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Section 414.804 is amended by a

One supported excluding heart failure subspecialists because they believed that cardiologists may provide the bulk of care for exceptionally complex patients

Batch-specific Certificates of Analysis (COAs) are available to verify identity, purity, Mass Spectrometry (MS) results, and Endotoxin (LAL) testing, providing transparent quality verification for every batch

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We proposed to apply this modified approach in determining ACOs' participation options for agreement periods beginning on or after January 1, 2027, since the application cycle for the January 1, 2027 start date (anticipated to occur in CY 2026) would be the next cycle following the anticipated effective date for the CY 2026 PFS final rule of January 1, 2026