B. Nationally 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.
2. 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 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 for heart transplantation by a Medicare-approved heart transplant center and is active on the Organ Procurement and Transplantation Network (OPTN) heart transplant waitlist.
- The implanting site, if different than the Medicare-approved transplant center, must receive written permission from the Medicare-approved transplant center under which the patient is listed prior to implantation of the VAD.
3. Destination Therapy (DT) (effective for services performed on or after October 1, 2003)
Destination therapy (DT) is for patients that require mechanical cardiac support. The VADs used for DT are covered only if they have received approval from the FDA for that purpose.
Patient Selection (effective November 9, 2010):
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 at the time of VAD implant, and meet the following conditions:
- Have failed to respond to optimal medical management (including beta-blockers and ACE inhibitors if tolerated) for 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 (effective October 30, 2013):
Facilities currently credentialed by the Joint Commission for placement of VADs as DT may continue as Medicare-approved facilities until October 30, 2014. At the conclusion of this transition period, these facilities must be in compliance with the following criteria as determined by a credentialing organization. As of the effective date, new facilities must meet the following criteria as a condition of coverage of this procedure as DT under section 1862(a)(1)(A) of the Social Security Act (the Act):
Beneficiaries receiving VADs for DT must be managed by an explicitly identified cohesive, multidisciplinary team of medical professionals with the appropriate qualifications, training, and experience. The team embodies collaboration and dedication across medical specialties to offer optimal patient-centered care. Collectively, the team must ensure that patients and caregivers have the knowledge and support necessary to participate in shared decision making and to provide appropriate informed consent. The team members must be based at the facility and must include individuals with experience working with patients before and after placement of a VAD.
The team must include, at a minimum:
- At least one physician with cardiothoracic surgery privileges and individual experience implanting at least 10 durable, intracorporeal, left VADs as BTT or DT over the course of the previous 36 months with activity in the last year.
- At least one cardiologist trained in advanced heart failure with clinical competence in medical and device-based management including VADs, and clinical competence in the management of patients before and after heart transplant.
- A VAD program coordinator.
- A social worker.
- A palliative care specialist.
Facilities must be credentialed by an organization approved by the Centers for Medicare & Medicaid Services.
C. Nationally Non-Covered Indications
All other indications for the use of VADs 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.
This policy does not address coverage of VADs for right ventricular support, biventricular support, use in beneficiaries under the age of 18, use in beneficiaries with complex congenital heart disease, or use in beneficiaries with acute heart failure without a history of chronic heart failure. Coverage under section 1862(a)(1)(A) of the Act for VADs in these situations will be made by local Medicare Administrative Contractors within their respective jurisdictions.