Centers for Medicare & Medicaid Services Questions with USP's Tim Casey, Senior Director of Government Affairs

As Congress and federal agencies increasingly examine the national security implications of US medicine supply chains, the Centers for Medicare & Medicaid Services enter the conversation, signaling that reimbursement policy may be a powerful lever for strengthening domestic manufacturing. Tim Casey, senior director of Government Affairs at the United States Pharmacopeia (USP), shares insight about USP's response to CMS's recent request for comment, what it means for health care providers and pharmacists on the front lines, and why this moment may represent a rare window for meaningful, bipartisan reform.

Question: How did we arrive at this moment? What caused CMS to solicit comments on this topic, and why was it a priority for USP to submit comments?

Tim Casey: Across Capitol Hill, bipartisan conversations increasingly focus on the intersection of national security and public health. Congress has studied these issues through hearings at the Senate Committee on Aging and the House Select Committee on China, and we may soon see these conversations take shape into draft legislation.

With the growing awareness of the national security implications of reliance on adversarial nations for critical medicines and ingredients, there has been bipartisan momentum to strengthen domestic manufacturing capacity. Policymakers recognize that government payors like CMS have a central role to play in strengthening US medical supply chains.

CMS’s request for comment aligns closely with USP’s commitment to supply chain resiliency efforts. USP recently launched the Resiliency Center, which brings together supply chain stakeholders, insights, and solutions to address systemic vulnerabilities. We’ve also developed and expanded the USP Medicine Supply Map data analytics platform, which provides end-to-end insights from finished dosage forms to upstream key starting materials.

Question: As policymakers focus on where medicines are made, how does that affect healthcare providers and other stakeholders who worry about the quality of those medicines when they reach patients?

Casey: Healthcare providers and other frontline stakeholders know how supply chain vulnerabilities and quality issues detract from patient care.

Drug shortages can severely disrupt patient access to critical medicines, as seen with generic sterile injectables used in hospitals. Generic drug manufacturers operate high-volume, low-margin businesses, and injectable products are especially vulnerable due to their complex manufacturing processes. Injectable medicines account for 63% of the USP Vulnerable Medicines List in 2025.

For patients, these shortages can be serious or even life-threatening, leading to increased mortality, adverse events, and treatment delays. For healthcare systems, shortages can also disrupt daily operations, increase labor costs, and contribute to workforce burnout as providers and pharmacists spend additional time identifying alternative therapies and managing supply constraints.

Question: What role can CMS play in incentivizing the production of essential medicines, and why is this an important moment to consider those approaches?

Casey: Drug reimbursement models often shape incentives and outcomes across our healthcare system. The medicine supply chain is no exception. In inpatient settings, drugs are reimbursed as part of a fixed bundled payment based on a patient’s diagnosis. Hospitals and GPOs face pressure to find savings, which often drives the purchasing of generic drugs towards the lowest-cost options.

As I mentioned before, generic drug manufacturers rely on high-volume production with relatively low profit margins. The result is offshoring, market exits, and supplier consolidation, all of which increase supply chain vulnerabilities and the risk of drug shortages.

USP believes in assigning value to resilience, reliability, and quality in purchasing and reimbursement decisions to incentivize changes in purchasing patterns with the goal of better meeting patients’ needs. Our Drug Supply Chain Resilience Initiative (DSCRI) proposes a system to define, evaluate, and provide a benchmark by providing criteria to value the resilience and reliability of manufacturers, promoting more sustainable prices for generic medicines. CMS can use an approach like this to provide data-driven, market-based incentives that support domestic manufacturing of essential medicines and ingredients.

Question: As CMS considers new procurement and reporting approaches, how else can medicine quality be supported by these changes?

Casey: CMS can continue working to level the playing field by ensuring manufacturers outside the U.S. are held to comparable quality testing standards. For medicines from countries that limit unannounced U.S. FDA inspections, CMS can incentivize health systems to purchase medicines from suppliers that participate in programs that use validated methods to test products.

In parallel, incentivizing resilient purchasing practices would foster a market that values security, reliability, and long-term investment in quality manufacturing.

Questions: How can increased visibility across the supply chain help strengthen confidence in the quality of essential medicines?

Casey: Transparency across the supply chain is foundational to strengthening resilience and the distribution of quality medicines. With greater upstream visibility through supply chain mapping tools, manufacturers, policymakers, and other industry members can identify hidden vulnerabilities, single-source dependencies, and supply chain chokepoints, enabling more strategic decision-making and cost-effective mitigation strategies that advance the Administration’s resilience goals.

Visibility should extend across all US-approved medicines, not just those already experiencing shortages, as even widely used drugs may rely on concentrated sources for critical inputs. Increasing transparency can also strengthen confidence in the quality of medicines sourced overseas, helping purchasers identify suppliers that prioritize quality and resiliency.