CMS Open Payments Four-Step Validation Process

20 Days! That’s how many days you have before the CMS Open Payments Sunshine Act report submission begins. Previously, (read here), we created the process of collecting aggregate spend data and where they might come from; what to look for to ensure they are correct and finally, what to watch for when submitting to CMS.

In this article, we attempt to take you a bit deeper into the validation process CMS puts your submitted data through. This will give you some insights into what the CMS is looking for in your data.

In the previous article, we highlighted the CMS has a well structured and automated validation process in place that analyzes every submitted report. CMS open payments process validates your report in a four-step process

CMS can return over 330 different errors during a File Submission.


Step 1 & 2: File Level Validation:

There are 24 file level validations that the CMS system verifies the report against, such as:
  • The file header row is not present
  • The file is not in CSV or ZIP format
  • The submitted file size is larger than 250 MB
  • An invalid value was provided for a given field such as error E-939 the Delay in Publication of Research Payment Indicator
  • And more…….

Step 3: Record Level Validation:

  • If the record is submitted to change an existing record. Here, it is checking if the record is a resubmission or is intended to delete or renew the delay in publication of an existing record, an original version of the record exists within the CMS Open Payments system.
  • The information in each field meets the formatting requirements of that field. If the field length, for example, is incorrect for the value of Applicable Manufacturer, the CMS will return an error stating Invalid Length for Applicable Manufacturer or Applicable GPO Entity Name. It will run such field level integrity verification on each submitted field.
  • All required fields are populated Ex: Consolidated Report Indicator is Required, Resubmission File Indicator is Required, Covered Recipient Type is Required and more.

Step 4: Record Matching

After a record passes record-level validations, the CMS Open Payments system attempts to match the covered recipient information in the record (e.g., Physician first name, address, license number, TIN, etc.) with a valid covered recipient using existing CMS resources and information. If the information in the record cannot be matched, the record will fail matching validation.

Another example of such data would be the NDC matching. If it does not match or is the wrong format, CMS will return error E-801 (Invalid NDC of Associated Covered Drug or Biological). Ensure that the NDC entered is in a valid NDC format with dashes in the appropriate places.
Your report can be rejected in any of the above four validation processes. This will cause your organization to go back correct the data and redo the submission process. You could also correct the errors on the CMS UI depending on the errors. However, any of this will be time-consuming.
With over 330 potential errors, it’s best to put in the energy to get it right the first time.
Each of the validation processes mentioned above can be a topic in itself which I will cover in later articles.

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