Medicare Proposes Changes To ASP Reporting Requirements For Part B Drugs
Executive Summary
CMS is proposing to expand average sales price (ASP) data reporting requirements for manufacturers to include wholesale acquisition costs of Medicare Part B drugs
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CMS is proposing to expand average sales price (ASP) data reporting requirements for manufacturers to include wholesale acquisition costs of Medicare Part B drugs. Since January, Medicare has reimbursed physician-administered Part B drugs at a rate of ASP plus 6%. The agency currently requires firms to submit the manufacturer's ASP for a drug, the manufacturer name, National Drug Code and number of units. The Centers for Medicare & Medicaid Services outlined ASP reporting for Part B drugs and biologics in an April 2004 interim final rule (1 (Also see "“Average Sales Price” Rule Issued; Definition Mirrors Medicare Rx Law" - Pink Sheet, 5 Apr, 2004.), p. 13). CMS acknowledged in the interim rule the possibility that "as we gain more experience with the ASP methodology, we may seek to modify the reporting requirements." Based on experience gained during the first six ASP reporting periods, CMS said in a notice in the Aug. 19 Federal Register that it plans to increase data collected from manufacturers. The notice seeks public comment within 60 days on the estimated burden and the perceived "necessity and utility" of the initiative. In addition to wholesale acquisition costs, other new information CMS is requesting to be submitted are the name of the Part B drug, its strength, volume per item and number of items per NDC. CMS would also collect the expiration date for the lot last manufactured. However, "we are proposing that manufacturers would no longer report ASP data for an NDC beginning the reporting period after the expiration date of the last lot manufactured," the agency says. "For NDCs first marketed or sold on or after October 1, 2005, we are also proposing to collect the date the NDC was first marketed and the date of first sale." CMS has been expanding its use of ASP data for Medicare drug reimbursement to other patient populations. For example, the agency intends to move to ASP-based reimbursement for outpatient drugs administered in hospital and dialysis settings. In addition, the White House has proposed legislation that would shift pharmacy drug reimbursement under Medicaid from an average wholesale price methodology to ASP plus 6% (2 (Also see "Medicaid Would Pay ASP+6% To Pharmacies Under White House Bill" - Pink Sheet, 15 Aug, 2005.), p. 23). |