In case you missed it, OIG recently published a report on its review of Open Payments data published by CMS. A key objective of this review was to “assess whether data published on the Open Payments website were missing data elements, were inaccurate, or were inconsistent.”

OIG only reviewed the data published by CMS for the program year 2015. In the data analysis conducted to determine whether the data contained inaccurate or inconsistent information, OIG made the following three key observations:

1. Product names that did not appear to be drugs or devices

2. Payment dates fell outside the program year 2015

3. NDC codes for products not found in three FDA databases.

In addition, the report concludes that less than 1 percent of transaction records were missing required data elements. This is good news for manufacturers and GPOs submitting more than 11 million records every year. The most common missing data elements were:

1. Physician specialty

2. Third-party recipient equals a covered recipient indicator.

CMS, on its part, has accepted the four key recommendations made by OIG:

1. Ensure that records contain all the required data

2. Strengthen validation rules

3. Revise the definition of the device-name data element to make it more specific

4. Ensure that manufacturers and GPOs report valid NDCs.

CMS has not yet conducted any audits of manufacturers and GPOs. At the time of OIG’s review, CMS was in the process of developing audit strategies and audit plans in anticipation of conducting such audits. CMS has the authority to impose civil monetary penalties on manufacturers and GPOs that fail to report or knowingly fail to report information regarding payments and ownership interests in a timely, accurate or complete manner.

Link to the full report: Click Here

Our top three recommendations based on the renewed interest in data accuracy for manufacturers and GPOs:

1. Ensure your aggregate spend reporting system can support NDC code lookups to ensure drug names and NDC codes match FDA databases.

2. Ensure you build validation rules that check for data ranges within a specific program year for submission. (This could be built in Excel or your agg spend tool).
3. Have completeness and accuracy metrics for each data source to determine which sources of internal data require more effort to get to CMS submission standards