Novo Nordisk on Jan.1 will implement a policy to let 340B hospitals buy its drugs at a reduced 340B price for shipment to an unlimited number of contract pharmacies if the hospitals submit their claims data for such drugs to drug industry contractor 340B ESP.
Hospitals reported getting email messages from Novo Nordisk on Saturday with an attached letter announcing the change. 340B ESP posted Novo Nordisk’s new policy on its website late yesterday. It said its platform will not be configured to support Novo Nordisk-related claims data submissions, contract pharmacy designations, or wholly owned contract pharmacy exemptions until Jan. 1.
Asked yesterday why it decided now to give hospitals the option of submitting their 340B contract pharmacy claims data in order keep their multiple contract pharmacy networks, the company said, “Novo Nordisk continues to support the 340B drug program so that uninsured and vulnerable patients have access to outpatient drugs. We regularly assess our policies in consideration of the 340B marketplace dynamics.”
Grantee covered entities are exempt from Novo Nordisk’s restrictions. Under its original policy that took effect Jan. 1, 2021, the company limited 340B hospitals to one contract pharmacy for those hospitals lacking an in-house outpatient pharmacy. Effective Feb. 1, 2022, it began letting 340B hospitals ship its drugs to two contract pharmacies—one retail and one specialty pharmacy.
Under Novo Nordisk’s new policy:
- If a hospital does not have a wholly owned contract pharmacy, Novo Nordisk will let it designate two contract pharmacies (one retail and/or one specialty, as determined by Novo Nordisk).
- If a hospital owns and operates a wholly owned contract pharmacy, Novo Nordisk will let the hospital designate multiple wholly owned contract pharmacy relationships.
- Novo Nordisk will let a hospital have an unlimited number of contract pharmacy relationships if the hospital provides claims level data associated with 340B dispenses made by those contract pharmacies.
Novo Nordisk says in a new FAQ document about its 340B pricing policy that it will use claims data submitted to 340B ESP “to identify and resolve ineligible Medicaid, Medicare
Part D, and commercial rebates and to determine eligibility for certain replenishment orders under the policy.”
Hospitals will have to submit 340B claims data within 45 days of the date of dispense. “Hospital [covered entities] will not be eligible to make 340B purchases for prescriptions dispensed outside of the 45-day period,” the FAQ says. “Once the required data submission has been made, Novo Nordisk will facilitate bill to/ship to [contract pharmacy] replenishment orders on product dispensed to eligible patients from and after the date of data submission as well as the prior 45-day period.”
If a hospital misses a data submission date, “Novo Nordisk may no longer facilitate bill to/ship
to [contract pharmacy] replenishment orders on 340B claims for the [contract pharmacy] locations for which data is not submitted,” the FAQ says.
The federal government told Novo Nordisk in May 2021 that its 340B contract pharmacy policy was illegal and had to be withdrawn and the company had to repay hospitals for overcharges. In September 2021 the government referred the company to the Department of Health and Human Services Office of Inspector General for possible imposition of civil monetary penalties.
Novo Nordisk is challenging the government’s findings in federal court. A federal appeals court is expected to rule in its case in the coming months.
Last month, an Arkansas health system filed a complaint with the state insurance department against Novo Nordisk. The system says the drug manufacturer’s denials of 340B pricing when hospitals use contract pharmacies violates the state’s novel 340B contract pharmacy anti-discrimination law.
