It’s That Time Again – Revisit Your GP Documentation!

By: Katie Lapins, Director Small and Mid-Market Pharma, and Chris Cobourn, VP of Regulatory Compliance
katielapins@cis-partners.com and chriscobourn@cis-partners.com

The recent Tricare legislation and the introduction of additional state reporting requirements for Medicaid related data may mean it’s time to update your GP documentation to account for these changes. While investigating new programs and their impact on your operations, it is also a great time to review all of your documents, including those affected by the changes made by the Final Rule. Key components that changed and should receive special attention include smoothing of assumptions, and evaluation of discounts and bona fide fees for services.

A core component of an effective documentation program is to define and implement a reasonable and consistent review cycle that ensures documents are compliant with current regulations. Here are a few areas where dramatic changes may have occurred in your company’s operations and are not yet captured in your documentation:

• The new Tricare rule, which may require separate policies and procedures, and its impact on your existing documents (i.e. clarifying the treatment of Tricare sales and rebates in your other GP calculations
• SPAP and Supplemental Programs (your company’s participation may have evolved over time)
• State Medicaid reporting requirements, such as those required by Maine and New Mexico
• Updates based on findings from an internal assessment or audit
• Updates based on a change in the company’s products and/or contracting strategies

The industry gave a lot of attention to the impact of the Final Rule when it was issued in 2007. The first step was to implement required methodology changes to the systems used to perform the calculations, (i.e., spreadsheets, commercial GP Systems). Coordinated with, or immediately following that effort, most companies put their efforts toward revising their policies and procedures. This was often followed by an assessment or audit in order to validate the accuracy of the procedures as well as the systems. The final step now is to return to the standard review cycle of the policies and procedures. It has been approximately 18 months since the Final Rule should have been implemented, so revisions to your documentation should be complete. These new areas requiring a focus on documentation provide a great opportunity to review all of your GP policies and procedures.

The key takeaway is this: Don’t let that GP Documentation just sit on your shelf! You have to see the documents as living and breathing, and they must be kept current in terms of your operations and the regulations.

As a final note, be sure to develop and implement a document naming convention that indicates the version of the document used at any given time and that you are using the current version. Remember, with the 10-Year Rule, you want to be able to show which policy and procedure documentation was valid at the time of the calculation, so document change control is a key component of audit-ability!
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