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DEPARTMENT OF HEALTH, BOARD OF PHARMACY vs CHARLES J. BESHARA, 04-002196PL (2004)
Division of Administrative Hearings, Florida Filed:West Palm Beach, Florida Jun. 22, 2004 Number: 04-002196PL Latest Update: Oct. 03, 2024
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DACCO BEHAVORIAL HEALTH, INC.; OPERATION PAR, INC.; AND ASPIRE PARTNERS, INC. vs DEPARTMENT OF CHILDREN AND FAMILIES, 17-006655RU (2017)
Division of Administrative Hearings, Florida Filed:Tallahassee, Florida Dec. 11, 2017 Number: 17-006655RU Latest Update: Mar. 14, 2019

The Issue The issue in this case is whether Florida Administrative Code Emergency Rule 65DER17-2 (the “Emergency Rule”) constitutes an invalid exercise of delegated legislative authority as defined in section 120.52(8), Florida Statutes. (Unless specifically stated otherwise herein, all references to Florida Statutes will be to the 2017 version.) More specifically, on September 19, 2017, the Florida Department of Children and Families (the “Department”), published the Emergency Rule, which dealt with the need for and licensing of new methadone medication-assisted treatment centers for persons dealing with opioid addiction. Pursuant to the Emergency Rule, the Department decided which providers would receive approval notices to submit licensure applications in certain counties based on the order in which complete and responsive applications were received by the Department. A number of parties are challenging the validity of the Emergency Rule.

Findings Of Fact Parties and Standing Respondent, the Department, is the state agency responsible for licensing providers of care in methadone medication-assisted treatment facilities. It is the agency, which promulgated the Emergency Rule. Petitioner, Dacco Behavioral Health, Inc. (“Dacco”), is a not-for-profit corporation and is currently licensed to operate methadone medication-assisted treatment clinics within the state of Florida. Dacco submitted three applications for licensure under the Emergency Rule. Its applications were not approved by the Department. Dacco timely filed an administrative challenge to its denied applications. Dacco has standing in this proceeding. Petitioner, OPI, is a not-for-profit corporation and is currently licensed to operate methadone medication-assisted treatment clinics within the state of Florida. OPI submitted six applications for licensure under the Emergency Rule. None of its applications were approved by the Department. OPI timely filed an administrative challenge to its denied applications. OPI has standing in this proceeding. Petitioner, Aspire Health Partners, Inc. (“Aspire”), is a not-for-profit corporation and is currently licensed to operate methadone medication-assisted treatment clinics within the state of Florida. Aspire submitted two applications for licensure under the Emergency Rule. Neither of its applications was approved by the Department. Aspire timely filed an administrative challenge to its denied applications. Aspire has standing in this proceeding. Intervenor, CRC, is a Delaware limited liability company registered to do business in Florida. CRC is currently licensed to operate a methadone medication-assisted treatment clinic in Florida. CRC submitted 16 applications for licensure under the Emergency Rule. Its applications were not approved by the Department. CRC timely filed an administrative challenge to its denied applications. CRC has standing to intervene in this proceeding. Intervenor, Riverwood Group, LLC (“Riverwood”), is a Delaware limited liability company authorized to do business in Florida. Riverwood is currently licensed to operate methadone medication-assisted treatment clinics within the state of Florida. Riverwood submitted six applications for licensure under the Emergency Rule. Its applications were not approved by the Department. Riverwood timely filed an administrative challenge to its denied applications. Riverwood has standing to intervene in this proceeding. Intervenor, Symetria, is a Florida limited liability company whose parent company is currently licensed to operate methadone medication-assisted treatment clinics within the state of Florida. Symetria submitted 11 applications for licensure under the Emergency Rule. One of its applications was approved; the other 10 were not approved by the Department. Symetria did not file an administrative challenge to the denial of its applications. Opposition to Symetria’s standing was raised by Intervenors appearing in support of Respondent. Symetria was allowed to participate at final hearing pending adequate proof of standing. Symetria did not prove its standing at final hearing. Symetria does not have standing in this proceeding on behalf of Petitioners as it does not satisfy the two-prong test announced in Agrico Chemical Company v. Department of Environmental Regulation, 406 So. 2d 478 (Fla. 1st DCA 1978). (After entry of this Final Order, Symetria will be stricken from the style of the case.) It should be noted that Symetria apparently never received notice as to its denied applications and may have challenged those denials, if notices had been issued, but that possibility is too speculative to award standing in this matter. It should also be noted that none of the parties hereto objected to Symetria’s involvement in the final hearing, including its introduction of evidence and examination of witnesses. Intervenor, CFSATC, d/b/a Central Florida Substance Abuse (“CFSATC”), is a Florida corporation and is currently licensed to operate methadone medication-assisted treatment clinics within the state of Florida. CFSATC submitted seven applications for licensure under the Emergency Rule. None of its applications were approved by the Department. CFSATC timely filed an administrative challenge to its denied applications. CFSATC has standing to intervene in this proceeding. Intervenor, Bay County Healthcare Services, LLC (“Bay County Healthcare”), is a Georgia limited liability company and is currently licensed to operate a methadone medication- assisted treatment clinic in Florida. Bay County Healthcare submitted eight applications for licensure under the Emergency Rule. None of its applications were approved by the Department. Bay County Healthcare timely filed an administrative challenge to its denied applications. Bay County Healthcare has standing to intervene in this proceeding. Intervenor, Palm Beach Drug Testing, LLC, d/b/a Relax Mental Health Care (“Relax”), submitted 14 applications for licensure under the Emergency Rule; eight of its applications were approved. Invalidation of the Emergency Rule would substantially affect the business interests of Relax. Relax has standing to intervene in this proceeding. Intervenor, Colonial Management Group, L.P. (“Colonial”), operates methadone medication-assisted treatment centers nationwide, including Florida. Colonial submitted 19 applications for licensure under the Emergency Rule; all 19 of its applications were approved. Invalidation of the Emergency Rule would substantially affect the business interests of Colonial. Colonial has standing to intervene in this proceeding. Intervenor, PAS, submitted 48 applications for licensure under the Emergency Rule; twenty of its applications were approved. Invalidation of the Emergency Rule would substantially affect the business interests of PAS. PAS has standing to intervene in this proceeding. Procedural History On May 3, 2017, Governor Scott signed Executive Order No. 17-146, alluding to the nearly 4,000 deaths in Florida caused by opioids during calendar year 2015. Florida had nearly 10 percent of all opioid-related deaths in the entire country that year. The Governor declared that an opioid epidemic threatens the State and has created an emergency situation. He directed the State Health Officer and Surgeon General to announce a statewide public health emergency. The Governor’s executive order noted that the United States Department of Health and Human Services had awarded a grant of $27,150,403 per year for two years to the Department to provide prevention, treatment, and recovery support services to address the opioid epidemic. The Governor said it was necessary to immediately draw down those federal grant funds in order to provide services to Florida communities, and that the State could not wait until the next fiscal year (which would start two months hence, on July 1, 2017) to begin that distribution. On June 29, 2017, the Governor signed Executive Order No. 17-177, extending for an additional 60 days the state of emergency declaration set forth in Executive Order 17-146. This action was precipitated by hurricanes threatening the State. The executive orders issued by the Governor appear to direct State agencies to utilize the federal grant monies to bolster existing providers of treatment. Nothing in the executive orders issued by the Governor directs the approval of additional opioid treatment centers. There is, however, an omnibus provision in the executive order directing the State Health Officer to “take any action necessary to protect the public health.” The Department’s response to the executive orders was to publish emergency rule 65DER17-1 in the FAR on August 25, 2017. That rule was superseded by the Emergency Rule, which revised the dates during which applications for licensure could be submitted. This change was deemed necessary in response to the devastation wrought by Hurricane Irma, making travel to Tallahassee (for delivery of applications) somewhat difficult during the timeframes set forth in emergency rule 65DER17-1. The Notice of Emergency Rule, as published in the Florida Administrative Register, states in full (with strikethrough/underline in original): Notice of Emergency Rule DEPARTMENT OF CHILDREN AND FAMILIESSubstance Abuse Program RULE NO.: RULE TITLE: 65DER17-2 Standards for Medication-Assisted Treatment for Opioid Addiction SPECIFIC REASONS FOR FINDING AN IMMEDIATE DANGER TO THE PUBLIC HEALTH, SAFETY OR WELFARE: On May 3, 2017, the Governor of the State of Florida signed Executive Order Number 17-146 declaring that the opioid epidemic threatens the State with an emergency and that, as a consequence of this danger, a state of emergency exists. Also, in the executive order, the Governor directed the State Health Officer and Surgeon General to declare a statewide public health emergency, pursuant to its authority in section 381.00315, F.S. On June 29, 2017, the Governor signed Executive Order Number 17-177 to extend the state of emergency declaration. The department was recently awarded a two-year grant to address this opioid epidemic. The department will use these funds in part to expand methadone medication-assisted treatment services in needed areas of the state as part of a comprehensive plan to address the opioid crisis. Revising the licensure requirements through an emergency rule is necessary to accommodate the critical need for more methadone medication-assisted treatment providers. Due to the impact of Hurricane Irma on providers and individuals in treatment, the department has determined that extending the submission dates for applicants is necessary. REASON FOR CONCLUDING THAT THE PROCEDURE IS FAIR UNDER THE CIRCUMSTANCES: The procedure is fair under the circumstances because it ensures equitable treatment of methadone medication-assisted treatment providers. SUMMARY: This rule makes changes to permanent Rule 65D-30.014 F.A.C., relating to licensure requirements for methadone medication-assisted treatment programs. THE PERSON TO BE CONTACTED REGARDING THE EMERGENCY RULE IS: Bill Hardin. He can be reached at William.Hardin@myflfamilies.com or Office of Substance Abuse and Mental Health, 1317 Winewood Boulevard, Building 6, Tallahassee, Florida 32399-0700. THE FULL TEXT OF THE EMERGENCY RULE IS: 65DER17-2 (65D-30.014): Standards for Medication-Assisted Treatment for Opioid Addiction. 65DER17-2 supersedes 65DER17-1. In addition to Rule 65D-30.004, F.A.C., the following standards apply to Standards for Medication-Assisted Treatment for Opioid Addiction. State Authority. The state authority is the department’s Office of Substance Abuse and Mental Health. Federal Authority. The federal authority is the Center for Substance Abuse Treatment. Determination of Need. Criteria. In accordance with s. 397.427, F.S., the department shall not license any new medication-assisted treatment programs for opioid addiction until the department conducts a needs assessment to determine whether additional providers are needed in Florida. The determination of need shall only apply to methadone medication-assisted treatment programs for opioid addiction. Department of Correction facilities are excluded from this process. The department shall use a methodology based on a formula that identifies the number of people who meet the criteria for dependence or abuse of heroin or pain relievers who did not receive any treatment, and the number of opioid-caused deaths. This formula will be weighted, with 70 percent driven by the number of people with an unmet need for treatment and 30 percent driven by the number of deaths. In its effort to determine need, the department shall examine the following data: Population estimates by age and by county; Number of opioid-caused deaths; Estimated number of past-year nonmedical pain reliever users; and Estimated number of life-time heroin users; Procedure. By August 28, 2017, the department will conduct a needs assessment to determine whether additional methadone medication-assisted treatment providers are needed in Florida. The department will publish a determination of need in the Florida Administrative Register and on the department’s website at http://www.myfl families.com/service-programs/substance- abuse on August 30, 2017. If the department determines that additional providers are needed, the department will also publish instructions for submitting an appropriate application. Applicants interested in providing methadone medication-assisted treatment must complete and submit CF-MH 4036 titled, “Methadone Medication-Assisted Treatment Provider Application in Response to Emergency Rule”, June 2017, incorporated herein by reference. Form CF-MH 4036 is available from the department’s website at https://eds.myflfamilies.com/DCFForms Internet/Search/DCFFormSearch.aspx and at http://www.myflfamilies.com/service- programs/substance-abuse. Applications must be complete and responsive to all of the questions on this form. Applications will be accepted at department headquarters from October 2, 2017 September 22, 2017 at 8 a.m. Eastern Time until October 23, 2017 October 13, 2017, at 5 p.m. Eastern Time. Applications must be delivered to the following address: Florida Department of Children and Families, Office of Substance Abuse and Mental Health, 1317 Winewood Boulevard, Building 6, Tallahassee, Florida 32399-0700. For the application review period in response to this emergency rule, the department will use CF-MH 4037 titled, “Review Form for Methadone Medication- Assisted Treatment Provider Application in Response to Emergency Rule”, June 2017, incorporated herein by reference. Form CF- MH 4037 is available from the department’s website at https://eds.myflfamilies.com/ DCFFormsInternet/Search/DCFFormSearch.aspx and at http://www.myflfamilies.com/service- programs/substance-abuse. Should the number of applications for a new provider in a Florida county exceed the determined need, the selection of a provider shall be based on the order in which complete and responsive applications are received by the Office of Substance Abuse and Mental Health headquarters. Applicants who are approved to apply for licensure will receive notices from the department by November 17, 2017 November 10, 2017. Applicants who receive approval notices shall submit applications for licensure to the department’s regional Substance Abuse and Mental Health office(s) where the service will be provided. The regional Substance Abuse and Mental Health office will process applications for licensure in accordance with the standards and requirements in 65D-30, F.A.C. through (6) No change. Rulemaking Authority 397.321(5) F.S. Law Implemented 397.311(25)(a)7., 397.321(1), 397.419, FS. History–New 5-25-00, Amended 4-3-03, Amended 8-25-17, Amended 9-19-17. THIS RULE TAKES EFFECT UPON BEING FILED WITH THE DEPARTMENT OF STATE UNLESS A LATER TIME AND DATE IS SPECIFIED IN THE RULE. EFFECTIVE DATE: 9/19/2017 Petitioners filed challenges to the Emergency Rule at DOAH on December 11, 2017, 83 days after the effective date set forth in the FAR. Respondent asserts that the Emergency Rule is merely an amendment to Rule 65DER 17-1, which had an effective date of August 25, 2017. Thus, reasons Respondent, challenges to the Emergency Rule were due on or before November 23, 2017, i.e., 90 days after August 25, 2017. However, emergency rules are not renewable so as to expand their validity beyond 90 days. § 120.54(4), Fla. Stat. As set forth above, the clear language appearing in the FAR establishes September 19, 2017, as the effective date of the Emergency Rule. Had the Department wished to retain the effective date from the prior rule, it certainly could have done so. It did not. Petitioners’ challenge to the Emergency Rule was timely. Background Florida has had rules in effect for 18 years regarding the need for opioid treatment centers around the State. Florida Administrative Code Rule 65D-30.014 is entitled, “Standards for Medication and Methadone Maintenance Treatment.” This rule sets forth the process for providers to request licenses to establish new opioid treatment facilities, based on the Department’s annual determination of need. According to the rule, the Department is to conduct an annual assessment of need, publishing the results of that assessment by June 30 of each year, although, inexplicably, no assessment was done for calendar years 2016 or 2017. After the need assessment is published, the Department directs interested parties to submit applications for licensure to the Department’s district office in the area where the need exists. All such applications would have to be submitted no later than on a “closing date” to be provided by the Department. The Department’s district office would receive the application(s) and conduct a formal rating of the applicant(s). There were minimum requirements each applicant must meet in order to be considered for licensure. If the number of applicants exceeded the determined need, the selection of a provider would be done based on certain substantive criteria, e.g., number of years the applicant has been licensed; the organizational capability of the applicant; and the applicant’s history of noncompliance with Department rules. Pursuant to rule 65D-30.014, the Department had conducted assessments in calendar years 2012, 2013, 2014, and 2015. The award of licenses based on the 2012 and 2013 need assessment was delayed by litigation. A need for 31 additional treatment centers was found in 2014, but no applications were accepted by the Department due to the ongoing litigation relating to the previous years. The following year, 2015, the Department found a need for only five additional treatment centers, even though none of the 31 treatment centers identified as needed in 2014 had been awarded to anyone. The 2015 assessment was lower than the prior year due to some changes in the methodology used by the Department. The Department did not accept any applications to meet the established need in 2015. One rationale for not accepting applications, even though there was a need, was that the Department was drafting new rules. That process would give stakeholders an opportunity for input. The notices that the rules were being developed, however, were not filed until some 11 months after the 2015 need projections were published. The Department explained that it was busy with other rulemaking duties during that time, causing some delay. Developing the Emergency Rule After entry of the Governor’s executive orders, the Department began the process of distributing the federal grant money to existing treatment centers. The Department, though it never met with the Governor to discuss use of the grant funds, handed out the funds to various existing clinics in order to help them deal with the clinics’ backlogs and waiting lists. There was no discussion between the Governor and the Department concerning the necessity for new clinics. A needs assessment was apparently conducted by the Department. The Department based its assessment in part on data it had gathered when applying for the federal grant. Existing treatment centers had provided the Department waiting lists, indicative of a greater need than could be met by the existing clinics. That data, however, was only from public providers; private providers were not included. The public providers were essentially those contracting with the Department’s “managing entities,” who act as intermediaries between the provider and the Department. An emergency rule was proposed as the vehicle for addressing the need and acquiring applications for licensure. Though the Department’s Director of Substance Abuse and Mental Health thought it best to simply proceed with the rule currently under development, the Emergency Rule was pursued. The thinking at the Department was that the existing rule had created considerable litigation that the Emergency Rule might avoid. That did not happen. The emergent situation warranting an emergency rule was, according to the Department, the scenario described by the Governor in his executive orders. The Department of Health had declared a public health emergency, which was also used as a basis for creating the Emergency Rule. The federal grant funds, however, were not an impetus for creating the Emergency Rule. The Emergency Rule relied upon data from calendar year 2015, as it was the latest data available to the Department at that time. The Governor’s executive orders had also relied upon 2015 data. Some interim data had been available, but the only full year of information available at the time the rule was promulgated was for 2015. The interim data, however, indicated a sharp (approximately 30 percent) increase in need. The Department published a determination of need on its website on August 30, 2017. Apparently the need determination was not published in the FAR despite the directive to do so in subsection (3)(b) of the Emergency Rule. The Department found a need for one clinic each in 47 of Florida’s 67 counties, as well as for two in Hillsborough County, for a total of 49 new clinics. Pursuant to the Emergency Rule, interested applicants were to file an application on the Department’s approved form (CF-MH 4036, attached hereto as an Addendum) expressing an interest in becoming licensed in one or more of those counties. Such applications were to be “accepted at department headquarters from October 2, 2017, at 8 a.m., Eastern Time, until October 27, 2017 at 5 p.m., Eastern Time. Applications must be delivered to [the department].” In contrast to rule 65D- 30.014, applications under the Emergency Rule were to be filed at the Department’s headquarters in Tallahassee rather than in the various district offices around the State. The application form utilized by the Department is a one-page document. The form requests minimal identification information concerning the applicant and its business (questions 1 through 10). Question 11 asks if the applicant plans to accept Medicaid-eligible, indigent, and/or pregnant women as patients. The 12th question directs the applicant to submit documentation concerning its target population, proof of a physician on staff, the anticipated date of initiation of services, and proof of registration with the Department of Revenue or Division of Corporations. The Department also created a “review form,” used to check the completeness of applications. The review form mirrors the application, providing a space for the Department reviewer to state whether the applicant had completed each section of the application form. The Department maintains that the applicants’ responses to Question 11 were not considered in its review of the applications submitted under the Emergency Rule. This was because, according to the Department, a response to that question might favor one applicant over another. The Department did not elaborate as to how this “favoritism” might negatively affect the process. The question had been used under the prior rules and had been deemed important, presumably because--as reported by some of the parties herein--a large majority of their patients were either Medicaid-eligible, indigent persons, or pregnant women. It certainly was reasonable that the Department would ensure that those groups of citizens, who were undoubtedly accounted for in the need assessment, had access to approved treatment centers under the Emergency Rule. Nonetheless, the Department did not utilize the Question 11 responses in its review. This is contrary to the plain language of the Emergency Rule, which states: “Applications must be complete and responsive to all questions on this form.” (emphasis added). See 65DER17- 2(3)(b)1. The Emergency Rule as published contained the following language: “REASON FOR CONCLUDING THAT THE PROCEDURE IS FAIR UNDER THE CIRCUMSTANCES: The procedure is fair under the circumstances because it ensures equitable treatment of methadone medication-assisted treatment providers.” Neither the Emergency Rule language nor the Department at final hearing provided a persuasive rationale for that statement and conclusion. In fact, the Department acknowledged that if the first person in line had filed applications for all 49 new clinics, all the other applicants would have been denied the right to seek licensure. How is that fair? What the Emergency Rule did was to set a window within which interested applicants could either mail, overnight-deliver, or hand-deliver a copy of the one-page application and attachments to the Department’s headquarters in Tallahassee. The Department felt that allowing applications to be submitted via email would potentially crash its email system, so email submission was not allowed. The applications received first by the Department were to be approved, notwithstanding any substantive shortcomings or comparative failings of those applications as compared to applications received later. No other criteria were considered; first was deemed best. What is fair about approving competing applications based on who filed first rather than on substantive differences in the services being proposed? What actually transpired vis-à-vis submission of the applications was not foreseen by the Department or by most of the applicants. That is, some applicants either lined up at Department headquarters days prior to the 8:00 a.m. acceptance time on October 2, 2017, or had someone wait in line for them. Then, when the doors opened at 8:00 a.m., the first person in line presented applications for 19 of the 49 sites identified by the Department as having a need. The second applicant in line submitted 17 applications, etc. By the time each of the Petitioners reached the front of the line, only minutes after the doors had opened, applications for their prospective counties of interest had already been filed. Under the Emergency Rule, the earlier filed applications were accepted without comparison to competing applications. As a result, Colonial was approved for 19 licenses; PAS was approved for 20; and Relax obtained eight; i.e., 47 of the 49 licenses were obtained by just three individual applicants. Again, the Department acknowledged that “[a]fter it, you know, happened the way it did, there were many considerations that we should have made.” Ute Gazioch, Jt. Exh. 6, page 81. Interestingly, the first application accepted by the Department was by an applicant who did not even appear at Department headquarters. That applicant, Lakeview Center, Inc., submitted its application via FedEx. The FedEx box containing Lakeview Center’s application was received and clocked in by an office at Department headquarters, other than the Substance Abuse and Mental Health office, at 7:40 a.m., i.e., prior to the window for filing. When the application made its way to the appropriate office, it was deemed received at 8:00 a.m. As a result, it was “first in line.” The incongruity of that situation was not persuasively justified by the Department. In fact, the Department testified that if all of the applications had been filed at the wrong office, it would likely have simply defaulted to an 8:00 a.m. arrival time for each one. Upon being approved, an applicant would then be allowed to submit an application for licensure. Under the licensure process, the applicant would be vetted in order to assure it met at least minimal requirements for obtaining a license. No comparison of the approved applicant to other applicants was made by the Department to ascertain whether another applicant might be superior as to services provided. Rather, if the approved applicant could satisfy, even minimally, the licensure requirements, it would be granted the right to seek a license. Once licensed, it could take considerable time and financial resources to effectuate the opening of a new opioid treatment clinic. There are many factors to be addressed and resolved, including but not limited to: acquisition of an appropriate site, whether by way of purchase of undeveloped property and new construction or lease/purchase of an existing building; construction or renovation, as needed; zoning concerns; permitting by state, county, and/or municipal bodies; staffing; coordination of state and federal licenses or certifications; etc. It is not uncommon for the process to take up to two years, sometimes more. In addition, the financial expenditures could be in the hundreds of thousands of dollars (and even as much as a million dollars) for each project. For this reason, the Department did not foresee that any entity might apply for so many applications as actually transpired. The likelihood that a single entity would have the time, money, or other resources to move forward on multiple products at one time is small. It is more likely that a single entity receiving approval for multiple new clinics might “bank” the approvals, expending time and money for only a few at a time, at best. If so, that could result in far fewer new clinics coming on line than the 49 projected by the Department under the Emergency Rule. As the applications contained no requirement to provide financial information, it is impossible for the Department to determine whether the approved entities, which received multiple approvals, could successfully–-and timely–-complete their projects. There is no specific time frame for which a granted applicant must commence operations once approved. However, as the approvals were done pursuant to an “emergency,” it follows that clinics should be opened as soon as practicable. Petitioners assert that the “first in line” scheme enunciated in the Emergency Rule is arbitrary, capricious, and patently contrary to a determination of the applicants’ ability to provide care to persons suffering opioid addiction. The facts bear that assertion out.

Florida Laws (14) 120.52120.54120.56120.569120.57120.595120.60120.68381.00315397.301397.305397.321397.419397.427
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DEPARTMENT OF HEALTH, BOARD OF PHARMACY vs STANLEY DYEN, R.PH., 07-001974PL (2007)
Division of Administrative Hearings, Florida Filed:Fort Lauderdale, Florida May 08, 2007 Number: 07-001974PL Latest Update: Oct. 03, 2024
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BOARD OF MEDICAL EXAMINERS vs. MARIA APIAU, 83-001206 (1983)
Division of Administrative Hearings, Florida Number: 83-001206 Latest Update: Aug. 29, 1990

The Issue Whether respondent, a licensed physician, violated provisions of Chapter 458, Florida Statutes, by allegedly (1) failing to keep medical records justifying her course of treatment; (2) prescribing controlled substances (Methaqualone) other than in the scope of her professional practice; (3) prescribing a Scheduled II controlled substance (Methaqualone) for a purpose not allowed by statutes; (4) engaging in gross or repeated malpractice or failing to practice medicine in accordance with medical standards recognized as acceptable by reasonably prudent similar physicians under similar conditions; (5) failing to perform a statutory obligation; (6) making untrue or fraudulent representations or employing a trick or scheme in the practice of medicine, and exploiting patients for financial gain.

Findings Of Fact Respondent, 54, is a female medical doctor licensed to practice medicine in the State of Florida. From August through December 1981, she was the sole physician employed by Northeast Medical Services, Inc. ("the clinic"), a clinic located at 4600 North Federal Highway, Ft. Lauderdale, Florida. The clinic also employed a nurse, a psychologist, and a receptionist. Clinic patients were processed under a standardized office procedure. First, they would fill out personal information and medical history forms, then answer a written "Stress Questioanaire," and sign a "drug potency warning." Next, they would be screened by a psychologist and physically examined by a nurse and respondent. Most patients came to the clinic complaining of stress or stress related symptoms. 1/ Most patients were diagnosed as suffering from stress. The treatment usually consisted of prescribing stress (vitamin) tablets and 45 tablets of 300 mg. Methaqualone, for which patients paid $75 to $100 in cash. During the several months she was employed by the clinic, respondent saw 15 to 20 patients a day, sometimes many more. From August 13, 1981, through October 30, 1981, she wrote at least 378 separate prescriptions for Methaualone (45 tablets, 300 mg.) totaling 17,010 tablets. (Petitioner's Exhibit No. 2) II. Barbara Bennett: Counts 1-24 On September 9, 1981, Barbara Ann Bennett visited respondent at the clinic. She completed the personal information and medical history forms, was screened by the psychologist, and physically examined by respondent. The physical examination included taking her weight, height, pulse, respiration, and blood pressure. Respondent checked her general appearance, skin, head, eyes, ears, nose, throat, heart, lymph nodes and neurological responses. Respondent spoke with her and noted in her progress report that the patient did not like her job as a bartender and did not sleep well. The Stress Questionnaire completed by Ms. Bennett indicated that she came to the clinic for the sole purpose of reducing stress. She checked-off items reflected that, among other symptoms, she had experienced poor sleep, was under a great deal of stress, and was unable to relax. Respondent rendered an initial impression or diagnosis of stress and prescribed stress (vitamin) tablets, 600, No. 30, 30 tablets and Methaqualone, 300 mg., 45 tablets, with directions to take one tablet at bedtime and one-quarter tablet twice a day, as needed. At that time, Chapter 893, Florida Statutes, identified Methaqualone as a Schedule II controlled substance, a substance with a high potential for abuse but which had an accepted but severely restricted medical use and treatment in the United States. This statute recognized that it could be abused and result in severe psychological and physical dependency. In 1981, Methaqualone--a non-barbiturate--was known as a highly potent hypnotic drug which was subject to widespread and growing abuse. It was gaining a reputation as a street drug, and was referred to as quaaludes. For patients diagnosed as suffering from stress, prevailing medical standards (in the area where respondent practiced) dictated the prescription of a mild tranquilizer for daytime use, not a potent hypnotic such as Methaqualone. Generalized complaints of stress, including checked-off items such as contained on the Stress Questionnaire used by respondent, were insufficient to justify prescribing a powerful drug such as Methaqualone, for either night or daytime use. As Dr. Warren Zundell, a qualified physician, testified at hearing: If 100 people were taken off the street and asked if they had stress--100 would say "yes." Prescribing Methaqualone for such patients was, in Dr. Zundell's opinion "like hunting ants with an elephant gun." (TR.-250) For sleeping problems, a milder hypnotic--of which there were several--was the appropriate treatment. Although respondent's initial diagnosis of stress was justified, her prescription of Methaqualone for night and daytime use (though with a lesser dosage) was inappropriate, medically unjustified, and constituted a failure to practice medicine with that level of care which is recognized by reasonably prudent similar physicians as acceptable under similar conditions. Under prevailing medical standards of practice then in effect, the diagnosis of stress did not justify more than the prescription of a mild tranquilizer or sedative. Ms. Bennett's alluded to sleeping problem did not justify the prescribing of Methaqualone when there were many other hypnotics available which were less potent and less subject to abuse. The medical records kept by respondent did not justify her prescribing Methaqualone to Ms. Bennett. The Methaqualone was thus prescribed other than in the course of respondent's professional practice and for other than a legitimate medical purpose. On September 11, 1981, Ms. Bennett was hospitalized at Hollywood Memorial Hospital for a drug overdose. The hospital staff contacted respondent who confirmed that she had issued the September 9, 1981 prescription for Methaqualone. Notation of this call was made in Ms. Bennett's patient records. On or about November 17, 1981, respondent issued Ms. Bennett another prescription for stress tablets and Methaqualone, identical in amount to the September 9, 1981, prescription. Presumably, this prescription was for the purpose of treating the same symptom--stress. It was not medically justified, inappropriate, and outside the scope of her professional practice. The patient's medical records did not justify this prescription. In fact, there are no records of Ms. Bennett's having visited the clinic on November 17, 1981. The prescribing of Methaqualone to Ms. Bennett, especially in light of her prior hospitalization for a drug overdose, constituted a gross failure to practice medicine with that level of care recognized by reasonably prudent similar physicians as accepted under similar conditions. Adrienne Gampel: Counts 25-48 On August 28, 1981, Ms. Adrienne Gampel visited respondent at the clinic. Personal and medical history were taken and the Stress Questionnaire was completed. She acknowledged that she came to the clinic for the sole purpose of reducing stress, and checked off descriptors on the questionnaire indicating that she was under a great deal of pressure at home and had experienced poor sleep. After seeing the psychologist she was given a complete physical examination, similar to that given Ms. Bennett. Respondent rendered a diagnosis of stress and prescribed stress tablets and Methaqualone, 300 mg., 45 tablets. For the reasons stated in paragraphs 6 and 7 above, the prescription of Methaqualone to Ms. Gampel was inappropriate, not medically justified, and not justified by respondent's medical records. It was outside the scope of her professional practice and constituted a failure to practice medicine with that level of care recognized by reasonably prudent similar physicians as acceptable under similar conditions. In October and November 1981, Ms. Gample revisited respondent at the clinic. It has not been shown, however, that a new Methaqualone prescription was issued on either occasion. Robert Distillator: Counts 49-81 On September 3, 1981, Robert Distillator visited the respondent at the clinic. His personal and medical history were taken, and the Stress Questionnaire was completed. He acknowledged that he came for the sole purpose of reducing stress and checked-off descriptors on the questionnaire indicating that he had experienced loss of appetite, poor sleep, boredom on weekends, difficulty in making decisions, inability to have a good time, and a great deal of pressure. He also indicated he felt tense, depressed, unable to relax, and had more problems than he could handle. A complete physical examination was given him and his blood was analyzed. Respondent rendered an initial diagnosis of stress and prescribed stress tablets and Methaqualone, 300 mg. 45 tablets, with directions identical to those given Ms. Bennett. For the reasons provided in paragraphs 6 and 7 above, respondent's prescribing of Methaqualone for night and daytime use was medically unjustified, inappropriate, not justified by the records, and outside the scope of her professional practice. It constituted a failure to practice medicine with that level of care recognized by reasonably prudent similar physicians as acceptable under similar circumstances. Furthermore, it was inappropriate to prescribe Methaqualone to a patient, such as Mr. Distillator, who indicated depression, since such a symptom would increase the likelihood of self-abuse. On or about October 7, 1981, Mr. Distillator revisited respondent at the clinic. However, it has not been shown that he was issued another Methaqualone prescription on that occasion. On or about November 5, 1981, he revisited respondent at the clinic. His blood was analyzed and he was then issued another prescription for stress tablets and Methaqualone--identical in all respects to his first prescription. This prescription was not even noted by respondent in the patient's medical records. For the reasons stated in paragraphs 6 and 7 above, her prescription of Methaqualone was inappropriate, not medically justified, outside the scope of her professional practice, and constituted a failure to practice medicine with that level of care recognized as acceptable by reasonably prudent similar physicians under similar conditions. On December 14, 1981, respondent issued Mr. Distillator another prescription of stress tablets and Methaqualone, in like amount. The prescription was not noted in his patient records. Presumably, it was given for the continued treatment of stress. For the reasons specified in paragraphs 6 and 7 above, this prescription was inappropriate, medically unjustified, not justified--or even noted--in the patient's medical records, and was outside the scope of professional practice. It constituted a failure to practice medicine with that level of care recognized as acceptable by reasonably prudent similar physicians under similar conditions. Joe Morreale: Counts 81-96 On October 12, 1981, Joe Morreale visited respondent at the clinic. His personal and medical history were taken, the Stress Questionnaire was completed, and a physical was given. He acknowledged on the questionnaire that his sole purpose for coming was to reduce stress, and checked-off descriptors indicating that he had experienced pressure at home and at work, headaches, nightmares, and poor sleep. Respondent rendered an initial diagnosis of stress and prescribed stress tablets and Methaqualone 300 mg., 45 tablets, with her standard instructions--one daily at bedtime and one-quarter tablet, twice a day, as needed. For the reasons specified in paragraphs 6 and 7 above, the prescribing of Methaqualone to Mr. Morreale was inappropriate, medically unjustified, not justified by the records, outside the scope of professional practice, and constituted a failure to practice medicine with that level of care recognized as acceptable by reasonably prudent similar physicians under similar circumstances. On December 11, 1981, Mr. Morreale revisited respondent at the clinic. However, it has not been shown that she issued him another prescription for Methaqualone at that time. Joani Levi: Counts 97-104 On September 30, 1981, Ms. Joani Levi visited respondent at the clinic. A personal medical history was taken, the questionnaire was completed, and a physical was given. On the questionnaire, she indicated that the sole purpose of her visit was to reduce stress, and checked-off descriptors indicating she had experienced poor sleep, marital problems, and pressure at work. Respondent noted in her records that the patient was confused, nervous, and suffering extreme anxiety. Respondent rendered an initial diagnosis of stress and prescribed stress tablets and Methaqualone, 300 mg., 45 tablets, with her standard instructions for night and daytime use. For the reasons provided in paragraphs 6 and 7 above, this prescription was inappropriate, not medically justified, not justified by the patient's medical records, and outside the scope of professional practice. It constituted a failure to practice medicine with that level of care which is recognized by reasonably similar prudent physicians as acceptable under similar conditions. Rachel Mack: Counts 105-112 On September 28, 1981, Ms. Rachel Mack visited Respondent at the clinic. Her medical history was taken and the Stress Questionnaire was completed; then she was given a physical. On the questionnaire, she indicated her sole reason for coming was to reduce stress. She checked-off descriptors indicating that she had experienced poor sleep, difficulty in making decisions, disturbing thoughts or fears, pressure at work and at home, and inability to have a good time. Respondent rendered an initial diagnosis of stress and prescribed stress tablets and Methaqualone, 300 mg., 45 tablets, with her usual instructions. For the reasons stated in paragraphs 6 and 7 above, the prescribing of Methaqualone to Ms. Mack was inappropriate, medically unjustified, not justified by her patient records, and beyond the scope of professional practice. It constituted a failure to practice medicine with that level of care recognized as acceptable by reasonably prudent similar physicians under similar conditions. Robin Millman: Counts 113-128 On September 14 and 23, 1981, respondent issued Ms. Robin Millman, an employee at the clinic, a prescription for Methaqualone, 300 mg., 45 tablets. The purpose of this prescription was to relieve stress. There are no medical records justifying this treatment. Indeed, there were no patient records for Ms. Millman. For the reasons stated in paragraphs 6 and 7 above, this prescription was medically unjustified, inappropriate, outside the scope of professional practice, and constituted a failure to practice medicine with that level of care recognized as acceptable by reasonably prudent similar physicians under similar circumstances. Brenda Villa: Counts 127-161 On September 5, 9, 14, October 22, and November 12, 1981, respondent issued Ms. Brenda Villa, another employee of the clinic, a prescription for Methaqualone, 300 mg., 45 tablets, for the purpose of treating stress. There were no patient records for Miss Villa, and there were no medical records justifying this prescription. For the reasons stated in paragraphs 6 and 7 above, the prescription was inappropriate, medically unjustified, outside the scope of professional practice, and constituted a failure to practice medicine with that level of care recognized as acceptable by reasonably similar prudent physicians under similar conditions. Michael Bransfield: Counts 162-169 On September 24, 1981, Michael Bransfield visited respondent at the clinic. A personal and medical history was taken, the Stress Questionnaire was completed, and a physical was given. On the questionnaire, he indicated that the sole purpose of his visit was to reduce stress. He checked off descriptors indicating he had experienced poor sleep, pressure at home and at work, and inability to relax. Respondent rendered a diagnosis of stress and prescribed stress tablets and Methaqualone, 300 mg., 45 tablets, with her usual instructions for night and daytime use. For the reasons provided in paragraphs 6 and 7 above, this prescription was inappropriate, not medically justified, not justified by the patient's medical records, and outside the scope of professional practice. It also constituted a failure to practice medicine with that level of care recognized as acceptable by reasonably prudent similar physicians under similar conditions.

Recommendation Based on the foregoing, it is RECOMMENDED: That respondent's license to practice medicine be revoked for multiple violations of the Medical Practice Act. DONE and ENTERED this 5th day of April 1984, in Tallahassee, Florida. R. L. CALEEN, JR. Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 FILED with the Clerk of the Division of Administrative Hearings this 5th day of April 1984.

Florida Laws (2) 120.57458.331
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PALM BEACH PHARMACY, INC., D/B/A EDDIE`S DRUG vs AGENCY FOR HEALTH CARE ADMINISTRATION, 00-005072MPI (2000)
Division of Administrative Hearings, Florida Filed:Miami, Florida Dec. 15, 2000 Number: 00-005072MPI Latest Update: Dec. 06, 2002

The Issue The issue for determination is whether Petitioner must reimburse Respondent for payments totaling $1,140,763.88 that Petitioner received from the Medicaid Program in compensation for the provision of prescription drugs between late-August and November of 1998. Respondent contends that Petitioner is not entitled to retain the payments in question because Petitioner allegedly has failed to demonstrate that it had available during the pertinent period a sufficient quantity of the prescription drugs in question.

Findings Of Fact The parties' Joint Stipulation of Facts and the evidence presented at final hearing established the facts that follow. The Parties The Agency for Health Care Administration (the “Agency”) is responsible for administering the Florida Medicaid Program. As one of its duties, the Agency must recover "overpayments . . . as appropriate," the term "overpayment" being statutorily defined to mean "any amount that is not authorized to be paid by the Medicaid program whether paid as a result of inaccurate or improper cost reporting, improper claiming, unacceptable practices, fraud, abuse, or mistake." See Section 409.913(1)(d), Florida Statutes. Palm Beach Pharmacy, Inc. (“PBPI”), d/b/a Eddie’s Drug (“Eddie’s”) was, at all times material hereto, a duly contracted Medicaid provider, having entered into a Medicaid Provider Agreement with the Agency and been assigned a Medicaid Provider Number: 106343000. Eddie’s is a Florida licensed pharmacy.1 As an enrolled Medicaid provider, Eddie’s is authorized to dispense drugs and supplies to Medicaid recipients. In return, Eddie’s has agreed to comply with all governing statutes, rules, and policies, including those policies set forth in the Florida Medicaid Prescribed Drug Services Coverage, Limitations and Reimbursement Handbook (the “Handbook”). The Agency, which prepared the Handbook and furnishes it to Medicaid providers, has incorporated the Handbook by reference into Rule 59G-4.250(2), Florida Administrative Code. PBPI, which owned and operated a number of pharmacies (including Eddie’s), maintained its corporate headquarters in West Palm Beach, Florida. Eddie’s was located in Miami, Florida. On July 1, 1998, PBPI acquired a drug store known as Jay’s Drugs (“Jay’s”). Jay’s was located in Miami, Florida, across the street from Eddie’s. Thus, before both stores came under common ownership, they had been competitors. This case arises out of the Agency's attempt to recover alleged overpayments on Medicaid claims for which Eddie’s was paid several years ago. The "audit period" that is the subject of the Agency's recoupment effort is April 1, 1998 to July 31, 1999, although the actual period in controversy is much shorter. From July 1, 1998, until the end of the audit period, PBPI owned and operated both Eddie’s and Jay’s. The Underlying Facts The transactions at the heart of this case occurred between late-August and November of 1998, during which period (the “Focal Period”) Medicaid reimbursed Eddie’s more than $1 million for prescription drugs including Neupogen and Epogen/Procrit (collectively, the “Drugs”). The Drugs are used to treat AIDS patients and persons infected with HIV. Prior to the Focal Period, Eddie’s had not dispensed $1 million worth of the Drugs——or any figure approaching that amount——in three or four months’ time. The reason for the dramatic spike in Eddie’s business is that Eddie’s was dispensing the Drugs to customers of Jay’s pursuant to an arrangement designed to manipulate PBPI’s contractual obligations to the former owner of Jay’s under the purchase and sale agreement by which PBPI had acquired Jay’s. Essentially, the arrangement was this. Jay’s was dispensing the Drugs to a large number (approximately 150) of Medicaid beneficiaries who were receiving treatment at a nearby clinic. Because the Drugs were administered to the patients via intravenous infusion, the clinic typically obtained the Drugs from Jay’s in bulk. To fill these prescriptions, Jay’s ordered the Drugs from a wholesale supplier, which usually delivered the Drugs to Jay’s the next day. At some point before the Focal Period, arrangements were made to have the clinic present its prescriptions for the Drugs to Eddie’s rather than Jay’s.2 The evidence does not show, exactly, how this was accomplished, but whatever the means, the clinic abruptly began bringing prescriptions for the Drugs to Eddie’s.3 This diversion of Jay’s’ business to Eddie’s was intended to deprive Jay’s of Medicaid reimbursements to which Jay’s’ former owner had access as a source of funds for paying down a note that PBPI had given for the purchase of Jay’s. By having Eddie’s dispense the Drugs and submit the Medicaid claims, Medicaid money flowed into Eddie’s’ bank account (rather than Jay’s’ bank account) and hence was not immediately available to the former owner of Jay’s to reduce PBPI’s debt. During the Focal Period, Eddie’s did not purchase the Drugs from a wholesaler but instead acquired them from Jay’s. The process by which this was accomplished involved a pharmacy technician named Wright, who was employed at Eddie’s, and a pharmacist named Shafor, who worked at Jay’s. Wright (at Eddie’s) accepted the prescriptions for the Drugs as the clinic brought them in Then, she called Shafor (at Jay’s) and told him the quantities needed to fill the prescriptions. Shafor ordered the Drugs from a wholesaler, which delivered them in bulk to Jay’s, usually the next day. Upon receiving the Drugs, Shafor personally delivered them to Wright, who, recall, was across the street at Eddie’s. Wright labeled and dispensed the Drugs. Eddie’s submitted a claim for the Drugs to Medicaid, and Medicaid paid Eddie’s. PBPI maintained separate accounting ledgers for Eddie’s and Jay’s, respectively. The company’s accountants recorded the subject transactions in these ledgers so that Jay’s——not Eddie’s——would “recognize” the sales of the Drugs. In a nutshell, this was done through “inter-company” transfers whereby all of the money that Eddie’s received from Medicaid for the Drugs was moved, on the books, into an account of Jay’s. In this way, any profit from the sales of the Drugs (the difference between the wholesale cost of the Drugs and the Medicaid reimbursement therefor, less overhead) was realized on Jay’s’ books.4 The Medicaid payments to Eddie’s that the Agency seeks to recoup were included in four remittance vouchers dated September 2, 1998; September 30, 1998; October 28, 1998; and November 25, 1998, respectively. The September 2 payment to Eddie’s totaled $287,205.52. Of this amount, $276,033.23 reimbursed Eddie’s for dispensing the Drugs. Eddie’s’ accounting ledger reflects that, as of September 30, 1998, the sum of $276,033.23 had been transferred from an account of Eddie’s to an account of Jay’s. The September 30 payment to Eddie’s totaled $439,175.77, of which $432,700.36 was paid in consideration of the Drugs. The October 28 Medicaid payment was $431,753.82, of which total the Drugs accounted for $424,202.76. Eddie’s’ accounting ledger reflects that, as of October 31, 1998, the sum of $870,929.59 (439,175.77 + 431,753.82) had been transferred from an account of Eddie’s to an account of Jay’s. The November 25 payment to Eddie’s totaled $407,088.00. Of this amount, $393,063.00 reimbursed Eddie’s for dispensing the Drugs. Eddie’s’ accounting ledger reflects that, as of November 30, 1998, the sum of $407,088.00 had been transferred from an account of Eddie’s to an account of Jay’s. The Agency’s Allegations On October 31, 2000, the Agency issued its Final Agency Audit Report (“Audit”) in which Eddie’s was alleged to have received $1,143,612.68 in overpayments relating to the Drugs. In the Audit, the Agency spelled out its theory of the case; indeed, the Audit is the only document in the record that does so. The Agency cited several statutory provisions. First, Section 409.913(7)(e), Florida Statutes, was referenced. This section states: When presenting a claim for payment under the Medicaid program, a provider has an affirmative duty to supervise the provision of, and be responsible for, goods and services claimed to have been provided, to supervise and be responsible for preparation and submission of the claim, and to present a claim that is true and accurate and that is for goods and services that: * * * (e) Are provided in accord with applicable provisions of all Medicaid rules, regulations, handbooks, and policies and in accordance with federal, state, and local law. Section 409.913(7)(e), Florida Statutes. The Agency did not allege (or prove), however, that Eddie’s had violated Section 409.913(7)(e), Florida Statutes.5 Put another way, the Agency did not plead or prove lack of supervision, submission of a false claim, or that the Drugs were not provided in accordance with applicable law. Next, the Agency cited Section 409.913(8), Florida Statutes, which provides: A Medicaid provider shall retain medical, professional, financial, and business records pertaining to services and goods furnished to a Medicaid recipient and billed to Medicaid for a period of 5 years after the date of furnishing such services or goods. The agency may investigate, review, or analyze such records, which must be made available during normal business hours. However, 24-hour notice must be provided if patient treatment would be disrupted. The provider is responsible for furnishing to the agency, and keeping the agency informed of the location of, the provider's Medicaid- related records. The authority of the agency to obtain Medicaid-related records from a provider is neither curtailed nor limited during a period of litigation between the agency and the provider. The Agency further alleged, as fact, that Eddie’s had failed, upon request, “to submit invoices from [its] suppliers to substantiate the availability of drugs that [were] billed to Medicaid” and thus had not “fully substantiated such availability.” The Agency, however, did not invoke any of the available remedial provisions as authority to impose a sanction for this alleged failure to turn over Medicaid-related records. See, e.g., Sections 409.913(14)(b), (c), and (d), Florida Statutes. The Agency cited Section 409.913(10), Florida Statutes, which authorizes the Agency to “require repayment for inappropriate, medically unnecessary, or excessive goods or services from the person furnishing them, the person under whose supervision they were furnished, or the person causing them to be furnished.” There was no allegation (or proof), however, that the Drugs which Eddie’s had purported to dispense (i.e. the Drugs for which it had submitted Medicaid claims) were “inappropriate, medically unnecessary, or excessive.” Thus, Eddie’s was not alleged (or shown) to have violated Section 409.913(10), Florida Statutes. Finally, the Agency relied upon Section 409.913(14)(n), Florida Statutes, which is the basis of the Agency’s legal theory. This section provides: The agency may seek any remedy provided by law, including, but not limited to, the remedies provided in subsections (12) and (15) and s. 812.035, if: * * * (n) The provider fails to demonstrate that it had available during a specific audit or review period sufficient quantities of goods, or sufficient time in the case of services, to support the provider's billings to the Medicaid program[.] The Agency contended, additionally, that “[b]illing Medicaid for drugs that have not been demonstrated as available for dispensing is a violation of the Medicaid laws and regulations and has resulted in the finding that [Eddie’s] ha[s] been overpaid by the Medicaid program.” (Emphasis added). The Agency explained, “Medicaid payments that have been substantiated by documented inventory are assumed to be valid; and payments in excess of that amount are regarded to be invalid.” Thus, the Agency’s theory of recovery is that Eddie’s must forfeit “overpayments” arising from its failure to demonstrate the availability, in inventory, of a sufficient quantity of the Drugs for which claims were submitted, as required by Section 409.913(14)(n), Florida Statutes. After the Audit was issued, the Agency accepted a handwritten note regarding the transfer of a small quantity of Drugs from Jay’s to Eddie’s as sufficient to demonstrate the availability of such amount. This resulted in a slight reduction of the amount of the alleged overpayment, to $1,140,763.88. The Separate Audit of Jay’s The Agency conducted a separate audit of Jay’s, concerning which some evidence was introduced at hearing. Without getting into unnecessary detail, the audit of Jay’s revealed that Jay’s had purchased, during and around the Focal Period, a quantity of the Drugs that exceeded the number of units that Jay’s had billed to Medicaid. It was Eddie’s theory that this “excess inventory” of Jay’s matched, more or less, the alleged inventory shortfall at Eddie’s, thereby corroborating the testimony concerning the transfer of these Drugs from Jay’s to Eddie’s for dispensation. At hearing, the parties sharply disputed whether, in fact, Jay’s had transferred the Drugs to Eddie’s. The Agency, of course, maintained that such transfers were not properly documented; Eddie’s argued that the documents and other evidence, including testimony about the transactions in question, adequately demonstrated that the transfers had, in fact, occurred. There was no dispute, however, that if it were found that such transfers had occurred, and if, further, the documents (and other evidence) pertaining to the inventory of Jay’s were accepted as proof of the quantities of Drugs so transferred, then all but $176,078.30 worth of the Drugs could be accounted for. Thus, as counsel for Eddie’s conceded at hearing, the Agency is entitled to recoup some sum of money. The question is whether that sum is $1,140,763.88 or $176,078.30. Ultimate Factual Determination Based on all of the evidence in the record, including the deposition testimony received through the parties’ joint stipulation, it is determined that, more likely than not, Eddie’s had available during the Focal Period a sufficient quantity of the Drugs to support all but $176,078.30 worth of the claims in dispute.

Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Agency enter a final order requiring Eddie’s to repay the Agency the principal amount of $176,078.30. DONE AND ENTERED this 12th day of March, 2002, in Tallahassee, Leon County, Florida. JOHN G. VAN LANINGHAM 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 12th day of March, 2002.

Florida Laws (4) 120.569120.57409.913812.035
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DEPARTMENT OF HEALTH, BOARD OF MEDICINE vs MICHAEL SHOOK, M.D., 10-010166PL (2010)
Division of Administrative Hearings, Florida Filed:Lauderdale Lakes, Florida Nov. 10, 2010 Number: 10-010166PL Latest Update: Oct. 03, 2024
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DEPARTMENT OF HEALTH, BOARD OF MEDICINE vs ARTHUR CHARLES ROSENBLATT, M.D., 16-005070PL (2016)
Division of Administrative Hearings, Florida Filed:West Palm Beach, Florida Aug. 31, 2016 Number: 16-005070PL Latest Update: Oct. 03, 2024
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