Thursday, September 16, 2010

MDRP 2010 Conference - Translating the GP Impact of Healthcare Reform for Senior Management

Katie Lapins – Government Program Specialists
Janet Dozois – Eisai, Inc.

We all know how important the Medicaid/GP rules are and how much change is coming down the line. This is why we all come to the conferences. However, it is sometimes difficult to educate our senior management on the very complex (and ever changing) regulations and get them to understand the implications of these rules.

One option is for your company to construct a Cross Functional Team with all stakeholders, including senior management staff. Various members can include your contracting and pricing staff and also your legal department. These are the people who will be furthest into the detail of the regulations and involved in the interpretation to the most extent. Inviting the managed markets and reimbursement team is also important as they will have to start thinking about how their detail impacts your calculations, the double dips that may come across the rebates, and BP implications.

You will also need your government affairs group to ensure that they are on the same page in regard to your products. Have they told the FDA that your product is an orphan product? Has their determination of the drug category put them in the grouping of the 5i drugs, and is that how they provided the paperwork to the FDA which then goes back to CMS?

Also on the team should be staff from the finance department, especially those doing the accruals as we have seen that the healthcare reform will bring a significant change in volume, thus a change in reimbursement/discounts information.

Another important group would be the commercial operations staff which includes the sales and marketing groups. Manufacturers will have to give thought to changes in their approach of how to market a drug and contract strategies. As we all know the types of sales and contract language for the commercial end of the business has impact on the GP side. With open communication you can head off any potential issues with current and future products that may arise out of their actions that would leave an unintentional reaction. Also if you are planning a product launch (or line extensions), discussions should include the impact of future WAC increases that will outpace the CPI-U.

And lastly, do not forget your IT staff! After all the planning and decisions you do not want someone to tell you it is impossible to do within your system. Make sure they are able to handle your needs before you need them.

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