2024-11978. 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 July 1, 2024.

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 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 Parham at [phone].

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: Reinstatement with change to a previously approved collection; Title of Information Collection: Ambulatory Surgical Center Conditions for Coverage; Use: The purpose of this package is to request from the Office of Management and Budget (OMB) the approval to reinstate, with changes, the collection of information. The conditions for coverage for ASCs are regulation based on criteria described and codified at § 42 CFR 416. The conditions for coverage establish standards designed to ensure that each ASC has properly trained staff to provide the appropriate type and level of care for the environment of ASC patients.

To determine ASC compliance with CMS standards, CMS, via the Secretary, authorizes States, through contracts, to survey ASC facilities. For Medicare purposes, certification is based on the State survey agency's recording of an ASC provider's compliance or non-compliance with the health and safety conditions for coverage as published and codified in 42 CFR 416.40 to 485.54. The information collections aid surveyors as they assess ASC compliance or non-compliance.

The previous iteration of this information collection request had a burden of 262,946 annual hours at an annual cost of $28,144,370. For this requested reinstatement, with changes, the adjusted annual hourly burden is 97,527 hours at a cost of $11,089,427. The reasons for this change, is the previous iteration of this IC assumed the development associated with IC-1 and IC-2 occurred frequently. We have revised this as development of drafts only occur on a one-time basis. Form Number: CMS-10279 (OMB control number: 0938-1071); Frequency: Annual; Affected Public: Business or other for-profit and Not-for-profit institutions; Number of Respondents: 6,257; Total Annual Responses: 6,257; Total Annual Hours: 97,527. (For policy questions regarding this collection contact Claudia Molinar at 410-786-8445.)

2. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Submission of 1135 Waiver Request Automated Process; Use: Waivers under Section 1135 of the Social Security Act (the Act) and certain flexibilities allow the CMS to relax certain requirements, known as the Conditions of Participation (CoPs) or Conditions of Coverage to promote the health and safety of beneficiaries. Under Section 1135 of the Act, the Secretary may temporarily waive or modify certain Medicare, Medicaid, and Children's Health Insurance Program (CHIP) requirements to ensure that sufficient health care services are available to meet the needs of individuals enrolled in Social Security Act programs in the emergency area and time periods. These waivers ensure that healthcare entities/caregivers who provide such services in good faith can be reimbursed and exempted from sanctions.

During emergencies, CMS must be able to apply program waivers and flexibilities under section 1135 of the Social Security Act, in a timely manner to respond quickly to unfolding events. In a disaster or emergency, waivers and flexibilities assist health care providers/suppliers in providing timely healthcare and services to people who have been affected and enables States, Federal districts, and U.S. territories to ensure Medicare and/or Medicaid beneficiaries have continued access to care. During disasters and emergencies, it is not uncommon to evacuate patients in health care facilities to other provider settings or across State lines, especially, during hurricane, wildfire, and tornado events. CMS must collect relevant information for which a provider is requesting a waiver or flexibility to make proper decisions about approving or denying such requests. Collection of this data aids in the prevention of gaps in access to care and services before, during, and after an emergency. CMS must also respond to inquiries related to a Public Health Emergency (PHE) from providers. CMS is not collecting information from these inquiries; we are merely responding to them.

The collection of the information surrounding 1135 Waiver requests/inquiries is based on a case-by-case basis and not regularly scheduled ( e.g., quarterly, annually, by all providers/suppliers). The collection of information only occurs when the healthcare entity, impacted by an emergency, is requesting waivers/flexibilities under Section 1135 of the Act or inquiring about PHEs. The collection of information is also dependent on provider types; therefore, it is not a collection for all Medicare-participating facilities. In 2021, we implemented a streamlined, automated process to standardize the 1135 waiver requests and inquiries submitted based on lessons learned during the COVID-19 PHE.

Furthermore, the normal operations of a healthcare provider are disrupted by emergencies or disasters occasionally. When this occurs, State Survey Agencies (SA) deliver a provider/beneficiary tracking report regarding the current status of all affected healthcare providers and their beneficiaries. We are revising this information collection streamlined automated process to update for clarity during emergencies. To quickly identify patient risks/needs, CMS added fields to assess sufficient staffing, equipment and supplies as well as added an assessment of a cyber security attack on the care and services provided to patients (if applicable). Moreover, to decrease the time/effort of stakeholders (State Survey Agencies (SAs)/Providers) submitting this data during emergencies, CMS also added a feature to autofill multiple fields when the stakeholder documents a valid CMS Certification Number (CCN). This streamlined automated process will consist of a public facing web form as well as a process for SAs/Providers to submit data using extracts (CSV or Excel) on emergent events impacting Health Care Facilities via automated mail handler system. Both processes (public facing web form and extracts via an automated mail handler system) are known as the Health Care Facility (HCF) Operational Status. Finally, Acute Hospital Care at Home waiver is granted at the individual hospital/CMS Certification Number (CCN) level and waives § 482.23(b) and (b)(1) of the Hospital Conditions of Participation (CoPs) which require nursing services to be provided on premises 24 hours a day, 7 days a week and the immediate availability of a registered nurse for care of any patient (This waiver allows hospitals to utilize models of at-home hospital care). This Acute Hospital Care at Home web form was revised to add questions for the respondents to meet requirements for all hospitals for (1) the Patient Rights CoP at 42 CFR 482.13, (2) the Consolidated Appropriations Act of 2023 and (3) for emergency response. Form Number: CMS-10752 (OMB control number: 0938-1384); Frequency: Occasionally; Affected Public: Private Sector: Business or other for-profits and Not-for-profit institutions and State, Local or Tribal Governments; Number of Respondents: 1,020; Total Annual Responses: 11,916; Total Annual Hours: 11,916. (For policy questions regarding this collection, contact Adriane Saunders at 404-562-7484.)

William N. Parham III,

Director, Division of Information Collections and Regulatory Impacts, Office of Strategic Operations and Regulatory Affairs.