Local Coverage Article Response to Comments

Response to Comments: Proton Beam Therapy


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Response to Comments: Proton Beam Therapy
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Response to Comments
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As an important part of Medicare Local Coverage Determination (LCD) development, National Government Services solicits comments from the provider community and from members of the public who may be affected by or interested in our LCDs. The purpose of the advice and comment process is to gain the expertise and experience of those commenting.

We would like to thank those who suggested changes to the draft of the Proton Beam Therapy LCD.
The official notice period for the final LCD begins on 07/07/2016, and the final determination will become effective on 08/22/2016.

Response To Comments

1A commenter from a national proton beam association and a proton center requested that NGS consider adopting The National Association for Proton Therapy Model Policy, noting that the ASTRO Model Policy is now almost two years old and more than 80 publications have been released since then. The association had these specific comments: Central Nervous System (CNS) Tumors In the Draft LCD, NGS initially appeared to be removing the following language (and associated ICD-10-CM codes) from the Group 1 list of Indications of Coverage: “Unresectable benign or malignant central nervous system tumors to include but not limited to primary and variant forms of astrocytoma, glioblastoma, medulloblastoma, acoustic neuroma, craniopharyngioma, benign and atypical meningiomas, pineal gland tumors, and arteriovenous malformations.” Based upon comments from NGS representatives in recent public forums, it is now our understanding that this change was an error and that coverage for these CNS tumors will remain in Group 1. These tumors are particularly difficult to treat as these tumors can be in close proximity to critical structures (e.g., the brain, brain stem, optic nerves and chiasm, pituitary gland, hypothalamus, hippocampi) and as such, require a steep dose gradient beyond the target area in order to minimize the impact to the surrounding critical structures. Ultimately, we appreciate NGS maintaining Group 1 coverage for CNS tumors, consistent with the current version of the policy. Esophagus Tumors Under the Draft LCD, malignant neoplasm of the upper third of the esophagus (ICD-10-CM C15.3) would be removed. While the upper third (or cervical) esophageal cancer is less common, the overall treatment approach is generally the same as other esophageal cancers. In addition, cancer in this anatomical region is found near organs of the head and neck where radiation doses have been shown to result in adverse side effects. Proton beam therapy can significantly reduce the frequency and severity of side effects, often to non-toxic levels or in part even eliminated completely. We also note that a Phase III randomized trial lead by researchers from MD Anderson in collaboration with Massachusetts General Hospital is nearing completion. This Phase III trial includes histologically documented adenocarcinoma or squamous cell carcinoma of the cervical or thoracic esophagus or gastroesophageal junction or cardia of stomach, given the expected relative benefits for the cervical region. As such, we respectfully request that NGS maintain the diagnosis code for cervical esophageal cancer (C15.3) in the Group 2 list of Indications of Coverage. Prostate The draft LCD proposes that “prostate cancer should be locally contained and not be an advanced prostate cancer (i.e. T3 or T4 where the tumor has spread through the capsule or has invaded seminal vesicles or other structures) and not any N disease (i.e. no spread to lymph nodes or there has been spread to the pelvic lymph nodes).” We believe that this policy is too restrictive as there may be benefits of proton therapy to Medicare beneficiaries battling certain high risk prostate cancer. This is supported by the published findings of the University of Florida (UF). These findings were published in 2014, subsequent to the adoption of the initial Wisconsin Physician Services local coverage determination for proton beam therapy which served as the basis for the current NGS local coverage determination. [Although not directly comparable], this clinical trial demonstrated cancer-free survival rates at five years for high-risk patients of 76 percent, while overall survival rates are 90 percent. In addition, initial randomized-controlled clinical trial data from Massachusetts General Hospital suggests that there may be a local control benefit to dose-escalated proton therapy, especially if they have high grade tumors. Lastly, node positive patients are now more routinely being offered pelvic radiotherapy in conjunction with hormone therapy. The advent of pencil beam scanning allows pelvic nodal RT that may be superior to IMRT. Therefore, we are asking NGS to expand Group 2 coverage for all prostate cancer, including high risk prostate cancer. This would allow providers who have demonstrated experience in data collection and analysis with a history of publication in the peer-reviewed medical literature to further study the value of proton therapy for Medicare beneficiaries fighting high risk prostate cancer. The current draft is a revision of the current policy and borrows heavily from the ASTRO model policy. Although the Particle Therapy Co-operative Group - North American and National Association for Proton Therapy model LCD provides helpful information, the ASTRO model provided a wider discussion of proton beam therapy and has been approved by the society’s board of directors which includes radiation oncologists with subspecialties beyond proton beam therapy (PBT). The indications for central nervous system (CNS) will be revised to include those in the current policy. The diagnosis for cervical esophageal cancer will also be retained given radiation therapy is one of the modalities which may be used for this condition. The language restricting the use of PBT in T3 and T4 prostate cancer will be removed; the current policy and draft already allow for treatment of prostate cancer without distant metastases.
2Dr. Hartsell (Radiation Oncology) commented that the changes to the PBRT policy were generally good. He noted a possible omission related to tumors in difficult locations as well as a request to restore the current CNS and cervical esophageal coverage and the removal of T3/T4 prostate prohibition. He also noted that there is emerging evidence on esophageal cancer which may warrant consideration of change to Group 1. A bibliography supporting the esophageal and prostate cancer requests was included. We appreciate the relevant bibliography. These papers were pulled and read and presented evidence to support the draft changes. Although the literature is growing for the use of PBT to treat esophageal cancer, we still consider it to be a Group 2 versus Group 1 condition. No diagnosis code was found to describe use of PBT in difficult locations. However, we reviewed the language in “Indications for Coverage” and would consider it to apply to and allow consideration of use in such situations. The medical record should document the rationale for such use.

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