Appeal type: Outpatient Therapies
Decision: Favorable

We decided that the Plan has to pre-approve stereotactic body radiation therapy (SBRT) services.
You asked the Plan to pre-approve the requested services. The Plan denied your request. The Plan says that it is
considered investigational as a treatment option for prostate 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 the requested services. Our physician
reviewer found that the enrollee has a recent diagnosis of intermediate risk (due to Gleason score 3+4=7 and
pretreatment PSA of 7.2 ng/ml) T1c prostate cancer. Notably his genomic score is high risk, though genomic
scores have not been historically used to group patients into risk groups, and therefore most published outcome
studies on SBRT have not considered this factor. Also, notably he has an iliac lymph node that based upon its
size is clinically determined to be reactive, in the absence of a biopsy (determined to not be feasible due to the
small size) or Axumin positive emission tomography (PET) scan, which would be informative. Stereotactic
body radiotherapy, delivering high fractional doses to the prostate in 3-5 fractions is an emerging approach to
the treatment of prostate cancer. Many clinical studies supporting the efficacy and safety of SBRT in the
treatment of prostate cancer have been published. At least one study has shown excellent five-year biochemical
control rates with very low rates of serious toxicity. Additionally, numerous studies have demonstrated the
safety of SBRT for prostate cancer after a follow-up interval long enough (two to three years) to provide an
opportunity to observe the incidence of late GU or GI toxicity. While it is necessary to observe patients treated
for prostate cancer for extended intervals to gauge the rate of long term (beyond 10 years) biochemical control
and overall survival, the interim results reported appear at least as good as other forms of radiotherapy
administered to patients with equivalent risk levels followed for the same duration post-treatment. Data
supporting the use of SBRT for prostate cancer have matured to a point where SBRT could be considered an
appropriate alternative for select patients with low to intermediate risk disease. It can be considered an accepted
standard, and as such meets standard medically necessary criteria.
We looked at this physician's review, the file, and Medicare rules. Based on this information, we decided that
Medicare rules for coverage of the requested services have been met. Therefore, we decided that the Plan has to
pre-approve stereotactic body radiation therapy (SBRT) services.
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.