As September approaches, there are a few things we can count on as summer winds down, such as football, colorful leaves in my home state of Maine, and IIR’s Annual Summit on the Medicaid Drug Rebate Program (MDRP). MDRP has long been one of the primary venues for the “GP Community” to network and get informed, (the GP community being the individuals in pharmaceutical manufacturers who fill the GP function, as well as consultants, lawyers and software vendors.
The ability for us to network within our pretty unique community is important, as we all face the same challenges. With limited regulations and guidance, it is important to know what your peers are thinking and how they are addressing common issues, especially in this very anxious period with our wait for the CMS Final Rule. A theme that you will hear me talk about is “what to do while you are waiting.” It will be an important topic at MDRP, and CIS will be talking about it in our free webinar series on September 20th.
When the CMS AMP Final Rule does hit, likely “sometime in 2013,” there will be no looking back. The impact on systems, processes and methodologies could be dramatic. Many manufacturers are evaluating their current systems and data in order to ensure that they a) will have confidence in the auditability of current (PPACA) and historical methodologies, b) have good underlying data for the new methodologies, and c) address key compliance issues and challenges. Many of the topical considerations that should be discussed include:
- • Bona Fide Service Fee evaluations, getting the documentation and assumptions in place
- • Closing recalculation and restatement issues
- • Research and documenting the Product Master
- • Evaluating the potential impact of the Proposed Rule, including impact on extension of the Medicaid Rebate to Puerto Rico and the Territories, Authorized Generics, Alternative 5i AMP, line extensions
- • 340B Program Integrity initiatives, including manufacturer audits
- • GP systems assessment and audit to validate the integrity of the calculations
- • Evaluating the accuracy of Class of Trade assignment, as well as PHS eligibility