CMS Should Offer Immediate Reimbursement Coverage To FDA-Approved Breakthrough Devices

CMS Should Offer Immediate Reimbursement Coverage To FDA-Approved Breakthrough Devices

Share to Linkedin UNITED STATES - April 15: Chiquita Brooks-LaSure testifies before the Senate Finance Committee ... [+] during her nomination hearing to be administrator of the Centers for Medicare & Medicaid Services in Washington on Thursday, April 15, 2021. (Photo by Caroline Brehman/CQ-Roll Call, Inc via Getty Images) In 2016 the U. S. Congress passed, and President Barack Obama signed, the 21st Century Cures Act. Section 3501 of the law granted the Food and Drug Administration (FDA) authority to designate certain medical devices as "breakthrough." The program, FDA Commissioner Scott Gottlieb explained in a report to Congress, "is intended to expedite the development and prioritize the review of certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions." FDA approval is but one hurdle in the regulatory obstacle course medical-device manufacturers must navigate. Device makers must also obtain reimbursement approval from the Centers for Medicare & Medicaid Services (CMS) for use of their products by Medicare beneficiaries. That approval has proven especially difficult for breakthrough device makers. As CMS itself acknowledged, "[W]ith the current Medicare coverage options, we have had challenges keeping national Medicare coverage on pace with these innovations."