[Federal Register Volume 88, Number 184 (Monday, September 25, 2023)]
[Notices]
[Pages 65689-65691]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-20739]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-R-26, CMS-R-185, CMS-116, CMS-2746 and CMS-
10261]


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 October 25, 2023.

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: Revision of a currently 
approved collection; Title of Information Collection: Clinical 
Laboratory Improvement Amendments (CLIA) Regulations; Use: The 
information is necessary to determine an entity's compliance with the 
Congressionally-mandated program with respect to the regulation of

[[Page 65690]]

laboratory testing (CLIA). In addition, laboratories participating in 
the Medicare program must comply with CLIA requirements as required by 
section 6141 of OBRA 89. Medicaid, under the authority of section 
1902(a)(9)(C) of the Social Security Act, pays for services furnished 
only by laboratories that meet Medicare (CLIA) requirements.
    This is a revision of the information collection. Based on the 
notice of proposed rulemaking, published in the Federal Register on 
July 26, 2022 (87 FR 44896), we are revising the information collection 
request by adding sections. The additional requirements include 
sections 493.1278, 493.1359, 493.1405-1411; 493.1423, 493.1443-1445, 
493.1461-1463; 493.1483; 493.1489-1491. These sections include 
histocompatibility (493.1278) and personnel (493.1359, 493.1405-1411; 
493.1423, 493.1443-1445, 493.1461-1463; 493.1483; 493.1489-1491) 
require laboratories to revise and update policies and procedures 
applicable to new or amended requirements. Form Number: CMS-R-26 (OMB 
Control Number: 0938-0612); Frequency: Monthly, occasionally; Affected 
Public: Business or other for-profits and Not-for-profit institutions, 
State, Local or Tribal Governments, and the Federal government; Number 
of Respondents: 49,626; Total Annual Responses: 88,259,802; Total 
Annual Hours: 14,514,802. (For policy questions regarding this 
collection contact Jelani Sanaa at 410-786-1139).
    2. Type of Information Collection Request: Revision of currently 
approved collection; Title of Information Collection: Granting and 
Withdrawal of Deeming Authority to Private Nonprofit Accreditation 
Organizations and CLIA Exemption Under State Laboratory Programs; Use: 
The information required is necessary to determine whether a private 
accreditation organization/State licensure program standards and 
accreditation/licensure process is at least equal to or more stringent 
than those of the Clinical Laboratory Improvement Amendments of 1988 
(CLIA). If an accreditation organization is approved, the laboratories 
that it accredits are ``deemed'' to meet the CLIA requirements based on 
this accreditation. Similarly, if a State licensure program is 
determined to have requirements that are equal to or more stringent 
than those of CLIA, its laboratories are considered to be exempt from 
CLIA certification and requirements. The information collected will be 
used by HHS to: determine comparability/equivalency of the 
accreditation organization standards and policies or State licensure 
program standards and policies to those of the CLIA program; to ensure 
the continued comparability/equivalency of the standards; and to 
fulfill certain statutory reporting requirements.
    We are revising the information collection request by adding and 
amending collection requirements for 493.553-557. The proposed rule 
published in the Federal Register on July 26, 2022 (87 FR 44896). These 
require laboratories to revise and update policies and procedures 
applicable to new or amended requirements. Form Number: CMS-R-185 (OMB 
control number: 0938-0686); Frequency: Occasionally; Affected Public: 
Private Sector--Business or other for-profits and Not-for-profit 
institutions; Number of Respondents: 9; Total Annual Responses: 9; 
Total Annual Hours: 5,359. (For policy questions regarding this 
collection contact Arlene Lopez at 410-786-6782.)
    3. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Clinical 
Laboratory Improvement Amendments (CLIA) Application Form and 
Supporting Regulations; Use: Section 353 (b) of the Public Health 
Service Act specifies that the laboratory must submit an application in 
such form and manner as the Secretary shall prescribe that describes 
the characteristics of the laboratory and examinations and procedures 
performed by the laboratory. The application must be completed by 
entities performing laboratory's testing specimens for diagnostic or 
treatment purposes. This information is vital to the certification 
process. In this revision, the majority of changes were minor changes 
to the form and accompanying instructions to facilitate the completion 
and data entry of the form. We anticipate that the changes will not 
increase the time to complete the form. Form Number: CMS-116 (OMB 
control number: 0938-0581); Frequency: Biennially and Occasionally; 
Affected Public: Private Sector--Business or other for-profits and Not-
for-profit institutions; Number of Respondents: 64,598; Total Annual 
Responses: 64,598; Total Annual Hours: 64,598. (For policy questions 
regarding this collection contact Kimberly Weaver at 410-786-3366.)
    4. Type of Information Collection Request: Reinstatement of a 
previously approved collection; Title of Information Collection: End 
Stage Renal Disease Death Notification; Use: The ESRD Death 
Notification form (CMS-2746) is completed by all Medicare-approved ESRD 
facilities upon death of an ESRD patient. Its primary purpose is to 
collect fact of death and cause of death of ESRD patients. The ESRD 
Program Management and Medical Information System (PMMIS) has the 
responsibility of collecting, maintaining, and disseminating, on a 
national basis, uniform data pertaining to ESRD patients and their 
treatment of care. All renal facilities approved to participate in the 
ESRD program are required by Public Law 95-292 to supply data to this 
system.
    Federal regulations require that the ESRD Networks examine the 
mortality rates of every Medicare-approved facility within its area of 
responsibility. CMS-2746 provides the necessary data to assist the ESRD 
Networks in making decisions that result in improved patient care and 
in cost-effective distribution of ESRD resources. The data is used by 
the ESRD Networks to verify facility deaths and to monitor facility 
performance. The form is also used by health care planning agencies and 
researchers to determine survival rates by diagnoses. This request is 
to revise the form to better align with the common verbiage used on 
standardized forms, by other Federal agencies, including the Census 
Bureau. Form Number: CMS-2746 (OMB control number: 0938-0448); 
Frequency: Yearly; Affected Public: Private Sector (Business or other 
for-profits, Not-for-Profit Institutions); Number of Respondents: 
7,726; Total Annual Responses: 101,491; Total Annual Hours: 50,746. 
(For policy questions regarding this collection contact Christina 
Goatee at 410-786-6689.)
    5. Type of Information Collection Request: Revision of currently 
approved collection; Title of Information Collection: Part C Medicare 
Advantage Reporting Requirements; Use: The Centers for Medicare and 
Medicaid Services (CMS) established reporting requirements for Medicare 
Advantage Organizations (MAOs) under the authority described in 42 CFR 
422.516(a). Each MAO must have an effective procedure to develop, 
compile, evaluate, and report to CMS, its enrollees, and the public at 
the times and in the manner that CMS requires.
    These Part C Reporting Requirements will provide key data to CMS on 
the utilization and cost of these benefits that has not been available 
since the removal of benefit utilization requirements in 2011. This 
proposed collection will also build upon the previous collection-by 
asking for information regarding all unique supplemental benefits 
categories. These categories match the current Plan Benefit Package 
(PBP)

[[Page 65691]]

which is submitted annually by plans. Additionally, the proposed 
collection will request information to be split out by the authority 
under which each plan offers the benefits (mandatory, optional, 
mandatory-SSBCI, mandatory-Uniformity Flexibility). Form Number: CMS-
10261 (OMB control number: 0938-1054); Frequency: Annually; Affected 
Public: Business or other for-profits; Number of Respondents: 743; 
Total Annual Responses: 6,687; Total Annual Hours: 187,979. (For policy 
questions regarding this collection contact Lucia Patrone at (410) 786-
8621).

    Dated: September 20, 2023.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2023-20739 Filed 9-22-23; 8:45 am]
BILLING CODE 4120-01-P