Abbott’s HeartMate 3 VAD system [Image courtesy of Abbott]
The policy updates, if approved, could be good news for major VAD makers Abbott (NYSE:ABT) and Medtronic (NYSE:MDT) — as well as people with heart failure who are waiting for a heart transplant or don’t meet the criteria for one.
“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. We look forward to CMS’ final decision in the months ahead,” 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.
Medtronic spokesperson Tracy McNulty said 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.
The proposed national coverage determination, according to CMS, provides updated coverage criteria for VADs that better aligns with current medical practice. The idea is to provide additional flexibility for patients and providers to choose the most appropriate treatments.
In the case of artificial hearts — a technology that only a small number of Medicare beneficiaries presently receive — the people receiving the hearts would no longer need to be under the “coverage with evidence development” paradigm when beneficiaries are enrolled in a clinical study. Local local Medicare Administrative Contractors (MACs) would make artificial heart coverage decisions because they are better able to consider each person’s particular clinical circumstances.
“With about 6.5 million American adults living with heart failure, today’s proposal ensures a patient-centered approach to treating end-stage heart disease without delaying care,” CMS Administrator Seema Verma said in a news release. “Our updated criteria better reflects the individualized needs of patients with heart failure and expands physicians’ ability to offer the most appropriate treatment options to their patients, both of which will lead to better health outcomes for Medicare beneficiaries.”
CMS will issue a decision no later than 60 days after the conclusion of the 30-day public comment period.
