On January 26, 2026, the Centers for Medicare & Medicaid Services (“CMS”) issued an Advance Notice of Proposed Rulemaking (“ANPRM”) seeking public input on potential policies to strengthen the domestic supply chain for personal protective equipment (“PPE”) and essential medicines used by Medicare‑participating hospitals. The initiative reflects lessons learned during the COVID‑19 public health emergency and signals a possible shift toward incentivizing or requiring greater reliance on U.S.-manufactured medical products within the Medicare program. This focus on domestic sourcing also aligns with the Trump administration’s broader trade policy agenda, including the April 2025 Executive Order 14257 establishing reciprocal tariffs to address non‑reciprocal trade practices and rebuild critical U.S. manufacturing capacity and supply chains deemed essential to national and economic security, which may further affect the cost and availability of imported PPE and pharmaceuticals.
CMS is seeking stakeholder feedback on a range of potential policy approaches, including:
- Promoting American-Made Supply Chain Procurement: CMS is exploring mechanisms to incentivize hospitals to procure American-made PPE and essential medicines, reducing reliance on foreign supply chains.
- “Secure American Medical Supplies” Designation: CMS is considering creating a voluntary designation that hospitals could earn by demonstrating commitment to domestic procurement of qualifying products. The designation could serve as a public quality signal and potentially be tied to future payment incentives or other support mechanisms.
- Potential Payment Policy Support: Recognizing that domestic sourcing may involve higher acquisition costs, CMS is seeking feedback on “new, streamlined payment policies” to reflect those added costs and support hospitals that choose to procure domestically made items.
- Hospital Quality Reporting Framework: CMS also seeks comments on whether to add a structural quality measure within the Hospital Inpatient Quality Reporting Program that would reflect hospital commitments to procure American-made PPE and essential medicines.
As noted above, the ANPRM reflects a growing emphasis from CMS and other federal agencies on domestic industrial capacity for critical medical supplies, especially in light of vulnerabilities revealed during the COVID-19 pandemic and subsequent supply disruptions. Chris Klomp, CMS Deputy Administrator and Director of the Center for Medicare, stated, “We want to hear from hospitals, manufacturers, suppliers, and the public on practical ways Medicare can support a stronger, more reliable domestic supply chain [. . .] our goal is to develop options that improve preparedness while giving providers workable, flexible policies that strengthen patient care.”
Submitting Comments
CMS is accepting public comments through March 30, 2026. Comments may be submitted by mail, hand delivered or submitted electronically at regulations.gov. Commenters should reference file code “CMS-1516-ANPRM” in their submissions to ensure their comments are considered.
