The Centers for Medicare and Medicaid Services today proposed coverage policy updates regarding artificial hearts and ventricular assist devices for patients with advanced heart failure.
The proposed policy update would eliminate the "coverage with evidence development" requirement for artificial hearts and permits coverage determinations for artificial hearts to be made by local Medicare Administrative Contractors.
For ventricular assist devices, the proposed rule would update the coverage criteria to better align with current medical practice, while allowing patients and providers to choose the best treatment for them.
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CMS is accepting comments on the proposed rule and a final decision will be given within 60 days after the 30-day public comment period.
WHY THIS MATTERS
Both artificial hearts and ventricular assist devices can be used as therapy for about 6.5 million American adults living with heart failure, according to CMS Administrator Seema Verma.
The technology can be used to save people's lives, according to CMS. Every year, between 4,000 and 4,500 heart transplants are performed each year, according to a study in the Journal of Thoracic Disease.
The national coverage determination for artificial hearts is no longer necessary, according to CMS. Instead, it believes that since there is a low percentage of the Medicare population needing this procedure, and because careful patient selection is needed, that local Medicare Administrative Contractors can make the appropriate decisions regarding artificial hearts.
The proposed update for ventricular assist devices would only apply to Left Ventricular Assist Devices (LVADs), according to CMS.
"We propose to update the coverage criteria to align with patient inclusion criteria derived from large, randomized controlled trials," the proposed rule says. "This will expand coverage to a greater number of LVAD candidates who are likely to benefit from LVAD use while maintaining an adequate safety profile."
THE LARGER TREND
Under current regulations, Medicare covers artificial hearts under the "coverage with evidence development" paradigm when beneficiaries are enrolled in a clinical study.
ON THE RECORD
"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," said CMS Administrator Seema Verma. "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."
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