Federal Register :: Agency Information Collection Activities: Proposed Collection; Comment Request

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-10277—Medicare and Medicaid Programs: Conditions of Participation for Hospices

CMS-265-11—Independent Renal Dialysis Facility Cost Report

CMS-10916—13th SOW QIN-QIO and AI/AN Advancing Healthcare Quality through Technology (AHQT) Readiness Assessment

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 Collections

1.
Type of Information Collection Request:
Reinstatement with change of a previously approved collection;
Title of Information Collection:
Medicare and Medicaid Programs: Conditions of Participation for Hospices;
Use:
Under the Medicare program, eligible beneficiaries may receive covered services in a hospice, provided that certain requirements are met by the hospice. Hospice care means a comprehensive set of services identified and coordinated by an interdisciplinary group to provide for the physical, psychosocial, spiritual and emotional needs of a terminally ill patient and/or family members, as delineated in a specific patient plan of care.

The information collection requirements (ICRs) described herein are needed to implement the Medicare Conditions of Participation (CoPs) for Medicare-participating hospices. The CoPs help assure an adequate level of patient health and safety in participating hospices and help ensure that Medicare hospice eligibility requirements are being met. CMS originally published the Hospice Conditions of Participation on June 5, 2008 (hereinafter “
2008 Final Rule
”). The regulations containing the information collection requirements are located at 42 CFR part 418 of the Code of Federal Regulations, Subparts B, C and D.

This is a reinstatement of the information collection request that expired on March 31, 2024. The previous iteration of this OMB Control Number: 0938-1067 (approved March 23, 2021) had an annual burden of 3,639,215 hours and annual costs of $273,001,454. For this requested reinstatement, with changes, the total annual burden hours for industry is 4,032,329 hours and the annual burden costs are $350,449,922. The 10.8% increase in hours is primarily due to the increase in the number of hospices since the last iteration.

Since the last reinstatement was approved in March 2021, CMS revised one of the hospice CoPs at 42 CFR 418.76 in the proposed rule,
Medicare Program: FY 2022 Hospice Wage Index and Payment Rate Update, Hospice Conditions of Participation Updates, Hospice and Home Health Quality Reporting Program Requirements
published on April 14, 2021 (86 FR 19700). As CMS addressed in the final rule (CMS-1754-F) published on August 4, 2021 (86 FR 42528), the comments received supported the proposed revisions and did not require any changes to the original burden estimates in this PRA package. This reinstatement incorporates the policy changes made to Section 418.76 through this rule and updates the associated burden estimates based on the original assumptions.

In November 2021, CMS required hospices to develop policies and procedures as a CoP to ensure all staff were fully vaccinated and the burden requirements were detailed in OMB Control Number: 0938-0266. However, CMS removed this requirement and related burden for hospices (and other facilities) in June 2023.
Form Number:
CMS-10277 (OMB control number: 0938-1067);
Frequency:
Yearly;
Affected Public:
Private sector (Business or other for-profit and Not-for-profit institutions);
Number of Respondents:
7,356;
Total Annual Responses:
9,209,893;
Total Annual Hours:
4,032,329. (For policy questions regarding this collection contact Claudia Molinar at 410-786-8445.)

2.
Type of Information Collection Request:
Extension of a currently approved collection;
Title of Information Collection:
Independent Renal Dialysis Facility Cost Report;
Use:
Under the authority of sections 1815(a) and 1833(e) of the Act, CMS requires that providers of services participating in the Medicare program submit information to determine costs for health care services rendered to Medicare beneficiaries. CMS requires that providers follow reasonable cost principles under 1861(v)(1)(A) of the Act when completing the Medicare cost report (MCR). Regulations at 42 CFR 413.20 and 413.24 require that providers submit acceptable cost reports on an annual basis and maintain sufficient financial records and statistical data, capable of verification by qualified auditors.

ESRD facilities participating in the Medicare program submit these cost reports annually to report cost and statistical data used by CMS to

( printed page 23689)

determine reasonable costs incurred for furnishing dialysis services to Medicare beneficiaries and to effect the year-end cost settlement for Medicare bad debts.
Form Number:
CMS-265-11 (OMB control number: 0938-0236);
Frequency:
Annually;
Affected Public:
Private Sector, Business or other for-profits, State, Local, or Tribal Governments);
Number of Respondents:
7,329;
Total Annual Responses:
7,329;
Total Annual Hours:
483,714. (For questions regarding this collection contact Keplinger, Jill C. at 410-786-4550.)

3.
Type of Information Collection Request:
New collection (Request for a new OMB control number);
Title of Information Collection:
13th SOW QIN-QIO and AI/AN Advancing Healthcare Quality through Technology (AHQT) Readiness Assessment;
Use:
This is a new information collection request. The Quality Improvement Network—Quality Improvement Organization (QIN-QIO) program and American Indian/Alaska Native (AI/AN) program assists providers/practices with high-quality, hands-on quality improvement assistance toward meeting their needs, and the healthcare quality and safety goals for beneficiaries. The purpose of this new information collection within these programs is to assess the readiness of participating nursing homes, hospitals, outpatient clinical practices, and AIAN facilities to access, share, and use data electronically for quality improvement and quality reporting. Use of health information technology (HIT) is imperative to assess, monitor, and improve healthcare quality, patient safety, and care coordination.

Many providers/practices continue to lack basic knowledge and capacity to implement HIT to support data exchange between providers/practices, payers, and patients, and to use data for improving quality and outcomes. This “digital divide” creates burden for patients, families, caregivers, providers/practices and increases costs and administrative waste. This burden is disproportionate for underserved populations. Advancing the use of technology and using interoperable standards can reduce the overall cost and burden associated with data collection and supports communication across the care continuum and is an agency priority.

CMS has developed a 41-item Assessment of Health care Quality Technical Readiness (AHQT) for use with participating providers/practices under the QIN-QIO 13th SOW. Provider/practice burden associated with the collection and reporting of quality measurement data has historically been a pain point for the QIN-QIO and AI/AN programs, especially in outpatient clinical practices and critical access hospitals; this burden has been a barrier to both achievement of quality improvement contract goals and proper evaluation of their impact. The results of the assessment will be used to determine which providers/practices may benefit from participation in a technical assistance pilot specific during the QIN-QIO 13th SOW intended to advance provider/practice capacity for engaging in quality improvement and reporting activities facilitated by HIT.
Form Number:
CMS-10916 (OMB control number: 0938-NEW);
Frequency:
Occasionally;
Affected Public:
Private Sector (Business or other for-profit and Not-for-profit institutions);
Number of Respondents:
53,000;
Total Annual Responses:
10,600;
Total Annual Hours:
10,600. (For policy questions regarding this collection contact Geoffrey Berryman at 410-299-7390).