Appeal type: Outpatient Therapies
Decision: Favorable

 
We decided that the Plan has to pre-approve Selective Internal Radiation Therapy (SIRT) / Yttrium-90 
radioembolization (77772). 
 
You asked the Plan to pre-approve SIRT. You say that you disagree with the denial. The Plan denied your 
request. The Plan says that the clinical value and effectiveness of SIRT to treat liver metastases from prostate 
cancer have not been demonstrated in the peer-reviewed literature. More research is needed to show safety and 
efficacy of the procedure. 
 
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. 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 FDA has in fact approved 
the use of 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 20-60 micro-m beads and therespheres being Y90 embedded glass beads with 
20-30 micro-m 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 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 with prostate cancer. There are no 
randomized trials for the use of radioembolization with hepatic metastases from prostate cancer. As stated 
above, the technique of radioembolization for liver metastases itself is not investigational.  For this enrollee, 
quality of life can be substantially improved with this technique. The radioembolization may not prolong life, 
and certainly will not cure the condition, but it has a reasonable likelihood of preventing (or delaying) 
symptomatic progression. In the reviewers opinion, Y-90 microspheres/radioembolization is medically 
necessary for non-colorectal cancer liver metastases, among enrollees with liver-only or liver-dominant 
metastases, in the setting of chemo refractory disease, or 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 paucity of 
literature supporting Y-90 microspheres in enrollees with liver metastases from prostate cancer; nevertheless, 
Y-90 microspheres do target the liver with an effective agent and can be considered medically necessary when 
other options are not available. Because of bulky liver disease that is imminently life-threatening, 
radioembolization would be within the accepted standard of care. The decision is therefore 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 have been met. Therefore, we decided that the Plan has to pre-approve 
Selective Internal Radiation Therapy (SIRT) / Yttrium-90 radioembolization (77772).   
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.