The Centers for Medicare & Medicaid Services (CMS) has proposed revisions for Medicare coverage to include ventricular assist devices (VAD) as a destination therapy for patients with end-stage heart failure who are not candidates for transplant.
According to CMS, “[E]vidence 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.”
The proposed changes come from a request from Thoratec that asked CMS to reconsider VADs as destination based on the outcomes of the HeartMate II Destination Therapy study.
While CMS said it will not make other changes to the “Artificial Heart and Related Devices” section of the coverage policy, it has proposed the following coverage changes for patients with NYHA class IV end-stage ventricular HF and not suitable for transplant:
- Patients who failed medical management with beta-blockers, ACE inhibitors for 45 out of the last 60 days or are balloon pump dependent for seven days or IV inotrope dependent for 14 days;
- Patients with a left ventricular ejection fraction of 25 percent or less; and
- Patients with functional limitation and a peak oxygen consumption that is less than or equal to 14 ml/kg/min.
“As the number of patients attaining long-term survival with VADs continues to rise, new research seeks to expand the indications for VAD implantation to include patients in earlier stage heart failure to prevent development of unsurvivable comorbidities, which could limit the clinical benefit of a VAD,” the agency said.
After results of the REMATCH trial showed that a bridge device was a suitable destination therapy for end-stage non-transplant patients in November 2002, CMS enacted coverage of VAD implantation for certain populations of Medicare beneficiaries beginning Oct. 1, 2003.
CMS is currently conducting a 30-day public comment period regarding the proposed changes that will end September 18.