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Part D does not cover B12 injections as vitamins are generally excluded

Considering the public input received and further internal analyses conducted, we proposed to make the following modifications to the Overall Hospital Quality Star Rating methodology: (1) implement a 4-star cap for hospitals in the lowest-performing quartile of the Safety of Care measure group for the 2026 Overall Hospital Quality Star Rating, and (2) implement a blanket 1-star reduction for hospitals in the lowest-performing quartile of the Safety of Care measure group for the 2027 Overall Hospital Quality Star Rating and thereafter

With respect to the newness criterion at 419.66(b)(1), FDA granted the applicant 510(k) clearance for the LithoVue TM Elite System on February, 2023

How long that takes will vary from individual to individual, but it will happen