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:
0938-1228
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:
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
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.
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
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:
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
Number of Information Collection (IC) in this ICR:
1
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
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
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.
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
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:
12/21/2023
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