MDRP 2010 Conference - Estimating and Operationizing Health Care Reform

Speakers:
Bob Inserra – Johnson & Johnson Healthcare Systems
Karin Moore – Johnson & Johnson Healthcare Systems

So, we all know that there are many changes coming from the healthcare reform bills. But are you aware of the increased scrutiny and additional resources that will be available to the government in an effort to ensure that these regulations are enforced?

This increase in oversight means that you not only need to be more diligent with your compliance, but that you need to convey that message to the other departments of your company. These departments may include ones that you have not found the need to communicate with in the past.

First and foremost you should become best friends with your regulatory group. If CMS determines that your product is or is not one of the pediatric drugs with the rebate percentage that goes alone with it, you should make sure that your regulatory group agrees. Your company may see your product differently than CMS and communication between the two of you will have to be opened. Same situation with an orphan drug; does your company view of the drug category pool equal to where CMS has classified it?

Getting together with your staff that is in charge of processing sales to discuss COT is imperative. They may have one way of classifying returns/reversals that makes sense to their department and to the person who processes the financial data into the company GL. But when it comes to your GP calculations their designation may cause you to inadvertently treat that transaction erroneously in the calculations.

Most importantly, whomever in your company maintains your products within the FDA database – get to know them and make sure they understand how important that database compliance is to CMS. This annually updated information is now one of the ways that CMS checks your products for how they are used and how they are packaged. To head off issues it is best to check that data and continue to ensure that it is accurate as you move forward.

Happy Processing!