End Stage Renal Disease Medical Evidence Report Medicare Entitlement and/or Patient Registration (CMS-2728)

Forms and Documents

Document Name	Status
Form CMS-2728 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.... Form	Modified
Crosswalk-Form 2728 0938-0046 mch.pdf Supplementary Document	2019-05-29
CMS-2728 Supporting_Statement-OMB 0938-0046 Redline-reviewed.docx Supporting Statement A	2019-05-29

IC Document Collections

IC ID	Document Title	Status
7806	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.... Form	Modified

ICR Details

OMB Control No: 0938-0046	ICR Reference No: 201905-0938-016
Status: Active	Previous ICR Reference No: 201404-0938-007
Agency/Subagency: HHS/CMS	Agency Tracking No: 20698
Title: End Stage Renal Disease Medical Evidence Report Medicare Entitlement and/or Patient Registration (CMS-2728)
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: 11/25/2019
	Date Received in OIRA: 06/04/2019
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2022	36 Months From Approved
Responses	138,000	0	0
Time Burden (Hours)	103,500	0	0
Cost Burden (Dollars)	0	0	0

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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.

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Authorizing Statute(s): US Code: 42 USC 241a Name of Law: Research and investigations generally
   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
  

Citations for New Statutory Requirements: None

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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:
	84 FR 5690	02/22/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 24154	05/24/2019
Did the Agency receive public comments on this ICR? Yes

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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

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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	0	0	8,000	0	130,000
Annual Time Burden (Hours)	103,500	0	0	6,000	0	97,500
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: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: Change in total estimated burden hours due to an increase in submission of CMS-2728 forms.

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Annual Cost to Federal Government: $0

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

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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: 06/04/2019

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