Inflation Reduction Act (IRA) Revised Program Guidance, 86904-86905 [2023-27551]
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86904
Federal Register / Vol. 88, No. 240 / Friday, December 15, 2023 / Notices
CureTB connects people with TB to
healthcare services as they move
between the United States and other
countries. The program is a
collaboration between CDC’s Division of
Global Migration Health (DGMH) and
the County of San Diego’s Tuberculosis
Control Program. CureTB collaborates
with health authorities throughout the
United States and around the world to
link people with TB to care at their
destinations. Health departments,
healthcare providers, and others seeking
help in linking patients to ongoing TB
care in other countries can refer patients
to CureTB. CureTB has an interagency
agreement with ICE (Immigration and
Custom Enforcement) to refer those
patients with suspected or confirmed
TB when they are repatriated to their
countries of origin.
CureTB collects the following types of
information: (1) referring entities
(referring agency and jurisdiction)
information including name of referring
person, telephone numbers, fax
numbers, email addresses; (2) patient’s
name and last name(s), demographics
date of birth, gender, address (U.S. and
outside of the U.S), telephone numbers,
email address, patient’s contact persons
including name and telephone number;
and (3) TB clinical information,
including diagnostic testing (radiology
reports, laboratory testing reports, other
diagnostic methods used, treatment
regimen and information about
comorbidities).
CDC is requesting OMB approval for
an additional three years. CDC requests
approval for an estimated 1,125 annual
burden hours. There is not cost to
respondents other than their time to
participate.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent
CureTB Transnational Notification ...........
CureTB Transnational Notification ...........
80
214
4
1
30/60
5/60
160
18
CureTB Transnational Notification ...........
CureTB Clinician Public Health Department Follow-up Script.
CureTB Contact/Source Investigation (CI/
CS) Notification.
CureTB Program Partner Satisfaction Assessment Questionnaire 1.
CureTB Program Partner Satisfaction Assessment Questionnaire 2.
587
870
1
3
45/60
10/60
440
435
20
5
30/60
50
100
1
10/60
17
50
1
6/60
5
...................................................................
....................
........................
....................
1,125
Form name
U.S. health departments ...........................
TB patients referred by U.S. health departments.
Tb patients referred by ICE ......................
TB treating physicians in new country ......
U.S. health departments ...........................
U.S. health departments ...........................
U.S. health departments ...........................
Total ...................................................
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Public Health Ethics and
Regulations, Office of Science, Centers for
Disease Control and Prevention.
[FR Doc. 2023–27549 Filed 12–14–23; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–1800–N2]
Inflation Reduction Act (IRA) Revised
Program Guidance
Centers for Medicare &
Medicaid Services, Health and Human
Services (HHS).
ACTION: Notice.
ddrumheller on DSK120RN23PROD with NOTICES1
AGENCY:
The Centers for Medicare &
Medicaid Services (CMS) is announcing
the availability of CMS’ revised
guidance for the Medicare Part B and
Part D Prescription Drug Inflation
Rebate Program for the implementation
of the Inflation Reduction Act. CMS will
be releasing additional Inflation
SUMMARY:
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17:57 Dec 14, 2023
Jkt 262001
Average
burden per
response
(in hours)
Number of
respondents
Type of respondents
Reduction Act-related guidance; all can
be viewed on the dedicated Inflation
Reduction Act section of the CMS
website.
FOR FURTHER INFORMATION CONTACT:
Inquiries related to the revised guidance
should be sent to IRARebateand
Negotiation@cms.hhs.gov with the
relevant subject line, ‘‘Medicare
Inflation Rebate Program Guidance.’’
SUPPLEMENTARY INFORMATION: The
Inflation Reduction Act was signed into
law on August 16, 2022. Section 11101
of the Inflation Reduction Act added a
new section 1847A(i) to the Social
Security Act (the Act), which
establishes a requirement for
manufacturers to pay Medicare Part B
rebates for single source drugs and
biological products with prices that
increase faster than the rate of inflation
for a calendar quarter to the Federal
Supplementary Medical Insurance Trust
Fund, and provides for lower Part B
beneficiary cost sharing on these drugs
and biologicals. Section 11102 of the
Inflation Reduction Act added a new
section 1860D–14B to the Act, which
establishes a requirement for
manufacturers to pay rebates to the
Federal Supplementary Medical
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Total
burden
hours
Insurance Trust Fund for certain Part D
drugs when prices increase faster than
the rate of inflation for each 12-month
applicable period. Collectively, this
program to implement these rebates is
referred to as the Medicare Prescription
Drug Inflation Rebate Program, or the
Inflation Rebate Program.
To obtain copies of the revised
guidance and the responses to
comments from the initial guidance, as
well as other Inflation Reduction Actrelated documents, please access the
CMS Inflation Reduction Act website by
copying and pasting the following web
address into your web browser: https://
www.cms.gov/inflation-reduction-actand-medicare. If interested in receiving
CMS Inflation Reduction Act updates by
email, individuals may sign up for CMS
Inflation Reduction Act’s email updates
at https://www.cms.gov/About-CMS/
Agency-Information/Aboutwebsite/
EmailUpdates.
The Administrator of the Centers for
Medicare & Medicaid Services (CMS),
Chiquita Brooks-LaSure, having
reviewed and approved this document,
authorizes Vanessa Garcia, who is the
Federal Register Liaison, to
electronically sign this document for
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15DEN1
Federal Register / Vol. 88, No. 240 / Friday, December 15, 2023 / Notices
purposes of publication in the Federal
Register.
Dated: December 12, 2023.
Vanessa Garcia,
Federal Register Liaison, Centers for Medicare
& Medicaid Services.
[FR Doc. 2023–27551 Filed 12–14–23; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifiers: CMS–304/–304a,
CMS–368/–R–144, and CMS–10249]
Agency Information Collection
Activities: Proposed Collection;
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
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
February 13, 2024.
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
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
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17:57 Dec 14, 2023
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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: ll, 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.
FOR FURTHER INFORMATION CONTACT:
William N. Parham at (410) 786–4669.
SUPPLEMENTARY INFORMATION:
Contents
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–304/–304a Reconciliation of
State Invoice (ROSI) (CMS–304) and
Prior Quarter Adjustment Statement
(PQAS) (CMS–304a)
CMS–368/–R–144 State Agency
Contact Form (CMS–368) and
Quarterly State Invoice (CMS–R–144)
CMS–10249 Administrative
Requirements for Section 6071 of the
Deficit Reduction Act
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.
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86905
Information Collection
1. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Reconciliation
of State Invoice (ROSI) and Prior
Quarter Adjustment Statement (PQAS);
Use: Form CMS–304 (ROSI) is used by
manufacturers to respond to the state’s
rebate invoice for current quarter
utilization. Form CMS–304a (PQAS) is
required only in those instances where
a change to the original rebate data
submittal is necessary. Form Number:
CMS–304 and –304a (OMB control
number: 0938–0676); Frequency:
Quarterly; Affected Public: Private
sector (business or other for-profits);
Number of Respondents: 749; Total
Annual Responses: 5,841; Total Annual
Hours: 248,584. (For policy questions
regarding this collection contact Robert
Giles at 667–290–8626.)
2. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Medicaid Drug
Rebate Program State Reporting Forms;
Use: Form CMS 368 is a report of
contact for the State to name the
individuals involved in the Medicaid
Drug Rebate Program (MDRP) and is
required only in those instances where
a change to the originally submitted
data is necessary. The ability to require
the reporting of any changes to these
data is necessary to the efficient
operation of these programs. Form
CMS–R–144 is required from States
quarterly to report utilization for any
drugs paid for during that quarter. Form
Number: CMS–368 and –R–144 (OMB
control number: 0938–0582); Frequency:
Quarterly and on occasion; Affected
Public: State, local, or Tribal
governments; Number of Respondents:
56; Total Annual Responses: 290; Total
Annual Hours: 13,669. (For policy
questions regarding this collection
contact Robert Giles at 667–290–8626.)
3. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Administrative
Requirements for Section 6071 of the
Deficit Reduction Act; Use: State
Operational Protocols should provide
enough information such that: the CMS
Project Officer and other Federal
officials may use it to understand the
operation of the demonstration, prepare
for potential site visits without needing
additional information, or both; the
State Project Director can use it as the
manual for program implementation;
and external stakeholders may use it to
understand the operation of the
demonstration. The financial
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]]>Agencies
[Federal Register Volume 88, Number 240 (Friday, December 15, 2023)]
[Notices]
[Pages 86904-86905]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-27551]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-1800-N2]
Inflation Reduction Act (IRA) Revised Program Guidance
AGENCY: Centers for Medicare & Medicaid Services, Health and Human
Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Centers for Medicare & Medicaid Services (CMS) is
announcing the availability of CMS' revised guidance for the Medicare
Part B and Part D Prescription Drug Inflation Rebate Program for the
implementation of the Inflation Reduction Act. CMS will be releasing
additional Inflation Reduction Act-related guidance; all can be viewed
on the dedicated Inflation Reduction Act section of the CMS website.
FOR FURTHER INFORMATION CONTACT: Inquiries related to the revised
guidance should be sent to [email protected] with
the relevant subject line, ``Medicare Inflation Rebate Program
Guidance.''
SUPPLEMENTARY INFORMATION: The Inflation Reduction Act was signed into
law on August 16, 2022. Section 11101 of the Inflation Reduction Act
added a new section 1847A(i) to the Social Security Act (the Act),
which establishes a requirement for manufacturers to pay Medicare Part
B rebates for single source drugs and biological products with prices
that increase faster than the rate of inflation for a calendar quarter
to the Federal Supplementary Medical Insurance Trust Fund, and provides
for lower Part B beneficiary cost sharing on these drugs and
biologicals. Section 11102 of the Inflation Reduction Act added a new
section 1860D-14B to the Act, which establishes a requirement for
manufacturers to pay rebates to the Federal Supplementary Medical
Insurance Trust Fund for certain Part D drugs when prices increase
faster than the rate of inflation for each 12-month applicable period.
Collectively, this program to implement these rebates is referred to as
the Medicare Prescription Drug Inflation Rebate Program, or the
Inflation Rebate Program.
To obtain copies of the revised guidance and the responses to
comments from the initial guidance, as well as other Inflation
Reduction Act-related documents, please access the CMS Inflation
Reduction Act website by copying and pasting the following web address
into your web browser: https://www.cms.gov/inflation-reduction-act-and-medicare. If interested in receiving CMS Inflation Reduction Act
updates by email, individuals may sign up for CMS Inflation Reduction
Act's email updates at https://www.cms.gov/About-CMS/Agency-Information/Aboutwebsite/EmailUpdates.
The Administrator of the Centers for Medicare & Medicaid Services
(CMS), Chiquita Brooks-LaSure, having reviewed and approved this
document, authorizes Vanessa Garcia, who is the Federal Register
Liaison, to electronically sign this document for
[[Page 86905]]
purposes of publication in the Federal Register.
Dated: December 12, 2023.
Vanessa Garcia,
Federal Register Liaison, Centers for Medicare & Medicaid Services.
[FR Doc. 2023-27551 Filed 12-14-23; 8:45 am]
BILLING CODE 4120-01-P
