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
Prescribers should take caution or consider prescribing alternatives for patients with the following (Padda, 2023): Renal impairment Pregnancy or breastfeeding Geriatric age range Adverse Effects and Black Box Warnings Patients may experience adverse effects when taking SGLT2 Inhibitors, including (10): Dyslipidemia Hyperphosphatemia Hypovolemia Nausea Fungal vaginosis Urinary tract infection Increased urine output Dysuria Influenza Bone fractures Renal impairment Drug Interactions SGLT2 Inhibitors interact with (16): Increases risk for hypoglycemia Insulin Increases the frequency of urination and the risk of dehydration Diuretics Increases the removal of canagliflozin Rifampin Phenytoin Phenobarbital Ritonavir Increases blood level and the effects of digoxin Ask yourself
The timing of blood pressure changes also matters
Intrinsic Factor Inhibiting Conditions Conditions such as autoimmune disease or pernicious anemia cause an inability to make the intrinsic factor that is essential for Vitamin B-12 absorption
