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

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
CMS-R-52 Supporting Statement 06-05-20.docx	Supporting Statement A	Uploaded 2020-08-14	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
224864	42 CFR 494.180(k)		Unchanged
224863	42 CFR 494.70(c) part 3		Modified
224858	42 CFR 494.70(c)		Modified
224857	42 CFR 494.70(c) part 2		Modified
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)		Unchanged
209396	42 CFR 494.110 old facilities		Modified
209395	42 CFR 494.110 new facilities		Modified
209394	42 CFR 494.100(C)(1)		Unchanged
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: 202008-0938-010
Status: Historical Active	Previous ICR Reference No: 201612-0938-014
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: Reinstatement without change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 03/04/2021
Retrieve Notice of Action (NOA)	Date Received in OIRA: 08/14/2020
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, until and unless that enjoinment is lifted. In the next revision, extension, or reinstatement request, CMS shall include a copy of guidance, if any, currently in effect related to this collection of information.

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2024	36 Months From Approved
Responses	180,313	0	0
Time Burden (Hours)	1,260,491	0	0
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:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 34735	06/08/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 49654	08/14/2020
Did the Agency receive public comments on this ICR? No

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

table that charts list of burden

IC Title	Form No.	Form Name
42 CFR 488.60
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)(iii)
42 CFR 494.180 (h)
42 CFR 494.180(f)(4)(ii)
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(k)
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 494.60(d)(4) old facilities
42 CFR 494.70(c)
42 CFR 494.70(c) part 2
42 CFR 494.70(c) part 3

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ICR Summary of Burden

table that charts list 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	180,313	0	0	0	9,889	170,424
Annual Time Burden (Hours)	1,260,491	0	0	0	97,662	1,162,829
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: The estimated burden for this reinstatement request has been adjusted based on the current number of Medicare- participating ESRD facilities, with a prediction for 272 new facilities each year. Changes to ongoing burden reflect these new facility counts. From 2016-2019, the average yearly growth in dialysis facilities seeking approval was 3.81 percent. We anticipate a similar rate of growth in dialysis facilities over the next few years. Thus, we believe that a total of 816 new and renovated dialysis facilities will request Medicare approval over the three-year period from 2020 to 2023. We estimate the average number of new facilities per year requesting approval would be 272 facilities per year, over three years. We estimate the average number of existing facilities each year from 2020 to 2023 to be 8,246 facilities. Due to the increase in the number of affected facilities, the estimated annual burden has increased from 1,162,829 hours to 1,260,491 hours.

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

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]? 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? No

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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: 08/14/2020

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