The Centers for Medicare & Medicaid Services (CMS) finalized policies that increase access to artificial hearts and ventricular assist devices (VADs).
In August, CMS proposed the coverage policy updates meant to increase access to VADs and artificial hearts, which represented potentially good news for major VAD makers Abbott (NYSE:ABT) and Medtronic (NYSE:MDT) and for people with heart failure who are waiting for a heart transplant or don’t meet the criteria for one.
According to the finalized decision, CMS is covering artificial hearts made by the Medicare Administrative Contractors (MACs), while the decision is limited to durable, intracorporeal left ventricular assist devices (LVADs) and doesn’t include temporary VADs or extracorporeal membrane oxygen (ECMO).CMS is establishing coverage under criteria that remove the current therapeutic intent-to-treat criteria of bridge-to-transplant (BTT) and destination therapy (DT). It extends evidence-based patient selection criteria for all LVAD procedures for the short-term and modifies patient selection criteria to reflect the major inclusion criteria of contemporary trials.The idea of the updated CMS policies is to provide more flexibility for patients and providers to choose the most appropriate treatments.
“CMS’ proposed revisions to its national coverage determination (NCD) for ventricular assist devices are very promising for people living with advanced heart failure. Providing patients with greater access to this technology is important as heart pumps can have a critical impact on saving and improving quality of life,” Dr. Robert L. Kormos, divisional VP of global medical affairs for Heart Failure at Abbott, said in a statement provided to Medical Design & Outsourcing and MassDevice in August.
Additionally, Medtronic spokesperson Tracy McNulty said at the time of the proposal that the company is pleased that CMS’ proposed national coverage decision memorandum for VADs will preserve patient access for all labeled LVADs currently on the market.