Recently, the Department of Health and Human Services Office of the Inspector General (OIG) issued a report about the accuracy and precision of Open Payments reporting. Potentially, the most consequential news to come out of the report is in the recommendations the OIG made to the Centers for Medicare & Medicaid Services (CMS).
If CMS implements these suggestions, then manufacturers, who struggle to capture accurate information related to pharmaceuticals, may be negatively affected. In addition, the OIG explained that CMS is developing strategies and plans, so it can conduct audits of manufacturers and group purchasing organizations (GPOs). So far, the organization has not audited these groups.
Open Payments reporting began in 2014 as a national disclosure program that promotes more transparency and accountability in the health care sector. As a result, patients can see for themselves the financial relationships between manufacturers and GPOs and physicians, and teaching hospitals. The CMS’ Center for Program Integrity manages Open Payments.
Pharmaceutical, biomedical, medical device, and dental companies include three types of records in Open Payments:
- General payments
- Research payments
- Ownership interests
OIG Recommendations for Open Payments Reporting
This OIG report focused on 2015 data and information provided by CMS about its processes. The good news is of 11.9 million records published on the Open Payments website, only 1 percent were missing required data. However, there were inaccuracies and insufficient information in some reports. As a result, the OIG made the following recommendations:
CMS should ensure records contain all required data, according to the OIG. Most of the records had all the necessary data and were complete. However, some of them managed to get through the system without all the required information. As a result, OIG suggests CMS check its validation process to determine why reports lacking required data were accepted into the system.
Get More Specific
What the OIG found was that in the part of the system asking for required names of drugs and devices, companies often included invalid text or numbers. In some cases, they included an ailment that was treated by the drug or device but not the product name itself. So, OIG suggests CMS strengthen its data validation rules to force manufacturers and GPOs to input real names of drugs and devices.
Insist on Precision
Revising the definition of the device-name data point was the next recommendation. The purpose for changing this definition is to ensure the reported information is more specific. Now, CMS permits GPOs and manufacturers to input therapeutic areas or product categories of devices but not the actual name. The OIG says the name would be better.
“More specific device names would enable consumers to determine whether their providers received payments related to devices that the providers used or planned to use as part of the consumer’s care,” according to the report.
The final recommendation relates to ensuring manufacturers and GPOs report the valid National Drug Code (NDC) for medications. NDCs are unique 10-digit, 3-segment numbers that identify drugs in the United States.
OIG argues that accurate NDCs make it easier for researchers to perform more valid research and analysis of Open Payments data. CMS, it suggests, should devise a way to validate the given code is correct. The department could turn to Food and Drug Administration data, widely used compendia, or its own drug product data to validate the reported codes.
Why care about these recommendations? Well, they could have an impact on your work and compliance strategy. If these recommendations get enacted, manufacturers and GPOs will have to become more precise in the data they report or risk the consequences.
In addition, CMS appears to be gearing up to conduct audits. CMS also “concurred with all four recommendations,” according to the report. In other words, having a compliance system of record and an organized plan for minimizing risk is more important than ever.