Are You Ready for Your First Filing After the Final AMP Rule?

 In Blog, MedTech, Pharmaceuticals, U.S. Commercial MedTech, US

When the AMP rule was published earlier this year, CMS made it clear that many provisions must be taken into account beginning with the April 2016 filing – which is due on May 30th. CMS has since clarified that they will allow manufacturers to take an additional quarter to comply with the “new rules”. However CMS still maintains that Q2 prices will need to be restated should manufacturers choose to take the additional time.

Regardless of whether your company is intending on filing April 2016 according to the new rules or waiting a bit longer with the intention of restating, we think now would be a great opportunity for you to take a step back and see if all the necessary work has been accomplished or is “on track” so that you are set up for maximum compliance.

Policy and Methodology Check List

  • Have you determined which drugs in your product portfolio you deem to be 5i?
  • Have you determined your methodology for calculating the “Not Generally Dispensed” retail community pharmacy (RCP) ratio?
    • How will you be calculating “all sales”?
    • How will you be calculating the RCP component?
    • Which Classes of Trade are considered “retail” according to your policy?
  • Have you established access to all the necessary data you require to do the RCP ratio calculation? This includes but is not limited to direct sales, chargebacks, and potentially prescription data.
  • Have you revised your work practices and monthly cadences to include the calculation and documentation of the RCP ratio?
  • Have you updated your Monthly AMP policy documentation to include different inclusion and calculation rules depending on the ratio calculation result for your 5i products?
  • Have you updated your Quarterly AMP policy documentation to reflect the new methodology for the numerator (AMP * Units as opposed to SUM of Net Dollars)?
  • Have you established whether you are going to restate Base AMP for one or more of your products?
    • For these products, have you determine whether you have sufficient data and where that data may be found?
  • Have you updated the DDR system to denote which products are Line Extensions?

System Check List

  • Will your system be updated to reflect the new DDR formats?
  • Will your system be updated to allow Monthly AMP to read the ratio results and calculate either the standard or 5i methodology accordingly?
  • Will your system be set up to consume the new, restated, BAMP should you decided to restate?
  • Will your system be setup to calculate the RCP ratio for your 5i drugs in an automated manner?
  • Will your system be set up to apply your new Monthly and Quarterly AMP methodologies to your data?

Model N can help you prepare. To discuss this article or learn about our solutions, please contact Eileen Scully at escully@modeln.com.

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