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

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form CMS-10846 TPA Data Entry Fields	Form and Instruction	New	Available
Form CMS-10846 HPMS Data Entry Fields	Form and Instruction	New	Available
Form CMS-10846 Part D Manufacturer Discount Program	Form and Instruction	New	Repair queued
CMS-10846 Part D Manufacturer Discount Program - Supporting Statement Part A.docx	Supporting Statement A	Uploaded 2023-07-10	Repair queued
Response to Public Comments Received CMS-10846.pdf	Supplementary Document	Uploaded 2023-07-06	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
260984	Part D Manufacturer Discount Program	Form and Instruction	New	TPA Data Entry Fields
260984	Part D Manufacturer Discount Program	Form and Instruction	New	HPMS Data Entry Fields
260984	Part D Manufacturer Discount Program	Form and Instruction	New

ICR Details

OMB Control No: 0938-1451	ICR Reference No: 202307-0938-003
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CMS	Agency Tracking No: CM-CPC
Title: Medicare Part D Manufacturer Discount Program Agreement - IRA (CMS-10846)
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 09/12/2023
Retrieve Notice of Action (NOA)	Date Received in OIRA: 07/11/2023
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2025	36 Months From Approved
Responses	659	0	0
Time Burden (Hours)	4,613	0	0
Cost Burden (Dollars)	0	0	0

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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).

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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: PL: Pub.L. 117 - 169 11201 Name of Law: Inflation Reduction Act of 2022
US Code: 42 USC 1395w-114c Name of Law: Manufacturer discount program

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 7976	02/07/2023
30-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 43355	07/07/2023
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 1

table that charts list of burden

IC Title	Form No.	Form Name
Part D Manufacturer Discount Program	CMS-10846, CMS-10846	HPMS Data Entry Fields ,   TPA Data Entry Fields

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ICR Summary of Burden

table that charts list 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	659	0	659	0	0	0
Annual Time Burden (Hours)	4,613	0	4,613	0	0	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: This is a new information collection request.

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Annual Cost to Federal Government: $3,187,628

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

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Common Form ICR:  No

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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: 07/11/2023

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