Drugmakers Are Doing a Better Job of Supplying 340B Ceiling Price Data, 340B Program Head Pedley Says

Drug manufacturers are doing a better job of providing the Health Resources and Services Administration (HRSA) with timely and accurate data needed to verify their 340B ceiling prices, the head of the federal 340B drug pricing program indicated today. Nonetheless, some still either have not created HRSA accounts to upload the figures or miss deadlines for submitting their data, she said.

Speaking this morning via Skype from suburban Washington, D.C., to 340B Coalition winter conference attendees in San Diego, Calif., HRSA Office of Pharmacy Affairs (OPA) Director Adm. Krista Pedley gave an update on the rough first anniversary of the congressionally mandated 340B ceiling price secure website. Known formally as the pricing component of the 340B OPA Information System (OPAIS), the secure website gives 340B covered entities view-only access to verified 340B ceiling prices for covered outpatient drugs. Congress told the Secretary of Health and Human Services (HHS) to build the website in 2010 in the Affordable Care Act. Its opening after a nine-year delay was considered a major win for 340B healthcare providers.

In her remarks to the 340B conference attendees, Pedley said HRSA has “captured important trends and learned important lessons about the system” during the year it has been up and running.

“Each quarter, we receive more and more manufacturer data,” Pedley said. “In the fourth quarter of 2019, about 670 labelers uploaded pricing data into the system, which represented about 36,300 [National Drug Codes]. By comparison, in the first quarter, there were approximately 560 labelers and 32,300 NDCs. So that number is increasingly going up.” (According to the Food and Drug Administration, a labeler “may be either a manufacturer, including a repackager or relabeler, or, for drugs subject to private labeling arrangements, the entity under whose own label or trade name the product will be distributed.”)

A recent check of OPAIS shows 791 active labelers registered.

Pedley said the number of labelers who do not submit data to HRSA, either because they did not create accounts or did not provide data within the requested time frame, “has also significantly decreased.”

“In the fourth quarter of 2019, 93 labelers, which represent about 3,000 NDCs, did not submit data, compared to 106 labelers or 6,300 NDCs” in the first quarter, she said. “For those labelers who did not submit data, HRSA published a 340B ceiling price solely from information that was received from First Databank and [the Centers for Medicare & Medicaid Services].”

Pedley also said HRSA has noticed an increase in matches between the data manufacturers supply and the data HRSA obtains from First Databank and CMS. “For the first quarter of 2019, the number of matches was approximately 29,000 NDCs,” she said. “For the fourth quarter, it rose to 33,300 NDCs. So, we are seeing improvement in the quality of data.”

340B Report will be providing additional stories and updates on key developments from the winter conference.