September 17, 2014—Drug companies that invite health care providers to talk about possible 340B drug diversion or duplicate discounts will often find that their customers are quite open and can either explain any anomalies or will be quick to rectify the matter, an attorney for manufacturers and an industry consultant said at an industry conference in Chicago yesterday. [ms-protect-content id=”2799″]
“How do you engage with covered entities? Engage with them informally,” said John Gould of the Arnold & Porter law firm during the Medicaid Drug Rebate Program Summit. “These are people on the other side of the table, they are customers, sometimes very large customers. So playing gotcha is not going to be productive.”
“It’s often possible to get useful information in an informal discussion,” he said later in his talk. “Bringing your lawyer isn’t really conducive to an informal, relaxed discussion. It’s often best with these site visits to leave your favorite lawyer at home,” he quipped. “Partner with your covered entities. Many are trying to do the right thing.”
Gould’s co-presenter, Romit Kamdar of the Akara Group consulting firm, added that “while data analysis matters, understanding your covered entity and the story behind the data matters even more.”
“We found several instances where the data told us one thing and in many cases, we learned more that was very different than what the data really suggested,” Kamdar said.
For example, he said, a search on behalf of a client for aberrant purchasing behavior revealed a break in 340B chargeback activity for a product for a certain customer, followed about a year and a half later by a spike in 340B purchasing for the same product. “This is where customer engagement comes in to play,” Kamdar continued. “We talked to the covered entity and said, ‘Hey, can we at least have a conversation? We’re trying to understand what’s going on with this data.'”
“Essentially, what happened is, the wholesaler had an issue where they were delaying issuing chargebacks,” he continued. “So, one year later, for whatever reasons, they sent these chargebacks through.”
“The point is,” Kamdar concluded, “the data suggested something weird was going on. The engagement and the talking with the customer suggested an explanation that was very reasonable. When we talked with the covered entity, they said, ‘Hey, do you want to see our policies and procedures, how we manage our WAC account and our 340B account?’ They were very forthcoming.” [/ms-protect-content]