, Montane and Lankford's son then went to Respondent's office to pick up a prescription for Lankford. They carried an empty vial of Vistaril so that Guest would know the type of drug needed. Guest gave them a new vial of Vistaril which he had in his office and wrote a prescription for Nubain in Lankford's name. The evidence is conflicting as to whether it was explained to Guest that the prescriptions were for two of Lankford's clients. The actual visit took no more than one or two minutes, and both women admitted they were quite excited and in a hurry at the time. They acknowledged that before Guest dispensed the drug and wrote a prescription he asked whether Lankford was suffering from a headache. Accordingly, it is found that Guest believed the drugs were to be used by Lankford, and not to be administered by Lankford to unknown third persons. Crall and Montane then filled the prescription for Nubain and gave both drugs to Lankford. Lankford later used the drugs to treat her client. Mary Ellen Odom was a patient of Dr. Guest between September, 1978 and October, 1980. Among her various ailments were an incarcerated incisional hernia, a previous head injury to the brain which caused recurring pain, hypertensive cardiovascular disease, arthritis and herpes of the vagina. Because Guest wished to alleviate the considerable pain caused by the various ailments, and to keep her in an ambulatory condition, he prescribed a number of drugs while treating her as a patient, including Talwin in an injectable form. An injectable form was used in lieu of a tablet since she had an intolerance to certain oral medications. However, Odom received the drug as an out- patient and was therefore able to inject herself. Between September 27, 1978 and November 21, 1980 Odom obtained approximately 168 prescriptions written or telephoned in by Guest to Boulevard Drugs, located at 227 East Davis Boulevard, Tampa, Florida. A detailed list of the dates, script, drug, quantity and quantity filled is found in Petitioner's Exhibit 16 received into evidence. The druggist at Boulevard Drugs became concerned with Odom's use of Talwin, particularly after Odom administered herself an injection at the drug counter. The druggist talked by telephone with Guest on a number of occasions and told him that he believed Odom was abusing the drug. On May 17, 1980, he made the following notation on the bottom of one of Odom's prescriptions: "Dr. aware of abuse". Despite these warnings Guest continued to give Odom prescriptions for injectable Talwin for at least six more months. He was also aware that Odom had been previously addicted to Demerol, a pain-killing narcotic drug. Dr. Guest "regrets" giving Odom the amount of drugs that he did, but did so because he believed the woman was in constant pain, and because he did not initially believe Talwin to be an addictive drug. He has subsequently changed his opinion on the addictive nature of Talwin based on literature that warns of the addictive characteristics of the drug. A physician-member of the Hillsborough County Utilization Review Committee examined the medical records of Odom, together with the amount of drugs prescribed, and concluded that the amount of injectable Talwin prescribed by Guest to Odom was "excessive", given her medical condition. He also concluded that while her ailments may have justified the use of Talwin in an oral form, there was no basis to prescribe Talwin in an injectable form, particularly on an outpatient basis. In reaching that conclusion, the physician was unaware of any impediment to Odom using Talwin in a tablet form. He acknowledged that Talwin tablets could cause nausea and vomiting while the injectable form does not, and that under certain circumstances the latter form might be preferable, although not in the magnitude prescribed by Guest. Based upon his review of the records, he concluded Guest did not practice medicine with the level of care, skill and treatment recognized by reasonably prudent similar physicians as being acceptable under similar conditions and circumstances acceptable, nor did he conform with generally prevailing standards of the medical community in his care and treatment of Odom. Respondent also treated Bernetha Cunningham as a patient for approximately twenty-two years. In 1976, Cunningham developed symptoms which were consistent with rheumatoid arthritis. After trying several medications which were unsuccessful, he began prescribing Talwin compound to ease her pain. He instructed her to take two tablets every four hours, or a total of twelve per day, which resulted in a daily dosage of 180 milligrams. At that time, he did not consider Talwin compound to be an addictive drug. He also prescribed Valium to relieve Cunningham's anxiety and to relax her muscles. Petitioner's Exhibit 15 received in evidence reflects that during the period between January 13, 1976, and February 5, 1979, Guest wrote prescriptions for 3,460 Valium tablets with authorization for 2500 tablets on refill, and 2,800 Talwin compound tablets with authorization for 2,200 tablets on refill. However, the last time he treated her as a patient was in December, 1977, at which time he advised her that he would not prescribe any more medicine. The evidence is conflicting as to whether Guest continued to telephone in prescriptions after that date, but it is found that Cunningham continued to refill her prescriptions in Dr. Guest's name after December, 1977, without his knowledge and consent. On February 1, 1979, Cunningham was examined by another Tampa physician (now deceased) whose specialty was psychiatry. In a deposition given prior to his death, he diagnosed her as having reactive depression and arthritis. He also concluded she displayed symptoms of being addicted to Talwin vis a vis Talwin compound, and that the drugs had been prescribed in dosages that would tend to addict the patient. In reaching these conclusions, the physician made no distinction between Talwin and Talwin compound, although the latter is a much less profound form of the drug. His examination was also conducted some fourteen months after Mrs. Cunningham had last been treated by Dr. Guest, and been given a prescription for drugs. In December, 1978, the Cunninghams filed a civil action against Respondent alleging that Respondent had been negligent in his treatment of Cunningham by prescribing an excessive level of central nervous system depressants. After being initially dismissed, the suit was refiled in April, 1979, and was ultimately settled out-of-court when Guest paid the Cunninghams $6,200. Guest represented himself in the initial stages of the suit, and only after a default summary final judgment as to the issue of liability was entered did he obtain counsel. Guest settled the case on advice of counsel since he had no malpractice insurance and would have incurred substantial legal fees had the case gone to trial on damages alone and then been appealed on the issues of liability and damages. A physician-member of the Hillsborough County Utilization Review Committee examined the medical records of Cunningham and concluded that Guest prescribed too great an amount of analgesics, sedatives and tranquilizers, and too little medication to counteract Cunningham's arthritic condition. He also concluded Guest failed to conform to generally prevailing standards of the medical community in his care and treatment of Cunningham, and failed to practice medicine with the level of care, skill and treatment recognized by reasonably prudent similar physicians as being acceptable under similar conditions and circumstances. Talwin is a controlled substance under Chapter 893, Florida Statutes. It is prescribed for relief of moderate to severe pain and is commonly referred to as an analgesic. The drug comes in various forms, including tablet, injectable and compound form. The latter form contains the least amount of Talwin in terms of milligrams. Its addictive characteristics were not recognized until approximately 1978 when reference to this was made in the Physicians' Desk Reference (PDR). The PDR provides that the maximum daily dosage should not exceed 600 milligrams, although the tolerance level will differ from individual to individual. Valium is also currently classified as a controlled substance pursuant to Chapter 893, Florida Statutes. It is used primarily as a tranquilizer although it has some muscle relaxant qualities. If given in sufficient quantity over time, a user may become addicted to the drug. Respondent was subjected to disciplinary action by the Board of Medical Examiners in 1978. In that action he was placed on probation for three years. Among the conditions of probation was the following: The licensee shall, during this probation period, demonstrate the type of exemplary conduct expected and required of a duly licensed physician in this State. If the licensee fails to meet the moral and professional standards expected of a duly licensed physician, said probationary order will be vacated and the licensee will be subject to further disciplinary action by the Board. In 1981, the probationary period was extended until August, 1982, presumably because of the case at bar. Respondent did not intentionally violate the law. While he wrote or telephoned an unusually large number of prescriptions for Odom and Cunningham, he believed that both patients were experiencing pain, and that the drugs were needed to aid them. However, because the patients were poor, could afford only one Medicaid trip per month to his office, and could not drive, Dr. Guest attempted to authorize a sufficient number of refills between office visits. In this respect, he was lax in failing to control the actual number of drugs obtained by the patients. Nonetheless, there were no monetary rewards or motivation in writing the prescriptions. Dr. Guest was portrayed by character witnesses as a sincere and dedicated practitioner. He has practiced medicine in Tampa, Florida, for almost thirty years. Although he suffered a heart attack in early 1980, he continues to work long hours. He is not motivated by the financial rewards of practicing medicine, for he has frequently accepted patients requiring medical care but who were too poor to pay the bill. There was no evidence that Respondent has any drinking or drug problems.
Recommendation Based on the foregoing findings of fact, and conclusions of law, it is RECOMMENDED that Respondent be found guilty as charged in Counts XIV, XV, XVII, XIX, XX and XXII. All other counts should be dismissed. It is further RECOMMENDED that Respondent's probation be extended for an additional seven years during which time he not be allowed to write prescriptions for scheduled controlled substances without such supervision and approval as the Board may require. DONE and ENTERED this 23rd day of June, 1982, in Tallahassee, Florida. DONALD R. ALEXANDER Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 23rd day of June, 1982.
The Issue At issue is whether Respondent committed the offenses set forth in the Administrative Complaint dated March 3, 2000, and, if so, what penalty should be imposed.
Findings Of Fact Respondent, Robert Gibson McLester, III ("McLester") is a licensed pharmacist 2 with a heretofore unblemished record. McLester graduated from the University of Florida with a degree in pharmacy in August 1977. He was licensed by the State of Florida to practice pharmacy in February 1978. He currently holds an Alabama pharmacy license, and was previously licensed in Mississippi but at some point ceased to pay the state's licensing fee; the license thus lapsed by operation of law. McLester received a Master of Science degree in hospital pharmacy from the University of Mississippi in December 1987 and a Master of Health Care Administration from the same institution the following May. McLester entered the Navy as an aviator cadet in June 1965, and was commissioned as a naval aviator in February 1967. He flew 103 missions with Attack Squadron 147 and was honorably discharged as a lieutenant in December 1970. Following a brief stint in the insurance and investment business, McLester applied unsuccessfully to medical school. McLester entered the University of Florida's pharmacy school in September 1974 and following his graduation in August 1977, has been continuously employed as a pharmacist when not pursuing advanced degrees in pharmacy and related fields. Much of McLester's pharmacy employment has been in the Navy, which he reentered in February 1978 as an ensign in the Medical Service Corps. McLester served in a variety of posts before retiring as a lieutenant commander in August 1992, including at the National Naval Medical Center in Bethesda, Maryland, where he supervised in excess of 25 pharmacists and pharmacy technicians in the preparation of an average of 1600 outpatient prescriptions per day. McLester continued the practice of pharmacy as a civilian, working briefly as a relief pharmacist for the Eckerd Drug chain in the Vero Beach area before being hired full time by Winn-Dixie in August 1992. Under McLester's supervision, Store No. 2358 enjoyed high sales volume and was used as a training site for other Winn-Dixie pharmacies. At all times during McLester's employment at Winn- Dixie, reports of annual inspections of his pharmacy conducted by the Agency for Health Care Administration ("AHCA") pursuant to law showed no deficiencies of any kind. McLester worked at the Winn-Dixie Store No. 2358 until June 17, 1998. McLester's separation from Winn-Dixie was voluntary. McLester left Winn-Dixie because he considered the hours assigned to him by his new supervisor, Steve Howard ("Howard") to be "slave hours." Following McLester's departure, sales and customer satisfaction at Store No. 2358 deteriorated. For most of the time relevant to this case, McLester was responsible for filling in the neighborhood of 150 prescriptions per day. That number placed his store at the high end of Winn- Dixie pharmacy productivity. 3 During the course of his employment at Winn-Dixie, McLester had occasion to report approximately a dozen instances of prescription drug fraud to the authorities, including St.Lucie County Detective Scott Silverman (Silverman). Following his resignation from Winn-Dixie, McLester worked briefly with various services which would find him work as a relief pharmacist. On the instructions of Howard, McLester was not permitted to work at any of the Winn-Dixie stores in the area. In October 1998, McLester found full-time employment with Doctors' Clinic Pharmacy in Vero Beach, a "closed pharmacy" which serves only the patients of that multi-specialty practice. During his term of employment at Winn-Dixie, McLester was assisted by about a half dozen pharmacy technicians. Pharmacy technicians are licensed by the state and must work under the close supervision of a registered pharmacist. Tasks which the law permits to be delegated to pharmacy technicians and which, in fact, are typically delegated to a pharmacy technician include ordering drugs, including controlled substances; receiving drugs and other inventory; counting and transferring drugs from their original containers to packages for individual prescriptions; shelf maintenance; department maintenance; and stocking shelves. Other tasks which pharmacy technicians may legally perform, and which were in fact performed by technicians at Winn-Dixie stores, include logging invoices into the computer system for payment; verifying orders shipped into the store; answering telephones; taking refills from patients or doctors provided that there is no change in any element of the prescription (i.e. instructions to the patient, dosage, etc.); requests to doctors to issue new prescriptions on behalf of a patient; preparing labels and delivering filled prescriptions to the pharmacist for final verification. Because of the nature of the tasks delegated to pharmacy technicians, the relationship between pharmacist and technician must be one of, as several witnesses testified, implicit trust. McLester trusted all of the pharmacy technicians with whom he worked at Winn-Dixie. One of the Winn-Dixie pharmacy technicians, Tonya Tipton ("Tipton") betrayed McLester's trust, along with the trust of the State of Florida which licensed her, Winn-Dixie which employed her, and several other pharmacists under whose supervision she worked. Weeks after McLester left Winn-Dixie, Tipton's betrayal of trust was discovered. Soon after, she was fired from Winn-Dixie and subsequently arrested for crimes she allegedly committed in and against the Winn-Dixie pharmacy. Tipton's arrest set in motion a chain of events which led to this Administrative Complaint. Following a work-related injury suffered in the early 1990s, Tipton developed a dependence upon prescription painkilling medication, including the narcotic nasal spray Stadol.4 Unbeknownst to anyone, Tipton devised a scheme by which she could steal Stadol from Winn-Dixie, and also obtain Stadol under a forged prescription. At all times prior to Tipton's firing from Winn-Dixie, she was a trusted employee. Tipton fell under suspicion when she stated to a co- worker that a package would be arriving the following day and that it should not be opened. Store employees opened the package nevertheless and discovered it contained Stadol. Thereafter, a fellow pharmacy technician followed Tipton into the ladies' room and discovered empty bottles of Stadol in the wastebasket. Confronted by store employees about her inappropriate instruction to the co-worker not to open the package, as well as the empty Stadol containers in the ladies' room, Tipton admitted only to taking one bottle of Stadol from the Winn-Dixie pharmacy. Abundant circumstantial evidence suggests that Tipton's dependence upon Stadol led her to commit more than the one offense to which she admitted. McLester had been the primary pharmacist on duty at Store No. 2358 during many of the shifts when Tipton was alleged to have illegally obtained Stadol. Following a criminal investigation by Detective Silverman and the arrest of Tipton, McLester's former supervisor, Howard, lodged a complaint against McLester with the Board of Pharmacy. In his letter of complaint, Howard characterized his complaint as an effort to protect the interests of Winn-Dixie "in case this problem was found out." Howard claimed that Mostafa Macida ("Macida"), who had replaced McLester as the store's primary pharmacist,"discovered" that Stadol was being stolen from the pharmacy but this testimony is rejected as inconsistent with the testimony of numerous individuals who, unlike Howard, had personal knowledge of the events surrounding Tipton's arrest. Macida suspected nothing and discovered nothing. Tipton's employment at Winn-Dixie began in February 1995 when she was hired as a pharmacy technician by McLester.5 In that capacity, Tipton worked not only with McLester, but also with then-Head Technician Ava Forsythe (Forsythe). Forsythe trained Tipton in the technicians' duties, including the various methods by which prescription drugs, both controlled and non-controlled, may be ordered. At all times relevant to this case, there are three ways in which Winn-Dixie pharmacies may procure drugs and medical supplies requiring prescriptions for resale to the public. The primary system is a computer-generated daily order. The system was referred to by many witnesses as "the PDX system" ("PDX"). Technicians, working under the supervision of the pharmacist, would review the order to verify that the required types and quantities of supplies were being ordered. When the order was deemed complete, "the button was pushed" and the order electronically transmitted to Winn-Dixie's major drug supplier, Bindley-Western.6 In theory, the computer would accurately track stock in over 2,000 line items. The computer was supposed to automatically add to the inventory based upon what was ordered, and subtract based upon records of what was actually dispensed to customers. In reality, the computer-generated inventory was corrupt on a daily basis. Because of the PDX system's unreliability, technicians often had to make adjustments by hand so that the computerized records would match what was actually in stock. Orders could also be manually keypunched into a unit called a Telxon, which also transmitted orders to Bindley- Western. The Telxon unit is portable. The size of a telephone, the Telxon unit at Store No. 2358 was generally kept in a drawer when not being used. Finally, drugs can be ordered from Bindley-Western and/or from one of two secondary suppliers used by Winn-Dixie from any telephone, whether or not the telephone is located in a Winn-Dixie store. None of the systems used by Winn-Dixie, either singly or in combination, had the ability to flag the fact that hundreds of bottles of Stadol had been ordered and paid for by Winn-Dixie, yet not placed on the shelves as pharmacy inventory in Store No. 2358, during the period of Tipton's employment. Under Winn-Dixie's system, it is possible for a pharmacy technician to order medications unbeknownst to the pharmacist, to have them paid for by Winn-Dixie, and to physically divert them to his possession before the medications were logged in to pharmacy inventory. Once drugs are properly entered into inventory, it is reasonable to expect that the pharmacist could be aware of large amounts of a drug being stolen from the inventory. Any single incident of placing unauthorized drug orders could take place in the two or three minutes the duty pharmacist might be absent to go to the restroom, or have his attention diverted for any reason. Silverman is an experienced police officer, having served for over two decades in various law enforcement positions in Florida. For nearly five years Silverman has been exclusively assigned to work with pharmacies and other law enforcement agencies in St. Lucie County. Silverman's job is to assist in the prevention and prosecution of crimes involving the misuse of prescription drugs. Silverman's involvement in this case began when Tipton sought him out. Tipton knew Silverman because her husband is a fellow St. Lucie County detective, and Tipton herself was a sworn St. Lucie officer. Tipton approached Silverman to confess that she had taken a bottle of Stadol from the Winn-Dixie store where she worked. Tipton's confession was not provoked by an attack of conscience. Rather, after she was fired by Winn-Dixie, she began damage control. As Silverman's investigation progressed, substantial effort was made to determine how Tipton had diverted Stadol and what, if any, other crimes may have been committed. Documents collected in the course of the investigation revealed that Tipton had developed a dependency on prescription painkillers dating to a back injury in 1990 in which she suffered a herniated disc. Tipton developed a dependency on Stadol in 1996, after dealing with pain related to the 1990 injury. Tipton claimed to Winn-Dixie security supervisor Robert Blakely ("Blakely") that she had told McLester of the problem, and that he referred her to her doctor for help. Ultimately, Silverman arrested Tipton on 17 counts of insurance fraud and one count of felony possession of a controlled substance. No evidence was offered regarding the disposition of Tipton's case. No evidence was presented of what, if any, effort was made to determine from Tipton if McLester had any complicity in her crimes. It was clear to Silverman that while Tipton had figured out a way to illegally divert Stadol to her unauthorized use, as of the date of the final hearing, "nobody knows how it was done." 7 There was conflicting testimony as to precisely how much Stadol was diverted by Tipton over the relevant period of time but Tipton's ability to obtain the drug through the use of fraudulent prescriptions and outright theft was audacious in scale. Stadol was a legend drug until June 1997 when the Drug Enforcement Agency upgraded its status to a Schedule IV controlled substance. Prior to October 19, 1996, Tipton had a legitimate prescription for Stadol. On that date, Les Gessley ("Gessley"), a relief pharmacist at Store No. 2358, approved a new Stadol prescription for Tipton under a legend number. Tipton used this approved prescription number subsequently when she herself prepared numerous unauthorized refills under this same number. Each of these unauthorized refills was listed on daily pharmacy logs certified mostly by McLester, but also by other duty pharmacists as well. Because these unauthorized prescriptions were refills rather than original prescriptions, the duty pharmacist was not required to personally view the original written prescription. McLester was the pharmacist on duty a majority of the days on which Tipton is believed to have diverted Stadol illegally. Somewhere between ten and twenty percent of the Stadol believed to have been unlawfully diverted by Tipton from Store No. 2358 was diverted after McLester had ceased to be employed there. Some of the Stadol obtained by Tipton under fraudulent prescription at Store No. 2358 was obtained on days when McLester was not the pharmacist on duty. In addition to Les Gessley and Mostafa Macida, other pharmacists on duty while Tipton was believed to have engaged in the criminal diversion of Stadol are Ted Kline and Al Leota. McLester admitted knowing Tipton had a problem with Stadol but did not know the extent of her problem. Forsythe told McLester that she thought there might be some Stadol missing from the shelves. When she shared her concern with McLester, he instructed Forsythe not to leave Tipton alone in the pharmacy. No evidence placed McLester's conversation[s] with Tipton and other parties about her use of Stadol in the context of when Tipton's alleged diversions occurred. According to Forsythe's unrebutted testimony, If you were that desperate you could order any medication you wanted on the Telxon machine or verbally order without knowledge of the pharmacist knowing what you were doing. And then when the medication comes in, you pay the invoice. You throw the invoice away. You throw the copy that you received from the computer away. The invoice is paid. The only person that will know about it will be the person at the headquarters that pays the payment on the invoice without knowing what is on it and the person gets the medication. Take the medication home via however and no one is the wiser. Winn-Dixie has no security procedures in place, such as searching handbags or packages, to prevent employee theft in the pharmacy. Winn-Dixie's ordering system is tailor-made to be abused by individuals who are, in Forsythe's words, "that desperate." It is not illegal for pharmacy technicians to fill their own prescriptions. It is possible for a pharmacy technician to fill or refill a prescription without the pharmacist knowing that had been done if he was absent from the pharmacy or had his attention diverted in some fashion. It appears that Tipton refilled her own fraudulent prescription on a number of occasions, but that her preferred method of diverting Stadol was outright theft. The Winn-Dixie system by which the pharmacies are stocked is flawed in a manner which allowed Tipton to divert Stadol without being detected by the duty pharmacist. The Department failed to show that McLester knew or should have known that Tipton had diverted Stadol to her unauthorized use at Store No. 2358.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the charges in the Administrative Complaint be dismissed. DONE AND ENTERED this 17th day of November, 2000, in Tallahassee, Leon County, Florida. FLORENCE SNYDER RIVAS Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 17th day of November, 2000.
