Sunflower Health Plan Total Artificial Heart (PDF) Form

The SynCardia temporary Total Artificial Heart (TAH) (SynCardia Systems Inc.), formerly known as the CardioWest Total Artificial Heart, is a biventricular pulsatile pump that replaces the patient’s native ventricles and valves. This policy describes the medical necessity requirements for the total artificial heart. Policy/Criteria I. It is the policy of health plans affiliated with Centene Corporation® that the Total Artificial Heart is medically necessary as a bridge to heart transplantation when all of the following criteria are met: A. Member/enrollee is approved for cardiac transplant and is currently on transplant list; B. New York Heart Association (NYHA) Functional Class IV; C. Presence of non-reversible biventricular failure unresponsive to all other treatments; D. Ineligible for other ventricular support devices; E. Compatible donor heart is currently unavailable; F. Imminent risk of death; G. The device is approved by the United States Food and Drug Administration (FDA) and used according to the FDA-labeled indications, contraindications, warnings and precautions; H. Member/enrollee is able to receive adequate anti-coagulation while on the total artificial heart. II. It is the policy of health plans affiliated with Centene Corporation that there is insufficient evidence to support the use of the Total Artificial Heart as destination therapy (permanent replacement of the failing heart). III.It is the policy of health plans affiliated with Centene Corporation that there is insufficient evidence to support hospital discharge of members/enrollees implanted with the Total Artificial Heart who are supported by portable drivers (e.g., the Freedom portable driver). Background Heart transplantation has become the standard treatment for eligible patients with irreversible biventricular failure unresponsive to medical and surgical treatment.15 The SynCardia temporary Total Artificial Heart (TAH) system is indicated as a bridge to transplantation in cardiac transplant eligible candidates at risk of imminent death from biventricular heart failure. The TAH is a biventricular pulsatile pump that replaces the patient’s native ventricles and valves and pumps blood to both the pulmonary and systemic circulations. The system consists of the implantable TAH and an external console connected by drivelines. Page 1 of 6 CLINICAL POLICY Total Artificial Heart CEN'l'.'ENE" ~·orporatwn There is limited evidence on the use of TAH as a bridge to transplantation as compared with the use of left ventricular assist devices. However, the available evidence demonstrates that the TAH improves survival in transplant-eligible patients with biventricular heart failure at imminent risk of death.1 Use of the TAH as a bridge to cardiac transplantation continues, but the volume of TAH implantations is very low (fewer than 100 cases per year in the United States).13 There is insufficient evidence on the use of TAH as destination therapy. The TAH was originally approved by the Food and Drug Administration (FDA) for in-hospital use. On June 26, 2014, the FDA approved the SynCardia Freedom portable driver for use in patients who have been implanted with the TAH and are clinically stable. The portable driver allows patients to be discharged from the hospital while waiting for a donor heart. There is a paucity of data evaluating the SynCardia Freedom portable driver. A retrospective review of 30 patients who underwent TAH implantation, 11 of whom successfully transferred to portable driver, reported that 90% of the 11 were bridged to transplantation. Five (45.5%) of 11 patients were discharged home and five (45.5%) remained in-patient on the portable driver before transplantation. Six patients (55%) transferred to the portable driver required a return to a main driver console. Two patients were temporarily maintained on the main driver then returned to the Freedom Driver for bridge to transplantation.2 According to UpToDate, as of 2017, there were fewer than 20 patients out-of-hospital in the United States with TAH.14 The SynCardia 50cc temporary Total Artificial Heart (TAH) is a smaller version of the SynCardia 70cc TAH. The 50cc temporary Total Artificial Heart System (50cc TAH-t) has received U.S. FDA approval as a bridge to transplantation in cardiac transplant eligible patients at risk of imminent death from biventricular failure. According to the manufacturer, Syncardia, the device is intended for use as a bridge to transplant in patients with smaller stature (i.e., BSA ≤ 1.85m²) and adequate T10 measurement (posterior sternum to anterior spine measurement at T10) or adequate room in the chest as determined by 3D imaging assessment or by other standard clinical assessments. Per SynCardia, those with a T10 measurement ≥ 10 cm should be considered for the 70cc TAH.14 Studies evaluating the 50cc TAH are very limited. A review of the SynCardia database between December 1985 and October 2019 identified fifty-one children supported, 36 with the 70 cc TAH-t and 15 with the 50 cc TAH-t with a total support time of 6,243 days.12 There have been an increase in implants between 2015 and 2019 with a total of 13 patients being converted to the Freedom Driver support, and the majority of implants in the last 5 years have been with the 50 cc TAH-t.12 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 2020, 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. Page 2 of 6 CLINICAL POLICY Total Artificial Heart CEN"l'.'ENE" ~·orporatwn CPT® Codes 33927 33928 Implantation of a total replacement heart system (artificial heart) with recipient cardiectomy Replacement or repair of thoracic unit of a total replacement heart system (artificial heart) - Systolic (congestive) heart failure ICD-10-CM Diagnosis Codes that Support Coverage Criteria ICD 10 CM - Code I50.20 through I50.23 I50.30 through I50.33 I50.40 through I50.43 I50.82 I50.84 I50.9 Biventricular heart failure End stage heart failure Heart failure, unspecified Diastolic (congestive) heart failure Combined systolic (congestive) and diastolic (congestive) heart failure Reviews, Revisions, and Approvals Policy adopted from Health Net NMP188. References reviewed and updated. References and codes reviewed and updated. Changed wording in I.G (criteria related to thoracic space) to allow for either body measurement, not both, to be considered. References reviewed and updated. Specialist review. In I.G, removed specifications about chest size related to the device, and added that the requested device is FDA approved and will be used according to FDA indications, which include chest measurements. Background updated. Specialist review. Replaced “member” with “member/enrollee” in all instances. Annual review. Replaced investigational/experimental language in II & III with, “insufficient evidence to support the use of …” Changed “review date” in the header to “date of last revision” and “date” in the revision log header to “revision date.” References reviewed, updated and reformatted. Annual review. Background updated with no impact on criteria. Changed “date” in the revision log header to “revision date.” References reviewed and updated. Specialist review. Revision Date 9/16 11/17 12/18 Approval Date 12/16 12/17 12/18 11/19 10/20 11/19 11/20 11/21 11/21 10/22 10/22 Page 3 of 6 CLINICAL POLICY Total Artificial Heart CEN"l'.'ENE" ~·orporatwn