The Centers for Medicare & Medicaid Services (CMS) issued the CY 2025 Medicare Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center Payment System Final Rule on November 8, 2024. The rule includes significant provisions to strengthen American personal protective equipment (PPE) manufacturing and essential medical supplies. These measures represent a critical step toward enhancing national supply chain resilience, reducing reliance on foreign sources, and promoting the production of high-quality, domestically manufactured medical essentials.
The CMS OPPS final rule incorporates significant policies to strengthen domestic manufacturing of PPE and essential medical supplies. Recognizing vulnerabilities exposed during the COVID-19 pandemic, the rule emphasizes the importance of building a resilient supply chain by prioritizing U.S. production.
It includes provisions to address the higher acquisition costs of domestically manufactured PPE, such as payment adjustments designed to offset these expenses and incentivize hospitals and outpatient facilities to purchase American-made products. By reducing reliance on foreign suppliers and fostering sustainable domestic manufacturing, the rule supports long-term preparedness and ensures a steady supply of critical medical resources during public health emergencies.
In updating payment policies for 2025, CMS has taken steps to help hospitals cover the additional costs of purchasing American-made, NIOSH-approved N95 respirators. This was a priority for AMMA, and its members weighed in and encouraged CMS to expand its pilot program.
The rule is a resounding victory for the American Medical Manufacturers Association (AMMA) and its member companies. AMMA’s unwavering commitment to producing high-quality, U.S.-made PPE has been instrumental in this achievement.
The rule is consistent with the American electorate and Congress’s prioritization of bringing manufacturing back to our shores. The incoming Trump administration has emphasized leveraging all available tools to promote domestic production. Both the Biden Administration and Congress have worked to push back against unfair competition from overseas, particularly from China. In this context, CMS’s actions are well-aligned with the nation’s renewed manufacturing momentum.
CMS has also recognized the demand for a stable and sustainable supply of diverse, high-quality PPE and medical supplies. In 2026, it is preparing to broaden this support to include other essential PPE items, such as nitrile gloves, gowns, and non-surgical respirators.
This OPPS rule is about more than Medicare payments; it’s about aligning healthcare policy with the American people’s patriotic, economic, and health priorities. Our reliance on overseas supply chains has exposed our healthcare system for too long, as painfully revealed by PPE shortages during the COVID-19 pandemic.
The invaluable insights provided by AMMA members to CMS throughout this process have been instrumental in shaping the OPPS rule. Their expertise and feedback underscore the importance of creating a lasting market for American PPE manufacturing and ensuring healthcare providers have what they need in real-time.
AMMA and its members are ready and eager to collaborate with CMS, the outgoing and incoming administrations, and Congress to expand this program, building on a foundation of strength, resilience, and American pride in every product. Now is the moment to go beyond reimagining our supply chains. We can work together to rebuild them even more robust, independent, and American.