Appeal type: Practitioner Services
Decision: Unfavorable

 
We decided that the Plan does not have to pre-approve image guided radiation therapy (IGRT). 
 
You asked the Plan to pre-approve IGRT servicers. You say that this radiation care is medically reasonable and 
necessary for the enrollee's condition. The Plan denied your request. The Plan says the criteria for coverage 
have not been met. 
 
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 IGRT servicers. Our reviewer says that 
the requested items/services are not considered medically reasonable and necessary in this case. Our physician 
reviewer found that radiation is a standard approach to the treatment of skin cancer, and is often preferred over 
surgery when resection is likely to result in unacceptable morbidity or cosmesis.  
 
The use of superficial radiotherapy (SRT) or electronic brachytherapy for skin cancers that would be well-
treated with standard radiotherapy modalities such as electron therapy or orthovoltage radiotherapy.  The most 
recent National Comprehensive Cancer Network guidelines for basal cell and squamous cell skin cancers 
explicitly state There are insufficient long-term efficacy and safety data to support routine use of electronic 
surface brachytherapy. However, the treatment itself is not disputed in this case but rather the need for image guidance. IGRT is a means to improve set-up accuracy. IGRT uses daily image guidance to help localize the 
target so as to minimize normal tissue dosing. Specifically, IGRT allows accuracy of treatment delivery, so 
when generating a planning target margin, the margins can be reduced, and thus allow reduction in the volume 
of normal tissues exposed to radiation.  
 
Usually, IGRT is used when critical structures are abutting or in close proximity to the target that is being 
treated to high doses. This situation does not apply to this patient for which the target lesion can be seen on the 
skin to assist in daily set up. When treating skin cancers, there is generally not a need for IGRT unless deep 
structures are being treated. The case file includes a paper describing the use of daily ultrasound (Yu L, Oh C, 
Shea CR. The Treatment of Non-Melanoma Skin Cancer with Image-Guided Superficial Radiation Therapy: 
An Analysis of 2917 Invasive and In Situ Keratinocytic Carcinoma Lesions. Oncol Ther. 2021 Jun;9(1):153-
166). 
 
The paper notes: An ultrasound unit specifically designed to detect dermatologic structures using frequencies 
of 22 MHz (which is ideal for visualizing superficial skin depths of 06 mm) has been integrated with the 
commercial IGSRT unit (Sensus Healthcare). ... Adjustments to prescribed energy and daily dose were made 
on the basis of ultrasound findings to minimize radiation exposure, optimize clinical outcomes, and reduce 
potential toxicity. While the authors note changing energies and depth dose delivery in patients, there are no 
data to corroborate that such an approach would not compromise true coverage of the target. 
 
Notably, this paper describes the feasibility of using this approach but not the medical necessity.  Both authors 
have significant conflicts of interest in receiving payments from the manufacturer which clouds the conclusions 
which simply say that the treatment is safe and effective. As the medical necessity of the requested services is 
not supported, the criteria for coverage have not been met. 
 
We looked at this physician's review, the file, and Medicare rules. Based on this information, we decided that 
Medicare rules for coverage of IGRT servicers have not been met. Therefore, we decided that the Plan does not 
have to pre-approve image guided radiation therapy (IGRT).