Appeal type: Experimental/Investigational
Decision: Overturned

Reviewer #3

Diagnosis: Hepatocellular carcinoma.

Treatment: internal radiation therapy outpatient services (37242 X 1, 37243 X 2).

The insurer denied coverage for internal radiation therapy outpatient services (37242 X 1, 37243 X 2).  The denial is overturned.

According to the medical records, the patient has a history of metastatic hepatocellular carcinoma as well as a large pituitary adenoma. The patient has extensive disease in the liver for which they have been recommended to proceed with palliative radiotherapy. The request is for approval of radioembolization and associated support codes.

The scientific evidence in peer-reviewed literature does support a result of improvement in health outcome. Radioembolization is proven to improve survival by preventing death from hepatic failure. It also minimizes the risk for worsening pain and liver dysfunction.      

Outpatient services (37242 X 1, 37243 X2) do have final approval from the appropriate regulatory bodies for this diagnosis. Radioembolization is Food and Drug Administration (FDA) approved in the member's setting.     

This patient is a good candidate for outpatient services (37242 X 1, 37243 X2). Radioembolization is indicated to improve survival and provide palliation for painful tumor bulk and liver capsule stretching.     

The outpatient services (37242 X 1, 37243 X2) are the best available treatment for this patient, at this time. Radioembolization will provide the quickest relief of symptoms.     
  
The adverse risks are not increased over standard treatment/services.     

The requested radioembolization service is likely to be more beneficial than any of the standard treatments/procedures for this patient. It will improve survival and quality of life significantly.

"Hepatocellular carcinoma (HCC) is the most common form of primary liver cancer and affects millions worldwide. Due to the lack of effective systemic therapies for HCC, researchers have been investigating the use of locoregional tumor control with Yttrium-90 (Y90) radioembolization since the 1960s. Following the development of glass and resin Y90 microspheres in the early 1990s, Y90 radioembolization has been shown to be a safe and efficacious treatment for patients with HCC across Barcelona Clinic Liver Cancer (BCLC) stages. By demonstrating durable local control, good long term outcomes, and equivalent if not superior tumor responses and tolerability when compared to alternative therapies including transarterial chemoembolization (TACE) and sorafenib, Y90 radioembolization is being increasingly used in HCC treatment. More recently, investigations into variations in Y90 radioembolization technique including radiation segmentectomy and radiation lobectomy have further expanded its clinical utility." (Saini, A. et al. 2019).

"Conclusions: Radioembolization with 90Y for unresectable ICC results in substantial downstaging, disease control, and survival" (Schartz, D. A. et al. 2022). 

In summary, the denial of outpatient services (37242 X 1, 37243 X2) and coverage for the requested treatment should be overturned. This treatment is likely to be more beneficial than any standard treatments for this patient's condition and the adverse risks are not substantially increased over standard treatments.