Pituitary Condition denials in California external review

What the reviewers wrote

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for (1) one millimeter (mm), fine cut T3 magnetic resonance imaging of the pituitary, (2) DXA bone density scan, and/or (3) additional testing for cyclic Cushing’s disease diagnosis (i.e. weekly 24-hour urine tests and late night salivary cortisol tests). The frequency of incidentally discovered signal abnormalities less than 10 mm varies. In this case, considering the stability of the pituitary lesion and the size of the reported microadenoma on previous magnetic resonance imaging (MRIs) of the pituitary gland, additional imaging is not indicated, as additional MRI would not change the management or outcome. MRI of the pituitary gland would be reasonable if a diagnosis of Cushing’s disease is established, and surgical treatments are being considered.

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for chromosomal microarray congenital hypothyroidism and thyroid hormone resistance panel. Accuracy in diagnosis is the bedrock of medicine. Diagnosis has been described as both a process and a classification scheme, a pre-existing set of categories agreed upon by the medical profession to designate a specific condition. Researchers explain, “Congenital hypothyroidism (CH) is the most common neonatal endocrine disorder. Although most patients present with isolated CH, some patients present with CH and extra-thyroidal congenital malformations (ECMs), for which less is known about the underlying genetics.” The authors further note that in a genetic study, chromosomal microarray (CMA) was used to identify 87.5% pathogenic and pathogenic variants in patients with CH.

Where the denial was upheld

Nature of Statutory Criteria/Case Summary: The parent of an enrollee has requested authorization and coverage for the medication Skytrofa Cartridge.Since 8/25/21, The U.S. Food and Drug Administration has approved Skytrofa (lonapegsomatropin-tcgd), a depot formulation of growth hormone administered weekly, to treat pediatric growth hormone deficiency. Published phase III randomized controlled trials (RCTs) have shown weekly lonapegsomatropin is non-inferior to daily somatotropin with respect to safety and efficacy for the treatment of growth hormone deficiency. Since lonapegsomatropin is administered weekly, the frequency of self-administration is reduced 86% each year, which improves compliance compared to daily injections.

Findings: The physician reviewer found that the patient has requested authorization and coverage for weekly 24-hour urine cortisol tests for five to six weeks total (in addition to the plan’s authorized weekly tests for three weeks) and late-night salivary cortisol collections two to three times per week for five to six weeks total (in addition to the plan’s authorized weekly tests for three weeks). A thorough review of the current medical literature suggests that cyclical Cushing’s is a difficult-to-diagnose condition, typically presenting with more definitive clinical and biochemical signs over time. The cycles of hypercortisolism can occur regularly or irregularly with inter-cyclic phases ranging from days to years. The frequency of testing that is requested by this patient is not supported by the current medical literature.

These outcomes describe eligible cases completed through California DMHC’s Independent Medical Review program. They do not estimate the chance that an internal appeal, an external review in another jurisdiction, or your individual case will succeed. Use the record to identify evidence patterns involving pituitary condition, then check the rights and deadlines that apply to your plan.