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September 8, 2016

Comments received on Draft DL36658 Proton Beam Therapy

Below are the comments CGS received during the open comment period for Proton Beam Therapy L36658. The name of the policy was changed to Wound Application of Cellular and/or Tissue Based Products (CTPs), Lower Extremities before the policy was finalized.

Comment 1: Commenter requests CGS to delay finalizing the draft policy for 6- 12months. This will allow time to gather data on patients treated since the claim volume is expected to be low.

Response: CGS plans to move ahead with finalizing the draft policy. As new literature becomes available we will review and take into consideration revising the policy as needed.

Comment 2: Please review indications, conditions, and referenced published evidence in the Model Policy and consider adapting.

Response: CGS has reviewed the ASTRO model policy as well as other comments received during the 45 day open comment period. We have incorporated all changes indicated into the final revised draft LCD.

Comment 3: Seems CGS modeled their draft policy from Wisconsin Physician Services (WPS). The version used as a template was determined to have a technical error in the transition from ICD-9 to ICD-10. After we conducted a detailed analysis numerous codes were found to have been left out of the policy. Upon bringing this to the attention of WPS they retroactively corrected their policy. Please review attachments of analysis and the technical error.

Response: CGS will review the group one and group two list of diagnosis and make additions as needed before finalizing the policy.

Comment 4: Currently in the draft policy malignant neoplasm of the esophagus would not be covered as radiation doses have been shown to have adverse side effects when used near organs of the head and neck, lungs, and heart. Proton beam therapy can significantly reduce the frequency and severity of side effects, often to non-toxic levels or in part even eliminate completely.  Please note a Phase II randomized trial is nearing completion. Based on the given expected benefits for the cervical region we ask you please to consider adding ICD-10 codes C15.3-C15.9 to group 2 list of Indications of Coverage.

Response:  We will add the esophageal diagnoses to the group two list to be used for patients in approved clinical trials before finalizing the policy.

Comment 5: Draft LCD proposes that the treatment of “solid Tumors in children” by proton beam therapy would be considered medically reasonable and necessary. We believe that the policy should be broader in coverage, covering all pediatric tumors including Hodgkin lymphoma.

While Hodgkin lymphoma can be cured, at least 20% of children with Hodgkin lymphoma will require radiotherapy - the majority requiring it to the mediastinum, exposing the heart and, in female patients, breast tissue to radiation. Based on current literature proton beam therapy, sparing breast tissue has the potential to reduce unnecessary breast dose in young girls with Hodgkin Lymphoma by as much as 80% relative to with three-dimensional conformal involved-field photon radiotherapy.

Two additional studies conducted on patients with Hodgkin Lymphoma have found that proton beam therapy is predicted to decrease the radiation dosages to major cardiac subunits, lower the risks of radiation induced cardiac mortality for certain cases, and to reduce the risks for secondary lung and breast cancers for young patients receiving thoracic radiotherapy compared to IMRT or conformal photon therapy.

Commenter requests CGS add ICD-10 code C81.00-C81.99 to group 1 list of Indication of Coverage.

Response: CGS will await definitive peer reviewed literature prior to adding these diagnoses to group one in the LCD. As additional literature becomes available we will review and consider revising the policy to include C81.00-C81.99 in group one in the future. At this time we will add the diagnoses to group two in the policy as payable as part of a clinical trial.

Comment 6: The Draft LCD proposes that treatment for "left breast tumors" would be covered under Group 2. We agree with this proposal and respectfully request that CGS consider expanding coverage to include certain right-sided breast cancers. Specifically, two patients groups - those treated with accelerated partial breast irradiation (APBI) and patients who require irradiation of the internal mammary lymph nodes - may benefit significantly from proton irradiation as compared to x-rays.

Please add coverage to group 2 for selected patients with right-sided breast cancer who will receive APBI or who require internal mammary lymph node irradiation.

Response: CGS will include ICD-10 codes for right breast in the group two lists of diagnoses for patients in approved clinical trials before finalizing the policy.

Comment 7: The Draft LCD proposes that "lf the patient cannot clearly meet the criteria for coverage but desires Proton beam radiotherapy based on a marketed theoretical advantage, the claim should be billed with the appropriate modifier appended to the treatment delivery code. (See Coding Guidelines)." However; the coding guidelines section does not discuss the use of modifiers under this, or other circumstances. It is unclear whether CGS expects to deny coverage for other uses of proton therapy or is allowing for individual claim determinations.

Given the nature of certain cancers that some Medicare beneficiaries fight, we request that CGS modify the policy to allow for individual claim review for beneficiaries with other unique circumstances or rare cancers that are not explicitly covered by the policy. We respectfully request that CGS consider revising the language as follows: "Claims for coverage that include any indication not listed in this policy must be supported by medical documentation for coverage consideration."

Response: CGS has a well defined and published appeals process that allows for non-covered diagnoses to be adjudicated based on literature and provider/specialty society opinion received by the appeals team. In addition, the CMD is available to discuss the issue on a case-by-case basis with the provider and appeals team. No prior authorization program is available for proton beam treatments at this time in the Medicare Program.

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