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Patients should verify reimbursements eligibility with their providers and submit appropriate documentation for optimal coverage consideration

BMC research notes

A spontaneous report cannot prove causation, but it is relevant to safety surveillance

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Comment: The applicant acknowledged that CMS applies a high evidentiary standard for substantial clinical improvement, typically requiring robust clinical data showing improved patient outcomes such as reduced complications, fewer reoperations, faster recovery, or better functional results compared to the current standard of care