Reimbursement Guide
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
Any and all references to reimbursement codes are provided as examples only and are not intended to be a recommendation or advice as to the appropriate code for a particular patient, diagnosis, product or procedure or a guarantee or promise of coverage or payment, nor does Artivion warranty that codes listed are appropriate in all related clinical scenarios. It is the responsibility of the provider to determine if coverage exists and what requirements are necessary for submitting a proper claim for reimbursement to a health plan or payer, including the appropriate code(s) for products provided or services rendered. Providers are responsible for all decisions relating to coding and reimbursement submissions. Medicare’s Correct Coding Initiative and commercial payer policies are reviewed and updated several times each year. Artivion recommends consultation with payers, reimbursement specialists and/or legal counsel regarding appropriate product or procedure codes, coverage, and reimbursement matters. ICD-10-CM Diagnosis Code 2 Diagnosis codes serve a crucial role for hospitals and physicians in describing the primary disease or medical condition requiring treatment. In cases of Acute Type A Aortic Dissection, the range of diagnosis code scenarios and their combinations is extensive and beyond the scope of this document. It is advisable for customers to seek guidance from local carriers or intermediaries and to consider advice from legal, financial, coding, or reimbursement experts for queries related to ICD-10-CM diagnosis codes. This document considers the patient primary diagnosis code for dissection of the ascending thoracic aorta.
ICD-10-CM Description I71.010 Dissection of Ascending Thoracic Aorta
Inpatient ICD-10-PCS Procedure Code 2 ICD-10-PCS is the classification system which is used for coding procedures and services provided in the inpatient setting of hospitals. Identification and reporting of the correct ICD-10-PCS procedure code permits appropriate mapping and reimbursement for the care provided to the patient. The most appropriate ICD-10-PCS codes that apply to patients diagnosed with Dissection of Ascending Thoracic Aorta include the following:
Reimbursement Guide - Effective 10/01/2025 | 3
ICD-10-PCS
Description
OPERATING ROOM PROCEDURE X2VY06B
Restriction of thoracic aortic arch and descending thoracic aorta using uncovered intraluminal device with support cuff, open approach, new technology group 11
WITH ONE OF THE FOLLOWING: 02RX07Z Replacement of thoracic aorta, ascending/arch with autologous tissue substitute, open approach
02RX08Z Replacement of thoracic aorta, ascending/arch with zooplastic tissue, open approach
02RX0JZ Replacement of thoracic aorta, ascending/arch with synthetic substitute, open approach
02RX0KZ Replacement of thoracic aorta, ascending/arch with nonautologous tissue substitute, open approach
Replacement of thoracic aorta, ascending/arch with autologous tissue substitute, percutaneous endoscopic approach Replacement of thoracic aorta, ascending/arch with zooplastic tissue, percutaneous endoscopic approach Replacement of thoracic aorta, ascending/arch with synthetic substitute, percutaneous endoscopic approach Replacement of thoracic aorta, ascending/arch with nonautologous tissue substitute, percutaneous endoscopic approach
02RX47Z
02RX48Z
02RX4JZ
02RX4KZ
Inpatient Hospital MS-DRG 3 Reimbursement for inpatient hospital services is governed by the Inpatient Prospective Payment System (IPPS), which determines hospital payment based on Medicare Severity - Diagnosis Related Groups (MS-DRGs). This system consolidates all services and supplies provided during an inpatient stay into one single payment DRG rate per patient admission. The DRG payment rates provided below are based on the 2025 national average Medicare Physician Fee Schedule (MPFS) and have not been adjusted for sequestration. The most appropriate DRGs that apply to the patient diagnosis include the following:
2026 CMS National Average Payment (Unadjusted for Sequestration)
MS-DRG
Description
209
Complex Aortic Arch Procedures
$82,364
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Physician Reimbursement ®4 Clinicians use Current Procedural Terminology (CPT®) codes to bill for procedures and services. Each CPT® code is assigned unique Relative Value Units (RVUs), which are used to determine payment by the Centers for Medicare & Medicaid Services (CMS). Non-Medicare payers may also use this information as a reference for provider reimbursement. The most commonly reported procedure CPT® codes used to describe the procedures related to placement Artivion’s AMDS Hybrid Prosthesis are listed below. This list is not intended be comprehensive and may include some procedures that are not medically indicated for every patient. Procedure code selection should be based upon the medically necessary procedures that are performed during each individual patient encounter. Providers should also be aware of National Correct Coding Initiative edits. The physician payment rates provided below are the 2025 national average Medicare Physician Fee Schedule (MPFS) and have not been adjusted for sequestration. Providers should be aware that the procedures may be subject to the CMS multiple procedure reduction rule. When applicable, 100% payment is made for the procedure with the greatest RVUs, and a payment reduction of 50% may be applied to the additional procedures reported. There is no specific CPT® code to report placement of the AMDS hybrid prosthesis. As such, the unlisted code for cardiac surgery should be reported (CPT® 33999). The physician should provide supporting documentation that describes the procedure and resources used in the operative notes. In addition, a concise description of the procedure should be included in Loop 2300 of the CMS-1500 claim form.
CPT®
Description
MPFS 5
33858 Ascending Aorta Graft, with Cardiopulmonary Bypass, Includes Valve Suspension, When Performed; for Aortic Dissection 33863 Ascen ding Aorta Graft, with Cardiopulmonary Bypass, with Aortic Root Replacement Using Valved Conduit and Coronary Reconstruction (e.g., Bentall)
$3,228
$2,991
Ascending Aorta Graft, with Cardiopulmonary Bypass with Valve Suspension, with Coronary Reconstruction and Valve-Sparing Aortic Root Remodeling (e.g., David Procedure, Yacoub Procedure)
33864
$3,057
33866 Aortic Hemiarch Graft Including Isolation and Control of the Arch Vessels, Beveled Open Distal Aortic Anastomosis Extending Under One or More of the Arch Vessels, and Total Circulatory Arrest or Isolated Cerebral Perfusion (List Separately in Addition to Code for Primary Procedure) $873 33871 Transverse aortic arch graft, with cardiopulmonary bypass, with profound hypothermia, total circulatory arrest, and isolated cerebral perfusion with reimplantation of arch vessels 3,094 33875 Descending Thoracic Aorta Graft, with or Without Bypass $2,608 33877 Thoracoabdominal Aortic Aneurysm Repair with Graft, with or Without Cardiopulmonary Bypass $3,425 33999 Unlisted Procedure, Cardiac Surgery (for Placement of the AMDS Device) By Report
Reimbursement Guide - Effective 10/01/2025 | 5
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
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References: 1. Isselbacher EM, Preventza O, Hamilton Black J 3rd, Augoustides JG, Beck AW, Bolen MA, Braverman AC, Bray BE, Brown-Zimmerman MM, Chen EP, Collins TJ, DeAnda A Jr, Fanola CL, Girardi LN, Hicks CW, Hui DS, Schuyler Jones W, Kalahasti V, Kim KM, Milewicz DM, Oderich GS, Ogbechie L, Promes SB, Gyang Ross E, Schermerhorn ML, Singleton Times S, Tseng EE, Wang GJ, Woo YJ. 2022 ACC/AHA Guideline for the Diagnosis and Management of Aortic Disease: A Report of the American Heart Association/American College of Cardiology Joint Committee on Clinical Practice Guidelines. Circulation. 2022 Dec 13;146(24):e334-e482. doi: 10.1161/ CIR.0000000000001106. Epub 2022 Nov 2. PMID: 36322642; PMCID: PMC9876736. 2. C D-10-CM and ICD-10-PCS codes referenced in this guide are effective for discharges on or after October 1, 2025, in accordance with the FY 2026 IPPS Final Rule (Centers for Medicare & Medicaid Services, available at https://www.cms.gov/medicare/coding/icd10). 3. D RG values were calculated using a base rate of $6,752.61 and a Capital Standard Payment of $524.15. The base payment rate assumes the hospital submitted quality data and is a meaningful user of EHR. The weighted rate used the 10% Cap Applied. The hospital’s base payment rate will change if the hospital does not meet either or both of these measures. Calculations were based on data provided in the FY 2026 IPPS Final Rule (Tables 1A, 1D, and 5). 4. C PT® 2025 Professional Edition. Copyright © 2024 American Medical Association. All Rights Reserved. CPT® is a registered trademark of the American Medical Association. 5. C Y 2025 Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment Policies; (CMS-1807-F); Addendum B. All MPFS Fee Schedules calculated using CF of $32.3465 effective January 1, 2025.
Reimbursement Guide - Effective 10/01/2025 | 7
www.Artivion.com
Rx Only: Humanitarian Use Device. Authorized by Federal Law for use in the treatment of acute DeBakey Type I Aortic Dissection. The effectiveness of this device for this use has not been demonstrated. Refer to the device’s Instructions for Use for indications, contraindications, warnings, precautions, and possible complications. All trademarks are owned by Artivion, Inc. or its subsidiaries. © 2025 Artivion, Inc. All rights reserved. Artivion, Inc. 1655 Roberts Blvd., NW, Kennesaw, GA 30144 USA
Phone: 888-427-9654 | Fax: 770-590-3573 | E-mail: inquiries@artivion.com For contact information by region, please visit. www.artivion.com/contact
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