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Additionally, as earlier outlined in more detail, we understands that the determination of potential 340B-eligibility of a PDE record using the methodology described herein does not necessarily mean that the covered entity replenished (or can in the future replenish) the units at the 340B price, and we therefore believe it is more probable that the proposed claims-based methodology may overestimate the number of units that are units for which a manufacturer provided a discount under the 340B Program, than undercount 340B units
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In the CY 2026 PFS proposed rule (90 FR 32597), we did not propose any exceptions for the Promoting Interoperability ASM performance category requirements
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