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  4. CAP Urges Transparency, Medical Experts Review in New Medicare Coverage

In a communication to Medicare agency officials, the CAP continued to urge the CMS to ensure that Medicare coverage decisions will be by health experts through a transparent process based on medical evidence. Additionally, the CAP asked the CMS to include robust transparency in any process providing coverage for Medicare beneficiaries. The CAP is concerned that the new CMS coverage for innovative medical devices would increase regulatory burdens that would complicate the current coverage determination process.

In the April 14 letter to the CMS about the Medicare Program; Medicare Coverage of Innovative Technology and Definition of ‘Reasonable and Necessary’ interim final regulation, the CAP asked the CMS and its Medicare Administrative Contractors (MACs) to “adopt the least restrictive coverage policy so as not to inadvertently limit coverage or impede access for Medicare patients.

“We continue to urge CMS to grandfather current policies, including those that were included as part of negotiated rulemaking. This revised definition should not put our prior efforts to ensure meaningful coverage for key items and services in jeopardy. Equally important, we do not support allowing MACs to develop alternate approaches to address any or all of the considerations outlined in the final rule. Coverage should continue to be based on the steps outlined in Chapter 13 of the PIM regarding the process for attaining an LCD {Local Coverage Determination}.”

Additionally, the CAP said it appreciated that the CMS increased beneficiary access to newly FDA market-authorized treatments and increased coverage under the new voluntary pathway. However, the CAP called for additional flexibility in national coverage policies to allow for new technologies.

The CAP has supported the CMS’s proposal to classify the existing coverage determination policy definition of reasonable, including the proposed modification.

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