Reimbursement Guide - Effective 10/1/25
Acute DeBakey Type I Aortic Dissection with Malperfusion AMDS has been granted a Humanitarian Device Exemption (HDE) by the FDA for use in the treatment of Acute DeBakey Type I Aortic Dissection with Malperfusion. The effectiveness of this device for this use has not been demonstrated. Institutional Review Board (IRB) full board review and approval is required prior to use. Artivion is required to verify adequate IRB approval documentation prior to product shipment. IRB continuing renewal maintenance is required. Humanitarian Use Device (HUD): A medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in not more than 8,000 individuals in the United States per year (Section 3052 of the 21st Century Cures Act (Pub. L. No. 114-255)). Humanitarian Device Exemption (HDE) : A marketing application for a HUD (Section 520(m) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)). A HDE is exempt from the effectiveness requirements of Sections 514 and 515 of the FD&C Act and is subject to certain profit and use restrictions. Introduction: This guide is intended to provide reference information regarding the reimbursement and proper coding related to the AMDS Hybrid Prosthesis used to treat patients diagnosed with Acute DeBakey Type I Aortic Dissection with Malperfusion, a serious and life- threatening condition involving the aorta. In this condition, a tear develops in the inner layer of the aorta’s wall, causing blood to flow between the layers of the wall of the aorta and forcing the layers apart. Left untreated, risk of death is 1-2% per hour after symptom onset, with approximately 50% mortality at 48 hours. 1 Reimbursement Hotline: Due to the emergent nature of this diagnosis, Artivion is providing live coding and reimbursement assistance from a dedicated team of specialists. Support is available at reimbursement@artivion.com. Disclaimer: The information provided in this document was obtained from third-party sources and is subject to change without notice as a result of complex and frequent changes in reimbursement laws, regulations, rules, policies, and payment amounts. This information is provided for informational purposes only. Artivion, Inc. makes no representation, warranty or guarantee as to the timeliness, accuracy, or completeness of the information. This information is not, and should not be construed as reimbursement, coding, or legal advice.
2 | Reimbursement Guide - Effective 10/01/2025
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