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FULL HEALTH CARE, INC. vs AGENCY FOR HEALTH CARE ADMINISTRATION, 00-004441 (2000)
Division of Administrative Hearings, Florida Filed:Miami, Florida Oct. 30, 2000 Number: 00-004441 Latest Update: Oct. 04, 2001

The Issue The issue for determination is whether Petitioner must reimburse Respondent for payments totaling $193,232.50 that Petitioner admittedly received between January 1, 1999, and June 15, 2000, under the Medicaid Program for the provision of universal precaution kits to AIDS patients, where the supplies in question allegedly were not specifically listed in the patients’ respective plans of care.

Findings Of Fact The evidence presented at final hearing established the facts that follow. The Parties and the Stake 1. 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. 2. This case arises out of the Agency's attempt to recover alleged overpayments from Full Health, a Florida-licensed home health agency. As an enrolled Medicaid provider, Full Health is authorized, under a provider agreement with the Agency, to provide services and supplies to Medicaid recipients. 3. It is undisputed that, at all times material to this proceeding, Full Health was authorized to provide home and community-based ("HCB") services and supplies to Medicaid recipients eligible for assistance under a program—more about which below—called the Project AIDS Care Waiver ("PAC Waiver"). 4. The "audit period" that is the subject of the Agency's recoupment effort is January 1, 1999 to June 15, 2000. It is undisputed that, during this audit period, the Medicaid Program reimbursed Full Health a total of $193,232.50 for "universal precaution kits" (packages containing disposable protective gear such as latex gloves, surgical masks and gowns, and eye shields) that Full Health had delivered to 57 clients in the PAC Waiver program. The Agency contends that the entire $193,232.50 is subject to recoupment because, under the PAC Waiver program, case manager approval is a necessary precondition to Medicaid reimbursement, and none had been given for the universal precaution kits at issue. PAC Waiver Program Basics 5. Broadly speaking, the State of Florida has obtained waivers from certain federal Medicaid requirements to allow for the provision of specified HCB services to patients at risk of institutionalization. See Rule 59G-8.200(1), Florida Administrative Code. The PAC Waiver program is one of six authorized HCB services waiver programs. Rule 59G-8.200(9), Florida Administrative Code.* 6. The PAC Waiver program "provides a range of HCB services designed to meet the needs of people living with AIDS related conditions." Rule 59G-8.200(14) (a), Florida Administrative Code. To be eligible for benefits under the PAC Waiver program, a recipient must satisfy a number of criteria, including having been diagnosed with AIDS. Rule 59G- 8.200(14) (c)2, Florida Administrative Code. 7. The Florida Medicaid office has prepared and furnishes to authorized Medicaid providers a manual entitled Project AIDS Care (PAC) Waiver Services Coverage and Limitations Handbook (the "Handbook"). In their joint Prehearing Stipulation, the parties agreed that the April 1999 version of the Handbook was in effect during the audit period, and this stipulation is accepted as fact. 8. The Handbook does not appear to have been incorporated by reference into the Florida Administrative Code as an Agency rule.?. Full Health, however, has not challenged the Agency's reliance on the Handbook as an authoritative source of the policies and procedures relating to reimbursement for services provided under the PAC Waiver program. To the contrary, not only did Full Health stipulate that the April 1999 Handbook was win effect" during the relevant period, but also it introduced the entire April 1999 Handbook into evidence as Petitioner's Exhibit 1. 9. In addition, Full Health's President, Ms. Gonzalez, credibly described Petitioner's Exhibit 1 as the place "where you find all of the rules and regulations that you have to follow when it comes to this kind of patients [sic] [meaning PAC Waiver recipients}]." Transcript of Final Hearing at 461. The trier believes Ms. Gonzalez‘s testimony on this point and adopts it as a fact. For purposes of this case at least, the Handbook sets forth pertinent, applicable Medicaid policies and claims processing requirements. See Rule 59G-8.200(14) (£), Florida administrative Code ("Medicaid will make payment for services provided to Project AIDS Care recipients in accordance with applicable Medicaid claims processing requirements.") .° 10. As the Handbook explains, "[e]very PAC waiver recipient must have a case manager who is employed by a Medicaid-enrolled PAC waiver case management agency." Handbook at 2-1.4 See also Rule 59G-8.200(14) (c)6., Florida Administrative Code (patient must have a case manager to be eligible under this waiver). 11. Among the case manager's responsibilities is the development of a "plan of care" for each PAC Waiver patient. "A plan of care is a written document that describes the service needs of a recipient, specifies the services to be provided, the provider of services, how frequently the services are to be provided, the duration of the services, and their estimated cost." Handbook at 2-7. The case manager is required to "review plans of care on an ongoing basis, but no less frequently than every six months." Rule 59G-8.200(14) (e)1.d., Florida Administrative Code. 12. Significantly, the "plan of care and the services specified in the plan of care are considered authorized when [the plan of care] is signed by the case manager." Handbook at 2-9. The case managers, however, do not have carte blanche to approve services. Rather, their discretionary approval authority is capped at $2,000 per month per patient, and "Medicaid must approve plans of care exceeding a cost of $2,000 per month before services are considered authorized." Handbook at 2-9. Indeed, "[i]f the total estimated cost of the Project BIDS Care services exceeds [this monthly limit], prior approval must be obtained from Medicaid before the service authorizations can be made." Rule 59G-8.200(14) (e)1.d., Florida Administrative Code. 13. Case manager approval, as manifested in a signed plan of care for the individual patient, is essential. Without it, HCB services rendered to a PAC Waiver patient are not Medicaid compensable, regardless of medical necessity, efficacy, the provider's competence or good intentions, or any other compelling justification. The Handbook is blunt and unambiguous about this: "Services not specified in the plan of care are not considered approved or authorized. Medicaid reimbursement for services furnished, but not specified in the plan of care for that specific time period are subject to recoupment." Handbook 2-9 (emphasis added); see also Rule 59G-8.200(6) (g), Florida Administrative Code. 14. The Handbook further informs providers: PAC waiver services are based on individual recipient needs and must be in the recipient’s plan of care. All recipients enrolled in the PAC waiver must receive case management and at least one other waiver service. Medicaid will reimburse only waiver services that are specifically identified in the approved plan of care by service type, frequency and duration. Handbook at 2-12 (emphasis added). 15. The case manager performs another crucial function in the delivery of services to PAC Waiver recipients: he or she instructs participating providers (such as Full Health) to commence furnishing an approved service or services to a particular patient. The case manager's instructions to the provider must be in writing on an instrument known as "service authorization." The applicable administrative rule directs: The case manager shall develop written service authorizations for all services except case management. These authorizations will provide sufficient information to allow the provider to bill for services with a minimum of assistance. The authorizations will parallel the plans of care in terms of specificity of the service, the duration of the service, frequency of service, and the total authorized amount to be spent. If a case manager authorizes a service orally, he will send a written authorization to the provider 10 within five working days as confirmation of the oral authorization. Rule 59G-8.200(14) (e)1.e., Florida Administrative Code. 16. ‘he Handbook amplifies the foregoing rule provision, explaining that {[iln order to implement services authorized on a plan of care, the case manager must transmit service authorizations to specific providers of PAC waiver services included in the plan of care. Service authorizations must be sent to PAC waiver services providers within five working days of services being authorized on the recipient's written plan of care. Handbook at 2-10. 17. Included with the Handbook, in Appendix Cc, is a Service Authorization form that case managers are encouraged to use. The instructions for use of this form state, in pertinent part, as follows: The case manager should notify providers that services have been authorized by using “the PAC Service Authorization form. Each enrolled Medicaid PAC program service provider must receive authorization before providing services to the PAC client. The authorization form includes the following: Make sure that all authorized services are contained in the current plan of care and that the services are based on needs identified in the needs assessment and that the level of service is justified in_the case narrative. Handbook, Appendix C (boldface in original). 11 18. The Service Authorization form reminds the provider that “[slervices beyond the amount, duration, and scope authorized [hereby] will not _be reimbursed.” Handbook, Appendix C (boldface in original). 19. Individuals eligible for assistance under the PAC Waiver program may receive a number of covered services, including the provision of “consumable medical supplies.” See Rule 59G-8.200(14) (b)4., Florida Administrative Code (setting forth qualifications needed to provide consumable medical supplies under PAC Waiver program). 20. The term "consumable medical supplies" is defined by rule to mean "expendable, disposable, and non-durable items used for the treatment of specific injuries or diseases or for persons who have chronic medical or disabling conditions. These supplies exceed those routinely furnished by the provider in conjunction with skilled care and home health aide visits." Rule 59G-8.200(2) (h), Florida Administrative Code (emphasis added). 21. The Handbook defines “consumable medical supplies” somewhat differently, incorporating several elements of the rule (expendable, disposable, non-durable) and adding to them a gloss that affords a fuller description of the covered items: Consumable medical supplies are medically- necessary medical or surgical items that are consumable, expendable, disposable or non- 12 durable, and appropriate for use in the recipient’s home. Medicaid only reimburses consumable medical supplies that if not provided could reasonably cause the recipient to require emergency treatment, become hospitalized, or be placed in a long- term care facility. Consumable medical supplies must not exceed one month’s usage. Handbook at 2-35 (emphasis added). 22. Consumable medical supplies fall within a Medicaid billing category called “Specialized Medical Equipment and Supplies” that is denoted by the procedure code W9994. Also included in this category of services is durable medical and adaptive equipment which “is medically-necessary . . . and can withstand repeated use . . . in the recipient’s home.” Handbook at 2-34. Examples of the latter are mattresses, humidifiers, and wheelchairs. 23. Medicaid will reimburse a provider of specialized medical equipment and supplies only for items furnished that are (1) “[slpecifically identified in the recipient's plan of care” and (2) “[p]lrescribed by a licensed physician, advanced registered nurse practitioner, or physician assistant designee.” Handbook at 2-34. 24. All Medicaid providers, including case managers and home health agencies such as Full Health, must “retain medical, professional, financial, and business records pertaining to 13 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.” Section 409.913(8), Florida Statutes; see also Section 409.907(3)(c), (e), Florida Statutes (prescribing provisions respecting records retention and review for inclusion in Medicaid provider agreements) . 25. By rule, the Agency specifically requires that case managers retain plans of care and service authorizations, among other documents, in their files. Rule 59G-8.200(14) (e)2.f£., g., Florida Administrative Code. The files of other participating provider agencies, such as Full Health, must contain at least the service authorizations, provider eligibility documents, and provider enrollment documents. Rule 59G-8.200(14) (e)3., Florida Administrative Code. Full Health's Provision of Universal Precaution Kits During the Audit Period 26. Full Health delivered the universal precaution kits at issue to 57 PAC Waiver recipients between the dates of November 15, 1999, and May 10, 2000——a period of about six months (the "Focal Period") that comprises a subset of the audit period. Ms. Gonzalez has been employed by Full Health since October 1999 as the company's President, a position she held, 14 therefore, during the entire Focal Period. Her extensive testimony on Full Health's business practices regarding the provision of universal precaution kits was believable and forms the primary basis of the fact findings set forth in this section of the Recommended Order. 27. During the Focal Period, Full Health automatically furnished universal precaution kits to all PAC Waiver recipients in the ordinary course of its business. Full Health followed this routine in part to comply with doctors’ orders that were communicated directly to Full Health verbally but never reduced to writing, and also because Ms. Gonzalez understood that the routine provision of universal precaution kits to AIDS patients was a generally accepted, standard practice in the medical community, one that home health agencies customarily observed. 28. As a matter of course, then, Full Health delivered universal precaution kits to each patient once a week, and a week's supply for each patient might consist of multiple universal precaution kits. Full Health thereafter would submit claims to Medicaid for payment on each individual universal precaution kit delivered, at a cost of $55.00 apiece, reporting a separate date of service for every single one. For example, during the month of January 2000, Full Health delivered 27 universal precaution kits to a patient named J.G. Full Health's subsequent Medicaid claims showed that J.G. had received this 15 $55.00 service on each day of the month (including New Year's Day) except January 9, 16, 23, and 30—all Sundays. 29. Full Health received not one service authorization for any of the universal precaution kits it delivered to PAC Waiver patients during the Focal Period. Indeed, these 57 patients’ case managers neither authorized, nor had any involvement whatsoever in, Full Health's provision of the universal precaution kits at issue. 30. Although Ms. Gonzalez credibly denied having seen any plans of care for the 57 patients who received universal precaution kits from Full Health during the Focal Period, her testimony nevertheless establishes that, more likely than not, the pertinent plans of care failed to identify universal precaution kits specifically as an authorized service. This crucial fact may be (and has been) reasonably inferred from Ms. Gonzalez's unequivocal and unambiguous testimony that none of the case managers involved had authorized any of the universal precaution kits that were delivered during the Focal Period, and none had sent Full Health a service authorization approving the provision of universal precaution kits.°* 31. The relevant plans of care (Respondent's Exhibits 13 through 69)° corroborate Ms. Gonzalez's testimony that the case managers were not involved with, and did not authorize, the provision of universal precaution kits during the Focal Period. 16 To the point, these documents—in which universal precaution kits are not specifically identified—supplement Ms. Gonzalez's testimony, in the sense of completing the picture that she herself had painted rather vividly; and, moreover, they confirm the accuracy of her perception and the acuity of her recollection of the historical facts. But, it must be stressed, the finding in the immediately preceding paragraph was not based on Respondent's Exhibits 13 through 69; the fact-finder could have and would have made the same finding without these documents, which have been considered as secondary evidence only—and then largely because to have ignored them completely would have violated the evidentiary principles that govern administrative proceedings.’ Ultimate Factual Determinations 32. The greater weight of evidence establishes—indeed, it is undisputed—that the universal precaution kits at issue were routinely furnished by Full Health in conjunction with home health aide visits.® Moreover, Rule 59G-8.200(2) (h), Florida Administrative Code, affirmatively and unambiguously places such routinely furnished items outside the boundaries which delimit "consumable medical supplies." Thus, as a matter of fact, the universal precaution kits at issue are not Medicaid-compensable “consumable medical supplies" as the rule defines that term. 17 33. Additionally, a preponderance of evidence demonstrates that none of the universal precaution kits that Full Health furnished to 57 patients during the Focal Period was specified in any patient's plan of care for the Focal Period. Therefore, the entire $193,232.50 that Medicaid indisputably paid to Full Health in reimbursement for these universal precaution kits was an "overpayment" as defined in Section 409.913(1) (d), Florida Statutes. This amount is subject to recoupment. See Rule 59G- 8.200(6) (g), Florida Administrative Code.

Conclusions J. Everett Wilson, Esquire Michael Gennett, Esquire Wilson, Suarez & Lopez Union Planters Bank Building 2151 LeJeune Road, Mezzanine Coral Gables, Florida 33134-4200 L. William Porter, II, Esquire Agency for Health Care Administration 2727 Mahan Drive, Suite 3431 Fort Knox Executive Center III Tallahassee, Florida 32308-5403

Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Agency enter a final order requiring Full Health to repay the Agency the principal amount of $193,232.50. DONE AND ENTERED this 25% day of dune, 2001, in Tallahassee, Leon County, 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 25% day of June, 2001.

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DEBRA L. SAVASUK AND TERRY SAVASUK, AS DULY APPOINTED GUARDIANS OF THE PERSON AND PROPERTY OF TAYA ROSE SAVASUK-MALDONADO, A MINOR vs AGENCY FOR HEALTH CARE ADMINISTRATION, 13-004130MTR (2013)
Division of Administrative Hearings, Florida Filed:Fort Myers, Florida Oct. 18, 2013 Number: 13-004130MTR Latest Update: Aug. 22, 2014

The Issue The issue in this case is the amount of the Petitioners' personal injury settlement required to be paid to the Agency for Health Care Administration (AHCA) to satisfy its Medicaid lien under section 409.910, Florida Statutes (2013).

Findings Of Fact The Petitioners are the grandparents and legal guardians of Taya Rose Savasuk-Maldonado, who is 11 years old. On October 2, 2010, Taya and six family members were involved in a horrific car crash. The driver of another car (the tortfeasor) failed to stop at an intersection and slammed into the family van, which rolled over, ejecting three passengers, including Taya and her great-grandparents. The great- grandparents died on the pavement next to Taya, and Taya suffered severe injuries, including a skull fracture, pancreatitis, bleeding in her abdomen, and severe road rash that required multiple skin graft surgeries and dressing changes so painful that anesthesia was required. Taya has significant, permanent scarring, which has left her self-conscious and unwilling to wear any clothing that exposes her scars, including bathing suits and some shorts. Taya's emotional injuries include nightmares and grief over the loss of both great-grandparents. Other family members also suffered injuries. Taya required emergency and subsequent medical care that has totaled $257,567 to date. It is not clear from the evidence how much, if any, of that total was reduced when providers accepted Medicaid. Future medical expenses are anticipated, but there was no evidence as to the amount of future medical expenses. The tortfeasor had a $100,000/$300,000 Hartford insurance liability policy on the car he was driving at the time of the accident. Hartford agreed to pay the policy limits. The injured family members agreed that $200,000 of the policy limits should be paid to Taya. On October 14, 2013, Hartford and the Petitioners agreed that the Petitioners would release Hartford, the tortfeasor and his wife (the other owner of the car) in return for payment of $200,000 to be held in trust by the Petitioners' attorneys for distribution as follows: $60,000 to be paid to the Prudential Assigned Settlement Services Corporation to fund future payments to Taya beginning in year 2020; up to $84,095 to lienholders in amounts to be determined; and the balance to the Petitioners' attorneys. The parties to that agreement, which did not include AHCA, agreed that $51,513 of the $200,000 should be allocated to payment of Taya's medical bills, with the rest allocated to claims other than medical expenses. There was no evidence that anything has been paid to AHCA towards its Medicaid lien, or that anything has been paid into an interest-bearing trust account for the benefit of AHCA pending the determination of the amount of its Medicaid lien, which at the time was claimed to be $55,944. The owner of the family van involved in the accident had a $10,000/$20,000 GEICO underinsured motorist policy, which also paid the policy limits. Although the evidence was not clear, the Petitioners appear to concede that all $20,000 was recovered by them for Taya's benefit. There was no evidence as to when the family's claim against the GEICO policy settled, or as to any agreement how the $20,000 should be allocated between medical expenses and other kinds of damages. There was no evidence that any of the $20,000 was paid to AHCA towards its Medicaid lien, or into an interest-bearing trust account for the benefit of AHCA pending the determination of the amount of its Medicaid lien. In addition to the insurance policy settlements, the owners of the other car paid the family approximately $250,000 from their own assets, which the family members agreed to apportion among themselves in a manner that was not disclosed by the evidence. There was no evidence as to when those funds were paid to the family, or when any of those funds was paid to Taya's benefit, if any. The evidence was not clear whether any of those funds was paid towards Taya's medical expenses that were not paid by Medicaid. The evidence suggested that some of the $250,000 was paid towards Taya's medical expenses to date, but it is possible that some of those expenses were reduced when providers accepted Medicaid. There was no evidence that any of those funds was paid to AHCA towards its Medicaid lien claim, or into an interest-bearing trust account for the benefit of AHCA, pending a determination of the amount of its Medicaid lien. A personal injury lawyer, who also was Taya's guardian ad litem, testified that the value Taya's claims against the owners of the other car was approximately $1.4 to $1.8 million. He did not testify as to the amount future medical expenses would contribute to the total value he estimated. AHCA has paid $55,710.98 in Medicaid benefits to treat Taya for her accident injuries. (The Petitioners stipulated to this amount.) Lee Memorial Hospital provided medical services for Taya and claims that it is owed $38,317.05, for which it appears to claim a statutory lien. The evidence was that Lee Memorial refused to accept Medicaid in payment for those services. If Medicaid were accepted, the amount of AHCA's lien would be more than $55,710.98, but probably not $38,317.05 more.

Florida Laws (2) 120.68409.910
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DESIREE WILLIAMS AND ROBERT WILLIAMS, INDIVIDUALLY AND AS PARENTS AND NEXT FRIENDS OF LYLYAUHNIE WILLIAMS, A MINOR vs FLORIDA BIRTH-RELATED NEUROLOGICAL INJURY COMPENSATION ASSOCIATION, 12-000848N (2012)
Division of Administrative Hearings, Florida Filed:West Palm Beach, Florida Mar. 05, 2012 Number: 12-000848N Latest Update: Nov. 12, 2014

The Issue The issues to be determined in this proceeding are whether Steven Pliskow, M.D. (Dr. Pliskow), provided notice as required by section 766.316, Florida Statutes, and whether Palms West Hospital, Limited Partnership, d/b/a Palms West Hospital (Palms West Hospital) provided notice as required by section 766.316.

Findings Of Fact Desiree Williams first presented to Dr. Pliskow on November 28, 2011, for a prenatal visit. She was 34 weeks' gestation. When she arrived at Dr. Pliskow's office, Mrs. Williams was given some forms to fill out by the receptionist. She filled out, signed, and dated a Patient Registration Form and a Policies and Consent form and returned them to the receptionist. The forms were initialed by the receptionist. After she returned the forms to the receptionist, Mrs. Williams returned to the waiting room, while her chart was being prepared by Dr. Pliskow's medical assistant, Marlena Lovely. Ms. Lovely took Mrs. Williams to the triage area. Mrs. Williams remembers Ms. Lovely because Ms. Lovely was wearing unusual pink tye-dyed shoes. While in the triage area, Ms. Lovely gave Mrs. Williams a copy of the brochure published by the Florida Birth-Related Neurological Injury Compensation Association (NICA brochure). She also gave Mrs. Williams the Patient Information Verification form, the Prenatal Risk Screening form, and the Prenatal Genetic Screening form for Mrs. Williams to fill out. Mrs. Williams filled out the forms. The Prenatal Information Verification form contains the following statement: The first OB visit is an important time to insure that you start you prenatal care informed and confident that you are making the right decision regarding your pregnancy. As we progress together through the pregnancy, we will discuss many aspects of the prenatal care and delivery. Please confirm that you have received the following information and that all your questions have been answered. After this statement, there is a list of items and beside each item is a blank for the date and a blank for the patient's initials. The first item listed is the NICA brochure. Mrs. Williams placed the date, "11/28/2011," on the blank for the date and placed her initials on the blank designated for the patient's initials. After filling out the forms in triage, Mrs. Williams was taken to Dr. Pliskow's office, where Dr. Pliskow discussed the pertinent items on the Prenatal Information Verification form with Mrs. Williams. Dr. Pliskow recalls seeing the NICA brochure in Mrs. Williams' lap while he was discussing the items on the form with Mrs. Williams. Dr. Pliskow initialed the Prenatal Information Verification form after he discussed the items with Mrs. Williams. After his discussion with Mrs. Williams, she was taken to the examination room, where Dr. Pliskow examined her. Mrs. Williams denies having received the NICA brochure during her visit to Dr. Pliskow's office on November 28, 2011. However, based on the normal routine and practice in Dr. Pliskow's office, it is more likely than not that Mrs. Williams did receive a copy of the NICA brochure from Dr. Pliskow's office on November 28, 2011. The routine practice in Dr. Pliskow's office for a first time obstetric patient was to have the receptionist give the patient the Patient Registration form and the Policies and Consent Form to fill out while the patient was in the waiting room. After the patient returned the forms to the receptionist, the receptionist would initial the forms and give them to Dr. Pliskow's medical assistant to compile a chart. The medical assistant would then take the patient to the triage area where the patient would be given the Prenatal Risk Screening form, the Prenatal Genetic Screening form, and a Prenatal Information Verification form to complete. The medical assistant would give the patient the NICA brochure while the patient was in triage. After triage, the patient would be taken to see Dr. Pliskow in his office, where Dr. Pliskow would discuss the items listed in the Prenatal Information Verification form with her. He would also discuss the NICA brochure and advise the patient that he was a participating physician. After this discussion, the patient would be taken to the examination room to be examined by Dr. Pliskow. Mrs. Williams presented to Palms West Hospital on December 19, 2011, and pre-registered for her delivery. On December 29, 2011, Mrs. Williams presented again to Palms West Hospital for a biophysical profile. Palms West Hospital did not provide Mrs. Williams with notice as to the limited no-fault alternative for birth-related neurological injuries under the Plan on December 19, 2011, or December 29, 2011. Palms West Hospital was not prohibited or constrained from providing notice to Mrs. Williams of the Plan on either December 19, 2011, or December 29, 2011. On January 3, 2012, Mrs. Williams presented to Palms West Hospital after a spontaneous rupture of membranes. When she arrived at the hospital, she was given some forms to complete and sign. One of the forms that she was given and which she signed and dated was the Acknowledgement of Patient's Receipt of the Florida Birth-Related Neurological Injury Compensation Plan Brochure. The form stated: I ACKNOWLEDGE THAT I HAVE RECEIVED THE OFFICIAL INFORMATION BROCHURE OF THE Florida Birth-Related Neurological Injury Compensation Plan. I acknowledge that any questions I may have had with regard to the operation of this plan and the potential benefits available to me have been answered to my satisfaction. I hereby consent to the rendering of all necessary medical services including having received the official information NICA brochure which describes my rights and limitations under that plan. I acknowledge and understand that I may contact the Florida Birth-Related Neurological Compensation Association about the details of the plan. Mrs. Williams' signature on the acknowledgement form was witnessed by Robin Torres, a registered nurse in the labor and delivery unit at Palms West Hospital. Part of Ms. Torres' duties and routine practice at Palms West Hospital is to give incoming obstetrical patients a copy of the NICA brochure prior to her signing her name to the acknowledgement form as a witness. Ms. Torres also routinely manually inputs data into the hospital computer showing that the NICA brochure was given to the patient. The records of Palms West Hospital show that on January 3, 2012, Ms. Torres entered data into the hospital computer system indicating that Mrs. Williams was provided a copy of the NICA brochure on that date. Mrs. Williams denies being given a copy of the NICA brochure when she presented to Palms West Hospital on January 3, 2012, but concedes that she did not read the forms that were provided to her on that date. The greater weight of the evidence demonstrates that Mrs. Williams was given a copy of the NICA brochure by the staff of Palms West Hospital on January 3, 2012. At the time that Mrs. Williams presented to Palms West Hospital on January 3, 2012, she could not be transferred to another hospital because her membranes had broken and she was in labor.

Florida Laws (10) 395.002766.301766.302766.303766.305766.309766.31766.311766.314766.316
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BOARD OF MEDICINE vs. ELIEZER FORTICH CASTRO, 89-001708 (1989)
Division of Administrative Hearings, Florida Number: 89-001708 Latest Update: Sep. 21, 1989

Findings Of Fact Petitioner is the state agency charged with regulating the practice of medicine pursuant to Section 20.30 and Chapters 455 and 458, F.S. Respondent is and has been at all times material hereto a licensed medical physician in the State of Florida, having been issued license number ME 0029506. Medicare is a health insurance program for beneficiaries 65 or older or disabled. It is a Federal program under Title 18, USCA, the Social Security Act. By contract, Blue Cross/Blue Shield administers the Medicare Program in Florida, and is hereafter also referred to as "Medicare" throughout this Recommended Order. On or about August 23, 1986, Respondent rendered care and treatment to patient G.C. by assisting one Dr. Kluger with patient G.C.'s surgery. On or about September 1, 1986, patient G.C. expired. He was survived by his widow, J.C. An assignment is an agreement between the physician and the patient/beneficiary whereby the patient/beneficiary transfers to the physician his rights to benefits based on covered services specified on the assigned claim. When the physician accepts said assignment, he agrees that the allowed charges determined by Medicare is the full amount he expects to receive, and his charges to the patient/beneficiary should be no more than 20% of the allowed charges. It is clear on the record that on January 9, 1987, Respondent advised J.C. that he would not accept a Medicare assignment for his services, and that he required full payment from her. On that date, she paid him in full by personal check the undiscounted amount of $731.75 which he had billed her on October 24, 1986. It is not certain whether Respondent ever specifically told J.C. before January 9, 1987 that he would not accept assignment, but it is clear that he never told her that he would accept assignment and that he billed her for the full amount on October 26, 1986, before anybody made any claim to Medicare. Prior to Respondent's January 9, 1987 conversation with J.C., Respondent's wife and office manager had, on November 28, 1986, submitted a claim to Medicare for Respondent's services to G.C. This claim was submitted over Respondent's (apparently stamped) signature, making him responsible for its contents. Despite her denials on the record, Mrs. Castro clearly has difficulty understanding others and expressing herself orally in the English language. Her recollection was that she had submitted the Medicare claim form dated November 28, 1986 without checking either the box on the form by which a physician signifies agreement to accept assignment or the box on the form whereby the physician declines to accept assignment. The reason she gave at formal hearing for not checking the assignment box is that she knew that Dr. Kluger had not accepted assignment for treatment of G.C. and that it also had been Respondent's oral instruction to her not to accept assignment of his associate fees. However, Mrs. Castro's only explanation as to why she had left both boxes blank instead of checking the one signifying "no assignment" was that she understood that forms without any election were usually processed as non-assigned claims. This November 28, 1986 claim form, as produced by Medicare authorities, shows the "yes assignment" box marked. The widow, J.C., had some memory retrieval problems in the course of her testimony. She testified that on January 10, 1987 she personally went to the Jacksonville, Florida, offices of Medicare and, using a receipt given her by Respondent for her check presented to him the day previously, she made a Medicare claim in her own name. (TR-20) However, she also testified that she received "no satisfaction" from her claim because the Respondent had already submitted a claim. (TR-21-23) Medicare has no record that such a claim was ever made by J.C. A physician can file claims with Medicare by applying for a provider number and using it on his claims for reimbursement. At all times material, Respondent had such a Medicare provider number. However, acceptance of such a provider number by a physician does not automatically make a physician a "participating physician," nor does it obligate him to accept assignments to Medicare. "Participating physicians" have also signed a contract agreeing to accept assignment on every claim they submit. For "non-participating physicians," assignments or non-assignments are done on a claim by claim basis. At all times material, Respondent was a "non-participating physician." If the physician submitting a claim is a "non-participating physician" and the assignment block is left blank on his claim form, Medicare's standard operating procedure is to process his claim form as a "non-assignment." If a physician discovers he has made an error in checking the wrong block on his claim form, it is also Medicare's standard operating procedure to correct that error provided both the physician and the patient/beneficiary notify Medicare prior to the time Medicare applies a reasonable charge to the claim. As a practical matter, the window for this type of notification covers only the period of time required for Medicare to receive the original erroneous claim form, microfilm it, and feed it into the Medicare computer; in total, perhaps less than one workday. After the computer applies a reasonable charge to the claim, Medicare will not permit mistaken assignments to be rescinded. On or about March 2, 1987, Medicare sent Respondent a check for $174.64, which is 80% of the amount Medicare approved for his services. There is no adequate explanation in the record why it took Medicare from December 3, 1986 when it received the November 28, 1986 claim form until March 2, 1987 to process the initial claim. Respondent's office deposited the $174.64 Medicare check in the normal course of business. On or about March 3, 1987, J.C. received an "Explanation of Medical Benefits" letter (EMOB) from Medicare advising her that Respondent had accepted assignment on G.C.'s claim, that Medicare had allowed Respondent $220.00 for his services, that Medicare had paid Respondent $174.64, and that J.C. owed Respondent $44.10. Quite naturally, J.C. was incensed by this notification from Medicare because she had already paid Respondent in full on January 9, 1987. Sometime after March 2, 1987, but prior to April 1, 1987, Respondent sent his own check for $174.64 to Medicare, stating that the money should have been sent by Medicare directly to J.C. In March of 1987, J.C. requested a refund from Respondent. Respondent refused to give her the refund, stating that Medicare should pay her directly. Therefore, J.C. contacted Medicare for a refund. Thereafter, various employees of Medicare contacted Respondent telling him repeatedly that because the "yes assignment" box had been checked on the November 28, 1986 claim form, he must take the discounted amount allowed by Medicare and refund an amount to J.C. sufficient so that she would not have paid more than 20% of the allowed charges. Apparently, Respondent was given to colorful language in his telephone conversations both with Respondent and with Medicare personnel, and no meeting of the minds ever was reached between Respondent and J.C. or between Respondent and Medicare. The situation was further complicated when Medicare sent Respondent a letter on May 5, 1987 acknowledging his return of the $174.64 to Medicare and advising Respondent that, We have received your $174.64 payment dated March 16, 1987. We have applied this money to your account. Thank you for returning the payment issued to you in error. Our records are being corrected accordingly. . . Therefore, when, on or about August 24, 1987, Medicare sent Respondent a new check for $165.45 for the same claimed services to G.C. because Medicare had unilaterally made a correction to its "Procedure Code," Respondent assumed that Medicare had made another mistake. His office again cashed this Medicare check, and only after Medicare fraud and abuse investigators contacted him, did Respondent send Medicare his own check, dated November 30, 1987, for the $165.45. With Respondent's check, Mrs. Castro enclosed a note, dated December 1, 1987, requesting that Medicare send payment directly to J.C. Respondent has no record of submitting a third check to Medicare, but Medicare records show that at some point Medicare issued yet another check to Respondent for $165.45, and that Respondent again returned the money through his own check. Mrs. Castro testified that she re-submitted the health insurance claim form to Medicare on or about April 20, 1987 with the "no assignment" box checked and that she did so in an attempt to get Medicare to pay J.C. directly and to straighten out the problem with G.C.'s bill. At that time, she did not indicate "signature on file" as she had on the initial November 28, 1986 claim form. Instead, she made a big "X" and signed the deceased patient's name beside the "X." Mrs. Castro asserted that she never attempted to emulate G.C.'s handwriting, and examination of the form does not suggest that she did. Medicare has no record of receiving this form contemporaneously with the April 20, 1987 date on it, but Medicare received it either from the Respondent with his November 30, 1987 check and Mrs. Castro's December 1, 1987 note requesting that Medicare pay J.C. direct or they received it at about the same time from Respondent's attorney. Medicare personnel interpreted the April 20 claim form to constitute a forgery of G.C.'s signature since it had not been received by Medicare in April 1987 and because G.C. had died in September, 1986. Medicare never processed the April 20, 1987 claim form as either a substitute for, or as an amendment to, the original November 28, 1986 claim form. Mrs. Castro was unable to explain at formal hearing why the April 20, 1987 claim form was not received by Medicare until December, 1987, and her explanation that she thought Medicare would interpret the "X" as an indication that someone else had signed for the decedent is illogical. However, upon Mrs. Castro's candor and demeanor while testifying, it is plausible that she genuinely believed that coupled with the repeated return of all monies to Medicare hers was an acceptable way to explain to Medicare the Respondent's consistent intent to refuse assignment and to defuse the escalating acrimony of the claim situation. Upon this basis, Medicare's interpretation of Mrs. Castro's meretricious motivation with regard to the April 20 claim form, which motivation Medicare also attributed to the Respondent, is rejected. The burden to prove fraud by clear and convincing evidence is upon Petitioner, and there is no affirmative proof of meretricious motive here. Throughout this dispute, Medicare continued to tell J.C. that after all adjustments, Respondent should pay her $689.97 (the balance of the full payment amount she had paid Respondent above the 20% of the charge allowed by Medicare). Respondent has never refunded any monies to J.C.

Recommendation Based upon the foregoing findings of fact and conclusions of law, it is: RECOMMENDED that the Board of Medicine enter a Final Order dismissing all charges against Respondent. DONE and ENTERED this 21st day of September, 1989, at Tallahassee, Florida. ELLA JANE P. DAVIS 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 21st day of September, 1989.

Florida Laws (2) 120.57458.331
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DEPARTMENT OF HEALTH, BOARD OF MEDICINE vs DONALD A. TOBKIN, M.D., 05-002590PL (2005)
Division of Administrative Hearings, Florida Filed:Lauderdale Lakes, Florida Jul. 19, 2005 Number: 05-002590PL Latest Update: Jun. 08, 2007

The Issue This is a license discipline case in which the Petitioner seeks to take disciplinary action against the Respondent on the basis of charges set forth in a three-count Administrative Complaint. The Administrative Complaint charges the Respondent with violations of paragraphs (m), (q), and (t) of Section 458.331(1) Florida Statutes.1

Findings Of Fact At all times material to this case, the Respondent, Donald A. Tobkin, M.D., has been licensed, and continues to be licensed, to practice medicine in the State of Florida. His license number is 30942.5 Sometime during the month of December 2004, the Police Department of Hollywood, Florida, (HPD) received information from a confidential informant that the Respondent was soliciting drug-prescribing business and was writing inappropriate and excessive prescriptions for controlled substances. On the basis of that information, the HPD initiated an undercover operation to investigate the information received from the confidential informant. As part of the undercover investigation, on the evening of January 20, 2005, at approximately 9:56pm, an HPD female detective named Nicole Coffin made a telephone call to the Respondent's telephone. The Respondent answered the telephone and identified himself by name. Detective Coffin pretended to be a person named Melissa Beech. She pretended to be a person who was seeking to obtain OxyContin, which is a Schedule II controlled substance. During the entire undercover investigation, Detective Coffin pretended to be a drug-seeker while interacting with the Respondent. On the telephone she told the Respondent that she wanted a prescription for OxyContin and also told the Respondent that a girl somewhere on Federal Highway had given her the Respondent's card and had told her she could call the Respondent if she needed a prescription. Detective Coffin, in her role as Melissa Beech, did not initially describe any medical complaint to the Respondent; she just said she wanted a prescription for OxyContin. In response to the request for a prescription for OxyContin, the Respondent told the make-believe drug-seeker that he could provide the requested prescription, but that they would have to have a "medical reason" for such a prescription. The Respondent then asked the make-believe drug-seeker if she had ever been in an automobile accident. The make-believe drug-seeker answered "yes," because that is the answer she thought would provide a basis for a "medical reason." The Respondent then proceeded to ask the make-believe drug-seeker a long series of leading questions which, if answered "yes," could provide the appearance of a "medical reason" for the requested prescription for OxyContin. This series of questions was for the purpose of establishing a contrived "medical reason" for the prescription sought by the make-believe drug-seeker. There never was, and there never appeared to be, any real "medical reason" for the prescription sought by the make-believe drug-seeker. The sole purpose for the many questions asked by the Respondent, and for the Respondent's written notations related to those questions, was to create the illusion, or the false impression, that there was a "medical reason' for the prescription when, in fact, there was no such reason. The detective who was pretending to be a drug-seeker answered "yes" to all of the leading questions asked by the Respondent. She answered "yes," even when that was not a truthful answer, because she was trying to give the answers she thought the Respondent wanted to hear.6 The Respondent's leading questions included questions asking about such things as whether the make-believe drug-seeker had ever had an automobile accident, whether she had suffered a herniated disk as a result of that accident, whether she had had an MRI, whether she had had any subsequent accidents, whether she had tried any other drugs to relieve pain, whether she had used Oxycontin in the past, and whether in the past the Oxycontin had relieved her pain. During the course of the first telephone conversation between Detective Coffin and the Respondent a number of significant matters were not discussed. The Respondent did not discuss the possibility of surgical treatments to treat the back pain described in response to the Respondent's questions. The Respondent did not discuss the necessity of reviewing the MRI or X-rays that supposedly would confirm the "herniated disc" he had inquired about. The Respondent did not discuss the necessity of obtaining future MRIs, X-rays, or other diagnostic tests to evaluate the "severe back pain" supposedly described by Detective Coffin in her role as Melissa Beech. The Respondent did not mention that she would need to have any follow-up visits with the Respondent. During the course of the first conversation between Detective Coffin and the Respondent, she told the Respondent that she had previously been obtaining Oxycontin "off the street" and that she was seeking a prescription from the Respondent because her street source had "dried up." She also told him that she had previously taken Valium and Percocet. During the course of the first telephone conversation Detective Coffin, pretending to be a drug-seeker, told the Respondent that she suffered from back pain as a result of the make-believe automobile accidents. She did not say that she was currently experiencing pain at the time of that telephone conversation. During the first telephone conversation the Respondent did not ask the make-believe drug-seeker any questions about her menstrual cycle, about whether she was pregnant, or about whether she had had any prior pregnancies or had ever had any children. However, in his written notes the Respondent included notations that purport to be answers to those unasked questions. Similarly, the Respondent did not ask the make-believe drug-seeker any questions about her consumption of alcohol, but included in his notes notations that purport to memorialize the answer to that unasked question. The Respondent's "history" notes also report that he warned the make-believe drug-seeker that OxyContin tablets should not be crushed or broken, even though he did not include any such warning in his telephone conversation with the make-believe drug-seeker. During the first telephone conversation, Detective Coffin was never asked about, and never provided any information about, whether other physicians had either prescribed OxyContin for her or had refused to prescribe OxyContin for her. The only prior sources of OxyContin she mentioned to the Respondent were non-prescription illegal sources on the street. The Respondent never discussed with Detective Coffin the possibility or necessity of a more structured medical treatment plan for addiction. The Respondent never discussed with Detective Coffin the possibility or necessity of a more structured medical treatment plan to treat a complaint of "severe pain." During the course of the first telephone conversation, the Respondent agreed to provide a prescription to the make- believe drug-seeker for a total of sixty-two 80-milligram OxyContin tablets. It was agreed that the make-believe drug- seeker would pay $100.00 for the first prescription and that the Respondent would provide similar prescriptions in the future for $50.00 per prescription. Towards the end of the first telephone conversation the Respondent told the make-believe drug-seeker that he had another matter to attend to and that she should call him later to arrange the time and place for the two of them to meet later that same evening. During the course of the first telephone conversation, which lasted for approximately 14 minutes, the Respondent made written notes of the answers given by the make-believe drug-seeker. Those notes were prepared in such a manner as to resemble the types of notes customarily made by physicians who are making a medical record of information elicited from a patient. A number of the details recorded in the Respondent's notes of the first telephone conversation were inconsistent with the information provided by the make-believe drug-seeker. Specifically, those notes contained a significant amount of information that was never uttered by the make-believe drug- seeker. The fictitious and false history details memorialized in the Respondent's notes are intentional falsehoods. Later that evening, at approximately 12:20am on January 21, 2005, Detective Coffin, still pretending to be the drug-seeking person named Melissa Beech, placed a second telephone call to the Respondent. She spoke with the Respondent for about three minutes on this occasion. Most of the second conversation consisted of providing the Respondent with information about the location where Detective Coffin would be waiting for him and information about where the Respondent should park when he arrived. Law enforcement officers of the HPD attempted to record both of the telephone conversations between the Respondent and Detective Coffin. Both of those attempts were unsuccessful. There is no recording of either of the telephone conversations. Sometime later that evening, during the early morning hours of January 21, 2005, the Respondent met the make-believe drug-seeker at the motel or efficiency apartment. He entered the room where the make-believe drug-seeker was pretending to be staying. Prior to his arrival, two cameras had been concealed in the room by the HPD police officers. During the entire time the Respondent was in the room the two cameras were attempting to record everything he said and everything he did, as well as everything said or done by the detective pretending to be the drug-seeking person named Melissa Beech. After entering the room, the Respondent spoke with the make-believe drug-seeker and asked her additional questions related to her request for a prescription for OxyContin. He made some written notes that purported to be summaries of her answers. During the course of the meeting with the make-believe drug-seeker the Respondent provided her with a document titled "Patient's Acknowledgement," which she signed, but did not read. That document contained information about the patient-physician relationship, about what was expected of the patient, and also memorialized the patient's informed consent to the treatment she was requesting from the Respondent. The Respondent also conducted a brief physical examination of the make-believe patient and made written notes that purported to be a memorialization of what he had observed during the course of his examination. The Respondent's examination of the make-believe drug-seeker included the following: check of pulse and blood pressure, check of reflex responses at several joints, and check of chest sounds with stethoscope. The Respondent performed a deep tendon reflex test on Detective Coffin by striking her wrists, elbows, and knees with a medical hammer. Detective Coffin's feet remained on the floor during this test. A deep tendon reflex test cannot be performed properly with the subject's feet touching the floor. Such a test performed in such a manner will not produce reliable results. The Respondent indicated in his written notes that he had examined Detective Coffin's head, eyes, ears, nose, and throat. However, the Respondent did not perform any examination at all of Detective Coffin's head, ears, nose, or throat. The Respondent perhaps performed a partial examination of Detective Coffin's eyes, but did not perform an adequate examination of her eyes. The Respondent indicated in his written notes that Detective Coffin's pupils were equal, round, and reactive to light and accommodation. However, the Respondent did not conduct any examination of Detective Coffin's eyes that was sufficient to support a conclusion that they were equal, round, and reactive to light and accommodation. The Respondent included in his written notes that Detective Coffin's chest and lungs were clear to auscultation and percussion. The Respondent did not examine Detective Coffin in a manner that could determine whether her chest and lungs were clear to auscultation and percussion. Therefore, the Respondent did not have any basis for writing that the detective's chest and lungs were clear to auscultation and percussion. The Respondent included in his written notes an observation that Detective Coffin's abdomen was soft. The Respondent never touched or otherwise examined Detective Coffin's abdomen. The Respondent had no factual basis for writing that Detective Coffin's abdomen was soft. In his written notes the Respondent indicated that Detective Coffin experienced pain upon lifting her leg thirty degrees. Detective Coffin never raised either leg in the Respondent's presence and never complained of pain in his presence. There was no factual basis for the subject notation. The Respondent never conducted a Rhomberg examination on Detective Coffin, but he included in his written notes an observation that a Rhomberg test was negative. There was no factual basis for such a notation. The Respondent included in his written notes an observation that he had examined Detective Coffin's gait. However, the Respondent never performed an adequate and sufficient examination of Detective Coffin's gait. The Respondent did not conduct a range of motion test of Detective Coffin. The Respondent never asked Detective Coffin to lift her leg towards her chest. Nor did he ask her to touch her toes. The Respondent never asked her to manipulate her body in any way. At no time during the encounter between Detective Coffin and the Respondent did Detective Coffin state that she was experiencing pain. At no time during that encounter did she behave or move in any manner that would suggest she was experiencing pain. To the contrary, Detective Coffin crossed and uncrossed her legs, alternatively slouched and sat up straight in her chair, and made other movements that would indicate to a reasonable prudent physician that she was not experiencing any pain at all. The Respondent never discussed with Detective Coffin the necessity of obtaining further MRIs, X-rays, or other forms of diagnostic testing. He never discussed any need to obtain and review any prior medical records. The Respondent never asked Detective Coffin to sign a medical records release document that would have authorized the Respondent to obtain prior medical records. The Respondent's written notations regarding his examination of the make-believe drug-seeker contain false information because, among other things, the notations contain the results of tests and examinations the Respondent did not perform. Such false notations are intentional falsehoods. The Respondent never discussed with Detective Coffin the need for a follow-up appointment. The Respondent never asked Detective Coffin for any form of identification. Under the circumstances presented in this case, a reasonable prudent physician would have performed a range of motion test and a leg-raising test, neither of which were performed by the Respondent. Under the circumstances presented in this case, a reasonably prudent physician would have established a treatment plan that would have included a schedule for follow-up visits, a review of prior medical records, and plans for future diagnostic tests. The Respondent did not establish any type of treatment plan. The prescription provided to Detective Coffin was inappropriate, unjustified, and excessive because the physical examination was inadequate, the medical record was falsified, and the patient never exhibited any sign of being in pain. Under the circumstances presented in this case, the Respondent's act of providing a prescription to a total stranger with no medical justification for doing so was an action taken other than in the course of the Respondent's professional practice. Ultimately, the Respondent wrote and delivered a prescription to the make-believe patient. The prescription was for sixty-two 80-milligram tablets of OxyContin. This was a 31- day supply if the OxyContin was taken as directed; one tablet every 12 hours. The Respondent wrote several warnings at the bottom of the prescription document. The warnings included such things as the fact that OxyContin impairs driving ability and may cause drowsiness, loss of balance, and/or loss of coordination. The Respondent also wrote on the prescription: "Must swallow whole and do not crush or break." Other law enforcement officers of the HPD were listening to and observing the events inside the room. Shortly after the Respondent handed the prescription to the make-believe patient and received the one hundred dollars from her, other law enforcement officers rushed into the room, arrested the Respondent, and seized various items of the Respondent's personal property, including the medical record he had been preparing regarding his care and treatment of the make-believe patient. With regard to obtaining information about the characteristics of, and the proper use of, specific drugs, medical doctors customarily rely on the information contained in the Physician Desk Reference (PDR) and on the information contained in the manufacturer's package insert that often accompanies a drug. The package insert for OxyContin includes the following information: (Following an initial caption reading WARNING) OxyContin Tablets are a controlled-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain when a continuous, around-the- clock analgesic is needed for an extended period of time. * * * (Following caption reading CLINICAL PHARMACOLOGY) Oxycodone is a pure agonist opioid whose principal therapeutic action is analgesia. *** With pure opioid agonist analgesics, there is no defined maximum dose; the ceiling to analgesic effectiveness is imposed only by side effects, the more serious of which may include somnolence and respiratory depression. * * * As with all opioids, the minimum effective plasma concentration for analgesia will vary widely among patients, especially among patients who have been previously treated with potent agonist opioids. As a result, patients must be treated with individualized titration of dosage to the desired effect. The minimum effective analgesic concentration of oxycodone for any individual patient may increase over time due to an increase in pain, the development of a new pain syndrome and/or the development of analgesic tolerance. * * * OxyContin Tablets are associated with typical opioid-related adverse experiences. There is a general relationship between increasing oxycodone plasma concentration and increasing frequency of dose-related opioid adverse experiences such as nausea, vomiting, CNS effects, and respiratory depression. In opioid-tolerant patients, the situation is altered by the development of tolerance to opioid-related side effects, and the relationship is not clinically relevant. As with all opioids, the dose must be individualized . . . because the effective analgesic dose for some patients will be too high to be tolerated by other patients. (Following caption reading WARNINGS) OxyContin 80 mg and 160 mg Tablets ARE FOR USE IN OPIOID-TOLERANT PATIENTS ONLY. These tablet strengths may cause fatal respiratory depression when administered to patients not previously exposed to opioids. * * * Concerns about abuse, addiction, and diversion should not prevent the proper management of pain. The development of addiction to opioid analgesics in properly managed patients with pain has been reported to be rare. However, data are not available to establish the true incidence of addiction in chronic pain patients.

Recommendation On the basis of the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be issued in this case to the following effect: Dismissing Counts One and Two of the Administrative Complaint; Concluding that the Respondent is guilty of having violated Section 458.331(1)(q), Florida Statutes, as charged in Count Three of the Administrative Complaint; and Imposing a penalty consisting of an administrative fine in the amount of ten thousand dollars ($10,000.00) and the revocation of the Respondent's license to practice medicine. DONE AND ENTERED this 26th day of June, 2006, in Tallahassee, Leon County, Florida. S MICHAEL M. PARRISH Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 26th day of June, 2006.

Florida Laws (10) 120.569120.5720.43456.073458.305458.326458.331766.102817.50893.03
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