CMS May Not Be Properly Verifying Data from Manufacturers for Reimbursement

The CMS does not verify sales price data from drug manufacturers being reimbursed for Part B drugs.

The US Government Accountability Office (GAO) recently published a report urging Congress to make the US Centers for Medicare and Medicaid Services (CMS) further verify that data used to set payment rates for prescription drugs are accurate.

The GAO recommends that CMS require manufacturers of drugs covered by Medicare Part B who are paid at average sales price (ASP) submit sales price data, according to the report. THE GAO further requests Congress ensures CMS has the proper authority to require source data to verify pricing data.

Currently, this is only required of manufacturers with Medicaid drug rebate agreements, with CMS validating manufacturers’ sales price data through 3 steps.

CMS requires an authorized official from the company to sign the ASP Certification form that states the information contained in the report is accurate. Then, they perform a set of data checks to make sure that the data is complete.

They check for missing data, duplicate entries, incorrect product information, and compare submissions to submissions from previous quarters, according to the report. No additional steps are taken to verify that the data reported and the actual sales price are the same.

The CMS stated that there have been very few problems with reported ASPs over the years, and any problems were very small, according to the GAO. Current practices to ensure complete data are in line with GAO recommendations.

However, the CMS does not go further to verify the data, and they do not trace the data to and from source documents because they do not have the proper authority to do so, according to the report. They have the authority to survey manufacturers with Medicaid drug rebate agreements to verify ASP through the Social Security Act, the report noted.

The Social Security Act does not allow them to collect any information beyond ASP data. Currently, the CMS is creating an automated ASP submission system, but the system will not take extra steps to ensure the information is correct.

Not verifying data can cause inflated Medicare payment rates, which could cost billions per year. The GAO recommends CMS verify sales price data from drug manufacturers through source documents that collaborate with reported data in addition to their current practices, the report concluded.