US proposal to collect manufacturer pricing data under 340B program

On Tuesday April 21, the US Department of Health and Human Services Health Resources and Services Administration (HRSA) issued a Federal Register Notice soliciting comments on its proposal to collect pricing data from drug manufacturers under the 340B drug discount program, said David Gibbons, writing on Hyman, Phelps and McNamara’s FDA Law Blog

This Information Collection Request (ICR) is intended to implement section 340B(d)(1)(B)(i) of the Public Health Service Act (PHSA), a provision added in 2010 by the Affordable Care Act that requires HRSA to develop a system to verify the accuracy of calculated drug ceiling prices charged to 340B covered entities, Mr Gibbons explains.

The notice explains that HRSA is developing a secure system for manufacturers to submit Average Manufacturer Price, Unit Rebate Amount, Package Sizes, National Drug Code (NDC), the quarter of sale, and the manufacturer’s calculated 340B ceiling price for each NDC. All but the last of these data points are already reported by manufacturers to CMS under the Medicaid Drug Rebate Program. The HRSA will compare the 340B ceiling prices submitted by manufacturers against those calculated by HRSA using CMS data, and resolve any discrepancies. Validated submissions will be made available to 340B covered entities and accessible through a secure, Internet-based platform, as required by PHSA section 340B(d)(1)(B)(iii).