Artificial Hearts and Related Devices

An artificial heart is a biventricular replacement device which requires removal of a substantial part of the native heart, including both ventricles. Removal of this device is not compatible with life, unless the patient has a heart transplant.

1. Bridge-to-transplant (BTT) (effective for services performed on or after May 1, 2008)

An artificial heart for bridge-to-transplantation (BTT) is covered when performed under coverage with evidence development (CED) when a clinical study meets all of the criteria listed below. The clinical study must address at least one of the following questions:

• Were there unique circumstances such as expertise available in a particular facility or an unusual combination of conditions in particular patients that affected their outcomes?
• What will be the average time to device failure when the device is made available to larger numbers of patients?
• Do results adequately give a reasonable indication of the full range of outcomes (both positive and negative) that might be expected from more widespread use?

The clinical study must meet all of the criteria stated in Section D of this policy. The above information should be mailed to: Director, Coverage and Analysis Group, Centers for Medicare & Medicaid Services (CMS), Re: Artificial Heart, Mailstop S3-02-01, 7500 Security Blvd, Baltimore, MD 21244-1850.

Clinical studies that are determined by CMS to meet the above requirements will be listed on the CMS Web site at: http://www.cms.gov/Medicare/Coverage/Coverage-with-Evidence-Development/Artificial-Hearts.html.

2. Destination therapy (DT) (effective for services performed on or after May 1, 2008)

An artificial heart for destination therapy (DT) is covered when performed under CED when a clinical study meets all of the criteria listed below. The clinical study must address at least one of the following questions:

• Were there unique circumstances such as expertise available in a particular facility or an unusual combination of conditions in particular patients that affected their outcomes?
• What will be the average time to device failure when the device is made available to larger numbers of patients?
• Do results adequately give a reasonable indication of the full range of outcomes (both positive and negative) that might be expected from more widespread use?

The clinical study must meet all of the criteria stated in Section D of this policy. The above information should be mailed to: Director, Coverage and Analysis Group, Centers for Medicare & Medicaid Services, Re: Artificial Heart, Mailstop S3-02-01, 7500 Security Blvd, Baltimore, MD 21244-1850.

Clinical studies that are determined by CMS to meet the above requirements will be listed on the CMS Web site at: http://www.cms.gov/Medicare/Coverage/Coverage-with-Evidence-Development/Artificial-Hearts.html.

All other indications for the use of artificial hearts not otherwise listed remain non-covered, except in the context of Category B investigational device exemption clinical trials (42 CFR 405) or as a routine cost in clinical trials defined under section 310.1 of the National Coverage Determinations (NCD) Manual.

Clinical study criteria:

• The study must be reviewed and approved by the Food and Drug Administration (FDA).
• The principal purpose of the research study is to test whether a particular intervention potentially improves the participants' health outcomes.
• The research study is well supported by available scientific and medical information, or it is intended to clarify or establish the health outcomes of interventions already in common clinical use.
• The research study does not unjustifiably duplicate existing studies.
• The research study design is appropriate to answer the research question being asked in the study.
• The research study is sponsored by an organization or individual capable of executing the proposed study successfully.
• The research study is in compliance with all applicable Federal regulations concerning the protection of human subjects found at 45 CFR Part 46. If a study is FDA-regulated it also must be in compliance with 21 CFR Parts 50 and 56.
• All aspects of the research study are conducted according to appropriate standards of scientific integrity (see http://www.icmje.org).
• The research study has a written protocol that clearly addresses, or incorporates by reference, the standards listed here as Medicare requirements for CED.
• The clinical research study is not designed to exclusively test toxicity or disease pathophysiology in healthy individuals. Trials of all medical technologies measuring therapeutic outcomes as one of the objectives meet this standard only if the disease or condition being studied is life threatening as defined in 21 CFR §312.81(a) and the patient has no other viable treatment options.
• The clinical research study is registered on the www.ClinicalTrials.gov Web site by the principal sponsor/investigator as demonstrated by having a Clinicaltrials.gov Identifier.
• The research study protocol specifies the method and timing of public release of all pre-specified outcomes to be measured including release of outcomes if outcomes are negative or study is terminated early. The results must be made public within 24 months of the end of data collection. If a report is planned to be published in a peer-reviewed journal, then that initial release may be an abstract that meets the requirements of the International Committee of Medical Journal Editors (ICMJE) (http://www.icmje.org). However a full report of the outcomes must be made public no later than three (3) years after the end of data collection.
• The research study protocol must explicitly discuss subpopulations affected by the treatment under investigation, particularly traditionally under-represented groups in clinical studies, how the inclusion and exclusion criteria effect enrollment of these populations, and a plan for the retention and reporting of said populations in the trial. If the inclusion and exclusion criteria are expected to have a negative effect on the recruitment or retention of under-represented populations, the protocol must discuss why these criteria are necessary.
• The research study protocol explicitly discusses how the results are or are not expected to be generalizable to the Medicare population to infer whether Medicare patients may benefit from the intervention. Separate discussions in the protocol may be necessary for populations eligible for Medicare due to age, disability, or Medicaid eligibility.

Consistent with section 1142 of the Social Security Act (the Act), the Agency for Healthcare Research and Quality (AHRQ) supports clinical research studies that CMS determines meet the above-listed standards and address the above-listed research questions.

The principal investigator of an artificial heart clinical study seeking Medicare payment should submit the following documentation to CMS and should expect to be notified when the CMS review is complete:

• Complete study protocol (must be dated or identified with a version number);
• Protocol summary;
• Statement that the submitted protocol version has been agreed upon by the FDA;
• Statement that the above study standards are met;
• Statement that the study addresses at least one of the above questions related to artificial hearts;
• Complete contact information (phone number, email address, and mailing address); and,
• Clinicaltrials.gov Identifier.

06/2022 - Transmittal 10832, dated June 2, 2021, is being rescinded and replaced by Transmittal 11453, dated, June 10, 2022, to revise NCD 90.2, NGS, revises business requirement 12124.2 and 12124.2.1 and its associated spreadsheet of coding by retainining all ICD-10 NOC diagnosis codes proposed for deletion effective July 1, 2022. (TN 11453) (CR12124)

06/2021 - This Change Request (CR) constitutes a maintenance update of ICD-10 conversions and other coding updates specific to NCDs. These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received. (TN 10832) (CR12124)

05/2021 - This Change Request (CR) constitutes a maintenance update of ICD-10 conversions and other coding updates specific to NCDs. These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received. (TN 10804) (CR12124)

03/2021 - This Change Request (CR) constitutes a maintenance update of ICD-10 conversions and other coding updates specific to NCDs. These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received. (TN 10624) (CR12124)

02/2020 - This Change Request (CR) constitutes a maintenance update of ICD-10 conversions and other coding updates specific to NCDs. These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received.
Previous NCD coding changes appear in ICD-10 quarterly updates that can be found at: https://www.cms.gov/Medicare/Coverage/CoverageGenInfo/ICD10.html, along with other CRs implementing new policy NCDs. Edits to ICD-10 and other coding updates specific to NCDs will be included in subsequent quarterly releases and individual CRs as appropriate. No policy-related changes are included with the ICD-10 quarterly updates. Any policy-related changes to NCDs continue to be implemented via the current, long-standing NCD process. (TN 2427) (CR11491)

01/2018 - This Change Request (CR) constitutes a maintenance update of International Code of Diseases, Tenth Revision (ICD-10) conversions and other coding updates specific to National Coverage Determinations (NCDs). These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received.

Previous NCD coding changes appear in ICD-10 quarterly updates that can be found at: https://www.cms.gov/Medicare/Coverage/CoverageGenInfo/ICD10.html, along with other CRs implementing new policy NCDs. Edits to ICD-10 and other coding updates specific to NCDs will be included in subsequent quarterly releases and individual CRs as appropriate. No policy-related changes are included with the ICD-10 quarterly updates. Any policy-related changes to NCDs continue to be implemented via the current, long-standing NCD process. (TN 2005) (CR10318)

11/2017 - This Change Request (CR) constitutes a maintenance update of International Code of Diseases, Tenth Revision (ICD-10) conversions and other coding updates specific to National Coverage Determinations (NCDs). These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received. (TN 1975) (CR10318)

06/2016 - Transmittal 1665, dated May 13, 2016, is being rescinded and replaced by Transmittal 1672 to: (1) 9631.1: Remove FISS responsibility and 1st sentence; (2) 9631.2: Remove additional procedure codes, including 0075T, 0076T; (3) 9631.4: Revise descriptor of dx L59.8; (4) 9631.6: Add deletion of dx C49.10, C65.9, remove deletion of dx C54.9, remove deletion of invalid dx C47.90; (5) 9631.8: Remove deletion of invalid dx C51.29, replace with deletion of dx C50.029; (6) 9631.9: Add deletion of 0V504ZZ, 0V500ZZ, override capability, and contractor discretion verbiage. All other information remains the same. (TN 1672) (CR9631)

05/2016 - This change request (CR) is the 7th maintenance update of ICD-10 conversions and other coding updates specific to national coverage determinations (NCDs). The majority of the NCDs included are a result of feedback received from previous ICD-10 NCD CR7818, CR8109, CR8197, CR8691, CR9087, CR9252, and CR9540. Some are the result of revisions required to other NCD-related CRs released separately. Edits to ICD-10 and other coding updates specific to NCDs will be included in subsequent, quarterly releases as needed. No policy-related changes are included with these updates. Any policy-related changes to NCDs continue to be implemented via the current, long-standing NCD process. (TN 1665) (CR9631)

12/2015 - This change request (CR) is the 3rd maintenance update of ICD-10 conversions/updates specific to national coverage determinations (NCDs). The majority of the NCDs included are a result of feedback received from previous ICD-10 NCD CR7818, CR8109, CR8197, CR8691, & CR9087. Some are the result of revisions required to other NCD-related CRs released separately that included ICD-10 coding. Implementation date: 01/04/2016 Effective date: 10/1/2015. (TN 1580) (CR9252)

08/2015 - This change request (CR) is the 3rd maintenance update of ICD-10 conversions/updates specific to national coverage determinations (NCDs). The majority of the NCDs included are a result of feedback received from previous ICD-10 NCD CR7818, CR8109, CR8197, CR8691, & CR9087. Some are the result of revisions required to other NCD-related CRs released separately that included ICD-10 coding. These updates do not expand, restrict, or alter existing coverage policy. Implementation date: 01/04/2016 Effective date: 10/1/2015. (TN 1537) (CR 9252)

08/2014 - This Change Request (CR) is effective for claims with dates of service on and after October 30, 2013; contractors shall pay claims for Ventricular Assisted Devices as destination therapy using the criteria in Pub. 100-03, chapter 1, section 20.9.1, and Pub. 100-04, Chapter 32, sec. 320. Effective date: 10/30/2013. Implementation date: 09/30/2014. (TN 172) (CR 8803)

01/2013 - CMS translated the information for this policy from ICD-9-CM/PCS to ICD-10-CM/PCS according to HIPAA standard medical data code set requirements and updated any necessary and related coding infrastructure. These updates do not expand, restrict, or alter existing coverage policy. Implementation date: 04/01/2013 Effective date: 10/1/2015. (TN 1165) (CR 8109)

12/2010 - Transmittal 128, dated November 19, 2010, is being rescinded and replaced with Transmittal 129. The only change is in the Summary of Changes, the date of November 19, 2010, was incorrect, the correct date is November 9, 2010. Transmittal 129, issued December 8, 2010 is being re-issued to change the implementation date from December 9, 2010 to January 6, 2011. It was erroneously changed to December 9, 2010 and should have remained as January 6, 2011. The transmittal number, date issued and all other material remain the same. (TN 129) (CR7220)

11/2010 - Effective for claims with dates of service on or after November 19, 2010, CMS has determined that the evidence is adequate to conclude that VAD implantation as destination therapy improves health outcomes and is reasonable and necessary when the device has received FDA approval for a destination therapy indication and only for patients with NYHA Class IV end-stage ventricular heart failure who are not candidates for heart transplant and who meet all specific conditions. Effective date 11/09/2010. Implementation date 01/06/2011. (TN 128) (CR7220)

09/2008 - This corrects Transmittal 93, Change Request 6185, dated August 29, 2008. The only change is the implementation date(12/01/2008). All other material remains the same. (TN 95)

08/2008 - Established coverage for artificial hearts when implanted under CED. CMS will maintain a web site that will list all studies approved to meet CED criteria. Coverage is only available when artificial hearts are implanted as part of one of the list clinical studies. Effective date 05/01/2008. Implementation date 10/06/2008. (TN 93) (CR6185)

04/2007 - New facility criteria is established and hospitals must now receive certification from the Joint Commission on Accreditation of Healthcare Organizations under their Disease Specific Certification Program for VADs. Currently approved hospitals will have until March 27, 2009, to become certified by the Joint Commission or they will be removed from the approved list. Effective date 03/27/2007. Implementation date 05/14/2007. (TN 68) (CR5516)

11/2003 - Issued provider education article that discusses expansion in coverage of VADs for destination therapy. Effective date 10/01/03. Implementation date 11/21/03. (TN 4) (CR 2985)

10/2003 - Expanded coverage of VADs for destination therapy if FDA approval received for that purpose, used according to FDA-approved labeling instructions, patient meets specified criteria, and procedure performed in specified facilities. All other indications remain the same. Effective and implementation dates 10/01/2003. (TN 2 ) (CR 2958)

12/2000 - Allowed sites other than Medicare approved heart transplant centers to implant VADs in patients approved and listed as candidates for heart transplant by Medicare approved heart transplant center. Also, implanting site must receive written permission from Medicare approved heart transplant center under which patient is listed prior to implantation of VAD. Effective and implementation dates 01/01/2001. (TN 134) (CR 1378)

04/1997 - Clarified that VADs covered only if FDA approval received and used according to FDA-approved labeling instructions. Also deleted specific product names and hemodynamic criteria. Effective date 05/05/1997. (TN 94)

11/1995 - Removed "not covered" from title, and allowed exception for HeartMate IP LVAS when used as bridge to cardiac transplantation. Effective date 01/22/1996. (TN 82)

10/1993 - Provided coverage of FDA-approved VAD only when used in patients suffering from postcardiotomy ventricular dysfunction. Device intended for short use and not covered when used as bridge to cardiac transplantation. Effective date 10/18/1993. (TN 65)

05/1986 - Specified that artificial hearts not covered, either as permanent replacements or as temporary life-support systems. Also, ventricular assist devices (VADs) not covered when used as temporary life-support systems in patients awaiting heart transplants. Effective date 05/19/1986. (TN 7)