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:
0938-0046
ICR Reference No:
202505-0938-008
Status:
Active
Previous ICR Reference No:
202402-0938-004
Agency/Subagency:
HHS/CMS
Agency Tracking No:
CCSQ
Title:
End Stage Renal Disease Medical Evidence Report Medicare Entitlement and/or Patient Registration (CMS-2728)
Type of Information Collection:
No material or nonsubstantive change to a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
05/29/2025
Retrieve Notice of Action (NOA)
Date Received in OIRA:
05/27/2025
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
11/30/2026
11/30/2026
11/30/2026
Responses
138,000
0
138,000
Time Burden (Hours)
172,500
0
172,500
Cost Burden (Dollars)
0
0
0
Abstract:
The primary purpose of the END STAGE RENAL DISEASE MEDICAL EVIDENCE REPORT MEDICARE ENTITLEMENT AND/OR PATIENT REGISTRATION is to determine if an individual is entitled to Medicare under the End Stage Renal Disease provisions of the law. This form SHOULD NOT be completed for those patients who are in acute renal failure. Completion of the form is voluntary, but failure to do so may result in denial of Medicare benefits.
Authorizing Statute(s):
US Code:
42 USC 289c
Name of Law: Research on public health emergencies
US Code:
42 USC 426-1
Name of Law: SPECIAL PROVISIONS RELATING TO COVERAGE UNDER MEDICARE PROGRAM FOR END STAGE RENAL DISEASE
US Code:
42 USC 241a
Name of Law: Research and investigations generally
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:
87 FR 76625
12/15/2022
30-day Notice:
Federal Register Citation:
Citation Date:
88 FR 34502
05/30/2023
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
End Stage Renal Disease Medical Evidence Report Medicare Entitlement and/or Patient Registration and Supporting Regulations in 42 CFR, 405.2133; PL 95-292; CFR Parts....
CMS-2728
ESRD Medical Evidence Report
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
138,000
138,000
0
0
0
0
Annual Time Burden (Hours)
172,500
172,500
0
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:
There is a change in total estimated burden hours of 69,000 (172,500 estimated hours- 103,500 previously estimated hours) due to an increase in the time to complete the CMS-2728 forms by 30 minutes and a decrease in submission of CMS-2728 forms by 5,929 submissions (138,000 previously estimated submissions-132,071 submissions).
Annual Cost to Federal Government:
$1,725,000
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:
Denise King 410 786-1013 Denise.King@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:
05/27/2025
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