Single Use Vial/Package Drug Wastage Billing and Coverage Guidelines
Palmetto GBA will consider payment for the unused and discarded portion of a single-use drug/biological product, including single dose vial or single dose preparation of radiopharmaceuticals, after administration of the appropriate (reasonable and necessary) dosage for the patient's condition. This applies to all drugs (even Not Otherwise Classified). The Centers for Medicare & Medicaid Services (CMS) encourages physicians, hospitals, and other providers to provide injectable drug therapy incident to a physician’s services in a fashion that maximizes efficiency of therapy in a clinically appropriate manner. If a physician, hospital, or other provider must discard the unused portion of a single-use vial or other single-use package after administering a dose/quantity appropriate to the clinical context for a Medicare beneficiary, the program provides payment for the entire portion of drug or biological indicated on the vial or package label. Covered wastage must be billed on a separate detail line with HCPCS modifier JW.
If less than a complete vial is administered at the time of service, and the unused portion is discarded, drug wastage must be documented in the patient’s medical record with the date, time, and quantity wasted. Upon review, any discrepancy between amount administered to the patient and the billed amount will be denied, unless wastage is clearly documented. The amount billed as 'wastage' must not be administered to another patient or billed again to Medicare. All procedures for drug storage, reconstitution and administration should conform to applicable Federal Drug Administration (FDA) guidelines and provider scope of practice.
- CMS IOM, Publication 100-04, Chapter 17, Section 40 (PDF, 434 KB)
- CMS IOM, Publication 100-04, Chapter 23, Section 20.3 (PDF, 1.81 MB)