Diagnosis: Head/Neck Cancer
Treatment: Proton Beam Therapy
The Proton Beam Therapy is not medically necessary.

The patient is a male with stage T3N3M0 HPV + squamous cancer of left base of tongue. Proton beam therapy is being requested for definitive concurrent chemoradiation treatment.

Currently, there is no published long term clinical outcome evidence of combined IMRT (intensity-modulated radiation therapy) and proton beam RT (radiation therapy) relative to photon IMRT for head and neck cancer. It is, therefore, not possible to draw any conclusions on the benefits of proton beam RT as "promising" compared to photon IMRT, which has demonstrated high locoregional control rate for the base of tongue cancer, as in this patient's case.

Proton radiation treatment for head and neck cancer such as base of tongue cancer, is currently under study in phase II/III clinical trial (a. Phase II/III Randomized Trial of Intensity-Modulated Proton Beam Therapy (IMPT) Versus Intensity-Modulated Photon Therapy (IMRT) for the Treatment of Oropharyngeal Cancer of the Head and Neck Cancer (ClinicalTrials.gov Identifier:NCT01893307)).

The 2017 ASTRO model policy for proton beam RT states that while PBT is not a new technology, there is a need for continued clinical evidence development and comparative effectiveness analyses for the appropriate use of PBT for various disease sites. All other indications not listed in Group 1 are suitable for Coverage with Evidence Development (CED).
The policy recommends coverage for Group 2 indications if the patient is enrolled in either an Institutional Research Board (IRB)-approved study or in a multi-institutional registry adhering to Medicare requirements for Coverage with Evidence Development (CED). These indications also represent the disease sites for which evidence is accumulating and may support future Group 1 coverage. While the policy specifies that no indications are deemed inappropriate for CED, it also specifies several systems for Group 2 indications:
Non-T4 and resectable head and neck cancers such a stage T3N3M0 the base of tongue cancer, as in this case.

However, medical documents do not indicate that proton beam RT was provided in clinical trial or in registry trial.

Thus, proton beam RT in this case is not consistent with the 2017 ASTRO model policy for proton beam therapy.