Novo Nordisk Expands 340B Claims Reporting Requirements

In a March 2 notice, drug manufacturer Novo Nordisk announced it will require all pharmacies to submit claims-level data for all 340B Drug Pricing Program purchases. The policy affects in-house pharmacies, which previously were exempt from claims-level reporting requirements.

Under the revised policy, hospitals without an in-house pharmacy will be limited to a single designated contract pharmacy for bill-to/ship-to distribution. That designated location must submit claims-level data for each 340B drug it dispenses.

Novo Nordisk will continue to allow an unlimited number of contract pharmacies that are wholly owned and operated by a hospital covered entity, provided the hospital submits complete and accurate claims-level data for those pharmacies. However, if any linked contract pharmacy fails to submit complete and accurate claims level data, Novo Nordisk intends to suspend access to 340B pricing to all contract pharmacies associated with the sponsoring covered entity. Novo Nordisk's revised policy is similar to one Eli Lilly adopted Feb. 1. America's Essential Hospitals sent a letter to Health Resources and Services Administrator Engels, urging the agency to prohibit implementation of Lilly's policy.

Contact Director of Policy Rob Nelb, MPH, at [email protected] or 202.585.0127 with questions.