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:
0938-0992
ICR Reference No:
202405-0938-020
Status:
Historical Active
Previous ICR Reference No:
202106-0938-012
Agency/Subagency:
HHS/CMS
Agency Tracking No:
CM-CPC
Title:
Medicare Part D Reporting Requirements and Supporting Regulations in MMA Title I, Part 423, §423.514(a) (CMS-10185) - IRA
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:
08/01/2024
Retrieve Notice of Action (NOA)
Date Received in OIRA:
05/29/2024
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
08/31/2027
36 Months From Approved
01/31/2025
Responses
14,325
0
12,575
Time Burden (Hours)
23,094
0
16,463
Cost Burden (Dollars)
0
0
0
Abstract:
Section 1860D–12(b)(3)(D) of the Act provides broad authority for the Secretary to add terms to the contracts with Part D sponsors, including terms that require the sponsor to provide the Secretary with information as the Secretary may find necessary and appropriate. Pursuant to our statutory authority, we codified these information collection requirements for Part D sponsors in regulation at 42 CFR §423.514(a). The Center for Medicare (CM) has identified the appropriate data needed to effectively monitor the Medicare Prescription Drug Benefit through these Part D reporting requirements. Changes to the currently approved data collection instrument reflect new executive orders, legislation, as well as recent changes to Agency policy and guidance. One example is the reporting section, Medicare Prescription Payment Plan, which will support the Inflation Reduction Act’s (Section 1860D-2(b)(2)(E) of the Social Security Act, as added by section 11202 of the IRA) provision that all Medicare Part D sponsors offer their Part D enrollees the option to pay their out-of-pocket (OOP) Part D drug costs through monthly payments over the course of the plan year. .
Authorizing Statute(s):
PL:
Pub.L. 117 - 169 11202
Name of Law: The Inflation Reduction Act’s (IRA)
Statute at Large:
1 Stat. 423
Citations for New Statutory Requirements:
PL: Pub.L. 117 - 169 11202 Name of Law: The Inflation Reduction Act’s (IRA)
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:
89 FR 7398
02/02/2024
30-day Notice:
Federal Register Citation:
Citation Date:
89 FR 45898
04/24/2024
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
Medicare Part D Reporting Requirements
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
14,325
12,575
0
1,750
0
0
Annual Time Burden (Hours)
23,094
16,463
6,388
243
0
0
Annual Cost Burden (Dollars)
0
0
0
0
0
0
Burden increases because of Program Change due to Agency Discretion:
Yes
Burden Increase Due to:
Changing Regulations
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
CMS added a new reporting section – Medicare Prescription Payment Program – which supports oversight of this new program under the Inflation Reduction Act. Based on comments received during the 60-day comment period, CMS also added data elements, removed one data element in the Medication Therapy Management (MTM) reporting and increased the hours for each response for this reporting section. Annual burden has increased due to the overall increase in contract respondents (from 814 to 1019) due to an increase in the total number of Part D contracts.
Annual Cost to Federal Government:
$300,000
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:
05/29/2024
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