Notice for Public Comments on Potential Viral Hepatitis Quality Measures in Medicaid, 38905-38906 [2024-10006]
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Federal Register / Vol. 89, No. 90 / Wednesday, May 8, 2024 / Notices
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Dated: May 3, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–10053 Filed 5–7–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Notice for Public Comments on
Potential Viral Hepatitis Quality
Measures in Medicaid
Office of Infectious Disease and
HIV/AIDS Policy, Office of the Assistant
Secretary for Health, Office of the
Secretary, Department of Health and
Human Services.
ACTION: Notice for public comment.
AGENCY:
The Department of Health and
Human Services’ (HHS) Office of
Infectious Disease and HIV/AIDS Policy
(OIDP) in the Office of the Assistant
Secretary for Health (OASH) invites
public comment on potential viral
hepatitis quality measures for
implementation at the state and territory
level. In March 2024, OIDP hosted a
technical consultation meeting (https://
youtu.be/YCVC8GwFE7E) to initiate the
process of understanding the needs and
developing national consensus on
clinically meaningful and feasible viral
hepatitis quality measures for proposal
to the Medicaid Adult Core Set.
DATES: All comments must be received
by 5 p.m. ET on June 7, 2024 to be
considered.
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SUMMARY:
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All comments must be
submitted electronically to
OIDPViralHepatitis@hhs.gov to be
considered.
FOR FURTHER INFORMATION CONTACT:
Jessica Deerin, Ph.D., MPH, OIDP, Viral
Hepatitis Policy Advisor at
Jessica.Deerin@hhs.gov or 202–795–
7625.
SUPPLEMENTARY INFORMATION: CDC
released updated hepatitis C and
hepatitis B screening recommendations
to screen all adults aged 18 years and
older at least once in a lifetime and all
pregnant women during each pregnancy
in April 2020 and March 2023,
respectively. Screening is an important
first step in the viral hepatitis
continuum of care and a necessary tool
to reach viral hepatitis elimination by
2030.
Additionally, hepatitis C has a lifesaving treatment resulting in a cure in
>95% of patients. Yet, many patients are
not linked to care and complete
treatment. Less than 1 in 3 people with
health insurance initiated DAA
treatment within a year of hepatitis C
diagnosis and people with Medicaid
were less likely to initiate treatment
than those with private insurance.
Hepatitis B treatment can reduce
hepatitis B viral load, lowering the risk
of liver cancer and mortality.
Quality measures are tools to monitor
and improve the quality of health care.
Scaling up viral hepatitis screening,
linkage to care, and access to treatment
will ultimately reduce transmission,
incidence of new infections, prevent
liver cancer and mortality, and allow
the U.S. to make strides in reaching
viral hepatitis elimination by 2030.
There are currently no viral hepatitis
quality measures in the Medicaid Adult
Core Set. The Medicaid Adult Core Set
is a core set of health care quality
measures related to physical and
behavioral health for adult Medicaid
enrollees. The Adult Core Set
encourages standardized reporting by
States on a uniform set of measures to
drive quality improvement. Since
Medicaid provides coverage for a
disproportionate number of people with
hepatitis B and hepatitis C, OIDP is
leading an initiative to develop
consensus around clinically meaningful
and feasible state level viral hepatitis
quality measures to propose to the
Medicaid Adult Core Set.
OIDP hosted a Viral Hepatitis Quality
Measures Technical Consultation
Meeting on March 7, 2024. State
panelists from Medicaid and public
health departments shared their
experience in selection, testing, and
implementation of current state viral
ADDRESSES:
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38905
hepatitis quality measures, as well as
recommendations for measures to
propose to the Medicaid Adult Core Set.
State panelists reached consensus to
prioritize the development, use, and
adoption of a hepatitis C screening and
treatment initiation measure based on
the following rationale:
• Clinical and public health insights
are high, leading to an understanding of
the cascade of care for infected people
who access treatment and cure;
• The measure drives screening and
linkage to care by translating recently
updated CDC recommendations into
routine practice in the health care
delivery system;
• Data for a screening and treatment
initiation measure is available to state
Medicaid programs through
administrative claims and encounter
data, and is consistent and comparable
across states; and
• The method of using administrative
data sources to represent hepatitis C
treatment through pharmacy claims was
explained as an acceptable proxy for
receipt of treatment.
HHS hereby requests public comment
on the clinical significance, usability,
feasibility, and likely uptake of hepatitis
C screening and hepatitis C treatment
initiation quality measures, as well as
recommendations with adequate
justifications on other feasible viral
hepatitis measures to consider.
Information Needs
HHS is seeking responses with
adequate justification to the questions
listed below.
1. Are you in support of adopting a
hepatitis C screening and treatment
initiation measure within state
Medicaid programs?
a. If you represent a state Medicaid
program, what is the likely uptake of
this measure?
2. What other measures should HHS
consider for testing and proposal to the
Medicaid Adult Core Set (i.e., hepatitis
B screening, hepatitis B linkage to care,
hepatitis C sustained virological
response (SVR))? Please provide support
for how that measure is clinically
meaningful, feasible, and actionable for
state Medicaid programs. What data
source or data element can be utilized
to calculate the measure?
3. Would it be feasible and clinically
meaningful to implement a hepatitis B
screening, hepatitis C screening and
hepatitis C treatment initiation quality
measure within state Medicaid
programs? If you represent a state
Medicaid program, what is the likely
uptake of this measure?
E:\FR\FM\08MYN1.SGM
08MYN1
38906
Federal Register / Vol. 89, No. 90 / Wednesday, May 8, 2024 / Notices
Dated: May 2, 2024.
B. Kaye Hayes,
Deputy Assistant Secretary for Infectious
Disease, Department of Health and Human
Services.
[FR Doc. 2024–10006 Filed 5–7–24; 8:45 am]
BILLING CODE 4150–44–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Interagency Coordinating Committee
on the Validation of Alternative
Methods; Notice of Public Meeting;
Request for Public Input
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The Interagency Coordinating
Committee on the Validation of
Alternative Methods (ICCVAM) will
hold a public forum to share
information and facilitate direct
communication of ideas and suggestions
from stakeholders. Interested persons
may attend in person or view the
meeting remotely by webcast. Time will
be set aside for questions and public
statements on the topics discussed.
Registration is requested for attending in
person and required for viewing the
webcast. Registration is also required for
presenting oral statements, whether in
person or online. Information about the
meeting and registration are available at
https://ntp.niehs.nih.gov/go/
iccvamforum-2024.
DATES:
Meeting: May 20, 2024, 1 p.m. to
approximately 5 p.m. EDT; Tuesday,
May 21, 2024, 9 a.m. to approximately
4:30 p.m. EDT.
Registration for Onsite Meeting:
Deadline is May 17, 2024.
Registration for Webcast: Deadline is
May 21, 2024.
Registration for Oral Statements:
Deadline is May 15, 2024.
Registration to attend in person is
requested; registration to view the
webcast and to present oral public
statements (in person or online) is
required.
ADDRESSES:
Meeting Location: William H. Natcher
Conference Center, National Institutes of
Health (NIH), Bethesda, MD 20892.
Meeting web page: Registration and
other meeting materials are at https://
ntp.niehs.nih.gov/go/iccvamforum2024. A preliminary agenda will be
posted on this page by May 3.
FOR FURTHER INFORMATION CONTACT: Dr.
Nicole Kleinstreuer, Director, National
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SUMMARY:
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Toxicology Program Interagency Center
for the Evaluation of Alternative
Toxicological Methods (NICEATM),
email: nicole.kleinstreuer@nih.gov,
telephone: 984–287–3150.
SUPPLEMENTARY INFORMATION:
Background: ICCVAM, a
congressionally mandated committee,
coordinates the development and
validation of alternative testing
strategies that protect human health and
the environment while replacing,
reducing, or refining animal use.
ICCVAM’s goals include promotion of
national and international partnerships
between governmental and
nongovernmental groups, including
academia, industry, advocacy groups,
and other key stakeholders. To foster
these partnerships ICCVAM initiated
annual public forums in 2014 to share
information and facilitate direct
communication of ideas and suggestions
from stakeholders (79 FR 25136).
This year’s meeting will be held on
May 20 and 21, 2024. NICEATM and
ICCVAM members will give
presentations on current activities
related to the development and
validation of alternative test methods
and approaches.
There will be opportunities for
participants to ask clarifying or followup questions of the ICCVAM members
about their presentations. Instructions
for submitting these questions will be
provided to webcast viewers prior to the
event. The agenda will also include time
for public oral statements relevant to the
ICCVAM mission and current activities
from participants who have registered to
do so in advance.
Preliminary Agenda and Other
Meeting Information: A preliminary
agenda will be posted by May 3 at
https://ntp.niehs.nih.gov/go/
iccvamforum-2024. Interested
individuals are encouraged to visit this
web page to stay abreast of the most
current meeting information.
Meeting and Registration: This
meeting is open to the public. The
public may attend the meeting at NIH,
where attendance is limited only by the
space available, or view remotely by
webcast. Those planning to attend the
meeting in person are encouraged to
register at https://ntp.niehs.nih.gov/go/
iccvamforum-2024 by May 15, 2024, to
facilitate planning for appropriate
meeting space. Registration for the
webcast is required and is open through
4:30 p.m. EDT on May 21, 2024, at
https://ntp.niehs.nih.gov/go/
iccvamforum-2024. Registrants will
receive instructions on how to access
and participate in the webcast in the
email confirming their registration.
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NIH visitor and security information
is available at https://www.nih.gov/
about/visitor/index.htm. Individuals
with disabilities who need
accommodation to participate in this
event should contact Nicole
Kleinstreuer at phone: 919–407–1609 or
email: nicole.kleinstreuer@nih.gov. TTY
users should contact the Federal TTY
Relay Service at 800–877–8339.
Requests should be made at least five
business days in advance of the event.
Request for Oral Public Statements: In
addition to time for clarifying or followup questions following scheduled
presentations, time will be allotted
during the meeting for oral public
statements with associated slides on
topics relevant to ICCVAM’s mission.
Separate registration for those wishing
to provide public statements is required
and is open through May 15, 2024, at
https://ntp.niehs.nih.gov/go/
iccvamforum-2024. Any meeting
attendee or webcast viewer may ask
clarifying questions during the
appropriate times in the agenda. The
additional registration is only required
for those who wish to give separate
public statements. The number and
length of presentations may be limited
based on available time. Submitters will
be identified by their name and
affiliation and/or sponsoring
organization, if applicable. Participants
registered to present oral public
statements must email their statement to
ICCVAMquestions@niehs.nih.gov by
May 15, 2024, to allow time for review
by NICEATM and ICCVAM and posting
to the meeting page prior to the forum.
Persons submitting public statements
and/or associated slides should include
their name, affiliation (if any), mailing
address, telephone, email, and
sponsoring organization (if any) with
the document. Guidelines for public
statements are at https://
ntp.niehs.nih.gov/ntp/about_ntp/
guidelines_public_comments_508.pdf.
Persons presenting oral public
statements will be contacted to arrange
the logistics of their presentations.
Presenters should plan for their
presentation to run seven minutes or
less; each public statement presentation
will be followed by up to three minutes
to allow for clarifying or follow-up
questions. Time allotted for
presentations and follow-up questions
may be reduced depending on the time
available.
Written statements on topics relevant
to ICCVAM’s mission may be submitted
to support an oral public statement or as
standalone documents. These should be
emailed to ICCVAMquestions@
niehs.nih.gov by May 15, 2024. Public
statements received prior to the May 15
E:\FR\FM\08MYN1.SGM
08MYN1
]]>Agencies
[Federal Register Volume 89, Number 90 (Wednesday, May 8, 2024)]
[Notices]
[Pages 38905-38906]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-10006]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Notice for Public Comments on Potential Viral Hepatitis Quality
Measures in Medicaid
AGENCY: Office of Infectious Disease and HIV/AIDS Policy, Office of the
Assistant Secretary for Health, Office of the Secretary, Department of
Health and Human Services.
ACTION: Notice for public comment.
-----------------------------------------------------------------------
SUMMARY: The Department of Health and Human Services' (HHS) Office of
Infectious Disease and HIV/AIDS Policy (OIDP) in the Office of the
Assistant Secretary for Health (OASH) invites public comment on
potential viral hepatitis quality measures for implementation at the
state and territory level. In March 2024, OIDP hosted a technical
consultation meeting (https://youtu.be/YCVC8GwFE7E) to initiate the
process of understanding the needs and developing national consensus on
clinically meaningful and feasible viral hepatitis quality measures for
proposal to the Medicaid Adult Core Set.
DATES: All comments must be received by 5 p.m. ET on June 7, 2024 to be
considered.
ADDRESSES: All comments must be submitted electronically to
[email protected] to be considered.
FOR FURTHER INFORMATION CONTACT: Jessica Deerin, Ph.D., MPH, OIDP,
Viral Hepatitis Policy Advisor at [email protected] or 202-795-
7625.
SUPPLEMENTARY INFORMATION: CDC released updated hepatitis C and
hepatitis B screening recommendations to screen all adults aged 18
years and older at least once in a lifetime and all pregnant women
during each pregnancy in April 2020 and March 2023, respectively.
Screening is an important first step in the viral hepatitis continuum
of care and a necessary tool to reach viral hepatitis elimination by
2030.
Additionally, hepatitis C has a life-saving treatment resulting in
a cure in >95% of patients. Yet, many patients are not linked to care
and complete treatment. Less than 1 in 3 people with health insurance
initiated DAA treatment within a year of hepatitis C diagnosis and
people with Medicaid were less likely to initiate treatment than those
with private insurance. Hepatitis B treatment can reduce hepatitis B
viral load, lowering the risk of liver cancer and mortality.
Quality measures are tools to monitor and improve the quality of
health care. Scaling up viral hepatitis screening, linkage to care, and
access to treatment will ultimately reduce transmission, incidence of
new infections, prevent liver cancer and mortality, and allow the U.S.
to make strides in reaching viral hepatitis elimination by 2030.
There are currently no viral hepatitis quality measures in the
Medicaid Adult Core Set. The Medicaid Adult Core Set is a core set of
health care quality measures related to physical and behavioral health
for adult Medicaid enrollees. The Adult Core Set encourages
standardized reporting by States on a uniform set of measures to drive
quality improvement. Since Medicaid provides coverage for a
disproportionate number of people with hepatitis B and hepatitis C,
OIDP is leading an initiative to develop consensus around clinically
meaningful and feasible state level viral hepatitis quality measures to
propose to the Medicaid Adult Core Set.
OIDP hosted a Viral Hepatitis Quality Measures Technical
Consultation Meeting on March 7, 2024. State panelists from Medicaid
and public health departments shared their experience in selection,
testing, and implementation of current state viral hepatitis quality
measures, as well as recommendations for measures to propose to the
Medicaid Adult Core Set. State panelists reached consensus to
prioritize the development, use, and adoption of a hepatitis C
screening and treatment initiation measure based on the following
rationale:
Clinical and public health insights are high, leading to
an understanding of the cascade of care for infected people who access
treatment and cure;
The measure drives screening and linkage to care by
translating recently updated CDC recommendations into routine practice
in the health care delivery system;
Data for a screening and treatment initiation measure is
available to state Medicaid programs through administrative claims and
encounter data, and is consistent and comparable across states; and
The method of using administrative data sources to
represent hepatitis C treatment through pharmacy claims was explained
as an acceptable proxy for receipt of treatment.
HHS hereby requests public comment on the clinical significance,
usability, feasibility, and likely uptake of hepatitis C screening and
hepatitis C treatment initiation quality measures, as well as
recommendations with adequate justifications on other feasible viral
hepatitis measures to consider.
Information Needs
HHS is seeking responses with adequate justification to the
questions listed below.
1. Are you in support of adopting a hepatitis C screening and
treatment initiation measure within state Medicaid programs?
a. If you represent a state Medicaid program, what is the likely
uptake of this measure?
2. What other measures should HHS consider for testing and proposal
to the Medicaid Adult Core Set (i.e., hepatitis B screening, hepatitis
B linkage to care, hepatitis C sustained virological response (SVR))?
Please provide support for how that measure is clinically meaningful,
feasible, and actionable for state Medicaid programs. What data source
or data element can be utilized to calculate the measure?
3. Would it be feasible and clinically meaningful to implement a
hepatitis B screening, hepatitis C screening and hepatitis C treatment
initiation quality measure within state Medicaid programs? If you
represent a state Medicaid program, what is the likely uptake of this
measure?
[[Page 38906]]
Dated: May 2, 2024.
B. Kaye Hayes,
Deputy Assistant Secretary for Infectious Disease, Department of Health
and Human Services.
[FR Doc. 2024-10006 Filed 5-7-24; 8:45 am]
BILLING CODE 4150-44-P
