Agency Information Collection Activities: Submission for OMB Review; Comment Request, 34502-34504 [2023-11403]
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34502
ACTION:
Federal Register / Vol. 88, No. 103 / Tuesday, May 30, 2023 / Notices
Contents
Notice.
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 (the
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
60 days for public comment on the
proposed action. Interested persons are
invited to send comments regarding our
burden estimates 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 must be received by
July 31, 2023.
ADDRESSES: When commenting, please
reference the document identifier or
OMB control number. 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: Document Identifier/OMB
Control Number: __, 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.
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
William N. Parham at (410) 786–4669.
SUPPLEMENTARY INFORMATION:
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Jkt 259001
This notice sets out a summary of the
use and burden associated with the
following information collections. More
detailed information can be found in
each collection’s supporting statement
and associated materials (see
ADDRESSES).
CMS–855S Medicare Enrollment
Application—Durable Medical
Equipment, Prosthetics, Orthotics
and Supplies (DMEPOS) Suppliers
Under the 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
requires federal agencies to publish a
60-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.
Information Collection
1. Type of Information Collection
Request: Revision of the currently
approved collection; Title of
Information Collection: Medicare
Enrollment Application—Durable
Medical Equipment, Prosthetics,
Orthotics and Supplies (DMEPOS)
Suppliers; Use: The primary function of
the Form CMS–855S Medicare
enrollment application for suppliers of
durable medical equipment, prosthetics,
orthotics, and supplies (DMEPOS) is to
gather information from the supplier
that tells us who the supplier is,
whether the supplier meets certain
qualifications to be a Medicare DMEPOS
supplier, where the supplier practices or
renders services, and other information
necessary to establish correct claims
payments. Form Number: CMS–855S
(OMB control number: 0938–1056);
Frequency: Yearly; Affected Public:
Private Sector, Business or other forprofits and Not-for-profit institutions;
Number of Respondents: 32,790; Total
Annual Responses: 32,790; Total
Annual Hours: 67,886. (For policy
questions regarding this collection
contact Frank Whelan at 410–786–
1302.)
PO 00000
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Fmt 4703
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Dated: May 24, 2023.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2023–11401 Filed 5–26–23; 8:45 am]
BILLING CODE P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10728, CMS–
10834, CMS–4040, CMS–R–297 and CMS–
2728]
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.
SUMMARY:
Comments on the collection(s) of
information must be received by the
OMB desk officer by June 29, 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.
DATES:
E:\FR\FM\30MYN1.SGM
30MYN1
Federal Register / Vol. 88, No. 103 / Tuesday, May 30, 2023 / Notices
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.
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: Extension of a currently
approved collection; Title of
Information Collection: Value in Opioid
Use Disorder Treatment Demonstration;
Use: Value in Opioid Use Disorder
Treatment (Value in Treatment) is a 4year demonstration program authorized
under section 1866F of the Social
Security Act (Act), which was added by
section 6042 of the Substance UseDisorder Prevention that Promotes
Opioid Recovery and Treatment for
Patients and Communities Act
(SUPPORT Act). The purpose of Value
in Treatment, as stated in the statute, is
to ‘‘increase access of applicable
beneficiaries to opioid use disorder
treatment services, improve physical
and mental health outcomes for such
beneficiaries, and to the extent possible,
reduce Medicare program
expenditures.’’ As required by statute,
Value in Treatment was implemented
January 1, 2021. Section
1866F(c)(1)(A)(ii) specifies that
individuals and entities must apply for
and be selected to participate in the
Value in Treatment demonstration
ddrumheller on DSK120RN23PROD with NOTICES1
SUPPLEMENTARY INFORMATION:
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Jkt 259001
pursuant to an application and selection
process established by the Secretary.
Section 1866F(c)(2)(B)(iii) specifies
that in order to receive CMF and
performance-based incentive payments
under the Value in Treatment program,
each participant shall report data
necessary to: monitor and evaluate the
Value in Treatment program; determine
if criteria are met; and determine the
performance-based incentive payment.
Form Number: CMS–10728 (OMB
control number: 0938–1388); Frequency:
Annually; Affected Public: Individuals
and Households; Number of
Respondents: 388; Total Annual
Responses: 388; Total Annual Hours:
282. (For policy questions regarding this
collection contact Rebecca VanAmburg)
at 410–786–0524.)
2. Type of Information Collection
Request: New collection (Request for a
new OMB control number); Title of
Information Collection: Requirement for
Electronic Prescribing for Controlled
Substances (EPCS) for a Covered Part D
Drug Under a Prescription Drug Plan or
an MA–PD Plan; Use: Section 2003 of
the SUPPORT for Patients and
Communities Act of 2018 requires that
prescribing of a Schedule II, III, IV, and
V controlled substance under Medicare
Part D be done electronically in
accordance with an electronic
prescription drug program beginning
January 1, 2021, subject to any
exceptions, which HHS may specify. In
the calendar year (CY) 2021 and 2022
Physician Fee Schedule (PFS) final
rules, CMS finalized the electronic
prescribing for controlled substances
(EPCS) requirements and exceptions at
42 CFR 423.160(a)(5). Compliance for
prescribers not in long-term care
facilities begins in CY 2023. Compliance
for prescribers in long-term care
facilities begins in CY 2025.
EPCS requirements do not require
prescribers or pharmacies to submit
additional data to CMS; however, CMS
did finalize one exception that requires
data collection. The EPCS exception, at
§ 423.160(a)(5)(iv), requires a prescriber
to apply for a waiver if the prescriber is
unable to conduct EPCS due to
circumstances beyond the prescriber’s
control. This collection of information is
necessary to provide adequate and
timely exception from the EPCS
requirements if the prescriber is unable
to conduct EPCS due to circumstances
beyond the prescriber’s control. Form
Number: CMS–10834 (OMB control
number: 0938–NEW); Frequency:
Annually; Affected Public: Private
Sector (Business or other for-profits,
Not-for-Profit Institutions), and Public
sector (State, Local or Tribal
Governments); Number of Respondents:
PO 00000
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34503
100; Total Annual Responses: 100; Total
Annual Hours: 17. (For policy questions
regarding this collection contact Mei
Zhang at (410) 786–7837).
3. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Request for
Enrollment in Supplementary Medical
Insurance (SMI); Use: CMS regulations
42 CFR 407.11 lists the CMS–4040 as
the application to be used by
individuals who are not eligible for
monthly Social Security/Railroad
Retirement Board benefits or free Part A.
The CMS–4040 solicits the information
that is used to determine entitlement for
individuals who meet the requirements
in section 1836 as well as the
entitlement of the applicant or their
spouses to an annuity paid by OPM for
premium deduction purposes. The
application follows the application
questions and requirements used by
SSA. This is done not only for
consistency purposes but to comply
with other Title II and Title XVIII
requirements because eligibility to Title
II benefits and free Part A under Title
XVIII must be ruled out in order to
qualify for enrollment in Part B only.
Form Number: CMS–4040 (OMB control
number: 0938–0245); Frequency: Once;
Affected Public: Individuals or
households; Number of Respondents:
42,011; Total Annual Responses:
42,011; Total Annual Hours: 10,503.
(For policy questions regarding this
collection contact Carla Patterson at
410–786–8911.)
4. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Request for
Employment Information; Use: The form
CMS–L564, also referred to as CMS–R–
297, is used, in conjunction with form
CMS–40–B, Application for
Supplementary Medical Insurance,
during an individual’s special
enrollment period (SEP). Completed by
an employer, the CMS–L564 provides
proof of an applicant’s employer group
health coverage. The Social Security
Administration (SSA) uses it to obtain
information from employers regarding
whether a Medicare beneficiary’s
coverage under a group health plan is
based on current employment status.
The form is available online via
Medicare.gov and CMS.gov for
individuals who are requesting the SEP
to obtain and submit to their employer
for completion. The employer must
complete and sign the form, and submit
it to the individual to accompany their
enrollment or late enrollment penalty
reduction request. The information on
the completed form is reviewed
E:\FR\FM\30MYN1.SGM
30MYN1
ddrumheller on DSK120RN23PROD with NOTICES1
34504
Federal Register / Vol. 88, No. 103 / Tuesday, May 30, 2023 / Notices
manually by SSA. Form Number: CMS–
R–297 (OMB control number: 0938–
0787); Frequency: Once; Affected
Public: Individuals or households,
Business or other for-profits, Not-forprofit institutions; Number of
Respondents: 676,526; Total Annual
Responses: 676,526; Total Annual
Hours: 56,355. (For policy questions
regarding this collection contact Carla
Patterson at 410–786–8911.)
5. Type of Information Collection
Request: Reinstatement with change of a
previously approved collection; Title of
Information Collection: End Stage Renal
Disease Medical Evidence Report
Medicare Entitlement and/or Patient
Registration; Use: Section 226A (2) of
the Social Security Act specifically
states that a person must be ‘‘medically
determined to have end stage renal
disease. . . .’’ Similarly, Section 188(a)
of the law states ‘‘The benefits provided
by parts A and B of this title shall
include benefits for individuals who
have been determined to have end stage
renal disease as provided in Section
226A’’. The End Stage Renal Disease
(ESRD) Medical Evidence (CMS–2728)
is completed for all ESRD patients either
by the first treatment facility or by a
Medicare-approved ESRD facility when
it is determined by a physician that the
patient’s condition has reached that
stage of renal impairment that a regular
course of kidney dialysis or a kidney
transplant is necessary to maintain life.
The data reported on the CMS–2728
is used by the Federal Government,
ESRD Networks, treatment facilities,
researchers and others to monitor and
assess the quality and type of care
provided to end stage renal disease
beneficiaries. The data collection
captures the specific medical
information required to determine the
Medicare medical eligibility of End
Stage Renal Disease claimants. It also
collects data for research and policy on
this population.
The three main data systems available
for evaluating the ESRD program and for
monitoring epidemiology, access, and
quality and reimbursement effects on
quality are: (1) The United States Renal
Data System (USRDS) provides basic
data on patterns of incidence of ESRD
in the United States. The USRDS
database is intended to be used for
biomedical research by investigators
throughout the United States and
abroad. The USRDS data is intended to
supplement (and not replace) public use
files produced by CMS. (2) United
Network for Organ Sharing (UNOS)
focus is on organ donation,
transplantation and educational
activities. (3) The ESRD Program
Management and Medical System
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17:16 May 26, 2023
Jkt 259001
(PMMIS), maintained by CMS, provide
the foundation data for the USRDS. This
system, as required by Public Law 95–
292, section C(1)(A), is designed to serve
the needs of the Department of Health
and Human Services in support of
program analysis, policy development,
and epidemiological research.
The ESRD PMMIS includes
information on both Medicare and nonMedicare ESRD patients and on
Medicare approved ESRD hospitals and
dialysis facilities. The methods of ESRD
data collection (e.g., use of same forms,
sharing of analysis) by CMS, UNOS, and
USRDS have all agreed on a common
data collection process that will provide
needed additional information on the
ESRD population.
Subsequent to publishing the 60-day
Federal Register notice on December 15,
2022 (87 FR 76625), questions were
added to the form and other were
clarified. Form Number: CMS–2728
(OMB control number: 0938–0046);
Frequency: Yearly; Affected Public:
Private Sector (Business or other forprofits, Not-for-Profit Institutions);
Number of Respondents: 7,828; Total
Annual Responses: 138,000; Total
Annual Hours: 138,000. (For policy
questions regarding this collection
contact Lisa Rees at (816) 426–6353).
Dated: May 24, 2023.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2023–11403 Filed 5–26–23; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review; Child
and Family Services Plan, Annual
Progress and Services Report, and
Annual Budget Expenses Request and
Estimated Expenditures (CFS–101)
(0970–0426)
Children’s Bureau;
Administration for Children and
Families; United States Department of
Health and Human Services.
ACTION: Request for public comment.
AGENCY:
The Administration for
Children and Families (ACF) is
requesting a 3-year extension of the
collection of information under the
Child and Family Services Plan (CFSP),
the Annual Progress and Services
Report (APSR), and the Annual Budget
Expenses Request and Estimated
SUMMARY:
PO 00000
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Fmt 4703
Sfmt 4703
Expenditures (Child and Family
Services (CFS)–101): Office of
Management and Budget (OMB) #0970–
0426, expiration September 30, 2023.
There are minor changes to the CFS–101
form and no changes to the burden
hours.
DATES: Comments due within 30 days of
publication. OMB is required to make a
decision concerning the collection of
information between 30 and 60 days
after publication of this document in the
Federal Register. Therefore, a comment
is best assured of having its full effect
if OMB receives it within 30 days of
publication.
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’’ of by using the
search function. You can also obtain
copies of the proposed collection of
information by emailing infocollection@
acf.hhs.gov. Identify all emailed
requests by the title of the information
collection.
SUPPLEMENTARY INFORMATION:
Description: Under title IV–B,
subparts 1 and 2, of the Social Security
Act (the Act), States, Territories, and
tribes are required to submit a CFSP.
The CFSP lays the groundwork for a
system of coordinated, integrated, and
culturally relevant family services for
the subsequent 5 years (45 CFR
1357.15(a)(1)). The CFSP outlines
initiatives and activities the State, Tribe
or Territory will carry out in
administering programs and services to
promote the safety, permanency, and
well-being of children and families,
including, as applicable, those activities
conducted under the John H. Chafee
Foster Care Program for Successful
Transition to Adulthood (section 477 of
the Act); and the State grant authorized
by the Child Abuse Prevention and
Treatment Act (CAPTA). By June 30 of
each year, States, Territories, and Tribes
are also required to submit an APSR and
a financial report called the CFS–101.
The APSR is a yearly report that
discusses progress made by a State,
Territory or Tribe in accomplishing the
goals and objectives cited in its CFSP
(45 CFR 1357.16(a)). The APSR contains
new and updated information about
service needs and organizational
capacities throughout the 5-year plan
period and includes information on the
use of the Family First Transition Grants
and Funding Certainty Grants
authorized by the Family First
E:\FR\FM\30MYN1.SGM
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Agencies
[Federal Register Volume 88, Number 103 (Tuesday, May 30, 2023)]
[Notices]
[Pages 34502-34504]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-11403]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-10728, CMS-10834, CMS-4040, CMS-R-297 and
CMS-2728]
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 June 29, 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.
[[Page 34503]]
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: Extension of a currently
approved collection; Title of Information Collection: Value in Opioid
Use Disorder Treatment Demonstration; Use: Value in Opioid Use Disorder
Treatment (Value in Treatment) is a 4-year demonstration program
authorized under section 1866F of the Social Security Act (Act), which
was added by section 6042 of the Substance Use-Disorder Prevention that
Promotes Opioid Recovery and Treatment for Patients and Communities Act
(SUPPORT Act). The purpose of Value in Treatment, as stated in the
statute, is to ``increase access of applicable beneficiaries to opioid
use disorder treatment services, improve physical and mental health
outcomes for such beneficiaries, and to the extent possible, reduce
Medicare program expenditures.'' As required by statute, Value in
Treatment was implemented January 1, 2021. Section 1866F(c)(1)(A)(ii)
specifies that individuals and entities must apply for and be selected
to participate in the Value in Treatment demonstration pursuant to an
application and selection process established by the Secretary.
Section 1866F(c)(2)(B)(iii) specifies that in order to receive CMF
and performance-based incentive payments under the Value in Treatment
program, each participant shall report data necessary to: monitor and
evaluate the Value in Treatment program; determine if criteria are met;
and determine the performance-based incentive payment. Form Number:
CMS-10728 (OMB control number: 0938-1388); Frequency: Annually;
Affected Public: Individuals and Households; Number of Respondents:
388; Total Annual Responses: 388; Total Annual Hours: 282. (For policy
questions regarding this collection contact Rebecca VanAmburg) at 410-
786-0524.)
2. Type of Information Collection Request: New collection (Request
for a new OMB control number); Title of Information Collection:
Requirement for Electronic Prescribing for Controlled Substances (EPCS)
for a Covered Part D Drug Under a Prescription Drug Plan or an MA-PD
Plan; Use: Section 2003 of the SUPPORT for Patients and Communities Act
of 2018 requires that prescribing of a Schedule II, III, IV, and V
controlled substance under Medicare Part D be done electronically in
accordance with an electronic prescription drug program beginning
January 1, 2021, subject to any exceptions, which HHS may specify. In
the calendar year (CY) 2021 and 2022 Physician Fee Schedule (PFS) final
rules, CMS finalized the electronic prescribing for controlled
substances (EPCS) requirements and exceptions at 42 CFR 423.160(a)(5).
Compliance for prescribers not in long-term care facilities begins in
CY 2023. Compliance for prescribers in long-term care facilities begins
in CY 2025.
EPCS requirements do not require prescribers or pharmacies to
submit additional data to CMS; however, CMS did finalize one exception
that requires data collection. The EPCS exception, at Sec.
423.160(a)(5)(iv), requires a prescriber to apply for a waiver if the
prescriber is unable to conduct EPCS due to circumstances beyond the
prescriber's control. This collection of information is necessary to
provide adequate and timely exception from the EPCS requirements if the
prescriber is unable to conduct EPCS due to circumstances beyond the
prescriber's control. Form Number: CMS-10834 (OMB control number: 0938-
NEW); Frequency: Annually; Affected Public: Private Sector (Business or
other for-profits, Not-for-Profit Institutions), and Public sector
(State, Local or Tribal Governments); Number of Respondents: 100; Total
Annual Responses: 100; Total Annual Hours: 17. (For policy questions
regarding this collection contact Mei Zhang at (410) 786-7837).
3. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Request for
Enrollment in Supplementary Medical Insurance (SMI); Use: CMS
regulations 42 CFR 407.11 lists the CMS-4040 as the application to be
used by individuals who are not eligible for monthly Social Security/
Railroad Retirement Board benefits or free Part A. The CMS-4040
solicits the information that is used to determine entitlement for
individuals who meet the requirements in section 1836 as well as the
entitlement of the applicant or their spouses to an annuity paid by OPM
for premium deduction purposes. The application follows the application
questions and requirements used by SSA. This is done not only for
consistency purposes but to comply with other Title II and Title XVIII
requirements because eligibility to Title II benefits and free Part A
under Title XVIII must be ruled out in order to qualify for enrollment
in Part B only. Form Number: CMS-4040 (OMB control number: 0938-0245);
Frequency: Once; Affected Public: Individuals or households; Number of
Respondents: 42,011; Total Annual Responses: 42,011; Total Annual
Hours: 10,503. (For policy questions regarding this collection contact
Carla Patterson at 410-786-8911.)
4. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Request for
Employment Information; Use: The form CMS-L564, also referred to as
CMS-R-297, is used, in conjunction with form CMS-40-B, Application for
Supplementary Medical Insurance, during an individual's special
enrollment period (SEP). Completed by an employer, the CMS-L564
provides proof of an applicant's employer group health coverage. The
Social Security Administration (SSA) uses it to obtain information from
employers regarding whether a Medicare beneficiary's coverage under a
group health plan is based on current employment status. The form is
available online via Medicare.gov and CMS.gov for individuals who are
requesting the SEP to obtain and submit to their employer for
completion. The employer must complete and sign the form, and submit it
to the individual to accompany their enrollment or late enrollment
penalty reduction request. The information on the completed form is
reviewed
[[Page 34504]]
manually by SSA. Form Number: CMS-R-297 (OMB control number: 0938-
0787); Frequency: Once; Affected Public: Individuals or households,
Business or other for-profits, Not-for-profit institutions; Number of
Respondents: 676,526; Total Annual Responses: 676,526; Total Annual
Hours: 56,355. (For policy questions regarding this collection contact
Carla Patterson at 410-786-8911.)
5. Type of Information Collection Request: Reinstatement with
change of a previously approved collection; Title of Information
Collection: End Stage Renal Disease Medical Evidence Report Medicare
Entitlement and/or Patient Registration; Use: Section 226A (2) of the
Social Security Act specifically states that a person must be
``medically determined to have end stage renal disease. . . .''
Similarly, Section 188(a) of the law states ``The benefits provided by
parts A and B of this title shall include benefits for individuals who
have been determined to have end stage renal disease as provided in
Section 226A''. The End Stage Renal Disease (ESRD) Medical Evidence
(CMS-2728) is completed for all ESRD patients either by the first
treatment facility or by a Medicare-approved ESRD facility when it is
determined by a physician that the patient's condition has reached that
stage of renal impairment that a regular course of kidney dialysis or a
kidney transplant is necessary to maintain life.
The data reported on the CMS-2728 is used by the Federal
Government, ESRD Networks, treatment facilities, researchers and others
to monitor and assess the quality and type of care provided to end
stage renal disease beneficiaries. The data collection captures the
specific medical information required to determine the Medicare medical
eligibility of End Stage Renal Disease claimants. It also collects data
for research and policy on this population.
The three main data systems available for evaluating the ESRD
program and for monitoring epidemiology, access, and quality and
reimbursement effects on quality are: (1) The United States Renal Data
System (USRDS) provides basic data on patterns of incidence of ESRD in
the United States. The USRDS database is intended to be used for
biomedical research by investigators throughout the United States and
abroad. The USRDS data is intended to supplement (and not replace)
public use files produced by CMS. (2) United Network for Organ Sharing
(UNOS) focus is on organ donation, transplantation and educational
activities. (3) The ESRD Program Management and Medical System (PMMIS),
maintained by CMS, provide the foundation data for the USRDS. This
system, as required by Public Law 95-292, section C(1)(A), is designed
to serve the needs of the Department of Health and Human Services in
support of program analysis, policy development, and epidemiological
research.
The ESRD PMMIS includes information on both Medicare and non-
Medicare ESRD patients and on Medicare approved ESRD hospitals and
dialysis facilities. The methods of ESRD data collection (e.g., use of
same forms, sharing of analysis) by CMS, UNOS, and USRDS have all
agreed on a common data collection process that will provide needed
additional information on the ESRD population.
Subsequent to publishing the 60-day Federal Register notice on
December 15, 2022 (87 FR 76625), questions were added to the form and
other were clarified. Form Number: CMS-2728 (OMB control number: 0938-
0046); Frequency: Yearly; Affected Public: Private Sector (Business or
other for-profits, Not-for-Profit Institutions); Number of Respondents:
7,828; Total Annual Responses: 138,000; Total Annual Hours: 138,000.
(For policy questions regarding this collection contact Lisa Rees at
(816) 426-6353).
Dated: May 24, 2023.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2023-11403 Filed 5-26-23; 8:45 am]
BILLING CODE 4120-01-P