A coalition of 67 organizations is urging the Centers for Medicare and Medicaid Services to address a multi-year delay between FDA authorization and reimbursement for new medical technologies.
Leading a coalition of 67 stakeholder groups, AdvaMed is urging the Centers for Medicare and Medicaid Services (CMS) to create a streamlined pathway for Medicare patients to access US Food and Drug Administration (FDA)-authorized breakthrough medical technology.
In a letter to CMS Administrator Dr Mehmet Oz, the organizations, which include patient advocacy groups and state medtech associations, highlight significant delays between when a device is approved by the FDA and when it becomes covered by Medicare.
The letter points to a recent study revealing that for technologies requiring a new reimbursement pathway, nearly six years passed between FDA market authorization and Medicare coverage. “Patients should not be forced to wait the better part of a decade for access to safe and effective medical technology that holds the potential to meaningfully improve their health and life,” the letter states.
A predictable Medicare coverage pathway for devices the FDA has already deemed useful and safe would allow beneficiaries to benefit from new advancements without unnecessary delays, the letter continues. For healthcare facilities, such a change could accelerate the adoption and implementation of new diagnostic and therapeutic equipment.
Momentum Builds for Policy Change
The effort to secure faster coverage appears to be gaining support from federal officials and legislators. In a recent interview, FDA Commissioner Marty Makary said he and Oz were working on automatic coverage of FDA-authorized breakthrough medtech to avoid a “repeat, duplicative approval process.”
“When FDA has identified a medtech solution as a ‘breakthrough’ and cleared it as safe and effective for patients, we believe Medicare should cover it,” says Scott Whitaker, AdvaMed president and CEO, in a release. “As this Administration and AdvaMed work toward our mutual goal of making Americans healthy again, I want to thank Dr Oz and Commissioner Makary for their commitment to improving Medicare beneficiaries’ access to the breakthrough medtech that could improve their health and even save their lives.”
In addition to the agency-level discussions, US senators have introduced the bipartisan Ensuring Patient Access to Critical Breakthrough Products Act to accelerate Medicare coverage.
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