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JOSEPH A. INFANTINO vs. DEPARTMENT OF ADMINISTRATION, 88-004905 (1988)
Division of Administrative Hearings, Florida Number: 88-004905 Latest Update: Apr. 05, 1989

Findings Of Fact Petitioner resigned from State Government on July 23, 1987. At the time of his resignation, Petitioner was covered under the Florida State Group Health Insurance Plan. His wife, who is a diabetic, was also covered under Petitioner's insurance. Upon termination Petitioner was eligible for continuation of coverage benefits under the federal COBRA Act. However, prior to receiving any notice of his COBRA rights, Petitioner elected to continue his State Employees' Insurance for two months from July 1, 1987 and then begin coverage under his new employer's insurance plan. 2/ Petitioner made advance payment on the 2 months additional coverage. The payments carried his State Employees' health insurance through September 1, 1987 when it was terminated. DOA notified Petitioner on August 27, 1987, of his right to elect continuation of coverage under the COBRA Act. This notice complied with the notice requirements under the COBRA Act. COBRA provides continued health insurance coverage for up to (18) months, after a covered employee leaves employment. However, coverage does not continue beyond the time the employee is covered under another group health plan. COBRA simply fills the gap between two different employers group health insurance plans so that an employee's group health insurance does not lapse while the employee changes jobs. Petitioner's new employer's health coverage began around September 1, 1987. After Petitioner had begun coverage under his new insurance plan, he discovered that his wife's preexisting diabetic condition would not be covered. However, no evidence was presented that Petitioner, within 60 days of September 1, 1987 requested the Division of State Employee's Insurance to continue his insurance coverage pursuant to COBRA. Moreover, Petitioner's COBRA rights terminated when he began his coverage under his new employer's health plan.

Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Department of Administration enter a Final Order denying Petitioner's request for continuation of coverage under COBRA. DONE and ENTERED this 5th day of April, 1989, in Tallahassee, Florida. DIANE CLEAVINGER 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 5th day of April, 1989.

USC (3) 26 U.S.C 16226 USC 16242 USC 300bb Florida Laws (1) 120.57
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BASHERE BCHARA vs DEPARTMENT OF MANAGEMENT SERVICES, DIVISION OF STATE GROUP INSURANCE, 08-004770 (2008)
Division of Administrative Hearings, Florida Filed:Lauderdale Lakes, Florida Sep. 24, 2008 Number: 08-004770 Latest Update: Jan. 16, 2009

The Issue Whether the Petitioner was entitled to enrollment for his son in the State of Florida Group Health Self Insurance Plan for the January 1, 2008, to December 31, 2008, plan year and, if so, whether he is entitled to reimbursement of $543 for student health insurance coverage that was added to his son's college tuition bill.

Findings Of Fact Petitioner, Bashere Bchara, has been employed by the Florida Department of Transportation for the past 9 years including the period October 2007 through December 2008. He is and was, on all relevant dates, entitled to state employees’ benefits, including participation for himself, his spouse, and eligible dependents in the State Group Health Insurance Program. On October 16, 2007, during the open enrollment period, the Petitioner accessed his state employee benefits from his computer to change his dental coverage, as he was required to do because of a change in State providers. Mr. Bchara believes that an error in the People First computer program, that is used to manage state human resources data, caused his son, Dani Bchara, to be removed from health insurance coverage as his dependent. He also said it was his first time using the computerized People First program to elect or change benefits. There is no dispute that Dani Bchara, who had been covered during the previous plan year, continued to be an eligible dependent. Mr. Bchara's witness, Michael Smith, testified that he too had problems trying to use People First to change dental plans. He found the People First computer screens confusing and disorganized. Dani Bchara was, at the time, a 22-year-old college student. As a part of his tuition and fees, Florida State University charged his account $543 for health insurance. In May 2008, after a claim for reimbursement for health expenses for Dani Bchara was rejected, Mr. Bchara, contacted plan insurer, Blue Cross Blue Shield; plan contract administrator, People First; and then Respondent, the Department of Management Services, Division of State Group Insurance (Respondent or DSGI). DSGI has the responsibility for administering the insurance program. See § 110.123, Fla. Stat. (2008). After reviewing his complaint, Sandi Wade, a benefits administrator for DSGI, notified Mr. Bchara that his son was not covered by the state health plan. She also determined that he could not add his son, at that time, due to the absence any qualifying status change, as required by federal and state law. There is no allegation nor evidence of a qualifying status change that would allow the addition of Mr. Bchara's son to his coverage. Ms. Wade was not aware of any other reports of possible computer glitches of the type Mr. Bchara believes he experienced during the open enrollment period in October 2007. James West, a manager for People First testified that, during the enrollment period in October 2007, computer screens for health insurance and dental insurance were entirely different. Each was displayed only after the appropriate tab was chosen. In addition, Mr. West noted that a "summary last step" had to be chosen and the final summary screen allowed employees to view changes from all prior screens before selecting the option to "complete enrollment." Mr. West examined logs of computer transactions on October 16, 2007. The logs showed that Mr. Bchara, using his People First identification number changed his health insurance by deleting coverage for his son. Mr. West reviewed correspondence logs that indicated that Mr. Bchara was sent a notice dated October 27, 2007, confirming the changes he had made to his benefits. The notice was sent from the Jacksonville service center of Convergys, the contract operator of the People First system, to an address that Mr. Bchara confirmed was correct. Mr. Bchara testified that he did not receive the letter. Mr. West testified that the letter was not returned, as confirmed by an electronic tracking system for mail. Scott Thompson, Director of Application Development for Convergys, testified that his records also show every time Mr. Bchara logged into the People First system using his identification number and password. The logs also show that his health plan was changed when he accessed the system on October 16, 2007. Based on the evidence in the computer records and logs that Mr. Bchara, albeit unintentionally, deleted coverage for his son in the group health insurance program, there is insufficient evidence of computer or human error attributable to Respondent. In the absence of sufficient evidence of any errors by DSIG or its agents, or any evidence of a qualifying status change in Mr. Bchara's employment or his family, DSIG correctly rejected the request for retroactive enrollment of his son in the state group health insurance.

Recommendation Based on the foregoing, it is recommended that the Respondent enter a final order denying Petitioner, Bashere Bchara, retroactive health insurance coverage for an additional dependent under the state plan for the 2008 plan year. DONE AND ENTERED this 16th day of January, 2009, in Tallahassee, Leon County, Florida. S ELEANOR M. HUNTER Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 16th day of January, 2009. COPIES FURNISHED: Sonja P. Matthews, Esquire Department of Management Services 4050 Esplanade Way, Suite 160 Tallahassee, Florida 32399-0950 Bashere Bchara 10178 Southwest 53rd Court Cooper City, Florida 33328 John Brenneis, General Counsel Department of Management Services 4050 Esplanade Way Tallahassee, Florida 32399-0950

Florida Laws (4) 110.123110.161120.569120.57
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THOMAS J. APPLEYARD, III vs. BUREAU OF INSURANCE, 84-002047 (1984)
Division of Administrative Hearings, Florida Number: 84-002047 Latest Update: May 05, 1991

The Issue Whether Petitioner's claim for medical expenses from August 6, 1982 through February 27, 1983 should be approved, pursuant to the State of Florida Employees Group Health Self Insurance Plan. Petitioner appeared at the hearing accompanied by legal counsel. The Hearing Officer thereupon explained his rights and procedures to be followed in the administrative hearing. Petitioner acknowledged that he understood his rights and elected to represent himself. Petitioner testified in his own behalf at the hearing and the parties stipulated to the introduction of Respondent's Exhibits 1 and 2. A late filed exhibit, Respondent's Exhibit 3, was also admitted in evidence. Respondent presented the testimony of one witness, William R. Seaton, Benefit Analyst for the Respondent's Bureau of Insurance.

Findings Of Fact Petitioner Thomas J. Appleyard, III, is a former state employee who retired with disability in 1976 as a result of cardiac disease. At the time Petitioner retired, he maintained coverage in the state Employees Group Health Self Insurance Plan under which the Blue Cross/Blue Shield of Florida, Inc. serves as the administrator of the plan for the state. Petitioner also receives disability benefits under the Medicare program for medical expenses. (Testimony of Petitioner) The State Group Health Self Insurance Plan provides in Section X, COORDINATION OF BENEFITS, that if an insured has coverage under Medicare, the benefits payable under the state plan will be coordinated with similar benefits paid under the other coverage to the extent that the combination of benefits will not exceed 100 percent of the costs of services and supplies to the insured. Paragraph D of Section X provides that the state plan will be the secondary coverage in such situations and will pay benefits only to the extent that an insured's existing insurance coverage does not entitle him to receive benefits equal to 100 percent of the allowable covered expenses. This provision applies when the claim is on any insured person covered by Medicare. (Testimony of Seaton, Respondent's Exhibit 3) Petitioner was hospitalized at the Tallahassee Memorial Regional Medical Center on three occasions in 1982-33. His Medicare coverage paid all but $261.75 of the hospital expenses. In February 1983, Petitioner also incurred medical expenses to his cardiologist, Dr. J. Galt Allee, in the amount of $248.33. Petitioner was originally denied his remaining hospital expenses by the administrator of the state plan under the erroneous belief that he was receiving regular Medicare benefits for persons over the age of 65. In addition, Dr. Allee's bill was only partially paid by Medicare, subject to the receipt of additional information from the physician. Payment under the state plan was limited to an amount sufficient to reimburse petitioner 100 percent of the amount originally allowed by Medicare. (Testimony of Seaton, petitioner, Respondent's Exhibit 1, 3) Respondent does not receive information on claims filed under the state plan until contacted by an employee. In February 1984, Petitioner requested assistance from William R. Seaton, Benefit Analyst, of Respondent's Bureau of Insurance, regarding his difficulties in receiving proper claims payments. Seaton investigated the matter with the Insurance administrator for the state, Blue Cross/Blue Shield of Florida, and discovered that the latter had not coordinated the hospital expense balance with Medicare. They thereafter did so and as of the date of hearing, there was no longer a balance due to Tallahassee Memorial Regional Medical Center. Seaton also gave written instructions to Blue Cross to review all of Petitioner's claims and make sure that they were paid properly, and to install controls on his and his wife's records. (Testimony of Petitioner, Seaton, Respondent's Exhibit 1-2) The full claim of Dr. Allee had not been paid by Medicare since it had been awaiting requested additional in formation from the physician. Such information was provided after a personal visit had been made to Dr. Allee by Seaton and Medicare then recognized additional eligible expenses. However, a balance of $36.00 is still owed to the physician due to the fact that Blue Cross/Blue Shield had not received the necessary payment information from Medicare as of the day before the hearing. (Testimony of Seaton, Respondent's Exhibit 1) Section XVII of the state's Group Health Self Insurance Plan benefit document provides that an employee who wishes to contest decisions of the state administrator considering the employee's coverage under the plan may submit a petition for a hearing for consideration by the Secretary of Administration. (Respondent's Exhibit 3)

Florida Laws (1) 110.123
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AURELIO DURANA vs. OFFICE OF STATE EMPLOYEES INSURANCE, 81-002622 (1981)
Division of Administrative Hearings, Florida Number: 81-002622 Latest Update: Apr. 13, 1982

Findings Of Fact Aurelio Durana has been employed with the Department of Administration continuously since 1979. He enrolled in the State of Florida Employees' Group Health Self-Insurance Plan before the period in dispute and had maintained individual coverage until August 1, 1980. Alina Durana, Petitioner's spouse, was employed by the Department of State from 1977 until her resignation on March 9, 1981. From September 9, 1980, through March 9, 1981, Alina Durana was on maternity leave without pay from her position at the Department of State. This maternity leave expired March 9, 1981 (Exhibit 2). Alina Durana had enrolled in the Group Health Insurance Plan from the beginning of her employment and maintained individual coverage until August 1, 1980. Effective August 1, 1980, Petitioner and his spouse elected family coverage, entitling them to a State contribution covering the entire premium. On Application for Multiple Contributions dated 1 July 1980 (Exhibit 8), Petitioner agreed to be responsible for any underpayment of premium resulting from his wife's ineligibility for a State contribution and agreed that any such underpayment should be deducted from any salary due him. Under the State Health Insurance program the agency for whom the employee worked contributes one-half of the family premium of $69.96 per month. Since both Petitioner and his wife were working for the State, each agency contributed $34.98 per month, thereby covering the entire premium. The agencies contribute this sum to the trust fund from which medical claims of employees are paid. When an employee ceases to be on the agency's payroll the agency stops this contribution to the fund and is supposed to notify the Department of Administration so pay adjustments to employees' pay can be made if necessary. When Mrs. Durana commenced her leave without pay on September 9, 1980, the Department of State failed to notify the Department of Administration that they were no longer contributing $34.98 per month to the Durana family health plan. Had they done so, the Department of Administration would have notified Durana that he would have $34.98 deducted from his pay each month if he desired to remain in the program. In September 1981 Petitioner notified the Department of Administration Personnel Office that health insurance premiums were not being deducted from his pay. Thereafter, Respondent learned of the departure of Mrs. Durana from the Department of State payroll in September 1980 and made claim against Durana for $316.14 for underpayment of premiums from the period the Department of State had not contributed to the fund and no premiums were paid by Petitioner. During the period Mrs. Durana was not on the payroll and the Department of State was contributing nothing to the trust fund, no claims were submitted by Durana for medical costs. However, during this period Petitioner was included in the list of beneficiaries of the State Health Insurance Plan and medical bills submitted by him would have been paid by the administrator of the trust fund.

Florida Laws (1) 120.56
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S. PHILIP FORD vs. DIVISION OF RETIREMENT, 86-004111 (1986)
Division of Administrative Hearings, Florida Number: 86-004111 Latest Update: Feb. 26, 1987

The Issue Whether the Petitioner is required to reimburse the Respondent for prescription drugs acquired by the Petitioner through the Prescription Drug Program of the State of Florida Employees Group Health Self Insurance Plan?

Findings Of Fact The Petitioner was an employee of the State of Florida during the latter part of 1985 and during 1986. His employment with the State began January 27, 1984. Prior to December 1, 1985, the Petitioner participated in the State of Florida Employees Group Health Self Insurance Plan (hereinafter referred to as the "State Plan"). On October 31, 1985, the Petitioner signed a Change of Information form electing to terminate his participation in the State Plan and to begin participation in a Health Maintenance Organization (hereinafter referred to as an "HMO"). The HMO the Petitioner selected was the Capital Health Plan. The title of the form the Petitioner signed on October 31, 1985, contained the following: STATE OF FLORIDA EMPLOYEES GROUP HEALTH SELF INSURANCE PLAN CHANGE OF INFORMATION FOR USE ONLY BY A CURRENT EMPLOYEE OF THIS PLAN [Emphasis added]. Above the Petitioner's signature was the following "employee authorization": I hereby request the above changes in my coverage and/or insurance information in the State of Florida Employees Group Health Self Insurance Plan....[Emphasis added] Prior to terminating his coverage under the State Plan, the Petitioner was given a brochure titled "A Comparison of Health Benefit Plans Offered to Employees of the State of Florida" (hereinafter referred to as the "Comparison Brochure"). The brochure was for employees working in North Florida. The Comparison Brochure indicates there are two general types of health insurance plans available to state employees: HMO Benefit Plans and the State Plan. The Comparison Brochure also indicates there are four HMO Benefit Plans available. Capital Health Plan, the plan the Petitioner elected on October 31, 1985, is one of the clearly designated HMO Benefit Plans listed in the Comparison Brochure. The Comparison Brochure provides the following with regard to prescription drugs for Capital Health Plan participants: "$3.00 co-payment at CHP pharmacy." The Comparison Brochure provides the following with regard to prescription drugs for State Plan participants: "PPC provider not available at this time" if a preferred provider is used and "20 percent co-payment (7)" when a non-preferred provider is used. The reference to "(7)" is a footnote which provides: "Prescription Drug Plan will be implemented by 1-1-86, paying 100 percent after nominal dispensing fee." The Comparison Brochure contains the following other pertinent information: Along with the conventional group health self insurance plan administered by Blue Cross/Blue Shield, the State of Florida offers its employees the opportunity to enroll in a different health care arrangement. This arrangement, called a Health Maintenance Organization (HMO), is available to eligible employees who live within a specific geographic area surrounding the HMO. The Comparison Brochure contains other information that indicates that the State Plan and the Capital Health Plan HMO are completely different types or methods of obtaining health insurance coverage available to state employees. Based upon the information contained in the Comparison Brochure, which the Petitioner indicated he read, the Petitioner should have known that he was entitled to health insurance benefits under the Capital Health Plan HMO as of December 1, 1985, and that he was not entitled to any health insurance benefits under the State Plan. Sometime after December 20, 1985, the Petitioner received a letter from the Department of Administration which provided in pertinent part: Dear Participant: We are pleased to announce the new Prescription Drug Program. Effective January 1, 1986, coverage for prescription drugs under the State Employees Group Health Self Insurance Plan is provided through a prescription drug program serviced by Paid Prescriptions and National Rx Services, Inc. This program is specifically designed to save you money when you use a Preferred Provider Organization (PPO) Pharmacy and Mail Service for your prescription drugs. [Emphasis added]. Included with the letter of December 20, 1985, was a "PLASTIC CARD to use at PPO and participating pharmacies" and a "brochure which gives you instruction on using the Program and a detachable patient profile for Mail Service." The prescription drug card the Petitioner received had "State of Florida Employees Group Health Self insurance Plan" printed on it. It did not contain any reference to Capital Health Plan or any other HMO. The brochure included with the letter of December 20, 1985, which the Petitioner received had "State of Florida Employees Group Health Self insurance Plan" printed at the top of the front cover of the brochure and elsewhere in the brochure. It did not contain any reference to Capital Health Plan or any other HMO. The brochure included with the letter of December 20, 1985, provided the following pertinent information: Coverage for prescription drugs under the State Employees' Group Health Self Insurance Plan is provided through the Prescription Drug Program.... A toll-free telephone number was provided on the prescription drug card and the brochure which the Petitioner was instructed could be used if he had any questions. The prescription drug card sent to the Petitioner was sent to all state employees participating in the "State Employees Group Health Self Insurance Plan." It was not for use by state employees participating in the Capital Health Plan or other HMO's. The card was erroneously sent to the Petitioner by the Respondent. Because the Petitioner had terminated his coverage under the State Plan and elected to participate in an HMO effective December 1, 1985, he was not entitled to use the prescription drug card which he received from the Respondent. In order for the Respondent to have the prescription drug cards ready to be mailed to participants in the State Plan before January 1, 1986, the Respondent used information concerning participants prior to December 1, 1985. Evidently no effort was made by the Respondent to insure that participants who left the State Plan during the end of 1985 did not receive a prescription drug card. The Respondent did send a memorandum dated December 20, 1985, to Personnel Officers and Insurance Coordinators requesting that they attempt to retrieve prescription drug cards from employees who terminated their participation in the State Plan after November 1, 1985. No one retrieved the Petitioner's card. After receiving his card, the Petitioner spoke to the business manager of the County Public Health Unit where the Petitioner worked for the Department of Health and Rehabilitative Services. The Petitioner asked the business manager whether he could use the card and was told that he did not know but would find out. The business manager later told the Petitioner that he had talked to the district personnel office and been told that the Petitioner could use the card. On February 26, 1986, and February 27, 1986, the Petitioner used the prescription drug card to purchase prescription drugs in south Florida. The Petitioner talked with a physician at Capital Health Plan by telephone before purchasing the medications and was authorized to receive treatment by other than a Capital Health Plan physician. The State was billed $5.82 for the medications purchased with the card on February 21, 1986 and February 26, 1986. On March 1, 1986, the Petitioner again used the card to purchase medications. The card was used in Tallahassee, Florida. The State was billed $63.95 ($55.43 and $8.52) for the medications purchased with the card on March 1, 1986. The Petitioner did not use the card on any other occasion. The Petitioner testified that he did not use the card because he discovered that it was less costly to acquire the medications he needed from Capital Health Plan. Based upon the evidence presented at the hearing, however, the cost to the Petitioner was the same whether he used the plastic card or Capital Health Plan's pharmacy: $3.00. On or about March 27, 1986 and April 10, 1986, the Petitioner was informed that he had used the card to obtain medications for which use of the card was not authorized. The Petitioner was requested to return the card and to repay the amount incurred for the medications. The Petitioner did not respond to these requests. On August 26, 1986, the Petitioner was sent a letter requesting that he repay the cost of the medications he had acquired with the card. Although the Petitioner was requested to remit $77.02, the evidence only proved that $69.77 of medication was paid for by the State. On August 28, 1986, the Petitioner returned the prescription drug card he had been given to Andrew Lewis, an employee of the Respondent. The Petitioner has not reimbursed the State for the cost of the medication he received. The $69.77 of medications paid for by the Respondent which the Petitioner acquired with the prescription drug card provided to him by the Respondent represents a payment on behalf of the Petitioner which he was not entitled to. The card was for use by state employees participating in the State Plan. As of December 1, 1985, the Petitioner was not a participant in this plan. When considered together, the information provided to the Petitioner should have put the Petitioner on notice as to the type of medical insurance coverage he was generally entitled to receive. In particular, the Petitioner should have known that he was eligible for coverage under the Capital Health Plan, an HMO, and that he was not entitled to coverage under the State Plan as of December 1, 1985. The Petitioner also should have known that the prescription drug card he received was for use of participants by the State Plan only and not participants of the Capital Health Plan. The Petitioner's reliance on the statements of the business manager of the County Public Health Unit where he worked was not reasonable in light of the other information which he had been provided about his coverage and the purpose of the prescription drug card he was sent. The Petitioner is not able to repay the $69.77 owed to the State in a lump sum. The Petitioner can only pay the $69.77 to the Respondent in monthly installments of $10.00 or less.

Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law it is RECOMMENDED that the Petitioner pay $69.77 to the Respondent for prescription drugs received by the Petitioner. DONE AND RECOMMENDED this 26th day of February, 1987, in Tallahassee, Florida. LARRY J. SARTIN Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 26th day of February, 1987. APPENDIX TO RECOMMENDED ORDER, CASE NO. 86-4111 The parties have submitted proposed findings of fact. It has been noted below which proposed findings of fact have been generally accepted and the paragraph number(s) in the Recommended Order where they were accepted. Those proposed findings of fact which have been rejected and the reasons for their rejection have also been noted. Paragraph numbers in the Recommended Order are referred to as "RO ." The Petitioner's Proposed Findings of Fact: Proposed Finding RO Number of Acceptance of Fact Number or Reason for Rejection 1 Although the Petitioner did not inten- ionally use the prescription card despite being informed that he was not entitled to it, he should have known that he was not entitled to use it. 2 RO 31. 3 RO 21. 4 Not supported by the weight of the evidence. In light of the information provided to the Petitioner concerning the differences between the State Plan and an HMO, the Petitioner did not use due care to determine if the card was a part of the benefits he was entitled to receive as a participant in an HMO. 5 RO 25. 6 Not supported by the weight of the evidence. Ms. Walker testified that the coverage available to state employees is not confusing. The Respondent's Proposed Findings of Fact: 1. RO 1. 2. RO 2. 3. RO 3-4 and 13-14. 4. RO 15, 18, 21 and 24. 5. RO 21 and 26. 6. RO 27. 7. RO 10. 8. RO 29. 9. RO 30. 10. RO 31. 11. COPIES FURNISHED: RO 36. Gilda Lambert, Secretary Department of Administration 435 Carlton Building Tallahassee, Florida 32399-1550 Augustus D. Aikens General Counsel Department of Administration 530 Carlton Building Tallahassee, Florida 32399-1500 S. Philip Ford Post Office Box 20232 Tallahassee, Florida 32316

Florida Laws (2) 110.123120.57
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DEPARTMENT OF FINANCIAL SERVICES vs EDWARD MICHAEL FARLEY, 03-001940PL (2003)
Division of Administrative Hearings, Florida Filed:Orlando, Florida May 22, 2003 Number: 03-001940PL Latest Update: Jun. 18, 2004

The Issue The issues are whether Respondent committed the acts and omissions alleged in the Administrative Complaint and, if so, what penalty should be imposed.

Findings Of Fact At all material times, Respondent has been licensed in Florida as a life, life and health, general lines--property and casualty, and health agent. His license number is A081006. Respondent was initially licensed on July 24, 1978. He was licensed as a health insurance agent in May 2000. At no time has Local 16, United States Workers of America Local 16 National Health Fund, IIAWU National Health Fund, or Local 16 National Health ever been licensed or authorized to do business in Florida as a life and health insurance company or reinsurance company. All references in this Recommended Order to "Local 16" include all of these entities. Patricia Holdridge is the owner of Patty Contracting Corporation, doing business as East Coast Electric and Mr. Electric (East Coast Electric) in Sebastian, Florida. She has owned East Coast Electric for 11 years. In May 2000, Ms. Holdridge served as the manager of East Coast Electric. In that capacity, she met with Respondent, who was an agent employed by Stuart Insurance, Inc., in Palm City, Florida. Respondent visited Ms. Holdridge's office and dropped off literature on group health insurance. Ms. Holdridge spoke with Respondent about her company's insurance needs. At the time, the company had temporary health insurance, following the insolvency of the prior health insurer. Respondent said that he could provide health insurance for the company's ten or eleven employees. After agreeing to the details of the new health insurance, Ms. Holdridge met with Respondent another time to sign the papers. At this time, she learned that a labor union was somehow involved. She told Respondent that there was no way that a labor union could be involved because her company could not afford to pay union wages to its employees. Respondent assured Ms. Holdridge that the union's participation in the health insurance was a "technicality." He told her that the union would never contact her or interfere with her business. Ms. Holdridge accepted this explanation, emphasizing again that no union could be involved with her company. The paperwork that Respondent produced for Ms. Holdridge to complete included an application for health insurance. One form was a Member Enrollment Application with the Local 16 National Health Fund in Newton, New Jersey. The application is for health insurance and asks basic questions concerning the insureds' medical and claims history. Another form in the package that Respondent gave Ms. Holdridge was a Membership Application with "USWA, Local 16, TCIU, AFL-CIO, CLC," also in Newton, New Jersey. Another form in the package was an "Application and Representatvie [sic] Authorization [for] Affiliated Business Trade Services," in Jacksonville. The materials that Respondent supplied Ms. Holdridge included descriptions of two plans, with differing co-payment amounts, with premiums set by the age groups containing the employee and his or her covered family members. The two plans were the "80/60" plan and the "90/70" plan. The Summary of Benefits for the 80/60 plan lists numerous covered types of services and assures 80 percent payment after deductible for listed providers and 60 percent payment after deductible for nonlisted providers. The Schedule of Benefits Summary for the 90/10 plan lists numerous covered types of services and assures 90 percent payment, purportedly without any copayment, for listed providers and 70 percent payment after deductible for nonlisted providers. A second Schedule of Benefits Summary for the 90/10 plan also bears the heading, "Local 16 National Health Fund." Respondent also provided Ms. Holdridge with insurance identification cards. The health insurance card is entitled, "USWA Local 16 TCU-AFL-CIOP, CLC National Health Fund." The dental insurance card is entitled, "Local 16 National Health Fund." After signing up for the insurance, East Coast Electric received invoices from Local 16. These invoices were broken down by employee and included entries for "welfare fund," "dues," and "ABTS." The amount entered for "welfare fund" is the premium for each employee's health insurance, based on the type of coverage and numbers and ages of dependents. The invoices directed East Coast Electric to pay this sum to Local 16, National Health Fund." The amount entered for "dues" is for union membership dues. The invoices directed East Coast Electric to pay this sum to Local 16, TCIU. The amount entered for ABTS is for the Affiliated Business Trade Services. The invoices directed East Coast to pay this sum to Affiliated Business Trade Services. The invoices directed East Coast Electric to send all of its payments to Affiliated Business Trade Services. At some point after signing up for the insurance, Respondent provided Ms. Holdridge with a Labor Agreement to sign. This detailed agreement provided that USWA Local 16 TCIU, AFL-CIO, CLC had been designated by a majority of the employer's employees to act as the exclusive bargaining agent. Ms. Holdridge refused to sign the agreement, and she heard nothing about her refusal to sign. East Coast Electric paid Local 16 a total of $32,000 from June 1, 2000, for group health insurance for its employees. Numerous employees of East Coast Electric signed up for the group health insurance offered by Local 16. Each of them signed forms indicating that he or she was joining the union, but none of them intended or wanted to join Local 16. Each employee understood that he or she was merely signing up for group health insurance. Allen Baurley was an electrician with East Coast Electric when the company purchased health insurance from Local After obtaining coverage with Local 16, Mr. Baurley suffered a sudden illness for which he submitted covered medical bills of over $34,000. Local 16 never paid any of these claims, in whole or in part. Mr. Baurley has paid $5000 of this debt through monthly payments and incurred $3500 in legal fees defending himself in a collection action brought by the hospital. Holly Emard was the office manager of East Coast Electric when the company purchased health insurance from Local 16. She signed up for group health insurance from Local 16. She incurred $300 in covered medical expenses, which Local 16 did not pay. Ms. Emard also handled communications between East Coast Electric and Local 16. As medical expenses went unpaid, she would contact Respondent, who offered to relay medical bills to Local 16. Sometimes, when she followed up, Respondent would claim not to have received the bill, and sometimes he would say that the union would be cutting checks later in the month. One time, Respondent suggested that Ms. Emard send an unpaid bill to a specified person with Local 16. Respondent was always very nice to Ms. Emard, but he did not help much with the payment problems. Eventually, Ms. Emard was spending half of her day on health insurance matters. Maurice Gay, Jr., was a scheduler and estimator with East Coast Electric when the company purchased health insurance from Local 16. Of the $1700 of covered medical expenses that he submitted to Local 16, the union health fund paid only $12. Mr. Gay's then-wife had a serious, lifetime pre-existing condition that had been covered by other health insurance. Induced by Respondent's representations of coverage from Local 16, she dropped her other insurance and enrolled with Local 16. When she tried to obtain health insurance elsewhere, after her adverse experience with Local 16, she found that insurers treated her situation as a lapse in coverage, so she incurred over $4000 in uncovered medical expenses--resulting in monthly payments to her health care providers and referrals to collection agencies. Catherine Desmarais was the only witness who was victimized by the sale of Local 16 group health insurance, but was not an employee of East Coast Electric. Ms. Desmarais was an accountant employed by Beacon Accounting Services, Inc., in Palm City, Florida, when the company purchased health insurance from Local 16. Ms. Desmarais testified that she never met Respondent. She signed up for group health insurance from Local 16 for herself, her husband, and two of her children sometime in 2000. Her supervisor at work informed her that she had to join Local 16, and Ms. Desmarais did so, although there was no union, shop steward, or other evidence of union activities at Beacon Accounting after she enrolled. Beacon Accounting employees joked at times, saying a supervisor could not do something, or else they would call the union. Ms. Desmarais' first attempt to use the Local 16 health insurance was when she tried, unsuccessfully, to fill a prescription. When the pharmacy refused to honor her insurance card, Ms. Desmarais told her supervisor, who suggested that she speak with Respondent. Ms. Desmarais telephoned Respondent, who said that someone else had had a similar problem and that he had already called someone in New Jersey and had corrected the problem. However, Ms. Desmarais eventually incurred about $3500 in covered medical expenses, for which Local 16 paid nothing. Later, in November 1991, after learning that Local 16 had filed for bankruptcy, Ms. Desmarais contacted Respondent, who informed her and her employer of another self-insured plan. However, Beacon Accounting elected to purchase group health insurance elsewhere. On November 15, 2002, a general adjuster for Fireman's Fund Insurance Company wrote Ms. Desmarais a letter in connection with its insured, Stuart Insurance. The letter attempts to initiate a process to conclude outstanding claims that arose when Local 16 became insolvent. The letter explains that its author was having difficulty linking Ms. Desmarais to a Local 16 group health policy. However, Ms. Desmarais produced at the hearing a copy of her Local 16 National Health Fund insurance identification card, which bears her name. Given the numerous administrative problems that East Coast Electric had with Local 16, the obvious explanation is that Local 16's poor recordkeeping resulted in the misplacing of Ms. Desmarais' insurance file. The employees of East Coast Electric never organized, never joined Local 16, never engaged in collective bargaining, and never negotiated the subject plan pursuant to any collective bargaining or union membership. At all material times, Respondent was aware of all of these facts, as he fraudulently required the employees of East Coast Electric to falsely indicate that they were or were applying to become members of Local 16. As marketed to persons who were not members or participants of Local 16, the subject plan was not an "employee benefit plan," as that term is described below. The subject plan was never an insured plan, as described below. If it had qualified as an "employee benefit plan," the subject plan would have been a "multiple employer welfare arrangement," as described below. United States Workers of America Local 16 National Health Fund filed for protection under Chapter 7 of the Bankruptcy Code the United States Bankruptcy Court, District of New Jersey (Newark Division), Case No. 01-42881, on November 27, 2001. The case is still pending.

Recommendation It is RECOMMENDED that the Department of Financial Services enter a final order revoking Respondent's license. DONE AND ENTERED this 30th day of December, 2003, in Tallahassee, Leon County, Florida. S ROBERT E. MEALE Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 30th day of December, 2003. COPIES FURNISHED: Honorable Tom Gallagher Chief Financial Officer Department of Financial Services The Capitol, Plaza Level 11 Tallahassee, Florida 32399-0300 Mark Casteel, General Counsel Department of Financial Services The Capitol, Plaza Level 11 Tallahassee, Florida 32399-0300 David J. Busch Philip M. Payne Department of Financial Services and Chief Financial Officer Division of Legal Services 612 Larson Building 200 East Gaines Street Tallahassee, Florida 32399-0333 Edward Michael Farley Post Office Box 1696 Palm City, Florida 34991

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ANNA LEIGH MILLER, A MINOR, BY AND THROUGH HER PARENTS AND NATURAL GUARDIANS, LEIGH LASSITER MILLER AND THOMAS B. MILLER, AND LEIGH LASSITER MILLER AND THOMAS B. MILLER, INDIVIDUALLY vs DEPARTMENT OF MANAGEMENT SERVICES, DIVISION OF STATE GROUP INSURANCE, 05-001851 (2005)
Division of Administrative Hearings, Florida Filed:West Palm Beach, Florida May 20, 2005 Number: 05-001851 Latest Update: Nov. 09, 2005

The Issue Whether the Dynamic Orthotic Cranioplasty band prescribed to treat Petitioner Anna Leigh Miller's deformational plagiocephaly in 2004 was a covered benefit under the 2004 State Employees' PPO Plan.

Findings Of Fact Based on the evidence adduced at hearing, and the record as a whole, the following findings of fact are made to supplement and clarify the factual stipulations set forth in the parties' August 23, 2005, Pre-Hearing Stipulation3: At all times material to the instant case, Petitioner Leigh Lassiter Miller has been employed by the State Attorney's Office in Palm Beach County. As a benefit of her employment, she has received group health insurance under the State Employees' PPO Plan (Plan). Respondent administers the Plan. It does so with the assistance of Blue Cross and Blue Shield of Florida, Inc. (BCBSF). BCBSF was hired by Respondent to provide medical claim processing services under the Plan. The terms and conditions of the Plan that were in effect during the time period at issue in the instant case are set forth in the 2004 Plan Booklet and Benefits Document (Plan Document). According to the Plan Document's "Introduction," the "PPO plan is designed to cover most major medical expenses for a covered illness or injury, including hospital and physician services." The Plan Document's "Summary of Plan Benefits, Covered Services" advises that the Plan "pays a percentage of the cost of covered care and medical supplies as long as the care or supplies are ordered by a covered provider and are considered medically necessary as a result of a covered accident, illness, condition or mental or nervous disorder." For covered "durable medical equipment" obtained from a "non-network" provider, the percentage paid by the Plan is 60 percent. The "Limitations and Exclusions" portion of the Plan Document contains a listing of "Services Not Covered By The Plan." This listing reads, in pertinent part, as follows: The following services and supplies are excluded from coverage under this health insurance plan unless a specific exception is noted. Exceptions may be subject to certain coverage limitations. Cosmetic surgery or treatment, unless it is: a result of a covered accident and the surgery or treatment is performed while the person is covered by this health insurance plan for correction of a congenital anomaly for an eligible dependent and performed while the dependent is covered by this health insurance plan a medically necessary procedure to correct an abnormal bodily function for reconstruction to an area of the body that has been altered by the treatment of a disease * * * 4. Any services or supplies which are not medically necessary, as determined by BCBSF clinical staff and DSGI. * * * 17. Any services provided for preventative care - except those services provided as part of the well-child health supervision services or those services obtained through the $100 Health Screening benefit (see page 22). * * * 45. Services and procedures considered by BCBSF to be experimental or investigational, or services and procedures not in accordance with generally accepted professional medical standards, including complications resulting from these non-covered services. The Plan Document contains the following description of the process involved in "Appealing A Denied Claim": If your benefit claim is totally or partially denied, BCBSF or Caremark, Inc. will send you a written notice on an Explanation of Benefits (EOB) statement stating the specific reason(s) for the denial within 30 days of receiving your claim. The notice will include a list of any additional information needed to appeal the denial to BCBSF or Caremark, Inc. Appealing To The Third Party Administrator- A Level I Appeal Within 90 days of the date of the EOB denial notice you or your authorized representative can appeal a claim that is denied. Your appeal must be in writing and should include any information, questions or comments you think are appropriate. Mail your written appeal to the third party administrator- BCBSF for medical claims or Caremark, Inc. for prescription drug claims - at the address shown on the inside cover of this booklet. The third party administrator will review your claim and provide you with a written notice of the review decision. On the notice, you will also receive information about appealing the decision to DSGI. Appealing To DSGI - A Level II Appeal If you are not satisfied with the first appeal decision given by the third party administrator, you may make a second appeal through DSGI. After you have asked the third party administrator to review your claim and you have received their written notification, you may submit a second appeal to DSGI. Your Level II Appeal must be in writing and must be received by DSGI not later than 60 days after the date of the written notice of the third party administrator decision regarding your Level I Appeal and must include: a copy of the EOB a copy of your letter requesting the third party administrator to review the claim a copy of the third party administrator's written notice of their review decision a letter to DSGI appealing the decision, and any other information or documentation you think is appropriate. Mail your written DSGI at the address shown on page 1. Send your appeal to the attention of the "Appeals Coordinator." Requesting An Administrative Hearing If you want to contest the second appeal decision, you must submit a petition for an administrative proceeding that complies with section 28-106.301, Florida Administrative Code. DSGI must receive your petition within 21 days after you received the written decision on your second appeal. "Definitions Of Selected Terms Used By The Plan" are found on pages 49 through 55 of the Plan Document. These definitions include the following: Accident [means] an accidental bodily injury that is not related to any illness. * * * Condition [means] any disease, illness, injury, accident, bodily dysfunction, pregnancy, drug addiction, alcoholism or mental or nervous disorder. * * * Covered services and supplies [mean] healthcare services and supplies, including pharmaceuticals and chemical compounds, for which reimbursement is covered under this health insurance plan. The Division of State Group Health Insurance has final authority to determine if a service or supply is covered by the plan. * * * Experimental or investigational services [mean] any evaluation, treatment, therapy or device that meets any one of the following criteria: cannot be lawfully marketed without approval of the US Food and Drug Administration or the Florida Department of Health if approval for marketing has not been given at the time the service is provided to the covered person [hereinafter referred to "Experimental/Investigational Criterion No. 1"]; or is the subject of ongoing Phase I or II clinical investigation, or the experimental or research arm of a Phase III clinical investigation - or is under study to determine the maximum dosage, toxicity, safety or efficacy, or to determine the efficacy compared to standard treatment for the condition [hereinafter referred to as "Experimental/Investigational Criterion No. 2"]; or is generally regarded by experts as requiring more study to determine maximum dosage, toxicity, safety or efficacy, or to determine the efficacy compared to standard treatment for the condition [hereinafter referred to as "Experimental/Investigational Criterion No. 3]; or has not been proven safe and effective for treatment of the condition based on the most recently published medical literature of the U.S., Canada or Great Britain using generally accepted scientific, medical or public health methodologies or statistical practices [hereinafter referred to as "Experimental/Investigational Criterion No. 4"]; or is not accepted in consensus by practicing doctors as safe and effective for the condition [hereinafter referred to as "Experimental/Investigational Criterion No. 5"]; or is not regularly used by practicing doctors to treat patients with the same or a similar condition [hereinafter referred to as "Experimental/Investigational Criterion No. 6]. BCBSF and DSGI determine whether a service or supply is experimental or investigational. * * * Illness [means] physical sickness or disease, pregnancy, bodily injury or congenital anomaly. For this plan, illness includes any medically necessary services related to non-emergency surgical procedures performed by a doctor for sterilization. Medically necessary [means] services required to identify or treat the illness, injury, condition, or mental and nervous disorder a doctor has diagnosed or reasonably suspects. The service must be: consistent with the symptoms, diagnosis and treatment of the patient's condition in accordance with standards of good medical practice required for reasons other than the convenience of the patient or the doctor approved by the appropriate medical body or board for the illness or injury in question at the most appropriate level of medical supply, service, or care that can be safely provided. The fact that a service is prescribed by a doctor does not necessarily mean that the service is medically necessary. Medical supplies or equipment [mean] supplies or equipment that are: ordered by a physician of no further use when medical need ends usable only by the particular patient not primarily for the patient's comfort or hygiene not for environmental control not for exercise, and specifically manufactured for medical use. * * * Among the terms not defined in this or any other portion of the Plan Document are "cosmetic," "disease," and "consensus." Petitioner Anna Leigh Miller (Anna) was born two weeks before she was due. Her delivery was normal. Her parents began to notice, immediately following her birth, that her "head tilt[ed]" to the left. Initially, they were not concerned, thinking that this "tilt" was just "temporary." At all times material to the instant case, Anna's primary pediatrician was Ronald Romear, M.D., of Infants and Children, P.A., in West Palm, Florida. When Dr. Romear was unavailable, Anna was seen by other pediatricians in Dr. Romear's practice, including James Beattie, M.D. Anna saw Dr. Romear for her two-week check-up on January 21, 2004. Dr. Romear's physical examination of Anna on this date revealed that her general appearance and head were "normal." In March of 2004, or perhaps somewhat earlier, Anna's parents first noticed that Anna had developed a "flat head." (Anna's "head shape [was] normal at birth.") Anna made a "sick visit" to Infants and Children, P.A., on April 28, 2004, and was seen by Dr. Beattie. She returned, accompanied by her mother, on May 12, 2004, for a "well child visit," and was again seen by Dr. Beattie. During this May 12, 2004, visit, Mrs. Miller shared with Dr. Beattie that, from the time of Anna's birth, Anna was "inclined to do things facing to the left." After examining Anna, Dr. Beattie determined that Anna had torticollis. Torticollis literally means "twisted neck" in Latin. It is a condition characterized by a tightening or foreshortening of the sternocleidomastoid muscle on one side of the neck, resulting in an inability to straighten or turn the head. Anna's torticollis was congenital (that is, present at birth). Dr. Beattie prescribed physical therapy for Anna. Physical therapy is the standard treatment for torticollis. Anna's parents took Anna to the physical therapist twice a week. BCBSF deemed these services to be "covered" under the Plan and authorized payment accordingly. In addition to taking Anna to the physical therapist, Anna's parents, in accordance with instructions they had received, did neck "stretching" exercises with Anna at home five to six times a day. The physical therapist did her "initial evaluation" of Anna on May 20, 2004. During this "initial evaluation," Anna's parents expressed concern about, and the physical therapist observed, "significant flattening of the left posterior aspect of [Anna's] skull resulting in moderated plagiocephalic appearance." The physical therapist told Anna's parents about a cranial orthotic device that was available to treat this "plagiocephalic appearance." Anna's parents knew that this device might not be covered by the Plan. Nonetheless, during a "sick visit" Anna made to Dr. Romear's office on May 26, 2004, Mrs. Miller asked Dr. Romear what his opinion was of the device. Dr. Romear expressed his concurrence with the physical therapist's assessment that Anna was suffering from plagiocephaly, and he referred Anna to Eric Stelnicki, M.D., a craniofacial and pediatric specialist. He also recommended that, before Anna saw Dr. Stelnicki, Anna's parents provide her with repositioning therapy at home. Repositioning therapy involves supervised "tummy time," as well as placement of the child on the side and the use of a strategically placed rolled- up towel or similar item to prevent the child from rolling over on the back and putting pressure on the flattened part of the head. It is the usual first-line treatment for plagiocephaly in those cases where the child is not "able to move readily out of placed positions." Anna's parents followed Dr. Romear's recommendation and attempted repositioning therapy at home. They abandoned their efforts without any success after less than a month because Anna kept moving out of her "placed positions." Instead of seeing Dr. Stelnicki, Anna saw another craniofacial and pediatric specialist in Dr. Stelnicki's practice, Drew Schnitt, M.D. Anna's first visit with Dr. Schnitt was on June 14, 2004. That same day, after the visit, Dr. Schnitt wrote the following letter to Dr. Romear, which accurately related what had occurred during the visit and what Dr. Schnitt had found and recommended: I am seeing Anna in my pediatric cleft and craniofacial office today. She is a 5½ month-old young lady who has been referred to me for an abnormal head shape. She received a full review of systems, history, physical examination, and a set of anthropometric measurements in the office today. Focally, on physical examination, she has a significant amount of left deformational plagiocephaly, with left anterior ear shift, left frontal bossing, fronto-orbital complex shift, and left temporomandibular joint shift. The anterior fontanelle is open. The neck reveals right neck torticollis. The remainder of her physical appearance is within normal limits. Due to the severity of her problem and her age, I am recommending an orthotic cranioplasty device. The preferred device is the DOC band by Cranial Technologies, Inc. I have given them an instruction sheet for range of motion exercises for the neck torticollis and we have demonstrated to them how to do these exercises. I will see them back in one month's time for a re-evaluation. Please do not hesitate to call or contact me with any questions or concerns. Deformational plagiocephaly (which is also known as nonsynostotic positional plagiocephaly) is plagiocephaly (that is, asymmetric or abnormal head shape) caused by external deforming forces. It may be congenital, but, more commonly (as in Anna's case), it occurs postnatally, as a result of, for example, torticollis or forced sleeping position. Deformational plagiocephaly is to be distinguished from another type of skull deformity, craniosynostosis (also referred to as cranial stenostosis), which, unlike deformational plagiocephaly, involves the premature fusion of skull sutures. These sutures need to stay unfused for an infant's head to grow properly and for the infant's brain to expand within the cranial skull. Their fusing prematurely can lead not only to a misshapen skull, but to other problems as well, including vision loss, developmental delay, learning difficulties, increased intracranial pressure and perhaps even herniation of the brain and death. Unlike deformational plagiocephaly, craniosynostosis "typically is a surgical problem, not a problem to try to treat with non-surgical means." Anna was diagnosed as having deformational plagiocephaly, not craniosynostosis. The "DOC band by Cranial Technologies, Inc.," that Dr. Schnitt prescribed for Anna to treat her deformational plagiocephaly4 is a lightweight, custom-fitted skull-molding device consisting of a semi-rigid shell bonded to a foam lining. Worn around the head 23-hours a day, it applies mild dynamic pressure to the prominent areas of the child's skull (while leaving room for growth in the flattened areas) to produce a more symmetrical head shape. Cranial orthotic devices, such as the DOC band, are commonly used to treat children with moderate to severe deformational plagiocephaly for whom repositioning therapy has not worked or for whom repositioning therapy is not a viable option because of their ability "to move readily out of placed positions" or because of the severity of their condition. (These devices are not, however, a treatment for torticollis.) Surgery is performed in "multiple places around the world" to treat deformational plagiocephaly. Cranial orthotic devices, though, are more cost-effective and have fewer complications than surgical intervention. At the time he prescribed the DOC band for Anna, Dr. Schnitt believed that this product was the "best [cranial orthotic device] on the market." Since 1998, the DOC band has been approved by the U.S. Food and Drug Administration (FDA) as safe and effective for the treatment of deformational plagiocephaly. The FDA's approval was announced in the Federal Register, 63 FR 40650-01 (July 30, 1998). The FDA's announcement read, in pertinent part, as follows: ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is classifying the cranial orthosis into class II (special controls). The special controls that will apply to the cranial orthosis are restriction to prescription use, biocompatibility testing, and certain labeling requirements. The agency is taking this action in response to a petition submitted under the Federal, Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976, the Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997. The agency is classifying cranial orthosis into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. EFFECTIVE DATE: August 31, 1998. * * * SUPPLEMENTARY INFORMATION: I. Background In accordance with section 513(f)(1) of the act (21 U.S.C. 360c(f)(1)), devices that were not in commercial distribution before May 28, 1976, the date of enactment of the Medical Device Amendments of 1976 (the amendments), generally referred to as postamendments devices, are classified automatically by statute into class III without any FDA rulemaking process. These devices remain in class III and require premarket approval, unless and until the device is classified or reclassified into class I or II or FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the act, to a predicate device that does not require premarket approval. The agency determines whether new devices are substantially equivalent to previously marketed devices by means of premarket notification procedures in section 510(k) of the act (21 U.S.C. 360(k)) and part 807 of the FDA regulations (21 CFR part 807). -Section 513(f)(2) of the act provides that any person who submits a premarket notification under section 510(k) of the act for a device that has not previously been classified may, within 30 days after receiving an order classifying the device in class III under section 513(f)(1), request FDA to classify the device under the criteria set forth in section 513(a)(1). FDA shall, within 60 days of receiving such a request, classify the device by written order. This classification shall be the initial classification of the device. Within 30 days after the issuance of an order classifying the device, FDA must publish a notice in the Federal Register announcing such classification. -In accordance with section 513(f)(1) of the act, FDA issued an order on March 12, 1998, classifying the Dynamic Orthotic Cranioplasty (DOCTM Band) in class III, because it was not substantially equivalent to a device that was introduced or delivered for introduction into interstate commerce for commercial distribution before May 28, 1976, or a device which was subsequently reclassified into class I or class II. On March 31, 1998, Cranial Technologies, Inc., submitted a petition requesting classification of the DOCTM Band under section 513(f)(2) of the act. The manufacturer recommended that the device be classified into class II. In accordance with 513(f)(2) of the act, FDA reviewed the petition in order to classify the device under the criteria for classification set forth in 513(a)(1) of the act. Devices are to be classified into class II if general controls, by themselves, are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls to provide reasonable assurance of the safety and effectiveness of the device for its intended use. After review of the information submitted in the petition and the medical literature, FDA determined that the DOCTM Band can be classified in class II with the establishment of special controls. FDA believes these special controls will provide reasonable assurance of safety and effectiveness of the device. -The device is assigned the generic name "cranial orthosis," and it is identified as a device intended for use on infants from 3 to 18 months of age with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads. The device is intended for medical purposes to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape. -FDA identified the following risks to health associated with this type of device: (1) Skin irritation, skin breakdown and subsequent infection due to excessive pressure on the skin; (2) head and neck trauma due to alteration of the functional center of mass of the head and the additional weight of the device especially with an infant who is still developing the ability to control his/her head and neck movements; (3) impairment of brain growth and development from mechanical restriction of cranial growth; (4) asphyxiation due to mechanical failure, poor fit, and/or excessive weight that alters the infant's ability to lift the head; (5) eye trauma due to mechanical failure, poor construction and/or inappropriate fit; and (6) contact dermatitis due to the materials used in the construction of the device. -FDA believes that the special controls described below address these risks and provide reasonable assurance of the safety and effectiveness of the device. Therefore, on May 29, 1998, FDA issued an order to the petitioner classifying the cranial orthosis as described previously into class II subject to the special controls described below. Additionally, FDA is codifying the classification of this device by adding new §882.5970. -In addition to the general controls of the act, the cranial orthosis is subject to the following special controls in order to provide reasonable assurance of the safety and effectiveness of the device: (1) The sale, distribution, and use of this device are restricted to prescription use in accordance with 21 CFR 801.109; (2) the labeling of the device must include: (a) Contraindications for the use of the device on infants with synostosis or with hydrocephalus; (b) warnings indicating the need to: (i) Evaluate head circumference measurements and neurological status at intervals appropriate to the infant's age and rate of head growth and to describe steps that should be taken in order to reduce the potential for restriction of cranial growth and possible impairment of brain growth and development and (ii) evaluate the skin at frequent intervals, e.g., every 3 to 4 hours, and to describe steps that should be taken if skin irritation or breakdown occurs; (c) precautions indicating the need to: (i) Additionally treat torticollis, if the positional plagiocephaly is associated with torticollis; (ii) evaluate device fit and to describe the steps that should be taken in order to reduce the potential for restriction of cranial growth, the possible impairment of brain growth and development and skin irritation and/or breakdown; and (iii) evaluate the structural integrity of the device and to describe the steps that should be taken to reduce the potential for the device to slip out of place and cause asphyxiation or trauma to the eyes or skin; (d) adverse events, i.e., skin irritation and breakdown that have occurred with the use of the device; (e) clinician's instructions for casting the infant, for fitting the device, and for care; and (f) parent's instructions for care and use of the device; (3) the materials must be tested for biocompatibility with testing appropriate for long term direct skin contact. * * * V. References -The following references have been placed on display in the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday. Petition from Cranial Technologies, Inc., dated March 31, 1998. Hellbusch, J. L., L. C. Hellbusch, and R. J. Bruneteau, "Active Counter-Positioning Treatment of Deformational Plagiocephaly," Nebraska Medical Journal, vol. 80, pp. 344 to 349, 1995. Moss, S. D. et. al., "Diagnosis and Management of the Misshapen Head in the Neonate," Pediatric Review, vol. 4, pp. 4 to 8, 1993. -Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 882 is amended as follows: List of Subjects in 21 CFR Part 882 Medical devices. PART 882--NEUROLOGICAL DEVICES * * * 2. Section 882.5970 is added to subpart F to read as follows: §882.5970 Cranial orthosis. -(a) Identification. A cranial orthosis is a device that is intended for medical purposes to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape in infants from 3 to 18 months of age, with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads. -(b) Classification. Class II (special controls) (prescription use in accordance with §801.109 of this chapter, biocompatibility testing, and labeling (contraindications, warnings, precautions, adverse events, instructions for physicians and parents)). Dated: July 21, 1998. A year earlier, in 1997, a "consensus statement" was issued "jointly by several pediatrics organizations (including the Section of Plastic Surgery of the American Academy of Pediatrics and the American Cleft Palate/Craniofacial Society)," in which it was asserted that "deformational plagiocephaly . . . usually responds to conservative measures [such as] the use of skull molding caps." In July of 2003, the American Academy of Pediatrics published a "clinical report" designed to provide "guidance for the clinician in rendering pediatric care" concerning the "[p]revention and [m]anagement of [p]osition [s]kull [d]eformities in [i]nfants."5 The report contained the following observations regarding "skull-molding helmets": Skull-Molding Helmets Several ancient civilization have used head- molding devices in infants to reshape a typically shaped skull into a different but desired skull form. Conversely, skull- molding helmets can be used to correct atypical skull shapes, and similar devices are now proposed for this purpose. However, results from 1 study suggest that repositioning infants may produce improvement in mild to moderate cases similar to that reported with external orthotic devices. Another study has linked the use or helmets with an improvement over that achieved by repositioning alone. The best response for helmets occurs in the age range of 4 to 12 months because of the greater malleability of the young infant skull bone and the normalizing effect of the rapid growth of the brain. There is less modification of the cranial configuration when used after 12 months of age. The use of helmets and other related devices seems to be beneficial primarily when there has been a lack of response to mechanical adjustments and exercises. In most situations, an improvement to repositioning and neck exercise is seen over a 2- to 3- month period if these measures are instituted as soon as the condition is recognized. Because use of skull-molding helmets incurs significant cost, further studies are needed to identify outcomes with and without them. At the end of the report was the following "summary": Summary In most cases, the diagnosis and successful management of deformational plagiocephaly can be assumed by the pediatrician or other primary care clinician. This includes examination for and counseling regarding deformational plagiocephaly in the newborn period and at health supervision visits during infancy, as well as monitoring for improvement or progression. Mechanical methods, if performed early in life, may be effective in preventing further skull deformity and may reverse existing deformity. Referral to a pediatric neurosurgeon with expertise in pediatrics or a craniofacial surgeon should be considered if there is progression or lack of improvement following a trial of mechanical adjustments. BCBSF has a written policy stating that, "[a]s a nonsurgical treatment of plagiocephaly . . . without synostosis, [the DOC band] is considered not medically necessary." This policy statement indicates that it is based on the "lack of [as of February 2004] documented functional impairment" associated with "plagiocephaly . . . without synostosis." The statement, however, does contain an acknowledgement that the "available data [as of February 2004, reveals] that the [DOC band] therapy can indeed reshape the cranium to a more normal contour." Further support for the notion that the DOC band and similar cranial orthotic devices are effective in "reshap[ing] the cranium to a more normal contour" is found in the "most recently published [of the] medical literature" received into evidence at hearing in the instant case: an article entitled, "Management of Deformational Plagiocephaly: Repositioning Versus Orthotic Therapy," authored by John Graham, M.D. and others. This article was published in the February 2005 edition of the Journal of Pediatrics, a "respected [peer-reviewed] journal." Based on their evaluation of the data they examined, the authors of the article concluded that, "[w]hen physical therapy and repositioning fail to treat or prevent plagiocephaly and there is more than 1 cm difference between the two cranial diagonal differences at age 6 months, orthotic therapy is effective in correcting such asymmetry," and they further concluded that "[d]elays in initiating corrective treatment until later infancy may lead to incomplete or ineffective correction even if orthotic therapy is initiated . . ."6 Anna was "cast for the DOC band" at Cranial Technologies, Inc., on June 23, 2004. She returned with her parents to Cranial Technologies, Inc., on July 1, 2003, to try on the DOC band that had been fabricated for her. Only some "trimming adjustments" had to be made. Anna started wearing the band that day. Anna continued wearing the DOC band (23 hours a day) until October 18, 2004. On that date (October 18, 204), the Cranial Technologies, Inc., clinician who had been working with Anna sent Dr. Schnitt a letter advising him that Anna's DOC band treatment had been successfully completed. Anna had obtained a "good result" from the DOC band treatment. Her cranial asymmetry had "markedly improved." Anna's last visit to Dr. Schnitt was on November 29, 2004. That day, after the visit, Dr. Schnitt wrote the following letter to Dr. Romear, which accurately related what had occurred during the visit and what Dr. Schnitt had found and recommended: I am seeing Anna back in my pediatric cleft and craniofacial office today. She is a young lady with left deformational plagiocephaly and right torticollis, who is here again for follow up. She is now 11 months old and was treated in the DOC band cranial molding device for four months and has been out of this since October. She received a full review of systems, history, physical examination, and a set of anthropometric measurements in the office today. Focally on physical examination, she has a mild to moderate amount of residual left deformational plagiocephaly with left anterior ear shift, left frontal bossing, and fronto-orbital complex shift. Her anterior fontanelle remains open. Examination of her neck reveals a minimal amount of residual right neck torticollis. The remainder of the physical examination is within normal limits. I have had a long discussion with mom about the treatment of deformational plagiocephaly. She has made a marked improvement since the beginning of her treatment, and mom is, overall, satisfied, but was asking about going into another helmet to try to improve things further. I have given her this option, but she has decided not to proceed with a second band. I have also advised her of the need to continue with neck range of motion exercises at least until Anna is two years old. Mom would like to continue to follow with me until she is satisfied with the torticollis outcome. I will see her back in two to three months' time. Mom also knows to make an appointment in a more timely manner if she notices any abnormal head growth or regression. Please do not hesitate to call or contact me with any questions or concerns. The Millers were billed $3,000.00 by Cranial Technologies, Inc., for the DOC band and related costs. They filed a claim requesting that the bill be treated as being for services and/or supplies "covered" by the Plan. The request was denied by BCBSF, which issued a Non- Payment Notice. The Millers filed an unsuccessful Level I appeal with BCBSF (as provided for in the Plan Document). They then filed a Level II appeal with Respondent (as provided for in the Plan Document). As noted above, Respondent rejected the Millers' Level II appeal, finding that Anna's DOC band treatment was "cosmetic" and "experimental and investigational" and not "medically necessary," as those terms are used in Plan Document. Thereafter, at the Millers' request, an administrative hearing on their claim was held. The preponderance of the evidence adduced at the administrative hearing establishes that Anna's DOC band treatment was "medically necessary," as that term is defined in the Plan Document, in that the evidence demonstrates the treatment was: "consistent with the symptoms, diagnosis and treatment of [her] condition" (moderate to severe deformational plagiocephaly7 that had not responded to repositioning therapy due, at least in part, to her moving out of her "placed positions"); "in accordance with standards of good medical practice"; "required for reasons other than the convenience of [Anna] or [her] doctor"; "approved by the appropriate medical body or board for the illness or injury in question" in that "pediatrics organizations" have documented their recognition of the beneficial effects devices such as the DOC band have in treating deformational plagiocephaly; and "at the most appropriate level of medical supply, service, or care that [could] be safely provided" in that repositioning therapy had already been attempted without success. The preponderance of the evidence adduced at the administrative hearing fails to establish that Anna's DOC band treatment was " experimental and investigational," as those terms are defined in the Plan Document. Respondent concedes (in its Proposed Recommended Order) the inapplicability of Experimental/Investigational Criterion No. 1 and Experimental/Investigational Criterion No. 2. With respect to the remaining Experimental/Investigational Criteria set forth in Plan Document's definition of "experimental or investigational services": regarding Experimental/Investigational Criterion No. 3, while it has been shown that some "experts" believe more study of DOC band treatment is needed "to determine maximum dosage, toxicity, safety or efficacy," the record evidence is insufficient to demonstrate that DOC band treatment "is generally regarded by experts as requiring [such additional] study"; regarding Experimental/Investigational Criterion No. 4, the record evidence is insufficient to demonstrate that, according to the "most recently published medical literature of the U.S., Canada or Great Britain using generally accepted scientific, medical or public health methodologies or statistical practices," the use of a DOC band to treat a child almost six months of age (Anna's age when she first started wearing the band) with moderate to severe deformational plagiocephaly that has not responded to repositioning therapy is not a "safe and effective . . . treatment of th[is] condition"; regarding Experimental/Investigational Criterion No. 5, while it has been shown that "practicing doctors" do not unanimously accept the DOC band as "safe and effective" for treating deformational plagiocephaly that has not responded to repositioning therapy, the record evidence is insufficient to demonstrate that there is not a consensus or majority8 of "practicing doctors" who are of this opinion9; and regarding Experimental/Investigational Criterion No. 6, the record evidence is insufficient to demonstrate that "practicing doctors" as a group do not "regularly" (meaning typically, but not necessarily in each and every instance, without exception10) use a DOC band or like device to treat deformational plagiocephaly that has not responded to repositioning therapy. The preponderance of the evidence adduced at the administrative hearing establishes that Anna's DOC band treatment was "cosmetic," as that term is used in the Plan Document,11 in that it was prescribed to improve her appearance by ameliorating her deformational plagiocephaly and giving her a more natural-looking, symmetrical head shape, and it had no purpose or effect beyond changing the asymmetrical appearance of her head. The preponderance of the evidence adduced at the administrative hearing fails to establish that this "cosmetic" treatment was the "result of a covered accident." The preponderance of the evidence adduced at the administrative hearing fails to establish that this "cosmetic" treatment was "for correction of a congenital anomaly." While Anna's torticollis was a "congenital anomaly," her deformational plagiocephaly was not, and her DOC band treatment addressed her deformational plagiocephaly, not her torticollis. The preponderance of the evidence adduced at the administrative hearing fails to establish that this "cosmetic" treatment was a "medically necessary procedure to correct an abnormal bodily function." While the treatment was "medically necessary" and undertaken to "correct" an abnormality, the abnormality (the asymmetrical shape of Anna's head) was structural, not functional, in nature. The preponderance of the evidence adduced at the administrative hearing fails to establish that this "cosmetic" treatment was "for reconstruction to an area of the body that has been altered by the treatment of a disease." Inasmuch as Anna's DOC band treatment was "cosmetic" in nature and not within any of the "specific exceptions" noted in the Plan Document, such treatment was excluded from coverage under the Plan.12

Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that Respondent enter a final order sustaining the denial of the claim at issue in the instant case. DONE AND ENTERED this 9th day of November, 2005, in Tallahassee, Leon County, Florida. S STUART M. LERNER Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 9th day of November, 2005.

CFR (3) 21 CFR 801 .10921 CFR 80721 CFR 882 Florida Laws (5) 110.123120.52120.569120.57627.6698
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DEPARTMENT OF INSURANCE AND TREASURER vs MICHAEL HALLORAN, 89-006118 (1989)
Division of Administrative Hearings, Florida Filed:Sarasota, Florida Nov. 08, 1989 Number: 89-006118 Latest Update: Apr. 04, 1990

The Issue The issue is whether respondent's license as a health insurance agent should be disciplined for the reasons stated in the administrative complaint.

Findings Of Fact Based upon all of the evidence, the following findings of fact are determined: At all times relevant hereto, respondent, Michael Halloran, was licensed and eligible for licensure as a health insurance agent by petitioner, Department of Insurance and Treasurer (Department). When the events herein occurred, respondent was licensed to solicit health insurance on behalf of National States Life Insurance Company (NSLIC) and Transport Life Insurance Company (TLIC). He was also under contract with Diversified Health Services of St. Petersburg, Florida until that firm terminated his agency appointment on May 5, 1989. This proceeding involves the sale by respondent of various health insurance policies to four customers in January and February 1989. In 1987, Raymond H. Koester, a Largo resident, purchased from respondent a supplemental Medicare policy for both him and his wife. Their first policy was issued by American Integrity. A year later, respondent persuaded the Koesters to replace that policy with one issued by Garden State Insurance Company on the ground the latter policy represented an "improvement" over their existing policy. On January 10, 1989 respondent met with the Koesters for the purpose of selling them new health insurance coverage. During their meeting, respondent advised the Koesters that a new NSLIC policy would provide unlimited custodial and home health care, a type of coverage desired by the Koesters. Relying upon respondent's representation, the Koesters agreed to purchase two new policies. They filled out an application and paid Halloran $2,628 which was the premium for the first year. When the application was completed, respondent answered "no" to the question of whether the new policies were intended to replace existing coverage. This was a false representation. In June 1989 the Koesters learned that they had a problem with their new policies. This advice was conveyed to them by petitioner's investigator who advised them that the policies sold by Halloran loran did not provide any custodial or home health care benefits. Had the Koesters known this, they would not have purchased the insurance. On January 18, 1989 respondent visited Grace Miller, an elderly resident of Venice, Florida, for the purpose of selling her a health insurance policy. At that time Miller had an existing policy in force since 1983 which provided supplemental Medicare coverage. Respondent advised Miller that her existing coverage was inadequate and that more coverage was needed. More specifically, Halloran represented that a new NSLIC policy would supplement her basic Medicare coverage and increase her overall health insurance coverage. Based on that representation, Miller agreed to purchase a replacement policy issued by NSLIC. As it turned out, the policy sold to Miller was of little or no value to a Medicare recipient, such as Miller, and simply filled in the gaps on a major medical policy. Had Miller known this to begin with, she would not have purchased the policy. Respondent also persuaded Miller to purchase a long-term care policy from TLIC. She allowed respondent to fill out the application using information from her old policy. Without telling Miller, respondent misrepresented on the application her date of birth as December 2, 1921 when in fact she was born on December 2, 1911, or ten years earlier. By doing this, Halloran was able to reduce Miller's premium from $1,159.92 to $441.72. Had Miller known that she was responsible for paying a much higher premium, she would not have purchased the policy. On February 25, 1989 respondent accepted another check from Miller in the amount of $773.00 for an unknown reason. At about the same time, respondent submitted to NSLIC an application for a medical-surgical expense policy dated the same date purportedly executed by Miller In fact, Miller had not executed the policy and her signature was forged. NSLIC declined to issue a new policy to Miller since she already had a policy of that type in effect. On January 20, 1989 respondent visited Gertrude Simms, an elderly resident of Fort Myers. Simms desired to purchase a hospital expense insurance policy with a provision for dental insurance coverage. Simms desired such coverage because she had a medical condition that required her to have her teeth cleaned frequently to avoid an infection. Respondent was aware of this condition. Nonetheless, Halloran prepared an application with NSLIC for a limited medical-surgical expense insurance policy which did not provide any dental coverage. Respondent accepted a $1,100 check from Simms which he represented to her was the first year's premium. In fact, the first year's premium was only $506. Although respondent was supposed to return to Simms' home to explain the policy provisions, he never returned. At about this same time, TLIC received an application on behalf of Simms for a long-term care insurance policy bearing the signature of respondent as agent. However, Simms had no knowledge of the application and did not wish to purchase such a policy. The information contained in the TLIC application misrepresented Simms' age so that the premium was lower than it should have been. Although TLIC issued a policy and sent it to respondent, Halloran never delivered it to Simms. On February 1, 1989 respondent visited Velma Sonderman, who resided in Venice, Florida, for the purpose of selling her a health insurance policy. She had become acquainted with respondent through Grace Miller, who is referred to in finding of fact 4. Sonderman was then covered by a supplemental medicare insurance policy issued by United American Medicare. According to Sonderman, respondent gave a "snow job" and represented he could sell her better coverage through NSLIC. Sonderman agreed to purchase a new policy for supplemental medicare coverage to replace her existing policy and signed an application filled in by respondent. However, the application submitted by respondent was for a NSLIC limited benefit health insurance policy rather than the medicare supplement insurance policy Sonderman believed she was purchasing. Respondent also convinced Sonderman to purchase a long-term nursing home care policy issued by TLIC. When filling out the application on her behalf, but without telling Sonderman, respondent misrepresented Sonderman's birth date as July 11, 1915 instead of the correct date of July 11, 1911. By doing this, Sonderman's premium was reduced from $999.36 to $599.04 per year.

Recommendation Based on the foregoing findings of fact and conclusions of law, it is RECOMMENDED that respondent's license as a health insurance agent be REVOKED. DONE and ENTERED this 4 day of April, 1990, in Tallahassee, Florida. DONALD ALEXANDER Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, FL 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 4 day of April, 1990. APPENDIX Petitioner: 1-3. Substantially used in finding of fact 1. 4-17. Substantially used in findings of fact 4, 5 and 6. 18-29. Substantially used in findings of fact 9 and 10. 30-33. Substantially used in findings of fact 2 and 3. 34-45. Substantially used in findings of fact 7 and 8. 46. Substantially adopted in finding of fact l. Copies furnished to: Honorable Tom Gallagher Insurance Commissioner Plaza Level, The Capitol Tallahassee, FL 32399-0300 James A. Bossart, Jr., Esquire 412 Larson Building Tallahassee, FL 32399-0300 Mr. Michael Halloran 2519 McMullen Booth Road Clearwater, FL 34621 Donald A. Dowdell, Esquire Department of Insurance Plaza Level, The Capitol Tallahassee, FL 32399-0300

Florida Laws (5) 120.57626.611626.621626.9521626.9541
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MARCUS E. PAUL vs. DEPARTMENT OF ADMINISTRATION, 88-001451 (1988)
Division of Administrative Hearings, Florida Number: 88-001451 Latest Update: Apr. 25, 1989

Findings Of Fact Petitioner, Marcus Paul, was employed part-time as a dentist by the State of Florida, Department of Health and Rehabilitative Services, Pensacola, Florida. As part of his employment Dr. Paul was enrolled in the State's Employee Health Insurance Plan. The State's Health Plan is a self-insurance plan. Blue Cross and Blue Shield (BCBS) of Florida is the State's agent for administering the Health Plan and is initially responsible for timely and promptly investigating and paying legitimate health claims. Under the State's Health Plan an employee is responsible for the first $1,000 of covered expenses. The Plan pays the balance of any covered expenses incurred by the employee. Covered expenses are defined in the plan. Such expenses are basically limited to reasonably necessary medical treatment or care of some kind. Dr. Paul also carried a direct pay health insurance policy with Blue Cross and Blue Shield of Philadelphia, Pennsylvania. The Pennsylvania policy was a non-coordinating policy with the State's Health Plan. In essence, the Pennsylvania policy paid directly to its insured, Dr. Paul, regardless of the benefits paid by the State's Plan and the State's Plan benefits are not reduced by the Pennsylvania policy's payment of health benefits. Around September 15, 1984, Dr. Paul suffered a pulmonary embolism. He was hospitalized for his condition from September 15, 1984 to September 30, 1984. On admission, the hospital obtained Dr. Paul's health insurance information and had him sign the usual authorizations to allow the hospital to file his insurance claim. The total hospital charge resulting from Petitioner's hospitalization was $10,873.01 of which $10,582.30 was eligible for payment under the State Plan. The hospital filed a claim on both of Dr. Paul's contracts of insurance. Both contracts of insurance paid benefits to the hospital. BCBS of Pennsylvania paid approximately $9,500 and BCBS of Florida paid $9,582.00. The amount paid by BCBS of Florida represents the total covered expenses less the $1,000 the insured is responsible for. Because of the double payment the hospital told Dr. Paul that he was entitled to a refund from it. However, before the hospital refunded the money to Dr. Paul, BCBS of Florida discovered the double payment. No evidence was presented as to how BCBS of Florida discovered the other insurance company's co-payment. BCBS of Florida immediately demanded the hospital refund its payment. The hospital did so. BCBS of Florida mistakenly took the position that it was not the primary payor on the claim and refused to pay the claim. The hospital thereafter looked to the Pennsylvania proceeds for its payment. Dr. Paul was thereby prevented from receiving the monies due him under his Pennsylvania policy at a time when his need for funds was high since, due to his illness, he could not conduct a regular practice. For approximately one year Dr. Paul attempted to correct BCBS of Florida's mistake. However, he ran into a brick wall. Finally, after Dr. Paul retained an attorney to deal with BCBS, BCBS admitted its mistake and paid the hospital as the primary payor of Dr. Paul's claim. BCBS' failure to pay Dr. Paul's claim for over one year was a breach of his contract of insurance and negligent. BCBS' actions caused Dr. Paul not to be able to receive other monies that were rightfully his and at a minimum caused Dr. Paul to incur damages in the amount of attorney's fee he was forced to pay to rectify BCBS' mistake. When BCBS paid the claim the second time the company paid $10,281.93 to the hospital. Dr. Paul's $1,000 deductible was not subtracted from the amount BCBS paid. The hospital then refunded $10,105.70 to Dr. Paul. The discrepancy between the original `84 payment and the second `85 payment is $300.17. Therefore, only $699.83 could be attributable to Dr. Paul. Additionally Dr. Paul did not receive the full BCBS payment from the hospital. The amount he received was $176.23 less than the amount paid by BCBS. Therefore, the amount owed by Dr. Paul, if any, is $523.60. The hospital has possession of the other $176.23. BCBS later discovered its error and attempted to collect the full $1,000 deductible from Dr. Paul. He refused to pay since he had incurred and paid more than $3,000 in attorney's fees when he was forced to hire an attorney to obtain proper payment of his insurance claim. Since Dr. Paul refused to pay, BCBS turned his name over to DOA, its principal, for further collection action. DOA terminated further payment of Dr. Paul's ongoing insurance claims. 1/ Additionally, DOA unsuccessfully attempted to have the comptroller garnish Dr. Paul's wages. These actions were taken even in light of the breach of contract and negligent failure of DOA's agent to properly pay Dr. Paul's claim.

Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is Recommended: That the Department enter a final order determining that Dr. Paul is liable to it for the $523.60. DONE and ENTERED this 25th day of April, 1989, in Tallahassee, Leon County, Florida. DIANE CLEAVINGER 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 25th day of April, 1989.

Florida Laws (3) 110.123582.30873.01
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TERRI K. CASSANO AND EDWARD M. MCDONALD vs DIVISION OF RETIREMENT, 89-006263 (1989)
Division of Administrative Hearings, Florida Filed:Bartow, Florida Nov. 16, 1989 Number: 89-006263 Latest Update: Feb. 09, 1990

The Issue The issue is whether petitioners' request to terminate, without penalty, their participation in the state group health insurance plan should be granted.

Findings Of Fact Based upon all of the evidence, the following findings of fact are determined: Petitioners, Terri K. Cassano (Cassano) and Edward M. McDonald (McDonald), are employees of the Office of State Attorney, Tenth Judicial Circuit, in Bartow, Florida. As such, they are eligible to participate in the State Group Health Insurance Program (program) administered by respondent, Department of Administration, Division of State Employees' Insurance (Division). At issue in this case is approximately $1,500 paid by petitioners and their employer for health insurance coverage under the program during the period October through December 1989. Effective July 1, 1989 the State of Florida implemented the first phase of a two-phase Flexible Benefits Plan (plan) which allowed, among other things, for employees who participate in the program to make their required monthly insurance premium contribution through a salary reduction agreement which has the effect of reducing the employee's taxable income by the amount of such contribution. Although not made clear in the record, it may be inferred that the plan is embodied in Chapters 22FB-1, 2 and 3, Florida Administrative Code (1987), which rules became effective on August 3, 1989. In federal bureaucratic parlance, the plan is known as a ``cafeteria'' plan /1 and was implemented after approval was obtained from the Internal Revenue Service (IRS). All state employees were automatically enrolled in the plan unless they signed a waiver form. Cassano and McDonald chose to participate in the plan, and they acknowledge that they received a Division brochure describing the plan prior to their enrollment. Under the rules of the plan, a participant was required to remain in the plan for the entire plan year, which in this case ended on November 30, 1989, unless a so-called "qualifying status change" occurred. Rule 22BF-1.008(13) cites a number of events as constituting a "qualifying status change". However, the event defined in subparagraph (13)(b) as a "change in a participant's health insurance coverage resulting in cessation of coverage" is the event upon which petitioners rely. The manner in which that rule should be interpreted is the source of controversy in this proceeding. In July 1989 petitioners were utilizing as their health insurer Health Alliance Plan (HAP), a health maintenance organization (HMO) serving Polk County. HAP was designated as a qualifying HMO under the program. In late July petitioners learned that HAP would cease doing business in Polk County effective September 30, 1989. Because of this, it was necessary that they consider other insurance alternatives to replace their existing coverage. After considering enrollment in Blue Cross Blue Shield (BCBS), which was the only other health alternative offered by the Division,/2 Cassano decided to enroll as a dependent in her husband's health insurance program because of the lower monthly premiums and she would not have to meet a new deductible as she would with BCBS. As for McDonald, who is also a military retiree, he considered BCBS but opted instead for Medicare because he was being treated for an existing ailment and his physicians were not listed as primary providers with BCBS. Consequently, it would cost him approximately $200 per visit with those doctors if he elected to use BCBS. Under these circumstances, petitioners' health coverage under the program ended since their HMO was no longer in business and their only other option, BCBS, would result in petitioners paying significantly higher costs. Cassano was able to immediately obtain coverage with her husband's health plan effective on July 28, 1989 while McDonald's coverage with Medicare became effective on October 1, 1989, the day after his HAP coverage ended. When the Division learned that HAP was ceasing doing business in Polk County, it mailed to petitioners a "health care provider selection form" which offered them a special enrollment period from August 15 through 31, 1989. The form offered the choice of enrolling in HOPC, BCBS or to cancel their health insurance coverage. However, respondent contends that even though the form offered petitioners the option of cancelling their insurance, it did not apply and that petitioners' only choice was to transfer coverage to one of the two remaining state insurers. The form also noted that if petitioners had any questions they should contact their personnel office or the Division by telephone. Although their personnel office later informed them that respondent might not agree they could do so, Cassano and McDonald executed the form on August 23 and 28, 1989, respectively, and elected to cancel their coverage. They also executed a "qualifying status change form" so that they could cease participation in the plan even though the plan year did not end until November 30, 1989. In so doing, they noted on the form that the qualifying status change event was "cessation of coverage by Health Alliance Plan" and relied in part upon a Division document sent to them which outlined the plan and listed a qualifying status change event as being a "change in participant's health coverage: resulting in cessation of coverage". That same document noted that in order to prove that such an event had occurred, the employee had to furnish a "letter from carrier stating that coverage has ceased due to change in insurance plan". In addition, explanatory literature concerning the plan previously disseminated: by the Division reflected that "a cafeteria plan may also allow for revocation of health plan elections of all affected participants in the event coverage is significantly curtailed or completely terminated in connection with a health plan, if the coverage is provided by an independent third party." Thus, petitioners reasonably assumed that a qualifying status change had occurred by virtue of the cessation of coverage by HAP. After informal efforts to resolve the matter were unsuccessful, on September 28, 1989 Cassano and McDonald formally requested by letter the right to discontinue their participation, without penalty, in the state program. Their requests were essentially denied by letters dated October 5, 1989 from the Division director. In the proposed agency action, the Division stated that it would be happy to comply with their requests but "since the premiums you pay for such coverage have been pretaxed for the five month period ending December 1, 1989, we will continue to deduct these premiums through October 1989 payroll pursuant to rule 22FB-2.005 F.A.C." /3 As a consequence, petitioners were involuntarily required to pay for coverage in BCBS during the months of October through December 1989 even though they were enrolled in other health insurance plans, and their employer (the office of state attorney) was forced to make its required contribution. Through testimony of the state benefits administrator, William R. Seaton, it was established that the Division interprets the term "cessation of (insurance) coverage" as the cessation of all health insurance coverage by the state, including BCBS, an event unlikely to ever occur. Indeed, the administrator acknowledged that such an event would not occur unless the state no longer functioned as a viable entity. Because the state offered petitioners the option of enrolling in BCBS, Seaton contended there was no cessation of insurance coverage, even if petitioners' former HMO in Polk County went out of business. Seaton also opined that petitioners' request was prohibited by IRS regulations and, if approved, would subject the Division to a possible fine if audited by IRS. However, he could not identify a regulation that prohibited approval of their request. Further, there is no evidence that the Division has received specific advice from the IRS on the subject or made inquiry as to whether or not petitioners' request is permissible under federal regulations. Petitioners construe the termination of coverage by their HMO to be a qualifying status change since they no longer could be covered by that HMO. Relying on the plain language in the rule and Division explanatory literature, they did not telephone the Division to ascertain whether they could discontinue state coverage since they had no reason to do so. Through a proffer of agency counsel at hearing, it was pointed out that the federal regulation that allegedly prohibits petitioners from obtaining relief is found on page 14,847-6 of the Standard Federal Tax Reports published by Commerce Clearing House and received in evidence as a part of respondent's composite exhibit 1. 4/ It reads as follows: (2) Coverage changes. If the coverage under a health plan provided by an independent, third-party provider is significantly curtailed or ceases during a period of coverage, a cafeteria plan may permit all affected participants to revoke their election of the health plan and, in lieu thereof, to receive on a prospective basis coverage under another health plan with similar coverage.

Recommendation Based on the foregoing findings of fact and conclusions of law, it is RECOMMENDED that the requests of Terri K. Cassano and Edward M. McDonald to discontinue participation in the state health program be granted and that appropriate refunds be given to petitioners and their employer. DONE and ORDERED this 9 day of February, 1990 in Tallahassee, Leon County, Florida. DONALD R. ALEXANDER Hearing Officer Division of Administrative Hearings The Desoto Building 1230 Apalachee Parkway Tallahassee, FL 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 9 day of February, 1990.

Florida Laws (2) 120.57120.68
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