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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 (HHS).

# ACTION:

Notice.

# SUMMARY:

This notice seeks comments on an updated draft recommendation for Well-Woman Preventive Visits, Counseling for Sexually Transmitted Infections, and Breastfeeding Services and Supplies, as part of the HRSA-supported Women's Preventive Services Guidelines. This updated draft recommendation has been developed through a national cooperative agreement, the Women's Preventive Services Initiative (WPSI), by the American College of Obstetricians and Gynecologists (ACOG). Under the Public Health Service Act, as added by the Patient Protection and Affordable Care Act, non-grandfathered group health plans and non-grandfathered group and individual health insurance issuers must include coverage, without cost sharing, for certain preventive services under that section, including those provided for in the HRSA-supported Women's Preventive Services Guidelines (Guidelines).

# DATES:

Members of the public are invited to provide written comments no later than September 20, 2021. All comments received on or before this date will be reviewed and considered by the WPSI Multidisciplinary Steering Committee.

# ADDRESSES:

                        Members of the public interested in providing comments on the draft recommendation statements can do so by accessing the initiative's web page at                         *https://www.womenspreventivehealth.org/​.*

# FOR FURTHER INFORMATION CONTACT:

                        Kimberly Sherman, HRSA, Maternal and Child Health Bureau, telephone (301) 443-8283, email:                         *wellwomancare@hrsa.gov.*

# SUPPLEMENTARY INFORMATION:

                    The HRSA-supported Women's Preventive Services Guidelines were originally established in 2011 based on a study and recommendations by the Institute of Medicine, now known as the National Academy of Medicine, commissioned by HHS. Since then, there have been advancements in science and gaps identified in these guidelines, including a greater emphasis on practice-based clinical considerations. In March 2016, HRSA awarded a 5-year cooperative agreement to convene a coalition representing clinicians, academics, and consumer-focused health professional organizations to conduct a rigorous review of current scientific evidence and recommend updates to existing guidelines. The ACOG was awarded the cooperative agreement and formed the WPSI, which consists of an Advisory Panel and two expert committees; the Multidisciplinary Steering Committee (MSC) and the Dissemination and Implementation Steering Committee, to improve adult women's health across the lifespan by engaging a coalition of health professional organizations to review evidence and recommend updates to the HRSA-supported Women's Preventive Services Guidelines. HRSA would then decide whether or not to support, in whole or                           ( print page 46857)                        in part, the recommended updates to the Guidelines.                

In March 2021, ACOG was awarded a subsequent cooperative agreement to further review and recommend updates to the Guidelines. As the award recipient, starting on March 1, 2021, ACOG has engaged in a process to consider and review new information developed by a multidisciplinary group of women's health professional organizations. Following recommendations by ACOG, HRSA will decide whether to support, in whole or in part, the recommended updates to the guidelines.

As part of this cooperative agreement, ACOG is required to base its recommended updates to the Guidelines on review and synthesis of existing clinical guidelines and new scientific evidence. The National Academy of Medicine standards for establishing foundations for and rating strengths of recommendations, articulation of recommendations, as well as external reviews are to be met in developing these guidelines. Additionally, processes are to be incorporated to assure opportunity for public input and transparency, including participation by patients and consumers, in the development of the updated Guideline recommendations.

This notice solicits comments from the public on the draft recommendation statements for the Well-Woman Preventive Visits, Counseling for Sexually Transmitted Infections, and Breastfeeding Services and Supplies. The updated draft clinical recommendation statements are provided below:

## Well Woman Preventive Visits

The MSC has updated the clinical recommendation statement to reflect that recommended services may be completed at a single visit or as part of a series of preventive health visits that take place over time to obtain the necessary services. Well Women Visits have also been further defined to include pre-pregnancy, prenatal, and interpregnancy visits.

“The 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. 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 include pre-pregnancy, prenatal, and interpregnancy visits. The primary purpose of well-woman visits is the delivery and coordination of all recommended preventive services as determined by age and risk factors.”

## Counseling for Sexually Transmitted Infections

The MSC has made minor updates to the counseling for sexually transmitted infections statement to include a review of a women's sexual history, and modified the risk factor list by stating that risk factors are “not limited to” the areas indicated.

“The WPSI recommends directed behavioral counseling by a health care provider or other appropriately trained individual for sexually active adolescent and adult women at an increased risk for sexually transmitted infections (STIs).

The WPSI recommends that health care providers review a woman's sexual history and risk factors to help identify those at an increased risk of 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 adolescents and women not identified as high risk, counseling to reduce the risk of STIs should be considered, as determined by clinical judgment.”

## Breastfeeding Services and Supplies

The MSC has updated the clinical recommendation to include consultative services that will optimize successful initiation and maintenance of breastfeeding.

“The WPSI recommends comprehensive lactation support services (including consultation, counseling, education, and breastfeeding equipment and supplies) during the antenatal, perinatal, and postpartum periods to optimize the successful initiation and maintenance of breastfeeding.”

                    Members of the public can view each complete updated draft recommendation statement by accessing the initiative's web page at                     *https://www.womenspreventivehealth.org/​.*

Diana Espinosa,

Acting Administrator.

[FR Doc. 2021-17826 Filed 8-19-21; 8:45 am]

BILLING CODE 4165-15-P