4120-01-U-P
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifiers: CMS-10545 and CMS-10842]
Agency Information Collection Activities: Submission for OMB Review; Comment Request
AGENCY: Centers for Medicare & Medicaid Services, Health and Human Services (HHS).
ACTION: Notice.
SUMMARY: The Centers for Medicare & Medicaid Services (CMS) is announcing an
opportunity for the public to comment on CMS’ intention to collect information from the public.
Under the Paperwork Reduction Act of 1995 (PRA), Federal agencies are required to publish
notice in the Federal Register concerning each proposed collection of information, including
each proposed extension or reinstatement of an existing collection of information, and to allow a
second opportunity for public comment on the notice. Interested persons are invited to send
comments regarding the burden estimate or any other aspect of this collection of information,
including the necessity and utility of the proposed information collection for the proper
performance of the agency’s functions, the accuracy of the estimated burden, ways to enhance
the quality, utility, and clarity of the information to be collected, and the use of automated
collection techniques or other forms of information technology to minimize the information
collection burden.
DATES: Comments on the collection(s) of information must be received by the OMB desk
officer by [INSERT DATE 30 DAYS AFTER DATE OF PUBLICATION IN THE
FEDERAL REGISTER].
ADDRESSES: Written comments and recommendations for the proposed information
collection should be sent within 30 days of publication of this notice to
www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting
"Currently under 30-day Review - Open for Public Comments" or by using the search function.

To obtain copies of a supporting statement and any related forms for the proposed
collection(s) summarized in this notice, please access the CMS PRA web site by copying and
pasting the following web address into your web browser: https://www.cms.gov/Regulationsand-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing
FOR FURTHER INFORMATION CONTACT: William Parham at (410) 786-4669.
SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 (PRA)
(44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management
and Budget (OMB) for each collection of information they conduct or sponsor. The term
“collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes
agency requests or requirements that members of the public submit reports, keep records, or
provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C.
3506(c)(2)(A)) requires Federal agencies to publish a 30-day notice in the Federal Register
concerning each proposed collection of information, including each proposed extension or
reinstatement of an existing collection of information, before submitting the collection to OMB
for approval. To comply with this requirement, CMS is publishing this notice that summarizes
the following proposed collection(s) of information for public comment:
1.

Type of Information Collection Request: Revision of a currently approved

collection; Title of Information Collection: Outcome and Assessment Information Set OASISE1; Use: This request is to modify the Outcome and Assessment Information Set (OASIS) that
home health agencies (HHAs) are required to collect to participate in the Medicare program.
The current OASIS version, OASIS-E, OMB control number 0938-1279, was approved by the
OMB on November 30, 2022, and implemented on January 1, 2023. We are seeking OMB
approval for the proposed revised OASIS data set, referred to hereafter as OASIS-E1, scheduled
for implementation in the HH QRP on January 1, 2025. The OASIS-E1 includes changes related
to addition of one item supporting an assessment-based quality measure (QM), removal of one
item due to retirement of a QM, and removal of two data elements no longer used in the HH

QRP or for other purposes in CMS programs. Form Number: CMS-10545 (OMB control
number: 0938-1279); Frequency: Occasionally; Affected Public: Private Sector (Business or
other for-profit and Not-for-profit institutions); Number of Respondents: 11,866; Total Annual
Responses: 18,017,056; Total Annual Hours: 16,683,290. (For policy questions regarding this
collection contact Jermama Keys at 410-786-7778).
2. Type of Information Collection Request: New collection (Request for a new OMB
control number); Title of Information Collection: End Stage Renal Disease (ESRD) Annual
Home Dialysis within Nursing Home Survey Form; Use: The End Stage Renal Disease (ESRD)
Network program is responsible to collect, validate, and analyze data as well as to evaluate the
process by which facilities determine the appropriateness of patients for a treatment modality.
Additional responsibilities of the ESRD Network program include encouraging participation in the
placement of patients in a self-care setting, such as home hemodialysis or peritoneal dialysis, as
described in sec. 1881. [42 U.S.C. 1395rr] (c)(1)(A)(i)(2) of the Social Security Act. On September
21, 2018, CMS clarified guidance that residents in a nursing home facility can receive dialysis either
administered and/or supervised by personnel who meet the criteria for training, and competency
verification at 42 CFR 494.100(a) and (b) for providing dialysis. The provision of dialysis within
a nursing home requires that the dialysis facility have an agreement with the nursing home. This
guidance was reinforced and updated on March 22, 2023, in a memo to the State Survey Agency
Directors titled, “Guidance and Survey Process for Reviewing Home Dialysis Services in a
Nursing Home REVISED”. Since the provision of dialysis within nursing homes is relatively new,
CMS designed the CMS-10842 form to capture home modality information from dialysis facilities
that provide dialysis within the nursing home in alignment with the Centers for Disease Control and
Prevention (CDC).
The care provided to residents of a nursing home is of particular interest because of the fragile
health state of the patient and the susceptibility to infection. Each facility certification/survey record
represents one provider. CMS-10842 collects information on dialysis facilities providing home

dialysis services within the nursing home related to the number of patients, setting of dialysis
services provided, who is providing dialysis services, who is providing dressing changes to dialysis
access, staff education and use of CDC Core Interventions used. The aggregate patient information is
collected from each Medicare-approved home dialysis provider to identify the specialized needs of
the ESRD community where home dialysis is provided in Long Term Care facilities. Form
Number: CMS-10842 (OMB control number: 0938-NEW); Frequency: Yearly; Affected Public:
Private Sector (Business or other for-profit and Not-for-profit institutions); Number of
Respondents: 7,726; Total Annual Responses: 7,726; Total Annual Hours: 5,795. (For policy
questions regarding this collection contact Christina Goatee at 410-786-6689).
William N. Parham, III,
Director,
Division of Information Collections and Regulatory Impacts,
Office of Strategic Operations and Regulatory Affairs.

[FR Doc. 2024-13130 Filed: 6/13/2024 8:45 am; Publication Date: 6/14/2024]