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In the event that CMS grants an ECE to the REH, the written decision specifies whether the REH is exempted from one or more reporting requirements or whether CMS has granted the REH an extension of time to comply with one or more reporting requirements

Patients who have undergone gastric sleeve surgery sometimes experience weight regain after the initial post-operative period, typically occurring 1824 months after surgery

no large-scale controlled human clinical trials establishing safety or efficacy currently exist

Abdominal obesity, also known as visceral obesity, is one of the most difficult types of overweight to combat

The comments and our responses are addressed in the applicable sections of this final rule with comment period, which include, but are not limited to sections III.C

In summary, after consideration of the public comment we received, we are finalizing the APC assignment for HCPCS code C8001 without modification