AHA urges HRSA to stop Novo Nordisk’s new claims-data submission policy on 340B hospitals from going into effect

The AHA March 3 urged the Health Resources and Services Administration to take immediate action to stop a new Novo Nordisk policy from taking effect by April 1.

Novo yesterday issued a notice to all 340B covered entities that the company was updating its data requirements for its 340B distribution program. This policy - identical to the policy announced by Eli Lilly and Company on Jan. 15 - would require 340B covered entities to submit claims data for all dispensations of all Novo drugs, regardless of setting.

"We hope that HRSA will take immediate enforcement action, including the use of civil monetary penalties, against both Lilly and Novo to halt their new policies," the AHA wrote. "But if HRSA is not going to take such action, it must let 340B hospitals and other stakeholders know that and explain why these new policies are lawful under the 340B statute."

On Jan. 26, the AHA urged HRSA to take immediate action to stop Lilly from requiring 340B covered entities to submit claims data for all dispensations of all Lilly drugs, regardless of setting. HRSA did not respond to the AHA's letter or take any action in response to Lilly's policy.