National Coverage Determination (NCD)

Artificial Hearts and Related Devices

20.9

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Tracking Information

Publication Number
100-3
Manual Section Number
20.9
Manual Section Title
Artificial Hearts and Related Devices
Version Number
2
Effective Date of this Version
10/01/2003
Ending Effective Date of this Version
03/27/2007
Implementation Date
10/01/2003
Implementation QR Modifier Date

Description Information

Benefit Category
Prosthetic Devices


Please Note: This may not be an exhaustive list of all applicable Medicare benefit categories for this item or service.

Item/Service Description

A ventricular assist device (VAD) or left ventricular assist device (LVAD) is used to assist a damaged or weakened heart in pumping blood. These devices are used for support of blood circulation post-cardiotomy, as a bridge to a heart transplant, or as destination therapy.

Indications and Limitations of Coverage

A. Covered Indications

  1. Post-cardiotomy (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.

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

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:

  1. The patient is approved and listed as a candidate for heart transplantation by a Medicare-approved heart transplant center; and,
  2. 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.

  1. Destination Therapy (effective for services performed on or after October 1, 2003)

Destination therapy is for patients that require permanent mechanical cardiac support. VADs used for destination therapy are covered only if they have received approval from the FDA for that purpose, and the device is used according to the FDA-approved labeling instructions. VADs are covered for patients who have chronic end-stage heart failure (New York Heart Association Class IV end-stage left ventricular failure for at least 90 days with a life expectancy of less than 2 years), are not candidates for heart transplantation, and meet all of the following conditions:

  1. The patient's Class IV heart failure symptoms have failed to respond to optimal medical management, including dietary salt restriction, diuretics, digitalis, beta-blockers, and ACE inhibitors (if tolerated) for at least 60 of the last 90 days;
  2. The patient has a left ventricular ejection fraction (LVEF) < 25%;
  3. The patient has demonstrated functional limitation with a peak oxygen consumption of < 12 ml/kg/min; or the patient has a continued need for intravenous inotropic therapy owing to symptomatic hypotension, decreasing renal function, or worsening pulmonary congestion; and,
  4. The patient has the appropriate body size (≥1.5 m²) to support the VAD implantation.

In addition, the Centers for Medicare & Medicaid Services (CMS) has determined that VAD implantation as destination therapy is reasonable and necessary only when the procedure is performed in a Medicare-approved heart transplant facility that, between January 1, 2001, and September 30, 2003, implanted at least 15 VADs as a bridge-to-transplant or as destination therapy. These devices must have been approved by the FDA for destination therapy or as a bridge-to-transplant, or have been implanted as part of an FDA investigational device exemption (IDE) trial for one of these two indications. VADs implanted for other investigational indications or for support of blood circulation post-cardiotomy do not satisfy the volume requirement for this purpose. Since the relationship between volume and outcomes has not been well-established for VAD use, facilities that have minimal deficiencies in meeting this standard may apply and include a request for an exception based upon additional factors. Some of the factors CMS will consider are geographic location of the center, number of destination procedures performed, and patient outcomes from VAD procedures completed.

Also, this facility must be an active, continuous member of a national, audited registry that requires submission of health data on all VAD destination therapy patients from the date of implantation throughout the remainder of their lives. This registry must have the ability to accommodate data related to any device approved by the FDA for destination therapy regardless of manufacturer. The registry must also provide such routine reports as may be specified by CMS, and must have standards for data quality and timeliness of data submissions such that hospitals failing to meet them will be removed from membership. CMS believes that the registry sponsored by the International Society for Heart and Lung Transplantation is an example of a registry that meets these characteristics.

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.

CMS plans to develop accreditation standards for facilities that implant VADs and, when implemented, VAD implantation will be considered reasonable and necessary only at accredited facilities.

A list of facilities eligible for Medicare reimbursement for VADs as destination therapy will be maintained on our website and available at www.cms.hhs.gov/coverage/lvadfacility.asp. In order to be placed on this list, facilities must submit a letter to the Director, Coverage and Analysis Group, 7500 Security Blvd, Mailstop C1-09-06, Baltimore, MD 21244. This letter must be received by CMS within 90 days of the issue date on this transmittal. The letter must include the following information:

  • Facility's name and complete address;
  • Facility's Medicare provider number;
  • List of all implantations between Jan. 1, 2001, and Sept. 30, 2003, with the following information:
    • Date of implantation,
    • Indication for implantation (only destination and bridge-to-transplant can be reported; post-cardiotomy VAD implants are not to be included),
    • Device name and manufacturer, and,
    • Date of device removal and reason (e.g., transplantation, recovery, device malfunction), or date and cause of patient's death;
  • Point-of-contact for questions with telephone number;
  • Registry to which patient information will be submitted; and,
  • Signature of a senior facility administrative official.

Facilities not meeting the minimal standards and requesting exception should, in addition to supplying the information above, include the factors that they deem critical in requesting the exception to the standards.

CMS will review the information contained in the above letters. When the review is complete, all necessary information is received, and criteria are met, CMS will include the name of the newly Medicare-approved facility on the CMS web site. No reimbursement for destination therapy will be made for implantations performed before the date the facility is added to the CMS web site. Each newly approved facility will also receive a formal letter from CMS stating the official approval date it was added to the list.

B. Noncovered Indications (effective for services performed on or after May 19, 1986)

  1. Artificial Heart

Since there is no authoritative evidence substantiating the safety and effectiveness of a VAD used as a replacement for the human heart, Medicare does not cover this device when used as an artificial heart.

  1. All other indications for the use of VADs not otherwise listed remain noncovered, except in the context of Category B IDE clinical trials (42 CFR 405) or as a routine cost in clinical trials defined under section 310.1 of the NCD manual (old CIM 30-1).

(This NCD last reviewed October 2003.)

Cross Reference

Transmittal Information

Transmittal Number
2
Revision History

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)

Other

National Coverage Analyses (NCAs)

This NCD has been or is currently being reviewed under the National Coverage Determination process. The following are existing associations with NCAs, from the National Coverage Analyses database.

Coding Analyses for Labs (CALs)

This NCD has been or is currently being reviewed under the National Coverage Determination process. The following are existing associations with CALs, from the Coding Analyses for Labs database.

Additional Information

Other Versions
Title Version Effective Between
Artificial Hearts and Related Devices - RETIRED 8 04/10/2023 - N/A View
Artificial Hearts and Related Devices 7 12/01/2020 - 04/10/2023 View
Artificial Hearts and Related Devices 6 10/30/2013 - 12/01/2020 View
Artificial Hearts and Related Devices 5 11/09/2010 - 10/30/2013 View
Artificial Hearts and Related Devices 4 05/01/2008 - 11/09/2010 View
Artificial Hearts and Related Devices 3 03/27/2007 - 05/01/2008 View
Artificial Hearts and Related Devices 2 10/01/2003 - 03/27/2007 You are here
Artificial Hearts and Related Devices 1 01/01/2001 - 10/01/2003 View
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Reasons for Denial
Note: This section has not been negotiated by the Negotiated RuleMaking Committee. It includes CMS’s interpretation of it’s longstanding policies and is included for informational purposes. Tests for screening purposes that are performed in the absense of signs, symptoms, complaints, or personal history of disease or injury are not covered except as explicity authorized by statue. These include exams required by insurance companies, business establishments, government agencies, or other third parties. Tests that are not reasonable and necessary for the diagnosis or treatment of an illness or injury are not covered according to the statue. Failure to provide documentation of the medical necessity of tests may result in denial of claims. The documentation may include notes documenting relevant signs, symptoms, or abnormal findings that substantiate the medical necessity for ordering the tests. In addition, failure to provide independent verification that the test was ordered by the treating physician (or qualified nonphysician practitioner) through documentation in the physician’s office may result in denial. A claim for a test for which there is a national coverage or local medical review policy will be denied as not reasonable and necessary if it is submitted without an ICD-9-CM code or narrative diagnosis listed as covered in the policy unless other medical documentation justifying the necessity is submitted with the claim. If a national or local policy identifies a frequency expectation, a claim for a test that exceeds that expectation may be denied as not reasonable and necessary, unless it is submitted with documentation justifying increased frequency. Tests that are not ordered by a treating physician or other qualified treating nonphysician practitioner acting within the scope of their license and in compliance with Medicare requirements will be denied as not reasonable and necessary. Failure of the laboratory performing the test to have the appropriate Clinical Laboratory Improvement Act of 1988 (CLIA) certificate for the testing performed will result in denial of claims.