OPA Staff Provides Update at ASHP Midyear Meeting

December 10, 2015

Michelle Herzog, Deputy Director of HRSA’s Office of Pharmacy Affairs provided an update during ASHP’s Midyear Clinical Meeting. A brief summary of her key points includes the following:

  • HRSA received 35 comments regarding the CMPs Notice of Proposed Regulation (NPRM) that was released in June, with the comment period closing in August. HRSA is currently evaluating the comments.

  • The Administrative Dispute Resolution NPRM is currently being drafted and is targeted to publish in 2016.

  • HRSA received 1,264 comments on the 340B omnibus guidelines published in August, with the comment period closing in October.

  • HRSA continues to enhance the Medicaid Exclusion File, which is the primary tool for preventing duplicate discounts through system fixes and continuing education. The areas of focus include fields of the file, quarterly changes, and provider identifiers. There is a dedicated email box for any comments, questions, concerns related to the exclusion file. It is OPAexclusion@hrsa.gov.

  • Since 2012, HRSA has conducted 444 on site audits encompassing over 5,000 outpatient facilities/sub-grantees and over 11,000 contract pharmacy locations. HRSA continues to rely on a risk stratification methodology, so that entities with higher risk factors are more likely to be selected for audit. Risk factors include: volume of purchases, # of child sites, # of contract pharmacies. HRSA has begun to remove child sites from hospitals for failure to be on the entity’s Medicare cost report and because the entity no longer owned and operated the child site. We have also removed contract pharmacies for lack of oversight by the covered entity.

  • HRSA conducted its first manufacturer audit in FY15 and the results have been posted on the OPA website. Additional manufacturer audits will be conducted by HRSA in FY 2016.

  • Per the statute, HRSA is required to collect information from manufacturers in order to verify the accuracy of 340B ceiling prices, and then make ceiling prices available to covered entities.

  • HRSA is currently working on the secure pricing system that will make ceiling prices available to covered entities via a secure process. This will also include spot checks of sales transactions. HRSA will be using analysis of these sales transactions as an early warning system to conduct proactive analysis and trending of pricing data to assess manufacturer compliance.