2024-07202. Agency Information Collection Activities: Proposed Collection; 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 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.

FOR FURTHER INFORMATION CONTACT:

William N. Parham at [phone].

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 [e-mail]).

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 410-786-8466 or [e-mail]).

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.