STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

ANDRES G. GIL, )

)

Petitioner, )

)

vs. ) Case No. 04-2370

) DEPARTMENT OF MANAGEMENT ) SERVICES, )

)

Respondent. )

)

RECOMMENDED ORDER

Robert E. Meale, Administrative Law Judge of the Division of Administrative Hearings, conducted the final hearing in Fort Lauderdale, Florida, on October 15, 2004.

APPEARANCES

For Petitioner: Andres G. Gil, pro se

206 Cameron Court Weston, Florida 33326

For Respondent: Sonja P. Mathews

Assistant General Counsel Office of the General Counsel

Department of Management Services 4050 Esplanade Way, Suite 260

Tallahassee, Florida 32399-0950 STATEMENT OF THE ISSUE

The issue is whether the Dynamic Orthotic Cranioplasty band and related services to correct cranial asymmetry in a one-year- old child are covered benefits under the State of Florida State Employees' self-insured health plan.

PRELIMINARY STATEMENT

By letter dated October 23, 2003, Respondent informed Petitioner that it was denying the Dynamic Orthotic Cranioplasty procedure that had been prescribed for S. G. on May 13, 2003, and invoiced for $3000. The letter explains that the procedure was experimental or investigational or a service not in accordance with generally accepted professional standards.

By letter dated December 12, 2003, Petitioner requested a formal hearing.

At the hearing, Petitioner called two witnesses and offered into evidence three exhibits: Petitioner Exhibits 1-3.

Respondent called two witnesses and offered into evidence eleven exhibits: Respondent Exhibits 1, 2, 4b, 7, 8b, 13-14, and

17-20. All exhibits were admitted.

The parties did not order a transcript. They filed proposed recommended orders by November 15, 2004.

FINDINGS OF FACT

1. At all material times, Petitioner Andres Gil has been a professor employed at Florida International University in Miami. At all material times, he has been a participant in the state group insurance programs, including the state group health insurance plan (Plan). The plan's benefits are described in the State Employees' PPO Plan Group Health Insurance Plan Booklet and Benefit Document (Benefit Document). At all material times,

   Petitioner's child, S. G., who was born on April 15, 2002, was a covered dependent under the Plan.

2. At birth, S. G.'s skull appeared normal, but, at about two months of age, she began to exhibit a slight flattening of the head. The flattening became more pronounced by four months of age. The flattening was probably due to positioning of the infant at night so that she would sleep on her back and presumably be safer from sudden infant death syndrome.

3. Petitioner and his wife took S. G. to a pediatrician, who diagnosed S. G. with severe bilateral deformational plagiocephaly. The pediatrician confirmed that S. G.'s condition was not congenital. After trying unsuccessfully conservative treatment, the pediatrician recommended the Dynamic Orthotic Cranioplasty band. This device is called a DOC Band.

4. The DOC Band is among the type of devices that attempt to reshape the skull of infants through the application of focused pressure on the still-forming skull. The U.S. Food and Drug Administration has approved 38 such devices, and many of them have been used for many years. These devices include rigid helmets, which are initially fitted, but not later adjusted, and more-flexible bands, which are adjusted periodically during the period that the infants wear them.

5. S. G. first wore the DOC Band for four months, starting in May 2003. Although she received little benefit from the device, Petitioner, his wife, and the pediatrician decided to give the device another try, starting in September or October 2003. During the second application of the DOC Band, which ended in February 2004, S. G.'s skull asymmetry reduced substantially.

6. When the pediatrician first prescribed the DOC Band, Petitioner submitted a claim to Blue Cross Blue Shield of Florida (BCBSF), which is the third-party administrator of the Plan. BCBSF denied the claim, and Petitioner appealed this decision to Respondent.

7. By letter dated October 24, 2003, Respondent informed Petitioner that it was sustaining the determination of BCBSF. The letter states that the service or procedure was "experimental or investigational" or "not in accordance with generally accepted professional standards."

8. On December 15, 2003, Petitioner filed a letter requesting a formal hearing. However, he never filed a claim for the second application of the DOC band.

9. The Benefit Document lists under the "Summary of Plan Benefits" an "overview" of the "services and supplies" that are covered by the Plan. Benefit Document, p. 11. The "Summary of

   Plan Benefits" states 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 physician and are "medically necessary" for treatment as a result of a covered accident, illness, condition, or mental or nervous disorder. Id.

10. The Benefit Document generally covers "doctor's care" and "durable medical equipment." Benefit Document, p. 12. However, under "Limitations and Exclusions," the Benefit Document does not cover: "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." Benefit Document, p. 31.

11. The Benefit Document defines "investigational or investigational services" as "any evaluation, treatment, therapy or device that:"

    • 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

      
      

    • 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

      
      

    • 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

      
      

    • has not been proven safe and effective for treatment of the condition based on the most recently published medical literature of the US, Canada or Great Britain using generally accepted scientific, medical or public health methodologies or statistical practices

      
      

    • is not accepted in consensus by practicing doctors as safe and effective for the condition

      
      

    • is not regularly used by practicing doctors to treat patients with the same or a similar condition

      
      

      BCBSF and [Respondent] determine whether a service or supply is experimental or investigational.

      
      

12. The first two bullets of the above-cited definition of experimental or investigational services are not at issue in this case. The U.S. Food and Drug Administration has approved the DOC Band, and it is not presently under clinical investigation or otherwise under study to determine its efficacy compared to other treatments.

13. Nor is the safety of the DOC Band at issue.

    
    

    Premature use, which is not applicable in this case, may present

    certain risks. Otherwise, the main risk is minor skin irritation, which obviously may be monitored. Thus, no substantial, unavoidable safety issues emerge in the use of the DOC Band in this case.

14. In addition to raising safety concerns, the third and fourth bullets of the above-cited definition of experimental or investigational services raise the issue of the efficacy of the DOC Band. In 2003, the American Academy of Pediatrics released a position paper on the management of skull deformities in infants and reached no firm conclusions about the efficacy of cranial orthoses. However, a significant number of physicians find the DOC Band to be effective in treating deformational plagiocephaly.

15. The fifth and sixth bullets of the above-cited definition of experimental or investigational classify the DOC Band as experimental or investigational if it is not accepted in "consensus" by practicing doctors as effective or if it is not "regularly used" by practicing doctors to treat deformational plagiocephaly.

16. "Consensus" is defined as: "1.a. general agreement: UNANIMITY . . . [,] b. the judgment arrived at by most of those concerned[,] and 2. group solidarity in sentiment and belief." Merriam-Webster's Collegiate Dictionary (Tenth Edition 1999).

17. Respondent has proved that DOC Band has failed to reach these levels of acceptance and use. Although insureds may be absorbing the cost of DOC Bands without filing claims, the fact that the Plan has received one claim for a DOC Band in 2004 and one claim for a DOC Band in 2003 militates against a finding of regular use, if not also widespread acceptance, of the device. Although significant numbers of physicians find the DOC Band to be effective in treating deformational plagiocephaly, the record reveals disagreement in the acceptance of the DOC Band and suggests that practitioners do not regularly use the device to treat deformational plagiocephaly.

18. The research articles on which Petitioner relies assist in determining the efficacy of the DOC Band, but do not assist in finding, at the practitioner level, the extent of acceptance and use of the device. The medical group endorsements suggest an invitation to the use of the DOC Band, but assist little in finding the acceptance of the device by practitioners and do not assist at all in finding the extent of use of the device by practitioners. Against this evidence, the scant number of claims and the testimony of Respondent's expert witness to similar effect establish that the DOC Band meets the fifth and sixth definitional bullets of experimental or investigational services.

    CONCLUSIONS OF LAW

    
    

19. The Division of Administrative Hearings has jurisdiction over the subject matter. §§ 120.569 and 120.57(1), Fla. Stat.(2004).

20. Section 110.123(3)(c), Florida Statutes, authorizes Respondent to administer the Plan.

21. As an insured, Petitioner has the burden of proving coverage under the policy, but Respondent has the burden of proving the applicability of a policy exclusion, such as the exclusion for experimental or investigational services. See, e.g., Herrera v. C. A. Seguros Catatumbo, 844 So. 2d 664, 668 (Fla. 3d DCA 2003) (per curiam).

22. At the hearing, Respondent attempted to add three grounds for the denial of Petitioner's claim. Respondent attempted to argue that the deformational plagiocephaly was not a "condition" and that the DOC Band was "cosmetic" treatment, as these terms are defined in the Benefit Document. The Administrative Law Judge excluded such evidence due to Respondent's tardy identification of these grounds for denial.

23. Respondent also attempted to argue that the DOC Band, as used in this case, was not "medically necessary." At the hearing, the Administrative Law Judge considered the clause in the October 24, 2003, denial letter from Respondent to Petitioner, which states that the DOC Band was "experimental or

    investigational" or "not in accordance with generally accepted professional standards." Although the latter clause appears with the former clause in the exclusions set forth in the Benefit Document, the latter clause does not appear explicitly in the definitions contained in the Benefit Document. Cf.

    Benefit Document, p. 31, with Benefit Document, p. 51. Thus, the Administrative Law Judge permitted Respondent to offer evidence that the use of the DOC Band in this case was not medically necessary. However, it was unnecessary to consider these arguments because Respondent prevailed on the issue of whether the DOC Band was experimental or investigational.

24. For the reasons stated above, Respondent has proved that the DOC Band is experimental or investigational, and Petitioner is therefore not entitled to payment of his claim that he has presented to the Plan.

RECOMMENDATION

It is

RECOMMENDED that Respondent enter a final order denying Petitioner's claim to the Plan for payment for the DOC Band and related services.

DONE AND ENTERED this 22nd day of November, 2004, 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 22nd day of November, 2004.

COPIES FURNISHED:

William Simon, Secretary Department of Management Services 4050 Esplanade Way

Tallahassee, Florida 32399-0950

Alberto Dominguez, General Counsel Department of Management Services 4050 Esplanade Way

Tallahassee, Florida 32399-0950

Andres G. Gil

206 Cameron Court Weston, Florida 33326

Sonja P. Mathews Assistant General Counsel

Office of the General Counsel Department of Management Services 4050 Esplanade Way, Suite 260

Tallahassee, Florida 32399-0950

NOTICE OF RIGHT TO SUBMIT EXCEPTIONS

All parties have the right to submit written exceptions within

15 days from the date of this recommended order. Any exceptions to this recommended order must be filed with the agency that will issue the final order in this case.

Docket for Case No: 04-002370

Orders for Case No: 04-002370