Appeal type: Outpatient Therapies
Decision: Favorable

We decided that the Plan has to pre-approve stereotactic body radiation therapy (SBRT).

You asked the Plan to pre-approve stereotactic body radiation therapy (SBRT). You say that the requested SBRT is medically necessary. The Plan denied your request. The Plan says that the requested SBRT does not meet criteria.

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 stereotactic body radiation therapy (SBRT). Our reviewer says that the requested SBRT is medically necessary. Our physician reviewer found Stereotactic body radiotherapy (SBRT), delivering high fractional doses in 2-5 fractions is an established approach for the treatment of discrete lesions from cancer. There is abundant data on the use of SBRT for Stage I non-small cell lung cancer (NSCLC).

With stereotactic radiation, technologies to improve targeting accuracy are used to allow for higher dose delivery in 5 or fewer fractions. The combination of proximity of critical structures to the target, as well as the very high dose delivered per treatment fraction necessitates many fields to deliver a more conformal dose. Generally, for lung tumors, the goal with SBRT is to maximize dose delivery to the target, and minimize dose delivery to the normal lung, heart (for left sided tumors), liver (for right sided tumors), chest wall, trachea, esophagus and spinal cord without compromising lung tumor dose.

Recent data, including 2 meta-analyses (one based on 3 randomized studies), suggest that SBRT is as effective as resection for Stage I NSCLC. In the meta-analysis of patients treated on 3 randomized studies, survival was actually better after SBRT than after resection.

The recent ASTRO model coverage policy states that SBRT for primary lung cancer (and for metastases to the lung) is considered medically necessary. This model policy reflects not only expert opinion, but is also evidence-based, based upon published literature. SBRT is only considered medically necessary for patients with good medical condition/performance status and for those whose tumor burden can be completely targeted. 

The NCCN guidelines also recognize SBRT as a standard of care procedure for stage T1-3N0 non small cell lung cancer. It describes how SBRT is generally accepted to be superior to other forms of radiation therapy.

The randomized TROG 0.9.02 CHISEL study concluded that "in patients with inoperable peripherally located stage 1 NSCLC, compared with standard radiotherapy, SABR resulted in superior local control of the primary disease without an increase in major toxicity."

Clearly the NCCN guidelines and ASTRO model policy acknowledge SBRT as a standard, accepted treatment, even in patients who have operable disease. The requested SBRT is medically reasonable and necessary in this case.

We looked at this physician's review, the file, and Medicare rules. Based on this information, we decided that Medicare rules for coverage of stereotactic body radiation therapy (SBRT) have been met. Therefore, we decided that the Plan has to pre-approve stereotactic body radiation therapy (SBRT).