Comparison of Average Sales Prices and Average Manufacturer Prices: Results for the Fourth Quarter of 2023

Why OIG Did This Review

• When Congress established average sales price (ASP) as the basis for reimbursement for Medicare Part B drugs (generally, drugs that are injected or infused in physicians’ offices or hospital outpatient settings), it also provided a mechanism for monitoring market prices and limiting potentially excessive payment amounts.
• The Social Security Act (the Act) mandates that OIG compare ASPs with average manufacturer prices (AMPs). If OIG finds that the ASP for a drug exceeds the AMP by a certain percentage (currently 5 percent), the Act directs the Secretary of Health and Human Services to substitute the ASP-based payment amount with a lower calculated rate.
• Through regulation, CMS outlined that it would make this substitution only if the ASP for a drug exceeded the AMP by 5 percent in the two previous quarters or three of the previous four quarters.

What OIG Found

In the fourth quarter of 2023, 11 drug codes met CMS’s price-substitution criteria by exceeding the 5 percent threshold for 2 consecutive quarters or 3 of the previous 4 quarters.

Mandatory Action

OIG is providing the 11 drug codes to CMS for its review. CMS should review this information to determine whether to pursue price substitutions that would limit excessive payments for Part B drugs.