Drug manufacturer Sanofi drew attention this month when it added 45-day time limits for replenishment orders and claims submissions to its conditions on 340B pricing when covered entities use contract pharmacies.
Pfizer and Amgen also recently added similar 45-day lookback requirements to their restrictions on 340B contract pharmacy arrangements. A senior pharmacist at a 340B hospital pointed out this week that GlaxoSmithKline (GSK), Johnson & Johnson (J&J), and Lilly’s contract pharmacy policies already had comparable language.
“We want to make sure the 340B community is aware of these 45-day lookback policies and their repercussions,” the hospital pharmacist said.
Implementing manufacturers’ 340B contract pharmacy claims submission requirements in exchange for being able to contract with more than one outside pharmacy is “clunky” and time-consuming, the pharmacist said. The hospital began submitting its contract pharmacy claims data via industry vendor Second Sight Solutions’ 340B ESP portal several weeks ago “and we still are not close to the replenishment step for a lot of our pharmacies,” the pharmacist said. At the current pace, all the claims data the hospital submitted already are or soon will be more than 45 days old.
Manufacturers’ conditions on 340B pricing were “advertised as a tool to eliminate duplicate discounts,” the pharmacist said. “Now it’s started to be used as a tool to cap and limit” resumption of 340B pricing even when entities give their 340B contract pharmacy claims data to drug makers.
No Uniform Standards
Drug manufacturers say they support the 340B program’s mission and that their conditions on 340B pricing when entities use contract pharmacies are designed to improve program integrity.
While the government challenges the drug industry’s right to impose contract pharmacy conditions, providers say they are increasingly frustrated with the lack of clarity about manufacturers’ policies. They point out that there are no rules telling manufacturers how to initially inform entities and other 340B stakeholders about their conditions on 340B pricing or how to inform them about updates. They say there is no single, public, verifiable, mutually agreed upon depository for all such communications—including past versions to let stakeholders track changes between old and new copies. 340B ESP makes only the newest versions of clients’ policies available on its website. But not all manufacturers contract with 340B ESP, and it can be hard to be able to tell when a change was made or what the change was.
Pfizer’s Policy
Pfizer’s recent change to its policy is an example.
Pfizer originally notified covered entities about its conditions on 340B contract pharmacy in this document dated Jan. 28, 2022.
The only known public notice about Pfizer’s change in its policy is an announcement in a banner at the top of 340B ESP’s Resources webpage that says, “Pfizer has added an FAQ” and “Learn More.” (Searching Pfizer’s own website for the term “340B” yields no results.)
Further down the 340B ESP Resources webpage is a box labeled “Document—Pfizer policy” with the date Jan. 28, 2022, and the phrase “Download the latest policy document from Pfizer.”
Clicking the download button opens this document. There is no date on the document. It otherwise appears almost identical to the one that covered entities received from Pfizer in January. A close examination, however, shows that page 9 of the newer document includes this addition:
Q. What is Pfizer’s timeframe to accept replenishment orders of NDC11 package sizes at 340B prices accumulated from prescriptions dispensed to 340B eligible patients at contract pharmacy locations?
A. Effective April 15, 2022, Pfizer will honor contract pharmacy replenishment orders only for prescriptions dispensed to eligible 340B patients not greater than forty-five (45) days prior to the date of each claims data submission on 340B ESP.
Amgen’s Policy
The circumstances of Amgen’s addition of a 45-day lookback provision to its 340B contract pharmacy policy are similar.
A few weeks before the 340B ESP Resources webpage banner appeared regarding Pfizer’s new policy document, there was a similar banner about Amgen’s policy.
Amgen announced its original policy on Dec. 1, 2021, in this document.
The box labeled “Document—Amgen policy” on 340B ESP’s Resources webpage is dated Dec. 1, 2021. Clicking the download button opens this document, which also is dated Dec. 1, 2021, on its first page.
However, a close comparison of the version of the Amgen document on the 340B ESP website and the version of the document that covered entities got from Amgen in December shows that three Q&As were added to the version on the 340B ESP website on March 15, 2022, including this one:
Q: Is there a limitation on how far back replenishment orders can be placed and still receive 340B pricing, once eligibility for our specialty contract pharmacies and/or contract pharmacy designations have been processed by our wholesaler?
A: All contract pharmacy replenishment orders for all covered entities registered with 340B ESP will be honored for prescriptions dispensed to eligible 340B patients within forty-five (45) days of each data submission to 340B ESP. Please allow for ten (10) days for the contract pharmacy designations to take effect with your wholesaler after your initial Amgen claims submission to 340B ESP.
AbbVie, GSK, J&J, and Lilly’s Policies
AbbVie’s 45-day lookback requirement has been in its 340B contract pharmacy policy since its release on Dec. 29, 2021:
Q: If my organization does not provide 340B claims data by the required date, can it elect to do so at a later date and gain access to 340B pricing for contract pharmacies?
A: If an entity begins to supply data after February 1, 2022, it must provide data for contract pharmacy dispenses to eligible patients in the prior 45-day period. Once the required data submission has been made, AbbVie 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.
GSK’s 45-day lookback requirement has been in its 340B contract pharmacy policy since its release on Feb. 14, 2022:
Covered entities that are interested in submitting 340B claims will need to register an account with 340B ESP and must submit the 340B claims within 45 days of the dispense date.
J&J’s 45-day lookback requirement has been in its 340B contract pharmacy policy since its release on March 21, 2022:
340B claims must be submitted within 45 days of the date of dispense in order for the contract pharmacy location to remain eligible to receive 340B purchased drugs.
Lilly added a 45-day lookback requirement to its 340B contract pharmacy policy on Dec. 16, 2021:
Starting on March 16, 2022, all contract pharmacy replenishment orders for all covered entities registered with 340B ESP will be honored for prescriptions dispensed to eligible 340B patients within forty-five (45) days of each data submission to 340B ESP.
