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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.

      ( print page 84355)    

# SUMMARY:

This notice seeks comment on draft recommendations for the HRSA-supported Women's Preventive Services Guidelines (“Guidelines”) relating to Screening and Counseling for Intimate Partner and Domestic Violence, Breast Cancer Screening for Women at Average Risk, and Patient Navigation for Breast and Cervical Cancer Screening. These draft recommendations have been developed by the Women's Preventive Services Initiative (WPSI), through which clinicians, academics, and expert health professionals develop draft recommendations for HRSA's consideration. Under applicable law, non-grandfathered group health plans and health insurance issuers must include coverage, without cost sharing, for certain preventive services, including those provided for in the HRSA-supported Guidelines. The Departments of Labor, HHS, and Treasury have issued regulations and policy guidance which describe how group health plans and health insurance issuers apply the coverage requirements.

# DATES:

Members of the public are invited to provide written comments no later than November 21, 2024. All comments received on or before this date will be reviewed and considered by WPSI and provided for further consideration by HRSA in determining the recommended updates that it will support.

# ADDRESSES:

                        Members of the public who wish to provide comments can do so by accessing the public comment 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:

Under section 1001(5) of the Patient Protection and Affordable Care Act, Public Law 111-148, which added section 2713 to the Public Health Service Act, 42 U.S.C. 300gg-13, the preventive care and screenings set forth in the HRSA-Supported Women's Preventive Services Guidelines are required to be covered without cost-sharing by certain group health plans and health insurance issuers. HRSA established the Guidelines in 2011 based on expert recommendations by the Institute of Medicine, now known as the National Academy of Medicine.

Since 2016, HRSA has funded cooperative agreements to support WPSI to convene clinicians, academics, and consumer-focused health professional organizations to conduct a rigorous review of current scientific evidence, solicit and consider public input, and make recommendations to HRSA regarding updates to the Guidelines to improve women's health across the lifespan. HRSA determines whether to support, in whole or in part, the recommended updates to the Guidelines. WPSI consists of an Advisory Panel and two expert committees, the Multidisciplinary Steering Committee and the Dissemination and Implementation Steering Committee, which are comprised of a broad coalition of organizational representatives who are experts in disease prevention and women's health issues. With oversight by the Advisory Panel, and with input from the Multidisciplinary Steering Committee, WPSI examines the evidence to develop new (and update existing) recommendations for women's preventive services. WPSI's Dissemination and Implementation Steering Committee takes HRSA-approved recommendations and disseminates them through the development of implementation tools and resources for both patients and practitioners.

WPSI bases its recommended updates to the Guidelines on review and synthesis of existing clinical guidelines and new scientific evidence, following the National Academy of Medicine standards for establishing foundations for and rating strengths of recommendations, articulation of recommendations, and external reviews. Additionally, HRSA requires that WPSI incorporate processes to assure opportunity for public comment, including participation by patients and consumers, in the development of its recommendations to update the Guidelines. This notice seeks comment on three Guidelines:

## (1) Screening and Counseling for Intimate Partner and Domestic Violence

WPSI recommends updating the existing Guideline for Screening and Counseling for Interpersonal and Domestic Violence. The current Guideline for Screening and Counseling for Interpersonal and Domestic Violence is: “WPSI recommends screening adolescents and women for interpersonal and domestic violence, at least annually, and, when needed, providing, or referring for initial intervention services. Interpersonal and domestic violence includes physical violence, sexual violence, stalking and psychological aggression (including coercion), reproductive coercion, neglect, and the threat of violence, abuse, or both. Intervention services include, but are not limited to, counseling, education, harm reduction strategies, and referral to appropriate supportive services.”

The proposed updated Guideline for Screening and Counseling for Intimate Partner and Domestic Violence is: “The Women's Preventive Services Initiative recommends screening adolescent and adult women for intimate partner and domestic violence, at least annually, and, when needed, providing or referring to intervention services. Intimate partner and domestic violence includes physical violence, sexual violence, stalking and psychological aggression (including coercion), reproductive coercion, neglect, and the threat of violence, abuse, or both. Intervention services include, but are not limited to, counseling, education, harm reduction strategies, and appropriate supportive services.”

### Background

WPSI recommends several updates to the language of this Guideline. The first change is a revision to the title of the Guideline from “Interpersonal and Domestic Violence” to “Intimate Partner and Domestic Violence.” This change to the title was made to be consistent with language generally used in the clinical setting and the more commonly used term of “intimate partner violence” in the medical field. Corresponding revisions to change references from “interpersonal” to “intimate partner” have been made throughout the text of the recommendation. WPSI also recommends adding the word “adult” prior to “women” in the recommendation, to clarify that both adolescent and adult women are included in the screening and counseling guidance. The words “referral to” were removed from the last sentence to assist with clarity on the meaning of “intervention services.” Comments are sought on these proposed updates.

## (2) Breast Cancer Screening for Women at Average Risk

                    WPSI is recommending updating the existing Guideline for Breast Cancer Screening for Average-Risk Women. The current guideline for Breast Cancer Screening for Average-Risk Women is: “WPSI recommends that average-risk women initiate mammography screening no earlier than age 40 and no later than age 50. Screening mammography should occur at least biennially and as frequently as annually. Screening should continue through at least age 74 and age alone should not be the basis to discontinue screening.                          ( print page 84356)    

These screening recommendations are for women at average risk of breast cancer. Women at increased risk should also undergo periodic mammography screening, however, recommendations for additional services are beyond the scope of this recommendation.”

                    The proposed updated Guideline for Breast Cancer Screening for Women at Average Risk is: “The Women's Preventive Services Initiative recommends that women at average-risk of breast cancer initiate mammography screening no earlier than age 40 and no later than age 50. Screening mammography should occur at least biennially and as frequently as annually. Women may require additional imaging to complete the screening process or to address findings on the initial screening mammography. If additional imaging (                    *e.g.,*                     MRI, ultrasound, mammography) and pathology exams are indicated, those services are also recommended to complete the screening process for malignancies. Screening should continue through at least age 74 and age alone should not be the basis to discontinue screening.                

“Women at increased risk should also undergo periodic mammography screening, however, recommendations for additional services are beyond the scope of this recommendation.”

### Background

WPSI recommends several updates to the language of this Guideline. The first change is a revision to the title from “Breast Cancer Screening for Average-Risk Women” to “Breast Cancer Screening for Women at Average Risk.” This change to the title was made to be consistent with changes recommended for the first sentence of this Guideline and to use person-first language that puts the individual before the diagnosis or screening modality. WPSI recommends updates to the first sentence of this Guideline, replacing the phrase “average-risk women” with “women at average-risk for breast cancer” to clarify that the target population for this recommendation is specific to breast cancer.

                    Two new sentences were added to follow the first sentence: “Women may require additional imaging to complete the screening process or to address findings on the initial screening mammography. If additional imaging (                    *e.g.,*                     MRI, ultrasound, mammography) and pathology exams are indicated, those services are also recommended to complete the screening process for malignancies.” These modifications address the circumstances where initial mammography screening for women at average risk for breast cancer is incomplete or additional action is necessary to fully complete breast cancer screening for the individual. Specifically, these two sentences were added to ensure completed screening for women who were initially screened for breast cancer and need additional screening tests. Imaging in addition to initial screening mammography, such as special mammography views, ultrasound, or MRI, may be needed in individual clinical situations when clinicians require an enhanced view of breast tissue to differentiate normal from abnormal findings. A tissue biopsy may also need to be performed to determine whether abnormal findings are cancer, normal tissue, or other type of lesion. In an analysis of 405,191 women in the Breast Cancer Surveillance Consortium breast imaging registry who underwent digital mammography, 40,557 (10 percent) were recommended for additional imaging, and 6,628 (1.6 percent) were recommended for biopsy.[1] 

WPSI also has recommended removing the following sentence from the existing Guideline, “These screening recommendations are for women at average risk of breast cancer” as this information is now included in the revised first sentence of the updated Guideline. Comments are sought on these proposed updates.

## (3) Patient Navigation for Breast and Cervical Cancer Screening

                    WPSI is proposing a new Guideline for Patient Navigation for Breast and Cervical Cancer Screening, as follows: “The Women's Preventive Services Initiative (WPSI) recommends patient navigation services for breast and cervical cancer screening and follow-up, as relevant, to increase utilization of screening recommendations based on an assessment of the patient's need for navigation services. Patient navigation services involve person-to-person (                    *e.g.,*                     in-person, virtual, hybrid models) contact with the patient. Components of patient navigation services should be individualized.                

                    Services include, but are not limited to, person-centered assessment and planning, health care access and health system navigation, referrals to appropriate support services (                    *e.g.,*                     language translation, transportation, and social services), and patient education.”                

### Background

WPSI has submitted a new draft clinical recommendation on Patient Navigation for Breast and Cervical Cancer Screening for review, comment, and consideration. Recent clinical research has found consistent effectiveness of patient navigation services for breast and cervical cancer screening in reducing barriers to screening and follow-up care, resulting in higher screening rates. Breast cancer screening rates were 14.1% higher for 35,752 patients randomized to patient navigation services versus usual care or active controls in a WPSI meta-analysis of 33 randomized control trials based in U.S. health care settings. The same meta-analysis showed rates for cervical cancer screening and follow-up were higher with patient navigation by 15.7%, based on 22 randomized control trials with 12,221 participants.

                    Research suggests that patient navigation is effective across a wide range of health care settings and provider types. In one study included in WPSI's meta-analysis, prevention care managers working in federally qualified health centers (FQHCs) who employed patient navigation services increased breast cancer screening among patients without a mammogram in the past 18 months to 68% compared to 57% for patients in usual care.[2]                                          Another study included in the meta-analysis analyzed rural Latinas who had not previously undergone recommended screening. The study found that enhanced education efforts increased cervical cancer screening to 53.4% as compared to 34% in usual care without these navigation services.[3] 

                    Research also shows that reducing barriers to screening and follow-up care can result in earlier identification of breast and cervical cancer, enabling patients to enter into treatment earlier, preventing progression of these conditions, improving health outcomes and survival rates, and ultimately can reduce disparities in cancer morbidity and mortality. In the meta-analysis, patient navigation services increased screening and follow-up for breast cancer by 10.2% in populations described as low-income. Based on this                           ( print page 84357)                        clinical evidence that supports the preventive benefits of patient navigation services for breast and cervical cancer screening, WPSI recommends adding these patient navigation services to the Guidelines. Comments are sought on this proposed Guideline.                

                    Members of the public can view the complete updated and new draft clinical recommendations, as well as the implementation considerations and research recommendations (which are not part of the Guidelines), by accessing WPSI's web page at                     *https://www.womenspreventivehealth.org/​.*

Carole Johnson,

Administrator.

# Footnotes

1.                             Nelson HD, O'Meara ES, Kerlikowske K, Balch S, Miglioretti D. Factors Associated With Rates of False-Positive and False-Negative Results From Digital Mammography Screening: An Analysis of Registry Data. Ann Intern Med. 2016 Feb 16;164(4):226-35. doi: 10.7326/M15-0971. Epub 2016 Jan 12. PMID: 26756902; PMCID: PMC5091936.                    
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2.                             Beach ML, Flood AB, Robinson CM, et al. Can language-concordant prevention care managers improve cancer screening rates? Cancer Epidemiol Biomarkers Prev. 2007;16(10):2058-64. doi: 10.1158/1055-9965.EPI-07-0373. PMID: 17932353.                    
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3.                             Thompson B, Carosso EA, Jhingan E, et al. Results of a randomized controlled trial to increase cervical cancer screening among rural Latinas. Cancer. 2017;123(4):666-74. doi: 10.1002/cncr.30399. PMID: 27787893.                    
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[FR Doc. 2024-24445 Filed 10-21-24; 8:45 am]

BILLING CODE 4165-15-P