[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: <a href="/cdn-cgi/l/email-protection#0a5941636e6e4a6278796b246d657c"><span class="__cf_email__" data-cfemail="c6958dafa2a286aeb4b5a7e8a1a9b0">[email protected]</span></a>.

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]
BILLING CODE 4165-15-P


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