Artificial Hearts and Related Devices

A. General

A ventricular assist device (VAD) or left ventricular assist device (LVAD) is surgically attached to one or both intact ventricles and is used to assist a damaged or weakened native heart in pumping blood. Improvement in the performance of the native heart may allow the device to be removed.

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.

B. Nationally Covered Indications

1. Postcardiotomy (effective for services performed on or after October 18, 1993). Post-cardiotomy is the period following open-heart surgery. VADs used for support of blood circulation post-cardiotomy are covered only if they have received approval from the Food and Drug Administration (FDA) for that purpose, and the VADs are used according to the FDA-approved labeling instructions.

2. Bridge-to-Transplant

   1. VADs as Bridge-to-Transplant (effective for services performed on or after January 22, 1996)

      The VADs used for bridge-to-transplant are covered only if they have received approval from the FDA for that purpose, and the VADs are used according to the FDA-approved labeling instructions. All of the following criteria must be fulfilled in order for Medicare coverage to be provided for a VAD used as a bridge-to-transplant:

      • The patient is approved and listed as a candidate for heart transplantation by a Medicare-approved heart transplant center; and,
      • The implanting site, if different than the Medicare-approved transplant center, must receive written permission from the Medicare-approved heart transplant center under which the patient is listed prior to implantation of the VAD.

      The Medicare-approved heart transplant center should make every reasonable effort to transplant patients on such devices as soon as medically reasonable. Ideally, the Medicare-approved heart transplant centers should determine patient-specific timetables for transplantation, and should not maintain such patients on VADs if suitable hearts become available.

   2. Artificial Hearts as Bridge-to-Transplant (effective for services performed on or after May 1, 2008)

      An artificial heart for bridge-to-transplantation 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 and Medicaid Services Re: Artificial Heart, Mailstop C1-09-06, 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/MedicareApprovedFacilitie/06_artificialhearts.asp.

3. Destination Therapy
   
   
   1. VADs as Destination Therapy (effective for services performed on or after October 1, 2003, facility criteria updated March 27, 2007, patient selection criteria updated November 9, 2010.

      Destination therapy is for patients that require permanent mechanical cardiac support. The VADs used for destination therapy are covered only if they have received approval from the FDA for that purpose.

      Patient Selection

      The VADs are covered for patients who have chronic end-stage heart failure (New York Heart Association Class IV end-stage left ventricular failure) who are not candidates for heart transplantation, and meet all of the following conditions:

      • Have failed to respond to optimal medical management (including beta-blockers and ACE inhibitors if tolerated) for at least 45 of the last 60 days, or have been balloon pump-dependent for 7 days, or IV inotrope-dependent for 14 days; and,
      • Have a left ventricular ejection fraction (LVEF) < 25%, and,
      • Have demonstrated functional limitation with a peak oxygen consumption of ≤ 14 ml/kg/min unless balloon pump- or inotrope-dependent or physically unable to perform the test.

      Facility Criteria

      • Facilities must have at least one member of the VAD team with experience implanting at least 10 VADs (as bridge-to-transplant or destination therapy) or artificial hearts over the course of the previous 36 months;
      • Facilities must be a member of the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS); and,
      • Effective March 27, 2009, all facilities must have met the above facility criteria and been credentialed by the Joint Commission under the Disease Specific Certification Program for Ventricular Assist Devices (standards dated February 2007).

      The Web site:
      http://www.cms.gov/MedicareApprovedFacilitie/VAD/list.asp#TopOfPage is updated continuously to list all approved facilities. Facilities gaining Joint Commission certification (including prior to March 27, 2009) are added to the Web site when certification is obtained.

      Hospitals also must have in place staff and procedures that ensure that prospective VAD recipients receive all information necessary to assist them in giving appropriate informed consent for the procedure so that they and their families are fully aware of the aftercare requirements and potential limitations, as well as benefits, following VAD implantation.

   2. Artificial Hearts as Destination Therapy (effective for services performed on or after May 1, 2008)

      An artificial heart for destination therapy 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 wide spread 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 and Medicaid Services, Re: Artificial Heart, Mailstop C1-09-06, 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/MedicareApprovedFacilitie/06_artificialhearts.asp.

C. Nationally Non-Covered Indications (effective for services performed on or after May 19, 1986)

All other indications for the use of VADs or 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 NCD Manual.

D. Other

Clinical study criteria:

• The study must be reviewed and approved by the 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 coverage with study participation (CSP) or CED coverage.
• 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 ClinicalTrials.gov Web site by the principal sponsor/investigator as demonstrated by having a National Clinical Trial control number.
• 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 underrepresented 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 underrepresented 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 the Centers for Medicare & Medicaid Services (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 registration number.

(This NCD last reviewed November 2010.)

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)