Q.H. v. Sunshine State Health Plan, Inc.
| Decision Date | 07 October 2020 |
| Docket Number | No. 4D20-741,4D20-741 |
| Citation | 307 So.3d 1 |
| Court | Florida District Court of Appeals |
| Parties | Q.H. c/o A.H., Appellant, v. SUNSHINE STATE HEALTH PLAN, INC., Appellee. |
Morgan L. Weinstein of Weinstein Law, P.A., Fort Lauderdale, and Maria T. Santi of Health and Medicine Law Firm, Miami, for appellant
Craig H. Smith and Paige S. Comparato of Hogan Lovells US LLP, Miami, for appellee.
Nicholas A. Merlin, Senior Attorney, Tallahassee, for amicus curiae Agency for Health Care Administration.
Q.H., a 12-year-old girl, timely appeals a final administrative order of the Agency for Health Care Administration ("AHCA") upholding the denial of Medicaid coverage for a growth hormone treatment, Norditropin
Flexpro, prescribed by her physician. We reverse because under the applicable statutory framework, the Agency took too restrictive a view of what constituted a necessary treatment for the child.
The child, who turned 12 years old in July 2020, is an enrolled member of appellee Sunshine State Health Plan, Inc.’s Medicaid plan. In August 2019, Dr. Colette Meehan, a board-certified pediatric endocrinologist, first evaluated the child for her "short stature." Over the three years preceding this initial visit, the child's height dropped from the 45th percentile to the 25th percentile. Dr. Meehan diagnosed the child with growth hormone deficiency and prescribed the growth hormone Norditropin
to treat the condition.
In October 2019, Dr. Meehan submitted a Prior Authorization Request to Sunshine Health for approval of the Norditropin
medication. Evolved Pharmacy Solutions, the pharmacy benefit manager for Sunshine Health, denied the request on the ground that it was not medically necessary because the child's bone age was not "a minimum of one year behind chronological age." In denying the request, Evolved applied the AHCA's authorization criteria for growth hormone treatment in children.
The AHCA's criteria require that the child have an approved diagnosis with supporting documentation, that the child be 16 years old or younger, and that the treatment be prescribed by an endocrinologist, a pediatric endocrinologist, or a pediatric nephrologist. Additionally, with respect to the specific diagnosis of pediatric growth hormone deficiency, the AHCA's treatment criteria are as follows:
, glucagon, insulin and levodopa ): Confirmation of stimulation test(s) with peak serum GH concentration less than 10 ng/ml; or ... [listing other criteria]
Sunshine Health issued a corresponding Notice of Adverse Benefit Determination to the child, stating that the drug was not medically necessary because she did not meet the coverage guideline that her "bone age must be at a minimum of one year behind chronological age."
The child's mother requested an expedited plan appeal. Sunshine Health denied the plan appeal as follows:
Your child does not have a height that is less than 95% of children her age. Your child does not, on the x-ray of her wrist
show that her bones are growing at a rate (speed) that is behind her actual (real) age by at least one year. The blood tests sent in with this plan appeal did not have enough information, to support the criteria for needing treatment with this drug at this time.
The denial of the plan appeal further stated that "[t]his decision was made with regards to EPSDT," referring to the Early and Periodic Screening, Diagnostic, and Treatment benefit under Medicaid.
The child requested a Medicaid Fair Hearing regarding the denial of coverage. The AHCA issued a scheduling order, which set the hearing for late January 2020.
In compliance with the scheduling order, the child submitted a statement of the case and a memorandum of law to support her position on medical necessity. The child argued, among other things, that Sunshine Health's adverse benefit determination violated the EPSDT.
In preparation for the Fair Hearing, Sunshine Health sent the child's prior authorization request for an "independent external review," which was conducted by a board-certified pediatric endocrinologist. The peer review report concluded that the child "did not meet current policy standards/criteria for growth hormone administration." The report explained:
The matter proceeded to a Fair Hearing. During opening statements, the child's counsel elaborated on some of the arguments raised in her memorandum of law. The child's counsel first contended that prescriptions were mandated as a minimum benefit under section 409.973(1), Florida Statutes, and that the only limit on the use of Norditropin
under the Medicaid summary of drug limitations is that it cannot be received after the age of 16. The child's counsel further stated that Sunshine Health's denial of the treatment violated the EPSDT for the following reasons:
(1) the EPSDT allows limits to be placed on a prescription, but a denial is not a limit; (2) the EPSDT required Sunshine Health to consider "the particular needs of a child"; and (3) "prior authorization cannot delay a child's treatment."
The child's mother testified that the child had "just stopped growing" about three years ago. The mother explained that the child had "stayed basically the same height for three years, give or take a couple of centimeters." The mother noted that the child's shoe size and clothing size had not changed since the age of nine. The child's pediatrician referred the child to Dr. Meehan.
Dr. Meehan, the child's pediatric endocrinologist, testified that she diagnosed the child with "short stature" at the child's initial visit in August 2009. Dr. Meehan testified that based upon the mother's height of 5'5? and the deceased father's reported height of 6'0?, the child's estimated target mid-parental height was 5'6?, plus or minus two inches. Dr. Meehan acknowledged that the child's "bone age was not delayed," but explained that the child's predicted height was between 60.7 to 61.8 inches, which was "about five to six inches less than her genetic potential."
Dr. Meehan testified that the child underwent growth hormone stimulation testing, which "confirmed growth hormone deficiency." During the stimulation testing, the child "only peaked to a growth hormone level of 3.2." Prescription of a growth hormone "is indicated when the growth hormone peak is less than 10." According to Dr. Meehan, delayed bone age is not required to confirm a diagnosis of growth hormone deficiency: "No, it is suggestive, but it is not required for the diagnosis, and that is also part of the guidelines that we all follow as endocrinologists." She elaborated:
Dr. Meehan prescribed Norditropin
since it was preferred by the child's Medicaid plan. Because the child had a 3.2 growth hormone level, Dr. Meehan testified, there was "no question that she needs this medication." This treatment was within the standard of care. She acknowledged that any growth hormone could be prescribed to the child, but emphasized that "there is no other alternative to growth hormone" and that the child "requires growth hormone to treat growth hormone deficiency." Time is of the essence because the treatment needs to be given before the child goes through puberty and her growth plates fuse.
Dr. Meehan testified that she did not base her treatment recommendation on the AHCA guidelines, but rather relied upon the guidelines that were endorsed by the Pediatric Endocrine Society in 2015. She reiterated that the guidelines she followed were the "substantive standard of care for pediatric endocrinology patients."
When asked whether the child's growth velocity was greater than two standard deviations below the mean for her age and gender, Dr. Meehan testified:
Dr. Meehan admitted that: (1) the child was not less than the 5th percentile in terms of height, as she was at the 20th percentile the last time she was charted; and (2) the child's bone age was not a minimum of one year behind the chronological age. Dr. Meehan further conceded that the child did not meet all of the AHCA guidelines, elaborating: "In this policy statement that an endocrinologist did not write, yes."
Ultimately, Dr. Meehan suggested that following the AHCA's insurance guidelines would have violated the standard of care:
Dr. Whitney Moore-Smith, a clinical pharmacist at Sunshine Health, described the process leading up to the decision to deny Norditropin
, including the pharmacy benefit manager's initial denial of the prior authorization request "due to the unmet bone age requirement" and Sunshine Health's decision to uphold the denial in each review of the request. Dr. Moore-Smith also noted that "an external review was...
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