[Federal Register Volume 89, Number 199 (Tuesday, October 15, 2024)]
[Notices]
[Pages 83015-83017]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-23737]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-855B, CMS-R-48 and CMS-10239]


Agency Information Collection Activities: Submission for OMB 
Review; 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 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 November 14, 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 (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: Reinstatement with 
change of a previously approved collection; Title of Information 
Collection: Medicare Enrollment Application for Clinics/Group Practices 
and Other Suppliers; Use: Various sections of the Act, the United 
States Code (U.S.C.), Internal Revenue Service (IRS) Code, and the CFR 
require providers and suppliers to furnish information concerning the 
amounts due and the identification of individuals or entities that 
furnish medical services to beneficiaries before payment can be made. 
The Form CMS-855B application is submitted when the applicant first 
requests Medicare enrollment. The application is used by the MACs to 
collect data to ensure the applicant has the necessary credentials to 
provide the health care services for which they intend to bill 
Medicare; this includes data that allows the Medicare contractor to 
correctly price, process, and pay the applicant's claims. It also 
gathers information that enables MACs to ensure that the supplier is 
neither excluded from the Medicare program nor debarred, suspended, or 
excluded from any other Federal agency or program. The application is 
also used by enrolled suppliers when they are reporting a change in 
their ownership, a change in their current Medicare enrollment 
information, or are revalidating or reactivating their Medicare 
enrollment. Form Number: CMS-855B (OMB control number: 0938-1377); 
Frequency: Occasionally; Affected Public: Private Sector; Business or 
other for-profits, and Not-for Profits; Number of Respondents: 132,800; 
Number of Responses: 132,800; Total Annual Hours: 155,884. (For 
questions regarding this collection, contact Frank Whalen at 410-786-
1302 or <a href="/cdn-cgi/l/email-protection#e3a591828d88cdb48b868f828da3808e90cd8b8b90cd848c95"><span class="__cf_email__" data-cfemail="3f794d5e51541168575a535e517f5c524c1157574c11585049">[email protected]</span></a>.)
    1. Type of Information Collection Request: Reinstatement with 
change of a previously approved collection; Title of Information 
Collection: Hospital Conditions of Participation (CoPs) and Supporting 
Regulations; Use: The purpose of this package is to request from the 
Office of Management and Budget (OMB) approval of the

[[Page 83016]]

reinstatement with change of the information collection request 
associated with OMB control number: 0938-0328.
    The information collection requirements described herein are needed 
to implement the Medicare and Medicaid Conditions of Participation 
(CoPs) for a total of 5,132 facilities that includes: 4,994 accredited 
and non-accredited hospitals and 138 Critical Access Hospitals (CAHs) 
with Distinct Part Units (DPUs); specifically, 119 CAHs with 
psychiatric DPUs and 19 CAHs with rehabilitation DPUs. The information 
collection requirements for the 1,245 CAHs without DPUs (1,383 total 
CAHs less 138 CAHs with DPUs) are covered under OMB control number: 
0938-1043 (CMS-10239).
    As previous stated, this notice is related to a reinstatement of 
the information collection request that expired on 11/30/2017. The 
previous iteration of this OMB control number 0938-0328 (approved 
November 14, 2014) had a burden of 14,424,655 annual hours. For this 
requested reinstatement, with changes, the adjusted annual hourly 
burden for industry is 3,566,521 hours at an annual cost of 
$310,989,894. The decrease in burden hours is primarily due to the fact 
that many of the information collections that were previously required 
as CoPs by CMS are now customary and usual industry practice and would 
take place in the absence of the Medicare and Medicaid programs. In 
addition, where possible, CMS reduced the burden of CoPs with prior 
information collections. For example, the burden for individual 
hospitals that are part of a multi-hospital system was reduced by 
allowing a multi-hospital system, which represent approximately 70% of 
hospitals today, to develop a unified Quality Assessment and 
Performance Improvement (QAPI) program rather than requiring each 
hospital in the system to maintain separate programs and reporting 
requirements.
    This reinstatement also reflects a change in how the annual burden 
costs for information collection requirements for Hospital CoPs are 
calculated. In prior submissions, the fully loaded wage estimates 
applied only an additional 33% to the hourly wage to account for fringe 
benefits. This reinstatement applies an additional 100% to the median 
hourly wage to reflect the costs more accurately to hospitals for 
compliance with the current CoPs.
    Additional changes reflected in this reinstatement are some of the 
information collections were placed on participating hospitals as CoPs 
during the recent COVID-19 Public Health Emergency (PHE), specifically 
regarding collecting and reporting data on incidents and hospital 
management of infection diseases. The burden of many of these 
information collections were accounted for in other OMB submissions, 
such as the ``Unified Hospital Data Surveillance System (U.S. 
Healthcare COVID-19 Collection'' (OMB control number 0990-0478), and 
some of these collections ended or were revised after HHS declared the 
end of the COVID-19 PHE in April 2024. As a result, this reinstatement 
does not include information collection requirements that have expired, 
and only includes the annual burden and costs to participating 
hospitals and CAHs with DPUs for information collections that have 
remained as CoPs after the COVID-19 PHE ended. In addition, in 
anticipation of an upcoming final rule titled ``Medicare and Medicaid 
Programs and the Children's Health Insurance Program; Hospital 
Inpatient Prospective Payment Systems for Acute Care Hospitals and the 
Long-Term Care Hospital Prospective Payment System and Policy Changes 
and Fiscal Year 2025 Rates; Quality Programs Requirements; and Other 
Policy Changes,'' this package includes burden estimates for additional 
information collection requirements that CMS is adding as CoPs in the 
interest of public health and ensuring resiliency in the U.S. health 
care system. The aforementioned final rule, CMS-1808-F (RIN 0938-AV34), 
is currently on public display at the Office of the Federal Register 
and scheduled for publication on August 28, 2024.
    Finally, this reinstatement incorporates additional information 
collection requirements associated with a number of new CoPs for 
hospitals and CAHs regarding obstetrical services which are outlined in 
detail in the July 2024 proposed rule titled ``Medicare and Medicaid 
Programs: Hospital Outpatient Prospective Payment and Ambulatory 
Surgical Center Payment Systems; Quality Reporting Programs, Including 
the Hospital Inpatient Quality Reporting Program; Health and Safety 
Standards for Obstetrical Services in Hospitals and Critical Access 
Hospitals; Prior Authorization; Requests for Information; Medicaid and 
CHIP Continuous Eligibility; Medicaid Clinic Services Four Walls 
Exceptions; Individuals Currently or Formerly in Custody of Penal 
Authorities; Revision to Medicare Special Enrollment Period for 
Formerly Incarcerated Individuals; and All-Inclusive Rate Add-On 
Payment for High-Cost Drugs Provided by Indian Health Service and 
Tribal Facilities'' (89 FR 59186). Form Number: CMS-R-48 (OMB control 
number: 0938-0328); Frequency: Yearly; Affected Public: Private Sector 
(Business or other for-profit); Number of Respondents: 4,664; Total 
Annual Responses: 2,647,647; Total Annual Hours: 3,566,521 (For policy 
questions regarding this collection contact Claudia Molinar at 410-786-
8445).
    3. Type of Information Collection Request: Reinstatement with 
change of a previously approved collection; Title of Information 
Collection: Conditions of Participation for Critical Access Hospitals 
(CAH) and Supporting Regulations; Use: The purpose of this package is 
to request from the Office of Management and Budget (OMB) the approval 
to reinstate, with changes, the information collection request, 
associated with OMB Control Number 0938-1043, titled ``Critical Access 
Hospital (CAH) Conditions of Participation (CoPs) and Supporting 
Regulations.''
    Sections 1820 and 1861(mm) of the Social Security Act provide that 
CAHs participating Medicare meet certain specified requirements. The 
regulations containing the information collection requirements are 
located at 42 CFR part 485, subpart F. These regulations implement 
sections 1102, 1138, 1814(a)(8), 1820(a-f), 1861(mm), 1864, and 1871 of 
the Act.
    This is a reinstatement of the information collection request that 
expired on March 31, 2024. The previous iteration of this OMB No. 0938-
1043 (approved March 25, 2021) had a burden of 33,905 annual hours. For 
this requested reinstatement, with changes, the estimated total annual 
burden hours for the industry is 898,332 hours and the estimated annual 
burden costs are $74,020,673.
    The increase in burden hours from the prior package is primarily 
due to new information collections associated with new CoPs for CAHs 
outlined in the two CMS rules referenced below. The new CoPs include 
multiple information collection requirements that are one-time burdens 
for developing new policies and protocols and ongoing reporting 
requirements, such as daily or biweekly reporting of respiratory 
illnesses as well as maternal deaths. The reasons for the increased 
information collections are discussed in more detail in the rules and 
are summarized in the information collection request.
    (1) Obstetrical services included in the proposed rule, Medicare 
and Medicaid Programs: Hospital Outpatient Prospective Payment and 
Ambulatory Surgical Center Payment Systems; Quality Reporting Programs, 
Including

[[Page 83017]]

the Hospital Inpatient Quality Reporting Program; Health and Safety 
Standards for Obstetrical Services in Hospitals and Critical Access 
Hospitals; Prior Authorization; Requests for Information; Medicaid and 
CHIP Continuous Eligibility; Medicaid Clinic Services Four Walls 
Exceptions; Individuals Currently or Formerly in Custody of Penal 
Authorities; Revision to Medicare Special Enrollment Period for 
Formerly Incarcerated Individuals; and All-Inclusive Rate Add-On 
Payment for High-Cost Drugs Provided by Indian Health Service and 
Tribal Facilities, 89 FR 59186 (July 22, 2024) (hereinafter referred to 
as the ``July 2024 Proposed Rule'').
    (2) Reporting of acute respiratory illnesses in the interest of 
public health and ensuring resiliency in the U.S. health care system 
included in the Final rule: Medicare and Medicaid Programs and the 
Children's Health Insurance Program; Hospital Inpatient Prospective 
Payment Systems for Acute Care Hospitals and the Long-Term Care 
Hospital Prospective Payment System and Policy Changes and Fiscal Year 
2025 Rates; Quality Programs Requirements; and Other Policy Changes. 
The aforementioned final rule, CMS-1808-F (RIN 0938-AV34), is currently 
on display at the Office of the Federal Register and scheduled for 
publication on August 28, 2024 (hereinafter referred to as the ``August 
2024 Final Rule'').
    The change in total burden hours is also due to prior information 
collection requests are exempt from the PRA because the requirements 
are customary and usual industry practice and would take place in the 
absence of the Medicare and Medicaid programs. Form Number: CMS-10239 
(OMB control number: 0938-1043); Frequency: Yearly; Affected Public: 
Private Sector (Business or other for-profit); Number of Respondents: 
1,245; Total Annual Responses: 9,145; Total Annual Hours: 898,332 (For 
policy questions regarding this collection contact Claudia Molinar at 
410-786-8445).

William N. Parham, III,
Director, Division of Information Collections and Regulatory Impacts, 
Office of Strategic Operations and Regulatory Affairs.
[FR Doc. 2024-23737 Filed 10-11-24; 8:45 am]
BILLING CODE 4120-01-P


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