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Merck has imposed 45-day time limit on replenishment orders under its restrictions on 340B pricing when covered entities use contract pharmacies.

Merck Adds 45-Day Time Limit on Replenishment Orders to its 340B Contract Pharmacy Policy

Merck is the latest drug company among the 16 that restrict 340B pricing when covered entities use contract pharmacies to impose a 45-day time limit on replenishment orders under its policy.

Merck disclosed the change last week in the same letter announcing it was extending its restrictions on 340B pricing involving contract pharmacies to community health centers.

The letter includes Merck’s FAQ about its 340B contract pharmacy initiative. The document’s title says it was updated on April 25.

This version of the FAQ includes a Q&A at the end that was not in the last version of Merck’s FAQ dated August 2021. It says:

Q: If a covered entity is registered with 340B ESP and has made contract pharmacy designations as part of the Merck 340B program integrity initiative, does Merck have a policy regarding timing for placing orders for replenishment at 340B pricing once those contract pharmacy designations have been processed?

A: Yes. If a covered entity is registered with 340B ESP and has made contract pharmacy designations as part of the Merck 340B program integrity initiative, Merck’s policy is to honor requests for replenishment orders at 340B pricing—for shipment to the designated contract pharmacy location(s)—for prescriptions dispensed to 340B-eligible patients within forty-five (45) days of data submission to 340B ESP.

Including Merck, eight of the 16 drug manufacturers that require entities to submit 340B claims data in exchange for being able to keep using multiple contract pharmacies have added 45-day time limits either for replenishment orders, claims submissions, or both to their policies. The other are AbbVie, Amgen, GlaxoSmithKline, Johnson & Johnson, Lilly, Pfizer, and Sanofi.

Some providers say the 45-day lookback requirements give manufacturers a way to avoid paying 340B prices even when entities give the companies their 340B contract pharmacy claims data.