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We appreciate the comments and recommendations and may consider them for use in any future rulemaking regarding policies and requirements related to the repository, including a potential requirement that covered entities and their contracted 340B TPAs retrospectively report, at a minimum, the 4 elements we described and solicited comment on in the CY 2025 PFS proposed rule (89 FR 61971)

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) [2] Presence of serum autoantibodies supports the diagnosis

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