Class of Trade Schema & Customer Class of Trade Validation

Appropriate and consistent customer categorization, or “Class of Trade,” is essential to the accurate calculation and reporting of statutory pricing information to Federal and State agencies. Data must be evaluated at the transactional and customer level in order to evaluate each transaction, be it direct or indirect sales, credits or rebates, for appropriate treatment in your Government Pricing systems.

The important guidance document, “The OIG Recommendations to Pharmaceutical Manufacturers,” published in April of 2003, defined three key risk areas, one of which was the validity and integrity of data being submitted to the government. Recent government investigations have reiterated the government's position that incorrect reporting of data to the government is a potential False Claims Act violation, even where there is no intent of wrong doing or fraud. Therefore, it is imperative to have sufficient policies, procedures, and systems in place to show that the manufacturer is acting responsibly and ensuring that accurate information is being submitted to the government.

An appropriate and consistent approach to Class of Trade (COT) is essential to the accuracy of your AMP, BP, Non-FAMP and ASP calculation and reporting, as each individual transaction is related to a specific customer, and your calculations can only be accurate if the underlying transactional data is filtered and extracted correctly. It is much like the old saying: “garbage in, garbage out.”

Yet despite the importance of COT, many manufacturers have insufficient or inconsistent procedures and systems related to COT. This may be due in part to historical system issues, procedural issues, or lack of coordination between the commercial function of managing customers and the Government Pricing function.

What can CIS do for you?

CIS Government Programs Specialists can assist you with:

  • Class of Trade Schema: Develop a compliant Class of Trade categorization, or "Schema," that is appropriate for your products and customers and meets current statutory, regulatory, and guidance requirements;
  • Class of Trade Impact Evaluation: Evaluate your current customer data to identify whether you may have potential historical issues, as well as how your COT procedures and systems will adapt to the new CMS rules for AMP and BP, effective July of 2007;
  • Customer and Class of Trade Validation: CIS can also perform a customer COT validation, reviewing and cleansing your customer data to ensure that a consistent and appropriate COT is assigned to each customer, according to defined logic and methodology.

 

CIS Government Programs Specialists can assist you with:

  • 340B Membership Validation and Historical Impact Analysis: Perform a validation, or “scrubbing,” of your existing historical customer data and conduct an analysis to see if there is a potential impact on your historical calculations.
  • 340B Membership Updating Procedures and Systems: Develop policies and procedures related to 340B membership updating, including procedures for researching and documenting new additions based upon chargeback submissions, as well as systems and procedures for end-dating eligibility. This often can present the most difficulty to the manufacturer, as it has been very difficult to create data mapping between the OPA membership and the manufacturer’s contracting system. CIS can implement this system for you and perform the initial scrubbing of your existing customers.