Understanding the Changing GP Calculation Environment and Evaluating your System Options

By: Chris Cobourn, VP of Regulatory Compliance
chriscobourn@cis-partners.com

There are 3 key things to consider when evaluating the evolving "GP Pricing Environment."

1. Guidance is continually evolving, sometimes dramatically as in the case of the Final Rule. We in the pharma industry must continue to keep our methodology current, and to update our systems and tools.

2. The "Audit-ability Factor" has grown. With certification requirements, the CMS 10-Year Rule, and the OIG Work-plan creating the need for a proactive audit environment, we must have the capability to view complete and accurate detailed transactional data in order to demonstrate that our calculations are accurate.

3. Your company’s choice of systems and tools can affect your audit-ability. There are low cost, resource intensive tools such as Microsoft Excel (lower audit-ability), large Commercial GP systems (higher audit-ability), and third parties who use automated tools to perform your calculations and provide GP expertise (high audit-ability).

Regardless of the size or type of your company, we all face similar challenges, and some of these considerations may be keeping you up at night. Can you rely on your current systems and toolset? Can you feel comfortable with your certification? What are the real risks to the business? What are my options?

We work with companies at various stages across the GP spectrum: those who have a system in place but want to audit or assess their system, those who are implementing a system and want to make sure that GP requirements are being met, and those who are struggling with spreadsheets but are not sure what other options they have, or what is right for their business.

Wherever you are on the spectrum, I think it is important to be informed and to focus on "audit-readiness." I would also encourage you to reach out to others in the industry - you will soon realize that you are facing similar challenges. Feel free to give me a call or send an email as well, I can provide a fresh perspective and answer the questions you might have when evaluating different systems.

Those who work in the GP space understand the complexities and challenges of an always-evolving GP compliance environment. Often, your key struggle is articulating your needs within your own organization, especially in this very budget-conscious environment. Managers on the business side of your organization want to be able to evaluate the true risk to the organization, and to conduct practical value and cost-benefit analyses for your business.

Thanks, and again, feel free to reach out to me at any time with questions and comments!

Chris