Notice2023-20739
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
September 25, 2023
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 184 (Monday, September 25, 2023)</title>
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[Federal Register Volume 88, Number 184 (Monday, September 25, 2023)]
[Notices]
[Pages 65689-65691]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. 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: <a href="https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing">https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing</a>.
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
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</html>Indexed from Federal Register on September 25, 2023.
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