Medicare Part D Manufacturer
Discount Program Agreement - IRA (CMS-10846)
Revision of a currently approved collection
No
Regular
09/30/2025
Requested
Previously Approved
36 Months From Approved
09/30/2025
40
659
320
4,613
0
0
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).
Burden has decreased due to the
removal of the one-time burden associated with program
implementation, which took place in 2024. CMS is using an annual
burden going forward based on the estimated number (40) of
manufacturers that will newly join the Discount Program each year,
and the number of new Part D plan contracts that are established
each year.
On behalf of this Federal agency, I certify that
the collection of information encompassed by this request complies
with 5 CFR 1320.9 and the related provisions of 5 CFR
1320.8(b)(3).
The following is a summary of the topics, regarding
the proposed collection of information, that the certification
covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a
benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control
number;
If you are unable to certify compliance with any of
these provisions, identify the item by leaving the box unchecked
and explain the reason in the Supporting Statement.
Form CMS-10846 Part D Manufacturer Discount Program
CMS-10846_Supporting Statement Part A_.docx
Part D Manufacturer Discount Program