Appeal type: Practitioner Services
Decision: Unfavorable

 
We decided that the Plan does not have to pre-approve intensity-modulated radiation therapy (IMRT). 
 
You asked the Plan to pre-approve IMRT. You say that IMRT is medically necessary for this patient with stage 
IIIA abdomen gall bladder adenocarcinoma. The Plan denied your request. The Plan says the patient does have 
locally advanced cholangiocarcinoma, but was able to have surgery at the end of 2022. There is no good data 
for the use of IMRT in this situation. There is no compelling comparison data with which to make a dosimetric 
case for IMRT in this situation. 
 
The Plan must follow Medicare rules. Medicare rules say that items and services that are not medically 
necessary are not covered.  
 
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 IMRT. Our reviewer says that the 
requested items/services are not considered medically reasonable and necessary in this case. Our physician 
reviewer found In general, IMRT is not an experimental technique, but rather a radiation planning and delivery tool available to the radiation oncologist to better shape the radiation dose distribution, and therefore minimize 
the dose to normal structures. IMRT is a tool that clinicians can use when there is concern about sparing 
normal tissues from high dose exposure. IMRT employs inverse planning, using input dose-volume constraints, 
and an inverse planning algorithm which maximized a plans adherence to these constraints.  
 
While cancer of the gallbladder is relatively rare, there are single institution studies to suggest that IMRT for 
pancreatic and biliary cancers yields improved radiation dosimetric plans versus conventional radiation with 
respect to normal tissue sparing.  Gallbladder malignancies are treated similarly to pancreatic and biliary 
cancers. The guidelines do not specifically address when IMRT should be used over 3D conformal radiation. 
The guidelines do describe normal tissue dose volume recommendations for the kidneys, stomach, small bowel, 
liver and spinal cord. 
 
The American Society for Radiation Oncology (ASTRO) model policy states that "disease sites that frequently 
support the use of IMRT include abdominal malignancies when dose constraints to small bowel or other 
normal tissues are exceeded." The doctors review states that IMRT is medically necessary when justified with 
quantitative dosimetric information that shows a clinically meaningful reduction in radiation dose exposure of 
normal tissues. In order for toxicity risks to be reduced, there should be a clinically significant reduction in 
dose to critical structures, with an evidence basis of benefit with dose reduction. 
 
There is a plan comparison in the case records, but it is not legible, and the records do not specify what 
dosimetric parameters necessitate IMRT. It is plausible that IMRT would reduce bowel exposure in a clinically 
meaningful manner, but the case records do not explicitly describe this, and the provided records are too grainy 
to decipher to know if the 3DRT plan is not acceptable. Simply providing 2 plans and stating that IMRT is 
necessary does not constitute sufficient documentation for medical necessity of IMRT for patients with gall 
bladder cancer, for which IMRT is not standard outside of a quantifiable dosimetric rationale. 
 
We looked at this physician's review, the file, and Medicare rules. Based on this information, we decided that 
Medicare rules for coverage of IMRT have not been met. Therefore, we decided that the Plan does not have to 
pre-approve intensity-modulated radiation therapy (IMRT).