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CMS outlines in section 40.4.5 of the Medicare Drug Price Negotiation Program final guidance for initial price applicability year 2027 and for initial price applicability year 2028 that a “provider or prescriber ID alone generally will not constitute sufficient evidence that a claim was 340B-eligible,” [362 363] meaning a manufacturer must be able to provide other evidence to conclude a claim was 340B-eligible to fulfill its statutory obligations under section 1193(d)(2) of the Act
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What the PA process requires: Documentation of type 2 diabetes diagnosis (A1C ≥ 6.5% or fasting glucose ≥ 126 mg/dL) BMI documentation (most plans require BMI ≥ 27 or ≥ 30) Trial and failure of at least one other diabetes medication (usually metformin) Cardiovascular risk factors (some plans) Prescriber attestation that the medication is medically necessary Timeline: Standard PA decision: 72 hours Expedited PA (urgent): 24 hours Appeal of denial: 7 days for reconsideration, 30 days for independent review Approval rates: A 2025 analysis of Medicare Part D PA decisions found that 78% of GLP-1 PA requests were approved on first submission, 14% were approved on appeal, and 8% were ultimately denied (Johnson et al., JAMA Health Forum 2025)
