STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

FLORETTA ALLEN, )

)

Petitioner, )

)

vs. ) CASE NO. 93-3728

)

DEPARTMENT OF MANAGEMENT ) SERVICES, DIVISION OF STATE ) EMPLOYEES' INSURANCE, )

)

Respondent. )

)

RECOMMENDED ORDER

Pursuant to written notice a formal hearing was held in this case before Larry J. Sartin, a duly designated Hearing Officer of the Division of Administrative Hearings, on March 10, 1994, in Gainesville, Florida.

APPEARANCES

For Petitioner: Arthur R. Shell, Jr., Esquire

502 Northwest 75th Street, Suite 10 Gainesville, Florida 32607

For Respondent: Augustus D. Aikens, Jr.

Chief of Bureau of Benefits and Legal Services

Division of State Employees' Insurance Department of Management Services

2002 Old St. Augustine Road, B-12 Tallahassee, Florida 32399-4876

STATEMENT OF THE ISSUES

Whether the Petitioner, Floretta Allen, is entitled to payment for medical services by the State of Florida Employees' Group Health Self Insurance Plan?

PRELIMINARY STATEMENT

The Petitioner sought approval for the payment by the State of Florida Employees' Group Health Self Insurance Plan of medical services she was to receive. By letter dated May 28, 1993, she was informed by the Respondent that payment for the services could not be made.

By letter dated June 18, 1993, the Petitioner requested a formal administrative hearing to contest the Respondent's decision. On July 1, 1993, the Respondent filed an Order Accepting Petition and Assignment to the Division of Administrative Hearings.

The matter was designated case number 93-3728 and was assigned to the undersigned.

The final hearing was scheduled for October 13, 1993 by Notice of Hearing entered August 4, 1993. The final hearing was continued twice at the request of the Petitioner.

At the final hearing the Petitioner testified on her own behalf and presented the testimony of Mary Aplin, M.D. Petitioner's two exhibits were accepted into evidence.

The Respondent presented the testimony of Lee Peacock. Respondent's exhibits 1, 2 and 3A through 3F were accepted into evidence.

Official recognition of certain federal regulations was taken. Those regulations have been marked as Respondent's "A" and "B."

At the conclusion of the final hearing the parties agreed that the record would remain open for the Respondent to take the deposition of Oscar Ballester,

M.D. Dr. Ballester's deposition was taken on March 30, 1994, and was filed on April 13, 1994.

There were several exhibits offered into evidence during Dr. Ballester's deposition. Those exhibits have been identified as Petitioner's exhibits A and B and Respondent's exhibits A, B and C. Those exhibits are hereby accepted into evidence. There were also several objections made during Dr. Ballester's deposition to questions. Those objections are hereby overruled.

A transcript of the final hearing was filed on May 10, 1994. The parties were informed at the close of the final hearing that they could file proposed recommended orders within fifteen days after the filing of the transcript or Dr. Ballester's deposition, whichever was later. Proposed recommended orders were due May 25, 1994. A proposed recommended order was filed by the Respondent on May 25, 1994. The Petitioner did not file a proposed recommended order.

The proposed recommended order filed by the Respondent contained proposed findings of fact. A ruling on each proposed finding of fact has been made either directly or indirectly in this Recommended Order or the proposed finding of fact has been accepted or rejected in the Appendix which is attached hereto.

FINDINGS OF FACT

1. The Parties.

   
   

   1. The Petitioner, Floretta Allen, is the wife of an employee of the State of Florida. Ms. Allen is a participant in the State of Florida Employees' Group Health Self Insurance Plan (hereinafter referred to as the "Insurance Plan").

      
      

   2. The Respondent, the Division of State Employees' Insurance, Department of Management Services (hereinafter referred to as the "Department"), is an agency of the State of Florida. Among other things, the Department is administrator of the Insurance Plan.

      
      

2. Ms. Allen's Illness.

   
   

   1. In April of 1992, Ms. Allen was diagnosed as suffering from multiple myeloma.

   2. Multiple myeloma is a form of cancer which affects the bone marrow and blood.

      
      

   3. Ms. Allen was diagnosed by Dr. Mary Alpin. Dr. Alpin specializes in hematology and oncology, disorders of the blood and cancer.

      
      

   4. Ms. Allen was diagnosed by Dr. Alpin as having Stage III-A Myeloma: "She had a very high total protein in her blood. She already had extensive involvement of her bone marrow. And although a large percentage of people respond to treatment, their prognosis is not very good with that stage of disease. In other words they tend to respond to treatment for a while and then relapse. They may respond to a second treatment, but they eventually succumb to their disease pretty rapidly." Page 42, lines 20-25 and page 43, lines 1-3 of the transcript of the final hearing.

      
      

3. Treatment and Referral of Ms. Allen by Dr. Alpin.

   
   

   1. Because of the stage of Ms. Allen's disease, Dr. Alpin "mentioned to her that there was some evidence suggesting that there were long-term disease remissions and possibly even cures of myeloma with bone marrow transplant."

      Page 42, lines 2-5 of the transcript of the final hearing. Therefore, Dr. Alpin referred Ms. Allen to the University of Florida medical facility, Shands, because there was a bone marrow transplant unit there.

      
      

   2. Shands did not perform bone marrow transplants for multiple myeloma.

      
      

   3. Dr. Alpin then referred Ms. Allen to the H. Lee Moffitt Cancer Center (hereinafter referred to as the "Cancer Center"), at the University of South Florida in Tampa, Florida.

      
      

4. Ms. Allen's Treatment at the Cancer Center.

   
   

   1. Ms. Allen was under the care of Oscar Ballester, M.D. at the Cancer Center.

      
      

   2. Ms. Allen first saw Dr. Ballester in July or August of 1992.

      
      

   3. Dr. Ballester confirmed Dr. Alpin's diagnosis of Ms. Allen's illness.

      
      

   4. At the time of Ms. Allen's referral to the Cancer Center, the Cancer Center was carrying on a Phase I-II Study, Protocol Number 10461 (hereinafter referred to as the "Phase I-II Study"), involving the treatment of multiple myeloma with high dosage chemotherapy and bone marrow transplantation.

      
      

   5. Dr. Ballester recommended that Ms. Allen agree to participate in the Phase I-II Study to treat her illness.

      
      

   6. Ms. Allen agreed to the recommended treatment. Initially Ms. Allen underwent approximately six months of chemotherapy. She underwent a short course of intensive chemotherapy after which her peripheral blood stem cells were harvested and then she was admitted for high-dose therapy with busulfan and cyclophosphamide.

      
      

   7. While undergoing chemotherapy during the end of 1992, a bone marrow donor, one of Ms. Allen's sisters, was found.

   8. In August of 1993 Ms. Allen underwent the bone marrow transplant.

      
      

5. Denial of Insurance Coverage.

   
   

   1. Petitioner's exhibits 1 and 2 are examples of booklets provided to employees of the State of Florida. Pursuant to Petitioner's exhibit 1, employees are informed on pages 5 and 6 of certain "exclusions" from coverage under the Insurance Plan. Among other things, "experimental or investigative procedures" are listed as excluded from coverage. Pursuant to Petitioner's exhibit 2, employees are informed on pages 10 through 12 of "exclusions" from coverage. Among other things, the following is listed as excluded: "Any service or procedures which are determined by the Administrator to be experimental or investigative "

      
      

   2. The Benefit Document for the Insurance Plan also provides that "experimental" procedures or services are excluded from coverage. The Benefit Document defines the terms "experimental or investigative" as follows:

      
      

      W(b) "Experimental or Investigative" means any evaluation, treatment, therapy, or device which involves the application, administration or use, of procedures, techniques, equipment, supplies, products, remedies, vaccines, biological products, drugs, pharmaceuticals, or chemical

      compounds if, as recommended by the Servicing Agent and determined by the Administrator:

      1. such evaluation, treatment, therapy, or device cannot be lawfully marketed without approval of the United States Food and Drug Administration or the Florida Department of Health and Rehabilitative Services and approval for marketing has not, in fact, been given at the time such is furnished to the Insured;

      2. reliable evidence shows that such evaluation, treatment, therapy, or device is the subject of an ongoing Phase I, II, or III clinical investigation or under study to determine: maximum tolerated dosage(s), toxicity, safety, efficacy, or efficacy as compared with the standard means for treatment or diagnosis of the condition in question;

      3. reliable evidence shows that the consensus of opinion among experts is that further studies, research, or clinical investigations are necessary to determine: maximum tolerated dosage(s), toxicity, safety, efficacy, or efficacy as compared with the standard means for treatment or diagnosis of the Condition question;

      4. reliable evidence shows that such evaluation, treatment, therapy, or device has not been proven safe and effective for treatment of the condition in question, as

         evidenced in the most recently published medical literature in the United States, Canada, or Great Britain, using generally accepted scientific, medical, or public

         health methodologies or statistical practices;

      5. there is no consensus among practicing Physicians that the treatment, therapy, or device is safe and effective for the condition in question; or

      6. such evaluation, treatment, therapy, or device is not the standard treatment, therapy or device utilized by practicing Physicians in treating other patients with the same or similar condition.

         NOTE: "Reliable evidence" is determined by the Administrator to mean:

         . . . .

         1. the written protocol or protocols relied upon by the treating physician or institution or the protocols of another physician or institution studying substantially the same evaluation, treatment, therapy, or device; or

         2. the written informed consent used by the treating physician or institution or by another physician or institution studying substantial the same evaluation, treatment, therapy, or device; or

         . . . .

         Respondent's exhibit 3-C.

         
         

   3. Ms. Allen was informed in August of 1992 that her Insurance Plan would not cover the treatment recommended by the Cancer Center because it was considered to be "experimental."

      
      

   4. By letter dated March 24, 1993, the Cancer Center was informed that treatment pursuant to the Phase I-II Study was not covered by the Insurance Plan because it was considered to be "experimental."

      
      

   5. Even though aware that the Insurance Plan had taken the position that treatment pursuant to the Phase I-II Study was not covered by the Insurance Plan, Ms. Allen and the Cancer Center proceeded with Ms. Allen's treatment.

      
      

   6. By letter dated April 23, 1993, Ms. Allen requested that the Department pay for the medical services she had received at the Cancer Center.

      
      

   7. In a letter dated May 28, 1993, the Department informed Ms. Allen that her request was denied. The Department informed Ms. Allen that Subsection G.28 of the Insurance Plan's Benefit Document excludes "any services or procedures which are experimental or investigative . . . ." The Department informed Ms. Allen that the Cancer Center's treatment of her was under a Phase I-II Study Program of the University of South Florida Health Science Center and was "experimental."

6. Was the Cancer Center's Treatment "Experimental."

1. Dr. Ballester is a member of the Cancer Center's bone marrow transplant division. Dr. Ballester is involved in cancer research at the Cancer Center.

   
   

2. Dr. Ballester was a co-investigator for the Phase I-II Study of the Cancer Center.

   
   

3. The rationale, purpose and nature of the Phase I-II Study is described in a Protocol, Respondent's exhibit 3F and Respondent's exhibits A and C (Respondent's exhibit C was not effective until December 7, 1993, after Ms. Allen's treatment). The rationale and purpose of the Phase I-II Study contained in the Protocol is hereby incorporated by reference into this Recommended Order.

   
   

4. The Phase I-II Study and the Protocol were approved by the Cancer Center on December 2, 1991, and by the University of South Florida on January 6, 1992.

   
   

5. The objectives of the Phase I-II Study are described as follows in the Protocol:

   
   

   1. To confirm the value of the combination of busulfan and cyclophosphamide and allogeneic bone marrow transportation in the treatment of standard risk leukemias, high risk leukemias, lymphomas not eligible for autologous bone marrow transplant, myelodysplasia, and multiple myeloma.

   2. To evaluate this combination of chemotherapy with the addition of total lymphoid irradiation for patients undergoing matched unrelated donor transplants for leukemia or lymphoma.

   3. To evaluate this combination of chemotherapy for patients with leukemia or myeloma not candidates for allogeneic bone marrow transplants but eligible for autologous peripheral stem cell transplantation.

   4. To determine response rates and long term remission rates as measured by disease free survival.

   5. To determine the toxicities of this drug combination with and without total lymphoid irraditation.

   
   

6. The number of patients that may be treated in the Phase I-II Study is limited to 60.

   
   

7. The procedures followed in the Phase I-II Study pursuant to the Protocol are consistent with guidelines for Phase I-II Studies established by the United States Food and Drug Administration.

   
   

8. The Protocol provides that all patients participating in the Phase I- II Study pursuant to the Protocol are to sign an informed consent form. See Respondent's exhibit 3E and Respondent's exhibit B. The informed consent form

   explains in some detail the purpose of the "research study," the procedures involved, the risks, discomforts or side effects that may be expected, possible benefits and alternative procedures or treatment.

   
   

9. The Protocol also contains the following: PARTICIPATION AS A RESEARCH SUBJECT:

   My participation in this study is voluntary and I am free to withdraw consent and stop participation in the study at any time without this decision affecting my medical care. . . .

   
   

10. Ms. Allen executed an informed consent form as required by the Protocol.

    
    

11. Dr. Ballester explained why he does not believe that the treatment that Ms. Allen received is "experimental." Dr. Ballester, however, did not indicate that he was aware of or took into account the definition of "experimental" for purposes of the Insurance Plan contained in the Benefits Document.

    
    

12. Dr. Ballester did not dispute that the services provided to Ms. Allen were part of a Phase I-II Study, that a consent form was required of Ms. Allen to participate in the Phase I-II Study and that the Phase I-II Study was intended to determine the "efficacy and safety" of the drugs involved in the study.

    
    

13. The definition of "experimental" contained in the Benefits Document includes evaluations, treatments, therapies and devices which are "subject of an ongoing Phase I, II or III clinical investigation" to determine ". safety,

    efficacy "

    
    

14. Although the treatment received by Ms. Allen may not be considered by some physicians to be experimental, the treatment received by Ms. Allen which is at issue in this case comes with the definition of "experimental" contained in the Benefits Document for purposes of the Insurance Plan.

    
    

    CONCLUSIONS OF LAW

    
    

    1. Jurisdiction.

       
       

15. The Division of Administrative Hearings has jurisdiction of the parties to and the subject matter of this proceeding. Section 120.57(1), Florida Statutes (1993).

    
    

    1. Burden of Proof.

       
       

16. The burden of proof, absent a statutory directive to the contrary, is on the party asserting the affirmative of the issue of the proceeding. Antel v. Department of Professional Regulation, 522 So.2d 1056 (Fla. 5th DCA 1988); Department of Transportation v. J.W.C. Co., Inc. 396 So.2d 778 (Fla. 1st DCA 1981); and Balino v. Department of Health and Rehabilitative Services, 348 So.2d

    249 (Fla. 1st DCA 1977).

17. In this proceeding, the parties stipulated that Ms. Allen is generally covered by the Insurance Plan. Therefore, she is entitled generally to payment of medical services she receives. The Department, however, has asserted that the type of medical services Ms. Allen received come within an exception. It is the Department, therefore, that is asserting the affirmative in this proceeding: that Ms. Allen's treatment comes within an exception to coverage. The fact that Ms. Allen is arguing that the exception does not apply does not constitute the taking of an affirmative position.

    
    

18. Based upon the foregoing, it is the Department that has the ultimate burden to establish by a preponderance of the evidence that the exclusion from coverage applies to Ms. Allen. J.W.C. Co., supra.

    
    

    1. Ms. Allen's Treatment is "Experimental" as Defined for Purposes of the Insurance Plan.

    
    

19. The Department has been delegated authority to administer the Insurance Plan. Section 110.123(5)(a), Florida Statutes. Pursuant to its authority, the Department has promulgated the Benefit Document establishing the benefits, limitations and exemptions of the Insurance Plan.

    
    

20. The Insurance Plan generally covers expenses incurred for medically necessary services or supplies. A "medically necessary service" is defined as a service that is required to identify or treat an illness, injury or mental or nervous disorder which a physician has diagnosed or reasonably suspects.

    
    

21. Pursuant to the Benefit Document and information provided to persons covered by the Insurance Plan, the Department has provided that services and procedures that are "experimental" are excluded from coverage under the Insurance Plan.

    
    

22. The Benefit Document provides a definition of what constitutes an "experimental" procedure or service. Among other things, the Benefit Document defines "experimental" if it is determined that:

    
    

    2. reliable evidence shows that such evaluation, treatment, therapy, or device is the subject of an ongoing Phase I, II, or III clinical investigation or under study to determine: maximum tolerated dosage(s), toxicity, safety, efficacy, or efficacy as compared with the standard means for treatment or diagnosis of the condition in question;

    
    

23. "Reliable evidence" is defined to include "the written protocol or protocols relied upon by the treating physician or institution" and "the written informed consent used by the treating physician or institution."

    
    

24. The Protocol and the consent form used by the Caner Center for the services provided to Ms. Allen indicate that the treatment provided to Ms. Allen was under a Phase I-II clinical investigation.

    
    

25. The Protocol and consent form constitute unrefuted "reliable evidence" that Ms. Allen's treatment comes within the definition of "experimental" contained in the Insurance Plan.

RECOMMENDATION

Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Department of Management Services, Division of State

Employees' Insurance, enter a Final Order denying payment for the services received by Ms. Allen pursuant to the Phase I-II Study and dismissing Floretta Allen's petition.

DONE AND ENTERED this 3rd day of June, 1994, in Tallahassee, Florida.

LARRY J. SARTIN

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 3rd day of June, 1994.

APPENDIX

Case Number 93-3728

The Department has 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 have been accepted, if any. Those proposed findings of fact which have been rejected and the reason for their rejection have also been noted. Ms. Allen did not file a proposed recommended order.

The Department's Proposed Findings of Fact

1. Accepted in 1-2.

2. Hereby accepted.

3. Accepted in 3 and 5.

4. See 4. The specific findings contained in this paragraph are based upon what purports to be an article published in a periodical. It constitutes unsubstantiated hearsay and the article was not properly identified or authenticated for the purpose for which the Department has relied upon it to support the proposed findings of fact contained in this paragraph.

5. Accepted in 6.

6. Accepted in 6.

7. Accepted in 7-8.

8-9 Hereby accepted.

1. Not supported by the weight of the evidence. The specific findings contained in this paragraph are based upon what purports to be an article published in a periodical. It constitutes unsubstantiated hearsay and the article was not properly identified or authenticated for the purpose for which the Department has relied upon it to support the proposed findings of fact contained in this paragraph.

2. Accepted in 9.

3. Accepted in 14.

4. Accepted in 13 and hereby accepted.

5. Accepted in 28 and hereby accepted. 15-16 See 27.

1. Accepted in 29.

2. Accepted in 26. 19-22 Hereby accepted.

1. Not supported by the weight of the evidence. The specific findings contained in this paragraph are based upon what purports to be an articles published in periodicals. They constitute unsubstantiated hearsay and the articles were not properly identified or authenticated for the purpose for which the Department has relied upon them to support the proposed findings of fact contained in this paragraph.

2. Accepted in 34 and hereby accepted. 25-27 Hereby accepted.

1. Accepted in 30 and 32.

2. Hereby accepted.

3. Accepted in 20 and hereby accepted.

4. Hereby accepted.

5. Accepted in 20.

6. Accepted in 21.

7. Accepted in 22.

8. Hereby accepted.

COPIES FURNISHED:

Arthur R. Shell, Jr., Esquire

502 Northwest 75th Street, Suite 10 Gainesville, Florida 32607

Augustus D. Aikens, Jr.

Chief of Bureau of Benefits and Legal Services

Division of State Employees' Insurance Department of Management Services

2002 Old St. Augustine Road, B-12 Tallahassee, Florida 32301-4876

William H. Lindner, Secretary Department of Management Services Knight Building, Suite 307

Koger Executive Center 2737 Centerview Drive

Tallahassee, Florida 32399-0950

Paul A. Rowell, General Counsel Department of Management Services Knight Building, Suite 312

Koger Executive Center 2737 Centerview Drive

Tallahassee, Florida 32399-0950

Alecia Runyon, Director Department of Management Services

Division of State Employees' Insurance 2002 Old St. Augustine Road, B-12 Tallahassee, Florida 32301-4876

NOTICE OF RIGHT TO SUBMIT EXCEPTIONS

All parties have the right to submit written exceptions to this Recommended Order. All agencies allow each party at least 10 days in which to submit written exceptions. Some agencies allow a larger period within which to submit written exceptions. You should contact the agency that will issue the final order in this case concerning agency rules on the deadline for filing exceptions to 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: 93-003728

Orders for Case No: 93-003728