At this weeks, ACI conference, John Shakow (King and Spaulding LCC), Kathleen Petersen (Epstein, Becker, & Green, P.C.) and I discussed the history of the program, current operational and management issues and what to anticipate moving forward. While we await guidance from CMS on AMP and HRSA on the refund process, there were interesting points raised. First that there is general consensus that restatements of 340B prices resulting in undercharging Covered Entities cannot be argued for transactions that occurred after the effective date of the statute. There is a case in which the undercharges were netted out, but this was related to transactions predating the Patient Protection and Affordable Care Acts. Additionally it was noted that manufacturers will likely be required to report 340B pricing and potentially AMP and URAs to HRSA at some point. Lastly there were several concerns expressed relative to contract pharmacy that serve a multiple patient populations including 340B, Medicaid and commercial managed care plans. Several manufacturers were concerned that pharmacies might not be reimbursed for their drugs in some cases such as penny pricing, etc. Certainly there is a great deal of change coming with or without further guidance from CMS and HRSA. Please share your thoughts and comments on this blog. We will be monitoring developments closely. For those interested in the presentation, please contact me at dweiss@modeln.com.