Appeal type: Practitioner Services
Decision: Unfavorable

 
We decided that the Plan does not have to pre-approve Stereotactic Body Radiation Therapy (SBRT). 
 
You asked the Plan to pre-approve SBRT. You say that the requested SBRT is medically necessary. The Plan 
denied your request. The Plan says the requested SBRT is not medically necessary. 
 
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 SBRT. Our reviewer says that the 
requested SBRT is not medically necessary. Our physician reviewer found SBRT, delivering high fractional 
doses in 3-5 fractions is an established approach for the treatment of discrete lesions from cancer. For 
metastatic disease, SBRT is generally indicated for patients with oligometastatic disease of for those 
undergoing palliation after prior radiation to the same site. 
 The most recent American Society of Radiation Oncology (ASTRO) model SBRT coverage policy, reflecting 
national expert opinion, states that SBRT for metastatic lung, liver, adrenal, and kidney lesions is medically 
necessary when the patients performance status justifies aggressive treatment, and for those whose tumor 
burden can be completely targeted with acceptable risks. 
 
Bone metastases (specifically of the spine, though applicable to other sites) are discussed in this model policy 
as follows: SBRT has been demonstrated to achieve durable tumor control when treating lesions in vertebral 
bodies or the paraspinous region, where extra care must be taken to avoid excess irradiation of the spinal cord 
when tumor-ablative doses are administered. There is an important clinical distinction between the status of 
patients described above and a patient with widely metastatic disease for whom palliation is the major 
objective. In one setting, a patient with limited metastatic disease and good performance status is treated with 
the intention of eradicating all known active disease or greatly reducing the total disease burden in a manner 
that can extend progression free survival. For such a patient, SBRT can be a reasonable therapeutic 
intervention. 
 
This enrollee has widely metastatic disease with computed tomography (CT) reports demonstrating regional 
and distant nodal, bone and subcutaneous metastases, some progressive from the last scan.  
 
In the Dutch PROSPECT study, patients with painful spine and non-spine bone metastases were randomized to 
conventional treatment of 8 Gy/1, 20 Gy/5, or 30 Gy/10 vs. SBRT regimens of 18 Gy/1, 30 Gy/3, or 35 Gy/5. 
Randomized patients were allowed to decline SBRT, with 42% doing so mostly due to the additional time to 
take for planning. There was not a significant improvement in pain response with SBRT (n=26 patients) vs. 
conventional palliative radiation (n=44). 
 
Pielkenrood BJ et al. Pain Response After Stereotactic Body Radiation Therapy Versus Conventional Radiation 
Therapy in Patients With Bone Metastases-A Phase 2 Randomized Controlled Trial Within a Prospective 
Cohort. Int J Radiat Oncol Biol Phys. In Press 
https://www.sciencedirect.com/science/article/pii/S0360301620346009?via%3Dihub 
 
 
Based on ASTRO model policy, routine use of SBRT for palliation of spine metastases in the setting of more 
widespread disease is not in accordance with accepted standards of medical practice. 
 
We looked at this physician's review, the file, and Medicare rules. Based on this information, we decided that 
Medicare rules for coverage of SBRT have not been met. Therefore, we decided that the Plan does not have to 
pre-approve Stereotactic Body Radiation Therapy (SBRT).