Association Urges HRSA to Prohibit Claims Reporting Changes

In a Jan. 29 letter to the Health Resources and Services Administration (HRSA), America's Essential Hospitals urged the agency to act immediately to prohibit drug manufacturer Eli Lilly and Company (Lilly) from implementing proposed changes to pharmacy claims reporting requirements.

In its letter, the association highlights the operational and compliance challenges this expansion would pose for essential hospitals, emphasizes that the policy would condition access to 340B pricing on submission of claims-level data, and argues that Lilly provided inadequate notice of the change-regardless of other flaws in the policy's construction.

The letter responds to a Jan. 15 notice in which Lilly announced it would require pharmacies-including in-house pharmacies at 340B covered entities-to submit claims-level data for Lilly products dispensed at 340B ceiling prices. With extremely limited exceptions, manufacturers historically have required claims-level data primarily for dispensations through contract pharmacies. Lilly's new policy represents a significant expansion of data submission requirements that would supplant HRSA's authority and oversight.

The association urged HRSA to prohibit the changes from taking effect Feb. 1, and notes that Lilly may be violating its pharmacy purchasing agreement if the change moves forward.

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