Proposal provides enhanced patient-centered access to Artificial Hearts and Ventricular Assist Devices for Medicare beneficiaries

Today the Centers for Medicare & Medicaid Services (CMS) proposed updates to coverage policies for artificial hearts and ventricular assist devices (VADs), both of which are used to treat patients with life-threatening advanced heart failure.

Medicare currently covers artificial hearts under the “coverage with evidence development” paradigm when beneficiaries are enrolled in a clinical study. The proposed decision memorandum would eliminate the “coverage with evidence development” requirement and provides for coverage determinations for artificial hearts to be made by local Medicare Administrative Contractors (MACs).  Although a small number of Medicare beneficiaries receive artificial hearts, the technology can save the lives of certain end-stage heart failure patients awaiting heart transplantation.  We believe this proposed decision is in the best interest of Medicare beneficiaries since careful patient selection is important, and the MACs are structured to take into account a beneficiary’s particular clinical circumstances to determine which patients will benefit from receiving an artificial heart.     

“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.”

The proposed national coverage determination also provides updated coverage criteria for VADs that better aligns with current medical practice and provides additional flexibility for patients and providers to choose the most appropriate treatments.       

CMS is seeking comments on the proposed national coverage determination. All public comments may be submitted at https://www.cms.gov/medicare-coverage-database/indexes/nca-open-for-public-comment-index.aspx. A final decision will be issued no later than 60 days after the conclusion of the 30-day public comment period.

To read the proposed decision, visit the CMS website at: https://www.cms.gov/medicare-coverage-database/details/nca-proposed-decision-memo.aspx?NCAId=298.