Appeal type: Experimental/Investigational
Decision: Overturned

Reviewer #1:

Diagnosis: Tonsil cancer

Treatment: Proton Beam Radiation Therapy (PBT)

The insurer denied coverage for Proton Beam Radiation Therapy (PBT)

The denial is upheld

This is the case of an adult patient who presented with T3-4,N1 stage III-IVa L tonsil cancer. Biopsy established diagnosis. Patient is being evaluated for PBT. This is the subject of review.

There has been interest in the use of proton beam radiation therapy (PBT) for the treatment of selected patients with head and neck cancer over the last decade with several trials published in peer reviewed medical literature over this period of time describing the safety and efficacy of this treatment modality in this patient population. The initial data are encouraging with good local control rates and low toxicity rates reported in most patients. However, the data are difficult to interpret due to a variety of treatment techniques and doses used as well as small patient numbers with limited follow-up times and outcomes reporting. Therefore, most investigators recommend additional study of the long-term safety and efficacy of protons in this clinical setting before adopting this technology as a standard treatment option for the treatment of patients with head and neck cancers (other than skull based tumors chordoma or chondrosarcoma). There is insufficient evidence to permit conclusions as to whether or not the use of protons in this specific clinical setting improves net health outcomes in comparison with standard radiation therapy techniques with photons. The American Society for Radiation Oncology (ASTRO) Model-Policy guideline for proton beam therapy states for head and neck malignancies the patient should be enrolled in either Institutional Review Board (IRB) approved clinical trial or in a multi-institutional patient registry adhering to the Medicare requirements for CED (coverage with evidence development). The current published evidence does not allow for any definitive conclusions about the safety and efficacy of proton beam radiation therapy (PBT) for the treatment of head and neck cancers (other than skull based chordoma and chondrosarcoma.

Currently, there are no clinical data in the medical literature to suggest that treatment with proton beam radiation offers a clinical benefit compared to conventional radiation therapy techniques for head and neck cancer. In this setting, there is no published literature that compares clinical outcomes of proton beam radiotherapy compared to standard photon techniques. In the majority of cases the standard approach to treat this malignancy is with standard photon techniques.

The scientific evidence in peer-reviewed literature does not support a result of improvement in health outcomes.

Proton beam radiation therapy (PBT); codes 77520, 77523 and 77525 have final approval from the appropriate regulatory bodies for this diagnosis. PBT is Food and Drug Administration (FDA) approved.

This patient is not a good candidate for proton beam radiation therapy (PBT); codes 77520, 77523 and 77525.

The adverse risks are not increased over standard treatment/services.

The requested service is not likely to be more beneficial than any of the standard treatments/procedures for this patient.

In summary, the denial of proton beam radiation therapy (PBT); codes 77520, 77523 and 77525 and coverage for the requested treatment should be upheld. 

This treatment is not likely to be more beneficial than any standard treatments for this patient's condition and the adverse risks are not substantially increased over standard treatments.