Agency Information Collection Activities: Submission for OMB Review; Comment Request, 12845-12846 [2024-03363]
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Federal Register / Vol. 89, No. 34 / Tuesday, February 20, 2024 / Notices
ddrumheller on DSK120RN23PROD with NOTICES1
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 currently approved
collection; Title of Information
Collection: Manufacturer Submission of
Average Sales Price (ASP) Data for
Medicare Part B Drugs and Biologicals;
Use: Section 1847A of the Act requires
that the Medicare Part B payment
amounts for covered drugs and
biologicals not paid on a cost or
prospective payment basis be based
upon manufacturers’ average sales price
data submitted quarterly to the Centers
for Medicare & Medicaid Services
(CMS). The reporting requirements are
specified in 42 CFR part 414 subpart J.
CMS, specifically, the Division of
Data Analysis and Market-based Pricing
(DDAMBP) will utilize the ASP data
(ASP and number of units sold as
specific in section 1847A of the Act) to
determine the Medicare Part B drug
payment amounts for CY 2005 and
beyond. The manufacturers submit their
ASP data for all of their National Drug
Codes (NDC) for Part B drugs. DDAMBP
compiles the data, analyzes the data and
runs the data through software to
calculate the volume-weighted ASP for
all of the NDCs that are grouped within
a given HCPCS code. The formula to
calculate the volume-weighted ASP is
the Sum (ASP * units) for all NDCs/Sum
(units * bill units per pkg) for all NDCs.
DDAMBP provides ASP payment
amounts for several components within
CMS that utilize 1847(A) payment
methodologies to implement various
payment policies including, but not
limited to, ESRD, OPPS, OTP and
payment models. CMS will also use
reported ASP and units to calculate
inflation adjusted coinsurance and
rebates. The Department of Health and
Human Services’ Office of the Inspector
General also uses the ASP data in
conducting studies. Form Number:
CMS–10110 (OMB Control Number:
0938–0921); Frequency: Quarterly;
Affected Public: Private and Business or
other for-profits; Number of
Respondents: 500; Number of
Responses: 2,00; Total Annual Hours:
VerDate Sep<11>2014
16:54 Feb 16, 2024
Jkt 262001
26,000. (For policy questions regarding
this collection contact Felicia Brown at
(410) 786–9287 or Felicia.brown@
cms.hhs.gov).
William N. Parham, III,
Director, Division of Information Collections
and Regulatory Impacts, Office of Strategic
Operations and Regulatory Affairs.
[FR Doc. 2024–03348 Filed 2–16–24; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10466]
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 March 21, 2024.
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
DATES:
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
12845
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 currently
approved collection; Title of
Information Collection: Patient
Protection and Affordable Care Act;
Exchange Functions: Eligibility for
Exemptions; Use: The data collection
and reporting requirements in ‘‘Patient
Protection and Affordable Care Act;
Exchange Functions: Eligibility for
Exemptions; Miscellaneous Minimum
Essential Coverage Provisions’’ (78 FR
39494 (July 1, 2013)), address Federal
requirements that states must meet with
regard to the Exchange minimum
function of performing eligibility
determinations and issuing certificates
of exemption from the shared
responsibility payment. In the final
regulation, CMS addresses standards
related to eligibility, including the
verification and eligibility
determination process, eligibility
redeterminations, options for states to
rely on HHS to make eligibility
determinations for certificates of
exemption, and reporting. CMS
developed four appendices of
E:\FR\FM\20FEN1.SGM
20FEN1
12846
Federal Register / Vol. 89, No. 34 / Tuesday, February 20, 2024 / Notices
application materials to illustrate the
process applicants use to apply for
exemptions from the shared
responsibility payment. This
information collection requests seeks
approval for the requirements associated
with the collection of information
associated with these four appendices.
No comments were received in response
to the 60-day comment period. Form
Number: CMS–10466 (OMB control
number 0938–1190); Frequency:
Annually; Affected Public: Individuals
and Households—State, Local, or Tribal
Governments; Number of Respondents:
849; Total Annual Responses: 849; Total
Annual Hours: 1,962. (For policy
questions regarding this collection
contact John Kenna at 301–492–4452.)
William N. Parham, III,
Director, Division of Information Collections
and Regulatory Impacts, Office of Strategic
Operations and Regulatory Affairs.
[FR Doc. 2024–03363 Filed 2–16–24; 8:45 am]
BILLING CODE 4120–01–P
[Document Identifier: CMS–10662 and CMS–
10219]
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
ddrumheller on DSK120RN23PROD with NOTICES1
16:54 Feb 16, 2024
Jkt 262001
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: Administrative
Simplification HIPAA Compliance
Review; Use: Section 1173 of the Social
Security Act (the Act), 42 U.S.C. 1320d–
2, and section 264 of HIPAA require the
Secretary to adopt a number of national
standards to facilitate the exchange of
certain health information and to
protect the privacy and security of such
information.
SUPPLEMENTARY INFORMATION:
Centers for Medicare & Medicaid
Services
VerDate Sep<11>2014
Comments on the collection(s) of
information must be received by the
OMB desk officer by March 21, 2024.
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:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
SUMMARY:
other forms of information technology to
minimize the information collection
burden.
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
The Secretary promulgated rules that
relate to compliance with, and
enforcement of, the HIPAA rules, which
are codified at 45 CFR part 160, subparts
C, D, and E and collectively referred to
as the Enforcement Rule. The Secretary
first issued an interim final rule
promulgating the procedural
requirements for imposition of civil
money penalties on violations of the
privacy standards on April 17, 2003,
Civil Money Penalties: Procedures for
Investigations, Imposition of Penalties
(68 FR 18896). The Secretary
subsequently proposed a rule on April
18, 2005, HIPAA Administrative
Simplification: Enforcement; Proposed
Rule (70 FR 20224), proposing the
amendment of 45 CFR part 160,
subparts A (General Provisions), C
(Compliance and Enforcement), and E
(Procedures for Hearing), and proposing
a new subpart D (Imposition of Civil
Money Penalties) that addressed the
substantive issues related to the
imposition of civil money penalties and
proposing the above provisions be
applied to all HIPAA rules.
The purpose of this collection is to
retrieve information necessary to
conduct a compliance review and carry
out the authority delegated to CMS as
described in CMS–0014–N (68 FR
60694). These forms will be submitted
to the Centers for Medicare & Medicaid
Services (CMS), National Standards
Group, from entities covered by HIPAA
Administrative Simplification
regulations. This collection is not
applicable to HIPAA Privacy and
Security Rules. Form Number: CMS–
10662 (OMB Control Number: 0938–
1390); Frequency: Weekly; Affected
Public: Private, State, Local, or Tribal
Governments, Federal Government,
Business or other for-profits, Not-forprofits institutions; Number of
Respondents: 50; Total Annual
Responses: 50; Total Annual Hours:
500. (For policy questions regarding this
collection contact Kevin Stewart at (410)
786–6149.)
2. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: HEDIS Data
Collection for Medicare Advantage; Use:
Sections 422.152 and 422.516 of title 42
of the Code of Federal Regulations (CFR)
specify that MAOs must submit quality
performance measures as specified by
the Secretary of the Department of
Health and Human Services and by
CMS. These quality performance
measures include HEDIS®. HEDIS®
data are used in the Medicare Part C
Star Ratings which are used to
determine Quality Bonus Payments to
Medicare Advantage contracts.
E:\FR\FM\20FEN1.SGM
20FEN1
]]>Agencies
[Federal Register Volume 89, Number 34 (Tuesday, February 20, 2024)]
[Notices]
[Pages 12845-12846]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-03363]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-10466]
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 March 21, 2024.
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: Patient
Protection and Affordable Care Act; Exchange Functions: Eligibility for
Exemptions; Use: The data collection and reporting requirements in
``Patient Protection and Affordable Care Act; Exchange Functions:
Eligibility for Exemptions; Miscellaneous Minimum Essential Coverage
Provisions'' (78 FR 39494 (July 1, 2013)), address Federal requirements
that states must meet with regard to the Exchange minimum function of
performing eligibility determinations and issuing certificates of
exemption from the shared responsibility payment. In the final
regulation, CMS addresses standards related to eligibility, including
the verification and eligibility determination process, eligibility
redeterminations, options for states to rely on HHS to make eligibility
determinations for certificates of exemption, and reporting. CMS
developed four appendices of
[[Page 12846]]
application materials to illustrate the process applicants use to apply
for exemptions from the shared responsibility payment. This information
collection requests seeks approval for the requirements associated with
the collection of information associated with these four appendices. No
comments were received in response to the 60-day comment period. Form
Number: CMS-10466 (OMB control number 0938-1190); Frequency: Annually;
Affected Public: Individuals and Households--State, Local, or Tribal
Governments; Number of Respondents: 849; Total Annual Responses: 849;
Total Annual Hours: 1,962. (For policy questions regarding this
collection contact John Kenna at 301-492-4452.)
William N. Parham, III,
Director, Division of Information Collections and Regulatory Impacts,
Office of Strategic Operations and Regulatory Affairs.
[FR Doc. 2024-03363 Filed 2-16-24; 8:45 am]
BILLING CODE 4120-01-P
