In a March 6 letter to the Health Resources and Services Administration (HRSA), America’s Essential Hospitals urged the agency to act immediately to prohibit drug manufacturer Novo Nordisk from unilaterally implementing a dramatic expansion of 340B Drug Pricing Program claims reporting obligations.
The policy, announced March 2, expands claims reporting obligations to in-house pharmacies. Manufacturer Eli Lilly implemented a similar policy in February, on which the association also commented. Novo Nordisk has included an additional risk for covered entities with contract pharmacy arrangements, declaring that if any contract pharmacy fails to submit full claims information, it will suspend 340B pricing for all contract pharmacies associated with the covered entity.
In the letter, the association highlights new operational and compliance challenges this expansion poses for essential hospitals. In addition to insufficient notice of this change, the association notes the additive financial cost of differing claims submission obligations from different manufacturers.
The letter urges HRSA to act immediately to prohibit the policy from taking effect. Further, it asks HRSA to publicly comment on the agency’s evaluation of these policies to provide certainty for covered entities regarding future agency action.
Contact Director of Policy Rob Nelb, MPH, at rnelb@essentialhospitals.org or 202.585.0127 with questions.
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