Sarcoidosis denials in California external review

What the reviewers wrote

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: A patient has requested authorization and coverage for positron emission tomography (PET) with concurrently acquired computed tomography (CT) for attenuation correction and anatomical localization imaging; skull base to mid-thigh. Although PET/CT is not considered part of the standard workup of sarcoidosis, there is increased evidence showing that it is a valuable tool in the diagnosis and management of sarcoidosis, as well as the detection of additional inflammatory processes. PET/CT is sensitive for the detection of inflammatory activity in any organ in the body and is especially useful in complex medical cases. PET/CT can detect the presence of reversible granuloma, treatment response, extent of disease, and organ involvement. Additionally, it can help determine the site of diagnostic biopsy.

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for HP Acthar Vial. Acthar Gel, an adrenocorticotropic hormone (ACTH) analogue, is U.S. Food and Drug Administration approved for treatment of symptomatic sarcoidosis at a recommended dose of 40-80 units intramusculary or subcutaneously every 24-72 hours. Sarcoidosis is a systemic granulomatous disease of unknown etiology. Over the past few years, there have been advances in understanding of sarcoidosis. These include observations about the etiopathogenesis, diagnosis, and treatment of the disease. The first-line treatment is recommended to be glucocorticosteroids. However, the patient has tried and failed these options without success. In addition, the patient is diabetic and long-term use of steroids is not recommended.

Where the denial was upheld

ature of Statutory Criteria/Case Summary: An enrollee has requested OxyContin for treatment of her sarcoidosis. Findings: The physician reviewer found that chronic pain that is unable to be cured can be considered palliative in nature and treatment. The step wise World Health Organization (WHO) ladder for pain relief is considered the reasonable approach to pain control in the palliative setting. In this patient, the submitted records do not indicate that all non-opioid treatment options have been utilized nor does the documentation indicate an optimization of all non-opioid medications. Rather, quite large doses of opioids are being used despite research to show the dangers of a high dose and its lack of efficacy as it impacts quality of life. The submitted records do not show that this patient has participated in behavior therapy despite much research supporting its use.

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for H.P. Acthar Gel corticotropin injection 80 units subcutaneously, three times a week.The submitted documentation fails to demonstrate the medical necessity of the requested medication. Based on the available information, symptomatic sarcoidosis is a presumptive diagnosis in this patient at the current time. Sarcoidosis is a diagnosis of exclusion, with a broad differential diagnosis, including mycobacterial/fungal infection, hypersensitivity pneumonitis, drug-induced hypersensitivity, pulmonary histiocytic disorders, foreign body granulomatosis, vascular inflammatory disease, and primary immunodeficiencies. Thus, the diagnosis of sarcoidosis necessitates a broader infectious, pulmonary, occupational/environmental and inflammatory work-up.

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 sarcoidosis, then check the rights and deadlines that apply to your plan.