[Federal Register Volume 89, Number 67 (Friday, April 5, 2024)]
[Notices]
[Pages 24008-24010]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-07202]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers: CMS-10545, CMS-R-246, CMS-43 and CMS-10842]


Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Centers for Medicare & Medicaid Services, Health and Human 
Services (HHS).

ACTION: Notice.

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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 60 days for public comment on 
the proposed action. Interested persons are invited to send comments 
regarding our burden estimates 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 must be received by June 4, 2024.

ADDRESSES: When commenting, please reference the document identifier or 
OMB control number. To be assured consideration, comments and 
recommendations must be submitted in any one of the following ways:
    1. Electronically. You may send your comments electronically to 
https://www.regulations.gov. Follow the instructions for ``Comment or 
Submission'' or ``More Search Options'' to find the information 
collection document(s) that are accepting comments.
    2. By regular mail. You may mail written comments to the following 
address: CMS, Office of Strategic Operations and Regulatory Affairs, 
Division of Regulations Development, Attention: Document Identifier/OMB 
Control Number: __, Room C4-26-05, 7500 Security Boulevard, Baltimore, 
Maryland 21244-1850.
    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 website by copying and pasting the following web address 
into your web browser: https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.

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FOR FURTHER INFORMATION CONTACT: William N. Parham at (410) 786-4669.

SUPPLEMENTARY INFORMATION:

Contents

    This notice sets out a summary of the use and burden associated 
with the following information collections. More detailed information 
can be found in each collection's supporting statement and associated 
materials (see ADDRESSES).

CMS-10545 Outcome and Assessment Information Set OASIS-E1
CMS-R-246 Medicare Advantage, Medicare Part D, and Medicare Fee-For-
Service Consumer Assessment of Healthcare Providers and Systems (CAHPS) 
Survey
CMS-43 Application for Part A (Hospital Insurance) and Part B (Medical 
Insurance) for People with End-Stage Renal Disease
CMS-10842 End Stage Renal Disease (ESRD) Annual Home Dialysis within 
Nursing Home Survey Form

    Under the 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 requires federal agencies 
to publish a 60-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.

Information Collection

    1. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Outcome and 
Assessment Information Set OASIS-E1; 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: Revision of a currently 
approved collection; Title of Information Collection: Medicare 
Advantage, Medicare Part D, and Medicare Fee-For-Service Consumer 
Assessment of Healthcare Providers and Systems (CAHPS) Survey; Use: CMS 
is required to collect and report information on the quality of health 
care services and prescription drug coverage available to persons 
enrolled in a Medicare health or prescription drug plan under 
provisions in the Medicare Prescription Drug, Improvement, and 
Modernization Act of 2003 (MMA). Specifically, the MMA under Sec. 
1860D-4 (Information to Facilitate Enrollment) requires CMS to conduct 
consumer satisfaction surveys regarding Medicare prescription drug 
plans and Medicare Advantage plans and report this information to 
Medicare beneficiaries prior to the Medicare annual enrollment period. 
The Medicare CAHPS survey meets the requirement of collecting and 
publicly reporting consumer satisfaction information. The Balanced 
Budget Act of 1997 also requires the collection of information about 
fee-for-service plans. The CAHPS survey measures are incorporated into 
the Part C and D Star Ratings that are published on www.medicare.gov 
each fall to help consumers choose a Medicare plan. A subset of the 
CAHPS measures is also included in the Medicare & You Handbook. CAHPS 
information from MA contracts also feeds into the calculation of MA 
Quality Bonus Payment Ratings that are required by statute and 
regulation.
    The primary purpose of the Medicare CAHPS surveys is to provide 
information to Medicare beneficiaries to help them make more informed 
choices among health and prescription drug plans available to them. 
Survey results are reported by CMS in the Medicare & You Handbook 
published each fall and on the Medicare Plan Finder website. 
Beneficiaries can compare CAHPS scores for each health and drug plan as 
well as compare MA and FFS scores when making enrollment decisions. The 
Medicare CAHPS also provides data to help CMS and others monitor the 
quality and performance of Medicare health and prescription drug plans 
and identify areas to improve the quality of care and services provided 
to enrollees of these plans. CAHPS data are included in the Medicare 
Part C & D Star Ratings and used to calculate MA Quality Bonus 
Payments. Form Number: CMS-R-246 (OMB control number: 0938-0732); 
Frequency: Yearly; Affected Public: Individuals and Households Number 
of Respondents: 794,500; Total Annual Responses: 794,500; Total Annual 
Hours: 192,265. (For policy questions regarding this collection contact 
Lauren Fuentes at 410-786-2290 or [email protected]).
    3. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Application for 
Part A (Hospital Insurance) and Part B (Medical Insurance) for People 
with End-Stage Renal Disease; Use: Form CMS-43 (Application for Part A 
(Hospital Insurance) and Part B (Medical Insurance) for People with 
End-Stage Renal Disease) supports section 226A(a) of the Social 
Security Act (the Act) and corresponding regulations at 42 CFR 
406.7(c)(3) and 406.13.
    Individuals with End-Stage Renal Disease (ESRD) have the 
opportunity to apply for Medicare benefits and obtain premium-free Part 
A if they meet certain criteria outlined in statute. Sections 226A of 
the Act authorizes entitlement for Medicare Hospital Insurance (Part A) 
if the individual with ESRD files an application for benefits and meets 
the requisite contributions through one's own employment or the 
employment of a related individual to meet the statutory definition of 
a ``currently insured'' individual outlined in section 214 of the Act. 
Further, for individuals who meet the requirements for premium-free 
Part A entitlement, Medicare coverage starts based on the dates in 
which the individual started dialysis treatment or had a kidney 
transplant. These statutory provisions are codified at 42 CFR 
406.7(c)(3) and 407.13. Form Number: CMS-43 (OMB control number: 0938-
0080); Frequency: Once; Affected Public: Individuals and Households 
Number of Respondents: 45,200; Total Annual Responses: 45,200; Total 
Annual Hours: 18,984. (For policy questions regarding this collection 
contact Candace Carter at

[[Page 24010]]

410-786-8466 or [email protected]).
    4. 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. 2024-07202 Filed 4-4-24; 8:45 am]
BILLING CODE 4120-01-P