Thursday, July 21, 2011

The GP Regulatory landscape, do you know what you don’t know?

The worst place to be in the world of GP compliance these days is to not know what you don’t know!

There may not always be definitive answers, and there will always be gray areas, but venues for dialogue are critical for you to be aware of how the industry, lawyers and consultants are viewing the current landscape.

Our mission at CIS is to foster the discussion in various ways, including our free monthly GP Forum, the GP Compliance Blog, and through our strong support for conferences like IIR’s Medicaid Drug Rebate Program. IIR is always one of the most popular and topical conferences for the GP community. This year its timing of September should make the MDRP Summit a must attend for many manufacturers.

The fall of 2011 should be an interesting time, with the expectation of a Final AMP rule for Average Manufacturer Price, and with anticipated guidance in the Public Health Program, such as patient definition and the proposed user fee. There is layer upon layer of changes in Government Programs that manufacturers have been integrating into their operations and forecasting, such as Part D Discount disputes, Medicaid Managed Care rebates, the industry fee, etc.

It is too much for any one person or one company to be a complete expert in. There is strength in numbers, and when the GP Community comes together for open discussion on the state of the programs, as well as understanding of guidance, we all walk away more informed. It is also essential for our industry to be vocal in our comments to the agencies in this critical rule making period.

Attending IIR’s Medicaid Drug Rebate Program gives you the opportunity to hear the questions, find out if they are the same questions you have, find out where there may be some answers, and furthermore, where there are not answers to at least know how the industry is viewing it. This will give you a shared understanding of the ambiguities which could potentially save your company millions of dollars or as well as avoid compliance risks!

Chris Cobourn, Vice President of Regulatory Affairs

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