Comprehensive Guide to 340B Drug Pricing
In order to ensure compliance with Comprehensive Guide to 340B Drug Pricing requirements, the Department of Health and Human Services (HHS) has issued a number of guidance documents on a variety of topics. These guidances are usually published in the Federal Register after a period of public notice and opportunity for comment. This proposed guidance is intended to consolidate a number of these existing guidances into a single document.
When a hospital or other non-hospital covered entity becomes eligible to participate in the 340B Program, HHS assigns it a 340B identification number and lists it on the public 340B database. The hospital’s associated off-site outpatient facilities and clinics are called “child sites.” A parent site is responsible for ensuring the compliance of its child sites and contract pharmacy arrangements. A hospital that violates the GPO prohibition could lose its 340B enrollment, as would any of its contract pharmacies.
Demystifying 340B: A Comprehensive Guide to Drug Pricing and Healthcare Savings
At the time of registration, a covered entity must decide whether it will purchase drugs for 340B Medicaid fee-for-service and/or Medicare Advantage managed care organization patients through 340B discounts or through other mechanisms (carve-in). A covered entity that elects to carve in must list its Medicaid billing number, National Provider Identifier, and contract pharmacies on HHS’ 340B Medicaid Exclusion File.
Under the 340B Program, manufacturers may not offer a 340B discount and a rebate for the same product at the same time. This prohibition is commonly known as the duplicate discount prohibition. However, 340B Program participants often encounter difficulties when trying to follow this requirement because they are often required by State Medicaid agencies to use specific modifiers and codes to distinguish 340B drugs from other drugs on the Medicaid claim.