Appeal type: Practitioner Services
Decision: Unfavorable

We decided that the Plan does not have to pre-approve proton beam radiation therapy (77523).
You asked the Plan to pre-approve proton beam radiation therapy (77523). You say that the requested proton
beam radiation therapy is medically necessary. The Plan denied your request. The Plan says the enrollee does
not meet Medicare criteria for the requested proton beam radiation therapy.
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 proton beam radiation therapy (77523).
Our reviewer says that the enrollee does not meet Medicare criteria for the requested proton beam radiation
therapy. Our physician reviewer found a proton is the charged nucleus of a hydrogen atom (hydrogen atom
minus an electron). Charged particles (such as protons and carbon) can be used to deliver therapeutic radiation.
"Standard radiation" is delivered with a linear accelerator (LINAC), which delivers photon therapy (akin to
high energy light), while protons (and other charged particles) are generated from a cyclotron. The difference
between proton and photon irradiation is that the protons (or charged particles) stop abruptly in the tissue
(Bragg peak) so there is less exit dose through normal tissue.
A nodal recurrence of skin cancer can be considered a "head and neck cancer. For most head and neck cancers,
IMRT should also be able to readily spare the salivary glands, pharyngeal constrictors, spinal cord, brainstem,
mandible and other normal tissues. That in fact is the purpose of IMRT-normal tissue sparing. ASTRO' model
policy includes head and neck cancers in "Group 2" for which there is a need for continued medical evidence
and comparative effectiveness analyses (as opposed to Group 1 - disease sites which frequently support the
need of proton therapy). ASTRO is the largest radiation oncology organization whose mission is to improve
"patient care through education, clinical practice, advancement of science and advocacy."
The most recent NCCN guidelines (v3.2019) state: "Use of proton therapy is an area of active investigation.
Proton therapy may be considered when normal tissue constraints cannot be met with photon-based therapy."
and "has typically been used to treat patients with the most challenging disease, for which other RT options
were not felt to be safe or of any benefit."
Thus, proton therapy is not an accepted standard of care for routine practice for typical locally advanced head
and neck cancers. As this enrollee has had prior radiotherapy (completing in Nov 2019) the need for proton
therapy is plausible as proton therapy can reduce the low to moderate dose spillage to previously irradiated
tissues. Reirradiation is one of the factors that can constitute medical necessity in the ASTRO model policy. I
believe that standard medical necessity criteria would be met. For this LCD, a DVH comparison is provided.
My decision is unfavorable solely for the LCD not being 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 proton beam radiation therapy (77523) have not been met. Therefore, we
decided that the Plan does not have to pre-approve proton beam radiation therapy (77523).