The 340B Drug Pricing Program Omnibus Guidance (Mega-Guidance) was published for public comment August 28, 2015. You can find it HERE. Please note, the comment deadline is quickly approaching as it is TUESDAY, OCTOBER 27, 2015. While the Mega-Guidance addressed numerous areas of the 340B program, the most significant proposed changes were in the areas of:
physician administered drugs (stricter guidance)
record retention standards
duplicate discounts including Medicaid Managed Care
Expanding on duplicate discounts, the proposed Mega-Guidance clarifies that the 340B covered entity will be responsible for having methods in place for preventing duplicate discounts in Medicaid Fee-for-Service (FFS) AS WELL AS Medicaid Managed Care Organizations (MCO). The Affordable Care Act (ACA) amended the Social Security Act extending Medicaid drug rebate eligibility to certain Medicaid Managed Care covered outpatient drugs. Like FFS, the MCO may not obtain a rebate on a drug that was discounted under the 340B program. This adds another level of complexity to the 340B covered entity since it is not always easy to distinguish between private insurance and Medicaid MCOs.
It appears the burden for identifying Medicaid MCO patients and putting methods in place to prevent duplicate discounts is being placed on the covered entity instead of the State. The Office of Inspector General (OIG) stated at the July 340B Coalition that they were reviewing what methods are in place to prevent 340B duplicate discounts in Medicaid Managed Care and if the methods are effective. They anticipate a report of their findings to be out in 2016.
The proposed guidance has given a little flexibility in the determination to carve-in or carve-out FFS and MCO. The determination does not have to be the same within the covered entity. If finalized as proposed, the covered entity can make different carve-in and carve-out determinations by entity site and Medicaid MCO as long as they can provide identifying information on each decision to HRSA. Currently, the only method to identify an entity’s decision to carve-in is by listing their Medicaid billing numbers and National Provider Identifier (NPI) on the 340B Medicaid Exclusion File (MEF). HRSA is seeking comments and suggestions on alternate practices or mechanisms to supplement the 340B MEF and prevent duplicate discounts.
The proposed Mega-Guidance also addresses drugs distributed to Medicaid MCO patients in contract pharmacies. If finalized as proposed, contract pharmacies cannot dispense 340B drugs to Medicaid MCO patients unless the covered entity has a written agreement with its contract pharmacy and Medicaid MCO describing their system to prevent duplicate discounts and the system has been approved by Health and Human Services (HHS). Some States have already made it clear that their Medicaid MCOs collect rebates from the drug manufacturers and many facilities already attempt to carve-out Medicaid MCO patients from their contract pharmacies. HRSA is requesting that covered entities, States and Medicaid MCOs work together to come up with a process to identify 340B claims and prevent duplicate discounts.
