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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:
0938-0386
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
Retrieve Notice of Action (NOA)
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
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.
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
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
0938-AT11
Final or interim final rulemaking
81 FR 90211
12/14/2016
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
Number of Information Collection (IC) in this ICR:
21
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
42 CFR 494.70(c)
42 CFR 494.70(c) part 2
42 CFR 494.70(c) part 3
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.
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
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:
12/16/2016
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