OPA director fields manufacturers' and wholesalers' questions during webinar.
May 2, 2012—A new program-integrity oath that hospitals must take to remain certified for 340B drug discounts has "the strongest language" about compliance that they have ever been asked to sign, the Office of Pharmacy Affairs (OPA) official leading its hospital recertification initiative said last week during a webinar for drug manufacturers and wholesalers.
"This is very strong language," said Lt. Cmdr. Joshua Hardin during the April 26 event. "It reiterates the program requirements for transparency, accountability, and integrity and verifies that [hospitals] understand the potential consequences of not meeting the program requirements."
During the April 26 webinar, Hardin read the list of stipulations aloud. Hospital senior executives, he said, will be required to attest that:
Hospitals and other 340B providers have always been obliged "to ensure the accuracy of their information in the database and that they're in compliance with 340B requirements," said OPA Director Krista Pedley. But now "they're actually attesting to that" and those with inaccurate information or that fail to comply "will be removed from the program," she emphasized.
"This is very important to us and we are taking it very seriously," Pedley said.
At present, there is only one known publicly accessible sample of the attestations and it appears to be incomplete. A version appears in a 340B recertification "user guide" on the OPA Web site, in an example of a recertification Web page. Although the guide is on the OPA Web site, it was not referenced in any of the three OPA webinars. It also is not mentioned in either the OPA or Pharmacy Services Support Center (PSSC) frequently-asked questions about recertification.
The guide itself indicates that OPA was to have directed covered entities to it in the emails they received notifying them about the recertification requirement. However, a copy of one of those email notifications that a hospital received contains no mention of the guide.
Pharmacies as Ship-To Sites
Several webinar participants asked Pedley to address why OPA is requiring hospitals to decertify pharmacies as child sites and re-list them as "ship-to" sites of either their parent hospital or one or more of its outpatient facilities. From their questions, it appears that manufacturers and distributors don't fully know what to make of the high number of such de-listings that occurred in the weeks leading up the start of the recertification initiative in mid-April.
Pedley stated that OPA's policy against pharmacies being listed as child sites "is nothing new" and their re-listing as ship-to sites is "actually accurate and what should be occurring."
"It doesn't mean that they were wrongly buying drugs, it was more about how they were listed in our database," she said. "We now want to correct that moving forward." Pedley urged hospitals, manufacturers, and wholesalers to cooperate "to ensure that if a pharmacy is removed as a child site and then listed as a ship-to, that the site is purchasing under the appropriate 340B ID and not under the ID that has been removed."
In response to questions, Pedley and Hardin also told the webinar participants: