View Information Collection Request (ICR) Package
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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0938-1451
ICR Reference No:
202509-0938-022
Status:
Active
Previous ICR Reference No:
202307-0938-003
Agency/Subagency:
HHS/CMS
Agency Tracking No:
CM-CPC
Title:
Medicare Part D Manufacturer Discount Program Agreement - IRA (CMS-10846)
Type of Information Collection:
Revision of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
12/30/2025
Retrieve Notice of Action (NOA)
Date Received in OIRA:
09/30/2025
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
12/31/2028
36 Months From Approved
12/31/2025
Responses
40
0
659
Time Burden (Hours)
320
0
4,613
Cost Burden (Dollars)
0
0
0
Abstract:
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).
Authorizing Statute(s):
US Code:
42 USC 1395w-114c
Name of Law: Manufacturer discount program
PL:
Pub.L. 117 - 117 11201
Name of Law: Inflation Reduction Act of 2022
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
90 FR 26301
06/20/2025
30-day Notice:
Federal Register Citation:
Citation Date:
90 FR 46895
09/30/2025
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
1
IC Title
Form No.
Form Name
Part D Manufacturer Discount Program
CMS-10846, CMS-10846
HPMS Data Entry Fields
,
TPA Data Entry Fields
ICR Summary of Burden
Total Approved
Previously Approved
Change Due to New Statute
Change Due to Agency Discretion
Change Due to Adjustment in Estimate
Change Due to Potential Violation of the PRA
Annual Number of Responses
40
659
0
0
-619
0
Annual Time Burden (Hours)
320
4,613
0
0
-4,293
0
Annual Cost Burden (Dollars)
0
0
0
0
0
0
Burden increases because of Program Change due to Agency Discretion:
No
Burden Increase Due to:
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
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.
Annual Cost to Federal Government:
$2,050,411
Does this IC contain surveys, censuses, or employ statistical methods?
No
Does this ICR request any personally identifiable information (see
OMB Circular No. A-130
for an explanation of this term)? Please consult with your agency's privacy program when making this determination.
No
Does this ICR include a form that requires a Privacy Act Statement (see
5 U.S.C. §552a(e)(3)
)? Please consult with your agency's privacy program when making this determination.
No
Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]?
No
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
No
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
No
Is this ICR related to the Pandemic Response?
No
Agency Contact:
Stephan McKenzie 410 786-1943 stephan.mckenzie@cms.hhs.gov
Common Form ICR:
No
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:
(a) It is necessary for the proper performance of agency functions;
(b) It avoids unnecessary duplication;
(c) It reduces burden on small entities;
(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;
(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;
(f) It indicates the retention periods for recordkeeping requirements;
(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:
(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;
(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.
(i) It uses effective and efficient statistical survey methodology (if applicable); and
(j) It makes appropriate use of information technology.
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.
Certification Date:
09/30/2025
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