Appeal type: Outpatient Therapies
Decision: Favorable

We decided that the Plan has to pre-approve Yttrium-90 selective internal radiation therapy (SIRT) radioembolization of the liver lesion.

You asked the Plan to pre-approve the requested Y-90 SIRT. You say that it is felt that this is the only good option for treating the liver metastasis, and this treatment can prolong survival. There is no reason to think this would not be effective for a liver lesion associating with lung cancer. The Plan denied your request. The Plan says that the treatment is not supported for routine use for the enrollee's cancer.

The Plan must follow Medicare rules. Medicare rules say that if there are no specific coverage rules for an item or service, then that item or service will be covered when it is medically necessary. 

We asked our physician reviewer to carefully review the case file and apply the relevant Medicare rules to determine if the Plan was correct in denying the request to pre-approve the requested Y-90 SIRT. Our reviewer says that the requested services are considered medically reasonable and necessary in this case. Our physician reviewer found that whole liver radiation is a reasonable approach for palliation, though the toxicity and efficacy are likely inferior to Y-90 embolization/radioembolization, because the dose used for whole liver radiation is generally sub-therapeutic (due to the toxicity with the use of higher whole liver dosing). In general, radioembolization has durable response (perhaps more so than transarterial chemoembolization (TACE) and tends to be better tolerated than TACE. 

There are innumerable prospective and retrospective studies demonstrating the use of of radioembolization for metastases for colorectal cancer or hepatocellular cancer. The Food and Drug Administration (FDA) has in fact approved the use of SIR-spheres/theraspheres for these indications. Thus, the treatment itself is not investigational. Radioembolization is not outside the generally accepted professional medical standards as being safe and effective. The relevant question in this case is whether or not radioembolization is indicated for non-small cell lung cancer (NSCLC) in this patient. 

Radioembolization can be considered medically necessary for non-colorectal cancer liver metastases when no other acceptable standard therapy is available, or no other therapy is likely to be effective (i.e., chemo-resistant tumors). There is a lack of literature supporting Y-90 microspheres in patients with liver metastases from lung cancer; nevertheless, Y-90 microspheres target liver lesions with an effective agent and can be considered medically necessary when other options are not available. This patient received standard systemic therapy, is not a candidate for stereotactic body radiation therapy (due to the size of the lesion), not a candidate for percutaneous ablation (due to the proximity of the lesion to the colon). Therefore, radioembolization appears to be the best option for this patient with limited other options.

We looked at this physician's review, the file, and Medicare rules. Based on this information, we decided that Medicare rules for coverage of the requested Y-90 SIRT have been met. Therefore, we decided that the Plan has to pre-approve Yttrium-90 selective internal radiation therapy (SIRT) radioembolization of the liver lesion.

If the Plan does not agree with our decision, they can ask us to open a case again. We only open a case again if we believe there was a mistake or if there is new information to review. The Plan has to show us the mistake and/or send us the new information. This does not happen often. If we decide to open the case again, we will send you a letter.