Breaking News: Potential 340B Changes on the Horizon

Several bills surrounding the expansion of 340B beyond the outpatient setting have recently been introduced in Congress. The draft Affordable Health Services Bill, Sections 611 & 612, in addition to H.R. 444 and S.1239, all seek to expand the 340B program to new entities and new patient distinctions.

Several 340B program improvements in the pending legislation include:

  • Requiring the Secretary to carry out activities to increase compliance by manufacturers and covered entities with the requirements of the drug discount program;
  • Establishing an administrative process to resolve claims by covered entities and manufacturers of violations of such requirements;
  • Providing clarifications about the ceiling price used to sell to 340B participants. (§ 612)
  • Requiring hospitals enrolled in the 340B program to provide a credit to each state on the annual costs of covered drugs provided to Medicaid recipients for inpatient use. (§ 611)

If passed, the program improvements could provide substantial additional savings to providers, but there are significant new reporting requirements that will be mandatory in order to remain compliant. Not only will providers be required to track dispensations and appropriate NDC information for Medicaid rebates, but the provider will be required to have an auditable record tracking all 340B drug dispensations in order to reconcile credits owed to the state, based upon actual usage costs. This type of detailed reporting of the inpatient environment is well beyond the current scope of 340B and traditional “split-billing” software, and underscores the importance of having a healthcare intelligence application that provides an auditable record.

While the potential increase in savings for providers are substantial, so too are the added reporting requirements these bills demand. Sentry’s solutions are currently able to seamlessly process the data required to meet expanded 340B requirements, regardless of the outcome of any proposed legislation. We will continue to monitor changes to the 340B landscape in order to serve our clients.