OIG to CMS: Get all drug manufacturers to submit ASPs

Wednesday, July 23, 2014

WASHINGTON – CMS lacks complete average sales price (ASP) data for certain drugs, hindering its ability to ensure that payment amounts are accurate and reflective of manufacturer sales prices, according to a new report from the Office of Inspector General (OIG).

At least one-third of the more than 200 manufacturers of Part B drugs did not submit ASPs for some of their products in the third quarter of 2012, despite being required to do so, according to the report. Another 45 manufacturers were not required to report ASPs during the same quarter.

The OIG also found a small number of inaccuracies in CMS’s ASP files, which may have affected Medicare payments.

The OIG recommends that CMS:

1. Continue to work with the OIG to identify and penalize manufacturers that do not meet ASP reporting requirements;

2. Seek a legislative change to require all manufacturers of Part B drugs to submit ASPs;

3. Ensure the accuracy of product information for the national drug codes (NDCs) listed in the background and crosswalk files; and

4. Finalize the implementation of automated ASP-related procedures by using processes related to average manufacturer price as a model, and subsequently require all manufacturers to submit ASPs through the automated system.

CMS concurred with the first, third, and fourth recommendations, but it did not concur with the second.

The report is a follow up to a previous report that recommended CMS seek a legislative change to require all manufacturers of Part B drugs to report ASPs.