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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:
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.
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
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:
Not associated with rulemaking
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
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(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
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.
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
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:
08/14/2020
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