Coverage Medicare Coverage: There are no current national policy coverage decisions (NCD) related to the coverage of HDE devices; therefore, as a general rule, coverage is based upon medical necessity and will be at the discretion of the Medicare Administrative Contractor (MAC). Hospitals and physicians may be required to submit prior authorization to their Internal Review Board (IRB). In emergency cases, prior authorization is not required; however, physicians must provide in writing a notification to the IRB chairperson of emergency use within 5 days. Complete HDE Guidance can be found on the FDA website. Private/Commercial Coverage: In emergency cases prior authorization may be waived by most commercial plans; however, a prior authorization should be obtained as quickly as possible following the procedure. In addition to the detailed operative notes, a well-written, clinically documented overview of the medical necessity is the cornerstone to successfully and consistently obtaining private insurers prior authorization and medical necessity support. Appeals Information Artivion provides a reimbursement support service to assist with reimbursement questions and appeal when needed. The most effective appeal provides the payer with a detailed operative note and an overview of the patient’s medical necessity for the procedure. Medical necessity should thoroughly document the patient’s emergent need for treatment and include detailed patient history with description of patient’s current medical status including diagnosis, prior and current medical issues related to the procedure, physical examination results, diagnostic test results, and level of impairment. Impact of the patient’s condition on activities of daily living (ADLs) should be documented. Clinical Justification Checklist for Appeal • S everity of the signs and symptoms exhibited by the patient and rationale for emergent life-saving intervention. • P revious treatments and interventions - noting procedures, medications, and/or therapies attempted, including the outcome/failure of each treatment. • T he medical necessity and rationale for the AMDS procedure; clinical specifics substantiating why this procedure is the most appropriate medical option for the patient. Current Procedural Terminology (CPT®) codes, descriptions, and other data only are copyright 2025 American Medical Association (AMA). All Rights Reserved. CPT® is a registered trademark of the American Medical Association. No fee schedules, basic units, relative values, or related listings are included in CPT®. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use
6 | Reimbursement Guide - Effective 10/01/2025
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