By Christina Lavoie
In the wake of the COVID-19 pandemic, federal regulators are placing more scrutiny on the medical supply chain. HIDA closely monitors federal agencies to keep our members informed of regulatory changes that may impact them. Among the hundreds of regulatory changes currently being considered by the Biden administration, we have identified three key trends that are important for the health distribution industry.
Domestic Manufacturing: The Centers for Medicare & Medicaid Services (CMS) are considering a regulation to increase Medicare payment adjustments for hospitals that purchase domestically manufactured surgical N95 respirators. This is an important step in creating commercial market support to sustain domestic production. The policy proposal also recognizes the substantial resources required to acquire domestically made NIOSH-approved surgical N95 respirators. HIDA supports diversified sourcing, which is essential for future preparedness efforts and supply chain resiliency. Medicare reimbursement policy can be an effective tool to incentivize domestic purchasing by providers and is critical to long term viability.
Device Sterilization: The Environmental Protection Agency (EPA) recently announced it would scrutinize commercial plants using the gas ethylene oxide (EtO) to perform sterilization of medical devices and other products. The EPA has identified commercial sterilizers in 13 states and Puerto Rico that regulators determined could contribute to long-term health impacts for people living in nearby communities if exposed to a lifetime of EtO emissions at the current levels. These commercial sterilizers are used by the medical products distribution industry. According to the Food and Drug Administration, EtO is currently used to treat approximately 50% of sterile medical devices, about 20 billion medical devices annually. For some devices, EtO is the only safe and effective sterilization method currently available.
Social Determinants: In one of his first acts as president, Joe Biden signed an executive order directing federal agencies to advance racial equity in all sectors of the government, including healthcare. One effort to maintain equity in healthcare outcomes is by focusing on social determinants of health (SDOH). The federal government defines SDOH as the conditions in places where people live, learn, work, and play that affect a wide range of health and quality-of life-risks and outcomes.
With political changes expected to come to Congress next year, the Biden administration will likely exercise more power through the process of executive orders and agency directives – the so-called “pen and phone” strategy of presidential power. CMS has been collecting comments from stakeholders on how to measure SDOH through the annual Medicare payment regulatory process. These regulatory analyses are available to our members on our website at HIDA.org.
Christina Lavoie, Director of Policy, Health Industry Distributors Association