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
03/31/2024
36 Months From Approved
180,313
0
0
1,260,491
0
0
0
0
0
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.
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.
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:
(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;
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.
CMS-R-52 Supporting Statement 06-05-20.docx
42 CFR 494.180(k)