Appeal type: Other
Decision: Favorable

We decided that the Plan has to pre-approve mapping and Y-90 radioembolization (37243, 77790, 79445, and
96373).
You asked the Plan to pre-approve mapping and Y-90 radioembolization (37243, 77790, 79445, and 96373).
You say that the requested mapping and Y-90 radioembolization is medically necessary. The Plan denied your
request. The Plan says that the requested mapping and Y-90 radioembolization is not medically necessary.
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 mapping and Y-90 radioembolization
(37243, 77790, 79445, and 96373). Our reviewer says that the requested mapping and Y-90 radioembolization
is medically necessary. Our physician reviewer found the enrollee is diagnosed with secondary liver cell
carcinoma. Localized treatment options for liver metastases include resection, cryotherapy, radiofrequency
ablation embolization (radioembolization or chemoembolziation), and stereotactic radiation. Systemic therapy
is the standard treatment option for patients with liver metastases. 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 chemoembolization-TACE) and tends to 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 FDA has in fact approved the use of SIRspheres/
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 liver metastases from prostate cancer
(or more generally cancers other than colorectal cancer, neuronendocrine cancer or hepatocellular cancer).
As stated above, the technique of radioembolization for liver metastases itself is not investigational.
Radioembolization will not prolong life, and certainly will not cure the condition, but it has a reasonable
likelihood of preventing (ore delaying) symptomatic progression. It appears that the requested therapy
(radioembolization of hepatic metastases) would be more beneficial than other available therapies, given that
there is a documented response rate, and that other options such as chemotherapy would likely be ineffective in
this enrollee who has progressed while on many different systemic (including hormonal) therapies and/or is not
a candidate for systemic therapies.
My decision is favorable as radioembolization would be within accepted standards of medical practice for this
enrollee with no viable systemic therapy 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 mapping and Y-90 radioembolization (37243, 77790, 79445, and 96373) have been met. Therefore, we decided that the Plan has to pre-approve mapping and Y-90 radioembolization (37243,
77790, 79445, and 96373).