By David C. Gibbons –
On Tuesday, April 21, 2015, the U.S. Department of Health and Human Services Health Resources and Services Administration (“HRSA”) issued a Notice soliciting comments on its proposal to collect pricing data from drug manufacturers under the 340B drug discount program. This Information Collection Request (“ICR”) is intended to implement § 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.
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. 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 § 340B(d)(1)(B)(iii). HRSA unrealistically estimates that it will take manufacturers one-half hour to prepare and submit each quarterly report. Comments on this ICR my be submitted through May 21, 2015.