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###### Department of Health and Human Services

###### Health Resources and Services Administration

# AGENCY:

Health Resources and Services Administration (HRSA), Department of Health and Human Services.

# ACTION:

Notice.

# 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:                         *SKidd@hrsa.gov.*

# 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                           ( print 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://      ( print 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.                

*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.

# Footnotes

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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