Agency Information Collection Activities: Submission for OMB Review; Comment Request, 73858-73859 [2023-23741]
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73858
Federal Register / Vol. 88, No. 207 / Friday, October 27, 2023 / Notices
When commenting, please
reference the applicable form number
(see below) and the OMB control
number (0938–1148). 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: CMS–10398 (#64)/OMB
control number: 0938–1148, 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/PRAListing
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
William N. Parham at (410) 786–4669.
Following
is a summary of the use and burden
associated with the subject information
collection(s). More detailed information
can be found in the collection’s
supporting statement and associated
materials (see ADDRESSES).
ddrumheller on DSK120RN23PROD with NOTICES1
SUPPLEMENTARY INFORMATION:
Generic Information Collection
1. Title of Information Collection:
CHIP State Plan Eligibility; Type of
Information Collection Request:
Revision of a currently approved
collection; Use: This iteration proposes
to revise CHIP State Plan template CS27
to make continuous eligibility
mandatory for separate CHIPs.
Additional revisions would: (1) revise
language in the template to reflect that
CE for children is mandatory, (2)
remove age selection for optional CE
and the drop-down menu for the
number of months for the CE eligibility
period, (3) add assurances for a state
that elects to provide coverage for the
from-conception-to-end-of pregnancy
(FCEP) population (otherwise known as
the ‘‘unborn’’), and (4) change the
authority of continuous eligibility from
section 2105(a)(4)(A) to 2107(e)(1)(K).
Form Number: CMS–10398 (#17) (OMB
control number: 0938–1148); Frequency:
VerDate Sep<11>2014
17:44 Oct 26, 2023
Jkt 262001
Once and on occasion; Affected Public:
State, Local, or Tribal Governments;
Number of Respondents: 56; Total
Annual Responses: 56; Total Annual
Hours: 2,800. For policy questions
regarding this collection contact: Joyce
Jordan at (410) 786–3413.
Dated: October 24, 2023.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2023–23787 Filed 10–26–23; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10393, CMS–
10861 and CMS–10146]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Centers for Medicare &
Medicaid Services, Health and Human
Services (HHS).
ACTION: Notice.
AGENCY:
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 27,
2023.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
SUMMARY:
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
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/PRAListing.
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 previously
approved collection; Title of
Information Collection: Beneficiary and
Family Centered Data Collection; Use:
To ensure the QIOs are effectively
meeting their goals, CMS collects
information about beneficiary
experience receiving support from the
QIOs. This is a request to revise the
information collection. The revisions to
this information collection include the
deletion of the previously approved
Direct Feedback Survey and associated
instructions and the General Feedback
Web Survey and associated instructions.
The information collection uses both
qualitative and quantitative strategies to
ensure CMS and the QIOs understand
beneficiary experiences through all
interactions with the QIO including
initial contact, interim interactions, and
case closure. Information collection
E:\FR\FM\27OCN1.SGM
27OCN1
ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 88, No. 207 / Friday, October 27, 2023 / Notices
instruments are tailored to reflect the
steps in each type of process, as well as
the average time it takes to complete
each process. The information
collection will:
• Allow beneficiaries to directly
provide feedback about the services they
receive under the QIO program;
• Provide quality improvement data
for QIOs to improve the quality of
service delivered to Medicare
beneficiaries; and
• Provide evaluation metrics for CMS
to use in assessing performance of QIO
contractors.
To achieve the above goals,
information collection will include:
Experience Survey: The Experience
Survey will be administered via
telephone and mail to beneficiaries/
representatives after the Quality of Care
(Medical Record Review) complaint/
Immediate Advocacy/appeal case has
been closed. The goal of the Experience
Survey is to assess beneficiary overall
and specific experiences with the BFCC
QIOs. Form Number: CMS–10393 (OMB
control number: 0938–1177); Frequency:
Once; Affected Public: Individuals or
households; Number of Respondents:
9,000; Number of Responses: 9,000;
Total Annual Hours: 2,250. (For policy
questions regarding this collection,
contact Renee Graves-Dorsey at 410–
786–7142.)
2. Type of Information Collection
Request: New collection (Request for a
new OMB control number); Title of
Information Collection: Medicare Health
Outcomes Survey Field Test; Use: CMS
is required to collect and report quality
and performance of Medicare health
plans under provisions of the Social
Security Act. Specifically, Section
1851(d) of the Act (Providing
Information to Promote Informed
Choice) requires CMS to collect data for
MA plan comparison, including data on
enrollee satisfaction and health
outcomes, and report this information
and other plan quality and performance
indicators to Medicare beneficiaries
prior to the annual enrollment period.
The HOS meets the requirement for
collecting and publicly reporting quality
and other performance indicators, as
HOS survey measures are incorporated
into the Medicare Part C Star Ratings
that are published each fall for
consumers on the Medicare website.
This request is to conduct a field test
with the goal of evaluating the
measurement properties of new survey
items, and the effects of new content
and a web-based mode on response
patterns and measure scores as
compared to existing HOS survey items
and protocols. Within each of the
proposed field test protocol arms, there
VerDate Sep<11>2014
17:44 Oct 26, 2023
Jkt 262001
will be two versions of the
questionnaire (see Attachments A and
B) that will be identical except for slight
differences in selected items where
empirical data are needed to ascertain
which of the two versions produces the
best results (see Attachment C). The two
versions of the questionnaire will test
alternatives for selected new survey
content that will potentially enhance
and refine existing measures, allow
CMS to develop new and
methodologically simpler crosssectional and longitudinal measures,
expand on CMS’s measurement of
physical functioning and mental health,
and add to CMS’s efforts to measure and
address health equity.
The data collected in this field test
will be used by CMS to inform decisions
on possible changes to HOS content and
survey administration procedures. The
items in the questionnaire reflect
current health priorities and would
provide CMS with data to study new
longitudinal PROMs, cross-sectional
measures, and enhancements to existing
HOS measures for MA plans to use as
a focus of their quality improvement
efforts. Potential new measures derived
from new HOS items will go through the
Measures Under Consideration (MUC)
process and rule-making before they are
added to Star Ratings. Form Number:
CMS–10861 (OMB Control Number:
0938–New); Frequency: Once; Affected
Public: Individuals and Households;
Number of Respondents: 136; Number
of Responses: 6,800; Total Annual
Hours: 2,267. (For policy questions
regarding this collection contact
Kimberly DeMichele at 410–786–4286.)
3. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Notice of Denial
of Medicare Prescription Drug Coverage;
Use: Part D plan sponsors are required
to issue the Notice of Denial of Medicare
Prescription Drug Coverage notice when
a request for a prescription drug or
payment is denied, in whole or in part.
The written notice must include a
statement, in understandable language,
the reasons for the denial and a
description of the appeals process.
The purpose of this notice is to
provide information to enrollees when
prescription drug coverage has been
denied, in whole or in part, by their Part
D plans. The notice must be readable,
understandable, and state the specific
reasons for the denial. The notice must
also remind enrollees about their rights
and protections related to requests for
prescription drug coverage and include
an explanation of both the standard and
expedited redetermination processes
and the rest of the appeal process. Form
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
73859
Number: CMS–10146 (OMB control
number 0938–0976); Frequency: Daily;
Affected Public: Private sector (Business
or other for-profits); Number of
Respondents: 743; Total Annual
Responses: 2,631,728; Total Annual
Hours: 657,932. (For policy questions
regarding this collection contact: Coretta
Edmondson at 410–786–0512.)
Dated: October 24, 2023.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2023–23741 Filed 10–26–23; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Registration Requirements in the 340B
Drug Pricing Program
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS or
Department).
ACTION: Notice.
AGENCY:
HRSA is issuing this Notice to
inform and remind stakeholders of the
registration requirements for off-site,
outpatient hospital facilities to
participate in the 340B Drug Pricing
Program (340B Program). This Notice
applies to all hospital types that
participate in the 340B Program.
FOR FURTHER INFORMATION CONTACT:
Questions should be directed to
Michelle Herzog, Deputy Director,
Office of Pharmacy Affairs, Office of
Special Health Initiatives, HRSA, 5600
Fishers Lane, Room 8W12, Rockville,
MD 20857, or by telephone at 301–594–
4353.
SUPPLEMENTARY INFORMATION: Section
340B(a)(4) of the Public Health Service
Act (PHS) Act (42 U.S.C. 256b) lists the
various types of organizations (‘‘covered
entities’’) eligible to participate in and
benefit from the 340B Program. Section
340B(d)(2)(B)(i and ii) of the PHS Act
requires the development of a system by
which covered entities can attest to, and
HRSA can verify, continued accuracy of
information in the 340B database and
compliance with 340B Program
requirements. Section 340B(a)(9) of the
PHS Act requires the Secretary to notify
participating manufacturers of the
identity of those organizations that meet
the definition of covered entity under
340B(a)(4). Section 340B(d)(2)(B)(iv) of
the PHS Act includes requirements for
the establishment of a standardized
SUMMARY:
E:\FR\FM\27OCN1.SGM
27OCN1
]]>Agencies
[Federal Register Volume 88, Number 207 (Friday, October 27, 2023)]
[Notices]
[Pages 73858-73859]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-23741]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-10393, CMS-10861 and CMS-10146]
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 November 27, 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 previously
approved collection; Title of Information Collection: Beneficiary and
Family Centered Data Collection; Use: To ensure the QIOs are
effectively meeting their goals, CMS collects information about
beneficiary experience receiving support from the QIOs. This is a
request to revise the information collection. The revisions to this
information collection include the deletion of the previously approved
Direct Feedback Survey and associated instructions and the General
Feedback Web Survey and associated instructions. The information
collection uses both qualitative and quantitative strategies to ensure
CMS and the QIOs understand beneficiary experiences through all
interactions with the QIO including initial contact, interim
interactions, and case closure. Information collection
[[Page 73859]]
instruments are tailored to reflect the steps in each type of process,
as well as the average time it takes to complete each process. The
information collection will:
Allow beneficiaries to directly provide feedback about the
services they receive under the QIO program;
Provide quality improvement data for QIOs to improve the
quality of service delivered to Medicare beneficiaries; and
Provide evaluation metrics for CMS to use in assessing
performance of QIO contractors.
To achieve the above goals, information collection will include:
Experience Survey: The Experience Survey will be administered via
telephone and mail to beneficiaries/representatives after the Quality
of Care (Medical Record Review) complaint/Immediate Advocacy/appeal
case has been closed. The goal of the Experience Survey is to assess
beneficiary overall and specific experiences with the BFCC QIOs. Form
Number: CMS-10393 (OMB control number: 0938-1177); Frequency: Once;
Affected Public: Individuals or households; Number of Respondents:
9,000; Number of Responses: 9,000; Total Annual Hours: 2,250. (For
policy questions regarding this collection, contact Renee Graves-Dorsey
at 410-786-7142.)
2. Type of Information Collection Request: New collection (Request
for a new OMB control number); Title of Information Collection:
Medicare Health Outcomes Survey Field Test; Use: CMS is required to
collect and report quality and performance of Medicare health plans
under provisions of the Social Security Act. Specifically, Section
1851(d) of the Act (Providing Information to Promote Informed Choice)
requires CMS to collect data for MA plan comparison, including data on
enrollee satisfaction and health outcomes, and report this information
and other plan quality and performance indicators to Medicare
beneficiaries prior to the annual enrollment period. The HOS meets the
requirement for collecting and publicly reporting quality and other
performance indicators, as HOS survey measures are incorporated into
the Medicare Part C Star Ratings that are published each fall for
consumers on the Medicare website.
This request is to conduct a field test with the goal of evaluating
the measurement properties of new survey items, and the effects of new
content and a web-based mode on response patterns and measure scores as
compared to existing HOS survey items and protocols. Within each of the
proposed field test protocol arms, there will be two versions of the
questionnaire (see Attachments A and B) that will be identical except
for slight differences in selected items where empirical data are
needed to ascertain which of the two versions produces the best results
(see Attachment C). The two versions of the questionnaire will test
alternatives for selected new survey content that will potentially
enhance and refine existing measures, allow CMS to develop new and
methodologically simpler cross-sectional and longitudinal measures,
expand on CMS's measurement of physical functioning and mental health,
and add to CMS's efforts to measure and address health equity.
The data collected in this field test will be used by CMS to inform
decisions on possible changes to HOS content and survey administration
procedures. The items in the questionnaire reflect current health
priorities and would provide CMS with data to study new longitudinal
PROMs, cross-sectional measures, and enhancements to existing HOS
measures for MA plans to use as a focus of their quality improvement
efforts. Potential new measures derived from new HOS items will go
through the Measures Under Consideration (MUC) process and rule-making
before they are added to Star Ratings. Form Number: CMS-10861 (OMB
Control Number: 0938-New); Frequency: Once; Affected Public:
Individuals and Households; Number of Respondents: 136; Number of
Responses: 6,800; Total Annual Hours: 2,267. (For policy questions
regarding this collection contact Kimberly DeMichele at 410-786-4286.)
3. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Notice of Denial
of Medicare Prescription Drug Coverage; Use: Part D plan sponsors are
required to issue the Notice of Denial of Medicare Prescription Drug
Coverage notice when a request for a prescription drug or payment is
denied, in whole or in part. The written notice must include a
statement, in understandable language, the reasons for the denial and a
description of the appeals process.
The purpose of this notice is to provide information to enrollees
when prescription drug coverage has been denied, in whole or in part,
by their Part D plans. The notice must be readable, understandable, and
state the specific reasons for the denial. The notice must also remind
enrollees about their rights and protections related to requests for
prescription drug coverage and include an explanation of both the
standard and expedited redetermination processes and the rest of the
appeal process. Form Number: CMS-10146 (OMB control number 0938-0976);
Frequency: Daily; Affected Public: Private sector (Business or other
for-profits); Number of Respondents: 743; Total Annual Responses:
2,631,728; Total Annual Hours: 657,932. (For policy questions regarding
this collection contact: Coretta Edmondson at 410-786-0512.)
Dated: October 24, 2023.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2023-23741 Filed 10-26-23; 8:45 am]
BILLING CODE 4120-01-P
