August 14, 2014—More than a third of drugmakers failed to submit average sales price data to the federal government for one or more of their Medicare Part B drugs during third quarter of 2012, despite being required to do so, the Department of Health and Human Services Office of Inspector General has found.[ms-protect-content id=”2799″]
Missing or inaccurate ASP data may have resulted in incorrect Medicare provider payment amounts, OIG said in the recent report. For example, OIG said Medicare might have underpaid by 9 percent during the first quarter of 2013 for interferon beta-1a injections. Similarly, Medicare might have overpaid by 12 percent during the same period for hydromorphone injections.
OIG has conducted several recent studies that have examined manufacturers’ accuracy in reporting pricing data for Part B drugs. In order for their drugs to be reimbursable by Medicaid, manufacturers must agree to pay rebates to state Medicaid agencies and to provide CMS with the ASP and sales volume for each of their Part B drugs. They also must provide 340B drug discounts to safety-net hospitals and other providers. Manufacturers can be fined or excluded from federal drug pricing programs for failing to meet such obligations.
OIG recommended that CMS continue to work with it to identify and penalize drugmakers that do not meet ASP reporting requirements. It also said CMS should implement an automated system for reporting Part B drugs’ ASPs, modeled after the one that manufacturers use to report drugs’ average manufacturer prices for Medicaid rebate and 340B discount purposes. OIG also said CMS should seek legislation requiring all manufacturers of Part B drugs to submit ASPs, regardless of whether the manufacturers have Medicaid drug rebate agreements in effect.[/ms-protect-content]