National_Coverage_Determinations_Manual / Artificial Hearts and Related Devices 20.9

Why This Topic Matters

Coverage for advanced cardiac support devices depends on specific Medicare policy details, including indication, patient selection, and facility readiness. Understanding this NCD helps organizations assess whether a case fits within covered use and whether non-covered or trial-based pathways apply.

Article Sections

1. A. General

   Provides background on ventricular assist devices and their role in mechanical circulatory support. Introduces the broad clinical contexts addressed by the policy.

2. B. Nationally Covered Indications

   Outlines the main categories of covered use under Medicare and the overarching conditions tied to each category. Also addresses the general administrative and facility framework associated with covered use.

3. 1. Postcardiotomy

   Describes one covered clinical indication and the related approval and labeling framework. This section is limited to use after open-heart surgery.

4. 2. Bridge-to-Transplant

   Describes the transplant-related coverage category and the associated transplant-center relationship requirements. It focuses on the coverage context for patients awaiting transplantation.

5. 3. Destination Therapy

   Covers the permanent-support category and the associated patient selection and facility criteria. This section includes the broader administrative and readiness expectations for participating facilities.

6. Patient Selection

   Summarizes the clinical and functional characteristics used in the destination therapy portion of the policy. It presents the general selection framework without detailing operational use.

7. Facility Criteria

   Describes the facility-level requirements for organizations involved in this type of device therapy. It also references registry participation and accreditation-related expectations.

8. The Web site

   Notes the public resource referenced for approved facilities and related updates. This section is administrative in nature.

9. C. Nationally Non-Covered Indications

   Identifies situations that are excluded from coverage and the limited exceptions discussed in the policy. It frames the non-covered portion of the determination.

10. 1. Artificial Heart

    Addresses non-covered use when the device is used as a replacement for the human heart. It also notes the relationship to other non-covered indications and trial-based exceptions.