Agency Information Collection Activities: Submission for OMB Review; Comment Request, 23429-23431 [2023-08069]
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Federal Register / Vol. 88, No. 73 / Monday, April 17, 2023 / Notices
You may submit comments
by mail to: Rashaun Roberts, National
Institute for Occupational Safety and
Health, Centers for Disease Control and
Prevention, 1090 Tusculum Avenue,
Mailstop C–24, Cincinnati, Ohio 45226.
Meeting Information: Audio
Conference Call via FTS Conferencing.
The USA toll-free dial-in number is 1–
866–659–0537; the pass code is
9933701.
FOR FURTHER INFORMATION CONTACT:
Rashaun Roberts, Ph.D., Designated
Federal Officer, National Institute for
Occupational Safety and Health, Centers
for Disease Control and Prevention,
1090 Tusculum Avenue, Mailstop C–24,
Cincinnati, Ohio 45226. Telephone
(513) 533–6800; Email ocas@cdc.gov.
SUPPLEMENTARY INFORMATION:
Background: The Advisory Board was
established under the Energy Employees
Occupational Illness Compensation
Program Act of 2000 to advise the
President on a variety of policy and
technical functions required to
implement and effectively manage the
new compensation program. Key
functions of the Advisory Board include
providing advice on the development of
probability of causation guidelines
which have been promulgated by the
Department of Health and Human
Services (HHS) as a final rule, advice on
methods of dose reconstruction which
have also been promulgated by HHS as
a final rule, advice on the scientific
validity and quality of dose estimation
and reconstruction efforts being
performed for purposes of the
compensation program, and advice on
petitions to add classes of workers to the
Special Exposure Cohort (SEC). In
December 2000, the President delegated
responsibility for funding, staffing, and
operating the Advisory Board to HHS,
which subsequently delegated this
authority to the CDC. NIOSH
implements this responsibility for CDC.
The charter was issued on August 3,
2001, renewed at appropriate intervals,
and rechartered under Executive Order
13889 on March 22, 2022, and will
terminate on March 22, 2024.
Purpose: This Advisory Board is
charged with (a) providing advice to the
Secretary, HHS, on the development of
guidelines under Executive Order
13179; (b) providing advice to the
Secretary, HHS, on the scientific
validity and quality of dose
reconstruction efforts performed for this
program; and (c) upon request by the
Secretary, HHS, advising the Secretary
on whether there is a class of employees
at any Department of Energy facility
who were exposed to radiation but for
whom it is not feasible to estimate their
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radiation dose, and on whether there is
reasonable likelihood that such
radiation doses may have endangered
the health of members of this class.
Matters To Be Considered: The agenda
will include discussions on the
following: Work Group and
Subcommittee Reports; Update on the
Status of SEC Petitions; and plans for
the August 2023 Advisory Board
Meeting. Agenda items are subject to
change as priorities dictate. For
additional information, please contact
toll free 1 (800) 232–4636.
The Director, Strategic Business
Initiatives Unit, Office of the Chief
Operating Officer, Centers for Disease
Control and Prevention, has been
delegated the authority to sign Federal
Register notices pertaining to
announcements of meetings and other
committee management activities, for
both the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Kalwant Smagh,
Director, Strategic Business Initiatives Unit,
Office of the Chief Operating Officer, Centers
for Disease Control and Prevention.
[FR Doc. 2023–08003 Filed 4–14–23; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifiers: CMS–10110, CMS–
10537, CMS–10344 and CMS–10527]
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
SUMMARY:
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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.
Comments on the collection(s) of
information must be received by the
OMB desk officer by May 17, 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/PRAListing.
DATES:
FOR FURTHER INFORMATION CONTACT:
William Parham at (410) 786–4669.
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: Manufacturer
Submission of Average Sales Price
(ASP) Data for Medicare Part B Drugs
and Biologicals; Use: Section 401 of
SUPPLEMENTARY INFORMATION:
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23430
Federal Register / Vol. 88, No. 73 / Monday, April 17, 2023 / Notices
Division CC of Title IV of the
Consolidated Appropriations Act
(CAA), 2021 amended section 1847A of
the Social Security Act (the Act) to add
new section 1847A(f)(2) of the Act,
which requires manufacturers without a
Medicaid drug rebate agreement to
report average sales price (ASP)
information to CMS for calendar
quarters beginning on January 1, 2022,
for drugs or biologicals payable under
Medicare Part B and described in
sections 1842(o)(1)(C), (E), or (G) or
1881(b)(14)(B) of the Act, including
items, services, supplies, and products
that are payable under Part B as a drug
or biological. The reported ASP data are
used to establish the Medicare payment
amounts. Form Number: CMS–10110
(OMB control number: 0938–0921);
Frequency: Quarterly; Affected Public:
Private sector, Business or other forprofit; Number of Respondents: 500;
Total Annual Responses: 2,000; Total
Annual Hours: 26,000. (For policy
questions regarding this collection
contact Felicia Brown at 410–786–9287)
2. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: CAHPS Hospice
Survey; Use: CMS is required to collect
and publicly report information on the
quality of services provided by hospices
under provisions in the Social Security
Act. Specifically, sections 1814(i)(5)(A)
through (C) of the Act, as added by
section 3132(a) of the Patient Protection
and Affordable Care Act (PPACA) (Pub.
L. 111–148), required hospices to begin
submitting quality data, based on
measures specified by the Secretary of
the Department of Health and Human
Services (the Secretary) for FY 2014 and
subsequent FYs.
The goal of the survey is to measure
the experiences of patients and their
caregivers with hospice care. The survey
was developed to:
• Provide a source of information
from which selected measures could be
publicly reported to beneficiaries and
their family members as a decision aid
for selection of a hospice program;
• Aid hospices with their internal
quality improvement efforts and
external benchmarking with other
facilities;
• Provide CMS with information for
monitoring the care provided.
Form Number: CMS–10537 (OMB
control number: 0938–1257); Frequency:
Once; Affected Public: Individuals and
Households; Number of Respondents:
1,140,695; Total Annual Responses:
1,140,695; Total Annual Hours: 198,481.
(For policy questions regarding this
collection contact Lauren Fuentes at
410–786 2290 or 443–618–2123.)
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3. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Elimination of
Cost-Sharing for full benefit dualeligible Individuals Receiving Home
and Community-Based Services; Use:
Section 1860 D–14 of the Social
Security Act sets forth requirements for
premium and cost-sharing subsidies for
low-income beneficiaries enrolled in
Medicare Part D. Based on this statute,
42 CFR 423.771, provides guidance
concerning limitations for payments
made by and on behalf of low-income
Medicare beneficiaries who enroll in
Part D plans. 42 CFR 423.771 (b)
establishes requirements for
determining a beneficiary’s eligibility
for full subsidy under the Part D
program. Regulations set forth in
423.780 and 423.782 outline premium
and cost sharing subsidies to which full
subsidy eligible are entitled under the
Part D program
Each month CMS deems individuals
automatically eligible for the full
subsidy, based on data from State
Medicaid Agencies and the Social
Security Administration (SSA). The
SSA sends a monthly file of
Supplementary Security Income-eligible
beneficiaries to CMS. Similarly, the
State Medicaid agencies submit
Medicare Modernization Act files to
CMS that identify full subsidy
beneficiaries. CMS deems the
beneficiaries as having full subsidy and
auto-assigns these beneficiaries to bench
mark Part D plans. Part D plans receive
premium amounts based on the monthly
assessments. Form Number: CMS–10344
(OMB control number 0938–1127);
Frequency: Monthly; Affected Public:
Private Sector (business or other forprofits, not-for-profit institutions);
Number of Respondents: 51; Number of
Responses: 612; Total Annual Hours:
621. (For policy questions regarding this
collection contact Roland Herrera at
410–786–0668).
4. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Annual
Eligibility Redetermination, Product
Discontinuation and Renewal Notices;
Use: Section 1411(f)(1)(B) of the
Affordable Care Act directs the
Secretary of Health and Human Services
(the Secretary) to establish procedures
to redetermine the eligibility of
individuals for premium tax credits on
a periodic basis in appropriate
circumstances. Section 1321(a) of the
Affordable Care Act provides authority
for the Secretary to establish standards
and regulations to implement the
statutory requirements related to
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Exchanges, qualified health plans
(QHPs) and other components of title I
of the Affordable Care Act. Under
section 2703 of the Public Health
Service Act (PHS Act), as added by the
Affordable Care Act, and former section
2712 and section 2741 of the PHS Act,
enacted by the Health Insurance
Portability and Accountability Act of
1996, health insurance issuers in the
group and individual markets must
guarantee the renewability of coverage
unless an exception applies.
The 2014 final rule ‘‘Patient
Protection and Affordable Care Act;
Annual Eligibility Redeterminations for
Exchange Participation and Insurance
Affordability Programs; Health
Insurance Issuer Standards Under the
Affordable Care Act, Including
Standards Related to Exchanges’’ (79 FR
52994, September 5, 2014), provides
that an Exchange may choose to conduct
the annual redetermination process for
a plan year (1) in accordance with the
existing procedures described in 45 CFR
155.335; (2) in accordance with
procedures described in guidance
issued by the Secretary for the
applicable benefit year; or (3) using an
alternative procedure proposed by the
Exchange and approved by the
Secretary. The 2014 final rule
established a renewal and reenrollment
hierarchy at 45 CFR 155.335(j) to
minimize potential enrollment
disruptions. The 2016 final rule ‘‘Patient
Protection and Affordable Care Act;
HHS Notice of Benefit and Payment
Parameters for 2017’’ (81 FR 12204,
March 8, 2016) amended the enrollment
hierarchy to further minimize potential
disruptions of enrollee eligibility for
cost-sharing reductions. The final rule
‘‘Patient Protection and Affordable Care
Act, HHS Notice of Benefit and Payment
Parameters for 2024’’ adopted changes
to 45 CFR 155.335(j) to allow the
Exchange, beginning in the 2024 plan
year, to direct re-enrollment for
enrollees who are eligible for costsharing reductions in accordance with
§ 155.305(g) from a bronze QHP to a
silver QHP with a lower or equivalent
premium after advance payments of the
premium tax credit within the same
product and QHP issuer, regardless of
whether their current plan is available
or not, if certain conditions are met
(referred to here as the ‘‘bronze to silver
crosswalk policy’’).
The guidance document ‘‘Guidance
on Annual Eligibility Redetermination
and Re-enrollment for Exchange
Coverage for 2019 and Later Years’’
contains the procedures that the
Secretary specified for the coverage
year, as noted in (2) above, and
specified that these procedures will be
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Federal Register / Vol. 88, No. 73 / Monday, April 17, 2023 / Notices
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used by all Exchanges using the Federal
eligibility and enrollment platform,
unless otherwise specified in future
guidance or rulemaking.
The 2014 final rule also amended the
requirements for product renewal and
re-enrollment (or non-renewal) notices
to be sent by QHP issuers in the
Exchanges and specifies content for
these notices. The guidance document
‘‘Updated Federal Standard Renewal
and Product Discontinuation Notices,
and Enforcement Safe Harbor for
Product Discontinuation Notices in
Connection with the Open Enrollment
Period for Coverage in the Individual
Market in the 2020 Benefit Year’’
provides standard notices for product
discontinuation and renewal to be sent
by issuers of individual market QHPs
and issuers in the individual market.
The Federal standard notices to be
sent by issuers of individual market
QHPs and issuers in the individual
market have been revised to improve
consumer understanding and update
out-of-date information, and to include
language to reference the potential for a
bronze to silver crosswalk under 45 CFR
155.335(j)(4). The revised notices in this
information collection will be required
for notices provided in connection with
coverage beginning in the 2024 plan
year.
Issuers in the small group market may
use the draft Federal standard small
group notices released in the June 26,
2014 bulletin ‘‘Draft Standard Notices
When Discontinuing or Renewing a
Product in the Small Group or
Individual Market’’, or any forms of the
notice otherwise permitted by
applicable laws and regulations. States
that are enforcing the guaranteed
renewability provisions of the
Affordable Care Act may develop their
own standard notices for product
discontinuances, renewals, or both,
provided the state-developed notices are
at least as protective as the Federal
standard notices. Form Number: CMS–
10527 (OMB Control Number 0938–
1254); Frequency: Annually; Affected
Public: Private Sector, State
Governments; Number of Respondents:
1,340; Total Annual Responses: 5,881;
Total Annual Hours: 72,147. (For policy
questions regarding this collection
contact Russell Tipps at 301–492–4371.)
ACTION:
Centers for Medicare & Medicaid
Services
SUMMARY:
Medicaid and Children’s Health
Insurance Program (CHIP) Generic
Information Collection Activities:
Proposed Collection; Comment
Request; Correction
Centers for Medicare &
Medicaid Services, Health and Human
Services (HHS).
ACTION: Notice; correction.
AGENCY:
On April 10, 2023, we
published a collection of information
notice in the Federal Register
concerning our revised Managed Care
Rate Setting Guidance. The notice
included an incorrect web address for
obtaining copies of the supporting
statement, the revised guide, and
supporting documents.
SUPPLEMENTARY INFORMATION:
SUMMARY:
Correction
In the Federal Register of April 10,
2023, in FR Doc. 2023–07473, on page
21191, in the third column, correct the
fourth paragraph under the ADDRESSES
caption to read as follows:
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.
Dated: April 12, 2023.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2023–08062 Filed 4–14–23; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–N–2480]
Dated: April 12, 2023.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
Rare Disease Endpoint Advancement
Pilot Program Workshop: Novel
Endpoints for Rare Disease Drug
Development; Public Workshop;
Request for Comments
[FR Doc. 2023–08069 Filed 4–14–23; 8:45 am]
AGENCY:
BILLING CODE 4120–01–P
HHS.
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Notice of public workshop;
request for comments.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: CMS–10398 #37]
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Food and Drug Administration,
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23431
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing a public workshop
entitled ‘‘Rare Disease Endpoint
Advancement Pilot Program Workshop:
Novel Endpoints for Rare Disease Drug
Development.’’ Convened by the DukeRobert J. Margolis, MD Center for Health
Policy (Duke-Margolis) and supported
by a cooperative agreement between
FDA and Duke-Margolis, the workshop
will include discussions of the Rare
Disease Endpoint Advancement (RDEA)
Pilot Program and novel endpoint
development for rare disease drug
development.
The public workshop will be
held virtually on June 7, 2023, and June
8, 2023, from 1 p.m. to 5 p.m., Eastern
Time. Either electronic or written
comments on this public workshop
must be submitted by July 23, 2023. See
the SUPPLEMENTARY INFORMATION section
for registration date and information.
ADDRESSES: The public workshop will
be held virtually using the Zoom
platform. The link for the public
workshop will be sent to registrants
upon registration.
You may submit comments as
follows. Please note that late, untimely
filed comments will not be considered.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
on July 23, 2023. Comments received by
mail/hand delivery/courier (for written/
paper submissions) will be considered
timely if they are received on or before
that date.
DATES:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
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]]>Agencies
[Federal Register Volume 88, Number 73 (Monday, April 17, 2023)]
[Notices]
[Pages 23429-23431]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-08069]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifiers: CMS-10110, CMS-10537, CMS-10344 and CMS-10527]
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 May 17, 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: Manufacturer
Submission of Average Sales Price (ASP) Data for Medicare Part B Drugs
and Biologicals; Use: Section 401 of
[[Page 23430]]
Division CC of Title IV of the Consolidated Appropriations Act (CAA),
2021 amended section 1847A of the Social Security Act (the Act) to add
new section 1847A(f)(2) of the Act, which requires manufacturers
without a Medicaid drug rebate agreement to report average sales price
(ASP) information to CMS for calendar quarters beginning on January 1,
2022, for drugs or biologicals payable under Medicare Part B and
described in sections 1842(o)(1)(C), (E), or (G) or 1881(b)(14)(B) of
the Act, including items, services, supplies, and products that are
payable under Part B as a drug or biological. The reported ASP data are
used to establish the Medicare payment amounts. Form Number: CMS-10110
(OMB control number: 0938-0921); Frequency: Quarterly; Affected Public:
Private sector, Business or other for-profit; Number of Respondents:
500; Total Annual Responses: 2,000; Total Annual Hours: 26,000. (For
policy questions regarding this collection contact Felicia Brown at
410-786-9287)
2. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: CAHPS Hospice
Survey; Use: CMS is required to collect and publicly report information
on the quality of services provided by hospices under provisions in the
Social Security Act. Specifically, sections 1814(i)(5)(A) through (C)
of the Act, as added by section 3132(a) of the Patient Protection and
Affordable Care Act (PPACA) (Pub. L. 111-148), required hospices to
begin submitting quality data, based on measures specified by the
Secretary of the Department of Health and Human Services (the
Secretary) for FY 2014 and subsequent FYs.
The goal of the survey is to measure the experiences of patients
and their caregivers with hospice care. The survey was developed to:
Provide a source of information from which selected
measures could be publicly reported to beneficiaries and their family
members as a decision aid for selection of a hospice program;
Aid hospices with their internal quality improvement
efforts and external benchmarking with other facilities;
Provide CMS with information for monitoring the care
provided.
Form Number: CMS-10537 (OMB control number: 0938-1257); Frequency:
Once; Affected Public: Individuals and Households; Number of
Respondents: 1,140,695; Total Annual Responses: 1,140,695; Total Annual
Hours: 198,481. (For policy questions regarding this collection contact
Lauren Fuentes at 410-786 2290 or 443-618-2123.)
3. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Elimination of
Cost-Sharing for full benefit dual-eligible Individuals Receiving Home
and Community-Based Services; Use: Section 1860 D-14 of the Social
Security Act sets forth requirements for premium and cost-sharing
subsidies for low-income beneficiaries enrolled in Medicare Part D.
Based on this statute, 42 CFR 423.771, provides guidance concerning
limitations for payments made by and on behalf of low-income Medicare
beneficiaries who enroll in Part D plans. 42 CFR 423.771 (b)
establishes requirements for determining a beneficiary's eligibility
for full subsidy under the Part D program. Regulations set forth in
423.780 and 423.782 outline premium and cost sharing subsidies to which
full subsidy eligible are entitled under the Part D program
Each month CMS deems individuals automatically eligible for the
full subsidy, based on data from State Medicaid Agencies and the Social
Security Administration (SSA). The SSA sends a monthly file of
Supplementary Security Income-eligible beneficiaries to CMS. Similarly,
the State Medicaid agencies submit Medicare Modernization Act files to
CMS that identify full subsidy beneficiaries. CMS deems the
beneficiaries as having full subsidy and auto-assigns these
beneficiaries to bench mark Part D plans. Part D plans receive premium
amounts based on the monthly assessments. Form Number: CMS-10344 (OMB
control number 0938-1127); Frequency: Monthly; Affected Public: Private
Sector (business or other for-profits, not-for-profit institutions);
Number of Respondents: 51; Number of Responses: 612; Total Annual
Hours: 621. (For policy questions regarding this collection contact
Roland Herrera at 410-786-0668).
4. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Annual
Eligibility Redetermination, Product Discontinuation and Renewal
Notices; Use: Section 1411(f)(1)(B) of the Affordable Care Act directs
the Secretary of Health and Human Services (the Secretary) to establish
procedures to redetermine the eligibility of individuals for premium
tax credits on a periodic basis in appropriate circumstances. Section
1321(a) of the Affordable Care Act provides authority for the Secretary
to establish standards and regulations to implement the statutory
requirements related to Exchanges, qualified health plans (QHPs) and
other components of title I of the Affordable Care Act. Under section
2703 of the Public Health Service Act (PHS Act), as added by the
Affordable Care Act, and former section 2712 and section 2741 of the
PHS Act, enacted by the Health Insurance Portability and Accountability
Act of 1996, health insurance issuers in the group and individual
markets must guarantee the renewability of coverage unless an exception
applies.
The 2014 final rule ``Patient Protection and Affordable Care Act;
Annual Eligibility Redeterminations for Exchange Participation and
Insurance Affordability Programs; Health Insurance Issuer Standards
Under the Affordable Care Act, Including Standards Related to
Exchanges'' (79 FR 52994, September 5, 2014), provides that an Exchange
may choose to conduct the annual redetermination process for a plan
year (1) in accordance with the existing procedures described in 45 CFR
155.335; (2) in accordance with procedures described in guidance issued
by the Secretary for the applicable benefit year; or (3) using an
alternative procedure proposed by the Exchange and approved by the
Secretary. The 2014 final rule established a renewal and reenrollment
hierarchy at 45 CFR 155.335(j) to minimize potential enrollment
disruptions. The 2016 final rule ``Patient Protection and Affordable
Care Act; HHS Notice of Benefit and Payment Parameters for 2017'' (81
FR 12204, March 8, 2016) amended the enrollment hierarchy to further
minimize potential disruptions of enrollee eligibility for cost-sharing
reductions. The final rule ``Patient Protection and Affordable Care
Act, HHS Notice of Benefit and Payment Parameters for 2024'' adopted
changes to 45 CFR 155.335(j) to allow the Exchange, beginning in the
2024 plan year, to direct re-enrollment for enrollees who are eligible
for cost-sharing reductions in accordance with Sec. 155.305(g) from a
bronze QHP to a silver QHP with a lower or equivalent premium after
advance payments of the premium tax credit within the same product and
QHP issuer, regardless of whether their current plan is available or
not, if certain conditions are met (referred to here as the ``bronze to
silver crosswalk policy'').
The guidance document ``Guidance on Annual Eligibility
Redetermination and Re-enrollment for Exchange Coverage for 2019 and
Later Years'' contains the procedures that the Secretary specified for
the coverage year, as noted in (2) above, and specified that these
procedures will be
[[Page 23431]]
used by all Exchanges using the Federal eligibility and enrollment
platform, unless otherwise specified in future guidance or rulemaking.
The 2014 final rule also amended the requirements for product
renewal and re-enrollment (or non-renewal) notices to be sent by QHP
issuers in the Exchanges and specifies content for these notices. The
guidance document ``Updated Federal Standard Renewal and Product
Discontinuation Notices, and Enforcement Safe Harbor for Product
Discontinuation Notices in Connection with the Open Enrollment Period
for Coverage in the Individual Market in the 2020 Benefit Year''
provides standard notices for product discontinuation and renewal to be
sent by issuers of individual market QHPs and issuers in the individual
market.
The Federal standard notices to be sent by issuers of individual
market QHPs and issuers in the individual market have been revised to
improve consumer understanding and update out-of-date information, and
to include language to reference the potential for a bronze to silver
crosswalk under 45 CFR 155.335(j)(4). The revised notices in this
information collection will be required for notices provided in
connection with coverage beginning in the 2024 plan year.
Issuers in the small group market may use the draft Federal
standard small group notices released in the June 26, 2014 bulletin
``Draft Standard Notices When Discontinuing or Renewing a Product in
the Small Group or Individual Market'', or any forms of the notice
otherwise permitted by applicable laws and regulations. States that are
enforcing the guaranteed renewability provisions of the Affordable Care
Act may develop their own standard notices for product discontinuances,
renewals, or both, provided the state-developed notices are at least as
protective as the Federal standard notices. Form Number: CMS-10527 (OMB
Control Number 0938-1254); Frequency: Annually; Affected Public:
Private Sector, State Governments; Number of Respondents: 1,340; Total
Annual Responses: 5,881; Total Annual Hours: 72,147. (For policy
questions regarding this collection contact Russell Tipps at 301-492-
4371.)
Dated: April 12, 2023.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2023-08069 Filed 4-14-23; 8:45 am]
BILLING CODE 4120-01-P
