[Federal Register Volume 89, Number 4 (Friday, January 5, 2024)]
[Notices]
[Pages 789-791]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-00024]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Update to the Bright Futures Periodicity Schedule as Part of the
HRSA-Supported Preventive Services Guidelines for Infants, Children,
and Adolescents
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services.
ACTION: Notice.
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SUMMARY: A Federal Register notice published on October 24, 2023,
detailed and sought public comment on recommendations under development
by the Infant, Child, and Adolescent Preventive Services (ICAPS)
Program, regarding updates to the HRSA-supported preventive services
guidelines for infants, children, and adolescents in the Bright Futures
Periodicity Schedule footnotes. The proposed updates are related to six
existing footnotes. The ICAPS Program convenes health professionals to
develop draft recommendations for HRSA's consideration. Twenty-five
respondents provided comments which were received and considered as
detailed below. On December 29, 2023, HRSA accepted as final the ICAPS
Program's recommended update to the six footnotes. None of the footnote
updates change the HRSA-supported clinical recommendations and
therefore none of these updates make any changes to coverage without
cost-sharing, as each of the footnotes merely update references to the
supporting evidence base for existing recommendations or adds
additional descriptive text.
Please see https://mchb.hrsa.gov/programs-impact/bright-futures for
additional information.
FOR FURTHER INFORMATION CONTACT: Savannah Kidd, Sr. Public Health
Advisor, HRSA, Maternal and Child Health Bureau, telephone: (301) 287-
2601, email: [email protected].
SUPPLEMENTARY INFORMATION: Under the Patient Protection and Affordable
Care Act, Public Law 111-148, the preventive care and screenings set
forth in HRSA-supported guidelines are required to be covered without
cost-sharing by certain group health plans and health insurance
issuers. The Department adopted the Bright Futures Periodicity Schedule
as a HRSA-supported guideline for infants, children, and adolescents
under section 2713 of the Public Health Service Act. See 75 FR 41726,
41740 (July 19, 2010). The Bright Futures Periodicity Schedule is a
schedule of clinical recommendations for preventive screenings and
assessments at each well-child visit from infancy through adolescence.
To develop recommendations for HRSA's consideration, the ICAPS
Program, carried out by the American Academy of Pediatrics (AAP) under
a cooperative agreement with HRSA, convenes a panel of pediatric
primary care experts to conduct rigorous reviews of current scientific
evidence, solicit and consider public input, and make recommendations
to HRSA regarding screenings and assessments recommended at each well-
child visit from infancy through adolescence. HRSA then determines
whether to
[[Page 790]]
support, in whole or in part, the recommended updates. The schedule of
preventive care and screenings for infants, children, and adolescents
is detailed in the Bright Futures Periodicity Schedule. The ICAPS
Program also disseminates final HRSA-supported recommendations through
the annual publication of the updated Bright Futures Periodicity
Schedule, with associated resources for practitioners and families.
The ICAPS Program bases its recommended updates to the Guidelines
on review and synthesis of existing clinical guidelines and new
scientific evidence. Additionally, HRSA requires that the ICAPS Program
incorporate processes to assure opportunity for public comment in the
development of the updated Bright Futures Periodicity Schedule.
The ICAPS Program proposed and HRSA has accepted recommended
updates to footnotes to the Bright Futures Periodicity Schedule. None
of these footnote updates change the HRSA-supported clinical
recommendations and associated requirement for coverage without cost-
sharing, as each of the footnotes merely update references to the
supporting evidence base for these recommendations. The footnote
updates are as follows:
1. Footnote 4, relating to the 3-5 Day Visit, is being updated by
replacing the previous reference with a new reference that aligns with
the Bright Futures recommendation regarding providers helping families
that choose to breastfeed.
2. Footnote 5, relating to Body Mass Index, is being updated by
replacing the previous reference with an updated reference to the
Clinical Practice Guideline for the Evaluation and Treatment of
Children and Adolescents with Obesity (https://doi.org/10.1542/peds.2022-060640), published in the January 2023 issue of Pediatrics.
This updated footnote reference aligns with the Bright Futures
recommendation regarding measuring body mass index starting at the 24-
month visit through the 21-year visit and provides non-stigmatizing
recommendations for evaluating and treating children who are
experiencing weight gains.
The updated footnote now reads:
Screen per ``Clinical Practice Guideline for the Evaluation and
Treatment of Children and Adolescents with Obesity'' (https://doi.org/10.1542/peds.2022-060640).
3. Footnote 14, relating to Behavioral/Social/Emotional Screening,
is being updated by adding a reference to the U.S. Preventive Services
Task Force Recommendation Statement, Screening for Anxiety in Children
and Adolescents (https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/screening-anxiety-children-adolescents), published in
the October 2022 issue of the Journal of the American Medical
Association. This additional reference aligns with the Bright Futures
recommendation to use screening instruments to better identify children
experiencing anxiety, followed by a confirmatory diagnostic assessment
and follow-up.
The updated footnote now reads:
Screen for behavioral and social-emotional problems per ``Promoting
Optimal Development: Screening for Behavioral and Emotional Problems''
(https://doi.org/10.1542/peds.2014-3716), ``Mental Health Competencies
for Pediatric Practice'' (https://doi.org/10.1542/peds.2019-2757),
``Clinical Practice Guideline for the Assessment and Treatment of
Children and Adolescents With Anxiety Disorders'' (https://pubmed.ncbi.nlm.nih.gov/32439401), ``Screening for Anxiety in
Adolescent and Adult Women: A Recommendation From the Women's
Preventive Services Initiative'' (https://pubmed.ncbi.nlm.nih.gov/32510990), and ``Anxiety in Children and Adolescents: Screening''
(https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/screening-anxiety-children-adolescents). The screening should be family
centered and may include asking about caregiver emotional and mental
health concerns and social determinants of health, racism, poverty, and
relational health. See ``Poverty and Child Health in the United
States'' (https://doi.org/10.1542/peds.2016-0339), ''The Impact of
Racism on Child and Adolescent Health'' (https://doi.org/10.1542/peds.2019-1765), and ``Preventing Childhood Toxic Stress: Partnering
With Families and Communities to Promote Relational Health'' (https://doi.org/10.1542/peds.2021-052582).
4. Footnote 15, relating to Tobacco, Alcohol, or Drug Use
Assessment, is being updated by adding clarifying information about
providers' use of validated screening tools and recommending or
prescribing naloxone and by adding new references to the Centers for
Disease Control and Prevention's Evidence-Based Strategies for
Preventing Opioid Overdose: What's Working in the United States
(https://www.cdc.gov/drugoverdose/pdf/pubs/2018-evidence-based-strategies.pdf) and the National Institute on Drug Abuse's policy
brief, Naloxone for Opioid Overdose: Life-Saving Science (https://nida.nih.gov/publications/naloxone-opioid-overdose-life-saving-science). This updated footnote aligns with the Bright Futures
recommendation to assess patients for substance use with a validated
screening tool and describes the utility of providers recommending or
prescribing naloxone if there is concern for substance or opioid use.
The updated footnote now reads:
A recommended tool to assess use of alcohol, tobacco and nicotine,
and marijuana is available at http://crafft.org. In addition, CDC and
the National Institute of Drug Abuse (NIDA) recommend assessing
patients for opioid use using a validated screening tool and if
positive, providers should consider recommending or prescribing
naloxone (see https://www.cdc.gov/drugoverdose/pdf/pubs/2018-evidence-based-strategies.pdf and https://nida.nih.gov/publications/naloxone-opioid-overdose-life-saving-science).
5. Footnote 21, relating to Newborn Bilirubin Screening, is being
updated by replacing the previous reference with a new reference to
Management of Hyperbilirubinemia in the Newborn Infant 35 or More Weeks
of Gestation (https://doi.org/10.1542/peds.2022-058859), published in
the August 2022 issue of Pediatrics. This updated reference aligns with
the Bright Futures recommendation for universal bilirubin screening for
all newborn infants between 24 and 28 hours after birth.
The updated footnote now reads:
Confirm initial screening was accomplished, verify results, and
follow up, as appropriate.
See Clinical Practice Guideline Revision: ``Management of
Hyperbilirubinemia in the Newborn Infant 35 or More Weeks of
Gestation'' (https://doi.org/10.1542/peds.2022-058859).
6. Footnotes 35 and 36, relating to Oral Health, are being updated
by replacing the previous reference with a new reference to Maintaining
and Improving the Oral Health of Young Children (https://doi.org/10.1542/peds.2022-060417), published in the December 2022 issue of
Pediatrics. This reference aligns with the Bright Futures
recommendation that every child has a dental home by 1 year of age
(footnote 35). Additionally, the new reference encourages providers to
screen for social determinants of health, as well as access to medical
and dental care, as they influence oral health status and oral health
inequities (footnote 36). These footnotes refer to the same updated
reference.
The updated footnotes now read:
Assess whether the child has a dental home. If no dental home is
identified, perform a risk assessment (https://
[[Page 791]]
www.aap.org/en/patient-care/oral-health/oral-health-practice-tools/ and
refer to a dental home. Recommend brushing with fluoride toothpaste in
the proper dosage for age. See ``Maintaining and Improving the Oral
Health of Young Children'' (https://doi.org/10.1542/peds.2022-060417).
and
Perform a risk assessment (https://www.aap.org/en/patient-care/oral-health/oral-health-practice-tools/). See ``Maintaining and
Improving the Oral Health of Young Children'' (https://doi.org/10.1542/peds.2022-060417).
Discussion of Recommended Updated Guidelines
A Federal Register notice on October 24, 2023, sought public
comment on these proposed footnote updates (88 FR 73034).\1\ The ICAPS
Program considered all public comments as part of its deliberative
process and provided the comments to HRSA for its consideration. A
total of 25 respondents commented on one or more of the six proposed
footnote updates. From the 25 respondents, 119 responses were provided.
Of these, 107 responses (89 percent) expressed agreement and 13
responses (11 percent) provided other comments or concerns. HRSA
appreciates the comments in support of the updates. The additional
comments and responses are summarized below.
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\1\ See https://www.federalregister.gov/documents/2023/10/24/2023-23396/notice-of-request-for-public-comment-on-proposed-update-to-the-bright-futures-periodicity-schedule.
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1. Footnote 4, relating to the first week well-child visit, also
called the 3-5 Day Visit.
20 respondents responded to this proposed footnote update, and 19
indicated agreement. One respondent expressed concern that formal
breastfeeding evaluation is not possible in every situation and
suggested the proposed footnote include a qualified statement such as,
``if services are available.'' As this suggestion pertains to
implementation and not the updated reference, the proposed footnote
update will not be modified.
2. Footnote 5, relating to Body Mass Index.
18 respondents responded to this proposed footnote update, and 17
indicated agreement. One respondent expressed concern regarding the use
of BMI at the individual level to determine intervention for children.
This suggestion does not align with the recommendation in the clinical
practice guidelines, which is the updated reference within the proposed
footnote change. The proposed footnote update will not be modified.
3. Footnote 14, relating to Behavioral/Social/Emotional Screening.
20 respondents responded to this proposed footnote update, and 15
indicated agreement. One respondent comment did not specifically
address the proposed footnotes or the Bright Futures Periodicity
Schedule and is therefore beyond the scope of the proposed updates.
Three respondents expressed concerns related to implementation
resources. As these suggestions pertain to implementation and not the
additional reference that was added, the proposed footnote update will
not be modified. One respondent suggested including the screening for
anxiety in children under 8 years of age. This suggestion does not
align with the AAP clinical guidance or the updated USPSTF reference.
The footnote update will be finalized as proposed.
4. Footnote 15, relating to Tobacco, Alcohol, or Drug Use
Assessment.
20 respondents responded to this proposed footnote update and 17
indicated agreement. Of the three respondents expressing concern, one
respondent noted the need to ensure insurance companies do not violate
the adolescent's privacy to safely perform recommended preventive
services. This suggestion is beyond the scope of the proposed footnote
update and the proposed footnote update will not be modified. One
respondent expressed concern with overprescribing naloxone and the
potential to create drug shortage as well as suggesting the need for
oversight with how to administer. The AAP has not found evidence
supporting the concern of overprescribing in the pediatric primary care
setting. The footnote will be finalized as proposed. Another respondent
suggested removing ``prescribing'' from the proposed footnote since
naloxone is also available over the counter. This comment is reflected
in the updated footnote language stating that providers should consider
recommending or prescribing naloxone. The footnote will be finalized as
proposed.
5. Footnote 21, relating to Newborn Bilirubin Screening.
20 respondents responded to this proposed footnote update and 18
indicated agreement. Two respondents expressed concern about the
implementation of this screening due to the cost and time for the
primary care provider to obtain patient hospital records. As these
suggestions pertain to implementation and not the updated reference.
The proposed footnote update will not be modified.
6. Footnote 35 and 36, relating to Oral Health.
22 respondents responded to this proposed footnote update and 21
indicated agreement. One respondent suggested adding the American
Academy of Pediatric Dentistry (AAPD) recommendation that the first
oral exam occur by age 12 months and that the interval of exams be
based on the child's individual needs or risk status and susceptibility
to disease. The proposed footnote simply adds an updated reference to
the latest AAP clinical report, which recommends a dental visit for
children by 1 year of age. The proposed footnote update will not be
modified in response to this comment.
After consideration of public comment, the ICAPS Program submitted
recommended footnote updates to HRSA for consideration, as detailed
above. On December 29, 2023, the HRSA Administrator accepted the ICAPS
Program recommendations and, as such, updated the HRSA-supported
guidelines as set forth in the Bright Futures Periodicity Schedule.
While non-grandfathered group health plans and health insurance issuers
offering group or individual health insurance coverage must cover
without cost-sharing the services and screenings listed as the HRSA-
supported preventive services guidelines for infants, children, and
adolescents as indicated above, these updates to the Bright Futures
Periodicity Schedule footnotes do not change the clinical
recommendations or the requirements for coverage without cost-sharing
under section 2713 of the Public Health Service Act. Additional
information regarding the ICAPS Program can be accessed at the
following link: https://mchb.hrsa.gov/maternal-child-health-topics/child-health/bright-futures.html.
Authority: Section 2713(a)(4) of the Public Health Service Act, 42
U.S.C. 300gg-13(a)(4).
Carole Johnson,
Administrator.
[FR Doc. 2024-00024 Filed 1-4-24; 8:45 am]
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