Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Long haul COVID 19

Treatment: code J3262 Actemra 400 milligrams (mg) / 20 milliliter (ml) vial

The insurer denied coverage for code J3262 Actemra 400 milligrams (mg) / 20 milliliter (ml) vial

The denial is overturned.

This case involves an adult who contracted COVID.  Her initial symptoms consisted of fever, cough, shortness of breath, and headaches.  She was previously treated with Paxlovid which helped with the acute infection.  Afterwards, the patient developed persistent palpitations and throbbing in the chest along with shortness of breath on exertion as well as persistent tachycardia.  The symptoms were classic for a diagnosis of long COVID.  The patient also reported a persistent brain fog and lightheadedness with laboratory work-up revealing no end-organ damage.  She was found to have persistently elevated interleukin (IL-6) level in the blood, consistent with severe inflammatory disease.  The patient had "very low" C-reactive protein, suggesting a loss of function mutation of the IL-6 receptor.  The physician recommended a course of treatment with tocilizumab (Actemra) to help manage the long COVID symptoms and elevated IL-6 levels.  The patient received a notice of adverse determination regarding Actemra claiming that Actemra used to treat post COVID-19 conditions and other specified abnormal findings of blood chemistry is/are considered experimental or investigational.  There are not enough current published medical studies to show this drug is effective for improved health outcomes for the patient's diagnosis.  As result, the drug is not covered by the patient's plan.  The physician responded stating that the intention was to minimize the patient's symptoms and prevent possible progression of disease, which could result in end-organ damage.  This review pertains to Actemra.

The Food and Drug Administration states that Actemra is indicated for the treatment of multiple conditions to include hospitalized adult patients with coronavirus disease (COVID-19) who are receiving systemic corticosteroids and require supplemental oxygen, noninvasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).  Current medical literature notes that the blockade of IL-6 function by an anti-IL-6 receptor (IL-6R) antibody (tocilizumab, trade name Actemra) has been shown to be effective for the treatment of chronic autoimmune inflammatory diseases.  The patient in question contracted COVID-19 and continued to have symptoms associated with the virus.  She had persistently elevated IL-6 levels in her blood, consistent with severe inflammatory disease. Studies have also shown that IL-6 is elevated in long haul COVID patients compared to controls. Because there is no set and confirmed treatment for patients with long-haul COVID, existing drugs may be capable of treating those individuals who continued to suffer from symptoms associated with this virus.  Given that Actemra is supported by the Food and Drug Administration for treatment of patients with COVID-19 in general, it would be reasonable to trial the patient on this medication to manage her long COVID symptoms and elevated IL-6 levels.  As such, the request is medically necessary.

Based on the above, the insurer's denial must be reversed. The health care plan did not act reasonably and with sound medical judgment and in the best interest of the patient. 

The medical necessity for procedure code J3262 Actemra 400mg/20 ml vial, 400mg infused intravenously every 4 weeks for 6 months=400 units per dose for a total of 2800 Healthcare Common Procedure Coding System (HCPCS) units is substantiated.