The Medicare Advantage and Prescription Drug Program: Part C Explanation of Benefits and Supporting Regulations (CMS-10453) - IRA

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form CMS-10453 Part D EOB Plan Instructions	Form and Instruction	Modified	Available
Form CMS-10453 PPO Quarterly Template	Form and Instruction	Modified	Repair queued
Form CMS-10453 PPO Monthly Template	Form and Instruction	Modified	Available
Form CMS-10453 PFFS quarterly Template	Form and Instruction	Modified	Available
Form CMS-10452 PFFS monthly Template	Form and Instruction	Modified	Available
Form CMS-10453 MSA Quarterly Template	Form and Instruction	Modified	Available
Form CMS-10453 MSA Monthly Template	Form and Instruction	Modified	Available
Form CMS-10453 HMO Quarterly Template	Form and Instruction	Modified	Available
Form CMS-10453 HMO Monthly Template	Form and Instruction	Modified	Available
Form CMS-10453 EOB	Form and Instruction	Modified	Available
CMS-10453 - Supporting Statement A.docx	Supporting Statement A	Uploaded 2023-12-18	Repair queued
Comments Received 2025 EOB PRA Package 60 day.pdf	Supplementary Document	Uploaded 2023-12-18	Repair queued
Part D Model EOB Crosswalk.pdf	Supplementary Document	Uploaded 2023-12-18	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
208197	EOB	Form and Instruction	Modified	Part D EOB Plan Instructions
208197	EOB	Form and Instruction	Modified	PPO Quarterly Template
208197	EOB	Form and Instruction	Modified	PPO Monthly Template
208197	EOB	Form and Instruction	Modified	PFFS quarterly Template
208197	EOB	Form and Instruction	Modified	PFFS monthly Template
208197	EOB	Form and Instruction	Modified	MSA Quarterly Template
208197	EOB	Form and Instruction	Modified	MSA Monthly Template
208197	EOB	Form and Instruction	Modified	HMO Quarterly Template
208197	EOB	Form and Instruction	Modified	HMO Monthly Template
208197	EOB	Form and Instruction	Modified
208197	EOB	Instruction	Modified

ICR Details

OMB Control No: 0938-1228	ICR Reference No: 202312-0938-004
Status: Active	Previous ICR Reference No: 201308-0938-013
Agency/Subagency: HHS/CMS	Agency Tracking No: CM-CPC
Title: The Medicare Advantage and Prescription Drug Program: Part C Explanation of Benefits and Supporting Regulations (CMS-10453) - IRA
Type of Information Collection: Reinstatement with change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 03/01/2024
Retrieve Notice of Action (NOA)	Date Received in OIRA: 12/21/2023
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2027	36 Months From Approved
Responses	1,065	0	0
Time Burden (Hours)	10,650	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: Section 11201 of the IRA makes significant changes to the Part D benefit design which require CMS to make corresponding revisions to the Part D EOB model. Beginning in 2024, the IRA revises section 1860D-2(b)(4)(A)(i)(II) of the Act to eliminate enrollee cost sharing after the enrollee has incurred costs equal to the annual out-of-pocket threshold specified in section 1860D-2(b)(4)(B)(i) of the Act. Beginning in 2025, the IRA eliminates the coverage gap benefit phase, sunsets the Coverage Gap Discount Program, and introduces new manufacturer discounts in the initial and catastrophic coverage phases. Medicare Advantage organizations (MAOs) and Medicare Prescription Drug Program (Part D) plan sponsors are required to provide their enrollees with a written explanation of benefits (EOB) when benefits are provided under the plan. Section 1860D-4(a)(4) of the Social Security Act, requires that Part D sponsors distribute to enrollees a notice of benefits used in relation to the Part D initial coverage limit and annual out-of-pocket threshold. CMS codified Part D EOB requirements at 42 CFR § 423.128(e). Section 1852(k)(2)(C)(i) of the Act requires MAOs that offer a private fee-for-service (PFFS) plan to provide enrollees with a written EOB, including a clear statement about the enrollee’s liability, when payment is sought under the plan. CMS regulations specifying that all MAOs provide an EOB when Part C benefits are used are codified at 42 CFR § 422.111(k). Information in this collection is needed to ensure that MA and Part D enrollees receive consistent and timely information about costs associated with their medical claims. Part C and Part D EOBs allow enrollees to track their out-of-pocket expenses and benefit utilization in relation to their plan’s deductible and out-of-pocket threshold.

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Authorizing Statute(s): PL: Pub.L. 108 - 117 201 Name of Law: The Medicare Prescription Drug Improvement, and Modernization Act of 2003
   PL: Pub.L. 110 - 275 103 Name of Law: The Medicare Improvements for Patients and Providers Act of 2008.
   PL: Pub.L. 117 - 169 11201 Name of Law: The Inflation Reduction Act of 2022
  

Citations for New Statutory Requirements: PL: Pub.L. 117 - 169 11201 Name of Law: the Inflation Reduction Act of 2022

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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 37066	06/06/2023
30-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 85622	12/08/2023
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
EOB	CMS-10453, CMS-10453, CMS-10453, CMS-10453, CMS-10452, CMS-10453, CMS-10453, CMS-10453, CMS-10453	HMO Monthly Template ,   HMO Quarterly Template ,   MSA Monthly Template ,   MSA Quarterly Template ,   PFFS monthly Template ,   PFFS quarterly Template ,   PPO Monthly Template ,   PPO Quarterly Template ,   Part D EOB Plan Instructions

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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	1,065	0	0	-5,703	0	6,768
Annual Time Burden (Hours)	10,650	0	0	-87,110	0	97,760
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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: CMS revised the burden associated with programming Part C and Part D EOBs, and, for Part D (one-time burden) to implement the redesign, corrections, and IRA-related changes. CMS removed the annual hourly burden associated with preparing individual EOBs because after changes to the EOBs are programmed, the production is automated. Thus, the previously approved annualized hourly burden estimate for preparing Part C EOBs has been removed because there are no changes to the Part C EOB templates and we assume the production is automated once EOB templates are programmed.

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Annual Cost to Federal Government: $1,073

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: 12/21/2023

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