STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

GEORGE AND ASHLEA YEARWOOD,

Petitioners,

vs.

DEPARTMENT OF MANAGEMENT SERVICES,

Respondent.

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) Case No. 10-0987

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RECOMMENDED ORDER

Pursuant to notice, a final hearing was conducted in this case on April 20, 2010, via video teleconference between sites in Tallahassee and Orlando, Florida, before Administrative Law Judge R. Bruce McKibben of the Division of Administrative Hearings.

APPEARANCES

For Petitioners: George and Ashlea Yearwood, pro se

1530 Eagle Nest Circle

Winter Springs, Florida 32708

For Respondent: Sonja P. Mathews, Esquire

Department of Management Services 4050 Esplande Way, Suite 160

Tallahassee, Florida 32399-0950 STATEMENT OF THE ISSUES

The issues in this case are whether the criteria for approval of the prescription drug Norditropin exist under the Specialty Guideline Management Program; and whether Petitioner's

son's growth hormone deficiency has been established by sufficient medical evidence.

PRELIMINARY STATEMENT

On December 1, 2009, Respondent, Department of Management Services (the "Department"), issued a letter to Petitioners, George and Ashlea Yearwood, indicating that their son, Tyler Yearwood, did not meet the State Employee's Preferred Provider Organization Health Plan (the "PPO" or "State Plan") criteria for coverage of the prescription drug, Norditropin, a human growth hormone. Petitioners timely filed a request for a formal administrative hearing to contest the final agency action by the Department.

At the final hearing, Petitioners represented themselves, and each of them testified under oath. Petitioners offered two exhibits into evidence. Respondent was allowed to file its objections to the two exhibits following conclusion of the final hearing. Petitioners were afforded the opportunity to respond to Respondent's objections. Based upon a review of the objections and response thereto, the exhibits were rejected on hearsay grounds.

The Department called one witness, Cathy Flippo, RN. Further, the testimony of Joan O'Rourke, vice president of strategic operations for CVS Caremark; and Karen O. Klein, M.D., was presented by way of deposition transcripts. The

Department's Exhibits 6, 7, 12, 17, 19, 20, 22, 23 and 26, as well as the aforementioned deposition transcripts, were accepted into evidence. The parties advised that no transcript of the final hearing would be ordered. The parties were given until ten days after ruling upon the Department's objections to Petitioners' two exhibits to file proposed findings of fact and conclusions of law. Each party timely submitted a Proposed Recommended Order, and each was duly considered in the preparation of this Recommended Order.

FINDINGS OF FACT

1. Petitioners are the parents of Tyler Yearwood, an 11-year-old child. Petitioners are employees of the State of

   Florida and are covered by a State Group Insurance policy under the State Plan.

2. Respondent is the state agency responsible for administration of the state health insurance program as set forth in the State Plan.

3. The State Plan is generally governed by the Group Health Insurance Plan Booklet and Benefits Document ("Benefits Document"), which contains the terms and conditions of participation in the PPO. Benefits to be provided to participants in the State Plan are set forth in the Benefits Document. The Benefits Document includes a Prescription Drug Program which states that certain medications are available only

   
   

   through Caremark Specialty Pharmacy Services ("Caremark"). Caremark was the designated provider of pharmacy services under the State Plan at all times relevant hereto.

4. Tyler was born on February 17, 1999, and was 20.5 inches at birth, weighing eight pounds and two ounces. Tyler's father is five feet, seven inches in height; his mother is five feet, six inches tall. When Tyler was quite young, his parents began having concerns as to whether Tyler would reach an "average" adult height. They began to monitor Tyler's growth and sought medical intervention. From age two through nine, Tyler remained at or near the 50th percentile in height. Three evaluations taken between age ten and 11 indicate that Tyler was at approximately the 30th percentile for height.

5. Petitioners have requested coverage under the State Plan for the prescription drug, Norditropin, by way of a Pediatric GHD Authorization filed by Paul Desrosiers, M.D. Norditropin, a specialty drug, is a human growth hormone used to address growth hormone deficiency ("GHD") issues in children. The Benefits Document advises participants that failure to meet the criteria of the Advanced Guideline Management Program (which dictates which specialty drugs will be approved) will result in denial of coverage.

6. At the time medical records were submitted in support of Petitioners' request for Norditropin, Tyler's adult height

   
   

   was projected to be five feet, three inches (which is within the standard set forth in the Caremark guidelines). Tyler's height deviation at that time was -.97 (i.e., less than the -2.25 standard set forth in the guidelines).

7. Authorization for a specialty drug can be obtained based on the application of currently acceptable medical guidelines. Growth hormones are one of the specialty drugs for which satisfaction of the medical review criteria is required.

8. Thus, Norditropin is only available through Caremark Specialty Services and, as a specialty drug, is subject to review and approval under Caremark's Specialty Guideline Management Program. That program includes the following

   provision:

   
   

   As part of the Caremark Specialty Services, Caremark will administer the Specialty Guideline Management program for the State Employees' PPO Plan. Specialty 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 Specialty 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 the concurrent use review.

   
   

   Therapies reviewed under the Specialty Guideline Management Program include, but are not limited to, the following: multiple sclerosis, oncology, allergic asthma, human

   
   

   grown hormone, hepatitis C, psoriasis, rheumatoid arthritis, and respiratory syncytial virus. Additional therapies may be added from time to time.

   
   

9. The Caremark guidelines criteria used to determine whether Norditropin is appropriate for a child diagnosed with GHD is set forth in Figure 2, an algorithm contained within the guidelines. Figure 2 contains a series of steps that are used to determine whether a participant meets the requirements for growth hormone therapy. Petitioner's son met four of the five steps in the algorithm. Step 1 determines whether there is a diagnosis of pediatric growth hormone deficiency--there is. Step 2 makes sure the patient is not a neonate; Tyler is not. Step 3 determines whether the patient is currently on growth hormone therapy; Tyler is not. And, then, Step 4 involves the collection of pre-treatment age and height information.

10. Step 5 of the algorithm states: "Does patient have delayed bone age AND pre-treatment growth velocity and height that meet the AACE criteria for short stature?" (AACE is the American Association of Clinical Endocrinologists.) The query then directs the user to Appendix N to the guidelines. Appendix N contains the following criteria:

    1. <2.25 standard deviations below the mean for age and sex;

       
       

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

       
       

11. The Department undertook a review of Petitioners' request for the GHD treatment for Tyler under the Specialty Guideline Management Program criteria. It found that the records provided by Petitioners did not establish the criteria for approval of Norditropin. In fact, the Department found that there was no evidence of GHD. Its independent medical reviewer (Dr. Klein) found:

    This patient [Tyler]'s lack of the criteria for short stature does not rule out growth hormone deficiency. However, he does not have enough criteria to make the diagnosis of growth hormone deficiency. He only has the failure of the test and short periods of slow growth interspersed with normal growth. His weight gain may have made him taller than expected at the 75th% and his weight loss brought him back to his genetic potential at the 25th-50th%. More time is needed to determine whether his growth persists at a low rate, in which case growth hormone treatment would be medically necessary.

    
    

12. Based upon its findings, the State Plan denied coverage for the requested GHD treatment because Tyler did not meet the criteria established by Caremark.

13. Petitioners assert that the -2.25 deviation standard used by Caremark is an idiopathic standard that does not apply to GHD children. While it is true that the standard does apply to idiopathic short-stature children, it is obviously used for GHD children as well. Dr. Klein agrees that the standard comes from idiopathic literature, but her conclusion regarding Tyler

    
    

    was not based on application of that standard. Dr. Klein's initial review of Tyler's case acknowledged that Caremark applied the -2.25 deviation standard, but she did not use that finding as the basis for her ultimate conclusion.

14. Both parties use articles and information from medical journals and publications in support of their positions. However, those hearsay statements, without corroboration by a person knowledgeable in the areas at issue, cannot be used to make findings in this case. The interpretations by the parties as to the use of the -2.25 deviation standard are both self- serving. Nonetheless, it is clear Caremark utilized the -2.25 deviation standard (and perhaps other standards, as well) in its published guidelines. Caremark's reliance on that standard has not been proven to be erroneous or improper. While other standards might also apply to the request by Petitioners for

    GHD treatment, there is no evidence that such standards are superior to the standard used by Caremark.

    CONCLUSIONS OF LAW

    
    

15. The Division of Administrative Hearings has jurisdiction over the parties to and the subject matter of this proceeding pursuant to Section 120.569 and Subsection 120.57(1), Florida Statutes (2009).

16. Petitioners have the burden of proof in this matter as they are asserting the affirmative of the issue. Balino v.

    
    

    Department of Health and Rehabilitative Services, 348 So. 2d 349 (Fla. 1st DCA 1977).

17. The Department is responsible for managing the state health insurance program. § 110.123(3)(c), Fla. Stat. (2009). Subsection 110.123(5)(c), Florida Statutes (2009), gives Respondent the authority to contract with private entities in the administration of the health insurance program. Pursuant to that authority, Respondent has contracted with Caremark for the provision of pharmacy services under the State Plan.

18. Under the guidelines set forth by Caremark in the administration of pharmacy services under the State Plan, Tyler Yearwood does not satisfy the criteria for approval of Norditropin to treat his GHD concerns. Although Petitioners correctly point out that the -2.25 deviation standard is more generally used to monitor idiopathic short-stature children, there is no showing that application of that standard to GHD children is wrong. Petitioners have failed to meet their burden of proof.

RECOMMENDATION

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

RECOMMENDED that a final order be entered by Petitioner, Department of Management Services, denying Petitioners, George

and Ashlea Yearwood's, request for growth hormone deficiency therapy.

DONE AND ENTERED this 11th day of June, 2010, in Tallahassee, Leon County, Florida.

R. BRUCE MCKIBBEN 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 11th day of June, 2010.

COPIES FURNISHED:

John Brenneis, General Counsel Department of Management Services 4050 Esplanade Way, Suite 160

Tallahassee, Florida 32399-0950

Sonja P. Matthews, Esquire Department of Management Services 4050 Esplanade Way, Suite 160

Tallahassee, Florida 32399-0950

George Yearwood Ashlea Yearwood

1530 Eagle Nest Circle

Winter Springs, Florida 32708

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: 10-000987

Orders for Case No: 10-000987