The Association of Medical Device Reprocessors (AMDR) submitted comments June 7th in response to the Center for Medicare and Medicaid Services’ (CMS) proposed rules to implement the Medicare Shared Savings Program (MSSP) and regulate Accountable Care Organizations (ACO). In short, AMDR believes reprocessed devices can play an important role for ACOs, and the following recommendations, if implemented, will better position hospitals participating in MSSP to achieve their savings goals by providing them with a tangible option to lower costs without compromising quality of care.
In particular, AMDR recommends that the final ACO regulations include a specific statement encouraging the use of lawful, FDA-regulated reprocessed devices. As an added step, we also encourage CMS to obtain assurance from hospitals that they are using an FDA-registered third-party vendor that can furnish proper documentation (510(k) or pre-market approval) upon request for each device reprocessed. With over a decade of success in the US market, we can proudly say that reprocessed devices purchased through an FDA-regulated vendor have been found to be just as safe and effective as their original counterparts, and through clear guidance, CMS has the opportunity to empower healthcare providers by giving them a viable option for cutting costs that will immediately benefit their ACO’s ability to meet and exceed the goals of a shared savings program.
In addition, AMDR recommends that CMS confirm that use of reprocessed devices will not implicate civil monetary penalties laws for an ACO participating in MSSP. The civil monetary penalties statute prohibits hospitals from compensating physicians to withhold necessary care from a patient (e.g., arrangements that incentivize physicians to limit spending on patients). While hospitals will spend less on reprocessed devices in an effort to promote savings, CMS should clearly state that using FDA-cleared or -approved devices—original or reprocessed—does not constitute improper patient care under the civil monetary penalties statute.
In today’s market, healthcare providers are struggling to find reliable, low-cost solutions to reduce the financial burden of providing excellent care. AMDR believes CMS has an opportunity to highlight that use of regulated reprocessed devices can be a successful means by which ACO-affiliated medical practices can provide the highest quality care while containing costs.