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:
201806-0938-006
Status:
Historical Active
Previous ICR Reference No:
201609-0938-008
Agency/Subagency:
HHS/CMS
Agency Tracking No:
CM-CPC
Title:
Medicare Part D Reporting Requirements and Supporting Regulations in MMA Title I, Part 423, section 423.514 (CMS-10185)
Type of Information Collection:
Revision of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved with change
Conclusion Date:
12/07/2018
Retrieve Notice of Action (NOA)
Date Received in OIRA:
06/15/2018
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
12/31/2021
36 Months From Approved
01/31/2020
Responses
13,603
0
11,438
Time Burden (Hours)
17,365
0
14,750
Cost Burden (Dollars)
0
0
818,775
Abstract:
MMA provides CMS the statutory authority to require all Part D Sponsors (MA-PDs and PDPs) to report data related to their operational costs and services. These data will be analyzed for oversight and monitoring purposes, as well as potentially initiating other groups within the agency to perform functions such as fraud/waste/abuse investigations, audit activities, and compliance. Title I, Part 423, ?423.514 describes CMS' regulatory authority to establish reporting requirements for Part D sponsors. It is noted that each Part D plan sponsor must have an effective procedure to develop, compile, evaluate, and report to CMS, to its enrollees, and to the general public, at the times and in the manner that CMS requires, statistics in the following areas: (1) The cost of its operations. (2) The patterns of utilization of its services. (3) The availability, accessibility, and acceptability of its services. (4) Information demonstrating that the Part D plan sponsor has a fiscally sound operation. (5) Other matters that CMS may require. Subsection 423.505 of the MMA regulation establishes as a contract provision that Part D Sponsors must comply with the reporting requirements for submitting drug claims and related information to CMS.
Authorizing Statute(s):
Statute at Large:
1 Stat. 423
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:
83 FR 8679
02/28/2018
30-day Notice:
Federal Register Citation:
Citation Date:
83 FR 26691
06/08/2018
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
13,603
11,438
0
2,726
-561
0
Annual Time Burden (Hours)
17,365
14,750
0
3,176
-561
0
Annual Cost Burden (Dollars)
0
818,775
0
0
-818,775
0
Burden increases because of Program Change due to Agency Discretion:
Yes
Burden Increase Due to:
Miscellaneous Actions
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
For the CY2019 Reporting Requirements, we removed the Retail, Home Infusion and Long-Term Care Pharmacy Access section since the data are no longer necessary for monitoring through these reporting requirements. There was an overall increase in contract respondents (from 561 to 627) and plan respondents (from 4,036 to 5,234) due to an increase in the total number of Part D contracts. Overall, there was an increase in responses (from 11,438 to 13,603) and total time (from 14,750 hr to 17,365 hr).
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?
Uncollected
Agency Contact:
Mitch Bryman 410 786-5258 Mitch.Bryman@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:
06/15/2018
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