Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services and Supporting Regulations

Forms and Documents

Document Name	Status
CMS-R-52 Supporting Statement 8-8-2013 - 508 Compliant.pdf Supporting Statement A	2013-11-13

IC Document Collections

IC ID	Document Title	Status
8031	Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services and Supporting Regulations Contained in 42 CFR 405.2100-.2171	Removed
46753	Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171	Removed
46752	Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171	Removed
46751	Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100-.2171	Removed
46750	Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171	Removed
46749	Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171	Removed
46748	Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171	Removed
46747	Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171	Removed
46746	Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171	Removed
46745	Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171	Removed
46744	Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171	Removed
46743	Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171	Removed
46742	Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171	Removed
46741	Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171	Removed
46740	Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171	Removed
46739	Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171	Removed
46738	Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171	Removed
46737	Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171	Removed
46736	Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171	Removed
46735	Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171	Removed
46734	Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171	Removed
46733	Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171	Removed
46732	Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171	Removed
46731	Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171	Removed
46730	Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171	Removed
46729	Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171	Removed
46728	Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171	Removed
46727	Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171	Removed
209405	42 CFR 494.60(d)(4) old facilities	New
209404	42 CFR 494.180 (h)	New
209403	42 CFR 494.180(g)(3)	New
209402	42 CFR 494.180(g)(3)	New
209401	42 CFR 494.180(g)(2)	New
209400	42 CFR 494.180 (f)(4)(iii)	New
209399	42 CFR 494.180(f)(4)(ii)	New
209398	42 CFR 494.180 (e)	New
209397	42 CFR 494.170 (d)	New
209396	42 CFR 494.110	New
209395	42 CFR 494.110	New
209394	42 CFR 494.100(C)(1)	New
209393	42 CFR 494.70	New
209392	42 CFR 494.60 9d)(4)	New
209391	42 CFR 494.40(c)	New
209390	42 CFR 494.30(b)(3) and 494.40 (b)92)(ii)(c)	New
209389	42 CFR 494.30 (a)(ii)	New
209388	42 CFR 488.60	New

ICR Details

OMB Control No: 0938-0386	ICR Reference No: 201311-0938-025
Status: Historical Active	Previous ICR Reference No: 200701-0938-010
Agency/Subagency: HHS/CMS	Agency Tracking No: 20951
Title: Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services and Supporting Regulations
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: 04/21/2014
	Date Received in OIRA: 11/20/2013
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2017	36 Months From Approved
Responses	142,660	0	0
Time Burden (Hours)	524,661	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: This package is needed to encourage proper distribution and effective utilization of ESRD treatment sources while maintaining and improving the efficient delivery of care by physicians and dialysis facilities.

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Authorizing Statute(s): None

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:
	78 FR 50060	08/16/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 63983	10/25/2013
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 18

IC Title	Form No.	Form Name
Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171
Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171
Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171
Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171
Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171
Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171
Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171
Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171
Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171
Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171
Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171
Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171
Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171
Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171
Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171
Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171
Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171
Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171
Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171
Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171
Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171
Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171
Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100-.2171
42 CFR 488.60
42 CFR 494.30 (a)(ii)
42 CFR 494.30(b)(3) and 494.40 (b)92)(ii)(c)
42 CFR 494.40(c)
42 CFR 494.60 9d)(4)
42 CFR 494.70
42 CFR 494.100(C)(1)
42 CFR 494.110
42 CFR 494.110
Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171
Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171
Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171
42 CFR 494.170 (d)
42 CFR 494.180 (e)
42 CFR 494.180(f)(4)(ii)
42 CFR 494.180 (f)(4)(iii)
42 CFR 494.180(g)(2)
42 CFR 494.180(g)(3)
42 CFR 494.180(g)(3)
42 CFR 494.180 (h)
42 CFR 494.60(d)(4) old facilities
Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services and Supporting Regulations Contained in 42 CFR 405.2100-.2171
Conditions for Coverage of Suppliers of End Stage Renal Disease (ESRD) Services & Suppt Regs. at 42 CFR 405.2100 - .2171

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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	142,660	0	0	74,055	0	68,605
Annual Time Burden (Hours)	524,661	0	0	363,951	0	160,710
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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: The estimated burden for this request is based on the current number of Medicare-participating ESRD facilities, with a prediction for 213 new facilities each year. Changes to ongoing burden reflect these new facility counts.

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Annual Cost to Federal Government: $1,300,000

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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: 11/20/2013

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