Download the GP podcast featuring Chris Cobourn

Today's podcast features Chris Cobourn, Senior Vice President of Commercial Compliance for CIS. Cobourn discussed his thoughts on the industry, as well as the challenge of forecasting Medicaid and Medicaid Managed Care, Bona Fide Services Fees and Fair Market Values, and mergers and acquisitions.

View our highlights below:

So before we begin, what are your thoughts on what’s going on in the industry today, Chris?

Chris: We are very much all in a “hurry up and wait” mode, especially from the pharmaceutical manufacturer perspective with continued delays of the final rule. But yet it is still really important to be as proactive as possible in your planning because when it hits, it could be significant and you really have to be in a comfortable position feeling that you‟ve planned for it.

Why is it important to conduct a company-specific impact analysis of the final rule?

Chris: At a high level, I think if you were to take a look at the question that we get increasingly from the CEO and CFO level, especially in smaller-sized companies where they are more involved, the simple question is: “What will the final rule mean to us and what will it take to implement it?”

When you look at all the variables and the proposed rule, if they all happen – and some of the significant things happen like the build-up rule, expansion of Medicaid to Puerto Rico, some of those types of things – it‟s significant. It‟s significant system changes, it‟s significant data that you‟ll need, it‟s significant materiality impact. So, how do you plan when you don't know which of those components will be in the final rule?

To hear more, download the full podcast.

Want to join Chris and CIS this March at IIR's 6th Annual Government Programs Summit? Register with code XP1951BLOG and receive 15% off of the standard rate. To view our full program, download our brochure. We hope to see you March 26-28 in Philadelphia, PA!

MDRP 2013 Track 1: Methodology

This week we'll be featuring MDRP 2013 event posts from our content partners, Huron Life Sciences. Today's author, Clay Willis recaps our day 2 Methodology track. 

Another great day at the MDRP 2013 Conference. In the afternoon session, the Methodology track (Track 1) covered a lot of interesting topics that are relevant for manufacturers today. In the first session, David Buckley of GlaxoSmithKline kicked off the track by discussing how to use State Invoices to Validate CMS Unit Rebate Amounts (URA). There was a general theme that manufacturers calculate their own URA’s internally and validate them when they receive the invoices from the states. David provided numerous considerations that manufacturers should look in to. This was a great session and topic to kick off the methodology session.

In the next session, there was a diverse panel with a lot of experience within the industry and on the topic. Jeff Park of Genentech, Mark Linver of Huron Life Sciences, and Robert LaPorte of West-Ward Pharmaceuticals each discussed how to Plan and Effects of Acquiring or Divesting a Product. Based on their experience they stressed that when going through an acquisition or divesting, they key is having a plan in place ahead of time and ensuring Government Pricing methodologies are in sync prior to selecting a system. There is a soft people side of these situations and it is a much easier process if you have buy-in from the business and IT.

In the next session, John Shakow of King and Spalding focused on Government Pricing Policies and Methodologies – The Foundation of Compliance. John’s key theme was that “Documentation is a Compliance Requirement” and provided various OIG guidance as to why this was the case. John provided a very thorough presentation where he covered all types of Government Pricing documentation and what would be included in each of these document. This presentation is a must get because it is a great reference to have internally and do reference on how to develop that element of a compliant Government Pricing department for manufacturers.

In the second to last session, Rick Moore of CIS covered Lessons Learned on Bona Fide Service Fees and Fair Market Value. This is one of the hottest areas within the industry right now and there were a lot of interest from the audience. Rick covered his thoughts on the four part test, the FMV definition, and lesson learned based on recent projects. There is not much guidance around this area but one thing is clear “ Manufacturers must do their due diligence and document everything around service fees.

In the last session, there was a panel of Miree Lee of M. Lee Consulting and Tom Evegan of CIS who covered Understanding Company Needs when Acquiring and Authorized Generic. They covered a lot of interesting perspective and real life examples of how this affects the various calculations. Interesting enough, this is one presentation you must download due to the checklist they provide for manufacturers at the end.

This track was great and the main topics within this track were pretty consistent throughout the day, which resulted in the audience being very interested in what the sessions offered. Great job to IIR and to each of the presenters around their topics. As a take away, manufacturers should look into ways of being proactive and always document what they are doing. Cannot wait to wake up tomorrow for another great day of sessions.