Can I request custom formulations or bulk quantities
We provided as an example in the CY 2025 PFS proposed rule (89 FR 61953) the following: if CMS grants a severe supply chain disruption request for a Part B rebatable biosimilar biological product that was submitted on February 15, 2024, and that product is currently in shortage from December 15, 2024 until May 15, 2025, CMS would apply a 75 percent reduction in the total rebate amount to all 4 calendar quarters in 2024, [674] and then would apply the shortage reduction as proposed in 427.401, beginning with a reduction of 25 percent for a Part B rebatable biosimilar biological product or 75 percent in the case of a plasma-derived product that is a Part B rebatable biosimilar biological product for the first 2 calendar quarters of 2025.At 427.402(b)(4)(iii), we proposed that if a Part B rebatable biosimilar biological product that is currently in shortage experiences a severe supply chain disruption, the manufacturer may submit a request for a severe supply chain disruption rebate reduction
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Introduction Cellular health depends on efficient energy production, DNA repair, and metabolic balance
