CMS has finalized the model Manufacturer Agreement and model Third Party Administrator Agreement for the ACA Medicare Coverage Gap Discount Program. Under the Discount Program, which takes effect January 1, 2011, Medicare beneficiaries in the Part D coverage gap (sometimes called the “donut hole”) will have access to manufacturer discounts equal to 50% of the negotiated price of applicable drugs (that is, prescription drugs approved or licensed under new drug applications or biologic license applications). In order to participate, manufacturers must sign an agreement with CMS to provide the discount on all of its applicable drugs. Notably, in response to comments received on the Draft Model Manufacturer Agreement released in May, the final Manufacturer Agreement requires manufacturers to pay quarterly invoices within 38 days of receipt, rather than 14 days. CMS also will provide certain claims-level utilization data to manufacturers with the invoices, and, upon audit, CMS will provide certain prescription drug event cost elements for a statistically significant sample size to allow manufacturers to validate discount calculations (CMS will not provide beneficiary-identifiable information, even upon audit). The deadline for manufacturers to return signed agreements and an associated labeler code spreadsheet is September 1, 2010.