What does 340B carve out mean?

What does 340B carve out mean?

“Carve-Out”: A commonly used term to describe a covered entity’s decision not to use 340B discounted drugs for Medicaid patients if such drugs are subject to a potential Medicaid rebate claim by a state Medicaid agency.

Are Medicaid patients eligible for 340B?

Can I Use 340B Drugs with Medicaid Patients? Yes, 340B drugs can be used with Medicaid patients.

What makes a patient 340B eligible?

The prescription must be filled at one of the covered entities registered 340B pharmacies. There must also be no dual discounts, i.e. it cannot be paid for by Medicaid. The Patient. Must have an established relationship with health records maintained by the covered entity.

Is 340B for outpatient only?

The 340B Program is an outpatient drug program. Enrolled covered entities have the responsibility to ensure that drugs purchased under the 340B Program be limited to outpatient use and provided to individuals who meet the requirements of the current patient definition.

What is 340B duplicate discount?

The 340B statute prohibits duplicate discounts, which occur when a covered entity obtains a 340B discount on a medication and a Medicaid agency obtains a discount in the form of a rebate from the manufacturer for the same medication.

Are all drugs 340B eligible?

According to the 340B statute, FQHCs (and other covered entities) may only provide 340B purchased drugs to individuals who are “patients” of the entity. As a result, policymakers often talk about the “patient definition” as the tool for determining eligibility for 340B drugs.

What is 340B in healthcare?

Section 340B of the Public Health Service Act requires pharmaceutical manufacturers participating in Medicaid to sell outpatient drugs at discounted prices to health care organizations that care for many uninsured and low-income patients.

What is Medicaid exclusion file?

The Medicaid Exclusion File (MEF) lists covered entities that have chosen to use 340B drugs for their Medicaid patients and to bill Medicaid for those drugs (carve-in). When covered entities choose to carve-in for Medicaid, they must provide OPA with the Medicaid Provider Number/NPI used to bill Medicaid.

How do Medicaid rebates work?

Congress enacted the Medicaid Drug Rebate Program (MDRP) to ensure Medicaid does not overpay for drugs compared to private purchasers. Under the program, a drug manufacturer must pay quarterly rebates to state Medicaid programs in exchange for Medicaid’s coverage of the manufacturer’s drug.

What does carve in mean in the 340B program?

The term “carve-in” is used to describe a covered entity’s decision to use 340B discounted drugs for its Medicaid patients that meet the 340B program’s patient definition test.

What does it mean to carve out Medicaid patients?

The term “carve-out” is used to describe a covered entity’s decision not to use 340B discounted drugs for any of its Medicaid patients. Covered entities that choose to carve out fee-for-service Medicaid patients must inform OPA of this decision.

Is the FQHC excluded from the 340B program?

Carve-Out: The FQHC excludes its Medicaid patients from its 340B program; in other words, the drugs it dis-penses to these patients were purchased outside of the 340B program. In short, “carve-in” models include Medicaid patients under 340B; “carve-out” models leave Medicaid patients outside of 340B.

Why is the intersection of 340B and Medicaid important?

The intersection of 340B and Medicaid is one of the most complex and significant areas within any health center’s 340B program, for two reasons: There are significant administrative and operational complexities involved, under both carve-in and carve-out models, that don’t apply with other payers. These issues are discussed in Section 9.B.