(CMS-R-52) End State Renal Disease (ESRD) Conditions for Coverage and Supporting Regulations

Forms and Documents

Document Name	Status
CMS-R-52 Final Supporting Statement - revised 6-23-17.docx Supporting Statement A	2017-07-17

IC Document Collections

IC ID	Document Title	Status
224864	42 CFR 494.180(k)	New
224863	42 CFR 494.70(c) part 3	New
224858	42 CFR 494.70(c)	New
224857	42 CFR 494.70(c) part 2	New
209405	42 CFR 494.60(d)(4) old facilities	Modified
209404	42 CFR 494.180 (h)	Modified
209403	42 CFR 494.180(g)(3) old facilities	Modified
209402	42 CFR 494.180(g)(3) new facilities	Modified
209401	42 CFR 494.180(g)(2)	Modified
209400	42 CFR 494.180 (f)(4)(iii)	Modified
209399	42 CFR 494.180(f)(4)(ii)	Modified
209398	42 CFR 494.180 (e)	Modified
209397	42 CFR 494.170 (d)	Modified
209396	42 CFR 494.110 old facilities	Modified
209395	42 CFR 494.110 new facilities	Modified
209394	42 CFR 494.100(C)(1)	Modified
209393	42 CFR 494.70	Removed
209392	42 CFR 494.60(d)(4) new facilities	Modified
209391	42 CFR 494.40(c)	Modified
209390	42 CFR 494.30(b)(3) and 494.40 (b)92)(ii)(c)	Modified
209389	42 CFR 494.30 (a)(ii)	Modified
209388	42 CFR 488.60	Modified

ICR Details

OMB Control No: 0938-0386	ICR Reference No: 201612-0938-014
Status: Historical Active	Previous ICR Reference No: 201311-0938-025
Agency/Subagency: HHS/CMS	Agency Tracking No: 20951
Title: (CMS-R-52) End State Renal Disease (ESRD) Conditions for Coverage and Supporting Regulations
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: 07/17/2017
	Date Received in OIRA: 12/16/2016
Terms of Clearance: OMB notes that on January 25, 2017, the U.S. District Court for the Eastern District of Texas enjoined the Department of Health and Human Services from implementing its interim final rule published on December 14, 2016, "Medicare Program; Conditions for Coverage for End-Stage Renal Disease Facilities-Third Party Payment" (81 FR 90211). Accordingly, the disclosure requirements in 42 CFR 494.70(c) and 494.180(k) associated with this interim final rule are not approved for use at this time.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2020	36 Months From Approved	07/31/2017
Responses	170,424	0	142,660
Time Burden (Hours)	1,162,829	0	524,661
Cost Burden (Dollars)	0	0	0

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Abstract: The CfCs were amended to create new disclosure requirements to prevent inappropriate steering of dialysis patients into individual market health plans rather than Medicare and/or Medicaid. These require certain facilities to make disclosures of premium assistance payments made by dialysis suppliers, funds available to patients, and complete information about the extents and limitations of all coverage options.

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Authorizing Statute(s): PL: Pub.L. 92 - 603 2991 Name of Law: Social Security Amendments of 1972
   PL: Pub.L. 99 - 272 1881 Name of Law: Consolidated Omnibus Budget Reconciliation Act of 1975
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0938-AT11	Final or interim final rulemaking	81 FR 90211	12/14/2016

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 90211	12/14/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 90211	12/14/2016
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 21

IC Title	Form No.	Form Name
42 CFR 494.70
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(d)(4) new facilities
42 CFR 494.100(C)(1)
42 CFR 494.110 new facilities
42 CFR 494.110 old facilities
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) new facilities
42 CFR 494.180(g)(3) old facilities
42 CFR 494.180 (h)
42 CFR 494.60(d)(4) old facilities
42 CFR 494.70(c) part 3
42 CFR 494.180(k)
42 CFR 494.70(c) part 2
42 CFR 494.70(c)

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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	170,424	142,660	0	27,764	0	0
Annual Time Burden (Hours)	1,162,829	524,661	0	638,168	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: 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 255 new facilities each year. Changes to ongoing burden reflect these new facility counts. There have been new paperwork requirements implemented since the last revision of CM-R-52. We estimate the average number of existing facilities each year from 2017 to 2021 to be 7,000 facilities. Since these provisions are currently in effect, we are using 2015 estimates of the numbers for new and renovated dialysis facilities for one- time burdens.

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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]? Yes

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: 12/16/2016

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