CPP-061_physician-administered-drugs_v2.0.md

# CPP-061 — Physician-administered drugs: dose, units and wastage **Version 2.0 · Effective 1 March 2026 · Supersedes v1.4** Owner: Pharmacy Payment Integrity Applies to: Medicare Advantage · Medicaid · Marketplace — all states External basis: CMS Part B ASP pricing file · Medically Unlikely Edits · JW / JZ modifier guidance ## 1. Purpose This policy governs how the number of units billed for an infused or injected drug on the medical benefit is reconciled against the dose the clinical record says was administered, and when drug discarded from a single-dose vial is separately payable. It applies to drugs billed under a HCPCS Level II J-code on a professional or institutional claim. It does not apply to drugs dispensed under the pharmacy benefit, which are governed by CPP-063. ## 2. What changed in version 2.0 Version 1.4 accepted billed units at or below the published Medically Unlikely Edit ceiling for the code without any reconciliation to the administered dose. That is no

2. What changed in version 2.0 Version 1.4 accepted billed units at or below the published Medically Unlikely Edit ceiling for the code without any reconciliation to the administered dose. That is no longer sufficient. Three changes take effect on 1 March 2026: 1. Billed units must reconcile to the administered dose recorded in the medication administration record for the date of service. 2. Passing the MUE ceiling is explicitly not validation. The MUE is a maximum, not an allowance. 3. Discarded single-dose-vial drug is payable only on a separate line carrying modifier JW. A line with no wastage requires modifier JZ.

## 3. Criteria ### 3.1 Unit calculation Billed units equal the administered dose divided by the billing unit published in the HCPCS long descriptor for the code, rounded to whole units. billed units = administered dose / HCPCS billing unit Where the quotient is not a whole number, round to the nearest whole unit and document the rounding. A code whose descriptor reads "up to" a quantity is billed as one unit for any dose at or below that quantity. ### 3.2 Documentation The administered dose must appear in the medication administration record for the date of service. An order, a prescription or a prior authorization is not by itself evidence of administration. Where the record and the claim disagree, the record governs and the difference is recoverable. ### 3.3 Unit ceilings Units at or below the Medically Unlikely Edit ceiling for the code and setting are not thereby validated. The ceiling exists to stop implausible quantities; it does not certify that a plausible quantity

its at or below the Medically Unlikely Edit ceiling for the code and setting are not thereby validated. The ceiling exists to stop implausible quantities; it does not certify that a plausible quantity was given. A claim inside the ceiling that exceeds the documented dose is recoverable for the excess. ### 3.4 Wastage Drug discarded from a single-dose or single-use vial is payable only where it is billed on a separate line carrying modifier JW, and the discarded amount is recorded in the medication administration record. A line for a single-dose vial with no wastage requires modifier JZ. Wastage from a multi-dose vial is not payable.

## 4. Interaction with prior authorization Where an authorization is on file for the drug, CPP-085 bars a post-service medical-necessity review of the therapy itself. It does not bar review of the quantity. Units billed beyond those authorised remain reviewable and recoverable under both this policy and CPP-085 section 4.2. ## 5. Recovery The recoverable amount is the excess units multiplied by the per-unit payment limit published in the CMS Part B ASP pricing file for the quarter containing the date of service. recovery = (billed units - supported units) x ASP payment limit per unit The quarter is the quarter of the date of service, not of payment and not of audit. Where an audit runs in a later quarter, the earlier file governs. ## 6. Provider dispute A provider disputing a finding under this policy may submit the medication administration record for the date of service. Where the record supports the billed dose, the finding is withdrawn in full. Payment activity is held

finding under this policy may submit the medication administration record for the date of service. Where the record supports the billed dose, the finding is withdrawn in full. Payment activity is held pending review for thirty days from the date of the notice.