Appeal type: Practitioner Services
Decision: Favorable

 
We decided that the Plan has to pre-approve Selective Internal Radiation Therapy (SIRT) treatments using 
yttrium 90 microspheres (77470, 79445). 
 
You asked the Plan to pre-approve SIRT treatments. You say that the treatment is medically necessary. The 
Plan denied your request. The Plan says that Medicare does not cover unproven and not medically necessary 
procedures. There is not enough evidence that this type of radiation therapy is needed or effective 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 SIRT treatments. Our reviewer says 
that the requested items/services are considered medically reasonable and necessary in this case. Our physician 
reviewer found there are innumerable prospective and retrospective studies demonstrating the use of 
radioembolization for metastases for colorectal cancer or hepatocellular cancer. The Food and Drug 
Administration (FDA) has in fact approved the use of Selective Internal Radiation (SIR)-spheres/theraspheres 
for these indications. Radioembolization with Y90 embedded SIR-spheres/theraspheres is not outside the 
generally accepted professional medical standards as being safe and effective. There are slight technical 
differences between SIR-spheres and therapspheres, with SIR spheres being Y90 embedded resin with 2060-
centimeter (cm) beads and therespheres being Y90 embedded glass beads with 20-30 cm size. SIR Spheres 
have more embolic effect and less radioactivity per sphere. While SIR spheres are FDA approved for colorectal 
cancer liver metastases and theraspheres are approved for hepatocellular carcinoma (HCC), the principles of 
using a radioactive embolizing agent is the same for both, and thus the concept of radioembolization applies to 
both. 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 this enrollee. In an enrollee with reasonably good performance status, with 
chemorefractory disease and whose disease burden is confined (or mostly) within the liver (i.e., no or stable 
extra-hepatic visceral metastases) radioembolization for the liver disease is an accepted standard of care. The 
enrollee has had progression while on capecitabine and had previously been on Abemaciclib as well as 
fulvestrant. The reviewer would expect that the enrollee would have other systemic options though she does 
indeed have chemorefractory disease and the records do not explicitly describe a plan to start a new drug. The 
liver disease appears to be potentially life-threatening, and radioembolization, can be considered to be 
furnished in accordance with accepted standards. The decision is favorable. 
 
We looked at this physician's review, the file, and Medicare rules. Based on this information, we decided that 
Medicare rules for coverage of SIRT treatments have been met. Therefore, we decided that the Plan has to pre-
approve Selective Internal Radiation Therapy (SIRT) treatments using yttrium 90 microspheres (77470, 
79445).  
 
 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.