Drug manufacturer Sanofi has made two major changes to its conditions on 340B pricing when health centers and certain hospitals and use contract pharmacies, a company spokesperson confirms. One is raising flags among 340B providers and the other appears to be the first of its kind and may be welcomed by covered entities.
The company requires health centers, disproportionate share hospitals, critical access hospitals, rural referral centers, and sole community hospitals that wish to dispense 340B-purchased Sanofi drugs at more than one contract pharmacy to submit claims data to Sanofi’s third-party vendor 340B ESP for those products filled by those pharmacies. If an affected entity declines to provide the data and lacks an in-house pharmacy, it can designate a single contract pharmacy to dispense 340B-purchased Sanofi drugs.
Affected entities began getting email messages from Sanofi late last week describing two changes to the company’s policy.
Limits on Replenishment Orders
Under the first change, replenishment orders subject to Sanofi’s claims submission requirement must be placed within 45 days of the eligible claim’s dispense date. Also, the required claims data must be submitted within 45 days of the eligible claim’s date of service.
“Failure to meet these requirements may result in loss of access to 340B pricing at contract pharmacy locations,” Sanofi said.
No other drug manufacturers with claims submission requirements for multiple 340B contract pharmacy arrangements are known to have similar timing requirements.
Covered entity pharmacy officials pointed out that drugs need to be replenished at different rates and some might not need to be replenished within 45 days. Also, pharmacy benefit managers’ or other payers’ claims submission requirements can be longer than within 45 days of the fill date.
First-Time Claims Submissions
Sanofi’s second change to its 340B contract pharmacy policy addresses a challenge that many covered entities have cited—and not just with Sanofi’s policy.
Most of the 16 manufacturers with restrictions on 340B pricing involving contract pharmacies let entities use more than one contract pharmacy if they submit their 340B contract pharmacy claims to 340B ESP.
Covered entities say they need to be able to have access to 340B pricing for contract pharmacy utilization first, otherwise they cannot generate claims that they can then submit to 340B ESP. Manufacturers’ policies, however, have been silent on which comes first—claims submission, or restoration of 340B pricing.
Sanofi’s policy update appears to have made the company the first to address that ambiguity.
“If you are unable to produce claims submissions prior to gaining access to 340B pricing, registered users may attest their intent to submit claims and participate in the 340B program integrity initiative from your entity profile in the 340B ESP platform,” the company says. “After attesting your intent to submit 340B claims data via 340B ESP, you will be given access to pricing at your contract pharmacy locations. If claims are not received by Sanofi via 340B ESP within 45 days of attesting, access to 340B pricing at contract pharmacy locations may be revoked.”