Thursday, September 12, 2013

MDRP 2013: Day 3 recap

The third and final day of MDRP 2013 kicked off with opening remarks from Edward McAdam, Daiichi Sankyo and the MDRP Lifetime Achievement Award. Congratulations to the 2013 recipient, Miree Lee!

Following the award announcement, Mark Myers, Office of the Inspector General and Mel Noel, Compliance Implementation Services, led us into the first Key Note session, Veteran Affairs Pricing Compliance and Management Updates. They covered drug pricing, transferred cover drugs, and data issues. What is the best way to signify adherence to statutory requirements? Signing a master and pharmaceutical agreement. In terms of transferred covered drugs and new drugs, one of the biggest issues is lack of timely submission. The bottom line? Make sure that you file on time, manufacturers will be responsible for overchargers based on late filing.

Myers and Noel also covered the issues of placing patented drugs on FSS contracts. They explained that, in a world where covered drugs are more frequently manufactured or have API sourced in India or China, it has become impossible for VA to place many patented covered drugs on FSS contracts of MFRS trying to comply with VHCA. So what is the solution?

VA FSS managers have tried unsuccessfully to obtain a waiver from GSAs guidance to allow FSS listing of patented covered drugs that are manufactured in or have API sourced in countries that are not TAA designated countries.

Rick Zimmerer, KPMG LLP, closed out the morning session with Operational Excellence with Minimal Resources. Zimmerer discussed some important elements to successful optimization. So what are some of the key components? Make sure it's competitive, marketable, and profitable. It's also important to remember what executives are looking for - GP as a strategic function, so where do you start?

Start by defining the issue, clearly state what decisions are required. Is legal guidance required? What's the organizational, financial impact? Potential solutions to problem? Provide a recommendation and then develop a communication plan. Once you've created a tool, it's vital you provide both training and guidance to other GP professionals on how to use it. So overall, the key steps to apply for successful optimization are: record, analyze, present, decide, and communicate. 

The final session of MDRP 2013 was the Current Legal Trends Affecting Pharmaceutical Manufacturers - Manufacturers Perspective panel moderated by Connie Wilkinson, Epstein Becker Green. Panelists included Sabrina Yohai, Pfizer and Christoper Jackson, Otsuka Pharmaceutical, Inc.
The panelists all specified the importance of planning accordingly, something that seem to be an overall theme of the conference. They reminded the audience that if something looks like a red flag, take action. They also discussed the impact on an organizations resources now that the final rule has been delayed. The panel agreed that the final rule will be a priority for everyone and knowing your portfolio, and the fact that people have the context already will hopefully help to expedite the process once the rule is released.  

They also recommended pulling  together a cross functional group of colleagues. Dissect the rule, what will it change? What operations/legal questions do you have? This will help you realize what you have, and figure out what you need. Everyone weighing in, leaves no room for surprise.

We hope you enjoyed the 2013 MDRP Conference, see you next year!

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