Attn: Providers Participating in the 340B Drug Program, CR 112772

Oct 12, 2022

Previously, MaineCare communicated 340B guidelines and providers were instructed to adjust claims that were billed incorrectly. Providers must ensure that service location enrollments are accurate according to their 340B status. This information must match the Health Resources and Services Administration (HRSA) website. 

In the future, the MaineCare system will DENY drug claim lines when a claim from a 340B covered entity is submitted with errors. During a recent analysis of claims data, we identified a significant number of providers with wrong data either in their enrollment area or billing processes for 340B claims.[EE1] [DL2]  The system will continue to use a WARN status to allow providers with claim processing errors to update their systems. On your Remittance Advice (RA) you will see Alert Remittance Advice Reason Code (RARC) N363 to indicate that there are 340B processing errors associated with the claim.

There are several reasons why a drug claim line could deny for this edit in the future. Here are some examples:

• Service location enrollments with 340B questions left blank or not completely answered
• 340B Agreement termination date incorrect on a service location enrollment
• Provider bills with appropriate 340B modifier, but modifier use does not agree with 340B service location enrollment question responses
• Provider bills with inappropriate modifier as compared to their 340B service location enrollment question responses
• 340B service location enrollment question responses do not match 340B Agreement for Medicaid carve in or carve out status.

Federal Law (42 USC 256b(a)(5)(A)(i)) prohibits duplicate discounts. Under this statute, 340B covered entities are responsible to ensure they bill claims appropriately to prevent duplicate discounts collected by the Medicaid Drug Rebate Program process. Billing with appropriate modifiers as outlined in previous guidance excludes 340B drugs from the rebate process. Claims are routinely audited by Office of Inspector General, the State, and manufacturers. Any 340B covered entity that fails to comply with 340B requirements may be liable to manufacturers for refunds of the discounts obtained. Additional information regarding 340B program eligibility, rules, regulations, and logistics may be found on the HRSA website at www.hrsa.gov/opa.