STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

RECOMMENDED ORDER

Pursuant to notice, a formal hearing was held in this case on January 4, 2010, in Tallahassee, Florida, before Lawrence P. Stevenson, a duly-designated Administrative Law Judge of the Division of Administrative Hearings.

APPEARANCES

For Petitioner: Debra Myers, RN, CCM, CLNC

Qualified Representative Pfizer Bridge Program Post Office Box 220746

Charlotte, North Carolina 28222-0746

For Respondent: Sonja P. Mathews, Esquire

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

Tallahassee, Florida 32399 STATEMENT OF THE ISSUE

Whether the Department of Management Services properly denied medical insurance reimbursement to Petitioner, a covered

dependent of a state employee insured by the State Employees' Preferred Provider Organization health plan, for Genotropin recombinant growth hormone prescribed for the treatment of long- term growth failure associated with idiopathic short stature.

PRELIMINARY STATEMENT

By letter dated May 14, 2009, the Department of Management Services, Division of State Group Insurance (the "Department") notified Debra Myers, the clinical liaison for the Pfizer Bridge Program, that her client, Petitioner Arturo Puerto, did not meet the relevant criteria for benefit coverage of Genotropin. By letter dated May 21, 2009 and filed with the Department on

May 29, 2009, Ms. Myers requested a formal administrative hearing to contest the denial of benefits. On October 23, 2009, the Department forwarded the case to the Division of Administrative Hearings for assignment of an Administrative Law Judge and the conduct of a formal administrative hearing. The case was scheduled for hearing on January 4, 2010, on which date the hearing was held. Without objection from the Department, the undersigned granted Petitioner's motion that Ms. Myers and Petitioner's mother, Dana Cribbs Puerto, be allowed to participate via telephone. Also without objection from the Department, Ms. Myers was accepted as Petitioner's qualified representative pursuant to Florida Administrative Code Rule 28- 106.106.

At the hearing, Petitioner presented the testimony of

Ms. Myers and Ms. Puerto. Petitioner offered no exhibits. The Department presented the testimony of Sandy Wade, its group benefits administrator, and the deposition testimony of

William L. Fulcher, M.D., M.Ed., medical director in the division of medical affairs for Caremark. The Department's Exhibits numbered 1 through 10 were admitted into evidence.

The hearing was not transcribed. The Department filed a Proposed Recommended Order on January 13, 2010. Petitioner did not submit a proposed recommended order.

FINDINGS OF FACT

Based on the oral and documentary evidence adduced at the final hearing, and the entire record in this proceeding, the following findings of fact are made:

1. The state group insurance program is a package of insurance plans offered to, among others, state employees and their dependents. § 110.123(2)(k), Fla. Stat.1/

2. Petitioner Arturo Puerto is insured as a dependent of a state employee, and is a participant in the state's group self- insured plan, known as the State Employees' Preferred Provider Organization health plan ("PPO plan" or "state plan"). The state plan includes a state employees' prescription drug program. § 110.12315, Fla. Stat.

3. Pursuant to Section 110.123(3)(c), Florida Statutes, the Department is responsible for contract management and day- to-day management of the state employee health insurance program. Section 110.123(5)(c), Florida Statutes, authorizes the Department to contract with an insurance carrier or professional administrator to administer the state plan.

4. The current contract provider of the state plan's pharmacy program is CareMark Inc. ("CareMark"). However, the Department makes all final decisions concerning the existence of coverage or covered benefits under the state plan. The Department's authority in this regard may not be delegated to a contract provider. § 110.123(5), Fla. Stat.

5. Petitioner was born on February 12, 1992.

   
   

6. On or about February 3, 2009, Petitioner's physician prescribed Genotropin, a recombinant growth hormone ("GH")2/ approved by the United States Food and Drug Administration ("FDA") as therapy for short stature, including idiopathic short stature ("ISS").

7. ISS is short stature that does not have a diagnostic explanation, in an otherwise healthy child. ISS is also called "non-GH-deficient short stature."

8. The Group Health Insurance Plan Booklet and Benefits Document, effective January 1, 2007, as modified on January 1,

   2009, includes the terms and conditions of participation in the PPO plan and the benefits provided by the PPO plan.

9. The booklet and benefits document contains a section describing the prescription drug program. Participants in the PPO plan are automatically enrolled in the prescription drug program, which features a network of retail pharmacies and a mail order program. The participant makes a co-payment for covered prescriptions.

10. The booklet and benefits document sets forth a list of drugs that are covered, and a list of drugs that are not covered under the prescription drug program. Under the heading "Important Information about the Prescription Drug Program," the document states the following concerning specialty medications:3/

    5. Certain medications, including most biotech drugs, are only available through Caremark Specialty Pharmacy Services. Generally, these drugs are for chronic or genetic disorders including, but not limited to, multiple sclerosis, growth deficiency and rheumatoid arthritis and may require special delivery options, (i.e. temperature control). Caremark Specialty Pharmacy provides 24/7 access and can be contacted at 1-800-237-2767.

    
    

    * * *

    
    

    12. As part of the Caremark Specialty Services, Caremark will administer the Advanced Guideline Management program for the State Employees' PPO Plan. Advanced Guideline Management is intended to optimize outcomes and promote the safe, clinically appropriate and cost-effective use of

    specialty medications supported by evidence based medical guidelines. Failure to meet the criteria for Advanced Guideline Management during the respective use review will result in denial of medication coverage for the Plan participant and discontinuation of medication coverage for the Plan participant in the case of concurrent use review.

    
    

    The Advanced Guideline Management Program is a process by which authorization for a specialty medication is obtained based on the application of currently acceptable medical guidelines and consensus statements for appropriate use of the medication in a specific disease state. Therapies reviewed under the Specialty Guideline Management Program include, but are not limited to, the following: multiple sclerosis, oncology, allergic asthma, human growth hormone, hepatitis C, psoriasis, rheumatoid arthritis, and respiratory syncytial virus. Additional therapies may be added from time to time....

    
    

11. CareMark's current guideline covering Genotropin and similar GH medications is set forth in a 2008 CareMark document titled, "Specialty Pharmacy Program for Growth Hormone and Endocrine-Metabolic Disorders." The document contains flow charts describing the criteria employed by CareMark to determine coverage for specific conditions.

12. Among the criteria set forth in the flow chart for prescribing GH to children with ISS is the following question: "Does pre-treatment growth velocity and height meet the AACE (American Association of Clinical Endocrinologists) criteria for short stature?" (See Appendix N). If the answer to the

    question is "no," then the criteria direct that coverage for the prescription of GH should be denied.

13. Appendix N sets forth the following "AACE criteria for short stature":

    • < -2.25 standard deviations below the mean for age and sex

      
      

    • based on patient's growth rate, adult height prediction of less than 5'3" for boys and less than 4'11" for girls.

      
      

14. Appendix N is based on the AACE's "Medical Guidelines for Clinical Practice for Growth Hormone Use in Adults and Children-- 2003 Update" and a December 2003 AACE Position Statement on growth hormone usage in short children.4/ The CareMark document is not explicit as to whether the quoted elements of the AACE criteria for short stature are to be considered in the disjunctive. However, the AACE Position Statement expressly states that GH use is indicated for ISS only for children whose height is "< - 2.25 standard deviations below the mean and have an adult height prediction of less than 5'3" for boys and less than 4'11" for girls." (Emphasis added.)

15. The height standard deviation criterion used by CareMark to determine the appropriateness of Genotropin therapy as a treatment for ISS was shown to be consistent with FDA criteria and the specifications established by Pfizer, the manufacturer of Genotropin.

16. The medical records submitted on behalf of Petitioner show that at the time Genotropin therapy was prescribed in February 2009, Petitioner's height was 162.5 cm (5'4"). This was 1.66 standard deviations below the mean for his age and sex. Untreated, his predicted final height was 164 cm (5'4 1/2").

17. At the time Genotropin therapy was prescribed, Petitioner did not meet the height standard deviation requirement. His height standard deviation was 1.66 standard deviations below the mean. The deviation required by the CareMark criteria was greater than 2.25 standard deviations below the mean.

18. At the time Genotropin therapy was prescribed, Petitioner did not meet the adult height prediction requirement. Petitioner was already 5'4" tall and was projected to reach a height of 5'4 1/2" without treatment. The CareMark criteria required a projected adult height without treatment of 5'3" or below.

19. The PPO plan denied payment for the Genotropin therapy because Petitioner did not meet criteria established by CareMark through its Specialty Pharmacy Program guidelines.

20. The booklet and benefits document makes no provision for exceptions to strict conformity to the CareMark criteria.

21. At the hearing, Petitioner's representative acknowledged that Petitioner does not meet the criteria for

    Genotropin therapy, but requested that the Department order such coverage as an exception to the criteria.

    CONCLUSIONS OF LAW

    
    

22. The Division of Administrative Hearings has jurisdiction over the parties and subject matter of this proceeding. §§ 120.569 and 120.57(1), Fla. Stat.

23. The Group Health Insurance Plan Booklet and Benefits Document contains the terms and conditions of participation in the state group insurance program. The booklet and benefits documents provides that insurance coverage is limited to the express written terms set forth therein.

24. Exclusions from coverage in insurance policies are to be strictly construed against the insurer. Comprehensive Health Association v. Carmichael, 706 So. 2d 319, 320 (Fla. 4th DCA 1997). Insurance contracts are to be construed in accordance with the plain language of the policy. Even an exclusionary provision should be enforced according to its terms, if the provision is clear and unambiguous. Bonich v. State Farm Mutual Automobile Insurance Company, 996 So. 2d 942, 943 (Fla. 2d DCA 2008).

    
    

25. In this case, the policy exclusion is plainly written, clear and unambiguous. The booklet and benefits document clearly states that growth hormone therapy is subject to the

    requirements of the CareMark Specialty Pharmacy Program. These requirements track the prescription requirements of the AACE, the FDA, and the manufacturer of Genotropin, the medication prescribed for Petitioner.

26. Petitioner did not meet the prescription requirements of the CareMark program.

27. Petitioner could point to no statute or rule that gives the Department discretion to depart from the plain meaning of the booklet and benefits document. Under the facts presented in this case, the Department correctly denied benefits coverage to Petitioner for Genotropin treatment.

RECOMMENDATION

Based upon the foregoing Findings of Fact and Conclusions of Law set forth herein, it is

RECOMMENDED:

That the Department of Management Services, Division of State Group Insurance enter a final order denying coverage for Petitioner's prescription for Genotropin therapy.

DONE AND ENTERED this 10th day of March, 2010, in Tallahassee, Leon County, Florida.

S

LAWRENCE P. STEVENSON

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 10th day of March, 2010.

ENDNOTES

1/ Unless otherwise indicated, references to the Florida Statutes are to the 2009 edition.

2/ "Recombinant" indicates that the growth hormone is synthesized in the laboratory. Genotropin's marketing materials indicate that it is an exact copy of the natural growth hormone produced by the human body.

3/ "Specialty medications" are generally defined in the pharmaceutical industry as high cost drugs that require special handling (such as refrigeration) and close monitoring of adherence to treatment protocols.

4/ The AACE Medical Guidelines were introduced as evidence in this proceeding. The AACE Position Statement is referenced at endnote 15 of the 2008 CareMark document, and may be found at http://www.aace.com/pub/positionstatements/ShortChildren.php.

COPIES FURNISHED:

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

Tallahassee, Florida 32399

Debra Myers, RN, CCM, CLNC Pfizer Bridge Program

Post Office Box 220746

Charlotte, North Carolina 28222-0746

John Brenneis, General Counsel Division of Management Services 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: 09-005872

Orders for Case No: 09-005872