Clinical Policy: Pediatric Heart Transplant Form

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Clinical Policy: Pediatric Heart Transplant

Indications

(10001) Is this for backbench standard preparation of cadaver donor heart allograft prior to transplantation? 
(10002) Is the CPT code 33944? 
(20001) Is this for heart transplant? 
(20002) Is this for heart transplant with recipient cardiectomy (CPT code 33945)? 
(20003) Is this for heart transplant without recipient cardiectomy (CPT code 33945)? 

YesNoN/A
YesNoN/A
YesNoN/A

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Effective Date

NA

Last Reviewed

NA

Original Document

  Reference



CENTENE
Corporation

Clinical Policy: Pediatric Heart Transplant
Reference Number: CP.MP.138
Date of Last Revision: 08/25

Coding Implications
Revision Log

See Important Reminder at the end of this policy for important regulatory and legal information.

Description

Pediatric heart disease may be a progressive disease, affecting cardiac structure and function in infants and children. Heart transplantation is the treatment of choice for pediatric patients with end-stage heart disease. This policy establishes the medical necessity requirements for pediatric heart transplants and re-transplants.

Policy/Criteria


Background

Pediatric heart disease incorporates a wide range of diseases and includes a variety of age ranges. Heart transplantation is recommended for end-stage pediatric heart disease. Cardiomyopathy is the most common indication for heart transplant in children and dilated cardiomyopathy is the most common form of cardiomyopathy in the pediatric population, followed by hypertrophic and restrictive diseases.¹

The American Heart Association has published a scientific statement specifically to address the requirements for heart transplantation and re-transplantations in pediatric heart disease.¹ Canter, et al, addresses the indications for heart transplants and defines the staging of heart failure as illustrated in Table 1.

The current survival rates in pediatric recipients one, five, and ten years after transplantation is approximately 90, 80, and 60%, respectively.² The median survival is 22.3 years for infants, 18.4 years for children ages one through five, 14.4 years for children ages six to ten, and 13.1 years for children ages 11 years or older at the time of transplantation.¹⁰ Several risk factors contribute to the decreasing survival in older ages groups, including immature immune system in infants, the absence of preformed antibodies in infants, sensitization in the older children due to surgical repair for congenital heart disease, and medication non-compliance in older children.³

Dipchand, et al, analyzed the Registry of the International Society for Heart and Lung Transplantation and reported the proportion of transplant recipients by age accordingly: 24% infants, 25% aged between one to five, 16% aged between six to ten years, and 35% aged between 11 and 17 years.⁵

Table 1: Heart Failure Stages in Pediatric Heart Disease

Classification Characteristics
A At high risk for developing heart failure
B Abnormal cardiac structure and/or function; no symptoms of heart failure
C Abnormal cardiac structure and/or function; past or present symptoms of heart failure
D Abnormal structure and/or function; continuous infusion of intravenous inotropes or prostaglandin E₁ to maintain patency of a ductus arteriosus; mechanical ventilatory and/or mechanical circulatory support

Coding Implications

This clinical policy references Current Procedural Terminology (CPT®). CPT® is a registered trademark of the American Medical Association. All CPT codes and descriptions are copyrighted 2024, American Medical Association. All rights reserved. CPT codes and CPT descriptions are from the current manuals and those included herein are not intended to be all-inclusive and are included for informational purposes only. Codes referenced in this clinical policy are for informational purposes only. Inclusion or exclusion of any codes does not guarantee coverage. Providers should reference the most up-to-date sources of professional coding guidance prior to the submission of claims for reimbursement of covered services.

CPT® Codes Description
33944 Backbench standard preparation of cadaver donor heart allograft prior to transplantation, including dissection of allograft from surrounding soft tissues to prepare aorta, superior vena cava, inferior vena cava, pulmonary artery, and left atrium for implantation
33945 Heart transplant, with or without recipient cardiectomy

Reviews, Revisions, and Approvals

Reviews, Revisions, and Approvals Revision Date Approval Date
New policy developed, specialist reviewed 12/16 01/17
Code I25.1 changed to I25.10. In D.15, replaced “Class II or III obesity (body mass index ≥35.0 kg/m²)” with BMI ≥120% of the 95th percentile and added a link to the CDC clinical growth Charts. Added Appendix A with the 95th percentile values. Specialist reviewed. 01/20 01/20
Edited malignancy contraindication to not specify within 2 years, and added exceptions of cancer that has been completely resected, or that has been treated and poses acceptable future risk. Removed coronary artery disease not amenable to revascularization from list of contraindications. 05/20 05/20
Reformatted criteria to group all class C heart failure scenarios together and added additional exclusion of ruling out reversible causes of heart failure. References reviewed and updated. Replaced “member” with “member/enrollee” in all instances. 12/20 12/20
In I.C., replaced “adequate functional status with ability for rehabilitation” and contraindications regarding past or current nonadherence to medical therapy, and psychological condition associated with the inability to comply with medical therapy with “Inability to adhere to the regimen necessary to preserve the transplant, even with caregiver support.” Changed “review date” in header to “Date 08/21 08/21
Reviews, Revisions, and Approvals Revision Date Approval Date
of Last Revision” and “Date” in the revision log header to “Revision Date.”
Annual review. Revised I.C.13, from “BMI ≥ 120% of the 95th percentile (varies by sex and age )” to “BMI ≥ 35 or BMI ≥ 120% of the 95th percentile (varies by sex and age), whichever is lower.” References reviewed and updated. Reviewed by specialist. 12/21 12/21
Moved criterion “all reversible causes of heart failure have been ruled out…” to I.C, and moved contraindications to I.D. Edited contraindications: added GFR rate; added “Acute liver failure or cirrhosis…”; added acute renal failure; added HIV infection with detectable viral load; added septic shock; added progressive cognitive impairment; replaced “untreatable significant dysfunction of another major organ system.” with “Other severe uncontrolled medical condition expected to limit survival after transplant”; slightly reworded substance use contraindication; removed “acute medical instability…” and “uncontrollable bleeding diathesis;” replaced “malignancy, except for non-melanoma…” with “Malignancy with high risk of recurrence or death related to cancer.” 02/22 02/22
Changed description and header of BMI charts from mentioning “male” and “female” to “those with a male reproductive system” and “those with a female reproductive system.” 09/22
Annual review. Appendix A tables updated to remove dashes. Removed ICD-10 codes. References reviewed and reformatted. 12/22 12/22
Annual review. Added additional criteria I.A.1.b.vi.a., pulmonary hypertension and a potential risk of developing fixed, irreversible elevation of pulmonary vascular resistance that could preclude orthotopic heart transplantation in the future. Updated I.D.1. from GFR < 40 mL/min/1.73m2 to GFR < 30 mL/min/1.73m2. Expanded I.D.2. with qualifying criteria for members who are HIV positive. Updated I.D.21. to exclude marijuana use when prescribed by a licensed practitioner and include required commitment to reducing substance use behaviors if urgent transplant timelines are present. Background reviewed and updated. References reviewed and updated. Reviewed by external specialist. 10/23 10/23
Annual review. Updated description and background with no clinical significance. References reviewed and updated. 08/24 08/24
Annual review. Updated verbiage in I.D.10. regarding liver disease and removed I.D.18. “BMI ≥ 35 or BMI…” Edit made to I.D.21. removing the sentence “Serial blood and urine…” Removed Appendix A regarding BMI charts. Background updated with no clinical significance. References reviewed and updated. Policy reviewed by internal specialist. 08/25 08/25

Important Reminder

This clinical policy has been developed by appropriately experienced and licensed health care professionals based on a review and consideration of currently available generally accepted standards of medical practice; peer-reviewed medical literature; government agency/program approval status; evidence-based guidelines and positions of leading national health professional organizations; views of physicians practicing in relevant clinical areas affected by this clinical policy; and other available clinical information. The Health Plan makes no representations and accepts no liability with respect to the content of any external information used or relied upon in developing this clinical policy. This clinical policy is consistent with standards of medical practice current at the time that this clinical policy was approved. “Health Plan” means a health plan that has adopted this clinical policy and that is operated or administered, in whole or in part, by Centene Management Company, LLC, or any of such health plan’s affiliates, as applicable.

The purpose of this clinical policy is to provide a guide to medical necessity, which is a component of the guidelines used to assist in making coverage decisions and administering benefits. It does not constitute a contract or guarantee regarding payment or results. Coverage decisions and the administration of benefits are subject to all terms, conditions, exclusions and limitations of the coverage documents (e.g., evidence of coverage, certificate of coverage, policy, contract of insurance, etc.), as well as to state and federal requirements and applicable Health Plan-level administrative policies and procedures.

This clinical policy is effective as of the date determined by the Health Plan. The date of posting may not be the effective date of this clinical policy. This clinical policy may be subject to applicable legal and regulatory requirements relating to provider notification. If there is a discrepancy between the effective date of this clinical policy and any applicable legal or regulatory requirement, the requirements of law and regulation shall govern. The Health Plan retains the right to change, amend or withdraw this clinical policy, and additional clinical policies may be developed and adopted as needed, at any time.

This clinical policy does not constitute medical advice, medical treatment or medical care. It is not intended to dictate to providers how to practice medicine. Providers are expected to exercise professional medical judgment in providing the most appropriate care and are solely responsible for the medical advice and treatment of members/enrollees. This clinical policy is not intended to recommend treatment for members/enrollees. Members/enrollees should consult with their treating physician in connection with diagnosis and treatment decisions.

Providers referred to in this clinical policy are independent contractors who exercise independent judgment and over whom the Health Plan has no control or right of control. Providers are not agents or employees of the Health Plan.

This clinical policy is the property of the Health Plan. Unauthorized copying, use, and distribution of this clinical policy or any information contained herein are strictly prohibited. Providers, members/enrollees and their representatives are bound to the terms and conditions expressed herein through the terms of their contracts. Where no such contract exists, providers, members/enrollees and their representatives agree to be bound by such terms and conditions by providing services to members/enrollees and/or submitting claims for payment for such services.

Note: For Medicaid members/enrollees, when state Medicaid coverage provisions conflict with the coverage provisions in this clinical policy, state Medicaid coverage provisions take precedence. Please refer to the state Medicaid manual for any coverage provisions pertaining to this clinical policy.

Note: For Medicare members/enrollees, to ensure consistency with the Medicare National Coverage Determinations (NCD) and Local Coverage Determinations (LCD), all applicable NCDs, LCDs, and Medicare Coverage Articles should be reviewed prior to applying the criteria set forth in this clinical policy. Refer to the CMS website at http://www.cms.gov for additional information.

©2016 Centene Corporation. All rights reserved. All materials are exclusively owned by Centene Corporation and are protected by United States copyright law and international copyright law. No part of this publication may be reproduced, copied, modified, distributed, displayed, stored in a retrieval system, transmitted in any form or by any means, or otherwise published without the prior written permission of Centene Corporation. You may not alter or remove any trademark, copyright or other notice contained herein. Centene® and Centene Corporation® are registered trademarks exclusively owned by Centene Corporation.

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