Hospitals become ineligible for the 340B Program on the day a Medicare Cost Report (MCR) is filed with Centers for Medicare & Medicaid Services (CMS) with a DSH percentage below the applicable eligibility threshold. Hospital offsite outpatient facilities failing to meet the registration eligibility requirements (listed as reimbursable on the MCR with associated outpatient costs and charges) become ineligible on the day the hospital files the MCR. If either occurs, the hospital should stop purchasing 340B drugs immediately and terminate their record in 340B OPAIS. If the hospital purchased while they were ineligible, the hospital should send the Office of Pharmacy Affairs (OPA) a self-disclosure to 340bselfdisclosure@hrsa.gov. HRSA may accept an amended MCR as long as it is considered the latest filed MCR by CMS. The hospital must submit a signed, dated, and electronically-stamped Worksheet S, along with other requested worksheets, as evidence the MCR was amended and filed with CMS. If the hospital chooses to file an amended MCR, the hospital may resume purchasing 340B covered outpatient drugs after the amended MCR is filed with CMS, sent to HRSA, and accepted by HRSA. The amended MCR may not be applied retroactively for 340B purposes and HRSA reserves the right to request additional documentation if necessary. The hospital may be liable for any 340B purchases made during the period of ineligibility between when the original MCR was filed to when the amended MCR was filed, depending on the specific circumstances of the case.
Does HRSA accept amended Medicare Cost Reports and can they be applied retroactively?
Does HRSA accept amended Medicare Cost Reports and can they be applied retroactively?
340B Program Eligibility
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