Weekly Policy Update: CBSA Meets with Federal Policymakers to Discuss the Role of Medtech in Value-Based Healthcare

CBSA was in DC this week representing Colorado’s life sciences ecosystem as part of the AdvaMed Fly-in. It was a great opportunity to meet with the Colorado delegation offices and advocate for federal priorities to support Colorado’s medical technology companies and the patients they serve.

CBSA met with every Colorado office to educate Members and staff about the hurdles that companies face in navigating the CMS coverage and reimbursement process. In particular, we asked for their support of H.R. 5333, a bill that would establish accelerated transitional coverage and payment for new breakthrough technologies. We will continue to weigh in with our federal policymakers on this issue to ensure patients have access to breakthrough devices and technologies.

CBSA also talked to Colorado offices about the role that medical device manufacturers play in value-based healthcare. Last October, the Health and Human Services Office of the Inspector General (OIG) released a proposed rule to update the Federal Anti-Kickback Statute (AKS) safe harbor regulations, which do not reflect the recent shift towards alternative payment models and value-based arrangements.

The current AKS safe harbors were designed for a volume-based, fee-for-service model that is outdated and does not support patient-centered, value-based healthcare. As a result of the broad prohibition under the current AKS, many services and technologies that could be part of the solution to achieve targeted outcomes cannot be integrated into value-based arrangements. In the recent proposed rule, however, OIG excluded durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) and is considering excluding all medical device manufacturers from the updated safe harbor regulations in its final rule. If finalized, medical device companies would not be able to participate in the shared accountability framework created by value-based arrangements.

Given the significant role medical device manufacturers play in care coordination and management, CBSA and our partners at AdvaMed want to make sure medical device manufacturers are included in the final rule. In our meetings, we asked the Colorado offices to weigh in with the Administration on this issue, and we shared examples of how DMEPOS and other medical devices can be integrated with mobile health, digital health, remote monitoring, and patient portals that help to improve care coordination and improve outcomes.

In the coming months, we will continue to weigh in with our Members of Congress on this critical issue and ask that device manufacturers are included in the final Anti-Kickback Statute rule.

Questions or feedback? Contact Emily Roberts at eroberts@cobioscience.com.

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Categories: CBSA News