Federal Register / Vol. 87, No. 8 / Wednesday, January 12, 2022 / Notices 1763 

1See https://www.federalregister.gov/documents/ 

2021/09/13/2021-19630/opportunity-for-commentson-proposed-updates-to-the-bright-futuresperiodicity-schedule-as-part-of. 

group or individual health insurance 

coverage provide coverage without costsharing for certain preventive health 

services. Section 2713(a)(3) describes 

such services for infants, children, and 

adolescents as ‘‘evidence-informed 

preventive care and screenings provided 

for in the comprehensive guidelines 

supported by the Health Resources and 

Services Administration.’’ HHS, along 

with the Departments of Treasury and 

Labor, issued an Interim Final Rule on 

July 19, 2010 (75 FR 41726–41760) that 

identified two specific resources as the 

comprehensive guidelines supported by 

HRSA for infants, children, and 

adolescents to be covered by insurance 

without cost sharing by nongrandfathered group health plans and 

health insurance issuers: (1) The Bright 

Futures Periodicity Schedule and (2) the 

Recommended Uniform Screening Panel 

of the Advisory Committee on Heritable 

Disorders in Newborns and Children. 

The Interim Final Rule provided that a 

future change to these comprehensive 

guidelines is considered to be issued for 

purposes of Section 2713 on the date on 

which it is accepted by the HRSA 

Administrator or, if applicable, adopted 

by the Secretary of HHS. 

A public comment period was 

announced and occurred from 

September 13, 2021, through October 

13, 2021 (86 FR 50894, September 13, 

2021),1 to allow public comment on the 

proposed recommended updates 

affecting clinical practice and health 

insurance coverage requirements. A 

total of 27 respondents gave 57 

comments during the public comment 

period. The Bright Futures grantee, the 

American Academy of Pediatrics, 

received and considered the public 

comments. The annual report (Tab A) 

provides a description of the comments, 

including a detailed tabulation of each 

comment. 

On December 30, 2021, the HRSA 

Administrator accepted the American 

Academy of Pediatrics’ recommended 

several updates to the Bright Futures 

Periodicity Schedule. The Bright 

Futures recommendations included 

recommended clinical practice updates, 

along with revisions to the footnotes on 

the Bright Futures Periodicity Schedule 

that do not require changes to clinical 

practice or health insurance coverage. 

The updates to the Bright Futures 

Periodicity Schedule are: (1) A new 

category for sudden cardiac arrest and 

sudden cardiac death risk assessment, 

(2) a new category for hepatitis B virus 

infection risk assessment, (3) addition of 

suicide risk as an element of universal 

depression screening for children ages 

12–21, and (4) updated category title 

from ‘‘Psychosocial/Behavioral 

Assessment’’ to ‘‘Behavioral/Social/ 

Emotional Screening,’’ with no revision 

to the ages in which the screening 

occurs (newborn to 21 years). Finally, 

two clarifying references related to 

dental fluoride varnish and fluoride 

supplementation have been added with 

no associated recommended changes to 

clinical practice. In light of these 

updates, all 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 on the updated Bright 

Futures Periodicity Schedule for plan 

years (in the individual market, policy 

years) that begin in 2023, which can be 

accessed at the following link: https://

mchb.hrsa.gov/maternal-child-healthtopics/child-health/bright-futures.html. 

Diana Espinosa, 

Acting Administrator. 

[FR Doc. 2022–00461 Filed 1–11–22; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Update to the Women’s Preventive 

Services Guidelines 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: On December 30, 2021, HRSA 

approved updates to the HRSAsupported Women’s Preventive Services 

Guidelines (Guidelines) that address 

health needs specific to women. The 

Guidelines are based on clinical 

recommendations from the Women’s 

Preventive Services Initiative (WPSI), a 

coalition of experts and health 

professional organizations convened by 

the American College of Obstetricians 

and Gynecologist (ACOG) under a 

cooperative agreement awarded by 

HRSA. Under the Public Health Service 

Act and pertinent regulations, 

preventive care and screenings for 

women provided for in comprehensive 

guidelines supported by HRSA are 

required to be covered without cost 

sharing by group health plans and 

health insurance issuers offering nongrandfathered group or individual 

health insurance coverage. This 2021 

update adds one additional service, 

Preventing Obesity in Midlife Women, 

and revises five services: Breastfeeding 

Services and Supplies, Contraception, 

Screening for Human 

Immunodeficiency Virus Infection, 

Counseling for Sexually Transmitted 

Infections, and Well-Woman Preventive 

Visits. This notice serves as an 

announcement of the decision to update 

the Guidelines as further described 

below. Please see https://www.hrsa.gov/ 

womens-guidelines/index.html for 

additional information. 

FOR FURTHER INFORMATION CONTACT: 

Kimberly Sherman, HRSA, Maternal 

and Child Health Bureau, telephone 

(301) 443–8283, email: wellwomancare@

hrsa.gov. 

SUPPLEMENTARY INFORMATION: The 

updated 2021 HRSA-supported 

Women’s Preventive Services 

Guidelines, along with information 

related to their development and 

implementation, are available at https:// 

www.hrsa.gov/womens-guidelines/ 

index.html. A summary of information 

regarding the updates to the 

comprehensive guidelines supported by 

HRSA on December 30, 2021, is set out 

below. 

Women’s Preventive Services 

Guidelines 

The first HRSA-supported Guidelines, 

based on recommendations of the 

Institute of Medicine, were established 

in 2011. The Guidelines were 

subsequently updated following review 

and recommendations by the ACOG 

under the WPSI cooperative agreement, 

awarded by HRSA in 2016. The purpose 

of WPSI is to improve adult women’s 

health across the lifespan by engaging a 

coalition of experts and health 

professional organizations to 

recommend updates to the HRSAsupported Guidelines. Following such 

review and recommendations, HRSA 

decides whether or not to support, in 

whole or in part, the recommended 

updates to the Guidelines. In March 

2021, HRSA awarded a subsequent 

cooperative agreement to ACOG to 

provide recommendations as 

appropriate over a 5-year period to 

update the HRSA-supported Guidelines. 

Under the cooperative agreement, 

ACOG, through the WPSI, engages in a 

process to consider and review new and 

existing Guidelines developed by a 

multidisciplinary group of women’s 

health experts and professional 

organizations. 

Under section 2713 of the Public 

Health Service Act, 42 U.S.C. 300gg–13, 

group health plans and issuers of nongrandfathered group and individual 


lotter on DSK11XQN23PROD with NOTICES1
1764 Federal Register / Vol. 87, No. 8 / Wednesday, January 12, 2022 / Notices 

1This refers to FDA’s Birth Control Guide 

(https://www.fda.gov/media/150299/download) as 

posted on December 22, 2021 with the exception of 

sterilization surgery for men, which is beyond the 

scope of the WPSI. 

health insurance coverage are required 

to cover specified preventive services 

without a copayment, coinsurance, 

deductible, or other cost sharing, 

including preventive care and 

screenings for women as provided for in 

comprehensive guidelines supported by 

HRSA for this purpose. Private health 

insurance companies must provide this 

coverage without cost-sharing in plan 

years (in the individual market, policy 

years) beginning on or after the date that 

is one year after the date the 

recommendation or guideline is issued. 

A change to the Guidelines is 

considered to be issued on the date on 

which it is accepted by the HRSA 

Administrator. 

Summary of the 2021 Updates 

Recommended by WPSI and Approved 

by HRSA 

Breastfeeding Services and Supplies 

WPSI recommends comprehensive 

lactation support services (including 

consultation, counseling, education by 

clinicians and peer support services, 

and breastfeeding equipment and 

supplies) during the antenatal, 

perinatal, and postpartum periods to 

optimize the successful initiation and 

maintenance of breastfeeding. 

Breastfeeding equipment and supplies 

include, but are not limited to, double 

electric breast pumps (including pump 

parts and maintenance) and breast milk 

storage supplies. Access to double 

electric pumps should be a priority to 

optimize breastfeeding and should not 

be predicated on prior failure of a 

manual pump. Breastfeeding equipment 

may also include equipment and 

supplies as clinically indicated to 

support dyads with breastfeeding 

difficulties and those who need 

additional services. 

Contraception 

WPSI recommends that adolescent 

and adult women have access to the full 

range of contraceptives and 

contraceptive care to prevent 

unintended pregnancies and improve 

health outcomes. Contraceptive care 

includes screening, education, 

counseling, and provision of 

contraceptives (including in the 

immediate postpartum period). 

Contraceptive care also includes followup care (e.g., management, evaluation, 

and changes, including the removal, 

continuation, and discontinuation of 

contraceptives). 

WPSI recommends that the full range 

of U.S. Food and Drug Administration 

(FDA)-approved, -granted, or -cleared 

contraceptives, effective family 

planning practices, and sterilization 

procedures be available as part of 

contraceptive care. The full range of 

contraceptives currently includes those 

listed in the FDA’s Birth Control 

Guide: 1 (1) Sterilization surgery for 

women, (2) implantable rods, (3) copper 

intrauterine devices, (4) intrauterine 

devices with progestin (all durations 

and doses), (5) injectable contraceptives, 

(6) oral contraceptives (combined pill), 

(7) oral contraceptives (progestin only), 

(8) oral contraceptives (extended or 

continuous use), (9) the contraceptive 

patch, (10) vaginal contraceptive rings, 

(11) diaphragms, (12) contraceptive 

sponges, (13) cervical caps, (14) 

condoms, (15) spermicides, (16) 

emergency contraception 

(levonorgestrel), and (17) emergency 

contraception (ulipristal acetate); and 

any additional contraceptives approved, 

granted, or cleared by the FDA. 

Screening for HIV Infection 

WPSI recommends all adolescent and 

adult women, ages 15 and older, receive 

a screening test for human 

immunodeficiency virus (HIV) at least 

once during their lifetime. Earlier or 

additional screening should be based on 

risk, and rescreening annually or more 

often may be appropriate beginning at 

age 13 for adolescent and adult women 

with an increased risk of HIV infection. 

WPSI recommends risk assessment 

and prevention education for HIV 

infection beginning at age 13 and 

continuing as determined by risk. 

A screening test for HIV is 

recommended for all pregnant women 

upon initiation of prenatal care with 

rescreening during pregnancy based on 

risk factors. Rapid HIV testing is 

recommended for pregnant women who 

present in labor with an undocumented 

HIV status. 

Counseling for Sexually Transmitted 

Infections 

WPSI recommends behavioral 

counseling by a health care clinician or 

other appropriately trained individual 

for sexually active adolescent and adult 

women at an increased risk for sexually 

transmitted infections (STIs). 

WPSI recommends that clinicians 

review a woman’s sexual history and 

risk factors to identify those at increased 

risk for STIs. Risk factors include, but 

are not limited to, age younger than 25 

years, a recent history of an STI, a new 

sex partner, multiple partners, a partner 

with concurrent partners, a partner with 

an STI, and a lack of or inconsistent 

condom use. For those without 

identified risk factors, counseling to 

reduce the risk of STIs should be 

considered on an individual basis as 

determined by clinical judgment. 

Well-Woman Preventive Visits 

WPSI recommends that women 

receive at least one preventive care visit 

per year beginning in adolescence and 

continuing across the lifespan to ensure 

the provision of all recommended 

preventive services. The primary 

purpose of well-woman visits is the 

delivery and coordination of 

recommended preventive services as 

determined by age and risk factors. 

These services may be completed at a 

single visit or as part of a series of visits 

that take place over time to obtain all 

necessary services depending on a 

woman’s age, health status, 

reproductive health needs, pregnancy 

status, and risk factors. Well-women 

visits also include pre-pregnancy, 

prenatal, postpartum, and 

interpregnancy visits. 

Preventing Obesity in Midlife Women 

WPSI recommends counseling midlife 

women aged 40 to 60 years with normal 

or overweight body mass index (BMI) 

(18.5–29.9 kg/m2) to maintain weight or 

limit weight gain to prevent obesity. 

Counseling may include individualized 

discussion of healthy eating and 

physical activity. 

Diana Espinosa, 

Acting Administrator. 

[FR Doc. 2022–00465 Filed 1–11–22; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Indian Health Service 

Request for Public Comment: 30 Day 

Notice for Extension of Fast Track 

Generic Clearance for the Collection of 

Qualitative Feedback on Agency 

Service Delivery: IHS Customer 

Service Satisfaction and Similar 

Surveys 

AGENCY: Indian Health Service, HHS. 

ACTION: Notice and request for 

comments. Request for extension of 

approval. 

SUMMARY: In compliance with the 

Paperwork Reduction Act of 1995, the 

Indian Health Service (IHS) invites the 

general public to take this opportunity 

to comment on the information 

collection Office of Management and 

Budget (OMB) Control Number 0917– 

0036, ‘‘Generic Clearance for the 


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