Medicare Part D Manufacturer Discount Program Agreement - IRA (CMS-10846)

Section 11201 of the Inflation Reduction Act of 2022 (IRA), eliminates the coverage gap phase of the Part D benefit and sunsets the coverage gap discount program after December 31, 2024, and amends the Social Security Act (the Act) to add §1860D-14C, requiring the Secretary to establish a new Medicare Part D manufacturer discount program (Discount Program) beginning January 1, 2025. Under the Discount Program, participating manufacturers are required to provide discounts on their “applicable drugs” (brand drugs, biologics, and biosimilars) both in the initial coverage phase and in the catastrophic coverage phase of the Part D benefit. Section 1860D-14C(d)(1) of the Act requires CMS to implement and administer the Discount Program, including determining discounted amounts, and ensuring that discounts are applied appropriately and payments/reimbursements are timely made. As with the existing coverage gap discount program, a CMS contractor will serve as the third party administrator (TPA) and facilitate payment processing. Information in this collection is needed to set up agreements between manufacturers and CMS, as required under §1860D-14C(a) of the Act. Such agreements are required in order for manufacturers to participate in the Discount Program and, under §1860D43(a), for their applicable drugs to be covered under Part D beginning in 2025. Information that will be collected from manufacturers in the Health Plan Management System (HPMS) (Appendix A) is needed to create and execute Discount Program agreements and to determine which manufacturers qualify as a specified manufacturer or specified small manufacturer for phased-in discounts, as described at §1860D-14C(g)(4). Banking information collected by the TPA from manufacturers and plan sponsors (Appendix B) is needed to prepare invoices and process financial transactions (deposits and payments) through the automated clearing house (ACH).

The latest form for Medicare Part D Manufacturer Discount Program Agreement - IRA (CMS-10846) expires 2028-12-31 and can be found here.