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We are also cognizant that some of the definitions for DMHT devices that commenters proposed, or devices commenters recommended should be payable under HCPCS code G0552, including most Class I devices (exempt from 510(k)) may not be aligned with similar terms used by other agencies and may encompass devices not evaluated or authorized by the FDA

This study aims to report the long-term treatment benefits of BoNT in initial responders with refractory neuropathic pain

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of this final rule, we are finalizing the proposed policy that to receive consideration for an inflation rebate reduction for a specific rebatable drug when the manufacturer believes there is a severe supply chain disruption or likely shortage, a manufacturer must submit to CMS a rebate reduction request form along with supporting documentation