Brian O'Rourke, CIS PCX Product Manager & Compliance Specialist
Here is a list of the GP Policies and Procedures we generally recommend and look for when performing an assessment. And I promise, once again, not to beat you over the proverbial head about the Final Rule.
1. Government Programs Compliance Policy
The Government Programs Compliance Policy is the overarching document containing your company’s governing policy statements. This Policy is corporate-level, as opposed to operational or functional-level. In other words, senior management, the Chief Compliance Officer, and the Manager in charge of your GP operations are the “authors.” I place authors in quotation marks because we all know they won’t actually write this document—what I mean to say is that the policy decisions contained herein are their policy decisions to make and proclaim.
This Policy addresses the issues that apply to all the Programs: delegation of responsibilities, calculation, review, approval, certification, submission, and retention.
In addition, you might consider having separate policies pertaining to the integrity of data and data extraction and validation. These concepts are all necessary components to a compliant process for submitting accurate data.
2. Class of Trade Policy and Supporting Procedure(s)
The Class of Trade (COT) Policy is typically not a GP-authored Policy, as it is usually commercially-defined and driven. However, it should be fairly obvious to anyone working in the GP space that your company’s COT Policy and supporting procedure(s) bear an enormous impact on your calculations.
Therefore, the appropriate GP personnel must be involved at some point in the authoring or review of these documents. For each COT, GP personnel need to know whether it constitutes sales to entities that are retail, non-retail, or Government, among other things. A sound COT schema, reflected in a Policy and Supporting Procedure(s), goes a long way in ensuring that calculations are accurate.
3. The Federal Programs Policies
Each Federal Program your company participates in merits its own Policy document, because each Program carries its own unique requirements. For example, your Medicaid Drug Rebate Program Policy references the CEO/CFO Certification and the company’s commitment to submitting AMP, BP, Nominal Price, and Customary Prompt Pay Discounts in a timely, error-free fashion. In contrast, your PHS/340B Program Policy lists your company’s position relative to 340B participation and contracting with the Prime Vendor for any sub-340B price.
Separate policies for each Program also make life a lot easier when your GP calculation responsibilities are spread out among several employees. Separate policies also make the review and revision cycle more manageable, because you will only need to update the policies as changes are made to those Programs.
4. The Federal Programs Supporting Procedures
Just as each Program requires its own Policy document due to the Program’s unique requirements, so too does each Program require its own supporting procedural documents. With respect to Medicaid, your company needs procedures around:
-AMP methodology and calculation
-BP methodology and calculation
-Nominal Price methodology and calculation
-Customary Prompt Pay Discount methodology and calculation
-Medicaid Claims processing
Given the fairly detailed methodologies these calculations require, especially AMP, we typically recommend placing your company’s methodology assumptions in an attachment to the calculation procedure. As CMS has shown over the years, the definition of AMP and all that it encompasses is constantly evolving. By placing your AMP methodology in an attachment, as opposed to the procedure itself, you can circumvent the lengthy and formal process of SOP revision because you are only revising an attachment when your methodology changes. Under this scenario, the calculation SOP remains the same.
Following the model described above, all other Programs should receive their own calculation procedures and methodology attachments.
With respect to the VA Program, you must consider whether you want to reference processes related to Most Favored Customer or Tracking Customer in the calculation procedure or whether you want to keep those tasks separate. How your company is structured will likely determine the outcome of this decision—some companies segregate non-FAMP and FCP calculation duties from Tracking Customer duties, while others do not.
The 340B Price calculation is fairly simple in nature. For the sake of brevity and creating fewer documents that need to be periodically reviewed, we typically recommend that companies combine the calculation methodology and procedure into one document, which also could include the process of 340B eligibility verification.