STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

RECOMMENDED ORDER

A formal hearing was conducted in this case on April 12, 2010, by video teleconference, with hearing sites located in Daytona Beach and Tallahassee, Florida, before Suzanne F. Hood, Administrative Law Judge with the Division of Administrative Hearings.

APPEARANCES

For Petitioner: Robert Skinner, pro se

256 Lake Lane

Debary, Florida 32713

For Respondent: Sonja P. Mathews, Esquire

Department of Management Services Office of the General Counsel 4050 Esplanade Way, Suite 160

Tallahassee, Florida 32399 STATEMENT OF THE ISSUE

The issue is whether Petitioner is entitled to payment of benefits for a medical procedure.

PRELIMINARY STATEMENT

By letter dated March 19, 2009, Respondent Department of Management Services, Division of State Group Insurance (Respondent) notified Petitioner Robert Skinner (Petitioner) that his request for coverage of a medical procedure was denied. On April 3, 2009, Petitioner requested an administrative hearing to contest Respondent's decision.

On October 8, 2009, Respondent referred this case to the Division of Administrative Hearings. Administrative Law Judge Harry L. Hooper issued an Initial Order on October 9, 2009.

On October 14, 2009, Respondent filed a Response to Initial Order on behalf of both parties. On October 16, 2009, Judge Hooper issued a Notice of Hearing, scheduling the hearing for January 14, 2010.

On January 5, 2010, this case was transferred to the undersigned.

On January 11, 2010, Petitioner filed an unopposed request for a continuance. In an Order Granting Continuance dated January 13, 2010, the undersigned required the parties to file a status report no later than January 27, 2010.

The parties filed a timely Status Report. On January 28, 2010, the undersigned issued an Order Re-scheduling Hearing by Video Teleconference on April 12, 2010.

At the hearing, Petitioner testified on his own behalf. Petitioner requested and was granted leave to file two post- hearing exhibits.

Respondent presented the testimony of one witness. During the hearing, Respondent offered Exhibit Nos. R1-R3, R6, R9-R14, R16, and R18, which were accepted as evidence. Respondent also requested and was granted leave to file a post-hearing deposition in lieu of live testimony.

The parties did not file a transcript of the proceeding.

On April 16, 2010, Respondent filed the deposition testimony of Daniel Hudec, M.D., an expert witness. The deposition is hereby accepted as evidence.

Both parties filed proposed findings of fact and conclusions of law on April 22, 2010. Petitioner's Exhibit Nos. P1 and P2, which were attached to his proposed order, are hereby accepted as evidence.

Except as otherwise noted, references hereinafter shall be to Florida Statutes (2009).

FINDINGS OF FACT

1. The State Employees' Preferred Provider Organization Health Plan (PPO or "State Plan") is the self-insured health plan that is offered to State of Florida officers, employees, retirees and their dependants pursuant to Section 110.123, Florida Statutes. As provided in Section 110.123(3)(c), Florida

   Statutes, Respondent is responsible for contract management and day-to-day administration of the plan.

2. As authorized in Section 110.123 (5)(c), Florida Statutes, Respondent has contracted with a third-party administrator, Blue Cross Blue Shield of Florida (BCBSFL). Section 110.123(5), Florida Statutes, also provides that final decisions concerning the existence of coverage or covered benefits under the PPO cannot be delegated by or deemed to have been delegated by Respondent.

3. Pursuant to Section 110.123(5)(a), Florida Statutes, Respondent has determined and identified in the "Group Health Insurance Plan Booklet and Benefits Document" (Plan Booklet and Benefits Document) the benefits to be provided to members of the state health plan. In this case, the Benefit Document effective January 1, 2007, as modified January 1, 2008, is applicable.

   The terms and conditions of participation in the PPO are set forth in the Plan Booklet and Benefits Document.

4. Petitioner has been a participating member in the PPO since approximately 1981. Petitioner knows that he has the responsibility to ensure that a doctor is approved to treat PPO members before seeking treatment if he expects the PPO to pay benefits.

5. Petitioner does not know which medical procedures or treatments might require BCBSFL's pre-approval. Petitioner has

   always relied on his doctors or their staff to seek approval to perform procedures or treatments.

6. Petitioner was experiencing severe back pain in the summer of 2008. Petitioner's family practitioner treated Petitioner for several weeks without any improvement. The family doctor then referred Petitioner to a pain management doctor.

7. The pain management doctor also treated Petitioner without success. Petitioner eventually decided to return to his family practitioner, who referred Petitioner to a surgeon.

8. Petitioner's surgeon explained that there were three different surgical procedures that could be performed. The first procedure involved the removal of portions of several vertebrae and the insertion of a steel rod. The second procedure involved the removal of bone from Petitioner's hip and placing it between his vertebrae like spacers. Both of these procedures would require significant post-operative physical therapy and months to heal.

9. The third procedure involved the implantation of an X- Stop, an interspinous process decompression device. Petitioner understood that the X-Stop would be inserted between his vertebrae and act like a hinged spacer that allowed flexibility. Petitioner also understood that the X-Stop required limited physical therapy and rehabilitation time.

10. Petitioner elected to have the X-Stop implanted. He did not check with Respondent or BCBSFL to determine whether the procedure was covered by the PPO. Petitioner had the surgery on July 11, 2008. He spent one night in the hospital.

11. When Respondent refused to pay for the medical procedure, Petitioner called BCBSFL. Petitioner was told that the X-Stop was not covered because it was experimental and/or investigational and because it was not approved by the Food and Drug Administration (FDA).

12. Petitioner subsequently learned that the FDA had given the X-Stop pre-marketing approval pending post-approval studies to obtain five-year follow-up. However, BCBSFL continued to maintain that the procedure was excluded from coverage because it was experimental and/or investigational.

13. Section 5 of the Plan Booklet list all exclusions, including the following:

    Experimental or Investigational service and procedures as determined by BCBSFL and DSGI, or services and procedures not in accordance with generally accepted medical standards, including complications resulting from these non-covered services.

    
    

14. Section 15 of the Plan Booklet defines experimental or investigational services as follows:

    1. ny evaluation, treatment, therapy or device that meets any one of the following criteria:

       1. cannot be lawfully marketed without approval of the US Food and Drug Administration or the Florida Department of Health, and approval for marketing in the United States has not been given at the time the services is provided to the covered person; or

          
          

       2. 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; or

          
          

       3. is generally regarded by experts in the United States as requiring more study to determine maximum dosage, toxicity, safety or efficacy or to determine the efficacy compared to standard treatment for the condition; or

          
          

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

          
          

       5. is not accepted in consensus by practicing doctors in the United States as safe and effective for the condition; or

          
          

       6. is not regularly used by practicing doctors in the United States to treat patients with the same or a similar condition.

          
          

          BCBSFL and DSGI determine whether a service or supply is experimental or investigational.

15. The applicable BCBSFL policy/medical coverage guideline on interspinous decompression implants is that they are considered experimental and investigational because there is "insufficient clinical peer-reviewed literature demonstrating the safety, efficacy, and the effects of interspinous distraction devices on long-term health conditions." This policy is based upon a review of the relevant technology assessment literature.

16. One resource published by Winifred S. Hayes, Inc., on November 13, 2007, states as follows in pertinent part:

    Although the results of the available studies are promising, only one controlled trial has been performed to determine whether X Stop implantation provides better outcomes than conservative therapies[.] [T]he only study that involved long-term follow-up was small and uncontrolled, and no controlled trials have been performed to compare the X Stop IPD System with procedures such as decompressive surgery or spinal fusion. The device manufacturer sponsored the only available controlled trial of the X Stop IPD System.

    
    

17. Another resource, published by ECRI Institute on March 9, 2009, rated the clinical evidence base for the X-Stop. The ECRI Institute found the quantity, quality, and consistency of the evidence base to be low.

18. The greater weight of the evidence indicates that research has failed to prove the X-Stop's efficacy and safety. The device is presently the subject of on-going clinical trials,

    including a Phase III clinical trial with an expected date of completion in December 2011.

    CONCLUSIONS OF LAW

    
    

19. The Division of Administrative Hearings has jurisdiction over the parties and the subject matter of this proceeding pursuant to Sections 120.569 and 120.57(1), Florida Statutes.

20. Petitioner has the burden of proving by a preponderance of the evidence that his claim qualifies for coverage. See State Comprehensive Health Ass'n v. Carmichael, 706 So. 2d 319 (Fla. 4th DCA 1997). Respondent "bears the burden of proving the applicability of a claimed policy exclusion." See Herrera v. C.A. Seguros Catatumbo, 844 So. 2d 2003).

21. In this case, Petitioner has not met his burden.

    
    

    Instead, he appears to take issue with Respondent's position that he, and not the physician, is responsible for verifying whether a medical procedure is covered under the PPO. However, Petitioner provides no support to show that a doctor, who is not a party to the insurance contract, bears that responsibility.

22. On the other hand, Respondent met its burden of showing that the X-Stop, an interspinous process distraction device, is excluded from coverage under the PPO. Uncontested testimony and documentary evidence prove that the X-Stop is

experimental or investigational as defined in the Benefits Document because it meets the second, third, and fourth criteria for exclusion.

RECOMMENDATION

Based on the foregoing Findings of Fact and Conclusions of Law, it is

RECOMMENDED:

That the Department of Management Services enter a final order denying coverage of Petitioner's claim.

DONE AND ENTERED this 30th day of April, 2010, in Tallahassee, Leon County, Florida.

S

SUZANNE F. HOOD

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 30th day of April, 2010.

COPIES FURNISHED:

Sonja P. Mathews, Esquire Department of Management Services Office of the General Counsel 4050 Esplanade Way, Suite 260

Tallahassee, Florida 32399

Robert Skinner

256 Lake Lane

DeBary, Florida 32713

John Brenneis, General Counsel Department of Management Services Office of the General Counsel 4050 Esplanade Way

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 should be filed with the agency that will issue the Final Order in this case.

Docket for Case No: 09-005530

Orders for Case No: 09-005530