Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Total Artificial Hearts (TAHs)

Policy #:11.02.19f

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.


The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's contract.

SYNCARDIA™ TEMPORARY TOTAL ARTIFICIAL HEART (TAH-t)

MEDICALLY NECESSARY
The SynCardia™ Temporary Total Artificial Heart (TAH-t) is considered medically necessary and, therefore, covered as a bridge to heart transplantation when all of the following criteria are met:
  • Presence of biventricular failure (both sides of the heart are failing), and the individual is ineligible for univentricular or biventricular support devices
  • Failure to respond to other treatments (e.g., medications and optimal medical management)
  • Risk of imminent death (i.e., not expected to survive until a donor heart can be obtained)
  • Currently listed as a heart transplant candidate or undergoing evaluation to determine candidacy for heart transplantation.

NOT MEDICALLY NECESSARY
Absolute Contraindications

The SynCardia™ Temporary Total Artificial Heart is considered not medically necessary and, therefore, not covered for individuals with any of the following absolute contraindications:
  • The individual is not eligible for a heart transplant.
  • The individual does not fit the device (i.e., thoracic volume is unable to accommodate the device with body surface areas less than 1.7 m2 or who have a distance between the sternum and the 10th anterior rib of less than 10 cm as measured by computed tomography [CT] scan).
  • The individual cannot be adequately anticoagulated.
  • The individual has left sided (univentricular) heart failure only.

EXPERIMENTAL/INVESTIGATIONAL
The use of the SynCardia™ Temporary Total Artificial Heart for any other indication not listed above is considered experimental/investigational and, therefore, not covered because its safety and/or effectiveness cannot be established by review of the available published peer-reviewed literature.

ABIOCOR® IMPLANTABLE REPLACEMENT HEART

HUMANITARIAN DEVICE EXEMPTION (HDE)
The AbioCor® Implantable Replacement Heart is covered for the following US Food and Drug Administration (FDA)--approved humanitarian device exemption (HDE) indication:
  • As destination therapy for use in severe biventricular end-stage heart disease, when all of the following criteria are met:
    • The individual is not a heart transplant candidate.
    • The individual is younger than 75 years of age.
    • The individual requires multiple inotropic support to maintain marginal cardiac output and systemic pressure.
    • The individual is not treatable with a single left ventricular heart assist device (LVAD) for destination therapy.
    • The individual cannot be weaned off heart support measures if on such support.

NOT MEDICALLY NECESSARY
Absolute Contraindications

The AbioCor® Implantable Replacement Heart is considered not medically necessary and, therefore, not covered for individuals with any of the following absolute contraindications:
  • The individual is eligible for a heart transplant.
  • The individual has left sided heart failure only (univentricular).
  • The individual has irreversible end organ dysfunction that would compromise the individual's survival.
  • The individual has a blood clotting disorder.
  • The individual does not fit the device (i.e., thoracic volume is unable to accommodate the device).
  • The individual does not have adequate psychosocial support.

EXPERIMENTAL/INVESTIGATIONAL
The use of the AbioCor® Implantable Replacement Heart for any other indication not listed above is considered experimental/investigational and, therefore, not covered because its safety and/or effectiveness cannot be established by review of the available published peer-reviewed literature.

The use of a fully bioprosthetic replacement heart (i.e., CARMAT TAH), containing bioprosthetic blood-contacting surfaces intended to be used as an end-stage device for individuals at imminent risk of death from biventricular heart failure and not eligible for transplant is considered experimental/investigational and, therefore, not covered because its safety and/or effectiveness cannot be established by review of the available published peer-reviewed literature.

HUMANITARIAN DEVICE EXEMPTION (HDE)

An HDE may only be used in facilities that have an institutional review board (IRB) to oversee the clinical application of such devices. The IRB must approve the application of the device to ensure that it will be used in accordance with the FDA-approved indication(s). In addition, documentation of IRB approval may be requested by the Company to ensure compliance with the FDA-approved HDE indication(s).

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.
Guidelines

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, total artificial hearts (Syncardia
Temporary Total Artificial Heart [TAH-t] and AbioCor® Implantable Replacement Heart) are covered under the medical benefits of the Company’s products when the medical necessity criteria listed in the medical policy are met. However, services that are identified in this policy as experimental/investigational or not medically necessary are not eligible for coverage or reimbursement by the Company.

Services that are experimental/investigational are a benefit contract exclusion for all products of the Company.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

The Syncardia Temporary Total Artificial Heart (P030011) was approved by the FDA on October 15, 2004, for use as a bridge to transplantation in cardiac transplant-eligible candidates at risk of imminent death from biventricular failure. It is intended for use inside the hospital.

The Syncardia Temporary Total Artificial Heart (P030011) with the Freedom Driver System was approved by the FDA on June 26, 2014, for use as a bridge to transplantation in cardiac transplant--eligible candidates who have been implanted with the TAH-T and are clinically stable.

The AbioCor® Implantable Replacement Heart (H040006) was approved by the FDA under the Humanitarian Device Exemption (HDE) on September 5, 2006, for use in individuals with severe biventricular, end-stage heart disease who are not cardiac transplant candidates, who are younger than 75 years of age, who require multiple inotropic support, who are not treatable by a left ventricular heart assist device (LVAD) destination therapy, and who are not weanable from biventricular support if on such support.


Description

The heart is a muscular pump consisting of four chambers. The two lower chambers of the heart (called ventricles) supply blood and oxygen to the body and brain. Heart failure occurs when the pumping action of the heart is impaired and blood does not move efficiently through the circulatory system. The blood begins to back up, increasing the pressure in the blood vessels and forcing fluid from the blood vessels into body tissues. Depending on whether the left or right ventricle fails, symptoms may include fatigue, shortness of breath, weight gain, swelling of the legs or ankles, and/or liver congestion. Heart failure is a progressive disease that is medically managed at all stages, but which over time leads to continued deterioration in the heart’s ability to pump sufficient amounts of adequately oxygenated blood. When optimal medical management becomes inadequate to support the individual, his/her heart failure is considered to be at the end stage of the disease, and a heart transplant or mechanical circulatory support is the only remaining treatment option. The disparity between the number of individuals needing transplants and the availability of heart donors has led to the development of other ways to support the severely failing heart.

A number of different mechanical devices may be used to support the ventricles of a failing heart on either a temporary or a permanent basis. External or implantable ventricular assist devices (VADs) are used for many individuals with end-stage congestive heart failure who are waiting for transplantation. External VADs may provide univentricular or biventricular support. Implantable VADs or left ventricular assist devices (LVADs) are univentricular devices that are used to support the left ventricle. However, LVADs are usually inadequate as a bridge to transplant for individuals with severe biventricular disease. In cases of severe biventricular disease, the total artificial heart (TAH) offers hope. Currently two TAHs, the Syncardia CardioWest™ temporary Total Artificial Heart (TAH-t) and the AbioCor® Implantable Replacement Heart, are approved by the US Food and Drug Administration (FDA) and are required by the FDA to undergo post-approval studies.

SYNCARDIA™ TEMPORARY TOTAL ARTIFICIAL HEART (TAH-t)

On October 15, 2004, the SynCardia™ temporary Total Artificial Heart (formerly known as the CardioWest™ temporary Total Artificial Heart) (SynCardia Systems, Inc., Tucson Arizona) device became the first TAH to receive FDA approval. The FDA approved the SynCardia™ TAH-t as a bridge to transplantation in cardiac transplant--eligible candidates at risk of imminent death from biventricular failure. The TAH-t is a pulsating biventricular device that is implanted into the chest to replace the individual's left and right ventricles (the bottom half of the heart). The device is sewn to the individual's remaining atria (the top half of the heart). Hospitalized individuals are connected by tubes from the heart through their chest wall to a large, power-generated console that operates and monitors the device. The device provides circulatory support to an individual waiting for a donor heart and assists kidney and liver function by restoring normal blood flow. The SynCardia™ device is intended for use inside the hospital. For individuals who have end stage heart failure who receive TAH-t as bridge to transplant, the evidence includes case series. Relevant outcomes are overall survival, symptoms, functional outcomes, quality of life, treatment-related mortality, and treatment-related morbidity. Compared with VADs, the evidence for TAH-t in these settings is less robust. However, given the limited evidence from case series and the lack of medical or surgical options for these individuals, TAH-t is likely to improve outcomes for a carefully selected population with end-stage biventricular heart failure awaiting transplant who are not appropriate candidates for an LVAD. The evidence is sufficient to determine qualitatively that the technology results in a meaningful improvement in the net health outcome.

On June 26, 2014, the FDA approved the portable Freedom® Driver System for use with the Syncardia™ temporary Total Artificial Heart (TAH-t) as a bridge to transplantation in clinically stable cardiac transplant--eligible candidates who have been implanted with the TAH-t. The Freedom® Driver is a portable, wearable pneumatic device that powers the existing Syncardia™ temporary Total Artificial Heart (TAH-t) and can be used outside of the hospital setting, allowing some TAH-t individuals to return home while awaiting a suitable donor.

A prospective, nonrandomized study of 130 individuals from five heart centers was conducted from 1993 to 2002. Participation was limited to individuals who were eligible for transplant, were in hemodynamically compromised class IV congestive heart failure, and required cardioactive drugs or an intra-aortic balloon pump. Eighty-one individuals received a SynCardia™ TAH-t for bridge to transplant. An additional 35 control individuals met the inclusion criteria but did not receive a TAH-t. The overall one-year survival rate of individuals receiving a TAH-t was 70 percent versus 31 percent for the control group. Infection and bleeding were common adverse events in the TAH-t group; however, only two related deaths were reported. One-year and five-year survival rates after transplantation among individuals who had received a TAH-t as a bridge to human heart transplant were 86 percent and 64 percent, respectively. Device malfunction was reported in one individual who survived more than 124 days before the malfunction caused a perforated diaphragm resulting in death.

Similar results were reported by a group of European researchers who looked at the SynCardia™/Jarvik TAH over a 12-year period (the Jarvik TAH was the predecessor to the SynCardia™/Jarvik TAH). The researchers looked at 127 individuals who received a bridge to transplant with the device. The longest TAH implantation was 602 days. An additional six individuals survived more than four months. The authors were in agreement that the SynCardia™ device was safe and effective for bridging individuals to transplant.

ABIOCOR® IMPLANTABLE REPLACEMENT HEART

On September 5, 2006, the FDA approved the AbioCor® Implantable Replacement Heart (AbioCor) for destination therapy via the Humanitarian Use Device (HUD) provision. Destination therapy is used in individuals who require permanent, mechanical cardiac support. The FDA approval permits implantation of no more than 4,000 devices annually in individuals with severe, end-stage biventricular heart failure who are not transplant candidates and for whom therapeutic options have been exhausted.

The AbioCor® Implantable Replacement Heart, made by Abiomed, Inc., (Danvers, MA) is intended for individuals who have severe biventricular, end-stage heart failure, who are not eligible for a heart transplant, who are younger than 75 years of age, who require multiple inotropic support, who are not treatable by LVAD destination therapy, and who could not be weaned off biventricular support if on such support. Most individuals are unlikely to live more than a month without intervention. Since the recipient of the AbioCor device is not expected to ever become a transplant candidate, the desired outcome is to prolong and increase the quality of life and allow discharge to home. During the implantation of an artificial heart, a substantial part of the native heart, including both ventricles, is removed. Since the artificial heart requires the resection of the ventricles, the native heart is no longer intact; thus the artificial heart is a permanent measure.

The AbioCor® device is an electrically powered pump that can deliver up to eight liters of blood per minute. The system consists of a thoracic unit that is connected to the heart’s upper two collecting chambers (the atria) and the two major outgoing vessels supplying blood to the lungs and body. Other components include: an energy conserver; a transfer coil that powers the system across the skin and recharges the internal battery from the outside; and a controller and an internal battery, which are implanted in the individual's abdomen. The controller monitors and controls the functioning of the device, including the pumping rate of the heart. The internal battery allows the recipient to be free from all external connections for up to one hour. The system also includes two external batteries.

Data concerning the artificial heart is available from information concerning the FDA approval and from a published article describing results for the first seven individuals who received the AbioCor® device. The FDA indicated that their decision was based on the manufacturer's laboratory and animal testing and on a small clinical study of 14 individuals conducted by Abiomed. It was determined that the individuals who had a one-month survival prognosis of no more than 30 percent were ineligible for cardiac transplants and would not benefit from destination VAD therapy. The study reported that the device is safe and beneficial for individuals with severe heart failure whose death is imminent and for whom no alternative treatments are available. Of the 14 individuals in the study, 12 survived surgery. Mean duration of support for the individuals was 5.3 months. In some cases, the device extended survival by several months; in one individual, it was 17 months. Six individuals were ambulatory, and one individual was discharged home. Complications included postoperative bleeding and neurological events. Device-related infection was nonexistent. Two reported deaths were attributable to device malfunction.

Based on a review of the available published literature, the AbioCor® device shows technological progress and promise. However, larger-scale studies are needed, as well as further analysis of relevant individual outcomes (e.g., complications, quality of life, survival).

A new fully bioprosthetic TAH, contains bioprosthetic blood-contacting surfaces and is intended to be used as an end-stage device with the reduction of thromboembolic and hemmorrhagic complications in mind. The bioprosthetic TAH which is electrohydrolically actuated, is fully implanted in the percardial sac after excision of the native ventricles. To date, as part of the feasibility and safety trial, the device (i.e., CARMAT TAH) has been successfully implanted in four individuals at imminent risk of death from biventricular heart failure, not eligible for heart transplant. The four implanted individuals have ultimately died due to either device failure or organ failure. The lack of back-up options, technical complexity, size, and weight remain unsolved. Further research is required to resolve these technical challenges along with well-designed studies needed to provide further clinical evidence of the safety and efficacy of the bioprosthetic TAH.

HUMANITARIAN DEVICE EXEMPTION (HDE)

In rare instances, certain medical devices intended to be used for humanitarian purposes are evaluated by the US Food and Drug Administration (FDA) through the Humanitarian Device Exemption (HDE) process. The FDA’s humanitarian use device (HUD) designation permits the use of certain medical devices when there is no comparable device available to treat or diagnose a disease or condition affecting fewer than 4,000 individuals annually. Since clinical investigation demonstrating the device's efficacy is not feasible (given the low prevalence of the disease in the population), an HDE grants manufacturers an exemption to the usual premarket approval process and allows marketing of the device only for the FDA-labeled HDE indication(s).

Under FDA requirements, an HUD may only be used after institutional review board (IRB) approval has been obtained for the use of the device in accordance with the FDA-labeled indication(s) under the HDE.
References


Agency for Healthcare Research and Quality (AHRQ). Portable Freedom Driver for in-home support of the total artificial heart. [AHRQ Web site]. June 2013. Available at: https://ahrq-ehc-application.s3.amazonaws.com/media/files/cvd-potential-high-impact-1406.pdf Accessed March 27, 2018.

American Heart Association (AHA). About Heart Failure. [AHA Web site]. May 2017. Available at:
http://www.heart.org/HEARTORG/Conditions/HeartFailure/AboutHeartFailure/About-Heart-Failure_UCM_002044_Article.jsp. Accessed March 27, 2018.

Argiriou M, Kolokotron SM, Sakellaridis T, et al. Right heart failure post left ventricular assist device implantation. J Thorac Dis. 2014; 6(S1):S52-S59.

Bonow RO, Bennett S, Casey DE Jr, et al. ACC/AHA clinical performance measures for adults with chronic heart failure: a report of the American College of Cardiology/American Heart Association Task Force on Performance Measures (Writing Committee to Develop Heart Failure Clinical Performance Measures) endorsed by the Heart Failure Society of America. J Am Coll Cardiol. 2005;46(6):1144-1178.

Boulate D, Marques MA, Ha R, et al. Biventricular VAD versus LVAD for right heart failure. Ann Cardiothorac Surg 2014;3(6):585-588.

Buntz B. Qmed. Medical Device Business. Fourth patient treated with Carmat artificial heart dies. [Qmed Web site]. 01/21/2016. Available at:
http://www.qmed.com/news/fourth-patient-treated-carmat-artificial-heart-dies. Accessed Accessed March 27, 2018.

Carpentier A, Latrémouille C, Cholley B, et al. First clinical use of a bioprosthetic total artificial heart: report of two cases. Lancet. 2015;386(10003):1556-1563.

Centers for Medicare & Medicaid Services (CMS). Artificial heart clinical study approvals. [CMS Web site]. 10/30/2017. Available at: http://www.cms.gov/Medicare/Coverage/Coverage-with-Evidence-Development/Artificial-Hearts.html. Accessed March 27, 2018.

Centers for Medicare & Medicaid Services (CMS). CMS Manual System. Pub 100-03: Medicare National Coverage Determinations. Transmittal 93. Artificial hearts. [CMS Web site]. 08/29/2008. Available at: http://www.cms.hhs.gov/transmittals/downloads/R93NCD.pdf. Accessed March 27, 2018.

Centers for Medicare & Medicaid Services (CMS). Decision memo for artificial hearts: CAG-00322N. [CMS Web site]. 05/01/2008. Available at: http://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=211&ver=16&NcaName=Artificial+Hearts&bc=BEAAAAAAEAAA&. Accessed March 27, 2018.

Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD). 20.9: Artificial hearts and related devices. [CMS Web site]. Original: 05/01/2008. (Revised: 10/30/2013). Available at: http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=246&ncdver=5&bc=BAABAAAAAAAA&. Accessed March 27, 2018.

Centers for Medicare & Medicaid Services (CMS). Press release. Medicare proposes coverage with evidence development for artificial heart devices. [CMS Web site]. 02/01/2008. Available at: https://www.cms.gov/Newsroom/MediaReleaseDatabase/Press-releases/2008-Press-releases-items/2008-02-01.html. Accessed March 27, 2018.

ClinicalTrials.gov. SynCardia Freedom® Driver System Study. [Clinical Trials.gov Web site]. 07/30/2015. Available at: https://clinicaltrials.gov/ct2/show/NCT00733447. Accessed March 27, 2018.

Cook JA, Shah KB, Quader MA, et al. The total artificial heart. J Thorac Dis. 2015;7(12):2172-2180.

Copeland JG, Arabia FA, Tsau PH, et al. Total artificial hearts: bridge to transplantation. Cardiol Clin. 2003;21(1):101-113.

Copeland JG, Copeland H, Gustafson M, et al. Experience with more than 100 total artificial heart implants. J Thorac Cardiovasc Surg. 2012; 143(3):727-734.

Copeland JG, Smith RG, Arabia FA, et al. Cardiac replacement with a total artificial heart as a bridge to transplantation. N Engl J Med. 2004;351(9):859-867.

Copeland JG, Smith RG, Bose RK, et al. Risk factor analysis for bridge to transplantation with the CardioWest Total Artificial Heart. Ann Thorac Surg. 2008;85(5):1639-1644.

Dowling RD, Gray LA, Jr., Etoch SW et al. Initial experience with the AbioCor implantable replacement heart system. J Thorac Cardiovasc Surg. 2004;127(1):131-141.

ERCI Institute. Freedom portable driver for powering the temporary artificial heart. Plymouth Meeting (PA): ERCI Institute; 2017 September 15. (ECRI hotline response). Also available at: http://www.ecri.org. Accessed March 27, 2018.

El-Hamamsy I, Jacques F, Perrault LP, et al. Results following implantation of mechanical circulatory support systems: the Montreal Heart Institute experience. Can J Cardiol. 2009;25(2):107-110.

Fitzpatrick JR, Frederick JR, Hiesinger W, et al. Early, Planned institution of biventricular mechanical circulatory support results in improved outcomes compared to delayed conversion of LVAD to BiVAD. J Thorac Cardiovasc Surg. 2009; 137(4), 971–977.

Goerlich CE, Frazier OH, Cohn WE. Previous challenges and current progress-the use of total artificial hearts in patients with end-stage heart failure. [Taylor and Francis Online]. 07/22/2016. Available at: http://www.tandfonline.com/doi/full/10.1080/14779072.2016.1217154. Accessed March 27, 2018.

Gray NA Jr, Selzman CH. Current status of the total artificial heart. Am Heart J. 2006;152(1):4-10.

Health Technology Forecast [database online]. Plymouth Meeting (PA): ECRI Institute; 2011 Oct 15 (Updated 2015 June 10). [accessed 2016 Aug 08]. Freedom Portable Driver for Powering the Temporary Total Artificial Heart. [6 p]. Available: http://www.ecri.org. Accessed March 27, 2018.

Holman WL, Kormos RL, Naftel DC, et al. Predictors of death and transplant in patients with a mechanical circulatory support device: a multi-institutional study. J Heart Lung Transplant. 2009;28(1):44-50.

Holman WL, Pae WE, Teutenberg JJ, et al. INTERMACS: interval analysis of registry data. J Am Coll Surg. 2009;208(5):755-761.

Ryan TD, et al. The evolving role of the total artificial heart in the management of end-stage congenital heart disease and adolescents. ASAIO J. 2015;61(1):8-14.

Torregrossa G, Morshuis M, Varghese R, et al. Results with SynCardia total artificial heart beyond 1 year. ASAIOJ. 2014;60(6):626-634.

Spiliopoulos S, et al. A first step beyond traditional boundaries: destination therapy with the SynCardia total artificial heart. Interact Cardiovasc Thorac Surg. 2014;18(6):855-856.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. AbioCor® Implantable Replacement Heart. Humanitarian device exception (HDE) approval letter. [FDA Web site]. 09/05/2006. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf4/H040006a.pdf. Accessed March 27, 2018.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. AbioCor® Implantable Replacement Heart. Summary of safety and probable benefit. [FDA Web site]. 09/05/2006. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf4/H040006b.pdf. Accessed March 27, 2018.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. CardioWest™ temporary Total Artificial Heart (TAHt). Summary of safety and effectiveness data. [FDA Web site]. 10/15/2004. (Updated 08/01/2016). Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf3/p030011b.pdf
Accessed March 27, 2018.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Premarket Approval. Freedom Driver System. [FDA Web site]. 07/29/2015. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P030011S031 Accessed March 27, 2018.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Post approval studies. AbioCor Artificial Heart. [FDA Web site]. 09/05/2006. (Updated 04/27/2012) Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma_pas.cfm?t_id=342280&c_id=50. Accessed March 27, 2018.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. SynCardia temporary CardioWest™ Total Artificial Heart (TAHt). Premarket approval letter. [FDA Web site]. 10/15/2004. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf3/P030011A.pdf. Accessed March 27, 2018.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Premarket Approval. Syncardia™ Temporary Total Artificial Heart. [FDA Web site]. 03/16/2018. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P030011S060Accessed March 27, 2018.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Premarket Approval. Temporary Total Artificial Heart (TAH-t) with Freedom Driver System. [FDA Web site]. 09/17/2015. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139311. Accessed March 27, 2018.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Update on SynCardia Systems - TAH-t Companion 2 Driver System (C2) and Freedom Driver System - Letter to Health Care Providers. Medical Devices. [FDA Web site]. 09/25/2017. Available at:
https://www.fda.gov/medicaldevices/safety/letterstohealthcareproviders/ucm577003.htm. Accessed March 27, 2018.





Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

33927, 33928, 33929


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

I09.81 Rheumatic heart failure

I11.0 Hypertensive heart disease with heart failure

I13.0 Hypertensive heart and chronic kidney disease with heart failure and stage 1 through stage 4 chronic kidney disease, or unspecified chronic kidney disease

I13.2 Hypertensive heart and chronic kidney disease with heart failure and with stage 5 chronic kidney disease, or end stage renal disease

I50.20 Unspecified systolic (congestive) heart failure

I50.21 Acute systolic (congestive) heart failure

I50.22 Chronic systolic (congestive) heart failure

I50.23 Acute on chronic systolic (congestive) heart failure

I50.30 Unspecified diastolic (congestive) heart failure

I50.31 Acute diastolic (congestive) heart failure

I50.32 Chronic diastolic (congestive) heart failure

I50.33 Acute on chronic diastolic (congestive) heart failure

I50.40 Unspecified combined systolic (congestive) and diastolic (congestive) heart failure

I50.41 Acute combined systolic (congestive) and diastolic (congestive) heart failure

I50.42 Chronic combined systolic (congestive) and diastolic (congestive) heart failure

I50.43 Acute on chronic combined systolic (congestive) and diastolic (congestive) heart failure

I50.9 Heart failure, unspecified

I97.130 Postprocedural heart failure following cardiac surgery

I97.131 Postprocedural heart failure following other surgery




HCPCS Level II Code Number(s)

L8698 Miscellaneous component, supply or accessory for use with total artificial heart system


Revenue Code Number(s)

N/A

Coding and Billing Requirements


Cross References


Policy History

11.02.19f:
01/01/2019This version of the policy will become effective 01/01/2019.

The following HCPCS code has been added to this policy:

L8698 Miscellaneous component, supply or accessory for use with total artificial heart system
11.02.19e:
04/25/2018The policy has been reviewed and reissued to communicate the Company’s continuing position on artificial hearts.
01/01/2018This policy has been identified for the CPT code update, effective 01/01/2018.

The following CPT codes have been added to this policy: 33927, 33928, 33929
The following CPT codes have been deleted from this policy: 0051T, 0052T, 0053T


Effective 10/05/2017 this policy has been updated to the new policy template format.
Version Effective Date: 01/01/2019
Version Issued Date: 01/03/2019
Version Reissued Date: N/A

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